Exemption of certain research and demonstration projects from regulations for protection of human research subjects--DHHS. Notice of proposed rulemaking

The Department of Health and Human Services (the Department or HHS) is proposing to include among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects), research and demonstration projects conducted under the Social Security Act and other Federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. This proposed amendment to the revised final regulations for protection of human research subjects (published January 26, 1981) would, in effect, restore to the regulations an exemption included in the initial notice of proposed rulemaking (NPRM) (published August 14, 1979). These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an IRB would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of an unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation.     

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.     

Notice regarding Section 602 of the Veterans Health Care Act of 1992; new drug pricing--PHS. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act ("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 Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. The purpose of this notice is to inform interested parties of final guidelines regarding new drug pricing.     

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--Office of the Secretary, HHS. Final rule

The Department of Health and Human Services (the Department or HHS) is including among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects) research and demonstration projects conducted under the Social Security Act and other federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an Institutional Review Board (IRB), as required under Part 46, would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of this unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation. However, in order to ensure the continued protection of human subjects participating in such research activity, the Department is adding a specific requirement of written, informed consent in any instance, not reviewed by an IRB, in which the Secretary determines that the research activity presents a danger to the physical, mental or emotional well-being of a participant.     

Administrative practices and procedures--Office of the Secretary, HHS. Proposed rule

These proposed rules would reaffirm the Department's policy ordinarily to use notice and comment procedures in the development of rules relating to public property, loans, grants, benefits, and contracts, even though such action is not required by the Administrative Procedure Act, and would set forth the circumstances for such use. The Secretary believes that public comment serves an important purpose in bringing the expertise and views of interested parties to the attention of the Department.     

Designation of medically underserved populations and areas--HRSA. Notice

Under the provisions of section 330(b)(6) of the Public Health Service (PHS) Act, 42 U.S.C. 254c(b)(6), as amended by Pub. L. 99-280, the Governors of the States of Hawaii and Maine have asked the Secretary of Health and Human Services (HHS) to designate specific populations within their States as medically underserved populations (MUPs). Also, under section 330(b)(3) of the PHS Act, certain geographic areas in the States of Missouri, Nebraska, South Carolina, South Dakota, and Washington have been proposed for designation as medically underserved areas (MUAs). This notice provides an opportunity for State and local officials, State organizations representing Community Health Centers, and other interested parties in the above-mentioned States to provide recommendations and to comment on the proposals to designate as medically underserved the areas and populations described in this notice.     

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.)     

Privacy Act of 1974; matching program--HCFA. Notice of a matching program--the Internal Revenue Service (IRS), the Social Security Administration (SSA), and HCFA--disclosure of IRS taxpayer identity and filing status information to be matched with SSA earned income information for Medicare beneficiaries and their spouses

As required by Section 6202 of the Omnibus Budget Reconciliation Act of 1989 (OBRA 1989), Public Law 101-239, the Department of Health and Human Services is providing public notice that the IRS and the SSA will disclose certain information regarding the taxpayer identification and filing status and the earned income of Medicare beneficiaries and their spouses for HCFA's use in identifying Medicare secondary payer (MSP) situations. This will enable HCFA to seek recovery of identified mistaken payments that were the liability of another primary insurer or other type of payer. The matching report set forth below is in compliance with the Computer Matching and Privacy Protection Act of 1988 (Pub. L. No. 100-503).     

Privacy Act of 1974; computer matching program--HCFA. Notice of a matching program--HCFA's Health Insurance (HI) Master Record and information from four Railroad Retirement Board (RRB) systems of records

The Department of Health and Human Services is providing public notice that the RRB agrees to disclose information concerning Medicare eligible railroad retirees to HCFA. The matching report set forth below is in compliance with the Computer Matching and Privacy Protection Act of 1988 (Pub. L. No. 100-503).     

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.     

Partners invited to participate in Steps to a HealthierUS. Notice

The Department of Health and Human Services (HHS) seeks to work with other public and private sector organizations to support a new Federal initiative to promote better health for all Americans. This initiative is called Steps to a HealthierUS and is part of the President's HealthierUS Initiative to help Americans live longer, better, and healthier lives. This Steps Partnership initiative is not a grant or contract award program and each partner will be responsible for supporting its own activities. Working together, it is intended that these partnerships will provide innovative opportunities to promote healthier living and successfully promote the principles and efforts of the Steps initiative. More information about Steps is available at: http://www.healthierus.gov/steps/. Partnerships are not limited to any existing list of priority projects.     

Cancer treatment clinical trials--DoD. Notice of demonstration project

This notice is to advise interested parties of a demonstration project in which the DoD will expand a current demonstration for breast cancer treatment clinical trials to include all cancer treatment clinical trials under approved National Institutes of Health, National Cancer Institute (NCI) clinical trials. Participation in these clinical trials will improve accessing to promising cancer therapies for CHAMPUS eligible beneficiaries when their conditions meet protocol eligibility criteria. DoD financing of these procedures will assist in meeting clinical trial goals and arrival at conclusions regarding the safety and efficacy of emerging therapies in the treatment of cancer. This demonstration project is under the authority of 10 U.S.C. 1092.     

Final notice regarding section 602 of the Veterans Health Care Act of 1992 entity guidelines--PHS. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service 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 agree to charge a price that will not exceed the amount determined under a statutory formula. The purpose of this notice is to inform interested parties of final program guidelines regarding eligible covered entities.     

Notice regarding Federally Supported Health Centers Assistance Act of 1992--HRSA. Notice

The Secretary of Health and Human Services (the "Secretary"), in consultation with the Attorney General, provides the following notice regarding Public Law 102-501, the "Federally Supported Health Centers Assistance Act of 1992" (the "Act"). The Act provides for liability protection for certain health care professionals and entities. This notice sets forth information whereby an entity or a person can determine when, and the extent to which, it is deemed to be an entity as described in the Act.     

Medicare program: request for public comments on implementation of risk adjusted payment for the Medicare+Choice program and announcement of public meeting--HCFA. Solicitation of comments; announcement of meeting

This notice solicits further public comments on issues related to the implementation of risk adjusted payment of Medicare+Choice organizations. Section 1853(a)(3) of the Social Security Act (the Act) requires the Secretary to implement a risk adjustment methodology that accounts for variation in per capita costs based on health status and demographic factors for payments no later than January 1, 2000. The methodology is to apply uniformly to all Medicare+Choice plans. This notice outlines our proposed approach to implementing risk adjusted payment. In order to carry out risk adjustment, section 1853(a)(3) of the Act also requires Medicare+Choice organizations, as well as other organizations with risk sharing contracts, to submit encounter data. Inpatient hospital data are required for discharges on or after July 1, 1997. Other data, as the Secretary deems necessary, may be required beginning July 1998. The Medicare+Choice interim final rule published on June 26, 1998 (63 FR 34968) describes the general process for the collection of encounter data. We also included a schedule for the collection of additional encounter data. Physician, outpatient hospital, skilled nursing facility, and home health data will be collected no earlier than October 1, 1999, and all other data we deem necessary no earlier than October 1, 2000. Given any start date, comprehensive risk adjustment will be made about three years after the year of initial collection of outpatient hospital and physician encounter data. Comments on the process for encounter data collection are requested in that interim final rule. We intend to consider comments received in response to this solicitation as we develop the final methodology for implementation of risk adjustment. This notice also informs the public of a meeting on September 17, 1998, to discuss risk adjustment and the collection of encounter data. The meeting will be held at the Health Care Financing Administration headquarters, located at 7500 Security Boulevard, Baltimore, MD, beginning at 8:30 a.m. Additional materials on the risk adjustment model will be available on or after October 15, 1998, and may be requested in writing from Chapin Wilson, Health Care Financing Administration, Department of Health and Human Services, 200 Independence Avenue, S. W., Room 435-H, Washington, DC 20201.     

Sanctions applicable to letter of credit administration--Office of the Secretary, HHS. Proposed rule

We are proposing regulations that would govern the imposition of sanctions against recipient organizations holding letters of credit under programs administered by the Department of Health and Human Services. The regulations would describe the conditions which may prompt the imposition of sanctions and would establish uniform procedures for providing affected recipient organizations: (1) Adequate notice of the grounds upon which proposed sanctions are based, (2) an opportunity to respond to the factual and legal bases of the proposed sanctions, and (3) a reasoned decision that articulates the factual and legal bases of the Department's final decision. We believe that these uniform procedures would be useful both as a sound management tool for the Department and as a guide to grantees and contractors.     

Maternal and child assistance programs; model application form--HHS, Department of Agriculture. Notice

This notice publishes a model application form that States have the option of using in full, in part, with modification or not at all. It would be used by pregnant women or by children under 6 years of age to apply for benefits simultaneously under several congressionally specified "maternal and child assistance programs": (1) The Medicaid program under title XIX of the Social Security Act; (2) the Health Care for the Homeless grant program under section 340 of the Public Health Service Act; (3) the Maternal and Child Health (MCH) Services block grand program under title V of the Social Security Act; (4) the Migrant and Community Health Centers programs under sections 329 and 330 of the Public Health Service Act; (5) the Head Start program under the Head Start Act; and (6) the Special Supplemental Food Program for Women, Infants and Children (WIC) under section 17 of the Child Nutrition Act of 1966. This notice is published in accordance with section 6506(a) of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239), which requires the Secretary of Health and Human Services, in consultation with the Secretary of Agriculture, to develop a model application form for the specified maternal and child assistance programs for publication in the Federal Register. This model application form represents a first effort to develop a joint model application form covering the programs mandated by Congress. If modifications are necessary due to changes in program requirements, or States or other user experience, they will be pursued.     

Violence in our society

Violent interactions between parent and child, and between spouses, occur at a high rate in the United States. In response to this situation, several federal agencies are involved in various research projects whose goal is a better understanding of the roots of violence. Among these agencies are the Division of Injury Epidemiology and Control (Centers for Disease Control), the Office of Minority Health (Department of Health and Human Services), and the Antisocial and Violent Behavior Branch (National Institute of Mental Health).     

Supplemental Security Income for the Aged, Blind and Disabled (SSI) program demonstration project; treatment of cash received and conserved to pay for medical or social services--SSA. Notice

The Commissioner of Social Security will conduct a demonstration project to test how certain altered resources counting rules might apply in the SSI program. The SSI program is authorized by title XVI of the Social Security Act (the Act). The rules which will be tested are those that apply to the treatment of cash received and conserved to pay for medical or social services. Cash which is received for the purposes of payment for medical or social services is not counted as income to the beneficiary when received. If cash received for medical or social services which is not a reimbursement for these services already paid for by the beneficiary is conserved, it is not counted as a resource for the calendar month following the month of receipt, so long as it remains separately identifiable from other resources of the individual. Beginning with the second calendar month following the month of receipt, cash received for the payment of medical or social services becomes a countable resource used in the determination of SSI eligibility. The Health Care Financing Administration of the Department of Health and Human Services (DHHS) is collaborating with the States of Arkansas, Florida, New Jersey and New York and with the National Program Office at the University of Maryland's Center on Aging, the Robert Wood Johnson Foundation, the Office of the Assistant Secretary for Planning and Evaluation of the DHHS, the National Council on Aging and Mathematica Policy Research (the evaluator) on a demonstration project to provide greater autonomy to the consumers of personal assistance services. Personal assistance services are help with the basic activities of daily living, including bathing, dressing, transferring, toileting, and eating, and/or instrumental activities of daily living such as housekeeping, meal preparation, shopping, laundry, money management and medication management. Consumers of personal assistance services who participate in this demonstration will be empowered by purchasing the services they require (including medical and social services) to perform the activities of daily living. In order to accomplish the objective of the demonstration project, cash allowances and information services will be provided directly to persons with disabilities to enable them to choose and purchase services from providers which they feel would best meet their needs. Medicaid is the predominant source of public financing for personal assistance services programs for the aged, blind and disabled. The demonstration which will permit the States of Arkansas, Florida, New Jersey and New York to waive certain requirements under title XIX of the Act to participate in this "Cash and Counseling" demonstration is within the authority granted to the Secretary of Health and Human Services (HHS) by section 1115 of the Act. Medicaid beneficiaries who participate in this demonstration will be given cash to purchase the services they need from traditional and nontraditional providers as they deem appropriate. Counseling will be available for these beneficiaries to assist them in effective use of funds allotted for personal assistance services. Many of the Medicaid beneficiaries who participate in the Cash and Counseling demonstration will be SSI beneficiaries or belong to coverage groups using eligibility methodologies related to those of the SSI program under title XIX of the Act. The Commissioner of Social Security wishes to test the appropriateness of current SSI rules which require counting cash received for the purchase of medical or social services as resources if retained for more than one month after the month of receipt. The test will also be used to assist the Secretary of HHS in testing the possibility of providing greater autonomy to the consumers of personal assistance services by empowering them to purchase the services they require (including medical and social services) to perform their activities of daily living. (ABSTRACT TRUNCATED)     

TRICARE: the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); specialized treatment services (STS) program--DoD. Notice

This notice is to advise interested parties that Naval Hospital Jacksonville (NAVHOSPJAX), Florida, has been designated a regional Specialized Treatment Services facility (STSF) for total joint replacement. The application for this STSF designation was submitted by NAVHOSPJAX and approved by the Assistant Secretary of Defense (Health Affairs). The Lead Agent for TRICARE Region 3 will oversee that the STSF maintains the quality and standards required for specialized treatment services. This designation covers the following Diagnostic Related Groups: 209--Major Joint and Limb Reattachment Procedures of Lower Extremity 491--Major Joint and Limb Reattachment Procedures of Upper Extremity DoD beneficiaries who reside in the NAVHOSPJAX STS Catchment Area must be evaluated by NAVHOSPJAX before receiving TRICARE/CHAMPUS cost sharing for procedures that fall under the above Diagnostic Related Groups, in accordance with TRICARE/CHAMPUS Nonavailability Statement policy. Travel and lodging for the patient and, if stated to be medically necessary by a referring physician, for a nonmedical attendant, will be reimbursed by NAVHOSPJAX in accordance with the provision of the Joint Federal Travel Regulation. Although evaluation in person is preferred, it is possible to conduct the evaluation telephonically if the patient is unable to travel to NAVHOSPJAX. If the procedures cannot be performed at NAVHOSPJAX, Humana Military Healthcare Services will provide a medical necessity review prior to issuance of a Nonavailability Statement or other similar authorizations. The NAVHOSPJAX STSF Catchment Area includes zip codes within TRICARE Region 3 that fall within a 200-mile radius South and West of NAVHOSPJAX.