[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]] ----------------------------------------------------------------------- Part II Department of Health and Human Services ----------------------------------------------------------------------- Centers for Medicare & Medicaid Services ----------------------------------------------------------------------- 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]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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

