[Federal Register: August 30, 1996 (Volume 61, Number 170)]
[Rules and Regulations]               
[Page 46165-46215]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
 

Table of Contents

Supplementary Information Addendum Appendix A Appendix B: Technical Appendix on the Capital Acquisition Model and Required Adjustments Appendix C: Rebased Market Basket Data Sources Appendix D: Recommendation of Update Factors for Opening Cost Rates of Payment for Inpatient Hospital Services [[Page 46165]] _______________________________________________________________________ Part V Department of Health and Human Services _______________________________________________________________________ Health Care Financing Administration _______________________________________________________________________ 42 CFR Part 412, et al. Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1997 Rates; Final Rule [[Page 46166]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Care Financing Administration 42 CFR Parts 412, 413, and 489 [BPD-847-F] RIN 0938-AH34 Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1997 Rates AGENCY: Health Care Financing Administration (HCFA), HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: We are revising the Medicare hospital inpatient prospective payment systems for operating costs and capital- related costs to implement necessary changes arising from our continuing experience with the systems. In addition, in the addendum to this final rule, we are describing changes in the amounts and factors necessary to determine prospective payment rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes are applicable to discharges occurring on or after October 1, 1996. We are also setting forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the prospective payment systems. EFFECTIVE DATE: This rule is a major rule as defined in Title 5, United States Code, section 804(2). Pursuant to 5 U.S.C. section 801(a)(3), this rule may not take effect until 60 days after the report required by that section is submitted to the Congress, which is October 29, 1996. However, for purposes of the policy discussions in this document, we have assumed that the effective date of this final rule will be October 1, 1996, the earliest date by which this rule could take effect under 5 U.S.C. section 801 and the Medicare statute. ADDRESSES: Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 or by faxing to (202) 512- 2250. The cost for each copy is $8.00. 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. FOR FURTHER INFORMATION CONTACT: Nancy Edwards (410) 786-4531: Operating Prospective Payment, DRG, Wage Index Issues. Tzvi Hefter (410) 786-4529: Capital Prospective Payment, Direct Graduate Medical Education, Excluded Hospitals. SUPPLEMENTARY INFORMATION: I. Background A. Summary Under section 1886(d) of the Social Security Act (the Act), a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively-set rates was established effective with hospital cost reporting periods beginning on or after October 1, 1983. Under this system, Medicare payment for hospital inpatient operating costs is made at a predetermined, specific rate for each hospital discharge. All discharges are classified according to a list of diagnosis-related groups (DRGs). The regulations governing the hospital inpatient prospective payment system are located in 42 CFR part 412. For cost reporting periods beginning before October 1, 1991, hospital inpatient operating costs were the only costs covered under the prospective payment system. Payment for capital-related costs had been made on a reasonable cost basis because, under sections 1886(a)(4) and (d)(1)(A) of the Act, those costs had been specifically excluded from the definition of inpatient operating costs. However, section 4006(b) of the Omnibus Budget Reconciliation Act of 1987 (Public Law 100-203) revised section 1886(g)(1) of the Act to require that, for hospitals paid under the prospective payment system for operating costs, capital-related costs would also be paid under a prospective payment system effective with cost reporting periods beginning on or after October 1, 1991. As required by section 1886(g) of the Act, we replaced the reasonable cost-based payment methodology with a prospective payment methodology for hospital inpatient capital-related costs. Under the new methodology, effective for cost reporting periods beginning on or after October 1, 1991, a predetermined payment amount per discharge is made for Medicare inpatient capital-related costs. (See subpart M of 42 CFR part 412, and the August 30, 1991 final rule (56 FR 43358) for a complete discussion of the prospective payment system for hospital inpatient capital-related costs.) B. Major Contents of the Provisions of the May 31, 1996 Proposed Rule On May 31, 1996, we published a proposed rule in the Federal Register (61 FR 27444) setting forth proposed changes to the Medicare hospital inpatient prospective payment systems for both operating costs and capital-related costs which would be effective for discharges occurring on or after October 1, 1996. The following is a summary of the major issues addressed and changes that we proposed to make: <bullet> We proposed changes for FY 1997 DRG classifications and relative weighting factors as required by section 1886(d)(4)(c) of the Act. <bullet> We proposed to update the wage index for FY 1997. We also solicited comments on the possible expansion of the types of contract labor costs included in the wage index and on possible revisions in Puerto Rico labor market areas. <bullet> We proposed revisions to the regulations governing the composition of the Medicare Geographic Classification Review Board (MGCRB). <bullet> We proposed to use a rebased and revised hospital market basket in developing the FY 1997 update factor for the operating prospective payment rates, the capital prospective payment rates, and the excluded hospital rate-of-increase limits. <bullet> We discussed several provisions of the regulations in 42 CFR parts 412, 413, and 489 and set forth proposed changes concerning the following: --Sole community hospitals. --Rural referral centers. --Disproportionate share adjustment. --Direct graduate medical education payments. --Hospital distribution of "An Important Message from Medicare." <bullet> We discussed several provisions of the regulations in 42 CFR part 412 concerning the prospective payment system for capital- related costs, including possible adjustments to the capital Federal and hospital-specific rates, and set forth a proposed change concerning the use of simplified cost accounting. <bullet> We discussed clarifications concerning the calculation of payments to hospitals excluded from the prospective payment system. <bullet> In the addendum to the proposed rule, we set forth proposed changes to the amounts and factors for determining [[Page 46167]] the FY 1997 prospective payment rates for operating costs and capital- related costs. We also proposed new update factors for determining the rate-of-increase limits for cost reporting periods beginning in FY 1997 for hospitals and hospital units excluded from the prospective payment system. <bullet> In Appendix A to the proposed rule, we set forth an analysis of the impact that the proposed changes would have on affected entities. <bullet> In Appendix B to the proposed rule, we set forth our technical appendix on the proposed FY 1997 capital acquisition model. <bullet> In Appendix C to the proposed rule, we set forth the data sources used to determine the market basket relative weights and choice of price proxies. <bullet> In Appendix D to the proposed rule, we included our report to Congress on our initial estimate of an update factor for FY 1997 for both hospitals included in and hospitals excluded from the prospective payment systems as required by section 1886(e)(3)(B) of the Act. <bullet> As required by sections 1886(e)(4) and (e)(5) of the Act, in Appendix E we provided our recommendation of the appropriate percentage change for FY 1997 for the following: --Large urban area and other area average standardized amounts (and hospital-specific rates applicable to sole community hospitals) for hospital inpatient services paid for 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 prospective payment system. <bullet> In the proposed rule, we discussed in detail the March 1, 1996 recommendations made by the Prospective Payment Assessment Commission (ProPAC). ProPAC is directed by section 1886(e)(2)(A) of the Act to make recommendations on the appropriate percentage change factor to be used in updating the average standardized amounts. In addition, section 1886(e)(2)(B) of the Act directs ProPAC to make recommendations regarding changes in each of the Medicare payment policies under which payments to an institution are prospectively determined. In particular, the recommendations relating to the hospital inpatient prospective payment systems are to include recommendations concerning the number of DRGs used to classify patients, adjustments to the DRGs to reflect severity of illness, and changes in the methods under which hospitals are paid for capital-related costs. Under section 1886(e)(3)(A) of the Act, the recommendations required of ProPAC under sections 1886(e)(2) (A) and (B) of the Act are to be reported to Congress not later than March 1 of each year. We printed ProPAC's March 1, 1996 report, which included its recommendations, as Appendix F to the proposed rule. The recommendations, and the actions we proposed to take with regard to them (when an action is recommended), were discussed in detail in the appropriate sections of the preamble, the addendum, or the appendices to the proposed rule. Set forth below in this preamble, the addendum to this final rule, and the appendices are detailed discussions of the May 31 proposed rule, the public comments received in response to the proposed rule, and the responses to those comments, as well as the changes we are making. In addition, in section V.E.3 of this preamble, we address a recent statutory amendment to the Public Health Service Act that prohibits certain abortion-related discrimination by the Federal Government and State and local governments. The new statutory provision requires the Federal Government to deem accredited for certain purposes any postgraduate physician training program that would otherwise be accredited, except for the accrediting agency's reliance on certain standards concerning induced abortions. C. Public Comments Received in Response to the May 31 Proposed Rule A total of 511 items of correspondence containing comments on the proposed rule were received timely. We received over 300 letters on payments for direct graduate medical education programs. The main other areas of concern addressed by the commenters were the following: <bullet> Requests for changes in DRG classification and relative weights. <bullet> Issues related to the wage index. <bullet> Disproportionate share adjustment. <bullet> Possible adjustments to the capital Federal and hospital- specific rates. Go to Top II. Changes to DRG Classifications and Relative Weights A. Background Under the prospective payment system, we pay for inpatient hospital services on the basis of a rate per discharge that varies by the DRG to which a beneficiary's stay is assigned. The formula used to calculate payment for a specific case takes an individual hospital's payment rate per case and multiplies it 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 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 changes to the DRG classification system and the recalibration of the DRG weights for discharges occurring on or after October 1, 1996 are discussed below. B. DRG Reclassification 1. General Cases are classified into DRGs for payment under the 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 Edition, Clinical Modification (ICD-9-CM). The Medicare fiscal intermediary enters the information into its claims system and subjects it 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 can be accomplished. After screening through the MCE and any further development of the claims, cases are classified by the GROUPER software program into the appropriate DRG. 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 demographic information (that is, sex, age, and discharge status). It is used both to classify past cases in order to measure relative hospital resource consumption to establish the DRG weights and to classify current cases for purposes of determining payment. 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 [[Page 46168]] classification changes and to recalibrate the DRG weights. Currently, cases are assigned to one of 492 DRGs in 25 major diagnostic categories (MDCs). Most MDCs are based on a particular organ system of the body (for example, MDC 6, Diseases and Disorders of the Digestive System); however, some MDCs are not constructed on this basis since they involve multiple organ systems (for example, MDC 22, Burns). In general, principal diagnosis determines MDC assignment. However, there are five DRGs to which cases are assigned on the basis of procedure codes rather than first assigning them to an MDC based on the principal diagnosis. These are the DRGs for liver, bone marrow, and lung transplant (DRGs 480, 481, and 495, 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 (based on a surgical hierarchy that orders individual procedures or groups of procedures by resource intensity) and medical DRGs. 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 (hereafter CC). Generally, GROUPER does not consider other procedures; that is, nonsurgical procedures or minor surgical procedures generally not performed in an operating room are not listed as operating room (OR) procedures in the GROUPER decision tables. However, there are a few non-OR 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. We proposed to make several changes to the DRG classification system for FY 1997 and other decisions concerning DRGs. These proposed changes and other revisions, the comments we received concerning them, our responses to those comments, and the final DRG changes are set forth below. 2. Pre-MDC DRGs Effective October 1, 1994, ICD-9-CM procedure code 41.04, Autologous hematopoietic stem cell transplant, was created to capture the transplantation of stem cells obtained from bone marrow or peripheral blood. At that time, we designated the code as non-OR. When we created this code, we received comments requesting that it be designated as an OR procedure and assigned to DRG 481 (Bone Marrow Transplant) based on the resource use associated with the type of transplant. However, as we stated in the September 1, 1994 final rule (59 FR 45340), when a new code is introduced, our longstanding practice is to assign it to the same DRG category as its predecessor code. Because we could not separately identify the stem cell transplant cases from the other cases coded with 99.73 (the code previously used for stem cell transplant) in order to reclassify them and their charges to a new DRG, we were unable to predict the new weights of both the DRGs in which this code currently is classified and the new DRG to which it would be assigned. Therefore, we were prevented from redesignating code 41.04 as an OR procedure or assigning it to a DRG. However, we stated that we would analyze the stem cell cases as soon as the FY 1995 cases were available. This year, the FY 1995 MedPAR file is available for use in DRG analysis and weight setting for FY 1997. Since the average resource use associated with stem cell transplant is similar to that associated with bone marrow transplant, we proposed to assign procedure code 41.04 to DRG 481 effective with discharges occurring on or after October 1, 1996. In addition, we proposed to designate stem cell transplant as an OR procedure. In the proposed rule, we noted that, as set forth in the Medicare Coverage Issues Manual at section 35-30.1 (see Transmittal No. 84, April 1996), autologous stem cell transplants are not covered when performed for the following conditions: <bullet> Acute leukemia not in remission (diagnosis codes 204.00, 205.00, 206.00, 207.00 and 208.00). <bullet> Chronic granulocytic leukemia (diagnosis codes 205.10 and 205.11). <bullet> Solid tumors (other than neuroblastomas) (diagnosis codes 140.0 through 199.1). <bullet> Multiple myeloma (diagnosis codes 203.00, 203.01, and 238.6). We received five comments supporting our proposal to assign procedure code 41.04 to DRG 481, and we will include this change in the final DRG classifications. Two other commenters had specific questions concerning the assignment of cases to DRG 481. Comment: One commenter questioned the DRG assignment of cases in which an autologous hematopoietic stem cell transplant is performed for one of the noncovered conditions such as acute leukemia not in remission or multiple myeloma. The commenter is unsure whether those cases would be assigned to DRG 481 or retain their current DRG assignment. Response: When a stem cell transplant is performed for a noncovered condition, the case will not be assigned to DRG 481. If the only reason that the patient is admitted to the hospital is to receive the noncovered procedure, then the case receives no Medicare payment because the hospital stay is not covered. If a patient receives a noncovered stem cell transplant during an otherwise Medicare-covered stay, then the case is assigned to a DRG based on the patient's principal and secondary diagnoses as well as any other covered procedure the patient receives. The stem cell transplant will not be considered in the DRG assignment. Comment: One commenter was concerned about the assignment of a case in which a kidney transplant patient receives an allogeneic bone marrow transplant (procedure code 41.03) from the kidney donor to reduce the incidence and magnitude of organ rejection. The commenter believes it is inappropriate to assign such a case to DRG 481 rather than DRG 302 (Kidney Transplant) and that we should therefore revise the pre-MDC surgical hierarchy. Response: Allogeneic bone marrow transplants performed for purposes of reducing rejection during a kidney transplant have not yet been subject to a national coverage decision. Therefore, under HCFA policy, the Medicare contractors (Part A fiscal intermediaries and Part B carriers) determine, on a case-by-case basis, whether or not to cover and pay for such claims. If a contractor did decide that one of these claims should be covered, then it would be paid under DRG 481. If the contractor determines that the bone marrow transplant is not covered, the claim would be assigned to a DRG without considering the bone marrow transplant. In most cases, this assignment would be DRG 302. 3. MDC 1 (Diseases and Disorders of the Nervous System) a. Sleep apnea. As discussed in the proposed rule, we have received correspondence requesting that we review the DRG assignment of cases in which surgery is performed to correct obstructive sleep apnea (diagnosis code 780.57). When coded as a principal diagnosis, sleep apnea is assigned to DRGS 34 and 35 (Other Disorders of the Nervous System) <SUP>1 in MDC 1. --------------------------------------------------------------------------- \1\ A single title combined with two DRG numbers is used to signify pairs. Generally, the first DRG is for cases with CC and the second DRG is for cases without CC. If a third number is included, it represents cases of patients who are age 0-17. Occasionally, a pair of DRGs is split on age>17 and age 0-17. --------------------------------------------------------------------------- [[Page 46169]] Recently, new surgical interventions to correct sleep apnea have been introduced. The procedures most frequently performed for this --------------------------------------------------------------------------- condition are the following: ------------------------------------------------------------------------ Code Description ------------------------------------------------------------------------ 27.69............................ Other plastic repair of palate. 29.4............................. Plastic operation on pharynx. 29.59............................ Other repair of pharynx. ------------------------------------------------------------------------ Since none of these surgical procedures is assigned to MDC 1, cases of sleep apnea treated with one of these surgeries are assigned to DRG 468 (Extensive OR procedure Unrelated to Principal Diagnosis) or to DRG 477 (Nonextensive OR Procedure Unrelated to Principal Diagnosis), depending on the procedure. We proposed to address this situation by assigning the three surgical procedures to MDC 1. Based on the charges associated with these cases and the fact that they are not clinically similar to the other surgical DRGs in MDC 1, we proposed to include them in DRGs 7 and 8 (Peripheral and Cranial Nerve and Other Nervous System Procedures). We received two comments in support of the addition of codes 27.69, 29.4 and 29.59 to DRGS 7 and 8. The commenters agree that these procedures are frequently used as surgical interventions to correct sleep apnea and are appropriately classified to DRGs 7 and 8. We also received two comments that disagreed, as discussed below. Comment: One commenter was opposed to moving the procedure codes to DRGS 7 and 8. The commenter stated that if the patient had obstructive sleep apnea, the more appropriate diagnosis code would be the underlying cause of the obstruction, such as upper airway blockage (diagnosis code 528.9, Other and Unspecified Diseases of the Oral Soft Tissues) or diagnosis code 478.29, Other Diseases of Pharynx for Redundant Pharyngeal Mucosa. Response: We agree that if the medical record provides a precise diagnosis for the obstruction, then that condition should be coded. However, information supporting these codes is not always provided in the medical record. Physicians frequently document obstructive sleep apnea as the reason for the surgery. In these cases, medical record coders are assigning code 780.57. As explained above, we believe that it is inappropriate to continue to assign these cases to DRGS 468 and 477 and that the better policy is to assign the procedures to MDC 1. Comment: We received one comment suggesting that obstructive sleep apnea reported in conjunction with procedure codes 27.69, 29.4, or 29.59 would be more appropriately classified to DRGs 76 and 77 (Other Respiratory System Procedures) in MDC 4 (Diseases of the Respiratory System). In addition, the commenter recommended that obstructive sleep apnea medical cases be assigned to DRGs 101 and 102 (Other Respiratory Diagnoses). Response: In order to properly classify each case, a diagnosis code may be assigned to only one MDC. Diagnoses in each MDC correspond to a single organ system or etiology and in general are associated with a particular medical specialty. In order to classify cases of obstructive sleep apnea to DRGs 76, 77, 101, and 102, code 780.57 would have to be reassigned from MDC 1 to MDC 4. We believe that obstructive sleep apnea is more appropriately classified to MDC 1; therefore, these cases cannot be assigned to a DRG in MDC 4. Comment: One commenter noted an error in the discussion of sleep apnea in the proposed rule. The second time we referred to the codes to be moved to MDC 1, we listed them as 25.59, 78.49, and 29.4 (see 61 FR 27447). Response: In the proposed rule, we inadvertently referred to procedures codes 25.59 and 78.49. The codes that will be added to DRGs 7 and 8 are 27.69, 29.4 and 29.59. b. Guillain-Barre Syndrome. Guillain-Barre syndrome (diagnosis code 357.0) is a post-infectious polyneuropathy in which severely affected patients may require ventilatory assistance and long stays in intensive care. In recognition of the high resource consumption associated with this diagnosis, effective with FY 1991, we reassigned code 357.0 from DRGs 18 and 19 (Cranial and Peripheral Nerve Disorders) to DRG 20 (Nervous System Infection Except Viral Meningitis). (See the September 4, 1990 final rule (55 FR 36024).) We have recently received requests that we again review this assignment. These commenters stated that the treatment for these cases remains very costly and often entails long hospital stays. Therefore, we conducted an analysis of the cases assigned to DRG 20 using the 10 percent random sample of the FY 1995 MedPAR file that we use for analyzing possible classification changes. Cases coded with 357.0 constitute approximately 20 percent of the cases assigned to DRG 20. The average standardized charges for these cases, approximately $22,400, was higher than the average charge for the DRG, approximately $17,100. However, the length of stay was virtually the same. Since we believe that DRG 20 is the appropriate assignment clinically for Guillain-Barre cases, we reviewed the other cases assigned to DRG 20 for possible change. We found that herpes zoster of the nervous system, NOS (diagnosis code 053.10) and herpes zoster of the nervous system, NEC (diagnosis code 053.19) had average charges of only $7,700 and $7,100, respectively. They also had lower average lengths of stay (6.2 and 6.1 days, respectively). (In the proposed rule, we mistakenly cited these lengths of stay as 4.4 and 4.2, respectively (61 FR 27447).) Because these two diagnoses account for approximately 20 percent of the cases in DRG 20, their low average charge has the effect of significantly lowering the average charge for the DRG. We proposed to reassign these codes to DRGs 18 and 19. Comment: We received two comments regarding our proposal to assign diagnosis codes 053.10 and 053.19 to DRGs 18 and 19, both of which supported the change. However, one commenter noted that even though these cases obviously do not consume the amount of resources as other cases assigned to DRG 20, clinically, they are more closely related to cases in DRG 20 than those in DRGs 18 and 19. The commenter also expressed an interest in the length of stay and charges for geniculate herpes zoster (diagnosis code 053.11), which we did not propose to move from DRG 20. Response: We do not believe that reassigning these codes to DRGs 18 and 19 is clinically unsound. There are currently two other herpes zoster diagnoses classified to those DRGs (Postherpetic trigeminal neuralgia (code 053.12) and postherpetic polyneuropathy (code 053.13)). Further, as the commenter noted, the charges and length of stay for 053.10 and 053.19 are very close to those for the cases assigned to DRGs 18 and 19. We had considered moving all three herpes diagnosis codes (035.10, 053.11, and 053.19) from DRG 20 to DRGs 18 and 19. However, the higher charges associated with geniculate herpes zoster ($11,000) and slightly higher length of stay (6.7 days) led us to decide instead to leave 053.11 in DRG 20 and to closely monitor these cases in upcoming years. 4. MDC 5 (Diseases and Disorders of the Circulatory System) Effective for discharges occurring on or after October 1, 1995, we created a [[Page 46170]] new code for insertion of a coronary artery stent (procedure code 36.06). Until creation of the new code, insertion of coronary artery stent had been included in the codes for percutaneous transluminal coronary angioplasty (PTCA) (procedure codes 36.01, 36.02, and 36.05). When a new code is introduced, our longstanding practice is to assign it to the same DRG category as its predecessor code or codes. Therefore, in the September 1, 1995 final rule (60 FR 45785), we assigned procedure code 36.06 to DRG 112 (Percutaneous Cardiovascular Procedures), the DRG to which PTCA is assigned. We also stated that the resource use and other data associated with procedure code 36.06 will be available in the FY 1996 Medicare cases which are used for analysis as part of FY 1998 DRG changes. We will evaluate the DRG assignment of coronary artery stent insertion at that time. Since publication of the September 1, 1995 final rule, we have received data on stent cases provided by the manufacturer of one of the two stent devices currently approved by the Food and Drug Administration (FDA). In addition, the manufacturer has provided us with an analysis of the charges and length of stay of approximately 7,500 Medicare patients who received stents in FY 1995. The manufacturer's analysis found that the FY 1995 average charge for PTCA cases without stent is approximately $15,700 and the average charge for cases with stent is approximately $21,000. However, our analysis of the data shows that there is wide variation in the hospital standardized charges reported for cases with implant of coronary artery stent. Individual hospital average charges for these cases range from about $9,000 to over $45,000. This inconsistency in the data illustrates why our policy of not reassigning new codes until we have collected an entire year of coded Medicare data for analysis is prudent. The uncertainty associated with using incomplete data collected outside the Medicare program that cannot be verified remains a problem. Therefore, we did not propose any DRG assignment change for implant of coronary artery stent. Comment: We received five comments on this issue. One commenter agreed that the strategy of not assigning new codes into different DRGs until Medicare data have been collected and reviewed is appropriate. Four commenters requested that we take action this year. The commenters suggested various options for reassigning code 36.06: assign the code to its own DRG; move the code to a higher-weighted DRG (DRG 116, Other Permanent Cardiac Pacemaker Implant or AICD Lead or Generator Procedure was suggested); or increase the weight for DRG 112 to recognize that some of these cases involve stents. One commenter believes that if we delay action, hospitals will not be able to provide stent therapy to Medicare beneficiaries, thereby depriving them of state-of-the-art technology and better outcomes. The commenter noted that although the literature has reported higher costs (for example, cost of the device itself, increased anticoagulation therapy, more frequent monitoring) related to this procedure, there has also been some offset noted because of the reduction in followup medical costs. There is also the potential that further improvement in stent design, implantation techniques, and other anticoagulant therapy could further increase this offset by reducing vascular complications or length of stay. One commenter, the manufacturer of a coronary stent device, stated that the assignment of coronary stent implant to DRG 112 is inappropriate in light of the higher average lengths of stay and charges associated with this procedure compared to traditional angioplasty. The commenter argued that, given these differences, DRG reclassification of procedure code 36.06 would be consistent with the statutory mandate to adjust the DRG classifications and relative weights to "reflect changes in treatment patterns, technology, and other factors which may change the relative use of hospital resources." (Section 1886(d)(4)(C) of the Act.) The commenter also cited 1,200 peer-reviewed clinical publications that demonstrate superior clinical outcomes with coronary stent implant. Finally, the commenter stated that the variation in hospital standardized charges for coronary stent implant cases is less than the variation in charges for all PTCA cases without stent implant. Response: As we stated in the proposed rule (61 FR 27447) and in the September 1, 1995 final rule (60 FR 45785), our practice is to assign a new code to the same DRG or DRGs as its predecessor code. One compelling reason for this practice is our inability to move the cases associated with the new code to a new DRG assignment as part of the DRG reclassification and recalibration process. Because the code is new, we cannot identify the stent cases in DRG 112 to remove the charges from that DRG, revise the relative weight accordingly, and move those cases to another DRG and establish the revised weight of that DRG. We do not disagree with the commenters that the stent implant cases are more costly, on average, than other PTCA cases. We also do not dispute the clinical superiority of this treatment for certain patients. However, until we can review actual Medicare data to determine exactly what the difference in charges is, we cannot make a reasoned decision as to whether those cases should be moved to another DRG or be assigned to a new DRG. We believe that waiting for appropriate data is entirely consistent with our statutory duty to adjust DRG classifications. Regarding the comment on the variation in charges for stent versus nonstent PTCA cases, we note that the charges for a specific procedure should vary less than the charges for a set of cases that vary in severity and for which many different treatments may be performed. That is, the homogeneity of the patients who received a stent implant should reflect a lower degree of variation. Finally, analysis of data provided by the stent manufacturer convinced us that Medicare beneficiaries have access to stent implants that is at least equal to the general population. Moreover, we note that it is a violation of a hospital's Medicare provider agreement to place restrictions on the number of Medicare beneficiaries it will accept for treatment unless it places the same restrictions on all other patients. We will carefully examine the PTCA cases with and without stent implant in the FY 1996 claims data file as soon as it is available. Any DRG changes we determine are supported by the data will be addressed in the FY 1998 proposed rule. 5. MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue) In the proposed rule, we reviewed the DRG assignment in MDC 8 of bipolar hip replacement cases as a follow-up to a comment received last year. The commenter believed that the procedure for partial hip replacement (code 81.52), currently assigned to DRG 209 (Major Joint and Limb Reattachment Procedures of Lower Extremity), is very similar to the procedure for open reduction of fracture of the femur with internal fixation (code 79.35), which is assigned to DRGs 210, 211, and 212 (Hip and Femur Procedures Except Major Joint). Further, the commenter noted that partial hip replacement patients are more frail individuals than the population that elects total hip replacement and need longer hospital stays to recover. [[Page 46171]] After reviewing the FY 1995 MedPAR file, we concluded that the charges and lengths of stay for partial hip replacement cases assigned to DRG 209 were very similar to the other cases assigned to DRG 209. However, the average charge for cases in DRG 210 was significantly less than the partial hip replacement charges. We note that the length of stay for partial hip replacement cases was closer to the average length of stay for DRG 210. However, the higher charges of the partial hip replacement cases indicate that they are more resource-intensive than the cases in DRG 210 and similar to the cases in DRG 209. Therefore, we proposed to retain procedure code 81.52 in DRG 209. We received three comments, all of which supported our proposal, and we will continue to assign partial hip replacement cases to DRG 209. 6. 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. It is, therefore, necessary to have a decision rule by which these cases are assigned to a single DRG. The surgical hierarchy, an ordering of surgical classes from most 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 recalibration, we reviewed the surgical hierarchy of each MDC, as we have for previous reclassifications, to determine if the ordering of classes coincided with the intensity of resource utilization, as measured by the same billing data used to compute the DRG relative weights. A relative class can be composed of one or more DRGs. For example, in MDC 5, the surgical class "heart transplant" consists of a single DRG (DRG 103) and the class "coronary bypass" consists of two DRGs (DRGS 106 and 107). Consequently, in many cases, the surgical hierarchy has an impact on more than one DRG. The methodology for determining the most resource-intensive surgical class, therefore, involves weighting each DRG for frequency to determine the average resources for each surgical class. For example, assume surgical class A includes DRGs 1 and 2 and surgical class B includes DRGs 3, 4, and 5, and that the average charge of DRG 1 is higher than that of DRG 3, but the average charges of DRGs 4 and 5 are higher than the average charge of DRG 2. To determine whether surgical class A should be higher or lower than surgical class B in the surgical hierarchy, we would weight the average charge of each DRG by frequency (that is, by the number of cases in the DRG) to determine average resource consumption for the surgical class. The surgical classes would then be ordered from the class with the highest average resource utilization to that with the lowest, with the exception of "other OR procedures" as discussed below. This methodology may occasionally result in a case involving multiple procedures being assigned to the lower- weighted DRG (in the highest, most resource-intensive surgical class) of the available alternatives. However, given that the logic underlying the surgical hierarchy provides that the GROUPER searches for the procedure in the most resource-intensive surgical class, which may sometimes occur in cases involving multiple procedures, this result is unavoidable. We note that, notwithstanding the foregoing discussion, there are a few instances when a surgical class with a lower average relative weight is ordered above a surgical class with a higher average relative weight. For example, the "other OR procedure" surgical class is uniformly ordered last in the surgical hierarchy of each MDC in which it occurs, regardless of the fact that the relative weights for the DRG or DRGS in that surgical class may be higher than that for other surgical classes in the MDC. The "other OR procedures" class is a group of procedures that are least likely to be related to the diagnosis in the MDC but are occasionally performed on patients with these diagnoses. Therefore, these procedures should only be considered if no other procedure more closely related to the diagnoses in the MDC has been performed. A second example occurs when the difference between the average weights for two surgical classes is very small. We have found that small differences generally do not warrant reordering of the hierarchy since, by virtue of the hierarchy change, the relative weights are likely to shift such that the higher-ordered surgical class has a lower average weight than the class ordered below it. Based on the preliminary recalibration of the DRGs, we proposed to modify the surgical hierarchy as set forth below. As we stated in the September 1, 1989 final rule (54 FR 36457), we are unable to test the effects of the proposed revisions to the surgical hierarchy and to reflect these changes in the proposed relative weights due to the unavailability of revised GROUPER software at the time the proposed rule is prepared. Rather, we simulate most major classification changes to approximate the placement of cases under the proposed reclassification and then determine the average charge for each DRG. These average charges then serve as our best estimate of relative resource use for each surgical class. We test the proposed surgical hierarchy changes after the revised GROUPER is received and reflect the final changes in the DRG relative weights in the final rule. We proposed to revise the surgical hierarchy for the Pre-MDC DRGs, MDC 3 (Diseases and Disorders of the Ear, Nose, Mouth, and Throat), and MDC 10 (Endocrine, Nutritional and Metabolic Diseases and Disorders) as follows: <bullet> In the Pre-MDC DRGs, we proposed to reorder Tracheostomy Except for Face, Mouth and Neck diagnoses (DRG 483) above Liver Transplant (DRG 480). <bullet> In MDC 3, we proposed to reorder Cleft Lip and Palate Repair (DRG 52) and Sinus and Mastoid Procedures (DRGs 53 and 54) above Tonsillectomy and Adenoidectomy, Except Tonsillectomy and/or Adenoidectomy Only (DRGs 57 and 58). <bullet> In MDC 10, we proposed to reorder Adrenal and Pituitary Procedures (DRG 286) above Amputation of Lower Limb for Endocrine, Nutritional, and Metabolic Disorders (DRG 285). We received two comments in support of the three surgical hierarchy changes. In addition, based on a test of the proposed changes using the most recent MedPAR file and the revised GROUPER software, we have found that the changes are still supported by the data and no additional changes are indicated. Therefore, we are incorporating these changes in this final rule. 7. Refinement of Complications and Comorbidities List a. Addition or Deletion of CCs. There is a standard list of diagnoses that are considered complications or comorbidities (CCs). We developed this list using physician panels to include those diagnoses that, when present as a secondary condition, would be considered a substantial complication or comorbidity. In previous years, we have made changes to the standard list of CCs, either by adding new CCs or deleting any of the diagnosis codes on the CC list. In the September 1, 1995 final rule (60 FR 45782), we added diagnosis code 008.49 (Bacterial enteritis) to the CC list. [[Page 46172]] In response to a request from one commenter that we also add diagnosis code 008.45 (Clostridium difficile), we stated that we would review that request as part of our DRG analysis for FY 1997. We have reevaluated diagnosis code 008.45 as well as the remainder of the "family" of codes assigned to the category of Intestinal infections due to other specified bacteria (008.41, 008.42, 008.43, 008.44, 008.46, and 008.47). Our analysis shows that all of these diagnoses, when present as a secondary condition, do lead to higher resource use. Therefore, we proposed to add the following diagnosis codes to the CC list: 008.41 Intestinal infections due to staphylococcus 008.42 Intestinal infections due to pseudomonas 008.43 Intestinal infections due to campylobacter 008.44 Intestinal infections due to yersinia enterocolitica 008.45 Intestinal infections due to clostridium difficile 008.46 Intestinal infections due to other anaerobes 008.47 Intestinal infections due to other gram-negative bacteria These diagnoses would be considered CCs for any principal diagnosis not shown in Table 6f, Additions to the CC Exclusions List (see discussion of CC Exclusions list in section V of the addendum below). This same commenter also requested that we add the following codes to the CC list: 331.0 Alzheimer's disease 423.9 Unspecified disease of the pericardium 348.5 Cerebral edema 333.4 Huntington's chorea 458.0 Orthostatic hypotension 458.9 Hypotension, not otherwise specified Our analysis of these codes demonstrated that their presence as a secondary diagnosis did not significantly add to the resource use of the case. Therefore, we did not propose to add them to the CC list. Finally, the commenter suggested that the following diagnoses be added as cardiovascular complications for DRG 121 (Circulatory Disorders with AMI and Cardiovascular Complications, Discharged Alive): 434.xx Occlusion of cerebral arteries 436 Acute, but ill-defined, cerebrovascular disease Based on our analysis, charges associated with those cases were indeed comparable to the other cases assigned to DRG 121. However, when we sought the advice of our medical specialists (physicians who work directly for or under contract with HCFA), they strongly opposed adding these codes to the list of conditions for DRG 121 based on the fact that these are not cardiovascular complications. Therefore, they are not clinically similar to other cases assigned to this DRG. Our analysis of DRG 121 did reveal a large variation in the charges and lengths of stay within this DRG. We believe that a close examination of the list of complicating conditions assigned to DRG 121 is needed. Therefore, we plan to perform a thorough analysis of the cases assigned to that DRG as part of our DRG analysis agenda for FY 1998. In the meantime, we did not propose any change to DRG 121. We received three comments supporting the addition of the remainder of the "family" of codes for intestinal infection due to bacteria to the CC list. We received one comment in support of our decision not to add 331.0, 423.9, 348.5, 333.4, 458.0, and 458.9 to the CC list. Comment: Two commenters requested that we reconsider our decision not to add codes 434.xx (Occlusion of cerebral arteries) and 436 (Acute, but ill-defined, cerebrovascular disease) to the list of conditions that are designated cardiovascular complications for assignment to DRG 121 (Circulatory Disorders with AMI and Cardiovascular Complications, Discharged Alive). One commenter noted that even though these diagnoses are not cardiac in nature, they are vascular complications. The other commenter stated that there are other conditions assigned to DRG 121, such as acute renal failure, that are not strictly cardiovascular conditions. The commenter supports our decisions to completely review DRG 121, but believes diagnosis codes 434.xx and 436 should be added this year. Response: As explained in the proposed rule (61 FR 27449), in our initial analysis, cases assigned to DRG 121 that had these diagnoses coded as secondary conditions contained charges that were indeed comparable to the other cases assigned to DRG 121. However, our analysis of DRG 121 and the list of cardiovascular conditions revealed large variations in the charges and lengths of stay for cases within this DRG. Because the diagnoses associated with codes 434.xx and 436 are not strictly cardiovascular in nature, we believe the better course would be to do a comprehensive review of DRG 121, including considering adding additional diagnosis as complicating conditions. We will address these issues as part of our DRG analysis agenda for FY 1998. b. CC Exclusions List. In the September 1, 1987 final notice concerning changes to the DRG classification system (52 FR 33143), we modified the GROUPER logic so that certain diagnoses included on the standard list of CCs would not be considered a valid CC in combination with a particular principal diagnosis. Thus, we created the CC Exclusions List. We made these changes to preclude duplicative coding or inconsistent coding from being treated as CCs, and to ensure that cases are appropriately classified between the complicated and uncomplicated DRGs in a pair. In the May 19, 1987 proposed notIce concerning changes to the DRG classification system (52 FR 18877), we explained that the excluded secondary diagnoses were established using the following five principles: <bullet> Chronic and acute manifestations of the same condition should not be considered CCs for one another (as subsequently corrected in the September 1, 1987 final notice (52 FR 33154)). <bullet> Specific and nonspecific (that is, not otherwise specified (NOS)) diagnosis codes for a condition should not be considered CCs for one another. <bullet> Conditions that may not co-exist, such as partial/total, unilateral/bilateral, obstructed/unobstructed, and benign/malignant, should not be considered CCs for one another. <bullet> The same condition in anatomically proximal sites should not be considered CCs for one another. <bullet> Closely related conditions should not be considered CCs for one another. The creation of the CC Exclusions List was a major project involving hundreds of codes. The FY 1988 revisions were intended to be only a first step toward refinement of the CC list in that the criteria used for eliminating certain diagnoses from consideration as CCS were intended to identify only the most obvious diagnoses that should not be considered complications or comorbidities of another diagnosis. For that reason, and in light of comments and questions on the CC list, we have continued to review the remaining CCs to identify additional exclusions and to remove diagnoses from the master list that have been shown not to meet the definition a CC. (See the September 30, 1988 final rule for the revisions made for the discharges occurring in FY 1989 (53 FR 38485); the September 1, 1989 final rule for the FY 1990 revisions (54 FR 36552); the September 4, 1990 final rule for the FY 1991 revisions (55 FR 36126); the August 30, 1991 final rule for the FY 1992 revision (56 FR 43209); the September 1, 1992 final rule for the [[Page 46173]] FY 1993 revisions (57 FR 39753); the September 1, 1993 final rule for the FY 1994 revisions (58 FR 46278); the September 1, 1994 final rule for the FY 1995 revisions (59 FR 45334); and the September 1, 1995 rule for the FY 1996 revisions (60 FR 45782).) The proposed rule reflected a limited revision of the CC Exclusions List to take into account the changes that will be made in the ICD-9-CM diagnosis coding system effective October 1, 1996, as well as the proposed CC changes described above. (See section II.B.8, below, for a discussion of ICD-9-CM changes.) These changes are being made in accordance with the principles established when we created the CC Exclusions List in 1987. The changes discussed above have been added to Table 6g, Additions to the CC Exclusions List, in section V of the addendum to this final rule. Table 6g and 6h in section V of the addendum to this final rule contain the revisions to the CC Exclusions List that will be effective for discharges occurring on or after October 1, 1996. Each table shows the principal diagnoses with final changes to the excluded CCs. Each of these principal diagnoses is shown with an asterisk, and the additions or deletions to the CC Exclusions List are provided in an indented column immediately following the affected principal diagnosis. CCs that are added to the list are in Table 6g--Additions to the CC Exclusions List. Beginning with discharges on or after October 1, 1996, the indented diagnoses will not be recognized by the GROUPER as valid CCs for the asterisked principal diagnosis. CCs that are deleted from the list are in Table 6h--Deletions from the CC Exclusions List. Beginning with discharges on or after October 1, 1996, the indented diagnoses will be recognized by the GROUPER as valid CCs for the asterisked principal diagnosis. Copies of the original CC Exclusions List applicable to FY 1988 can be obtained for the National Technical Information Service (NTIS) of the Department of Commerce. It is available in hard copy for $92.00 plus $6.00 shipping and handling and on microfiche for $20.50, plus $4.00 for shipping and handling. A request for the FY 1988 CC Exclusions List (which should include the identification accession number, (PB) 88-133970) should be made to the following address: National Technical Information Service; United States Department of Commerce; 5285 Port Royal Road; Springfield, Virginia 22161; or by calling (703) 487-4650. Users should be aware of the fact that all revisions to the CC Exclusions List (FYs 1989, 1990, 1991, 1992, 1993, 1994, 1995, and 1996) and those in Tables 6g and 6h of this document must be incorporated into the list purchased from NTIS in order to obtain the CC Exclusions List applicable for discharges occurring on or after October 1, 1996. Alternatively, the complete documentation of the GROUPER logic, including the current CC Exclusions List, is available from 3M/Health Information Systems (HIS), which under contract with HCFA, is responsible for updating and maintaining the GROUPER program. The current DRG Definitions Manual, Version 13.0, is available for $195.00, which includes $15.00 for shipping and handling. Version 14.0 of this manual, which will include the final FY 1997 DRG changes, will be available in October 1996 for $195.00. These manuals may be obtained by writing 3M/HIS at the following address: 100 Barnes Road; Wallingford, Connecticut 06492; or by calling (203) 949-0303. Please specify the revision or revisions requested. 8. Review of Procedure Codes in DRGs 468, 476, and 477 Each year, we review cases assigned to DRG 468 (Extensive OR Procedure Unrelated to Principal Diagnosis), DRG 476 (Prostatic OR Procedure Unrelated to Principal Diagnosis), and DRG 477 (Nonextensive OR Procedure Unrelated to Principal Diagnosis) in order to determine whether it would be appropriate to change the procedures assigned among these DRGs. DRGs 468, 476, and 477 are reserved for those cases in which none of the OR procedures performed is related to the principal diagnosis. These DRGs are intended to capture atypical cases, that is, those cases not occurring with sufficient frequency to represent a distinct, recognizable clinical group. DRG 476 is assigned to those discharges in which one or more of the following prostatic procedures are performed and are unrelated to the principal diagnosis: 60.0 Incision of prostate 60.12 Open biopsy of prostate 60.15 Biopsy of periprostatic tissue 60.18 Other diagnostic procedures on prostate and periprostatic tissue 60.21 Transurethral prostatectomy 60.29 Other transurethral prostatectomy 60.61 Local excision of lesion of prostate 60.69 Prostatectomy NEC 60.81 Incision of periprostatic tissue 60.82 Excision of periprostatic tissue 60.93 Repair of prostate 60.94 Control of (postoperative) hemorrhage of prostate 60.95 Transurethral balloon dilation of the prostatic urethra 60.99 Other operations on prostate All remaining OR procedures are assigned to DRGs 468 and 477, with DRG 477 assigned to those discharges in which the only procedures performed are nonextensive procedures that are unrelated to the principal diagnosis. The original list of the ICD-9-CM procedure codes for the procedures we consider nonextensive procedures if performed with an unrelated principal diagnosis was published in Table 6c in section IV of the addendum to the September 30, 1988 final rule (53 FR 38591). As part of the final rules published on September 4, 1990, August 30, 1991, September 1, 1992, September 1, 1993, September 1, 1994, and September 1, 1995, we moved several other procedures from DRG 468 to 477. (See 55 FR 36135, 56 FR 43212, 57 FR 23625, 58 FR 46279, 59 FR 45336, and 60 FR 45783, respectively.) a. Adding Procedure Codes to MDCs. We annually conduct a review of procedures producing DRG 468 or 477 assignments on the basis of volume of cases in these DRGs with each procedure. Our medical consultants then identify those procedures occurring in conjunction with certain principal diagnoses with sufficient frequency to justify adding them to one of the surgical DRGs for the MDC in which the diagnosis falls. This year's review did not identify any necessary changes; therefore, we did not propose to move any procedures from DRG 468 or DRG 477 to one of the surgical DRGs. b. Reassignment of Procedures Among DRGs 468, 476, and 477. We also reviewed the list of procedures that produce assignments to DRGs 468, 476, and 477 to ascertain if any of those procedures should be moved from one of these DRGs to another based on average charges and length of stay. Generally, we move only those procedures for which we have an adequate number of discharges to analyze the data. Based on our review this year, we moved one procedure from DRG 468 to DRG 477. In reviewing the list of OR procedures that produce DRG 468 assignments, we analyzed the average charge and length of stay data for cases assigned to that DRG to identify those procedures that are more similar to the discharges that currently group to either DRG 476 or 477. We identified one procedure, Closed endoscopic biopsy of lung (code [[Page 46174]] 33.27), a needle biopsy, that is significantly less resource-intensive than the other procedures assigned to DRG 468. Therefore, we proposed to move procedure code 33.27 to the list of procedures that result in assignment to DRG 477. In reviewing the list of procedures assigned to DRG 477, we did not identify any procedures that should be assigned to either DRG 468 or 476. We did, however, identify the following procedures that we believe should be reassigned from an OR to a non-OR designation: 08.81 Linear repair of laceration of eyelid or eyebrow 08.82 Repair of laceration involving lid margin, partial-thickness 08.83 Other repair of laceration of eyelid, partial-thickness 08.84 Repair of laceration involving lid margin, full-thickness 08.85 Other repair of laceration of eyelid, full-thickness 08.86 Lower eyelid rhytidectomy 08.87 Upper eyelid rhytidectomy 08.89 Other eyelid repair Our analysis of the data associated with these eyelid repair procedures leads us to conclude that the procedures are performed following accidental injury or falls, incurred while the patient is in the hospital. These procedures, which are normally performed at bedside and do not necessitate a trip to the operating room, are significantly less resource-intensive than other procedures designated as OR procedures. Therefore, we proposed to change the procedures from OR to non-OR procedures. We noted that these procedures are assigned to surgical DRGs in MDCs 2, 9, 21, 22, and 24. With this change, cases in which procedure codes 08.81 through 08.89 are the only OR procedure codes listed would no longer be assigned to a surgical DRG. Comment: We received two comments that generally supported our proposal to move procedure code 33.27 to the list of procedures that result in assignment to DRG 477. However, one of the commenters was concerned because this code also includes transbronchial lung biopsy. The commenter believes that transbronchial lung biopsy is a high-risk procedure and questions whether this would be considered a nonextensive procedure. Response: In analyzing the procedures that produce assignments to each of DRG 468, 476, and 477 for possible reassignment, we evaluate average charges and lengths of stay. The cases in DRG 468 with procedure code 33.27 are significantly less resource-intensive than the other procedures assigned to DRG 468, and more closely resemble the average charge and length of stay for procedures classified to DRG 477. Although transbronchial lung biopsy may be a more difficult procedure to perform than other procedures assigned to 33.27, we do not know how many of these cases are actually assigned to DRG 468, that is, how many times this procedure is performed for an unrelated principal diagnosis. It is possible that the lower charges associated with closed endoscopic biopsy of lung cases in DRG 468 do not include many transbronchial lung biopsy cases. We also note that in MDC 4, procedure code 33.27 is not assigned to the major procedures DRG (DRG 75). In any case, our data support the reclassification of these procedures to DRG 477. Therefore, we are reassigning procedure code 33.27 from DRG 468 to DRG 477, as proposed. Comment: We received four comments regarding our proposal to designate procedure code category "other repair of eyelid" (codes 08.81 through 08.89) as non-OR. Two commenters supported our decision, although one of those commenters stated that even though these procedures may not require an operating room, they may require a specialist. One commenter requested that we consider designating these eyelid repair codes as non-OR procedures that affect DRG assignment when the procedure is the only one performed in connection with a related principal diagnosis. The fourth commenter understood that our reason for making this change had to do with our belief that many of these injuries are sustained during hospital stays. That commenter believes that the causes surrounding the injury are not necessarily indicative of the nature of the services furnished or the procedures performed and that we should not make this change unless we reviewed the resources consumed delivering these services. Response: Our proposal to change the OR designation for these procedures was not based on where the injuries were incurred. Rather, we based the decision on our analysis of claims data as part of our annual review of procedures that result in assignment to DRGs 468, 476, and 477, and on the clinical opinions of our physician consultants. Cases in which 08.81 was coded as the only OR procedure, unrelated to the principal diagnosis, were the second most frequently assigned to DRG 477. Our evaluation of the average charges and length of stay for these cases was the deciding factor in our proposal. Both of these statistics were much lower for the eyelid repair cases than the average case assigned to DRG 477. In addition, the opinion of our medical staff was that these repairs would not normally necessitate a trip to the OR, even if they are performed by a specialist. Because there are so many cases of eyelid repair performed for unrelated diagnoses, we speculated that they were the result of injuries sustained while the patient was in the hospital. Regarding the request to designate codes 08.81 through 08.89 as non-OR procedures that affect DRG assignment in the MDCs to which they were previously assigned, we analyzed the FY 1995 MedPAR file cases in which one of these codes is assigned to DRG 40 and 41 (Extraocular Procedures Except Orbit) in MDC 2 (Diseases and Disorders of the Eye) and DRG 268 (Skin, Subcutaneous Tissue and Breast Plastic Procedures) in MDC 9 (Disease and Disorders of the Skin, Subcutaneous Tissue and Breast). In both DRGs 40 and 268 (no cases were assigned to DRG 41 in FY 1995), there were no cases in which an eyelid repair was the only related procedure coded. That is, in every case, there was another OR procedure code present on the claim that would cause it to be assigned to either DRG 40 or 268. This means that assignment of cases to these DRGs will not be affected by changing the OR designation for the eyelid repair codes. 9. Changes to the ICD-9-CM Coding System As discussed above in section II.B.1 of this preamble, the ICD-9-CM is a coding system that is used for the reporting of diagnoses and procedures performed on a patient. In September 1985, the ICD-9-CM Coordination and Maintenance Committee was formed. This is a Federal interdepartmental committee charged with the mission of maintaining and updating the ICD-9-CM. That mission includes approving coding changes, and developing errata, addenda, and other modifications to the ICD-9-CM to reflect newly developed procedures and technologies and newly identified diseases. The Committee is also responsible for promoting the use of Federal and non-Federal educational programs and other communication techniques with a view toward standardizing coding applications and upgrading the quality of the system. The Committee is co-chaired by the National Center for Health Statistics (NCHS) and HCFA. The NCHS has lead responsibility for the ICD-9-CM diagnosis codes included in Volume 1--Diseases: Tabular List and Volume 2--Diseases: Alphabetic Index, while HCFA has lead responsibility for the ICD-9-CM procedure codes included in [[Page 46175]] Volume 3--Procedures: Tabular List and Alphabetic Index. The Committee encourages participation in the above process by health-related organizations. In this regard, the Committee holds public meetings for discussion of educational issues and proposed coding changes. These meetings provide an opportunity for representatives of recognized organizations in the coding field, such as the American Health Information Management Association (AHIMA) (formerly American Medical Record Association (AMRA)), the American Hospital Association (AHA), and various physician specialty groups as well as physicians, medical record administrators, health information management professionals, and other members of the public to contribute ideas on coding matters. After considering the opinions expressed at the public meetings and in writing, the Committee formulates recommendations, which then must be approved by the agencies. The Committee presented proposals for coding changes at public meetings held on May 5 and November 30, 1995, and finalized the coding changes after consideration of comments received at the meetings and in writing within 30 days following the November 1995 meeting. The initial meeting for consideration of coding issues for implementation in FY 1998 was held on June 6, 1996. Copies of the minutes of these meetings may be obtained by writing to one of the co-chairpersons representing NCHS and HCFA. We encourage commenters to address suggestions on coding issues involving diagnosis codes to: Donna Pickett, Co-Chairperson; ICD-9-CM Coordination and Maintenance Committee; NCHS; Room 1100; 6525 Belcrest Road; Hyattsville, Maryland 20782. Comments may be sent by E- mail to: dfp4@nch11a.em.cdc.gov. Questions and comments concerning the procedure codes should be addressed to: Patricia E. Brooks, Co-Chairperson; ICD-9-CM Coordination and Maintenance Committee; HCFA, Office of Hospital Policy; Division of Prospective Payment System; C5-06-27; 7500 Security Boulevard; Baltimore, Maryland 21244-1850. Comments may be sent by E-mail to: pbrooks@hcfa.gov. The ICD-9-CM codes changes that have been approved will become effective October 1, 1996. The new ICD-9-CM codes are listed, along with their DRG classifications, in Tables 6a and 6b (New Diagnosis Codes and New Procedure Codes, respectively) in section V of the addendum to this final rule. As we stated above, the code numbers and their titles were presented for public comment in the ICD-9-CM Coordination and Maintenance Committee meetings. Both oral and written comments were considered before the codes were approved. Further, the Committee has approved the expansion of certain ICD-9- CM codes to require an additional digit for valid code assignment. Diagnosis codes that have been replaced by expanded codes, and other codes, or have been deleted, are in Table 6c (Invalid Diagnosis Codes). The procedure codes that have been replaced by expanded codes or have been deleted are in Table 6d (Invalid Procedure Codes). These invalid diagnosis and procedure codes will not be recognized by the GROUPER beginning with discharges occurring on or after October 1, 1996. The corresponding new or expanded codes are included in Tables 6a and 6b. Revisions to diagnosis and procedure code titles are in Tables 6e (Revised Diagnosis Code Titles) and 6f (Revised Procedure Code Titles), which also include the DRG assignments for these revised codes. Based on the comments received and our own review, we have corrected a code title and added omitted secondary DRG assignments to several codes in Tables 6a and 6b. The code title corrected is 995.59, Other child abuse and neglect. The codes for which DRG changes have been made are as follows: <bullet> In Table 6a, MDC 15 and DRG 391 were added to 752.51 and 752.52 because they are considered "major problems" in this DRG; 922.31, 922.32, and 922.33 were modified to add MDC 24 and DRGs 484, 485, 486, and 487; and MDC 15 and DRGs 387 and 389 were added to 998.11, 998.12, 998.13, 998.51 and 998.59 because they are considered "major problems" in these DRGs. <bullet> In Table 6b, DRG 303 was added to code 59.03. Comment: One commenter supported the creation of new procedure codes for partial cholecystectomies; however, the commenter disagreed with their assignment to DRGs 193 and 194 (Biliary Tract Procedures except only Cholecystectomy with or without C.D.E.). The commenter believes that partial cholecystectomy (code 51.21) is similar to cholecystectomy (code 51.22) and laparoscopic partial cholecystectomy (51.23) is similar to laparoscopic cholecystectomy (51.24). Therefore, procedure codes 51.21 and 51.23 should be assigned to the same DRGs as 51.22 and 51.24, respectively. Response: We agree with the commenter. Partial cholecystectomies are clinically similar to cholecystectomies and laparoscopic partial cholecystectomies are clinically similar to laparoscopic cholecystectomies, as well as being similar in terms of resource use. Therefore, we have revised Table 6b to indicate that procedure code 51.21 is assigned to DRGs 195 and 196 (Cholecystectomy with C.D.E.) and DRGs 197 and 198 (Cholecystectomy except by Laparoscope) and 51.23 is assigned to DRGs 195 and 196 and DRGs 493 and 494 (Laparoscopic Cholecystectomy). Comment: We received one comment on modifications made to the ICD- 9-CM codes involving psychiatric diagnoses. The commenter had participated in the ICD-9-CM Coordination and Maintenance Committee meetings and had submitted written proposals for revisions. The commenter stated that although the proposed rule listed all final code revisions, it did not explain the final action on specific proposals or why that action was taken. The commenter suggested that this information be included in the final rule. The commenter also objected to changing the title of category V61.1 from "Marital Problems" to "Counseling for Marital and Partner Problems" because it narrows the use of the category. Response: The National Center for Health Statistics (NCHS) has the lead responsibility for maintaining the diagnosis part of ICD-9-CM. As explained above, after receiving comments at the public meetings held by the Coordination and Maintenance Committee and reviewing subsequent written comments, NCHS proposes final revisions to ICD-9-CM diagnosis codes. These revisions are then jointly approved by NCHS and HCFA. The purpose of printing the final codes in the Federal Register is simply to notify the public and solicit comment on the proposed DRG classifications. We recommend that the commenter, or any other interested party, contact NCHS directly to discuss the final codes. If further revisions are sought, then these can be handled through future meetings of the Coordination and Maintenance Committee. We will forward the commenter's concerns on category V61.1 to NCHS for review. Comment: One commenter supported the ICD-9-CM code revisions for October 1, 1996, but suggested that rules relating to the sequencing of the new code V66.7, Encounter for palliative care, should be developed prior to its use beginning on October 1, 1996. Response: We agree with the commenter that medical records technicians and administrators will [[Page 46176]] need advice on coding this diagnosis. Specific directions in the form of a note within the tabular section of the ICD-9-CM will direct the coder to "code first underlying disease" when coding V66.7. The NCHS has also developed an extensive set of V code guidelines that will also clarify that V66.7 should be sequenced second. In addition, AHA routinely includes advice on the use of new and modified codes in the fourth quarter issue of their publication, Coding Clinic for ICD-9-CM Coding. This year's issue will clarify that V66.7 will be used only as a secondary diagnosis. The coding advice in Coding Clinic is a collaborative effort among HCFA, NCHS, AHA, and AHIMA. Information on ordering Coding Clinic can be obtained from the following: American Hospital Association, Central Office on ICD-9-CM, One North Franklin, Chicago, IL 60606, (312) 422-3366. Comment: Although the Committee made no revisions to the pacemaker codes, a commenter noted that there have been advances in pacemaker technology that may have an effect on coding and DRG classification. One new pacemaker device functions as a dual-chamber pacemaker (procedure code 37.83) but has only a single lead (procedure code 37.71 or 37.73). If these pairs of codes are reported on a claim, the case is assigned to a medical DRG rather than DRG 115 or 116 (Permanent Cardiac Pacemaker Implant). Response: This coding issue was addressed recently by the Editorial Advisory Board of the Coding Clinic for ICD-9-CM. After consultation with the manufacturer of the new pacemaker device, the Board decided that, although this pacemaker has a single lead, it functions as dual electrodes. Therefore, the insertion of this pacemaker should be coded with procedure codes 37.83 and 37.72 (dual lead insertion). If a hospital follows this coding advice, the case will be classified to DRG 115 or 116. This advice will be included in an upcoming issue of Coding Clinic. We will monitor this situation to determine if hospitals are following this coding advice or if a change in the DRG software is necessary. C. Recalibration of DRG Weights We used the same basic methodology for the FY 1997 recalibration as we did for FY 1996. (See the September 1, 1995 final rule (60 FR 45791).) That is, we recalibrated the weights based on charge data for Medicare discharges. However, we used the most current charge information available, the FY 1995 MedPAR file, rather than the FY 1994 MedPAR file. The MedPAR file is based on fully-coded diagnostic and surgical procedure data for all Medicare inpatient hospital bills. The recalibrated DRG relative weights are constructed from FY 1995 MedPAR data, based on bills received by HCFA through June 1996, from all hospitals subject to the prospective payment system and short-term acute care hospitals in waiver States. The FY 1995 MedPAR file includes data for approximately 11.1 million Medicare discharges. The methodology used to calculate the DRG relative weights from the FY 1995 MedPAR file is as follows: <bullet> All the claims were regrouped using the final DRG classification revisions discussed above in section II.B of this preamble. <bullet> Charges were standardized to remove the effects of differences in area wage levels, indirect medical education costs, disproportionate share payments, and for hospitals in Alaska and Hawaii, the applicable cost-of-living adjustment. <bullet> The average standardized charge per DRG was calculated by summing the standardized charges for all cases in the DRG and dividing that amount by the number of cases classified in the DRG. <bullet> We then eliminated statistical outliers, using the same criteria as were used in computing the current weights. That is, we eliminated all cases that are outside of 3.0 standard deviations from the mean of the log distribution of both the charges per case and the charges per day for each DRG. <bullet> The average charge for each DRG was then recomputed (excluding the statistical outliers) and divided by the national average standardized charge per case to determine the relative weight. A transfer case is counted as a fraction of a case based on the ratio of its length of stay to the geometric mean length of stay of the cases assigned to the DRG. That is, a 5-day length of stay transfer case assigned to a DRG with a geometric mean length of stay of 10 days is counted as 0.5 of a total case. <bullet> We established the relative weight for heart and heart- lung, liver, and lung transplants (DRGs 103, 480, and 495) in a manner consistent with the methodology for all other DRGs except that the transplant cases that were used to establish the weights were limited to those Medicare-approved heart, heart-lung, liver, and lung transplant centers that have cases in the FY 1995 MedPAR file. (Medicare coverage for heart, heart-lung, liver, and lung transplants is limited to those facilities that have received approval from HCFA as transplant centers.) <bullet> Acquisition cost for kidney, heart, heart-lung, liver, and lung transplants continue to be paid on a reasonable cost basis. Unlike other excluded costs, the acquisition costs are concentrated in specific DRGs (DRG 302 (Kidney Transplant); DRG 103 (Heart Transplant for heart and heart-lung transplants); DRG 480 (Liver Transplant); and DRG 495 (Lung Transplant)). Because these costs are paid separately from the prospective payment rate, it is necessary to make an adjustment to prevent the relative weights for these DRGs from including the effect of the acquisition costs. Therefore, we subtracted the acquisition charges from the total charges on each transplant bill that showed acquisition charges before computing the average charge for the DRG and before eliminating statistical outliers. When we recalibrated the DRG weights for previous years, we set a threshold of 10 cases as the minimum number of cases required to compute a reasonable weight. We proposed to use that same case threshold in recalibrating the DRG weights for FY 1997. For this final rule, using the June 1996 FY 1995 MedPAR data set, there are 37 DRGs that contain fewer than 10 cases. We computed the weights for the 37 low-volume DRGs by adjusting the FY 1996 weights of these DRGs by the percentage change in the average weight of the cases in the other DRGs. We note that the FY 1996 weights for the low-volume DRGs were recalculated based on non-Medicare data we acquired from 19 States. This was the first update of the weights since they were initially calculated for FY 1984 based on data from Maryland and Michigan. For a complete description of this process, see the September 1, 1995 final rule (60 FR 45781). The weights developed according to the methodology described above, using the DRG classification changes, result in an average case weight that is different from the average case weight before recalibration. Therefore, the new weights are normalized by an adjustment factor, so that the average case weight after recalibration is equal to the average case weight before recalibration. This adjustment is intended to ensure that recalibration by itself neither increases nor decreases total payments under the prospective payment system. Section 1886(d)(4)(C)(iii) of the Act requires that beginning with FY 1991, reclassification and recalibration changes be made in a manner that assures that the aggregate payments are neither greater than nor less than the aggregate payments that would have been made without the changes. Although normalization is intended to [[Page 46177]] achieve this effect, equating the average case weight after recalibration to the average case weight before recalibration does not necessarily achieve budget neutrality with respect to aggregate payments to hospitals because payment to hospitals is affected by factors other than average case weight. Therefore, as we have done in past years and as discussed in section II.A.4.b. of the addendum to this final rule, we are making a budget neutrality adjustment to assure that the requirement of section 1886(d)(4)(C)(iii) of the Act is met. Go to Top III. Changes to the Hospital Wage Index A. Background Section 1886(d)(3)(E) of the Act requires that, as part of the methodology for determining prospective payments to hospitals, the Secretary must adjust the standardized amounts "for area differences in hospital wage levels by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital compared to the national average hospital wage level." In accordance with the broad discretion conferred by this provision, we currently define hospital labor market areas based on the definitions of Metropolitan Statistical Areas (MSAs) (and New England County Metropolitan Areas), issued by the Office of Management and Budget (OMB). In addition, as discussed below, we adjust the wage index to take into account the geographic reclassification of hospitals in accordance with sections 1886(d)(8)(B) and 1886(d)(10) of the Act. Section 1886(d)(3)(E) of the Act requires that the wage index be updated annually beginning October 1, 1993. Furthermore, this section provides that the Secretary base the update on a survey of wages and wage-related costs of short-term, acute care hospitals. The survey should measure, to the extent feasible, the earnings and paid hours of employment by occupational category, and must exclude the wages and wage-related costs incurred in furnishing skilled nursing services. B. FY 1997 Wage Index Update The final FY 1997 wage index (effective for hospital discharges occurring on or after October 1, 1996 and before October 1, 1997) is based on the data collected from the Medicare cost reports submitted by hospitals for cost reporting periods beginning in FY 1993 (the FY 1996 wage index is based on FY 1992 wage data). We used the same categories of data that were used in the FY 1996 wage index. Therefore, the FY 1997 wage index reflects the following: <bullet> Total salaries and hours from short-term, acute care hospitals. <bullet> Home office costs and hours. <bullet> Fringe benefits associated with hospital and home office salaries. <bullet> Direct patient care contract labor costs and hours. <bullet> The exclusion of salaries and hours for nonhospital type services such as skilled nursing facility services, home health services, or other subprovider components that are not subject to the prospective payment system. Finally, we are making a minor revision to Sec. 412.63(s)(1) to state clearly that we update the wage index annually as required by section 1886(d)(3)(E) of the Act. Although we did not propose any changes in the reporting of hospital wage index data, we received comments regarding our current policies. (Comments specifically related to our policy on contract labor are addressed below in section III.D of this preamble.) Comment: We received several comments concerning the treatment of Medicare Part A physician salaries in the wage index calculation. One commenter stated that we should immediately exclude all of these costs, using Worksheet A-8-2 of the Medicare cost report to identify physician Part A costs. Alternatively, the commenter suggested that we should include contracted Part A physician salaries in those States where hospitals are prohibited from employing physicians. Two other commenters suggested we should prepare an impact analysis of the effects of the exclusion of Part A physician salaries. Response: As stated in the September 1, 1994 final rule (59 FR 45355), effective with cost reporting periods beginning on or after October 1, 1994, we revised the Medicare cost report to provide for the separate reporting of all salary costs for physicians (including teaching physicians), interns and residents, and certified registered nurse anesthetists. After evaluating these data, we will consider appropriate changes in developing the FY 1999 wage index update. In response to the suggestion that we should use Worksheet A-8-2 to expedite our evaluation of excluding physician Part A salaries, we will explore the technical feasibility of using the data from that worksheet. Regarding the suggestion that we should allow contracted Part A physician salaries to be included in the wage index calculation in those States that do not allow hospitals to employ physicians directly, we note that, if we were to adopt such a policy it would not be effective until hospitals' FY 1997 cost reporting periods. Therefore, the data would not be available until the FY 2001 wage index. Because we are already collecting data that would allow us to exclude all physician Part A salaries by the FY 1999 wage index, we are not adopting this comment. With respect to the comments that we should prepare an analysis of the impact on the wage index of excluding Part A physician salaries, any such analysis is, of course, contingent upon having reliable data to analyze. At this point, we do not foresee having such data prior to the availability of hospitals' FY 1995 cost reports. Comment: A commenter stated that the wage index value of rural hospitals with swing-bed programs is unfairly deflated by the inclusion of the lower salaries related to skilled nursing level care provided to patients in swing-beds. The commenter indicated that since hospitals can separately identify these salaries, they should be excluded from total salaries to be consistent with the way salaries are reported for hospitals without a swing-bed program. Response: Salaries related to skilled nursing level care provided to patients in swing-beds are not reported separately on the Medicare cost report. Salary costs for swing-beds are combined with those for general adult and pediatric care on the cost report at line 25 of Worksheet A. Therefore, it would not be possible under the current cost report format to remove from the wage index calculation these costs as we do for direct salaries associated with distinct part skilled nursing facilities and units. Furthermore, given the nature of the swing-bed program, we do not believe it would be appropriate to impose on hospitals the additional recordkeeping requirements that would be necessary to report these salaries. 1. Verification of Wage Data from the Medicare Cost Report The data for the FY 1997 wage index were obtained from Worksheet S- 3, Part II of the Medicare cost report. The data file used to construct the wage index includes FY 1993 data submitted to the Hospital Cost Report Information System (HCRIS). As in past years, we performed an intensive review of the wage data, mostly through the use of edits designed to identify aberrant data. In the proposed rule, we discussed in detail our review of the wage data as well as the process that hospitals could use to verify their wage data and submit requests for corrections if necessary (61 FR 27455). To be reflected in the final wage index, wage data corrections had [[Page 46178]] to be reviewed, verified, and transmitted to HCFA through HCRIS by June 17, 1996 (any changes after this date are limited to errors related to handling the data, as described below in section III.C of this preamble). All data elements that failed edits have been resolved and are reflected in this final rule. 2. Computation of the Wage Index As noted above, we are basing the FY 1997 wage index on wage data reported on the FY 1993 cost reports. The final wage index is based on data from 5,231 hospitals paid under the prospective payment system and short-term acute care hospitals in waiver States. The method used to compute the final wage index is as follows: Step 1--We gathered data from each of the non-Federal short-term, acute care hospitals for which data were reported on the Worksheet S-3, Part II of the Medicare cost report for the hospital's cost reporting periods beginning on or after October 1, 1992 and before October 1, 1993. In addition, we included data from a few hospitals that had cost reporting periods beginning in September 1992 and reported a cost reporting period exceeding 52 weeks. The data were included because no other data from these hospitals would be available for the cost reporting period described above, and particular labor market areas might be affected due to the omission of these hospitals. However, we generally describe these wage data as FY 1993 data. Step 2--For each hospital, we subtracted the excluded salaries (that is, direct salaries attributable to skilled nursing facility services, home health services, and other subprovider components not subject to the prospective payment system) from gross hospital salaries to determine net hospital salaries. To determine total salaries plus fringe benefits, we added direct patient care contract labor costs, hospital fringe benefits, and any home office salaries and fringe benefits reported by the hospital, to the net hospital salaries. Step 3--For each hospital, we adjusted the total salaries plus fringe benefits resulting from Step 2 to a common period to determine total adjusted wages. To make the wage inflation adjustment, we used the percentage change in average hourly earnings for each 30-day increment from October 14, 1992 through September 15, 1994, for hospital industry workers from Standard Industry Classification 806, Bureau of Labor Statistics Employment and Earnings Bulletin. The annual inflation rates used were 4.8 percent for FY 1992, 3.6 percent for FY 1993, and 2.7 percent for FY 1994. The inflation factors used to inflate the hospital's data were based on the midpoint of the cost reporting period as indicated below. Midpoint of Cost Reporting Period ------------------------------------------------------------------------ After Before Adjustment factor ------------------------------------------------------------------------ 10/14/92............... 11/15/92............... 1.044482 11/14/92............... 12/15/92............... 1.041408 12/14/92............... 01/15/93............... 1.038343 01/14/93............... 02/15/93............... 1.035287 02/14/93............... 03/15/93............... 1.032240 03/14/93............... 04/15/93............... 1.029203 04/14/93............... 05/15/93............... 1.026174 05/14/93............... 06/15/93............... 1.023154 06/14/93............... 07/15/93............... 1.020143 07/14/93............... 08/15/93............... 1.017141 08/14/93............... 09/15/93............... 1.014147 09/14/93............... 10/15/93............... 1.011163 10/14/93............... 11/15/93............... 1.008920 11/14/93............... 12/15/93............... 1.006683 12/14/93............... 01/15/94............... 1.004450 01/14/94............... 02/15/94............... 1.002223 02/14/94............... 03/15/94............... 1.000000 03/14/94............... 04/15/94............... 0.997782 04/14/94............... 05/15/94............... 0.995570 05/14/94............... 06/15/94............... 0.993362 06/14/94............... 07/15/94............... 0.991159 07/14/94............... 08/15/94............... 0.988961 08/14/94............... 09/15/94............... 0.986767 ------------------------------------------------------------------------ For example, the midpoint of a cost reporting period beginning January 1, 1993 and ending December 31, 1993 is June 30, 1993. An inflation adjustment factor of 1.020143 would be applied to the wages of a hospital with such a cost reporting period. In addition, for the data for any cost reporting period that began in FY 1993 and covers a period of less than 360 days or greater than 370 days, we annualized the data to reflect a 1-year cost report. Annualization is accomplished by dividing the data by the number of days in the cost report and then multiplying the results by 365. Step 4--For each hospital, we subtracted the reported excluded hours from the gross hospital hours to determine net hospital hours. We increased the net hours by the addition of any direct patient care contract labor hours and home office hours to determine total hours. Step 5--As part of our editing process, we deleted data for eight hospitals for which we lacked sufficient documentation to verify data that failed edits because the hospitals are no longer participating in the Medicare program or are in bankruptcy status. We retained the data for other hospitals that are no longer participating in the Medicare program because these hospitals reflected the relative wage levels in their labor market areas during their FY 1993 cost reporting period. Step 6--Each hospital was assigned to its appropriate urban or rural labor market area prior to any reclassifications under sections 1886(d)(8)(B) or 1886(d)(10) of the Act. Within each urban or rural labor market area, we added the total adjusted wages obtained in Step 3 for all hospitals in that area to determine the total adjusted wages for the labor market area. Step 7--We divided the total adjusted wages obtained in Step 6 by the sum of the total hours (from Step 4) for all hospitals in each labor market area to determine an average hourly wage for the area. Step 8--We added the total adjusted wages obtained in Step 3 for all hospitals in the nation and then divided the sum by the national sum of total hours from Step 4 to arrive at a national average hourly wage. Using the data as described above, the national average hourly wage is $19.5533. Step 9--For each urban or rural labor market area, we calculated the hospital wage index value by dividing the area average hourly wage obtained in Step 7 by the national average hourly wage computed in Step 8. We note that on June 28, 1996, OMB announced the designation of the Pocatello, Idaho MSA comprising Bannock County, Idaho and the Jonesboro, Arkansas MSA comprising Craighead County, Arkansas and the addition of Chester County, Tennessee to the Jackson, Tennessee MSA. These changes are reflected in the final wage index. 3. Revisions to the Wage Index Based on Hospital Redesignation Under section 1886(d)(8)(B) of the Act, hospitals in certain rural counties adjacent to one or more MSAs are considered to be located in one of the adjacent MSAs if certain standards are met. Under section 1886(d)(10) of the Act, the Medicare Geographic Classification Review Board (MGCRB) considers applications by hospitals for geographic reclassification for purposes of payment under the prospective payment system. The methodology for determining the wage index values for redesignated hospitals is applied jointly to the hospitals located in those rural counties that were deemed urban under section 1886(d)(8)(B) of the Act and those hospitals that were reclassified as a result of the MGCRB decisions under section 1886(d)(10) of the Act. Section 1886(d)(8)(C) of the Act provides that the application of the wage index to redesignated hospitals is dependent on the hypothetical impact that the wage data from these hospitals would have on [[Page 46179]] the wage index value for the area to which they have been redesignated. Therefore, as provided in section 1886(d)(8)(C) of the Act, the wage index values were determined by considering the following: <bullet> If including the wage data for the redesignated hospitals reduces the MSA wage index value by 1 percentage point or less, the MSA wage index value determined exclusive of the wage data for the redesignated hospitals applies to the redesignated hospitals. <bullet> If including the wage data for the redesignated hospitals reduces the wage index value for the area to which the hospitals are redesignated by more than 1 percentage point, the hospitals that are redesignated are subject to the wage index value of the area that results from including the wage data of the redesignated hospitals (the "combined" wage index value). However, the wage index value for the redesignated hospitals cannot be reduced below the wage index value for the rural areas of the State in which the hospitals are located. <bullet> If including the wage data for the redesignated hospitals increases the MSA wage index value, the MSA and the redesignated hospitals receive the combined wage index value. <bullet> Rural areas whose wage index values would be reduced by excluding the data for hospitals that have been redesignated to another area continue to have their wage index calculated as if no redesignation had occurred. Those rural areas whose wage index values increase as a result of excluding the wage data for the hospitals that have been redesignated to another area have their wage indexes calculated exclusive of the redesignated hospitals. <bullet> The wage index value for an urban area is calculated exclusive of the wage data for hospitals that have been reclassified to another area. However, geographic reclassification may not reduce the wage index for an urban area below the Statewide rural average, provided the wage index prior to reclassification was greater than the Statewide rural wage index value. <bullet> A change in classification of hospitals from one area to another may not result in the reduction in the wage index for any urban area whose wage index is below the rural wage index for the State. This provision also applies to any urban area that encompasses an entire State. We note that, except for those rural areas where redesignation would reduce the rural wage index value, and those urban areas whose wage index values are already below the rural wage index and would be reduced by redesignations, the wage index value for each area is computed exclusive of the data for hospitals that have been redesignated from the area for purposes of their wage index. As a result, several MSAs listed in Table 4a have no hospitals remaining in the MSA. This is because all the hospitals originally in these MSAs have been reclassified to another area by the MGCRB. These areas receive the prereclassified wage index value. The prereclassified wage index value will apply as long as the MSA remains empty. The final wage index values for FY 1997 are shown in Tables 4a, 4b, and 4c in the Addendum to this final rule. The FY 1997 wage index values incorporate all hospital redesignations for FY 1997, withdrawals of requests for reclassification, wage index corrections, appeals, and the Administrator's review process. For FY 1997, 385 hospitals are redesignated for purposes of the wage index (hospitals redesignated under section 1886(d)(8)(B) or 1886(d)(10) of the Act). For hospitals that are redesignated, the wage index values are shown in Table 4c. For some areas, Table 4c shows more than one wage index value. This occurs when hospitals from more than one State are included in the group of redesignated hospitals, and one State has a higher Statewide rural wage index value than the wage index value otherwise applicable to the redesignated hospitals. Tables 4d and 4e list the average hourly wage for each labor market area, prior to the redesignation of hospitals, based on the FY 1993 wage data. In addition, Table 3C in the addendum to this final rule includes the adjusted average hourly wage for each hospital based on the FY 1993 data. Hospitals should use the average hourly wage published in this final rule in applying to the MGCRB for wage index reclassifications that would be effective for FY 1998. The MGCRB will use the average hourly wage published in the final rule to evaluate a hospital's application for reclassification, unless that average hourly wage is later revised in accordance with the wage data correction policy described in Sec. 412.63(s)(2). In such cases, the MGCRB will use the most recent revised data used for purposes of the hospital wage index. C. Requests for Wage Data Corrections In the proposed rule, we noted that we would make a diskette available in mid-August that contained the wage data used to construct the wage index values in this final rule. As with the diskette made available in March 1996, HCFA made the August diskette available to hospital associations and the public. (Please note that this data file is also available on HCFA's World-Wide Web page, public use files address (http://www.hcfa.gov/stats/stats.html).) This file is made available only for the purpose of identifying any potential errors made by HCFA or the intermediary in the handling of the final wage data that result from the process described above, not for the initiation of new wage data correction requests. In addition, as noted above, Table 3C in the Addendum to this final rule contains each hospital's adjusted average hourly wage used to construct the wage index values. A hospital can verify its average hourly wage as reflected on its cost report (after taking into account any adjustments made by the intermediary), by dividing the adjusted average hourly wage in Table 3C by the applicable wage inflation adjustment factors as set forth above in Step 3 of the computation of the wage index. As noted in the proposed rule, after mid-August, we will make changes to the hospital wage data only in those very limited situations involving an error by the intermediary or HCFA that the hospital could not have known about before its review of the August diskette. Specifically, after that point, neither the intermediary nor HCFA will accept the following types of requests in conjunction with this process: <bullet> Requests for wage data corrections that were submitted too late to be included in the data transmitted to the HCRIS system on or before June 17, 1996. <bullet> Requests for correction of errors made by the hospital that were not, but could have been, identified during the hospital's review of the March 1996 data. <bullet> Requests to revisit factual determinations or policy interpretations made by the intermediary or HCFA during the wage data correction process. If, after reviewing the data in the August diskette or this final rule, a hospital believes that its wage data are incorrect due to a fiscal intermediary or HCFA error in the entry or tabulation of the final wage data, it should send a letter to both its fiscal intermediary and HCFA. The letters should outline why the hospital believes an error exists and provide all supporting information. These requests must be received by HCFA and the intermediaries no later than September 16, 1996. We have set this year's deadline one week earlier than last year's deadline because we found the later deadline made it difficult to evaluate the requests and recalculate the wage index values before [[Page 46180]] the start of FY 1997 (that is, October 1, 1996). Requests sent to HCFA should be sent to: Health Care Financing Administration, Office of Hospital Policy, Attention: Stephen Phillips, Technical Advisor, Division of Prospective Payment System; C5-06-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Each request must also be sent to the hospital's fiscal intermediary. The intermediary will review requests upon receipt, and, if it is determined that an intermediary or HCFA error exists, the fiscal intermediary will notify HCFA immediately. We believe the wage data correction process described above and in the proposed rule provides hospitals with sufficient opportunity to bring errors made during the preparation of the Worksheet S-3 to the intermediary's attention. Moreover, because hospitals had access to the wage data in mid-August, they will have had the opportunity to detect any data entry or tabulation errors made by the intermediary or HCFA before the implementation of the FY 1997 wage index on October 1, 1996. If hospitals avail themselves of this opportunity, the wage index implemented on October 1 should be free of such errors. Nevertheless, in the unlikely event that such errors should occur, we retain the right to make midyear changes to the wage index under very limited circumstances. Specifically, in accordance with Sec. 412.63(s)(2), we may make midyear corrections to the wage index only in those limited circumstances where a hospital can show: (1) That the intermediary or HCFA made an error in tabulating its data, and (2) that the hospital could not have known about the error, or did not have an opportunity to correct the error, before the beginning of FY 1997 (that is, by the September 16, 1996 deadline). As indicated earlier, since a hospital will have had the opportunity to verify its data, and the intermediary will notify the hospital of any changes, we do not foresee any specific circumstances under which midyear corrections would be made. However, should a midyear correction be necessary, the wage index change for the affected area will be effective prospectively from the date the correction is made. Comment: One commenter commended us for making the wage data file available on the HCFA home page. The commenter also suggested that the file be updated frequently and include such additional information as the MSA name where the hospital is located, the applicable inflation adjustment factors, and the MSA to which each hospital has been reclassified by the MGCRB, if applicable. Response: The wage data file is currently updated twice a year, in mid-March and mid-August, in conjunction with the issuances of the proposed and final rules for the hospital inpatient prospective payment systems. This effort is very labor intensive, and since hospitals are able to submit cost reports throughout the year, it is impractical to update the wage data file more frequently. In addition, we would point out that the intent of making these data available is primarily to provide hospitals the opportunity to verify the data used in the calculation of their wage index. Updating this file more frequently is not necessary to fulfill this primary objective. Regarding the suggestion to include additional information on the wage data file that we make available to the public, we note that the suggested data elements are not necessary for the purpose of allowing an opportunity for providers to verify the accuracy of their wage data. We note that we publish the MSA names and inflation adjustment factors in the proposed and final rules, and the MSAs to which hospitals are reclassified can be found on the PPS Payment Impact Public Use File, available shortly after publication of the proposed and final rules. D. Contract Labor--Costs Included in the Hospital Wage Index Our policy concerning inclusion of contract labor costs for purposes of calculating the wage index has evolved over the past several years. Primarily, this has occurred as we recognized the role of contract labor in meeting special personnel needs of many hospitals. In addition, improvements in the wage data have allowed us to more accurately identify contract labor costs and hours. As a result, effective with the FY 1994 wage index, we included the costs of direct patient care contract services in the wage index calculation. Effective with the FY 1999 wage index, which will use data from FY 1995 cost reports, we will begin to include the costs and hours of certain management contract services. In the proposed rule, we provided a general overview of the issues related to including contract labor costs in the wage index calculation and solicited comments from the public regarding further expansion of the types of contract labor costs included in the wage index. We also listed nine specific issues on which we were seeking public comment. The following background material is identical to the overview included in the proposed rule, but we believe it is useful as a reference for responding to many of the comments we received. 1. Background In the May 9, 1990 proposed rule (55 FR 19442), we reported the results of the 1988 wage index survey which collected, among other information, data on the costs and hours associated with direct patient care contract labor. All prospective payment hospitals completed the wage survey for their cost reporting periods ending in calendar year 1988. The survey data indicated that hospitals had difficulty in tracking and recording the actual hours worked associated with the contract labor. In addition, there were reporting inconsistencies. For example, some hospitals inappropriately reported patient care services furnished directly by physicians, which are not included in the wage data because they are paid under Medicare Part B rather than Part A. In the May 9, 1990 proposed rule, we also discussed public comments we received in response to issues we raised related to including contract labor costs in the wage index. Specifically, in the May 8, 1989 proposed rule (54 FR 19647), we requested comment on the following issues: <bullet> Should the wage index include data on contract labor? <bullet> Should the definition of contract services in the wage index survey be expanded to include services indirectly related to patient care, such as billing or housekeeping services? A majority of the commenters supported the inclusion of contract services, and many argued for the expansion of contract labor services to include indirect patient care services. Those opposed to including contract services, in addition to some commenters who supported including contract service costs, were concerned about the difficulty of accurately tracking and recording hours worked for all types of contract labor. Other commenters were also concerned that if a hospital contracts for services from outside its labor market area, the contract wages could artificially increase or decrease the hospital's area wage index. Based on the comments and the overall poor quality of the 1988 survey data, we decided to exclude all contract labor from the FY 1991 wage index. We stated that we would continue our analysis of contract labor. In addition, we announced that we would develop a new wage index survey with improved [[Page 46181]] instructions and auditing criteria to facilitate the inclusion of contract labor in future wage index updates. The new survey, Worksheet S-3, Part II, was included in the hospital cost report effective with cost reporting periods beginning on or after October 1, 1989. The Worksheet S-3, Part II consists of detailed information for use in the hospital wage index including contract labor for direct patient care services. In the instructions for completing this worksheet, contract labor costs and hours were limited to labor-related payments and hours attributable to direct patient care contract services, such as nursing services. Specifically, we instructed hospitals to exclude indirect patient care contract services (for example, management and housekeeping services), nonlabor-related expenses (for example, equipment and supplies), and any contract services for which labor- related payments and hours could not be accurately determined. In the September 4, 1990 final rule (55 FR 36036), we discussed additional comments we received on the contract labor issue. Those commenters who supported the inclusion of contract labor stated that some hospitals, especially rural hospitals, are dependent on contract labor for nursing services, and it would be unfair not to include these wage data. Other commenters requested that the definition of contract labor be expanded to include indirect patient care services. We also received several comments requesting that we continue to exclude contract labor from the wage index. These commenters stated that the contract labor data are not reliable because of the difficulty in tracking and reporting hours and the lack of consistency in the reporting of contract labor. In addition, inclusion of nonlabor contract costs would inappropriately drive up labor costs, and contract labor brought in from outside the labor market area would artificially increase or decrease the area wage index value. Finally, commenters were concerned that contract labor costs are too variable, temporary, and not reflective of true wage costs. Therefore, some suggested that contract labor should not be included in the wage index. The FY 1994 wage index, which was based on the data collected on the Worksheet S-3, Part II, was the first to include direct patient care contract labor costs. In making the decision to include these costs, we analyzed hospitals' FY 1990 data to determine if it was sufficiently complete for inclusion in the wage index calculation (see the May 26, 1993 proposed rule (58 FR 30236)). We noted that, in most labor market areas, including contract labor in the wage index computation had little effect on the average hourly wage. We further stated that, based on our analysis of the data, including direct patient care contract labor would more accurately and fairly reflect wage levels across hospitals and MSAs. In the September 1, 1993 final rule, we also responded to comments from the hospital industry expressing concern that we did not recognize the costs of certain contract management services (58 FR 46296). In particular, many rural hospitals stated they were either unable to recruit or afford top managers such as hospital administrators and must contract for these services. In the September 1, 1994 final rule (59 FR 45355), we expanded the definition of contract labor for purposes of determining the hospital wage index to include the personnel costs and hours associated with certain contract management personnel. Contract management services would be limited to individuals working in the top four positions in the hospital: the Chief Executive Officer/Hospital Administrator, Chief Operating Officer, Chief Financial Officer, and Nursing Administrator. We noted that while exact titles may vary, individuals should be performing essentially the same duties as customarily assigned these management positions. We further noted that, since the cost report did not provide at that time for the collection of management contract data, this revised definition would not be effective until cost reporting periods beginning on or after October 1, 1994 (FY 1995). Hospitals were instructed to continue to exclude all management contract costs and hours until the FY 1995 data were reported (these data will be used to compute the FY 1999 wage index). In addition, we began requiring hospitals to provide descriptions and aggregate totals for all management contracts and complete details on all direct patient care contracts on the Form HCFA-339 (the Provider Cost Report Reimbursement Questionnaire). A hospital must file this form with its corresponding cost report. We continue to receive requests that we expand our contract labor definition to include more types of contract services in the wage index. In particular, we have been asked to include the costs for pharmacy and laboratory services on the basis that these services are consistent with our definition of direct patient care (see the September 1, 1995 final rule (60 FR 45792)). Others have asked that we expand our definition to include all contracted services, both direct and indirect patient care services, in order to more appropriately calculate relative hospital wage costs. We have limited the contract services that are included in the wage index to direct patient care services and specific management services for several reasons. First, hospitals reported difficulty in accurately tracking the hours associated with contract services, especially for off-site facilities that serve more than one hospital. Second, we are concerned about the contractor's ability to separate nonlabor costs from labor costs. We believe that the generally higher costs for contract labor compared to salaried labor, due at least in part to the added costs of overhead and supplies not separately identified in most contracts, may distort the wage index. Finally, we are concerned that it is difficult to remove the costs and hours for services such as legal and accounting from total management contracts. Our goal is to ensure that our wage index policy continues to be responsive to the changing need for contract labor, allowing those hospitals that must depend on contract labor to supply needed services to reflect those costs in their wage data. At the same time, however, we wish to avoid providing an opportunity for hospitals to inflate their average hourly wage inappropriately by including nonlabor contract costs. The advantage of our approach of including only contract labor costs and hours associated with direct patient care and specific management services is that it minimizes distortions in the wage index that are due to a hospital's inability to identify and exclude nonlabor costs. While changes to the wage index values are made in a budget neutral manner and are not expected to affect aggregate payments, we strive for policies that are equitable for all hospitals. Finally, due to the 4-year time lag between the cost reporting period itself and the fiscal year when data for that period are used in calculating the wage index, it is important that we anticipate any need to change our policy on contract labor. Therefore, in order to formulate the most responsive and responsible policy, we solicited comments on the following issues: <bullet> To what extent do hospitals rely on the use of contract services? <bullet> For which services are contracts typically used? <bullet> Can hospitals accurately determine hours related to contract services? <bullet> Can hospitals accurately isolate labor-related costs from nonlabor- related costs? <bullet> Should the contract labor definition be expanded to include contract [[Page 46182]] services indirectly related to patient care? <bullet> If contract labor remains limited to direct patient care, what categories of services, if any, in addition to those identified above, should be included? <bullet> Would the wage index more accurately reflect relative wage levels if we did not limit contract labor to direct patient care (generally high wage) services? <bullet> Would expanding the types of contract labor that are included in the wage index provide less incentive to hospitals to keep their labor costs low, as higher labor costs may result in a higher wage index value for that hospital or allow it to reclassify to a labor market with a higher wage index? <bullet> What other issues should be considered in revising the policy for including contract labor in the wage index? 2. Discussion of Comments We received 27 individual letters addressing the issue of contract labor in the wage index. We