[Federal Register: November 13, 2000 (Volume 65, Number 219)]
[Rules and Regulations]
[Page 67797-67846]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no00-24]
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Part II
Department of Health and Human Services
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Health Care Financing Administration
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42 CFR Part 419
Medicare Program; Prospective Payment System for Hospital Outpatient
Services; Interim Final Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 419
[HCFA-1005-IFC]
RIN 0938-A156
Medicare Program; Prospective Payment System for Hospital
Outpatient Services
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Interim final rule with comment period.
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SUMMARY: This interim final rule with comment period provides for the
annual update to the Medicare hospital outpatient prospective payment
system conversion factor that is used to calculate the payment amount
for each payment group, effective January 1, 2001. It also updates the
wage index values and incorporates the year 2001 changes in the
procedure codes that are used to make payments under this system. In
this rule, we are also responding to public comments received on those
portions of the April 7, 2000 final rule with comment period (which
established the hospital outpatient prospective payment system) that
implemented related provisions of the Balanced Budget Refinement Act
(BBRA) of 1999. In addition, we are responding to public comments on
the August 3, 2000 interim final rule with comment period that modified
the April 7, 2000 final rule with comment period by revising the
criteria used to define new or innovative medical devices, drugs, and
biologicals eligible for transitional pass-through payments and
correcting the criteria for grandfathering provider-based Federally
Qualified Health Centers (FQHC) into the prospective payment system.
DATES:
Effective Date: These regulations are effective on January 1, 2001.
Comment Period: We will consider comments if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on January
12, 2001.
ADDRESSES: Mail written comments (1 original and 3 copies) to the
following address:
Health Care Financing Administration, Department of Health and Human
Services, Attention: HCFA-1005-IFC, P.O. Box 8013, Baltimore, MD 21244-
8013.
To ensure that mailed comments are received in time for us to
consider them, please allow for possible delays in delivering them.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses:
Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201, or
Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Comments mailed to the above addresses may be delayed and received
too late for us to consider them. Because of staff and resource
limitations, we cannot accept comments by facsimile (FAX) transmission.
In commenting, please refer to file code HCFA-1005-IFC. of the received
timely will be available for public inspection as they are received,
generally beginning approximately 3 weeks after publication of a
document, in Room 443-G of the Department's office at 200 Independence
Avenue, SW., Washington, DC, on Monday through Friday of each week from
8:30 to 5 p.m. (phone: (202) 690-7890).
FOR FURTHER INFORMATION CONTACT:
Janet Wellham (410) 786-4510, Chuck Braver, (410) 786-6719, or Jana
Petze (410) 786-9374, (for general information).
Kity Ahern, (410) 786-4515 (for information related to ambulatory
payment classification groups and transitional pass-through payments
related to drugs and biologicals).
Majorie Baldo, (410) 786-4617 or Barry Levi, (410) 786-4529 (for
information related to transitional pass-through payments for medical
devices).
George Morey (410) 786-4653 (for information related to the criteria
for grandfathering provider-based FQHCs into the prospective payment
system).
SUPPLEMENTARY INFORMATION:
Availability of Copies and Electronic Access
Copies: To order copies of the Federal Register containing this
document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose your Visa or Master Card
number and expiration date. Credit card orders can also be placed by
calling the order desk at (202) 512-1800 or by faxing to (202) 512-
2250. The cost for each copy is $8. As an alternative, you can view and
photocopy the Federal Register document at most libraries designated as
Federal Depository Libraries and at many other public and academic
libraries throughout the country that receive the Federal Register.
This Federal Register document is also available from the Federal
Register online database through GPO Access, a service of the U.S.
Government Printing Office. The Website address is
http://www.gpoaccess.gov/nara/index.html.
To assist readers in referencing sections contained in this
document, we are providing the following table of contents:
Table of Contents
I. Background
A. General Summary of April 7, 2000 Final Rule With Comment Period
that Implemented Amendments Enacted by the Balanced Budget Act of
1997 and the Balanced Budget Refinement Act of 1999
B. June 30, 2000 Notice of Delay of Effective Date for the April 7,
2000 Final Rule with Comment Period
C. August 3, 2000 Interim Final Rule with Comment Period
D. Summary of This Interim Final Rule with Comment Period
II. Analysis of, and Responses to, Public Comments on the BBRA 1999
Provisions and the August 3, 2000 Interim Final Rule with Comment
Period
A. April 7, 2000 BBRA 1999 Provisions
1. Outlier Adjustment
2. Transitional Pass-Through for Additional Costs of Innovative
Medical Devices, Drugs, and Biologicals
a. Definition of a device
b. Eligibility criteria
c. Investigational device exemption (IDE) device
d. Removing cost of predicate item
e. Excluded costs
f. Effect on conversion factor
g. Cost significance tests
h. Brand-specific versus categorization approaches
i. Issues pertaining to specific items
j. Pass-through applications process
k. Payment for pass-through items
l. Focus medical review
3. Budget Neutrality Applied to New Adjustments
4. Limitation on Judicial Review
5. Inclusion in the Hospital Outpatient Prospective Payment
System of Certain Implantable Items
6. Payment Weights Based on Median or Mean Hospital Costs
7. Limitation on Variation of Costs of Services Classified
Within a Group
8. Annual Review of the Components of the Hospital Outpatient
Prospective Payment System
9. Copayment Amounts Not Affected by Pass-Throughs
10. Extension of Cost Reductions
11. Clarification of Congressional Intent Regarding Base Amounts
Used in Determining the Hospital Outpatient Prospective Payment
System
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12. Transitional Corridors for Application of Outpatient
Prospective Payment System
a. Interim payment versus final settlement
b. Payment-to-cost ratios
c. Cost-to-charge ratios
d. Interim payments limited to 85 percent of the estimated
transitional corridor payment
e. Providers having more than one 1996 cost report
f. Providers having no 1996 cost report
g. Prospective payment system delay and transitional corridor
payments
h. Rural hold-harmless provision
i. Covered charges
j. Cancer hospitals and transitional corridor payments
k. Teaching hospitals and transitional corridor payments
13. Limitation on Coinsurance for a Procedure
14. Reclassification of Certain Hospitals
B. August 3, 2000 Interim Final Rule With Comment Period
1. Transitional Pass-Through Provisions
a. "Not insignificant" cost criteria
b. Definition of medical device
2. Revision to Grandfather Provision for Certain FQHCs and
"Look-Alikes"
3. Clarification of Notice of Beneficiary Cost-Sharing Liability
4. Clarification of Protocols for Off-Campus Departments
5. Typographical Errors in the Provider-Based Regulations
III. Provisions of This Interim Final Rule With Comment Period
A. Changes Relating to the BBRA 1999 Public Comments
B. Annual Updates to Components of the Hospital Outpatient
Prospective Payment System
1. APC Groups
a. New codes
b. Deleted codes
c. Revisions to correct errors or inconsistencies
d. Device-related codes
e. Inpatient codes moved to the outpatient setting
f. "Two-times" rule
g. Inpatient codes moved to outpatient and affected by device
h. Newly covered codes
i. Pass-through requests for drugs
2. Inpatient Procedures List Update
3. Wage Index Adjustment
4. Conversion Factor Update
IV. Waiver of Notice of Proposed Rulemaking
V. Collection of Information Requirements
VI. Regulatory Impact
A. General
B. Analysis for Changes in this Interim Final Rule with
Comment Period
C. Federalism
D. Executive Order 12866 and 5 U.S.C. 804(2) Regulation Text
Addenda
Note to the Addenda
Addendum A--List of Hospital Outpatient Ambulatory Payment
Classifications with Status Indicators, Relative Weights, Payment
Rates, and Coinsurance Amounts--Calendar Year 2001
Addendum B--Hospital Outpatient Department (HOPD) Payment Status by
HCPCS Code and Related Information--Calendar Year 2001
Addendum C--[Reserved]
Addendum D--Status Indicators: How Various Services Are Treated
under the Hospital Outpatient Prospective Payment System
Addendum E--CPT Codes Which Will Be Paid Only As Inpatient
Procedures--Calendar Year 2001
Addendum F--Wage Index for Urban Areas
Addendum G--Wage Index for Rural Areas
Addendum H--Wage Index for Hospitals That Are Reclassified
Alphabetical List of Acronyms Appearing in the Interim Final Rule With
Comment Period
APC Ambulatory payment classification
APG Ambulatory patient group
ASC Ambulatory surgical center
AWP Average wholesale price
BBA 1997 Balanced Budget Act of 1997
BBRA 1999 Balanced Budget Refinement Act of 1999
CAT Computerized axial tomography
CCI [HCFA's] Correct Coding Initiative
CCR Cost center specific cost-to-charge ratio
CMHC Community mental health center
CORF Comprehensive outpatient rehabilitation facility
CPI Consumer Price Index
CPT [Physicians'] Current Procedural Terminology, 4th Edition,
2000, copyrighted by the American Medical Association
DME Durable medical equipment
DMEPOS DME, prosthetics (which include prosthetic devices and
implants) orthotics, and supplies
DRG Diagnosis-related group
FDA Food and Drug Administration
FQHC Federally qualified health center
HCPCS HCFA Common Procedure Coding System
HHA Home health agency
ICD-9-CM International Classification of Diseases, Ninth Edition,
Clinical Modification
IME Indirect medical education
JCAHO Joint Commission on Accreditation of Healthcare Organizations
MRI Magnetic resonance imaging
MSA Metropolitan statistical area
NECMA New England County Metropolitan Area
PPS Prospective payment system
RFA Regulatory Flexibility Act
RHC Rural health clinic
RRC Rural referral center
SCH Sole community hospital
SNF Skilled nursing facility
I. Background
A. General Summary of April 7, 2000 Final Rule With Comment Period That
Implemented Amendments Enacted by the Balanced Budget Act of 1997 and
the Balanced Budget Refinement Act of 1999
On April 7, 2000, we published in the Federal Register (65 FR
18434) a final rule with comment period to implement a new prospective
payment system for hospital outpatient services. This new system
establishes prospective payment rates for covered outpatient hospital
services using ambulatory payment classification (APC) groups. The
April 7, 2000 final rule with comment period implemented section 4523
of the Balanced Budget Act of 1997 (the BBA 1997), Public Law 105-33,
and related sections of the Balanced Budget Refinement Act of 1999 (the
BBRA 1999), Public Law 106-113. Section 4523 of the BBA 1997 amended
section 1833 of the Social Security Act (the Act) by adding subsection
(t) to provide for implementation of a prospective payment system for
hospital outpatient services furnished to Medicare beneficiaries.
Section 1833(t) of the Act, as added by the BBA 1997--
Authorizes the Secretary to designate the hospital
outpatient services that would be paid under the prospective payment
system and requires that the hospital outpatient prospective payment
system include hospital inpatient services designated by the Secretary
that are covered under Medicare Part B for beneficiaries who are
entitled to Part A benefits but who have exhausted them or are
otherwise entitled to them.
Sets forth certain requirements for the hospital
outpatient prospective payment system, including the requirement that a
classification system for covered outpatient services be developed that
may consist of groups arranged so that the services within each group
are comparable clinically and with respect to the use of resources.
Specifies data requirements for establishing relative
payment weights. The weights are to be based on the median hospital
costs determined by 1996 claims data and data from the most recent
available cost reports. (This provision has subsequently been changed
by the BBRA 1999, as discussed later in this preamble.)
Requires that the portion of the Medicare payment and the
beneficiary coinsurance that are attributable to labor and labor-
related costs be adjusted for geographic wage differences in a budget
neutral manner.
Authorizes the Secretary under section 1833(t)(2)(E) of
the Act to establish, in a budget neutral manner, other adjustments,
such as outlier adjustments or adjustments for certain classes of
hospitals, that the Secretary determines to be necessary to ensure
equitable payments.
Requires the Secretary to develop a method for controlling
unnecessary
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increases in the volume of covered outpatient services.
Specifies how beneficiary deductibles are to be treated
when calculating the Medicare payment and beneficiary coinsurance
amounts and requires that rules be established regarding determination
of coinsurance amounts for covered services that were not furnished in
1996. The statute freezes beneficiary coinsurance at 20 percent of the
national median charges for covered services (or a group of covered
services) furnished during 1996 and updated to 1999 using the
Secretary's estimated charge growth from 1996 to 1999.
Prescribes the formula for calculating the initial
conversion factor used to determine 1999 Medicare payment amounts and
the method for updating the conversion factor in subsequent years.
Describes the method for determining the Medicare payment
amount and the beneficiary coinsurance amount for services covered
under the outpatient prospective payment system. (This section was
amended by the BBRA 1999, as discussed later in this preamble.)
Requires the Secretary to establish a procedure whereby
hospitals may voluntarily elect to reduce beneficiary copayment for
some or all covered services to an amount no less than 20 percent of
the Medicare payment amount. Hospitals are further allowed to
disseminate information on any such reductions of copayment amounts.
Section 4451 of the BBA 1997 added section 1861(v)(1)(T) to the Act,
which provides that any reduction in copayment, must not be treated as
a bad debt.
Authorizes periodic review and revision of the payment
groups, relative payment weights, wage index, and conversion factor.
(This section was amended by the BBRA 1999, as discussed later in this
preamble.)
Describes how payment is to be made for ambulance
services, which are specifically excluded from the hospital outpatient
prospective payment system under section 1833(t)(1)(B) of the Act.
Provides that the Secretary may establish a separate
conversion factor for services furnished by cancer hospitals that are
excluded from the hospital inpatient prospective payment system.
Prohibits administrative or judicial review of the
hospital outpatient prospective payment system classification system,
the payment groups, relative payment weights, wage adjustment factors,
other adjustments, calculation of base amounts, periodic adjustments,
and the establishment of a separate conversion factor for those cancer
hospitals excluded from hospital inpatient prospective payment system.
(This section was expanded by the BBRA 1999, as discussed later in this
preamble.)
Section 4523(d) of the BBA 1997 made a conforming amendment to
section 1833(a)(2)(B) of the Act to provide for payment under the
hospital outpatient prospective payment system for some services
described in section 1832(a)(2) of the Act that are currently paid on a
cost basis and furnished by providers of services, such as
comprehensive outpatient rehabilitation facilities (CORFs), home health
agencies (HHAs), hospices, and community mental health centers (CMHCs).
This amendment provides that partial hospitalization services furnished
by CMHCs be paid under the hospital outpatient prospective payment
system.
Before enactment of section 4521(b) of the BBA 1997, the blended
payment formulas for ambulatory surgery centers (ASC) procedures,
radiology, and other diagnostic services, the ASC or physician fee
schedule portion were calculated as if the beneficiary paid 20 percent
of the ASC rate or physician fee schedule amount instead of the actual
amount paid, which was 20 percent of the hospital's billed charges.
Section 4521(b) of the BBA 1997, which amended sections
1833(i)(3)(B)(i)(II) and 1833(n)(1)(B)(i) of the Act, corrected this
anomaly by changing the blended calculations so that all amounts paid
by the beneficiary are subtracted from the total payment in the
calculation to determine the amount due from the program. Effective for
services furnished on or after October 1, 1997, payment for ASC
surgery, radiology, and other diagnostic services calculated by blended
payment methods is now calculated by subtracting the full amount of
coinsurance due from the beneficiary (based on 20 percent of the
hospital's billed charges).
Section 1861(v)(1)(S)(ii) of the Act was amended by section 4522 of
the BBA 1997 to require that the amounts otherwise payable for hospital
outpatient operating costs and capital costs be reduced by 5.8 percent
and 10 percent, respectively, through December 31, 1999. (This section
was further amended by the BBRA 1999.)
(Refer to the April 7, 2000 hospital outpatient prospective payment
system final rule with comment period for a more in-depth description
of how the changes made by the BBA 1997 and the BBRA 1999 were
implemented.)
On November 29, 1999, after we had published a proposed rule to
implement section 4253 of the BBA 1997, the BBRA 1999 was enacted. The
BBRA 1999 made major changes that affected the hospital outpatient
prospective payment system that was established by the BBA 1997 and
implemented in the April 7, 2000 final rule with comment period.
Therefore, in the April 7, 2000 final rule with comment period, we also
implemented 14 provisions of the BBRA 1999 that affected the hospital
outpatient prospective payment system and solicited public comments on
those provisions. The BBRA 1999 provisions on which we solicited
comments included the following:
1. Outlier Adjustment
Section 201(a) of the BBRA 1999 amended section 1833(t) of the Act
by adding a new paragraph (5) to provide that the Secretary must make
payment adjustments (that is, an outlier payment) for covered services
whose costs exceed a threshold determined by the Secretary. This
section describes how the additional payments are to be calculated and
caps the projected outlier payments at no more than 2.5 percent of the
total projected payments (sum of both Medicare and beneficiary payments
to the hospital) made under the hospital outpatient prospective payment
system for years before 2004 and 3.0 percent of the total projected
payments for 2004 and subsequent years.
2. Transitional Pass-Through for Additional Costs of Innovative Medical
Devices, Drugs, and Biologicals
Section 201(b) of the BBRA 1999 added new section 1833(t)(6) to the
Act, establishing transitional pass-through payments for certain
medical devices, drugs, and biologicals. This provision specifies the
types of items for which additional payments must be made; describes
the amount of the additional payments; limits these payments to at
least 2, but not more than 3 years; and caps the projected payment
adjustments annually at 2.5 percent of the total projected payments for
hospital outpatient services each year before 2004 and no more than 2.0
percent in subsequent years. Under this provision, the Secretary must
reduce pro rata the amount of the additional payments if, before the
beginning of a year, he or she estimates that these payments would
otherwise exceed the caps.
3. Budget Neutrality Applied to New Adjustments
Section 201(c) of the BBRA 1999 amended section 1833(t)(2)(E) of
the Act to require that the establishment of outlier and transitional
pass-through payment adjustments be made in a budget neutral manner.
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4. Limitation on Judicial Review
Section 201(d) of the BBRA 1999 amended redesignated section
1833(t)(11) of the Act by extending the prohibition of administrative
or judicial review to include the factors for determining outlier
payments (that is, the fixed multiple, or a fixed dollar cutoff amount,
the marginal cost of care, or applicable total payment percentage), and
the determination of additional payments for certain medical devices,
drugs, and biologicals, the insignificant cost determination for these
items, the duration of the additional payment or portion of the
prospective payment system payment amount associated with particular
devices, drugs, or biologicals, and any pro rata reduction.
5. Inclusion in the Hospital Outpatient Prospective Payment System of
Certain Implantable Items
Section 201(e) of the BBRA 1999 amended section 1833(t)(1)(B) of
the Act to include as covered hospital outpatient services implantable
prosthetics, durable medical equipment (DME), diagnostic x-ray,
laboratory, and other tests associated with those implantable items.
6. Payment Weights Based on Median or Mean Hospital Costs
Section 201(f) of the BBRA 1999 amended section 1833(t)(2)(C) of
the Act, which specifies data requirements for establishing relative
payment weights, to allow the Secretary the discretion to base the
weights on either the median or mean hospital costs determined by data
from the most recent available cost reports.
7. Limitation on Variation of Costs of Services Classified Within a
Group
Section 201(g) of the BBRA 1999 amended section 1833(t)(2) of the
Act to limit the variation of costs of services within each payment
classification group by providing that the highest median cost (or mean
cost, if elected by the Secretary) for an item or service within the
group cannot be more than 2 times greater than the lowest median (or
mean) cost for an item or service within the group. The provision
allows the Secretary to make exceptions in unusual cases, such as for
low volume items and services.
8. Annual Review of the Hospital Outpatient Prospective Payment System
Components
Section 201(h) of the BBRA 1999 amended redesignated section
1833(t)(8) of the Act to require at least an annual review of the
payment groups, relative payment weights, and the wage and other
adjustments made by the Secretary to take into account changes in
medical practice, the addition of new services, new cost data, and
other relevant information and factors. Section 201(h)(2) provides that
the first annual review must be conducted in 2001 for application in
2002. The section was further amended to require the Secretary to
consult with an expert outside advisory panel composed of an
appropriate selection of provider representatives who will review the
clinical integrity of the groups and weights and advise the Secretary
accordingly. The panel may use data other than those collected or
developed by the Department of Health and Human Services (HHS) for
review and advisory purposes.
9. Coinsurance Not Affected by Pass-Throughs
Section 201(i) of the BBRA 1999 amended redesignated section
1833(t)(7) of the Act to provide that the beneficiary coinsurance
amount will be calculated as if the outlier and transitional pass-
throughs had not occurred; that is, there will be no additional
coinsurance collected from beneficiaries for the additional payments
made to hospitals by Medicare for these adjustments.
10. Extension of Cost Reductions
Section 201(k) of the BBRA 1999 amended section 1861(v)(1)(S)(ii)
of the Act to extend, until the first date that the hospital outpatient
prospective payment system is implemented, the 5.8 and 10 percent
reductions for hospital operating and capital costs, respectively.
11. Clarification of Congressional Intent Regarding Base Amounts Used
in Determining the Hospital Outpatient Prospective Payment System
Section 201(l) of the BBRA 1999 provided that, "With respect to
determining the amount of copayments described in paragraph (3)(A)(ii)
of section 1833(t) of the Social Security Act, as added by section
4523(a) of BBA, Congress finds that such amount should be determined
without regard to such section, in a budget neutral manner with respect
to aggregate payments to hospitals, and that the Secretary of Health
and Human Services has the authority to determine such amount without
regard to such section."
12. Transitional Corridors for Application of Outpatient Prospective
Payment System
Section 202 of the BBRA 1999 amended section 1833(t) of the Act by
redesignating paragraphs (7) through (11) as paragraphs (8) through
(12), respectively, and adding a new paragraph (7), which provides for
a transitional adjustment to limit payment reductions under the
hospital outpatient prospective payment system. More specifically, from
the date the prospective payment system is implemented through 2003, a
provider, including a CMHC, will receive an adjustment if its
prospective payment system payments for outpatient services furnished
during the year is less than a set percentage of its "pre-BBA" amount
for that year. The pre-BBA amount is the product of the reasonable
costs the hospital incurs for prospective payment system services
during the year and the payment-to-cost ratio for covered prospective
payment system services furnished during the cost report period ending
during 1996. Two categories of hospitals, rural hospitals with 100 or
fewer beds and cancer hospitals, will be held harmless under this
provision. Small rural hospitals will be held harmless for services
furnished before January 1, 2004. The hold-harmless provision applies
permanently to cancer centers. Section 202 also requires the Secretary
to make interim payments to affected hospitals subject to retrospective
adjustments and requires that the provisions of this section do not
affect beneficiary coinsurance. Finally, this provision is not subject
to budget neutrality.
13. Limitation on Coinsurance for a Procedure
Section 204 of the BBRA 1999 amended redesignated section
1833(t)(8) of the Act to provide that the copayment amount for a
procedure performed in a year cannot exceed the hospital inpatient
deductible for that year.
14. Reclassification of Certain Hospitals
Section 401 of the BBRA 1999 added section 1886(d)(8)(E) to the Act
to permit reclassification of certain urban hospitals as rural
hospitals for purposes of section 1886(d) of the Act. Section 401 added
section 1833(t)(13) to the Act to provide that a hospital being treated
as a rural hospital under section 1886(d)(8)(E) is also to be treated
as a rural hospital under the hospital outpatient prospective payment
system.
A discussion of how each of these BBRA 1999 provisions was
implemented in the April 7, 2000 final rule with comment period appears
in section II of this preamble preceding our summary of the public
comments received and our responses to those comments.
[[Page 67802]]
B. June 30, 2000 Notice of Delay of Effective Date for the April 7,
2000 Final Rule With Comment Period
On June 30, 2000, we published a notice in the Federal Register (65
FR 40535) announcing a delay in the effective date of the April 7, 2000
hospital outpatient prospective payment system final rule with comment
period from July 1, 2000 to August 1, 2000. This delay was based on our
determination that the appropriate claims processing changes could not
feasibly be made to our computer systems and properly tested in time to
ensure that proper payments would be made for Medicare hospital
outpatient services under the new prospective payment system by the
original July 1, 2000 effective date.
C. August 3, 2000 Interim Final Rule With Comment Period
On August 3, 2000, we published an interim final rule with comment
period in the Federal Register (65 FR 47670) that changed one criterion
and postponed the effective date for two other criteria that a new
device, drug, or biological must meet in order for its cost to be
considered "not insignificant" for purposes of determining its
eligibility for transitional pass-through payments from the hospital
outpatient prospective payment system. It also changed the transitional
pass-through payment policy to include new single use medical devices
that come in contact with human tissue and are surgically implanted or
inserted into patients, whether or not the devices remain with the
patients following their release. These policies were a departure from
those presented in the April 7, 2000 final rule with comment period.
The August 3, 2000 rule also corrected a trigger date for
grandfathering of provider-based FQHCs to conform with the intent not
to disrupt existing FQHCs with longstanding provider-based treatment
that we discussed in the April 7, 2000 rule. Under the criteria in the
April 7, 2000 final rule with comment period, FQHCs would have been
treated as departments of a provider without regard to the criteria for
provider-based status if they continued to qualify as FQHCs and were
designated as FQHCs before 1995. In accordance with the August 3, 2000
interim final rule with comment period and this interim final rule with
comment period, facilities that continue to qualify as FQHCs and were
designated as FQHCs or "look-alikes" on or before April 7, 2000 would
continue to be treated as provider-based facilities. In addition, we
clarified how the requirement for prior notices to beneficiaries is to
be applied in emergency situations. We also clarified the protocols for
off-campus departments in emergency situations.
D. Summary of This Interim Final Rule With Comment Period
In section II of this preamble, we--
Respond to public comments received timely on the 14 BBRA
1999 provisions that were included in the April 7, 2000 final rule with
comment period. (We received numerous public comments on other aspects
of the April 7, 2000 final rule with comment period that were not open
for comment. We will not address those comments in this rule.)
Respond to public comments on the August 3, 2000 interim
final rule with comment period that revised the criteria for defining
new or innovative medical devices, drugs, and biologicals eligible for
pass-through payments and corrected the criteria for the grandfathering
provision for certain FQHCs as provider-based.
In section III of this preamble, we are updating, for services
furnished during calendar year 2001, the wage index values and the
conversion factor, and revising the APCs to reflect new codes for 2001
effective January 1, 2001. As required under section 1833(t)(8)(A) of
the Act, in 2001, we will begin our annual review process of the APC
groups, relative weights, and the wage and other adjustments for the
prospective payment systems payments that will become effective on
January 1, 2002. The statute requires the Secretary to consult with an
expert outside advisory panel composed of an appropriate selection of
representatives of providers to review (and advise the Secretary
concerning) the clinical integrity of the groups and weights. This
provision allows these experts to use data other than those collected
or developed by us during our review of the APC groups and weights.
II. Analysis of, and Responses to, Public Comments on the BBRA 1999
Provisions and the August 3, 2000 Interim Final Rule With Comment
Period
We received a total of 747 pieces of timely correspondence
containing public comments on the April 7, 2000 final rule with comment
period. In addition to receiving comments from various organizations
throughout the hospital industry, we also received comments from
beneficiaries and their families, physicians, health care workers,
individual hospitals, professional associations and societies, legal
and nonlegal representatives and spokespersons for beneficiaries and
hospitals, members of the Congress, and other interested citizens. The
majority of the comments addressed the BBRA 1999 provisions relating to
the limitation on variation of costs of services classified within a
group, the transitional pass-through provision for devices, drugs, and
biologicals, and the inclusion of implantable items.
We received 13 comments in response to the August 3, 2000 interim
final rule with comment period. These comments were submitted by major
associations, drug and device manufacturers, providers, a private
citizen, and a law firm. More than half of the comments addressed
issues for which we did not solicit comments in the August 3, 2000
interim final rule with comment period. Those comments specifically
addressed payment policy and typographical errors present in the April
7, 2000 final rule with comment period. The remaining commenters
addressed the revisions to the criteria to define new or innovative
medical devices, drugs, and biologicals eligible for pass-through
payments and corrections to the criteria for the grandfathering
provision for certain FQHCs. These commenters took issue with some of
the provisions and raised additional concerns regarding our actions. A
summary of the public comments and our responses to them appears
following the discussion of the April 7, 2000 final rule with comment
period.
We have carefully reviewed and considered all comments received
timely. The modifications that we are making in response to commenters'
suggestions and recommendations are summarized in section III.A of this
preamble and, as appropriate, reflected in the regulation text.
A. April 7, 2000 BBRA 1999 Provisions
Below we discuss the implementation of the BBRA 1999 provisions
addressed in the April 7, 2000 final rule with comment period and
modified in the August 3, 2000 interim final rule with comment period,
the public comments received on each provision, and our response to
those comments.
1. Outlier Adjustment
Section 1833(t)(5) of the Act, as added by section 201(a) of the
BBRA 1999, required that the Secretary make an additional payment (that
is, an outlier adjustment) for outpatient services for which a
hospital's charges, adjusted to cost, exceed a fixed multiple of the
sum of the outpatient prospective payment system payment and the
transitional pass-through payments. The Secretary is
[[Page 67803]]
authorized to determine the amount of this fixed multiple and the
percent of costs above the threshold that is to be paid under this
outlier provision. Under the statute, projected outlier payments may
not exceed an "applicable percentage" of projected total program
payments. The applicable percentage means a percentage specified by the
Secretary (projected percentage of outlier payments relative to total
payments), subject to the following limits: For years before 2004, the
projected percentage that the Secretary specifies cannot exceed 2.5
percent; for 2004 and later, the projected percentage cannot exceed 3.0
percent. Section 1833(t)(2)(E) of the Act requires that these payments
be budget neutral.
Section 1833(t)(5)(D) of the Act grants the Secretary authority
until 2002 to identify outliers on a bill basis rather than on a
specific service basis and to use an overall hospital cost-to-charge
ratio (CCR) to calculate costs on the bill rather than using
department-specific CCRs for each hospital.
In the April 7, 2000 final rule with comment period, in accordance
with the statute, we presented how the additional outlier payments are
to be calculated.
To set the threshold or fixed multiple and the payment percentage
of costs above that multiple for which an outlier payment would be
made, we first had to determine what specified percentage of total
program payment, up to 2.5 percent, we should select. We decided to set
the outlier target at 2.0 percent. In order to set the fixed multiple
outlier threshold and payment percentage, we simulated the prospective
payment system payments. We calibrated the threshold and the payment
percentage applying an iterative process so that the simulated outlier
payments were 2.5 percent of simulated total payments. For purposes of
the simulation, we set a "target" of 2.5 percent (rather than 2.0
percent), because we believed that a given set of numerical criteria
would result in a higher percentage of outlier payments under the
simulation using 1996 data than under the prospective payment system.
This is because we believe that the 1996 data reflects undercoding of
services, which means simulated total payments would likely be
understated and, in turn, the percentage of outlier payments would be
overstated. In addition, we were not able to fully estimate the amount
and distribution of pass-through payments using the 1996 data. Our
inability to make these estimates further understated the total
payments under the simulation. We believe that a set of numerical
criteria that results in simulated outlier payments of 2.5 percent
using the 1996 data would result in outlier payments of 2.0 percent
under the prospective payment system. The difference arises from the
effect of undercoding in the historical data and the payment of pass-
throughs under prospective payment system. We set the outlier threshold
at 2.5 times the prospective payment system payments.
Comment: Several commenters asked us to clarify how series bills
for services such as chemotherapy that are billed monthly for multiple
sessions are treated in determining outlier payments. They also asked
that we clarify how bills for multiple clinic visits on the same day
are treated in calculating the outlier payment.
Response: In accordance with section 1833(t)(5)(D) of the Act,
until 2002, outliers will be determined on a bill basis rather than on
a specific service basis. Therefore, the charges (converted to costs)
associated with all services under the hospital outpatient prospective
payment system reported on series bills or all payable multiple clinic
visits billed on a single claim would be used to determine whether the
outlier threshold is exceeded and to calculate the outlier payment.
Comment: One commenter suggested that we prospectively adjust the
conversion factor if we determine that the actual outlier expenditures
are less than estimated in a given year.
Response: Consistent with our outlier policies in other prospective
payment systems, we will not adjust the conversion factor for a given
year to account for an underestimation (or overestimation) of outlier
payments in a previous year. The statute does not provide for such an
adjustment to the conversion factor. We set outlier policies
prospectively, using the best available data. Outlier payments, like
many aspects of a prospective payment system, reflect estimates, and we
believe it would be inappropriate to adjust the conversion factor
(upward or downward) for a given year simply because an estimate for a
previous year ultimately turned out to be inaccurate. If we
underestimate or overestimate the percentage of outlier payments, the
divergence of our estimate from actual experience might provide
information that might help us improve estimates in the future, but it
would have no direct effect on the conversion factor for any following
year.
Comment: One commenter urged us to provide additional information
about the cost-to-charge ratios that will be used to determine whether
a claim exceeds the outlier threshold for payment. The commenter stated
that the preamble language on page 18498 of our April 7, 2000 final
rule with comment period conflicts with statements contained in Program
Memorandum Transmittal No. A-00-23 regarding which cost-to-charge ratio
would be used to determine whether a claim meets the outlier threshold
requirements for payment. According to the commenter, we stated in the
final rule with comment period that we will use a hospital's overall
cost-to-charge ratio to make this determination, but stated in the
program memorandum that we will use an outpatient cost-to-charge ratio.
The commenter asked us to clarify the conflicting statements.
Response: On September 8, 2000, we issued Program Memorandum
Transmittal No. A-00-63, titled "Cost-to-Charge Ratios (CCRs) for
Calculating Certain Payments Under the Hospital Outpatient Prospective
Payment System" which describes how we calculated the cost-to-charge
ratios that are used to determine payments for outliers, interim
transitional corridors, and device pass-throughs for calendar year
2000. That program memorandum defined the cost-to-charge ratio that is
used to calculate these payments as the overall hospital outpatient
cost-to-charge ratio. This is consistent with what we stated in our
April 7, 2000 final rule with comment period. The September program
memorandum contains the latest and most complete information available
on cost-to-charge ratio calculation for the hospital outpatient
prospective payment system.
Comment: One commenter assumed that we will use department level
cost-to-charge ratios after 2002 to determine if a particular
outpatient service qualifies for outlier payment. The commenter asked
if we will use a "national cost-to-charge mapping procedure" to
determine the appropriate department cost-to-charge ratios to use. The
commenter expressed concern about the appropriateness of that approach
because of the variability among providers in assigning costs to
departments. For this reason, the commenter recommended, if we use a
national cost-to-charge mapping procedure, we permit providers to
request outlier payments if they can demonstrate that the actual
department cost-to-charge ratio to which they assign costs for a
service results in a cost calculation that meets the outlier threshold.
Response: We plan to address this issue and seek comments on it in
the rulemaking process for the annual update for 2002.
Comment: One commenter urged us to publish annually the "cost
reporting
[[Page 67804]]
year" used to determine the cost-to-charge ratios that will be used in
determining outlier payments. The commenter also asked that we explain
how we computed cost-to-charge ratios for hospitals that have merged or
been acquired.
Response: On September 8, 2000, we issued Program Memorandum
Transmittal No. A-00-63 that describes the specific criteria we used
and provides detailed instructions for calculating the cost-to-charge
ratios for hospitals that have merged or been acquired. It also
identifies the specific cost reporting year end that was used to
calculate each provider's cost-to-charge ratio.
Comment: One commenter asked that we lower the outlier threshold
from 2.5 to 2.0. The commenter strongly recommended that we permanently
retain the lowered threshold to ensure appropriate patient care and
adequate provider reimbursement.
Response: We oppose lowering the outlier threshold to 2.0. As
discussed in our April 7, 2000 final rule with comment period, we set
the outlier threshold at 2.5 by simulating total prospective payment
system payments (using 1996 hospital outpatient data) and using an
iterative process to calculate a threshold under which outlier payments
are projected to equal 2.0 percent of total payments. If we lowered the
threshold as the commenter suggests, then the projected percentage of
outlier payments would increase and we would have to reduce the
conversion factor correspondingly (thus reducing the payment for all
non-outlier cases.)
2. Transitional Pass-Through for Additional Costs of Innovative Medical
Devices, Drugs, and Biologicals
Section 1833(t)(6) of the Act, as added by section 201(b) of the
BBRA 1999, requires the Secretary to make additional payments to
hospitals, outside the hospital outpatient prospective payment system
for a period of 2 to 3 years for specific items. The items designated
by the law are the following: Current orphan drugs, as designated under
section 526 of the Federal Food, Drug, and Cosmetic Act; current drugs,
biologic agents, and brachytherapy devices used for treatment of
cancer; current radiopharmaceutical drugs and biological products; and
new medical devices, drugs, and biologic agents, in instances where the
item was not being paid as a hospital outpatient service as of December
31, 1996, and where the cost of the item is "not insignificant" in
relation to the hospital outpatient prospective payment system payment
amount. In this context, "current" refers to those items for which
hospital outpatient payment is being made on the first date the new
prospective payment system is implemented.
Section 1833(t)(6)(C)(i) of the Act sets the additional payment
amounts for the drugs and biologicals as the amount by which the amount
determined under section 1842(o) of the Act (95 percent of the average
wholesale price (AWP)) exceeds the portion of the otherwise applicable
hospital outpatient department fee schedule amount that the Secretary
determines to be associated with the drug or biological. Section
1833(t)(6)(C)(ii) of the Act provides that the additional payment for
medical devices be the amount by which the hospital's charges for the
device, adjusted to cost, exceed the portion of the otherwise
applicable hospital outpatient department fee schedule amount
determined by the Secretary to be associated with the device. Under
section 1833(t)(6)(D), the total amount of pass-through payments for a
given year cannot be projected to exceed an "applicable percentage"
of total payments. For a year (or a portion of a year) before 2004, the
applicable percentage is 2.5 percent; for 2004 and subsequent years,
the applicable percentage is 2.0 percent. If the Secretary estimates
that total pass-through payments would exceed the caps, the statute
requires the Secretary to reduce the additional payments uniformly to
ensure the ceiling is not exceeded.
These pass-through payments must be made in a budget neutral
manner. In addition, these additional payments do not affect the
computation of the beneficiary coinsurance amount.
In the April 7, 2000 final rule with comment period, we specified
the types of items for which additional payments would be made;
described the amount of the additional payments; announced that these
payments would be limited to at least 2 years but not more than 3
years; and announced a cap of the projected payment adjustments
annually at 2.5 percent of the total projected payments for hospital
outpatient services each year before 2004 and no more than 2.0 percent
in subsequent years.
a. Definition of a Device
Comment: Some commenters argued that we have adopted a very narrow
definition of a device that restricts pass-through payments to
prosthetic devices and excludes valuable new nonprosthetics from pass-
through consideration. They asserted that the definition of a device
should mirror the definition set forth in the Federal Food, Drug, and
Cosmetic Act. They agreed that such a definition should exclude capital
equipment, reusable items, and incidental supplies. However, they
argued that we should clarify and revise our definition of devices to
those that are "implanted or inserted" and "remain with the patient
after the patient is released from the hospital outpatient
department."
Response: The definition of a device under the Food, Drug, and
Cosmetic Act is extremely broad. In summary, it refers to a device as
an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any
component, part, or accessory, which is--
Recognized in the official national formulary, or the U.S.
Pharmacopeia, or any supplement to them;
Intended for the use of the diagnosis of conditions other
than diseases such as pregnancy;
Intended to affect the structure or any function of the
body of man or other animals; or
Considered an in vitro diagnostic product, including those
previously regulated as drugs, and which does not achieve any of its
principal intended purposes through chemical action within or on the
body of man or other animals and which is not dependent upon being
metabolized for the achievement of any of its principal intended
purposes.
This definition is inappropriate for use in the context of the
transitional pass-through payments for several reasons: It would
include (as the commenters noted) items that are treated as supplies,
reusable items, or capital equipment by Medicare payment systems,
including the outpatient prospective payment system. It has a number of
inappropriate elements, including reference to pharmaceuticals and to
use in animals. Further, it is insufficiently specific for Medicare
purposes, as it does not mention medical necessity or the test of
whether the cost of a device is "not insignificant" relative to the
associated APC.
We have instead provided a definition of a device specific to the
purposes of the transitional pass-through provision. This definition
was presented in the preamble to the April 7, 2000 final rule with
comment period and revised in the August 3, 2000 interim final rule
with comment period, which added Sec. 413.43(e)(4).
In the August 3, 2000 interim final rule with comment period, we
revised the criteria that we had set forth in the
[[Page 67805]]
April 7, 2000 final rule with comment period to define a device. Among
the changes included is a revision of the criterion relating to whether
a device must remain with the patient. The new criterion
(Sec. 419.43(e)(4)(iv)) includes devices that are surgically implanted
or inserted in a patient "whether or not they remain with the patient
when the patient is released from the hospital outpatient department."
This change allows pass-through payments for devices that are
surgically implanted or inserted even temporarily in a patient
providing the devices meet all other requirements for pass-through
payments. As a result, nonprosthetic devices, such as cardiac
catheters, guidewires, or stents that commenters noted would be
excluded, may be eligible for pass-through status.
In Sec. 419.43(e)(4)(iv), we have retained the limitation to
devices that are surgically implanted or inserted because we believe
this offers the best interpretation of section 201(e) of the BBRA 1999,
which indicates that implantable devices are to be included in the
APCs. To further clarify how we interpret Sec. 419.43(e)(4)(iv), we
consider that a device is surgically implanted or inserted if it is
introduced into the human body through a surgically created incision.
We do not consider an item used to cut or otherwise create a surgical
opening to be a device that is surgically implanted or inserted. We
consider items used to create incisions, such as scalpels,
electrocautery units, biopsy apparatuses, or other commonly used
operating room instruments, to be supplies or capital equipment, and
hence, in accordance with Sec. 419.43(e)(4)(vi) or (vii), we consider
these items not eligible for transitional pass-through payments. We
believe the function of these items is different and distinct from that
of devices that are used for surgical implantation or insertion.
Generally, we would expect that surgical implantation or insertion of a
device occurs after the surgeon uses certain primary tools, supplies,
or instruments to create the surgical path or site for implanting the
device.
We have discovered some items that do not meet the requirement of
being surgically implanted or inserted were erroneously approved for
pass-through payments. Consequently, we will eliminate these items from
the list of items eligible for pass-through payments, effective January
1, 2001.
Comment: One commenter claimed that it was inappropriate for us to
change the definition of devices through letters to manufacturers. The
commenter believed that this was done outside the rulemaking process.
Response: We did not make a change to our policy through a letter.
As we began to evaluate the hundreds of applications for approval of
numerous devices, it was apparent that our definition for new medical
devices as published in our April 7, 2000 final rule with comment
period would have resulted in denials for items that we believe might
warrant pass-through payments. Examples of such potential denials are
many types of general and specialty catheters. Based on our experience
in reviewing these applications, we decided to change three of the
eight specific criteria that a new device must meet in order to be
eligible for pass-through payments. We published these changes in our
August 3, 2000 interim final rule with comment period.
b. Eligibility Criteria
Comment: Some commenters believed that we should accept and process
applications for items while they are undergoing the FDA review
process.
Response: We have accepted and begun processing all applications,
including those for which items are pending FDA approval or clearance.
However, in those instances where the FDA approval or clearance
documentation is missing, the application is considered incomplete. In
order for an item to be eligible for transitional pass-through
payments, it must have been approved or cleared by the FDA for
marketing. We will not make a final determination on any applications
that are pending FDA approval or clearance until all the required
documentation is submitted. Resources permitting, we will commence
preliminary processing of the applications when received. The applying
party is responsible for providing us with proper evidence of FDA
approval or clearance for any item, once approval or clearance has been
obtained. Once we receive documentation of FDA approval or clearance
and determine the item is determined to be eligible for transitional
pass-through payments, payment for the item will commence at the start
of the next quarterly update of pass-through items.
Comment: Some commenters asked that we clarify that items must meet
Medicare coverage requirements in order to qualify for pass-through
status.
Response: As stated in both our April 7, 2000 final rule with
comment period and our August 3, 2000 interim final rule with comment,
items that qualify for pass-through payments must be covered by
Medicare. They must have been determined to be reasonable and necessary
for the diagnosis or treatment of an illness or injury or to improve
the functioning of a malformed body part, as required by section
1862(a)(1)(A) of the Act. (See Sec. 419.43(e)(4)(iii).)
c. Investigational Device Exemption (IDE) Devices
Comment: Some commenters recommended that we automatically define
as "new" any device that receives an investigational device exemption
(IDE) from the FDA, with a Category B designation. They believed that
we should pay for IDE devices through the pass-through payment
methodology rather than limit the payment to no more than what is
currently paid for an equivalent device.
Response: As stated in our August 3, 2000 interim final rule with
comment period, we have changed the payment methodology for eligible
IDE Category B devices so that they will be paid using the transitional
pass-through methodology. Since these noninvestigational devices are
required to meet the same eligibility criteria as other devices, we
determined that they should be paid in a similar manner. However, we do
not accept the commenter's recommendation that all IDE Category B
devices "automatically" be considered as new. The statute defines
"new" medical device on the basis of a date certain (that is, payment
for the device was not being made as an hospital outpatient service as
of December 31, 1996) rather than based on a class of devices (such as
IDEs).
d. Removing Cost of Predicate Item
Comment: Some commenters stated that we did not have adequate data
to ensure appropriate removal of the costs for predecessor items
(particularly radiopharmaceuticals and devices) from their relevant
APCs. They advocated that we reevaluate this provision as soon as
possible after implementation of our new system and make necessary
changes.
Response: We will be continuously evaluating our data to remove the
costs of predecessor items from the pass-through payments. As of
January 1, 2001, a specific dollar amount will be deducted from
selected devices (see explanation below). Over time, such deductions
will be made, as we are able to make appropriate estimates from the
data.
e. Excluded Costs
Comment: A number of commenters stated that the APC construction
excluded costs for implantable devices billed with revenue codes 274,
275 and 278. The commenters recommended
[[Page 67806]]
that implantable devices associated with these revenue codes be
included on the pass-through list until data is collected to adequately
reflect the cost of such devices. In addition to claims that revenue
codes 274, 275 and 278 were not represented in the data, some
commenters alleged that implant procedures were infrequently performed
on an outpatient basis prior to 1997 and therefore the costs associated
with them were not represented in the data used to develop the APC
rates. Some commenters recommended, on that basis, that all implantable
devices be included for pass-through payment regardless of FDA approval
dates.
Response: Following enactment of the BBRA of 1999, we did not have
sufficient time to re-run our data to package the costs of implantable
device revenue centers into the APC weights and still be able to
publish a final rule in time to implement the prospective payment
system by July 1, 2000.
As of January 1, 2001, the APC rates will reflect the inclusion of
revenue codes 274, 275 and 278. While the aggregate amount of these
revenue centers is small (0.3 percent of total charges in 1996), the
costs of certain procedures such as implantation of cardiac pacemakers
did increase substantially. As detailed in section III.B.1 of this
interim final rule, some APC groups were modified because of the
inclusion of these revenue centers, and rates for some procedures will
increase to reflect these costs. A reduction in an amount equal to the
increase in the APC rates will be deducted from the relevant devices
that are either eligible for pass-through payments or that can be
billed for additional payment through the new technology APCs.
f. Effect on Conversion Factor
Comment: Some commenters believed that lowering the outpatient
prospective payment system conversion factor to reflect the 2.5 percent
transitional pass-through adjustment could affect hospitals' financial
health. They asserted that any risks to the financial health of
hospitals resulting from reducing the conversion factor should be
balanced against any benefits that would be gained from higher payments
for new drugs and devices. Another commenter advocated that we increase
the conversion factor if we find that the transitional pass-through
payments do not comprise 2.5 percent of the total outpatient
prospective payment system payments.
Response: Section 1833(t)(2)(E), as amended by section 201(c) of
the BBRA 1999, requires that transitional pass-through payments be
implemented in a budget neutral manner. We set prospective payment
system rates prospectively and, consistent with our policies in other
aspects of the prospective payment system, we will not adjust (upward
or downward) the conversion factor for a given year to account for the
difference between 2.5 percent and the actual percentage of pass-
through payments in a previous year.
g. Cost Significance Tests
Comment: Some commenters asserted that we could preclude some
worthwhile technologies from achieving pass-through status if we set
the "not insignificant" cost threshold at 25 percent of the APC
payment rate for the relevant procedure with which it is used. They
contend that technologies associated with higher payment APCs would be
more likely to be disqualified.
Response: We have lowered the cost threshold from 25 percent to 10
percent of the applicable fee schedule amount for the service
associated with the item. This change is effective for services
furnished on or after August 1, 2000.
Comment: A hospital association asked that we clarify how the "not
insignificant" criteria will be applied when a new device, drug, or
biological is associated with more than one APC. The commenter stated
that, under the current provisions of the rule, an item could be
determined to be eligible for pass-through payment when used in
performing a procedure in one APC, but not another. The commenter
suggested that an item that meets the criteria for one APC be treated
as a pass-through item for all APCs in which it is used.
Response: We agree with the stated approach. This has been the
policy that we have applied in processing applications.
Comment: One manufacturer stated that we did not make information
available on the "not insignificant" rule in sufficient time for
applicants to take the criteria into account in preparing applications
for payment effective August 1, 2000. The commenter alleged that the
term "not insignificant" can be interpreted widely and caused
manufacturers not to apply for all potentially eligible pass-through
items. The commenter recommended that we review applications submitted
for the following HCPCS codes to be certain that they meet the
published cost criteria and remove them from the pass-through list if
they do not. The commenter also advocated that we allow other
manufacturers to submit applications retroactive to July 1, 2000, to
assure that we are not promoting a competitive disadvantage for some
companies.
HCPCS Codes
C1029
C1034
C1061
C1072
C1073
C1074
C1100
C1101
C1155
Response: In order for a device to be included on the pass-through
list, it must meet the criteria for transitional pass-through payments.
These criteria include a test of whether the cost of a device is "not
insignificant" relative to the payment for the associated APC. This
test was first put forth in the April 7, 2000 final rule with comment
period, and subsequently revised in the August 3, 2000 interim final
rule with comment period. All the devices denoted by the HCPCS codes
listed above were tested and met the 10-percent "not insignificant"
test as well as the other applicable criteria. The "not
insignificant" test was applied uniformly to all applications that had
been received timely. We believe that permitting retroactive
applications is unwarranted (and would be inconsistent with principles
of prospectivity); moreover, resource and systems constraints would
make it infeasible to give retroactive effect to determinations of
eligibility for pass-through payments.
h. Brand-Specific Versus Categorization Approaches
Comment: Many commenters criticized us for implementing a brand-
specific approach to items on the pass-through list. Device
manufacturers in particular recommended a category scheme to classify
pass-through devices. Representatives of the device industry also
offered to assist us in creating the categories. They argued that a
category system would allow devices to be added immediately upon FDA
approval. They stated that under a category approach manufacturers
would only approach us to obtain new pass-through categories and codes
when items reflect a technological advance and are significantly more
costly than existing payment amounts.
Response: We adopted a trade-name specific approach for several
reasons. First, such an approach provides better information. Codes
that are largely item-specific allow us to track what procedures the
items are used with and costs of the items. When the pass-through
payments for an item ends, we would expect to have good information
[[Page 67807]]
for assigning it to relevant APCs and ensuring appropriate payment for
these APCs. Adopting a scheme with a significant degree of
categorization would require use of averages in making assignments and
setting payment rates. Decisions based on these more limited data would
be likely to lead to intensified concerns about the appropriateness of
APC assignment and payment.
Second, this approach permits finer discrimination in eligibility
decisions. An item-by-item approach allows us to be sure individual
items in fact meet the criteria for eligibility. Of major concern in
this instance is whether a device is "new" using the standard of the
statute. Section 1833(t)(6)(A) of the Act limits transitional pass-
through payment to those devices for which "* * * payment for the
device * * * as an outpatient hospital service under this part was not
being made as of December 31, 1996." Adopting categories would in some
cases mix "old" and "new" devices. In these instances, either some
old devices would get special treatment that they would not be eligible
for if they were examined on an item-specific basis, or an entire
category could be considered old, thus depriving some new devices from
special treatment they would be eligible for if they were examined on
an item-specific basis.
Third, an item-specific scheme avoids issues associated with the
design of categories needed for purposes of transitional pass-through
payments. It largely avoids concerns about what items should be in what
category or whether new categories should be created to accommodate
items that may appear to be little different from those in existing
categories.
Fourth, an item-specific approach allows us to assure that a newly
arriving device can obtain the full period of pass-through status it is
arguably eligible for under the statute. A categorization approach
would likely lead to latecomers being eligible for pass-through
payments for a shorter period. Insofar as revision to APC payment rates
reflected the costs of items in the category by the time the category
was terminated, the shorter period would be of little consequence.
However, if the costs of the late-coming item were significantly
higher, this procedure could appear objectionable. A solution in this
case would be to create a new code, which could be specific to that
item, thus departing from a categorization approach.
We recognize that a category approach would lessen concerns about
competitive disadvantages that may have been inadvertently created by
an item specific approach and about access to specific items by
hospitals and their patients. However, we found no satisfactory way of
establishing categories that would not run into difficulty regarding
the test of whether a device is "new" as described above.
Consequently, we are making no change in our approach.
Comment: Many commenters argued that competitive advantages have
resulted and will continue to result from using a brand-specific
approach to implementing transitional pass-through payments for
devices. Some commenters alleged that our use of the FDA approval date
as a proxy for determining payment in concert with the brand-specific
approach causes further competitive disadvantages. Some hospitals
claimed that the brand-specific approach would create winners and
losers if a device that one hospital uses obtains pass-through status,
but one that another hospital uses does not. A number of commenters
asserted that a category approach would decrease the administrative
burden on hospitals, manufacturers, and us that a brand-specific
approach for application and approval of new devices now incurs.
Response: It was never our intent to competitively disadvantage
anyone or any product. To the maximum extent possible, given the
limitations under the BBRA 1999 and our resource constraints, we have
worked closely with the pharmaceutical and medical device industries to
identify and resolve such issues. By October 1, 2000, we had determined
that more than 700 devices are eligible for pass-through payments.
Therefore, we believe that hospitals will receive additional payments
for many of the devices they use.
i. Issues Pertaining to Specific Items
Comment: A medical association advocated pass-through status for
the following devices: new pacemakers, implantable cardioverter
defibrillators, insertable loop recorders, electrophysiology catheters
(ablation and diagnostic), intracardiac echocardiography ultrasound
catheters, and advanced three-dimensional mapping system catheters.
Response: All of these items are already on the pass-through list.
For a complete list of items approved on the pass-through list, refer
to Addendum B of this rule for short descriptions of the items. Refer
to Program Memoranda Transmittals Nos.
A-00-42,
A-00-61 and
A-00-72 for
the long descriptors for each of the C-codes listed in Addendum B. We
are developing an additional program memorandum that we expect to issue
shortly. This additional program memorandum will contain a list of
additional devices, drugs, and new technology services that will be
effective January 1, 2001.
Comment: Several device manufacturers alleged that the following
devices were not included on the pass-through list:
PALMAZ Balloon-Expandable Stent
Corinthian IQ Biliary Stent
SMART Cordis Nitinol Stent
CARTO EP Navigation System Catheters
HYDROLYSER Catheter
Indigo Prostate Seeding Needle
Lioresal Intrathecal
SynchroMed and SynchroMed EL infusion pumps
Response: All of these devices have been approved for pass-through
payments and assigned C-codes. They have been assigned the following
codes: the PALMAZ Balloon-Expandable Stent, C8522; Corinthian IQ
Biliary Stent, C5004; SMART Cordis Nitinol Stent, C1372; CARTO EP
Navigation System Catheters, C1047; HYDROLYSER Catheter, C1054; Indigo
Prostate Seeding Needle, C1706; Lioresal Intrathecal, C9007, C9008,
C9009, and C9010; SynchroMed and SynchroMed EL infusion pumps, C8505
and C3800, respectively.
Comment: Another device manufacturer claimed that the following
devices were not included on the pass-through list:
Mitek Bone Anchors
Innovasive Bone Anchors
VAPR and VAPR Thermal T Electrode
Gynecare TVT Tension-Free Support for Incontinence System (TVT)
Gynecare Thermachoice Uterine Balloon Therapy System
Response: Many of the items above have been approved for pass-
through status and assigned C-codes. The Mitek and Innovasive Bone
Anchors have been assigned to C1109; VAPR and VAPR Thermal T Electrode,
to C1323; TVT Single-Use Tension-Free Vaginal Tape, to C1370; and the
Gynecare Thermachoice II Catheter, to C1056. However, some of the items
included in the Gynecare TVT Tension-Free Support for Incontinence
System and the Gynecare Thermachoice Uterine Balloon Therapy System did
not meet the criteria for pass-through status and, therefore, are
ineligible for additional payments. The eligible pass-through items are
listed in Addendum B.
Comment: A device manufacturer believed that we should have
approved the Targis System, which provides prostatic microwave
thermotherapy, for pass-through payments.
Response: We assigned the prostatic microwave thermotherapy
procedure to
[[Page 67808]]
a new technology APC, that is, APC 0980. In making this assignment, we
took into account the costs associated with performing this procedure,
including the cost of the Targis system. Therefore, we would not also
make a pass-through payment for the system.
Comment: A number of commenters contended that only 39 of the more
than 70 eligible radiopharmaceuticals have been given pass-through
status. They recommended that we approve the following
radiopharmaceuticals for pass-through payments:
Strontium Sr 82 Rubidium Rb 82 Generator
Sodium Chromate Cr-51
Co 57 Cobaltous Chloride
Co 57 Cyanocobalamin
Ferrous Citrate Fe59
Fludeoxyglucose F 18
Intrinsic Factor Concentrate Capsules
In 111 Imciromab (Myoscint)
In 111 Labeled WBCs, Platelets
I 123 and I 131 Hippurate
Iodinated I 131 Albumin (I 131 Albumin)
Iodinated I 125 Albumin (I 125 Albumin)
Iothalamate Sodium I 125 Albumin (I125 Iothalamate)
Technetium Tc 99m Pertechnetate
Technetium Tc 99m Albumin Colloid
Technetium Tc 99m Lidofenin
Technetium Tc 99m Tebroxime
Technetium Tc 99m Nofetumomab (Verluma)
Technetium Tc 99m HMPAO labeled WBCs
Technetium Tc 99m Human Serum Albumin
Technetium Tc 99m Serum Albumin (Tc 99m HSA kit)
Xenon XE 127 Gas
Response: While a number of radiopharmaceuticals are already on the
pass-through list, we are unable to add some of the ones listed above
because we do not have AWPs for them. The AWPs are the basis for
payment for these items and without the AWPs we cannot approve them for
pass-through payments. As soon as the AWPs are made available to us, we
will complete our review to determine their pass-through status. If
eligible, they will be added to the pass-through list during the
appropriate quarterly update cycle.
Comment: One commenter stated that our transitional pass-through
policy for devices precludes pass-through eligibility for capital
equipment and therefore does not provide a mechanism under our new
system for recognizing the incremental costs associated with capital
equipment. The commenter recommended that we recognize capital-
equipment costs through our new technology APCs.
Response: Under our new outpatient prospective payment system,
capital costs are not paid separately. Payment for these costs are
included in the total APC payment amount for each procedure or medical
visit and will be updated through our annual updating process.
Therefore, the new technology APCs will not be used to make separate
payments for capital related costs.
Comment: A number of commenters claimed that we denied pass-through
status for the contrast agents.
Response: As clarified in our August 3, 2000 interim final rule
with comment, contrast agents other than radiopharmaceuticals are
considered supplies and are not eligible for pass-through payments.
(See Sec. 419.43(e)(4)(vii).)
Comment: A medical association claimed that we denied pass-through
status requests for high dose rate brachytherapy. Another industry
group alleged that many brachytherapy related items that manufacturers
applied for were excluded from the pass-through list.
Response: Since publishing our initial list of potentially eligible
pass-through items to our website on March 9, 2000, we have added 38
brachytherapy items to our pass-through list. High-dose rate
brachytherapy will be eligible for pass-through payment effective for
services furnished on or after January 1, 2001.
j. Pass-Through Applications Process
Comment: Some commenters urged that we process transitional pass-
through applications in a more timely manner. A few other commenters
believed that we should have chosen a date later than July 14, 2000 as
the application deadline for the October 1, 2000 quarterly update for
pass-through items.
Response: We have committed considerable resources to process pass-
through applications in a timely manner. Since publication of our
preliminary list of 149 potentially eligible pass-through items on our
website on March 9, 2000, we have approved nearly 1000 additional items
for pass-through payments. We have instituted a coding strategy that
allows us to assign a temporary HCPCS code immediately to an eligible
pass-through item if a national HCPCS code has not been assigned. We
have committed to making quarterly updates to the pass-through list, a
commitment that is unprecedented in Medicare's history. We have
reviewed all applications timely submitted for each update cycle.
Unfortunately, however, we have had to defer items with significantly
unclear applications or for which sufficient information was not
included to determine that the item meets the statutory criteria. We
have endeavored to work closely with the applicants to obtain this
information and respond timely to their questions.
Regarding objections to setting a July 14, 2000 deadline for
receipt of pass-through applications for the October 1 update, this
deadline was established in order to evaluate the applications and make
the necessary systems modifications in time for the October release to
our fiscal intermediaries and standard systems maintainers.
Comment: One commenter believed that we should update our
transitional pass-through list more frequently than quarterly. Some
other commenters were concerned that the quarterly updating process
could potentially create systems problems for both HCFA and hospitals
that would delay payments. They believed that such a delay would, in
turn, create cash flow difficulties for hospitals. They urged that we
develop contingency plans to address cash flow problems resulting from
the transitional pass-through process.
Response: Because of the complexity of our new system, we cannot
institute systems changes more frequently than quarterly for pass-
through payments. While we believe that making quarterly updates to the
pass-through list will present challenges both for HCFA and the
hospital industry, we have not been advised that any hospital is
experiencing cash flow problems attributable to the transitional pass-
through process.
Comment: One commenter urged us to issue guidelines that detail the
planned methodologies, data sources, and associated timelines for
updating the pass-through list.
Response: Since March 10, 2000, we have published information on
our website which provides detailed instructions and deadlines for
submitting transitional pass-through applications. These instructions
have been revised as needed in order to clarify and update information
and may be found on the following HCFA website:
hcfa.gov/medlearn/refopps.
Comment: One commenter claimed that our method and timing of
assigning HCPCS codes to eligible transitional pass-through items would
preclude Medicare beneficiaries from receiving appropriate treatment.
The commenter also alleged that hospitals will not always be adequately
reimbursed for their costs for such items and that they will have an
incentive to switch to more invasive treatment options with higher
costs.
[[Page 67809]]
Response: We have expedited the process of assigning HCPCS codes to
pass-through items. When an item is determined eligible for pass-
through status, a temporary HCPCS code is assigned immediately in order
that hospitals may begin billing the item as soon as it is effective
for payment.
In addition, section 1833(t)(6)(C)(i) of the Act requires that the
hospital's additional payment for drugs and biologicals be determined
as the difference between the amount determined under section 1842(o)
of the Act (95 percent of AWP) and the portion of the hospital
outpatient department fee schedule amount determined by the Secretary
to be associated with those items. For devices, the additional payment
is the difference between the hospitals' charges adjusted to costs and
the portion of the applicable hospital outpatient department fee
schedule amount associated with the device. We believe that this
payment method will appropriately reimburse hospitals for eligible
pass-through items and that hospitals will act in a prudent manner and
not compromise their patients' safety and care.
k. Payment for Pass-Through Items
Comment: Several commenters questioned how payment would be made
when a pass-through item is included on an outpatient claim. Another
commenter stated that our April 7, 2000 final rule with comment period
does not state the actual payment amount that will be made for each
pass-through item, or provide a good reason for not updating drug and
biological average wholesale prices quarterly, or pledge timely
correction of payment amount errors. The latter commenter believed that
we should make available the actual APC payment rates for pass-through
items and institute quarterly pricing-updates for drug and biological
APCs.
Response: Transitional pass-through payments for devices are
established by taking the hospital charges for each billed item (on an
item-by-item basis), reducing them to cost by use of the hospital's
cost-to-charge ratio, and subtracting an amount representing the device
cost contained in the APC payments for procedures involving that
device. Note that for services furnished prior to January 1, 2001, we
have not subtracted an amount for the predicate device that is packaged
in the relevant APC. However, we will implement this policy beginning
with services furnished on or after January 1, 2001. These calculations
are all done in the outpatient prospective payment system pricer.
Because there are no predetermined APC payment rates for eligible pass-
through devices, we cannot publish them in the same manner as we
publish the APC payment rates for other services.
For drugs and biologicals, pass-through payments are determined
based on 95 percent of the AWP for the eligible drug or biological. We
described in our April 7, 2000 final rule (65 FR 18481) the process we
used to subtract the cost of the eligible drug or biological contained
in the APC payments for procedures involving that drug,
radiopharmaceutical or biological. The year 2000 AWPs for pass-through
drugs and biologicals on which payments are currently based will be
updated annually at the beginning of the next quarter following
publication of the updated values. Due to the complexity of our new
system, we cannot update AWPs quarterly as requested.
Comment: A number of commenters stated that the codes for drugs in
Addendum K of our April 2000 final rule are specific to the dosage
amount dispensed and asked what happens if the dosage dispensed to a
patient is not equal to the amount associated with the eligible codes.
The commenters requested additional information about how providers
should account for these situations. They asked if we would allow
providers to bill for the product amount associated with the container
opened to treat the patient and round up to the nearest whole billing
unit.
Response: The APC payment amount for drugs and biologicals is
established at the lowest dosage level for the specific drug or
biological. If the dosage required in treating the patient exceeds the
lowest level specified in the HCPCS code descriptor for the drug or
biological, providers may bill the number of units necessary to treat
the patient and round them up to the nearest unit. To determine the
payment for the drug or biological, multiply the number of billed units
by the APC payment amount.
Comment: One commenter stated that the APC payment amount for
Eptifibatide, a drug on the pass-through list, does not equal 95
percent of the average wholesale price ($6.28 per 5-mg. service unit).
The commenter claimed that the APC payment is 42 percent lower than 95
percent of the AWP. The commenter asked that we correct the payment
immediately.
Response: The correct APC payment amount for Eptifibatide
injection, 5 mg. is $12.57, of which $1.68 is the minimum unadjusted
coinsurance.
Comment: One commenter stated that the APC payment amount for
Quadramet, a pass-through drug, is incorrect. The commenter claimed the
AWP for this drug is $2,975 rather than $2,875, which the commenter
believed is the basis for our APC payment amount. The commenter stated
that the pass-through payment should be $942.08 instead of $910.42.
Response: The correct APC payment amount for Quadramet is $942.09.
Of this amount, $134.87 is the minimum unadjusted coinsurance.
Comment: A commenter stated that the APC payment amount for
Thyrogen, a pass-through drug, should be $494.00 rather than $404.18
per vial.
Response: The APC payment amount of $404.18 is for 0.9 mg. units of
Thyrogen rather than 1.1 mg., which appears to be the standard vial
dosage. However, because Thyrogen is not available in a vial dosage
less than 1.1 mg., we are eliminating the APC payment for 0.9 mg. units
(HCPCS code J3240) effective for outpatient prospective payment system
services furnished on or after January 1, 2001. We have established a
new code, C9108, for Thyrogen, 1.1 mg. with an APC payment amount of
$494.00. This new code is effective for outpatient prospective payment
system services furnished on or after January 1, 2001.
Comment: A medical association acknowledged our short lead-time for
implementing the transitional pass-through provision and urged that we
hold a series of face-to-face meetings with physicians and suppliers to
clarify and revise our pass-through policies.
Response: Since publishing our April 7, 2000 final rule with
comment period, we have met on numerous occasions with physicians and
representatives of hospitals, pharmaceutical companies and device
manufacturers. During these meetings, we have discussed our
transitional pass-through policies and clarified information regarding
the pass-through applications process.
Comment: One commenter stated that the April 7, 2000 final rule
with comment period requiring the submittal of applications for
national HCPCS codes to bill eligible transitional pass-through was
published after the application deadline had passed. The commenter
alleged that some manufacturers obtained information about the pass-
through provisions prior to publication of the final rule, submitted
their applications timely, and thus dominated the hospital outpatient
market.
Response: On March 9, 2000, we posted information on our website
similar to that contained in the April 7, 2000 final rule with comment
period about applying for national HCPCS codes for pass-through items.
We also
[[Page 67810]]
discussed the coding deadline with representatives of the
pharmaceutical and device manufacturers associations as well as with
hospital industry representatives through conference calls, meetings,
and e-mails. We note that the instructions and deadline for submitting
applications for a national HCPCS code are well established and were
published on HCFA's website (http://www.hcfa.gov/medicare/hcpcs.htm)
more than a year prior to publication of our April 7, 2000 final rule
with comment period. Subsequent to these publications, we adopted a new
system for assigning codes exclusively for pass-through items to
expedite their availability to the hospital industry and Medicare
beneficiaries. Therefore, interested parties applying for pass-through
status for items have not been required to obtain national HCPCS codes
for these items unless they want to bill other payment systems in
addition to the hospital outpatient prospective payment system.
l. Focus Medical Review
Comment: One commenter asked that we clarify why we intend to
conduct focused medical review of pass-through eligible drugs,
biologicals and medical devices.
Response: Our goal is to identify inappropriate billing for these
services and to ensure that payment is not made for noncovered
services.
3. Budget Neutrality Applied to New Adjustments
In the April 7, 2000 final rule with comment period, in accordance
with section 1833(t)(2)(E) of the Act, as amended by section 201(c) of
the BBRA 1999, we made the outlier and transitional pass-through
payment adjustments under section 1833(t)(5) and section 1833(t)(6) of
the Act, respectively, budget neutral. We did not receive any public
comments on this provision.
4. Limitation on Judicial Review
In the April 7, 2000 final rule with comment period (65 FR 18503-
18504), in accordance with section 1833(t)(12) of the Act (as amended
by section 201(d) of the BBRA 1999 and redesignated by section 202(a)
of the BBRA 1999), we implemented the extension of the prohibition of
administrative or judicial review to include the factors for
determining outlier payments (that is, the fixed multiple, or a fixed
dollar cutoff amount, the marginal cost of care, or applicable total
payment percentage), and the factors used to determine additional
payments for certain medical devices, drugs, and biologicals, the
insignificant cost determination for these items, the duration of the
additional payment or portion of the prospective payment system payment
amount associated with particular devices, drugs, or biologicals, and
any pro rata reduction.
We did not receive any public comments on this provision.
5. Inclusion in the Hospital Outpatient Prospective Payment System of
Certain Implantable Items
In the April 7, 2000 final rule with comment period, we specified
that section 1833(t)(1)(B) of the Act, as amended by section 201(e) of
the BBRA 1999, provides that "covered OPD services" include
implantable items described in section 1861(s)(3), (6), or (8) of the
Act.
The conference report accompanying the BBRA 1999, H.R. Rept. No.
479, 106th Cong., 1st Sess. at 869-870, (1999), expresses the belief of
the conferees that the current DMEPOS fee schedule is not appropriate
for certain implantable medical items such as pacemakers,
defibrillators, cardiac sensors, venous grafts, drug pumps, stents,
neurostimulators, and orthopedic implants as well as items that come
into contact with internal human tissue during invasive medical
procedures, but are not permanently implanted. In the conference report
agreement, the conferees state their intention that payment for these
items be made through the hospital outpatient prospective payment
system, regardless of how they might be classified on current HCFA fee
schedules.
In the April 7, 2000 final rule with comment period, we included
the following in the list of items and services whose costs are
included in hospital outpatient prospective payment rates: Prosthetic
implants (other than dental) that replace all or part of an internal
body organ (including colostomy bags and supplies directly related to
colostomy care), and including replacement of these devices;
implantable DME; and implantable items used in performing diagnostic x-
rays, diagnostic laboratory tests, and other diagnostic tests. In
accordance with the BBRA 1999 provision, we require that an implantable
item be classified to the group that includes the service to which the
item relates. We indicated that we would continue to review the impact
of packaging implantables in future updates. For more detailed
information on this provision, refer to the April 7, 2000 final rule
with comment period (65 FR 18443-18444).
Comment: Two commenters (hospitals) expressed concern that the APC
for the Cyberonics-NeuroCybernetic Prosthesis (NCP) System, an
implantable device used to treat epilepsy patients with partial-onset
seizures, will not adequately reimburse hospitals for the cost of the
device and the implantation procedure cost. The hospitals recommended
that HCFA create a separate APC group for the NCP System implantation.
Response: The NCP System was approved for pass-through status
effective for services furnished on or after August 1, 2000 (see
Program Memorandum Transmittal No. A-00-42 issued on July 26, 2000).
The two components of this system, the NeuroCybernetic Prosthesis
Generator and the NeuroCybernetic Prosthesis Lead, will be paid based
on the hospital's charges that are converted to cost using the
hospital's assigned cost-to-charge ratio. These devices have been
assigned to two separate pass-through APCs (1048 and 1306,
respectively) and should be billed using HCPCS code C1048 for the
generator and C1306 for each lead.
Comment: Several commenters from physician practices and a device
manufacturer raised concerns that the APC payment level for the
Contigen Implant procedure is inadequate to cover the facility costs
and the Contigen Implant supplies. According to the commenters, the APC
reimbursement amount only covers the 2-3 Contigen Implant syringes used
per procedure. The commenters recommended that we map the Contigen
Implant procedure and the collagen skin test to higher paying
completely new APCs, to more adequately reflect reasonable costs for
syringes and skin tests used in the procedure, in addition to
appropriate facility fees.
Other commenters raised concerns that the separate APC
reimbursement for the pre-Contigen Implant procedure testing is
inadequate to reimburse for the reasonable cost of the supply. They
recommended that we allow payment of Contigen Implant syringes
according to the DMEPOS fee schedule.
One commenter recommended that we create a special ancillary APC to
cover Contigen Implant syringes and the collagen skin test.
Response: While we understand the commenters' concerns, Contigen
Implant syringes do not qualify for transitional pass-through status
because they do not meet all of the device criteria set forth in
Sec. 419.43(e)(4). Specifically, they are not items that are surgically
implanted or inserted in a patient. However, both collagen implant
[[Page 67811]]
material and the collagen skin test are paid as APCs (that is, APCs
6012 through 6016 and 343, respectively). We will examine data after
the first year of billing under the prospective payment system to
determine if we are adequately capturing the cost of performing these
procedures.
As stated in our April 7, 2000 final rule with comment period, we
will initiate the annual review process for the various components of
our system, including the APC groupings, in calendar year 2001 for
services furnished on or after January 1, 2002. We expect to publish
our proposed rule for 2002 in the spring of 2001.
Comment: A device manufacturer inquired as to what will happen when
devices are taken off the transitional pass-through list after 2 to 3
years. The commenter stated that the additional expense of these
implantable devices will require that HCFA reassign these CPT codes to
an APC that is comparable clinically and in terms of resources used at
the close of the transition period. If this does not occur, the
commenter indicated that hospitals would be seriously underpaid for the
use of these technologies and other technologies in similar
circumstances.
Response: As stated above, the BBRA 1999 allows for 2 to 3 years of
transitional pass-through payments to be made for new devices, drugs,
and biologicals. After the temporary payment period expires for any
item, its cost will be packaged with the relative procedure code or
medical visit and assigned to the APC group that is clinically related
and comparable in resources used. Thus, the APC groupings, weights, and
payments will be updated in a subsequent year to include costs
associated with former pass-through items.
Comment: A coalition of health care providers and insurers
indicated that providers should be allowed to report all DME,
orthotics, and prosthetic devices, both implantable and nonimplantable,
on the UB-92 to the fiscal intermediary. The fiscal intermediary should
be able to either pay for the item via the DMEPOS fee schedule or
through the APC. This also would allow a tracking system for future
ratesetting, and consolidate the billing into one claim. This would
consolidate all charges on one bill per encounter, which simplifies
processing and is consistent with other third party payer claims
processing as well as Medicare inpatient claims processing.
Response: Section 201(e) of the BBRA 1999 amended section
1833(t)(1)(B) of the Act to require that covered outpatient prospective
payment system services include implantable medical items, described in
section 1861(s)(3), (6), or (8) of the Act. These items were formerly
paid under the DMEPOS fee schedule. The statute is explicit in defining
which DME items are payable under the hospital outpatient prospective
payment system.
Also, we cannot adopt the suggested billing changes for DME as the
commenter suggested. All services that are billed through the fiscal
intermediaries, whether they are paid under the hospital outpatient
prospective payment system or DMEPOS, may be submitted on the UB-92 (or
the equivalent electronic transaction). However, there are numerous,
very exacting, specific criteria and rules that govern Medicare
coverage and payment for nonimplantable DME and oxygen. The DME
regional carriers are exclusively qualified to deal with these issues.
Therefore, claims for nonimplantable DME and oxygen cannot be billed to
the fiscal intermediaries. Instead, providers must continue to submit
claims for nonimplantable DME and oxygen to the DME regional carriers
using form HCFA-1500 (or the equivalent electronic transaction).
It should be noted that if a health care provider submits an
electronic claim for these services, the transaction must comply with
the standards adopted by the Secretary in the August 17, 2000 final
rule (65 FR 50312) Standards for Electronic Transactions. The
compliance date of that rule is October 16, 2002.
Comment: A device manufacturer expressed concern about how the new
system will change the payment mechanism for cochlear implants. Under
the DMEPOS fee schedule, payments were fixed and unrelated to hospital
charges. Now, under the new system, hospitals must properly establish
charges that, when multiplied by the ratio of cost to charges, provide
an accurate reflection of cost. This manufacturer was concerned that
they will have to collect data to determine the charges hospitals have
set for these devices and the applicable ratio of cost to charges. They
believe the charges may not have been set appropriately to be
consistent with the ratio of cost to charges. If not, pass-through
payments might be substantially less than the actual cost for these
medical devices.
This manufacturer indicated that it is working to obtain the
required charge and cost report data from providers of cochlear implant
procedures and will report back to us once it has these data. The
manufacturer requested that we agree to work with them in setting any
future update to the payment allowance recognizing the short timeframe
available to collect the data.
Response: We appreciate the commenter's offer to assist us in
collecting cost and charge data on cochlear implants billed by
hospitals. However, for purposes of making transitional pass-through
payments for new medical devices such as cochlear implants, it is not
necessary for manufacturers to obtain cost report data from hospitals
to assist us in developing hospital-specific, cost-to-charge ratios to
calculate these payments. We have already calculated these ratios and
assigned them to providers. Each provider is responsible for accurately
reporting its charges in order that we may calculate the appropriate
payment for the pass-through device.
6. Payment Weights Based on Median or Mean Hospital Costs
Section 1833(t)(2)(C) of the Act requires the Secretary to
establish relative payment weights for covered hospital outpatient
services. This section requires that the weights be developed using
data on claims from 1996 and data from the most recent available
hospital cost reports.
As specified in the April 7, 2000 final rule with comment period
(65 FR 18482), section 201(f) of the BBRA 1999 amended section
1833(t)(2)(C) of the Act to authorize the Secretary to base the
relative payments weights on median or mean hospital costs. In
implementing the BBRA 1999 provision, we decided to adopt as final our
previously proposed policy to base the relative payment weights on
median (as opposed to mean) costs. We had already used median costs to
reconstruct our database for the outpatient prospective payment system
group weights and conversion factors in a proposed rule and we believe
that this method is still valid, especially considering the time
constraints for implementation of the BBRA 1999 provision. We indicated
that, among other things, reconstructing our database to evaluate the
impact of using mean costs after the BBRA 1999 was enacted would have
delayed implementation of the hospital outpatient prospective payment
system rule.
Comment: A group of hospitals urged us to adopt a mean-based APC
relative weight system to implement section 201(f) of the BBRA 1999,
which authorizes, but does not require, the Secretary to use mean
(rather than median) costs in determining the APC payment weights. The
commenters contend that use of the geometric mean is standard in the
industry as the basis
[[Page 67812]]
for calculating payment weights for prospective payment systems. They
pointed out that the geometric mean is used because costs are not
distributed "normally" (that is, there are no negative costs) and
that for APCs that include low volume, high costs procedures, the
geometric mean is preferable for adequately accounting for these costs.
The commenters believed that our use of median costs also forced us to
select an arbitrary value for relative weight 1.0, because finding the
median of medians is meaningless. The commenters believed that, given
the Congress' clarification in section 201(f) of the BBRA 1999, we
should at least evaluate the impact of a mean-based system in our
system review for 2001.
Response: We plan to further evaluate the feasibility of using mean
rather than median costs for calculating APC payment weights in future
updates. In order to make a decision about whether we should change the
basis we are using for determining payment weights, we have to analyze
and rerun claims data and conduct extensive impact analyses to assess
the impact such a change would have on different types of providers and
different types of services.
7. Limitation on Variation of Costs of Services Classified Within a
Group
Section 1833(t)(2) of the Act was amended by section 201(g) of the
BBRA 1999 to limit the variation in resource use among the procedures
or services within an APC group. Specifically, section 1833(t)(2) of
the Act provides that the items and services within a group cannot be
considered comparable with respect to the use of resources if the
highest cost item or service within a group is more than 2 times
greater than the lowest cost item or service within the same group. The
Secretary is to use either the mean or median cost of the item or
service.
Section 1833(t)(2) of the Act, as amended, also allows the
Secretary to make exceptions to this limit on the variation of costs
within each group in unusual cases such as low volume items and
services, although we may not make such an exception in the case of a
drug or biological that has been designated as an orphan drug under
section 526 of the Federal Food, Drug, and Cosmetic Act.
In the April 7, 2000 final rule with comment period, we elected to
use the median cost because we have continued to set the relative
payment weights for each APC based on median hospital costs. We
modified the composition of the APC groups and then made additional
changes to the APC in response to public comments on individual or
serial APCs.
In determining whether or not to accept changes recommended by
commenters, we focused on five criteria that are fundamental to the
definition of a group within the APC system. The decision to accept or
decline a modification to an APC group was determined based on whether
the change enhanced, detracted from, or had no effect on the integrity
of an APC group within the context of the following five criteria:
Resource homogeneity;
Clinical homogeneity;
Provider concentration;
Frequency of services; and
Minimal opportunity for upcoding and code fragmentation.
For a full explanation of these criteria, refer to the April 7,
2000 final rule with comment period (65 FR 18457).
After we modified the composition of the APC groups based on the
recommendations of commenters, we applied the median cost variation
limit required by section 201(g) of the BBRA 1999 to the revised APC
groups. As a result of our analysis of the array of median costs within
the revised APC groups, we had to split some otherwise clinically
homogeneous APC groups into smaller groups. We listed the APC groups
that we had designated as exceptions to the "two times" requirement
and our reasons for granting the exception. We based the exceptions on
factors such as low procedure volume, suspect or incomplete cost data,
concerns about inaccurate or incorrect coding, or compelling clinical
arguments. We indicated that we would be examining the extent to which
the APC reorganization due to the "two times" rule results in
upcoding (refer to the April 7, 2000 final rule with comment period (65
FR 18458-18475)).
Comment: We received requests to examine 51 APCs that commenters
alleged violated the "two times" rule.
Response: We reevaluated the APCs listed below, upon which we
received comments, and found that most of them did not warrant
revision. We received no new information about these APC groups that
would alter our previous decision. These APCs are identified below
under numbers 1 and 2.
Our review also revealed that a few APC groups did warrant revision
and we have reconfigured these APCs accordingly. We have listed these
APCs under number 3. In addition, our review identified some APCs that
are additional exceptions to the "two times" requirement. These APC
groups and our reasons for the exception are listed below under number
4.
In reviewing the APC groups for conformance to the "two times"
requirement, we exempted from the analysis codes for unlisted services
and procedures and those codes that represent less than 2 percent of
the claims in the APC (our test for low volume).
1. Taking into account the exemptions mentioned above, the
following APC groups that we reviewed based on comments have not been
reconfigured:
0005 Level II Needle Biopsy/Aspiration Except Bone Marrow
0076 Endoscopy Lower Airway
0088 Thrombectomy
0090 Level II Implantation/Removal/Revision of Pacemaker, AICD or
Vascular Device
0111 Blood Product Exchange
0112 Extracorporeal Photopheresis
0121 Level I Tube changes and Repositioning
0143 Lower GI Endoscopy
0146 Level I Sigmoidoscopy
0149 Level II Anal/Rectal Procedure
0150 Level III Anal/Rectal Procedure
0151 Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
0162 Level III Cystourethroscopy and other Genitourinary Procedures
0260 Level I Plain Film Except Teeth
0262 Plain Film of Teeth
0265 Level I Diagnostic Ultrasound Except Vascular
0268 Guidance Under Ultrasound
0269 Echocardiogram Except Transesophageal
0278 Diagnostic Urography
0280 Level II Diagnostic Angiography and Venography Except Extremity
0282 Level I Computerized Axial Tomography
0283 Level II Computerized Axial Tomography
0284 Magnetic Resonance Imaging
0286 Myocardial Scans
0290 Standard Non-Imaging Nuclear Medicine
0291 Level I Diagnostic Nuclear Medicine Excluding Myocardial Scans
0292 Level II Diagnostic Nuclear Medicine Excluding Myocardial Scans
0294 Level I Therapeutic Nuclear Medicine
0297 Level II Therapeutic Radiologic Procedures
0301 Level II Radiation Therapy
0303 Treatment Device Construction
0304 Level I Therapeutic Radiation Treatment Preparation
0305 Level II Therapeutic Radiation Treatment Preparation
2. The following APC groups were listed in the April 7, 2000 final
rule
[[Page 67813]]
with comment period as exceptions to the "two times" rule and our
review found no factual basis for modifying our decision:
0030 Breast Reconstruction/Mastectomy
0264 Level II Miscellaneous Radiology Procedures
0274 Myelography
0279 Level I Diagnostic Angiography and Venography Except Extremity
0311 Radiation Physics Services
0371 Allergy Injections
3. We have reconstructed the four APCs shown below as a result of
adding the cost of certain devices used in performing procedures
included in these APCs. We discuss this change in section III.B. of
this preamble.
0080 Diagnostic Cardiac Catheterization
0081 Non-Coronary Angioplasty or Atherectomy
0082 Coronary Atherectomy
0083 Athrectomy
4. Following are additional exceptions to the "two times" rule
and our reasons for the exceptions. We are excepting these APCs from
the "two times limit" on an interim basis, until we can review data
from the first year of billing under the hospital outpatient
prospective payment system.
0142 Small Intestine Endoscopy: The codes in APC 0142 are
clinically similar and should show a relative progression of cost with
slight increases in complexity. This effect does not occur, presumably
due to low volume (although exceeding our low volume threshold) or
inconsistent coding. Splitting this APC into two, based on current
data, would be unjustified.
0145 Therapeutic Anoscopy: The costs of the codes in this APC are
aberrant, with several of them exceeding the costs of more extensive
procedures such as sigmoidoscopy and colonoscopy.
0152 Percutaneous Biliary Endoscopic Procedures: The codes in this
APC have so few occurrences that we cannot justify splitting the group.
Several of the codes call for the use of devices such as stents that
may be paid for separately.
0161 Level II Cystourethroscopy and other Genitourinary
Procedures: The costs of the codes in this APC are aberrant, with more
comprehensive codes costing less than the base codes.
0195 Level V Female Reproductive Procedures: This is a low volume
APC, with aberrant cost data. In several instances, codes that are more
comprehensive cost less than the related, simpler code.
0296 Level I Therapeutic Radiologic Procedures: We believe the
codes at the lower end of the median cost in this APC would be
underpaid if we were to move them to a lower-paying APC.
0300 Level I Radiation Therapy: We believe we would underpay codes
at the lower end of median cost in this APC if we were to move them to
a lower-paying APC.
0312 Radioelement Applications: We believe the costs in this very
low volume APC are aberrant. However, the group is completely coherent
clinically. The radioactive elements related to these codes would
receive separate payment.
0313 Brachytherapy: We believe the costs in this very low volume
APC are aberrant. The group is coherent clinically. The radioactive
elements related to these codes would receive separate payment.
0314 Hyperthermic Therapies: This APC has an extremely low volume,
with aberrant costs.
8. Annual Review of the Components of the Hospital Outpatient
Prospective Payment System
In the April 7, 2000 final rule with comment period (65 FR 18501-
18502), we indicated that, in accordance with section 1833(t)(9) (as
redesignated and revised by sections 201(h) and 202(a) of the BBRA
1999), we would review and update annually, for implementation
effective January 1 of each year, the APC groups, the relative payment
weights, and the wage and other adjustments that are components of the
hospital outpatient prospective payment system. In accordance with
section 201(h)(2) of the BBRA 1999, an annual review process will begin
in calendar year 2001 for the hospital outpatient prospective payments
that would take effect for services furnished on or after January 1,
2002. This review process will involve consultation with an expert
advisory panel. We will provide notice of the formation of the expert
advisory panel in the Federal Register. The expert outside advisory
panel will review and make recommendations to us on the clinical
integrity of the groups and weights and may use data other than those
collected or developed by us for their review and advisory functions.
We note that in section III of this preamble, we are updating the
wage index values and the conversion factor under the hospital
outpatient prospective payment system effective for calendar year 2001.
We also are making appropriate changes to the APC groups to reflect
additions and deletions of CPT codes and changes to a limited number of
APCs to incorporate the cost of certain devices used in performing
those procedures that were excluded from our initial ratesetting
methodology.
Comment: One commenter stated that the wage index for the
Hattiesburg, Mississippi Metropolitan Statistical Area (MSA), .7306,
was printed incorrectly in our April 7, 2000 final rule with comment
period. The commenter stated that use of this value would result in an
underpayment for that area. The commenter further stated that, "the
appropriate wage index for the Hattiesburg, Mississippi MSA for the
fiscal year 2000 is .7634." The commenter was concerned that we had
previously acknowledged this error and promised to correct it via a
program memorandum to fiscal intermediaries dated April 2000
(Transmittal Number A-00-17), but had failed to do so in our April 7,
2000 final rule with comment period.
Response: We apologize for the confusion. The fiscal year 2000
hospital inpatient prospective payment system wage index value for the
Hattiesburg, Mississippi (MSA) was changed from .7306 to .7634 in
accordance with section 153 of the BBRA 1999 that required us to
include wage data from Wesley Medical Center in calculating the wage
index for this MSA. On August 1, 2000, we published in the Federal
Register an interim final rule with comment period (65 FR 47026) that
included Hattiesburg's new hospital inpatient prospective payment
system wage index. For services paid under the hospital outpatient
prospective payment system, the new wage index value is effective for
services furnished on or after August 1, 2000.
9. Copayment Amounts Not Affected by Pass-Throughs
Section 1833(t) of the Act, as established by the BBA of 1997,
includes a mechanism designed to achieve a beneficiary coinsurance
level equal to 20 percent of the prospectively determined payment rate
established for the service. In the April 7, 2000 final rule with
comment period, we specified how a copayment amount is calculated
annually for each APC group under the hospital outpatient prospective
payment system.
We also explained that sections 201(a) and (b) of the BBRA 1999
amended section 1833(t) of the Act to provide for additional payments
to hospitals for outlier cases and for certain medical devices, drugs,
and biologicals and that these additional payments to hospitals will
not affect copayment amounts. Redesignated section 1833(t)(8)(D) of the
Act, as amended by section 201(i) of the BBRA 1999, provides that the
copayment amount is to be computed as
[[Page 67814]]
if outlier adjustments, adjustments for certain medical devices, drugs,
and biologicals, as well as any other adjustments we may establish
under section 1833(t)(2)(E) of the Act, had not occurred.
In addition, we specified that section 202 of the BBRA 1999 added a
new section 1833(t)(7) to the Act to provide transitional corridor
payments to certain hospitals through calendar year 2003 and
indefinitely for certain cancer centers. Section 1833(t)(7)(H) of the
Act provides that the transitional corridor payment provisions will
have no effect on determining copayment amounts.
We specified that copayment from beneficiaries will not be
collected for the additional payments made to hospitals (outlier and
transitional pass-throughs) by Medicare. Beneficiary copayment amounts
will be calculated as if the outlier and transitional pass-throughs had
not occurred (65 FR 18487-18488).
When a drug or device pass-through payment is reduced by the
otherwise applicable APC payment amount that is associated with the
drug or device, it is only the portion of the payment that represents
an additional pass-through payment that is not subject to copayment.
The portion that does not represent an additional pass-through payment
will be subject to copayment.
We did not receive any public comments on this provision.
10. Extension of Cost Reductions
In the April 7, 2000 final rule with comment period (65 FR 18439),
we announced that, in accordance with section 1861(v)(1)(S)(ii) of the
Act (as amended by section 201(k) of the BBRA 1999), the 5.8 and 10
percent reductions for hospital operating and capital costs,
respectively, would extend until the first date that the hospital
outpatient prospective payment system is implemented (which was August
1, 2000).
We did not receive any public comments on this provision.
11. Clarification of Congressional Intent Regarding Base Amounts Used
in Determining the Hospital Outpatient Prospective Payment System
Section 201(l) of the BBRA 1999 provided that, "With respect to
determining the amount of copayments described in paragraph (3)(A)(ii)
of section 1833(t) of the Act, as added by section 4523(a) of BBA,
Congress finds that such amount should be determined without regard to
such section, in a budget neutral manner with respect to aggregate
payments to hospitals, and that the Secretary of Health and Human
Services has the authority to determine such amount without regard to
such section." In accordance with this provision, in the April 7, 2000
final rule with comment period (65 FR 18482-18493), we explained how we
determined APC group weights, calculated an outpatient prospective
payment system conversion factor, and determined national prospective
payment rates, standardized for area wage variations, for the APC
groups. We then explained how we calculated the aggregate hospital
outpatient prospective payment to hospitals in a budget neutral manner
and how we calculated beneficiary coinsurance amounts for each APC
group.
We did not receive any public comments on this provision.
12. Transitional Corridors for Application of Outpatient Prospective
Payment System
Section 1833(t)(7) of the Act, as added by section 202(a)(3) of the
BBRA 1999, provides for payment adjustments during a transition period
to limit the decline in payments under the outpatient prospective
payment system for hospitals. These additional payments are to be
implemented without regard to budget neutrality and are in effect
through 2003.
In the April 7, 2000 final rule with comment period (65 FR 18499-
18500), we specified that, from the date the prospective payment system
is implemented through 2003, a provider, including a CMHC, will receive
an adjustment if its prospective payment system payments for outpatient
services furnished during the year is less than a set percentage of its
pre-BBA amount for that year. The pre-BBA amount is the product of the
reasonable cost the hospital incurs for prospective payment system
services furnished during the year and the payment-to-cost ratio for
covered prospective payment system services furnished during the cost
reporting period ending in calendar year 1996. Additionally, we
provided that small rural hospitals with 100 or fewer beds and cancer
hospitals will be held harmless under this provision. Small rural
hospitals will be held harmless for services furnished before January
1, 2004. The hold-harmless provision applies permanently to cancer
centers. We announced that we will make interim payments to the
affected hospitals subject to retrospective adjustments and that these
provisions do not affect beneficiary coinsurance. Finally, we specified
that this provision is not subject to budget neutrality.
a. Interim Payment Versus Final Settlement
Comment: One commenter recommended that we make retroactive
payments to hospitals in those "situations where underpayments have
been made between the prospective payment system payments as compared
to the pre-prospective payment system amounts." Another commenter
asked that we set forth the process that would be used to determine
retroactive payment adjustments if the hospital's interim payments are
higher or lower than its actual experience. The commenter further asks
that we state whether the interim payments will be compared to
outpatient payments shown on settled or audited cost reports.
Response: Final transitional corridor payments are determined based
on a provider's settled cost report. At the time the cost report is
settled, the reasonable costs incurred by the provider to furnish
outpatient prospective payment system services during the calendar year
are known and that amount is then multiplied by the provider's 1996
payment-to-cost ratio to calculate the pre-BBA amount. The pre-BBA
amount for a calendar year is compared to the actual prospective
payment system payments the provider received to determine whether the
provider may be entitled to a transitional corridor payment. Although
the final transitional corridor payment is based on a settled cost
report, beginning in October 2000, we have been making monthly interim
payments to providers based on estimates of what their transitional
corridor payments should be based on the monthly bills the provider
submits. The monthly payments are designed to maintain some additional
cash flow to providers that may otherwise realize significant losses on
services that are being paid under the prospective payment system.
b. Payment-to-Cost Ratios
Comment: One commenter argued that our formula for calculating the
base payment-to-cost ratio for the transitional corridor payments does
not comport with the statutory requirements. The commenter stated that
we define the denominator of the base payment-to-cost ratio to be
"[the] reasonable cost of these services for the period, without
applying the cost reductions under section 1861(v)(1)(S) of the Act."
The commenter contends that the phrase "without applying the cost
reductions under section 1861(v)(1)(S) of the Act" is not included in
section 1833(t)(7)(F)(ii)(II) of the Act, as
[[Page 67815]]
amended by section 212 of the BBRA 1999. The commenter claimed that by
defining the denominator in this manner, the payment-to-cost ratio is
understated and transitional corridors payments to hospitals would be
reduced. The commenter stated that such a reduction is contrary to
Congressional intent and urged us to modify our base payment-to-cost
denominator set forth in Sec. 419.70(f)(2)(ii) to exclude the phrase
"without applying the cost reduction under section 1861(v)(1)(S) of
the Act."
Response: The phrase "without applying the cost reductions under
section 1861(v)(1)(S) of the Act" was intended to make clear that a
hospital's 1996 "reasonable costs" do not include the effects of the
reductions in section 1861(v)(1)(S) of the Act. We did not mean to
suggest that we were taking the hospital's 1996 "reasonable costs"
and then adding back the reductions for purposes of determining the
denominator of the base payment-to-cost ratio. We view the hospital's
1996 reasonable costs as the unreduced amount; thus, the denominator of
the hospital's base payment-to-cost ratio (1996 reasonable costs) does
not reflect the reductions. We believe that our policy is consistent
with the purpose of the transitional corridor provision. Under this
policy, if a hospital incurs the same amount of costs during the
transitional corridor as in 1996, then its pre-BBA amount (the amount
that estimates what the hospital would have received in the current
year if payments were calculated under the pre-prospective payment
system) would be the same as the payments the hospital received in
1996. Under the methodology suggested by the commenter, if a hospital
incurs the same amount of costs during the transitional corridor as in
1996, then its pre-BBA amount would be higher than the payments the
hospital received in 1996. The language in Sec. 419.70(f)(2)(ii) as set
forth in the April 7, 2000 final rule with comment period was intended
to clarify, not revise, the definition of 1996 reasonable costs, but we
recognize that the phrase at issue may have inadvertently caused
confusion to the extent it is redundant; accordingly, we are revising
that section to remove the phrase.
Comment: One commenter asked us to clarify the term "payment-to-
cost ratio" and the data that will be used to compute the ratio.
Several commenters asked why we did not give the 1996 outpatient
prospective payment system-specific amounts required to compute the
payment-to-cost ratio and the methodology for calculating it.
Response: The statutory definition of base "payment-to-cost
ratio" is fairly straightforward. Under section 1833(t)(7)(F) of the
Act, the base payment-to-cost ratio for a given hospital is the ratio
of (1) the hospital's Medicare Part B reimbursement for covered OPD
services for the cost reporting period ending during 1996, to (2) the
hospital's reasonable costs for that period. We are in the process of
developing program instructions for fiscal intermediaries (for
notification to providers) to provide detailed information on how
payment-to-cost ratios are calculated. These instructions will be made
available as soon as possible.
Comment: One hospital association recommended that we revise our
regulations to explicitly state that we will adjust the provider's 1996
payment-to-cost ratio "whenever subsequent developments occur that
affect the data used in the calculation." The commenter cited final
audit adjustments and appeal determinations as examples of adjustments
that would warrant changing the 1996 cost data used to calculate the
provider's payment-to-cost ratio. The commenter stated that this policy
is consistent with similar adjustments made under the prospective
payment systems for both inpatient operating and capital-related costs.
Response: We agree with the commenter. In the event final audit
adjustments or appeals result in a change in outpatient costs or
payments for the provider's 1996 cost report, the provider's payment-
to-cost ratio would be recalculated.
Comment: One commenter asked for clarification on the treatment of
direct graduate medical education costs and education costs for nursing
and allied health programs in calculating the payment-to-cost ratio.
The commenter assumed that such costs are excluded from the pre-BBA
amount because they will continue to be paid on a cost pass-through
basis.
Response: The commenter is correct that direct graduate medical
education costs and certain costs of nursing and allied health programs
are paid on a cost pass-through basis and will not be included in
calculating a provider's pre-BBA amount.
Comment: One commenter asked that we explain our reasons for basing
the transitional corridor interim payments on a 0.8 payment-to-cost
ratio. The commenter suggested that a provider be allowed to modify its
interim transitional corridor payment if it can show that its payment-
to-cost ratio is higher or lower than the 0.8 level.
Several commenters questioned why we chose to use a standard 0.8
payment-to-cost ratio for all providers in calculating the interim
payment if provider-specific payment-to-cost ratios were available.
They stated that 9 of the 10 cancer centers have payment-to-cost ratios
that exceed 0.8.
Response: The standard payment-to-cost ratio of 80 percent is an
average value that we calculated for payment-to-cost ratios across all
hospitals. We decided to use 80 percent for all providers to permit us
to make interim payments as soon as possible following the
implementation of the outpatient prospective payment system. If we had
attempted to calculate individual payment-to-cost ratios for all
providers, it would have delayed, perhaps for several months, the
introduction of interim payments. Final transitional corridor payments
will be calculated using each provider's payment-to-cost ratio for the
relevant year at the time of settlement of the cost report. In the
future, as we gain more experience with interim payments, we will
consider permitting modification of payment-to-cost ratios to reflect
particular circumstances.
c. Cost-to-Charge Ratios
Comment: One commenter stated that the April 7, 2000 final rule
with comment period did not explain how the transitional corridor
payments would be implemented for the 10 cancer hospitals. The
commenter noted that while Program Memorandum Transmittal No. A-00-23
issued by us on April 7, 2000, does describe how these payments are to
be calculated it does not clarify how we derived the hospital-specific
cost-to-charge ratios used to compute the transitional corridor
payments.
Several commenters representing the 10 cancer centers stated that
the cost-to-charge ratios for their centers that will be used in
calculating their transitional corridor, outlier, and transitional
pass-through payments are significantly lower than their estimates.
They requested that we explain how we determined their ratios and
comment on the appropriateness of our methodology. They also asked that
we respond to a number of specific questions to allow hospitals to
determine whether the cost-to-charge ratios accurately reflect the
hospital's cost and provide a fair base for calculating their
transitional corridor payments.
Response: On September 8, 2000, we issued a Program Memorandum
Transmittal No. A-00-63, which provides a detailed explanation of how
hospital cost-to-charge ratios were
[[Page 67816]]
calculated. This program memorandum is available on HCFA's internet
website at www.hcfa.gov/medicare/medicare.htm [Editor: or on IRP's website here].
d. Interim Payments Limited to 85 Percent of the Estimated Transitional
Corridor Payment
Comment: One commenter asked why we will only pay 85 percent of the
estimated transitional corridor payment as an interim payment. Another
commenter recommended that we reconsider our policy to pay providers
only 85 percent of their transitional corridor payments on the interim
basis. The commenter stated that our policy to withhold 15 percent of
each provider's payment until the fiscal intermediary finalizes the
provider's cost report is contrary to Congressional intent to preserve
hospitals' cash flow and ensure them of an ability to provide
outpatient services to beneficiaries, especially those in rural areas.
Another commenter stated that retaining 15 percent of each provider's
estimated transitional corridor payments until the provider's cost
report is settled is contrary to Congressional intent and defers relief
provided by statute for several years.
Response: We limited the interim payment to less than 100 percent
of the estimated payment in order to minimize the risk of overpayment.
If interim payments exceed the final settled amounts, we would need to
initiate recoupment procedures that place additional burden both on the
agency and on providers. Eighty-five percent was chosen as a reasonable
percentage that prudently balances the cash flow needs of some
providers with concerns regarding possible difficulties in the recovery
of overpayments. We have used comparable figures in other situations in
which we make interim or advance payments. One example where we
specified 85 percent for advance payments is in the contingency plan
that we published to address the possibility that either our
contractors or individual providers would be unable to process claims
at the initiation of the outpatient prospective payment system. In the
future, as cost reports are settled and we are able to determine how
well interim transitional corridor payments relate to final
transitional corridor payments, we will reevaluate this aspect of our
interim payment policy.
e. Providers Having More Than One 1996 Cost Report
Comment: Several commenters stated that we did not discuss in our
final rule how we would calculate the 1996 payment-to-cost ratio in
cases where a provider has more than one cost report that is less than
12 full months during the fiscal year ending in 1996. The commenters
asked which would be the appropriate cost report to use in calculating
the transitional corridor payments. One commenter explained that this
situation may occur if ownership changed during the provider's fiscal
year ending in 1996.
Response: The 1996 cost report that will be used to calculate a
payment-to-cost ratio is the cost report period that ends in calendar
year 1996. If a provider has two cost reports that end in 1996, we will
make a decision about which cost report to use on a case-by-case basis,
depending on which appeared to be the most representative of the
provider's experience in 1996. For example, if one cost report covers a
longer period, we would likely use that one.
f. Providers Having No 1996 Cost Report
Comment: One commenter expressed concern about insufficient
guidance from us about how transitional corridor payments would be
determined for providers that did not file cost reports during 1996.
The commenter believed that because the statute is silent on this
issue, we have the discretion to develop such policy. The commenter
strongly opposed any decisions by us to preclude providers without 1996
cost reports from being eligible to receive transitional corridor
payments.
Another commenter requested that we treat new hospitals that did
not file a 1996 cost report the same as rural hospitals. The commenter
contended that the pre-BBA payment level for these hospitals should be
based on the hospital's first full cost reporting period, and would be
guaranteed at that level through December 31, 2003. Another commenter
suggested as an option that we assign a regional average payment-to-
cost ratio for existing providers to providers without a 1996 cost
report.
Response: Under the statute, the amount of transitional payments to
providers depends on the provider's reimbursement for the 1996 cost
reporting period. We intend to monitor the adequacy of payments to
providers not having a 1996 cost report, but we believe that a
statutory change is required in order to provide transitional payments
to providers that did not have a 1996 cost report.
g. Prospective Payment System Delay and Transitional Corridor Payments
Comment: One commenter expressed concern about the potential effect
of delaying implementation of the hospital outpatient prospective
payment system on the duration of the transitional corridor payments as
provided by law. The commenter stated that our decision to delay
implementation of the prospective payment system for 1 month, from July
1, 2000 to August 1, 2000, should not result in a 1-month loss of
transitional corridor payments for providers. The commenter believed
that the 3\1/2\ years of corridor payments required by law for non-
cancer hospitals paid under the outpatient prospective payment system
should not be reduced due to delayed implementation of the prospective
payment system. The commenter urged us to seek a legislative change if
we determine the 3\1/2\ year period for transitional corridor payments
must coincide with the first 3\1/2\ years of actual prospective payment
system implementation.
Response: For hospitals that do not qualify for the permanent hold-
harmless provision applicable to cancer hospitals, the statute provides
for transitional corridor payments through the end of calendar year
2003. We will monitor and evaluate prospective payment system payments
and will consider whether it would be appropriate to recommend that
Congress legislate an extension of transitional corridor payments.
h. Rural Hold-Harmless Provision
Comment: One commenter suggested that we reevaluate the definition
of rural outpatient hospitals eligible for the hold-harmless provision
and consider including rural hospitals that have 100 to 200 beds, "but
whose outpatient volumes are not sufficient to maintain the facilities'
finances."
Response: The bed size for hospitals to qualify for the rural
hospital hold-harmless provision is limited by statute, under section
1833(t)(7)(D)(i) of the Act, to hospitals that have no more than 100
beds.
Comment: One commenter stated that on page 18501 of the April 7,
2000 final rule with comment period, we state that bed size under the
rural hospital hold-harmless provision will be determined in the same
manner as it is for the hospital inpatient prospective payment system
indirect medical education adjustment. The commenter contended that we
have not provided these instructions to fiscal intermediaries. The
commenter questioned whether the fiscal intermediaries are using the
number of beds reported on the hospital cost reports to determine the
bed size. Still another commenter stated that we failed to specify how
beds are to be counted under the hospital outpatient prospective
payment system. The commenter further stated that our impact analysis
published in the April 7, 2000 final rule with comment period
[[Page 67817]]
suggests that available bed counts shown on the HCFA-2552 cost report
S-3 Worksheet are used to determine if a hospital has 100 or fewer beds
to qualify for the rural hold-harmless transitional corridor payment
provision. The commenter urged us to clarify this issue.
Response: In Program Memorandum Transmittal No. A-00-23, later
revised in June 2000 as Program Memorandum Transmittal No. A-00-36, we
provided instructions to fiscal intermediaries concerning how to
calculate interim transitional corridor payments. As indicated in the
April 7, 2000 final rule with comment period, the bed size used for
transitional corridor payments will be the same bed size defined in and
used to calculate indirect medical education costs and disproportionate
share adjustments under the hospital inpatient prospective payment
system. Fiscal intermediaries are instructed to obtain certain
provider-specific information needed to make the calculation from the
outpatient provider-specific file that they maintain. Certain items on
the outpatient provider-specific file, including bed size, are taken
directly from the provider file used in processing inpatient claims.
Comment: One commenter urged that we revise policy for determining
bed size for purposes of defining rural providers eligible for the
hold-harmless provision. The commenter advocated that we adjust a
provider's count of acute inpatient days to account for observation
patients occupying acute inpatient beds.
Response: The commenter did not provide a rationale for their
recommendation. We believe that it is appropriate to adopt a policy for
purposes of the outpatient prospective payment system that is
consistent with the policy for purposes of the inpatient prospective
payment system; therefore, we are not making a change at this time.
Comment: A commenter specifically asked that, for purposes of
determining bed size for rural providers, we clarify what year is used
to determine bed size. The commenter also asked what our policy is
regarding providers that changed their inpatient capacity prior to July
1, 2000, and those that may change this capacity during the 3\1/2\ year
transition period. The commenter suggested that we permit hospitals to
downsize capacity without affecting their eligibility for hold-harmless
status.
Response: Under Sec. 412.105(b), to determine bed size for the
rural hold-harmless provision, we calculated bed size on the basis of
the provider's cost reporting period. A rural hospital's bed size and,
therefore, its eligibility for hold-harmless treatment may change from
one cost reporting period to the next.
Comment: Several commenters asked us to clarify whether a
hospital's reclassification for either the wage index area or
standardized amount affects its eligibility for the rural hold-harmless
payment. The commenter believed that, because the BBRA 1999 statutory
provision relevant to the rural hold-harmless provision refers to
providers "located in a rural area" rather than the provider's
payment status, a provider's geographic reclassification for wages or
standardized amount has no bearing on its rural hold-harmless status. A
few commenters argued that a geographic reclassification under
inpatient prospective payment system for the wage index or the
standardized amount is not relevant for purposes of the hold-harmless
rural payment provision and that these reclassified hospitals should be
included in the rural hold-harmless payment.
Response: If a hospital is located in a rural area, it will not
lose its eligibility for hold-harmless payments if it obtains a
geographic reclassification under the inpatient prospective payment
system for purposes of determining its wage index or standardized
amount.
Comment: A number of commenters expressed concern about the various
aspects of the hold-harmless provision, referring to sections
1886(d)(8)(E) and 1833(t)(13) under section 401 of the BBRA 1999, and
asked about a hospital's eligibility for the rural hold-harmless
provision.
Response: Under section 1886(d)(8)(E) of the Act, as added by
section 401 of the BBRA 1999, if a hospital submits an application and
meets certain criteria, the Secretary treats the hospital as being
located in a rural area for purposes of section 1886(d) of the Act.
Under section 1833(t)(13) of the Act, as added by section 401(b) of the
BBRA 1999, if a hospital is treated as being located in a rural area
under section 1886(d)(8)(E) of the Act, then the Secretary shall treat
the hospital as being located in a rural area for purposes of the
outpatient prospective payment system. Therefore, if a hospital is
treated as being located in a rural area under section 1886(d)(8)(E) of
the Act, then the hospital is treated as a rural hospital for purposes
of the hold-harmless provision.
Comment: One commenter stated that the 2-month waiting period for
interim transitional payments may adversely affect a large number of
small rural hospitals. The commenter also believed these hospitals will
require a higher interim payment than planned. The commenter asked that
we use a hospital-specific impact analyses to create a process for
interim payments for these small rural hospitals that would begin
concurrently with the start of the prospective payment system.
Response: In order to calculate interim transitional corridor
payments for any hospital, we needed to have some amount of claims that
had been processed under the prospective payment system. For this
reason, we were not able to begin transitional corridor payments
concurrently with the implementation of the prospective payment system.
Because of our concerns discussed earlier about having to initiate
recoupment procedures in cases of overpayments, we are not increasing
interim payments at this time. However, as cost reports are settled and
we are able to determine how well interim payments predict final
transitional corridor payments, we will be able to reevaluate this
policy.
i. Covered Charges
Comment: Several commenters asked that we clarify the definition of
"covered charges" used to compute the rural hold-harmless
transitional corridor payment. One commenter stated that total
procedures and thus the hold-harmless payment will be understated
should we eliminate from these calculations the charges for incidental
procedures or procedures that the Outpatient Code Editor consolidates
into the main procedures.
Response: In the preamble and the regulation text of the April 7,
2000 final rule with comment period, we refer to "covered hospital
outpatient services" to describe the services that are paid under the
prospective payment system and, therefore, subject to the transitional
corridor provision. To determine a provider's costs for purposes of
calculating the pre-BBA amount for both interim payments and for final
cost report settlement, we will take into account all costs encompassed
under the prospective payment system, including the cost of incidental
services that are packaged into the APC rate. These services are
identified as those having HCPCS codes with a status indicator of "N"
(as listed in Addendum B) and incidental services that may not be
billed with HCPCS codes, but which are billed under revenue codes that
indicate a packaged service such as observation services, recovery
room, supplies and many drugs.
Comment: One commenter asked us to clarify how charges for packaged
services, for example observation services, should be billed when they
are
[[Page 67818]]
the only service provided. The commenter stated that inclusion of
charges for these packaged services in the total bill charges are
necessary to calculate the proper transitional corridor payment.
Response: Packaged services will not be the only items that appear
on a bill. Packaged services will appear on a bill with the service to
which they are incidental. For example, observation services are
properly billed with the clinic visit, emergency room visit, surgery,
etc., that results in the need for the incidental observation service.
j. Cancer Hospitals and Transitional Corridor Payments
Comment: Several commenters believed that the process described in
Program Memorandum Transmittal No. A-00-23 for calculating the hold-
harmless transitional corridor payments should be revised because it
does not reflect Congressional intent and will not provide the relief
to the 10 cancer centers that the Congress intended. These commenters
contended that the method described in the program memorandum for
calculating the transitional corridor payments will result in a 22
percent loss in outpatient patient revenues for the cancer centers
compared to those received in 1998. The commenters further claimed that
their revenue losses under the new outpatient prospective payment
system may increase an additional 2 percent, or 24 percent in total,
because we will not pay claims for any medical visits that are billed
in conjunction with related significant procedures.
In addition, these commenters urged us to:
Establish an appeal process for providers with cash flow
problems that would permit fiscal intermediaries to adjust a provider's
cost-to-charge ratio "to rectify ongoing OPPS losses prior to
reconciliation."
Reduce interim payments to the 10 cancer centers by only 5
percent rather than 15 percent. (The commenters contended that this
approach would be consistent with the method currently used to
determine their inpatient interim payments under the TEFRA cost limits
system.)
Pay the 10 cancer centers the balance of the hold-harmless
payments due at the time the cost report is subjected to desk review
rather than at the time it is settled. (The commenters stated that
settlement of the centers' cost reports is completed within 2 to 4
years after a completed cost report is filed, whereas the cost report
desk review is generally completed 90 days after it is filed.)
Response: Medical visits may be billed with significant procedures
as long as the medical visit is a separate and distinct service from
the significant procedure, even though the significant procedure is
related to the medical visit. For example, as a result of an
examination performed as part of a clinic or emergency room visit, a
patient is determined to need a CT scan or MRI, or as a result of a
dermatology examination performed as a clinic visit, a patient also has
a surgical procedure to remove a mole. In these types of situations,
payment will be made for both a medical visit and a significant
procedure.
Program Memorandum Transmittal No. A-00-63 provides for adjustment
of a provider's cost-to-charge ratio in certain specific situations. In
the future, in order to reflect changes in hospital costs and charges,
we will allow fiscal intermediaries to make additional updates of a
provider's cost-to-charge ratio to ensure that interim payments
accurately reflect our best estimates of final transitional corridor
payments.
Although we limited the interim payment to 85 percent of the
estimated payment in order to minimize the risk of overpayment, in the
future, as cost reports are settled and we are able to determine how
well interim payments predict final transitional corridor payments, we
will be able to reevaluate this aspect of our interim payment policy
and we will consider permitting modification of payment-to-cost ratios
to reflect particular circumstances.
The statute indicates that interim payments are made subject to
retrospective adjustments based on settled cost reports. However, it is
current practice that, depending on the provider's specific situation,
a fiscal intermediary may make additional payments as part of a
tentative settlement action prior to final settlement of the cost
report.
k. Teaching Hospitals and Transitional Corridor Payments
Comment: One commenter urged that we retain the transitional
corridor payments permanently for major teaching hospitals.
Response: Section 1833(t)(7) of the Act provides permanent
transitional corridor payments only for cancer hospitals described in
section 1886(d)(1)(B)(v) of the Act. As indicated earlier, we will
monitor and evaluate the prospective payment system payments and will
consider whether it would be appropriate to recommend that Congress
extend transitional corridor payments.
Comment: One commenter stated that while the transitional corridor
payments will mitigate some of the losses to teaching hospitals under
the prospective payment system compared to the former cost-based
payment system, these payments are temporary. The commenter believed
that we underestimated the losses that some teaching hospitals will
experience. Another commenter urged us to monitor closely the impact of
the prospective payment system on major teaching hospitals during the
3\1/2\ year transitional corridor payments. The commenter believed that
these hospitals will require a payment adjustment after the
transitional corridor payment period expires to mitigate their
potential financial losses under the prospective payment system.
Response: As we stated in the preamble of the April 7, 2000 final
rule with comment period, we will perform further comprehensive
analyses of cost and payment differences between different classes of
hospitals as soon as there is a sufficient amount of claims data
submitted under the prospective payment system. We will use data from
the initial years of the prospective payment system to conduct
regression and simulation analyses. In addition, we will carefully
track and analyze the additional payments made to hospitals under the
transitional corridor provision. These analyses will be used to
consider and possibly propose adjustments in the system, particularly
beginning in 2004 when the transitional corridor provisions expire.
13. Limitation on Coinsurance for a Procedure
In the April 7, 2000 final rule with comment period (65 FR 18488),
we specified that, in accordance with section 1833(t)(8) of the Act (as
amended by section 204(a) of the BBRA 1999), the coinsurance amount for
a procedure performed in a year cannot exceed the hospital inpatient
deductible for that year. We specified that we would apply the
limitation to the wage-adjusted coinsurance amount (not the unadjusted
coinsurance amount) after any Part B deductible amounts are taken into
account. Therefore, although the unadjusted coinsurance amount for any
APC may be higher or lower than the inpatient hospital deductible, the
actual coinsurance amount for an APC, determined after any deductible
amounts and adjustments for variations in geographic areas are taken
into account, will be limited to the Medicare inpatient hospital
deductible. Any reduction in coinsurance that occurs in applying the
limitation will be paid to
[[Page 67819]]
hospitals as additional program payments.
Comment: One commenter disagreed with our interpretation of the
BBRA 1999 provision that amended section 1833(t)(8) of the Act to limit
the coinsurance amount for a procedure to the amount of the inpatient
hospital deductible. The commenter believed that our interpretation
that applies the limitation to coinsurance on an APC by the APC basis
is too narrow.
The commenter concluded that, at a minimum, the limitation should
be more broadly interpreted to apply to the total coinsurance incurred
by a beneficiary in connection with an outpatient visit, that is, from
the time the beneficiary walks into an outpatient department until he
or she is released. However, to implement the provision as envisioned
by the Congress, the commenter suggested that we also consider
developing a service period unit for outpatient procedures that is
similar to the "spell of illness" concept used to define the set of
services to which a single inpatient hospital deductible applies.
Therefore, when a patient comes to an outpatient department for
treatment of a particular condition, his or her coinsurance liability
for all the services required for that condition should not exceed the
inpatient hospital deductible. The commenter recommended that we apply
the limitation regardless of how many or which APCs are billed or the
number of visits required for such treatment.
Response: APCs are based on CPT codes. We believe that the most
plausible meaning for "procedure" in this context is a CPT code or,
by extension, an APC. Thus we interpret the limitation of coinsurance
for a procedure in section 1833(t)(8)(C) of the Act as added by section
204 of the BBRA 1999 to apply in general to APCs.
We do not believe that it was the intent of the Congress to apply
the coinsurance limitation to the beneficiary's aggregate coinsurance
amounts for all outpatient services received during the entire service
period for a specific condition or even to the services a beneficiary
receives in one day. During the Congressional committee deliberations
on this provision before it was enacted, we held technical discussions
with committee staff. At their request, we identified the specific 10
APCs in the September 1998 proposed rule that would be likely to have a
coinsurance that exceeded the inpatient hospital deductible. The
Congressional Budget Office also used that information to project the
cost of this statutory provision. Therefore, we believe that our
interpretation in the April 7, 2000 final rule with comment period of
how the coinsurance limitation is to be applied is consistent with the
intent of Congress.
Comment: Several commenters pointed out that because APCs for drugs
and biologicals are defined based on HCPCS codes for the lowest unit of
the drug or biological, if we intend to apply the inpatient deductible
limit at the APC level, we might disadvantage beneficiaries who receive
multiple units. For example, the coinsurance for a specific drug APC
may not exceed the inpatient deductible amount. However, if multiple
units of the same drug are administered, the coinsurance based on the
multiple APCs may, in fact, exceed the inpatient deductible. The
commenters believed that the total coinsurance amount for a drug or
biological based on the amount administered should be subjected to the
inpatient deductible limit. The commenters believed that constructing
APCs for drugs based on the lowest unit of the drug is solely a payment
convention and does not mean that each dose is a separate
"procedure." Therefore, the commenters contended, a better reading of
the statute is that the administration of a drug or biological,
regardless of the dose, is one procedure for purposes of applying the
hospital outpatient prospective payment system and it would be
inappropriate to compare the inpatient deductible limit to anything but
the total coinsurance amounts.
Response: In the case of services that involve the administration
of drugs and biologicals in separate APCs, we have concluded that we
should apply the limitation on coinsurance to include both the drug or
biological (in whatever units it is administered) and the service that
leads to its administration. We constructed separate APCs for drugs and
biologicals, and established pricing on the basis of the lowest dose,
not to reflect CPT codes, but solely as a matter of convenience in
administering the payment system. Consequently, we think that the
interpretation with the most clinical relevance in this instance is to
treat a drug or biological and the service that leads to its
administration as a single procedure. We had not proposed separate APCs
for drugs and biologicals in the proposed rule for the outpatient
prospective payment system and the Congress did not know we would
segment APCs at the time it passed the BBRA 1997.
Effective for drugs and biologicals furnished on or after January
1, 2001, when multiple units of a drug or biological are furnished to a
beneficiary during one day, resulting in multiple APC payments for the
same drug, we will aggregate the total coinsurance applicable to the
drug or biological, and the aggregated amount cannot exceed the
inpatient hospital deductible for the calendar year. In order to
accomplish this change in our bill processing systems, we are assigning
a new status indicator designated as "K" to APCs for nonpass-through
drugs and biologicals (as reflected in Addendum D of this interim final
rule with comment period). Effective for services furnished on or after
July 1, 2001, in the same circumstances, we will aggregate the total
coinsurance applicable to the drug or biological and to the service
that resulted in the administration of the drug, and the aggregated
amount cannot exceed the inpatient hospital deductible for the calendar
year. We are unable to make the latter provision effective earlier
because of systems constraints.
Comment: One commenter stated that the BBRA 1999 requirement that
coinsurance for a procedure cannot exceed the inpatient hospital
deductible for that year adds confusion to an already complicated
formula for determining coinsurance. The commenter stated that the
monitoring of coinsurance needed to ensure the limitation is being
applied on a procedure basis will add undue burden and increase a
provider's costs. To make the hospital outpatient prospective payment
system less complicated, the commenter believed that we should consider
eliminating the threshold.
Response: The coinsurance limitation is required by statute.
Therefore, a statutory change would be required to eliminate this
provision.
14. Reclassification of Certain Hospitals
In the August 1, 2000 Federal Register (65 FR 47029), we
implemented section 401 of the BBRA 1999 for the hospital inpatient
prospective payment system. Section 401(a) of the BBRA 1999, which
amended section 1886(d)(8) of the Act by adding a new paragraph (E),
directs the Secretary to treat any subsection (d) hospital located in
an urban area as being located in the rural area of the State in which
the hospital is located if the hospital files an application (in the
form and manner determined by the Secretary) and meets certain
statutorily specified criteria. Additionally, section 401(a) of the
BBRA 1999 includes hospitals "* * * located in an area designated by
any law or regulation of such State as a rural area (or is designated
by such State as a rural hospital)." A hospital also may seek to
qualify for reclassification premised on the fact that, had it been
located in a
[[Page 67820]]
rural area, it would have qualified as a rural referral center or as a
sole community hospital.
Section 401(b) of the BBRA 1999 made a conforming change to section
1833(t) of the Act. Specifically, section 401(b) added section
1833(t)(13) to the Act which provides that if a hospital is being
treated as being located in a rural area under section 1886(d)(8)(E) of
the Act (for purposes of section 1886(d) of the Act), the hospital will
also be treated under section 1833(t)(13) of the Act as being located
in a rural area.
In the April 7, 2000 final rule with comment period, we explained
that we use the same yearly version of the hospital inpatient
prospective payment system wage index (which takes effect each October
1) to adjust the portion of the outpatient prospective payment system
payment rate and the coinsurance amount that is attributable to labor-
related costs for relative differences in labor and labor-related costs
across geographic areas (and that will be applied effective each
January 1). This wage index reflects the effects of hospital
designations under section 1886(d)(8)(B) of the Act and hospital
reclassifications under section 1886(d)(10) of the Act.
We did not receive any comments on this conforming change.
B. August 3, 2000 Interim Final Rule With Comment Period
Following are the issues addressed in the August 3, 2000 interim
final rule with comment period, the public comments received on each
issue, and our response to those comments. In that interim final rule,
we--
Revised the regulation at Sec. 419.43(e)(1)(iv) to change
one criterion and postpone the effective date for two other criteria
that a new device, drug, or biological must meet in order for its cost
to be considered "not insignificant" for purposes of determining its
eligibility for transitional pass-through payments;
Changed our interpretation for three of the eight criteria
set forth in the April 7, 2000 final rule with comment period for
defining a new medical device that would be eligible for transitional
pass-through payments and amended Sec. 419.43 by adding new paragraph
(e)(4) to include all eight criteria;
Clarified the assignment of "C" codes to eligible pass-
through items;
Corrected a trigger date for grandfathering of provider-
based FQHCs; and
Clarified our intent regarding prior notice of beneficiary
cost-sharing liability in emergency situations.
1. Transitional Pass-Through Provisions
a. "Not Insignificant" Cost Criteria
Section 1833(t)(6) of the Act, as added by section 201(b) of the
BBRA 1999, requires the Secretary to make transitional pass-through
payments for post-1996 new drugs, biologicals, and devices for at least
2 but no more than 3 years when the cost of the item is "not
insignificant" in relation to the hospital outpatient prospective
payment system payment amount. In the April 7, 2000 final rule with
comment period, we established three criteria that a new device, drug,
or biological must meet to determine whether its costs are not
insignificant relative to the APC payment with which the item is
associated (65 FR 18480-81). We stated that all of the following cost
criteria must be satisfied in order for a new device, drug, or
biological to be eligible for transitional pass-through payments:
Its expected reasonable cost exceeds the applicable fee
schedule amount determined to be associated with the drug, biological,
or device by 25 percent.
The expected reasonable cost of the new drug, biological,
or device exceeds the portion of the fee schedule amount determined to
be associated with the drug, biological, or device by 25 percent.
The difference between the expected, reasonable cost of
the item and the portion of the hospital outpatient department fee
schedule amount determined to be associated with the item exceeds 10
percent of the applicable hospital outpatient fee schedule amount.
After we published the April 7, 2000 final rule with comment
period, we gained considerable experience from reviewing applications
for transitional pass-through payments. Based on that experience, we
concluded that the 25-percent limitation was too restrictive and could
result in limiting Medicare beneficiaries' access to new products.
Therefore, in the August 3, 2000 interim final rule with comment
period, we changed that criterion to ensure that Medicare beneficiaries
would continue to have access to the latest technologies. We now
require that the expected reasonable cost of a new drug, biological, or
device must exceed 10 percent of the applicable fee schedule amount for
the associated service. In addition, we also postponed the effective
date of the other two criteria applying to a new device, biologicals,
or drugs for which a transitional pass-through payment is first made to
on or after January 1, 2003. As stated in the August 3, 2000 interim
final rule with comment period, the delay in the effective date for
these two criteria is necessary so that we will have sufficient time to
gather and analyze data needed to determine the current portion of the
fee schedule amounts associated with a device, drug, or biological,
which is an essential factor in applying these criteria.
Comment: Several commenters commended us for revising the one "not
insignificant" criterion and postponing the other two criteria until
after December 31, 2002. However, some argued that we created an uneven
playing field by changing our policies after we published our April 7,
2000 final rule and announced pass-through application deadlines. They
claimed that our untimely lowering of the cost threshold from 25
percent to 10 percent unfairly disadvantaged companies that did not
submit pass-through applications by the deadline for our August 1, 2000
payments because they believed that their products would not qualify
for payment. One commenter recommended that we rapidly process
applications submitted for our January 1, 2001 update and change the
effective date of that update to November 1, 2000. Another commenter
advocated that we apply the 10-percent cost threshold retroactively to
all device pass-through applications to ensure equitable treatment for
all manufacturers.
Response: Based on our review of transitional pass-through
applications, we believe that we have not applied our policy change
inconsistently to applications that we received. The change to the
lower cost threshold is effective for services furnished on or after
August 1, 2000. If an applicant's product was denied pass-through
status because its cost was considered to be "not insignificant" and
that applicant can show that our decision was not based on the 10-
percent criterion, the applicant may request that we reevaluate the
application. In addition, we encourage other interested parties who
withheld applications because they believed that their products would
not qualify for pass-through status to submit them. Further, we cannot
update the pass-through payments effective November 1, 2000 as
requested. Adding new pass-through items to our outpatient prospective
payment system requires changes to our complex Medicare computerized
claims processing systems that we can make only at the beginning of a
calendar quarter.
Comment: One commenter believed that reducing the cost threshold to
10 percent for new devices may be too low. The commenter stated that
the lower
[[Page 67821]]
cost threshold would expose hospitals to financial risk created by the
use of new and expensive technology furnished in providing patient
care. The commenter advocated that we consider as an option
"establishing * * * a floor--or a variable percentage that is higher
for low-cost cases and lower for high-cost cases."
Response: We believe that this option will require time to evaluate
its merits, assess its impact on our systems and determine systems
changes that would be required to implement it. Therefore, we will
consider this request for possible inclusion in our future proposed
rule for outpatient prospective payment system updating that we expect
to publish in the spring of 2001.
Comment: One commenter urged that we grant the public another
opportunity to evaluate and comment on all three "not insignificant"
cost criteria before implementing them.
Response: Before we implement all three of these criteria, we plan
to provide notice and opportunity for public comment. Since we do not
expect to implement two of these criteria before January 1, 2003, we
would not expect to publish a proposed rulemaking until the spring of
2002.
Comment: One commenter asked how we would apply the three "not
insignificant" cost criteria in instances when multiple units of a new
device are used in performing a procedure. The commenter recommended
that we use the "weighted average cost of the product, based on the
average number of unit used in a procedure."
Response: We plan to fully describe our approach to implementing
these three criteria in a future proposed rule. As previously stated,
we will not implement two of these criteria before January 1, 2003.
Therefore, we do not expect to publish a proposed rulemaking until the
spring of 2002.
Comment: One commenter asked that we clarify how transitional pass-
through payments will be incorporated into the APC payments at the end
of the 2- to 3-year transitional period for a given device. The
commenter also asked how we would prevent the cost for the pass-through
items from being diluted significantly by the median cost of other
procedures grouped in the same APC.
Response: We plan to use a methodology similar to that currently
used to construct the APC groups to incorporate payment for pass-
through items into the APC payments once their pass-through status
expires. That is, we have assigned a unique HCPCS code to each eligible
pass-through item that will allow us to track its payments and
utilization over the 2 to 3 years that it is eligible for pass-through
status. The codes will allow us to match the pass-through items to the
specific procedures or medical visits with which they are used. After
we gain appropriate information about the actual costs a hospital
incurs to provide a pass-through item, we will package the cost for the
pass-through with that for the relevant procedure or medical visit with
which it is used and assign the packaged service to a clinically
related APC group with comparable resources. We will limit the cost
variation within each group as required by section 1833(t)(2) of the
Act, as amended by section 201(g) of the BBRA 1999. In accordance with
this provision, the items and services within a group cannot be
considered comparable with respect to the use of resources if the
highest median cost item or service within a group is more than two
times greater than the lowest median cost item or service within the
same group. By law, the Secretary is allowed certain exceptions to this
requirement, that is, for low volume items and services.
Comment: One commenter asked if we would provide adequate
recognition for multiple devices used in a procedure "if multiple
procedure discounting is allowed to cut the pass-through generated
recognition of these costs in half."
Response: Under the hospital outpatient prospective payment system,
devices eligible for pass-through payments are paid separately and not
subject to the multiple procedure discounting policy. This policy
applies only to the actual surgical procedure that is performed to
implant the pass-through device. These procedures are denoted by a
status indicator "T" and listed in Addendum B of this rule.
Comment: One commenter urged us to correct erroneous APC groupings
more frequently than during our scheduled quarterly or annual update
cycles until we stabilize the hospital outpatient prospective payment
system.
Response: We understand the importance of paying appropriately for
services billed under our new outpatient system and are committed to
resolving problems that would preclude us from making appropriate
payments in a timely manner. However, because of the complexity of our
system we cannot commit to making changes other than during the
scheduled updating cycles.
b. Definition of Medical Device
In the April 7, 2000 final rule with comment period, we established
eight specific criteria that new or innovative medical devices must
meet to be considered eligible for pass-through payments under section
1833(t)(6) of the Act. We stated in that rule that new or innovative
medical devices must meet all of the following criteria to be
considered eligible for transitional pass-through payments:
(1) They were not recognized for payment as a hospital outpatient
service prior to 1997.
(2) They have been approved or cleared for use by the FDA.
(3) They are determined to be reasonable and necessary for the
diagnosis or treatment of an illness or injury or to improve the
functioning of a malformed body part, as required by section
1862(a)(1)(A) of the Act. We recognize that some investigational
devices are refinements of existing technologies or replications of
existing technologies and may be considered reasonable and necessary.
Therefore, we indicated that we will consider devices for coverage
under the hospital outpatient prospective payment system if they have
received an FDA investigational device exemption (IDE) and are
classified by the FDA as Category B devices. However, in accordance
with regulations at Sec. 405.209, payment for a nonexperimental
investigation device is based on, and may not exceed, the amount that
would have been paid for a currently used device serving the same
medical purpose that has been approved or cleared for marketing by the
FDA.
(4) They are an integral and subordinate part of the procedure
performed, are used for one patient only, are surgically implanted or
inserted, and remain with that patient after the patient is released
from the hospital outpatient department.
(5) The associated cost is not insignificant in relation to the APC
payment for the service in which the innovative medical equipment is
packaged.
(6) They are not equipment, instruments, apparatuses, implements,
or items for which depreciation and financing expenses are recovered as
depreciable assets as defined in Chapter 1 of the Medicare Provider
Reimbursement Manual (HCFA Pub. 15-1).
(7) They are not materials and supplies such as sutures, clips, or
customized surgical kits furnished incident to a service or procedure.
(8) They are not materials such as biologicals or synthetics that
may be used to replace human skin.
In the August 3, 2000 rule, we revised criteria (3), (4), and (7)
and amended Sec. 419.43(e)(4) to include all eight criteria. We stated
in that rule that our change in policies reflects experience
[[Page 67822]]
gained in reviewing and processing transitional pass-through
applications for devices since publishing our April 7, 2000 final rule
with comment period. With regard to criteria (3), we revised it by
removing the cost limitation provision for IDE Category B devices that
qualify for transitional pass-through payments. We explained in the
August 3, 2000 interim final rule that on review of our policy for such
new devices, we believed that it would be more appropriate to remove
the cost limitation because they are subjected to the same eligibility
requirements as any other device applying for pass-through status and
because pass-through payments for a specific device are temporary.
For criteria (4), we modified our interpretation of which devices
are eligible for transition pass-through payments to include new
medical devices that are used for one patient only, are single use,
come in contact with human tissue, and are surgically implanted or
inserted in a patient during a procedure but may also be removed during
that procedure so that the patient leaves the hospital without the
device. Our revised interpretation also includes clips that are used as
radiological site or tissue markers.
As explained in the August 3, 2000 interim final rule, it became
apparent, based on experience gained in processing a large number of
applications for new medical device pass-through status, that our
attempt to distinguish implantable devices using the criteria we had
outlined in our April 7, 2000 final rule with comment period had some
practical limitations. We also explained that, in some instances, the
new medical device is implanted temporarily rather than permanently as
indicated in our original policy published in the April 7, 2000 final
rule with comment period. However, we did not intend for our policy to
exclude new medical devices that are implanted or inserted during a
procedure but also may be removed during that procedure so that the
patient leaves the hospital without the device. Rather, we believed
that these devices should be considered for pass-through payments
because they also are implantables. We further stated in the August 3,
2000 interim final rule with comment period that it had become apparent
that some implantable clips are expensive and function other than as
tools or supplies necessary for a surgeon to perform a surgical
procedure. We did not intend to exclude such clips from consideration
for pass-through payments. Therefore, we revised our interpretation of
which devices are eligible for transitional pass-through status to
include also new single use medical devices that may be temporarily
implanted or inserted in a patient.
Finally, in criterion (7), we became aware of the need, based on
our review of pass-through applications, to clarify that supplies
include pharmacological imaging and stressing agents, including
contrast media but excluding radiopharmaceuticals (for which payment
under the transitional pass-through provision is established by section
1833(t)(6)(A) of the Act).
Comment: One commenter urged that we issue detailed guidelines that
clarify whether an IDE Category B device with pass-through status will
be assigned only one "C-code" for both its clinical investigation and
commercialization.
Response: Our general policy is to assign only one code to an
eligible pass-through item.
Comment: One commenter asked how we would reconcile differences in
pass-through payment differences (over 2 to 3 years) that are made for
an eligible IDE Category B device during its clinical investigation
phase versus those paid once the device is commercialized.
Response: Policy decisions regarding the analytical treatment of
costs associated with specific items that will be included in our
database for constructing APCs will be made in the context of the
methodology that we use to derive updated APC weights and payments.
This methodology will be fully described in a subsequent proposed rule
prior to incorporating the cost for pass-through devices such as
eligible IDE Category B devices into our APC payments.
Comment: One commenter asked that we clarify when the definition of
a device includes or excludes all of a device's components. The
commenter also asked whether we assigned separate codes for the
device's components.
Response: If a device can be separated into distinct components and
such components are considered integral to the functioning of that
device, we evaluate the device and all its component parts to determine
whether any or all would qualify for transitional pass-through payment.
For example, we have approved several implantable neurostimulator
systems for pass-through payment. These systems usually include at
least two or three separate components such as a generator, leads, and
receiver/transmitter. In this case, we have assigned separate HCPCS
codes to each of the eligible components. However, if an eligible pass-
through item is considered a component of a non-eligible item, such as
a piece of capital equipment, only the eligible item will receive a
HCPCS code to bill for pass-through payments.
Comment: One commenter warned us about medical devices that we have
approved for pass-through payments such as electrophysiology catheters
that the commenter alleges are not single use items. The commenter
stated that hospitals use them more than once. The commenter advocated
that we advise hospitals not to request additional payments for any
approved pass-through item if they reprocess or reuse them.
Response: In the August 3, 2000 interim final rule with comment
period, we revised criterion "d" of the eight medical device
eligibility criteria to explicitly preclude pass-through payments for
new medical devices other than those that are single use. Therefore,
additional payments will not be made for devices that are reprocessed
or reused. Hospitals that bill these devices might be considered to be
engaging in fraudulent billing practices.
Comment: A number of the commenters urged that we abandon the use
of an individual or brand-specific approach to approving devices for
transitional pass-through payments and adopt an approach that
distinguishes devices based on categories. The commenters argued that a
category approach is more appropriate and more efficient to implement
than an individual, item-specific approach. They alleged that the
latter approach creates winners and losers and delays timely approval
of new technologies.
Response: As previously stated, we adopted a trade-name specific
approach for several reasons. First, such an approach provides better
information. Codes that are largely item-specific allow us to track
what procedures the items are used with and costs of the items. When
the pass-through payments for an item ends, we would expect to have
good information for assigning it to relevant APCs and ensuring
appropriate payment for these APCs. Adopting a scheme with a
significant degree of categorization would require use of averages in
making assignments and setting payment rates. Decisions based on these
more limited data would likely lead to intensified concerns about the
appropriateness of APC assignment and payment.
Second, this approach permits finer discrimination in eligibility
decisions. An item-by-item approach allows us to be sure individual
items in fact meet the criteria for eligibility. Of major concern in
this instance is whether a device is "new" using the standard of the
statute. Section 1833(t)(6)(A) of the Act limits
[[Page 67823]]
transitional pass-through payment to those devices for which " * * *
payment for the device * * * as an outpatient hospital service under
this part was not being made as of December 31, 1996." Adopting
categories would in some cases mix "old" and "new" devices. In
these instances, either some old devices would get special treatment
that they would not be eligible for if they were examined on an item-
specific basis, or an entire category could be considered old, thus
depriving some new devices from special treatment they would be
eligible for if they were examined on an item-specific basis.
Third, an item-specific scheme avoids issues associated with the
design of categories needed for purposes of transitional pass-through
payments. It largely avoids concerns about what items should be in what
category or whether new categories should be created to accommodate
items that may appear to be little different from those in existing
categories.
Fourth, an item-specific approach allows us to assure that a newly
arriving device can obtain the full period of pass-through status it is
arguably eligible for under the statute. A categorization approach
would likely lead to latecomers being eligible for pass-through
payments only for a shorter period. Insofar as revision to APC payment
rates reflected the costs of items in the category by the time the
category was terminated, the shorter period would be of little
consequence. However, if the costs of the late-coming item were
significantly higher, this procedure could appear objectionable. A
solution in this case would be to create a new code, which could be
specific to that item, thus departing from a categorization approach.
We recognize that a category approach would lessen concerns about
competitive disadvantages that may have been inadvertently created by
an item specific approach and about access to specific items by
hospitals and their patients. However, we found no satisfactory way of
establishing categories that would not run into difficulty regarding
the test of whether a device is "new" as described above.
Consequently, we are making no change in our approach in response to
comments.
2. Revision to Grandfather Provision for Certain FQHCs and "Look-
Alikes"
In the April 7, 2000 final rule with comment period, which
discussed the provider-based status criteria and requirements, we
grandfathered FQHCs or "look-alikes" that were designated as such
before 1995 in order to assure the continuity of care and access to
care for patients of some of these facilities. To meet our original
policy intent of helping to ensure that the new criteria do not disrupt
the delivery of services to patients of these facilities, in the August
3, 2000 interim final rule with comment period (65 FR 47674), we
corrected Sec. 413.65(m) to state that a facility that has since April
7, 1995 furnished only services that were billed as if they had been
furnished by a department of a provider will continue to be considered
as a department of a provider, without regard to compliance with the
provider-based criteria, if the facility--
(1) Received a grant on or before April 7, 2000 under section 330
of the Public Health Service Act and continues to receive funding under
such a grant, or is receiving funding from a grant made on or before
April 7, 2000 under section 330 of the Public Health Service Act under
a contract with recipient of such a grant, and continues to meet the
requirements to receive a grant under section 330 of the Public Health
Service Act; or
(2) Based on the recommendation of the Public Health Service, was
determined by HCFA on or before April 7, 2000 to meet the requirements
for receiving a grant under section 330 of the Public Health Service
Act, and continues to meet such requirements. We made this change to
clarify that grandfathering under Sec. 413.65 is based on continued
status as a section 330 of the Public Health Service Act grantee or a
"look-alike" facility. We received no comments on this change.
3. Clarification of Notice of Beneficiary Cost-Sharing Liability
In the August 3, 2000 interim final rule with comment, we also
addressed whether hospitals could reasonably be expected to furnish an
exact statement of the patient's financial liability, since the exact
scope of services needed may not be known at the time notice must be
given. Specifically, we stated that when the extent of care needed is
not known before the patient is admitted, the hospital may furnish a
written notice to the patient that explains the general fact that the
beneficiary will incur a coinsurance liability to the hospital that he
or she would not incur if the facility were not provider based.
Furthermore, we clarified that the estimate of "potential financial
liability" in this written notice may be based on typical or average
charges for visits to the facility or organization, while stating that
the patient's actual liability will depend upon the actual services
furnished by the hospital.
Comment: One commenter stated that our clarification regarding the
notice of beneficiary cost sharing liability was helpful, but
recommended that we amend or modify the regulations at
Sec. 413.65(g)(7) to reflect such clarification since the wording of
the existing regulations states twice that the notice must be given
"prior to the delivery of services" without an exclusion for
emergency medical conditions. In addition, the regulation states that
the hospital has an obligation to notify the beneficiary of the
"potential financial liability" not just to provide the beneficiary
with "an estimate based upon typical or average charges" in the event
that the exact type and extent of care is not known.
The commenter also recommended that we require hospitals to only
notify the beneficiary of the fact that the beneficiary will incur a
coinsurance liability for hospital outpatient services without giving a
dollar amount of beneficiary copayment. Such a notice could include a
statement that the copayment liability will be determined by us and the
beneficiary will be notified of the exact amount once the hospital is
notified of the amount determined by us. The commenter believes that an
estimate based on charges would "miss the point" of this provision
since beneficiary copayment amounts are now determined by HCFA using an
APC grouper, not charges.
Response: We appreciate the commenter's concerns and agree that a
change in the regulations is needed to reflect the clarification
provided in the August 3, 2000 interim final rule with comment period
in a future proposed rule. As we stated in the August 3, 2000 interim
final rule with comment period (65 FR 47675), we are developing a
proposed rule that will further revise and clarify the notice
requirements. We are doing this to allow the public a full opportunity
to comment on the changes and to ensure that we have the benefit of all
relevant comments.
We disagree with the commenter's statement that an estimate based
on charges would "miss the point" of this provision since such a
notice is required only to give the beneficiary an idea or an example
of their "potential financial liability". As stated in the August 3,
2000 interim final rule with comment period (65 FR 47675), the estimate
should state that the beneficiary's "actual liability will depend upon
actual services furnished by the hospital." Also, with the delay in
the effective date of the provider-based status regulations until
January 10, 2001, hospitals will have at least five months of
experience with APC
[[Page 67824]]
payments under outpatient prospective payment system and should be able
to develop an appropriate estimate of a copayment amount based on APCs
rather than charges.
4. Clarification of Protocols for Off-Campus Departments
In the April 7, 2000 final rule, under new Sec. 489.24(i)(2) we
require hospitals to establish protocols for handling individuals with
potential emergency conditions who arrive at hospital off-campus
departments. Section 489.24(i)(2)(ii) further requires that if the off-
campus department is a physical therapy, radiology, or other facility
not routinely staffed with physicians, RNs, or LPNs, the department
personnel must be given protocols that direct them to contact emergency
personnel at the main hospital campus.
In the August 3, 2000 interim final rule with comment period, we
clarified that Sec. 489.24(i)(2) does not require a delay of an
appropriate transfer when the main hospital campus does not have the
specialized capability or facilities required by the individual or when
the individual's condition is deteriorating so rapidly that the time
needed to move the individual to the main hospital campus would
significantly jeopardize the individual's life or health. We also
stated that the contact with emergency personnel at the main hospital
campus should be made either after, or concurrently with, the actions
needed to arrange an appropriate transfer under Sec. 489.24(i)(3)(ii),
if doing otherwise would significantly jeopardize the individual's life
or health. We noted that this clarification does not relieve the off-
site department of the responsibility for making this contact, but only
clarifies that the contact may be delayed in specific cases when doing
otherwise would endanger a patient subject to EMTALA protection. We
received no comments on this clarification.
5. Typographical Errors in the Provider-Based Regulations
Comment: One commenter questioned whether the provider-based
regulations in Secs. 413.65 and 489.24, as they appeared in the April
7, 2000 final rule with comment period (65 FR 18538), contained
typographical errors.
Response: We are aware of typographical errors in the provider-
based regulations as published in the April 7, 2000 final rule with
comment period (65 FR 18538) and will be publishing a correction notice
(HCFA-1005-CN) to make these corrections.
III. Provisions of This Interim Final Rule With Comment Period
A. Changes Relating to the BBRA 1999 Public Comments
Except for the changes discussed in the preamble, we are adopting
the BBRA 1999 provisions implemented in the April 7, 2000 final rule
with comment period and the August 3, 2000 interim final rule with
comment period, described in section II of this preamble, as final
without modification. We are making the following changes to the
regulation text as a result of the public comments received:
We are revising Sec. 419.41(c)(4)(i) to provide that, effective
January 1, 2001, when multiple APCs for a single drug or biological are
furnished to a beneficiary on the same day, the inpatient hospital
deductible limitation on coinsurance will be applied to the aggregate
coinsurance for the drug or biological. The section is further revised
to provide that, effective July 1, 2001, the coinsurance amount for the
procedure or service that resulted in the administration of the drug or
biological will be aggregated with the coinsurance for the drug or
biological in applying the limit.
We are revising Sec. 419.70(f)(2)(ii) to remove the phrase
"without applying the cost reductions under section 1861(v)(1)(S) of
the Act". We recognize that the phase may have inadvertently caused
confusion to the extent it is redundant, as pointed out by a commenter.
B. Annual Updates to Components of the Hospital Outpatient Prospective
Payment System
In this interim final rule with comment period, for calendar year
2001, we are updating the wage index and the conversion factor
adjustment for covered hospital outpatient services furnished beginning
January 1, 2001. We also are updating the existing APC groups to
reflect new codes that have been assigned. In accordance with section
1833(t)(9)(A) of the Act and section 201(h)(2) of the BBRA 1999, we
will undertake a complete system update in 2001 for hospital outpatient
prospective payments. That update will take effect on January 1, 2002.
We will consult with an expert outside advisory panel composed of
appropriate representatives of providers. This panel will review and
advise us concerning the clinical integrity of the APC groups and
relative weights. The panel will be allowed to use data other than
those we have collected or developed during our review of the APC
groups and relative weights.
1. APC Groups
We are updating the existing APC groups effective January 1, 2001
to reflect the addition of new CPT and alpha-numeric codes, the
deletion of invalid codes, changes to the list of procedures we pay for
only in an inpatient setting (the "inpatient list"), the creation of
a new status indicator, newly covered procedures, reconfigurations due
to the inclusion of device costs, and revisions to correct errors and
provide consistency in the placement of codes.
a. New Codes
There are 936 new codes, 645 of which are "C" codes. "New" in
this context means new since the April 7, 2000 final rule with comment
period was published. Many of the "C" codes were published in program
memoranda over the intervening months. New codes are shown in Addendum
B with an asterisk in the column preceding the code.
b. Deleted Codes
With the exception of "C" codes, codes deleted effective January
1 of each year are given a 3-month grace period in which they will
still be recognized. "C" codes are temporary codes used exclusively
to bill pass-through items and new technology services and items paid
under the hospital prospective payment system. We will retire these
codes prospectively at the start of a new calendar quarter based on
specific service dates and are not extending the same 3-month grace
period to them. We will drop all non "C" codes from APCs effective
April l. Deleted codes are shown in Addendum B. They are followed by
the letter D. The AMA's CPT books also list deleted codes.
c. Revisions to Correct Errors or Inconsistencies
We are revising the APCs in order to correct errors and to provide
greater consistency in the placement of codes. For example, we had
assigned various types of cardiovascular diagnostic tests to four APCs,
with rates based on data that, on subsequent review, appeared limited.
We are recategorizing these APCs. This recategorization results in
three APCs with greater clinical coherence.
Medicare covers influenza, pneumococcal, and hepatitis B
immunizations routinely, with no copayment or deductible due for flu
and pneumonia vaccines or their administration. Other vaccines may be
covered in certain circumstances, but are, in fact, given so
infrequently that our cost data are limited. We are
[[Page 67825]]
rearranging the preventive vaccines and assigning the less frequently
furnished vaccines based on their reported costs, but within a smaller
range. We expect very few immunizations other than influenza and
pneumonia to be billed, but if they are billed, we will update our
data.
We also are changing the APCs to which bone density studies are
assigned. The codes used in 1996 captured both central and peripheral
bone density studies. Coding changes since that time have separated the
two types of studies, but this distinction was not reflected in the
1996 data. In order to better reflect these differences, we are
separating the various codes and assigning central dual energy x-ray
absorptiometry (DEXA) bone density studies to a new technology APC.
We did not include the codes for transfusion laboratory services
(for example, typing and crossmatching) in APCs in the April 7, 2000
final rule with comment period. We are now creating three APCs to
capture these codes, and an additional APC to capture fertility
procedures.
d. Device-Related Codes
As described in the April 7, 2000 final rule with comment period,
revenue centers 274, 275, and 278 were not included for purposes of
calculating the APC rates because prior to the BBRA 1999, we
anticipated paying for durable medical equipment and prosthetics
(including implantable devices) outside of the outpatient prospective
payment system and it was unfeasible to revise our database to reflect
the revenue centers in time to publish a final rule and implement the
prospective payment system by July 1, 2000. To reflect the inclusion of
implantable devices as required under the BBRA 1999, we have
recalculated APC rates with these revenue centers included. As a
result, the median cost for certain procedures such as inserting
pacemakers, replacing leads, and providing neurostimulators increased
significantly.
In order to recognize these cost increases, which are attributable
to the devices, and to aid in the assignment of devices to APCs at the
end of the pass-through period, we are reconfiguring certain APCs. That
is, we are creating APC groups for the insertion of pacemakers, the
replacement of pacemaker electrodes, the implantation of a pacemaker
and electrodes, and the removal of a pacemaker. These changes reflect
our basic criteria that procedures within an APC group be clinically
similar and comparable in terms of resources, with the highest cost
item or service within a group being no more than 2 times greater than
the lowest cost item or service within the same group.
e. Inpatient Codes Moved to the Outpatient Setting
In response to numerous requests, we reviewed the composition of
the inpatient list. While we continue to believe that we have the
majority of the codes assigned properly, for the reasons discussed in
section III.B.2. we are persuaded to move a number of codes to the
outpatient setting. We are able to place most codes into closely
related APCs.
f. "Two-times" Rule
The BBRA 1999 required us to ensure that no APC contains codes such
that the highest median cost in the APC exceed twice the lowest median
cost. We undertook an analysis of APCs in relation to this requirement
as part of the 2001 update. (Note that the law provides for exceptions
based on low volume and other reasons. We consider a code that captures
fewer than 2 percent of the services within an APC to be low volume,
and we disregard codes for unlisted services or procedures, since we do
not know what service or procedure was billed.) For example, moving a
radical mastectomy code from the inpatient list to a breast procedure
APC caused the group to fail the two-times test. In another instance,
as described above, we packaged costs associated with implantable
devices into the relevant procedure codes. This change would also cause
device-related APCs to fail the two-times test. For these situations
and others that failed the two-times test, we are reconfiguring the
APCs appropriately.
g. Inpatient Codes Moved to Outpatient and Affected by Device
Seven codes related to vascular and neurological procedures were
moved from the inpatient list into APCs, that were then split according
to device use, in response to comments.
h. Newly Covered Codes
The updated APCs reflect recent HCFA decisions to provide Medicare
coverage for an electrical bioimpedance procedure and three magnetic
resonance angiography services. The codes for these newly covered
services are M0302 and 71555, 73725, and 74185, respectively.
i. Pass-Through Requests for Drugs
Since publication of the April 7, 2000 final rule with comment
period, we have received additional requests for pass-through status
for a number of drugs. The codes for the additional eligible pass-
through drugs are shown in Addendum B.
The following table contains a listing of the changes in the APC
groups discussed above.
Summary of Changes to APCs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes to APC Placement of Existing Codes
---------------------------------------------------------------------------------------------------------------------------------
Inpatient codes
New Codes Revisions or moved to Pass-through
corrections of Device-related Inpatient moved "Two-times" outpatient and Newly covered requests for
errors codes to outpatient rule affected by codes drugs
device
--------------------------------------------------------------------------------------------------------------------------------------------------------
936 codes added, 645 111 codes changed 87 codes changed. 56 codes changed 25 codes changed. 7 codes changed. 4 codes changed. 4 codes changed
of which are "C". (12 as of 8/1/
2000).
[[Page 67826]]
Denoted by asterisk in APCs--0004, 0087, APCs--0082, 0083, APCs--0005, 0020, APCs--0028 and HCPCS--37620, HCPCS--71555, HCPCS--J1650,
Addendum B. 0099, 0100, 0089, 0091, 0021, 0029, 0029. 35011, 36834, 73725, 74185, J2770, J1810,
0102, 0123, 0093, 0103, 0046, 0050, 61880, 61888, M0302. J7315
0282, 0340, 0104, 0105, 0081, 0114, 33284, 63741.
0342, 0346, 0106, 0107, 0115, 0120,
0347, 0348, 0108, 0109, 0121, 0162,
0349, 0354, 0115, 0119, 0165, 0194,
0356, 0602, 0124, 0185, 0195, 0198 ,
0761, 0970, 0224, 0225, 0216, 0254,
0971, 0974, 0226, 0227, 0256, 0263,
0976, 1044, 0228, 0229, 0264, 0279,
1401, 1402, 0256, and 1002. 0280, 0970,
1403, 1404, 0974, and 0981..
1405, 1406,
1407, and 1409.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Addenda A and B reflect changes to the APC groups, effective
January 1, 2001. Addendum C, entitled "Hospital Outpatient Department
(HOPD) Payment for Procedures by APC, Calendar Year 2001," is not
published in this interim final rule with comment period, but will be
posted on our website at http://www.hcfa.gov/medlearn/refopps.htm.
Addendum C will display data similar to those contained in Addenda A
and B, but sorted by APCs with each procedure code listed that is
assigned to the APC.
2. Inpatient Procedures List Update
In the preamble to the April 7, 2000 final rule with comment
period, we indicated that, as part of our annual update process, we
would update the procedures on the inpatient list. The first annual
revision of this list is effective on January 1, 2001. We are removing
44 procedures from the list and placing them in APCs. (Several
procedures that were inadvertently left on the inpatient list in the
April 7, 2000 final rule with comment period were removed from the list
and placed in APCs in August 2000.) The revised list is included in
Addendum E.
We have attempted to limit the inpatient only list to those
procedures that, in current medical practice as understood by our
clinical staff, require inpatient care, such as those that are highly
invasive, result in major blood loss or temporary deficits of organ
systems (such as neurological impairment or respiratory insufficiency),
or otherwise require intensive or extensive postoperative care. Insofar
as advances in medical practice mitigate concerns about these
procedures being performed on an outpatient basis, we will be prepared
to remove them from the inpatient list and provide for payment under
the hospital outpatient prospective payment system. Since the April 7,
2000 final rule with comment period was published, we have received
requests to move a number of procedures from the inpatient list
because, based on medical evidence, the procedures can be performed
safely in a hospital outpatient setting. These included breast and
other cancer procedures, repairs of facial trauma, many orthopedic
procedures, several vascular procedures, and some genito-urinary
procedures.
Among the procedures we are removing from the inpatient list and
placing in APCs as a result of these requests are excision of chest
wall tumors, several orthopedic repairs, vascular procedures, and
ureteral endoscopies. We are moving overnight pulse oximetry from the
inpatient list to packaged status. We also are moving several
comparable procedures, for example, related ureteral endoscopies.
At this time, we are not removing from the inpatient list various
spinal procedures, including osteotomies and laminectomies. We also are
not removing several open abdominal and retroperitoneal procedures from
the inpatient list because many of these procedures involve prolonged
invasion of the thoracic cavity, the peritoneum, or the retroperitoneal
space. Patients undergoing these procedures typically require prolonged
postoperative monitoring. Moreover, the information provided to us by
requesters did not provide convincing evidence that these procedures
are currently being performed or can be safely performed in an
outpatient setting. However, we are aware that, with advances in
technology and surgical techniques, many of these procedures may
eventually be performed safely in a hospital outpatient setting. We
will continue to review all the procedures on the inpatient list and
will consider additional requests to move specific procedures to the
outpatient setting. We ask that these requests contain detailed
rationale along with medical evidence that the procedure may be
performed safely in an outpatient setting.
We note that, in some instances, requests for removing a particular
procedure from the inpatient list may have resulted from a
misunderstanding about appropriate coding. Less invasive versions of
the procedure on the inpatient list may be in an APC. The presence of
certain thoracoscopies on the inpatient list, for example, does not
mean that no thoracoscopy will be paid under the outpatient prospective
payment system.
We also were asked to move several procedures from APCs to the
inpatient list. Because of the rapid advance in technology and surgical
techniques mentioned above, we believe that if procedures have been
assigned APCs, we should not reverse that status unless it becomes
obvious that we have made an error. Thus, we are moving to the
inpatient setting only one of the codes for which we received a request
(open treatment of a knee dislocation, which requires more than
outpatient
[[Page 67827]]
postoperative monitoring), and two other codes (for nephrectomy with
total ureterectomy and for escharotomy) that had been assigned APCs in
error.
Beginning in April 2001, we will, if warranted, revise the
inpatient list at least quarterly to better reflect changes in medical
practice that permit procedures that were previously performed only in
an inpatient setting to be safely and effectively performed in an
outpatient setting. In the April 7, 2000 final rule with comment
period, we discussed our intent to revise the list as part of the
annual update of APCs and asked that interested parties advise us of
procedures that can be performed in an outpatient setting. Since we
will be making quarterly updates to the outpatient prospective payment
system for other purposes, we will also change the inpatient list
quarterly, if warranted. Generally, because of systems limitations, 3
months or more are required after a decision is made before we can
implement a change.
The inpatient list was not a result of a provision of the BBRA
1999; it was included in the September 1998 proposed rule and we
responded to comments and made the provision final in the April 7, 2000
final rule with comment. Accordingly, we did not request comments on
our policy on the establishment of the inpatient list at that time.
Nonetheless, we received a number of comments concerning the existence
of this list, the provisions for updating it, and its implications for
other Medicare payment systems. We will consider these comments and
expect to discuss the matter further in the proposed rule updating the
hospital outpatient prospective payment system for 2002, which we will
publish in the spring of 2001.
3. Wage Index Adjustment
Under section 1833(t)(2)(D) of the Act, we are required to
determine a wage adjustment factor to adjust, in a budget neutral
manner, the portion of the payment rate and the coinsurance amount that
is attributable to labor-related costs for relative differences in
labor and labor-related costs across geographic regions under the
hospital outpatient prospective payment system.
In the April 7, 2000 final rule with comment period, we specified,
in regulations at Sec. 419.43(c), that each year we use the hospital
inpatient prospective payment system wage index established in
accordance with 42 CFR Part 412 to make a wage adjustment for relative
differences in labor and labor-related costs across geographic areas
under the hospital outpatient prospective payment system. We note that,
by statute, we implement the annual update of the hospital inpatient
prospective payment system on a fiscal year basis. However, we update
the hospital outpatient prospective payment system on a calendar year
basis. Therefore, the hospital inpatient prospective payment system
wage index values established for urban and rural areas and for
reclassified hospitals published in the Federal Register on August 1,
2000 (65 FR 47149 through 47157) are being applied for wage adjustments
under the hospital outpatient prospective payment system, effective
January 1, 2001. The fiscal year 2001 hospital inpatient wage index
reflects the effects of hospitals redesignated under section
1886(d)(8)(B) of the Act and hospital reclassifications under section
1886(d)(10) of the Act. After publication of the hospital inpatient
wage index values for fiscal year 2001 on August 1, 2000, we discovered
several errors in the values for several geographic areas. The correct
wage index values for all areas are republished in Addenda F, G, and H
of this interim final rule with comment period.
In this interim final rule with comment period, we are establishing
the methodology that we will use in making adjustments for area wage
differences for services furnished in the Virgin Islands. We note that
a hospital inpatient prospective payment system wage index value is not
calculated for the Virgin Islands because there are no hospitals
located in that area that are paid under the inpatient hospital
prospective payment system. Because the wage index that we adopted in
our April 7, 2000 final rule with comment period does not include a
value for adjusting wage differences for the Virgin Islands, we will
use the wage index for the Virgin Islands as calculated for the skilled
nursing facilities prospective payment system to make this adjustment.
The skilled nursing facilities prospective payment system uses the
inpatient hospital wage index data to adjust its prospective payment
rates for the same fiscal year (that is effective October 1, 2000) as
covered by the hospital inpatient prospective payment system wage index
values. As stated in the July 31, 2000 skilled nursing facilities
prospective payment system final rule (65 FR 46770), "The computation
of the wage index * * * incorporate[s] the latest data and methodology
used to construct the hospital wage index. For these reasons, the wage
index adjustment that we will apply to the Virgin Islands for services
furnished on or after January 1, 2001 is 0.6306.
Although the wage index for skilled nursing facilities is based on
a fiscal year beginning October 1, we will apply the wage index factor
for the Virgin Islands that goes into effect on October 1 of each year
to the hospital outpatient prospective payment system services
furnished during the following calendar year. This is consistent with
how we apply the hospital inpatient prospective payment system wage
index values to the hospital outpatient prospective payment system
services.
Consistent with the methodology applicable for services furnished
in 2000 (on or after August 1, 2000), in making adjustments for area
wage differences for services furnished in 2001, we will recognize 60
percent of the hospital's costs as labor-related costs that are
standardized for geographic wage differences.
4. Conversion Factor Update
Section 1833(t)(3)(C)(ii) of the Act requires us to update annually
the conversion factor used to determine APC payment rates. Section
1833(t)(3)(C)(iii) of the Act provides that the update be equal to the
hospital inpatient market basket percentage increase applicable to
hospital discharges under section 1886(b)(3)(B)(iii) of the Act,
reduced by one percentage point for the years 2000, 2001, and 2002.
Thus, the update to the outpatient hospital prospective payment system
conversion factor for 2001 is 2.4 percent (3.4 percent minus 1
percent).
In accordance with section 1833(t)(9)(B) of the Act, the conversion
factor for 2001 also has been adjusted to ensure that the revisions we
made to update the wage index are made on a budget-neutral basis. A
budget neutrality factor of .9989 was calculated for wage index changes
by comparing total payments from our simulation model using the wage
index values that will be effective January 1, 2001.
The market basket increase of 2.4 percent for 2001 and the required
budget neutrality adjustment calculated to be .9989 result in a
conversion factor for 2001 of $49.596.
IV. Waiver of Notice of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comments on the proposed rule. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and substance
of the proposed rule or a description of the subjects and
[[Page 67828]]
issues involved. This procedure can be waived, however, if an agency
finds good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest, and incorporates a
statement of the finding and its reasons in the rule. For the reasons
set forth below, we find that the circumstances surrounding this
interim final rule with comment period make it either unnecessary or
impracticable to pursue a notice-and-comment procedure before the
provisions of this interim final rule with comment period take effect.
As discussed earlier in this interim final rule with comment
period, we implemented the hospital outpatient prospective payment
system on August 1, 2000 in accordance with the methodology that we set
forth in the April 7, 2000 final rule with comment period (65 FR
18434). In section III.I. of the April 7, 2000 final rule with comment
period (65 FR 18501), we discuss how we will update the outpatient
prospective payment system on an annual basis. We are required under
section 1833(t)(3)(C)(ii) of the Act to update annually the conversion
factor used to determine the APC payment rates. Under the regulations,
42 CFR 419.43, the wage adjustment under outpatient prospective payment
system is based on the hospital inpatient wage index, and we updated
the hospital inpatient wage index after the publication of the April 7,
2000 final rule with comment period. Accordingly, in this interim final
rule with comment period, we are updating the conversion factor and the
wage index adjustment for covered hospital outpatient services
furnished beginning January 1, 2001, using the methodology published in
the April 7, 2000 final rule with comment period, for which we had
previously received comments. We also are updating the existing APC
groups to reflect new and deleted CPT codes for 2001 and reconfiguring
certain APC groups using more recent data to ensure clinical integrity
and consideration of resource use as required by section 1833(t)(8)(A)
of the Act and as described in the April 7, 2000 final rule with
comment period (65 FR 18456 and 18501). Because these various
adjustments are being made in accordance with existing methodology as
set forth in the April 7, 2000 final rule with comment period, we
believe it is unnecessary to address them further through the notice-
and-comment procedure.
In addition, we find good cause to waive prior notice-and-comment
procedures with respect to the Virgin Islands wage index methodology
because it would have been impracticable to undertake and complete
notice-and-comment procedures on this issue in time for the Virgin
Islands outpatient prospective payment system wage index value to be
effective at the same time as the updated outpatient prospective
payment system wage index values for all other areas.
Accordingly, we find good cause to waive the notice-and-comment
procedure with respect to the annual update of the wage index values,
conversion factor, and the APC groups. However, we are providing for a
60-day comment period as specified in the "Dates" section of this
preamble.
II. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
VI. Regulatory Impact
A. General
We have examined the impacts of this interim final with comment
period rule as required by Executive Order 12866, the Unfunded Mandates
Reform Act of 1965, and the Regulatory Flexibility Act (RFA) (Public
Law 96-354). Executive Order 12866 directs agencies to assess all costs
and benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more annually).
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in an expenditure in any one year by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $100 million. This final rule does not mandate any
requirements for State, local, or tribal governments.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations and government agencies. For
purposes of the RFA, we consider all hospitals to be small entities.
Individuals and States are not included in the definition of a small
entity.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. With
the exception of hospitals located in certain New England counties, for
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area (MSA) or New England County Metropolitan Area (NECMA).
Section 601(g) of the Social Security Amendments of 1983 (Public Law
98-21) designated hospitals in certain New England counties as
belonging to the adjacent NECMA. Thus, for purposes of the hospital
outpatient prospective payment system, we classify these hospitals as
urban hospitals.
B. Analysis for Changes in this Interim Final Rule with Comment Period
We implemented the outpatient prospective payment system on August
1, 2000 in accordance with the methodology published in the April 7,
2000 final rule with comment period. In section III.I. of the April 7,
2000 final rule with comment period (65 FR 18501), we discuss how we
will update the outpatient prospective payment system on an annual
basis. We are required under section 1833(t)(3)(C)(ii) of the Act to
update annually the conversion factor used to determine the APC payment
rates. We are required under section 1833(t)(8)(A) of the Act to revise
not less often than annually the wage and other adjustments.
Accordingly, in this interim final rule with comment period, we are
updating the conversion factor and the wage index adjustment for
covered hospital outpatient services furnished beginning January 1,
2001, using the methodology published in the April 7, 2000 final rule
with comment period, for which we had previously received comments.
In section IX.B. of the preamble of the April 7, 2000 final rule
with comment period, we gave our Office of the Actuary's projection of
the additional benefit expenditures from the Medicare Part B Trust Fund
resulting from implementation of the hospital outpatient prospective
payment system and the hospital outpatient provisions enacted by the
BBRA 1999. The impact of implementing the hospital outpatient
prospective payment system on the Medicare program is reflected in the
table below, which is republished from the April 7, 2000 final rule
with
[[Page 67829]]
comment period (65 FR 18530). The calendar year 2001 increase in total
payments to hospitals, which results primarily from the updated
conversion factor, is already included as part of HCFA's current law
baseline expenditures for hospital outpatient services under the
outpatient prospective payment system.
------------------------------------------------------------------------
Impact (in
Fiscal year millions)
------------------------------------------------------------------------
2001....................................................... $3,030
2002....................................................... 3,520
2003....................................................... 4,230
2004....................................................... 4,670
------------------------------------------------------------------------
We also are updating the existing APC groups to reflect new and
deleted CPT codes for 2001 and adjusting the groups to reflect more
recent data as we described in the April 7, 2000 final rule with
comment period. The provisions of this interim final rule with comment
period do not measurably alter the effect of the outpatient prospective
payment system on the groups of hospitals or geographic areas as
projected in Table 2 of the April 7, 2000 final rule with comment
period (65 FR 18533-18534).
C. Federalism
We have examined this interim rule with comment period in
accordance with Executive Order 13132, Federalism, and have determined
that it will not have any negative impact on the rights, roles, and
responsibilities of State, local or Tribal governments.
D. Executive Order 12866 and 5 U.S.C. 804(2)
The statutory effects of the provisions that are being implemented
by this interim final rule with comment period result in expenditures
exceeding $100 million per year. Therefore, this interim final rule
with comment period is an economically significant rule under Executive
Order 12866, and a major rule under 5 U.S.C. 804(2).
In accordance with the provisions of Executive Order 12866, this
interim final rule with comment period was reviewed by the Office of
Management and Budget.
List of Subjects in 42 CFR Part 419
Health facilities, Hospitals, Medicare.
For the reasons set forth in the preamble, 42 CFR Part 419 is
amended as set forth below:
PART 419--PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT
DEPARTMENT SERVICES
1. The authority citation for Part 419 continues to read as
follows:
Authority: Secs. 1102, 1833(t), and 187l of the Social Security
Act (42 U.S.C. 1302, 1395l(t), and 1395hh).
2. Section 419.41 is amended by revising paragraph (c)(4)(i) to
read as follows:
Sec. 419.41 Calculation of national beneficiary coinsurance amounts
and national Medicare program payment amounts.
* * * * *
(c) * * *
(4) * * *
(i) The coinsurance amount for an APC cannot exceed the amount of
the inpatient hospital deductible, established in accordance with
Sec. 409.82 of this chapter, for that year. For purposes of this
paragraph (c)--
(A) Effective for drugs and biologicals furnished on or after
January 1, 2001, the coinsurance amount for multiple APCs for a single
drug or biological furnished on the same day will be aggregated and
treated as the coinsurance amount for one APC.
(B) Effective for drugs and biologicals furnished on or after July
1, 2001, the coinsurance amount for the APC or APCs for a drug or
biological furnished on the same day will be aggregated with the
coinsurance amount for the APC that reflects the administration of the
drug or biological furnished on that day and treated as the coinsurance
amount for one APC.
* * * * *
3. Section 419.70 is amended by revising paragraph (f)(2)(ii) to
read as follows:
Sec. 419.70 Transitional adjustment to limit decline in payment.
* * * * *
(f) * * *
(2) * * *
(ii) The reasonable cost of these services for this period.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare'Supplementary Medical Insurance Program)
Dated: November 1, 2000.
Michael M. Hash,
Acting Administrator, Health Care Financing Administration.
Approved: November 1, 2000.
Donna E. Shalala,
Secretary.
Note to the Addenda: The following Addenda A through H will not
appear in the Code of Federal Regulations.
Addenda A through H provide various data pertaining to the
Medicare hospital outpatient prospective payment system. Addendum A
contains the APCs with title, status indicators, relative weight,
payment rate, national unadjusted coinsurance, and minimum
unadjusted coinsurance. Addendum B differs from Addendum A in that
the APC titles are not listed and both HCPCS codes and descriptions
appear. Addendum C, entitled "Hospital Outpatient Department (HOPD)
Payment for Procedures by APC, Calendar Year 2001," is not
published in this interim final rule with comment period, but will
be posted on our website at (http://www.hcfa.gov/medlearn/
refopps.htm). Addendum C will display data similar to those
contained in Addenda A and B, but sorted by APCs with each procedure
code listed that is assigned to the APC. Addendum D lists the status
indicators for how various services are treated under the hospital
outpatient prospective payment system. Addendum E lists the
procedures that we pay for only in an inpatient setting. Addendum F
lists the wage index for urban areas, Addendum G lists the wage
index for rural areas, and Addendum H lists the wage index for
hospitals that are reclassified.
Addendum A.--List of Hospital Outpatient Ambulatory Payment
Classification Groups with Status Indicators, Relative Weights, Payment
Rates, and Coinsurance Amounts
The payment rate (once wage adjusted) is the total payment to
the hospital. The coinsurance amount is part of the total payment
rate.
Those APCs with status indicators "G" or "J" denote the
inclusion of drugs that are eligible for pass-through payments. The
relative weight column for these drug APCs is empty since payment
for pass-through drugs/biologicals is calculated using the average
wholesale price for the drug/biological rather than the relative
weight. Note also that the only coinsurance column that has been
filled is the minimum unadjusted coinsurance column. The coinsurance
is applied to the nonpass-through portion of the payment rate for
the drug/biological.
Those APCs with status indicator "H" denote the inclusion of
devices that are eligible for pass-through payments. The relative
weight, payment rate, and coinsurance columns are not filled for
these APCs. The relative weight and payment rate columns are empty
because payment for pass-through devices is determined based on the
hospital's submitted charges adjusted to cost using the hospital's
cost-to-charge ratio. This calculation is done in the PRICER. The
coinsurance columns for these APCs are not filled since the
coinsurance is applied to the APC that contains the procedure with
which the pass-through device is used rather than to the device APC.
Addendum B.--Hospital Outpatient Department (HOPD) Payment Status by
HCPCS Code and Related Information
The codes listed in this addendum include the 2001 CPT codes as
published in CPT 2001 by the American Medical Association. Also
listed are the codes that have been deleted for 2001. These codes
are denoted in the CPT column with the subscript letter "D". These
codes are billable through March 31, 2001 for services occurring
before January 1, 2001. Deleted codes billed after March 31,
[[Page 67830]]
2001 will be rejected. CPT codes appearing for the first time in
2001 are denoted in the CPT column with bolded print. These codes
are new for 2001 and are billable effective January 1, 2001.
All CPT codes that are paid only as inpatient procedures are
denoted by the status indicator "C". A number of procedures that
appeared on the inpatient list in the April 7, 2000 final rule with
comment period are now payable under the hospital outpatient
prospective payment system. The status indicators for these codes
have been updated to reflect their current payment status.
Addendum A.--List of Hospital Outpatient Ambulatory Payment Classifications With Status Indicators, Relative
Weights, Payment Rates, and Coinsurance Amounts, Calendar Year 2001
----------------------------------------------------------------------------------------------------------------
National Minimum
APC Group title Status indicator Relative Payment unadjusted unadjusted
weight rate coinsurance coinsurance
----------------------------------------------------------------------------------------------------------------
0001 Photochemotherapy.......... S 0.47 $23.31 $8.49 $4.66
0002 Fine needle Biopsy/ T 0.62 $30.75 $17.66 $6.15
Aspiration.
0003 Bone Marrow Biopsy/ T 0.98 $48.61 $27.99 $9.72
Aspiration.
0004 Level I Needle Biopsy/ T 1.84 $91.26 $32.57 $18.25
Aspiration Except Bone
Marrow.
0005 Level II Needle Biopsy / T 5.41 $268.32 $119.75 $53.66
Aspiration Except Bone
Marrow.
0006 Level I Incision & Drainage T 2.00 $99.19 $33.95 $19.84
0007 Level II Incision & T 3.68 $182.51 $72.03 $36.50
Drainage.
0008 Level III Incision & T 6.15 $305.02 $113.67 $61.00
Drainage.
0009 Nail Procedures............ T 0.74 $36.70 $9.63 $7.34
0010 Level I Destruction of T 0.55 $27.28 $9.86 $5.46
Lesion.
0011 Level II Destruction of T 2.72 $134.90 $50.01 $26.98
Lesion.
0012 Level I Debridement & T 0.53 $26.29 $9.18 $5.26
Destruction.
0013 Level II Debridement & T 0.91 $45.13 $17.66 $9.03
Destruction.
0014 Level III Debridement & T 1.50 $74.39 $24.55 $14.88
Destruction.
0015 Level IV Debridement & T 1.77 $87.78 $31.20 $17.56
Destruction.
0016 Level V Debridement & T 3.53 $175.07 $74.67 $35.01
Destruction.
0017 Level VI Debridement & T 12.45 $617.47 $289.16 $123.49
Destruction.
0018 Biopsy Skin, Subcutaneous T 0.94 $46.62 $17.66 $9.32
Tissue or Mucous Membrane.
0019 Level I Excision/ Biopsy... T 4.00 $198.39 $78.91 $39.68
0020 Level II Excision/ Biopsy.. T 6.51 $322.87 $130.53 $64.57
0021 Level III Excision/ Biopsy. T 10.49 $520.26 $236.51 $104.05
0022 Level IV Excision/ Biopsy.. T 12.49 $619.45 $292.94 $123.89
0023 Exploration Penetrating T 1.98 $98.20 $40.37 $19.64
Wound.
0024 Level I Skin Repair........ T 2.43 $120.51 $44.50 $24.10
0025 Level II Skin Repair....... T 3.74 $185.49 $70.66 $37.10
0026 Level III Skin Repair...... T 12.11 $600.61 $277.92 $120.12
0027 Level IV Skin Repair....... T 15.80 $783.62 $383.10 $156.72
0028 Level I Incision/Excision T 12.37 $613.52 $303.74 $122.70
Breast.
0029 Level II Incision/Excision T 31.39 $1,557.05 $820.79 $311.41
Breast.
0030 Breast Reconstruction...... T 31.11 $1,543.16 $763.55 $308.63
0032 Placement Transvenous T 5.40 $267.82 $119.52 $53.56
Catheters/Arterial Cutdown.
0033 Partial Hospitalization.... P 4.17 $206.82 $48.17 $41.36
0040 Arthrocentesis & Ligament/ T 2.11 $104.65 $40.60 $20.93
Tendon Injection.
0041 Arthroscopy................ T 24.57 $1,218.58 $592.08 $243.72
0042 Arthroscopically-Aided T 29.22 $1,449.19 $804.74 $289.84
Procedures.
0043 Closed Treatment Fracture T 1.64 $81.34 $25.46 $16.27
Finger/Toe/Trunk.
0044 Closed Treatment Fracture/ T 2.17 $107.63 $38.08 $21.53
Dislocation Except Finger/
Toe/Trunk.
0045 Bone/Joint Manipulation T 11.02 $546.55 $277.12 $109.31
Under Anesthesia.
0046 Open/Percutaneous Treatment T 22.29 $1,105.50 $535.76 $221.10
Fracture or Dislocation.
0047 Arthroplasty without T 22.09 $1,095.58 $537.03 $219.12
Prosthesis.
0048 Arthroplasty with T 29.06 $1,441.26 $725.94 $288.25
Prosthesis.
0049 Level I Musculoskeletal T 15.04 $745.93 $356.95 $149.19
Procedures Except Hand and
Foot.
0050 Level II Musculoskeletal T 21.13 $1,047.96 $513.86 $209.59
Procedures Except Hand and
Foot.
0051 Level III Musculoskeletal T 27.76 $1,376.79 $675.24 $275.36
Procedures Except Hand and
Foot.
0052 Level IV Musculoskeletal T 36.16 $1,793.39 $930.91 $358.68
Procedures Except Hand and
Foot.
0053 Level I Hand T 11.32 $561.42 $253.49 $112.28
Musculoskeletal Procedures.
0054 Level II Hand T 19.66 $975.06 $472.33 $195.01
Musculoskeletal Procedures.
0055 Level I Foot T 15.47 $767.26 $355.34 $153.45
Musculoskeletal Procedures.
0056 Level II Foot T 17.30 $858.02 $405.81 $171.60
Musculoskeletal Procedures.
0057 Bunion Procedures.......... T 21.00 $1,041.52 $496.65 $208.30
0058 Level I Strapping and Cast S 1.09 $54.06 $19.27 $10.81
Application.
0059 Level II Strapping and Cast S 1.74 $86.30 $29.59 $17.26
Application.
0060 Manipulation Therapy....... S 0.77 $38.19 $7.80 $7.64
0070 Thoracentesis/Lavage T 3.64 $180.53 $79.60 $36.11
Procedures.
0071 Level I Endoscopy Upper T 0.55 $27.28 $14.22 $5.46
Airway.
0072 Level II Endoscopy Upper T 1.26 $62.49 $41.52 $12.50
Airway.
0073 Level III Endoscopy Upper T 4.11 $203.84 $91.07 $40.77
Airway.
0074 Level IV Endoscopy Upper T 13.61 $675.00 $347.54 $135.00
Airway.
0075 Level V Endoscopy Upper T 18.55 $920.01 $467.29 $184.00
Airway.
0076 Endoscopy Lower Airway..... T 8.06 $399.75 $197.05 $79.95
0077 Level I Pulmonary Treatment S 0.43 $21.33 $12.62 $4.27
0078 Level II Pulmonary S 1.34 $66.46 $29.13 $13.29
Treatment.
0079 Ventilation Initiation and S 3.18 $157.72 $107.70 $31.54
Management.
0080 Diagnostic Cardiac T 31.55 $1,564.75 $838.92 $312.95
Catheterization.
0081 Non-Coronary Angioplasty or T 28.81 $1,428.86 $710.91 $285.77
Atherectomy.
0082 Coronary Atherectomy....... T 51.01 $2,529.89 $1,351.74 $505.98
0083 Coronary Angioplasty....... T 29.70 $1,473.00 $794.30 $294.60
0084 Level I Electrophysiologic S 10.70 $530.68 $177.79 $106.14
Evaluation.
0085 Level II Electrophysiologic S 27.06 $1,342.07 $654.48 $268.41
Evaluation.
0086 Ablate Heart Dysrhythm S 47.62 $2,361.76 $1,265.37 $472.35
Focus.
0087 Cardiac Electrophysiologic S 9.53 $472.65 $214.72 $94.53
Recording/Mapping.
0088 Thrombectomy............... T 26.49 $1,313.80 $678.68 $262.76
[[Page 67831]]
0089 Insertion/Replacement of T 78.45 $3,890.81 $2,275.19 $778.16
Permanent Pacemaker and
Electrodes.
0090 Insertion/Replacement of T 78.28 $3,882.37 $2,133.88 $776.47
Pacemaker Pulse Generator.
0091 Level I Vascular Ligation.. T 14.79 $733.52 $348.23 $146.70
0092 Level II Vascular Ligation. T 20.21 $1,002.34 $505.37 $200.47
0093 Vascular Repair/Fistula T 12.82 $635.82 $277.34 $127.16
Construction.
0094 Resuscitation and S 4.51 $223.68 $105.29 $44.74
Cardioversion.
0095 Cardiac Rehabilitation..... S 0.64 $31.74 $16.98 $6.35
0096 Non-Invasive Vascular S 2.06 $102.16 $61.48 $20.43
Studies.
0097 Cardiac Monitoring for 30 X 1.62 $80.35 $62.40 $16.07
days.
0098 Injection of Sclerosing T 1.19 $59.02 $20.88 $11.80
Solution.
0099 Electrocardiograms......... S 0.38 $18.85 $14.68 $3.77
0100 Stress Tests and Continuous X 1.70 $84.32 $71.57 $16.86
ECG.
0101 Tilt Table Evaluation...... S 4.47 $221.70 $128.84 $44.34
0102 Electronic Analysis of S 0.45 $22.32 $12.62 $4.46
Pacemakers/other Devices.
0103 Miscellaneous Vascular T 13.09 $649.21 $295.70 $129.84
Procedures.
0104 Transcatheter Placement of T 14.94 $740.96 $339.51 $148.19
Intracoronary Stents.
0105 Revision/Removal of T 15.06 $746.92 $372.32 $149.38
Pacemakers, AICD, or
Vascular Device.
0106 Insertion/Replacement/ T 18.96 $940.34 $503.07 $188.07
Repair of Pacemaker
Electrodes.
0107 Insertion of Cardioverter- T 147.51 $7,315.91 $5,086.37 $1,463.18
Defibrillator.
0108 Insertion/Replacement/ T 210.84 $10,456.84 $5,484.72 $2,091.37
Repair of Cardioverter-
Defibrillator Leads.
0109 Removal of Implanted T 6.53 $323.86 $133.51 $64.77
Devices.
0110 Transfusion................ S 5.83 $289.15 $122.73 $57.83
0111 Blood Product Exchange..... S 14.17 $702.77 $300.74 $140.55
0112 Extracorporeal S 39.60 $1,964.01 $663.65 $392.80
Photopheresis.
0113 Excision Lymphatic System.. T 13.89 $688.89 $326.55 $137.78
0114 Thyroid/Lymphadenectomy T 19.56 $970.10 $493.78 $194.02
Procedures.
0115 Cannula/Access Device T 19.34 $959.19 $506.74 $191.84
Procedures.
0116 Chemotherapy Administration S 2.34 $116.06 $23.21 $23.21
by Other Technique Except
Infusion.
0117 Chemotherapy Administration S 1.84 $91.26 $71.80 $18.25
by Infusion Only.
0118 Chemotherapy Administration S 2.90 $143.83 $72.03 $28.77
by Both Infusion and Other
Technique.
0119 Implantation of Devices.... T 9.87 $489.59 $161.50 $97.92
0120 Infusion Therapy Except T 1.66 $82.33 $42.67 $16.47
Chemotherapy.
0121 Level I Tube changes and T 2.36 $117.05 $52.53 $23.41
Repositioning.
0122 Level II Tube changes and T 5.04 $249.96 $114.93 $49.99
Repositioning.
0123 Bone Marrow Harvesting and S 4.13 $204.83 $40.97 $40.97
Bone Marrow/Stem Cell
Transplant.
0124 Revision of Implanted T 2.55 $126.64 $81.36 $25.33
Infusion Pump.
0130 Level I Laparoscopy........ T 25.36 $1,257.75 $659.53 $251.55
0131 Level II Laparoscopy....... T 41.81 $2,073.61 $1,089.88 $414.72
0132 Level III Laparoscopy...... T 48.91 $2,425.74 $1,239.22 $485.15
0140 Esophageal Dilation without T 4.74 $235.09 $107.24 $47.02
Endoscopy.
0141 Upper GI Procedures........ T 7.15 $354.61 $184.67 $70.92
0142 Small Intestine Endoscopy.. T 7.45 $369.49 $162.42 $73.90
0143 Lower GI Endoscopy......... T 7.98 $395.78 $199.12 $79.16
0144 Diagnostic Anoscopy........ T 2.23 $110.60 $49.32 $22.12
0145 Therapeutic Anoscopy....... T 7.46 $369.98 $179.39 $74.00
0146 Level I Sigmoidoscopy...... T 2.83 $140.36 $65.15 $28.07
0147 Level II Sigmoidoscopy..... T 6.26 $310.47 $149.11 $62.09
0148 Level I Anal/Rectal T 2.34 $116.06 $43.59 $23.21
Procedure.
0149 Level II Anal/Rectal T 12.86 $637.80 $293.06 $127.56
Procedure.
0150 Level III Anal/Rectal T 17.68 $876.86 $437.12 $175.37
Procedure.
0151 Endoscopic Retrograde T 10.53 $522.25 $245.46 $104.45
Cholangio-Pancreatography
(ERCP).
0152 Percutaneous Biliary T 8.22 $407.68 $207.38 $81.54
Endoscopic Procedures.
0153 Peritoneal and Abdominal T 19.62 $973.08 $496.31 $194.62
Procedures.
0154 Hernia/Hydrocele Procedures T 22.43 $1,112.45 $556.98 $222.49
0157 Colorectal Cancer S 1.79 $88.78 ........... $22.19
Screening: Barium Enema.
0158 Colorectal Cancer S 7.98 $395.78 ........... $98.94
Screening: Colonoscopy.
0159 Colorectal Cancer S 2.83 $140.36 ........... $35.09
Screening: Flexible
Sigmoidoscopy.
0160 Level I Cystourethroscopy T 5.43 $269.30 $110.11 $53.86
and other Genitourinary
Procedures.
0161 Level II Cystourethroscopy T 10.94 $542.58 $249.36 $108.52
and other Genitourinary
Procedures.
0162 Level III Cystourethroscopy T 17.49 $867.44 $427.49 $173.49
and other Genitourinary
Procedures.
0163 Level IV Cystourethroscopy T 28.98 $1,437.30 $792.58 $287.46
and other Genitourinary
Procedures.
0164 Level I Urinary and Anal T 2.17 $107.64 $33.03 $21.53
Procedures.
0165 Level II Urinary and Anal T 3.89 $192.92 $91.76 $38.58
Procedures.
0166 Level I Urethral Procedures T 10.17 $504.39 $218.73 $100.88
0167 Level II Urethral T 21.06 $1,044.50 $555.84 $208.90
Procedures.
0168 Level III Urethral T 24.94 $1,236.93 $536.11 $247.39
Procedures.
0169 Lithotripsy................ T 46.72 $2,317.13 $1,384.20 $463.43
0170 Dialysis for Other Than S 6.68 $331.30 $72.26 $66.26
ESRD Patients.
0180 Circumcision............... T 13.62 $675.49 $304.87 $135.10
0181 Penile Procedures.......... T 32.37 $1,605.43 $906.36 $321.09
0182 Insertion of Penile T 52.11 $2,584.45 $1,525.05 $516.89
Prosthesis.
0183 Testes/Epididymis T 18.26 $905.62 $448.94 $181.12
Procedures.
0184 Prostate Biopsy............ T 4.94 $245.01 $122.96 $49.00
0185 Removal or Repair of Penile T 32.37 $1,605.43 $906.36 $321.09
Prosthesis.
0190 Surgical Hysteroscopy...... T 17.85 $885.29 $443.89 $177.06
0191 Level I Female Reproductive T 1.19 $59.02 $17.43 $11.80
Procedures.
0192 Level II Female T 2.38 $118.04 $35.33 $23.61
Reproductive Procedures.
0193 Level III Female T 8.93 $442.89 $171.13 $88.58
Reproductive Procedures.
[[Page 67832]]
0194 Level IV Female T 16.21 $803.96 $395.94 $160.79
Reproductive Procedures.
0195 Level V Female Reproductive T 18.68 $926.46 $483.80 $185.29
Procedures.
0196 Dilatation & Curettage..... T 14.47 $717.66 $357.98 $143.53
0197 Infertility Procedures..... T 2.40 $119.03 $49.55 $23.81
0198 Pregnancy and Neonatal Care T 1.34 $66.46 $33.03 $13.29
Procedures.
0199 Vaginal Delivery........... T 11.20 $555.48 $157.83 $111.10
0200 Therapeutic Abortion....... T 13.89 $688.89 $373.23 $137.78
0201 Spontaneous Abortion....... T 13.00 $644.75 $329.65 $128.95
0210 Spinal Tap................. T 3.00 $148.79 $62.40 $29.76
0211 Level I Nervous System T 3.32 $164.66 $74.78 $32.93
Injections.
0212 Level II Nervous System T 3.64 $180.53 $88.78 $36.11
Injections.
0213 Extended EEG Studies and S 11.15 $553.00 $290.42 $110.60
Sleep Studies.
0214 Electroencephalogram....... S 2.32 $115.06 $58.50 $23.01
0215 Level I Nerve and Muscle S 1.15 $57.04 $30.05 $11.41
Tests.
0216 Level II Nerve and Muscle S 2.87 $142.34 $64.69 $28.47
Tests.
0217 Level III Nerve and Muscle S 5.87 $291.13 $156.68 $58.23
Tests.
0220 Level I Nerve Procedures... T 13.96 $692.36 $326.21 $138.47
0221 Level II Nerve Procedures.. T 18.36 $910.58 $463.62 $182.12
0222 Implantation of T 124.43 $6,171.23 $2,955.13 $1,234.25
Neurological Device.
0223 Implantation of Pain T 7.05 $349.65 $154.27 $69.93
Management Device.
0224 Implantation of Reservoir/ T 17.89 $887.27 $453.41 $177.45
Pump/Shunt.
0225 Implantation of T 17.72 $878.84 $408.33 $175.77
Neurostimulator Electrodes.
0226 Implantation of Drug T 5.62 $278.73 $109.42 $55.75
Infusion Reservoir.
0227 Implantation of Drug T 11.17 $553.99 $330.11 $110.80
Infusion Device.
0228 Creation of Lumbar T 25.06 $1,242.88 $696.46 $248.58
Subarachnoid Shunt.
0229 Transcatherter Placement of T 34.81 $1,726.44 $1,030.12 $345.29
Intravascular Shunts.
0230 Level I Eye Tests.......... S 0.98 $48.61 $22.48 $9.72
0231 Level II Eye Tests......... S 2.64 $130.94 $59.87 $26.19
0232 Level I Anterior Segment T 6.04 $299.56 $134.66 $59.91
Eye.
0233 Level II Anterior Segment T 13.79 $683.93 $331.60 $136.79
Eye.
0234 Level III Anterior Segment T 20.64 $1,023.66 $502.16 $204.73
Eye Procedures.
0235 Level I Posterior Segment T 2.94 $145.81 $78.91 $29.16
Eye Procedures.
0236 Level II Posterior Segment T 6.70 $332.29 $147.96 $66.46
Eye Procedures.
0237 Level III Posterior Segment T 33.96 $1,684.28 $852.68 $336.86
Eye Procedures.
0238 Level I Repair and Plastic T 2.80 $138.87 $58.96 $27.77
Eye Procedures.
0239 Level II Repair and Plastic T 6.26 $310.47 $123.42 $62.09
Eye Procedures.
0240 Level III Repair and T 13.47 $668.06 $315.31 $133.61
Plastic Eye Procedures.
0241 Level IV Repair and Plastic T 16.60 $823.30 $384.47 $164.66
Eye Procedures.
0242 Level V Repair and Plastic T 23.70 $1,175.42 $597.36 $235.08
Eye Procedures.
0243 Strabismus/Muscle T 17.99 $892.23 $431.39 $178.45
Procedures.
0244 Corneal Transplant......... T 32.88 $1,630.72 $851.42 $326.14
0245 Cataract Procedures without T 26.55 $1,316.77 $623.85 $263.35
IOL Insert.
0246 Cataract Procedures with T 26.55 $1,316.77 $623.85 $263.35
IOL Insert.
0247 Laser Eye Procedures Except T 4.89 $242.52 $112.86 $48.50
Retinal.
0248 Laser Retinal Procedures... T 4.19 $207.81 $94.05 $41.56
0250 Nasal Cauterization/Packing T 2.21 $109.61 $38.54 $21.92
0251 Level I ENT Procedures..... T 1.68 $83.32 $27.99 $16.66
0252 Level II ENT Procedures.... T 5.18 $256.90 $114.24 $51.38
0253 Level III ENT Procedures... T 12.02 $596.14 $284.00 $119.23
0254 Level IV ENT Procedures.... T 12.45 $617.47 $272.41 $123.49
0256 Level V ENT Procedures..... T 25.40 $1,259.74 $623.05 $251.95
0258 Tonsil and Adenoid T 18.62 $923.48 $462.81 $184.70
Procedures.
0260 Level I Plain Film Except X 0.79 $39.18 $22.02 $7.84
Teeth.
0261 Level II Plain Film Except X 1.38 $68.44 $38.77 $13.69
Teeth Including Bone
Density Measurement.
0262 Plain Film of Teeth........ X 0.40 $19.83 $10.90 $3.97
0263 Level I Miscellaneous X 1.68 $83.32 $45.88 $16.66
Radiology Procedures.
0264 Level II Miscellaneous X 3.83 $189.96 $108.97 $37.99
Radiology Procedures.
0265 Level I Diagnostic S 1.17 $58.03 $38.08 $11.61
Ultrasound Except Vascular.
0266 Level II Diagnostic S 1.79 $88.78 $57.35 $17.76
Ultrasound Except Vascular.
0267 Vascular Ultrasound........ S 2.72 $134.90 $80.06 $26.98
0268 Guidance Under Ultrasound.. X 2.23 $110.60 $69.51 $22.12
0269 Echocardiogram Except S 4.40 $218.22 $114.01 $43.64
Transesophageal.
0270 Transesophageal S 5.55 $275.25 $150.26 $55.05
Echocardiogram.
0271 Mammography................ S 0.70 $34.72 $19.50 $6.94
0272 Level I Fluoroscopy........ X 1.40 $69.43 $39.00 $13.89
0273 Level II Fluoroscopy....... X 2.49 $123.49 $61.02 $24.70
0274 Myelography................ S 4.83 $239.55 $128.12 $47.91
0275 Arthrography............... S 2.74 $135.89 $72.26 $27.18
0276 Level I Digestive Radiology S 1.79 $88.78 $49.78 $17.76
0277 Level II Digestive S 2.47 $122.50 $69.28 $24.50
Radiology.
0278 Diagnostic Urography....... S 2.85 $141.35 $81.67 $28.27
0279 Level I Angiography and S 6.30 $312.46 $174.57 $62.49
Venography except
Extremity.
0280 Level II Angiography and S 14.98 $742.95 $380.12 $148.59
Venography except
Extremity.
0281 Venography of Extremity.... S 4.40 $218.22 $115.16 $43.64
0282 Level I Computerized Axial S 2.38 $118.04 $94.51 $23.61
Tomography.
0283 Level II Computerized Axial S 4.89 $242.52 $179.39 $48.50
Tomography.
0284 Magnetic Resonance Imaging. S 8.02 $397.76 $257.39 $79.55
0285 Positron Emission S 15.06 $746.92 $415.21 $149.38
Tomography (PET).
[[Page 67833]]
0286 Myocardial Scans........... S 7.28 $361.06 $200.04 $72.21
0290 Standard Non-Imaging S 1.94 $96.21 $55.51 $19.24
Nuclear Medicine.
0291 Level I Diagnostic Nuclear S 3.15 $156.22 $93.14 $31.24
Medicine Excluding
Myocardial Scans.
0292 Level II Diagnostic Nuclear S 4.36 $216.24 $126.63 $43.25
Medicine Excluding
Myocardial Scans.
0294 Level I Therapeutic Nuclear S 5.13 $254.43 $144.06 $50.89
Medicine.
0295 Level II Therapeutic S 19.85 $984.48 $609.17 $196.90
Nuclear Medicine.
0296 Level I Therapeutic S 3.57 $177.06 $100.25 $35.41
Radiologic Procedures.
0297 Level II Therapeutic S 6.13 $304.03 $172.51 $60.81
Radiologic Procedures.
0300 Level I Radiation Therapy.. S 1.98 $98.20 $47.72 $19.64
0301 Level II Radiation Therapy. S 2.21 $109.61 $52.53 $21.92
0302 Level III Radiation Therapy S 8.21 $407.18 $216.55 $81.44
0303 Treatment Device X 2.83 $140.36 $69.28 $28.07
Construction.
0304 Level I Therapeutic X 1.49 $73.90 $41.52 $14.78
Radiation Treatment
Preparation.
0305 Level II Therapeutic X 4.06 $201.36 $97.50 $40.27
Radiation Treatment
Preparation.
0310 Level III Therapeutic X 13.98 $693.35 $339.05 $138.67
Radiation Treatment
Preparation.
0311 Radiation Physics Services. X 1.32 $65.46 $31.66 $13.09
0312 Radioelement Applications.. S 4.09 $202.85 $109.65 $40.57
0313 Brachytherapy.............. S 7.89 $391.31 $164.02 $78.26
0314 Hyperthermic Therapies..... S 5.88 $291.62 $150.95 $58.32
0320 Electroconvulsive Therapy.. S 3.68 $182.51 $80.06 $36.50
0321 Biofeedback and Other S 1.26 $62.49 $29.25 $12.50
Training.
0322 Brief Individual S 1.32 $65.46 $14.22 $13.09
Psychotherapy.
0323 Extended Individual S 1.85 $91.75 $22.48 $18.35
Psychotherapy.
0324 Family Psychotherapy....... S 1.87 $92.74 $20.19 $18.55
0325 Group Psychotherapy........ S 1.55 $76.88 $19.96 $15.38
0330 Dental Procedures.......... S 1.51 $74.89 $14.98 $14.98
0340 Minor Ancillary Procedures. X 1.04 $51.58 $12.85 $10.32
0341 Immunology Tests........... X 0.13 $6.44 $3.67 $1.29
0342 Level I Pathology.......... X 0.26 $12.90 $8.03 $2.58
0343 Level II Pathology......... X 0.45 $22.32 $12.16 $4.46
0344 Level III Pathology........ X 0.79 $39.18 $23.63 $7.84
0345 Transfusion Laboratory X 0.22 $10.92 $5.37 $2.18
Procedures Level I.
0346 Transfusion Laboratory X 0.51 $25.49 $12.03 $5.10
Procedures Level II.
0347 Transfusion Laboratory X 0.84 $41.90 $20.13 $8.38
Procedures Level III.
0348 Fertility Laboratory X 0.52 $25.57 $5.11 $5.11
Procedures.
0349 Miscellaneous Laboratory X 0.48 $23.65 $4.73 $4.73
Procedures.
0354 Administration of Influenza/ K 0.13 $6.33 ........... ...........
Pneumonia Vaccine.
0355 Level I Immunizations...... K 0.19 $9.42 $5.05 $1.88
0356 Level II Immunizations..... K 0.36 $17.86 $4.82 $3.57
0359 Injections................. X 0.96 $47.61 $9.52 $9.52
0360 Level I Alimentary Tests... X 1.38 $68.44 $34.75 $13.69
0361 Level II Alimentary Tests.. X 3.53 $175.07 $88.09 $35.01
0362 Fitting of Vision Aids..... X 0.51 $25.30 $9.63 $5.06
0363 Otorhinolaryngologic X 2.83 $140.36 $53.22 $28.07
Function Tests.
0364 Level I Audiometry......... X 0.68 $33.72 $13.31 $6.74
0365 Level II Audiometry........ X 1.47 $72.91 $22.48 $14.58
0367 Level I Pulmonary Test..... X 0.83 $41.16 $20.65 $8.23
0368 Level II Pulmonary Tests... X 1.66 $82.33 $42.44 $16.47
0369 Level III Pulmonary Tests.. X 2.34 $116.06 $58.50 $23.21
0370 Allergy Tests.............. X 0.57 $28.27 $11.81 $5.65
0371 Allergy Injections......... X 0.32 $15.87 $3.67 $3.17
0372 Therapeutic Phlebotomy..... X 0.43 $21.33 $10.09 $4.27
0373 Neuropsychological Testing. X 3.21 $159.20 $44.96 $31.84
0374 Monitoring Psychiatric X 1.17 $58.03 $13.08 $11.61
Drugs.
0600 Low Level Clinic Visits.... V 0.98 $48.61 $9.72 $9.72
0601 Mid Level Clinic Visits.... V 1.00 $49.60 $9.92 $9.92
0602 High Level Clinic Visits... V 1.66 $82.33 $16.47 $16.47
0610 Low Level Emergency Visits. V 1.34 $66.46 $20.65 $13.29
0611 Mid Level Emergency Visits. V 2.11 $104.65 $36.47 $20.93
0612 High Level Emergency Visits V 3.19 $158.21 $54.14 $31.64
0620 Critical Care.............. S 8.60 $426.53 $152.78 $85.31
0701 SR 89 chloride, per mCi.... G ........... $783.75 ........... $95.62
0702 SM 153 lexidronam, 50 mCi.. G ........... $942.09 ........... $134.87
0704 IN 111 Satumomab pendetide G ........... $712.50 ........... $86.93
per dose.
0705 TC 99M tetrofosmin, per G ........... $136.80 ........... $16.69
dose.
0725 Leucovorin calcium inj, 50 G ........... $49.73 ........... $6.66
mg.
0726 Dexrazoxane hcl injection, G ........... $161.11 ........... $21.59
250 mg.
0727 Etidronate disodium inj 300 G ........... $63.65 ........... $8.53
mg.
0728 Filgrastim 300 mcg G ........... $171.38 ........... $22.96
injection.
0730 Pamidronate disodium, 30 mg G ........... $232.51 ........... $31.16
0731 Sargramostim injection 50 G ........... $27.42 ........... $3.67
mcg.
0732 Mesna injection 200 mg..... G ........... $36.51 ........... $4.89
0733 Non esrd epoetin alpha inj, G ........... $11.40 ........... $1.53
1000 u.
0750 Dolasetron mesylate, 10 mg. G ........... $14.81 ........... $1.98
0754 Metoclopramide hcl G ........... $2.00 ........... $0.27
injection up to 10 mg.
0755 Thiethylperazine maleate G ........... $5.02 ........... $0.67
inj up to 10 mg.
0761 Unspecified oral anti- G ........... $0.60 ........... $0.08
emetic.
0762 Dronabinol 2.5mg oral...... G ........... $3.20 ........... $0.48
[[Page 67834]]
0763 Dolasetron mesylate oral, G ........... $65.21 ........... $8.74
100 mg.
0764 Granisetron hcl injection G ........... $1.85 ........... $0.25
100 mcg.
0765 Granisetron hcl 1 mg oral.. G ........... $44.70 ........... $5.99
0768 Ondansetron hcl injection 1 G ........... $6.09 ........... $0.82
mg.
0769 Ondansetron hcl 8mg oral... G ........... $25.15 ........... $3.37
0800 Leuprolide acetate, 3.75 mg G ........... $492.71 ........... $63.27
0801 Cyclophosphamide oral 25 mg G ........... $2.12 ........... $0.28
0802 Etoposide oral 50 mg....... G ........... $45.95 ........... $6.16
0803 Melphalan oral 2 mg........ G ........... $2.07 ........... $0.28
0807 Aldesleukin/single use vial G ........... $569.76 ........... $76.35
0809 Bcg live intravesical vac.. G ........... $159.39 ........... $19.45
0810 Goserelin acetate implant G ........... $446.49 ........... $59.83
3.6 mg.
0811 Carboplatin injection 50 mg G ........... $98.90 ........... $13.25
0812 Carmus bischl nitro inj 100 G ........... $103.27 ........... $13.84
mg.
0813 Cisplatin 10 mg injection.. G ........... $42.18 ........... $5.65
0814 Asparaginase injection G ........... $57.41 ........... $7.69
10,000 u.
0815 Cyclophosphamide 100 mg inj G ........... $6.13 ........... $0.82
0816 Cyclophosphamide G ........... $6.13 ........... $0.82
lyophilized 100 mg.
0817 Cytarabine hcl 100 mg inj.. G ........... $5.94 ........... $0.80
0818 Dactinomycin 0.5 mg........ G ........... $12.73 ........... $1.71
0819 Dacarbazine 10 mg inj...... G ........... $1.13 ........... $0.15
0820 Daunorubicin 10 mg......... G ........... $80.04 ........... $10.73
0821 Daunorubicin citrate G ........... $64.60 ........... $8.66
liposom 10 mg.
0822 Diethylstilbestrol G ........... $4.20 ........... $0.56
injection 250 mg.
0823 Docetaxel, 20 mg........... G ........... $283.65 ........... $38.01
0824 Etoposide 10 mg inj........ G ........... $4.06 ........... $0.54
0826 Methotrexate Oral 2.5 mg... G ........... $2.92 ........... $0.39
0827 Floxuridine injection 500 G ........... $129.56 ........... $17.36
mg.
0828 Gemcitabine HCL 200 mg..... G ........... $88.46 ........... $11.85
0830 Irinotecan injection 20 mg. G ........... $117.81 ........... $15.79
0831 Ifosfomide injection 1 gm.. G ........... $141.50 ........... $18.96
0832 Idarubicin hcl injection 5 G ........... $341.38 ........... $45.75
mg.
0833 Interferon alfacon-1, 1 mcg G ........... $3.91 ........... $0.52
0834 Interferon alfa-2a inj G ........... $33.22 ........... $4.45
recombinant 3 million u.
0836 Interferon alfa-2b inj G ........... $11.28 ........... $1.51
recombinant, 1 million.
0838 Interferon gamma 1-b inj, 3 G ........... $199.50 ........... $26.73
million u.
0839 Mechlorethamine hcl inj 10 G ........... $11.01 ........... $1.48
mg.
0840 Melphalan hydrochl 50 mg... G ........... $363.48 ........... $48.71
0841 Methotrexate sodium inj 5 G ........... $0.45 ........... $0.06
mg.
0842 Fludarabine phosphate inj G ........... $237.03 ........... $31.76
50 mg.
0843 Pegaspargase, singl dose G ........... $1,321.65 ........... $177.10
vial.
0844 Pentostatin injection, 10 G ........... $1,562.75 ........... $209.41
mg.
0847 Doxorubicin hcl 10 mg vl G ........... $15.79 ........... $2.12
chemo.
0849 Rituximab, 100 mg.......... G ........... $420.29 ........... $56.32
0850 Streptozocin injection, 1 G ........... $65.79 ........... $8.82
gm.
0851 Thiotepa injection, 15 mg.. G ........... $100.30 ........... $13.44
0852 Topotecan, 4 mg............ G ........... $573.75 ........... $76.88
0853 Vinblastine sulfate inj, 1 G ........... $4.11 ........... $0.55
mg.
0854 Vincristine sulfate 1 mg G ........... $30.16 ........... $4.04
inj.
0855 Vinorelbine tartrate, 10 mg G ........... $75.51 ........... $10.12
0856 Porfimer sodium, 75 mg..... G ........... $2,603.67 ........... $348.89
0857 Bleomycin sulfate injection G ........... $294.48 ........... $39.46
15 u.
0858 Cladribine, 1mg............ G ........... $53.47 ........... $7.16
0859 Fluorouracil injection 500 G ........... $2.75 ........... $0.37
mg.
0860 Plicamycin (mithramycin) G ........... $93.80 ........... $12.57
inj 2.5 mg.
0861 Leuprolide acetate G ........... $22.90 ........... $3.07
injection 1 mg.
0862 Mitomycin 5 mg inj......... G ........... $121.65 ........... $16.30
0863 Paclitaxel injection, 30 mg G ........... $173.50 ........... $23.25
0864 Mitoxantrone hcl, 5 mg..... G ........... $223.02 ........... $29.88
0865 Interferon alfa-n3 inj, G ........... $7.86 ........... $1.05
human leukocyte derived,
250,000 iu.
0884 Rho d immune globulin inj, G ........... $35.91 ........... $4.38
1 dose pkg.
0886 Azathioprine oral 50mg..... G ........... $1.24 ........... $0.17
0887 Azathioprine parenteral 100 G ........... $67.88 ........... $9.10
mg.
0888 Cyclosporine oral 100 mg... G ........... $5.80 ........... $0.78
0889 Cyclosporin parenteral G ........... $15.81 ........... $2.12
250mg.
0890 Lymphocyte immune globulin G ........... $249.13 ........... $30.39
250 mg.
0891 Tacrolimus oral per 1 mg... G ........... $2.66 ........... $0.36
0900 Alglucerase injection, per G ........... $37.53 ........... $5.03
10 u.
0901 Alpha 1 proteinase G ........... $2.09 ........... $0.28
inhibitor, 10 mg.
0902 Botulinum toxin a, per unit G ........... $4.39 ........... $0.59
0903 Cytomegalovirus imm IV, G ........... $370.50 ........... $49.65
vial.
0905 Immune globulin 500 mg..... G ........... $27.28 ........... $3.33
0906 RSV-ivig, 50 mg............ G ........... $427.73 ........... $57.32
0907 Ganciclovir Sodium 500 mg K 0.45 $22.26 ........... $4.45
injection.
0908 Tetanus immune globulin inj G ........... $102.60 ........... $13.75
up to 250 u.
0909 Interferon beta-1a, 33 mcg. G ........... $204.73 ........... $27.43
0910 Interferon beta-1b, .25 mg. G ........... $57.00 ........... $7.64
0911 Streptokinase per 250,000 K 1.76 $87.25 ........... $17.45
iu.
[[Page 67835]]
0913 Ganciclovir long act G ........... $4,750.00 ........... $636.50
implant 4.5 mg.
0914 Reteplase, per 37.6mg...... G ........... $2,612.50 ........... $350.08
0915 Alteplase inj rec, per 10 K 3.80 $188.46 ........... $37.69
mg.
0916 Imiglucerase, unit......... G ........... $3.75 ........... $0.50
0917 Pharmacologic stressors.... K 0.36 $17.86 ........... $3.57
0918 Brachytherapy Seeds, Any H ........... ........... ........... ...........
type, Each.
0925 Factor viii per iu......... G ........... $0.88 ........... $0.12
0926 Factor VIII (porcine) per G ........... $2.09 ........... $0.28
iu.
0927 Factor viii recombinant per G ........... $1.17 ........... $0.16
iu.
0928 Factor ix complex per iu... G ........... $.71 ........... $0.10
0929 Anti-inhibitor per iu...... G ........... $1.43 ........... $0.19
0930 Antithrombin iii injection G ........... $.82 ........... $0.11
per iu.
0931 Factor IX non-recombinant, G ........... $0.72 ........... $0.10
per iu.
0932 Factor IX recombinant, per G ........... $1.12 ........... $0.10
iu.
0949 Plasma, Pooled Multiple K 2.94 $145.76 ........... $29.15
Donor, Solvent/Detergent
Treated, Frozen.
0950 Blood (Whole) For K 2.08 $103.33 ........... $20.67
Transfusion.
0952 Cryoprecipitate............ K 0.70 $34.70 ........... $6.94
0953 Fibrinogen Unit............ K 0.48 $23.80 ........... $4.76
0954 RBC Leukocytes Reduced..... K 2.83 $140.35 ........... $28.07
0955 Plasma, Fresh Frozen....... K 2.26 $111.85 ........... $22.37
0956 Plasma Protein Fraction.... K 1.26 $62.49 ........... $12.50
0957 Platelet Concentrate....... K 0.98 $48.55 ........... $9.71
0958 Platelet Rich Plasma....... K 1.16 $57.54 ........... $11.51
0959 Red Blood Cells............ K 2.04 $101.31 ........... $20.26
0960 Washed Red Blood Cells..... K 3.81 $188.75 ........... $37.75
0961 Infusion, Albumin (Human) K 2.77 $137.38 ........... $27.48
5%, 500 ml.
0962 Infusion, Albumin (Human) K 1.38 $68.44 ........... $13.69
25%, 50 ml.
0970 New Technology-- I ($0-$50) T 0.52 $25.79 ........... $5.16
0971 New Technology-- II ($50- S 1.55 $76.88 ........... $15.38
$100).
0972 New Technology-- III ($100- T 3.09 $153.26 ........... $30.65
$200).
0973 New Technology-- IV ($200- T 5.16 $255.91 ........... $51.18
$300).
0974 New Technology-- V ($300- S 8.25 $409.17 ........... $81.83
$500).
0975 New Technology-- VI ($500- T 12.90 $639.79 ........... $127.96
$750).
0976 New Technology-- VII ($750- S 18.05 $895.21 ........... $179.04
$1000).
0977 New Technology-- VIII T 23.20 $1,150.63 ........... $230.13
($1000-$1250).
0978 New Technology-- IX ($1250- T 28.36 $1,406.54 ........... $281.31
$1500).
0979 New Technology-- X ($1500- T 33.51 $1,661.96 ........... $332.39
$1750).
0980 New Technology-- XI ($1750- T 38.67 $1,917.89 ........... $383.58
$2000).
0981 New Technology-- XII ($2000- S 46.40 $2,301.26 ........... $460.25
$2500).
0982 New Technology-- XIII T 61.87 $3,068.50 ........... $613.70
($2500-$3500).
0983 New Technology-- XIV ($3500- T 87.65 $4,347.09 ........... $869.42
$5000).
0984 New Technology-- XV ($5000- T 113.43 $5,625.67 ........... $1,125.13
$6000).
0987 New Device Technology-- I X ........... $127.86 ........... $25.57
($0-$250).
0988 New Device Technology-- II X ........... $383.58 ........... $76.72
($250-$500).
0989 New Device Technology-- III X ........... $639.30 ........... $127.86
($500-$750).
0990 New Device Technology-- IV X ........... $895.01 ........... $179.00
($750-$1000).
0991 New Device Technology-- V X ........... $1,278.59 ........... $255.72
($1000-$1500).
0992 New Device Technology-- VI X ........... $1,790.03 ........... $358.01
($1500-$2000).
0993 New Device Technology-- VII X ........... $2,557.18 ........... $511.44
($2000-$3000).
0994 New Device Technology-- X ........... $3,580.05 ........... $716.01
VIII ($3000-$4000).
0995 New Device Technology-- IX X ........... $4,602.92 ........... $920.58
($4000-$5000).
0996 New Device Technology-- X X ........... $6,137.23 ........... $1,227.45
($5000-$7000).
0997 New Device Technology-- XI X ........... $8,182.98 ........... $1,636.60
($7000-$9000).
1000 Perclose Closer Prostar H ........... ........... ........... ...........
Arterial Vascular Closure.
1001 AcuNav-diagnstic ultrsnd ca H ........... ........... ........... ...........
1002 Cochlear Implant System.... H ........... ........... ........... ...........
1003 Cath, ablation, Livewire TC H ........... ........... ........... ...........
1004 Fast-Cath,Swartz,SAFL,CSTA. H ........... ........... ........... ...........
1006 ARRAY post chamb IOL....... H ........... ........... ........... ...........
1007 Ams 700 penile prosthesis.. H ........... ........... ........... ...........
1008 Urolume-implt urethral H ........... ........... ........... ...........
stent.
1009 Plasma, cryoprecipitate- K 0.86 $42.76 ........... $8.55
reduced, unit.
1010 Blood, L/R, CMV-neg........ K 2.88 $142.84 ........... $28.57
1011 Platelets, L/R, CMV-neg, K 11.86 $588.15 ........... $117.63
unit.
1012 Platelet concentrate, L/R, K 1.92 $95.23 ........... $19.05
irradiated, unit.
1013 Platelet concentrate, L/R, K 1.18 $58.30 ........... $11.66
unit.
1014 Platelets, aph/pher, L/R, K 8.93 $443.11 ........... $88.62
unit.
1016 Blood, L/R, froz/deglycerol/ K 7.15 $354.68 ........... $70.94
washed.
1017 Platelets, aph/pher, L/R, K 9.33 $462.54 ........... $92.51
CMV-neg, unit.
1018 Blood, L/R, irradiated..... K 3.13 $155.48 ........... $31.10
1019 Platelets, aph/pher, L/R, K 9.64 $478.09 ........... $95.62
irradiated, unit.
1024 Quinupristin 150 mg/ J ........... $102.05 ........... $13.67
dalfopriston 350 mg.
1025 Marinr CS catheter......... H ........... ........... ........... ...........
1026 RF Perfrmr cath 5F RF H ........... ........... ........... ...........
Marinr.
1027 Magic x/short, Radius14mm.. H ........... ........... ........... ...........
1028 Prcis Twst trnsvg anch sys. H ........... ........... ........... ...........
1029 CRE guided balloon dil cath H ........... ........... ........... ...........
1030 Cthtr:Mrshal,Blu Max Utr H ........... ........... ........... ...........
Dmnd.
[[Page 67836]]
1033 Sonicath mdl 37-410........ H ........... ........... ........... ...........
1034 SURPASS, Long30 SURPASS- H ........... ........... ........... ...........
cath.
1035 Cath, Ultra ICE............ H ........... ........... ........... ...........
1036 R port/reservoir impl dev.. H ........... ........... ........... ...........
1037 Vaxcelchronic dialysis cath H ........... ........... ........... ...........
1038 UltraCross Imaging Cath.... H ........... ........... ........... ...........
1039 Wallstent/RP: Trach........ H ........... ........... ........... ...........
1040 Wallstent/RP TIPS--20/40/60 H ........... ........... ........... ...........
1042 Wallstent, UltraFlex: Bil.. H ........... ........... ........... ...........
1043 Atherectomy sys, coronary.. H ........... ........... ........... ...........
1045 I-131 MIBG (ioben-sulfate) G ........... $1,140.00 ........... $139.08
O.5mCi.
1047 Navi-Star, Noga-Star cath.. H ........... ........... ........... ...........
1048 NeuroCyberneticPros: gen... H ........... ........... ........... ...........
1051 Oasis Thrombectomy Cath.... H ........... ........... ........... ...........
1053 EnSite 3000 catheter....... H ........... ........... ........... ...........
1054 Hydrolyser Thromb Cath 6/7F H ........... ........... ........... ...........
1055 Transesoph 210, 210-S Cath. H ........... ........... ........... ...........
1056 Thermachoice II Cath....... H ........... ........... ........... ...........
1057 Micromark Tissue Marker.... H ........... ........... ........... ...........
1059 Carticel,auto cult-chndr G ........... $14,250.00 ........... $2,010.00
cyte.
1060 ACS multi-link tristor H ........... ........... ........... ...........
stent.
1061 ACS Viking Guiding cath.... H ........... ........... ........... ...........
1063 EndoTak Endurance EZ, RX H ........... ........... ........... ...........
leads.
1067 Megalink biliary stent..... H ........... ........... ........... ...........
1068 Pulsar DDD pmkr............ H ........... ........... ........... ...........
1069 Discovery DR, pmaker....... H ........... ........... ........... ...........
1071 Pulsar Max, Pulsar SR pmkr. H ........... ........... ........... ...........
1072 Guidant: blln dil cath..... H ........... ........... ........... ...........
1073 Gynecare Morcellator....... H ........... ........... ........... ...........
1074 RX/OTW Viatrac-peri dil H ........... ........... ........... ...........
cath.
1075 Guidant: lead.............. H ........... ........... ........... ...........
1076 Ventak mini sc defib....... H ........... ........... ........... ...........
1077 Ventak VR Prizm VR, sc H ........... ........... ........... ...........
defib.
1078 Ventak: Prizm, AVIIIDR H ........... ........... ........... ...........
defib.
1079 CO 57/58 0.5 mCi........... G ........... $264.10 ........... $32.22
1084 Denileukin diftitox, 300 G ........... $942.88 ........... $126.35
mcg.
1086 Temozolomide, 5 mg......... G ........... $5.70 ........... $0.76
1087 I-123 per uCi capsule...... G ........... $0.84 ........... $0.10
1089 CO 57, 0.5 mCi............. G ........... $91.20 ........... $11.13
1090 IN 111 Chloride, per mCi... G ........... $152.00 ........... $18.54
1091 IN 111 Oxyquinoline, per 5 G ........... $508.25 ........... $62.01
mCi.
1092 IN 111 Pentetate, per 1.5 G ........... $769.50 ........... $93.88
mCi.
1094 TC 99M Albumin aggr, per J ........... $34.20 ........... $4.17
vial.
1095 TC 99M Depreotide, per vial G ........... $760.00 ........... $101.84
1096 TC 99M Exametazime, per G ........... $445.31 ........... $63.75
dose.
1097 TC 99M Mebrofenin, per vial G ........... $46.76 ........... $5.71
1098 TC 99M Pentetate, per vial. G ........... $22.80 ........... $2.78
1099 TC 99M Pyrophosphate, per J ........... $42.75 ........... $5.22
vial.
1100 Medtronic AVE GT1 guidewire H ........... ........... ........... ...........
1101 Medtronic AVE, AVE Z2 cath. H ........... ........... ........... ...........
1102 Synergy Neurostim Genrtr... H ........... ........... ........... ...........
1103 Micro Jewel Defibrillator.. H ........... ........... ........... ...........
1104 RF Conductor Ablative Cath. H ........... ........... ........... ...........
1105 Sigma 300VDD pacmker....... H ........... ........... ........... ...........
1106 SynergyEZ Pt Progrmr....... H ........... ........... ........... ...........
1107 Torqr, Solist cath......... H ........... ........... ........... ...........
1108 Reveal Cardiac Recorder.... H ........... ........... ........... ...........
1109 Implantable anchor: Ethicon H ........... ........... ........... ...........
1110 Stable Mapper, cath electrd H ........... ........... ........... ...........
1111 AneuRxAort-Uni- H ........... ........... ........... ...........
Ilicstnt&cath.
1112 AneuRx Stent graft/del.cath H ........... ........... ........... ...........
1113 Tlnt Endo Sprng Stnt Grft H ........... ........... ........... ...........
Sys.
1114 TalntSprgStnt+Graf endo H ........... ........... ........... ...........
pros.
1115 5038S,5038,5038L pace lead. H ........... ........... ........... ...........
1116 CapSureSP pacing Lead...... H ........... ........... ........... ...........
1117 Ancure Endograft Del Sys... H ........... ........... ........... ...........
1118 Sigma300DR LegIIDR,pacemkr. H ........... ........... ........... ...........
1119 Sprint6932,6943 defib lead. H ........... ........... ........... ...........
1120 Sprint6942,6945 defib lead. H ........... ........... ........... ...........
1121 Gem defibrillator.......... H ........... ........... ........... ...........
1122 TC 99M arcitumomab per dose G ........... $926.25 ........... $124.12
1123 Gem II VR defibrillator.... H ........... ........... ........... ...........
1124 InterStim Test Stim Kit.... H ........... ........... ........... ...........
1125 Kappa 400SR,Ttopaz II SR H ........... ........... ........... ...........
pmkr.
1126 Kappa 700 DR pacemakr...... H ........... ........... ........... ...........
1127 Kappa 700SR,pmkr sgl H ........... ........... ........... ...........
chamber.
1128 Kappa 700D,Ruby IID pmkr... H ........... ........... ........... ...........
1129 Kappa 700VDD,pacmkr........ H ........... ........... ........... ...........
[[Page 67837]]
1130 Sigma 200D,LGCY IID sc pmkr H ........... ........... ........... ...........
1131 Sigma 200DR, pmker......... H ........... ........... ........... ...........
1132 Sigma 200SR Leg II:sc pac.. H ........... ........... ........... ...........
1133 Sigma SR, Vita SR, pmaker.. H ........... ........... ........... ...........
1134 Sigma 300D pmker........... H ........... ........... ........... ...........
1135 Entity DR 5326L/R, DC, pmkr H ........... ........... ........... ...........
1136 Affinity DR 5330L/R, DC, H ........... ........... ........... ...........
pmkr.
1137 CardioSEAL implant syst.... H ........... ........... ........... ...........
1143 AddVent mod 2060BL,VDD..... H ........... ........... ........... ...........
1144 Afnty SP 5130,Integrity H ........... ........... ........... ...........
SR,pmkr.
1145 Angio-Seal 6fr, 8fr........ H ........... ........... ........... ...........
1147 AV Plus DX 1368: lead...... H ........... ........... ........... ...........
1148 Contour MD sc defib........ H ........... ........... ........... ...........
1149 Entity DC 5226R-pmker...... H ........... ........... ........... ...........
1151 Passiveplus DX lead, 10mdls H ........... ........... ........... ...........
1152 LifeSite Access System..... H ........... ........... ........... ...........
1153 Regency SC+ 2402L pmker.... H ........... ........... ........... ...........
1154 SPL:SPOI,02,04- defib lead. H ........... ........... ........... ...........
1155 Repliform 8 sq cm.......... H ........... ........... ........... ...........
1156 Tr 1102TrSR+ H ........... ........... ........... ...........
2260L,2264L,5131.
1157 Trilogy DCT 23/8L pmkr..... H ........... ........... ........... ...........
1158 TVL lead SV01,SV02,SV04.... H ........... ........... ........... ...........
1159 TVL RV02,RV06,RV07: lead... H ........... ........... ........... ...........
1160 TVL-ADX 1559: lead......... H ........... ........... ........... ...........
1161 Tendril DX, 1388 pacing H ........... ........... ........... ...........
lead.
1162 TempoDr, TrilogyDR+DC pmkr. H ........... ........... ........... ...........
1163 Tendril SDX, 1488T pacing H ........... ........... ........... ...........
lead.
1164 Iodine-125 brachytx seed... H ........... ........... ........... ...........
1166 Cytarabine liposomal, 10 mg G ........... $371.45 ........... $49.77
1167 Epirubicin hcl, 2 mg....... J ........... $24.94 ........... $3.34
1171 Autosuture site marker H ........... ........... ........... ...........
stple.
1172 Spacemaker dissect ballon.. H ........... ........... ........... ...........
1173 Cor stntS540,S670,o-wire H ........... ........... ........... ...........
stn.
1174 Bard brachytx needle....... H ........... ........... ........... ...........
1178 Busulfan IV, 6 mg.......... G ........... $26.48 ........... $3.55
1180 Vigor SR, SC, pmkr......... H ........... ........... ........... ...........
1181 Meridian SSI, SC, pmkr..... H ........... ........... ........... ...........
1182 Pulsar SSI, SC, pmkr....... H ........... ........... ........... ...........
1183 Jade IIS, Sigma 300S,SC, H ........... ........... ........... ...........
pmkr.
1184 Sigma 200S, SC, pmkr....... H ........... ........... ........... ...........
1188 I 131, per mCi............. G ........... $5.86 ........... $0.75
1200 TC 99M Sodium G ........... $113.05 ........... $13.79
Glucoheptonate, per vial.
1201 TC 99M succimer, per vial.. G ........... $135.66 ........... $16.55
1202 TC 99M Sulfur Colloid, per G ........... $38.00 ........... $4.64
dose.
1203 Verteporfin for Injection.. G ........... $1,458.25 ........... $195.41
1205 TC 99M Disofenin, per vial. G ........... $427.50 ........... $57.29
1207 Octreotide acetate depot G ........... $135.10 ........... $16.48
1mg.
1302 SQ01: lead................. H ........... ........... ........... ...........
1303 CapSure Fix 6940/4068-110, H ........... ........... ........... ...........
lead.
1304 Sonicath mdl 37-416,-418... H ........... ........... ........... ...........
1305 Apligraf................... G ........... $1,157.81 ........... $163.31
1306 NeuroCyberneticPros: lead.. H ........... ........... ........... ...........
1311 Trilogy DR+/DAO pmkr....... H ........... ........... ........... ...........
1312 Magic WALLSTENT stent-Mini. H ........... ........... ........... ...........
1313 Magic medium, Radius 31mm.. H ........... ........... ........... ...........
1314 Magic WALLSTENT stent-Long. H ........... ........... ........... ...........
1315 Vigor DR, Meridian DR pmkr. H ........... ........... ........... ...........
1316 Meridian DDD pmkr.......... H ........... ........... ........... ...........
1317 Discovery SR, pmkr......... H ........... ........... ........... ...........
1318 Meridian SR pmakr.......... H ........... ........... ........... ...........
1319 Wallstent/RP Enteral--60mm. H ........... ........... ........... ...........
1320 Wallstent/RP Iliac Del Sys. H ........... ........... ........... ...........
1325 Pallidium -103 seed........ H ........... ........... ........... ...........
1326 Angio-jet rheolytic thromb H ........... ........... ........... ...........
cath.
1328 ANS Renew NS trnsmtr....... H ........... ........... ........... ...........
1333 PALMZA Corinthian bill H ........... ........... ........... ...........
stent.
1334 Crown,Mini-crown,CrossLC... H ........... ........... ........... ...........
1335 Mesh, Prolene.............. H ........... ........... ........... ...........
1336 Constant Flow Imp Pump..... H ........... ........... ........... ...........
1337 IsoMed 8472-20/35/60....... H ........... ........... ........... ...........
1348 I 131 per mCi solution..... G ........... $146.57 ........... $17.88
1350 Prosta/OncoSeed, RAPID H ........... ........... ........... ...........
strand, I-125.
1351 CapSure(Fix)pacing lead.... H ........... ........... ........... ...........
1352 Gem II defib............... H ........... ........... ........... ...........
1353 Itrel Interstm H ........... ........... ........... ...........
neurostim+ext.
1354 Kappa 400DR,Diamond II H ........... ........... ........... ...........
820DR.
1355 Kappa 600DR, Vita DR....... H ........... ........... ........... ...........
1356 Profile MD V-186HV3 sc H ........... ........... ........... ...........
defib.
[[Page 67838]]
1357 Angstrom MD V-190HV3 sc H ........... ........... ........... ...........
defib.
1358 Affinity DC 5230R-Pacemaker H ........... ........... ........... ...........
1359 Pulsar,Pulsar Max DR,pmkr.. H ........... ........... ........... ...........
1363 Gem DR, DC, defib.......... H ........... ........... ........... ...........
1364 Photon DR V-230HV3 DC defib H ........... ........... ........... ...........
1365 Guidewire, Hi-Torque14/18/ H ........... ........... ........... ...........
35.
1366 Guidewire,PTCA, Hi-Torque.. H ........... ........... ........... ...........
1367 Guidewire, Hi-Torque H ........... ........... ........... ...........
CrossIt.
1369 ANS Renew Stim Sys recvr... H ........... ........... ........... ...........
1370 Tension-Free Vaginal Tape.. H ........... ........... ........... ...........
1371 Symp Nitinol Transhep Bil H ........... ........... ........... ...........
Sys.
1372 Cordis Nitinol bil stent... H ........... ........... ........... ...........
1375 Stent, coronary, NIR....... H ........... ........... ........... ...........
1376 ANS Renew Stim Sys lead.... H ........... ........... ........... ...........
1377 Specify 3988 neuro lead.... H ........... ........... ........... ...........
1378 InterStim Tx 3080/3886 lead H ........... ........... ........... ...........
1379 Pisces-Quad 3887 lead...... H ........... ........... ........... ...........
1400 Diphenhydramine hcl 50mg... G ........... $1.18 ........... $.16
1401 Prochlorperazine maleate G ........... $1.31 ........... $.18
5mg.
1402 Promethazine hcl 12.5mg G ........... $.03 ........... $.00
oral.
1403 Chlorpromazine hcl 10mg G ........... $.55 ........... $.07
oral.
1404 Trimethobenzamide hcl 250mg G ........... $.36 ........... $.05
1405 Thiethylperazine G ........... $.69 ........... $.09
maleate10mg.
1406 Perphenazine 4mg oral...... G ........... $.71 ........... $.10
1407 Hydroxyzine pamoate 25mg... G ........... $.20 ........... $.03
1409 Factor viia recombinant, G ........... $1,596.00 ........... $213.86
per 1.2 mg.
1410 Prosorba column............ H ........... ........... ........... ...........
1411 Herculink,OTW SDS bil stent H ........... ........... ........... ...........
1420 StapleTac2 Bone w/Dermis... H ........... ........... ........... ...........
1421 StapleTac2 Bone wo Dermis.. H ........... ........... ........... ...........
1450 Orthosphere Arthroplasty... H ........... ........... ........... ...........
1451 Orthosphere Arthroplasty H ........... ........... ........... ...........
Kit.
1500 Atherectomy sys, peripheral H ........... ........... ........... ...........
1600 TC 99M sestamibi, per G ........... $109.25 ........... $13.33
syringe.
1601 TC 99M medronate, per dose. G ........... $38.38 ........... $4.68
1602 TC 99M apcitide, per vial.. G ........... $47.50 ........... $5.80
1603 TL 201, mCi................ G ........... $28.50 ........... $3.48
1604 IN 111 capromab pendetide, G ........... $1,008.90 ........... $135.19
per dose.
1605 Abciximab injection, 10 mg. G ........... $513.02 ........... $68.74
1606 Anistreplase, 30 u......... G ........... $2,693.80 ........... $360.97
1607 Eptifibatide injection, 5 G ........... $12.57 ........... $1.68
mg.
1608 Etanercept injection, 25 mg G ........... $134.42 ........... $18.01
1609 Rho(D) immune globulin h, G ........... $20.55 ........... $2.51
sd, 100 iu.
1611 Hylan G-F 20 injection, 16 G ........... $204.87 ........... $27.45
mg.
1612 Daclizumab, parenteral, 25 G ........... $397.29 ........... $53.24
mg.
1613 Trastuzumab, 10 mg......... G ........... $48.85 ........... $6.55
1614 Valrubicin, 200 mg......... G ........... $423.23 ........... $56.71
1615 Basiliximab, 20 mg......... G ........... $1,250.01 ........... $167.50
1616 Histrelin Acetate, 0.5 mg.. G ........... $14.91 ........... $2.00
1617 Lepirdin, 50 mg............ G ........... $124.49 ........... $16.68
1618 Von Willebrand factor, per G ........... $.95 ........... $.13
iu.
1619 Ga 67, per mCi............. G ........... $25.97 ........... $3.17
1620 TC 99M Bicisate, per vial.. G ........... $417.53 ........... $55.95
1621 Xe 133, per mCi............ G ........... $28.50 ........... $3.66
1622 TC 99M Mertiatide, per vial G ........... $185.82 ........... $24.90
1623 TC 99M Gluceptate.......... G ........... $22.61 ........... $2.76
1624 P32 sodium, per mCi........ G ........... $74.10 ........... $9.04
1625 IN 111 Pentetreotide, per G ........... $283.42 ........... $37.98
mCi.
1626 TC 99M Oxidronate, per vial G ........... $38.38 ........... $4.68
1627 TC-99 labeled red blood G ........... $38.95 ........... $4.75
cell, per test.
1628 P32 phosphate chromic, per G ........... $137.12 ........... $16.73
mCi.
1700 Authen Mick TP brachy H ........... ........... ........... ...........
needle.
1701 Medtec MT-BT-5201-25 ndl... H ........... ........... ........... ...........
1702 WWMT brachytx needle....... H ........... ........... ........... ...........
1703 Mentor Prostate Brachy..... H ........... ........... ........... ...........
1704 MT-BT-5001-25/5051-25...... H ........... ........... ........... ...........
1705 Best Flexi Brachy Needle... H ........... ........... ........... ...........
1706 Indigo Prostate Seeding Ndl H ........... ........... ........... ...........
1707 Varisource Implt Ndl....... H ........... ........... ........... ...........
1708 UroMed Prostate Seed Ndl... H ........... ........... ........... ...........
1709 Remington Brachytx Needle.. H ........... ........... ........... ...........
1710 US Biopsy Prostate Needle.. H ........... ........... ........... ...........
1711 MD Tech brachytx needle.... H ........... ........... ........... ...........
1712 Imagyn brachytx needle..... H ........... ........... ........... ...........
1790 Iridium 192 HDR............ H ........... ........... ........... ...........
1791 OncoSeed, Rapid Strand I- H ........... ........... ........... ...........
125.
1792 UroMed I-125 Brachy seed... H ........... ........... ........... ...........
1793 Bard InterSource P-103 seed H ........... ........... ........... ...........
[[Page 67839]]
1794 Bard IsoSeed P-103 seed.... H ........... ........... ........... ...........
1795 Bard BrachySource I-125.... H ........... ........... ........... ...........
1796 SourceTech Med I-125....... H ........... ........... ........... ...........
1797 Draximage I-125 seed....... H ........... ........... ........... ...........
1798 Syncor I-125 PharmaSeed.... H ........... ........... ........... ...........
1799 I-Plant I-125 Brachytx seed H ........... ........... ........... ...........
1800 Pd-103 brachytx seed....... H ........... ........... ........... ...........
1801 IoGold I-125 brachytx seed. H ........... ........... ........... ...........
1802 Iridium 192 brachytx seeds. H ........... ........... ........... ...........
1803 Best Iodine 125 brachytx H ........... ........... ........... ...........
sds.
1804 Best Palladium 103 seeds... H ........... ........... ........... ...........
1805 IsoStar Iodine-125 seeds... H ........... ........... ........... ...........
1806 Gold 198................... H ........... ........... ........... ...........
1810 D114S Dilatation Cath...... H ........... ........... ........... ...........
1811 Surgical Dynamics Anchors.. H ........... ........... ........... ...........
1812 OBL Anchors................ H ........... ........... ........... ...........
1850 Repliform 14/21 sq cm...... H ........... ........... ........... ...........
1851 Repliform 24/28 sq cm...... H ........... ........... ........... ...........
1852 TransCyte, per 247 sq cm... H ........... ........... ........... ...........
1853 Suspend, per 8/14 sq cm.... H ........... ........... ........... ...........
1854 Suspend, per 24/28 sq cm... H ........... ........... ........... ...........
1855 Suspend, per 36 sq cm...... H ........... ........... ........... ...........
1856 Suspend, per 48 sq cm...... H ........... ........... ........... ...........
1857 Suspend, per 84 sq cm...... H ........... ........... ........... ...........
1858 DuraDerm, per 8/14 sq cm... H ........... ........... ........... ...........
1859 DuraDerm, per 21/24/28 sq H ........... ........... ........... ...........
cm.
1860 DuraDerm, per 48 sq cm..... H ........... ........... ........... ...........
1861 DuraDerm, per 36 sq cm..... H ........... ........... ........... ...........
1862 DuraDerm, per 72 sq cm..... H ........... ........... ........... ...........
1863 DuraDerm, per 84 sq cm..... H ........... ........... ........... ...........
1864 SpermaTex, per 13.44 sq cm. H ........... ........... ........... ...........
1865 FasLata, per 8/14 sq cm.... H ........... ........... ........... ...........
1866 FasLata, per 24/28 sq cm... H ........... ........... ........... ...........
1867 FasLata, per 36/48 sq cm... H ........... ........... ........... ...........
1868 FasLata, per 96 sq cm...... H ........... ........... ........... ...........
1869 Gore Thyroplasty Dev....... H ........... ........... ........... ...........
1870 DermMatrix, per 16 sq cm... H ........... ........... ........... ...........
1871 DermMatrix, 32 or 64 sq cm. H ........... ........... ........... ...........
1872 Dermagraft, per 37.5 sq cm. H ........... ........... ........... ...........
1873 Bard 3DMax Mesh............ H ........... ........... ........... ...........
1929 Maverick PTCA Cath......... H ........... ........... ........... ...........
1930 Coyote Dil Cath, 20/30/40mm H ........... ........... ........... ...........
1931 Talon Dil Cath............. H ........... ........... ........... ...........
1932 Scimed Remedy Dil Cath..... H ........... ........... ........... ...........
1933 Opti-Plast XL/Centurion H ........... ........... ........... ...........
Cath.
1934 Ultraverse 3.5F Bal Dil H ........... ........... ........... ...........
Cath.
1935 Workhorse PTA Bal Cath..... H ........... ........... ........... ...........
1936 Uromax Ultra Bal Dil Cath.. H ........... ........... ........... ...........
1937 Synergy Balloon Dil Cath... H ........... ........... ........... ...........
1938 UroForce Bal Dil Cath...... H ........... ........... ........... ...........
1939 Raptur, Ninja PTCA Dil Cath H ........... ........... ........... ...........
1940 PowerFlex,OPTA 5/LP Bal H ........... ........... ........... ...........
Cath.
1941 Jupiter PTA Dil Cath....... H ........... ........... ........... ...........
1942 Cordis Maxi LD PTA Bal Cath H ........... ........... ........... ...........
1943 RXCrossSail OTW OpenSail... H ........... ........... ........... ...........
1944 Rapid Exchange Bil Dil Cath H ........... ........... ........... ...........
1945 Savvy PTA Dil Cath......... H ........... ........... ........... ...........
1946 R1s Rapid Dil Cath......... H ........... ........... ........... ...........
1947 Gazelle Bal Dil Cath....... H ........... ........... ........... ...........
1948 Pursuit Balloon Cath....... H ........... ........... ........... ...........
1949 Oracle Megasonics Cath..... H ........... ........... ........... ...........
1979 Visions PV/Avanar US Cath.. H ........... ........... ........... ...........
1980 Atlantis SR Coronary Cath.. H ........... ........... ........... ...........
1981 PTCA Catheters............. H ........... ........... ........... ...........
2000 Orbiter ST Steerable Cath.. H ........... ........... ........... ...........
2001 Constellation Diag Cath.... H ........... ........... ........... ...........
2002 Irvine 5F Inquiry Diag EP H ........... ........... ........... ...........
Cath.
2003 Irvine 6F Inquiry Diag EP H ........... ........... ........... ...........
Cath.
2004 Biosense EP Cath--Octapolar H ........... ........... ........... ...........
2005 Biosense EP Cath--Hexapolar H ........... ........... ........... ...........
2006 Biosense EP Cath--Decapolar H ........... ........... ........... ...........
2007 Irvine 6F Luma-Cath EP Cath H ........... ........... ........... ...........
2008 7F Luma-Cath EP Cath 81910- H ........... ........... ........... ...........
15.
2009 Irvine 7F Luma-Cath EP Cath H ........... ........... ........... ...........
2010 Fixed Curve EP Cath........ H ........... ........... ........... ...........
2011 Deflectable Tip Cath--Quad. H ........... ........... ........... ...........
2012 Celsius Abln Cath.......... H ........... ........... ........... ...........
2013 Celsius Large Abln Cath.... H ........... ........... ........... ...........
[[Page 67840]]
2014 Celsius II Asym Abln Cath.. H ........... ........... ........... ...........
2015 Celsius II Sym Abln Cath... H ........... ........... ........... ...........
2016 Navi-Star DS, Navi-Star H ........... ........... ........... ...........
Ther.
2017 Navi-Star Abln Cath........ H ........... ........... ........... ...........
2018 Polaris T Ablation Cath.... H ........... ........... ........... ...........
2019 EP Deflectable Cath........ H ........... ........... ........... ...........
2020 Blazer II XP Abln Cath..... H ........... ........... ........... ...........
2021 SilverFlex EP Cath......... H ........... ........... ........... ...........
2022 CP Chilli Cooled Abln Cath. H ........... ........... ........... ...........
2023 Chilli Cld AblnCath-std, lg H ........... ........... ........... ...........
2100 CP CS Reference Cath....... H ........... ........... ........... ...........
2101 CP RV Reference Cath....... H ........... ........... ........... ...........
2102 CP Radii 7F EP Cath........ H ........... ........... ........... ...........
2103 CP Radii 7F EP Cath w/Track H ........... ........... ........... ...........
2104 Lasso Deflectable Cath..... H ........... ........... ........... ...........
2151 Veripath Guiding Cath...... H ........... ........... ........... ...........
2152 Cordis Vista Brite Tip Cath H ........... ........... ........... ...........
2153 Bard Viking Cath........... H ........... ........... ........... ...........
2200 Arrow-Trerotola PTD Cath... H ........... ........... ........... ...........
2300 Varisource Stnd Catheters.. H ........... ........... ........... ...........
2597 CliniCath/kit 16/18 sgl/dbl H ........... ........... ........... ...........
2598 CliniCath 18/20/24G-single. H ........... ........... ........... ...........
2599 CliniCath 16/18G-double.... H ........... ........... ........... ...........
2601 Bard DL Ureteral Cath...... H ........... ........... ........... ...........
2602 Vitesse Laser Cath 1.4/ H ........... ........... ........... ...........
1.7mm.
2603 Vitesse Laser Cath 2.0mm... H ........... ........... ........... ...........
2604 Vitesse E Laser Cath 2.0mm. H ........... ........... ........... ...........
2605 Extreme Laser Catheter..... H ........... ........... ........... ...........
2606 SpineCath XL Catheter...... H ........... ........... ........... ...........
2607 SpineCath Intradiscal Cath. H ........... ........... ........... ...........
2608 Scimed 6F Wiseguide Cath... H ........... ........... ........... ...........
2609 Flexima Bil Drainage Cath.. H ........... ........... ........... ...........
2610 FlexTipPlus Intraspinal H ........... ........... ........... ...........
Cath.
2611 AlgoLine Intraspinal Cath.. H ........... ........... ........... ...........
2612 InDura Catheter............ H ........... ........... ........... ...........
2700 MycroPhylax Plus SC defib.. H ........... ........... ........... ...........
2701 Phylax XM SC defib......... H ........... ........... ........... ...........
2702 Ventak Prizm 2 VR Defib.... H ........... ........... ........... ...........
2703 Ventak Prizm VR HE Defib... H ........... ........... ........... ...........
2704 Ventak Mini IV+ Defib...... H ........... ........... ........... ...........
2801 Defender IV DR 612 DC defib H ........... ........... ........... ...........
2802 Phylax AV DC defib......... H ........... ........... ........... ...........
2803 Ventak Prizm DR HE Defib... H ........... ........... ........... ...........
2804 Ventak Prizm 2 DR Defib.... H ........... ........... ........... ...........
2805 Jewel AF 7250 Defib........ H ........... ........... ........... ...........
2806 GEM VR 7227 Defib.......... H ........... ........... ........... ...........
2807 Contak CD 1823............. H ........... ........... ........... ...........
2808 Contak TR 1241............. H ........... ........... ........... ...........
3002 EasyTrak Defib Lead........ H ........... ........... ........... ...........
3001 Kainox SL/RV defib lead.... H ........... ........... ........... ...........
3003 Endotak SQ Array XP lead... H ........... ........... ........... ...........
3004 Intervene Defib Lead....... H ........... ........... ........... ...........
3400 Siltex Spectrum, Contour H ........... ........... ........... ...........
Prof.
3401 Saline-Filled Spectrum..... H ........... ........... ........... ...........
3500 Mentor Alpha I Inf Penile H ........... ........... ........... ...........
Pros.
3510 AMS 800 Urinary Pros....... H ........... ........... ........... ...........
3551 Choice/PT Graphix/Luge/ H ........... ........... ........... ...........
Trooper.
3552 Hi-Torque Whisper.......... H ........... ........... ........... ...........
3553 Cordis guidewires.......... H ........... ........... ........... ...........
3554 Jindo guidewire............ H ........... ........... ........... ...........
3555 Wholey Hi-Torque Plus GW... H ........... ........... ........... ...........
3556 Wave/FlowWire Guidewire.... H ........... ........... ........... ...........
3557 HyTek guidewire............ H ........... ........... ........... ...........
3800 SynchroMed EL infusion pump H ........... ........... ........... ...........
3801 Arrow/MicroJect PCA Sys.... H ........... ........... ........... ...........
3851 Elastic UV IOL AA-4203T/TF/ H ........... ........... ........... ...........
TL.
4000 Opus G 4621, 4624 SC pmkr.. H ........... ........... ........... ...........
4001 Opus S 4121/4124 SC pmkr... H ........... ........... ........... ...........
4002 Talent 113 SC pmkr......... H ........... ........... ........... ...........
4003 Kairos SR SC pmkr.......... H ........... ........... ........... ...........
4004 Actros SR, Actros SLR SC H ........... ........... ........... ...........
pmkr.
4005 Philos SR/SR-B SC pmkr..... H ........... ........... ........... ...........
4006 Pulsar Max II SR pmkr...... H ........... ........... ........... ...........
4007 Marathon SR pmkr........... H ........... ........... ........... ...........
4008 Discovery II SSI pmkr...... H ........... ........... ........... ...........
4009 Discovery II SR pmkr....... H ........... ........... ........... ...........
4300 Integrity AFx DR 5342 pmkr. H ........... ........... ........... ...........
4301 Integrity AFx DR 5346 pmkr. H ........... ........... ........... ...........
[[Page 67841]]
4302 Affinity VDR 5430 pmkr..... H ........... ........... ........... ...........
4303 Brio 112 DC pmkr........... H ........... ........... ........... ...........
4304 Brio 212, Talent 213/223 DC H ........... ........... ........... ...........
pmkr.
4305 Brio 222 DC pmkr........... H ........... ........... ........... ...........
4306 Brio 220 DC pmkr........... H ........... ........... ........... ...........
4307 Kairos DR DC pmkr.......... H ........... ........... ........... ...........
4308 Inos2, Inos2+ DC pmkr...... H ........... ........... ........... ...........
4309 Actros DR,D,DR-A,SLR DC H ........... ........... ........... ...........
pmkr.
4310 Actros DR-B DC pmkr........ H ........... ........... ........... ...........
4311 Philos DR/DR-B/SLR DC pmkr. H ........... ........... ........... ...........
4312 Pulsar Max II DR pmkr...... H ........... ........... ........... ...........
4313 Marathon DR pmkr........... H ........... ........... ........... ...........
4314 Momentum DR pmkr........... H ........... ........... ........... ...........
4315 Selection AFm pmkr......... H ........... ........... ........... ...........
4316 Discovery II DR............ H ........... ........... ........... ...........
4317 Discovery II DDD........... H ........... ........... ........... ...........
4600 Snynox,Polyrox,Elox,Retrox. H ........... ........... ........... ...........
4602 Tendril SDX, 1488K pmkr H ........... ........... ........... ...........
lead.
4603 Oscor/Flexion pmkr lead.... H ........... ........... ........... ...........
4604 CrystallineActFix,CapsureFi H ........... ........... ........... ...........
x.
4605 CapSure Epi pmkr lead...... H ........... ........... ........... ...........
4606 Flextend pmkr lead......... H ........... ........... ........... ...........
4607 FinelineII/EZ, ThinlineII/ H ........... ........... ........... ...........
EZ.
5000 BX Velocity w/Hepacoat..... H ........... ........... ........... ...........
5001 Memotherm Bil Stent, sm, H ........... ........... ........... ...........
med.
5002 Memotherm Bil Stent, large. H ........... ........... ........... ...........
5003 Memotherm Bil Stent, x- H ........... ........... ........... ...........
large.
5004 PalmazCorinthian IQ Bil H ........... ........... ........... ...........
Stent.
5005 PalmazCorinthian IQ Trans/ H ........... ........... ........... ...........
Bil.
5006 PalmazTrans Bil Stent Sys- H ........... ........... ........... ...........
Med.
5007 PalmazTrans XL Bil Stent-- H ........... ........... ........... ...........
40mm.
5008 PalmazTrans XL Bil Stent-- H ........... ........... ........... ...........
50mm.
5009 VistaFlex Biliary Stent.... H ........... ........... ........... ...........
5010 Rapid Exchange Bil Stent H ........... ........... ........... ...........
Sys.
5011 IntraStent, IntraStent LP.. H ........... ........... ........... ...........
5012 IntraStent DoubleStrut LD.. H ........... ........... ........... ...........
5013 IntraStent DoubleStrut, XS. H ........... ........... ........... ...........
5014 AVE Bridge Stent Sys-10/17/ H ........... ........... ........... ...........
28.
5015 AVE/X3 Bridge Sys, 40-100.. H ........... ........... ........... ...........
5016 Biliary stent single use H ........... ........... ........... ...........
cov.
5017 WallstentRP Bil--20/40/60/ H ........... ........... ........... ...........
68mm.
5018 WallstentRP Bil--80/94mm... H ........... ........... ........... ...........
5019 Flexima Bil Stent Sys...... H ........... ........... ........... ...........
5020 Smart Nitinol Stent--20mm.. H ........... ........... ........... ...........
5021 Smart Nitinol Stent--40/ H ........... ........... ........... ...........
60mm.
5022 Smart Nitinol Stent--80mm.. H ........... ........... ........... ...........
5023 BX Velocity Stent--8/13mm.. H ........... ........... ........... ...........
5024 BX Velocity Stent--18mm.... H ........... ........... ........... ...........
5025 BX Velocity Stent--23mm.... H ........... ........... ........... ...........
5026 BX Velocity Stent--28/33mm. H ........... ........... ........... ...........
5027 BX Velocity w/Hep--8/13mm.. H ........... ........... ........... ...........
5028 BX Velocity w/Hep--18mm.... H ........... ........... ........... ...........
5029 BX Velocity w/Hep--23mm.... H ........... ........... ........... ...........
5030 Stent, coronary, S660 9/ H ........... ........... ........... ...........
12mm.
5031 Stent,coronary, S660 15/ H ........... ........... ........... ...........
18mm.
5032 Stent,coronary, S660 24/ H ........... ........... ........... ...........
30mm.
5033 Niroyal Stent Sys, 9mm..... H ........... ........... ........... ...........
5034 Niroyal Stent Sys, 12/15mm. H ........... ........... ........... ...........
5035 Niroyal Stent Sys, 18mm.... H ........... ........... ........... ...........
5036 Niroyal Stent Sys, 25mm.... H ........... ........... ........... ...........
5037 Niroyal Stent Sys, 31mm.... H ........... ........... ........... ...........
5038 BX Velocity Stent w/Raptor. H ........... ........... ........... ...........
5039 IntraCoil Periph Stent-- H ........... ........... ........... ...........
40mm.
5040 IntraCoil Periph Stent-- H ........... ........... ........... ...........
60mm.
5041 BeStent Over-the-Wire 24/ H ........... ........... ........... ...........
30mm.
5042 BeStent Over-the-Wire 18mm. H ........... ........... ........... ...........
5043 BeStent Over-the-Wire 15mm. H ........... ........... ........... ...........
5044 BeStent Over-the-Wire 9/ H ........... ........... ........... ...........
12mm.
5045 Multilink Tetra Cor Stent H ........... ........... ........... ...........
Sys.
5046 Radius 20mm cor stent...... H ........... ........... ........... ...........
5047 Niroyal Elite Cor Stent Sys H ........... ........... ........... ...........
5048 GR II Coronary Stent....... H ........... ........... ........... ...........
5130 Wilson-Cook Colonic Z-Stent H ........... ........... ........... ...........
5131 Bard Colorectal Stent-60mm. H ........... ........... ........... ...........
5132 Bard Colorectal Stent-80mm. H ........... ........... ........... ...........
5133 Bard Colorectal Stent-100mm H ........... ........... ........... ...........
5134 Enteral Wallstent--90mm.... H ........... ........... ........... ...........
5279 Contour/Percuflex Stent.... H ........... ........... ........... ...........
[[Page 67842]]
5280 Inlay Dbl Ureteral Stent... H ........... ........... ........... ...........
5281 Wallgraft Trach Sys 70mm... H ........... ........... ........... ...........
5282 Wallgraft Trach Sys 20/30/ H ........... ........... ........... ...........
50.
5283 Wallstent/RP TIPS--80mm.... H ........... ........... ........... ...........
5284 Wallstent TrachUltraFlex... H ........... ........... ........... ...........
5600 Closure dev, VasoSeal ES... H ........... ........... ........... ...........
5601 VasoSeal Model 1000........ H ........... ........... ........... ...........
6001 Composix Mesh 8/21 in...... H ........... ........... ........... ...........
6002 Composix Mesh 32 in....... H ........... ........... ........... ...........
6003 Composix Mesh 48 in........ H ........... ........... ........... ...........
6004 Composix Mesh 80 in........ H ........... ........... ........... ...........
6005 Composix Mesh 140 in....... H ........... ........... ........... ...........
6006 Composix Mesh 144 in....... H ........... ........... ........... ...........
6012 Pelvicol Collagen 8/14 sq H ........... ........... ........... ...........
cm.
6013 Pelvicol Collagen 21/24/28 H ........... ........... ........... ...........
sq cm.
6014 Pelvicol Collagen 36 sq cm. H ........... ........... ........... ...........
6015 Pelvicol Collagen 48 sq cm. H ........... ........... ........... ...........
6016 Pelvicol Collagen 96 sq cm. H ........... ........... ........... ...........
6017 Gore-Tex DualMesh 75/96 sq H ........... ........... ........... ...........
cm.
6018 Gore-Tex DualMesh 150 sq cm H ........... ........... ........... ...........
6019 Gore-Tex DualMesh 285 sq cm H ........... ........... ........... ...........
6020 Gore-Tex DualMesh 432 sq cm H ........... ........... ........... ...........
6021 Gore-Tex DualMesh 600 sq cm H ........... ........... ........... ...........
6022 Gore-Tex DualMesh 884 sq cm H ........... ........... ........... ...........
6023 Gore-TexPlus 1mm, 75/96sq H ........... ........... ........... ...........
cm.
6024 Gore-TexPlus 1mm, 150sq cm. H ........... ........... ........... ...........
6025 Gore-TexPlus 1mm, 285sq cm. H ........... ........... ........... ...........
6026 Gore-TexPlus 1mm, 432sq cm. H ........... ........... ........... ...........
6027 Gore-TexPlus 1mm, 600sq cm. H ........... ........... ........... ...........
6028 Gore-TexPlus 1mm, 884 sq cm H ........... ........... ........... ...........
6029 Gore-TexPlus 2mm, 150 sq cm H ........... ........... ........... ...........
6030 Gore-TexPlus 2mm, 285 sq cm H ........... ........... ........... ...........
6031 Gore-TexPlus 2mm, 432 sq cm H ........... ........... ........... ...........
6032 Gore-TexPlus 2mm, 600 sq cm H ........... ........... ........... ...........
6033 Gore-TexPlus 2mm, 884 sq cm H ........... ........... ........... ...........
6034 Bard ePTFE: 150 sq cm--2mm. H ........... ........... ........... ...........
6035 Bard ePTFE 150 sqcm-1mm,75- H ........... ........... ........... ...........
2mm.
6036 Bard ePTFE: 50/75 sqcm- H ........... ........... ........... ...........
1,2mm.
6037 Bard ePTFE: 300 sq cm-1,2mm H ........... ........... ........... ...........
6038 Bard ePTFE: 600 sq cm-1mm.. H ........... ........... ........... ...........
6039 Bard ePTFE: 884 sq cm-1mm.. H ........... ........... ........... ...........
6040 Bard ePTFE: 600 sq cm-2mm.. H ........... ........... ........... ...........
6041 Bard ePTFE: 884 sq cm-2mm.. H ........... ........... ........... ...........
6050 Female Sling Sys w/wo Matrl H ........... ........... ........... ...........
6051 Stratasis Sling, 20/40 cm.. H ........... ........... ........... ...........
6052 Stratasis Sling, 60 cm..... H ........... ........... ........... ...........
6053 Surgisis Soft Graft........ H ........... ........... ........... ...........
6054 Surgisis Enhanced Graft.... H ........... ........... ........... ...........
6055 Surgisis Enhanced Tissue... H ........... ........... ........... ...........
6056 Surgisis Soft Tissue Graft. H ........... ........... ........... ...........
6057 Surgisis Hernia Graft...... H ........... ........... ........... ...........
6058 SurgiPro Hernia Plug, med/ H ........... ........... ........... ...........
lg.
6080 Male Sling Sys w/wo Matrl.. H ........... ........... ........... ...........
6200 Exxcel Sft ePTFE vas graft. H ........... ........... ........... ...........
6201 Impra Venaflo--10/20cm..... H ........... ........... ........... ...........
6202 Impra Venaflo-30/40cm...... H ........... ........... ........... ...........
6203 Impra Venaflo-50cm,vt45.... H ........... ........... ........... ...........
6204 Impra Venaflo-stepped...... H ........... ........... ........... ...........
6205 Impra Carboflo--10cm....... H ........... ........... ........... ...........
6206 Impra Carboflo--20cm....... H ........... ........... ........... ...........
6207 Impra Carboflo--30/35/40cm. H ........... ........... ........... ...........
6208 Impra Carboflo--40/50cm.... H ........... ........... ........... ...........
6209 Impra Carboflo--ctrflex.... H ........... ........... ........... ...........
6210 Exxcel ePTFE vas graft..... H ........... ........... ........... ...........
6300 Vanguard III Endovas Graft. H ........... ........... ........... ...........
6500 Preface Guiding Sheath..... H ........... ........... ........... ...........
6501 Soft Tip Sheaths........... H ........... ........... ........... ...........
6502 Perry Exchange Dilator..... H ........... ........... ........... ...........
6525 Spectranetics Laser Sheath. H ........... ........... ........... ...........
6600 Micro Litho Flex Probes.... H ........... ........... ........... ...........
6650 Fast-Cath Guiding H ........... ........... ........... ...........
Introducer.
6651 Seal-AwayGuiding Introducer H ........... ........... ........... ...........
6652 Bard Excalibur Introducer.. H ........... ........... ........... ...........
6700 Focal Seal-L............... H ........... ........... ........... ...........
7000 Amifostine, 500 mg......... G ........... $350.31 ........... $46.94
7001 Amphotericin B lipid G ........... $95.00 ........... $12.73
complex, 50 mg.
7003 Epoprostenol injection 0.5 G ........... $16.53 ........... $2.22
mg.
7004 Immune globulin 5 gms...... G ........... $272.80 ........... $33.28
[[Page 67843]]
7005 Gonadorelin hydroch, 100 G ........... $14.80 ........... $1.98
mcg.
7007 Milrinone lactate, per 5 K 0.47 $23.31 ........... $4.66
ml, inj.
7010 Morphine sulfate G ........... $7.41 ........... $.99
(preservative free) 10 mg.
7011 Oprelvekin injection, 5 mg. G ........... $236.31 ........... $31.67
7014 Fentanyl citrate inj up 2 G ........... $0.98 ........... $0.13
ml.
7015 Busulfan, oral, 2 mg....... G ........... $1.73 ........... $0.23
7019 Aprotinin, 10,000 kiu...... G ........... $196.35 ........... $26.31
7022 Elliot's B solution, per ml G ........... $14.25 ........... $1.91
7023 Treatment for bladder G ........... $23.54 ........... $3.15
calculi, per 500 ml.
7024 Corticorelin ovine G ........... $353.88 ........... $45.77
triflutate, per 0.1 mg.
7025 Digoxin immune FAB (Ovine), G ........... $530.44 ........... $64.71
40 mg vial.
7026 Ethanolamine oleate, 100 mg G ........... $27.21 ........... $3.65
7027 Fomepizole, 1.5 mg......... G ........... $728.33 ........... $97.60
7028 Fosphenytoin, 50 mg........ G ........... $8.55 ........... $1.15
7029 Glatiramer acetate, 20 mg.. G ........... $27.40 ........... $3.67
7030 Hemin, 1 mg................ G ........... $0.90 ........... $0.12
7031 Octreotide acetate G ........... $115.34 ........... $15.46
injection 1mg.
7032 Sermorelin acetate, 0.5 mg. G ........... $15.78 ........... $2.11
7033 Somatrem, 5 mg............. G ........... $199.50 ........... $26.73
7034 Somatropin, 1 mg (any G ........... $39.90 ........... $5.35
derivation).
7035 Teniposide, 50 mg.......... G ........... $195.28 ........... $26.17
7036 Urokinase, inj, IV, 250,000 K 6.78 $336.29 ........... $67.26
I.U..
7037 Urofollitropin, 75 I.U..... G ........... $69.73 ........... $9.34
7038 Muromonab-CD3, 5 mg........ G ........... $741.00 ........... $99.29
7039 Pegademase bovine inj 25 G ........... $139.33 ........... $18.67
I.U.
7040 Pentastarch 10% inj, 100 ml G ........... $15.11 ........... $2.04
7041 Tirofiban hydrochloride G ........... $399.00 ........... $53.47
12.5 mg.
7042 Capecitabine, oral, 150 mg. G ........... $1.94 ........... $0.26
7043 Infliximab injection 10 mg. G ........... $58.08 ........... $7.78
7045 Trimetrexate glucoronate 25 G ........... $69.83 ........... $9.36
mg.
7046 Doxorubicin hcl liposome G ........... $311.72 ........... $41.77
inj 10 mg.
7047 Droperidol/fentanyl inj.... G ........... $7.02 ........... $0.90
7048 Alteplase, 1 mg............ K 0.38 $18.70 ........... $3.74
7049 Filgrastim 480 mcg G ........... $273.03 ........... $35.06
injection.
7315 Sodium hyaluronate, 20 mg.. G ........... $125.59 ........... $16.83
8099 Spectranetics Lead Lock Dev H ........... ........... ........... ...........
8100 Adhesion barrier, ADCON-L.. H ........... ........... ........... ...........
8102 SurgiVision Esoph Coil..... H ........... ........... ........... ...........
9000 Na chromate Cr51, per G ........... $259.36 ........... $34.75
0.25mCi.
9001 Linezolid inj, 200mg....... J ........... $34.14 ........... $4.57
9002 Tenecteplase, 50mg/vial.... J ........... $2,612.50 ........... $350.08
9003 Palivizumab, per 50mg...... J ........... $664.49 ........... $89.04
9004 Gemtuzumab ozogamicin J ........... $1,929.69 ........... $258.58
inj,5mg.
9005 Reteplase inj, half-kit, G ........... $1,306.25 ........... $175.04
18.8 mg/vial.
9006 Tacrolimus inj, per 5mg (1 J ........... $109.83 ........... $14.72
amp).
9007 Baclofen Intrathecal kit- G ........... $79.80 ........... $10.69
1amp.
9008 Baclofen Refill Kit--500mcg G ........... $222.30 ........... $29.79
9009 Baclofen Refill Kit-- G ........... $467.40 ........... $62.63
2000mcg.
9010 Baclofen Refill Kit-- G ........... $820.80 ........... $109.99
4000mcg.
9011 Caffeine Citrate, inj, 1ml. G ........... $12.22 ........... $1.57
9100 Iodinated I-131 Albumin.... G ........... $246.05 ........... $30.02
9102 51 Na chromate, 50mCi...... G ........... $216.60 ........... $26.43
9103 Na Iothalamate I-125, 10uCi G ........... $12.27 ........... $1.50
9104 Anti-thymocyte G ........... $251.75 ........... $33.73
globulin,25mg.
9105 Hep B imm glob, per 1 ml... G ........... $152.00 ........... $20.37
9106 Sirolimus 1mg/ml........... J ........... $6.51 ........... $.87
9107 Tinzaparin sodium, 2ml vial J ........... $159.60 ........... $20.50
9108 Thyrotropin Alfa,1.1 mg.... G ........... $494.00 ........... $70.72
9109 Tirofiban hydrochloride G ........... $199.50 ........... $28.56
6.25 mg.
9217 Leuprolide acetate for G ........... $592.60 ........... $79.40
depot suspension, 7.5 mg.
9500 Platelets, irrad, ea unit.. K 1.77 $87.97 ........... $17.59
9501 Platelets, pheresis, ea K 9.69 $480.75 ........... $96.15
unit.
9502 Platelets, pher/irrad, ea K 10.52 $521.66 ........... $104.33
unit.
9503 Fresh frozen plasma, ea K 1.65 $81.83 ........... $16.37
unit.
9504 RBC, deglycerolized, ea K 4.35 $215.83 ........... $43.17
unit.
[[Page 67844]]
9505 RBC, irradiated, ea unit... K 2.58 $127.86 ........... $25.57
9998 Enoxaparin................. G ........... $5.53 ........... $0.79
----------------------------------------------------------------------------------------------------------------
--------------------
CPT codes and descriptions only are copyright American Medical
Association. All Rights Reserved. Applicable FARS/DFARS Apply.
Copyright American Dental Association. All rights reserved.
* Code is new in 2001.
[[Page 67844]]
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