Student health insurance coverage. Final rule

This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines "student health insurance coverage" as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.     

Individual market health insurance reform: portability from group to individual coverage: federal rules for access in the individual market; state alternative mechanisms to federal rules--HHS. Interim final rule with comment period

This interim final rule with comment period implements section 111 of the Health Insurance Portability and Accountability Act of 1996, which sets forth Federal requirements designed to improve access to the individual health insurance market. Certain "eligible individuals" who lose group health insurance coverage are assured availability of coverage in the individual market, on a guaranteed issues basis, without preexisting condition exclusions. In addition, all individual health insurance coverage must be guaranteed renewable. This rule also sets forth procedures that apply to States that choose to implement a mechanism under State law, as an alternative to the Federal requirements, with respect to guaranteed availability for eligible individuals. It also sets forth the rules that apply if a State does not substantially enforce the statutory requirements.     

Medical loss ratio requirements under the Patient Protection and Affordable Care Act. Final rule

This final rule amends the regulations implementing medical loss ratio (MLR) standards for health insurance issuers under the Public Health Service Act in order to establish notice requirements for issuers in the group and individual markets that meet or exceed the applicable MLR standard in the 2011 MLR reporting year.     

Rate increase disclosure and review. Final rule with comment period

This final rule with comment period implements requirements for health insurance issuers regarding disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act. The final rule establishes a rate review program to ensure that all rate increases that meet or exceed a specified threshold are reviewed by a State or CMS to determine whether they are unreasonable and that certain rate information be made public.     

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).     

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.)     

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.     

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.     

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.     

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.     

Mental health and substance abuse emergency response criteria. Final rule

Section 3102 of the Children's Health Act of 2000, Pub. L. 106-310, amends section 501 of the Public Health Service (PHS) Act (42 U.S.C. 290aa) to add a new subsection (m) entitled "Emergency Response." This newly enacted subsection 501(m) authorizes the Secretary to use up to, but no more than, 2.5% of all amounts appropriated under Title V of the PHS Act, other than those appropriated under Part C, in each fiscal year to make "noncompetitive grants, contracts or cooperative agreements to public entities to enable such entities to address emergency substance abuse or mental health needs in local communities." Because Congress believed the Secretary needed the ability to respond to emergencies, it exempted any grants, contracts, or cooperative agreements authorized under this section from the peer review process. See section 501(m)(1) of the PHS Act. Instead, the Secretary is to use an objective review process by establishing objective criteria to review applications for funds under this authority.     

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.     

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.     

National vaccine injury compensation program: calculation of average cost of a health insurance policy. Final rule

Subtitle 2 of Title XXI of the Public Health Service Act, as enacted by the National Childhood Vaccine Injury Act of 1986, as amended (the Act), governs the National Vaccine Injury Compensation Program (VICP). The VICP, administered by the Secretary of Health and Human Services (the Secretary), provides that a proceeding for compensation for a vaccine-related injury or death shall be initiated by service upon the Secretary, and the filing of a petition with the United States Court of Federal Claims (the Court). In some cases, the injured individual may receive compensation for future lost earnings, less appropriate taxes and the "average cost of a health insurance policy, as determined by the Secretary." The final rule establishes the new method of calculating the average cost of a health insurance policy and determines the amount of the average cost of a health insurance policy to be deducted from the compensation award.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); enhancement of dental benefits under the TRICARE retiree dental program. Office of the Secretary, DoD. Interim final rule with request for comments

This interim final rule implements section 704 of the National Defense Authorization Act for Fiscal Year 2000, to allow additional benefits under the retiree dental insurance plan for Uniformed Services retirees and their family members that may be comparable to those under the Dependents Dental Program. The Department is publishing this rule as an interim final rule in order to comply timely with the desire of Congress to meet the needs of retirees for additional dental coverage. Public comments are invited and will be considered for possible revisions to this rule at the time of publication of the final rule.     

Criteria for designation of mental health professional shortage areas--PHS. Final rule

This final rule amends the existing regulations governing the criteria for designation of health manpower shortage areas, or HMSAs (now health professional shortage areas, or HPSAs; name changed by Public Law 101-597, the National Health Service Corps Revitalization Amendments of 1990) under section 332 of the Public Health Service Act. Specifically, this amendment revises the existing criteria for designation of HMSAs having shortages of psychiatric manpower, transforming them into criteria for designation of HPSAs having shortages of mental health professionals, to take into account not only psychiatrists but also mental health service providers other than psychiatrists. The intended effect of this amendment is to more accurately assess the supply of mental health service providers when making shortage area determinations. This notice also summarizes the comments received by the Department on the Notice of Proposed Rulemaking published on August 8, 1989, which set forth the proposed methodology for making this and other changes to the HMSA criteria. It also formally changes "HMSA" to "HPSA" throughout the regulation, to conform with Public Law 101-597.     

Interim rules for group health plans and health insurance issuers under the Newborns' and Mothers' Health Protection Act--IRS; DoL; HCFA. Interim rules with request for comments

This document contains interim rules governing the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA). The interim rules provide guidance to employers, group health plans, health insurance issuers, and participants and beneficiaries relating to new requirements for hospital lengths of stay in connection with childbirth. The rules contained in this document implement changes to the Employee Retirement Income Security Act of 1974 (ERISA) and the Public Health Service Act (PHS Act) made by NMHPA, and changes to the Internal Revenue Code of 1986 (Code) enacted as part of the Taxpayer Relief Act of 1997 (TRA '97). 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.     

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (PHS Act). In lieu of filing an establishment license application (ELA) and product license application (PLA) in order to market a biological product in interstate commerce, a manufacturer would file a single biologics license application (BLA) with the agency. Upon approval of the BLA, a manufacturer would receive a biologics license to market the product in interstate commerce. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and is intended to reduce unnecessary burdens for industry without diminishing public health protection. This action also proposes regulations to implement certain sections of the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Cooperation in USDA studies and evaluations, and full use of federal funds in nutrition assistance programs nondiscretionary provisions of the Healthy, Hunger-Free Kids Act of 2010, Public Law 111-296. Final Rule

This final rule incorporates into the regulations governing the Programs authorized under the Richard B. Russell National School Lunch Act (NSLA) and the Child Nutrition Act of 1966 (CNA) two nondiscretionary provisions of the Healthy, Hunger-Free Kids Act of 2010 (HHFK Act). The HHFK Act requires State and local cooperation in Department of Agriculture studies and evaluations related to Programs authorized under the NSLA and the CNA. The HHFK Act also amends the NSLA to stipulate that Federal funds must not be subject to State budget restrictions or limitations, including hiring freezes, work furloughs, and travel restrictions. This final rule amends regulations for the National School Lunch Program; the Special Milk Program for Children; the School Breakfast Program; the Summer Food Service Program; the Child and Adult Care Food Program; State Administrative Expense Funds ; the Special Supplemental Nutrition Program for Women, Infants and Children; and the WIC Farmers' Market Nutrition Program. These provisions will strengthen program integrity by ensuring that sufficient data is made available for studies and evaluations. Additionally, exempting Federal funds from State budgetary restrictions or limitations is intended to increase the ability of State agencies to administer USDA's nutrition assistance programs effectively.     

Medical loss ratio requirements under the Patient Protection and Affordable Care Act. Final rule with comment period

This final rule with comment period revises the regulations implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act in order to address the treatment of "mini-med" and expatriate policies under these regulations for years after 2011; modify the way the regulations treat ICD-10 conversion costs; change the rules on deducting community benefit expenditures; and revise the rules governing the distribution of rebates by issuers in group markets.