[Federal Register: August 30, 2002 (Volume 67, Number 169)] [Rules and Regulations] [Page 56003-56052] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr30au02-22] [[pp. 56003-56052]] Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Implementation and FY 2003 Rates [[Continued from page 56002]] [[Page 56003]] for inappropriate discharges and readmittance exist for satellite LTCHs that are located within acute care hospitals, described in Sec. 412.22(h), as well as for distinct part SNFs co-located with LTCHs. (We address the particular issues of onsite discharges and readmittances in section X.G. (Sec. 412.532(d)) in this final rule.) We proposed that whether or not a LTCH patient who is discharged to an inpatient acute care hospital, an IRF, or a SNF and then returns to the same LTCH is treated as an interrupted stay (with one LTC-DRG payment) or as a new admission (with two separate LTC-DRG payments) depended on the patient's length of stay at the acute care hospital, IRF, or SNF compared to the arithmetic average length of stay and the standard deviation for the acute care hospital inpatient prospective payment system DRG, the IRF combination of the CMG and the comorbidity tier, or 45 days for all Medicare SNF cases. In the proposed rule, we specified in tables the arithmetic average length of stay and one standard deviation for each acute care hospital DRG and each IRF combination of the CMG and the comorbidity tier. (As noted above, this was not necessary for SNFs, as we used a set number of days for SNF stays in the proposed rule.) While the proposed interrupted stay policy under Sec. 412.531 was based in part on clinical considerations, we realized that it may be somewhat administratively burdensome for the LTCH to determine the DRG for the acute care hospital stay or the combination of the CMG and the comorbidity tier for the IRF stay, in order to determine whether or not a beneficiary who is discharged to an acute care hospital or an IRF and then returns to the LTCH would be an interrupted stay (with a single LTCH prospective payment system payment) or a new admission (with two separate LTCH prospective payment system payments). Therefore, we discussed in the proposed rule our intent to further analyze Medicare claims data to determine if we should consider treating all patients who are discharged to either an acute care hospital or an IRF and admitted back to the LTCH within a fixed number of days (as we had proposed for SNFs), regardless of the DRG of the patient in the acute care hospital or the combination of the CMG and the comorbidity tier of the patient in the IRF, as an interrupted stay. We indicated that 9 days for acute care hospitals and 27 days for IRFs might be appropriate thresholds to identify interrupted stay cases because, in both cases, the thresholds are one standard deviation from the average length of stay of all patients in those respective settings. We were aware that, under such a policy, less clinically complex brief acute care hospital and IRF stays would be included and would become an interrupted stay if the beneficiary returns to a LTCH. However, those types of cases would be offset by other stays that require more intensive and lengthy care. For this final rule, we have decided to treat all patients who are discharged to either an acute care hospital or an IRF and admitted back to the LTCH within a fixed period of time (as we did in the proposed rule for discharges to SNFs), regardless of the DRG or the combination CMG and comorbidity tier, as an interrupted stay. This decision will relieve the administrative burden on providers and eliminate the need to make claims billing system changes, as discussed in our responses to the first two public comments in this section. We believe that 9 days for acute care hospital stays and 27 days for IRF stays are appropriate thresholds to identify interrupted stay cases because, in both cases, the thresholds are one standard deviation from the average length of stay of all patients in those respective settings. We are retaining as final the proposed 45-day threshold for SNFs. Comment: Over half of the commenters objected to our proposed policy for determining the LTC-DRG payment for an interrupted stay (with a single LTCH prospective payment system payment) based on a number-of-day threshold that equals one standard deviation from the average length of stay for the DRG for the acute care hospital or the IRF combination of CMG and comorbidity tier for the IRF stay. The same commenters did not object to the proposed policy for SNFs, because it used a specified number of days (45) for all stays in a SNF for computing the period of interruption. The commenters believed that (1) the proposed methodology for acute care hospitals and IRF stays would be an extreme administrative burden on providers; (2) it would be difficult for LTCHs to determine assigned DRGs and CMGs and comorbidity tiers and length of stays (discharge and readmittance dates) during the interruption for these cases; and (3) the proposed policy would be too costly for both providers and intermediaries to implement within the Medicare claims billing and data systems. Some commenters believed there might be an issue of possible compromise of the Privacy Rule relating to disclosure of certain individually identifiable patient health information to certain entities under the provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Response: In the proposed rule, we acknowledged that it might be somewhat administratively burdensome to determine the DRG for the acute care hospital stay or the combination of the CMG and the comorbidity tier for the IRF stay in order to determine whether or not a beneficiary who is discharged to an acute care hospital or an IRF and then returns to the LTCH will be considered an interrupted stay (with a single LTCH prospective payment system payment) or a new admission (with two separate LTCH prospective payment system payments). For that reason, we solicited specific comments on an alternative methodology. We have further evaluated our proposal and agree that LTCHs might be unnecessarily burdened if they were required to determine the other facility's assigned DRGs and CMG and comordibity tiers for the interruption and that numerous changes would have to be made to the Medicare billing and data systems to implement the policy. As a result, we agree with the commenters that it is more feasible to implement the proposed alternative methodology for determining the LTC-DRG payment for interrupted stays based on a fixed day threshold for each provider level of care, as discussed in our response to the next comment. This policy change should relieve most of the administrative burden that the commenters were concerned with and eliminate the need to determine the DRGs and CMGs and comorbidity tiers assigned to the patient at the other facility. In response to the commenters' concern regarding HIPPA, even under the proposed rule, we do not believe privacy implications under HIPPA would have been implicated. Comment: In response to our request for alternatives to the proposed methodology for determining the interruption of stay threshold, commenters recommended several methodologies for assigning a fixed number of days of absences at each provider level for determining an interrupted stay. Specifically, some commenters agreed with our proposed alternatives of a 9-day threshold for acute care hospital stays, a 27-day threshold for IRF stays, and retention of the 45-day threshold for SNF stays. One commenter believed that the 45-day threshold for SNFs is too long. Other commenters recommended one of the following for all sites: (1) A 9-day threshold, regardless of the service codes or discharge setting; (2) a threshold range of 10 to 12 days or 11 days or less; or (3) a fixed threshold that [[Page 56004]] reflects the average length of stay of hospitalizations for all DRGs. Two commenters recommended not including any interrupted stay policies in the final rule. One commenter suggested that any positive or negative effects of the 9-day, 27-day, and 45-day thresholds on budget neutrality as set forth in the proposed rule be adjusted through the standard Federal payment amount. Response: After consideration of the public comments and our further analysis of MedPAR data, we are revising the proposed thresholds under our interrupted stay policy, as it relates to discharges to acute care hospitals and IRFs, to incorporate a fixed period of time. For this final rule, we have decided to treat all patients who are discharged to either an acute care hospital or an IRF and admitted back to the LTCH within a fixed period of time (as we did in the proposed rule for discharges to SNFs), regardless of the DRG or the combination CMG and comorbidity tier, as an interrupted stay. We believe that 9 days for acute care hospital stays and 27 days for IRF stays are appropriate thresholds to identify interrupted stay cases because, in both cases, the thresholds are set at one standard deviation from the average length of stay of all patients in those respective settings. We are retaining in the final rule the proposed 45-day threshold for SNFs. We do not agree with the commenter who stated that the 45-day threshold for SNFs is too long. A length of stay of 45 days is the average number of days plus one standard deviation for all SNF Medicare patients. In addition, we are not adopting the commenters' suggestion that we dispense with the interrupted stay policy because we believe this policy is an essential component of the LTCH prospective payment system, as explained elsewhere in this section. In response to the comment about the impact that any revised interrupted stay policy will have on the budget neutrality calculations, we wish to assure the commenter that the interrupted stay policy in this final rule is one of several policies that have been revised based on public comments and taken into consideration in developing the final standard Federal prospective payment rates for FY 2003. The recalibration of the prospective payment rates in this final rule based on those revisions will continue to satisfy the statutory requirement for budget neutrality. Comment: Some commenters believed the payment system should not penalize those providers who make clinically appropriate transfers. Four commenters indicated that, based on experience, the number of readmissions to LTCHs are minimal, especially from IRFs and SNFs, and questioned CMS data on interruptions of stays at LTCHs. These commenters objected to the proposed interrupted stay policy because they believed it would impose a significant burden solely to prevent certain questionable transfers that rightfully should be reviewed on an individual basis for appropriateness. Response: We proposed making one payment under the LTCH prospective payment system for an interrupted stay to preserve the integrity of the per discharge LTCH prospective payment system. We are not attempting to restrict a LTCH from pursuing necessary clinical care from another facility. However, we do not believe it is appropriate for the LTCH to receive a second payment for a patient if the patient returns to the LTCH to complete treatment already begun in the LTCH at the time of the earlier admission. Nowhere in the interrupted stay policy are we suggesting that the treatment at the secondary site would be unnecessary or clinically inadvisable. In addition, we believe that LTCHs, certified as acute care hospitals, should generally be able to handle nonsurgical urgent care needs. Therefore, the need to transfer should not arise as frequently as it might from a different provider. While we did not base this policy on specific data, and at this point we cannot quantify the number of readmissions to LTCHs, the interrupted stay policy is intended, in part, to reduce the incentives inherent in a discharge-based prospective payment system of ``shifting'' patients between Medicare-covered sites of care in order to maximize Medicare payments. We believe that payment under this policy is fair and is particularly appropriate for LTCHs since, by definition, the hospital treats patients with an average length of stay of greater than 25 days, and while payments are determined based on average lengths of stay, there may be an incentive for the LTCH to discharge the patient for part of that stay to another hospital. We believe we have eliminated the significant burden that the commenters were concerned with by revising the threshold criteria, as discussed earlier. Comment: A few commenters suggested that cases that are readmitted to the LTCH from another facility in less than the specified timeframe should be treated as separate cases under the LTCH prospective payment system if the second admission to the LTCH is unrelated to the primary reason for the initial admission. Response: As noted above, under the interrupted stay policy that we are adopting in this final rule, if the patient's length of stay away from the LTCH does not exceed the fixed day thresholds, the return to the LTCH is considered part of the first admission and will be paid as one admission. The situation the commenters describe is, and will continue to be, viewed as one stay. In section VIII. of this preamble, we provide details on patient classifications by DRG and highlight the fact that the principal diagnosis and secondary diagnoses form the basis upon which a LTC-DRG will be assigned for the entire stay. On the other hand, if the patient exceeds the total fixed day threshold outside of the LTCH at another facility before being readmitted, two separate LTC-DRG payments would be made, one based on the principal diagnosis for the first admittance and the other based on the principal diagnosis for the second admittance. If the principal diagnoses are the same for both admissions, the hospital could receive two similar payments. If the LTCH stay were not interrupted, the patient still could have developed other indications or complicating factors while in the LTCH. In this situation, grouping for the LTC-DRG would be based predominantly on the principal diagnosis, along with data from complicating secondary or additional diagnoses, any procedures, and age, gender, and discharge status as is done under the acute care hospital inpatient prospective payment DRG system. However, secondary diagnoses that have no bearing on the LTCH stay may be discarded by the GROUPER software when classifying cases for the purposes of determining payment. The presence of additional diagnoses does not automatically generate a comorbid or complicating condition for all DRGs, as explained in section IX.E. of this preamble relating to the ICD-9-CM coding system. In a situation of an interrupted stay or a stay that is not considered an interrupted stay, comorbidity could develop and the principal diagnosis would still be the factor most significantly affecting the DRG assignment. The acute care hospital inpatient prospective payment system, upon which we based the LTCH prospective payment system, treats one stay at an acute care facility similarly, where cases are classified into DRGs for payment based on the patient's principal diagnosis. Additional or secondary diagnoses may be recorded and may slightly influence DRG assignment for a case. However, the principal diagnosis, [[Page 56005]] with which the patient originally entered the acute care facility, is the dominant indicator for the DRG assignment. In addition, the typical LTCH patient has multiple, complex medical problems represented by several ICD-9-CM codes that will be listed on any one patient's claim. If we were to allow a new LTC-DRG assignment after an interrupted stay based solely upon whether one of these other conditions had increased in severity, it would not be difficult for the LTCH to select a different principal diagnosis following the patient's return to the LTCH. Medicare would then make two payments for what was, in reality, one single episode of treatment for the type of patient who is ideally suited for hospitalization in a LTCH, a very sick patient with multiple comorbidities. A DRG-based prospective payment system is designed to set payment at an average of hospital charges for all admittances of a particular type of diagnosis. This average should reflect more complex and costly cases along with cases that require less care. As cases are paid based on an average, some less resource intensive cases of the same diagnosis will receive the same payment as more resource intensive cases. Overall, under prospective payment systems, hospitals that are efficient will receive fair compensation. We believe that this payment system ultimately results in more equitable payments for LTCHs. Comment: One commenter questioned why there is not an interrupted stay policy for discharge and readmittance between one LTCH and another LTCH. Response: In our data, we did not find that transfers between LTCHs occurred frequently enough to require a separate policy. However, we will be monitoring LTCH behavior and if, in the future, we become aware of data that indicate that this activity is occurring, we would revisit this issue. Comment: One commenter questioned whether the following scenario would be considered an interrupted stay: a LTCH patient is discharged to an acute care hospital for 3 days, the acute care hospital then discharges the patient to a SNF for 43 days, and then the patient is readmitted to the LTCH. Response: In this final rule, the interrupted stay policy only encompasses situations where a patient is discharged from a LTCH to another facility and then readmitted directly from that one facility to the same LTCH. It does not address situations where the patient is admitted to more than one facility or goes home between LTCH stays. Our data did not show this situation to be a significant problem. Therefore, at this time we are not extending the interrupted stay policy to this situation. Currently, a patient admitted to a LTCH who is subsequently discharged to home or to at least two other facilities before readmission at the LTCH will be paid for as two admissions, and not be subject to the interrupted stay policy. However, we will continue to monitor LTCH readmissions and should the above example, where the LTCH patient has multiple short stays in several facilities before readmission, prove to be significant, we will consider proposing a change in policy. Comment: One commenter asked whether, for hospitals paid under the 5-year transition, an interrupted stay under the LTCH prospective payment system would still qualify as two discharges for TEFRA payment purposes. Response: As explained earlier in section VIII. of this preamble, we are implementing a 5-year transition period from reasonable cost- based reimbursement to fully Federal prospective payment for LTCHs. During this period, two payment percentages will be used to determine a LTCH's total payment. The blend percentages can be found in sections II.D. and X.N. of this final rule. The interrupted stay policy will apply to the portion of the blended percentage that represents the prospective payment Federal rate percentage. TEFRA policy on readmissions will apply to the portion of the blended percentage that represents the reasonable cost-based reimbursement percentage. Under TEFRA policy, each admission and discharge is counted separately as two discharges with no consideration given to the length of stay at another facility before readmission. However, there is one scenario when, even under the TEFRA payment policy, two discharges from a LTCH will be counted as one stay for payment purposes. There are specific TEFRA regulations governing readmission to excluded hospitals, such as LTCHs, with regard to hospitals-within-hospitals at Sec. 413.40(a)(3) (July 30, 1999, Federal Register, 64 FR 41535). During a cost reporting period, if the hospital-within-a-hospital discharges more than 5 percent of its inpatients to another co-located hospital, and those patients are directly readmitted to the excluded hospital, Medicare considers each patient's entire stay as one discharge for purposes of calculating the cost per discharge of the excluded hospital. This policy is still in effect for the TEFRA portion of the payment blend for long-term care hospitals-within-hospitals. (For more information on how a hospital- within-a-hospital would be paid under the LTCH prospective payment system, see section X.G. of this preamble, which outlines onsite discharge and readmission policy.) Therefore, other than this particular scenario for LTCHs that are hospitals-within-hospitals, for an episode of patient care that, under the LTCH prospective payment system, would be paid as an interrupted stay, the portion of payments under TEFRA paid to LTCHs during the transition period will continue to count separately for each discharge from the LTCH. Accordingly, based on the public comments received and our further analysis of Medicare claims data, in this final rule we are adopting the proposed interrupted stay policy as final with the following changes. We are revising the interrupted day threshold so that patients who are discharged from a LTCH to an acute care hospital and readmitted to the LTCH within a 9-day period of time will be considered as an interrupted stay and only a single LTCH prospective payment system payment will be made. To be considered an interrupted stay for patients who are discharged from the LTCH to an IRF and readmitted to the LTCH, the fixed day threshold is 27 days. We are retaining as final the proposed 45-day threshold for discharges from a LTCH to a SNF and readmission to the LTCH. Any readmissions to a LTCH from these three provider levels of care that are subsequently discharged from the LTCH that involve interruptions that are longer than these thresholds will be treated as new admissions and two separate LTCH prospective payments will be made. We wish to point out that an interrupted stay could occur during a regular inlier case (length of stay greater than five-sixths of the geometric average length of stay for the LTC-DRG), as described in section X.A. of this final rule. A short-stay outlier (as explained in section X.C. of this preamble) could also become an interrupted stay if the beneficiary is discharged to an acute care hospital, an IRF, or a SNF. Whether or not the beneficiary's stay would remain in this category depends on the total length of stay in the LTCH. Upon the initial discharge to the acute care hospital, the IRF, or the SNF, the LTCH ``day count'' would stop. For an interrupted stay case, this count is resumed upon readmission to the LTCH until the beneficiary's final discharge (home, another site of care, or death). Thus, the period of absence (number of days) that the beneficiary is a patient in [[Page 56006]] the acute care hospital, the IRF, or the SNF during a LTCH interrupted stay is not included in determining the length of stay of the LTCH stay. If the total number of days at the LTCH, from the initial admission to the final discharge, still falls into the short-stay outlier payment category, the LTCH receives payment according to the short-stay outlier policy described in section X.C. of this preamble. If, on the other hand, the total number of days in the LTCH exceeds five-sixths of the geometric average length of stay of the LTC-DRG (the short-stay outlier criteria), one full LTC-DRG payment is made for the case. Moreover, all applicable payment policies, including outliers and transfers for the acute care hospital inpatient prospective payment system and the IRF prospective payment system still apply under this policy. The following are examples of possible ways in which these policies would interact: Example 1: A beneficiary stays in the LTCH for 5 days and is discharged to an inpatient acute care hospital and the length of stay at the acute care hospital is greater than 9 days before being discharged and readmitted back to the LTCH. Medicare hospital payments for this beneficiary are as follows:One short-stay outlier LTCH prospective payment system payment to the LTCH for the first (5-day length of stay) LTCH discharge. Payment to the acute care hospital under the acute care hospital inpatient prospective payment system for the acute care stay. A separate LTCH prospective payment system payment either as a short-stay outlier (see Sec. 412.529) or regular inlier case (as described in section X.A.2. of this preamble), depending on the second LTCH length of stay. This case would not be an interrupted stay because the acute care hospital stay was greater than 9 days, which represents more days than one standard deviation from the average length of stay under the acute care hospital inpatient prospective payment system for all DRGs. Example 2: A beneficiary stays in the LTCH for 5 days and is discharged to an inpatient acute care hospital and the length of stay at the acute care hospital is a number of days that is 9 days or less before being discharged and readmitted back to the LTCH. The beneficiary remains in the LTCH for an additional 9 days after readmission to the LTCH following the acute care hospital stay. This case would be treated as an interrupted stay and Medicare hospital payments for this beneficiary would be as follows: Payment to the acute care hospital under the acute care hospital inpatient prospective payment system for the DRG for the acute care hospital stay. The stay was interrupted because the acute care hospital stay was 9 days or less. Therefore, a single payment will be made to the LTCH under the LTCH prospective payment system. This payment would be a short-stay outlier payment (under Sec. 412.529) if the total LTCH length of stay (14 days) is up to and including five-sixths of the geometric average length of stay of the LTC-DRG. If the total LTCH length of stay is greater than five-sixths of the geometric average length of stay of the LTC-DRG, then the LTCH would receive the full DRG payment. Example 3: A beneficiary stays in the LTCH for 5 days and is discharged to an IRF and the length of stay at the IRF is 27 days or less. The beneficiary is readmitted to the LTCH for an additional 12 days, so that the combined 17 days is greater than five-sixths of the geometric average length of stay for the LTC-DRG after readmission to the LTCH following the IRF stay. This case will be an interrupted stay and Medicare hospital payments for this beneficiary will be as follows: Payment to the IRF under the IRF prospective payment system for the combination of the CMG and the comorbidity tier for the IRF stay; and Since the stay was interrupted because the IRF stay was within one standard deviation from the geometric average length of stay at an IRF, a single payment will be made under LTCH prospective payment system. This payment will be a full LTC-DRG payment because the total LTCH length of stay is greater than five-sixths of the geometric average length of stay of the LTC-DRG. In Example 2 and Example 3, upon return to the LTCH following the discharge from the acute care hospital or the IRF, the day count will be resumed at day 6 of the LTCH stay. If the beneficiary was then discharged within a period that is up to and including five-sixths of the geometric average length of stay for the LTC-DRG, the stay will be paid as a short-stay outlier (see Sec. 412.529); and if the beneficiary was discharged beyond the short-stay threshold (five-sixths of the geometric average length of stay for the LTC-DRG), the case will be paid for the full LTC-DRG. F. Other Special Cases Under other Medicare prospective payment systems, specifically for inpatient acute care hospitals and for IRFs, there are separate policies for other types of special cases such as transfer cases and patients who expire. As stated in the proposed rule, we continue to believe the short-stay outlier policy (under Sec. 412.529) and the interrupted stay policy (under Sec. 412.531) will adequately address these circumstances. For instance, a case with a stay that is up to and including five-sixths of the geometric average length of stay of the LTC-DRG will be paid under the short-stay outlier policy regardless of whether or not the patient is transferred upon discharge to his or her home or to another setting where Medicare will make additional payments, or whether the patient expired. Moreover, if a beneficiary's stay at the LTCH is greater than five-sixths of the geometric average length of stay of the LTC-DRG, a full LTC-DRG payment will be made regardless of the destination following discharge. Therefore, in this final rule, we are not implementing a separate policy for cases that are transferred (except for those that are encompassed by the interrupted stay policy) or for patients who expire. Currently, under the acute care hospital inpatient prospective payment system, discharges in 10 DRGs are considered to be transfers if the patients are discharged to another Medicare postacute site of care, such as a LTCH, under section 1886(d)(5)(J)(ii) of the Act and implemented in regulations at Sec. 412.4. The rationale behind this provision was Congressional concern that Medicare may, in some cases, be ``overpaying hospitals for patients who are transferred to a postacute care setting after a very short acute care hospital stay.'' (Conference Agreement, H.R. Conf. Rept. No. 105-217, 105th Cong., 1st Sess., at 740 (1997).) In such a scenario, Medicare will also have to pay the postacute care provider for care that theoretically could have been provided at the acute care hospital. Section 1886(d)(5)(J)(iv) of the Act authorizes the Secretary to expand the postacute care transfer policy to additional DRGs. From the standpoint of LTCHs, the impact of expanding the acute care hospital inpatient prospective payment system postacute care transfer policy could be significant for the LTCH prospective payment system since this policy could affect behavior at acute care hospitals. If additional discharges will be paid as transfers, these patients may be kept longer at acute care hospitals in order to avoid a reduced payment for the transfer and then have a shorter length of stay during the subsequent stay at the LTCH. Presently, approximately 70 percent of LTCH Medicare patients are admitted following discharge from an acute care hospital. In the FY 2003 acute care hospital inpatient prospective payment system proposed rule (67 FR 31455), we solicited public comment on the feasibility of an expansion of the postacute care transfer policy (10-DRG policy). However, based on the public comments received, as described in the acute care hospital inpatient prospective payment system final rule on August 1, 2002 (67 FR 50048-50052), we decided not to expand this policy for FY 2003, but to further study the issue for consideration at a later date. [[Page 56007]] Comment: One commenter argued against a possible expansion of the inpatient acute hospital postacute care transfer policy to LTCHs because of its possible effects on LTCHs. Response: As we indicated above, we have decided to postpone any expansion of the postacute care transfer policy under the acute care hospital inpatient prospective payment system until we have done further study and evaluation. G. Onsite Discharges and Readmittances As we explained above, we do not believe that a separate policy governing transfers of Medicare patients between LTCHs and acute care hospitals is necessary at this time. However, we are implementing a policy that will address transfers between LTCHs and distinct-part SNFs, acute care hospitals, IRFs, or psychiatric facilities when the LTCH and any of these other providers are co-located because of the potential for inappropriate shifting of patients among these providers without clinical justification to maximize Medicare payment. This situation may occur when a distinct-part SNF is part of a LTCH or when the LTCH is located within an acute care hospital or an IRF as either a ``hospital-within-a-hospital (as defined in Sec. 412.22(e)) or a ``satellite facility'' (as defined in Sec. 412.22(h)) and a distinct- part SNF (as defined in section 1819(a) of the Act) is also part of the same acute care hospital or IRF. (Section V.C.9. of this preamble describes findings from Urban's research on the admission and discharge patterns between LTCHs and SNFs.) Similarly, a long-term care ``hospital-within-a-hospital'' or satellite facility may be co-located with a psychiatric or rehabilitation hospital that is also a hospital within the same acute care hospital or is a satellite facility situated in the same acute care hospital (Secs. 412.25 and 412.27), or may be co-located in an acute care hospital with a psychiatric unit (Sec. 412.27) or a satellite psychiatric or rehabilitation unit (Sec. 412.25(e)). We believe that a per discharge system, such as the prospective payment system for LTCHs, could provide inappropriate incentives to prematurely discharge patients to one of these other onsite providers once their lengths of stay at the LTCH exceeded the thresholds established by the short-stay outlier policies described in section X.C. of this preamble. These discharges will be based on payment considerations rather than on a clinical basis as an extension of the normal progression of appropriate patient care. If the long-term care hospital-within-a-hospital inappropriately discharges Medicare patients to the distinct-part SNF, or the onsite IRF, psychiatric facility, or acute care hospital without providing a complete episode of hospital- level care, Medicare will make inappropriate payments to the long-term care hospital-within-a-hospital, since payments under the prospective payment system will have been calculated based on a complete episode of such care. This type of a case could then be followed by a readmission to the LTCH from the onsite provider for an additional LTC-DRG payment. (In the case of a discharge from a LTCH to an offsite acute care hospital, an IRF, or a SNF with a subsequent return to the LTCH, payments will also be considered under the interrupted stay policy set forth at section X.E. of this final rule and at Sec. 412.531.) In determining an appropriate response to onsite discharges and readmittances, we are implementing a policy consistent with our policy described in the July 30, 1999 acute care hospital inpatient prospective payment system final rule (64 FR 41535) that addresses inappropriate discharges of patients between an acute care hospital inpatient prospective payment system excluded hospital-within-a- hospital (such as a LTCH) to the host acute care hospital, that culminated in a readmission to the hospital-within-a-hospital. In that context, we expressed the same concern noted above--that these types of moves were occurring for financial rather than clinical reasons. In order to discourage these practices, we implemented regulations at Sec. 413.40(a)(3) to specify how to calculate the cost per discharge under the excluded hospital payment provisions. Under those regulations, during a cost reporting period, if the hospital-within-a- hospital discharges more than 5 percent of its inpatients to the acute care hospital where it is located, and those patients are readmitted to the excluded hospital-within-a-hospital, Medicare considers each patient's entire stay as one discharge for purposes of calculating the cost per discharge of the excluded hospital-within-a-hospital. In determining whether a patient has previously been discharged and then readmitted, we consider all prior discharges, even if the discharge occurs late in one cost reporting period and the readmission occurs in the next cost reporting period. Only when the excluded hospital's number of cases involving a discharge from the excluded hospital- within-a-hospital to the host acute care hospital followed by a readmission to the hospital-within-a-hospital exceed 5 percent of the total number of its discharges in a particular cost reporting period are the first discharges not counted for payment purposes. (If the 5- percent threshold is not triggered, all discharges are counted separately.) With the implementation of the per discharge prospective payment system for LTCHs, in this final rule and in the proposed rule, we are adopting a similar policy to address inappropriate discharges and readmittances between LTCHs and other onsite providers by establishing a threshold beyond which the original patient stay and the readmission will be paid as one discharge (see Sec. 412.532). By paying only one discharge, we will discourage those transfers that will be based on payment considerations instead of on a clinical basis. Generally, if a LTCH readmits more than 5 percent of its Medicare patients who are discharged to an onsite SNF, IRF, or psychiatric facility, or to an onsite acute care hospital, only one LTC-DRG payment will be made to the LTCH for discharges and readmittances during the LTCH's cost reporting period. Therefore, payment for the entire stay will be paid either as one full LTC-DRG payment or a short-stay outlier, depending on the duration of the entire LTCH stay. In applying the 5-percent threshold, we will apply one threshold for discharges and readmittances with a co-located acute care hospital, consistent with the policy that has been in place under Sec. 413.40(a)(3) for acute care hospitals and excluded hospitals described above. There will also be a separate 5-percent threshold for all discharges and readmittances with co-located SNFs, IRFs, and psychiatric facilities. In the case of a LTCH that is co-located with an acute care hospital, an IRF, or a SNF, the onsite discharge and readmittance policies would apply in addition to the interrupted stay policy that we discussed in section X.E. of this preamble and at Sec. 412.531. This means that even if a discharged LTCH patient who was readmitted to the LTCH following a stay in an acute care hospital of greater than 9 days, if the facilities share a common location and the 5-percent threshold were exceeded, the subsequent discharges from the LTCH will not represent a separate hospitalization for payment purposes, so only one LTC-DRG payment will be made. Similarly, if the LTCH has exceeded its 5-percent threshold for all discharges to an onsite IRF, SNF, or psychiatric hospital or unit with readmittances to the LTCH, the subsequent discharges [[Page 56008]] will not be treated as a separate discharge for Medicare payment purposes, notwithstanding provisions of the interrupted stay policy with regard to lengths of stay at an IRF or a SNF (see Secs. 412.531(b)(4)(ii) and (b)(4)(iii)). (As under the interrupted stay policy, payment to an acute care hospital under the acute care hospital inpatient prospective payment system, to an IRF under the IRF prospective payment system, and to a SNF under the SNF prospective payment system, will not be affected. Payments to the psychiatric facility also will not be affected.) We are aware that situations could arise where, under sound clinical judgment, a patient who no longer required LTCH-level of care could be discharged to a SNF and then experience a setback necessitating rehospitalization. However, it is likely that, in such a scenario, in most cases the patient will be subsequently admitted to an acute care hospital rather than readmitted to the LTCH located within the acute care hospital. In addition, as we stated in the proposed rule, if the patient is being treated by a LTCH that also specializes in treating psychiatric or rehabilitation patients, it is unlikely that the patient who, for some medical reason, needed to be transferred to an onsite psychiatric or rehabilitation hospital or unit, will need to be readmitted to the LTCH. We believe that the 5-percent thresholds for discharges to onsite acute care hospitals and for discharges to onsite IRFs, SNFs, and psychiatric facilities followed by readmission to the LTCH provide adequate flexibility for those rare circumstances where such actions would be clinically preferable. We continue to believe that the combination of a discharge-based payment system that inherently contains financial incentives for shifting patients to another site of care and the close proximity of other sites of care such as other onsite hospitals-within-hospitals, satellites, and distinct-part SNFs, necessitates this type of policy. We will monitor such discharges and analyze data and compare practice patterns before and after the implementation of the LTCH prospective payment system and, if warranted, may consider extending it to offsite providers. Comment: Several commenters urged us to postpone implementation of this policy pending the collection of data or a formal study confirming that patient-shifting abuses among co-located providers are actually occurring. Response: As we note in section X.I. of this final rule, we will be developing a monitoring system that would, among other things, assist us in evaluating the impact of the LTCH prospective payment system on patient care patterns among Medicare providers. We are sufficiently concerned about the growth in the number of co-located providers and the inappropriate shifting of patients to co-located providers. Therefore, we disagree with commenters that our onsite discharges and readmittances policy should be postponed. As noted above, we have designed this policy in order to discourage patient-shifting for other than clinical purposes. In addition, our policy for onsite discharges and readmittances is consistent with the policy originally described in the July 30, 1999 acute care hospital inpatient prospective payment system final rule (64 FR 41535) which addressed inappropriate discharges from an excluded hospital paid under the TEFRA system, such as a LTCH, that was co-located as a hospital-within-a-hospital to a host acute care hospital, culminating in the readmission to the LTCH. In establishing this onsite policy (as well as the interrupted stay policy discussed in section X.E. of this preamble) for separately located providers, there has been no attempt to discourage the transfer of a Medicare patient at a LTCH to another onsite provider for treatment not available at the LTCH or for nonhospital level care available in a SNF. However, we have established regulations regarding a patient's subsequent readmission to the LTCH immediately following the discharge from this other onsite provider, a circumstance that we believe could have less clinical justification than the initial LTCH discharge and admission to the other onsite provider. We continue to believe that the two 5-percent thresholds in this final rule for readmittances to the LTCH prior to the triggering of payment consequences for the LTCH provide sufficient flexibility for those unusual cases when such action could be clinically warranted. Comment: Several commenters noted that the onsite discharge and transfer policy was unnecessary since the interrupted stay policy already addressed our concerns in this area. In addition, one commenter stated that readmissions to freestanding LTCHs equaled those to onsite LTCHs and that an additional onsite policy imposed expensive and unnecessary recordkeeping responsibilities on providers. Response: Notwithstanding the concerns that led us to establish our interrupted stay policy, we believe that the very nature of co-located Medicare providers provides an even stronger incentive for unnecessary patient shifting and must be discouraged at the outset of establishing prospective payments for LTCHs. Unless and until a LTCH exceeds the 5- percent threshold for readmittances from the onsite acute care hospital or the 5-percent threshold for readmittances from onsite IRFs, psychiatric hospitals or units, or SNFs, Medicare payments will be based on the interrupted stay policy. This means that if a LTCH patient is admitted to one of these other providers following a LTCH hospitalization, and then readmitted to the LTCH, the length of stay at the intervening provider will determine whether the LTCH hospitalizations are paid as one or more discharges. Should one of the 5-percent thresholds be exceeded, all LTCH readmissions from either the acute care hospital or the IRF, SNF, and psychiatric facility combined for that cost reporting year will be paid as one discharge, regardless of the length of stay at the intervening provider. We wish to clarify that if, for example, the 5-percent threshold for onsite discharges and readmissions is exceeded during a particular cost reporting period between the co-located LTCH and the acute care hospital, all onsite discharges and readmittances between these two providers during that cost reporting period will be paid as one discharge, even those that occurred prior to the threshold having been exceeded. This would also be the case for onsite discharges and readmissions that exceed the combined 5-percent threshold for IRFs, SNFs, and psychiatric facilities that are co-located with a LTCH. This policy reflects our concerns about patient transfers among co- located providers that are based on financial rather than medical considerations. As noted above, although a patient's discharge from a LTCH to another Medicare provider could represent a reasonable sequence of care, the direct admission of that patient to the LTCH should be a relatively rare occurrence. However, if over 5 percent of the total number of patients who are discharged from a LTCH during a cost reporting period are subsequently directly readmitted from a co-located provider, we believe that such behavior signifies a pattern of inappropriate patient-shifting among onsite Medicare providers and, therefore, we will treat all of the patients in that site of care group who are discharged and readmitted as if they are only one discharge and make only one LTC-DRG payment for those discharges. We do not believe that the onsite policy (or the interrupted stay policy as it has been revised in this final rule) [[Page 56009]] imposes an additional burden on providers since the standard of care in clinical practice requires tracking a patient's recent medical history upon admission, and sound hospital management requires ongoing evaluation of discharge and readmittance patterns. Comment: Several commenters urged us to support, with research, any extension of the onsite policy to Medicare providers that are not co- located with LTCHs. Response: Our monitoring of all LTCH discharges and readmittances as we implement the LTCH prospective payment system will yield data that will enable us to determine whether extension of this policy is warranted. Comment: One commenter pointed to the distinction between co- located and co-owned hospitals. Two commenters sought to clarify what was meant by the category of ``co-located'' or ``onsite'' providers. Another commenter suggested that we apply the onsite policy with regard to SNFs only to those SNFs that are co-located in the same building. Response: There is clearly a distinction between the co-location and co-ownership of Medicare providers, although some hospitals and units are both co-located and owned by the same corporate entity. Governing regulations at Sec. 412.22(e) and (f) for hospitals-within- hospitals and Sec. 412.22(h) and (i) for satellite facilities, and at Sec. 412.25 for satellite units place no restriction on hospital or unit ownership. As we monitor the implementation of the LTCH prospective payment system, we will be noting the impact of ownership and location patterns, among others, in our evaluation of existing payment policy. We are defining ``co-located'' and ``onsite'' for purposes of the policy established under Sec. 412.532, in accordance with existing definitions for hospitals-within-hospitals and satellite facilities. Under Sec. 412.22(e), hospitals-within-hospitals are defined as ``* * * hospital that occupies space in a building also used by another hospital, or in one or more entire buildings located on the same campus as buildings used by another hospital * * *'' Satellite facilities are defined in Sec. 412.22(h) as ``* * * a part of a hospital that provides inpatient services in a building that is also used by another hospital, or in one or more entire buildings located on the same campus as buildings used by another hospital.'' The definition of ``campus'' is set forth in Sec. 413.65(a)(2). In this final rule, we have revised Sec. 412.532 to specifically reference these definitions. We do not see any basis for us to change these definitions only for SNFs and, therefore, we will be categorizing onsite SNFs by the same standards as that used for other Medicare providers. Comment: Two commenters expressed concern that, in promulgating a policy that discouraged onsite patient transfers, we were ignoring the fact that SNFs were a logical destination for LTCH patients upon completion of their course of treatment. These commenters believed that we should not establish payment disincentives for a LTCH that discharges a patient to a co-located SNF. Response: We agree with the commenters that, in some instances, a patient's placement in a SNF following hospitalization in a LTCH is a reasonable sequence of care. Our onsite discharge and readmission policy does not challenge the initial discharge from the LTCH or admission to the SNF, but rather the subsequent readmission to the LTCH directly from the onsite SNF. We do not believe that our onsite transfer policy discourages appropriate onsite patient transfers. Under the LTCH prospective payment system, if, during a cost reporting period, a LTCH readmits more than 5 percent of its total number of Medicare patients from an onsite or co-located SNF, IRF, or psychiatric hospital or unit or readmits more than 5 percent of its patients from an onsite acute care hospital (in both situations, generating a second admission to the LTCH for that patient), the Medicare program will pay the LTCH for only one discharge in such cases for all patient discharges and readmittances from that provider or group of providers during that cost reporting period. The principal goal of our onsite discharge and readmission policy is to discourage patient-shifting from one Medicare site of care to another so that Medicare will pay only once for a particular episode of illness. Existing ownership regulations do not guard against the potential gaming of the Medicare system in this way by a corporate entity owning both co-located providers (as well as an onsite acute care hospital, an IRF, or a psychiatric hospital or unit). Therefore, our policies under the LTCH prospective payment system have been designed to discourage financially motivated movement of patients among onsite Medicare providers. We also believe that the two distinct 5-percent thresholds allow for those unusual circumstances when therapeutic judgment could reasonably dictate a patient's readmission to the onsite LTCH from the other onsite provider to which the patient had been originally discharged. Comment: One commenter, a corporation that owns IRFs, suggested that the onsite discharge and readmission policy should limit readmissions to LTCHs to 5 percent total readmissions from all co- located providers (acute care hospitals, IRFs, psychiatric facilities, and SNFs) rather than 5 percent from an onsite acute care hospital and 5 percent from an onsite IRF, SNF, and psychiatric facility combined. Response: We believe that the 2 distinct 5-percent onsite discharge and readmission thresholds are based on a realistic understanding of current treatment patterns at LTCHs and provide adequate flexibility for clinical decisionmaking. When we were designing the onsite discharge and readmission policy, we took into account research by Urban that detailed sources and destinations of LTCH patients. As we noted in our discussion of the universe of LTCHs in section V.C. of this final rule, most LTCH patients who are transferred to other sites of care go to acute care hospitals. Therefore, at one end of the spectrum were patients who required further acute care, and at the other end, patients who no longer required LTCH-level care. Our two 5- percent threshold policies recognize that there are two distinct groups of patient groups being discharged from LTCHs: (1) Those requiring more intensive, acute hospital care; and (2) those whose medical conditions have stabilized or improved so that they can receive care at an IRF, a psychiatric facility or to a SNF. We believe that it is appropriate that acute care hospitals have a separate 5-percent threshold, and since fewer patients go to SNFs, IRFs, and psychiatric facilities, a collective 5-percent threshold for those facilities is adequate. Comment: Two commenters questioned how we would actually implement the onsite discharge and readmission policy from a systems perspective. Response: In order to practically implement payments under the onsite discharge and readmission policy, fiscal intermediaries will reconcile Medicare payments and discharge data received by LTCHs during the course of that cost reporting year, at the close of each cost reporting period. We will issue program memoranda detailing instructions for fiscal intermediaries and providers regarding billing, data collection, and systems operations following the publication of this final rule. Comment: One commenter supported reducing the incentives to transfer patients inappropriately, but also [[Page 56010]] expressed concern that our onsite policy may not take into account the clinical needs of Medicare patients and could discourage even appropriate transfers. The commenter further suggested that Medicare's QIO should monitor patient care at LTCHs in general and onsite readmissions in particular. Another commenter believed that our onsite policy constrained clinical decisionmaking and restricted a Medicare beneficiary's choice of provider. Response: We appreciate the commenter's support for our policy efforts regarding inappropriate transfer of patients among onsite Medicare providers. While we agree that the decision to move a patient from one care setting to another should be made on purely clinical grounds, we remain concerned about discharges based on financial concerns, particularly among Medicare providers that are both co- located and owned by the same parent corporation. In this final rule, we are establishing a payment policy for LTCHs based on our best available data. We are not prohibiting a LTCH from serving a patient nor have we dictated where a patient should receive care. For this reason, we will retain the onsite discharge and readmission policy as we implement the LTCH prospective payment system. Regarding review by QIOs, we have established medical review requirements at Sec. 412.508(a) in accordance with existing regulations at Secs. 412.44, 412.46, and 412.48 and consistent with other established prospective payment systems policies. As noted throughout this final rule, we expect that the implementation of the LTCH prospective payment system will generate data that will allow indepth analysis and evaluation of our policies. To that end, we have established a monitoring protocol with our Office of Research, Development, and Information. H. Additional Issues for Onsite Facilities 1. Issues Proposed for Discussion in the March 22, 2002 Proposed Rule (67 FR 13416) As we prepare to implement a prospective payment system for LTCHs, we are reevaluating certain existing policies for hospitals-within- hospitals and satellite facilities that were established under the TEFRA payment system for excluded hospitals. Existing regulations at Sec. 412.22(e) specify exclusion criteria based on ownership and control for hospitals-within-hospitals and their host hospitals (59 FR 45330, September 1, 1994). We are concerned about possible manipulation of Medicare payments by a single entity that owns or controls an acute care hospital and a co-located LTCH. We believe that such a situation could lead to premature patient discharges from the acute care hospital to the co-located LTCH, resulting in two Medicare payments to the controlling entity for one episode of care. Since LTCHs are generally capable of providing a wide range of medical treatment, we are concerned about the following scenario: the costs of treating an acute care hospital patient exceed the payment that the hospital would receive for that specific DRG and the acute care hospital ``discharges'' the patient who still requires treatment, for admission to an onsite LTCH. Under this circumstance, the LTCH would, in fact, function as an excluded unit of an acute care hospital, a situation inconsistent with section 1886(d)(1)(B) of the Act, which allows excluded rehabilitation and psychiatric units in acute care hospitals but not long-term care units. Through the interrupted stay and onsite discharge and readmittance policies set forth in sections X.E. and X.G., respectively, of this final rule, which limit potential inappropriate Medicare payments, we believe that we have addressed some of the concerns that originally led us to establish the rules in Sec. 412.22(e). In the March 22, 2002 proposed rule, we solicited comments on possible changes to our payment policy regarding ownership and control for hospitals-within-hospitals. Comment: Two commenters supported maintaining the existing regulations governing hospitals-within-hospitals and further endorsed the proposed interrupted stay and co-located discharge and readmittance provisions. Several commenters encouraged stricter enforcement of our present policy on control and ownership. The commenters believed that, even though our regulations require hospital-within-hospitals to have separate governing bodies, chief medical officers, separate medical staffs and chief executive officer from host hospitals (Sec. 412.23(e)(1) through (e)(4)) and require basic hospital functions to be separated according to the fulfillment of one of three criteria at Sec. 412.23(e)(5), some hospitals-within-hospitals and their host hospitals have managed to circumvent the regulations. One of these commenters noted that, in such situations, the long-term care hospitals-within-hospitals were, in effect, functioning as LTCH units. Response: The expressed intent of existing separateness criteria at Sec. 412.22(e), first presented in the September 1, 1994 acute care hospital inpatient prospective payment system final rule (59 FR 45390 and 45396), was to disallow the formation of a single hospital facility that included an acute care hospital paid under the prospective payment system and what would effectively be a LTCH unit that would be paid under the TEFRA payment system. We believe that formation of such a facility was contrary to the statutory intent of section 1886(d)(1)(B) of the Act. The existing regulations were implemented to prohibit such an arrangement. As we implement the prospective payment system for LTCHs, we remain extremely concerned about rapid growth in long-term care hospitals-within-hospitals and will be collecting data on the relationship among host hospitals, hospitals-within-hospitals, and parent corporations in order to determine the need for additional regulation or monitoring. Comment: Ten commenters urged us to strengthen existing separateness criteria in the regulation. Among the policies suggested were disallowing the establishing of separate corporations with common ownership and funding to operate a hospital-within-hospital by parent or controlling companies or host hospitals; precluding the provision of goods and services not consistent with ``fair market value''; and the guaranteeing of the long-term care hospital-within-hospital's loans or debts by the host hospital. Commenters pointed to loopholes in existing regulations that allow corporations to evade our intent. One hospital association urged us to disallow a parent company of the host hospital to establish a separate corporation that would control both the host hospital and finance a hospital-within-a-hospital. Another commenter proposed a percentage ceiling on patients that a long-term care hospital-within-a-hospital could admit from the host hospital, a strict definition of ``direct'' and ``indirect'' control for purposes of limiting common corporate ownership. One commenter noted that, although the forthcoming LTCH prospective payment system onsite discharge and admission policies (section X.G. of this final rule and Sec. 412.532) could deter LTCHs from financially benefiting from discharging patients and subsequently readmitting them, acute care hospitals could still make financially driven transfers of patients to LTCHs. Response: We believe that existing regulations, including the existing 10-DRG postacute care transfer policy at Sec. 412.4, are effective disincentives for acute care hospitals to transfer patients, for whom they could reasonably provide [[Page 56011]] treatment, to LTCHs. However, as noted below, we are requiring all LTCHs to inform their fiscal intermediary and their CMS Regional Office if they are co-located Medicare providers and will be collecting data on the corporate relationships between these providers. We plan to revise our policies and take action as necessary if our research reveals circumvention of CMS policy goals. Comment: One commenter suggested that an additional criteria to prevent abuse by hospitals-within-hospitals would be to strengthen the regulations about disclosure of other alternatives as part of hospital discharge planning, one of the Medicare conditions of participation for hospitals, as described in Sec. 482.43. Response: Discharge planning is one of our basic hospital health and safety requirements. Under Sec. 482.43(b)(6), a hospital is currently required to discuss the results of the discharge planning evaluation with the patient or individual acting on the patient's behalf. In addition, Secs. 482.43(c)(4) and (c)(5) already require the hospital to reassess the patient's discharge plan if there are factors that may affect continuing care needs or the appropriateness of the discharge plan and to counsel and prepare patients and family members for posthospital care. Accordingly, based on these existing safeguards, we do not believe that there is a need to modify Sec. 482.43. Comment: Five commenters urged us to refrain from issuing any additional regulations affecting hospitals-within-hospitals, particularly relating to ownership of a hospital-within-a-hospital. Two commenters recommended the elimination of all LTCH ownership rules, and one commenter suggested that we consider ``leveling the long-term acute care hospital playing field''. The commenter believed that such action would allow true competition and remove any unnecessary barrier to general acute care hospitals entering into the long-term acute care hospital business. Response: We believe it essential to establish regulations discouraging the transfer of Medicare patients from one provider to another for any reason other than for clear clinical benefits of the patient. However, without the separate ownership and control requirements at Sec. 412.22(e), we believe that LTCHs located within a host acute care hospital could function as LTCH units. This is a prospect that is inconsistent with the purpose and scheme of section 1886(d)(1)(B) of the Act, which provides for the exclusion of psychiatric and rehabilitation units, but not for the exclusion of LTCH units. The acute care hospital inpatient prospective payment system was originally based on the principle of determining an average cost per discharge, and the average was determined by including all discharges, short and long stays. For an acute care hospital to move its patients to a ``LTC unit'' rather than treating the patient for the entire spell of illness would allow the hospital to have had the benefit of a payment for that patient that had been based on including long-stay patients in calculating the average cost per discharge, while in actuality no longer treating those longer stay types of patients. In our final rule for the acute care hospital inpatient prospective payment system (September 1, 1994 Federal Register (59 FR 45389)), we noted that we intended for the hospital-within-hospital policy to allow ``adequate flexibility for legitimate networking and sharing of services * * *'' and we believe that existing policies can contribute to efficiency, convenience and clinical benefits. Whether or not we will promulgate additional ownership and control regulations for hospitals-within-hospitals will be based on the results of our collection and analysis of data that we will be gathering for monitoring and compliance purposes. Comment: Several commenters urged us to publish a proposed rule to provide the opportunity for public comments for any proposed changes to the regulations governing hospitals-within-hospitals. Response: At this point, we do not have specific plans to revise any existing policies on hospitals-within-hospitals. As we implement the LTCH prospective payment system, we will be monitoring hospitals- within-hospitals and satellite facilities for, among other behaviors, compliance with existing regulations, growth in numbers, and transfer patterns. In order to facilitate this monitoring and compliance, we are requiring that LTCHs notify their fiscal intermediaries and their CMS regional office about their co-location with any other Medicare providers by December 1, 2002 (within 60 days following the initial effective date of the LTCH prospective payment system). Therefore, we are revising the regulations at Secs. 412.22(e) and 412.22(h) to incorporate this required notification. If, as a consequence of these monitoring activities, we determine that we need to revisit existing regulations dealing with ownership and control of hospitals-within-hospitals, we will follow the notice and comment rulemaking process. Comment: One commenter, a LTCH that is co-located, as a hospital- within-a-hospital with a larger tertiary care center that is an acute care hospital, with both facilities having a common owner, asserted that the single ownership of both hospitals actually affords significant benefits to patients in the LTCH from the standpoint of clinical care as well as medical efficiency and management. Response: We agree with the commenter's assertion that the location of a long-term care hospital-within-a-hospital co-located within a host acute care hospital has a number of advantages from the standpoint of patient convenience and management, provided the requirements set forth in Sec. 412.22(e) are satisfied and the patients in each of the co- located hospitals receive a full episode of care in that hospital. Comment: One commenter suggested that the prospective payment system for LTCHs take into account that freestanding LTCHs have considerably higher infrastructure costs than LTCHs that exist as hospitals-within-hospitals. Response: The Urban Institute's research based on FY 1997 cost reports from LTCHs revealed that there is no significant difference between the payment-to-cost ratios for LTCHs that exist as hospitals- within-hospitals and freestanding LTCHs. We expect to update these data and, therefore, as noted above, we are revising the regulations at Secs. 412.22(e) and (h) to require LTCHs to notify their fiscal intermediaries and their CMS regional office of their co-location with any other Medicare providers within 60 days of their first cost reporting period that begins on or after October 1, 2002. These data will enable us to evaluate possible cost differentials between LTCHs that are co-located and those that are freestanding. As we analyze the data, we will determine if and what payment system adjustments would be appropriate to propose. Comment: One commenter questioned whether we were soliciting comments on the possibility of allowing LTCHs to house units of other excluded hospital categories, such as rehabilitation or psychiatric units. Response: Under Sec. 412.25(a)(1)(ii), a unit excluded from the acute care hospital inpatient prospective payment system is precluded from locating in a facility that is excluded from the acute care hospital inpatient prospective payment system, such as a LTCH. We have no plans to revise this policy. We also solicited comments on our policy regarding LTCHs that have established satellite facilities. In Sec. 412.22(h)(1), we define a satellite as ``a part of a hospital that provides inpatient [[Page 56012]] services in a building also used by another hospital, or in one or more entire buildings located on the same campus as buildings used by another hospital.'' Satellite arrangements exist when an existing hospital that is excluded from the acute care hospital inpatient prospective payment system and that is either a freestanding hospital or a hospital-within-a-hospital under Sec. 412.22(e) shares space in a building or on a campus occupied by another hospital in order to establish an additional location for the excluded hospital. The July 30, 1999 acute care hospital inpatient prospective payment system final rule (64 FR 41532-41534) includes a detailed discussion of our policies regarding Medicare payments for satellite facilities of hospitals excluded from the acute care hospital inpatient prospective payment system. In the March 22, 2002 proposed rule, we indicated that we would consider the possibility of revisiting the policies we established for these satellites. In accordance with section 1886(b) of the Act, as amended by sections 4414 and 4416 of Public Law 105-33, we established two different target limits on payments to excluded hospitals, depending upon when the facilities were established. The target amount limit for excluded hospitals or units established before October 1, 1997 was set at the 75th percentile of the target amounts of similarly classified hospitals, as specified in Sec. 413.40(c)(4)(iii), for cost reporting periods ending during FY 1996, as updated to the applicable cost reporting period. For excluded hospitals and units established on or after October 1, 1997, under section 4416 of Public Law 105-33, the payment amount for the hospital's first two 12-month cost reporting periods, as specified at Sec. 413.40(f)(2)(ii), may not exceed 110 percent of the national median of target amounts of similarly classified hospitals for cost reporting periods ending during FY 1996, updated to the first cost reporting period in which the hospital receives payment. Because we were concerned that a number of pre-1997 excluded hospitals, governed by Sec. 413.40(c)(4)(iii), would seek to create satellite arrangements in order to avoid the effect of the lower payment caps that would apply to new hospitals under Sec. 413.40(f)(2)(ii), we established rules regarding the exclusion of and payments to satellites of existing facilities. If the number of beds in the hospital or unit (including both the base hospital or unit and the satellite location) exceeds the number of State-licensed and Medicare-certified beds in the hospital or unit on the last day of the hospital's or unit's last cost reporting period beginning before October 1, 1997, the facility would be paid under the acute care hospital inpatient DRG system. Therefore, while an excluded hospital or unit could ``transfer'' bed capacity from a base facility to a satellite, if it increased total bed capacity beyond the level it had in the most recent cost reporting period before October 1, 1997 (see 64 FR 41532-41533, July 30, 1999), the hospital will not be paid as a hospital excluded from the acute care hospital inpatient prospective payment system. However, no similar limitation was imposed with respect to the number of total beds in excluded hospitals and units and satellite facilities of those excluded hospitals and units established after October 1, 1997, since those excluded hospitals and units were already subject to the lower payment limits of section 4416 of Public Law 105-33, and would, therefore, not benefit from the higher cap by creating a satellite facility. Section 123 of Public Law 106-113 confers broad authority on the Secretary regarding the implementation of the prospective payment system for LTCHs, and as described in section X.N. of this final rule, we will transition the LTCH prospective payment system over 5 years. During this period, payments to LTCHs will gradually change from a blend of hospital-specific reasonable cost-based payments and the Federal rate to a fully 100 percent Federal per-discharge LTC-DRG-based prospective payment system. In addition, IRFs also will be transitioned to 100 percent fully Federal prospective payment system payment starting with cost reporting periods beginning during FY 2003. In the proposed rule, we stated that we would consider whether to propose elimination of the bed-number criteria in Sec. 412.22(h)(2)(i) for pre- 1997 hospitals, once the applicable prospective payment system is fully phased in. All LTCHs would be paid based on 100 percent of the LTCH Federal rate by FY 2007 and the payment rates established under the TEFRA system at that time will no longer exist for this class of hospitals. In addition, we noted that, starting with cost reporting periods that begin during FY 2003, payment to IRFs are no longer cost based. We also noted that any policy change for lifting the bed-number criteria for hospitals under the LTCH or IRF prospective payment systems that we consider to propose would not apply while hospitals continue to be paid under the TEFRA system. Therefore, in the proposed rule, we stated that during the 5-year phasein period, the policies in Sec. 412.22(h)(2)(i) would continue to apply to LTCH satellites facilities. Comment: One commenter endorsed the policy that we may limit criterion for LTCHs with satellites once the LTCH prospective payment system is fully phased in by FY 2007. Under that existing policy, we limit a LTCH with a satellite to the number of beds that does not exceed the total number of beds the hospital was licensed to have on the last day of the hospital's last cost reporting period beginning before October 1, 1997. Ten other commenters urged us to adopt a policy eliminating the bed-number restrictions for satellites established by pre-1997 LTCHs as soon as a LTCH elects to be paid based on 100 percent of the standard Federal rate. The commenters recommended not waiting to eliminate the bed limit until FY 2007. The commenters explained that the rationale for the policies regarding bed limits for LTCHs with satellites was established subsequent to the enactment of the BBA in 1997, which set different target amount limits for each group. The commenters believed the policy should be obsolete once a LTCH is paid 100 percent under the fully Federal rate. Two of these commenters, while agreeing that we should adopt regulations eliminating the bed limits for pre-1997 LTCHs that elect to be paid based on 100 percent of the Federal rate, suggested limiting any proposal to those situations when the LTCH's TEFRA payment rate is lower than the most recent cap under Sec. 413.40(f)(2)(ii). Response: We agree that it may be appropriate to propose an elimination of the bed restriction prior to all hospitals transition to the LTCH prospective payment system. Although, in the proposed rule, we indicated that we would consider proposing a change to the existing bed-limit criterion in Sec. 412.22(h)(2)(i) for pre-1997 LTCHs once the LTCH prospective payment system was fully phased in, we agree with the argument presented by the commenters that it may be appropriate to propose dispensing with bed-number restrictions for those pre-1997 LTCHs that elect to be paid under 100 percent of the Federal rate, at the start of the cost reporting period when this election is made. The rationale for the bed limit provision at Sec. 412.22(h)(2)(i) was the potential for gaming by creating a satellite location with a higher TEFRA target amount cap, where in reality the satellite would have been a separately certified LTCH but would have been subject to the lower cap on payments. [[Page 56013]] Once the hospital is paid under 100 percent of the prospective payment system rate, there is no longer a reason for the hospital to create a new hospital as a satellite since such a creation would not affect the hospital's prospective payment system payment. Accordingly, we will address a change in the policy concerning bed limits in the next update of the LTCH prospective payment system. Since the bed-restriction provisions on LTCHs with satellites were applicable under the TEFRA payment system, those LTCHs that are transitioning into full prospective payment and that, therefore, are still receiving a percentage of their payments under TEFRA rules, we believe, should continue to be subject to these restrictions during the phasein. Finally, we do not believe that it may be appropriate to propose the more restrictive option suggested by the two commenters. Allowing only those hospitals with TEFRA target amounts that are below the BBA cap or the target amount to exceed the limit is not consistent with our original basis for the limit. Once a hospital is not subject to the BBA cap on the target amount, the limit should be lifted with no consideration of the comparison of the hospital's cost to its target amount. Comment: Several commenters urged us to consider dispensing with the satellite bed-number restrictions for IRFs once the IRF prospective payment system is fully phased in for cost reporting periods beginning during FY 2003. Response: We appreciate the comments on this issue. This area is currently under our review and may be addressed in the future when changes to the IRF prospective payment system are addressed. Comment: One commenter suggested that, under the LTCH prospective payment system, satellite facilities should not have to independently comply with the 25-day average length of stay requirements separate from the parent LTCH. Response: We disagree with the commenter's suggestion and are not revising the regulations that require a satellite facility of a LTCH to independently meet the average 25-day length of stay requirement under Sec. 412.22(h)(2)(ii)(D). In establishing regulations for satellite facilities of excluded hospitals in the July 30, 1999 acute care hospital inpatient prospective payment system final rule (64 FR 41534), we clarified the need to establish financial and administrative linkage between the satellite facility and the parent excluded hospital, and we required the satellite facility to comply independently with selected statutory requirements for qualifying into the category of excluded provider of the parent hospital. We were concerned that existing hospitals that were excluded from the prospective payment system were establishing new hospitals under the guise of satellite facilities in order to circumvent several Medicare payment provisions. We also wanted to safeguard against the possibility of these satellites of excluded hospitals actually functioning as a part of an acute care hospital for the financial benefit of both facilities without any consequential clinical benefit to patients who could have reasonably been treated at an acute care hospital. We continue to believe it is essential that the satellite facility of such an excluded hospital retain the identity of the type of excluded hospital of which it is a part by separately complying with such requirements, thereby ensuring that patients hospitalized at the satellite facility would receive the appropriate specialized care for which Medicare is paying. In the case of a LTCH, we require that a satellite facility meet the 25-day average length of stay requirement independently, since we do not believe patients not requiring long-term hospital-level care should be admitted to either the LTCH or its satellite and we are concerned that, without requiring separate compliance, shorter lengths of stay at either the LTCH or its satellite could be balanced by longer stays at the other. Therefore, we will continue to separately calculate the length of stay for patients at LTCH satellite facilities to ensure that the satellite facility is actually a LTCH that warrants payments under the LTCH prospective payment system. Comment: One commenter urged us to limit the growth of LTCH satellites by prohibiting additional LTCH satellites from being established after October 1, 2002. Response: We do not believe that the action suggested by the commenter is warranted at this time. 2. Criteria for Exclusion of Satellite Facilities From the Hospital Inpatient Prospective Payment System Published in the August 1, 2002 Acute Care Hospital Final Rule (67 FR 49982) In the final rule for the acute care hospital inpatient prospective payment system, published on August 1, 2002 (67 FR 49982), we included a discussion of policy changes for satellites of prospective payment system-excluded hospitals and units and revised Sec. 412.22(h) (67 FR 50105). Effective for cost reporting periods beginning on or after October 1, 2002, a hospital or unit that has a satellite facility must meet the following criteria in order to be excluded from the acute care hospital inpatient prospective payment system for any period: (1) It is not under the control of the governing body or the chief executive officer of the hospital in which it is located; and (2) it furnishes inpatient care through the use of medical personnel who are not under the control of the medical staff or the chief medical officer of the hospital in which it is located. We further indicated that a number of the criteria that apply to hospitals-within-hospitals would not be applicable to satellite facilities. One example is the requirement that the cost of services that the hospital-within-a-hospital receives from the ``host'' hospital is not more than 15 percent of the hospital's inpatient operating costs would not be an appropriate criterion. This criterion would not be appropriate because the test would not only look at the costs incurred by the satellite facility but also at the costs incurred by the entire hospital, including both the satellite facility and the main hospital. We remain concerned that a significant potential exists for co- located providers to circumvent Medicare policy. For example, an excluded hospital would not be prohibited, under current rules, from setting up one or more satellites that could be much larger than the main provider hospital, but under the rules published on August 1, 2002, do not need to meet the separateness requirements for hospitals- within-hospitals in Sec. 412.22(e)(5). In this scenario, a small main provider (having, for example, 50 beds), which itself could be co- located with an acute hospital as a hospital-within-a-hospital, could establish a large satellite (having, for example, 200 beds). Although this activity would be equivalent to the creation of a hospital-within- a-hospital, the hospital would, under current rules, only be required to comply with the satellite regulations at Sec. 412.22(h), not the additional requirements for hospitals-within-hospitals (see Sec. 412.22(e)(5)). We believe such a result would defeat the purpose of the hospital-within-a-hospital and satellite rules, by leading to the creation of facilities which are not sufficiently independent of the hospitals in which they are located to qualify for separate payment. As noted in the above discussion of hospitals-within-hospitals and satellites under the LTCH prospective payment system, we will be monitoring all aspects of onsite Medicare providers. If we see potentially abusive configurations being developed, we may consider proposing further regulations [[Page 56014]] that would provide effective safeguards against such abuse, such as requiring any satellite facility of a prospective payment system- excluded hospital that shares a building or a campus with another Medicare provider to individually meet separateness requirements substantially the same as those in Sec. 412.22(e)(5). I. Monitoring System In the March 22, 2002 proposed rule, we proposed various policies that we believed would provide equitable payment for stays that reflect less than the full course of treatment and reduce the incentives for inappropriate admissions, transfers, or premature discharges of patients that are present in a discharge-based prospective payment system. We also proposed to collect and interpret data on changes in average lengths of stay under the prospective payment system for specific LTC-DRGs and the impact of these changes on the Medicare program. We are planning to develop a monitoring system that will assist us in evaluating the LTCH prospective payment system. If our data indicate that changes might be warranted, we may revisit these issues and consider proposing revisions to these policies in the future. Comment: One commenter stated that, in designing the LTCH prospective payment system, we compared current costs to payments under the new prospective payment system. The commenter indicated that, since these costs may be higher than necessary, it is possible that additional payments for care provided in LTCHs may not be an appropriate expenditure of Medicare funds. The commenter urged us to gather data on the following basic issues: Where patients who need acute long-term care are treated in areas where there are no LTCHs; How costs and outcomes compare for similar patients in long-term care hospitals and other settings in areas where LTCHs do not exists; How costs compare for hospitals with and without onsite LTCHs; How costs compare for onsite LTCHs and freestanding LTCHs; and How the presence or absence of LTCHS affects transfers to acute care hospitals and other post-acute care settings. Response: We agree with the commenter that these areas of study are essential to our ongoing monitoring and evaluation activities for implementation of the LTCH prospective payment system. We note that the establishment of the prospective payment system for LTCHs is required by statute. The statute specifically requires that the system be budget neutral to payments under the current TEFRA system. However, as we stated earlier, we intend to develop a monitoring system that will assist us in evaluating the LTCH prospective payment system. If our data indicate that changes are warranted, we may revisit these issues and, consistent with statutory requirements, consider revising these policies in the future. Given that the only unique requirement that distinguishes a LTCH from other hospitals is an average length of stay of greater than 25 days, we continue to be concerned about the extent to which LTCH services and patients differ from those services and patients treated in other Medicare covered settings (for example, SNFs and IRFs) and how the LTCH prospective payment system will affect the access, quality, and costs across the health care continuum. Thus, we will monitor trends in the supply and utilization of LTCHs and Medicare's costs in LTCH and relative to other Medicare providers. For example, we may conduct medical record reviews of Medicare patients to monitor changes in service use (for example, ventilator use) over a LTCH episode of care and to assess patterns in the average length of stay at the facility level. We will consider future changes to LTCH coverage and payment policy based upon the results of such analyses. J. Payment Adjustments As indicated earlier, the Secretary generally has broad authority under section 123 of Public Law 106-113 in developing the prospective payment system for LTCHs. Thus, the Secretary has discretion to determine whether (and how) to make adjustments to the prospective payments to LTCHs. Section 307(b) of Public Law 106-554 directs the Secretary to ``examine'' appropriate adjustments to the prospective payments to LTCHs, including certain specific adjustments, but under that section the Secretary continues to have discretion as to whether to provide for adjustments. In determining whether to include specific payment adjustments under the prospective payment system for LTCHs, we conducted extensive regression analyses of the relationship between LTCH costs (including both operating and capital-related costs per case) and several factors that may affect costs such as the percent of Medicaid patients treated, the percent of Supplemental Security Income (SSI) patients treated, geographic location, and medical education programs. The appropriateness of potential payment adjustments is based on both cost effects estimated by regression analysis and other factors, including simulated payments that we discuss later in this section of the preamble. Our analyses in the proposed rule were based on data from 222 LTCHs for which both costs from the cost reports in HCRIS and case-mix data from the MedPAR file were available. For this final rule, we collected costs from the cost reports and case-mix data from the MedPAR file on 198 LTCHs. We excluded LTCHs that are all-inclusive providers and providers reimbursed in accordance with demonstration projects (section X.K.2.a. of this preamble). We estimated costs for each case by multiplying hospital-specific cost-to-charge ratios by the LTCH's charges for that case. Cost-to-charge ratios were determined by obtaining costs from FY 1998 or FY 1999 cost report data, or both, as available in the HCRIS minimum data set, and charges from the Medicare claims data available in the MedPAR file. Because the universe of LTCHs has grown relatively rapidly over the last several years, in order to maximize the number of LTCHs in the database, we used the most recent cost report data available for each LTCH. If we had both FY 1998 and FY 1999 cost report data, we used the most complete cost reporting period (that is, the cost reporting period with the greater number of months). If we used FY 1998 cost report data because FY 1999 data were either unavailable (due to the time lag in cost report settlement) or incomplete, we updated the FY 1998 data for inflation using the FY 1999 excluded hospital market basket increase (2.4 percent) as published in the July 31, 1998 acute care hospital inpatient prospective payment system FY 1999 final rule (63 FR 40954). As indicated in Appendix A of this final rule, we are using the excluded hospital market basket with a capital component to update payment rates. The excluded hospital market basket is currently used to update LTCHs' target amounts for inflation under the TEFRA system. We believe that the use of the excluded hospital market basket to update LTCHs' costs for inflation is appropriate because the excluded hospital market basket measures price increases of the services furnished by excluded hospitals, including LTCHs. We believe that there is insufficient data to develop a market basket based only on LTCH costs at this time. As we explained in the proposed rule, in computing hospital- specific cost-to-charge ratios, we matched the costs for which we had the most recent and [[Page 56015]] complete cost reporting period data to the claims in the MedPAR file for each month in that cost reporting period. Comment: One commenter believed that a rural adjustment is an important component of the LTCH prospective payment system; the IRF prospective payment system provides for a 19.4 percent payment adjustment for rural hospitals and units. In the absence of a rural adjustment, the commenter believed that those LTCHs located in rural areas will be placed at a competitive disadvantage in the purchasing of hospital services and medical supplies since they share the labor market with rehabilitation hospitals. Response: As we explained in the proposed rule, while our data did identify 14 rural LTCHs, the analysis of the data associated with these rural providers did not support a payment adjustment for LTCHs located in rural areas. Therefore, under the proposed LTCH prospective payment system, all LTCHs would be treated the same for the purposes of payment, regardless of location. With regard to the 14 rural LTCHs, in the proposed rule, we compared the hospital's projected payments to both their projected costs and to what TEFRA payments would be and determined a proposed LTCH prospective payment system payment-to-cost ratio of 1.1337 and a proposed new LTCH prospective payment system payment-to-current TEFRA payment ratio of 1.2327 for those hospitals. These ratios showed that the prospective payments under the proposed LTCH prospective payment system for rural hospitals were expected to exceed their costs by 13.37 percent and exceed their payments under the TEFRA system by 23.27 percent. In this final rule, based on updated data and including the policy changes discussed above, rural hospitals are still projected to have positive ratios; for example, a new LTCH prospective payment system payment-to-current TEFRA payment ratio of 1.0796 and a new LTCH prospective payment system payment-to-cost ratio of 1.0333 (based on estimated TEFRA payments and case-mix data that were available from the MedPAR file for 194 LTCHs). Therefore, we believe the data continue to support our position that a rural location adjustment is not warranted at this time. We also point out that this was not the case for rehabilitation facilities. The regression data for IRFs showed a basis for recognizing additional costs at rural locations. Thus, under the IRF prospective payment system, there was a need for some type of adjustment for rural location. Comment: One commenter supported our assessment that because of the low number of rural LTCHs (5 percent of the total universe) and the modest volume of patients treated in these facilities, there should not be a rural location adjustment. Response: We appreciate the commenter's support of our position on this issue. However, we note that our policy was not based on the number of rural LTCHs or the volume of patients. Rather, the policy decision not to include a rural adjustment in the LTCH prospective payment system is based on a regression analysis of data from rural hospitals, which did not show that an adjustment is appropriate. Comment: One commenter asked whether the cost-to-charge ratios that appear in the ratesetting file on the CMS website were adjusted for inflation. Response: We did not apply an inflation factor to the cost-to- charge ratios since both costs and charges were taken from the same year's data (for example, FY 1999). Since we would use the same inflation factor for both the numerator (costs) and denominator (charges), the resulting ratio with the inflation factor applied would be equal to the ratio without the application of the inflation factor. Therefore, an inflation factor is unnecessary. In determining the cost- to-charge ratios, costs were taken directly from the MedPAR file. Comment: One commenter asked why cost-to-charge ratios greater than ``2'' were in the calculation of payment amounts. Response: We believe that the cost-to-charge ratios greater than ``2'' are legitimate and, thus, we did not believe it was appropriate to exclude them. Comment: One commenter noted that cost-to-charge ratios are defined as the ``ratio of costs to charges from total cost report data in HCRIS matching charge data from the MedPAR files,'' and asked if this meant that a ratio of costs from the cost report to charges from the MedPAR file was used to determine the cost-to-charge ratio or if this meant that the cost-to-charge ratios appearing in the cost reports were applied to charges in the MedPAR file. If the latter method was used, the commenter wanted to know how the cost-to-charge ratios were calculated from the cost report data. Response: A ratio of costs from the cost report to charges from the MedPAR file was created to determine the cost-to-charge ratio. The cost-to-charge ratios were determined by dividing the average cost per case from the LTCH's most recent available cost report by the LTCH's average covered charge per case from corresponding MedPAR data for the same months as the months covered by the cost reporting period. For example, for a LTCH with a 12-month cost reporting period beginning on July 1, 1999 and ending on June 30, 2000, we used MedPAR data for claims discharged from July 1999 through June 2000 to compute its cost- to-charge ratio. The cost per case for each hospital is calculated by summing all costs and dividing by the number of corresponding cases. Multivariate regression analysis is the standard statistical technique for examining cost variation that was used to analyze potential payment adjustments for LTCHs. We looked at two standard models--(1) a double log regression explanatory model to examine the impact of all relevant factors that might potentially affect a LTCH's cost per case; and (2) a payment model that examines the impacts of those factors that were determined to affect costs and, therefore, were used to determine payment rates. In multivariate regression, the estimated average cost per case (the dependent variable) at the LTCH can be explained or predicted by several independent variables, including the case-mix index, the wage index for the LTCH, and a vector of additional explanatory variables that may affect a LTCH's cost per case, such as a teaching program or the proportion of low-income patients. The case-mix index is the average of the LTC-DRG weights, derived by the hospital-specific relative value method, for each LTCH. Short-stay outlier cases are weighted based on the ratio of the length of stay for the short-stay case to the average length of stay for nonshort-stay cases in that LTC-DRG. We simulated payments using an estimated budget-neutral payment rate and the regression coefficients as proxies for payment system adjustments. Then we calculated payment- to-cost ratios for different classes of hospitals for specific combinations of payment policies. We examined payment variables applicable to the hospital inpatient and IRF prospective payment systems, including the disproportionate share patient percentage, both the resident-to-average daily census ratio and the resident-to-bed ratio teaching variables, and variables that account for location in a rural or large urban area. A discussion of the major payment variables and our findings appears below. 1. Area Wage Adjustment Section 307(b) of Public Law 106-554 requires that we examine the [[Page 56016]] appropriateness of an area wage adjustment. Such an adjustment would account for area differences in hospital wage levels and would be made by adjusting the LTCH prospective payment system payment rate by a factor that will reflect the relative hospital wage level in the geographic area of the hospital, as compared to the national average hospital wage level. In the March 22, 2002 proposed rule, we did not propose implementing an area wage adjustment for payments to LTCHs because our regression analysis indicated at that time that a wage adjustment would not increase the accuracy of payments. However, as discussed below, based on the comments we received, we have reconsidered the appropriateness of including an area wage adjustment in the LTCH prospective payment system. Under the acute care hospital inpatient prospective payment system, a wage index is applied to the labor-related share of the operating standardized amount to adjust for local cost variation. The hospital wage data are used also to make an area wage adjustment under the IRF prospective payment system, the SNF prospective payment system, the home health prospective payment system, and the outpatient hospital prospective payment system. As we discussed in the March 22, 2002 proposed rule, we analyzed the appropriateness of an area wage adjustment for LTCHs by evaluating the labor-related share from the excluded hospital with capital market basket. (This is the same market basket that is used in the IRF prospective payment system.) Currently, under the TEFRA reasonable cost-based reimbursement system, the excluded hospital market basket is used to update the cap on LTCHs' target amounts, which are used to determine payments to LTCHs for inpatient operating costs. Since we proposed to implement a single standard Federal rate under the LTCH prospective payment system (section X.K. of this preamble), we used a market basket with a capital component. A further explanation of the excluded hospital with capital market basket can be found in Appendix A of this final rule. The labor-related share is the relative importance of wages, fringe benefits, professional fees, postal services, labor-intensive services, and a portion of the capital share for FY 2003. We determined a labor- related share of the excluded hospital with capital market basket by first estimating the portion related to operating costs. The excluded hospital with capital market basket is based on available cost data for facilities excluded from the acute care hospital inpatient prospective payment system, including long-term care, rehabilitation, psychiatric, cancer, and children's hospitals. In the proposed rule, we determined a labor-related share of the excluded hospital with capital market basket by first estimating the portion related to operating costs. Using the excluded hospital with capital market basket, we determined the labor-related share of operating costs to be 69.428 percent for FY 2003, which is calculated as the sum of the relative importance for wages and salaries (50.381 percent), employee benefits (11.525), professional fees (2.059), postal services (0.244), and all other labor intensive services (5.219). The labor-related share of capital costs in the market basket needed to be considered as well. We used the portion of capital attributed to labor, which our Office of the Actuary estimated on the basis of cumulative knowledge of prospective payment systems, to be 46 percent. This was the same percentage used for both the acute care hospital inpatient capital prospective payment system and the IRF prospective payment system. In the proposed rule for FY 2003, we estimated, based on the historical knowledge of prospective payment systems, the relative importance for capital to be 7.552 percent of the excluded hospital with capital market basket. We then multiplied 46 percent by 7.552 percent to determine that the labor-related share for capital costs for FY 2003 to be 3.474 percent. We then added the 3.474 percent for capital costs to the 69.428 percent for operating costs to determine the total labor-related share based on the excluded hospital with capital market basket. Thus, in the proposed rule, when we examined an adjustment to account for area differences in hospital wage levels, we used a labor-related share of 72.902 percent for the LTCH prospective payment system. Based on updated data, for this final rule we estimate the relative importance for capital for FY 2003 to be 7.515 percent of the excluded hospital with capital market basket. We then, for this final rule, multiplied 46 percent by 7.515 percent to determine that the labor- related share for capital costs for FY 2003 to be 3.457 percent. Accordingly, based on updated data for FY 2003, the labor-related share of the excluded hospital with capital market basket is 72.885 percent (69.428 plus 3.457). Specifically, in the proposed rule, we examined the appropriateness of accounting for differences in area wage levels by multiplying the labor-related share of the unadjusted Federal payment by the FY 2002 inpatient acute care hospital wage index, without taking into account geographic reclassification under sections 1886(d)(8) and (d)(10) of the Act. (This methodology is the same as the methodology used under the IRF prospective payment system and the SNF prospective payment system.) For purposes of both the proposed rule and the final rule, wage data to compute LTCH-specific wage indices were not available. However, LTCHs and other postacute care facilities (for example, IRFs, SNFs, and HHAs) generally compete in the same local labor market for the same types of employees as inpatient acute care hospitals. Comment: Several commenters recommended that we develop a wage index based on LTCH data. One commenter suggested that if LTCH wage data are unavailable due to the lack of Worksheet S-3 data, other means could be utilized in the short term to create a labor adjustment mechanism. Alternatively, the commenter suggested that the wage indices used for the acute care hospital inpatient prospective payment system could be weighted to account only for those wage areas containing a LTCH. One commenter suggested that the payments under the LTCH prospective payment system should be adjusted using the current inpatient acute care hospital wage indices, but a different labor- related share should be chosen to reflect the experience of LTCHs. Another commenter recommended establishing a LTCH wage index using the labor share estimated by the excluded hospital market basket and the wage indices used in the IRF prospective payment system. Response: At this time, we are unable to develop a separate wage index for LTCHs based solely on LTCH data. Currently, there is a lack of specific LTCH wage and staffing data necessary to develop a separate LTCH wage index accurately. As we stated in the proposed rule, in order to accumulate the data needed for such an effort, we would need to make modifications to the Medicare hospital cost report. Because we do not have LTCH specific wage data, at this time we are unable to determine an appropriate weighting factor for the acute care wage index to account only for those wage areas containing a LTCH. In the future, we will continue to research the appropriateness of the acute care hospital wage index for LTCHs and may investigate the feasibility of developing a wage index specific to LTCHs. However, at this time, we believe that the wage index based on acute care [[Page 56017]] hospital wage data contains the best and most appropriate data to use, and it is the same wage index used in the prospective payment system for other postacute care for providers (IRFs, SNFs, and HHAs). Therefore, we believe the acute care hospital wage index for FY 2003 is appropriate since LTCHs and other postacute care facilities generally compete in the same local labor market for the same types of employees as inpatient acute care hospitals. In addition, we believe that the labor-related share, which is based on the excluded hospital with capital market basket, appropriately reflects the experience of LTCHs since it is based on available cost data for facilities excluded from the acute care hospital inpatient prospective payment system, including long-term care, rehabilitation, psychiatric, cancer, and children's hospitals. Comment: Many commenters expressed concern that no area wage adjustment was provided for in the LTCH prospective payment system. Specifically, they noted the following issues: (1) LTCHs in high wage areas will have difficulty competing in labor markets with other providers whose payments are wage adjusted; (2) LTCHs in high wage areas will have difficulty in recruiting staff with the appropriate skill mixes; and (3) services in high wage areas will need to be cut to meet fixed LTCH prospective payment system payments that are not adjusted to account for differences in area wages. Given these concerns, one commenter submitted findings by The Lewin Group regarding the regression analysis on a wage adjustment for LTCHs. The Lewin Group performed an analysis which showed that by removing from the sample one LTCH that has high volume and very low cost per case, the wage index is shown to have a positive and statistically significant impact on overall costs (the wage index coefficient was found to be 18.8 percent, which is approximately 25 percent of the full labor-cost share). Therefore, the commenter believed it is appropriate to include the area wage adjustment in a 5-year transition period. The commenter also suggested that if we are not inclined to include an area wage adjustment, an alternative would be to use a modified area wage index adjustment that have ``soft'' upper and lower wage adjustment limits to lessen the gains and losses that otherwise might occur. Another commenter stated that based on the analysis by The Lewin Group, the statistical results found by us may be influenced by a small number of extreme values from a few hospitals that unduly influenced the statistical models. Other commenters asserted that the sample of LTCHs used by us is not statistically valid for determining whether a wage adjustment is appropriate. One commenter pointed out that the ratesetting file used by us consisted of 20 percent of the LTCHs being located in Texas and 10 percent located in Louisiana. The commenter believed that, since these two States typically have lower wages than the rest of the country, by not incorporating a wage adjustment, we are inappropriately reimbursing providers across all States and failing to take into account the evidence before it. One commenter claimed that as it is obvious the data or the statistical analysis, or both, used by us are not accurate or appropriate for the sample of LTCHs used, it is not reasonable to conclude that LTCHs have a labor-related share of cost of only 19.91 percent. The commenter cited Tables 7 and 8 of the Health Care Financing Administration Review/Winter 2001, which show the cost of routine nursing care (including bed and board) as representing an average 66 percent of costs of the LTCHs. Another commenter stated that even though the results of our regression model do not support a wage adjustment, there is empirical data compiled by the Bureau of Labor Statistics that clearly identified the wide variability of wages across the country. Several other commenters asserted that allowing a wage adjustment for other providers, but not LTCHs, based on statistical accuracy from a past time period, is poor public policy and this policy could lead to destabilization of payments rates and should be avoided. One commenter stated that our belief that an area wage index adjustment as a component of a LTCH prospective payment system does not improve the statistical accuracy of the payment is counter intuitive, fails to address concerns that inadequate financing of labor costs will adversely affect patient care, and fails to address a statement made by MedPAC staff that the quality of LTCH data may have an effect on analysis of this issue. Several commenters also cited MedPAC's June 2001 Report to Congress, in which it states that ``the objective of the geographic adjustment is to make Medicare's payment rates accurately reflect the costs efficient providers would incur in furnishing services to beneficiaries given local market wages.'' In that same report, MedPAC also stated that without a geographic wage adjustment, Medicare's payment rates would be too high in labor markets with relatively low wage rates and providers would face incentives to furnish too many services, while Medicare's payment rates would be too low in labor markets with relatively high wage rates, ``giving providers financial incentives to produce too few services, stint on services or inputs (especially labor), or cease participating in Medicare.'' Other commenters pointed out that numerous older LTCHs, located primarily in high wage areas, have been constrained by their TEFRA target amounts and have been more vigilant in reigning in their expenses. Another commenter speculated that if the average cost per case in LTCHs did not vary with the wage index, the data were unreliable or there is a wide heterogeneity among services. The commenter believed that service heterogeneity is significant because newer facilities have not been subject to the same cost limits as older facilities, and there is a large mix of old and new facilities in the LTCH sector. Furthermore, the commenter explained that, historically, older facilities tend to be located in the northeastern region of the country where the cost of labor is higher on average than in other areas of the country. Therefore, the historical effect of the TEFRA caps may be obscuring the effect of regional differences in wage levels in the empirical model. The commenter added that, moreover, the theory of prospective payment systems is that the national rate is intended to cover a set of clinically similar services. Given that wage levels have proven to vary regionally, by not providing a wage adjustment, the policy gives the national average rate less purchasing power in high labor cost regions of the country, thus diminishing the level of care available to LTCH Medicare beneficiaries in those areas. Other commenters expressed concern that since, at present, approximately 33 percent of LTCHs are geographically clustered in three States (Texas, Louisiana, and Massachusetts), it would appear that a prospective payment system with no wage adjustment would encourage further clustering of LTCHs. Another commenter also noted that the negative statistical finding could perpetuate acknowledged distortions of the TEFRA payment system. Thus, a wage adjustment for high wage areas would be appropriate. With respect to our assertion that including a wage adjustment would inappropriately redistribute payments to LTCHs by shifting reimbursement to LTCHs that are located in an area within a higher wage index, but in fact, with lower costs, one commenter stated that [[Page 56018]] we need to recognize and reward these efficient providers, which would be consistent with the objectives of the proposed prospective payment system for LTCHs, that is, ``to provide incentives to control costs and to furnish services as efficiently as possible.'' Response: In examining the comments and suggestions we received, several issues led us to reconsider our previous decision. First, we agree with the commenters that there is a possibility that TEFRA policies may have in some way affected the relationship between LTCHs' geographic location and costs. As was pointed out by several commenters, older LTCHs with relatively low TEFRA ceilings are often located in large urban areas, which may provide an explanation for the results of our statistical analysis. In addition, the historical effect of the TEFRA caps may be affecting the expected effect of regional differences in wage levels of LTCHs operating under the prospective payment system. We also agree with many of the commenters' concerns that, by providing for a wage adjustment, LTCHs in high wage areas may help ensure that these LTCHs can compete in labor markets with other providers whose payments are wage adjusted; can recruit appropriate staff; and can deliver sufficient high quality services to Medicare beneficiaries. As to the sensitivity analysis that was conducted, we agree with commenters that it is reasonable to expect that a hospital's wage costs will affect total costs and that, in consequence, the payment amounts under the new system should be adjusted using a wage index. However, the statistical analysis presented by one commenter included analysis where the effect of wages, though small, was positive and significant, as well as other models where the effect was small and negative, but also significant. This indicates that the regression estimates are very sensitive to the inclusion and exclusion of certain facilities. Unfortunately, this limits our ability to base policy on the results of the commenter. We believe that it is reasonable to assume that wages have an effect on case-mix adjusted LTCH costs. However, we believe that these inconsistent results may be due to limitations in the current data from the LTCHs. This is not surprising because case-mix information has not been previously used for payment for these hospitals, and since various LTCHs have been subject to varying TEFRA limits. Despite the results of the commenter's statistical analysis, we have reconsidered our proposal not to include a wage adjustment and now believe that the conceptual reasons for having an area wage adjustment support transitioning into a wage adjustment, notwithstanding the data problems and issues with the regression analysis. We reevaluated the statistical analysis presented in the proposed rule along with our most recent findings based on the latest available data. Based on the results of this reevaluation, we now agree with the commenter's suggestion that it is appropriate to phase-in a wage adjustment over a transition period. In the proposed rule, we analyzed the results of the wage index coefficient derived from regression analysis to validate the labor- related share calculated from the market basket. In the regression, we standardized each LTCH's cost per case by the various factors, such as case-mix, bed size, number of cases, length of stay, and occupancy. The wage index coefficient allowed us to approximate the labor-related portion of cost per case. Since the labor-related share derived from the market basket is the proportion of costs that have been identified as being influenced by the local labor amount, we expected this coefficient to be statistically significant and near our market basket measure. The double-log regression analysis in the proposed rule generated a wage index coefficient, which approximated the labor- related portion of cost per case, that was not near the market basket measure (72.902 percent). For this final rule, based on updated data we reran the regression, and the double log regression continues to show a wage index coefficient for the market basket, which at most is approximately 20 percent. While the statistical analysis did not show a significant relationship between LTCHs' costs and their geographic location, we believe it is appropriate to include some adjustment for area wages. Accordingly, we will incorporate a wage index adjustment, but beginning with FY 2003, as one commenter suggested, we will transition to a full wage adjustment over a 5-year period. Accordingly, for the first year of the LTCH prospective payment system, the area wage adjustment will be one-fifth of the full FY 2002 wage index without geographic reclassifications. We will continue to reevaluate LTCH data as they become available and would propose to adjust the phasein if subsequent data support a change. Therefore, we are amending Sec. 412.525 to add a new paragraph (c), which provides for an appropriate adjustment to the labor-related share of the unadjusted LTCH Federal rate. As we described in the proposed rule and as several commenters supported, we are establishing a LTCH wage index using the labor- related share estimated by the excluded hospital market basket with capital and the wage indices computed from data from inpatient acute care hospital wage data without regard to reclassifications under sections 1886(d)(8) or 1886(d)(10) of the Act. This is consistent with the area wage adjustments under the prospective payment systems for other postacute care providers (IRFs, SNFs, and HHAs). As discussed above, to calculate wage adjusted payments for the payment rates set forth in this final rule, the prospectively determined unadjusted LTCH Federal rate is multiplied by the labor- related percentage (72.902) to determine the labor-related share of LTCH Federal rate. The labor-related share is then multiplied by the applicable LTCH wage index as shown in Table 1 (for urban areas) and Table 2 (for rural areas) in the Addendum of this final rule. For FY 2003, the applicable LTCH wage index will be one-fifth (the first year's proportionate fraction of a 5-year phasein) of the full FY 2002 inpatient acute care hospital wage index, without taking into account geographic reclassification under sections 1886(d)(8) and (d)(10) of the Act. (See section X.J.2. of this preamble regarding geographic reclassification.) The resulting wage-adjusted labor-related share is then added to the nonlabor-related share (27.098 percent), resulting in a wage adjusted payment rate. The following example illustrates how the wage-adjusted LTCH Federal rate would be computed for a LTCH located in Chicago, IL (MSA 1600) with a hypothetical LTCH unadjusted Federal rate of $10,000. The FY 2003 one-fifth LTCH wage index value for MSA 1600 is 1.0202. The labor-related share (72.885 percent) of the hypothetical LTCH Federal rate is $7,288.50 ($10,000 x 0.72885) and the nonlabor- related share (27.115 percent) is $2,711.50 ($10,000 x 0.27115). Therefore, the wage-adjusted LTCH payment rate is: $10,147.23 = ($7,288.50 x 1.0202) + $2,711.50. For FY 2003, the applicable LTCH wage index for LTCHs located in urban areas and for LTCHs located in rural areas are shown in Tables 1 and 2, respectively, in the Addendum to this final rule. Comment: MedPAC examined two possible reasons why we found that the differences in local input prices were not significant predicators of costs for care in LTCHs: high correlation of patient need with local wages and a lack [[Page 56019]] of variation in wages for locations. It found ``the correlation of patient need and wages to be low'' and that ``the wages for counties where LTCHs are located did vary widely.'' MedPAC also hypothesized that limitations on increases in costs imposed by the TEFRA payment system could have distorted costs; however, it was unable to test this third possibility. MedPAC expressed concern that if we do not adjust rates for local input prices, ``hospitals with low wages may be overpaid and those with high wages may be underpaid.'' However, MedPAC also contended that ``if CMS does adjust to account for differences in wages, the opposite error may result.'' In conclusion, MedPAC stated that the need for a wage adjustment should be reexamined when better data are available. Three additional commenters agreed with our proposal not to include an adjustme

