Medicaid program; time limitation on price recalculations and recordkeeping requirements under the drug rebate program. Final rule with comment period

On September 19, 1995, we published a proposed rule in the Federal Register that introduced requirements for States and manufacturers pertaining to the Medicaid drug rebate program. We received several comments from States and manufacturers regarding recordkeeping requirements and drug price recalculations. This final rule with comment period finalizes separately, in an accelerated timeframe, two specific provisions of the September 1995 proposed rule. It establishes new recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. It also sets forth a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announces the pressing need for codification of fundamental recordkeeping requirements. Furthermore, it announces our intention to continue to work on finalizing the complete drug rebate regulation for the Medicaid drug rebate program.     

Medicaid program; time limitation on recordkeeping requirements under the drug rebate program. Final rule

This final rule finalizes 10-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. Manufacturers must retain records for 10 years from the date the manufacturer reports data to us for a rebate period. This final rule also finalizes the requirement that manufacturers must retain records beyond the 10-year period if the records are known by the manufacturer to be the subject of an audit or a government investigation. Furthermore, this final rule responds to public comments on the January 6, 2004 interim final rule with comment period and the proposed rule pertaining to the 10-year recordkeeping requirements, respectively.     

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.     

Medicaid program; freedom of choice waiver; conforming changes--HCFA. Interim final rule with comment period

This interim final rule amends existing Medicaid regulations on freedom of choice waivers granted under section 1915(b) of the Social Security Act (the Act) to conform them to the amendments made to the Act by sections 4604 and 4742 of the Omnibus Budget Reconciliation Act of 1990. This rule: Specifies that the Secretary may not waive the requirement that the State plan provide for adjustments in payment for inpatient hospital services furnished to infants under one year of age, or to children under 6 years of age who receive these services in disproportionate share hospitals. Extends to any provider participating under a section 1915(b)(4) waiver the same prompt payment standards that apply to all other health care practitioners furnishing Medicaid services. This rule also makes technical changes in the regulations relating to a recipient's free choice of providers of family planning services and cost-sharing requirements under waivers.     

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.     

Medicaid program; Medicaid managed care. Withdrawal of final rule with comment period

This document withdraws all provisions of the final rule with comment period on Medicaid managed care that we published in the Federal Register on January 19, 2001 (66 FR 6228) with an initial effective date of April 19, 2001. This January 19, 2001 final rule, which has never taken effect, would have combined Medicaid managed care regulations in a new part 438, implemented Medicaid managed care requirements of the Balanced Budget Act of 1997 (Pub. L. 105-33), and imposed new requirements on entities currently regulated as "prepaid health plans' (PHPs). The regulations set forth in the final rule being withdrawn have been superseded by regulations promulgated in a subsequent rulemaking initiated on August 20, 2001 (66 FR 43613). In addition, this document addresses comments received in response to an interim final rule with comment period that we published on August 17, 2001 in the Federal Register (66 FR 43090) that further delayed, until August 16, 2002, the effective date of the January 19, 2001 final rule with comment period.     

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; State share of financial participation--HCFA. 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. Because of misunderstanding created by certain portions of that rule, we are publishing this interim final rule to withdraw and cancel it and to set forth a clearer interim final rule on donations and taxes.     

Medicaid program; State share of financial participation--HCFA. Interim final rule with comment

Under certain circumstances, States are currently permitted to use voluntary contributions (donated funds) from providers and all revenues from State-imposed taxes, as the State share of the costs of the Medicaid program. There is now widespread use of State donations or other voluntary provider payment programs that unfairly affect the Federal share of Federal Financial Participation (FFP). This practice circumvents the States' statutory obligation to expend funds for medical assistance. Therefore, effective January 1, 1992, this interim final rule requires that the amount of funds donated from Medicaid providers be offset from Medicaid expenditures incurred on or after this date before calculating the amount of FFP in Medicaid expenditures. It also interprets section 4701(b)(2) of the Omnibus Budget Reconciliation Act of 1990, which added section 1903(i)(10) to the Social Security Act. Section 1903(i)(10), precludes Federal Financial Participation (FFP) in State payments to hospitals, nursing facilities, and intermediate care facilities for the mentally retarded for facility expenditures that are attributable to provider-specific State taxes.     

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.     

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; 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 and Medicaid programs; fire safety requirements for certain health care facilities; amendment. Interim final rule with comment period

This interim final rule with comment period adopts the substance of the April 15, 2004 temporary interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment will allow certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This interim final rule with comment period also requires that nursing facilities install smoke detectors in resident rooms and public areas if they do not have a sprinkler system installed throughout the facility or a hard-wired smoke detection system in those areas.     

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.     

Medicaid program; home and community-based services waivers for individuals age 65 or older--HCFA. Interim final rule with comment period

This interim final rule amends current Medicaid regulations to permit States to offer, under a Secretarial waiver, a wide array of home and community-based services to individuals age 65 or older who are determined, but for the provision of these services, to be likely to require the level of care furnished in a skilled nursing facility (SNF) or intermediate care facility (ICF) (nursing facility (NF) effective October 1, 1990). The rule allows Federal payment for these and other long term care services, up to an amount specified in section 1915(d)(5)(B) of the Social Security Act, subject to HCFA's approval of the States' requests for waivers and certain assurances made by the States. Once granted, waivers are in effect for 3 years, unless terminated by the State with notice to the Secretary, and are renewable for periods of 5 years. Periodic evaluation, assessment, and review of the care furnished under the waivers is required. This rule implements section 4102 of the Omnibus Budget Reconciliation Act of 1987, as modified by section 411(k) of the Medicare Catastrophic Coverage Act of 1988, section 8432 of the Technical and Miscellaneous Revenue Act of 1988, and section 4741(b) of the Omnibus Budget Reconciliation Act of 1990. This rule is being issued in final and, for the most part, without a delay in the effective date for the reasons explained in section IV, "Waiver of Proposed Rulemaking and Delay in the Effective Date."     

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.