Data breaches. Final rule

This document adopts, without change, the interim final rule that was published in the Federal Register on June 22, 2007, addressing data breaches of sensitive personal information that is processed or maintained by the Department of Veterans Affairs (VA). This final rule implements certain provisions of the Veterans Benefits, Health Care, and Information Technology Act of 2006. The regulations prescribe the mechanisms for taking action in response to a data breach of sensitive personal information.     

Caregivers program. Interim final rule

This document promulgates Department of Veterans Affairs (VA) interim final regulations concerning a new caregiver benefits program provided by VA. This rule implements title I of the Caregivers and Veterans Omnibus Health Services Act of 2010, which was signed into law on May 5, 2010. The purpose of the new caregiver benefits program is to provide certain medical, travel, training, and financial benefits to caregivers of certain veterans and servicemembers who were seriously injured in the line of duty on or after September 11, 2001.     

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.     

Tribal child welfare. Interim final rule

The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.     

TRICARE: certified mental health counselors. Interim final rule

This rule is submitted as an interim final rule (IFR) in order to meet the Congressional requirement set forth in the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, Section 724, which required the Department of Defense to prescribe regulations by June 20, 2011, to establish the criteria, as had previously been studied in accordance with Section 717 of the NDAA 2008, that would allow licensed or certified mental health counselors to be able to independently provide care to TRICARE beneficiaries and receive payment for those services. Under current TRICARE requirements, mental health counselors (MHCs) are authorized to practice only with physician referral and supervision. This interim final rule establishes a transition period to phase out the requirement for physician referral and supervision for MHCs and to create a new category of allied health professionals, to be known as certified mental health counselors (CMHCs), who will be authorized to practice independently under TRICARE. During this transition period the MHCs who do not meet the requirements for independent practice as established in this rule, may continue to provide services to TRICARE beneficiaries under the requirements of physician referral and ongoing supervision. This transition period, ending December 31, 2014, will allow time for those MHCs who seek to continue providing services under the TRICARE program to meet the independent practice requirements as outlined in this notice. After December 31, 2014, the Department of Defense will no longer recognize those mental health counselors who do not meet the criteria for a CMHC and will no longer allow them to provide services even upon the referral and supervision of a physician.     

Control of communicable diseases. Interim final rule with comment period

The Public Health Service Act authorizes the Secretary, in consultation with the Surgeon General, to make and enforce regulations as are necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. The existing regulations are outdated and do not address communicable diseases that currently pose a substantial public health threat. As of April 2, 2003, the World Health Organization (WHO) has reported 2236 cases and 78 deaths related to outbreaks of a severe form of pneumonia of unknown origin in Hong Kong SAR, Vietnam, Guangdong province in southern China, Canada, Singapore, and Thailand, which appears to have spread rapidly. For this reason, the Director General of the World Health Organization (WHO) issued a global alert about cases of atypical pneumonia and recommended that travelers with atypical pneumonia who may be related to these outbreaks be placed into isolation and assessed by quarantine officials. The Centers for Disease Control and Prevention (CDC) is currently investigating 85 suspected cases of the disease in the United States. This is being issued as an interim final rule because this newly-detected disease is likely spread in person-to-person fashion and may have an adverse public health impact if further introduced into the United States.     

Disclosure of information to organ procurement organizations. Interim final rule

This document amends the Department of Veterans Affairs (VA) regulations to implement section 204 of the Veterans Benefits, Health Care, and Information Technology Act of 2006. This regulatory change will provide authority for VA to provide individually-identifiable VA medical records of veterans or dependents of veterans who are deceased or whose death is imminent to representatives of organ procurement organizations (OPOs) as defined in section 371(b) of the Public Health Service Act (PHS Act), eye banks, and tissue banks to determine whether the patients are suitable potential donors.     

Smallpox Vaccine Injury Compensation Program: administrative implementation. Interim final rule

The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), authorizes the Secretary of Health and Human Services (the Secretary), to establish the Smallpox Vaccine Injury Compensation Program ("the Program"). This program is designed to provide benefits and/or compensation to certain persons harmed as a direct result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a direct result of contracting vaccinia through certain accidental exposures. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of these injuries. On August 27, 2003, the Secretary published an interim final rule that set out a Smallpox (Vaccinia) Vaccine Injury Table ("the Table"). The table includes adverse effects (including injuries, disabilities, conditions, and deaths) within specific time periods that shall be presumed to result from the receipt of, or exposure to, the smallpox vaccine. The Secretary will use this table, as well as the procedures set out in this regulation, in deciding whether persons are eligible to receive benefits under the program. In this interim final rule, the Secretary is setting out the administrative policies, procedures, and requirements governing the program, as authorized by the SEPPA. The Secretary is seeking public comment on this interim final rule.     

Medicaid program; citizenship documentation requirements. Interim final rule with comment period

This interim final rule with comment period amends Medicaid regulations to implement the provision of the Deficit Reduction Act that requires States to obtain satisfactory documentary evidence of an applicant's or recipient's citizenship and identity in order to receive Federal financial participation. This regulation provides States with guidance on the types of documentary evidence that may be accepted, including alternative forms of documentary evidence in addition to those described in the statute and the conditions under which this documentary evidence can be accepted to establish the applicant's declaration of citizenship. It also gives States guidance on the processes that may be used to help minimize the administrative burden on both States and applicants and recipients.     

Servicemembers' Group Life Insurance Traumatic Injury Protection program--genitourinary losses. Interim final rule

The Department of Veterans Affairs (VA) is issuing this interim final rule that amends the regulations governing the Servicemembers' Group Life Insurance Traumatic Injury Protection (TSGLI) program by adding certain genitourinary (GU) system losses to the TSGLI Schedule of Losses and defining terms relevant to these new losses. This amendment is necessary to make qualifying GU losses a basis for paying GU-injured Servicemembers TSGLI benefits. The intended effect is to expand the list of losses for which TSGLI payments can be made.     

Sexual Assault Prevention and Response (SAPR) Program. Interim final rule

This part implements Department of Defense (DoD) policy and assigns responsibilities for the SAPR Program on prevention, response, and oversight to sexual assault. It is DoD policy to establish a culture free of sexual assault by providing an environment of prevention, education and training, response capability, victim support, reporting procedures, and accountability that enhances the safety and well being of all persons covered by the regulation.     

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.     

Medicare program; payment for customized wheelchairs--HCFA. Interim final rule with comment period

Section 4152(c)(4)(B) of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) amended section 1834(a)(4) of the Social Security Act to provide that a wheelchair furnished on or after January 1, 1992 is treated as a customized item for payment purposes under part B of Medicare if it meets the definition provided in that paragraph, unless the Secretary develops specific criteria before January 1, 1992, in which case the Secretary's criteria go into effect. This interim final rule with comment period sets forth the Secretary's criteria that a wheelchair must meet to be considered a customized item.     

Medicaid program; State share of financial participation--HCFA. Interim final rule with comment

On September 12, 1991, we published in the Federal Register an interim final rule with comment entitled "Medicaid Program; State Share of Financial Participation" (56 FR 46380). It dealt with the use of State taxes and provider donations as the State share of the costs of the Medicaid program. Because of misunderstanding created by certain portions of that rule, we are publishing this interim final rule to withdraw and cancel it and to set forth a clearer interim final rule on donations and taxes.     

Medicare program; Medicare coverage of screening mammography--HCFA. Interim final rule with comment

This interim final rule implements section 4163 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508), which provides limited coverage for screening mammography services. It amends current Medicare regulations to set forth payment limitations and conditions for coverage of screening mammography. The conditions consist of quality standards to assure the safety and accuracy of screening mammography services performed by qualified physicians and other suppliers of these services.     

Medicare and Medicaid programs; advance directives--HCFA. Interim final rule with comment period

This interim final rule amends the Medicare and Medicaid regulations governing provider agreements and contracts to establish requirements for States, hospitals, nursing facilities, skilled nursing facilities, providers of home health care or personal care services, hospice programs and prepaid health plans concerning advance directives. An advance directive is a written instruction, such as a living will or durable power of attorney for health care, recognized under State law, relating to the provision of health care when an individual's condition makes him or her unable to express his or her wishes. The intent of these provisions is to enhance an individual's control over medical treatment decisions. This rule implements sections 4206 and 4751 of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), Public Law 101-508.     

Medicaid program; State share of financial participation--HCFA. Interim final rule with comment

Under certain circumstances, States are currently permitted to use voluntary contributions (donated funds) from providers and all revenues from State-imposed taxes, as the State share of the costs of the Medicaid program. There is now widespread use of State donations or other voluntary provider payment programs that unfairly affect the Federal share of Federal Financial Participation (FFP). This practice circumvents the States' statutory obligation to expend funds for medical assistance. Therefore, effective January 1, 1992, this interim final rule requires that the amount of funds donated from Medicaid providers be offset from Medicaid expenditures incurred on or after this date before calculating the amount of FFP in Medicaid expenditures. It also interprets section 4701(b)(2) of the Omnibus Budget Reconciliation Act of 1990, which added section 1903(i)(10) to the Social Security Act. Section 1903(i)(10), precludes Federal Financial Participation (FFP) in State payments to hospitals, nursing facilities, and intermediate care facilities for the mentally retarded for facility expenditures that are attributable to provider-specific State taxes.     

Medical devices; exception from general requirements for informed consent. Interim final rule

The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.