Performance of functions; claims for compensation under the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended. Final rule

On June 8, 2005, the Department of Labor (DOL) published interim final regulations that govern its responsibilities under the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended (EEOICPA or Act). Part B of the Act provides lump-sum payments of $150,000 and medical benefits to covered employees and, where applicable, to survivors of such employees, of the Department of Energy (DOE), its predecessor agencies and certain of its vendors, contractors and subcontractors. Part B also provides lump-sum payments of $50,000 and medical benefits to individuals found eligible by the Department of Justice (DOJ) for $100,000 under section 5 of the Radiation Exposure Compensation Act (RECA) and, where applicable, to their survivors. Part E of the Act provides variable lump-sum payments (based on a worker's permanent impairment and/or calendar years of qualifying wage-loss) and medical benefits for covered DOE contractor employees and, where applicable, provides variable lump-sum payments to survivors of such employees (based on a worker's death due to a covered illness and any calendar years of qualifying wage-loss). Part E also provides these same payments and benefits to uranium miners, millers and ore transporters covered by section 5 of RECA and, where applicable, to survivors of such employees. At the same time the Department published the interim final regulations, it also invited written comments and advice from interested parties regarding possible changes to those regulations. This document amends the interim final regulations based on comments that the Department received.     

Guidelines for determining probability of causation under the Energy Employees Occupational Illness Compensation Program Act of 2000; revision of guidelines on non-radiogenic cancers. Final rule

In a notice of proposed rulemaking published in the Federal Register on March 21, 2011, the Department of Health and Human Services (HHS) proposed to treat chronic lymphocytic leukemia (CLL) as a radiogenic cancer under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) (76 FR 15268). Under this final rule, CLL will be treated as being potentially caused by radiation and hence as potentially compensable under EEOICPA. HHS reverses its decision to exclude CLL from such treatment.     

Performance of functions; claims for compensation under the Energy Employees Occupational Illness Compensation Program Act. Interim final rule; request for comments

This document contains the interim final regulations governing the administration of the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended (EEOICPA or Act) by the Department of Labor (Department or DOL). Part B of the Act provides uniform lump-sum payments and medical benefits to covered employees and, where applicable, to survivors of such employees, of the Department of Energy (DOE), its predecessor agencies and certain of its vendors, contractors and subcontractors. Part B of the Act also provides smaller uniform lump-sum payments and medical benefits to individuals found eligible by the Department of Justice (DOJ) for benefits under section 5 of the Radiation Exposure Compensation Act (RECA) and, where applicable, to their survivors. Part E of the Act provides variable lump-sum payments (based on a worker's permanent impairment and/or years of established wage-loss) and medical benefits for covered DOE contractor employees and, where applicable, provides variable lump-sum payments to survivors of such employees (based on a worker's death due to a covered illness and any years of established wage-loss). Part E of the Act also provides these same payments and benefits to uranium miners, millers and ore transporters covered by section 5 of the RECA and, where applicable, to survivors of such employees. The Office of Workers' Compensation Programs (OWCP) administers the adjudication of claims and the payment of benefits under EEOICPA, with the Department of Health and Human Services (HHS) estimating the amounts of radiation received by employees alleged to have sustained cancer as a result of such exposure and establishing guidelines to be followed by OWCP in determining whether such cancers are at least as likely as not related to employment. Both DOE and DOJ are responsible for notifying potential claimants and for submitting evidence necessary for OWCP's adjudication of claims under EEOICPA.     

Federal Employees Health Benefits Program; benefits for medically underserved areas--Office of Personnel Management. Final rule

The Office of Personnel Management (OPM) is amending its regulations pertaining to benefits under the Federal Employees Health Benefits (FEHB) Program for individuals in medically underserved areas. These regulations are necessary to implement the FEHB law, as amended, which mandates special consideration for enrollees of certain FEHB plans who receive covered health service in States with critical shortages of primary care physicians.     

Federal Employees Health Benefits Program; benefits for medically underserved areas--Office of Personnel Management. Final rule

The Office of Personnel Management (OPM) is amending its regulations pertaining to benefits under the Federal Employees Health Benefits (FEHB) Program for individuals in medically underserved areas, these regulations are necessary to implement the FEHB law, as amended, which mandates special consideration for enrollees of certain FEHB plans who receive covered health service in States with critical shortages of primary care physicians.     

Exemption of certain systems of records under the Privacy Act. Final rule

This final rule exempts four systems of records (SORs) from subsections (c)(3), (d)(1) through (d)(4), (e)(4)(G) and (H), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2): The Automated Survey Processing Environment (ASPEN) Complaint/ Incidents Tracking System (ACTS), HHS/CMS, System No. 09-70-0565; the Health Insurance Portability and Accountability Act (HIPAA) Information Tracking System (HITS), HHS/CMS, System No. 09-70-0544; the Organ Procurement Organizations System (OPOS), HHS/CMS, System No. 09-70- 0575; and the Fraud Investigation Database (FID), HHS/CMS, System No. 09-70-0527.     

Medicaid program; eligibility changes under the Affordable Care Act of 2010. Final rule, Interim final rule

This final rule implements several provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). The Affordable Care Act expands access to health insurance coverage through improvements to the Medicaid and Children's Health Insurance (CHIP) programs, the establishment of Affordable Insurance Exchanges ("Exchanges"), and the assurance of coordination between Medicaid, CHIP, and Exchanges. This final rule codifies policy and procedural changes to the Medicaid and CHIP programs related to eligibility, enrollment, renewals, public availability of program information and coordination across insurance affordability programs.     

Work activity of persons working as members of advisory committees established under the Federal Advisory Committee Act (FACA). Final rule

We are revising our disability regulations under titles II and XVI of the Social Security Act to establish a new, special rule that affects individuals who are receiving payments or providing services as members or consultants of a committee, board, commission, council or similar group established under the Federal Advisory Committee Act (FACA). Under this special rule, we will not count any earnings an individual is receiving from serving as a member or consultant of a FACA advisory committee when we determine if the individual is engaging in substantial gainful activity under titles II and XVI of the Social Security Act (the Act). In addition, we will not evaluate any of the services the individual is providing as a member or consultant of the FACA advisory committee when determining if the individual has engaged in substantial gainful activity under titles II and XVI of the Act. Based on our experience with FACA advisory committees and the frequency and level of activity required by these committees, we believe that performance of activity on these committees does not demonstrate the ability to perform substantial gainful activity. We believe this to be consistent with Congress's view, as it has recognized in creating the Ticket to Work advisory committee, for example, that current disability beneficiaries should be considered for membership. This also will encourage individuals with disabilities to serve on FACA advisory committees, thereby providing the benefit of their unique perspective on policies and programs to the Federal Government.     

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.     

Suspension of enrollment in the Federal Employees Health Benefits (FEHB) Program for Peace Corps volunteers. Final rule

The Office of Personnel Management is issuing a final regulation to allow Peace Corps volunteers who are FEHB Program enrolled annuitants, survivors, and former spouses to suspend their FEHB enrollments and then return to the FEHB Program during the Open Season, or return to FEHB coverage immediately, if they involuntarily lose health benefits coverage under the Peace Corps. The intent of this final rule is to allow these beneficiaries to avoid the expense of continuing to pay FEHB Program premiums while they have other health coverage as Peace Corps volunteers, without endangering their ability to return to the FEHB Program in the future.     

Procedures for disclosure or production of information under the Freedom of Information Act; amendments--Consumer Product Safety Commission. Final Rule

The Electronic Freedom of Information Act Amendments of 1996, which amend the Freedom of Information Act, are designed to make government documents more accessible to the public in electronic form. The amendments are also intended to expedite and streamline the process by which agencies disclose information generally. In this notice, the Commission amends its Freedom of Information Act regulations to comply with the requirements of the new statute.     

Medicare program; establishment of the Medicare Advantage Program; interpretation. Final rule; interpretation

This final rule clarifies our interpretation of the meaning of "entity" in the final rule titled "Medicare Program; Establishment of the Medicare Advantage Program" published in the Federal Register on January 28, 2005 (70 FR 4588). Subsequent to the publication of the Medicare Advantage (MA) final rule on January 28, 2005, we have received inquiries from parties interested in offering an MA Regional Plan concerning whether they could jointly enter into a contract with us to offer a single MA Regional Plan in a multistate region. The participating health plans wish to contract with each other to create a single "joint enterprise." They have asked us whether such a joint enterprise could be considered an "entity" under sections 1859(a)(1)and 1855(a)(1) of the Social Security Act, for purposes of offering an MA Regional Plan. The MA final rule is scheduled to take effect on March 22, 2005. Our interpretation of the word "entity" that follows in the "Supplementary Information" section of this final rule is deemed to be included in that final rule.     

Medical devices; device tracking--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date

The Food and Drug Administration (FDA) is issuing a final rule to establish a device tracking requirement for certain categories of medical devices as required by the Safe Medical Devices Act of 1990 (the SMDA). In a proposed rule issued on May 27, 1992, and published elsewhere in this issue of the Federal Register, FDA discussed the agency's initial review of certain comments received in response to an earlier proposed rule that published in the Federal Register of March 27, 1992 (57 FR 10702), that has been withdrawn. In issuing this final rule, FDA is providing notice that the proposed rule published elsewhere in this issue of the Federal Register now has the status of a final rule by operation of section 3(c)(2) of the SMDA. FDA is also confirming that the effective date of this rule is March 1, 1993. This rule applies to all devices subject to tracking under the SMDA that are initially introduced into interstate commerce or presented for importation into the United States on or after March 1, 1993. In the proposed rule published elsewhere in this issue of the Federal Register, FDA requests comments on that proposal. Upon closure of the comment period for that proposed rule and consideration of comments responding to both the original March 27, 1992, proposed rule and the new proposed rule, FDA will, if necessary, take further actions to revise the rule.     

Prohibition of "gag clauses" in the Federal Employees Health Benefits Program--OPM. Final rule making

The office of Personnel Management (OPM) is issuing a final regulation amending the Federal Employees Health Benefits Acquisition Regulations (FEHBAR) to prohibit health benefit carriers participating in the Federal Employees Health Benefits (FEHB) Program from entering into contracts or employment agreements with health care providers, provider groups, or health care workers that would include provisions or financial incentives that have the effect of limiting or restricting communication of medically necessary services to FEHB enrollees.     

Privacy Act of 1974; proposed implementation. Office of the Secretary, HHS. Final rule

The Department of Health and Human Services is exempting a new system of records, 09-25-0213, "Administration: Investigative Records, HHS/NIH/OM/OA/OMA," from certain requirements of the Privacy Act to protect records compiled in the course of an inquiry and/or investigation and to protect the identity of confidential sources who furnish information to the Government under an express promise that the identity of such source would be held in confidence.     

Classification of two steroids, prostanozol and methasterone, as Schedule III anabolic steroids under the Controlled Substance Act. Final rule

With the issuance of this Final Rule, the Administrator of the DEA classifies the following two steroids as "anabolic steroids' under the Controlled Substances Act (CSA): prostanozol (17[beta]-hydroxy-5[alpha]-androstano[3,2-c]pyrazole) and methasterone (2[alpha],17[alpha]-dimethyl-5[alpha]-androstan-17[beta]-ol-3-one). These steroids and their salts, esters, and ethers are Schedule III controlled substances subject to the regulatory control provisions of the CSA.     

TRICARE; expansion of geographic scope of the TRICARE Retiree Dental Program. Final rule

This final rule expands the geographic scope of the TRICARE Retiree Dental Program (TRDP) to overseas locations not currently covered by the program. At this time, TRDP is applicable only in the 50 United States (U.S.) and the District of Columbia, Canada, Puerto Rico, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and the U.S. Virgin Islands. Expanding the geographic scope of the program will ensure that all TRICARE-eligible retirees are eligible for the same dental benefits, regardless of their location. There are no additional Government costs associated with this final expansion of TRDP overseas as TRDP costs are borne entirely by enrollees through premium payments.     

Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date

The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA.     

Medical devices; device tracking--FDA. Final rule; suspension of effective date; notification of status under the Safe Medical Devices Act; technical amendments

The Food and Drug Administration (FDA) is announcing that it is suspending the effective date of the final rule on device tracking that appeared in the Federal Register of May 29, 1992, until August 29, 1993. The agency is also announcing that the revised proposed rule is now a final rule by operation of law. Further, the agency is amending the regulations to make certain technical amendments. This action is being taken to implement requirements of the Safe Medical Devices Act of 1990 (the SMDA) and the Medical Device Amendments of 1992 (the 1992 amendments).     

TRICARE; Individual Case Management Program; Program for Persons with Disabilities; extended benefits for disabled family members of active duty service members; custodial care. Final Rule

The Department is publishing this final rule to implement requirements enacted by Congress in section 701(g) of the National Defense Authorization Act for Fiscal Year 2002 (NDAA-02), which terminates the Individual Case Management Program. The Department withdraws its proposed rule published at 66 FR 39699 on August 1, 2001, regarding the Individual Case Management Program. This rule also implements section 701(b) of the NDAA-02 which provides additional benefits for certain eligible active duty dependents by amending the TRICARE regulations governing the Program for Persons with Disabilities. The Program for Persons with Disabilities is now called the Extended Care Health Option. Other administrative amendments are included to clarify specific policies that relate to the Extended Care Health Option, custodial care, and to update related definitions.