Miscellaneous amendments to the HHS procurement regulations--HHS. Final rule

The Office of the Secretary, Department of Health and Human Services is amending its procurement regulations by revising and updating the general provisions for use in fixed price and cost-reimbursement type contracts (HHS-314,-315,-315A, and-316) and related miscellaneous amendments. The revisions will result in the consolidation of all additions, removals and revisions to the general provisions. The effect of the amendment will be the updating of the Department's general provisions.     

Availability of information to the public--Department of Health and Human Services. Proposed rule

The Department of Health and Human Services is proposing to amend its regulations implementing the Freedom of Information Act (FOIA). This proposal would increase fees for FOIA searches and copying, to reflect increased costs to the Department. It also proposes guidelines for the waiver or reduction of fees.     

Rural Development Loan Fund--Office of Community Services. HHS. Proposed rule

The Secretary of Health and Human Services proposes new regulations governing the Rural Development Loan Fund [RDLF]. These regulations embody changes in existing regulations [45 CFR Subpart 1076.50] including a new definition of "rural" and certain amendments and refinements to clarify and make more specific the requirements of the regulations with a view toward strengthening the administration of the program.     

General and procurement by negotiation--DHHS. Proposed rule

The Office of the Secretary, Department of Health and Human Services, is proposing to amend 41 CFR 3-1.453, Establishment of cost rates, to identify officials delegated authority to approve indirect cost rates and special rates for commercial organizations. Part 3-3, Procurement by negotiation, is proposed to be amended by adding a new Subpart 3-3.7. Negotiated overhead rates, which sets forth policies and procedures concerning the approval of indirect cost rates and special rates for use in the pricing and administration of contracts.     

Administrative practices and procedures--Office of the Secretary, HHS. Proposed rule

These proposed rules would reaffirm the Department's policy ordinarily to use notice and comment procedures in the development of rules relating to public property, loans, grants, benefits, and contracts, even though such action is not required by the Administrative Procedure Act, and would set forth the circumstances for such use. The Secretary believes that public comment serves an important purpose in bringing the expertise and views of interested parties to the attention of the Department.     

Unified agenda of regulations--Department of Health and Human Services. Publication of unified agenda of regulations

The President's February 17, 1981, Executive Order (12291) and the Regulatory Flexibility Act of 1980 require the Department to publish an agenda of significant regulations being developed and an indication of those regulatory actions that are being analyzed for their effect on small businesses. The Department published its last agenda on April 30, 1982.     

Organ Procurement and Transplantation Network. Health Resources and Services Administration, HHS. Final rule

This document sets forth improvements to the final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), published in 1998. It reflects the advice of a panel convened by the National Academy of Science's Institute of Medicine, as called for in the Department's appropriation act for 1999. It also reflects comments on the 1998 rule and consultation with representatives of the organ transplantation community, as recommended in the same legislation; and it summarizes new transplant data developed in the period since enactment of the appropriations act.     

Sanctions applicable to letter of credit administration--Office of the Secretary, HHS. Proposed rule

We are proposing regulations that would govern the imposition of sanctions against recipient organizations holding letters of credit under programs administered by the Department of Health and Human Services. The regulations would describe the conditions which may prompt the imposition of sanctions and would establish uniform procedures for providing affected recipient organizations: (1) Adequate notice of the grounds upon which proposed sanctions are based, (2) an opportunity to respond to the factual and legal bases of the proposed sanctions, and (3) a reasoned decision that articulates the factual and legal bases of the Department's final decision. We believe that these uniform procedures would be useful both as a sound management tool for the Department and as a guide to grantees and contractors.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); revisions to the eligibility requirements--DoD. Proposed rule

This proposed rule revises the comprehensive CHAMPUS regulation pertaining to basic CHAMPUS benefits in accordance with several statutory changes. This proposed rule: sets forth the requirements for reinstatement of CHAMPUS eligibility for beneficiaries under age 65 who would otherwise have lost eligibility for CHAMPUS due to eligibility for Medicare as a result of disability or end-stage renal disease (ESRD); establishes new classes of CHAMPUS eligibles; establishes the Transitional Assistance Management Program which provides transitional health care for members (and their dependents) who served on active duty in support of a contingency operation and for members (and their dependents) who are involuntarily separated from active duty; allows former spouses who buy a conversion health policy to keep CHAMPUS eligibility for twenty-four (24) months for preexisting conditions that are not covered by the conversion policy; and makes minor technical revisions to the double coverage provisions. This proposed rule also adds a new category of eligible beneficiary under the Continued Health Care Benefit Program.     

Medicare program; revision to accrual basis of accounting policy. Department of Health and Human Services (HHS), Health Care Financing Administration (HCFA). Final rule

Medicare policy provides that payroll taxes that a provider becomes obligated to remit to governmental agencies are included in allowable costs only in the cost reporting period in which payment (upon which the payroll taxes are based) is actually made to an employee. Therefore, for payroll accrued in 1 year but not paid until the next year, the associated payroll taxes are not an allowable cost until the next year. This final rule provides for an exception when payment would be made to the employee in the current year but for the fact the regularly scheduled payment date is after the end of the year. In that case, the rule requires allowance in the current year of accrued taxes on payroll that is accrued through the end of the year but not paid until the beginning of the next year, thus allowing accrued taxes on end-of-the year payroll in the same year that the accrual of the payroll itself is allowed. The effect of this rule is not on the allowability of cost but rather only on the timing of payment; that is, the cost of payroll taxes on end-of-the-year payroll is allowable in the current period rather than in the following period.     

Traineeships. National Institutes of Health, HHS. Final rule

The National Institutes of Health (NIH) is amending the regulations governing traineeships to add conditions under which NIH may terminate traineeship awards and revise the authorities for the awards.     

National Vaccine Injury Compensation Program: addition of vaccines against rotavirus to the program. Department of Health and Human Services (HHS), Public Health Service (PHS), Health Resources and Services Administration (HRSA). Final rule

This final rule amends the existing regulations governing the National Vaccine Injury Compensation Program (VICP) by adding vaccines against rotavirus to the Table of Injuries, which lists the vaccines covered under the VICP. This action is taken under section 2114(e) of the Public Health Service Act (the Act). The VICP provides a system of no-fault compensation for certain individuals who have been injured by specific childhood vaccines. The two prerequisites for adding vaccines against rotavirus to the VICP have been satisfied. An excise tax of 75 cents per dose was enacted on October 21, 1998, and took effect for sales of the vaccines after October 21, 1998. The Centers for Disease Control and Prevention (CDC) has recommended to the Secretary of HHS that this vaccine be routinely administered to children. Thus, vaccines against rotavirus are now included in the VICP.     

Quality mammography standards. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Direct final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments are intended to incorporate changes required by the Mammography Quality Standards Reauthorization Act (MQSRA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event that the agency withdraws the direct final rule.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE prime enrollment procedures--DOD. Proposed rule

This proposed rule modifies the TRICARE Prime enrollment for active duty families by specifying that the enrollment period is continuous rather than a 12 month enrollment period and it allows monthly installment payments of enrollment fees for those beneficiaries required to pay an annual fee in order to enroll in TRICARE Prime. These modifications are being made because TRICARE will soon be available wordwide for active duty family members.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE program; reimbursement--DoD. Proposed rule

This rule proposes to revise certain requirements and procedures for reimbursement under the TRICARE program, the purpose of which is to implement a comprehensive managed health care delivery system composed of military medical treatment facilities and CHAMPUS. Issues addressed in this proposed rule include: implementation of changes made to the Medicare Prospective Payment System (PPS) upon which the CHAMPUS DRG-based payment system is modeled and required by law to follow wherever practicable, along with changes to make our DRG-based payment system operate better; extension of the balance billing limitations currently in place for individual and professional providers to non-institutional, non-professional providers; adjusting the CHAMPUS maximum allowable charge (CMAC) rate in the small number of cases where the CMAC rate is less than the Medicare rate; and implementing the government-wide debarment rule where any provider excluded or suspended from CHAMPUS shall be excluded from all other programs and activities involving Federal financial assistance, such as Medicare or Medicaid, and adding violations of our balance billing or claims filing requirements to the list of provider actions considered violations of the TRICARE/CHAMPUS program.     

Health and Human Services policy for protection of human subjects research--HHS. Final rule

The Department of Health and Human Services (HHS) is amending its Human Subjects Protection regulations to rescind the provision requiring prior review and advice from an Ethical Advisory Board for research applications and proposals involving in vitro fertilization (IVF) of human ova as a prerequisite to funding by HHS and its components. The provision was nullified by the National Institutes of Health Revitalization Act of 1993. The regulations are being amended to reflect this statutory nullification. Institutional Review Board (IRB) review and approval of applications and proposals involving in vitro fertilization (IVF) of human ova continues to be required in accordance with other provisions of the Human Subjects Protection regulations. Furthermore, the Secretary may still exercise the option of seeking advice from an Ethical Advisory Board on ethical issues, including IVF, raised by research applications and proposals.     

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 2000 rates. Department of Health and Human Services (HHS), Health Care Financing Administration (HCFA). Final rule

We are revising the Medicare hospital inpatient prospective payment systems for operating costs and capital-related costs to implement changes arising from our continuing experience with the systems. In addition, in the addendum to this final rule, we describe changes in the amounts and factors necessary to determine rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes are applicable to discharges occurring on or after October 1, 1999. We also set forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the prospective payment systems. Finally, we are revising certain policies governing payment to hospitals for the direct costs of graduate medical education.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities. Department of Health and Human Services (HHS), Health Care Financing Administration (HCFA). Final rule

This final rule responds to comments submitted by the public on our May 12, 1998 interim final rule, that implemented provisions in section 4432 of the Balanced Budget Act of 1997 regarding Medicare payment for skilled nursing facility services. This legislation established a prospective payment system, a consolidated billing provision, and a number of related changes.     

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.     

Opioid drugs in maintenance and detoxification treatment of opiate addiction; Substance Abuse and Mental Health Services Administration, HHS. Final rule

The Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration (SAMHSA) are issuing final regulations for the use of narcotic drugs in maintenance and detoxification treatment of opioid addiction. This final rule repeals the existing narcotic treatment regulations enforced by the Food and Drug Administration (FDA), and creates a new regulatory system based on an accreditation model. In addition, this final rule shifts administrative responsibility and oversight from FDA to SAMHSA. This rulemaking initiative follows a study by the Institute of Medicine (IOM) and reflects recommendations by the IOM and several other entities to improve opioid addiction treatment by allowing for increased medical judgment in treatment.