Medicare program; end-stage renal disease quality incentive program. Final rule

This final rule will implement a quality incentive program (QIP) for Medicare outpatient end-stage renal disease (ESRD) dialysis providers and facilities with payment consequences beginning January 1, 2012, in accordance with section 1881(h) of the Act (added on July 15, 2008 by section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA)). Under the ESRD QIP, ESRD payments made to dialysis providers and facilities under section 1881(b)(14) of the Social Security Act will be reduced by up to two percent if the providers/facilities fail to meet or exceed a total performance score with respect to performance standards established with respect to certain specified measures.     

Medicare program; coverage of epoetin (EPO) used by competent home dialysis patients--HCFA. Final rule

This final rule adopts as final the interim final rule that provided 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 established criteria for selection of patients that can be considered "competent" and for monitoring of the patients who are selected. It also makes minor changes in response to public comments on the interim rule. The interim rule was necessary to implement section 4201(d)(1) of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90). The purpose of the amendments is to facilitate use of EPO at home, while ensuring that such use of the drug is safe.     

Medicare program; end-stage renal disease (ESRD) payment exception requests and organ procurement costs--HCFA. Final rule

These final regulations specify the criteria HCFA uses to determine if a facility that furnished dialysis services to Medicare patients with end-stage renal disease (ESRD) qualifies for a higher payment under an exception to its prospectively determined payment rate and the procedures HCFA uses to evaluate ESRD payment exception requests. These regulations also revise the way HCFA computes acquisition costs for organs that are transplanted into Medicare beneficiaries.     

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; 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; 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 and Medicaid programs; conditions for coverage for end-stage renal disease facilities. Final rule

This rule finalizes the February 4, 2005 proposed rule entitled "Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities." It establishes new conditions for coverage that dialysis facilities must meet to be certified under the Medicare program. This final rule focuses on the patient and the results of care provided to the patient, establishes performance expectations for facilities, encourages patients to participate in their plan of care and treatment, eliminates many procedural requirements from the previous conditions for coverage, preserves strong process measures when necessary to promote meaningful patient safety, well-being, and continuous quality improvement. This final rule reflects the advances in dialysis technology and standard care practices since the requirements were last revised in their entirety in 1976.     

Medicare program; date for filing Medicare cost reports--HCFA. Final rule

This final rule extends the time frame providers have to file cost reports from no later than 3 months after the close of the period covered by the report to no later than 5 months after the close of that period. This change is necessary to ensure that providers have an adequate amount of time to file complete and accurate cost reports. We are also defining what HCFA considers to be an "acceptable" cost report submission.     

Medicare program; payment for customized wheelchairs--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to payment for customized wheelchairs that was published on December 20, 1991 (56 FR 65995). The interim rule set forth the Secretary's criteria that a wheelchair must meet to be considered a customized item and allowed for a payment for the purchase of customized items based on the carrier's case-by-case determination. This rule establishes the interim rule as a final regulation with one change. The change is based on our review and consideration of the public comments. EFFECTIVE DATE: This final rule is effective on July 30, 1993.     

Medicare program; payment for preadmission services--HCFA. Final rule

This final rule responds to public comments on the January 12, 1994, interim final rule with comment period that provided that inpatient hospital operating costs include certain preadmission services furnished by the hospital (or by an entity that is wholly owned or operated by the hospital) to the patient up to 3 days before the date of the patient's admission to that hospital. These provisions implement amendments made to section 1886(a)(4) of the Social Security Act by section 4003 of the Omnibus Budget Reconciliation Act of 1990.     

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; aggregation of Medicare claims for administrative appeals--HCFA. Final rule

Medicare beneficiaries and, under certain circumstances, providers, physicians and other entities furnishing health care services may appeal adverse determinations regarding certain claims for benefits payable under part A and part B of Medicare. For administrative appeals at the carrier or intermediary hearing level or administrative law judge (ALJ) level and for any subsequent judicial review, the amount remaining in dispute must meet or exceed threshold amounts set by statute. Section 1869(b)(2) of the Social Security Act permits claims to be aggregated to reach the ALJ hearing threshold amounts. This final rule establishes a system of aggregation under which individual appellants have one set of requirements for aggregating claims and two or more appellants have a different set of requirements for aggregating claims.     

Medicare program; availability of Medicare data for performance measurement. Final rule

This final rule implements Section 10332 of the Affordable Care Act regarding the release and use of standardized extracts of Medicare claims data for qualified entities to measure the performance of providers of services (referred to as providers) and suppliers. This rule explains how entities can become qualified by CMS to receive standardized extracts of claims data under Medicare Parts A, B, and D for the purpose of evaluation of the performance of providers and suppliers. This rule also lays out the criteria qualified entities must follow to protect the privacy of Medicare beneficiaries.     

Medicare program; Medicare and laboratory certification program; enforcement procedures for laboratories--HCFA. Final rule

These regulations set forth the rules for sanctions that HCFA may impose on laboratories that are found not to meet Federal requirements. These include the principal sanctions of suspending, limiting, or revoking the laboratory's certificate issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and cancelling the laboratory's approval to receive Medicare payment for its services, and the alternative sanctions that may be imposed instead of or before the principal sanctions. These amendments are necessary to conform HCFA regulations to changes made in the law by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) and the 1988 amendments to section 353 of the Public Health Service Act (PHS Act). The latter are commonly referred to as "CLIA 88". The purpose of the amendments is to ensure that functioning laboratories are capable of providing accurate and reliable test results and that the health of individuals served by the laboratory and that of the general public is not adversely affected by laboratory operations and by testing procedures that do not meet the standards set forth in other subparts of part 493 of the HCFA regulations.     

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.     

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; fee schedule for physicians' services--HCFA. Final rule

This final rule sets forth a fee schedule for payment for physicians' services beginning January 1, 1992. Establishment of this fee schedule is required by section 6102(a) of the Omnibus Budget Reconciliation Act of 1989, as amended by the Omnibus Budget Reconciliation Act of 1990. This final rule explains which services will be included in the fee schedule and sets forth the formula for computing payment amounts. Application of transition rules during 1992 through 1995 is also described, as well as other adjustments to fee schedule payment amounts.