S. 1744 (99th): State Comprehensive Mental Health Services Plan Act of 1986

99th Congress, 1985–1986. Text as of Nov 14, 1986 (Passed Congress/Enrolled Bill).

Status & Summary | PDF | Source: GPOStatutes at Large

PUBLIC LAW 99-660—NOV. 14, 1986                                  100 STAT. 3743
Public Law 99-660
99th Congress
                                   An Act
To require States to develop, establish, and implement State comprehensive mental    Nov. 14, 1986
                                    health plans.                                      [S. 1744]

 Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

                TITLE I—DRUG EXPORTS                                                Drug Export
                                                                                    Amendments
                                                                                                     j
                                                                                    Act of 1986.
SEC. 101. SHORT TITLE, REFERENCE.                                                   21 u s e 301 note.
  (a) SHORT TITLE.—This title may be cited as the "Drug Export
Amendments Act of 1986".
  (b) REFERENCE.—Whenever in this title an amendment or repeal is
expressed in terms of an amendment to, or repeal of, a section or
other provision, the reference shall be considered to be a reference
to a section or other provision of the Federal Food, Drug, and
Cosmetic Act.                                                                       21 u s e 301.
SEC. 102. EXPORT AUTHORITY.
  Chapter VIII is amended—                                                          21 u s e 381 et
     (1) by inserting after the chapter heading the following:                      seq.

                       "IMPORTS AND EXPORTS", and

       (2) by inserting after section 801 the following:
              "EXPORTS OF CERTAIN UNAPPROVED PRODUCTS

   "SEC. 802. (a) A drug (including a biological product) intended for Animals.
human or animal use—                                                   21 u s e 382.
       (1) which—
            "(A) requires approval by the Secretary under section 505 21 u s e 355.
          or section 512, or                                            21 u s e 360b.
            "(B) requires licensing by the Secretary under section 351 Commerce and
          of the Public Health Service Act or by the Secretary of trade.
          Agriculture under the Act of March 4, 1913 (known as the 42 u s e 262.
          Virus Serum Toxin Act),                                      21 u s e 151 note.
     before it may be introduced or delivered for introduction into
     interstate commerce to a country, and
       "(2) which does not have such approval or license, which is
     not exempt from such sections or Act, and which is introduced
     or delivered for introduction into interstate commerce to a
     country,
is adulterated, misbranded, and in violation of such sections or Act
unless the export of the drug is authorized under subsection (b).
   "(bXD A drug (including a biological product) may, upon approval
of an application submitted under paragraph (3), be exported if—
       "(A) the drug contains the same active ingredient as a—
             "(i) new drug—

100 STAT. 3744 PUBLIC LAW 99-660—NOV. 14, 1986 21 u s e 355. "(I) which has an exemption under section 505(i), and "(II) for which approval is actively being pursued by the person who has the exemption, "(ii) biological product for human use— "(I) which has an exemption under section 505(i), and n; tiQj^ ^Qj. ^jjjgjj licensing of the biological product 42 u s e 262. under section 351 of the Public Health Service Act is v. actively being pursued by the person who has the exemption, "(iii) biological product for animal use— "(I) for which authority heis been granted under the 21 u s e 151 note. Virus-Serum Toxin Act for the preparation of an experimental drug product, and "(II) for which the licensing of the biological product under such Act is actively being pursued by the person who has the authority, or ^ "(iv) new animal drug— 21 u s e 360b. . * . "(I) which has an exemption under section 512(j), and "(II) for which approval is actively being pursued by the person who has the exemption, "(B) except as provided in paragraph (2), the drug is exported to a country which is listed under paragraph (4) and in which the drug is approved and has not been withdrawn from sale, "(C) an application for the drug under section 505 or 512, section 351 of the Public Health Service Act, or the Virus- Serum Toxin Act has not been disapproved by an order of the Secretary under section 505(d) or 512(d) or 351 of the Public Health Service Act or by the Secretary of Agriculture in the case of an application under the Virus-Serum Toxin Act, "(D) the drug is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and is not adulterated under paragraph (aXD, (aX2)(A), (a)(3), (c), or (d) 21 u s e 351. of section 501, Labeling. "(E) the outside of the shipping package is labeled with the following statement: 'This drug may be sold or offered for sale only in the following countries: ', the blank space being filled with a list of the countries to which export of the drug is authorized under this subsection, Safety. "(F) the drug is not the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the manu- facture of the drug in the United States for export to a country is contrary to the public health and safety of the United States, "(G) the requirements of subparagraphs (A) through (D) of 21 u s e 381. section 801(dXl) have been met. The Secretary shall determine that an applicant is actively pursuing the approval or licensing of a drug if the applicant has demonstrated that degree of attention and continuous directed effort as may reasonably be expected from, and are ordinarily exercised by, a person before approval or licensing of a drug, such as the prepara- tion for and the conduct of preclinical or clinical investigations, the analysis of the results of such investigations, conferences on such investigations with government officials, and the preparation of an application of approval or licensing for the drug. "(2) The Secretary may permit the export of a drug under para- graph (1) to a country which is listed under paragraph (4) and in which the drug is not approved if the drug is exported to such
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3745 country solely for the purpose of further export to a country listed in paragraph (4) in which the drug is approved. "(3XA) Any person may apply to have a drug exported under paragraph (1). Such an application shall be filed at least 90 days before the date the applicant proposes to export the drug for which the application is submitted. Before the expiration of 10 days from Federal the date of the submission of such an application, the Secretary Register, publication. shall publish a notice in the Federal Register which identifies the applicant under such application, the drug proposed to be exported under such application, and the country to which the drug is proposed to be exported. "(B) An application for the export of a drug shall— "(i) identify the drug to be exported, "(ii) list each country to which the drug is to be exported and list the persons in each such country to which the drug is to be exported, "(iii) contain a certification by the applicant that— "(I) the applicant will export the drug only to a country which is listed in paragraph (4) and in which the drug is approved unless the drug is authorized to be exported under paragraph (2) and will export only those quantities of the J drug which may reasonably be sold in each country to which it is to be exported, "(II) the drug is approved by each country to which it is to be exported unless the drug is authorized to be exported under paragraph (2) and the drug has not been withdrawn from sale in such country, "(III) the drug meets the requirements of paragraph (IXD), "(IV) the drug will be labeled in accordance with para- graph (IXE), and "(V) the drug meets the requirements of paragraphs (IXC) and (IXG), "(iv) contain a certification by the holder of the exemption or authority for such drug described in paragraph (IXA) that the holder will actively pursue the approval or licensing of the drug, "(v) identify the exemption or authority for an experimental drug product in effect for such drug under the laws referred to in paragraph (IXA), "(vi) identify the establishments in which the drug is manu- factured, and "(vii) include a written agreement from each importer to Contracts. whom the drug is to be exported from the United States that Records. such importer will not export the drug to a country which is not . listed under paragraph (4) and will provide notice to the ap- plicant of any knowledge of an export of the drug to such a. country by any person and will maintain records of the drug wholesale distributors to which the drug is sold. "(CXi) Before the expiration of 30 days after the date an applica- tion is submitted to the Secretary, the Secretary shall review the application to determine if the application meets the requirements of clauses (i), (ii), (iv), (v), (vi), and (vii) of subparagraph (B) and contains the certifications described in clauses (iii) (other than the certification required by clause (iiiXID) and (iv). If the Secretary determines that the application meets such requirements and con- tains such certifications the Secretary shall conditionally approve the application. An application which is so conditionally approved
100 STAT. 3746 PUBLIC LAW 99-660—NOV. 14, 1986 shall be finally approved within 5 days of the submission of the certification required by clause (iiiXII). "(ii) If the Secretary proposes to disapprove an application, the Secretary shall provide the applicant with a written statement specifying— "(I) the deficiencies which the applicant must correct in order to enable the Secretary to approve the application, and ' "(II) that the applicant has 60 days after receiving the state- ment to correct such deficiencies. "(D) If the holder of an application approved under subpara- graph (C) for the export of a drug intends to export such drug to a country listed in paragraph (4) which is not listed in such application, such holder shall submit an amendment to such application to the Secretary not later than 30 days before the date of the proposed export to such country identifying the country to which the holder intends to export such drug and containing information sufficient to show that the drug is approved by such country and has not been withdrawn from sale in such country. The Secretary shall approve or disapprove the export of such drug to such country within 15 days of the receipt of the notice required by this subparagraph. Recipient "(4XA) The countries to which a drug may be exported under countries. paragraph (1) are— "(i) Australia, ^ "(ii) Austria, :. : .ti.s "(iii) Belgium, '- "(iv) Canada, ;,''"(v) Denmark, "(vi) Federal Republic of Germany, i^"s: "(vii) Finland, "(viii) France, ' "(ix) Iceland, - /. "(x) Ireland, ^ ^ "(xi)Italy, ' ' - "(xii) Japan, ' ' '"'• "(xiii) Luxembourg, "(xiv) The Netherlands, "(xv) New Zealand, "(xvi) Norway, n "(xvii) Portugal, ., "(xviii) Spain, . » "^ "(xix) Sweden, , '" *^ "(xx) Switzerlgmd, and "(xxi) The United Kingdom, "(B) Changes in the list contained in subparagraph (A) shall be based on the following criteria: Safety. "(i) Statutory or r ^ u l a t o r y requirements which require the review of drugs for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific train- ing and experience to evaluate the safety and effectiveness of drugs.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3747 ,,, "(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for, the manufac- ture, processing, and packing of drugs in the country are ade- quate to preserve their identity, quality, purity, and strength, "(iii) Statutory or regulatory requirements for the reporting Safety. of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective, "(iv) Statutory or regulatory requirements that the labeling Labeling. and promotion of drugs must be in accordance with the Marketing. approval of the drug. "(cXD The holder of an approved application under subsection Qi) Reports. authorizing the export of a drug shall report to the Secretary— "(A) any withdrawal of an approval of the drug by any country to which it has been exported, "(B) any withdrawal of the drug from sale in any such coun- try, "(C) the withdrawal of an application by the holder under section 505 or 512, section 351 of the Public Health Service Act, 21 u s e 355, or the Virus-Serum Toxin Act, and 3606; 42 USC "(D) the receipt of any credible information indicating that 262. 21 USC 151 note. the drug is being or may have been exported from a country listed under subsection (b)(4) to a country which is not listed under such subsection. The reporting of an event described in subparagraph (A), (B), or (C) Reports. shall be made within 15 days of the occurrence of the event and the reporting of the receipt of information under subparagraph (D) shall be made within 15 days of the receipt of such information. "(2) The holder of an approved application under subsection (b) Reports. authorizing the export of a drug shall report annually to the Sec- retary after the date of the approval of the application of the actions taken by the holder in pursuit of the approval of such drug during the yeai reported on. Not later than 90 days from the date of the receipt of a report under this paragraph the Secretary shall deter- mine if the holder is actively pursuing the approval of such drug. "(d) A drug authorized to be exported to a country under an application approved under subsection (b) may not be exported to such country if— "(1) an approval of such drug is withdrawn by such country, "(2) the drug is withdrawn from sale in such country, ^^ "(3) the Secretary issues an order refusing to approve an application of the holder of such application under section 505 or 512, section 351 of the Public Health Service Act, or the Virus-Serum Toxin Act, or "(4) an application for such drug under such section or Act is withdrawn or if an exemption for such drug under section 505(i) or 512(j) or the authority granted for such drug to prepare an experimental drug product under the Virus-Serum Toxin Act is withdrawn and no application for approval of such drug has been submitted under section 505 or 512, section 351 of the Public Health Service Act, or the Virus-Serum Toxin Act. "(eXD If the Secretary determines that— "(A) a drug for which an application was approved under subsection (b) no longer complies with subparagraphs (A), (D), (E), and (G) of paragraph (1) of such subsection or with para- graph (2) of such subsection or the holder of such application has not made the reports required by subsection (c), or
100 STAT. 3748 PUBLIC LAW 99-660—NOV. 14, 1986 Safety. "(B) the manufacture of a drug in the United States for export is contrary to the public health and safety of the United States and an application for the export of such drug has been approved under subsection (b), then before taking action against the holder of an application for which a determination was made under subparagraph (A) or (B), the Secretary shall notify the holder in writing of the determination and provide the holder 30 days to take such action as may be required so that the Secretary would be unable to make such determination. When the Secretary takes action against such holder because of ..5- ,, such a determination, the Secretary shall provide the holder a written statement specifying the reasons for such determination and provide the person, on request, an opportunity for an informal hearing with respect to such determination. "(2) If the Secretary determines that the approval of a drug is not being actively pursued as required by subsection (b)(1)(A), the Sec- retary shall give the holder of the application authorizing the export of such drug 60 days to assure that actions are taken to actively =' pursue such approval. During the 60-day period the Secretary shall give the holder an opportunity for an informal hearing on the determination of the Secretary. If upon the expiration of such 60-day period the Secretary determines that approval of such drug is not being actively pursued, the Secretary shall prohibit the export of such drug. "(3)(A) If at any time the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that— "(i) the holder of an approved application under subsection (b) J ;,, 3. I is exporting a drug from the United States to an importer, "(ii) such importer is exporting the drug to a country which is s. not listed under subsection (b)(4), and "(iii) such export presents an imminent hazard to the public health in such country, the Secretary shall immediately prohibit the export of the drug to such importer, give the person exporting the drug from the United States prompt notice of the determination, and afford such person an opportunity for an expedited hearing. "(B) The authority conferred by subparagraph (A) shall not be delegated by the Secretary. A determination by the Secretary under subparagraph (A) may not be stayed pending final action by a reviewing court. "(4)(A) If the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that the holder of an approved application under subsection Ob) is exporting a drug to a country which is not listed under subsection Ot))(4) and that the export of the drug presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug to such country, give the holder prompt notice of the determination, and afford the holder an opportunity for an expedited hearing. "(B) The authority conferred by subparagraph (A) shall not be delegated by the Secretary. A determination by the Secretary under subparagraph (A) may not be stayed pending final action by a reviewing court. "(5) If the Secretary receives credible evidence that the holder of an application approved under subsection (b) is exporting a drug to a country which is not listed under subsection (b)(4), the Secretary shall give the holder 60 days to provide information to the Secretary respecting such evidence and shall provide the holder an oppor-
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3749 tunity for an informal hearing on such evidence. Upon the expira- tion of such 60 days the Secretary shall prohibit the export of such drug to such country if the Secretary determines that the holder of the application is exporting the drug to a country which is not listed under subsection Ot)X4). "(6) If the Secretary receives credible evidence that an importer is Reports, exporting a drug to a country which is not listed under subsection Ot)X4), the Secretary shall notify the holder of the application authorizing the export of such drug of such evidence and shall require the holder to investigate the export by such importer and to report to the Secretary within 14 days of the receipt of such notice the findings of the holder. If the Secretary determines that the importer has exported a drug to such a country, the Secretary shall prohibit such holder from exporting such drug to the importer unless the Secretary determines that the export by the importer was unintentional. "(fKl) A drug (including a biological product) which is to be used in the prevention or treatment of a tropical disease may, upon approval of an application submitted under paragraph (2), be ex- ported if— "(A) the Secretary finds, based on credible scientific evidence, Safety. including clinical investigations, that the drug is safe and effec- '• tive in the country to which it is to be exported in the preven- tion or treatment of a tropical disease in such country, "(B) the drug is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and is not adulterated under parsigraph (aXD, (aX2XA), (aX3), (c), or (d) of section 501, 21 u s e 351. "(C) the outside of the shipping package is labeled with the Labeling. ^i^ following statement: 'This drug may be sold or offered for sale only in the following countries: ', the blank space being filled with a list of the countries to which export of the drug is authorized under this subsection, "(D) the drug is not the subject of a notice by the Secretary or Safety. the Secretary of Agriculture of a determination that the manu- facture of the drug in the United States for export to a country is contrary to the public health and safety of the United States, and "(E) the requirements of subparagraphs (A) through (D) of section 801(dXl) have been met. 21 u s e 381. "(2) Any person may apply to have a drug exported under para- graph (1). The application shall— "(A) describe the drug to be exported, "(B) list each country to which the drug is to be exported, "(C) contain a certification by the applicant that the drug will not be exported to a country for which the Secretary cannot make a finding described in paragraph (IXA), "(D) identify the establishments in which the drug is manu- factured, and "(E) demonstrate to the Secretary that the drug meets the requirements of paragraph (1). "(3) The holder of an approved application for the export of a drug Reports. under this subsection shall report to the Secretary— "(A) the receipt of any information indicating that the drug is being or may have been exported from a country for which the Secretary made a finding under paragraph (IXA) to a country for which the Secretary cannot make such a finding, and
100 STAT. 3750 PUBLIC LAW 99-660—NOV. 14, 1986 "(B) the receipt of any information indicating any adverse reactions to such drug. . "(4XA) If the Secretary determines that— "(i) a drug for which an appHcation is approved under para- graph (2) does not continue to meet the requirements of para- , graph (1), "(ii) the holder of such application has not made the report required by paragraph (3), or "(iii) the manufacture of such drug in the United States for export is contrary to the public health and safety of the United States and an application for the export of such drug has been approved under paragraph (2), then before taking action against the holder of an application for which a determination was made under clause (i), (ii), or (iii), the Secretary shall notify the holder in writing of the determination and provide the holder 30 days to take such action as may be required so that the Secretary would be unable to make such determination. When the Secretary takes action against such holder because of such a determination, the Secretary shall provide the holder a written statement specifying the reasons for such determination and provide the person, on request, an opportunity for an informal hearing with respect to such determination. "(B) If at any time the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that— "(i) the holder of an approved application under paragraph (2) is exporting a drug from the United States to an importer, - "(ii) such importer is exporting the drug to a country for , J which the Secretary cannot make a finding under paragraph ,,, .,^_..; dXA),and "(iii) such export presents an imminent hazard to the public health in such country, the Secretary shall immediately prohibit the export of the drug to such importer, give the person exporting the drug from the United ^ ,,j,. States prompt notice of the determination, and afford such person an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary. "(C) If the Secretary, or in the absence of the Secretary the );i individual acting as the Secretary, determines that the holder of an approved application under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (IXA), and that the export of the drug presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug to such country, give the holder prompt notice of the determination, and afford the holder an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary. "(D) If the Secretary receives credible evidence that the holder of -, an application approved under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (IXA), the Secretary shall give the holder 60 days to provide information to the Secretary respecting such evidence and shall provide the holder an opportunity for an informal hearing on such evidence. Upon the expiration of such 60 days the Secretary
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3751 shall prohibit the export of such drug to such country if the Sec- retary determines the holder is exporting the drug to a country for which the Secretary cannot make a finding under paragraph (IXA). "(E) If the Secretary receives credible evidence that an importer is Reports. exporting a drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), the Secretary shall notify the holder of the application authorizing the export of such drug of such evidence and shall require the holder to investigate the export by such importer and to report to the Secretary within 14 days of the receipt of such notice the findings of the holder. If the Secretary determines that the importer has exported a drug to such a country, the Secretary shall prohibit such holder from exporting such drug to the importer unless the Secretary determines that the export by the importer was unintentional. "(g) For purposes of this section— "(1) a reference to the Secretary shall in the case of a biological product which is required to be licensed under the Virus-Serum Toxin Act be considered to be a reference to the Secretary of Agriculture, and "(2) a reference in paragraph (3), (4), (5), or (6) of subsection (e) and in subparagraph (B), (C), (D), or (E) of subsection (f)(4) to the holder of an application shall be considered a reference to any person which is under common control with holder, is controlled by the holder, controls the holder, is owned by the holder, or owns the holder.". SEC. 103. ENFORCEMENT. 21 u s e 333 note. For the fines authorized to be imposed under section 303 of the Federal Food, Drug, and Cosmetic Act, see section 3623 of title 18, 21 u s e 333. United States Code, for the period ending October 31, 1986, and sections 3559 and 3571 of such title for the period beginning Novem- ber 1,1986. SEC. 104. TROPICAL DISEASES. Section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by adding at the end the following: "(c) The Secretary may conduct biomedical research, directly or Research and through grants or contracts, for the identification, control, treat- development. ment, and prevention of diseases (including tropical diseases) which Grants. Contracts. do not occur to a significant extent in the United States.". SEC. 105. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS. (a) AMENDMENT.—Section 351 of the Public Health Service Act (42 U.S.C 262) is amended by adding at the end the following: Post, p. 3783. "(h)(1)(A) A partially processed biological product which is not in a Labeling. form applicable to the prevention, treatment, or cure of diseases or injuries of man, which is not intended for sale in the United States, and which is intended for further manufacture into final dosage form outside the United States in a country listed under section 802(b)(A) of the Federal Food, Drug, and Cosmetic Act may, upon Ante, p. 3743. approval of an application meeting the requirements of subpara- graph (B), be exported to a country listed under section 802(b)(4) of the Federal Food, Drug, and Cosmetic Act. The Secretary may not approve an application to export such a product unless the Sec- retary determines that the product is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and the outside of the shipping package is labeled with the
100 STAT. 3752 PUBLIC LAW 99-660—NOV. 14, 1986 following statement: 'This product may be sold or offered for sale only in the following countries: ', the blank space being filled with a list of the countries to which export of the drug is authorized. "(B) An application for the export of a partially processed bio- logical product shall— "(i) describe the partially processed biological product to be exported, "(ii) list each country to which the product is to be exported, "(iii) contain a certification by the applicant that the product will not be exported to a country not listed under clause (ii), "(iv) identify the establishments in which the product is manufactured, and "(v) contain a certification by the applicant that the final product to be developed from the partially processed product is approved in the country to which it is to be exported or approval of the final product is being sought in such country. "(2) A product described in paragraph (1) is not subject to licen- sure under this section. "(3) If the Secretary determines that prohibiting the export of a product described in paragraph (1) is necessary for protection of the public health in the United States or the country to which it is to be exported, the Secretary may not approve an application under paragraph (1) for the export of such product.". 42 u s e 262 note. (b) EFFECTIVE DATE.—Paragraph (1) of section 351(h) of the Public Health Service Act as added by subsection (a) shall take effect upon the expiration of 90 days after the date of the enactment of this Act. National Commission to TITLE II—NATIONAL COMMISSION TO Prevent Infant Mortality Act of PREVENT INFANT MORTALITY 1986. 42 u s e 289g SEC. 201. SHORT TITLE. note. This title may be cited as the "National Commission to Prevent Infant MortaHty Act of 1986". 42 u s e 289g SEC. 202. DEFINITION. note. For the purposes of this title, the term "infant mortality" refers to the number of infants bom alive but who die before their first birthday. 42 u s e 289g SEC. 203. ESTABLISHMENT OF A NATIONAL COMMISSION. ^ note. (a) E^ABLiSHMENT.—There is established the National Commis- sion to Prevent Infant Mortality (hereinafter referred to as the "Commission"). (b) COMPOSITION.—The Commission shall be composed of fifteen members, as follows: (1) Two members of the Senate, one to be selected by the majority leader of the Senate, the other to be selected by the minority leader of the Senate. (2) Two members of the House, one to be selected by the Speaker of the House, the other to be selected by the minority leader of the House. (3) Three representatives of State government shall be jointly selected by the majority leader of the Senate and the Speaker of the House. One shall be a (Jovernor; one shall be a chief State official responsible for administering the State medicaid pro-
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3753 gram; and one shall be the chief State official responsible for ' administering the State maternal and child health programs. (4) The Secretary of Health and Human Services shall be a member. (5) The Comptroller General of the United States shall be a member. (6) Six at large members, with demonstrated expertise in maternal and child health, including representatives of health care consumer and provider organizations, shall be jointly selected by the majority leader of the Senate and the Speaker of the House. (c) CHAIRMAN AND VICE CHAIRMAN.—The Commission shall select a Chairperson and Vice Chairperson from among its members. (d) QUORUM.—Eight members of the Commission shall constitute a quorum, but a lesser number may hold hearings. (e) MEETINGS.—The Commission shall meet at the call of the Chairperson. (f) VACANCIES.—Members shall be appointed for the life of the Commission. Any vacancy in the Commission shall not affect its powers, but shall be filled in the same manner as the original appointment. SEC. 204. DUTIES OF THE COMMISSION. 42 USC 285g '- (a) DUTIES.—The Commission shall: (1) Identify and examine comprehensively Federal, State, local, and private resources which impact infant mortality, including but not limited to— (A) the effectiveness and adequacy of programs such as the Supplemental Feeding Program for Women, Infants, and Children; the Maternal and Child Health Block Grant; Community Health Centers; prepregnancy services and other programs that increase access to prenatal and post- natal education, care, and nutrition; (B) the effectiveness of current Federal and State policies under the Medicaid Program to ensure adequate access to prenatal and post-natal care for low-income pregnant women, mothers, and infants up to age one; (C) the role of income maintenance and other programs that impact infant mortality such as Aid to Families with Dependent Children and Federal housing subsidies; (D) the adequacy of current Federal and State efforts to enable an appropriate distribution of properly trained health care professionals to provide comprehensive mater- nal and child health services; (E) the adequacy of private health care financing systems and mechanisms to enable pregnant women and infants to receive comprehensive health care; and ,,. ,,„-. r^ (F) the adequacy of the national biostatistics registration '''^" ^'^' ;.^.;,'. ^ system with respect to the collection and reporting of infant health statistics. (2) Identify current financial, intergovernmental, and within the Federal Government, interagency barriers to the health care needed to prevent high infant mortality. (3) Review recommendations made in recent regional and national reports that promote the health status of childbearing women and their infants and carry forward such recommenda- tions as deemed appropriate.
100 STAT. 3754 PUBLIC LAW 99-660—NOV. 14, 1986 (4) Hold hearings, in accordance with section 205(a), in areas of the United States with high infant mortality rates. (b) RECOMMENDATIONS.—The Q)mmission shall— (1) recommend a national policy designed to reduce and pre- vent infant mortality, including recommendations concerning populations at risk of high infant death rates and recommenda- tions concerning appropriate roles for the Federal Government, States, local governments, and private sector; (2) recommend to the Congress and the President the specific changes needed within Federal laws and Federal programs to achieve an effective Federal role in preventing infant mortality, including the programs specified in subparagraphs (A) and (B) of subsection (aXD; (3) recommend to the Congress and the President the specific changes needed to improve the national vital statistics registra- tion system with respect to infant death statistics; and (4) present such recommendations to the President, the Committee on Energy and Commerce of the House of Represent- atives, and the Committees on Finance and Governmental Affairs of the Senate no later than one year after enactment of this Act. 42 u s e 285g SEC. 205. POWERS OF THE COMMISSION. ? it « i- (a) HEARINGS.—The Commission, or at its direction, any sub- committee or member thereof, may for the purpose of carrying out the provisions of this title, hold such hearings, sit and act at such times and places, take such testimony, receive such evidence and administer such oaths, as the Commission or such subcommittee or member may deem advisable. Any member of the Commission may administer oaths or affirmations to witnesses appearing before the Commission, subcommittee, or member thereof. Qo) INFORMATION.—The Commission may secure directly from any Federal department or agency such information as may be nec- essary to enable the Commission to carry out this title. Upon request of the Chairman of the Commission, the head of such department or agency shall furnish such information to the Commission. (c) CONTRACTS.—^To carry out this title, the Commission may entei into such contracts and other arrangements to such extent or in such amounts as are provided in appropriation Acts, and without regard to the provisions of section 3709 of the Revised Statutes (41 U.S.C. 5). Contracts and other arrangements may be entered into under this subsection with or without consideration or bond. (d) APPLICABILITY OF FEDERAL ADVISORY COMMITTEE ACT.—The 5 use app. provisions of the Federal Advisory Committee Act shall not apply to the Commission. 42USC285g SEC. 206. COMMISSION STAFF. (a) EXECUTIVE DIRECTOR.—The Chairperson and Vice Chairperson of the Commission shall appoint an executive director. The employ- ment of such executive director shall be subject to confirmation by the Commission. (b) OTHER PERSONNEL.—The Commission may appoint and termi- nate the executive director selected under subsection (a) and such other personnel as it considers appropriate to assist in the perform- ance of its duties under this title, without regard to the provisions of title 5, United States Code, governing appointments in the competi-
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3755 tive service, and may pay such executive director and other person- nel without regard to the provisions of chapter 51 and subchapter 5 u s e 5101 et 111 of chapter 53 of such title relating to classification and General seq. 5 u s e 5331. Schedule pay rates, except that the rate of pay for such executive director and other personnel may not exceed the rate payable for GS-18 of the General Schedule under section 5332 of such title. (c) APPLICABILITY OF OTHER FEDERAL LAWS.—Service of an individ- ual as a member of the Commission or employment of an individual by the Commission on a part-time or full-time basis and with or without compensation shall not be considered as service or employ- ment bringing such individual within the provisions of any Federal law relating to conflicts of interest or otherwise imposing restric- tions, requirements, or penalties in relation to the employment of persons, the performance of services, or the payment or receipt of compensation in connection with claims, proceedings, or matters involving the United States. Service as a member of the Commission or as an employee of the Commission, shall not be considered service in an appointive or elective position in the Government for purposes of section 8344 of title 5, United States Code, or comparable provi- sions of Federal law. (d) EXPERTS AND CONSULTANTS.—Subject to such rules as may be prescribed by the Commission, the Chairman of the Commission may procure temporary and intermittent services under section 3109 of title 5, United States Code, at rates for individuals not to exceed the daily rate payable for GS-18 of the General Schedule under section 5332 of such title. SEC. 207. SUNSHINE PROVISION. 42 u s e 285g note. The Commission shall establish procedures to ensure its proceed- ings are open to the public to the maximum extent practicable. SEC. 208. TERMINATION OF THE COMMISSION. 42 u s e 285g note. Ninety days after the Commission submits its recommendations as required by section 204(b)(4) the Commission shall terminate. SEC. 209. AUTHORIZATION OF APPROPRIATIONS. 42 u s e 285g note. There are authorized to be appropriated to the Commission such sums as may be necessary. Amounts appropriated under this section shall remain available until the day on which the Commission terminates under section 208. TITLE III—VACCINE COMPENSATION National Childhood Vaccine Injury SEC. 301. SHORT TITLE. Act of 1986. This title may be cited as the "National Childhood Vaccine Injury 42 u s e 201. Act of 1986". PART A—VACCINES SEC. 311. AMENDMENT TO PUBLIC HEALTH SERVICE ACT. 42 u s e 300aa et seq., (a) NEW TITLE.—The Public Health Service Act is amended by 300cc et seq. redesignating title XXI as title XXIII, by redesignating sections 2101 through 2116 as sections 2301 through 2316, respectively, and by inserting after title XX the following new title:
100 STAT. 3756 PUBLIC LAW 99-660—NOV. 14, 1986 "TITLE XXI—VACCINES . 'Subtitle 1—National Vaccine Program ESTABUSHMENT 42 u s e 300aa-l. "SEC. 2101. The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immuniza- tion and to achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a Director selected by the Secretary. "PROGRAM RESPONSIBILITIES 42 u s e 300aa-2. "SEC. 2102. (a) The Director of the Program shall have the follow- ing responsibilities: "(1) VACCINE RESEARCH.—The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for research carried out in or through the National Institutes of Health, the Centers for Disease Control, the Office of Biologies Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development on means to induce human immunity against naturally occurring infectious dis- eases and to prevent adverse reactions to vaccines. "(2) VACCINE DEVELOPMENT.—The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for activities carried out in or through the National Institutes of Health, the Office of Biologies Research and Review of the Food and Drug Administration, the Depart- ment of Defense, and the Agency for International Development to develop the techniques needed to produce safe and effective vaccines. "(3) SAFETY AND EFFICACY TESTING OF VACCINES.—The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for safety and efficacy testing of vaccines carried out in or through the National Institutes of Health, the Centers for Disease Control, the Office of Biologies Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development. "(4) LICENSING OF VACCINE MANUFACTURERS AND VACCINES.— The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for the allocation of resources in the implementation of the licensing 42 u s e 263a. program under section 353. "(5) PRODUCTION AND PROCUREMENT OF VACCINES.—The Direc- tor of the Program shall, through the plan issued under section 2103, ensure that the governmental and non-governmental production and procurement of safe and effective vaccines by the Public Health Service, the Department of Defense, and the , .ft- Agency for International Development meet the needs of the United States population and fulfill commitments of the United States to prevent human infectious diseases in other countries. "(6) DISTRIBUTION AND USE OF VACCINES.—The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction to the Centers for Disease
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3757 Control and assistance to States, localities, and health practitioners in the distribution and use of vaccines, including efforts to encourage public acceptance of immunizations and to make health practitioners and the public aware of potential adverse reactions and contraindications to vaccines. "(7) EVALUATING THE NEED FOR AND THE EFFECTIVENESS AND ADVERSE EFFECTS OF VACCINES AND IMMUNIZATION ACTIVITIES.— The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction to the National Institutes of Health, the Centers for Disease Control, the Office of Biologies Research and Review of the Food and Drug Administration, the National Center for Health Statistics, the National Center for Health Services Research and Health Care Technology Assessment, and the Health Care Financing Administration in monitoring the need for and the effectiveness and adverse effects of vaccines and immunization activities. "(8) COORDINATING GOVERNMENTAL AND NON-GOVERNMENTAL ACTIVITIES.—The Director of the Program shall, through the plan issued under section 2103, provide for the exchange of information between Federal agencies involved in the implementation of the Program and non-governmental entities engaged in the development and production of vaccines and in vaccine research and encourage the investment of non-govern- mental resources complementary to the governmental activities under the Program. "(9) FUNDING OF FEDERAL AGENCIES.—The Director of the Program shall make available to Federal agencies involved in the implementation of the plan issued under section 2103 funds appropriated under section 2106 to supplement the funds other- wise available to such agencies for activities under the plan. "(h) In carrying out subsection (a) and in preparing the plan under section 2103, the Director shall consult with all Federal agencies involved in research on and development, testing, licensing, produc- tion, procurement, distribution, and use of vaccines. PLAN "SEC. 2103. The Director of the Program shall prepare and issue a 42 u s e 300aa-3. plan for the implementation of the responsibilities of the Director under section 2102. The plan shall establish priorities in research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines, describe an optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their vaccine func- tions in consultation and coordination with the Program and in conformity with such priorities. The first plan under this section shall be prepared not later than January 1, 1987, and shall be revised not later than January 1 of each succeeding year. REPORT "SEC. 2104. The Director shall report to the Committee on Energy 42 u s e 300aa-4. and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate not later than January 1, 1988, and annually thereafter on the implementation of the Program and the plan prepared under section 2103.
100 STAT. 3758 PUBLIC LAW 99-660—NOV. 14, 1986 NATIONAL VACCINE ADVISORY COMMITTEE 42 use 300aa-5. "SEC. 2105. (a) There is established the National Vaccine Advisory Committee. The members of the Committee shall be appointed by the Director of the Program, in consultation with the National Academy of Sciences, from among individuals who are e n g ^ e d in vaccine research or the manufacture of vaccines or who are physi- cians, members of parent organizations concerned with immuniza- tions, or representatives of State or local health agencies or public health organizations. "(b) The Committee shall— "(1) study and recommend ways to encourage the availability of an adequate supply of safe and effective vaccination products in the States, "(2) recommend research priorities and other measures the Director of the Program should take to enhance the safety and efficacy of vaccines, "(3) advise the Director of the Program in the implementation of sections 2102, 2103, and 2104, and "(4) identify annually for the Director of the Program the most important areas of government and non-government cooperation that should be considered in implementing sections 2102,2103, and 2104. H*5^ ' fff AUTHORIZATIONS r 42 u s e 300aa-6. "SEC. 2106. (a) To carry out this subtitle other than section 2102(9) there are authorized to be appropriated $2,000,000 for fiscal year 1987, $2,500,000 for fiscal year 1988, $3,000,000 for fiscal year 1989, $3,500,000 for fiscal year 1990, $4,000,000 for fiscal year 1991. "(b) To carry out section 2102(9) there are authorized to be appro- priated $20,000,000 for fiscal year 1987, $22,500,000 for fiscal year 1988, $25,000,000 for fiscal year 1989, $27,500,000 for fiscal year 1990, $30,000,000 for fiscal year 199L , . .^ "Subtitle 2—National Vaccine Injury Compensation Program "PART A—PROGRAM REQUIREMENTS "ESTABLISHMENT OP PROGRAM 42 use "SEC. 2110. (a) PROGRAM ESTABLISHED.—There is established the 300aa-10. National Vaccine Injury Compensation Program to be administered by the Secretary under which compensation may be paid for a vaccine-related injury or death. "(b) ATTORNEY'S OBUGATION.—It shall be the ethical obligation of any attorney who is consulted by an individual with respect to a vaccine-related injury or death to advise such individual that com- pensation may be available under the program for such injury or death. "PETITIONS FOR COMPENSATION 42 use "SEC. 2111. (a) GENERAL RULE.— 300aa-ll. "(1) A proceeding for compensation under the Program 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 district court for the district in which the petitioner resides or in which the injury or death occurred.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3759 "(2)(A) No person may bring a civil action for damages in an amount greater than $1,000 or in an unspecified amount against a vaccine manufacturer in a State or Federal court for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this subtitle, and no such court may award damages in an amount greater than $1,000 in a civil action for damages for such a vaccine-related injury or death, unless— "(i) a petition has been filed, in accordance with section 2116, under subsection Oa) for compensation under the Pro- gram for such injury or death, "(ii) a district court of the United States has issued a Ckjurts, U.S. judgment under section 2112 on such petition, and "(iii) such person elects under section 2121(a) to file such an action. "(B) If a civil action which is barred under subparagraph (A) Ck)urts, U.S. is filed in a State or Federal court, the court shall dismiss the action. If a petition is filed under this section with respect to the injury or death for which such civil action was brought, the date such dismissed action was filed shall, for purposes of the limita- tions of actions prescribed by section 2116, be considered the date the petition was filed if the petition was filed within one year of the date of the dismissal of the civil action. "(3) No vaccine manufacturer may be made a party to a civil action (other than a civil action which may be brought under paragraph (2)) for damages for a vaccine-related injury or death associated with the administration of a vaccine after the effec- tive date of this subtitle. "(4) If in a civil action brought against a vaccine manufac- turer before the effective date of this subtitle damages were denied for a vaccine-related injury or death or if such civil action was dismissed with prejudice, the person who brought such action may file a petition under subsection (b) for such injury or death. "(5)(A) A plaintiff who on the effective date of this subtitle has pending a civil action for damages for a vaccine-related injury or death may, at any time within 2 years after the effective date of this title or before judgment, whichever occurs first, elect to withdraw such action without prejudice and file a petition under subsection (b) for such injury or death. "(B) If a plaintiff who on the effective date of this subtitle had pending a civil action for damages for a vaccine-related injury or death does not withdraw the action under subparagraph (A), such person may not file a petition under subsection Ot)) for such injury or death. "(6) If a person brings a civil action after the effective date of this subtitle for damages for a vaccine-related injury or death associated with the administration of a vaccine before the effec- tive date of this subtitle, such person may not file a petition under subsection (b) for such injury or death. "(7) If in a civil action brought against a vaccine manufac- turer for a vaccine-related injury or death damages are awarded under a judgment of a court or a settlement of such action, the person who brought such action may not file a petition under subsection (b) for such injury or death. *(b) PETITIONERS.—
100 STAT. 3760 PUBLIC LAW 99-660—NOV. 14, 1986 "(IXA) Except as provided in subparagraph (B), any person who has sustained a vaccine-related injury, the legal represent- ative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine set forth in the Vaccine Injury Table may file a petition for compensation under the Program. "(B) No person may file a petition for a vaccine-related injury or death associated with a vaccine administered before the effective date of this subtitle if compensation has been paid under this subtitle for 3500 petitions for such injuries or deaths. "(2) Only one petition may be filed with respect to each a j; .»! administration of a vaccine. "(c) PETITION CONTENT.—A petition for compensation under the Program for a vaccine-related injury or death shall contain— "(1) an affidavit, and supporting documentation, demonstrat- ,-i,,: u, ing that the person who suffered such injury or who died— "(A) received a vaccine set forth in the Vaccine Injury Table or, if such person did not receive such a vaccine, contracted polio, directly or indirectly, from another person who received an oral polio vaccine, "(BXi) if such person received a vaccine set forth in the Vaccine Injury Table— "(I) received the vaccine in the United States or in its trust territories, "(11) received the vaccine outside the United States or :'i\ a trust territory and at the time of the vaccination such - ,j person was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the United States or a dependent of such a citizen, or "(HI) received the vaccine outside the United States or a trust territory and the vaccine was manufactured by a vaccine manufacturer located in the United States and such person returned to the United States not later than 6 months after the date of the vaccination, "(ii) if such person did not receive such a vaccine but contracted polio from another person who received an oral polio vaccine, was a citizen of the United States or a dependent of such a citizen, "(CXi) sustained, or had significantly aggravated, any o, • illness, disability, injury, or condition set forth in the Vac- cine Injury Table in association with the vaccine referred to in subparagraph (A) or died from the administration of such vaccine, and the first symptom or manifestation of the onset or of the significant aggravation of any such illness, disability, injury, or condition or the death occurred within the time period after vaccine administration set forth in the Vaccine Lijury Table, or "(iiXD sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the <x" Vaccine Injury Table but which was caused by a vaccine r referred to in subparagraph (A), or "(II) sustained, or had significantly aggravated, any ill- i-ljjfj ness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3761 within the time period set forth in the Table but which was caused by a vaccine referred to in subparagraph (A), "(D)(i) suffered the residual effects or complications of such illness, disability, injury, or condition for more than 1 year after the administration of the vaccine, (ii) incurred unreimbursable expenses due in whole or in part to such illness, disability, injury, or condition in an amount greater than $1,000, or (iii) died from the administration of the vaccine, and "(E) has not previously collected an award or settlement of a civil action for damages for such vaccine-related injury or death, "(2) all available relevant medical records (including autopsy reports, if any) relating to the person who suffered such injury or who died from the administration of the vaccine and an identification of any unavailable records known to the peti- tioner and the reasons for their unavailability, and "(3) appropriate assessments, evaluations, and prognoses and such other records and documents as are reasonably necessary for the determination of the amount of compensation to be paid to, or on behalf of, the person who suffered such injury or who died from the administration of the vaccine. COURT JURISDICTION "SEC. 2112. (a) GENERAL RULE.—The district courts of the United 42 use States shall have jurisdiction (1) over proceedings to determine if a 300aa-12. petitioner under section 2111 is entitled to compensation under the Program and the amount of such compensation, and (2) to issue and enforce such orders as the courts deem necessary to assure the prompt payment of any compensation awarded. "(b) PARTIES.— "(1) The Secretary shall be named as the respondent in all proceedings brought by the filing of a petition under section 2111(b). Except as provided in paragraph (2), no other person may intervene in any such proceeding. "(2) Within 30 days after the Secretary receives service of any Federal petition filed under section 2111 the Secretary shall publish Register, notice of such petition in the Federal Register. The special publication. master designated with respect to such petition under subsec- tion (c) shall afford all interested persons an opportunity to submit relevant, written information— "(A) relating to the existence of the evidence described in section 2113(a)(1)(B), or "(B) relating to any allegation in a petition with respect to the matters described in section 2111(c)(lXC)(ii). "(c) SPECIAL MASTERS.— "(1) Following receipt of a petition under subsection (a), the district court of the United States in which the petition is filed shall designate a special master to carry out the functions authorized by paragraph (2). "(2) A special master shall serve as an adjunct to the court and may— "(A) require such evidence as may be appropriate for the preparation of proposed findings of fact and conclusions of law with respect to whether compensation is to be provided
100 STAT. 3762 PUBLIC LAW 99-660—NOV. 14, 1986 under the Program and the amount of any such compensa- tion, "(B) require the submission of such information as may be reasonable and necessary to determine if the petitioner is entitled to compensation, "(C) require the testimony of any person and the produc- tion of any document as may be reasonable and necessary to determine if the petitioner is entitled to compensation, "(D) conduct such hearings as may be appropriate, and "(E) prepare and submit to the court proposed findings of fact and conclusions of law. Information submitted to a special master in a proceeding on a petition may not be disclosed to a person who is not a party to the proceeding without the express, written consent of the person who submitted the information. There may be no discov- ery in a proceeding on a petition other than the discovery required under this paragraph. "(d) ACTION BY THE Ck>uRT,— Records. "(1) Upon objection by the petitioner or respondent to the proposed findings of fact or conclusions of law prepared by the special master or upon the court's own motion, the court shall undertake a review of the record of the proceedings and may thereafter make a de novo determination of any matter and issue its judgment accordingly, including findings of fact and conclusions of law, or remand for further proceedings. "(2) If no objection is filed under parsigraph (1) or if the court does not choose to review the proceeding, the court shall adopt the proposed findings of fact and conclusions of law of the special master as its own and render judgment thereon. "(3) The court shall render its judgment on any petition filed under the Program as expeditiously as practicable but not later than 365 days after the date on which the petition was filed. "(e) ADMINISTRATION OF AWARD.—The Program shall administer the payments of such compensation. The Program shall audit the pa3rments of compensation under a judgment. A petitioner awarded compensation shall notify the Program of any changes which signifi- cantly affect the compensation to be paid. "(0 REVISION OF AWARD.— "(1) If the court issues a judgment awarding to a petitioner compensation described in section 2115(aXlXA) for unreimburs- able expenses and the compensation is insufficient to meet such expenses, such petitioner may petition the court to (A) review such award, and (B) increase the award to make it sufficient to meet such expenses or amend the periodic payment schedule established under section 2115, or both. "(2) If an audit conducted under subsection (e) discloses the improper use of compensation awarded under a judgment or the termination of a need for an item of compensation, the Program shall petition the court which awarded the compensation to make an appropriate revision in the compensation. "(g) APPEALS.—The findings of fact and conclusions of law of a district court of the United States on a petition shall be final determinations of the matters involved, except that the Secretary or any petitioner aggrieved by the findings or conclusions of the court may obtain review of the judgment of the court in the United States court of appeals for the circuit in which the court is located upon petition filed with such court of appeals.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3763 DETERMINATION OF EUGIBIUTY AND COMPENSATION 'SEC. 2113. (a) GENERAL RULE.— Ck)urts, U.S. "(1) Compensation shall be awarded under the Program to a Records. petitioner if the court finds on the record as a whole— 42 use 300aa-13. "(A) that the petitioner has demonstrated by a preponder- ance of the evidence the matters required in the petition by section 2111(c)(1), and "(B) that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition. The court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by medi- cal opinion. "(2) For purposes of paragraph (1), the term 'factors unrelated to the administration of the vaccine'— "(A) does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition, and "(B) may, as documented by the petitioner's evidence or other material in the record, include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally respon- sible for causing the petitioner's illness, disability, injury, condition, or death. '(b) MATTERS TO B E CONSIDERED.— "(1) In determining whether to award compensation to a Courts, U.S. petitioner under the Program, the court shall consider, in addi- Records. tion to all other relevant medical and scientific evidence con- tained in the record— "(A) any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death, and "(B) the results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions. Any such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the court. In evaluating the weight to be afforded to any such diagnosis, conclusion, judg- ment, test result, report, or summary, the court shall consider the entire record and the course of the injury, disability, illness, or condition until the date of the judgment of the court. "(2) The court may find the first symptom or manifestation of onset or significant aggravation of an injury, disability, illness, condition, or death described in a petition occurred within the time period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such period. Such a finding may be made only upon demonstra- tion by a preponderance of the evidence that the onset or significant aggravation of the injury, disability, illness, condi-
100 STAT. 3764 PUBLIC LAW 99-660—NOV. 14, 1986 tion, or death described in the petition did in fact occur within the time period described in the Vaccine Injury Table. ' '^ "(c) RECORD DEFINED.—For purposes of this section, the term 'record' means the record established by a distict court of the United States in a proceeding on a petition filed under section 2111. i^w, !v tf" " V A C C I N E INJURY TABLE H 42 use "SEC. 2114. (a) INITIAL TABLE.—The following is a table of vaccines, 300aa-14. the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manifestation of onset or of the signifi- cant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program: "VACCINE INJURY TABLE I. DTP; P; DTP/Polio Combination; or , , Any Other Vaccine Containing Whole Cell Pertussis Bacteria, •jc 2' Extracted or Partial Cell Bacte- ria, or Specific Pertussis Antigen(s). Illness, disability, injury, or condi- Time period for first symptom or C= tion covered: manifestation of onset or of signif- icant aggravation after vaccine administration: A. Anaphylaxis or anaphylactic shock 24 hours B. Encephalopathy (or encephalitis)... 3 days ••'- '• C. Shock-collapse or hypotonic-hy- , , , . ^ *' poresponsive collapse 3 days •',t'^ -' " jp' ' . -^ D Residual seizure disorder in ac- ' . ^. , '''•''" cordance with subsection (cX2) 3 days E. Any acute complication or seque- " '• la (including death) of an illness, ^ , »' ^ . disability, injury, or condition re- ,;;- •• ferred to above which illness, dis- ability, injury, or condition arose within the time period prescribed... Not applicable n. Measles, mumps, rubella, or any j-^ . . i. vaccine containing any of the ,^ , foregoing as a component; DT; Td; - ! or Tetanus Toxoid. .-- . ' , A. Anaphylaxis or anaphylactic shock 24 hours B. Encephalopathy (or encephalitis)... 15 days (for mumps, rubella, mea- sles, or any vaccine containing •J '• any of the foregoing as a compo- nent). 3 days (for DT, Td, or teta- nus toxoid). C. Residual seizure disorder in ac- cordance with subsection (cX2) 15 days (for mumps, rubella, mea- sles, or any vaccine containing •\f^ , any of the foregoing as a compo- ' ' nent). 3 days (for DT. Td, or teta- ' ' nus toxoid). D. Any acute complication or seque- la (including death) of an illness, disability, injury, or condition re- ., . ferred to above which illness, dis- ability, injury, or condition arose within the time period prescribed... Not applicable m. Polio Vaccines (other than Inacti- vated Polio Vaccine). . . . „,». ,, , , . . . , , - - \ . ijam A. Paralytic polio *^ ^ ' ' -• ^ -
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3765 : • ' ' —in a non-immunodeficient re- cipient 30 days —in an immunodeficient recipi- ent 6 months —in a vaccine-associated com- munity case Not applicable B. Any acute complication or seque- la (including death) of an illness, disability, injury, or condition re- ferred to above which illness, dis- ability, injury, or condition arose within the time period prescribed... Not applicable IV. Inactivated Polio Vaccine. A. Anaphylaxis or anaphylactic shock 24 hours B. Any acute complication or seque- la (including death) of an illness, disability, injury, or condition re- ferred to above which illness, dis- ability, injury, or condition arose within the time period prescribed... Not applicable "(b) QUALIFICATIONS AND AIDS TO INTERPRETATION.—The following qualifications and aids to interpretation shall apply to the Vaccine Injury Table in subsection (a): "(1) A shock-collapse or a hypotonic-hyporesponsive collapse may be evidenced by indicia or symptoms such as decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning pale white or blue, unresponsiveness to environmental stimuli, depression of con- sciousness, loss of consciousness, prolonged sleeping with dif- ficulty arousing, or cardiovascular or respiratory arrest. / "(2) A petitioner may be considered to have suffered a resid- ual seizure disorder if the petitioner did not suffer a seizure or convulsion unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit before the first seizure or convulsion after the administration of the vaccine involved and if— "(A) in the case of a measles, mumps, or rubella vaccine or any combination of such vaccines, the first seizure or convulsion occurred within 15 days after administration of the vaccine and 2 or more seizures or convulsions occurred ' • within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of ''''^'' less than 102 degrees Fahrenheit, and : "(B) in the case of any other vaccine, the first seizure or . _;, convulsion occurred within 3 days after administration of the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of •"" less than 102 degrees Fahrenheit. "(3)(A) The term 'encephalopathy' means any significant acquired abnormality of, or injury to, or impairment of function of the brain. Among the frequent manifestations of encephalopathy are focal and diffuse neurologic signs, increased intracranial pressure, or changes lasting at least 6 hours in level of consciousness, with or without convulsions. The neuro- logical signs and symptoms of encephalopathy may be tem- porary with complete recovery, or may result in various degrees of permanent impairment. Signs and symptoms such as high
100 STAT. 3766 PUBLIC LAW 99-660—NOV. 14, 1986 pitched and unusual screaming, persistent unconsolable crjdng, and bulging fontanel are compatible with an encephalopathy, but in and of themselves are not conclusive evidence of encephalopathy. Encephalopathy usually can be documented by slow wave activity on an electroencephalogram. "(B) If in a proceeding on a petition it is shown by a prepon- derance of the evidence that an encephalopathy was caused by infection, toxins, trauma, or metabolic disturbances the encephalopathy shall not be considered to be a condition set forth in the table. If at the time a judgment is entered on a petition filed under section 2111(b) for a vaccine-related injury or death it is not possible to determine the cause, by a prepon- derance of the evidence, of an encephalopathy, the encephalopathy shall be considered to be a condition set forth in the table. In determining whether or not an encephalopathy is a condition set forth in the table, the court shall consider the entire medical record. "(4) For purposes of paragraphs (2) and (3), the terms 'seizure' and 'convulsion' include grand mal, petit mal, absence, myoclonic, tonic-clonic, and focal motor seizures and signs. If a provision of the table to which paragraph (1), (2), (3), or (4) applies is revised under subsection (c) or (d), such paragraph shall not apply to such provision after the effective date of the revision unless the revision specifies that such paragraph is to continue to apply. '(c) ADMINISTRATIVE REVISION OF THE TABLE.— Regulations. "(1) The Secretary may promulgate regulations to modify in accordance with paragraph (3) the Vaccine Injury Table. In promulgating such regulations, the Secretary shall provide for notice and opportunity for a public hearing and at least 180 days of public comment. "(2) Any person (including the Advisory (Ilommission on Child- hood Vaccines) may petition the Secretary to propose rq^lations to amend the Vaccine Injury Table. Unless clearly frivolous, or initiated by the Commission, any such petition shall be referred to the (Dommission for its recommendations. Following— "(A) receipt of any recommendation of the Commission, or Federal "(B) 180 days after the date of the referral to the Commis- Register, sion, publication. whichever occurs first, the Secretary shall conduct a rule- msiking proceeding on the matters proposed in the petition or publish in the Federal Register a statement of reasons for not conducting such proceeding. "(3) A modification of the Vaccine Injury Table under para- graph (1) may add to, or delete from, the list of injuries, disabilities, illnesses, conditions, and deaths for which com- pensation may be provided or may change the time periods for the first symptom or manifestation of the onset or the signifi- cant aggravation of any such injury, disability, illness, condi- tion, or death. "(4) Any modification under paragraph (1) of the Vaccine Injury Table shall apply only with respect to petitions for compensation under the Program which are filed after the effective date of such regulation.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3767 "(d) ROLE OF COMMISSION.—Except with respect to a regulation Regulations. recommended by the Advisory Commission on Childhood Vaccines, the Secretary may not propose a regulation under subsection (c) or any revision thereof, unless the Secretary has first provided to the Commission a copy of the proposed regulation or revision, requested recommendations and comments by the Commission, and afforded the Commission at least 90 days to make such recommendations. "(e) RECOMMENDATION.—The Secretary may recommend to Con- gress revisions of the table to change the vaccines covered by the table. "COMPENSATION "SEC. 2115. (a) GENERAL RULE.—Compensation awarded under the 42 use Program to a petitioner under section 2111 for a vaccine-related 300aa-15. injury or death associated with the administration of a vaccine after the effective date of this subtitle shall include the following: "(1)(A) Actual unreimbursable expenses incurred from the date of the judgment awarding such expenses and reasonable projected unreimbursable expenses which— "(i) result from the vaccine-related injury for which the petitioner seeks compensation, "(ii) have been or will be incurred by or on behalf of the person who suffered such injury, and "(iii)(I) have been or will be for diagnosis and medical or other remedial care determined to be reasonably necessary, or "(II) have been or will be for rehabilitation, developmen- tal evaluation, special education, vocational training and placement, case management services, counseling, emo- tional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary. The amount of unreimbursable expenses which may be recov- ered under this subparagraph shall be limited to the amount in excess of the amount set forth in section 2111(c)(l)(D)(ii). "(B) Subject to section 2116(a)(2), actual unreimbursable ex- penses incurred before the date of the judgment awarding such expenses which— "(i) resulted from the vaccine-related injury for which the petitioner seeks compensation, "(ii) were incurred by or on behalf of the person who suffered such injury, and "(iii) were for diagnosis, medical or other remedial care, rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling, emotional or behavioral therapy, resi- dential and custodial care and service expenses, special equipment, related travel expenses, and facilities deter- mined to be reasonably necessary. The amount of unreimbursable expenses which may be recov- ered under this subparagraph shall be limited to the amount in excess of the amount set forth in section 2111(c)(l)(D)(ii). "(2) In the event of a vaccine-related death, an award of $250,000 for the estate of the deceased. "(3)(A) In the case of any person who has sustained a vaccine- related injury after attaining the age of 18 and whose earning
100 STAT. 3768 PUBLIC LAW 99-660—NOV. 14, 1986 «*-' "0— capacity is or has been impaired by reason of such person's vaccine-related injury for which compensation is to be awarded, compensation for actual and anticipated loss of earnings deter- mined in accordance with generally recognized actuarial prin- ciples and projections. "(B) In the case of any person who heis sustained a vaccine- related injury before attaining the age of 18 and whose earning capacity is or has been impaired by reason of such person's vaccine-related injury for which compensation is to be awarded and whose vaccine-related injury is of sufficient severity to permit reasonable anticipation that such person is likely to suffer impaired earning capacity at age 18 and beyond, com- pensation after attaining the age of 18 for loss of earnings '•' determined on the basis of the average gross weekly earnings of I workers in the private, non-farm sector, less appropriate taxes and the average cost of a health insurance policy, as determined by the Secretary. •1 "(4) For actusd and projected pain and suffering and emo- tional distress from the vaccine-related injury, an award not to exceed $250,000. Pajnnents for projected expenses shall be paid on a periodic basis 0)ut no pajonent may be made for a period in excess of 1 year). Payments for pain and suffering and emotional distress and incurred expenses may be paid in a lump sum. "Q)) VACCINES ADMINISTERED BEFORE THE EFFECTIVE DATE.—Com- pensation awarded under the Program to a petitioner under section 2111 for a vaccine-related injury or death associated with the administration of a vaccine before the effective date of this subtitle shall only include the compensation described in paragraphs (IXA) and (2) of subsection (a). "(c) RESIDENTIAL AND CUSTODIAL CARE AND SERVICE.—The amount of any compensation for residential and custodial care and service expenses under subsection (aXD shall be sufficient to enable the compensated person to remain living at home. "(d) TYPES OF COMPENSATION PROHIBITED.—(Dompensation awarded under the Program may not include the following: "(1) Punitive or exemplary damages. "(2) Except with respect to compensation payments under paragraphs (2) and (3) of subsection (a), compensation for other H than the health, education, or welfare of the person who suf- fered the vaccine-related injury with respect to which the com- pensation is paid. "(e) ATTORNEYS' FEES.— Ck)urts, U.S. "(1) The judgment of a court on a petition filed under section 2111 awarding compensation shall include an amount to cover— "(A) reasonable attorneys' fees, and "(B) other costs, incurred in any proceeding on such petition. If the judgment of i a court on such a petition does not award compensation, the court may include in the judgment an amount to cover petition- er's reasonable attorneys' fees and other costs incurred in any proceeding on such petition if the court determines that the civil action was brought in good faith and there w£is a reason- 'a able basis for the claim for which the civil action was brought. "(2) If the petitioner, before the effective date of this title, > filed a civil action for damages for any vaccine-related injury or lir death for which compensation may be awarded under the Pro-
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3769 gram, and elected under section 2111(a)(4) to withdraw such action and to file a petition for compensation under the Pro- gram, the judgment of the court on such petition may include an amount limited to the costs and expenses incurred by the petitioner and the attorney of the petitioner before the effective date of this subtitle in preparing, filing, and prosecut- ing such civil action (including the reasonable value of the attorney's time if the civil action was filed under contingent fee arrangements). "(3) No attorney may charge any fee for services in connection with a petition filed under section 2111 which is in addition to any amount included under paragraph (1) in a judgment on such petition. "(f) PAYMENT OF COMPENSATION.— "(1) Except as provided in paragraph (2), no compensation may be paid until an election has been made, or has been deemed to have been made, under section 2121(a) to receive compensation. "(2) Compensation described in subsection (a)(l)(A)(iii) shall be paid from the date of the judgment of the district court of the United States under section 2112 awarding the compensation. Such compensation may not be paid after an election under • section 2121(b) to file a civil action for damages for the vaccine- related injury or death for which such compensation was r-jit awarded. "(3) Payments of compensation shall be exempt from reduc- tion under any order issued under part C of the Balanced Budget and Emergency Deficit Control Act of 1985. 2 USC 901 et seq. "(f) PROGRAM NOT PRIMARILY LIABLE.—Payment of compensation under the Program shall not be made for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service (1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program, or (2) by an entity which provides health services on a prepaid basis. j • * :^ "(g) LIABILITY OF HEALTH INSURANCE CARRIERS, PREPAID HEALTH '•"•~^>- ^K. PLANS, AND BENEFIT PROVIDERS.—No policy of health insurance may make payment of benefits under the policy secondary to the pay- ment of compensation under the Program and— "(1) no State, and "(2) no entity which provides health services on a prepaid basis or provides health benefits, may make the provision of health services or health benefits second- ary to the payment of compensation under the Program. " ''" " i "LIMITATIONS OF ACTIONS "SEC. 2116. (a) GENERAL RULE.—In the case of— 42 use "(1) a vaccine set forth in the Vaccine Injury Table which is 300aa-l6. "^ administered before the effective date of this title, if a vaccine- related injury or death occurred as a result of the administra- tion of such vaccine, no petition may be filed for compensation under the Program for such injury or death after the expiration > of 24 months after the effective date of this title, "(2) a vaccine set forth in the Vaccine Injury Table which is administered after the effective date of this title, if a vaccine- related injury occurred as a result of the administration of such
100 STAT. 3770 PUBLIC LAW 99-660—NOV. 14, 1986 vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury, and "(3) a vaccine set forth in the Vaccine Injury Table which is administered after the effective date of this title, if a death occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such death after the expiration of 24 months from the date of the death and no such petition may be filed more than 48 months after the date of the occurrence of the first sjonptom or manifestation of onset or of the significsmt aggravation of the injury from which the death resulted. "0)) EFFECT OF REVISED TABLE.—If at any time the Vaccine Injury Table is revised and the effect of such revision is to permit an individual who was not, biefore such revision, eligible to seek com- pensation under the Program, such person may file a petition for such compensation not later than 2 years after the effective date of the revision, except that no compensation may be provided under the Program with respect to a vaccine-related injury or death covered under the revision of the table if— "(1) the vaccine-related death occurred more than 8 years ^ before the date of the revision of the table, or "(2) the vaccine-related injury occurred more than 8 years before the date of the revision of the table. "(c) STATE LIMITATIONS OF ACTIONS.—If a petition is filed under section 2111(b) for a vaccine-related injury or death, limitations of actions under State law shall be stayed with respect to a civil action brought for such injury or death for the period beginning on the date the petition is filed and ending on the date a final judgment is entered on the petition. "SUBROGRATION .... •,.; -H' 42 use "SEC. 2117. (a) GENERAL RULE.— 300aa-17. "(1) Upon payment of compensation to any petitioner under the Program, the trust fund which has been established to provide such compensation shall be subrograted to all rights of the petitioner with respect to the vaccine-related injury or death for which compensation was paid, except that the trust fund may not recover under such rights an amount greater than the amount of compensation paid to the petitioner. Courts, U.S. "(2) In any case in which it deems such action appropriate, a Records. district court of the United States may, after entry of a final Claims. judgment providing for compensation to be paid under section 2115 for a vaccine-related injury or death, refer the record of such proceeding to the Secretary and the Attorney General with such recommendation as the court deems appropriate with respect to the investigation or commencement of a civil action by the Secretary under paragraph (1). "(b) DISPOSITION OF AMOUNTS RECOVERED.—Amounts recovered under subsection (a) shall be collected on behalf of, and deposited in, the trust fund which has been established to provide compensation under the Program.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3771 > INCREASE FOR INFLATION "SEC. 2118. The compensation under subsections (a)(2) and (a)(4) of Effective date. section 2115 and the civil penalty under section 2127(b) shall, effec- 42 use tive December 1 of each year beginning 1 year after the effective 300aa-18. date of this title, be increased by the percent change in the Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base quarter of the preceding year, adjusted to the nearest Vi o of 1 percent. For purposes of this section, the term 'base quarter', as used with respect to a year, means the calendar quarter ending on September 30 of such year and the price index for a base quarter is the arithmetical mean of such index for the 3 months comprising such quarter. ADVISORY COMMISSION ON CHILDHOOD VACCINES "SEC. 2119. (a) ESTABLISHMENT.—There is established the Advisory 42 use Commission on Childhood Vaccines. The Commission shall be com- 300aa-19. posed of: "(1) Nine members appointed by the Secretary as follows: "(A) Three members who are health professionals, who are not employees of the United States, and who have expertise in the health care of children, the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines, of whom at least two shall be pediatricians. "(B) Three members from the general public, of whom at least two shall be legal representatives of children who have suffered a vaccine-related injury or death. "(C) Three members who are attorneys, of whom at least i one shall be an attorney whose specialty includes represen- tation of persons who have suffered a vaccine-related injury or death and of whom one shall be an attorney whose specialty includes representation of vaccine manufacturers. "(2) The Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the Centers for Disease Control, and the Commissioner of Food and Drugs (or the designees of such officials), each of whom shall be a nonvoting ex officio member. The Secretary shall select members of the Commission within 90 days of the effective date of this subtitle. The members of the Commission shall select a Chair from among the members. "(b) TERM OF OFFICE.—Appointed members of the Commission shall be appointed for a term of office of 3 years, except that of the members first appointed, 3 shall be appointed for a term of 1 year, 3 shall be appointed for a term of 2 years, and 3 shall be appointed for a term of 3 years, as determined by the Secretary. "(c) MEETINGS.—The Commission shall first meet within 60 days after all members of the Commission are appointed, and thereafter shall meet not less often than four times per year and at the call of the chair. A quorum for purposes of a meeting is 5. A decision at a meeting is to be made by a ballot of a majority of the voting members of the Commission. "(d) COMPENSATION.—Members of the Commission who are offi- cers or employees of the Federal Government shall serve as mem- bers of the Commission without compensation in addition to that received in their regular public employment. Members of the
100 STAT. 3772 PUBLIC LAW 99-660—NOV. 14, 1986 Commission who are not officers or employees of the Federal Government shall be compensated at a rate not to exceed the daily equivalent of the rate in effect for grade GS-18 of the General 5 use 5332. Schedule for each day (including traveltime) they are engaged in the performance of their duties as members of the Commission. All members, while so serving away from their homes or regular places of business, may be allowed travel expenses, including per diem in < lieu of subsistence, in the same manner as such expenses are authorized by section 5703, title 5, United States Code, for employees serving intermittently. "(e) STAFF.—The Secretary shall provide the Commission with such professional and clerical staff, such information, and the serv- ices of such consultants as may be necessary to assist the Commis- sion in carrying out effectively its functions under this section. "(f) FUNCTIONS.—The Commission shall— "(1) advise the Secretary on the implementation of the 3eu s* Program, "(2) on its own initiative or as the result of the filing of a petition, recommend changes in the Vaccine Injury Table, •' ' "(3) advise the Secretary in implementing the Secretary's ' responsibilities under section 2127 regarding the need for child- " hood vaccination products that result in fewer or no significant adverse reactions, ^ "(4) survey Federal, State, and local programs and activities ^ relating to the gathering of information on injuries associated with the administration of childhood vaccines, including the Js Hi adverse reaction reporting requirements of section 2125(b), and ortw advise the Secretary on means to obtain, compile, publish, and use credible data related to the frequency and severity of ^ adverse reactions associated with childhood vaccines, and "(5) recommend to the Director of the National Vaccine Pro- T gram research related to vaccine injuries which should be con- * ducted to carry out this subtitle. IB ' "PART B—ADDITIONAL REMEDIES '"^ "AUTHORITY TO BRING ACTIONS 42 use "SEC. 2121. (a) ELECTION.—After the judgment of a district court of 300aa-2l. the United States under section 2111 on a petition filed for com- pensation under the Program for a vaccine-related injury or death has become final, the person who filed the petition shall file with the 1 court— ^. "(1) if the judgment awarded compensation, an election in 1 writing to receive the compensation or to file a civil action for 1 damages for such injury or death, or "(2) if the judgment did not award compensation, an election g^^K in writing to accept the judgment or to file a civil action for damages for such injury or death. I An election shall be filed under this subsection not later than 90 ! days after the date of the entry of the court's judgment with respect ^ to which the election is to be made. If a person required to file an election with a court under this subsection does not file the election within the time prescribed for filing the election, such person shall - be deemed to have filed an election to accept the judgment of the 3 court. If a person elects to receive compensation under a judgment 5i of a court or is deemed to have accepted the judgment of a court,
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3773 such person may not bring or maintain a civil action for damages against a vaccine manufacturer for the vaccine-related injury or death for which the judgment was entered. "(b) LIMITATIONS OF ACTIONS.—A civil action for damages arising State and local from a vaccine-related injury or death for which a petition was filed governments. under section 2111 shall, except as provided in section 2116(c), be brought within the period prescribed by limitations of actions under State law applicable to such civil action. STANDARDS OF RESPONSIBILITY "SEC. 2122. (a) GENERAL RULE.—Except as provided in subsections State and local (b), (c), and (e) State law shall apply to a civil action brought for governments. Claims. damages for a vaccine-related injury or death. "(b) UNAVOIDABLE ADVERSE SIDE EFFECTS; WARNINGS.— 42 use 300aa-22. "(1) No vaccine manufacturer shall be liable in a civil action ; . for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after the effec- tive date of this subtitle if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings. "(2) For purposes of paragraph (1), a vaccine shall be pre- : ! sumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material *'" respects with all requirements under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service 21 u s e 301 note. Act (including regulations issued under such provisions; 42 u s e 262. applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows— >'i' "^ "(A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 2123(dX2), or c)t fftfis "(B) by clear and convincing evidence that the manufac- turer failed to exercise due care notwithstanding its compli- »£iii. ance with such Act and section (and regulations issued under such provisions). "(c) DIRECT WARNINGS.—No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this subtitle solely due to the manufacturer's failure to provide direct warnings to the injured party (or the injured party's legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer. "(d) CONSTRUCTION.—The standards of responsibility prescribed by this section are not to be construed as authorizing a person who >8; brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in which damages were denied or which was dismissed with prejudice to bring a new civil action against such manufacturer for such injury or death. "(e) PREEMPTION.—No State may establish or enforce a law which State and local prohibits an individual from bringing a civil action against a vaccine governments. manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this subtitle.
100 STAT. 3774 PUBLIC LAW 99-660—NOV. 14, 1986 TRIAL f* f •• ' ^ - - - • • '•• 42 use "SEC. 2123. (a) GENERAL RULE.—A civil action against a vaccine 300aa-23. manufacturer for damages for a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this subtitle which is not barred by section 2111(aX2) shall be tried in three stages. "O?) LIABILITY.—The first stage of such a civil action shall be held to determine if a vaccine manufacturer is liable under section 2122. "(c) GENERAL DAMAGES.—The second stage of such a civil action shall be held to determine the amount of damages (other than punitive damages) a vaccine manufacturer found to be liable under section 2122 shall be required to pay. "(d) PUNITIVE DAMAGES.— "(1) If sought by the plaintiff, the third stage of such an action shall be held to determine the amount of punitive damages a vaccine manufacturer found to be liable under section 2122 shall be required to pay. Fraud. "(2) If in such an action the manufacturer shows that it complied, in all material respects, with all requirements under 21 u s e 301 note. the Federal Food, Drug, and Cosmetic Act and the Public 42 u s e 201 note. Health Service Act applicable to the vaccine and related to the vaccine injury or death with respect to which the action was brought, the manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in— "(A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a 42 u s e 262. proceeding for approval of the vaccine under section 351, Safety. "(B) intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or Safety. "(C) other criminal or illegal activity relating to the safety and effectiveness of vaccines, which activity related to the vaccine-related injury or death for which the civil action was brought. "(e) EVIDENCE.—In any stage of a civil action, the Vaccine Injury Table, any finding of a district court of the United States or a master appointed by such court in a proceeding on a petition filed under section 2111 and the final judgment of a district court of the United States on such a petition shall not be admissible. "PART C—ASSURING A SAFER CJHILDHOOD VACCINATION PROGRAM IN THE U N I T E D STATES RECORDING AND REPORTING OF INFORMATION 42 use "SEC, 2125. (a) GENERAL RULE.—Each health care provider who 300aa-25. administers a vaccine set forth in the Vaccine Injury Table to any person shall record, or ensure that there is recorded, in such per- son's permanent medical record (or in a permanent office log or file to which a legal representative shall have access upon request) with respect to each such vaccine— "(1) the date of administration of the vaccine, "(2) the vaccine manufacturer and lot number of the vaccine, "(3) the name and address and, if appropriate, the title of the health care provider administering the vaccine, and
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3775 "(4) any other identifying information on the vaccine required pursuant to regulations promulgated by the Secretary. "(b) REPORTING.— "(1) Each health care provider and vaccine manufacturer shall report to the Secretary— "(A) the occurrence of any event set forth in the Vaccine Injury Table, including the events set forth in section 2114(b) which occur within 7 days of the administration of any vaccine set forth in the Table or within such longer period as is specified in the Table or section, "(B) the occurrence of any contraindicating reaction to a vaccine which is specified in the manufacturer's package insert, and "(C) such other matters as the Secretary may by regula- tion require. Reports of the matters referred to in subparagraphs (A) and (B) shall be made beginning 90 days after the effective date of this subtitle. The Secretary shall publish in the Federal Register as Federal soon as practicable after such date a notice of the reporting Register, requirement, publication. "(2) A report under paragraph (1) respecting a vaccine shall include the time periods after the administration of such vac- cine within which vaccine-related illnesses, disabilities, injuries, or conditions, the symptoms and manifestations of such ill- nesses, disabilities, injuries, or conditions, or deaths occur, and the manufacturer and lot number of the vaccine. "(3) The Secretary shall issue the regulations referred to in Regulations paragraph (1)(C) within 180 days of the effective date of this subtitle. "(c) RELEASE OF INFORMATION.— "(1) Information which is in the possession of the Federal State and local Government and State and local governments under this sec- governments. tion and which may identify an individual shall not be made available under section 552 of title 5, United States Code, or otherwise, to any person except— "(A) the person who received the vaccine, or "(B) the legal representative of such person. "(2) For purposes of paragraph (1), the term 'information which may identify an individual' shall be limited to the name, street address, and telephone number of the person who re- ceived the vaccine and of that person's legal representative and the medical records of such person relating to the administra- tion of the vaccine, and shall not include the locality and State of vaccine administration, the name of the health care provider who administered the vaccine, the date of the vaccination, or information concerning any reported illness, disability, injury, or condition resulting from the administration of the vaccine, any symptom or manifestation of such illness, disability, injury, or condition, or death resulting from the administration of the vaccine. "(3) Except as provided in paragraph (1), all information Public reported under this section shall be available to the public. information. VACCINE INFORMATION "SEC. 2126. (a) GENERAL RULE.—Not later than 1 year after the 42USC effective date of this subtitle, the Secretary shall develop and 300aa-26.
100 STAT. 3776 PUBLIC LAW 99-660—NOV. 14, 1986 disseminate vaccine information materials for distribution by health care providers to the legal representatives of any child receiving a Federal vaccine set forth in the Vaccine Injury Table. Such materials shall Register' be published in the Federal Register and may be revised. publication. *?QJ) DEVELOPMENT AND REVISION OF MATERIALS.—Such m a t e r i a l s shall be developed or revised by rule— "(1) after notice to the public, opportunity for a public hear- V ing, and 90 days of comment thereon, and 'tmn "^^^ ^^ consultation with the Advisory Commission on Child- "^' hood Vaccines, appropriate health care providers and parent ^. ^, organizations, the Centers for Disease Control, and the Food and Drug Administration. "(c) INFORMATION REQUIREMENTS.—The information in such mate- rials shall be presented in understandable terms and shall include— "(1) the frequency, severity, and potential long-term effects of ,fr the disease to be prevented by the vaccine, "(2) the symptoms or reactions to the vaccine which, if they occur, should be brought to the immediate attention of the health care provider, "(3) precautionary measures legal representatives should take IIo 4 ^ reduce the risk of any major adverse reactions to the vaccine that may occur, "(4) early warning signs or symptoms to which legal rep- '||. , resentatives should be alert as possible precursors to such major ?. adverse reactions, "(5) a description of the manner in which legal representa- . ,, ^^f „; „4 tives should monitor such major adverse reactions, including a e.s Ufc /^3.i * ^ form on which reactions can be recorded to assist l ^ a l "* '" representatives in reporting information to appropriate authorities, J,,, "(6) a specification of when, how, and to whom legal rep- ^ resentatives should report any major adverse reaction, ^ "(7) the contraindications to (and bases for delay of) the ^^ " . administration of the vaccine, "(8) an identification of the groups, categories, or characteris- tics of potential recipients of the vaccine who may be at signifi- cantly higher risk of major adverse reaction to the vaccine than ^^^.jp tJ^e general population, ; ' "(9) a summary of relevant State and Federal laws concerning the vaccine, including information on— f "(A) the number of vaccinations required for school attendance and the schedule recommended for such vac- 'J, cinations, and "(B) the availability of the Program, and ,! "(10) such other relevant information as may be determined * by the Secretary. "(d) HEALTH CARE PROVIDER DUTIES.—On and after a date deter- * mined by the Secretary which is— „ ,_ ^, "(1) after the Secretary develops the information materials required by subsection (a), and •j'ddt "(2) not later than 6 months after the date such materials are published in the Federal Register, each health care provider who administers a vaccine set forth in the Vaccine Injury Table shall provide to the legal representatives of any child to whom such provider intends to administer such vaccine n.r, , ^. a copy of the information materials developed pursuant to subsec- •^i' r- fe tion (a), or other written information which meets the requirements
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3777 of this section. Such materials or other information shall be pro- .buB-^l. vided prior to the administration of such vaccine. -IW'X" MANDATE FOR SAFER CHILDHOOD VACCINES "SEC. 2127. (a) GENERAL RULE.—In the administration of this 42 use subtitle and other pertinent laws under the jurisdiction of the 300aa-27. Secretary, the Secretary shall— "(1) promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on the effective date of this subtitle and 3« promote the refinement of such vaccines, and 13 g "(2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveil- lance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines. "(b) REPORT.—Within 2 years after the effective date of this subtitle, and periodically thereafter, the Secretary shall prepare and transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursu- ant to subsection (a) during the preceding 2-year period. 9fl3 MANUFACTURER RECORDKEEPING AND REPORTING "SEC. 2128. (a) GENERAL RULE.—Each vaccine manufacturer of a State and local vaccine set forth in the Vaccine Injury Table or any other vaccine governments. the administration of which is mandated by the law or regulations 42 use 300aa-28. of any State, shall, with respect to each batch, lot, or other quantity manufactured or licensed after the effective date of this subtitle— "(1) prepare and maintain records documenting the history of the manufacturing, processing, testing, repooling, and rework- ing of each batch, lot, or other quantity of such vaccine, includ- ing the identification of any significant problems encountered ,-*a in the production, testing, or handling of such batch, lot, or other quantity, "(2) if a safety test on such batch, lot, or other quantity Safety. indicates a potential imminent or substantial public health hazard is presented, report to the Secretary within 24 hours of such safety test which the manufacturer (or manufacturer's 0811 S^. representative) conducted, including the date of the test, the type of vaccine tested, the identity of the batch, lot, or other quantity tested, whether the batch, lot, or other quantity tested is the product of repooling or reworking of previous batches, lots, or other quantities (and, if so, the identity of the previous batches, lots, or other quantities which were repooled or reworked), the complete test results, and the name and address of the person responsible for conducting the test, "(3) include with each such report a certification signed by a responsible corporate official that such report is true and com- plete, and "(4) prepare, maintain, and upon request submit to the Sec- retary product distribution records for each such vaccine by batch, lot, or other quantity number.
100 STAT. 3778 PUBLIC LAW 99-660—NOV. 14, 1986 Fraud. "(b) SANCTION.—Any vaccine manufacturer who intentionally destroys, alters, falsifies, or conceals any record or report required under paragraph (1) or (2) of subsection (a) shall— "(1) be subject to a civil penalty of up to $100,000 per occur- rence, or "(2) be fined $50,000 or imprisoned for not more than 1 year, or both. Such penalty shall apply to the person who intentionally destroyed, altered, falsified, or concealed such record or report, to the person who directed that such record or report be destroyed, altered, fal- sified, or concealed, and to the vaccine manufacturer for which such person is an agent, employee, or representative. Each act of destruc- tion, alteration, falsification, or concealment shall be treated as a separate occurrence. "PART D—GENERAL PROVISIONS " C I T I Z E N ' S ACTIONS 42 use "SEC. 2131. (a) GENERAL RULE.—Except as provided in subsection 300aa-31. (b), any person may commence in a district court of the United States a civil action on such person's own behalf against the Sec- retary where there is alleged a failure of the Secretary to perform any act or duty under this subtitle. "(b) NOTICE.—No action may be commenced under subsection (a) before the date which is 60 days after the person bringing the action has given written notice of intent to commence such action to the Secretary. Courts, U.S. "(c) COSTS OF LITIGATION.—The court, in issuing any final order in any action under this section, may award costs of litigation (includ- ing reasonable attorney and expert witness fees) to any party, whenever the court determines such award is appropriate. : ' ' JUDICIAL R E V I E W Regulations. "SEC. 2132. A petition for review of a regulation under this 42 use subtitle may be filed in a court of appeals of the United States 300aa-32. within 60 days from the date of the promulgation of the regulation or after such date if such petition is based solely on grounds arising after such 60th day. "DEFINITIONS 42 use "SEC. 2133. For purposes of this subtitle: 300aa-33. "(1) The term 'health care provider' means any licensed health care professional, organization, or institution, whether public or private (including Federal, State, and local depart- ments, agencies, and instrumentalities) under whose authority a vaccine set forth in the Vaccine Injury Table is administered. "(2) The term 'legal representative' means a parent or an individual who qualifies as a legal guardian under State law. "(3) The term 'manufacturer' means any corporation, organization, or institution, whether public or private (includ- Ti ing Federal, State, and local departments, agencies, and instrumentalities), which manufactures, imports, processes, or distributes under its label any vaccine set forth in the Vaccine Injury Table, except that, for purposes of section 2128, such term shall include the manufacturer of any other vaccine cov-
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3779 ered by that section. The term 'manufacture' means to manu- facture, import, process, or distribute a vaccine. "(4) The term 'significant aggravation' means any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health. "(5) The term 'vaccine-related injury or death' means an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine. "(6XA) The term 'Advisory Commission on Childhood Vac- cines' means the Commission established under section 2119. "(B) The term 'Vaccine Injury Table' means the table set out in section 2114.". Ante, p. 3764. (b) CONFORMING AMENDMENTS.— (1) Sections 217(c), 465(f), and 497 of the Public Health Service 42 u s e 218, 286, Act (42 U.S.C. 218(c), 286(f), 289(f)) are each amended by striking 289f. out "2101" and inserting in lieu thereof "2301". (2) Section 305(h) of such Act (42 U.S.C. 242c(h)) is amended by striking out "2113" each place it occurs and inserting in lieu thereof "2313". SEC. 312. RELATED STUDIES. (a) REVIEW OF PERTUSSIS VACCINES AND RELATED ILLNESSES AND 42 u s e 300aa-l CONDITIONS.—Not later than 3 years after the effective date of this note. title, the Secretary of Health and Human Services shall complete a review of all relevant medical and scientific information (including information obtained from the studies required under subsection (e)) on the nature, circumstances, and extent of the relationship, if any, between vaccines containing pertussis (including whole cell, extracts, and specific antigens) and the following illnesses and conditions: (1) Hemolytic anemia. (2) Hjrpsarrhythmia. (3) Infantile spasms. (4) Reye's sjoidrome. (5) Peripheral mononeuropathy. (6) Deaths classified as sudden infant death sjmdrome. (7) Aseptic meningitis. (8) Juvenile diabetes. (9) Autism. (10) Learning disabilities. (11) Hyperactivity. (12) Such other illnesses and conditions as the Secretary may choose to review or as the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act recommends for inclusion in such review. Ante, p. 3771. The review under this subsection shall include notice and oppor- tunity for a public hearing, consideration of written information submitted by the public, and consultation with such Advisory Commission. Ob) FINDINGS WITH RESPECT TO PERTUSSIS.—Not later than 3 years Federal after the effective date of this title, the Secretary shall make, and Register, publish in the Federal Register, the following specific findings: publication.
100 STAT. 3780 PUBLIC LAW 99-660—NOV. 14, 1986 (1) Whether each of the illnesses or conditions set forth in subsection (a) can reasonably be determined in some circumstances to be caused or significantly aggravated, by pertussis-containing vaccines. (2) For each illness or condition for which a finding of causa- tion or aggravation related to vaccines containing pertussis is made under paragraph (1), the circumstances under which such causation or aggravation can reasonably be determined to occur. (3) For each illness or condition for which a finding of causa- tion or aggravation related to vaccines containing pertussis is made under paragraph (1), and for each illness or condition set forth in the Vaccine Injury Table under section 2114 of the Ante, p. 3764. Public Health Service Act, the time periods within which the first symptom or manifestation of onset or aggravation of each such illness or condition can reasonably be determined to occur after pertussis vaccination. Regulations. (c) REVISION OF TABLE WITH J{ESPECT TO PERTUSSIS VACCINES.—At the same time the Secretary publishes in the Federal Register findings under subsection (b), the Secretary shall propose regula- tions to amend the Vaccine Injury Table under section 2114 of the Public Health Service Act as a result of such findings. Not later than 42 months after the effective date of this title, the Secretary shall promulgate such proposed regulations with such modifications as may be necessary after opportunity for public hearing. i-i^j6«R (d) REVIEW OF M M R VACCINES AND RELATED ILLNESSES AND CONDI- TIONS.—Not later than 3 years after the effective date of this title, the Secretary of Health and Human Services shall complete a review similar to the review conducted under subsection (a) with respect to the potential relationship between vaccines containing rubella (including MMR) and radiculoneuritis. The review under this subsection shall include notice and opportunity for a public hearing, consultation with the Advisory Commission on Childhood Vaccines and consideration of written information submitted by the Federal public. Not later than 3 years after the effective date of this title, Register, the Secretary shall make and publish in the Federal Register find- publication. ings similar to those required by subsection (b) and shall, if appro- priate, propose similar regulations (and thereafter promulgate such regulations) to those required by subsection (c), with respect to compensation under the National Vaccine Injury Compensation Program established under section 2110 of the Public Health Service Ante, p. 3758. Act for radiculoneuritis caused, contributed to, or significantly aggravated by vaccines containing rubella. (e) PERTUSSIS AND MMR STUDIES.— (1) In order to assist the Secretary in making the findings required under subsections (b) and (d), the Secretary shall, in accordance with subparagraph (B), arrange for the conduct of studies of— fiij (A) the relationship between vaccines containing pertus- sis (including whole cell, extracts, and specific antigens) and the illnesses or conditions set forth in paragraphs (1) through (11) of subsection (a), ^iCc.. (B) the relationship between vaccines containing pertus- sis and any other illnesses and conditions, as selected by the Secretary or the Advisory Commission on Childhood Vac- ' (•••'-. I'il cines established under section 2119 of the Public Health Ante, p. 3771. Service Act, and -;*- .I^J^M..,;,•:A ;*, .-AJ-S^J fi?..: w; i'suitusi
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3781 1 ' (C) the relationship between vaccines containing rubella (including MMR) and radiculoneuritis. (2XA) The Secretary shall request the Institute of Medicine of the National Academy of Sciences to conduct the studies required by paragraph (1) under an arrangement by which the actual expenses incurred by such Academy in conducting such study will be paid by the Secretary. (B) If the Institute of Medicine is unwilling to conduct such Reports, study under such an arrangement, the Secretary shall enter into a similar arrangement with other appropriate nonprofit private groups or associations under which such groups or associations will conduct such study and prepare and submit the reports thereon as provided in paragraph (3). (C) The Institute of Medicine or other group or association conducting the studies required by paragraph (1) shall conduct such studies in consultation with the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act. Ante, p. 3771. (3) Reports on the results of the studies required by paragraph Reports. (1) shall be completed and submitted to the Committee on Public information. Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate and to the Secretary not later than 32 months after the effective date of this title. Upon submission to the Secretary, the reports shall be made available to the public. (4) There are authorized to be appropriated such sums as are Appropriation necessary for the purpose of making payments for the conduct authorization. of the studies required under this subsection. (f) DEFINITIONS.—For purposes of this section: (1) The term "medical and scientific information" includes epidemiologic, clinical, biostatistical, pathological, toxicologic, and other laboratory data and case study information, observa- tions, studies, and reports in peer-reviewed literature or official Government publications, as well as relevant unpublished information, data, studies, and observations. (2) The term "MMR" means a vaccine containing material intended to prevent or confer immunity against measles, mumps, and rubella disease. SEC. 313. STUDY OF OTHER VACCINE RISKS. (a) STUDY.— 42 u s e 300aa-l (1) Not later than 3 years after the effective date of this title, note. the Secretary shall, after consultation with the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act— i (A) arrange for a broad study of the risks (other than the risks considered under section 102) to children associated with each vaccine set forth in the Vaccine Injury Table under section 2114 of such Act, and Ante, p. 3764. (B) establish guidelines, after notice and opportunity for public hearing and consideration of all relevant medical and scientific information, respecting the administration of such vaccines which shall include— (i) the circumstances under which any such vaccine should not be administered.
100 STAT. 3782 PUBLIC LAW 99-660—NOV. 14, 1986 (ii) the circumstances under which administration of any such vaccine should be delayed beyond its usual ^' time of administration, and -'- (iii) the groups, categories, or characteristics of poten- tial recipients of such vaccine who may be at signifi- cantly higher risk of major adverse reactions to such vaccine than the general population of poten- tial recipients. (2)(A) The Secretary shall request the Institute of Medicine of the National Academy of Sciences to conduct the study required by paragraph (1) under an arrangement by which the actual expenses incurred by such Academy in conducting such study will be paid by the Secretary. (B) If the Institute of Medicine is unwilling to conduct such study under such an arrangement, the Secretary shall enter into a similar arrangement with other appropriate nonprofit private groups or associations under which such groups or associations will conduct such study. (C) The Institute of Medicine or other group or association conducting the study required by paragraph (1) shall conduct such studies in consultation with the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Ante, p. 3771. Health Service Act. Federal (b) REVISION OF GUIDELINES.—The Secretary shall periodically, but Register, at least every 3 years after establishing guidelines under subsection publication. (a), review and revise such guidelines after notice and opportunity for public hearing and consideration of all relevant medical and scientific information, unless the Secretary finds that on the basis of all relevant information no revision of such guidelines is warranted and publishes such finding in the Federal Register. (c) FACTORS AFFECTING GUIDELINES.—Guidelines under subsection (a) shall take into account— (1) the risk to potential recipients of the vaccines with respect to which the guidelines are established, (2) the medical and other characteristics of such potential recipients, and (3) the risks to the public of not having such vaccines administered. Physicians. (d) DISSEMINATION.—The Secretary shall widely disseminate the Hospitals. guidelines established under subsection (a) to— Nurses. State and local (1) physicians and other health care providers, ••-• - * governments. (2) professional health associations, ;>. ) (3) State and local governments and agencies, and (4) other relevant entities. 42 u s e 300aa-l SEC. 314. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTION- note. ARY INFORMATION. Not later than 1 year after the effective date of this title and after consultation with the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act and with other appropriate entities, the Secretary of Health and Human Services shall review the warnings, use instructions, and precaution- ary information presently issued by manufacturers of vaccines set forth in the Vaccine Injury Table set out in section 2114 of the Ante, p. 3764. Public Health Service Act and shall by rule determine whether such warnings, instructions, and information adequately warn health care providers of the nature and extent of dangers posed by such
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3783 vaccines. If the Secretary determines that any such warning, instruction, or information is inadequate for such purpose in any respect, the Secretary shall at the same time require the manufac- turers to revise and reissue such warning, instruction, or informa- tion as expeditiously as practical, but not later than 18 months after the effective date of this title. SEC. 315. RECALL AUTHORITY. , "" Subsection (d) of section 351 of the Public Health Service Act (42 U.S.C. 262) is amended— Ante, p. 3751. (1) by inserting "(1)" after "(d)", and (2) by adding at the end thereof the following new paragraph: "(2XA) Upon a determination that a batch, lot, or other quantity of a product licensed under this section presents an imminent or substantial hazard to the public health, the Secretary shall issue an order immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this paragraph shall be issued in accordance with section 554 of title 5, United States Code. '' "(B) Any violation of subparagraph (A) shall subject the violator to Law a civil penalty of up to $100,000 per day of violation. The amount of enforcement and a civil penalty under this subparagraph shall, effective December 1 crime. of each year beginning 1 year after the effective date of this subparagraph, be increased by the percent change in the Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base quarter of the preceding year, adjusted to the nearest Vio of 1 percent. For purposes of this subparagraph, the term 'base quarter*, as used with respect to a year, means the calendar quarter ending on September 30 of such year and the price index for a base quarter is the arithmetical mean of such index for the 3 months comprising such quarter.". SEC. 316. STUDY OF IMPACT ON SUPPLY OF VACCINES. 42 u s e 300aa-4 note. On June 30, 1987, and on June 30 of each second year thereafter, the Secretary of Health and Human Services shall submit to the Committee on Energy and CJommerce of the House of Representa- tives and the Committee on Labor and Human Resources of the Senate— (1) an assessment of the impact of the amendments made by this title on the supply of vaccines listed in the Vaccine Injury Table imder section 2114 of the Public Health Service Act, and Ante, p. 3764. (2) an assessment of the ability of the administrators of vaccines (including public clinics and private administrators) to provide such vaccines to children. PART B—MISCELLANEOUS SEC. 321. WAIVER OF PAPERWORK REDUCTION. 44 u s e 3501 et Chapter 35 of title 44, United States Code, shall not apply to seq.u s e 300aa-l information required for purposes of carrying out this title and 42 note. implementing the amendments made by this title. SEC. 322. NONSEVERABILITY. 42 u s e 300aa-l note. If any provision of this title or the application of any provision of this title to any person or circumstance is held invalid by reason of a violation of the Constitution, the entire title shall be considered invalid.
100 STAT. 3784 PUBLIC LAW 99-660—NOV. 14, 1986 42 u s e 300aa-l SEC. 323. E F F E m V E DATE, note. (a) GENERAL RULE.—Subtitle 1 of title XXI of the Public Health Ante, p. 3756. Service Act shall take effect on the date of the enactment of this Act Ante, p. 3758. and Subtitle 2 of such title and this title shall take effect on the effective date of a tax enacted after the date of the enactment of this Act to provide funds for compensation paid under such subtitle 2. Claims. (b) INSUFFICIENCY OF FUNDS,—If at any time there are insufficient funds to pay all of the claims payable under subtitle 2 of title XXI of the Public Health Service Act for 180 days, such subtitle shall cease to be in effect until sufficient funds to pay all of the claims under such subtitle become available. Health Care Quality TITLE IV—ENCOURAGING GOOD FAITH Improvement Act of 1986. PROFESSIONAL REVIEW ACTIVITIES 42 u s e 11101 SEC. 401. SHORT TITLE. note. This title may be cited as the "Health Care Quality Improvement Act of 1986". 42 u s e 11101. SEC. 402. FINDINGS. . ^ ^ _ . . \^ The Congress finds the following: '' (1) The increasing occurrence of medical malpractice and the t need to improve the quality of medical care have become nation- £ wide problems that warrant greater efforts than those that can be undertaken by any individual State. (2) There is a national need to restrict the ability of incom- ~ petent physicians to move from State to State without disclo- sure or discovery of the physician's previous damaging or incompetent performguice. (3) This nationwide problem can be remedied through effec- tive professional peer review. (4) The threat of private money damage liability under Fed- eral laws, including treble damage liability under Federal 3 antitrust law, unreasonably discourages physicians from partici- pating in effective professional peer review. 'i (5) There is an overriding national need to provide incentive and protection for physicians engaging in effective professional » peer review. PART A—PROMOTION OF PROFESSIONAL REVIEW ACTIVITIES 42 u s e 11111. SEC. 411. PROFESSIONAL REVIEW. -^ ' State and local (a) I N GENERAL.— governments. (1) LIMITATION ON DAMAGES FOR PROFESSIONAL REVIEW ACTIONS.—If a professional review action (as defined in section 431(9)) of a professional review body meets all the standards specified in section 412(a), except as provided in subsection (b)— .,^ ,^. .,. (A) the professional review body, (B) any person acting as a member or staff to the body, ' .- n-.'r (C) any person under a contract or other formal agree- f ment with the body, and ?^ (D) any person who participates with or assists the body with respect to the action.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3785 shall not be liable in damages under any law of the United States or of any State (or political subdivision thereof) with respect to the action. The preceding sentence shall not apply to damages under any law of the United States or any State S.{3J3ff{*I relating to the civil rights of any person or persons, including the Civil Rights Act of 1964, 42 U.S.C. 2000e, et seq. and the Civil Rights Acts, 42 U.S.C. 1981, et seq. Nothing in this para- graph shall prevent the United States or any Attorney General of a State from bringing an action, including an action under section 4C of the Clayton Act, 15 U.S.C. 15C, where such an action is otherwise authorized. (2) PROTECTION FOR THOSE PROVIDING INFORMATION TO PROFES- Phsrsicians. SIONAL REVIEW BODIES.—Notwithstanding any other provision of law, no person (whether as a witness or otherwise) providing information to a professional review body regarding the com- petence or professional conduct of a physician shall be held, by reason of having provided such information, to be liable in damages under any law of the United States or of any State (or political subdivision thereof) unless such information is false and the person providing it knew that such information was false. (b) EXCEPTION.—If the Secretary has reason to believe that a health care entity has failed to report information in accordance with section 423(a), the Secretary shall conduct an investigation. If, Federal after providing notice of noncompliance, an opportunity to correct Register, the noncompliance, and an opportunity for a hearing, the Secretary publication. determines that a health care entity has failed substantially to report information in accordance with section 423(a), the Secretary shall publish the name of the entity in the Federal Register. The protections of subsection (aXD shall not apply to an entity the name of which is published in the Federal Register under the previous sentence with respect to professional review actions of the entity commenced during the 3-year period beginning 30 days after the date of publication of the name. (c) TREATMENT UNDER STATE LAWS.— (1) PROFESSIONAL REVIEW ACTIONS TAKEN ON OR AFTER OCTO- BER 14, 1989.—Except as provided in paragraph (2), subsection (a) shall apply to State laws in a State only for professional 1^!. review actions commenced on or after October 14,1989. (2) EXCEPTIONS.— »fl (A) STATE EARLY OPT-IN.—Subsection (a) shall apply to State laws in a State for actions commenced 91,1 before October 14, 1989, if the State by legislation elects such treatment. (B) STATE OPT-OUT.—Subsection (a) shall not apply to State laws in a State for actions commenced on or after October 14, 1989, if the State by legislation elects such treatment. (C) EFFECTIVE DATE O F ELECTION.—An election u n d e r S t a t e law is n o t effective, for purposes of s u b p a r a g r a p h s (A) a n d (B), for actions commenced before t h e effective d a t e of IT, the State law, which may not be earlier than the date of the enactment of that law. SEC. 412. STANDARDS FOR PROFESSIONAL REVIEW ACTIONS. 42 u s e 11112. (a) I N GENERAL.—For purposes of the protection set forth in section 411(a), a professional review action must be taken—
100 STAT. 3786 PUBLIC LAW 99-660—NOV. 14, 1986 (1) in the reasonable belief that the action was in the further- ance of quality health care, (2) after a reasonable effort to obtain the facts of the matter, Physicians. (3) after adequate notice and hearing procedures are afforded to the physician involved or after such other procedures as are fair to the physician under the circumstances, and (4) in the reasonable belief that the action was warranted by the facts known after such reasonable effort to obtain facts and after meeting the requirement of paragraph (3). A professional review action shall be presumed to have met the preceding standards necessary for the protection set out in section " 411(a) unless the presumption is rebutted by a preponderance of the evidence. Physicians. (b) ADEQUATE NoTiCE AND HEARING.—A health care entity is deemed to have met the adequate notice and hearing requirement of subsection (aX3) with respect to a physician if the following condi- tions are met (or are waived voluntarily by the physician): (1) NOTICE OF PROPOSED ACTION.—The physician has been given notice stating— (AXi) that a professional review action has been proposed to be taken against the physician, (ii) reasons for the proposed action, (BXi) that the physician has the right to request a hearing on the proposed action, (ii) any time limit (of not less than 30 days) within which to request such a hearing, and (C) a summary of the rights in the hearing under para- graph (3). (2) NOTICE OF HEARING.—If a hearing is requested on a timely basis under paragraph (IXB), the physician involved must be given notice stating— (A) the place, time, and date, of the hearing, which date shall not be less than 30 days after the date of the notice, and (B) a list of the witnesses (if any) expected to testify at the hearing on behalf of the professional review body. (3) CONDUCT OF HEARING AND NOTICE.—If a hearing is requested on a timely basis under paragraph (IXB)— (A) subject to subparagraph (B), the hearing shall be held (as determined by the health care entity)— (i) before an arbitrator mutually acceptable to the physician and the health care entity, (ii) before a hearing officer who is appointed by the entity and who is not in direct economic competition ^'' ' with the physician involved, or ;3»' (iii) before a panel of individuals who are appointed ihu' by the entity and are not in direct economic competi- tion with the physician involved; (B) the right to the hearing may be forfeited if the physician fails, without good cause, to appear; (C) in the hearing the physician involved has the right— f (i) to representation by an attorney or other person of the physician's choice. Records. ^, (ii) to have a record made of the proceedings, copies * *^ of which may be obtained by the physician upon pay- ru dJ'?? ment of any reasonable charges associated with the preparation thereof^ ., « ..,,.;.«-
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3787 . (iii) to call, examine, and cross-examine witnesses, (iv) to present evidence determined to be relevant by the hearing officer, regardless of its admissibility in a court of law, and (v) to submit a written statement at the close of the hearing; and (D) upon completion of the hearing, the physician involved has the right— (i) to receive the written recommendation of the arbitrator, officer, or panel, including a statement of the basis for the recommendations, and (ii) to receive a written decision of the health care entity, including a statement of the basis for the decision. A professional review body's failure to meet the conditions described in this subsection shall not, in itself, constitute failure to meet the standards of subsection (a)(3). (c) ADEQUATE PROCEDURES IN INVESTIGATIONS OR HEALTH EMER- GENCIES.—For purposes of section 411(a), nothing in this section shall be construed as— (1) requiring the procedures referred to in subsection (a)(3)— (A) where there is no adverse professional review action taken, or ,.,. (B) in the case of a suspension or restriction of clinical privileges, for a period of not longer than 14 days, during which an investigation is being conducted to determine the ' need for a professional review action; or (2) precluding an immediate suspension or restriction of clini- cal privileges, subject to subsequent notice and hearing or other adequate procedures, where the failure to take such an action may result in an imminent danger to the health of any individual. SEC. 413. PAYMENT OF REASONABLE ATTORNEYS' FEES AND COSTS IN 42 u s e 11113. DEFENSE OF SUIT. In any suit brought against a defendant, to the extent that a Courts, U.S. defendant has met the standards set forth under section 412(a) and the defendant substantially prevails, the court shall, at the conclu- sion of the action, award to a substantially prevailing party defend- ing against any such claim the cost of the suit attributable to such claim, including a reasonable attorney's fee, if the claim, or the claimant's conduct during the litigation of the claim, was frivolous, unreasonable, without foundation, or in bad faith. For the purposes of this section, a defendant shall not be considered to have substan- tially prevailed when the plaintiff obtains an award for damages or permanent injunctive or declaratory relief. SEC. 414. GUIDELINES OF THE SECRETARY. 42 u s e 11114. The Secretary may establish, after notice and opportunity for comment, such voluntary guidelines as may assist the professional review bodies in meeting the standards described in section 412(a). SEC. 415. CONSTRUCTION. 42 u s e 11115. (a) IN GENERAL.—Except as specifically provided in this part, nothing in this part shall be construed as changing the liabilities or immunities under law.
100 STAT. 3788 PUBLIC LAW 99-660—NOV. 14, 1986 Physicians. fl>) SCOPE OF CLINICAL PRIVILEGES.—Nothing in this part shall be Nurses. construed as requiring health care entities to provide clinical privi- leges to any or all classes or types of physicians or other licensed health care practitioners. State and local (c) TREATMENT OF NURSES AND OTHER PRACTITIONERS.—Nothing in governments. this part shall be construed as affecting, or modifying any provision of Federal or State law, with respect to activities of professional review bodies regarding nurses, other licensed health care practitioners, or other health professionals who are not physicians. State and local (d) TREATMENT OF PATIENT MALPRACTICE CLAIMS.—Nothing in this governments. title shall be construed as affecting in any manner the rights and Physicians. remedies afforded patients under any provision of Federal or State Hospitals. law to seek redress for any harm or injury suffered as a result of negligent treatment or care by any ph)^ician, health care practi- tioner, or health care entity, or as limiting any defenses or immuni- ties available to any physician, health care practitioner, or health care entity. 42 u s e 11111 SEC. 416. EFFECTIVE DATE. '•""'^w^ ^^ ^rrAiitM-.- ru note. This part shall apply to professional review actions commenced on or after the date of the enactment of this Act. Claims. PART B—REPORTING OF INFORMATION Physicians. Nurses. SEC. 421. REQUIRING REPORTS ON MEDICAL MALPRACTICE PAYMENTS. Hospitals. 42 u s e 11131. (a) IN GENERAL.—Each entity (including an insurance company) Insurance. which makes pa}anent under a policy of insurance, self-insurance, or Reports. otherwise in settlement (or partial settlement) of, or in satisfaction of a judgment in, a medical malpractice action or claim shall report, in accordance with section 424, information respecting the pa3anent and circumstances thereof. (b) INFORMATION T O B E REPORTED.—The information to be reported under subsection (a) includes— (1) the name of any physician or licensed health care practi- tioner for whose benefit the pajonent is made^ (2) the amoimt of the payment, (3) the name (if known) of any hospital with which the physician or practitioner is affiliated or associated, (4) a description of the acts or omissions and injuries or illnesses upon which the action or claim was based, and (5) such other information as the Secretary determines is required for appropriate interpretation of information reported under this section. (c) SANCTIONS FOR FAILURE TO REPORT.—Any entity that fails to report information on a payment required to be reported under this section shall be subject to a civil money penalty of not more than $10,000 for each such payment involved. Such penalty shall be imposed and collected in the same manner as civil money penalties Ante. p. 2003. under subsection (a) of section 1128A of the Social Security Act are imposed and collected under that section. (d) REPORT ON TREATMENT OF SMALL PAYMENTS.—The Secretary shall study and report to CJongress, not later than two years after .&ilH 2I> the date of the enactment of this Act, on whether information respecting small payments should continue to be required to be reported under subsection (a) and whether information respecting all claims made concerning a medical malpractice action should be required to be reported under such subsection.
PUBLIC LAW 99-660—NOV. 14,1986 100 STAT. 3789 SEC. 422. REPORTING OF SANCTIONS TAKEN BY BOARDS OF MEDICAL 42 u s e 11132. EXAMINERS. (a) IN GENERAL.— (1) ACTIONS SUBJECT TO REPORTING.—Each Board of Medical Examiners— (A) which revokes or suspends (or otherwise restricts) a ' physician's license or censures, reprimands, or places on probation a physician, for reasons relating to the physi- cian's professional competence or professional conduct, or (B) to which a physician's license is surrendered, shall report, in accordance with section 424, the information described in paragraph (2). (2) INFORMATION TO BE REPORTED.—The information to be reported under paragraph (1) is— i-^...w_ (A) the name of the physician involved, (B) a description of the acts or omissions or other reasons (if known) for the revocation, suspension, or surrender of license, and (C) such other information respecting the circumstances of the action or surrender as the Secretary deems appropriate. (b) FAILURE TO REPORT.—If, after notice of noncompliance and providing opportunity to correct noncompliance, the Secretary determines that a Board of Medical Examiners has failed to report information in accordance with subsection (a), the Secretary shall designate another qualified entity for the reporting of information under section 423. SEC. 423. REPORTING OF CERTAIN PROFESSIONAL REVIEW ACTIONS 42 USC11133. TAKEN BY HEALTH CARE ENTITIES. (a) REPORTING BY HEALTH CARE ENTITIES.— (1) O N PHYSICIANS.—Each health care entity which— (A) takes a professional review action that adversely i . affects the clinical privileges of a physician for a period longer than 30 days; (B) accepts the surrender of clinical privileges of a physician— (i) while the physician is under an investigation by the entity relating to possible incompetence or improper professional conduct, or (ii) in return for not conducting such an investigation or proceeding; or (C) in the case of such an entity which is a professional r society, takes a professional review action which adversely fli affects the membership of a physician in the society, shall report to the Board of Medical Examiners, in accordance with section 424(a), the information described in paragraph (3). (2) PERMISSIVE REPORTING ON OTHER UCENSED HEALTH CARE PRACTITIONERS.—A health care entity may report to the Board of Medical Examiners, in accordance with section 424(a), the information described in paragraph (3) in the case of a licensed health care practitioner who is not a physician, if the entity would be required to report such information under paragraph (1) with respect to the practitioner if the practitioner were a physician. (3) INFORMATION TO BE REPORTED.—The information to be reported under this subsection is—
100 STAT. 3790 PUBLIC LAW 99-660—NOV. 14, 1986 • (A) the name of the physician or practitioner involved, (B) a description of the acts or omissions or other reasons for the action or, if known, for the surrender, and . , .K (C) such other information respecting the circumstances of the action or surrender as the Secretary deems appropriate. (b) REPORTING BY BOARD OF MEDICAL EXAMINERS.—Each Board of Medical Examiners shall report, in accordance with section 424, the information reported to it under subsection (a) and known instances of a health care entity's failure to report information under subsec- tion (aXD. (c) SANCTIONS.— t (1) HEALTH CARE ENTITIES.—A health care entity that fails substantially to meet the requirement of subsection (aXD shall lose the protections of section 411(aXl) if the Secretary publishes 3 the name of the entity under section 4110b). (2) BOARD OF MEDICAL EXAMINERS.—If, after notice of non- compliance and providing an opportunity to correct noncom- 6fc pliance, the Secretary determines that a Board of Medical g Examiners has failed to report information in accordance with subsection (b), the Secretary shall designate another qualified entity for the reporting of information under subsection (b). State and local (d) REFERENCES TO BOARD OF MEDICAL EXAMINERS.—Any reference governments. in this part to a Board of Medical Examiners includes, in the case of a Board in a State that fails to meet the reporting requirements of section 422(a) or subsection (b), a reference to such other qualified entity as the Secretary designates. .,„, , _ 42 u s e 11134. SEC. 424. FORM OF REPORTING. (a) TIMING AND FORM.—The information required to be reported under sections 421, 422(a), and 423 shall be reported regularly (but not less often than monthly) and in such form and manner as the Secretary prescribes. Such information shall first be required to be reported on a date (not later than one year after the date of the enactment of this Act) specified by the Secretary. Classified (b) To WHOM REPORTED.—The information required to be reported information. under sections 421, 422(a), and 423(b) shall be reported to the Secretary, or, in the Secretary's discretion, to an appropriate private or public agency which has made suitable arrangements with the Secretary with respect to receipt, storage, protection of confidential- ity, and dissemination of the information under this part. (c) REPORTING TO STATE LICENSING BOARDS.— (1) MALPRACTICE PAYMENTS.—Information required to be reported under section 421 shall also be reported to the appropriate State licensing board (or boards) in the State in s:: which the medical malpractice claim arose. *< (2) REPORTING TO OTHER LICENSING BOARDS.—Information required to be reported under section 423(b) shall also be re- ported to the appropriate State licensing board in the State in which the health care entity is located if it is not otherwise reported to such board under subsection (b). 42 u s e 11135. SEC. 425. DUTY OF HOSPITALS TO OBTAIN INFORMATION. (a) I N GENERAL.—It is the duty of each hospital to request from the Secretary (or the agency designated under section 424(b)), on and after the date information is first required to be reported under section 424(a))—
PUBLIC LAW 99-660-NOV. 14,1986 100 STAT. 3791 (1) at the time a physician or Ucensed health care practitioner applies to be on the medical staff (courtesy or otherwise) of, or for clinical privileges at, the hospital, information reported under this part concerning the physician or practitioner, and (2) once every 2 years information reported under this part concerning any physician or such practitioner who is on the medical staff (courtesy or otherwise) of, or has been granted clinical privileges at, the hospital. A hospital may request such information at other times. (b) FAILURE TO OBTAIN INFORMATION.—With respect to a medical malpractice action, a hospital which does not request information respecting a physician or practitioner as required under subsection (a) is presumed to have knowledge of any information reported under this part to the Secretary with respect to the physician or practitioner. (c) RELIANCE ON INFORMATION PROVIDED.—Each hospital may rely upon information provided to the hospital under this title and shall not be held liable for such reliance in the absence of the hospital's knowledge that the information provided was false. SEC. 426. DISCLOSURE AND CORRECTION OF INFORMATION. Regulations. 42 u s e 11136. With respect to the information reported to the Secretary (or the agency designated under section 424(b)) under this part respecting a physician or other licensed health care practitioner, the Secretary shall, by regulation, provide for— (1) disclosure of the information, upon request, to the physician or practitioner, and (2) procedures in the case of disputed accuracy of the information. SEC. 427. MISCELLANEOUS PROVISIONS. State and local governments. (a) PROVIDING LICENSING BOARDS AND OTHER HEALTH CARE ENTI- 42 u s e 11137. TIES WITH ACCESS TO INFORMATION.—The Secretary (or the agency Health designated under section 424(b)) shall, upon request, provide maintenance information reported under this part with respect to a physician or organizations. other licensed health care practitioner to State licensing boards, to hospitals, and to other health care entities (including health mainte- nance organizations) that have entered (or may be entering) into an employment or affiliation relationship with the physician or practi- tioner or to which the physician or practitioner has applied for clinical privileges or appointment to the medical staff. (b) CONFIDENTIALITY OF INFORMATION.— (1) I N GENERAL.—Information reported under this part is considered confidential and shall not be disclosed (other than to the physician or practitioner involved) except with respect to professional review activity, with respect to medical malpractice actions, or in accordance with regulations of the Secretary promulgated pursuant to subsection (a). Nothing in this subsec- tion shall prevent the disclosure of such information by a party which is otherwise authorized, under applicable State law, to make such disclosure. (2) PENALTY FOR VIOLATIONS.—Any person who violates para- graph (1) shall be subject to a civil money penalty of not more than $10,000 for each such violation involved. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1128A of the
100 STAT. 3792 PUBLIC LAW 99-660—NOV. 14, 1986 42 use Social Security Act are imposed and collected under that 1320a-7a. section. (3) USE OF INFORMATION.—Subject to paragraph (1), informa- tion provided under section 425 and subsection (a) is intended to be used solely with respect to activities in the furtherance of the quality of health care. (c) RELIEF FROM LIABILITY FOR REPORTING.—No person or entity shall be held liable in any civil action with respect to any report made under this part without knowledge of the falsity of the information contained in the report. (d) INTERPRETATION OF INFORMATION.—In interpreting information reported under this part, a payment in settlement of a medical malpractice action or claim shall not be construed as creating a presumption that medical malpractice has occurred. . .„ -q PART C—DEFINITIONS AND REPORTS 42 u s e 11151. SEC. 431. DEFINITIONS. 1 !'.yft !0* > ,. • jfj In this title: (1) The term "adversely affecting" includes reducing, restrict- rfvi• ^ ' ^ ing, suspending, revoking, denjdng, or feiiling to renew clinical privileges or membership in a health care entitjjr. (2) The term "Board of Medical Examiners' includes a body comparable to such a Board (as determined by the State) with responsibility for the licensing of physicians and also includes a subdivision of such a Board or bodv. (3) The term "clinical privileges' includes privileges, member- ship on the medical staff, and the other circumstances pertain- ing to the furnishing of medical care under which a physician or other licensed health care practitioner is permitted to furnish such care by a health care entity. (4XA) The term "health care entity" means— s'JiisnSklnJBm (i) a hospital that is licensied to provide health care services by the State in which it is located, (ii) an entity (including a health maintenance organiza- tion or group medical practice) that provides health care services and that follows a formal peer review process for the purpose of furthering quality health care (as deter- mined under regulations of the Secretary), and ^1! (jij) subject to subparagraph (B), a professional society (or committee thereof) of physicians or other licensed health care practitioners that follows a formal peer review process Si t*r««r £QJ. ^j^g purpose of furthering quality health care (as deter- mined under regulations of the Secretary). (B) The term "health care entity" does not include a profes- sional society (or committee thereof) if, within the previous 5 years, the society has been found by the Federal Trade C!ommis- sion or any court to have engaged in any anti-competitive practice which had the effect of restricting the practice of «-^' t licensed health care practitioners. (5) The term "hospital" means an entity described in para- 42 use I395x. graphs (1) and (7) of section 1861(e) of the Social Security Act. (6) The terms "licensed health care practitioner" and "practi- tioner" mean, with respect to a State, an individual (other than a physician) who is licensed or otherwise authorized by the c»ri J State to provide health care services.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3793 (7) The term "medical malpractice action or claim" means a i written claim or demand for payment based on a health care provider's furnishing (or failure to furnish) health care services, t- and includes the filing of a cause of action, based on the law of e tort, brought in any court of any State or the United States 3 seeking monetary damages. (8) The term "physician" means a doctor of medicine or osteopathy or a doctor of dental surgery or medical dentistry legally authorized to practice medicine and surgery or dentistry ' '• J 0 by a State (or any individual who, without authority holds ^i^ himself or herself out to be so authorized). (9) The term "professional review action" means an action or ?^ recommendation of a professional review body which is taken or made in the conduct of professional review activity, which is t, based on the competence or professional conduct of an individ- 0 ual physician (which conduct affects or could affect adversely yg ^ ^^>p^ 9 the health or welfare of a patient or patients), and which affects tv (or may affect) adversely the clinical privileges, or membership s in a professional society, of the physician. Such term includes a b formal decision of a professional review body not to take an ft action or make a recommendation described in the previous sentence and also includes professional review activities relat- j ing to a professional review action. In this title, an action is not ,^y,. r p. considered to be based on the competence or professional con- ,,- jdi ^ duct of a physician if the action is primarily based on— i^ (A) the physician's association, or lack of association, with f a professional society or association, f (B) the physician's fees or the physician's advertising or engaging in other competitive acts intended to solicit or retain business, , , -, .^ (C) the physician's participation in prepaid group health plans, salaried employment, or any other manner of deliv- ering health services whether on a fee-for-service or other basis, (D) a physician's association with, supervision of, delega- ,^, tion of authority to, support for, training of, or participation in a private group practice with, a member or members of a particular class of health care practitioner or professional, or (E) any other matter that does not relate to the com- petence or professional conduct of a physician. ^, iBim ^^^^ '^^ term "professional review activity" means an activ- ity of a health care entity with respect to an individual physician— (A) to determine whether the physician may have clinical •~hm privileges with respect to, or membership in, the entity, :()<; ,.-, ,-. |, Qfi* (B) to determine the scope or conditions of such privileges or membership, or (C) to change or modify such privileges or membership. (11) The term "professional review body" means a health care entity and the governing body or any committee of a health care entity which conducts professional review activity, and includes any committee of the medical staff of such an entity when assisting the governing body in a professional review activity. (12) The term "Secretary" means the Secretary of Health and Human Services.
100 STAT. 3794 PUBLIC LAW 99-660—NOV. 14, 1986 (13) The term "State" means the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. (14) The term "State licensing board" means, with respect to a t ' physician or health care provider in a State, the agency of the State which is primarily responsible for the licensing of the physician or provider to furnish health care services. 42 u s e 11152. SEC. 432. REPORTS AND MEMORANDA OF UNDERSTANDING. (a) ANNUAL REPORTS TO (I!ONGRESS.—The Secretary shall report to Congress, annually during the three years after the date of the enactment of this Act, on the implementation of this title. (b) MEMORANDA OF UNDERSTANDING.—The Secretary of Health and Human Services shall seek to enter into memoranda of under- standing with the Secretary of Defense and the Administrator of Ante, p. 3788. Veterans' Affairs to apply the provisions of part B of this title to hospitals and other facilities and health care providers under the jurisdiction of the Secretary or Administrator, respectively. The Secretary shall report to CJongress, not later than two years after the date of the enactment of this Act, on any such memoranda and on the cooperation among such officials in establishing such memoranda. Drugs and drug (c) MEMORANDUM OF UNDERSTANDING WITH D R U G ENFORCEMENT abuse. ADMINISTRATION.—The Secretary of Health and Human Services shall seek to enter into a memorandum of understanding with the ' Administrator of Drug Enforcement relating to providing for the reporting by the Administrator to the Secretary of information respecting physicians and other practitioners whose registration to dispense controlled substances has been suspended or revoked under 21 use 824. section 304 of the Controlled Substances Act. The Secretary shall report to Congress, not later than two years after the date of the enactment of this Act, on any such memorandum and on the cooperation between the Secretary and the Administrator in establishing such a memorandum. State TITLE V—STATE COMPREHENSIVE eomprehensive Mental Health MENTAL HEALTH SERVICES PLANS Services Plan Act of 1986. 42 u s e 201 note. SEC. 501. SHORT TITLE. This title may be cited as the "State (Domprehensive Mental Health Services Plan Act of 1986". SEC. 502. STATE COMPREHENSIVE MENTAL HEALTH SERVICES PLAN. 42 u s e 300x. Part B of title XIX of the Public Health Service Act is amended— (1) by inserting before the heading for section 1911 the following: "SUBPART 1—BLOCK GRANT"; and (2) by adding at the end thereof the following:
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3795 "SUBPART 2—STATE COMPREHENSIVE MENTAL HEALTH SERVICES PLAN DEVELOPMENT GRANTS "SEC. 1920B. (a) The Secretary shall make grants to States for the Regulations. development of State comprehensive mental health services plans 42 u s e 300X-10. which comply with section 1920C. In order to receive a grant under this section, a State shall submit an application to the Secretary. Such application shall be in such form, and shall contain such information, as the Secretary may by regulation prescribe. "(bXD Except as provided in paragraph (2), the amount of a grant to a State under this section for a fiscal year shall be the amount which bears the same ratio to the amount appropriated to carry out this section for such fiscal year as the population of the State bears to the total of the population of all States which submit applications under this section. "(2) Notwithstanding paragraph (1), the amount of a grant to any State under this section shall not be less than $150,000. "(c) To carry out this section, there are authorized to be appro- Appropriation priated $10,000,000 for each of the fiscal years 1988 and 1989. authorization. STATE C O M P R E H E N S I V E MENTAL HEALTH SERVICES PLANS "SEC. 1920C. (a) For each fiscal year, beginning with fiscal year 42 use 300x-ll. 1988, each State shall submit a State comprehensive mental health services plan (hereafter referred to in this subpart as the 'State plan') to the Secretary. "(b) A State plan shall, for the fiscal year for which the plan is submitted and each of the 2 succeeding fiscal years, meet the following requirements: "(1) The State plan shall provide for the establishment and of implementation of an organized community-based system of care for chronically mentally ill individuals. "(2) The State plan shall contain quantitative targets to be achieved in the implementation of such system, including num- bers of chronically mentally ill individual residing in the areas to be served under such system. "(3) The State plan shall describe services to be provided to chronically mentally ill individuals to enable such individuals to gain access to mental health services, including access to treatment, prevention, and rehabilitation services. "(4) The State plan shall describe rehabilitation services, employment services, housing services, medical and dental care, and other support services to be provided to chronically men- tally ill individuals in order to enable such individuals to func- tion outside of inpatient institutions to the maximum extent of their capabilities. "(5) TTie State plan shall provide for activities to reduce the rate of hospitalization of chronically mentally ill individuals. "(6) Except as provided in paragraph (7), the State plan shall require the provision of case management services to each chronically mentally ill individual in the State who receives substantisd amounts of public funds or services. For purposes of this paragraph, the term 'chronically mentally ill individual' means a chronically mentally ill individual as defined under State laws and regulations.
100 STAT. 3796 PUBLIC LAW 99-660—NOV. 14, 1986 "(7) The State plan may provide for the implementation of the requirements of paragraph (6) in a manner which— "(A) phases in, beginning in fiscal year 1989, the provi- sion to all chronically mentally ill individuals to which such paragraph applies the case management services required to be provided under such paragraph; and "(B) provides for the substantial completion of the phas- ing in of the provision of such services by the end of fiscal year 1992. Homeless "(g) The State plan shall provide for the establishment and P®"^**^' implementation of a program of outreach to, and services for, chronically mentally ill individuals who are homeless. "(c) In developing each State plan required under this section, the State shall consult with representatives of employees of State institutions and public and private nursing homes who care for chronically mentally ill individuals. "(d) The Secretary shall provide technical assistance to States in the development and implementation of State plans which comply with this section. Such technical assistance shall include the devel- opment and publication by the Secretary of model elements for State plans and model data systems for the collection of data concerning the implementation of State plans. "ENFORCEMENT - . 42 use 300X-12. "SEC. 1920D. (a) If the Secretary determines that a State has not, by the end of fiscal year 1989, developed the State plan required by section 1920C, the Secretary shall reduce the amount of the State's allotment under subpart 1 for fiscal year 1990 by the amount specified in subsection (d). "(b) If the Secretary determines that a State has not, by the end of fiscal year 1990, developed and substantially implemented the State plan required by section 1920C, the Secretary shall reduce the Ante, p. 3794. amount of the State's allotment under subpart 1 for fiscal year 1991 by the amount specified in subsection (d). "(c) If the Secretary determines that a State has not, by the end of fiscal year 1991, developed and completely implemented the State plan required by section 1920C, the Secretary shall reduce the amount of the State's allotment under subpart 1 for fiscal year 1992 and each succeeding fiscal year by the amount specified in subsec- tion (d). The Secretary shall discontinue the reduction under this subsection of a State's allotment under subpart 1 for a fiscal year if the Secretary determines that the State has, in the preceding fiscal year, developed and completely implemented the State plan required by section 1920C. "(d) The amount referred to in subsections (a), (b), and (c) with respect to a State is the total amount expended by the State for administrative expenses for fiscal year 1986 from amounts paid to the State under subpart 1 for such fiscal year. "(e) Notwithstanding any other provision of this subpart, the Secretary shall not require a State government, in carrying out a State plan submitted under this subpart, to expend an amount for mental health services for any fiscal year which exceeds the total amount that would have been expended for such services by such government for such fiscal year if such plan had not been implemented.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3797 MODEL STANDARDS FOR THE PROVISION OF CARE TO THE CHRONICALLY MENTALLY ILL "SEC. 1920E. (a) Within one year after the date of enactment of 42 USC 300x-13. this subpart, the Secretary shall develop and make available a model plan for a community-based system of care for chronically mentally ill individuals. Such plan shall be developed in consulta- tion with State mental health directors, providers of mental health services, chronically mentally ill individuals, advocates for such individuals, and other interested parties.". SEC. 503. STATE MENTAL HEALTH SERVICES PLANNING COUNCILS. Section 1916(f) of the Public Health Service Act is amended— 42 USC 300x-4. (1) by striking out "With amounts available under section 1915(a), the chief executive officer of the State may" and insert- 42 USC 300x-3. Z ing in lieu thereof "The chief executive officer of the State ^ shall"; and (2) by adding at the end thereof the following new sentence: "The State may use amounts available under section 1915(a) to establish and operate such a council.". SEC. 504. DEMONSTRATION PROJECTS FOR SERVICES FOR HOMELESS CHRONICALLY MENTALLY ILL INDIVIDUALS. (a) DEMONSTRATION PROJECTS.—Section 504(f)(1) of the Public Aged persons. Health Service Act is amended by striking out "and elderly individ- 42 USC 290aa-3. uals" and inserting in lieu thereof "elderly individuals, and home- less chronically mentally ill individuals". (b) AUTHORIZATION.—Section 504(f)(3) of such Act is amended by striking out "1985, 1986, and 1987" and inserting in lieu thereof "1985 and 1986, and $24,000,000 for fiscal year 1988^. (c) ADMINISTRATIVE EXPENSES.—Section 504(f) of such Act is fur- ther amended by adding at the end thereof the following new paragraph: "(4)(A) Not more than 25 percent of the total amount of a grant for Grants fiscal year 1988 made to a State under this subsection for a project for services for chronically mentally ill adults (other than a project for services for elderly individuals or a project for services for homeless chronically mentally ill individuals) may be used by the State for administrative expenses in carrying out such grant in such fiscal year. "(B) Not more than 25 percent of the total amount of any grant made to a State under this subsection for services to chronically mentally ill adults for any fiscal year (beginning with fiscal year 1989) may be used by the State for administrative expenses in carrying out such grant in such fiscal year.". TITLE VI—GERIATRIC TRAINING SEC. 601. ESTABLISHMENT OF TRAINING PROGRAM. (a) Section 788 of the Public Health Service Act is amended— 42 USC 295g-8. (1) by redesignating subsections (e), (f), and (g) as subsections (f), (g), and (h), respectively; and (2) by inserting after subsection (d) the following new subsection: "(e)(1) The Secretary may make grants to, and enter into contracts GrEints. with, schools of medicine, schools of osteopathy, teaching hospitals, Contracts. Schools and colleges. Education. Physicians. Dentists.
100 STAT. 3798 PUBLIC LAW 99-660—NOV. 14, 1986 and graduate medical education programs, for the purpose of provid- ing support for geriatric medicine training projects to train physi- cians and dentists who plan to teach geriatric medicine or geriatric ^ ;i dentistry. "(2) Each project for which a grant or contract is made under this subsection shall— "(A) be staffed by full-time teaching physicians who have experience or training in geriatric medicine; "(B) be staffed by full-time or part-time teaching dentists who have experience or training in geriatric dentistry; "(C) be based in a graduate medical education program in internal medicine or family medicine; '- "(D) provide participgmts in the project with exposure to a diversified population of elderly individuals; "(E) provide training in geriatrics and exposure to the phys- ' ical and mental disabilities of elderly individuals through a variety of service rotations, such as geriatric consultation serv- ices, acute care services, dental services, geriatric psychiatry units, day and home care programs, rehabilitation services, extended care facilities, geriatric ambulatory care and com- : prehensive evaluation units, and community care programs for elderly mentally retarded individuals; and "(F) provide training in geriatrics through one or both of the n tredning options described in subparagraphs (A) and (B) of paragraph (3). "(3) The training options referred to in subparagraph (F) of para- graph (2) are as follows: "(A) A one-year retraining program in geriatrics for— "(i) physicians who are faculty members in departments of internal medicine, family medicine, g3mecology, and psychiatry at schools of medicine and osteopathy; and "(ii) dentists who are faculty members at schools of den- tistry or at hospital departments of dentistry. Fellowships. "(B) A one-year or two-year internal medicine or family medi- cine fellowship program providing emphasis in geriatrics, which shall be designed to provide training in clinical geriatrics and geriatrics research for— "(i) physicians who have completed graduate medical education programs in intemgd medicine, family medicine, psychiatry, neurology, gynecology, or rehabilitation medi- cine; and "(ii) dentists who have completed post-doctoral dental education programs. "(4) For purposes of this subsection— "(A) the term 'graduate medical education program' means a program sponsored by a school of medicine, a school of osteop- athy, a hospital, or a public or private institution, which— "(i) offers postgraduate medical training in the specialties and subspecialties of medicine; and "(ii) has been accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association through its Committee on Postdoctoral Train- ing; and "(B) the term 'post-doctoral dental education program', means a program sponsored by a school of dentistry, a hospital, or a public or private institution, which—
PUBLIC LAW 99-660—NOV. 14,1986 100 STAT. 3799 H- "(i) offers post-doctoral training in the specialties of den- tistry, advanced education in general dentistry, or a dental general practice residency; and fs "(ii) has been accredited by the Commission on Dental A.ccT*Gdit3.tion (b) Section 788(d)(1)(b) of such Act is amended by inserting "(other 42 USC 295g-8. than training and retraining of faculty for schools of medicine and osteopathy) before the semicolon. (c) Section 788(h) of such Act (as redesignated by subsection (a)(1) of this section) is amended— (1) by striking out "$8,000,000" the third place it appears in the first sentence and inserting in lieu thereof "$12,000,000"; (2) by striking out "each of the fiscal years" in paragraph (2) and inserting in lieu thereof "the fiscal year"; (3) by inserting "25 percent of such amount for the fiscal year il ff ending" before "September 30, 1988" in paragraph (2); and (4) by adding at the end thereof the following: "One-third of the amounts appropriated to carry out this section for fiscal year 1988 shall be available to carry out subsection (e) for such fiscal year.". TITLE VII—HEALTH PLANNING SEC. 701. REPEAL OF TITLE XV. a (a) REPEAL.—Title XV of the Public Health Service Act is repealed Effective date, effective January 1,1987. 42 USC 300k-l et Qo) FUNDS.—The repeal made by subsection (a) shall not affect any H^usc 300k-i funds obligated for the purposes of title XV of the Public Health note. Service Act before January 1,1987. .-,;i TITLE VIII—HEALTH MAINTENANCE Health Maintenance ORGANIZATIONS Organization Amendments of 1986. SEC. SOL SHORT TITLE, This title may be cited as the 'Health Maintenance Organization 42 USC 201 note. Amendments of 1986". SEC. 802. REFERENCE. Whenever in this title an amendment or repeal is expressed in terms of an amendment to, or a repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Public Health Service Act. 42 USC 201 note. SEC. 803. ELIMINATION OF AUTHORIZATION OF SUPPORT FOR FEASIBIL- ITY SURVEYS, PLANNING, AND INITIAL DEVELOPMENT COSTS. (a) Sections 1303, 1304, and 1307(c) (42 U.S.C. 300e-2, 300e-3, and 300e-6(c)) are repealed. (b)(1) Section 1306 (42 U.S.C. 300e-5) is amended— Loans. (A) by striking out "grant, contract, loan," each place it appears (except in subsection (b)(6)) and inserting in lieu thereof "loan", (B) by striking out "in the case of an application for assistance under section 1303 or 1304, such application meets the applica-
100 STAT. 3800 PUBLIC LAW 99-660—NOV. 14, 1986 tion requirements of such section and in the case of an applica- tion for a loan or loan guarantee," in subsection (bXD, (C) by striking out "1304," in subsection (bX2), and (D) by striking out "grants, contracts, loans," in subsection (c) and inserting in lieu thereof "loans". Loans. (2) Section 1307 (42 U.S.C. 300e-6) is amended— (A) by striking out "grant, contract, loan," each place it appears and inserting in lieu thereof "loan", (E) by striking out "grant, contract, or" in subsection (aXD, and (C) by striking out "such assistance" in subsection (aXD and inserting in lieu thereof "the loan". (3) Section 1309(a) (42 U.S.C. 300e-8(a)) is amended— (A) by striking out paragraph (1), and - (B) by striking out "(2)". (4) The first sentence of section 1317(b) (42 U.S.C. 300e-16(b)) is amended— (A) by striking out clause (1), and (B) by redesignating clauses (2) and (3) as clauses (1) and (2), respectively. Grants. (c) The amendments made by this section do not apply to £iny Contracts. grant made or contract entered into under title XIII of the Public 42 u s e 300e-5 note. Health Service Act before October 1,1985. 42 u s e 300e SEC. 804. LIMITATION ON LOANS AND LOAN GUARANTEES FOR INITIAL et seq. COSTS OF OPERATION. Grants. (a) The last sentence of section 1305(a) (42 U.S.C. 300e-4(a)) is Contracts. amended by inserting before the period ", and unless the Secretary has made a grant or loan to, entered into a contract with, or guaranteed a loan for, the organization in fiscal year 1981, 1982, Ante, p. 3799. 1983,1984, or 1985 under this section or section 1304(b) (as in effect before October 1,1985)". 42 u s e 300e-4 (b) The amendment made by subsection (a) does not apply to any note. loan or loan guarantee for the initial costs of operation of a health maintenance organization made under title XIII of the Public Health Service Act before October 1,1985. SEC. 805. ELIMINATION OF LOANS AND LOAN GUARANTEES FOR ACQUISITION AND CONSTRUCTION OF AMBULATORY CARE FACILITIES. (a) Section 1305A (42 U.S.C. 300e-4a) is repealed, tt)) Section lS06(bX2) (42 U.S.C. 300e-5(bX2)) is amended by strik- ing out "or 1305A,". 42 u s e 300e-5 (c) The amendments made by this section do not apply to any loan note. or loan guarantee made under section 1305A of the Public Health Service Act before October 1,1985. SEC. 806. REPEAL OF REQUIREMENT FOR HEALTH SYSTEMS AGENCY REVIEW. Section 13060)) (42 U.S.C. 3006-50))) is amended by striking out paragraph (5) and by redesignating paragraphs (6), (7), and (8) as paragraphs (5), (6), and (7), respectively. SEC. 807. LIMITATION ON BORROWING BY LOAN GUARANTEE FUND. The first sentence of section 1308(dX2) (42 U.S.C. 300e-7(dX2)) is amended b^ inserting "before October 1, 1986," after "guarantees issued by hun".
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3801 SEC. 808. REPEAL OF REQUIREMENT FOR PERIODIC DEMONSTRATION OF COMPLIANCE. Section 1310(d) (42 U.S.C. 300e-9(d)) is amended by striking out the last sentence. SEC. 809. ANNUAL UPDATE OF STATE LAW DIGEST. The first sentence of section 1311(c) (42 U.S.C. 300e-10(c)) is amended by striking out "quarterly" and inserting in lieu thereof "annually". SEC. 810. ELIMINATION OF UNNECESSARY REPORT. Section 1318(e) (42 U.S.C. 300e-17(e)) is repealed. SEC. 811. AUTHORIZATION OF APPROPRIATIONS. Section 1309(b) (42 U.S.C. 300e-80t))) is amended to read as follows: Loans. "(b) To meet the obligations of the loan fund established under section 1308(e) resulting from defaults on loans made from the fund and to meet the other obligations of the fund, there is authorized to be appropriated to the loan fund for fiscal years 1987, 1988, and 1989, such sums as may be necessary.". SEC. 812. ORGAN TRANSPLANTS AS PART OF BASIC COVERAGE. (a) Section 1302(1) (42 U.S.C. 300e-l(l)) is amended bv inserting before the last sentence the following new sentence: ' Such term ^ includes a health service directly associated with an organ trans- plant only if such organ transplant was required to be included in basic health services on April 15,1985.". (bXD The amendment made by subsection (a) shall take effect on Effective date. October 1, 1985, and shall cease to be in effect on April 1, 1988. Termination (2) After April 1, 1988, for purposes of title XIII of the Public date. 42 u s e 300e-l Health Service Act, no health service directly associated with an note. organ transplant shall be considered to be a basic health service if 42 u s e 300e such service would otherwise have been added as a basic health et seq. service between April 15,1985, and April 1,1988. SEC. 813. STUDY ON THE HEALTH MAINTENANCE ORGANIZATION PROGRAM. (a) The Secretary of Health and Human Services shall provide for 42 USC 300e the conduct of a study to assess the operation and impact of the note. provisions of title XIII of the Public Health Service Act. The study shall— (1) assess the attitudes of employers and employees toward x prepaid health benefits plans, particularly health msdntenance organization plans; (2) examine the operation of the community rating approach |,r and the impact of such approach on the membership composi- tion and competitiveness of health maintenance organizations ^;i^ qualified under such title; '° ^ (3) analyze the effects of the dual choice option provided in section 1310 of such Act on health maintenance organizations 42 USC 300e-9. and on other health benefits plans; jbi. (4) assess the approach used to add services no longer consid- ; ered to be experimental to basic health services for health maintenance organizations qualified under such title, particu- larly with respect to the addition of organ transplants to such basic health services and the impact of such addition on the competitiveness of such health maintenance organizations; and
100 STAT. 3802 PUBLIC LAW 99-660—NOV. 14, 1986 (5) examine the effect of minimum benefit requirements, underwriting restrictions, restrictions on cost sharing, and the requirement that services be provided without limitation as to time or cost on the competitiveness of health maintenance organizations qualified under such title. Reports. (b) Within 18 months after the date of enactment of this Act, the Secretary shall prepare and transmit to the Congress a report which describes the findings and conclusions of the study conducted under subsection (a) and contains such recommendations for legislative and regulatory action as the Secretary considers appropriate, Contracts. (c) Any contract entered into under this section shall be to such extent or in such amounts as are provided in appropriation Acts. 42 u s e 300e-l. SEC. 814. SERVICES OF PSYCHOLOGISTS. (a) Paragraphs (1) and (2) of section 1302 of the Public Health Service Act are amended by inserting "psychologist," after "podia- trist," each place it appears. (b) Paragraph (4) of such section is amended by striking out "and podiatrists" and inserting in lieu thereof "podiatrists, and psychologists". (c) Paragraph (5) of such section is amended by inserting "psychol- ogy," after "optometry,". 42 u s e 300e-l SEC. 815. EFFECTIVE DATE. note. (a) Except as provided in subsection 0?) and section 812(b), this title and the amendments made by this title shall take effect on October 1,1985. (b) Section 813 shall take effect on the date of enactment of this Act. 42 u s e 300e-l SEC. 816. CONSTRUCTION. note. The provisions of this title and of the amendments made by this title do not authorize the appropriation of any funds for fiscal year 1986. Alzheimer's TITLE IX—ALZHEIMER'S DISEASE AND Disease and Related RELATED DEMENTIAS SERVICES Dementias Services RESEARCH Research Act of 1986. * .. PART A—GENERAL PROVISIONS SHORT TITLE 42 u s e 11201 SEC. 901. This title may be cited as the "Alzheimer's Disease and note. Related Dementias Services Research Act of 1986". ..^-I-^ ,-..v,r •^.:J,. , , FINDINGS 42 use 11201. SEC. 902. The Congress finds that— (1) best estimates indicate that between 2,000,000 and 3,000,000 Americans presently have Alzheimer's disease or related dementias; (2) estimates of the number of individuals afflicted with Alz- heimer's disease and related dementias are unreliable because current diagnostic procedures lack accuracy and sensitivity and because there is a need for epidemiological data on incidence and prevalence of such disease and dementias;
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3803 (3) studies estimate that between one-half and two-thirds of patients in nursing homes meet the clinical and mental status criteria for dementia; (4) the care for individuals with Alzheimer's disease and related dementias falls primarily on their families, and such care is very often financially and emotionally devastating; (5) the cost of caring for individuals with Alzheimer's disease and related dementias is great, and conservative estimates range between $38,000,000,000 and $42,000,000,000 per year solely for direct costs; (6) although substantial progress has been made in recent years in identifying possible leads to the causes of Alzheimer's disease and related dementias and more progress can be expected in the near future, there is little likelihood of a breakthrough in the foreseeable future which would eliminate or substantially reduce the number of individuals with such disease and dementias or the difficulties of caring for such individuals; (7) attempts to reduce the emotional and financial burden of caring for dementia patients is impeded by a lack of knowledge about such patients, how to care for such patients, the costs associated with such care, the effectiveness of various modes of care, the quality and t)rpe of care necessary at various stages of the disease, and other appropriate services that are needed to provide quality care; (8) the results of the little research that has been undertaken concerning dementia has been inadequate or the results have not been widely disseminated; (9) more knowledge is needed concerning— (A) the epidemiology of, and the identification of risk factors for, Alzheimer's disease and related dementias; (B) the development of methods for early diagnosis, func- tional assessment, and psychological evaluation of individ- uals with Alzheimer's disease for the purpose of monitoring the course of the disease and developing strategies for improving the quality of life for such individuals; (C) the understanding of the optimal range and cost- effectiveness of community and institutional services for individuals with Alzheimer's disease and related dementias and their families, particularly with respect to the design, delivery, staffing, and mix of such services and the coordination of such services with other services, and with respect to the relationship of formal to informal support services; (D) the understanding of optimal methods to combine formal support services provided by health care profes- sionals with informal support services provided by family, friends, and neighbors of individuals with Alzheimer's dis- ease, and the identification of ways family caregivers can be sustained through interventions to reduce psychological and social problems and physical problems induced by stress; (E) existing data that are relevant to Alzheimer's disease and related dementias; and '.-. : (F) the costs incurred in caring for individuals with Alz- heimer's disease and related dementias;
100 STAT. 3804 PUBLIC LAW 99-660—NOV. 14, 1986 (10) it is imperative to provide appropriate coordination of the efforts of the Federal Government in the provision of services for individuals with Alzheimer's disease and related dementias; (11) it is important to increase the understanding of Alz- heimer's disease and related dementias by the diverse range of personnel involved in the care of individuals with such disease and dementias; and (12) it is imperative that the Social Security Administration be provided information pertaining to Alzheimer's disease and related dementias, particularly for personnel in such Adminis- tration involved in the establishment and updating of criteria for determining whether an individual is under a disability for 42 u s e 401 et purposes of titles II and XVI of the Social Security Act. seq., 1381 et seq. PART B—COUNCIL ON ALZHEIMER'S DISEASE - ESTABLISHMENT 42 use 11211. SEC. 911. (a) There is established in the Department of Health and Human Services (hereinafter referred to as the "Department") the Council on Alzheimer's Disease (hereinafter referred to as the "Council"). The Council shall be composed of— (1) the Assistant Secretary for Health; (2) the Surgeon General of the United States; (3) the Assistant Secretary for Planning and Evaluation; ;» . (4) the Director of the National Institute of Allergy and a Infectious Diseases; (5) the Director of the National Institute of Mental Health; (6) the Director of the National Institute of Neurological and ;, Communicative Diseases and Stroke; (7) the Director of the National Institute on Aging; •> "" (8) the Commissioner on Aging; ; (9) the Administrator of the Health Care Financing Adminis- a tration (or the designee of such Administrator); • (10) the Director of the National Center for Health Services Research and Health Care Technology Assessment; (11) the Administrator of Veterans' Affairs (or the designee of t such Administrator); and (12) such additional members as the Secretary of Health and Human Services (hereinafter referred to as the "Secretary") considers appropriate. (b) The Secretary shall select a Chairman for the Council from among its members. (c) A majority of the members of the Council shall constitute a quorum, but a lesser number may hold hearings. (d) The Council shall meet periodically at the call of the Chair- man, but not less than twice each year. (e) The Secretary shall appoint an Executive Secretary for the Council and shall provide the Council with such additional adminis- trative staff and support as may be necessary to enable the Council to carry out its functions. FUNCTIONS 42 use 11212. SEC. 912. (a) The Council shall— (1) coordinate continuing research conducted by or through the Department on Alzheimer's disease and related dementias;
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3805 (2) establish a mechanism for the sharing of information Aged persons. among all officers and employees of the Department involved in carrying out programs serving elderly individuals; (3) identify the most promising areas of research concerning Alzheimer's disease and related dementias; (4) establish mechanisms to use the results of research Aged persons. concerning Alzheimer's disease and related dementias in the development of policies, programs, and means to improve the quality of life for older Americans; and (5) assist the National Institute on Aging, the National Institute of Mental Health, and the National Center for Health Services Research and Health Care Technology Assessment in developing and coordinating the plans for research required under part E, and in making revisions in such plans. Post, p. 3808. (b)(1) Not later than 9 months after the date of enactment of this Reports. Act, the Council shall transmit to the Congress and make available to the public a report detailing the plans for research prepared by the National Institute on Aging, the National Institute of Mental Health, and the National Center for Health Services Research and Health Care Technology Assessment under part E. Such report shall— (A) describe, insofar as feasible, the activities to be carried out under such part during each of the fiscal years 1987, 1988, 1989, 1990, and 1991; and (B) ensure that activities carried out under such part are Aged persons. coordinated with, and use, to the maximum extent feasible, the resources of, other Federal programs relating to Alzheimer's disease and related dementias, including centers supported under section 445 of the Public Health Service Act, centers 42 u s e 289h. supported by the National Institute of Mental Health on the psychopathology of the elderly, relevant activities of the Administration on Aging, other centers supported by Federal funds involved in research on Alzheimer's disease and related dementias, and other programs relating to Alzheimer's disease and related dementias which are planned or conducted by Federal agencies other than the Department, State or local agencies, community organizations, or private foundations. (2) Within 1 year after the date on which the report required by Reports. paragraph (1) is transmitted to the Congress, and annually there- Public after, the Council shall transmit to the Congress, and make avail- information. able to the public, a report on— (A) the revisions made by the National Institute on Aging, the ?' National Institute of Mental Health, and the National Center for Health Services Research and Health Care Technology Assessment in the plans for research required by part E; (B) progress made by research sponsored by the Federal 3 Government on Alzheimer's disease and related dementias; and (C) new directions in research on Alzheimer's disease and related dementias which the Council considers potentially important.
100 STAT. 3806 PUBLIC LAW 99-660—NOV. 14, 1986 .V. , 3.4.. PART C—ADVISORY P A N E L ON ALZHEIMER'S DISEASE ESTABUSHMENT OF PANEL 42 use 11221. SEC. 921. (a) There is established in the Department the Advisory Panel on Alzheimer's Disease (hereinafter referred to as the 'Panel'). The Panel shall be composed of— (1) 15 voting members appointed by the Director of the Office of Technology Assessment, of which— (A) 3 shall be individuals who are biomedical research scientists with demonstrated achievements in biomedical research relating to Alzheimer's disease, including at least one individual who is a researcher at a center supported 42 use 289h. under section 445 of the Public Health Service Act; (B) 3 shall be individuals with demonstrated achieve- ments in research relevant to services for the care of individuals with Alzheimer's disease and related dementias; (C) 3 shall be individuals who are providers of services, or 5 administrators of organizations which provide services, for individuals with Alzheimer's disease and related dementias and their families; (D) 3 shall be individuals who are experts in the financing of health care services and long-term care services, includ- ing one individual who is a representative of private health care services insurers; and -. ' • (E) 3 shall be representatives of national voluntary organizations which are concerned with the problems of individuals with Alzheimer's disease and related dementias and their families; and ,•( s,,^ (2) the Chairman of the Council, the Director of the National Institute on Aging, the Director of the National Institute of Mental Health, the Director of the National Center for Health ? Services Research and Health Care Technology Assessment, and the Commissioner on Aging, who shall be nonvoting ex officio members, flt)) The Director of the Office of Technology Assessment shall appoint members to the Panel under subsection (aXD within 90 days after the date of enactment of this Act. (c) The Secretary shall appoint a Chairman of the Panel from among the members appointed under subsection (aXl). ,. c. (d) Members of the Panel shall serve for the life of the Panel. A vacancy on the Panel shall be filled in the same manner as the originsd appointment was made. A vacancy on the Panel shall not affect its powers. (e) A majority of the members of the Panel appointed under subsection (aXl) shall constitute a quorum, but a lesser number may hold hearings. The Panel may establish such subcommittees as the Panel considers appropriate. (f) The Panel shall meet at the call of the Chairman, but not less than twice per year. (g) The Executive Secretary of the Council shall serve as Execu- tive Secretary of the Panel. The Secretary shall provide the Panel with such additional administrative staff and support as may be necessary to enable the Panel to carry out its functions. (h) Each member of the Panel appointed under subsection (aXD shall receive compensation at a rate of $100 per day for each day, including travel time, that such member is engaged in duties as a
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3807 member of the Panel. While away from their homes or regular places of business in the performance of duties as a member of the Panel, members of the Panel appointed under subsection (a)(1) shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for employees of agencies under section 5702 of title 5, United States Code. FUNCTIONS OF THE PANEL SEC. 922. (a) The Panel shall assist the Secretary and the Council 42 USC 11222. in the identification of priorities and emerging issues with respect to Alzheimer's disease and related dementias and the care of individ- uals with such disease and dementias. The Panel shall advise the Secretary and the Council with respect to the identification of— (1) emerging issues in, and promising areas of, biomedical research relating to Alzheimer's disease and related dementias; (2) emerging issues in, and promising areas of, research relat- ing to services for individuals with Alzheimer's disease and related dementias and their families; (3) emerging issues and promising initiatives in home and community based services, and systems of such services, for individuals with Alzheimer's disease and related dementias and their families; and (4) emerging issues in, and innovative financing mechanisms for, payment for health care services and social services for individuals with Alzheimer's disease and related dementias and their families, particularly financing mechanisms in the private sector. (b) The Panel shall prepare and transmit to the Congress, the Reports. Secretary, and the Council, and make available to the public, an Public information. annual report. Such report shall contain such recommendations as the Panel considers appropriate for administrative and legislative actions to improve services for individuals with Alzheimer's disease and related dementias and their families and to provide for promis- ing biomedical research relating to Alzheimer's disease and related dementias. AUTHORIZATION OF APPROPRIATIONS SEC. 923. To carry out this part, there are authorized to be 42 USC 11223. appropriated $100,000 for each of the fiscal years 1988 through 1991. PART D—AWARDS FOR LEADERSHIP AND EXCELLENCE IN ALZHEIMER'S DISEASE AND RELATED DEMENTIAS AWARDS AUTHORIZED SEC. 931. (a) The Director of the National Institute on Aging shall Research and make awards to senior researchers who have made distinguished development. achievements in biomedical research in areas relating to Alz- 42 USC 11231. heimer's disease and related dementias. Awards under this section shall be used by the recipients to support research in areas relating to such disease and dementias, and may be used by the recipients to train junior researchers who demonstrate exceptional promise to conduct research in such areas. (b) The Director of the National Institute on Aging may make awards under this section to researchers at centers supported under
100 STAT. 3808 PUBLIC LAW 99-660—NOV. 14, 1986 42 use 289h. section 445 of the Public Health Service Act and to researchers at other public and nonprofit private entities. (c) The Director of the National Institute on Aging shall make awards under this section only to researchers who have been rec- ommended for such awards by the National Advisory Council on Aging. (d) The Director of the National Institute on Aging shall establish procedures for the selection of the recipients of awards under this IIVI ,; i section. (e) Awards under this section shall be made for a one-year period, and may be renewed for not more than six additional consecutive one-year periods. AUTHORIZATION OF APPROPRIATIONS Research and SEC. 932. To carry out this part, there are authorized to be development. appropriated $5,000,000 for each of the fiscal years 1988 through 42 u s e 11232. 1991. Amounts authorized to be appropriated under this section are in addition to amounts authorized to be appropriated for biomedical research relating to Alzheimer's disease and related dementias under part E of this title and under other provisions of law. PART E—RESEARCH RELATING TO SERVICES FOR INDIVIDUALS WITH ALZHEIMER'S DISEASE AND RELATED DEMENTIAS AND THEIR FAMILIES SUBPART 1—RESPONSIBILITIES OF THE NATIONAL INSTITUTE ON AGING RESEARCH PROGRAM AND PLAN Grants. SEC. 941. (a) The Director of the National Institute on Aging shall 42 u s e 11241. conduct, or make grants for the conduct of, research relevant to appropriate services for individuals with Alzheimer's disease and related dementias and their families. (b)il) Within 6 months after the date of enactment of this Act, the Director of the National Institute on Aging shall prepare and transmit to the Chairman of the Council a plan for the research to be conducted under subsection (a). The plan shall— (A) provide for research concerning— (i) the epidemiology of, and the identification of risk factors for, Alzheimer's disease and related dementias; and (ii) the development and evaluation of reliable and valid i:, multidimensional diagnostic and assessment procedures and instruments; and (B) ensure that research carried out under the plan is coordi- nated with, and uses, to the maximum extent feasible, resources of, other Federal programs relating to Alzheimer's disease and related dementias, including centers supported under section 445 of the Public Health Service Act, centers supported by the National Institute of Mental Health on the psychopathology of the elderly, relevant activities of the Administration on Aging, other programs and centers involved in research on Alzheimer's disease and related dementias supported by the Department, and other programs relating to Alzheimer's disease and related dementias which are planned or conducted by Federal agencies other than the Department, State or local agencies, community organizations, or private foundations.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3809 (2) Within one year after transmitting the plan required under paragraph (1), and annually thereafter, the Director of the National Institute on Aging shall prepare and transmit to the Chairman of the Council such revisions of such plan as the Director considers appropriate. (c) In preparing and revising the plan required by subsection (b), the Director of the National Institute on Aging shall consult with the Chairman of the Council and the heads of agencies within the Department. DISSEMINATION SEC. 942. The Director of the National Institute on Aging shall Research and disseminate the results of research conducted under this subpart to development 42 u s e 11242. appropriate professional entities and to the public. AUTHORIZATION OF APPROPRIATIONS SEC. 943. To carry out this subpart, there are authorized to be 42 use 11243. appropriated $2,000,000 for each of fiscal years 1988 through 1991. Subpart 2—Responsibilities of the National Institute of Mental Health RESEARCH PROGRAM AND PLAN SEC. 944. (a) The Director of the National Institute of Mental Grants. Health shall conduct, or make grants for the conduct of, research 42 u s e 11251. relevant to appropriate services for individuals with Alzheimer's disease and related dementias and their families. (b)(1) Within 6 months after the date of enactment of this Act, the Director of the National Institute of Mental Health shall prepare and transmit to the Chairman of the Council a plan for the research to be conducted under subsection (a). The plan shall— (A) provide for research concerning— (i) mental health services and treatment modalities rel- evant to the mental, behavioral, and psychological prob- lems associated with Alzheimer's disease and related dementias; (ii) the most effective methods for providing comprehen- sive multidimensional assessments to obtain information ji, ™ about the current functioning of, and needs for the care of, individuals with Alzheimer's dise£ise and related dementias; (iii) the optimal range and cost-effectiveness of commu- nity and institutional services for individuals with Alz- heimer's diseeise and related dementias and their families, particularly with respect to the design of such services, appropriate staffing for the provision of such services, the timing of such services during the progression of such disease or dementias, and the appropriate mix and coordination of such services; (iv) the efficacy of various special care units in the United States for individuals with Alzheimer's disease, including an gissessment of the costs incurred in operating such units, appropriate standards to be used by such units, and the measurement of patient outcomes in such units; (v) methods to combine formal support services provided by health care professionals for individuals with Alz-
100 STAT. 3810 PUBLIC LAW 99-660—NOV. 14, 1986 heimer's disease and related dementias with informal sup- port services provided for such individuals by their families, friends, and neighbors, including services such as day care services, respite care services, home care services, and nurs- ing home services, and an evaluation of the services actu- ally used for such individuals and the sources of payment for such services; (vi) methods to sustain family members who provide care for individuals with Alzheimer's disease and related demen- tias through interventions to reduce psychological and social problems and physical problems induced by stress; and c (vii) improved methods to deliver services for individuals with Alzheimer's disease and related dementias and their families, including services such as outreach services, com- prehensive assessment and care management services, out- . - patient treatment services, home care services, respite care services, adult day care services, partial hospitalization services, and nursing home services; and (B) ensure that research carried out under the plan is coordi- nated with, and uses, to the maximum extent feasible, resources of, other Federal programs relating to Alzheimer's disease and dementia, including centers supported under section 445 of the 42 use 289h. Public Health Service Act, centers supported by the National Institute of Mental Health on the psychopathology of the - elderly, relevant activities of the Administration on Aging, other programs and centers involved in research on Alzheimer's disease and related dementias supported by the Department, and other programs relating to Alzheimer's diseeise and related dementias which are planned or conducted by Federal agencies other than the Department, State or local agencies, community organizations, or private foundations. (2) Within one year after transmitting the plan required under paragraph (1), and annually thereafter, the Director of the National Institute of Mental Health shall prepare and transmit to the Chair- man of the Council such revisions of such plan as the Director considers appropriate. (c) In preparing and revising the plan required by subsection 0)), the Director of the National Institute of Mental Health shall consult with the Chairman of the Council and the heads of agencies within the Department. DISSEMINATION Research and SEC. 945. The Director of the National Institute of Mental Health 4p\®Tap?foco shall disseminate the results of research conducted under this sub- part to appropriate professional entities and to the public. ' AtJTHORIZATION OF APPROPRIATIONS 42 use 11253. SEC. 946. To carry out this subpart, there are authorized to be appropriated $2,000,000 for each of fiscal years 1988 through 1991.
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3811 Subpart 3—Responsibilities of the National Center for Health Services Research and Health Care Technology Assessment RESEARCH PROGRAM AND PLAN SEC. 947. (a) The Director of the National Center for Health Grants. Services Research and Hesdth Care Technology Assessment shall ^2 USC 11261. conduct, or make grants for the conduct of, research relevant to appropriate services for individuals with Alzheimer's disease and related dementias and their families. (bXD Within 6 months £ifter the date of enactment of this Act, the Director of the National Center for Health Services Research and Health Care Technology Assessment shall prepare and transmit to the Chairman of the Council a plan for the research to be conducted under subsection (a). The plan shall— (A) provide for the inventory and analysis of existing data and studies relevant to Alzheimer's disease and related dementias, including data and studies available through the Health Care Financing Administration, the Administration on Aging, the National Center for Health Statistics, the Office of Human Development Services, the Office of the Assistant Secretary for Planning and Evaluation, and the Veterans' Administration; (B) provide for research concerning the costs incurred by individuals with Alzheimer's disease and related dementias in obtaining services, particularly services which are essential to such inchviduals and which are not needed by other patients under long-term care; (C) provide for research on the costs of various interventions to provide services for individuals with Alzheimer's disease and related dementias and their families; (D) provide for research on the cost-effectiveness of various service interventions for individuals with Alzheimer's disease and related dementias and their families; and (E) ensure that research carried out under the plan is coordi- nated with, and uses, to the maximum extent feasible, resources of, other Federal programs relating to Alzheimer's disease and dementia, including centers supported under section 445 of the Public Health Service Act, centers supported by the National 42 USC 289h. Institute of Mental Health on psychopathology of the elderly, relevant activities of the Administration on Aging, other pro- grams and centers involved in research on Alzheimer's disease and related dementias supported by the Department, and other programs relating to Alzheimer's disease and related dementias which are planned or conducted by Federal agencies other than the Department, State or local agencies, community organiza- tions, or private foundations. (2) Within one year after transmitting the plan required under paragraph (1), and annually thereafter, the Director of the National Center for Health Services Research and Health Care Technology Assessment shall prepare and transmit to the Chairman of the Council such revisions of such plan as the Director considers appropriate. (c) In preparing and revising the plsm required by subsection (b), the Director of the National Center for Health Services Research and Health Care Technology Assessment shsdl consult with the Chairman of the Council and the heads of agencies within the Department.
100 STAT. 3812 PUBLIC LAW 99-660—NOV. 14, 1986 DISSEMINATION Research and SEC. 948. The Director of the National Center for Health Services development. Research and Health Care Technology Assessment shall dissemi- 42 u s e 11262. nate the results of research conducted under this subpart to appro- priate professional entities and to the public. AUTHORIZATION OF APPROPRIATIONS 42 use 11263. SEC. 949. To carry out this subpart, there are authorized to be appropriated $2,000,000 for each of fiscal years 1988 through 1991. Subpart 4—Responsibilities of the Health Care Financing Administration i RESEARCH PROGRAM AND PLAN Grants. SEC. 949A. (a) The Administrator of the National Health Care 42 u s e 11271. Financing Administration shall conduct, or make grants for the conduct of, research relevant to appropriate services for individuals with Alzheimer's disease and related dementias and their families. (b)(1) Within 6 months after the date of enactment of this Act, the Administrator of the Health Care Financing Administration shall prepare and transmit to the Chairman of the Council a plan for research to be conducted under (a). The plan shall— (A) provide for a determination of the types of services required by individuals with Alzheimer's disease and related dementias and their families to allow such individuals to remain living at home or in a community-based setting; (B) provide for a determination of the costs of providing needed services to individuals with Alzheimer's disease and related dementias and their families, including the expendi- tures for institutional, home, and community-based services and the source of payment for such expenditures; (C) provide for an assessment of the adequacy of benefits provided through the Medicare and Medicaid programs and through private health insurance for needed services for individuals with Alzheimer's disease and related dementias and their families; and (D) provide for a determination of the costs to the Medicare and Medicaid programs and to private health insurers (if avail- able) of providing covered benefits to individuals with Alz- heimer's disease and related dementias and their families. (2) Within one year after transmitting the plan required under paragraph (1), and annually thereafter, the Administrator of the Health Care Financing Administration shall prepare and transmit to the Chairman of the Council such revisions of such plan as the Administrator considers appropriate. (c) In preparing and revising the plan required by subsection (b), the Administrator of the Health Care Financing Administration shall consult with the Chairman of the Council and the heads of agencies within the Department. DISSEMINATION 42 use 11272. SEC. 949B. The Administrator of the Health Care Financing Administration shall disseminate the results of research conducted
PUBLIC LAW 99-660—NOV. 14, 1986 100 STAT. 3813 under this subpart to appropriate professional entities and to the pubUc. AUTHORIZATIONS OF APPROPRIATIONS SEC. 949C. To carry out this subpart, there are authorized to be 42 u s e 11273. appropriated $2,000,000 for each of fiscal years 1988 through 1991. PART F—DISSEMINATION CLEARINGHOUSE ON ALZHEIMER S DISEASE SEC. 951. (a) The Director of the National Institute on Aging shall 42 u s e 11281. establish the Clearinghouse on Alzheimer's Disease (hereinafter referred to as the "Clearinghouse"). The purpose of the Clearing- house is the dissemination of information concerning services avail- able for individuals with Alzheimer's disease and related dementias and their families. The Clearinghouse shall— (1) compile, archive, and disseminate information concerning Research and research, demonstration, evaluation, and training programs and development. projects concerning Alzheimer's disease and related dementias; and (2) annually publish a summary of the information compiled Research and under paragraph (1) during the preceding 12-month period, and development. Education. make such information available upon request to appropriate individuals and entities, including educational institutions, research entities, and Federal and public agencies. Ot>) The Clearinghouse may charge an appropriate fee for informa- eommunications tion provided through the toll-free telephone line established under and tele- communications. subsection (aX3). (c) The Director of the National Institute on Aging, the Director of the National Institute of Mental Health, £uid the Director of the National Center for Health Services Research and Health Care Technology Assessment shall provide to the Clearinghouse sum- maries of the findings of research conducted under part E. Ante, p. 3808. DISSEMINATION PROJECT SEC. 952. (a) The Director of the National Institute on Aging shall Grants. make a grant to, or enter into a contract with, a national organiza- Contracts. tion representing individuals with Alzheimer's disease and related 42 u s e 11282. dementias for the conduct of the activities described in subsection (b). OJ) The oi^anization receiving a grant or contract under this section shall— (1) establish a central computerized information system to— Science and (A) compile and disseminate information concerning ini- technology. State and local tiatives by State and local governments and private entities governments. to provide programs and services for individuals with Alz- heimer's disesise and related dementias; and (B) translate scientific and technical information concern- ing such initiatives into information readily understand- able by the general public, and make such information available upon request; and (2) establish a national toll-free telephone line to make avail- eommunications able the information described in paragraph (1), and informa- and tele- tion concerning Federal programs, services, and benefits for communications.
100 STAT. 3814 PUBLIC LAW 99-660—NOV. 14, 1986 individuals with Alzheimer's disease and related dementias and their families. (c) The organization receiving a grant or contract under this section may charge appropriate fees for information provided ;' : through the toll-free telephone line established under subsection (b)(2), and may make exceptions to such fees for individuals and organizations who are not financially able to pay such fees. (d) In order to receive a grant or contract under this section, an organization shall submit an application to the Director of the National Institute on Aging. Such application shall contain— (1) information demonstrating that such organization has a network of contacts which will enable such organization to receive information necessary to the operation of the central computerized information system described in subsection (b)(1); (2) information demonstrating that, by the end of fiscal year 1991, such organization will be financially able to, and will, carry out the activities described in subsection (b) without a grant or contract from the Federal Government; and (3) such other information as the Director may prescribe. AUTHORIZATION OF APPROPRIATIONS 42 use 11283. SEC. 953. To carry out this part, there are authorized to be appropriated $300,000 for each of the fiscal years 1988 through 1991. PART G—EDUCATIONAL ACTIVITIES PROVIDING INFORMATION FOR PERSONNEL OF THE SOCIAL SECURITY ADMINISTRATION 42 u s e 11291. SEC. 961. (a) The Secretary shall develop a mechanism to ensure the prompt provision of the most current information concerning Alzheimer's disease and related dementias to the Commissioner of Social Security, particularly information which will increase the understanding of personnel of the Social Security Administration concerning such disease and dementias. (b) The Commissioner of Social Security shall ensure that informa- tion received under subsection (a) is provided to personnel of the Social Security Administration, particularly personnel involved in the process of determining, for purposes of titles II and XVI of the 42 u s e 401 et Social Security Act, whether an individual is under a disability. seq, 1381 et seq. EDUCATION PROGRAMS FOR PROVIDERS OF CARE FOR INDIVIDUALS WITH ALZHEIMER'S DISEASE Physicians. SEC. 962. The Director of the National Institute on Aging, through Nurses. centers supported under section 445 of the Public Health Service Psychologists. Social workers. Act, professional associations, and continuing education programs, Therapists. shall conduct education and information dissemination activities 42 u s e 11292. concerning the special problems of individuals with Alzheimer's 42 u s e 289h. disease and their families. Such activities shall be designed to enhance the understanding of such problems by individuals who provide care for individuals with Alzheimer's disease and related dementias, including physicians, nurses, psychologists, social work- ers, occupational therapists, nursing home administrators, nurses, and health care aides. i; ^ t '; ^3i«t0 ' ' r
PUBLIC LAW 99-660-NOV. 14, 1986 100 STAT. 3815 EDUCATION PROGRAMS FOR SAFETY AND TRANSPORTATION PERSONNEL SEC. 963. The Director of the National Institute on Aging, through 42 USC 11293. centers supported under section 445 of the Public Health Service Act, training academies, and continuing education programs, shall 42 USC 289h. conduct education and information dissemination activities concern- ing Alzheimer's disease and related dementias for personnel in- volved in ensuring the public safety and providing public transpor- tation. Such activities shall be designed to enhance the ability of such personnel to respond appropriately to individuals with Alz- heimer's disease and related dementias whom such personnel may encounter in the course of their employment. ^ " AUTHORIZATION OF APPROPRIATIONS SEC. 964. To carry out this part, there are authorized to be 42 use 11294. appropriated $1,000,000 for each of the fiscal years 1988 through 1991. Approved November 14, 1986. y^i >i.:. ••.-/ ^% .•-•«, t,J . , •, >i J'i' LEGISLATIVE HISTORY—S. 1744: SENATE REPORTS: No. 99-380 (Comm. on Labor and Human Resources). CONGRESSIONAL RECORD, Vol. 132 (1986): Aug. 12, considered and passed Senate. Oct. 17, considered and passed House, amended. Oct. 18, Senate concurred in House amendment. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 22 (1986): Nov. 14, Presidential statement.