Medicare, Medicaid, and Maternal and Child Health Services Block Grant programs; civil money penalties and assessments for false or improper claims--Department of Health and Human Services. Notice of proposed rulemaking

These proposed regulations are intended to strengthen the Department's ability to protect the health care financing programs against persons and organizations who defraud and abuse those programs. The regulations would specify procedures for implementing the authority provided to the Department by section 2105 of the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), as amended by section 137(b)(26) of the Tax Equity and Fiscal Responsibility Act of 1982 (Pub. L. 97-248), to impose civil money penalties and assessments administratively for the filing of false or certain other improper claims in the Medicare, Medicaid, or Maternal and Child Health Services Block Grant programs. The statute also permits an individual upon whom the Department imposes a civil money penalty or assessment to be suspended from participation in the Medicare and Medicaid programs. Until enactment of the civil money penalties legislation, the federal government had to rely upon litigation under the False Claims Act or criminal proceedings in order to compel restitution of funds falsely or improperly claimed under HHS health care financing programs.     

Health maintenance organizations; amendments of 1981--Health Resources and Services Administration. Notice of proposed rulemaking

This notice proposes to amend the Public Health Service rules on health maintenance organizations (HMOs) to conform with the 1981 amendments to the HMO statute regarding member protection in the event of insolvency, community rating by class, and primary care within the service area of a non-metropolitan HMO. In addition, this notice proposes: (a) to remove provisions of the rules that are considered unnecessary or burdensome, such as the regulatory specification of contractual provisions, and (b) to increase one of the regulatory limits on copayments to permit HMOs to become more competitive with alternative forms of health insurance.     

Project grants for migrant health; proposed rulemaking--Public Health Service. Notice of proposed rulemaking

The Assistant Secretary for Health with the approval of the Secretary of Health and Human Services proposes to revise the regulations governing the Migrant Health Centers grant program. The Health Services and Centers Amendments of 1978 made a number of changes in the statutory requirements governing the operation of the centers. The Amendments, among other things, change pharmacy services from supplemental to primary health services, make former migratory agricultural workers who are disabled eligible for services, establish priority for certain supplemental health services, provide an incentive for maximized collection of fees, permit conversion for certain centers from fee for service to prepaid operations and change the governing board requirements for public centers. The proposed revisions are intended to revise the present regulations consistent with the revised statutory provisions.     

Respiratory protective devices--NIOSH. Notice of proposed rulemaking

This proposed rule addresses NIOSH's and the Department of Labor/Mine Safety and Health Administration's (MSHA) certification requirements for respiratory protective devices. Specifically, the proposal would replace existing MSHA regulations with new public health regulations, while also upgrading current testing requirements for particulate filters. This action is the first of a series of modulates which will, over the next several years, upgrade current respirator requirements. This modular approach will allow improvements to be implemented on a priority basis as well as facilitate adaptation to new requirements by the manufacturers and users of respirators. Except for the particulate-filter requirements, most requirements of existing regulations would be incorporated into the new regulations without change. The proposed testing requirements for particulate filters would significantly improve the current approach to evaluating the effectiveness of an air-purifying respirator's filter to remove toxic particulates from the ambient air, updating existing provisions to be consistent with two decades of advances in respiratory protection technology. The certification of air-purifying respirators under these proposed requirements would also enable respirator users to select from a broader range of certified respirators that meet the current performance criteria recommended by CDC for respiratory devices used in health-care settings for protection against Mycobacterium tuberculosis, the infectious agent that causes tuberculosis (TB). This Notice also announces an informal public meeting on the proposed rule, as indicated below. Elsewhere in this issue of the Federal Register, MSHA is publishing a proposal to remove existing regulations at 30 CFR part 11, which would be made obsolete by a final rule resulting from this proposed rule.     

NIH center grants--PHS. Notice of proposed rulemaking

This Notice sets forth proposed regulations covering grants by the National Institutes of Health for the support of research and demonstration centers. These regulations would replace existing regulations covering just centers supported by the National Heart, Lung, and Blood Institute.     

HIPAA Mental Health Parity Act--IRS. Notice of proposed rulemaking by cross-reference to temporary regulations

Elsewhere in this issue of the Federal Register, the IRS is issuing temporary regulations relating to mental health parity requirements imposed on group health plans. These requirements were added to the Internal Revenue Code by section 1532 of the Taxpayer Relief Act of 1997. The IRS is issuing the temporary regulations at the same time that the Pension and Welfare Benefits Administration of the U.S. Department of Labor and the Health Care Financing Administration of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations relating to mental health parity requirements added by the Mental Health Parity Act of 1996 to the Employee Retirement Income Security Act of 1974 and the Public Health Service Act. The temporary regulations provide guidance to employers and group health plans relating to the new mental health parity requirements. The text of those temporary regulations also serves as the text of these proposed regulations.     

Projects grants for community health services; proposed rulemaking--Public Health Service. Notice of proposed rulemaking

The Assistant Secretary for Health with the approval of the Secretary of Health and Human Services proposes to revise the regulations governing the Community Health Centers grant program. The Health Services and Centers Amendments of 1978 made a number of changes in the statutory requirements governing the operation of the centers. The Amendments, among other things, change pharmacy services from supplemental to primary health services, establish priority for certain supplemental health services, provide an incentive for maximized collection of fees, permit conversion of certain centers from fee for service to prepaid operations, and change the governing board requirements or public centers. The proposed revisions are intended to revise the present regulations consistent with the revised statutory provisions.     

Nursing student loan program--PHS. Notice of proposed rulemaking

This proposed rule would revise existing regulations governing the Nursing Student Loan (NSL) program. These revisions would impose more detailed requirements concerning the exercise of due diligence by schools in loan collections.     

Patient safety and quality improvement. Notice of proposed rulemaking

This document proposes regulations to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The proposed regulations establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for analysis of patient safety events. The proposed regulations also outline the requirements that entities must meet to become PSOs and the processes for the Secretary to review and accept certifications and to list PSOs. In addition, the proposed regulation establishes the confidentiality protections for the information that is assembled and developed by providers and PSOs, termed "Patient safety work product" by the Patient Safety Act, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.     

HIPAA Newborns' and Mothers' Health Protection Act--IRS. Notice of proposed rulemaking by cross-reference to temporary regulations

Elsewhere in this issue of the Federal Register, the IRS is issuing temporary regulations relating to minimum hospital length-of-stay requirements imposed on group health plans with respect to mothers and newborns. The hospital length-of-stay requirements were added to the Internal Revenue Code by section 1531 of the Taxpayer Relief Act of 1997. The IRS is issuing the temporary regulations at the same time that the Pension and Welfare Benefits Administration of the U.S. Department of Labor and the Health Care Financing Administration of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations relating to hospital length-of-stay requirements added by the Newborns' and Mothers' Health Protection Act of 1996 to the Employee Retirement Income Security Act of 1974 and the Public Health Service Act. The temporary regulations provide guidance to employers and group health plans relating to the new hospital length-of-stay requirements. The text of those temporary regulations also serves as the text of these proposed regulations.     

Protection of human research subjects--HHS. Notice of proposed rulemaking

The Department of Health and Human Services (HHS) is proposing to amend its human subjects protection regulations applicable to research conducted or supported by HHS, by replacing the existing Subpart B of the regulations entitled "Additional DHHS Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization" with new regulations entitled "Additional DHHS Protections for Pregnant Women, Human Fetuses, and Newborns Involved as Subjects in Research, and Pertaining to Human In Vitro Fertilization." This revision continues the Department's recognition of the need to provide special protections for the human fetus and newborn in research, while eliminating unnecessary barriers to consent to research that can benefit fetuses or newborns. Additionally, consistent with recent practices and statutory changes, this proposed regulation provides a mechanism for special ethical reviews on an ad hoc basis as may be deemed appropriate by the Secretary, HHS.     

Health insurance portability for group health plans--IRS. Notice of proposed rulemaking by cross-reference to temporary regulations

Elsewhere in this issue of the Federal Register, the IRS is issuing temporary regulations relating to group health plan portability, access, and renewability requirements added to the Internal Revenue Code by section 401 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The IRS is issuing the temporary regulations at the same time that the Pension and Welfare Benefits Administration of the U.S. Department of Labor and the Health Care Financing Administration of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations relating to the group health plan portability, access, and renewability requirements added by HIPAA to the Employee Retirement Income Security Act of 1974 and the Public Health Service Act. The temporary regulations provide guidance to employers and group health plans relating to the obligation of plans to comply with new requirements relating to preexisting condition exclusions, discrimination based on health status, access to coverage, and other requirements. The text of those temporary regulations also serves as the text of these proposed regulations.     

National Library of Medicine programs--PHS. Notice of proposed rulemaking

The Public Health Service, HHS, proposes to revise the regulations for the programs of the National Library of Medicine. The proposed revisions would: (1) Permit the Regional Medical Libraries to recover part or all of the costs of providing photocopies of biomedical materials, (2) improve readability of the regulations, (3) update references to statutory authorities and uniform administrative requirements, and (4) revoke Part 63 (Traineeships) which is obsolete.     

Program grants for black lung clinics--PHS. Notice of proposed rulemaking

The Public Health Service proposed to revise the regulations governing the grants program for black lung clinics established under section 427(a) of the Federal Mine Safety and Health Act of 1977. The revision is in keeping with the Department of Health and Human Services' desire to remove as many programmatic burdens and restrictions from grantees as possible, while maintaining program integrity.     

National guidelines for health planning: Public Health Service, HHS. Notice of proposed rulemaking

This Notice proposes to add national health planning goals to the National Guidelines for Health Planning under section 1501 of the Public Health Service Act. These goals concern health status outcomes, disease prevention and health promotion and personnel resources and systems of care. They supplement Subparts A and C of the Guidelines published as final regulations on March 28, 1978, which addressed standards for nine types of health services and facilities. Later issuances will provide additional goals and standards.     

Accounting for long-term contract--Internal Revenue Service. Notice of proposed rulemaking

This document contains proposed amendments to regulations under sections 446, 451 and 471 of the Internal Revenue Code relating to accounting for long-term contracts. The proposed amendments would conform the regulations to section 229 of the Tax Equity and Fiscal Responsibility Act of 1982 and would affect taxpayers who have long-term contracts whether or not they use a long-term contract method of accounting for such contracts.     

Governing body requirements for health systems agencies: Public Health Service. Notice of proposed rulemaking

These regulations set forth proposed amendments to the regulations governing the selection, composition and responsibility of health systems agency (HSA) governing bodies. They are intended to implement section 1512(b)(3) of the Public Health Service Act, as amended. The proposed regulations have been developed because some of the statutory provisions concerning body composition and selection require elaboration and regulation to ensure that they will be interpreted consistently with Congressional intent.     

Child abuse and neglect prevention and treatment program--HHS. Notice of proposed rulemaking

This rule proposed changes in the regulations that implement the Child Abuse Prevention and Treatment Act. Recent amendments to this Act (Pub. L. 98-457) made changes in several definitions regarding child abuse and neglect which may require State regulatory changes. These and other proposed requirements are the subject of this notice. On December 10, 1984 (49 FR 48160), the Department published a notice of proposed rulemaking to implement the requirement for State child protective service agencies to establish programs and/or procedures for the protection and treatment of disabled infants with life-threatening conditions ("Baby Does"). These requirements were also a part of Pub. L. 98-457.     

National guidelines for health planning--rescission of computed tomographic scanner standards--Public Health Service. Notice of proposed rulemaking

This document proposes to recind the standards for computed tomographic (CT) scanners with respect to the appropriate supply, distribution and organization of health resources. Concern has been expressed that the standards are to rigid and inflexible, and that they don't take into account recent advances in the state-of-the-art in scanning technology. This action will give states and local communities the fullest possible discretion and flexibility in health systems planning. Non-regulatory technical information materials concerning CT scanners are being made available to the public.