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; Medicare Geographic Classification Review Board--procedures and criteria--HCFA. Final rule with comment period

This final rule with comment period responds to public comments on the September 6, 1990 interim final rule with comment period that established the Medicare Geographic Classification Review Board (MGCRB) and sets forth the criteria for the MGCRB to use in issuing its decisions concerning the geographic reclassification of hospitals for purposes of payment under the prospective payment system. In addition, this final rule with comment period implements provisions of the Omnibus Budget Reconciliation Act of 1990 concerning the MGCRB.     

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; State Health Insurance Assistance Program (SHIP). Health Care Financing Administration (HCFA), HHS. Interim final rule with comment period

This interim final rule explains the terms and conditions that apply to grants to States for counseling and assistance to Medicare beneficiaries, and makes several minor technical clarifications about program compliance. We also specify our policies regarding the treatment of funds associated with the management of this program, including user fee assessments not in effect when prior regulations were issued. This interim final rule is issued in accordance with section 4360 of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) and section 1857(e)(2) of the Social Security Act (the Act).     

Medicare program; beneficiary counseling and assistance grants program--HCFA. Interim final rule with comment period

This interim final rule establishes a minimum level of funding for grants made to States for the purpose of providing information, counseling, and assistance relating to the procurement of adequate and appropriate health insurance coverage to individuals who are eligible to receive benefits under the Medicare program. This rule implements, in part, section 4360(a) of the Omnibus Budget Reconciliation Act of 1990.     

Medicaid program; Drug Use Review program and electronic claims management system for outpatient drug claims--HCFA. Interim final rule with comment period

This interim rule implements provisions of section 4401 of the Omnibus Budget Reconciliation Act of 1990 by specifying requirements for a Drug Use Review program, including the establishment of Drug Use Review Boards, and for an Electronic Claims Management system for outpatient drugs.     

Registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.     

Office of Inspector General; Medicare and state health care programs: fraud and abuse; issuance of advisory opinions by the OIG. Final rule

OIG is adopting in final form, without change, an interim final rule published on March 26, 2008 (73 FR 15937). We received no comments to the interim final rule. The interim final rule revised the process for advisory opinion requestors to submit payments for advisory opinion costs.     

Medicaid program: outstation intake locations for certain low-income pregnant women, infants, and children under age 19--HCFA. Interim final rule with comment period

This interim final rule interprets the statutory requirement that State Medicaid agencies must provide for receiving and initially processing Medicaid applications by certain low-income pregnant women, infants, and children under age 19 at locations other than those used for the receipt and processing of applications for Aid to Families with Dependent Children (AFDC). The statutory requirement also provides that the application form for these individuals must be different from the application form used for AFDC. The basis for the rule is section 1902(a)(55) of the Social Security Act, as added by section 4602(a)(3) of the Omnibus Budget Reconciliation Act of 1990.     

Medicare program; Medicare coverage of screening mammography--HCFA. Interim final rule with comment

This interim final rule implements section 4163 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508), which provides limited coverage for screening mammography services. It amends current Medicare regulations to set forth payment limitations and conditions for coverage of screening mammography. The conditions consist of quality standards to assure the safety and accuracy of screening mammography services performed by qualified physicians and other suppliers of these services.     

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 and Medicaid programs; programs of all-inclusive care for the elderly (PACE); program revisions. Final rule

This rule finalizes the interim final rule with comment period published in the Federal Register November 24, 1999 (64 FR 66234) and the interim final rule with comment period published in the Federal Register on October 1, 2002 (67 FR 61496). The November 1999 interim final rule implemented sections 4801 through 4803 of the Balanced Budget Act of 1997 (Pub. L. 105-33) and established requirements for Programs of All-inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The interim final rule with comment period published on October 1, 2002 (67 FR 61496) implemented section 903 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554).     

Medicaid program; limitations on provider-related donations and health care-related taxes; limitations on payments to disproportionate share hospitals--HCFA. Final rule

This final rule clarifies HCFA's policies concerning provider related donations and health care related taxes. In addition, this final rule revises regulations with regard to disproportionate share hospital spending limitations. This final rule amends an interim final rule that was published in the Federal Register on November 24, 1992. The interim final rule established in Medicaid regulations limitations on Federal financial participation (FFP) in State medical assistance expenditures when States receive funds from provider-related donations and revenues generated by certain health care-related taxes. The interim final rule also added provisions that establish limits on the aggregate amount of payments a State may make to disproportionate share hospitals for which FFP is available. The provisions of the interim final rule were required by the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991.     

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.     

Medicaid program; state share of financial participation--HCFA. Withdrawal of interim final rule with comment

On September 12, 1991, we published in the Federal Register an interim final rule with comment entitled "Medicaid Program; State Share of Financial Participation" (56 FR 46380). It dealt with the use of State taxes and provider donations as the State share of the costs of the Medicaid program. On October 31, 1991, we published a clarifying interim final rule with comment (56 FR 56132), which withdrew and cancelled the September 12, 1991, interim final rule. After further consideration, the Secretary has also decided to withdraw the October 31, 1991 interim final rule.     

Medicare program; payment for preadmission services--HCFA. Interim final rule with comment period

This interim final rule specifies 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.