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.     

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.     

Public Health Service--Health systems agency and state health planning and development agency reviews: certificate of need programs. Final regulation

These rules amend the Public Health Service regulations on health systems agency and State health planning and Development agency (State Agency) certificate of need reviews. These final regulations implement changes to Title XV of the Public Health Service Act made by the Health Planning and Resources Development Amendments of 1979 (Pub L. 96-79). Under the amended provisions of the Public Health Service Act, the planning agencies are required to review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth the minimum requirements for satisfactory certificate of need programs.     

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).     

High risk pools. Interim final rule with comment period. Interim final rule with comment period

This interim final rule with comment period will amend our regulations regarding grants to States for operation of qualified high risk pools to conform to provisions of the Deficit Reduction Act of 2005 and the State High Risk Pool Funding Extension Act of 2006. Those provisions extended funding for seed and operational grants for State High Risk Pools and amended section 2745 of the Public Health Service Act.     

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.     

Waiver of the two-year home country physical presence requirement for certain foreign medical graduates--INS. Interim rule with request for comments

This rule amends the Immigration and Naturalization Service (Service) regulations by allowing certain foreign medical graduates who entered the United States in J-1 status, or who acquired J-1 status after arrival in the United States, to obtain a waiver of the 2-year home country residence and physical presence requirement under section 212(e)(iii) of the Immigration and Nationality Act (Act) pursuant to a request by a State Department of Public Health, or its equivalent. The waiver is intended to permit these foreign medical graduates to work at a health care facility in an area designated by the Secretary, Health and Human Services (HHS), as having a shortage of health care professionals ("HHS-designated shortage area"). This interim rule also contains provisions which will permit these foreign medical graduates to change their nonimmigrant status in the United States from J-1 exchange visitor to H-1B specialty occupation worker.     

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.     

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.     

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.     

Interim rules for mental health parity--IRS, DoL, HCFA. Interim rules with request for comments

This document contains interim rules governing parity between medical/surgical benefits and mental health benefits in group health plans and health insurance coverage offered by issuers in connection with a group health plan. The rules contained in this document implement changes made to certain provisions of the Internal Revenue Code of 1986 (Code), the Employee Retirement Income Security Act of 1974 (ERISA or Act), and the Public Health Service Act (PHS Act) enacted as part of the Mental Health Parity Act of 1996 (MHPA) and the Taxpayer Relief Act of 1997. Interested persons are invited to submit comments on the interim rules for consideration by the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (Departments) in developing final rules. The rules contained in this document are being adopted on an interim basis to ensure that sponsors and administrators of group health plans, participants and beneficiaries, States, and issuers of group health insurance coverage have timely guidance concerning compliance with the requirements of MHPA.     

Disclosure of children's free and reduced price meals and free milk eligibility information in the child nutrition programs. Final rule

This final rule establishes requirements for the disclosure of children's free and reduced price meals or free milk eligibility information under the Child Nutrition Programs. The Child Nutrition Programs include the National School Lunch Program, School Breakfast Program, Special Milk Program, Summer Food Service Program, and Child and Adult Care Food Program. Within certain limitations, children's free and reduced price meal or free milk eligibility information may be disclosed, without parental/guardian consent, to persons directly connected to certain education programs, health programs, means-tested nutrition programs, the Comptroller General of the United States, and some law enforcement officials. Additionally, officials also may disclose children's free and reduced price meal or free milk eligibility information to persons directly connected with State Medicaid (Medicaid) and the State Children's Health Insurance Program (SCHIP) when parents/guardians do not decline to have their information disclosed. These regulations affect State agencies and local program operators that administer the Child Nutrition Programs and households which apply for and/or are approved for free and reduced price meals or free milk. The final rule reflects the disclosure provisions of the Healthy Meals for Healthy Americans Act of 1994 and comments received on the proposed rule published in anticipation of implementing those provisions. Additionally, this final rule includes the regulatory disclosure provisions implementing the Agricultural Risk Protection Act of 2000 and comments received on the interim rule issued to implement those provisions. This final rule also implements nondiscretionary provisions of the Child Nutrition and WIC Reauthorization Act of 2004, allowing certain third party contractors access to children's eligibility status and will allow school officials to communicate with Medicaid and SCHIP officials to verify that children are eligible for free and reduced price school meals or free milk. The disclosure provisions are intended to reduce paperwork for administrators of certain programs that target low-income households and for low-income households which may benefit from those programs by allowing some sharing of household's free and reduced price meal eligibility information. This rule also includes several technical amendments.     

Interim rules for health insurance portability for group health plans--HCFA. Interim rules with request for comments

This document contains interim rules governing access, portability and renewability requirements for group health plans and issuers of health insurance coverage offered in connection with a group health plan. The rules contained in this document implement changes made to certain provisions of the Internal Revenue Code of 1986 (Code), the Employee Retirement Income Security Act of 1974 (ERISA), and the Public Health Service Act (PHS Act) enacted as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Interested persons are invited to submit comments on the interim rules for consideration by the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (Departments) in developing final rules. The rules contained in this document are being adopted in an interim basis to accommodate statutorily established time frames intended to ensure that sponsors and administrators of group health plans, participants and beneficiaries, States, and issuers of group health insurance coverage have timely guidance concerning compliance with the recently enacted requirements of HIPAA.     

Grants for hospital construction and modernization; federal right of recovery and waiver of recovery--PHS. Notice of proposed rulemaking

As a result of recent amendments to sections 609 and 1622 of the Public Health Service Act, the Public Health Service proposes to amend its regulations to provide for (1) written notification to the Secretary when a grant-assisted hospital is sold or no longer used as a health facility eligible for a grant under Title VI or XVI of the Act, (2) waiver of the Government's right of recovery under certain circumstances, and (3) interest on recovery amounts.     

Control of communicable diseases; apprehension and detention of persons with specific diseases; transfer of regulations. Food and Drug Administration and Centers for Disease Control and Prevention, HHS. Final rule

The Secretary of Health and Human Service (the Secretary) is transferring a portion of the Food and Drug Administration (FDA) "Control of Communicable Diseases" regulations to the Centers for Disease Control and Prevention (CDC). In general, these regulations provide the Secretary with the authority to apprehend, detain, or conditionally release individuals to prevent the spread of specified communicable diseases. The regulations implement the provisions of the Public Health Service Act (PHS Act) to prevent the introduction, transmission, or spread of communicable diseases from one State or possession into any other State or possession. CDC will have authority for interstate quarantine over persons, while FDA will retain regulatory authority over animals and other products that may transmit or spread communicable diseases. The Secretary is taking this action to consolidate regulations designed to control the spread of communicable diseases, thereby increasing the agencies' efficiency and effectiveness.     

Countermeasures Injury Compensation Program (CICP): administrative implementation, interim final rule. Interim final rule with request for comments

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this interim final rule with request for comments in order to establish administrative policies, procedures, and requirements for the CICP. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The Secretary is seeking public comments on this interim final rule.     

Supplemental Security Income: determining disability for a child under age 18. Social Security Administration. Final rules

On February 11, 1997, we published interim final rules with a request for comments to implement the Supplemental Security Income (SSI) childhood disability provisions of sections 211 and 212 of Public Law (Pub. L.) 104-193, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996. We are now publishing revised final rules in response to public comments. We are also conforming our rules to amendments to Public Law 104-193 made by the Balanced Budget Act of 1997, Public Law 105-33. Finally, we are simplifying and clarifying some rules in keeping with the President's goal of using plain language in regulations.     

National Vaccine Injury Compensation Program: revisions to the vaccine injury table. Final rule

On September 13, 2010, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table) to create distinct listings for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus vaccines. The Secretary is now making this amendment to the Table by final rule; it is technical in nature. The four categories of vaccines described in this final rule are already covered vaccines under the VICP (starting in 2004) and are currently listed in a placeholder category (box XIII) in the Table. This final rule will list these vaccines as separate categories on the Table, with no associated injuries noted at this time, in order to help the public identify clearly that these vaccines are covered by the VICP. The changes implemented here are authorized by section 2114(e) of the Public Health Service Act (the Act).     

Interim final rules for nondiscrimination in health coverage in the group market. Internal Revenue Service, Department of the Treasury; Pension and Welfare Benefits Administration, Department of Labor; Health Care Financing Administration, Department of Health and Human Services. Interim final rules with request for comments

This document contains interim final rules governing the provisions prohibiting discrimination based on a health factor for group health plans and issuers of health insurance coverage offered in connection with a group health plan. The rules contained in this document implement changes made to the Internal Revenue Code of 1986 (Code), the Employee Retirement Income Security Act of 1974 (ERISA), and the Public Health Service Act (PHS Act) enacted as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).     

Establishment of criteria for determining priorities among designated health professional shortage areas--HRA. Notice

In accordance with the requirement of section 333A(c) of the Public Health Service Act, as amended by Public Law 101-597 (the National Health Service Corps Revitalization Amendments of 1990), this Notice establishes the criteria which the Secretary will use to make determinations under section 333A(a)(1)(A) of the health professional shortage areas (HPSAs) with the greatest shortages, using the exclusive factors specified in section 333A(b).