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; time limitation on record keeping requirements under the drug rebate program. Interim final rule with comment period

On August 29, 2003, we published a final rule with comment period in the Federal Register that finalized two specific provisions: it established new 3-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program and set 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 announced the pressing need for codification of fundamental recordkeeping requirements. On September 26, 2003, we issued a correction notice to change the effective date of the August 29, 2003 rule from October 1, 2003 to January 1, 2004. In this interim final rule with comment period, we are removing the 3-year recordkeeping requirements, replacing them with 10-year recordkeeping requirements on a temporary basis, and soliciting comments on the 10-year requirements. Manufacturers must retain records beyond the 10-year period if the records are the subject of an audit or a government investigation of which the manufacturer is aware. These provisions contain a sunset date with respect to the record retention requirements to ensure that we reexamine whether the retention rule remain necessary and effective. This interim final rule with comment period also responds to public comments on the August 29, 2003 final rule with comment period that pertain to the 3-year recordkeeping requirement at Sec. 447.534(h).     

Medicaid program; eligibility and coverage requirements--HCFA. Final rule with comment period

These regulations amend the requirements for coverage of certain groups of individuals under Medicaid and the requirements for determining Medicaid eligibility. The regulations relate to coverage of individuals in optional categorically needy groups; aged, blind and disabled individuals in States that use more restrictive requirements for Medicaid than those under the Supplemental Security Income (SSI) program; individuals receiving optional State supplementary payments; individuals under age 21 who are not receiving AFDC; individuals who are ineligible for cash assistance under the Social Security Act because of requirements that do not apply under Medicaid; and medically needy groups. In addition, the regulations revise the methodologies for determining income and resource eligibility under Medicaid, including financial responsibility of relatives, and for determining financial eligibility of medically needy groups, including determining medically needy income levels. These regulations interpret provisions of the Tax Equity and Fiscal Responsibility Act of 1982, as amended by several acts, including, most recently, the Omnibus Budget Reconciliation Act of 1987, the Medicare Catastrophic Coverage Act of 1988, the Family Support Act of 1988, the Omnibus Budget Reconciliation Act of 1989, and the Omnibus Budget Reconciliation Act of 1990. We are also making some administrative changes to achieve more efficient operation of the Medicaid Program.     

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; Medicaid eligibility quality control (MEQC) program requirements--HCFA. Final rule with comment period

This rule revises the regulations governing the Medicaid eligibility quality control (MEQC) program to include more specific program requirements and to establish new timeframes for completing and reporting MEQC case findings to HCFA. The rule also establishes a performance-based threshold for States to meet before HCFA will consider good faith waiver requests of disallowance of Federal financial participation (FEP) in erroneous Medicaid payments and provides more definitive criteria for evaluating States' good faith efforts to meet the national standard error rate. In addition, the rule makes several technical changes and provides that a State may rebut its projected error rate only when it can present evidence that its projected error rate was based on erroneous data. These revisions will strengthen the basic MEQC program and provide flexibility and incentives to States to produce accurate Medicaid eligibility determinations.     

Medicaid program; citizenship documentation requirements. Final rule

This final rule 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. It also incorporates changes made to these requirements through section 405(c)(1)(A) of Division B of the Tax Relief and Health Care Act (TRHCA), Pub. L. 109-432, enacted December 20, 2006. 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 citizenship.     

Medicaid integrity program; limitation on contractor liability. Final rule

The Medicaid Integrity Program (the Program) provides that the Secretary promote the integrity of the Medicaid program by entering into contracts with contractors that will review the actions of individuals or entities furnishing items or services (whether fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of the plan approved under section 1115 of the Social Security Act; audit claims for payment of items or services furnished, or administrative services furnished, under a State plan; identify overpayments of individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This final rule will provide for limitations on a contractor's liability while performing these services under the Program. The final rule will, to the extent possible, employ the same or comparable standards and other substantive and procedural provisions as are contained in section 1157 (Limitation on Liability) of the Social Security Act.     

Medicare, Medicaid, and CLIA programs; personnel requirements for cytotechnologists--HCFA. Final rule with comment period

This rule amends certain personnel requirements for cytotechnologists that perform testing in laboratories subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). We are providing an adequate period of time for individuals to gain the necessary 2 years experience performing cytology testing which is currently included in two of the provisions for qualifying as a cytotechnologist. Also, we are extending the time for individuals to either meet the educational qualifications by virtue of completing training in an approved cytotechnology training program or be certified by an approved organization. We are making these changes to prevent the loss of qualified personnel in the field of cytotechnology.     

Medicaid program: redeterminations of Medicaid eligibility due to welfare reform--HCFA. Final rule with comment period

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 and the Contract with America Advancement Act of 1996 created changes in Federal law affecting the eligibility of large numbers of Medicaid recipients. These changes include revisions to the definition of disability for children and to the eligibility requirements of non-U.S. citizens and individuals receiving disability cash assistance based on a finding of alcoholism and drug addiction. This final rule with comment period protects Federal financial participation (FFP) in State Medicaid expenditures for states with unusual volumes of eligibility redeterminations caused by these recent changes in the law. We are making changes to the regulations to provide for additional time for States to process these redeterminations and provide services pending the redeterminations.     

Medicaid program; eligibility of qualified severely impaired individuals who work--HCFA. Final rule with comment period

This rule amends the Medicaid regulations to specify, for Medicaid coverage, a permanent eligibility group of qualified individuals who, although severely impaired, work and demonstrate ability to perform substantial gainful activity and who are considered to be Supplemental Security Income (SSI) recipients. It also specifies how SSI payments made to certain institutionalized individuals are to be disregarded as income under Medicaid for a limited period. The amendments conform the regulations to provisions of the Omnibus Budget Reconciliation Act of 1986 and the Employment Opportunities for Disabled Americans 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.     

Medicaid program; multiple source drug definition. Final rule

This final rule revises the definition of "multiple source drug" to better conform the regulatory definition to the provisions of section 1927(k)(7) of the Social Security Act. It also responds to public comments received on the March 14, 2008 interim final rule with comment period.     

Medicaid program; Medicaid managed care. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period amends the Medicaid regulations to implement provisions of the Balanced Budget Act of 1997 (BBA) that allow the States greater flexibility by permitting them to amend their State plan to require certain categories of Medicaid beneficiaries to enroll in managed care entities without obtaining waivers if beneficiary choice is provided; establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services; eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing. In addition, this final rule expands on regulatory beneficiary protections provided to enrollees of prepaid health plans (PHPs) by requiring that PHPs comply with specified BBA requirements that would not otherwise apply to PHPs.     

Medicaid program; deduction of incurred medical expenses (spenddown)--HCFA. Final rule with comment period

This final rule with comment period permits States flexibility to revise the process by which incurred medical expenses are considered to reduce an individual's or family's income to become Medicaid eligible. This process is commonly referred to as "spenddown." Only States which cover the medically needy, and States which use more restrictive criteria to determine eligibility of the aged, blind, and disabled, than the criteria used to determine eligibility for Supplemental Security Income (SSI) benefits (section 1902(f) States) have a spenddown. These revisions permit States to: Consider as incurred medical expenses projected institutional expenses at the Medicaid reimbursement rate, and deduct those projected expenses from income in determining eligibility; combine the retroactive and prospective medically needy budget periods; either include or exclude medical expenses incurred earlier than the third month before the month of application (States must, however, deduct current payments on old bills not previously deducted in any budget period); and deduct incurred medical expenses from income in the order in which the services were provided, in the order each bill is submitted to the agency, by type of service. All States with medically needy programs using the criteria of the SS program may implement any of the provisions. States using more restrict criteria than the SSI program under section 1902(f) of the Social Security Act may implement all of these provisions except for the option to exclude medical expenses incurred earlier than the third month before the month of application.     

Medicaid program; home and community-based services and respiratory care for ventilator-dependent individuals--HCFA. Final rule with comment period

This final rule with comment period expands coverage of Medicaid home and community-based services under the waiver provisions of section 1915(c) of the Social Security Act. This final rule also adds coverage of respiratory care services as an optional benefit under State Medicaid plans. These revisions and additions incorporate changes made by the Consolidated Omnibus Budget Reconciliation Act of 1985 and the Omnibus Budget Reconciliation Act of 1986 and respond to the public comments that we received as a result of the June 1, 1988, publication of a proposed rule. This final rule with comment period also incorporates self-implementing provisions of the Omnibus Budget Reconciliation Act of 1987, the Medicare Catastrophic Coverage Act of 1988, the Technical and Miscellaneous Revenue Act of 1988, and the Omnibus Budget Reconciliation Act of 1990 concerning home and community-based services, and makes other technical changes not specifically related to these statutes.     

Medicare program; incentive programs-fraud and abuse--HCFA. Final rule with comment period

This final rule with comment period establishes a program for payment to individuals who provide information on Medicare fraud and abuse or other sanctionable activities. This final rule implements section 203(b) of the Health Insurance Portabilty and Accountability Act of 1996.     

Medicare and Medicaid programs; approved information collection requirements and HCFA's claims collection authority--HCFA. Final rule with comment period

This final rule updates our display of control numbers assigned by the Office of Management and Budget (OMB) to approved "collection of information" requirements contained in regulations governing the Medicare and Medicaid programs. In addition, it incorporates a technical change to our regulations to reflect increased agency authority under the Federal Claims Collection Act, 31 U.S.C. 3711 et seq. This rule is issued in accordance with OMB regulations concerning approved collections of information and to conform to changes made by Public Law 101-552.     

Medicare and Medicaid programs; surety bond and capitalization requirements for home health agencies--HCFA. Final rule with comment period

The Balanced Budget Act of 1997-(BBA '97) requires each home health agency (HHA) to secure a surety bond in order to participate in the Medicare and Medicaid programs. This requirement applies to all participating Medicare and Medicaid HHAs, regardless of the date their participation began. This final rule with comment period requires that each HHA participating in Medicare must obtain from an acceptable authorized Surety a surety bond that is the greater of $50,000 or 15 percent of the annual amount paid to the HHA by the Medicare program, as reflected in the HHA's most recently accepted cost report. The BBA '97 also requires that provider agreements be amended to incorporate the surety bond requirement; this rule deems such agreements to be amended accordingly. The BBA '97 prohibits payment to a State for home health services under Medicaid unless the HHA has furnished the State with a surety bond that meets Medicare requirements. This final rule with comment period requires that, in order to participate in Medicaid, each HHA must obtain from an acceptable authorized Surety, a surety bond that is the greater of $50,000 or 15 percent of the annual Medicaid payments made to the HHA by the Medicaid agency for home health services for which Federal Financial Participation (FFP) is available. In addition to the surety bond requirement, an HHA entering the Medicare or Medicaid program on or after January 1, 1998 must demonstrate that it actually has available sufficient capital to start and operate the HHA for the first 3 months. Undercapitalized providers represent a threat to the quality of patient care.     

Medicare and Medicaid programs; approved information collection requirements--HCFA. Final rule with comment period

This final rule updates our display of approved control numbers for the collection of information that have been assigned to HCFA by the Office of Management and Budget (OMB). OMB regulations require each agency to include the approval numbers in the agency's rules.