Medicare program; coverage of erythropoietin (EPO) used by competent home dialysis patients--HCFA. Interim final rule with comment period

This final rule-- Provides for Medicare coverage of EPO used by ESRD beneficiaries who dialyze at home and are competent to use the drug without medical or other supervision; and Establishes criteria for selection of patients that can be considered "competent" and for monitoring of the patients who are selected. This rule is necessary to implement section 4201(d)(1) of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90). The purpose is to facilitate use of EPO at home, while ensuring that such use of the drug is safe and effective.     

Medicare program; Medicare coverage of screening mammography--HCFA. Final rule

This final rule revises interim final regulations on Medicare coverage of screening mammography that were published in the Federal Register on December 31, 1990 (55 FR 53510). Those regulations implemented section 4163 of the Omnibus Budget Reconciliation Act of 1990, setting forth payment limitations and conditions for coverage of screening mammography. The conditions consist of quality standards to ensure the safety and accuracy of screening mammography services performed by qualified physicians and other suppliers of these services. As a result of the implementation of the Mammography Quality Standards Act of 1992 (MQSA) by the Food and Drug Administration (FDA), we are conforming the conditions for coverage to the applicable FDA certification requirements that all Medicare suppliers of services must meet effective October 1, 1994. The revisions in this final rule also respond to certain comments we received on the interim final rule published on December 31, 1990; they provide clarification of certain of its provisions; and they establish conditions for coverage of diagnostic mammography that are similar to those we have established for screening mammography. In addition, this final rule reflects changes resulting from the final rule on the fee schedule for physicians' services, which was published in the Federal Register on December 2, 1993 (58 FR 63626).     

Medicare program; payment for physician outpatient maintenance dialysis services and other physician services for ESRD patients--HCFA. Final rule

This final rule reinstates a modified version of the initial method of payment for physician dialysis services and clarifies and modifies some of the principles of the monthly capitation payment method. Under both the initial method and the monthly capitation payment method, we specify that, to be payable, physician services must meet certain requirements that distinguish services furnished to individual patients from services furnished to facilities that benefit the facilities' patients generally. The reinstatement of a modified version of the initial method is necessitated by a court order.     

Medicare program; Medicare coverage of home health services, Medicare conditions of participation, and home health aide supervision--HCFA. Final rule

This regulation specifies home health aide supervision and duty requirements applicable to all home health agencies (HHAs) and hospices that furnish home health aide services under the Medicare program. It also specifies limitations and exclusions applicable to home health services covered under Medicare. The purpose of this regulation is to clarify Medicare home health policy and to promote consistent administration of the home health benefit.     

Medicare program; payment change for home dialysis--HCFA. Final rule

This final rule implements section 6203(b) of the Omnibus Budget Reconciliation Act of 1989, which limits Medicare payment for home dialysis equipment, supplies, and support services. Also, in accordance with section 6203(b), we are requiring that, for Medicare payments to be made to a supplier of home dialysis supplies and equipment when the patient's self-care home dialysis is not under the direct supervision of a Medicare approved renal dialysis facility, the patient must certify that the supplier is the sole supplier of his or her dialysis supplies and equipment. In addition, the supplier must agree to receive payment on an assignment basis only and must certify that it has entered into a written agreement with an approved dialysis facility, under which the facility agrees to furnish the patient with all home dialysis services. We are also providing a one-time-only opportunity for certain home dialysis patients to immediately change their current method of payment.     

Medicare program; standards for quality of water used in dialysis and revised guidelines on reuse of hemodialysis filters for end-stage renal disease (ESRD) patients--HCFA. Final rule

This final rule revises the Medicare conditions for coverage of suppliers of end-stage renal disease services. The revisions remove general language in the regulations regarding water quality; incorporate by reference standards for monitoring the quality of water used in dialysis as published by the Association for the Advancement of Medical Instrumentation (AAMI) in its document, "Hemodialysis Systems" (second edition); and update existing regulations to incorporate by reference the second edition of AAMI's voluntary guidelines on "Reuse of Hemodialyzers."     

Medicare program; protocol for the reuse of dialysis bloodlines--HCFA. Final rule

This final rule implements section 1881(f)(7) (B) and (C) of the Social Security Act, added by sections 9335(k) and 4036(c) of the Omnibus Budget Reconciliation Acts of 1986 and 1987. That legislation precludes end-stage renal disease (ESRD) facilities from reusing dialysis bloodlines after July 1, 1988 unless the Secretary has established a protocol for their reuse and the facility follows the protocol. These provisions constitute both a Medicare condition of coverage for ESRD facilities and a condition for payment for dialysis treatment involving reused bloodlines for those facilities which elect to reuse them.     

Medicare program; swing-bed program changes--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to hospital swing beds that was published on September 7, 1989 (54 FR 37270). The interim rule expanded the swing-bed program to encompass rural hospitals with 50 to 99 beds. It established requirements that approved swing-bed hospitals with more than 49 beds must meet. This rule establishes the interim rules as final regulations with changes. These changes are based on our review and consideration of the public comments.     

Medicare program; home health agencies: conditions of participation--HCFA. Final rule

This final rule responds to the major comments we received on an interim final rule that was published on August 14, 1989 (54 FR 33354). That interim final rule added requirements to the current conditions of participation for home health agencies (HHAs). Specifically, the rule specified requirements for protecting and promoting patient rights; training and competency evaluation of home health aides; notifying State entities responsible for the licensing or certification of HHAs of changes in ownership of the agency or management of the agency; including an individual's plan of care as part of the individual's clinical records; and operating and furnishing services in compliance with applicable Federal, State, and local laws and regulations and with accepted professional standards and principles that apply to professionals furnishing home health services. Most of the provisions of the rule implemented section 930 of the Omnibus Reconciliation Act of 1980 (Pub. L. 96-499), section 4021 of the Omnibus Budget Reconciliation Act of 1987 (Pub. L. 100-203), and section 411(d) of the Medicare Catastrophic Coverage Act of 1988 (Pub. L. 100-360). This final rule implements changes, based on our review and consideration of the public comments, concerning patient notification of changes in payment liability, requirements for evaluators and instructors of home health aides, in-service training, and supervisory visits, and clarifies other home health issues.     

Medicare program: review of national coverage determinations and local coverage determinations. Final rule

This final rule will create a new process to allow certain Medicare beneficiaries to challenge national coverage determinations (NCDs) and local coverage determinations (LCDs). It will implement portions of section 522 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000. The right to challenge NCDs and LCDs will be distinct from the existing appeal rights that Medicare beneficiaries have for the adjudication of Medicare claims.     

Medicare program; Medicare Part D claims data. Final rule

This final rule allows the Secretary to collect claims data that are presently being collected for Part D payment purposes for other research, analysis, reporting, and public health functions. The Secretary needs to use these data because other publicly available data are not, in and of themselves, sufficient for the studies and operations that the Secretary needs to undertake as part of the Department of Health and Human Service's obligation to oversee the Medicare program, protect the public's health, and respond to Congressional mandates. These data will also be used to better identify, evaluate and measure the effects of the Medicare Modernization Act of 2003, (MMA).     

Medicare program; photocopying reimbursement methodology. Final rule

This final rule increases the rate of reimbursement for expenses incurred by prospective payment system PPS) hospitals for photocopying medical records requested by Quality Improvement Organizations (QIOs), formerly known as Utilization and Quality Control Peer Review Organizations (PROs). We are increasing the rate from 7 cents per page to 12 cents per page to reflect inflationary changes in the labor and supply cost components of the formula. This final rule also provides for the periodic review and adjustment of the per-page reimbursement rate to account for inflation and changes in technology. The methodology for calculating the per-page reimbursement rate will remain unchanged. We are also providing for the payment of the expenses of furnishing photocopies to QIOs, to other providers subject to a PPS (for example, skilled nursing facilities and home health agencies), in accordance with the rules established for reimbursing PPS hospitals for these expenses.     

Medicare program; hospice wage index--HCFA. Final rule

This final rule establishes a methodology to update the wage index used to adjust Medicare payment rates for hospice care. It also includes the new wage index, to be effective October 1, 1997. The wage index is used to reflect local differences in wage levels. A new wage index is needed because the index currently applied is based on 1981 wage and employment data and has not been updated since 1983. The methodology is based on the recommendations of a negotiated rulemaking advisory committee comprised of persons who represent interests affected by the hospice rules.     

Medicare program; hospice care amendments. Final rule

This final rule revises existing regulations that govern coverage and payment for hospice care under the Medicare program. These revisions reflect the statutory changes required by the Balanced Budget Act of 1997 (BBA), the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA). Additionally, these revisions reflect current policy on the documentation needed to support a certification of terminal illness, admission to Medicare hospice, and a new requirement that allows for discharges from hospice for cause under very limited circumstances. This final rule does not address the requirement for hospice data collection, the changes to the limitation of liability rules, or the changes to the hospice conditions of participation that were included in the BBA. The intent of this final rule is to expand the hospice benefit periods, improve documentation requirements to support certification and recertification of terminal illness, provide guidance on hospice admission procedures, clarify hospice discharge procedures, update coverage and payment requirements, and address the changing needs of beneficiaries, suppliers, and the Medicare program.     

Medicare program; hospital inpatient value-based purchasing program. Final rule

This final rule implements a Hospital Inpatient Value-Based Purchasing program (Hospital VBP program or the program) under section 1886(o) of the Social Security Act (the Act), under which value-based incentive payments will be made in a fiscal year to hospitals that meet performance standards with respect to a performance period for the fiscal year involved. The program will apply to payments for discharges occurring on or after October 1, 2012, in accordance with section 1886(o) (as added by section 3001(a) of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act)). Scoring in the Hospital VBP program will be based on whether a hospital meets or exceeds the performance standards established with respect to the measures. By adopting this program, we will reward hospitals based on actual quality performance on measures, rather than simply reporting data for those measures.     

Medicare program; revision of the Medicare Economic Index--HCFA. Final rule

Before January 1, 1992, Medicare payments for physicians' services under Part B were limited by the Medicare Economic Index (MEI), which capped prevailing charges. Beginning January 1, 1992, Medicare payments for physicians' services under Part B are made based on a fee schedule. Annual updates to the conversion factor used in establishing the physician fee schedule are based in part on the MEI. This final rule revises the method used to calculate the MEI to more accurately reflect year-to-year price changes affecting the cost of providing physicians' services, thus ensuring appropriate adjustment of Medicare payments.