Consultations with state and local officials prior to awarding community health center grants--HRSA. Notice

Section 1923 of the Public Health Service (PHS) Act (42 U.S.C. 300y-2) requires that if a State does not apply for a Primary Care Block Grant under section 1924 of the PHS Act (42 U.S.C. 300y-3), or does not qualify for such a grant, a Secretary of Health and Human Services will use those funds not allotted to States participating in the block grant to make grants under section 330 of the PHS Act (42 U.S.C. 254c) to individual community health centers (CHCs). Section 1923 also requires that the Secretary consult with the chief executive officer of the State and with appropriate local officials before making such grants for community health centers in a State. This notice describes the manner in which the Health Resources and Services Administration (HRSA) will fulfill the requirement for consultation. In addition, it solicits comments from local officials regarding CHCs in their areas. A State may elect to supply comments under the system established in accordance with 45 CFR Part 100, "Intergovernmental Review of the Department of Health and Human Services Programs and Activities." (See 48 FR 29188, June 24, 1983.)     

Notice regarding HRSA grant requirement--participation in the 340B drug pricing program--HRSA. Notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service (PHS) Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of HHS in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed that amount determined under a statutory formula. The purpose of this notice is to request comments on a proposed grant award requirement in which all entities, except those entities which fall within excepted categories, that receive HRSA grants listed in section 340B(a)(4) and that purchase or reimburse for covered outpatient drugs must participate in the 340B Drug Pricing Program, or demonstrate good cause for nonparticipation. When the Prime Vendor program is operational, HRSA intends to publish a second Federal Register notice proposing an expansion of the grant award requirement to include participation in the Prime Vendor Program.     

Notice regarding section 602 of the Veterans Health Care Act of 1992 rebate option--HRSA. Notice

Section 602 of Pub. L. 102-585, the "Veterans Health Care Act of 1992", enacted section 340B of the Public Health Service (PHS) Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of HHS in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed that amount determined under a statutory formula. The purpose of this notice is to request comments on the proposal of a rebate option for State AIDS Drug Assistance Programs (ADAPs) receiving funds under Title XXVI of the PHS Act.     

Notice regarding section 602 of the Veterans Health Care Act of 1992--rebate option--HRSA. Final notice

Section 602 of Pub. L. 102-585, the "Veterans Health Care Act of 1992", enacted section 340B of the Public Health Service (PHS) Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of HHS in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed that amount determined under a statutory formula. The purpose of this notice is to inform interested parties of the final guidelines recognizing a rebate option for State AIDS Drug Assistance Programs (ADAPs) receiving funds under Title XXVI of the PHS Act as an optional alternate means of accessing section 340B discount pricing.     

Consultation with state and local officiaLs prior to awarding community health center grants--PHS. Notice

Section 1923 of the Public Health Service (PHS) Act (42 U.S.C. 300y-2) requires that if a State does not apply for a Primary Care Block Grant under section 1924 of the PHS Act (42 U.S.C. 300y-3), or does not qualify for such a grant, the Secretary of Health and Human Services will use those funds not allotted to States participating in the block grant to make grants under section 330 of the PHS Act (42 U.S.C. 254c) to individual community health centers (CHCs). Section 1923 also requires that the Secretary consult with the chief executive officer of the State and with appropriate local officials before making such grants for community health centers in a State. This notice describes the manner in which the Health Resources and Services Administration (HRSA) will fulfill the requirement for consultation. In addition, it solicits comments from local officials regarding CHCs in their areas.     

Notice regarding Section 602 of the Veterans Health Care Act of 1992; new drug pricing--PHS. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act ("PHS Act"), "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. The purpose of this notice is to inform interested parties of final guidelines regarding new drug pricing.     

Notice regarding section 602 of the Veterans Health Care Act of 1992 inclusion of outpatient hospital facilities--PHS. Notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992" (the "Act"), enacted section 340B of the Public Health Service Act ("PHS Act"), "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement (the "Agreement") with the Secretary, Department of Health and Human Services, in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed the amount determined under a statutory formula. Section 340B(a)(4) lists the entities eligible to receive discount outpatient drug pricing (i.e., certain disproportionate share hospitals (DSHs) and PHS grantees). The definition of a disproportionate share hospital found in section 340B(a)(4)(L) provides criteria to determine which such hospitals are eligible to participate in the program. However, the definition does not include criteria to determine which outpatient facilities (including off-site or satellite clinics) working in conjunction with the eligible hospital would be considered part of the hospital for purposes of eligibility for section 340B drug discounts. The Office of Drug Pricing, which administers this program with PHS, is proposing certain procedures to determine which outpatient hospital facilities are included as part of an eligible disproportionate share hospital.     

Grants to for-profit organizations; implementing amendments--Public Health Service. Final rule

This issuance amends 42 CFR Part 52 applicable to grants made for research projects under sections 301 and 356 of the Public Health Service Act to delete the prohibition on eligibility for research awards to entities that are organized or operated for profit. Elsewhere in this issue of the Federal Register is a final rule which, among other things, amends 42 CFR Part 87 to allow for-profit organizations to apply for health research and demonstration grants under section 20 of the Occupational Safety and Health Act and section 501 of the Federal Mine Safety and Health Act.     

Removal of obsolete regulations on limitation on federal participation for capital expenditures under Section 1122 of the Social Security Act--HCFA. Final rule

This rule removes obsolete regulations governing the section 1122 capital expenditures review program. With the repeal of the comprehensive health planning authority, Title XV of the Public Health Service (PHS) Act, no funds were appropriated to support State capital expenditure review activities, or to administer the program.     

Notice regarding Federally Supported Health Centers Assistance Act of 1992--HRSA. Notice

The Secretary of Health and Human Services (the "Secretary"), in consultation with the Attorney General, provides the following notice regarding Public Law 102-501, the "Federally Supported Health Centers Assistance Act of 1992" (the "Act"). The Act provides for liability protection for certain health care professionals and entities. This notice sets forth information whereby an entity or a person can determine when, and the extent to which, it is deemed to be an entity as described in the Act.     

Lists of designated primary medical care, mental health, and dental health professional shortage areas--HRSA. Notice

This notice provides lists of all areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of September 30, 1996. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act.     

Lists of designated primary medical care, mental health, and dental health professional shortage areas--HRSA. Notice

This notice provides lists of all areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of June 15, 1995. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act.     

List of designated primary medical care, mental health, and dental health professional shortage areas--HRSA. Notice

This notice provides lists of all areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of March 31, 1997. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 322 of the Public Health Service (PHS) Act.     

State offices of rural health grant program--HRSA. Notice of availability of funds

The Office of Rural Health Policy, Health Resources and Services Administration (HRSA), announces that applications are being accepted for matching grants to States for the purpose of improving health care in rural areas through the continued operation of State Offices of Rural Health. This program is authorized by section 338J of the Public Health Service Act 42 U.S.C. 254r. Awards will be made from funds appropriated under Public Law 105-78 (HHS Appropriations Act for Fiscal Year 1998). Approximately $3.0 million will be available to support 50 grants in fiscal year (FY) 1998.     

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.     

Designation of medically underserved populations and areas--HRSA. Notice

Under the provisions of section 330(b)(6) of the Public Health Service (PHS) Act, 42 U.S.C. 254c(b)(6), as amended by Pub. L. 99-280, the Governors of the States of Hawaii and Maine have asked the Secretary of Health and Human Services (HHS) to designate specific populations within their States as medically underserved populations (MUPs). Also, under section 330(b)(3) of the PHS Act, certain geographic areas in the States of Missouri, Nebraska, South Carolina, South Dakota, and Washington have been proposed for designation as medically underserved areas (MUAs). This notice provides an opportunity for State and local officials, State organizations representing Community Health Centers, and other interested parties in the above-mentioned States to provide recommendations and to comment on the proposals to designate as medically underserved the areas and populations described in this notice.     

Availability of funds for home health services and training--HRSA

The Health Resources and Services Administration (HRSA) announces that funds are available for grants and loans for the development and expansion of home health programs and services. Public Law (Pub. L.) 98-139, the Labor, Health and Human Services, and Education Appropriations Act of 1984, signed on October 31, 1983, appropriates $5 million under section 339 of the Public Health Service (PHS) Act (42 U.S.C. 255) to provide home health services and for the training of paraprofessionals to provide home health services. This notice contains information of interest to prospective applicants for such funding.     

Grants for nurse practitioner traineeship programs--PHS. Interim final regulations

These regulations set forth requirements for grants to schools of nursing, medicine, and public health, to public or nonprofit private hospitals, and to other public or nonprofit private entities to meet the costs of traineeships for training nurse practitioners. A trainee must sign a commitment with the Secretary to practice full-time as a nurse practitioner in a primary medical care health manpower shortage area, designated under section 332 of the Public Health Service Act (the Act), for a period equal to 1 month for each month of traineeship support, after completion of the training. If this obligation is not fulfilled, a trainee must pay back traineeship support. The purpose of these regulations is to respond to the comments on the 1980 interim final regulations and to conform 42 CFR Part 57, Subpart AA, with the Paperwork Reduction Act of 1980, Pub. L. 96-511, and with the Omnibus Budget Reconciliation Act of 1981, Pub. L. 97-35, which requires, among other provisions, that the Secretary provide, by regulation, for the waiver or suspension of the repayment obligation under certain conditions. In addition, other minor changes have been made and Office of Management and Budget (OMB) numbers are cited in those sections which have approved reporting and recordkeeping requirements.     

Civil money penalties: procedures for investigations,imposition of penalties,and hearings. Interim final rule; request for comments

This interim final rule establishes rules of procedure for the imposition, by the Secretary of Health and Human Services, of civil money penalties on entities that violate standards adopted by the Secretary under the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). We intend that this be the first installment of a rule that we term the "Enforcement Rule." The Enforcement Rule, when issued in complete form, will set forth procedural and substantive requirements for imposition of civil money penalties. In the interim, we are issuing these rules of procedure to inform regulated entities of our approach to enforcement and to advise regulated entities of certain procedures that will be followed as we enforce the Administrative Simplification provisions of HIPAA.     

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.