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; Medicare integrity program, intermediary and carrier functions, and conflict of interest requirements--HCFA. Proposed rule

This proposed rule would implement section 1893 of the Social Security Act (the Act) by establishing the Medicare integrity program (MIP) to carry out Medicare program integrity activities that are funded from the Medicare Trust Funds. Section 1893 expands our contracting authority to allow us to contract with "eligible entities" to perform Medicare program integrity activities. These activities include review of provider and supplier activities, including medical, fraud, and utilization review: cost report audits; Medicare secondary payer determinations; education of providers, suppliers, beneficiaries, and other persons regarding payment integrity and benefit quality assurance issues; and developing and updating a list of durable medical equipment items that are subject to prior authorization. This proposed rule would set forth the definition of eligible entities, services to be procured, competitive requirements based on Federal acquisition regulations and exceptions (guidelines for automatic renewal), procedures for identification, evaluation, and resolution of conflicts of interest, and limitations on contractor liability. In addition, this proposed rule would bring certain sections of the Medicare regulations concerning fiscal intermediaries and carriers into conformity with the Act. The rule would distinguish between those functions that the statute requires be included in agreements with intermediaries and those that may be included in the agreements. It would also provide that some or all of the listed functions may be included in carrier contracts. Currently all these functions are mandatory for carrier contracts. These changes would give us the flexibility to transfer functions from one intermediary or carrier to another or to otherwise limit the functions an intermediary or carrier performs if we determine that to do so would result in more effective and efficient program administration.     

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.     

State child health; implementing regulations for the State Children's Health Insurance Program. Health Care Financing Administration (HCFA), HHS. Final rule

Section 4901 of the Balanced Budget Act of 1997 (BBA) amended the Social Security Act (the Act) by adding a new title XXI, the State Children's Health Insurance Program (SCHIP). Title XXI provides funds to States to enable them to initiate and expand the provision of child health assistance to uninsured, low-income children in an effective and efficient manner. To be eligible for funds under this program, States must submit a State plan, which must be approved by the Secretary. This final rule implements provisions related to SCHIP including State plan requirements and plan administration, coverage and benefits, eligibility and enrollment, enrollee financial responsibility, strategic planning, substitution of coverage, program integrity, certain allowable waivers, and applicant and enrollee protections. This final rule also implements the provisions of sections 4911 and 4912 of the BBA, which amended title XIX of the Act to expand State options for coverage of children under the Medicaid program. In addition, this final rule makes technical corrections to subparts B, and F of part 457.     

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.     

Technical revisions to conform to the Caregivers and Veterans Omnibus Health Services Act of 2010. Final rule

This final rule amends Department of Veterans Affairs (VA) medical regulations to incorporate statutory amendments. Certain statutes authorizing VA health care benefits were amended by the Caregivers and Veterans Omnibus Health Services Act of 2010. The statutory amendments affect enrollment in certain health care priority categories and exempt catastrophically disabled veterans from copayment requirements.     

Medicaid program; review and approval process for Section 1115 demonstrations. Final rule

This final rule will implement provisions of section 10201(i) of the Patient Protection and Affordable Care Act of 2010 that set forth transparency and public notice procedures for experimental, pilot, and demonstration projects approved under section 1115 of the Social Security Act relating to Medicaid and the Children's Health Insurance Program (CHIP). This final rule will increase the degree to which information about Medicaid and CHIP demonstration applications and approved demonstration projects is publicly available and promote greater transparency in the review and approval of demonstrations. It will also codify existing statutory requirements pertaining to seeking advice from Indian health care providers and urban Indian organizations for section 1115 demonstration projects, and for the first time impose as regulatory requirements tribal consultation standards that were previously only published as guidance documents.     

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.     

Dental care--provision of one-time outpatient dental care for certain veterans. Final rule

The Department of Veterans Affairs (VA) is amending its regulations regarding the authority to provide one-time outpatient dental treatment to eligible veterans following discharge or release from active duty. In section 1709 of Public Law 110-181, the National Defense Authorization Act for Fiscal Year 2008, Congress amended the eligibility criteria for the one-time dental treatment benefit. This rule is necessary to incorporate the statutory amendments into VA regulations.     

Medicaid program; eligibility groups, coverage, and conditions of eligibility; legislative changes under OBRA '87, COBRA, and TEFRA--HCFA. Final rule

This rule amends the Medicaid regulations to incorporate or revise the following mandatory and optional eligibility groups of individuals for Medicaid coverage: (1) Pregnant women; (2) qualified children under a specified age; (3) children in adoptions and foster care; (4) certain disabled widows and widowers; and (5) certain disabled children being cared for at home. The rule also adds a condition of eligibility relating to third party liability for medical assistance expenditures. The amendments conform the regulations to certain statutory provisions of the Omnibus Budget Reconciliation Act of 1987, the Consolidated Omnibus Budget Reconciliation Act of 1985, and the Tax Equity and Fiscal Responsibility Act of 1982.     

TRICARE; changes included in the National Defense Authorization Act for Fiscal Year 2010; expansion of survivor eligibility under the TRICARE Dental Program. Final rule

The Department is publishing this final rule to implement the National Defense Authorization Act for Fiscal Year 2010 (NDAA for FY10), as amended by the National Defense Authorization Act for Fiscal Year 2011 (NDAA for FY11). Specifically, that legislation expands the survivor eligibility under the TRICARE Dental Program (TDP). The 2011 amendment to the legislation entitles the surviving spouse and child(ren) continuation of eligibility for the TDP regardless of whether they were previously enrolled in the TDP. Prior enrollment in the TDP had been a requirement of the 2010 legislation for both the spouse and children. The period of continued eligibility for a spouse will be 3 years beginning on the date of the member's death. The legislation entitles a child to continuation of eligibility for the TDP for the longer of three years or until age 21 (or 23 for most full-time students). Survivors, who meet the new eligibility requirements, will obtain TDP eligibility as of the publishing of the final rule in the Federal Register. Retroactive payment of premiums or claims paid for dental treatment during the time of loss of TDP eligibility will not be reimbursed to surviving dependents.     

Additional protections for children involved as subjects in research--Department of Health and Human Services. Final rule

The Department of Health and Human Services (Department or HHS)( is prescribing additional requirements for protection of children involved as subjects in research. These regulations adopt, with some changes, the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) as were presented in the notice of proposed rulemaking (NPRM) 43 FR 31786 which preceded this final rule. Specifically, these regulations impose certain added responsibilities on Institutional Review Boards (IRBs) depending on the degree of risk involved in the research and the extent that the research is likely to be a benefit to the subject or relate to a subject's illness.     

Medicare program; Medicare Integrity Program, fiscal intermediary and carrier functions, and conflict of interest requirements. Final rule

This final rule establishes the Medicare Integrity Program (MIP) and implements program integrity activities that are funded from the Federal Hospital Insurance Trust Fund. This final rule sets forth the definitions related to eligible entities; services to be procured; competitive requirements based on Federal acquisition regulations and exceptions (guidelines for automatic renewal); procedures for identification, evaluation, and resolution of conflicts of interest; and limitations on contractor liability. This final rule brings certain sections of the Medicare regulations concerning fiscal intermediaries (FIs) and carriers into conformity with the Social Security Act (the Act). The rule distinguishes between those functions that the statute requires to be included in agreements with FIs and those that may be included in the agreements. It also provides that some or all of the functions may be included in carrier contracts.     

Medicare program; Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period responds to comments on the June 26, 1998 interim final rule that implemented the Medicare+Choice (M+C) program and makes revisions to those regulations where warranted. We also are making revisions to the regulations that are necessary to reflect the changes to the M+C program resulting from the Balanced Budget Refinement Act of 1999 (BBRA). Revisions to the regulations reflecting changes in the law made by the BBRA are subject to public comment. Issues discussed in this rule include eligibility, election, and enrollment policies; marketing requirements; access requirements; service area and benefit policy; quality improvement standards; payment rates, risk adjustment methodology, and encounter data submission; provider participation rules; beneficiary appeals and grievances; contractual requirements; and preemption of State law by Federal law. This final rule also addresses comments on the interim final rule published on December 2, 1997, which implemented user fees for section 1876 risk contractors for 1998, and formed the basis for the M+C user fee provisions in the June 26, 1998 interim final rule, and the provider-sponsored organization (PSO) interim final rule published April 14, 1998.     

Medicaid program; eligibility and coverage requirements--HCFA. Final rule with comment period

These regulations amend the requirements for coverage of certain groups of individuals under Medicaid and the requirements for determining Medicaid eligibility. The regulations relate to coverage of individuals in optional categorically needy groups; aged, blind and disabled individuals in States that use more restrictive requirements for Medicaid than those under the Supplemental Security Income (SSI) program; individuals receiving optional State supplementary payments; individuals under age 21 who are not receiving AFDC; individuals who are ineligible for cash assistance under the Social Security Act because of requirements that do not apply under Medicaid; and medically needy groups. In addition, the regulations revise the methodologies for determining income and resource eligibility under Medicaid, including financial responsibility of relatives, and for determining financial eligibility of medically needy groups, including determining medically needy income levels. These regulations interpret provisions of the Tax Equity and Fiscal Responsibility Act of 1982, as amended by several acts, including, most recently, the Omnibus Budget Reconciliation Act of 1987, the Medicare Catastrophic Coverage Act of 1988, the Family Support Act of 1988, the Omnibus Budget Reconciliation Act of 1989, and the Omnibus Budget Reconciliation Act of 1990. We are also making some administrative changes to achieve more efficient operation of the Medicaid Program.     

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.     

Recordkeeping and reporting under Title VII and the ADA--EEOC. Final rule

This final rule is based on two separate Notices of Proposed Rulemaking (NPRM) published on February 13, 1989 (54 FR 6551), and March 5, 1991 (56 FR 9185). This final rule amends 29 CFR part 1602, EEOC's regulations on Recordkeeping and Reporting under title VII of the Civil Rights Act of 1964 (title VII), to add recordkeeping requirements under the Americans with Disabilities Act of 1990 (ADA). It increases the records retention period required in part 1602 for title VII and the ADA from 6 months to one year. The Commission also is adding a new subpart R to part 1602, 29 CFR 1602.56, that will clarify that the Commission has the authority to investigate persons to determine whether they comply with the reporting or recordkeeping requirements of part 1602. In addition, the Commission is making several minor changes to sections 1602.7 and 1602.10. The Commission also is deleting section 1602.14(b) of its title VII recordkeeping regulations, which provides that the section 1602 recordkeeping requirements do not apply to temporary or seasonal positions. Information regarding such employees now must be reported on Standard Form 100 on September 30 of each year, in the same fashion as information regarding permanent employees is reported. Similarly, the Commission is deleting sections 1627.3(b) and 1627.4(a)(2) of the Age Discrimination in Employment Act recordkeeping regulations, which provide for a 90-day retention period for temporary positions, and is clarifying the mandatory nature of such recordkeeping. The Commission is not issuing a final rule on proposed section 1602.57 at this time.