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 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; Medicare coverage of and payment for bone mass measurements--HCFA. Interim final rule with comment period

This interim final rule with comment period provides for uniform coverage of, and payment for, bone mass measurements for certain Medicare beneficiaries for services furnished on or after July 1, 1998. It implements provisions in section 4106(a) of the Balanced Budget Act of 1997.     

Medicare program; payment for customized wheelchairs--HCFA. Interim final rule with comment period

Section 4152(c)(4)(B) of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) amended section 1834(a)(4) of the Social Security Act to provide that a wheelchair furnished on or after January 1, 1992 is treated as a customized item for payment purposes under part B of Medicare if it meets the definition provided in that paragraph, unless the Secretary develops specific criteria before January 1, 1992, in which case the Secretary's criteria go into effect. This interim final rule with comment period sets forth the Secretary's criteria that a wheelchair must meet to be considered a customized item.     

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.     

Medicare program; continuous use of durable medical equipment--HCFA. Interim final rule with comment period

We are setting forth in this interim final rule with comment period the Secretary's determination, required under section 1834(a)(7)(A) of the Social Security Act, of the meaning of the term "continuous" as that term is used in defining a period of continuous use for which we make payments for durable medical equipment.     

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.     

High risk pools. Interim final rule with comment period. Interim final rule with comment period

This interim final rule with comment period will amend our regulations regarding grants to States for operation of qualified high risk pools to conform to provisions of the Deficit Reduction Act of 2005 and the State High Risk Pool Funding Extension Act of 2006. Those provisions extended funding for seed and operational grants for State High Risk Pools and amended section 2745 of the Public Health Service Act.     

Medicare program; final waivers in connection with the Shared Savings Program. Interim final rule with comment period

This interim final rule with comment period establishes waivers of the application of the Physician Self-Referral Law, the Federal anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the Shared Savings Program), including ACOs participating in the Advance Payment Initiative. Section 1899(f) of the Act, as added by the Affordable Care Act, authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act.     

Medicare program; definition of provider-sponsored organization and related requirements--HCFA. Interim final rule with comment period

The Balanced Budget Act of 1997 establishes a new Medicare + Choice program that significantly expands the health care options available to Medicare beneficiaries. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plans that contract with HCFA. Among the new options available to Medicare beneficiaries is enrollment in a provider-sponsored organization (PSO). This interim final rule with comment period defines the term "provider-sponsored organization" for purposes of the Medicare program and establishes requirements related to meeting this definition. We believe that setting forth the definition of a PSO and the related requirements will facilitate the submission of applications to participate in the Medicare program as a PSO.     

Medicare program; Geographical Classification Review Board; procedures and criteria--HCFA. Interim final rule with comment period

This interim final rule with comment period implements provisions of the Omnibus Budget Reconciliation Act of 1989 establishing the Medicare Geographical Classification Review Board (MGCRB) and sets forth 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.     

Medicare and Medicaid programs; advance directives--HCFA. Interim final rule with comment period

This interim final rule amends the Medicare and Medicaid regulations governing provider agreements and contracts to establish requirements for States, hospitals, nursing facilities, skilled nursing facilities, providers of home health care or personal care services, hospice programs and prepaid health plans concerning advance directives. An advance directive is a written instruction, such as a living will or durable power of attorney for health care, recognized under State law, relating to the provision of health care when an individual's condition makes him or her unable to express his or her wishes. The intent of these provisions is to enhance an individual's control over medical treatment decisions. This rule implements sections 4206 and 4751 of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), Public Law 101-508.     

Medicaid program; citizenship documentation requirements. Interim final rule with comment period

This interim final rule with comment period amends Medicaid regulations to implement the provision of the Deficit Reduction Act that requires States to obtain satisfactory documentary evidence of an applicant's or recipient's citizenship and identity in order to receive Federal financial participation. This regulation provides States with guidance on the types of documentary evidence that may be accepted, including alternative forms of documentary evidence in addition to those described in the statute and the conditions under which this documentary evidence can be accepted to establish the applicant's declaration of citizenship. It also gives States guidance on the processes that may be used to help minimize the administrative burden on both States and applicants and recipients.     

Medicare program; waiver requirements and solvency standards for provider-sponsored organizations--HCFA. Interim final rule with comment period

This interim final rule with a request for comments implements authority to waive, in the case of provider-sponsored organizations (PSOs) that meet certain criteria, the requirement that Medicare + Choice organizations be licensed by a State as risk-bearing entities. The waivers will be approved only under certain conditions where the State has denied or failed to act on an application for licensure. This rule also establishes solvency standards that certain entities must meet to contract as PSOs under the new Medicare + Choice program. These standards apply to PSOs that have received a waiver of the requirement that Medicare + Choice organizations be licensed by a State as risk-bearing entities.     

Medicare program; partial hospitalization services in community mental health centers--HCFA. Interim final rule with comment period

This rule sets forth the coverage criteria and payment methodology for partial hospitalization services in community mental health centers. The purpose of this rule is to establish regulations governing this coverage under the provisions of section 4162 of the Omnibus Budget Reconciliation Act of 1990.     

Medicare Program; establishment of the Medicare+Choice Program--HCFA. Interim final rule with comment period

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice (M+C) program that significantly expands the health care options available to Medicare beneficiaries. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plan choices beyond the original Medicare program or the plans now available through managed care organizations under section 1876 of the Social Security Act. Among the alternatives that will be available to Medicare beneficiaries are M+C coordinated care plans (including plans offered by health maintenance organizations, preferred provider organizations, and provider-sponsored organizations), M+C "MSA" plans, that is, a combination of a high deductible M+C health insurance plan and a contribution to an M+C medical savings account (MSA), and M+C private fee-for-service plans. The introduction of the M+C program will have a profound effect on Medicare beneficiaries and on the health plans and providers that furnish care. The new provisions of the Medicare statute, set forth as Part C of title XVIII of the Social Security Act, address a wide range of areas, including eligibility and enrollment, benefits and beneficiary protections, quality assurance, participating providers, payments to M+C organizations, premiums, appeals and grievances, and contracting rules. This interim final rule explains and implements these provisions. In addition, we are soliciting letters of intent from organizations that intend to offer M+C MSA plans to Medicare beneficiaries and/or to serve as M+C MSA trustees.