I R PInnovative Resources for Payors
	
[Federal Register: May 9, 2002 (Volume 67, Number 90)]
[Proposed Rules]               
[Page 31403-31452]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my02-27]                         



To assist readers in referencing sections contained in this 
document, we are providing the following table of contents.


Outline of Contents

Summary

I.    Background
    A. Summary
    B. Major Contents of This Proposed Rule
II.   Proposed Changes to DRG Classifications and Relative Weights
    A. Background

    B. DRG Reclassification
    C. Recalibration of DRG Weights
    D. Proposed Add-On Payments for New Services and Technologies
III.  Proposed Changes to the Hospital Wage Index
    A. Background

    B. Proposed FY 2003 Wage Index Update
    C. FY 2003 Wage Index Proposal
    D. Verification of Wage Data From the Medicare Cost Report
    E. Computation of the Proposed FY 2003 Wage Index

    F. Revisions to the Wage Index Based on Hospital Redesignation
    G. Requests for Wage Data Corrections
IV.   Proposed Rebasing and Revision of the Hospital Market Baskets
    A. Operating Costs
    B. Capital Input Price Index

V.    Other Decisions and Proposed Changes to the Prospective Payment 
      System for Inpatient Operating Costs and Graduate Medical Education 
      Costs
    A. Transfer Payment Policy
    B. Sole Community Hospitals (SCHs) (Secs. 412.77 and 412.92)
    C. Outlier Payments: Technical Change (Sec. 412.80)
    D. Rural Referral Centers (Sec. 412.96)
    E. Indirect Medical Education (IME) Adjustment (Sec. 412.105)
    F. Medicare-Dependent, Small Rural Hospitals: Ongoing Review of 
       Eligibility Criteria (Sec. 412.108(b))
    G. Eligibility Criteria for Reasonable Cost Payments to Rural Hospitals 
       for Nonphysician Anesthetists (Sec. 412.113(c))
    H. Medicare Geographic Classification Review Board (MGCRB) 
       Reclassification Process (Secs. 412.230, 412.232, and 412.273)
    I. Payment for Direct Costs of Graduate Medical Education (Sec. 413.86)
    J. Responsibilities of Medicare-Participating Hospitals in Emergency 
       Cases (EMTALA)

    K. Provider-Based Entities
    L. CMS Authority Over Reopening of Intermediary Determinations and 
       Intermediary Hearing Decisions on Provider Reimbursement
VI. Proposed Changes to the Prospective Payment System for Capital-
    Related Costs
    A. Background
    B. New Hospitals

    C. Extraordinary Circumstances
    D. Restoration of the 2.1 Percent Reduction to the Standard Federal 
       Capital Prospective Payment System Payment Rate
    E. Clarification of Special Exceptions Policy
VII. Proposed Changes for Hospitals and Hospital Units Excluded 
     From the Acute Care Hospital Inpatient Prospective Payment System
    A. Payments to Excluded Hospitals and Hospital Units (Secs. 413.40(c), 
       (d), and (f))
    B. Criteria for Exclusion of Satellite Facilities from the Hospital 
       Inpatient Prospective Payment System
    C. Critical Access Hospitals (CAHs)

VIII. MedPAC Recommendations
IX. Other Required Information
    A. Requests for Data From the Public
    B. Information Collection Requirements
    C. Public Comments

Addendum--Proposed Schedule of Standardized Amounts Effective with 
        Discharges Occurring On or After October 1, 2002 and Update Factors and 
        Rate-of-Increase Percentages Effective With Cost Reporting Periods 
        Beginning On or After October 1, 2002
I.   Summary and Background
II.  Proposed Changes to Prospective Payment Rates for Hospital 
     Inpatient Operating Costs for FY 2003
III. Proposed Changes to Payment Rates for Acute Care Hospital 
     Inpatient Capital-Related Costs for FY 2003
IV.  Proposed Changes to Payment Rates for Excluded Hospitals and 
     Hospital Units: Rate-of-Increase Percentages

V. Tables
    This section contains the tables referred to throughout the 
    preamble to this proposed rule and in this Addendum.

Appendix A--Regulatory Impact Analysis
I.   Introduction
II.  Objectives
III. Limitations of Our Analysis
IV.  Hospitals Included In and Excluded From the Acute Care Hospital 
     Inpatient Prospective Payment System
V.   Impact on Excluded Hospitals and Hospital Units

VI.  Quantitative Impact Analysis of the Proposed Policy Changes 
     Under the Hospital Inpatient Prospective Payment System for 
     Operating Costs
    Table I.--Impact Analysis of Changes for FY 2003 Operating Prospective Payment System
    Table II.--Impact Analysis of Changes for FY 2003 Operating Prospective Payment System
    Table III.--Comparison of Total Payments Per Case
    A. Basis and Methodology of Estimates
    B. Impact of the Proposed Changes to the Labor Share (Column 1)
    C. Impact of the Proposed Changes to the DRG Reclassifications and 
       Recalibration of Relative Weights (Column 3)
    D. Impact of Wage Index Changes (Columns 3, 4, and 5)
    E. Combined Impact of DRG and Wage Index Changes--Including Budget 
    Neutrality Adjustment (Column 6)
    F. Impact of MGCRB Reclassifications (Column 7)
    G. All Changes (Column 8)
VII. Impact of Specific Proposed Policy Changes

    A. Impact of Proposed Policy Changes Relating to Hospital Bed Counts
    B. Impact of Proposed Changes Relating to EMTALA Provisions
    C. Impact of Proposed Policy Changes Relating to Provider-Based Entity
VIII. Impact of Proposed Policies Affecting Rural Hospitals
    A. Raising the Threshold To Qualify for the CRNA Pass-Through Payments
    B. Removal of Requirement for CAHs To Use State Resident Assessment
    Instrument
IX. Impact of Proposed Changes in the Capital Prospective Payment 
System

Appendix B--Report to Congress (available only at Federal Register Website)

Appendix C--Recommendation of Update Factors for Operating Cost 
    Rates of Payment for Inpatient Hospital Services

[[Page 31403]]

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Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 405, 412 et al.



Medicare Program; Changes to the Hospital Inpatient Prospective Payment 
Systems and Fiscal Year 2003 Rates; Proposed Rule


[[Page 31404]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 412, 413, 482, 485, and 489

[CMS-1203-P]
RIN 0938-AL23

 
Medicare Program; Changes to the Hospital Inpatient Prospective 
Payment Systems and Fiscal Year 2003 Rates

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.


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SUMMARY: We are proposing to revise the Medicare acute care hospital 
inpatient prospective payment systems for operating and capital costs 
to implement changes arising from our continuing experience with these 
systems. In addition, in the Addendum to this proposed rule, we 
describe the proposed changes to the amounts and factors used to 
determine the rates for Medicare hospital inpatient services for 
operating costs and capital-related costs. These changes would be 
applicable to discharges occurring on or after October 1, 2002. We also 
are setting forth proposed rate-of-increase limits as well as proposed 
policy changes for hospitals and hospital units excluded from the acute 
care hospital inpatient prospective payment systems.
    In addition, we are proposing changes to other hospital payment 
policies, which include policies governing: payments to hospitals for 
the direct and indirect costs of graduate medical education; pass-
through payments for the services of nonphysician anesthetists in some 
rural hospitals; clinical requirements for swing-bed services in 
critical access hospitals (CAHs); payments to provider-based entities; 
and implementation of the Emergency Medical Treatment and Active Labor 
Act (EMTALA).

DATES: Comments will be considered if received at the appropriate 
address, as provided below, no later than 5 p.m. on July 8, 2002.

ADDRESSES: Mail written comments (an original and three copies) to the 
following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-1203-P, P.O. Box 8010, Baltimore, MD 
21244-1850.
    If you prefer, you may deliver, by hand or courier, your written 
comments (an original and three 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, Central Building, 7500 Security Boulevard, Baltimore, MD 
21244-1850.

    (Because access to the interior of the Humphrey Building is not 
readily available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for commenters who wish to retain proof of filing by stamping 
in and keeping an extra copy of the comments being filed.)
    Comments mailed to those addresses specified as appropriate for 
courier delivery may be delayed and could be considered late.
    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code CMS-1203-P.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.
    For comments that relate to information collection requirements, 
mail a copy of comments to the following addresses:

Centers for Medicare & Medicaid Services, Office of Information 
Services, Security and Standards Group, Division of CMS Enterprise 
Standards, Room N2-14-26, 7500 Security Boulevard, Baltimore, Maryland 
21244-1850. Attn: John Burke, CMS-1203-P; and
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 3001, New Executive Office Building, Washington, DC 20503, 
Attn: Allison Herron Eydt, CMS Desk Officer.

FOR FURTHER INFORMATION CONTACT: Stephen Phillips, (410) 786-4548, 
Operating Prospective Payments, Diagnosis-Related Groups (DRGs), Wage 
Index, New Medical Services and Technology, Hospital Geographic 
Reclassifications, and Postacute Transfer Issues. Tzvi Hefter, (410) 
786-4487, Capital Prospective Payment, Excluded Hospitals, Graduate 
Medical Education, Provider-Based Entities, Critical Access Hospital 
(CAH), EMTALA Issues. Stephen Heffler, (410) 786-1211, Hospital Market 
Basket Rebasing. Jeannie Miller, (410) 786-3164, Clinical Standards for 
CAHs. Tom Hutchinson, (410) 786-8953, Hospital Communication with 
Medicare+Choice Organizations.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments

    Comments received timely will be available for public inspection as 
they are received, generally beginning approximately 3 weeks after 
publication of a document, in Room C5-12-08 of the Centers for Medicare 

& Medicaid Services, 7500 Security Blvd., Baltimore, MD, on Monday 
through Friday of each week from 8:30 a.m. to 5 p.m. Please call (410) 
786-7197 to schedule an appointment to view public comments.

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 $9.00. 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. Free public access is available on a Wide 
Area Information Server (WAIS) through the Internet and via 
asynchronous dial-in. Internet users can access the database by using 
the World Wide Web; the Superintendent of Documents home page address 
is 
http://www.access.gpo.gov/nara_docs/, by using local WAIS client 
software, or by telnet to swais.access.gpo.gov, then login as guest (no 
password required). Dial-in users should use communications software 
and modem to call (202) 512-1661; type swais, then login as guest (no 
password required).
                                                              

I. Background

A. Summary

1. Acute Care Hospital Inpatient Prospective Payment System
    Section 1886(d) of the Social Security Act (the Act) sets forth a 
system of payment for the operating costs of acute care hospital 
inpatient stays under Medicare Part A (Hospital Insurance)

[[Page 31405]]

based on prospectively set rates. Section 1886(g) of the Act requires 
the Secretary to pay for the capital-related costs of hospital 
inpatient stays under a prospective payment system. Under these 
prospective payment systems, Medicare payment for hospital inpatient 
operating and capital-related costs is made at predetermined, specific 
rates for each hospital discharge. Discharges are classified according 
to a list of diagnosis-related groups (DRGs).
    The base payment rate is comprised of a standardized amount that is 
divided into a labor-related share and a nonlabor-related share. The 
labor-related share is adjusted by the wage index applicable to the 
area where the hospital is located; and if the hospital is located in 
Alaska or Hawaii, the nonlabor share is adjusted by a cost-of-living 
adjustment factor. This base payment rate is multiplied by the DRG 
relative weight.
    If the hospital is recognized as serving a disproportionate share 
of low-income patients, it receives a percentage add-on payment for 
each case paid through the acute care hospital inpatient prospective 
payment system. This percentage varies, depending on several factors 
which include the percentage of low-income patients served. It is 
applied to the DRG-adjusted base payment rate, plus any outlier 
payments received.
    If the hospital is an approved teaching hospital, it receives a 
percentage add-on payment for each case paid through the acute care 
hospital inpatient prospective payment system. This percentage varies, 
depending on the ratio of residents to beds.
    The costs incurred by the hospital for a case are evaluated to 
determine whether the hospital is eligible for an additional payment as 
an outlier case. This additional payment is designed to protect the 
hospital from large financial losses due to unusually expensive cases. 
Any outlier payment due is added to the DRG-adjusted base payment rate.
    Although payments to most hospitals under the acute care hospital 
inpatient prospective payment system are made on the basis of the 
standardized amounts, some categories of hospitals are paid the higher 
of a hospital-specific rate based on their costs in a base year (the 
higher of Federal fiscal year (FY) 1982, FY 1987, or FY 1996) or the 
prospective payment system rate based on the standardized amount. For 
example, sole community hospitals (SCHs) are the sole source of care in 
their areas, and Medicare-dependent, small rural hospitals (MDHs) are a 
major source of care for Medicare beneficiaries in their areas. Both of 
these categories of hospitals are afforded this special payment 
protection in order to maintain access to services for beneficiaries 
(although MDHs receive only 50 percent of the difference between the 
prospective payment system rate and their hospital-specific rates, if 
the hospital-specific rate is higher than the prospective payment 
system rate).
    The existing regulations governing payments to hospitals under the 
acute care hospital inpatient prospective payment system are located in 
42 CFR part 412, Subparts A through M.

2. Hospitals and Hospital Units Excluded From the Acute Care Hospital 
Inpatient Prospective Payment System

    Under section 1886(d)(1)(B) of the Act, as amended, certain 
specialty hospitals and hospital units are excluded from the acute care 
hospital inpatient prospective payment system. These hospitals and 
units are: psychiatric hospitals and units; rehabilitation hospitals 
and units; long-term care hospitals; children's hospitals; and cancer 
hospitals. Various sections of the Balanced Budget Act of 1997 (Public 
Law 105-33), the Medicare, Medicaid, and SCHIP [State Children's Health 
Insurance Program] Balanced Budget Refinement Act of 1999 (Public Law 
106-113), and the Medicare, Medicaid, and SCHIP Benefits Improvement 
and Protection Act of 2000 (Public Law 106-554) provide for the 
implementation of prospective payment systems for rehabilitation 
hospitals and units, psychiatric hospitals and units, and long-term 
care hospitals, as discussed below. Children's hospitals and cancer 
hospitals will continue to be paid on a cost-based reimbursement basis.
    The existing regulations governing payments to excluded hospitals 
and hospital units are located in 42 CFR parts 412 and 413.
    Under section 1886(j) of the Act, as amended, rehabilitation 
hospitals and units are being transitioned from a blend of reasonable 
cost-based reimbursement subject to a hospital-specific annual limit 
under section 1886(b) of the Act and Federal prospective payments for 
cost reporting periods beginning January 1, 2002 through September 30, 
2002, to payment on a fully Federal prospective rate effective for cost 
reporting periods beginning on or after October 1, 2002 (66 FR 41316, 
August 7, 2001). The statute also provides that IRFs may elect to 
receive the full prospective payment instead of a blended payment. The 
existing regulations governing payment under the inpatient 
rehabilitation facility prospective payment system (for rehabilitation 
hospitals and units) are located in 42 CFR part 412, subpart P.
    Under the broad authority conferred to the Secretary by section 123 
of Public Law 106-113 and section 307(b) of Public Law 106-554, we are 
proposing to transition long-term care hospitals from payments based on 
reasonable cost-based reimbursement under section 1886(b) of the Act to 
fully Federal prospective rates during a 5-year period. For cost 
reporting periods beginning on or after October 1, 2006, we are 
proposing to pay long-term care hospitals under the fully Federal 
prospective payment rate. (See the proposed rule issued in the Federal 
Register on March 22, 2002 (67 FR 13416).) Under the proposed rule, 
long-term care hospitals would also be permitted to elect to be paid 
based on full Federal prospective rates. The proposed regulations 
governing payments under the long-term care hospital prospective 
payment system would be located in 42 CFR part 412, subpart O.
    Sections 124(a) and (c) of Public Law 106-113 provide for the 
development of a per diem prospective payment system for payment for 
inpatient hospital services furnished by psychiatric hospitals and 
units under the Medicare program, effective for cost reporting periods 
beginning on or after October 1, 2002. This system must include an 
adequate patient classification system that reflects the differences in 
patient resource use and costs among these hospitals and must maintain 
budget neutrality. We are in the process of developing a proposed rule, 
to be followed by a final rule, to implement the prospective payment 
system for psychiatric hospitals and units.
3. Critical Access Hospitals
    Under sections 1814, 1820, and 1834(g) of the Act, payments are 
made to critical access hospitals (CAHs) (that is, rural hospitals or 
facilities that meet certain statutory requirements) for inpatient and 
outpatient services on a reasonable cost basis. Reasonable cost is 
determined under the provisions of section 1861(v)(1)(A) of the Act and 
existing regulations under 42 CFR parts 413 and 415.
4. Payments for Graduate Medical Education
    Under section 1886(a)(4) of the Act, costs of approved educational 
activities are excluded from the operating costs of inpatient hospital 
services. Hospitals with approved graduate medical education (GME) 
programs are paid for the direct costs of GME in accordance with 
section 1886(h) of the Act; the

[[Page 31406]]

amount of payment for direct GME costs for a cost reporting period is 
based on the hospital's number of residents in that period and the 
hospital's costs per resident in a base year.
    The existing regulations governing GME payments are located in 42 
CFR part 413.

                                                              

B. Major Contents of This Proposed Rule

    In this proposed rule, we are setting forth proposed changes to the 
Medicare hospital inpatient prospective payment systems for operating 
costs and for capital-related costs in FY 2003. We also are proposing 
changes relating to payments for GME costs; payments to excluded 
hospitals and units; policies implementing EMTALA; clinical 
requirements for swing beds in CAHs; and other hospital payment policy 
changes. The proposed changes would be effective for discharges 
occurring on or after October 1, 2002.
    The following is a summary of the major changes that we are 
proposing to make:
1. Proposed Changes to the DRG Reclassifications and Recalibrations of 
Relative Weights
    As required by section 1886(d)(4)(C) of the Act, we adjust the DRG 
classifications and relative weights annually. Based on analyses of 
Medicare claims data, we are proposing to establish a number of new 
DRGs and to make changes to the designation of diagnosis and procedure 
codes under other existing DRGs. Our proposed changes for FY 2003 are 
set forth in section II. of this preamble.
    Among the proposed changes discussed are:
     Revisions of DRG 1 (Craniotomy Age >17 Except for Trauma) 
and DRG 2 (Craniotomy for Trauma Age >17) to reflect the current 
assignment of cases involving head trauma patients with other 
significant injuries to MDC 24;
     Reconfiguration of DRG 14 (Specific Cerebrovascular 
Disorders Except Transient Ischemic Attack) and DRG 15 (Transient 
Ischemic Attack and Precerebral Occlusions) and creation of a new DRG 
524 (Transient Ischemia);
     Creation of a new DRG for heart assist devices;
     Reassignment of the diagnosis code for rheumatic heart 
failure with cardiac catheterization;
     Assignment of new, and reassignment of existing, cystic 
fibrosis principal diagnosis codes;
     Designation of a code for insertion of totally implantable 
vascular access device (VAD);
     Changes in the DRG assignment for the bladder 
reconstruction procedure code.
     Changes in DRG and MDC assignments for numerous newborn 
and neonate diagnosis codes; and
     Changes in DRG assignment for cases of tracheostomy and 
continuous mechanical ventilation greater than 96 hours.
    We also are presenting our analysis of applicants for add-on 
payments for high-cost new medical technologies.
2. Proposed Changes to the Hospital Wage Index
    In section III. of this preamble, we discuss proposed revisions to 
the wage index and the annual update of the wage data. Specific issues 
addressed in this section include the following:
     The FY 2003 wage index update, using FY 1999 wage data.
     Exclusion from the wage index of Part A physician wage 
costs that are teaching-related, as well as resident and Part A 
certified registered nurse anesthetist (CRNA) costs.
     Collection of data for contracted administrative and 
general, housekeeping, and dietary services.
     Revisions to the wage index based on hospital 
redesignations and reclassifications by the Medicare Geographic 
Classification Review Board (MGCRB).
     Requests for wage data corrections, including 
clarification of our policies on mid-year corrections.
3. Revision and Rebasing of the Hospital Market Basket
    In section IV. of this preamble, we discuss issues relating to our 
proposed rebasing and revision of the hospital market basket in 
developing the recommended FY 2003 update factor for the operating 
prospective payment rates and the excluded hospital rate-of-increase 
limits. We also set forth the data sources used to determine the 
proposed revised market basket relative weights and choice of price 
proxies.
4. Other Decisions and Proposed Changes to the Prospective Payment 
System for Inpatient Operating and Graduate Medical Education Costs
    In section V. of this preamble, we discuss several provisions of 
the regulations in 42 CFR Parts 412 and 413 and set forth certain 
proposed changes concerning the following:
     Options for expanding the postacute care transfer policy.
     Refinement of the application of a hospital bed-count 
policy that would more accurately reflect the size of a hospital's 
operations.
     Clarification of the application of the statutory 
provisions on the calculation of hospital-specific rates for SCHs.
     Technical change regarding additional payments for outlier 
cases.
     Rural referral centers proposed case-mix index values for 
FY 2003.
     Changes relating to the IME adjustment, including 
resident-to-bed ratio caps and counting beds for IME and DSH 
adjustments.
     Clarification and codification of classification 
requirements for MDHs and intermediary evaluations of cost reports for 
these hospitals.
     Changes to policies on pass-through payments for the costs 
of nonphysician anesthetists in some rural hospitals.
     Clarification of policies relating to implementing 3-year 
reclassifications of hospitals and other policies related to hospital 
reclassifications decisions made by the MGCRB.
     Changes relating to payment for the direct costs of GME.
     Changes related to emergency medical conditions in 
hospital emergency department under the EMTALA provisions.
     Criteria for and payments to provider-based entities.
     CMS-directed reopening of intermediary determinations and 
hearing decisions on provider reimbursements.
5. Prospective Payment System for Capital-Related Costs
    In section VI. of this preamble, we specify the proposed payment 
requirements for capital-related costs which include:
     Capital-related costs for new hospitals.
     Additional payments for extraordinary circumstances.
     Restoration of the 2.1 percent reduction to the standard 
Federal capital prospective payment system rate.
     Clarification of the special exceptions payment policy.
6. Proposed Changes for Hospitals and Hospital Units Excluded From the 
Prospective Payment Systems
    In section VII. of this preamble, we discuss the following 
proposals concerning excluded hospitals and hospital units and CAHs:
     Payments for existing excluded hospitals and hospital 
units for FY 2003.
      Updated caps for new excluded hospitals and hospital 
units.
     Revision of criteria for exclusion of satellite facilities 
from the acute care hospital inpatient prospective payment system.

[[Page 31407]]

     The prospective payment systems for inpatient 
rehabilitation hospitals and units and long-term care hospitals.
     Changes in the advance notification period for CAHs 
electing the optional payment methodology.
     Removal of the requirement on CAHs to use a State resident 
assessment instrument (RAI) for patient assessments for swing-bed 
patients.
7. Determining Prospective Payment Operating and Capital Rates and 
Rate-of-Increase Limits
    In the Addendum to this proposed rule, we set forth proposed 
changes to the amounts and factors for determining the FY 2003 
prospective payment rates for operating costs and capital-related 
costs. We also establish the proposed threshold amounts for outlier 
cases. In addition, we address update factors for determining the rate-
of-increase limits for cost reporting periods beginning in FY 2003 for 
hospitals and hospital units excluded from the acute care hospital 
inpatient prospective payment system.
8. Impact Analysis
    In Appendix A, we set forth an analysis of the impact that the 
proposed changes described in this proposed rule would have on affected 
entities.
9. Report to Congress on the Update Factor for Hospitals Under the 
Prospective Payment System and Hospitals and Units Excluded From the 
Prospective Payment System
    Section 1886(e)(3) of the Act requires the Secretary to report to 
Congress on our initial estimate of a recommended update factor for FY 
2003 for payments to hospitals included in the acute care hospital 
inpatient prospective payment system, and hospitals excluded from this 
prospective payment system. This report is included as Appendix B to 
this proposed rule.
10. Proposed Recommendation of Update Factor for Hospital Inpatient 
Operating Costs
    As required by sections 1886(e)(4) and (e)(5) of the Act, appendix 
C provides our recommendation of the appropriate percentage change for 
FY 2003 for the following:
     Large urban area and other area average standardized 
amounts (and hospital-specific rates applicable to SCHs and MDHs) for 
hospital inpatient services paid under the prospective payment system 
for operating costs.
     Target rate-of-increase limits to the allowable operating 
costs of hospital inpatient services furnished by hospitals and 
hospital units excluded from the acute care hospital inpatient 
prospective payment system.
11. Discussion of Medicare Payment Advisory Commission Recommendations
    Under section 1805(b) of the Act, the Medicare Payment Advisory 
Commission (MedPAC) is required to submit a report to Congress, not 
later than March 1 of each year, that reviews and makes recommendations 
on Medicare payment policies. This annual report makes recommendations 
concerning hospital inpatient payment policies. In section VIII. of 
this preamble, we discuss the MedPAC recommendations and any actions we 
are proposing to take with regard to them (when an action is 
recommended). For further information relating specifically to the 
MedPAC March 1 report or to obtain a copy of the report, contact MedPAC 
at (202) 653-7220 or visit MedPAC's website at: http://www.medpac.gov.

                                                              

II. Proposed Changes to DRG Classifications and Relative Weights

A. Background

    Under the acute care hospital inpatient prospective payment system, 
we pay for inpatient hospital services on a rate per discharge basis 
that varies according to the DRG to which a beneficiary's stay is 
assigned. The formula used to calculate payment for a specific case 
multiplies an individual hospital's payment rate per case by the weight 
of the DRG to which the case is assigned. Each DRG weight represents 
the average resources required to care for cases in that particular DRG 
relative to the average resources used to treat cases in all DRGS.
    Congress recognized that it would be necessary to recalculate the 
DRG relative weights periodically to account for changes in resource 
consumption. Accordingly, section 1886(d)(4)(C) of the Act requires 
that the Secretary adjust the DRG classifications and relative weights 
at least annually. These adjustments are made to reflect changes in 
treatment patterns, technology, and any other factors that may change 
the relative use of hospital resources. The proposed changes to the DRG 
classification system and the proposed recalibration of the DRG weights 
for discharges occurring on or after October 1, 2002 are discussed 
below.
                                                              

B. DRG Reclassification

1. General
    Cases are classified into DRGs for payment under the acute care 
hospital inpatient prospective payment system based on the principal 
diagnosis, up to eight additional diagnoses, and up to six procedures 
performed during the stay, as well as age, sex, and discharge status of 
the patient. The diagnosis and procedure information is reported by the 
hospital using codes from the International Classification of Diseases, 
Ninth Revision, Clinical Modification (ICD-9-CM).
    For FY 2002, cases are assigned to one of 506 DRGs in 25 major 
diagnostic categories (MDCs). Most MDCs are based on a particular organ 
system of the body. For example, MDC 6 is Diseases and Disorders of the 
Digestive System. However, some MDCs are not constructed on this basis 
because they involve multiple organ systems (for example, MDC 22 
(Burns)).
    In general, cases are assigned to an MDC based on the patients' 
principal diagnosis before assignment to a DRG. However, for FY 2002, 
there are eight DRGs to which cases are directly assigned on the basis 
of ICD-9-CM procedure codes. These are the DRGs for heart, liver, bone 
marrow, lung transplants, simultaneous pancreas/kidney, and pancreas 
transplants (DRGs 103, 480, 481, 495, 512, and 513, respectively) and 
the two DRGs for tracheostomies (DRGs 482 and 483). Cases are assigned 
to these DRGs before classification to an MDC.
    Within most MDCs, cases are then divided into surgical DRGs and 
medical DRGs. Surgical DRGs are based on a hierarchy that orders 
operating room (O.R.) procedures or groups of O.R. procedures, by 
resource intensity. Medical DRGs generally are differentiated on the 
basis of diagnosis and age. Some surgical and medical DRGs are further 
differentiated based on the presence or absence of complications or 
comorbidities (CC).
    Generally, nonsurgical procedures and minor surgical procedures not 
usually performed in an operating room are not treated as O.R. 
procedures. However, there are a few non-O.R. procedures that do affect 
DRG assignment for certain principal diagnoses, such as extracorporeal 
shock wave lithotripsy for patients with a principal diagnosis of 
urinary stones.
    Patients' diagnosis, procedure, discharge status, and demographic 
information is fed into the Medicare claims processing systems and 
subjected to a series of automated screens called the Medicare Code 
Editor (MCE). These screens are designed to identify cases that require 
further review before classification into a DRG.
    After screening through the MCE and any further development of the 
claims, cases are classified into the appropriate

[[Page 31408]]

DRG by the Medicare GROUPER software program. The GROUPER program was 
developed as a means of classifying each case into a DRG on the basis 
of the diagnosis and procedure codes and, for a limited number of DRGs, 
demographic information (that is, sex, age, and discharge status). The 
GROUPER is used both to classify current cases for purposes of 
determining payment and to classify past cases in order to measure 
relative hospital resource consumption to establish the DRG weights.
    The records for all Medicare hospital inpatient discharges are 
maintained in the Medicare Provider Analysis and Review (MedPAR) file. 
The data in this file are used to evaluate possible DRG classification 
changes and to recalibrate the DRG weights. However, in the July 30, 
1999 final rule (64 FR 41500), we discussed a process for considering 
non-MedPAR data in the recalibration process. In order for the use of 
particular data to be feasible, we must have sufficient time to 
evaluate and test the data. The time necessary to do so depends upon 
the nature and quality of the data submitted. Generally, however, a 
significant sample of the data should be submitted by mid-October, so 
that we can test the data and make a preliminary assessment as to the 
feasibility of using the data. Subsequently, a complete database should 
be submitted no later than December 1 for consideration in conjunction 
with next year's proposed rule.
    The major changes we are proposing to the DRG classification system 
for FY 2003 GROUPER version 20.0 and to the methodology to recalibrate 
the DRG weights are set forth below. Unless otherwise noted, our DRG 
analysis is based on data from 100 percent of the FY 2001 MedPAR file, 
which contains hospital bills received through May 31, 2001, for 
discharges in FY 2001.
2. MDC 1 (Diseases and Disorders of the Nervous System)
a. Proposed Revisions of DRGs 1 and 2
    Currently, adult craniotomy patients are assigned to either DRG 1 
(Craniotomy Age >17 Except for Trauma) or DRG 2 (Craniotomy for Trauma 
Age >17). The trauma distinction recognizes that head trauma patients 
requiring a craniotomy often have multiple injuries affecting other 
body parts. However, we note that the structure of these DRGs predates 
the creation in FY 1991 of MDC 24 (Multiple Significant Trauma). The 
creation of MDC 24 resulted in head trauma patients with other 
significant injuries being assigned to MDC 24 and removed from DRG 2. 
In FY 1990, there was a 16-percent difference in the DRG weights for 
DRG l and DRG 2. In FY 1992, after the creation of MDC 24, the 
percentage difference in the DRG weights for DRG 1 and DRG 2 had 
declined to 1.2 percent. The FY 2002 payment weight for DRG 1 is 3.2713 
and for DRG 2 is 3.3874, a 3.5 percent difference.
    For FY 2003, we reevaluated the GROUPER logic for DRGs 1 and 2 by 
combining the patients assigned to these DRGs and examining the impact 
of other patient attributes on patient charges. The presence or absence 
of a CC was found to have a substantial impact on patient charges.

------------------------------------------------------------------------
                                                       Number
                Cases in DRGs 1 and 2                    of      Average
                                                      patients   charges
------------------------------------------------------------------------
With CC.............................................    19,012   $49,659
Without CC..........................................     9,618    26,824
------------------------------------------------------------------------

    Thus, there is an 85.1 percent difference in average charges for 
the groups with and without CC for the combined DRGs 1 and 2. On this 
basis, we are proposing to redefine and retitle DRGs 1 and 2 as 
follows: DRG 1 (Craniotomy Age >17 with CC); and DRG 2 (Craniotomy Age 

>17 without CC).
b. Proposed Revisions of DRGs 14 and 15
    To assess the appropriate classification of patients with stroke 
symptoms, we evaluated the assignment of cases to DRGs 14 (Specific 
Cerebrovascular Disorders Except Transient Ischemic Attack (TIA) and 
DRG 15 (Transient Ischemic Attack and Precerebral Occlusions). Our data 
review indicated that the cases in DRGs 14 and 15 fell into three 
discrete groups. The first group included cases in which the patients 
were very sick, with severe intracranial lesions or subarachnoid 
hemorrhage and severe consequences. The second group included cases in 
which patients had not suffered a debilitating stroke but instead may 
have experienced a transient ischemic attack. The patients in the 
second group had one half of the average length of stay in the hospital 
as the first group. The third group of cases included patients who 
appeared to suffer strokes with minor consequences, as well as those 
having occluded vessels without having a full-blown stroke.
    We found that patients who have intracranial hemorrhage and 
patients who have infarction are similar in severity. These cases are 
more frequent in occurrence than cases with patients who have 
subarachnoid hemorrhage. Therefore, we are proposing to continue to 
group patients with intracranial hemorrhage and infarction together. 
These types of cases are different from patients with, for example, an 
occlusive carotid artery without infarction. In this common group of 
cases, patients are not as severely ill because they typically have 
lesser degrees of functional status deficits.
    Our analysis indicates that we can improve the clinical and 
resource cohesiveness of DRGs 14 and 15 by reassigning several specific 
ICD-9-CM codes. For example, code 436 (Acute, but ill-defined, 
cerebrovascular disease) is not a specific code and contains patients 
with a wide range of deficits and anatomic problems. Our data show that 
these cases consume fewer resources and have shorter lengths of stay 
than other cases in DRG 14. Therefore, we are proposing to remove code 
436 from DRG 14 and reassign it to DRG 15. We also are proposing to 
create a third new DRG to further identify these cases. The proposed 
revised or new DRG titles are as follows: DRG 14 (Intracranial 
Hemorrhage and Stroke with Infarction); DRG 15 (Nonspecific 
Cerebrovascular and Precerebral Occlusion without Infarction); and DRG 
524 (Transient Ischemia).
    The following table represents a proposed reconfiguration of DRGs 
14 and 15 and the creation of a new DRG 524 reflecting these three 
categorizations:

----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average length
                     Proposed DRG and title                            cases      of stay (days)  Average charge
----------------------------------------------------------------------------------------------------------------
Revised DRG 14 (Intracranial Hemorrhage and Stroke with                  164,786             6.1         $15,643
 Infarction)....................................................
Revised DRG 15 (Nonspecific Cerebrovascular and Precerebral               70,866             4.9          11,595
 Occlusion without Infarction)..................................
New DRG 524 (Transient Ischemia)................................          92,835             3.3           8,633
----------------------------------------------------------------------------------------------------------------


[[Page 31409]]

    The proposed reconfiguration of DRGs 14 and 15 would result in the 
following codes being designated as principal diagnosis codes in 
proposed revised DRG 14:

 430, Subarachnoid hemorrhage
 431, Intracerebral hemorrhage
 432.0, Nontraumatic extradural hemorrhage
 432.1, Subdural hemorrhage
 432.9, Unspecified intracranial hemorrhage
 433.01, Occlusion and stenosis of basilar artery, with 
cerebral infarction
 433.11, Occlusion and stenosis of carotid artery, with 
cerebral infarction
 433.21, Occlusion and stenosis of vertebral artery, with 
cerebral infarction

 433.31, Occlusion and stenosis of multiple and bilateral 
arteries, with cerebral infarction
 433.81, Occlusion and stenosis of other specified precerebral 
artery, with cerebral infarction
 433.91, Occlusion and stenosis of unspecified precerebral 
artery, with cerebral infarction
 434.01, Cerebral thrombosis with cerebral infarction
 434.11, Cerebral embolism with cerebral infarction
 434.91, Cerebral artery occlusion, unspecified, with cerebral 
infarction

    In addition, we are proposing that the following two codes be moved 
from DRG 14 to DRG 34 (Other Disorders of Nervous System with CC) and 
DRG 35 (Other Disorders of Nervous System without CC): Code 437.3 
(Cerebral aneurysm, nonruptured) and Code 784.3 (Aphasia). These codes 
do not represent acute conditions. Aphasia, for example, could result 
from a cerebral infarction, but if it does, the infarction should be 
correctly coded as the principal diagnosis.
    The proposed redefined DRG 15 would contain the following principal 
diagnosis codes:

 433.00, Occlusion and stenosis of basilar artery, without 
mention of cerebral infarction
 433.10, Occlusion and stenosis of carotid artery, without 
mention of cerebral infarction
 433.20, Occlusion and stenosis of vertebral artery, without 
mention of cerebral infarction

 433.30, Occlusion and stenosis of multiple and bilateral 
arteries, without mention of cerebral infarction
 433.80, Occlusion and stenosis of other specified precerebral 
artery, without mention of cerebral infarction
 433.90, Occlusion and stenosis of unspecified precerebral 
artery, without mention of cerebral infarction
 434.00, Cerebral thrombosis without mention of cerebral 
infarction
 434.10, Cerebral embolism without mention of cerebral 
infarction
 434.90, Cerebral artery occlusion, unspecified, without 
mention of cerebral infarction
 436, Acute, but ill-defined, cerebrovascular disease

    In addition, we are proposing to remove the following codes from 
the existing DRG 15 and place them in the proposed newly created DRG 
524:

 435.0, Basilar artery syndrome
 435.1, Vertebral artery syndrome

 435.2, Subclavian steal syndrome
 435.3, Vertebrobasilar artery syndrome
 435.8, Other specified transient cerebral ischemias
 435.9, Unspecified transient cerebral ischemia

    We are proposing to move code 437.1 (Other generalized ischemic 
cerebrovascular disease) from DRG 16 (Nonspecific Cerebrovascular 
Disorders with CC) and DRG 17 (Nonspecific Cerebrovascular Disorders 
without CC) and add it to the proposed new DRG 524. This proposed 
change represents a modification to improve clinical coherence and 
seems to be a logical change for the construction of the proposed new 
DRG 524.
3. MDC 5 (Diseases and Disorders of the Circulatory System)
a. Heart Assist Systems
    Heart failure is typically caused by persistent high blood pressure 
(hypertension), heart attack, valve disease, other forms of heart 
disease, or birth defects. It is a chronic condition in which the lower 
chambers of the heart (ventricles) cannot pump sufficient amounts of 
blood to the body. This causes the organs of the body to progressively 
fail, resulting in numerous medical complications and frequently death. 
DRG 127 (Heart Failure and Shock), to which heart failure cases are 
assigned, is the single most common DRG in the Medicare population, and 
represents the medical, not surgical, treatment options for this group 
of patients.
    In many cases, heart transplantation would be the treatment of 
choice. However, the low number of donor hearts limits this treatment 
option. Circulatory support devices, also known as heart assist systems 
or left ventricular assist devices (LVADs), offer a surgical 
alternative for end-stage heart failure patients. This type of device 
is often implanted near a patient's native heart and assumes the 
pumping function of the weakened heart's left ventricle. Studies are 
currently underway to evaluate LVADs as permanent support for end-stage 
heart failure patients.
    We have reviewed the payment and DRG assignment of this type of 
device in the past. Originally, these cases were assigned to DRG 110 
(Major Cardiovascular Procedures with CC) and DRG 111 (Major 
Cardiovascular Procedures without CC) in the September 1, 1994 final 
rule (59 FR 45345). A more specific procedure code, 37.66 (Implant of 
an implantable, pulsatile heart assist system) was made effective for 
use with hospital discharges occurring on or after October 1, 1995. In 
the August 29, 1997 final rule (62 FR 45973), we reassigned these cases 
to DRG 108 (Other Cardiothoracic Procedures), because it was the most 
clinically similar DRG with the best match in resource consumption 
according to our data. In the July 31, 1998 final rule (63 FR 40956), 
we again reviewed our data and discovered that the charges for 
implantation of an LVAD were increasing at a greater rate than the 
average charges for DRG 108. The length of stay for cases with code 
37.66 was approximately 32 days, or three times as long as all other 
DRG 108 cases. Therefore, we decided to move LVAD cases from DRG 108 to 
DRG 104 (Cardiac Valve and Other Major Cardiothoracic Procedures with 
Cardiac Catheterization) and DRG 105 (Cardiac Valve and Other Major 
Cardiothoracic Procedures without Cardiac Catheterization). We 
continued to review our data and discuss this topic in the FY 1999 and 
FY 2000 annual final rules: July 30, 1999 (64 FR 41498) and August 1, 
2000 (65 FR 47058).
    In the August 1, 2001 final rule (66 FR 39838), we remodeled MDC 5 
to add five new DRGs. We also added procedure codes 37.62 (Implant of 
other heart assist system), 37.63 (Replacement and repair of heart 
assist system), and 37.65 (Implant of an external, pulsatile heart 
assist system) to DRGs 104 and 105. We removed defibrillator cases from 
DRGs 104 and 105 and assigned them to DRG 514 (Cardiac Defibrillator 
Implant with Cardiac Catheterization) and DRG 515 (Cardiac 
Defibrillator Implant without Cardiac Catheterization) to make these 
DRGs more clinically coherent. This also increased the relative weights 
for DRGs 104 and 105, as the defibrillator cases had lower average 
charges than other cases in those two DRGs.
    In the FY 2001 MedPAR data file, we found 185 LVAD cases in DRG 104 
and 90 cases in DRG 105, for a total of 275 cases. These cases 
represent 1.3 percent of the total cases in DRG 104, and approximately 
0.5 percent of the total

[[Page 31410]]

cases in DRG 105. However, the average charges for these cases are 
approximately $36,000 and $85,000 higher than the average charges for 
cases in DRGs 104 and 105, respectively.
    This situation presents a dilemma, in that the technology has been 
available since 1995 and is gradually increasing in utilization, while 
LVAD cases involving the technology remain a small part of the total 
cases in these two DRGs. In fact, removing LVAD cases from the 
calculation of the average charge changes the average by only -0.4 
percent and -0.5 percent for DRGs 104 and 105, respectively. Therefore, 
despite the dramatically higher average charges for LVADs compared to 
the DRG averages, the relative volume is insufficient to affect the 
average to any great degree.
    Therefore, we are proposing to create a new DRG 525 (Heart Assist 
System Implant), which would contain these cases. The proposed FY 2003 
relative weight for proposed new DRG 525 is 11.3787.
    The new DRG would consist of any principal diagnosis in MDC 5, plus 
one of the following surgical procedures:

 37.62, Implant of other heart assist system
 37.63, Replacement and repair of heart assist system
 37.65, Implant of an external, pulsatile heart assist system

 37.66, Implant of an implantable, pulsatile heart assist 
system

    Cases in which a subsequent heart transplant occurs during the 
hospitalization episode would continue to be assigned to DRG 103 (Heart 
Transplant) because cases involving procedure codes 336 (Combined 
heart/lung transplant) and 375 (Heart transplant) are assigned to DRG 
103, regardless of other codes included on the bill.
    We reiterate a discussion we included in the August 1, 2000 final 
rule (65 FR 47058) regarding placement of code 37.66 in the MCE 
screening software as a noncovered procedure. The default designation 
for that code will continue to be ``noncovered'' because of the 
stringent conditions that must be met by hospitals in order to receive 
payment for implantation of the device.
    Section 65-15 of the Medicare Coverage Issues Manual (Artificial 
Hearts and Relative Devices) provides the national coverage 
determination regarding Medicare coverage of these devices. This 
section may be accessed online at http://www.hcfa.gov/pubforms/06_cim/ci00.htm.
b. Moving Diagnosis Code 398.91 (Rheumatic Heart Failure) From DRG 125 
to DRG 124
    DRG 124 (Circulatory Disorders Except Acute Myocardial Infarction 
(AMI), with Cardiac Catheterization and Complex Diagnosis) and DRG 125 
(Circulatory Disorders Except Acute Myocardial Infarction (AMI) with 
Cardiac Catheterization without Complex Diagnosis) have a somewhat 
complex DRG logic. In order to be assigned to DRG 124 or 125, the 
patient must first have a circulatory disorder, which would be one of 
the diagnoses included in MDC 5. However, these DRGs exclude acute 
myocardial infarctions. Therefore, these DRGs are comprised of cases 
with a diagnosis from MDC 5, excluding acute myocardial infarction, but 
also with a cardiac catheterization during the stay.
    DRGs 124 and 125 are then further defined by whether or not the 
patient had a complex diagnosis. If the patient had a complex 
diagnosis, the case is assigned to DRG 124. If the patient does not 
have a complex diagnosis, the case is assigned to DRG 125. A list of 
diagnoses that comprise complex diagnoses is identified within DRG 124. 
These diagnoses can be listed as either a principal or secondary 
diagnosis.
    We have received correspondence regarding the current assignment of 
diagnosis code 398.91 (Rheumatic heart failure). The correspondent 
pointed out that, while other forms of heart failure are listed as 
complex diagnoses under DRG 124, rheumatic heart failure is not 
included as a complex diagnosis within that DRG. Currently, if a 
patient with rheumatic heart failure receives a cardiac 
catheterization, the case is assigned to DRG 125.
    The correspondent had conducted a study and found that patients 
with rheumatic heart failure who receive a cardiac catheterization have 
lengths of stay that are significantly longer than patients with other 
forms of heart failure who receive a cardiac catheterization and who 
are assigned to DRG 125. The correspondent found that these patients 
have lengths of stay more similar to those cases assigned to DRG 124 
(which have other forms of heart failure), and recommended that 
diagnosis code 398.91 be added to the list of complex diagnoses within 
DRG 124.
    Within our claims data, we found 439 cases of patients in DRG 125 
with rheumatic heart failure who received a cardiac catheterization. 
The average charges for these rheumatic heart failure cases were almost 
twice as much as for other cardiac patients in DRG 125 who received a 
cardiac catheterization and who did not have a diagnosis of rheumatic 
heart failure. We also conferred with our medical consultants and they 
agree that rheumatic heart failure with cardiac catheterization is a 
complex diagnosis and should be assigned to DRG 124 along with the 
other complex forms of heart failure cases involving cardiac 
catheterization.
    We are proposing to add code 398.91 to DRG 124 as a complex 
diagnosis. As a result, catheterization cases with rheumatic heart 
disease would no longer be assigned to DRG 125.
c. Radioactive Element Implant
    In the August 1, 2001 final rule, we created DRG 517 (Percutaneous 
Cardiovascular Procedure without Acute Myocardial Infarction (AMI) with 
Coronary Artery Stent Implant) as a result of the overall DRG splits 
based on the presence of AMI (66 FR 39839). We assigned code 92.27 
(Implantation or insertion of radioactive elements) to DRG 517 because 
we believed that code 92.27 would always accompany cases involving a 
percutaneous cardiovascular procedure and intravascular radiation 
treatment. We have since determined that code 92.27 can also be present 
as a stand-alone code in other types of cases. When cases with code 
92.27 do not meet the criteria for DRG 517, they are currently directed 
into DRG 468 (Extensive O.R. Procedure Unrelated to Principal 
Diagnosis). Because DRG 468 is for cases in which the O.R. procedure is 
unrelated to the principal diagnosis, rather than assign cases with 
code 92.27 that would otherwise be assigned to MDC 5 to DRG 468 because 
they do not meet the criteria for assignment to DRG 517, we are 
proposing to assign these cases to DRG 120 (Other Circulatory System 
O.R. Procedures).
4. MDC 10 (Endocrine, Nutritional, and Metabolic Diseases and 
Disorders)
    Currently, when ICD-9-CM code 277.00 (Cystic Fibrosis without 
mention of meconium ileus) is reported as the principal diagnosis, it 
is assigned to the following DRG series in MDC 10: DRG 296 (Nutritional 
and Metabolic Disease, Age >17 with CC); DRG 297 (Nutritional and 
Metabolic Disease, Age >17 without CC); and DRG 298 (Nutritional and 
Metabolic Disease, Age 0-17).
    As part of our annual review of DRG assignments and based on 
correspondence that we have received, we examined claims relating to 
cases involving code 277.00 as a principal diagnosis in DRGs 296, 297, 
and 298. Our analysis of the average charges for cases in which code 
277.00 was the principal diagnosis in DRGs 296, 297, and 298 indicates 
that resource

[[Page 31411]]

utilization for these cases is quite different from resource 
utilization for other cases in the three DRGs. We believe that this 
difference in resource utilization is due to the fact it is not 
uncommon for cystic fibrosis patients to be admitted with pulmonary 
complications. Our findings on the number of cases and the average 
charges in the three DRGs when code 277.00 is assigned as the principal 
diagnosis, and our findings for all cases in the three DRGs, are 
indicated in the charts below.

    Cases in DRG 296, 297, and 298 With Code 277.00 as the Principal
                                Diagnosis
------------------------------------------------------------------------
                                             Number of        Average
           DRG and description                 cases          charges
------------------------------------------------------------------------
DRG 296 (Nutritional & Metabolic Disease             271         $34,111
 Age >17 with CC).......................
DRG 297 (Nutritional & Metabolic Disease             133          21,998
 Age >17 with CC).......................
DRG 298 (Nutritional & Metabolic Disease               0  ..............
 Age 0-17)..............................
------------------------------------------------------------------------


                     All Cases in DRG 296, 297, 298
------------------------------------------------------------------------
                                             Number of        Average
           DRG and description                 cases          charges
------------------------------------------------------------------------
DRG 296 (Nutritional & Metabolic Disease         169,768         $10,480
 Age >17 with CC).......................
DRG 297 (Nutritional & Metabolic Disease          31,560           6,190
 Age >17 without CC)....................
DRG 298 (Nutritional & Metabolic Disease              17           8,603
 Age 0-17)..............................
------------------------------------------------------------------------

    Based on the results of our analysis, we are proposing that three 
new cystic fibrosis principal diagnosis codes be assigned to specific 
DRGs and MDCs, and that other changes be made to DRG and MDC 
assignments of existing cystic fibrosis codes, as discussed below.
    We are proposing to create the following three new principal 
diagnosis codes:

 277.02 (Cystic fibrosis with pulmonary manifestations)
 277.03 (Cystic fibrosis with gastrointestinal manifestations)
 277.09 (Cystic fibrosis with other manifestations)

    We are proposing that existing code 277.01 (Cystic fibrosis with 
mention of meconium ileus) would continue to be assigned to DRG 387 
(Prematurity with Major Problems) and DRG 389 (Full Term Neonate with 
Major Problems) in MDC 15 (Newborns and Other Neonates with Conditions 
Originating in the Perinatal Period), since it is a newborn diagnosis 
code.
    Because proposed new code 277.02 would identify those patients with 
cystic fibrosis who have pulmonary manifestations, we are proposing to 
assign cases in which the principal diagnosis is the proposed new code 
277.02 to DRG 79 (Respiratory Infection and Inflammations Age >17 with 
CC), DRG 80 (Respiratory Infections and Inflammations Age >17 without 
CC), or DRG 81 (Respiratory Infections and Inflammations Age 0-17) in 
MDC 4 (Diseases and Disorders of the Respiratory System).
    We are proposing that proposed new code 277.03 would be assigned to 
DRG 188 (Other Digestive System Diagnoses Age >17 with CC), DRG 189 
(Other Digestive System Diagnoses Age >17 without CC), and DRG 190 
(Other Digestive System Diagnoses Age 0-17) in MDC 6 (Diseases and 
Disorders of the Digestive System), because of its specific 
relationship to the digestive system.
    Since proposed new code 277.09 could involve a number of 
manifestations (excluding pulmonary and gastrointestinal), we are 
proposing to assign this proposed new code to DRGs 296, 297, and 298 in 
MDC 10, where we are retaining the current assignment of existing code 
277.00.
    The following chart summarizes our proposed DRG and MDC assignments 
for new and existing cystic fibrosis principal diagnosis codes:

------------------------------------------------------------------------
                                           Proposed MDC    Proposed DRG
Principal diagnosis code and description    assignment      assignments
------------------------------------------------------------------------
Existing 277.00 (Cystic fibrosis without              10   296, 297, 298
 mention of meconium ileus).............
Existing 277.01 (Cystic fibrosis with                 15        387, 389
 mention of meconium ileus).............
Proposed new 277.02 (Cystic fibrosis                   4      79, 80, 81
 with pulmonary manifestations).........
Proposed new 277.03 (Cystic fibrosis                   6   188, 189, 190
 with gastrointestinal manifestations)..
Proposed new 277.09 (Cystic fibrosis                  10   296, 297, 298
 with other manifestations).............
------------------------------------------------------------------------

5. MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract)
a. Insertion of Totally Implantable Vascular Access Device (VAD)
    In the August 1, 2001 final rule (66 FR 39844), we discussed our 
review of the DRG assignment of code 86.07 (Insertion of totally 
implantable vascular access device (VAD)). Code 86.07 is considered a 
nonoperative procedure when it occurs in MDC 11. Therefore, patients in 
renal (kidney) failure requiring implantation of this device for 
dialysis are grouped to medical DRG 316 (Renal Failure). We examined 
whether implantation of this device should be removed from DRG 316 and 
placed into surgical DRG 315 (Other Kidney and Urinary Tract O.R. 
Procedures).
    Implantation of a VAD into the chest wall and blood vessels of a 
patient's upper body allows access to a patient's vessels via an 
implanted valve and cannula. Two devices are implanted during one 
operative session. One system is implanted arterially (the ``draw''), 
while the other is implanted venously (the ``return''). Typically, the 
VAD allows access to the patient's blood for hemodialysis purposes when 
other sites in the body have been exhausted. The device is usually 
inserted in the outpatient setting. Operative time is approximately 1 
to 1.5 hours.

[[Page 31412]]

    In the FY 2002 final rule (66 FR 39844-39845), we pointed out that 
cases where the VAD was inserted as an inpatient procedure also 
involved other complications, leading to higher average charges. 
Therefore, we indicated that we were not assigning code 86.07 to DRG 
315 at that time, but we would consider other alternative adjustments 
to DRGs 315 and 316.
    For FY 2003, we explored whether DRG 315 should be split based on 
existence or nonexistence of CCs. However, during our consideration of 
this alternative, we discovered that DRG 315 does not lend itself to a 
CC split due to the high occurrence of cases in this DRG that already 
have complications identified on the CC list. Therefore, we reexamined 
cases in DRGs 315 and 316 in the FY 2001 MedPAR file. The results are 
reflected in the chart below:

------------------------------------------------------------------------
                                                           Without Code
                                      With Code 86.07         86.07
------------------------------------------------------------------------
DRG 315 (surgical):
  Number of Cases.................  354................  21,089.
  Average Length of Stay..........  12.6 days..........  6.7 days.
  Average Charges.................  $47,251............  $25,622.
DRG 316 (Medical):
  Number of Cases.................  887................  76,676.
  Average Length of Stay..........  10.3...............  6.6 days.
  Average Charges.................  $31,904............  $16,934.
------------------------------------------------------------------------

    These results are similar to the findings included in the FY 2002 
final rule that were based on data from the FY 2000 MedPAR file (66 FR 
39845).
    We found that the average length of stay in DRG 315 for patients 
not receiving the VAD is 6.7 days, while those patients who received 
the VAD had an average length of stay of 12.6 days. We found the 
average charges in DRG 315 for patients not receiving the VAD were 
approximately $25,622, while the average charges for those patients who 
received the VAD were $47,251.
    We found that the cases receiving the VAD as an inpatient procedure 
are significantly more costly than other cases in DRG 316. Therefore, 
we are proposing to designate code 86.07 as an O.R. procedure under MDC 
11. Specifically, code 86.07 would be recognized as an O.R. procedure 
code in MDC 11 and assigned to DRG 315 when combined with the following 
principal diagnosis codes from DRG 316:

 403.01, Malignant hypertensive renal disease with renal 
failure
 403.11, Benign hypertensive renal disease with renal failure
 403.91, Unspecified hypertensive renal disease with renal 
failure
 404.02, Malignant hypertensive heart and renal disease with 
renal failure

 404.12, Malignant hypertensive heart and renal disease with 
renal failure
 404.92, Unspecified hypertensive heart and renal disease with 
renal failure
 584.5, Acute renal failure with lesion of tubular necrosis
 584.6, Acute renal failure with lesion of renal cortical 
necrosis
 584.7, Acute renal failure with lesion of renal medullary 
(papillary) necrosis
 584.8, Acute renal failure with other specified pathological 
lesion in kidney
 584.9, Acute renal failure, unspecified
 585, Chronic renal failure
 586, Renal failure, unspecified

 788.5, Oliguria and anuria
 958.5, Traumatic anuria
b. Bladder Reconstruction
    We received correspondence regarding the current classification of 
procedure code 57.87 (Reconstruction of urinary bladder) as a minor 
bladder procedure and the assignment of the code under DRG 308 (Minor 
Bladder Procedures with CC) and DRG 309 (Minor Bladder Procedures 
without CC). The correspondent believed that bladder reconstruction is 
not a minor procedure, submitted individual hospital charges to support 
this contention, and recommended that the code be classified as a major 
procedure and assigned to a higher weighted DRG.
    Our clinical advisors indicated that reconstruction of the bladder 
is a more extensive procedure than the other minor bladder procedures 
in DRGs 308 and 309. They agree that the bladder reconstruction 
procedure is as complex as the procedures under code 57.79 (Total 
cystectomy) and the other major bladder procedures in DRGs 303 through 
305.
    As indicated in the chart below, we found that the average charges 
for bladder reconstruction are significantly higher than the average 
charges for other minor procedures within DRGs 308 and 309:

------------------------------------------------------------------------
                                                        With     Without
                                                        Code      Code
                                                        57.87     57.87
------------------------------------------------------------------------
DRG 308 (minor bladder procedure with CC):
  Number of Cases...................................        64     5,066
  Average Charges...................................   $36,560   $19,923
DRG 309 (minor bladder procedures without CC):
  Number of Cases...................................        25     3,021
  Average Charges...................................   $23,390   $11,200
------------------------------------------------------------------------

    We found that procedure code 57.87 may be more appropriately placed 
in DRG 303 (Kidney, Ureter and Major Bladder Procedures for Neoplasm), 
304 (Kidney, Ureter and Major Bladder Procedures for Nonneoplasm with 
CC), and DRG 305 (Kidney, Ureter and Major Bladder Procedures for 
Nonneoplasm without CC), based on average charges for procedures in 
these three DRGS as indicated in the following chart:

------------------------------------------------------------------------
                                             Number of        Average
                   DRG                         cases          charges
------------------------------------------------------------------------
303 (Kidney, Ureter and Major Bladder             14,116         $30,691
 Procedures for Neoplasm)...............
304 (Kidney, Ureter and Major Bladder              8,060          30,577
 Procedures for Nonneoplasm with CC)....
305 (Kidney, Ureter and Major Bladder              2,029          15,492
 Procedures for Nonneoplasm without CC).
------------------------------------------------------------------------

    Based on the results of our analysis and the advice of our medical 
consultants discussed above, we are proposing to classify code 57.87 as 
a major bladder procedure and to assign it to DRGs 303, 304, and 305.
6. MDC 15 (Newborns and Other Neonates with Conditions Originating in 
the Perinatal Period)
    The primary focus of updates to the Medicare DRG classification 
system is for changes relating to the Medicare patient population, not 
the pediatric or neonatal patient populations. However, the Medicare 
DRGs are sometimes used to classify other patient populations. Over the 
years, we have received comments about aspects of the Medicare newborn 
DRGs that appear problematic, and we have responded to these on an 
individual basis. Some correspondents have requested that we take a 
closer

[[Page 31413]]

overall look at the DRGs within MDC 15.
    To respond to this request relating to review of MDC 15, we 
contacted the National Association of Children's Hospitals and Related 
Institutions (NACHRI), along with our own medical advisors, to obtain 
proposals for possible revisions of the existing DRG categories in MDC 
15. The focus of the requested proposals was to refine category 
definitions within the framework of the existing seven broadly defined 
neonatal DRGs. The proposals also were to take advantage of the new, 
more specific neonatal diagnosis codes to be adopted, effective October 
1, 2002, to assist with refinements to the existing DRG category 
definitions.
    In preparing these proposed changes to MDC 15, we have considered 
comments and suggestions previously received, including suggestions 
from NACHRI on how to make improvements within the existing framework 
of seven very broadly defined neonatal DRGs. In the future, we may 
consider broader changes to MDC 15.
a. Definition of MDC 15
    The existing diagnosis definitions for MDC 15 include certain 
diagnoses that may be present at the time of birth but may also 
continue beyond the perinatal period.
    These diagnoses are basically congenital anomalies, and even though 
they may continue beyond the perinatal period, they are assigned to MDC 
15 which is specific to newborns and neonates.
    The diagnosis codes assigned to the DRGs under MDC 15 have been a 
source of confusion because older children and adults can be admitted 
with these principal diagnoses and assigned to newborn or neonate DRGs 
in MDC 15 as if they were newborns.
    Our medical consultants and NACHRI have reviewed the listing of 
diagnosis codes and identified those that should not be routinely 
classified under MDC 15. As a result of this review, we are proposing 
that the following list of diagnosis codes be removed from MDC 15:
 758.9, Conditions due to anomaly of unspecified chromosome

 759.4, Conjoined twins
 759.7, Multiple congenital anomalies, so described
 759.81, Prader-Willi Syndrome
 759.83, Fragile X Syndrome
 759.89, Other specified anomalies
 759.9, Congenital anomaly, unspecified
 779.7, Periventricular leukomalacia
 795.2, Nonspecific abnormal findings on chromosomal analysis

    We are proposing to assign the nine diagnosis codes listed above to 
the following MDCs and DRGs (if medical):

----------------------------------------------------------------------------------------------------------------
                                                                   Proposed MDC
         Diagnosis code                        Title                assignment        Proposed DRG assignment
----------------------------------------------------------------------------------------------------------------
758.9...........................  Conditions due to anomaly of                23  467 (Other Factors Influencing
                                   unspecified chromosome.                         Health Status).
759.4...........................  Conjoined twins...............               6  188, 189, 190 (Other Digestive
                                                                                   System Diagnoses, age >17
                                                                                   with CC, Age >17 without CC,
                                                                                   and Age 0-17, respectively).
759.7...........................  Multiple congenital anomalies,               8  256 (Other Musculoskeletal
                                   so described.                                   System and Connective Tissue
                                                                                   Diagnoses).
759.81..........................  Prader-Willi Syndrome.........               8  256 (Other Musculoskeletal
                                                                                   System and Connective Tissue
                                                                                   Diagnoses).
759.83..........................  Fragile x Syndrome............              19  429 (Organic Disturbances and
                                                                                   Mental Retardation)
759.89..........................  Other specified anomalies.....               8  256 (Other Musculoskeletal
                                                                                   System and Connective Tissue
                                                                                   Diagnoses).
759.9...........................  Congenital anomaly,                         23  467 (Other Factors Influencing
                                   unspecified.                                    Health Status).
779.7...........................  Periventricular leukomalacia..               1  34, 35 (Other Disorders of the
                                                                                   Nervous System with CC and
                                                                                   without CC, respectively).
795.2...........................  Nonspecific abnormal findings               23  467 (Other Factors Influencing
                                   on chromosomal analysis.                        Health Status).
----------------------------------------------------------------------------------------------------------------

    The following three specific 4-digit diagnosis codes have been 
determined invalid by the ICD-9-CM Coordination and Maintenance 
Committee, effective October 1, 2002, and we are proposing to remove 
---------------------------------------------------------------------------
them from MDC 15.


 770.8, Other newborn respiratory problems
 771.8, Other infection specific to the perinatal period
 779.8, Other specified conditions originating in the perinatal 
period

    The above three codes are being replaced by 5-digit codes to 
capture more detail. These new 5-digit codes are assigned to DRGs 
within MDC 15 and are listed among the codes in Table 6A--New Diagnosis 
Codes in the Addendum of this proposed rule.
    In addition, the ICD-9-CM Coordination and Maintenance Committee 
created a number of new codes, effective October 1, 2002, to capture 
newborn and neonatal conditions. Therefore, we are proposing to add the 
following new 23 diagnosis codes to MDC 15:

 747.83, Persistent fetal circulation
 765.20, Unspecified weeks of gestation
 765.21, Less than 24 completed weeks of gestation
 765.22, 24 completed weeks of gestation
 765.23, 25-26 completed weeks of gestation
 765.24, 27-28 completed weeks of gestation

 765.25, 29-30 completed weeks of gestation
 765.26, 31-32 completed weeks of gestation
 765.27, 33-34 completed weeks of gestation
 765.28, 35-36 completed weeks of gestation
 765.29, 37 or more completed weeks of gestation
 770.81, Primary apnea of newborn
 770.82, Other apnea of newborn
 770.83, Cyanotic attacks of newborn
 770.84, Respiratory failure of newborn

 770.89, Other respiratory problems after birth
 771.81, Septicemia [sepsis] of newborn
 771.82, Urinary tract infection of newborn
 771.83, Bacteremia of newborn
 771.89, Other infections specific to the perinatal period
 779.81, Neonatal bradycardia
 779.82, Neonatal tachycardia
 779.89, Other specified conditions originating in perinatal 
period


[[Page 31414]]


b. DRG 386 (Extreme Immaturity or Respiratory Distress Syndrome, 
Neonate)
    The existing DRG 386 is defined by the presence of one of the ICD-
9-CM extreme prematurity codes (765.01 through 765.05) with the fifth 
digit indicating birthweight less than 1,500 grams (3.3 pounds). NACHRI 
has identified two weaknesses in the use of the fifth digit to define 
prematurity.
    One weakness relates to determining extreme immaturity, which, in 
part, is limited by the existing ICD-9-CM diagnosis codes. The existing 
ICD-9-CM definition for the extreme immaturity codes ``usually implies 
birthweight less than 1,000 grams (2.2 pounds) or gestational age less 
than 28 completed weeks,'' or both. The fifth digit provides range 
values for birthweight but gives no information on gestational age. A 
specific and distinct set of ICD-9-CM diagnosis codes for gestational 
age is to be introduced effective October 1, 2002. These new codes will 
provide a clearer basis for differentiating extreme immaturity or 
gestational age, or both.
    The second weakness is that diagnosis code 769 (Respiratory 
distress syndrome in newborn) is currently only associated with DRG 
386, which requires extreme prematurity, but respiratory distress 
syndrome in newborns can occur with all levels of prematurity. 
Therefore, we believe that code 769 should not be used to classify a 
diagnosis under DRG 386.
    The proposed revision to DRG 386 would reflect the upcoming new 
ICD-9-CM diagnosis codes. We are proposing to redefine DRG 386 to 
include those newborns whose preterm birthweight is less than 1,000 
grams or gestational age is less than 27-28 completed weeks, or both. 
Therefore, we would remove diagnosis code 769 from DRG 386, as this 
code is associated with all levels of prematurity, not just extreme 
immaturity. In addition, we are proposing to revise the title of DRG 
386 to read ``Extreme Immaturity''.
    Because birthweight for neonates varies at all gestational ages, 
some neonates will meet the DRG 386 criteria for preterm extremely low 
birthweight (less than 1,000 grams) but not the DRG 386 criteria for 
extremely short gestation age (less than 27-28 completed weeks). The 
reverse may also occur, where a neonate meets the DRG 386 criteria for 
extremely short gestational age (less than 27-28 completed weeks) but 
not for preterm extremely low birthweight (less than 1,000 grams). In 
either situation, the neonate would be assigned to the proposed 
retitled DRG 386 (Extreme Immaturity).
    NACHRI provided the following information on the measurement of 
gestational age and its use in the definition of Medicare neonatal 
DRGs. First, they noted that gestational age can be as powerful a 
predictor of a newborn's hospitalization course as birthweight and 
corresponds more directly to organ system immaturity. Second, while 
gestational age can be identified with a reasonable level of accuracy, 
it cannot be measured as precisely as birthweight. These two 
considerations led NACHRI to recommend the inclusion of gestational age 
in the definition of the Medicare neonatal DRGs, but in a conservative 
manner. Specifically, extremely short gestational age, as identified 
earlier, usually implies gestational age less than 28 weeks. The 
proposed new definition of DRG 386 includes only the gestational age 
codes for less than 27 to 28 completed weeks. Thus, there is a 1-week 
conservative bias in the use of the new gestational age codes for DRG 
386. It is also important to note that the existing DRG 386 definition 
includes existing codes 765.01 through 765.05, which include extreme 
immaturity without a specific identification of gestational age and 
birthweight up to 1,499 grams (3.3 pounds). Thus, the proposed revised 
definition of DRG 386 is actually somewhat more stringent as well as 
more specific.
    To implement these changes, we are proposing to remove the 
following diagnosis codes from the list of ``principal or secondary 
diagnosis'' under DRG 386:


 765.04, Extreme immaturity, 1,000-1,249 grams
 765.05, Extreme immaturity, 1,250-1,499 grams
 769, Respiratory distress syndrome in newborn

    Note, as explained above, while we are proposing to remove 
diagnosis codes 765.04, 765.05, and 769 from the list of principal or 
secondary diagnosis under DRG 386, a neonate would still be assigned to 
DRG 386 if there is a diagnosis of gestational age less than 27 to 28 
completed weeks reported (765.21 through 765.23).
    We are proposing to add the following diagnosis codes to the list 
of ``principal or secondary diagnosis'' under DRG 386:

 765.11, Other preterm infants, less than 500 grams
 765.12, Other preterm infants, 500-749 grams
 765.13, Other preterm infants, 750-999 grams
 765.21, Less than 24 completed weeks of gestation
 765.22, 24 completed weeks of gestation
 765.23, 25-26 completed weeks of gestation

c. DRG 387 (Prematurity With Major Problems)
    The existing definition of DRG 387 has the following three 
components: (1) Principal or secondary diagnosis of prematurity; (2) 
Principal or secondary diagnosis of major problem (these are diagnoses 
that define MDC 15); or (3) secondary diagnosis of major problem (these 
are diagnoses that do not define MDC 15 so they can only be secondary 
diagnosis codes for patients assigned to MDC 15). We are proposing 
changes for each component of the definition for DRG 387.
    We are proposing to revise the definition for the first component 
of DRG 387, ``principal or secondary diagnosis of prematurity'', to 
include all preterm low birthweight codes with fifth digit range code 
values indicating birthweight between 1,000 grams (2.2 pounds) and 
2,499 grams (5.5 pounds), or gestational age between 27 to 28 and 35 to 
36 completed weeks, or both. This would include all of the preterm low 
birthweight and gestational age codes except those assigned to the 
proposed revised DRG 386 and except for the following four preterm and 
gestational age codes: 765.10, 765.19, 765.20, and 765.29.
    It is possible for a neonate to be premature and greater than 2,500 
grams (5.5 pounds). In this instance, one of the new gestational age 
codes that specifically identifies the newborn to be less than 37 
completed weeks of gestation would need to be present to meet the 
criteria for inclusion in DRG 387. This is not a conceptual change for 
DRG 387, in that diagnosis codes 765.10 and 765.19 should both refer to 
newborns less than 37 completed weeks of gestation. Therefore, we are 
proposing to take into consideration the new ICD-9-CM codes that 
require a more specific affirmation that the newborn is less than 37 
completed weeks of gestation. Because DRG 387 is a broadly defined 
category (1,000-2,499 grams or 27-36 completed weeks of gestation), 
NACHRI recommends that it is important to require specific information 
for inclusion of patients at the high end of the birthweight/
gestational age range.
    We are proposing to remove the following diagnosis codes from the 
list of diagnoses defined as ``principal or secondary diagnosis of 
prematurity'' for DRG 387:


 765.10, Other preterm infants, unspecified (weight)

[[Page 31415]]

 765.11, Other preterm infants, less than 500 grams
 765.12, Other preterm infants, 500-749 grams
 765.13, Other preterm infants, 750-999 grams
 765.19, Other preterm infants, 2,500+ grams

    We are proposing to add the following diagnosis codes to the list 
of diagnoses defined as ``principal or secondary diagnosis of 
prematurity'' for DRG 387:

 765.04, Extreme immaturity, 1000-1249 grams
 765.05, Extreme immaturity, 1250-1499 grams
 765.24, 27-28 completed weeks of gestation
 765.25, 29-30 completed weeks of gestation

 765.26, 31-32 completed weeks of gestation
 765.27, 33-34 completed weeks of gestation
 765.28, 35-36 completed weeks of gestation

    We are proposing to revise the definition for the second component 
of DRG 387, ``principal or secondary diagnosis of major problem'', to 
remove certain diagnosis codes and to add other diagnosis codes. We are 
proposing to remove three groups of diagnosis codes. The first group of 
diagnosis codes that we are proposing to remove includes the fetal 
malnutrition codes for the birthweight ranges less than 2500 grams. 
NACHRI indicates that these newborns are not necessarily more 
complicated than preterm infants of the same birthweight range. These 
newborns have fewer problems related to organ system immaturity and 
often demonstrate excellent catch-up growth after delivery. Some of the 
fetal malnutrition diagnosis neonates may have serious problems. 
Therefore, it is best for the classification system to look for other 
more specific, major problem diagnoses than to include all of these 
newborns in DRG 387. We are proposing to remove the following diagnosis 
codes from DRG 387.

 764.11, ``Light-for-dates'' with signs of fetal malnutrition, 
less than 500 grams
 764.12, ``Light-for-dates'' with signs of fetal malnutrition, 
500-749 grams
 764.13, ``Light-for-dates'' with signs of fetal malnutrition, 
750-999 grams
 764.14, ``Light-for-dates'' with signs of fetal malnutrition, 
1,000-1,249 grams
 764.15, ``Light-for-dates'' with signs of fetal malnutrition, 
1,250-1,499 grams
 764.16, ``Light-for-dates'' with signs of fetal malnutrition, 
1,500-1,749 grams

 764.17, ``Light-for-dates'' with signs of fetal malnutrition, 
1,750-1,999 grams
 764.18, ``Light-for-dates'' with signs of fetal malnutrition, 
2,000-2,499 grams
 764.21, Fetal malnutrition without mention of ``light-for-
dates'', less than 500 grams
 764.22, Fetal malnutrition without mention of ``light-for-
dates'', 500-749 grams
 764.23, Fetal malnutrition without mention of ``light-for-
dates'', 750-999 grams
 764.24, Fetal malnutrition without mention of ``light-for-
dates'', 1,000-1,249 grams
 764.25, Fetal malnutrition without mention of ``light-for-
dates'', 1,250-1,499 grams
 764.26, Fetal malnutrition without mention of ``light-for-
dates'', 1,500-1,749 grams
 764.27, Fetal malnutrition without mention of ``light-for-
dates'', 1,750-1,999 grams

 764.28, Fetal malnutrition without mention of ``light-for-
dates'', 2,000-2,499 grams

    The second group of codes we are proposing to remove from the list 
of ``principal or secondary diagnosis of major problems'' under DRG 387 
consists of the following 13 diagnosis codes. The majority of these 
diagnosis codes do not represent a major problem for a newborn at or 
shortly after birth. NACHRI believes that costs associated with 
newborns with these conditions are similar to costs associated with 
neonates without a major problem.

 763.4, Cesarean delivery affecting fetus or newborn
 770.1, Meconium aspiration syndrome
 770.8, Other newborn respiratory problems
 771.8, Other infection specific to the perinatal period
 772.0, Fetal blood loss
 773.2, Hemolytic disease due to other and unspecified 
isoimmunization of fetus or newborn
 773.5, Late anemia due to isoimmunization of fetus or newborn
 775.5, Other transitory neonatal electrolyte disturbances

 775.6, Neonatal hypoglycemia
 776.0, Hemorrhagic disease of newborn
 776.6, Anemia of prematurity
 777.1, Meconium obstruction in fetus or newborn
 777.2, Intestinal obstruction due to inspissated milk in 
newborn

    We note that diagnosis code 770.8 (Other newborn respiratory 
problems) and diagnosis code 771.8 (Other infection specific to the 
perinatal period) are 4-digit codes that are being replaced by a series 
of more specific 5-digit codes, effective October 1, 2002. (See Table 
6C in the Addendum of this proposed rule.) The listing of the codes on 
the second group above includes some of these new 5-digit codes.
    The third group of diagnosis codes that we are proposing to remove 
from the list of diagnosis defined as ``principal or secondary 
diagnosis of major problem'' under DRG 387 includes the following two 
diagnosis codes. These codes are no longer assigned to MDC 15 when they 
are the principal diagnosis.

 759.4, Conjoined twins
 779.7, Periventricular leukomalacia

    We are proposing to add the following nine new and existing 
diagnosis codes to the list of ``principal or secondary diagnosis of 
major problem'' that defines DRG 387. These nine diagnosis codes 
generally represent major problems at the time of birth and have costs 
more similar to those of neonates with major problems than neonates 
without major problems. Many of these diagnosis codes are related to 
congenital anomaly conditions.

 747.83, Persistent fetal circulation (new code)
 769, Respiratory distress syndrome in newborn

 770.84, Respiratory failure of newborn (new code)
 771.3, Tetanus neonatorum
 771.81, Septicemia of newborn (new code)
 771.82, Neonatal urinary tract infection (new code)
 771.83, Bacteremia of newborn (new code)
 771.89, Other infections specific to perinatal period (new 
code)
 776.7, Transient neonatal neutropenia

    Of special note is the handling of diagnosis code 769 (Respiratory 
distress syndrome in newborn). Earlier in this preamble, we discussed 
the proposed removal of this diagnosis code from the definition of 
proposed retitled DRG 386 (Extreme Immaturity) because, even though it 
is usually associated with prematurity, it may occur with all levels of 
prematurity. We are proposing to add respiratory distress syndrome 
(which was previously assigned to existing DRG 386) to the list of 
diagnoses that define ``principal or secondary diagnosis of major 
problem'' for DRG 387. We are not proposing to add it to the list of 
diagnoses that define ``principal or secondary diagnosis of 
prematurity'' for DRG 387. The rationale for not adding code 769 as a 
prematurity diagnosis is that it occurs in only a small subset of 
neonates in the birthweight range of 1,000 to 2,499 grams (2.2 to 5.5 
pounds), and the vast majority of occurrences is in the upper end of 
this birthweight range. Respiratory distress syndrome

[[Page 31416]]

might not be indicative of a major problem for neonates at the low end 
of this range (for example, those closer to 1,000 to 1,249 grams), 
because these neonates will most likely have multiple significant 
problems. Therefore, we are proposing that respiratory distress 
syndrome be classified as a major problem and included among the list 
of ``principal or secondary diagnosis of major problem'' for DRG 387.
    In addition, we are proposing to revise the definition for the 
third defining component of DRG 387, ``secondary diagnosis of major 
problem''. This list of major problem diagnoses can only be secondary 
diagnoses because they are not among the list of principal diagnoses 
that defines MDC 15 for the Medicare DRG classification system. Based 
on NACHRI's recommendations, we are proposing to add and remove 
diagnoses from this list on the same basis as previously described for 
the list of ``principal or secondary diagnosis of major problems'' for 
DRG 387. That is, diagnoses are removed if, in the majority of 
instances, the condition does not represent a major problem for a 
newborn at or shortly after birth, and on average exhibits costs 
similar to the costs associated with neonates without a major problem. 
In addition, we are proposing to remove the asthma with status 
asthmaticus diagnosis codes, as these diagnosis codes pertain to 
newborns or other conditions arising in the perinatal period.
    We are proposing to remove the following diagnosis codes from the 
list of ``secondary diagnosis of major problem'' for DRG 387:


 276.5, Volume depletion
 349.0, Reaction to spinal or lumbar puncture
 457.2, Lymphangitis
 493.01, Extrinsic asthma with status asthmaticus
 493.11, Intrinsic asthma with status asthmaticus
 493.91, Asthma, unspecified type, with status asthmaticus
 578.1, Blood in stool
 683, Acute lymphadenitis
 693.0, Dermatitis due to drugs and medicines taken internally

 695.0, Toxic erythema
 708.0, Allergic urticaria
 745.4, Ventricular septal defect
 785.0, Tachycardia, unspecified
 995.2, Unspecified adverse effect of drug, medicinal and 
biological substance, not elsewhere classified
 999.5, Other serum reaction, not elsewhere classified
 999.6, ABO incompatibility reaction, not elsewhere classified
 999.7, Rh incompatibility reaction, not elsewhere classified
 999.8, Other transfusion reaction, not elsewhere classified

    We are proposing to add the following 65 diagnosis codes to the 
list of ``secondary diagnosis of major problem'' for DRG 387:


 416.0, Primary pulmonary hypertension
 416.8, Other chronic pulmonary heart diseases
 425.3, Endocardial fibroelastosis
 425.4, Other primary cardiomyopathies
 427.0, Paroxysmal supraventricular tachycardia
 427.1, Paroxysmal ventricular tachycardia
 466.11, Acute bronchiolitis due to respiratory syncytial virus 
(RSV)
 466.19, Acute bronchiolitis due to other infectious organisms
 478.74, Stenosis of larynx

 480.0, Pneumonia due to adenovirus
 480.1, Pneumonia due to respiratory syncytial virus
 480.2, Pneumonia due to parainfluenza virus
 480.8, Pneumonia due to other virus not elsewhere classified
 480.9, Viral pneumonia, unspecified
 745.0, Common truncus
 745.10, Complete transposition of great vessels
 745.11, Double outlet right ventricle
 745.12, Corrected transposition of great vessels

 745.19, Other transposition of great vessels
 745.2, Tetralogy of Fallot
 745.3, Common ventricle
 745.60, Endocardial cushion defect, unspecified type
 745.61, Ostium primum defect
 745.69, Other endocardial cushion defects
 746.01, Atresia of pulmonary valve, congenital
 746.1, Tricuspid atresia and stenosis, congenital
 746.2, Ebstein's anomaly

 746.7, Hypoplastic left heart syndrome
 746.81, Subaortic stenosis, congenital
 746.82, Cor triatriatum
 746.84, Obstructive anomalies of heart, congenital, not 
elsewhere classified
 746.86, Congenital heart block
 747.10, Coarctation of aorta (preductal) (postductal)
 747.11, Interruption of aortic arch
 747.41, Total anomalous pulmonary venous connection
 747.81, Anomalies of cerebrovascular system, congenital

 748.3, Other congenital anomalies of larynx, trachea, and 
bronchus
 748.4, Cystic lung, congenital
 748.5, Agenesis, hypoplasia, and dysplasia of lung, congenital
 750.3, Tracheoesophageal fistula, esophageal atresia and 
stenosis, congenital
 751.1, Atresia and stenosis of small intestine, congenital
 751.2, Atresia and stenosis of large intestine, rectum, and 
anal canal, congenital
 751.3, Hirschsprung's disease and other congenital functional 
disorders of colon
 751.4, Anomalies of intestinal fixation, congenital
 751.62, Congenital cystic disease of liver

 751.69, Other congenital anomalies of gall bladder, bile 
ducts, and liver
 751.7, Anomalies of pancreas, congenital
 753.0, Renal agenesis and dysgenesis
 753.5, Exstrophy of urinary bladder
 756.51, Osteogenesis imperfecta
 756.6, Anomalies of diaphragm, congenital
 756.70, Congenital anomaly of abdominal wall, unspecified
 756.71, Prune belly syndrome
 756.79, Other congenital anomalies of abdominal wall

 758.1, Patau's Syndrome
 758.2, Edwards' Syndrome
 758.3, Autosomal deletion syndromes
 759.4, Conjoined twins
 759.7, Multiple congenital anomalies, so described
 759.81, Prader-Willi Syndrome
 759.89, Other specified anomalies
 7797, Periventricular leukomalacia
 785.51, Cardiogenic shock

 785.59, Other shock without mention of trauma
 789.5, Ascites

d. DRG 388 (Prematurity Without Major Problems)
    We are proposing to revise the definition for prematurity for DRG 
388 ((Prematurity without Major Problems) in the same manner that we 
proposed to revise the definition of prematurity for DRG 387 
(Prematurity with Major Problems).
    We are proposing to remove the following five diagnosis codes from 
the list of codes pertaining to the ``principal or secondary diagnosis 
of prematurity'' for DRG 388:

 765.10, Other preterm infants unspecified (weight)
 765.11, Other preterm infants, less than 500 grams
 765.12, Other preterm infants, 500-749 grams
 765.13, Other preterm infants, 750-999 grams

[[Page 31417]]

 765.19, Other preterm infants, 2,500+ grams

    We are proposing to add the following seven diagnosis codes to the 
definition of principal or secondary diagnosis of prematurity for DRG 
388:

 765.04, Extreme immaturity, 1000-1249 grams
 765.05, Extreme immaturity, 1250-1499 grams

 765.24, 27-28 completed weeks of gestation
 765.25, 29-30 completed weeks of gestation
 765.26, 31-32 completed weeks of gestation
 765.27, 33-34 completed weeks of gestation
 765.28, 35-36 completed weeks of gestation
e. DRG 389 (Full Term Neonate With Major Problem)
    We are proposing to revise the definition of ``principal or 
secondary diagnosis of major problem'' for DRG 389 (Full Term Neonate 
with Major Problem) in the same manner that we proposed to revise the 
definition for DRG 387 (Prematurity with Major Problem).
f. DRG 390 (Neonate With Other Significant Problems)
    DRG 390 is defined as patients with ``principal or secondary 
diagnosis of newborn or neonate, with other significant problems, not 
assigned to DRG 385 through 389, 391, or 469 (principal diagnosis 
invalid as discharge diagnosis). As a result of our proposed changes to 
other neonatal DRGs, we are proposing to make conforming changes 
related to diagnosis codes assigned to DRG 390.
g. DRG 391 (Normal Newborn)
    DRG 391 (Normal Newborn) is defined by a list of principal 
diagnoses (for example, V30, Newborn codes plus certain minor newborn 
problems) and no secondary diagnoses or only certain secondary 
diagnoses (that is, minor problem diagnoses). NACHRI recommended that 
the definition of DRG 391 be modified to expand the number of minor 
problem newborn diagnoses included in both the list of principal 
diagnoses and the list of only certain secondary diagnoses that define 
DRG 391. The diagnoses that we are proposing to add to DRG 391 are 
conditions that NACHRI has identified as occurring with some frequency 
in the newborn population and having costs more similar to that of DRG 
391 than DRG 390 (Neonates with Other Significant Problems).
    We are proposing to add the following diagnosis codes to the list 
of ``principal diagnosis'' that defines DRG 391:

 764.00, ``Light-for-dates'' without mention of fetal 
malnutrition, unspecified (weight)
 764.90, Fetal growth retardation unspecified (weight)
 765.10, Other preterm infants unspecified (weight)
 765.19, Other preterm infants, 2,500+ grams

 765.20, Unspecified weeks of gestation
 765.29, 37 or more completed weeks of gestation

    We also are proposing to add the above six diagnosis codes to the 
list of ``only certain secondary diagnosis'' that defines DRG 391, as 
indicated below. Of these diagnosis codes, NACHRI indicates that the 
highest volume diagnosis code is 765.19 (Other preterm infants, 2,500+ 
grams). NACHRI notes that when this diagnosis code is recorded and no 
major problem or significant problem diagnosis is recorded, these 
patients have costs that are not much different than those for other 
normal newborns.
    We are proposing to add the following codes to the list of ``only 
certain secondary diagnosis'' that defines DRG 391:

 216.0, Benign neoplasm of skin of lip
 216.1, Benign neoplasm of eyelid, including canthus
 216.2, Benign neoplasm of ear and external auditory canal
 216.3, Benign neoplasm of skin of other and unspecified parts 
of face
 216.4, Benign neoplasm of scalp and skin of neck
 216.5, Benign neoplasm of skin of trunk, except scrotum
 216.6, Benign neoplasm of skin of upper limb, including 
shoulder

 216.7, Benign neoplasm of skin of lower limb, including hip
 216.8, Benign neoplasm of other specified sites of skin
 216.9, Benign neoplasm of skin, site unspecified
 228.00, Hemangioma of unspecified site
 228.01, Hemangioma of skin and subcutaneous tissue
 228.1, Lymphangioma, any site
 379.8, Other specified disorders of eye and adnexa
 379.90, Disorder of eye, unspecified
 379.92, Swelling or mass of eye

 379.93, Redness or discharge of eye
 379.99, Other ill-defined disorders of eye
 427.60, Premature beats, unspecified
 427.61, Supraventricular premature beats
 427.9, Cardiac dysrhythmia, unspecified
 528.4, Cysts of oral soft tissues
 553.1, Umbilical hernia without mention of obstruction or 
gangrene
 603.8, Other specified types of hydrocele
 603.9, Hydrocele, unspecified

 607.89, Other specified disorders of penis
 607.9, Unspecified disorder of penis and perineum
 624.9, Unspecified noninflammatory disorder of vulva and 
perineum
 692.9, Contact dermatitis and other eczema unspecified cause
 701.1, Keratoderma, acquired
 701.3, Striae atrophicae
 701.8, Other specified hypertrophic and atrophic conditions of 
skin
 701.9, Unspecified hypertrophic and atrophic conditions of 
skin
 702.8, Other specified dermatoses

 705.1, Prickly heat
 706.1, Other acne
 706.2, Sebaceous cyst
 709.8, Other specified disorders of skin
 709.9, Unspecified disorder of skin and subcutaneous tissue
 719.61, Other symptoms referable to joint of shoulder region
 719.65, Other symptoms referable to joint of pelvic region and 
thigh
 755.00, Polydactyly, unspecified digits
 755.01, Polydactyly of fingers

 755.02, Polydactyly of toes
 755.10, Syndactyly of multiple and unspecified sites
 755.11, Syndactyly of fingers without fusion of bone
 755.12, Syndactyly of fingers with fusion of bone
 755.13, Syndactyly of toes without fusion of bone
 755.14, Syndactyly of toes with fusion of bone
 755.66, Other congenital anomalies of toes
 755.67, Anomalies of foot, congenital, not elsewhere 
classified
 755.9, Unspecified congenital anomaly of unspecified limb

 757.2, Dermatoglyphic anomalies
 757.32, Vascular hamartomas
 757.39, Other specified congenital anomalies of skin
 757.4, Specified congenital anomalies of hair
 757.5, Specified congenital anomalies of nails
 757.6, Specified congenital anomalies of breast
 757.8, Other specified congenital anomalies of the integument
 757.9, Unspecified congenital anomaly of the integument
 760.0, Maternal hypertensive disorders affecting fetus or 
newborn

[[Page 31418]]


 760.1, Maternal renal and urinary tract diseases affecting 
fetus or newborn
 760.2, Maternal infections affecting fetus or newborn
 760.3, Other chronic maternal circulatory and respiratory 
diseases affecting fetus or newborn
 760.4, Maternal nutritional disorders affecting fetus or 
newborn
 760.5, Maternal injury affecting fetus or newborn
 760.6, Surgical operation on mother affecting fetus or newborn
 760.70, Unspecified noxious substance affecting fetus or 
newborn via placenta or breast milk
 760.74, Anti-infectives affecting fetus or newborn via 
placenta or breast milk
 760.76, Diethylstilbestrol (DES) exposure affecting fetus or 
newborn via placenta or breast milk

 760.79, Other noxious influences affecting fetus or newborn 
via placenta or breast milk
 760.8, Other specified maternal conditions affecting fetus or 
newborn
 760.9, Unspecified maternal condition affecting fetus or 
newborn
 761.0, Incompetent cervix affecting fetus or newborn
 761.1, Premature rupture of membranes affecting fetus or 
newborn
 761.5, Multiple pregnancy affecting fetus or newborn
 761.7, Malpresentation before labor affecting fetus or newborn
 761.8, Other specified maternal complications of pregnancy 
affecting fetus or newborn
 761.9, Unspecified maternal complication of pregnancy 
affecting fetus or newborn

 762.8, Other specified abnormalities of chorion and amnion 
affecting fetus or newborn
 762.9, Unspecified abnormality of chorion and amnion affecting 
fetus or newborn
 763.4, Cesarean delivery affecting fetus or newborn
 763.5, Maternal anesthesia and analgesia affecting fetus or 
newborn
 763.7, Abnormal uterine contractions affecting fetus or 
newborn
 763.89, Other specified complications of labor and delivery 
affecting fetus or newborn
 764.00, ``Light-for-dates'' without mention of fetal 
malnutrition, unspecified (weight)
 764.90, Fetal growth retardation unspecified (weight)
 765.10, Other preterm infants unspecified (weight)

 765.19, Other preterm infants, 2,500+ grams
 765.20, Unspecified weeks of gestation
 765.29, 37 or more completed weeks of gestation
 767.2, Fracture of clavicle due to birth trauma
 767.3, Other injuries to skeleton due to birth trauma
 767.8, Other specified birth trauma
 767.9, Unspecified birth trauma
 768.2, Fetal distress before onset of labor, in liveborn 
infant
 768.3, Fetal distress first noted during labor, in liveborn 
infant

 768.4, Fetal distress, unspecified as to time of onset, in 
liveborn infant
 768.9, Unspecified severity of birth asphyxia in liveborn 
infant
 70.9, Unspecified respiratory condition of fetus and newborn
 772.8, Other specified hemorrhage of fetus or newborn
 772.9, Unspecified hemorrhage of newborn
 773.1, Hemolytic disease due to ABO isoimmunization of fetus 
or newborn
 773.2, Hemolytic disease due to other and unspecified 
isoimmunization of fetus or newborn
 773.5, Late anemia due to isoimmunization of fetus or newborn
 775.6, Neonatal hypoglycemia

 775.9, Unspecified endocrine and metabolic disturbances 
specific to the fetus and newborn
 776.4, Polycythemia neonatorum
 776.8, Other specified transient hematological disorders of 
fetus or newborn
 776.9, Unspecified hematological disorder specific to fetus or 
newborn
 777.1, Meconium obstruction in fetus or newborn
 777.3, Hematemesis and melena due to swallowed maternal blood 
of newborn
 777.8, Other specified perinatal disorders of digestive system
 777.9, Unspecified perinatal disorder of digestive system
 778.3, Other hypothermia of newborn

 778.4, Other disturbances of temperature regulation of newborn
 778.6, Congenital hydrocele
 778.7, Breast engorgement in newborn
 778.9, Unspecified condition involving the integument and 
temperature regulation of fetus and newborn
 779.9, Unspecified condition originating in the perinatal 
period
 780.6, Fever
 781.0, Abnormal involuntary movements
 781.3, Lack of coordination
 782.1, Rash and other nonspecific skin eruption

 782.2, Localized superficial swelling, mass, or lump
 782.4, Jaundice, unspecified, not of newborn
 782.61, Pallo
 782.62, Flushin
 782.7, Spontaneous ecchymose
 782.8, Changes in skin texture
 782.9, Other symptoms involving skin and integumentary tissues
 783.3, Feeding difficulties and mismanagement
 784.2, Swelling, mass, or lump in head and neck

 784.9, Other symptoms involving head and neck
 785.2, Undiagnosed cardiac murmurs
 785.3, Other abnormal heart sounds
 785.9, Other symptoms involving cardiovascular system
 786.00, Respiratory abnormality, unspecified
 786.7, Abnormal chest sounds
 786.9, Other symptoms involving respiratory system and chest
 787.3, Flatulence, eructation, and gas pain
 790.6, Other abnormal blood chemistry

 790.7, Bacteremia
 790.99, Other nonspecific findings on examination of blood
 795.6, False positive serological test for syphilis
 795.79, Other and unspecified nonspecific immunological 
findings
 796.1, Abnormal reflex
 910.0, Abrasion or frictions burn of face, neck, and scalp 
except eye, without mention of infection
 910.2, Blister of face, neck, and scalp except eye, without 
mention of infection
 910.8, Other and unspecified superficial injury of face, neck, 
and scalp, without mention of infection
 920, Contusion of face, scalp, and neck except eye(s)

 999.5, Other serum reaction, not elsewhere classified
 999.6, ABO incompatibility reaction, not elsewhere classified
 V01.1, Contact with or exposure to tuberculosis
 V01.6, Contact with or exposure to venereal diseases
 V01.7, Contact with or exposure to other viral diseases
 V01.81, Contact with or exposure to communicable diseases, 
anthrax
 V01.89, Contact with or exposure to communicable diseases, 
other communicable diseases
 V01.9, Contact with or exposure to unspecified communicable 
disease
 V02.3, Carrier or suspected carrier of other gastrointestinal 
pathogens

 V05.3, Need for prophylactic vaccination and inoculation 
against viral hepatitis
 V05.4, Need for prophylactic vaccination and inoculation 
against varicella

[[Page 31419]]

 V05.8, Need for prophylactic vaccination and inoculation 
against other specified disease
 V05.9, Need for prophylactic vaccination and inoculation 
against unspecified single disease
 V07.8, Need for other specified prophylactic measure
 V07.9, Need for unspecified prophylactic measure
 V18.0, Family history of diabetes mellitus
 V18.1, Family history of other endocrine and metabolic 
diseases
 V18.2, Family history of anemia

 V18.3, Family history of other blood disorders
 V18.8, Family history of infectious and parasitic diseases
 V19.2, Family history of deafness or hearing loss
 V19.8, Family history of other condition
 V71.9, Observation for unspecified suspected condition
 V72.0, Examination of eyes and vision
 V72.6, Laboratory examination
 V73.89, Special screening examination for other specified 
viral diseases
 V73.99, Special screening examination for unspecified viral 
disease
7. MDC 23 (Factors Influencing Health Status and Other Contacts With 
Health Services)
    In the August 1, 2001 final rule, we included in Table 6A--New 
Diagnosis Codes (66 FR 40064) code V10.53 (History of malignancy, renal 
pelvis), which was approved by the ICD-9-CM Coordination and 
Maintenance Committee as a new code effective October 1, 2001. We 
assigned the code to DRG 411 (History of Malignancy without Endoscopy) 
and DRG 412 (History of Malignancy with Endoscopy).
    We received correspondence which suggested that we should have also 
assigned code V10.53 to DRG 465 (Aftercare with History of Malignancy 
as Secondary Diagnosis). The correspondent pointed out that all other 
codes for a history of malignancy are included in DRG 465.
    We agree that code V10.53 should be included in the list of the 
history of malignancy codes within DRG 465. Therefore, we are proposing 
to add V10.53 to the list of secondary diagnosis in DRG 465.
8. Pre-MDC: Tracheostomy
    DRG 483 (Tracheostomy Except for Face, Mouth and Neck Diagnoses) is 
used to classify patients who require long-term mechanical ventilation. 
Mechanical ventilation can be administered through an endotracheal tube 
for a limited period of time. When an endotracheal tube is used for an 
extended period of time (beyond 7 to 10 days), the patient runs a high 
risk of permanent damage to the trachea. In order to maintain a patient 
on mechanical ventilation for a longer period of time, the endotracheal 
tube is removed and a tracheostomy is performed. The mechanical 
ventilation is then administered through the tracheostomy.
    A tracheostomy also may be performed on patients for therapeutic 
purposes unrelated to the administration of mechanical ventilation. 
Patients with certain face, mouth, and neck disease may have a 
tracheostomy performed as part of the treatment for the face, mouth, or 
neck disease. These patients are assigned to DRG 482 (Tracheostomy for 
Face, Mouth and Neck Diagnoses).
    Therefore, patients assigned to DRGs 482 and 483 are differentiated 
based on the principal diagnosis of the patient. At certain times, 
selecting the appropriate principal diagnosis for the patients 
receiving tracheostomies for assignment to a DRG can be difficult. The 
overall number of tracheostomy patients increased by 13 percent between 
1994 and 1999. During the same period, the percent of tracheostomy 
patients in DRG 483 (patients without certain face, mouth, or neck 
diseases) versus DRG 482 increased from 83.6 percent to 87.6 percent.
    The payment weight for DRG 483 is more than four times greater than 
the DRG 482 payment weight, and this has led to concerns about coding 
compliance. Specifically, the fact that cases are assigned to DRG 483 
based on the absence of a code indicating face, mouth, or neck 
diagnosis creates an incentive to omit codes indicating these 
diagnoses.
    To address issues of possible coding noncompliance, we are 
proposing to modify DRGs 482 and 483 to differentiate the assignment to 
either DRG based on the presence or absence of continuous mechanical 
ventilation that lasts more than 96 hours (code 96.72). This 
modification would ensure that the patients assigned to DRG 483 are 
patients who had the tracheostomy for long-term mechanical ventilation. 
Based on an examination of claims data from the FY 2001 MedPAR file, we 
found that many patients assigned to DRG 483 do not have the code 96.72 
for mechanical ventilation greater than 96 hours recorded. In part, 
this is the result of the limited number of procedure codes (six) that 
can be submitted on the current uniform hospital claim form, and the 
fact that code 96.72 does not currently affect the DRG assignment.
    We found that many of the patients who are assigned to DRG 483 have 
multiple procedures, making it impossible for all procedures performed 
to be submitted on the hospital claim form. Because of the current 
underreporting of code 96.72 for continuous mechanical ventilation 
greater than 96 hours, we do not believe we can accurately determine 
the payment weights for modified DRGs 482 and 483 as described above.
    In order to encourage the reporting of the code 96.72 for 
continuous mechanical ventilation for greater than 96 hours, we are 
proposing to change the definition of DRG 483 so that patients who have 
a tracheostomy and continuous mechanical ventilation greater than 96 
hours (code 96.72) with a principal diagnosis unrelated to disease of 
the face, mouth, or neck would be assigned to DRG 483. DRG 483 would be 
retitled ``Tracheostomy/Mechanical Ventilation 96+ Hours Except Face, 
Mouth, and Neck Diagnosis.''
    We will give future consideration to modifying DRGs 482 and DRG 483 
based on the presence of code 96.72, and invite comments on this area.
9. Medicare Code Editor (MCE) Change
    As explained under section II.B.1. of this preamble, the MCE is a 
software program that detects and reports errors in the coding of 

Medicare claims data.
    The MCE includes an edit for ``nonspecific principal diagnosis'' 
that identifies a group of codes that are valid according to the ICD-9-
CM coding scheme, but are not as specific as the coding scheme permits. 
The fiscal intermediaries use cases identified in this edit for 
educational purposes for hospitals only. That is, when a hospital 
reaches a specific threshold of cases (usually 25) in this edit, the 
fiscal intermediary will contact the hospital and educate it on how to 
code diagnoses using more specific codes in the ICD-9-CM coding scheme. 
The claims identified in this nonspecific principal diagnosis edit are 
neither denied nor returned to the hospital.
    Code 436 (Acute, but ill-defined, cerebrovascular disease) is one 
of the codes included in the groups of codes identified in the 
nonspecific principal diagnosis edit, and is widely used in smaller 
hospitals where testing mechanisms are not available to more 
specifically identify the location and condition of cerebral and 
precerebral vessels. Because of the frequent use of code 436 among 
smaller hospitals, we

[[Page 31420]]

are proposing to remove the code from the nonspecific principal 
diagnosis edit in the MCE. We address the use of code 436 in section 
II.B.3. of this proposed rule under the discussion of MDC 5 changes 
with regard to the remodeling of DRGs 14 and 15.
10. Surgical Hierarchies
    Some inpatient stays entail multiple surgical procedures, each one 
of which, occurring by itself, could result in assignment of the case 
to a different DRG within the MDC to which the principal diagnosis is 
assigned. Therefore, it is necessary to have a decision rule within the 
GROUPER by which these cases are assigned to a single DRG. The surgical 
hierarchy, an ordering of surgical classes from most resource-intensive 
to least resource-intensive, performs that function. Its application 
ensures that cases involving multiple surgical procedures are assigned 
to the DRG associated with the most resource-intensive surgical class.
    Because the relative resource intensity of surgical classes can 
shift as a function of DRG reclassification and recalibrations, we 
reviewed the surgical hierarchy of each MDC, as we have for previous 
reclassifications and recalibrations, to determine if the ordering of 
classes coincides with the intensity of resource utilization.
    A surgical class can be composed of one or more DRGs. For example, 
in MDC 11, the surgical class ``kidney transplant'' consists of a 
single DRG (