Smallpox vaccine injury compensation program: Smallpox (Vaccinia) Vaccine Injury Table. Adoption of interim final rule as final rule with an amendment

This document adopts the Smallpox (Vaccinia) Vaccine Injury Table (the Table) Interim Final Rule as the Final Rule with an amendment, as follows: the Final Rule clarifies that, in order for the presumption of causation to apply, the time intervals listed on the Table refer specifically to the period in which the first symptom or manifestation of onset of injury must appear following administration of the smallpox vaccine or exposure to vaccinia, and that the time intervals listed have no relevance to time of diagnosis of the injury.     

Smallpox Vaccine Injury Compensation Program: Smallpox (Vaccinia) Vaccine Injury Table. Interim final rule

The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), Public Law 108-20, 117 Stat. 638, authorized the Secretary of Health and Human Services (the Secretary), through the establishment of the Smallpox Vaccine Injury Compensation Program (the Program), to provide benefits and/or compensation to certain persons who have sustained injuries as a result of the administration of smallpox covered countermeasures (including the smallpox vaccine) or as a result of vaccinia contracted through accidental vaccinia inoculations. The SEPPA directed the Secretary to establish, by interim final rule, a table identifying adverse effects (including injuries, disabilities, conditions, and deaths) that shall be presumed to result from the administration of or exposure to the smallpox vaccine, and the time interval in which the first symptom or manifestation of each listed injury must manifest in order for such presumption to apply. As mandated by law, the Secretary is establishing such a Smallpox (Vaccinia) Vaccine Injury Table (the Table) through this interim final rule. The Secretary is also establishing a set of Table Definitions and Requirements, which define the terms and conditions included on the Table and are to be read in conjunction with the Table. The Secretary is seeking public comment on the Table established through this interim final rule. At a later date, the Secretary will publish a companion final rule setting forth the administrative implementation of the Program. The public will then be afforded an additional opportunity to comment on the procedures set forth therein.     

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.     

National Vaccine Injury Compensation Program: revisions to the vaccine injury table. Final rule

On September 13, 2010, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table) to create distinct listings for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus vaccines. The Secretary is now making this amendment to the Table by final rule; it is technical in nature. The four categories of vaccines described in this final rule are already covered vaccines under the VICP (starting in 2004) and are currently listed in a placeholder category (box XIII) in the Table. This final rule will list these vaccines as separate categories on the Table, with no associated injuries noted at this time, in order to help the public identify clearly that these vaccines are covered by the VICP. The changes implemented here are authorized by section 2114(e) of the Public Health Service Act (the Act).     

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.     

Medicare Program; physician performance standard rates of increase for fiscal year 1994 and physician fee schedule update for calendar year 1994--HCFA. Correction of final notice with comment period

This document corrects an error that occurred in the calculation of the fiscal year 1994 Medicare volume performance standard for surgical services and that appeared in the final notice with comment period published in the Federal Register on December 2, 1993 (58 FR 63856) entitled "Medicare Program; Physician Performance Standard Rates of Increase for Fiscal Year 1994 and Physician Fee Schedule Update for Calendar Year 1994." This notice also corrects a typographical error in a date.     

National Vaccine Injury Compensation Program (VICP): effective date provisions of coverage of certain vaccines to the vaccine injury table--HRSA. Final rule

Section 904(b) of the Taxpayer Relief Act of 1997 provides for an excise tax for three new vaccines, effective August 6, 1997. Petitions for compensation for injuries or deaths related to hepatitis B, Hib, and varicella vaccines may now be filed under the Vaccine Injury Compensation Program (VICP). This technical amendment amends the Code of Federal Regulations (CFR) to include a date certain (August 6, 1997) in section 100.3(c) of the Vaccine Injury Compensation regulations, so that there will be no uncertainty as to the coverage of these three vaccines.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities; correction--HCFA. Correction of interim final rule with comment period

This document corrects technical errors that appeared in the interim final rule with comment period published in the Federal Register on May 12, 1998 entitled "Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities."     

Medicare program; home health agencies: conditions of participation--HHS. Correction of final rule

This document corrects technical errors that appeared in the final rule published in the Federal Register on July 18, 1991 [56 FR 32967] entitled "Medicare Program; Home Health Agencies: Conditions of Participation."     

美国疫苗伤害补偿计划及其对我国的启示

上世纪80年代,美国为了应对疫苗供应危机,颁布了《国家儿童疫苗伤害法》,1988年开始实行疫苗伤害补偿计划,经过几年的努力,初步实现了国会的双重立法目标。我国应借鉴美国的经验,明确立法目标,由国家制定统一的补偿标准,不断扩大补偿范围,制定更具操作性的规定,进一步完善我国的疫苗伤害补偿制度。     

Registration and reregistration application fees. Confirmation of final rule,remanded for further notice and comment,and response to comments

DEA is publishing a final rule regarding the registration and reregistration fees charged to controlled substances registrants. DEA is required to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances. To address this mandate, on March 22, 1993 DEA published a final rule in the Federal Register, establishing registration fees for controlled substances registrants (58 FR 15272). Following publication of the final rule, the American Medical Association (AMA) and others filed a complaint in the United States District Court for the District of Columbia objecting to the new fees. The district court issued its final order granting the government's motion for summary judgment and disposing of all claims. The AMA appealed. The United States Court of Appeals for the District of Columbia Circuit found DEA's rulemaking to be inadequate. The appeals court remanded, without vacating, the rule to DEA, requiring the agency to provide an opportunity for meaningful notice and comment on the fee-funded components of the Diversion Control Program. DEA responded to the remand requirement through a document published in the Federal Register on December 30, 1996 (61 FR 68624). This Final Rule supplements the December 30, 1996 Federal Register document and with that document, constitutes the final rule on the Drug Diversion Control Fee Account.     

Medicare and Medicaid programs; hospital conditions of participation: laboratory services. Interim final rule with comment period

This interim final rule with comment period requires hospitals that transfuse blood and blood components to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. These changes are based on recommendations by the Secretary's Advisory Committee on Blood Safety and Availability and are being published in conjunction with the Food and Drug Administration's (FDA) Final Rule, "Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection" ("lookback") found elsewhere in this issue of the Federal Register. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.     

Medicare program; fee schedule for physicians' services for calendar year 1993--HCFA. Correction of final notice with comment period

This document corrects technical errors that appeared in the final notice with comment period published in the Federal Register on November 25, 1992 (57 FR 55914) entitled "Medicare Program; Fee Schedule for Physicians' Services for Calendar Year 1993."     

Medicare program; revisions to payment policies and five-year review of and adjustments to the relative value units under the physician fee schedule for calendar year 1997; correction--HCFA. Correction of final rule with comment period

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on November 22, 1996 entitled "Medicare Program; Revisions to Payment Policies and Five-Year Review of and Adjustments to the Relative Value Units Under the Physician Fee Schedule for Calendar Year 1997."     

National Vaccine Injury Compensation Program: addition of vaccines against rotavirus to the program. Department of Health and Human Services (HHS), Public Health Service (PHS), Health Resources and Services Administration (HRSA). Final rule

This final rule amends the existing regulations governing the National Vaccine Injury Compensation Program (VICP) by adding vaccines against rotavirus to the Table of Injuries, which lists the vaccines covered under the VICP. This action is taken under section 2114(e) of the Public Health Service Act (the Act). The VICP provides a system of no-fault compensation for certain individuals who have been injured by specific childhood vaccines. The two prerequisites for adding vaccines against rotavirus to the VICP have been satisfied. An excise tax of 75 cents per dose was enacted on October 21, 1998, and took effect for sales of the vaccines after October 21, 1998. The Centers for Disease Control and Prevention (CDC) has recommended to the Secretary of HHS that this vaccine be routinely administered to children. Thus, vaccines against rotavirus are now included in the VICP.     

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; refinements to geographic adjustment factor values, revisions to payment policies, adjustments to the relative value units (RVUs) under the physician fee schedule for calendar year 1995, and the 5-year refinement of RVUs--HCFA. Correction of final rule with comment period

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on December 8, 1994 (59 FR 63410) entitled "Medicare Program; Refinements to Geographic Adjustment Factor Values, Revisions to Payment Policies, Adjustments to the Relative Value Units (RVUs) Under the Physician Fee Schedule for Calendar Year 1995, and the 5-Year Refinement of RVUs."     

Regulation for the enforcement of federal health care provider conscience protection laws. Final rule

The Department of Health and Human Services issues this final rule which provides that enforcement of the federal statutory health care provider conscience protections will be handled by the Department's Office for Civil Rights, in conjunction with the Department's funding components. This Final Rule rescinds, in part, and revises, the December 19, 2008 Final Rule entitled "Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law" (the "2008 Final Rule"). Neither the 2008 final rule, nor this final rule, alters the statutory protections for individuals and health care entities under the federal health care provider conscience protection statutes, including the Church Amendments, Section 245 of the Public Health Service Act, and the Weldon Amendment. These federal statutory health care provider conscience protections remain in effect.     

Waiver of two-year home-country physical presence requirement, foreign medical graduates, exchange visitor program--USIA. Final rule

Section 220 of the Immigration and Nationality Technical Corrections Act of 1994 (Pub. L. 103-416) amended Section 212(e) of the Immigration and Nationality Act (8 U.S.C. 1182(e)) and added a new subsection (k) to section 214 of that Act (8 U.S.C. 1184) regarding waiver of the two-year foreign residence requirement as it applies to foreign medical graduates. An Interim Final Rule with request for comments was published in the Federal Register on April 3, 1995 (60 FR 16785). This final rulemaking amends the Exchange Visitor Program regulations to reflect those legislative changes.     

Medicare program; fee schedule for physicians' services--HCFA. Correction of final rule

In the November 25, 1991 final rule (56 FR 59624) on the Medicare fee schedule for physician services, we inadvertently set forth regulations on the fee schedule at 42 CFR, part 415. However, our plan for the recodification of HCFA regulations calls for general regulations on payment for Part B medical and other health services to be codified in part 414, with part 415 reserved for regulations on payment to teaching physicians, teaching hospitals, and provider-based physicians. Therefore, in this correction notice, we are redesignating in their entirety the physician fee schedule regulations contained in part 415, subpart A to part 414, subpart A, and reserving part 415 for future use. Also, this document corrects technical errors that appeared in the final rule published in the Federal Register on November 25, 1991 (56 FR 59502) entitled "Medicare Program; Fee Schedule for Physicians' Services".