Health care programs: fraud and abuse; amendments to OIG exclusion and CMP authorities resulting from Public Law 100-93--HHS. Final rule

This final rule implements the OIG sanction and civil money penalty provisions established through section 2 and other conforming amendments in the Medicare and Medicaid Patient and Program Protection Act of 1987, along with certain additional provisions contained in the Consolidated Omnibus Budget Reconciliation Act of 1985, the Omnibus Budget Reconciliation Act (OBRA) of 1987, the Medicare Catastrophic Coverage Act of 1988, OBRA of 1989, and OBRA of 1990. Specifically, these regulations are designed to protect program beneficiaries from unfit health care practitioners, and otherwise to improve the anti-fraud provisions of the Department's health care programs under titles V, XVIII, XIX and XX of the Social Security Act.     

Medicare and Medicaid program; civil money penalties, assessments, exclusions, and related appeals procedures--HCFA. Final rule with comment period

This rule establishes procedures for imposing civil money penalties, assessments, and exclusions for certain violations of the Medicare and Medicaid programs. The regulations also provide for hearings and appeals when those penalties, assessments, and exclusions are imposed. These procedures are based on the procedures that the Office of the Inspector General has promulgated for the civil money penalties, assessments, and exclusions. These regulations are designed to protect program beneficiaries from unfit health care practitioners and to otherwise improve antifraud provisions under the Medicare and Medicaid Acts.     

Privacy Act of 1974; exempt record system--HHS. Final rule

The Office of the Secretary of the Department of Health and Human Services is amending its Privacy Act Regulations to exempt the system of records, "Civil and Administrative Investigative Files of the Inspector General, HHS/OS/OIG," from certain provisions of the Privacy Act. This exemption is authorized by subsection (k)(2) of the Privacy Act, which applies to investigative materials compiled for law enforcement purposes. The Office of Inspector General (OIG) is authorized to gather information for Civil and administrative law enforcement purposes under Pub. L. 94-505, establishing the HHS Office of Inspector General, and section 1128A of the Social Security Act, authorizing civil money penalties for the filing of false claims in certain health care financing programs. In order to maintain the integrity of the OIG investigative process and to assure that the OIG will be able to obtain access to complete and accurate information, the Department is exempting this system, under subsection (k)(2), from the notification, access, correction and amendment provisions of the Privacy Act.     

Deletion of regulations pertaining to certain social services programs under the Social Security act: Office of Human Development Services, HHS. Final rule

Pub. L 97-35, the Omnibus Budget Reconciliation Act of 1981, combined the social services programs administered under title XX of the Social Security Act in the States and in the Territories under titles 1, IV-A, X, XIV and XVI (AABD), into a single block grant known as "The Title XX Block Grant to States for Social Services." The block grant program is effective October 1, 1981. Since existing regulations governing those programs do not apply to the block grant program, this rule deletes both entire Parts and references within a Part that apply to the above grant-in-aid programs. These regulations also remove the Department's day care requirements which were issued under statutory authorities that no longer exist as a result of various changes made by Pub. L 97-35.     

Limitation on federal participation for capital expenditures--PHS. Notice of proposed rulemaking

Section 1122 of the Social Security Act, "Limitation on Federal Participation for Capital Expenditures," establishes under which the Secretary may deny Federal reimbursement under titles XVIII and XIX of the Act for expenses related to capital expenditures by or on behalf of health care facilities (1) which the health planning agency designated for a State has found to be inconsistent with standards, criteria, or plans developed under the Public Health Service Act, or (2) for which the designated planning agency was not provided notification as required. These proposed regulations include changes in the regulations now codified at 42 CFR Part 100 based on (1) the proposed amendments to the regulations published in the Federal Register on March 19, 1976, and comments submitted in response to that Notice, (2) the amendments to Title XV of the Public Health Service Act enacted by the Health Planning and Resources Development Amendments of 1979 (Pub. L. 96-79), the Health Programs Extension Act of 1980 (Pub. L. 96-538), and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and (3) the amendments to section 1122 enacted by the Health Maintenance Organization Amendments of 1978 (Pub. L. 95-559), the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and the Social Security Amendments of 1983 (Pub. L. 98-21). Interested persons are invited to submit written comments and suggestions concerning this Notice of Proposed Rulemaking (NPRM).     

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).     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, amends the regulations governing certificate of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The amendments accomplish two tasks: (1) To implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and (2) to reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Department's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations change the requirements for satisfactory certificate of need programs.     

Area health education center programs--Public Health Service. Final regulations

These regulations set forth requirements for cooperative agreements entered into by the Secretary of Health and Human Services with schools of medicine or osteopathy for the planning, development, and operation of area health education center programs. The regulations conform provisions in 42 CFR Part 57, Subpart MM--Area Health Education Center Programs to Nurse Training Amendments of 1979 Pub. L. 96-76), the Federal Grant and Cooperative Agreement Act (Pub. L. 95-224), and the Omnibus Reconciliation Act of 1981 (Pub. L. 97-35). Also in response to public comments to the interim final regulations published in the Federal Register on November 27, 1978, clarification of several provisions were made to the final regulations.     

Medicaid program; eligibility of aliens for Medicaid--HCFA. Final rule

This regulation revises current Medicaid rules applicable to aliens who meet eligibility requirements as categorically needy or medically needy. It establishes that aliens lawfully admitted for permanent residence or permanently residing in the United States under color of law may be eligible for all Medicaid services. It clarifies and identifies certain categories of persons permanently residing in the United States under color of law. It also identifies those aliens who may be eligible only for limited services as a result of recent legislation. These revisions conform our regulations to changes made by the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99-509), and the Immigration Reform and Control Act of 1986 (Pub. L. 99-603), and the Medicare Catastrophic Coverage Act of 1988 (Pub. L. 100-360).     

Medicaid program; early and periodic screening, diagnosis, and treatment (EPSDT) program--HCFA. Proposed rule

This proposal would modify present regulations to conform to recent legislative changes enacted by section 2181 of Pub. L. 97-35, the Omnibus Budget Reconciliation Act of 1981. That section eliminates the penalty which reduces by one percent Federal funds for a States's Title IV-A program, Aid to Families with Dependent Children (AFDC), for any quarter during which a State fails to: (1) inform all AFDC families of the availability of early and periodic screening, diagnosis, and treatment EPSDT services; (2) provide or arrange for requested screening services; and (3) arrange for corrective treatment of health problems found. In addition, section 2181 mandates that States incorporate these three requirements into their State Medicaid plan with respect to all EPSDT eligibles. Further, this proposed rule would modify current Medicaid EPSDT regulations to reflect Congressional intent that States should continue to develop fully effective EPSDT programs; however, current requirements which entail a large volume of paperwork should be significantly streamlined.     

Medicare and state health care programs: fraud and abuse, civil money penalties and intermediate sanctions for certain violations by health maintenance organizations and competitive medical plans--HHS. Final rule

This final rule implements sections 9312(c)(2), 9312(f), and 9434(b) of Public Law 99-509, section 7 of Public Law 100-93, section 4014 of Public Law 100-203, sections 224 and 411(k)(12) of Public Law 100-360, and section 6411(d)(3) of Public Law 101-239. These provisions broaden the Secretary's authority to impose intermediate sanctions and civil money penalties on health maintenance organizations (HMOs), competitive medical plans, and other prepaid health plans contracting under Medicare or Medicaid that (1) substantially fail to provide an enrolled individual with required medically necessary items and services; (2) engage in certain marketing, enrollment, reporting, or claims payment abuses; or (3) in the case of Medicare risk-contracting plans, employ or contract with, either directly or indirectly, an individual or entity excluded from participation in Medicare. The provisions also condition Federal financial participation in certain State payments on the State's exclusion of certain prohibited entities from participation in HMO contracts and waiver programs. This final rule is intended to significantly enhance the protections for Medicare beneficiaries and Medicaid recipients enrolled in a HMO, competitive medical plan, or other contracting organization under titles XVIII and XIX of the Social Security Act.     

Health care programs: fraud and abuse; revisions to the civil money penalty provisions relating to the misuse of certain names, symbols and emblems--HHS. Final rule

In accordance with amendments to section 1140 of the Social Security Act, resulting from the Social Security Independence and Program Improvements Act of 1994, this final rule makes a number of revisions to the civil money penalty authority regulations relating to the misuse of certain symbols, emblems and names. Among other revisions, this rule eliminates the annual cap on penalties, includes the words and letters of the Department and Medicaid under the prohibition, and redefines a violation with regard to mailings. In addition, this final rule serves to remove references to Social Security and the Social Security Administration (SSA) from the HHS/OIG penalty regulations. The penalty regulations addressing the misuse of certain words, letters, symbols and emblems for SSA and its programs are being set forth in a new part of the Code of Federal Regulations published elsewhere in this edition of the Federal Register.     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS. Notice of proposed rulemaking

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, proposes to amend the regulations governing certificates of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The proposed amendments would accomplish two tasks: (1) Implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35) and (2) reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Secretary's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth proposed changes to the requirements for satisfactory certificate of need programs. Interested persons are invited to submit written comments and recommendations concerning these proposed rules as well as suggestions for alternative methods of implementing any of the provisions of the amendments that affect the requirements for certificate of need programs.     

Medicare and State health care programs: fraud and abuse; OIG anti-kickback provisions--HHS. Final rule

This final rule implements section 14 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, by specifying various payment practices which, although potentially capable of inducing referrals of business under Medicare or a State health care program, will be protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.     

Medicare program; payment to health maintenance organizations and competitive medical plans--HCFA. Final rules with comment period

These regulations implement section 114 of the Tax Equity and Fiscal Responsibility Act of 1982 by authorizing Medicare reimbursement for health care services to eligible health maintenance organizations (HMOs) and competitive medical plans (CMPs) on a prospective basis for those entities that have a risk contract or on a reasonable cost basis for those that have a cost contract. The regulations set forth the requirements that an entity must meet in order to be: Eligible to enter into a Medicare contract (either risk or reasonable cost) as an eligible organization; and Reimbursed by Medicare on a capitation basis (either prospectively or retrospectively) for items and services furnished to Medicare enrollees. In addition, these regulations implement sections 2322 and 2350 (b) and (c) of Pub. L. 98-369 (Deficit Reduction Act of 1984), which further amended the Social Security Act concerning payments to HMOs and CMPs.     

Early and periodic screening, diagnosis, and treatment (EPSDT) program--HCFA. Final rule

This final rule modifies present regulations to conform to legislative changes enacted by section 2181 of Pub. L. 97-35, the Omnibus Budget Reconciliation Act of 1981. That section eliminates the penalty which reduces by one percent Federal funds for a State's Title IV-A program, Aid to Families with Dependent Children (AFDC), for any quarter during which a State fails to: (1) Inform all AFDC families of the availability of Early and Periodic Screening, Diagnosis, and Treatment (EPSDT), services; (2) provide or arrange for requested screening services; and (3) arrange for corrective treatment of health problems found as a result of screening. In addition, even though the penalty has been eliminated, section 2181 mandates that States incorporate these three requirements into their Medicaid State plan with respect to all EPSDT eligibles. Further, this rule modifies current regulations to reflect Congressional intent that while States should continue to develop fully effective EPSDT programs, the Federal government should work to reduce current reporting requirements which entail a large volume of paperwork.     

Medicare and Medicaid programs; civil money penalties for nursing homes. Final Rule

This final rule will revise and expand current Medicare and Medicaid regulations regarding the imposition and collection of civil money penalties by CMS when nursing homes are not in compliance with Federal participation requirements in accordance with section 6111 of the Affordable Care Act of 2010.     

Health care programs: fraud and abuse; revised OIG sanction authorities resulting from Public Law 105-33--OIG. Notice of proposed rulemaking

This rulemaking proposes revisions to the OIG's exclusion and civil money penalty authorities set forth in 42 CFR parts 1001, 1002 and 1003, resulting from the Balanced Budget Act of 1997, Public Law 105-33. These proposed revisions are intended to protect and strengthen Medicare and State health care programs by increasing the OIG's anti-fraud and abuse authority through new or revised exclusion and civil money penalty provisions.     

Medicare program: access to books, documents, and records of subcontractors--Health Care Financing Administration

These regulations implement section 952 of the Omnibus Reconciliation Act of 1980 (Pub. L. 96-499), which conditions Medicare reimbursement for the cost of services performed under certain contracts upon compliance with prescribed criteria. If a contract between a provider and a subcontractor covers services valued at or costing $10,000 or more over a 12-month period, Medicare reimbursement cannot be made for the services unless the contract includes a clause allowing the Secretary of Health and Human Services and the Comptroller General access to the contract and to the subcontractor's books, documents, and records necessary to verify the costs of the contract. The clause in the contract must also permit similar access top any subcontract between the subcontractor and a related organization of the subcontractor when the subcontract is worth or costs $10,000 or more over a 12-month period. These regulations specify the criteria and procedures that the Department will use to obtain access to affected books, documents, and records. The purpose of the legislation and these proposed regulations is to permit the Secretary and Comptroller General to make an accurate determination of the reasonable costs under these contracts.