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 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 Program, 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 prosecuting 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 vaccinerelated injury or death for which such compensation was r-jit awarded. "(3) Payments of compensation shall be exempt from reduction 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 PLANS, AND BENEFIT PROVIDERS.—No policy of health insurance may

make payment of benefits under the policy secondary to the payment 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 secondary to the payment of compensation under the Program.

'•"•~^>-

" ''" " i

"LIMITATIONS OF ACTIONS

2116. (a) GENERAL RULE.—In the case of— 42 USC "(1) a vaccine set forth in the Vaccine Injury Table which is 300aa-l6. "^ administered before the effective date of this title, if a vaccinerelated injury or death occurred as a result of the administration 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 vaccinerelated injury occurred as a result of the administration of such "SEC.

^K.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/296

 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 compensation 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

42 USC

300aa-17.

Courts, U.S. Records. Claims.

....

•,.; -H'

"SEC. 2117. (a) GENERAL RULE.—

"(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. "(2) In any case in which it deems such action appropriate, a district court of the United States may, after entry of a final 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.

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license: Creative Commons - Attribution Share-Alike - https://creativecommons.org/licenses/by-sa/4.0/


text: Dictionary of National Biography, 1885-1900/Paterson, Daniel


text:
Page:United States Statutes at Large Volume 100 Part 5.djvu/297

 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 USC 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 USC 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 representation 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 officers or employees of the Federal Government shall serve as members of the Commission without compensation in addition to that received in their regular public employment. Members of the

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 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 USC 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 services of such consultants as may be necessary to assist the Commission in carrying out effectively its functions under this section. "(f) FUNCTIONS.—The Commission shall— "(1) advise the Secretary on the implementation of the Program, 3eu s* "(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 ProT gram research related to vaccine injuries which should be con* ducted to carry out this subtitle. IB

' '"^

42 USC 300aa-2l.

"PART B—ADDITIONAL REMEDIES "AUTHORITY TO BRING ACTIONS

"SEC. 2121. (a) ELECTION.—After the judgment of a district court of the United States under section 2111 on a petition filed for compensation 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,

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Page:United States Statutes at Large Volume 100 Part 5.djvu/299

 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

(b), (c), and (e) State law shall apply to a civil action brought for damages for a vaccine-related injury or death. "(b) UNAVOIDABLE ADVERSE SIDE EFFECTS; WARNINGS.—

"(1) No vaccine manufacturer shall be liable in a civil action associated with the administration of a vaccine after the effective 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 Act (including regulations issued under such provisions; 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(d)(2), or c)t fftfis "(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compli»aii. 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 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 prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this subtitle.
 * . for damages arising from a vaccine-related injury or death

State and local governments. Claims.

42 USC 300aa-22.

21 USC 301 note. 42 USC 262.

>8;

State and local governments.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/300

 100 STAT. 3774

PUBLIC LAW 99-660—NOV. 14, 1986 TRIAL

42 USC

300aa-23.

f* ••

f

'

^

-

-

-

•

•

'••

2123. (a) GENERAL RULE.—A civil action against a vaccine 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(a)(2) 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. "SEC.

"(d) PUNITIVE DAMAGES.—

Fraud.

21 USC 301 note. 42 USC 201 note.

42 USC 262. Safety.

Safety.

"(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. "(2) If in such an action the manufacturer shows that it complied, in all material respects, with all requirements under the Federal Food, Drug, and Cosmetic Act and the Public 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 proceeding for approval of the vaccine under section 351, "(B) intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or "(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 UNITED STATES

RECORDING AND REPORTING OF INFORMATION

42 USC 300aa-25.

2125. (a) GENERAL RULE.—Each health care provider who administers a vaccine set forth in the Vaccine Injury Table to any person shall record, or ensure that there is recorded, in such person'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 "SEC,

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Page:United States Statutes at Large Volume 100 Part 5.djvu/301

 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 regulation 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 soon as practicable after such date a notice of the reporting requirement, "(2) A report under paragraph (1) respecting a vaccine shall include the time periods after the administration of such vaccine within which vaccine-related illnesses, disabilities, injuries, or conditions, the symptoms and manifestations of such illnesses, 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 paragraph (1)(C) within 180 days of the effective date of this subtitle.

Federal Register, publication.

Regulations

"(c) RELEASE OF INFORMATION.—

"(1) Information which is in the possession of the Federal Government and State and local governments under this section 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 received the vaccine and of that person's legal representative and the medical records of such person relating to the administration 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 reported under this section shall be available to the public.

State and local governments.

Public information.

VACCINE INFORMATION

2126. (a) GENERAL RULE.—Not later than 1 year after the 42 USC effective date of this subtitle, the Secretary shall develop and 300aa-26. "SEC.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/302

 100 STAT. 3776

Federal Register' publication.

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 vaccine set forth in the Vaccine Injury Table. Such materials shall be published in the Federal Register and may be revised.
 * ?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 hearV 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 materials 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 lic /^3.i * ^ form on which reactions can be recorded to assist l ^ a l f "* '" 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 characteristics of potential recipients of the vaccine who may be at significantly 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 "(2) not later than 6 months after the date such materials are •j'ddt 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

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Page:United States Statutes at Large Volume 100 Part 5.djvu/303

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3777

of this section. Such materials or other information shall be provided prior to the administration of such vaccine. -IW'X"

.buB-^l.

MANDATE FOR SAFER CHILDHOOD VACCINES

2127. (a) GENERAL RULE.—In the administration of this 42 USC 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 1 g 3 "(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 surveillance, 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 pursuant to subsection (a) during the preceding 2-year period. "SEC.

MANUFACTURER RECORDKEEPING AND REPORTING

9fl3

2128. (a) GENERAL RULE.—Each vaccine manufacturer of a vaccine set forth in the Vaccine Injury Table or any other vaccine the administration of which is mandated by the law or regulations 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 reworking of each batch, lot, or other quantity of such vaccine, including the identification of any significant problems encountered 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 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 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 complete, and "(4) prepare, maintain, and upon request submit to the Secretary product distribution records for each such vaccine by batch, lot, or other quantity number. "SEC.

State and local governments.

42 USC

300aa-28.

,-*a Safety.

0811 S^.

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text: Dictionary of National Biography, 1885-1900/Paterson, Emma Anne


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Page:United States Statutes at Large Volume 100 Part 5.djvu/304

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3778 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 occurrence, 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, falsified, or concealed, and to the vaccine manufacturer for which such person is an agent, employee, or representative. Each act of destruction, 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 USC

300aa-31.

Courts, U.S.

"SEC. 2131. (a) GENERAL RULE.—Except as provided in subsection

(b), any person may commence in a district court of the United States a civil action on such person's own behalf against the Secretary 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. "(c) COSTS OF LITIGATION.—The court, in issuing any final order in any action under this section, may award costs of litigation (including reasonable attorney and expert witness fees) to any party, whenever the court determines such award is appropriate.

Regulations.

42 USC

300aa-32.

JUDICIAL R E VI E W

"SEC. 2132. A petition for review of a regulation under this subtitle may be filed in a court of appeals of the United States 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 USC 300aa-33.

"SEC. 2133. For purposes of this subtitle: "(1) The term 'health care provider' means any licensed health care professional, organization, or institution, whether public or private (including Federal, State, and local departments, 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 (includTi 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-

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Page:United States Statutes at Large Volume 100 Part 5.djvu/305

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3779

ered by that section. The term 'manufacture' means to manufacture, 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. "(6)(A) The term 'Advisory Commission on Childhood Vaccines' 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 USC 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

CONDITIONS.—Not later than 3 years after the effective date of this 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. The review under this subsection shall include notice and opportunity 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 after the effective date of this title, the Secretary shall make, and publish in the Federal Register, the following specific findings:

42 USC 300aa-l note.

Ante, p. 3771.

Federal Register, publication.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/306

 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 causation 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 causation 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 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.

Ante, p. 3764.

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 regulations 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. (d) REVIEW OF M M R VACCINES AND RELATED ILLNESSES AND CONDI-

ri^j6«R

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 public. Not later than 3 years after the effective date of this title, the Secretary shall make and publish in the Federal Register findings similar to those required by subsection (b) and shall, if appropriate, 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 Act for radiculoneuritis caused, contributed to, or significantly aggravated by vaccines containing rubella.

Federal Register, publication.

Ante, p. 3758.

(e) PERTUSSIS AND MMR STUDIES.—

' (•••'-.

Ante, p. 3771.

I'il

(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 pertussis (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 pertussis and any other illnesses and conditions, as selected by the Secretary or the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act, and -;*- .I^J^M..,;,•:A;*,.-AJ-S^J fi?..: w; i'suitusi

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text: Dictionary of National Biography, 1885-1900/Paterson, James


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 PUBLIC LAW 99-660—NOV. 14, 1986 1

100 STAT. 3781

'

(C) the relationship between vaccines containing rubella (including MMR) and radiculoneuritis. (2)(A) 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 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. (3) Reports on the results of the studies required by paragraph (1) shall be completed and submitted to the Committee on 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 necessary for the purpose of making payments for the conduct 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, observations, 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.

Reports,

Ante, p. 3771. Reports. Public information.

Appropriation authorization.

SEC. 313. STUDY OF OTHER VACCINE RISKS. (a) STUDY.—

42 USC 300aa-l note.

(1) Not later than 3 years after the effective date of this title, 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.

�


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 100 STAT. 3782

Ante, p. 3771. Federal Register, publication.

Physicians. Hospitals. Nurses. State and local governments.

42 USC 300aa-l note.

Ante, p. 3764.

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 potential recipients of such vaccine who may be at significantly higher risk of major adverse reactions to such vaccine than the general population of potential 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 Health Service Act. (b) REVISION OF GUIDELINES.—The Secretary shall periodically, but at least every 3 years after establishing guidelines under subsection (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. (d) DISSEMINATION.—The Secretary shall widely disseminate the guidelines established under subsection (a) to— (1) physicians and other health care providers, ••-• - * (2) professional health associations, (3) State and local governments and agencies, and (4) other relevant entities. SEC. 314. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY 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 precautionary information presently issued by manufacturers of vaccines set forth in the Vaccine Injury Table set out in section 2114 of the 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

�


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 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 manufacturers to revise and reissue such warning, instruction, or information 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: "(2)(A) 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 USC 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 Commerce of the House of Representatives 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 under 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.

Chapter 35 of title 44, United States Code, shall not apply to information required for purposes of carrying out this title and implementing the amendments made by this title. SEC. 322. NONSEVERABILITY.

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.

44 USC 3501 et seq. 42 USC 300aa-l note. 42 USC 300aa-l note.

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 100 STAT. 3784 42 USC 300aa-l note. Ante, p. 3756. Ante, p. 3758.

Claims.

Health Care Quality Improvement Act of 1986. 42 USC 11101 note.

42 USC 11101.

PUBLIC LAW 99-660—NOV. 14, 1986

SEC. 323. E F F E m V E DATE,

(a) GENERAL RULE.—Subtitle 1 of title XXI of the Public Health Service Act shall take effect on the date of the enactment of this Act 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. (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.

TITLE IV—ENCOURAGING GOOD FAITH PROFESSIONAL REVIEW ACTIVITIES SEC. 401. SHORT TITLE.

This title may be cited as the "Health Care Quality Improvement Act of 1986". 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 disclosure or discovery of the physician's previous damaging or incompetent performguice. (3) This nationwide problem can be remedied through effective professional peer review. (4) The threat of private money damage liability under Federal laws, including treble damage liability under Federal 3 antitrust law, unreasonably discourages physicians from participating 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 USC 11111. State and local governments.

.,^,^..,.

SEC. 411. PROFESSIONAL REVIEW. (a) IN GENERAL.— (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 agreef ment with the body, and ? ^ (D) any person who participates with or assists the body with respect to the action.

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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 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 paragraph 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.

S.{3J3ff{*I

(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 competence 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, after providing notice of noncompliance, an opportunity to correct the noncompliance, and an opportunity for a hearing, the Secretary 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 (a)(1) 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.

Federal Register, publication.

(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

91,1

IT,

(A) STATE EARLY OPT-IN.—Subsection (a) shall apply to

State laws in a State for actions commenced 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 under State law is not effective, for purposes of subparagraph s (A) and (B), for actions commenced before the effective date of the State law, which may not be earlier than the date of the enactment of that law.

SEC. 412. STANDARDS FOR PROFESSIONAL REVIEW ACTIONS.

(a) IN GENERAL.—For purposes of the protection set forth in section 411(a), a professional review action must be taken—

42 USC 11112.

�


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 100 STAT. 3786

Physicians.

" Physicians.

PUBLIC LAW 99-660—NOV. 14, 1986

(1) in the reasonable belief that the action was in the furtherance of quality health care, (2) after a reasonable effort to obtain the facts of the matter, (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. (b) ADEQUATE NoTiCE AND HEARING.—A health care entity is deemed to have met the adequate notice and hearing requirement of subsection (a)(3) with respect to a physician if the following conditions are met (or are waived voluntarily by the physician): (1) NOTICE OF PROPOSED ACTION.—The physician has been given notice stating— (A)(i) that a professional review action has been proposed to be taken against the physician, (ii) reasons for the proposed action, (B)(i) 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 paragraph (3). (2) NOTICE OF HEARING.—If a hearing is requested on a timely basis under paragraph (I)(B), 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)

Records.

CONDUCT OF HEARING AND NOTICE.—If a

hearing

is

requested on a timely basis under paragraph (I)(B)— (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 (iii) before a panel of individuals who are appointed ihu' by the entity and are not in direct economic competition 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. ^, (ii) to have a record made of the proceedings, copies ^ of which may be obtained by the physician upon payru dJ'?? ment of any reasonable charges associated with the preparation thereof^., « ..,,.;.«-
 * 3»'

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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 clinical 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 DEFENSE OF SUIT.

42 USC 11113.

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 conclusion of the action, award to a substantially prevailing party defending 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 substantially prevailed when the plaintiff obtains an award for damages or permanent injunctive or declaratory relief. SEC. 414. GUIDELINES OF THE SECRETARY.

42 USC 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.

(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.

42 USC 11115.

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 100 STAT. 3788

PUBLIC LAW 99-660—NOV. 14, 1986

fl>) SCOPE OF CLINICAL PRIVILEGES.—Nothing in this part shall be construed as requiring health care entities to provide clinical privileges to any or all classes or types of physicians or other licensed health care practitioners.

Physicians. Nurses.

State and local governments.

State and local governments. Physicians. Hospitals.

42 USC 11111 note.

Claims. Physicians. Nurses. Hospitals. 42 USC 11131. Insurance. Reports.

(c) TREATMENT OF NURSES AND OTHER PRACTITIONERS.—Nothing in

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. (d) TREATMENT OF PATIENT MALPRACTICE CLAIMS.—Nothing in this title shall be construed as affecting in any manner the rights and remedies afforded patients under any provision of Federal or State law to seek redress for any harm or injury suffered as a result of negligent treatment or care by any ph)^ician, health care practitioner, or health care entity, or as limiting any defenses or immunities available to any physician, health care practitioner, or health care entity. SEC. 416. EFFECTIVE DATE.

'•""'^w ^^

^rrAiitM-.- ru

This part shall apply to professional review actions commenced on or after the date of the enactment of this Act. PART B—REPORTING OF INFORMATION SEC. 421. REQUIRING REPORTS ON MEDICAL MALPRACTICE PAYMENTS.

(a) IN GENERAL.—Each entity (including an insurance company) which makes pa}anent under a policy of insurance, self-insurance, or 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 TO B E REPORTED.—The information

Ante. p. 2003.

to be

reported under subsection (a) includes— (1) the name of any physician or licensed health care practitioner for whose benefit the payment is made^ (2) the amount 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 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

.&ilH

2I>

shall study and report to Congress, not later than two years after 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.

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100 STAT. 3789

SEC. 422. REPORTING OF SANCTIONS TAKEN BY BOARDS OF MEDICAL EXAMINERS. (a) IN GENERAL.— (1) ACTIONS SUBJECT TO REPORTING.—Each

'

42 USC 11132.

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 physician'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 TAKEN BY HEALTH CARE ENTITIES. (a) REPORTING BY HEALTH CARE ENTITIES.—

fli

(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 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—

42 USC 11133.

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 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 subsection (a)(D. (c) SANCTIONS.— (1) HEALTH CARE ENTITIES.—A health care entity that fails

t 3 6c f g State and local governments.

42 USC 11134.

substantially to meet the requirement of subsection (a)(1) shall lose the protections of section 411(a)(l) if the Secretary publishes the name of the entity under section 4110b). (2) BOARD OF MEDICAL EXAMINERS.—If, after notice of noncompliance and providing an opportunity to correct noncompliance, the Secretary determines that a Board of Medical 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). (d) REFERENCES TO BOARD OF MEDICAL EXAMINERS.—Any reference

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. .,„,, _ 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 information.

(b) To WHOM REPORTED.—The information required to be reported

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 confidentiality, and dissemination of the information under this part. (c) REPORTING TO STATE LICENSING BOARDS.— (1) MALPRACTICE PAYMENTS.—Information

s:: <

required

to be

reported under section 421 shall also be reported to the appropriate State licensing board (or boards) in the State in which the medical malpractice claim arose. (2) REPORTING TO OTHER LICENSING

BOARDS.—Information

required to be reported under section 423(b) shall also be reported 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 USC 11135.

SEC. 425. DUTY OF HOSPITALS TO OBTAIN INFORMATION.

(a) IN 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))—

�


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 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.

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. (a) PROVIDING LICENSING BOARDS AND OTHER HEALTH CARE ENTITIES WITH ACCESS TO INFORMATION.—The Secretary (or the agency

designated under section 424(b)) shall, upon request, provide information reported under this part with respect to a physician or other licensed health care practitioner to State licensing boards, to hospitals, and to other health care entities (including health maintenance organizations) that have entered (or may be entering) into an employment or affiliation relationship with the physician or practitioner or to which the physician or practitioner has applied for clinical privileges or appointment to the medical staff. (b) CONFIDENTIALITY OF INFORMATION.—

(1) IN 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 subsection 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 paragraph (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

Regulations. 42 USC 11136.

State and local governments. 42 USC 11137. Health maintenance organizations.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/318

 100 STAT. 3792 42 USC

1320a-7a.

PUBLIC LAW 99-660—NOV. 14, 1986

Social Security Act are imposed and collected under that section. (3) USE OF INFORMATION.—Subject to paragraph (1), information 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. ..„ PART C—DEFINITIONS AND REPORTS

42 USC 11151.

SEC. 431. DEFINITIONS.

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In this title: (1) The term "adversely affecting" includes reducing, restrictrfvi• ^ ' ^ ing, suspending, revoking, denying, 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, membership on the medical staff, and the other circumstances pertaining 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. (4)(A) The term "health care entity" means— (i) a hospital that is licensied to provide health care s'JiisnSklnJBm services by the State in which it is located, (ii) an entity (including a health maintenance organization 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 determined 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 determined under regulations of the Secretary). (B) The term "health care entity" does not include a professional society (or committee thereof) if, within the previous 5 years, the society has been found by the Federal Trade Commission 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 para42 USC I395x. graphs (1) and (7) of section 1861(e) of the Social Security Act. (6) The terms "licensed health care practitioner" and "practitioner" 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.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/319

 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, tand 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 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 individ0 ual physician (which conduct affects or could affect adversely 9 the health or welfare of a patient or patients), and which affects ty (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 relatj ing to a professional review action. In this title, an action is not p. considered to be based on the competence or professional con^ 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 delivering 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 competence or professional conduct of a physician. iBim ^^^^ '^^ term "professional review activity" means an activity 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.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/320

 100 STAT. 3794

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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 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 USC 11152.

SEC. 432. REPORTS AND MEMORANDA OF UNDERSTANDING.

Ante, p. 3788.

(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 understanding with the Secretary of Defense and the Administrator of 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 Congress, 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

abuse.

21 USC 824.

State eomprehensive Mental Health Services Plan Act of 1986. 42 USC 201 note.

(c) MEMORANDUM OF UNDERSTANDING WITH D R U G ENFORCEMENT

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 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.

TITLE V—STATE COMPREHENSIVE MENTAL HEALTH SERVICES PLANS 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 USC 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:

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Page:United States Statutes at Large Volume 100 Part 5.djvu/321

 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 development of State comprehensive mental health services plans 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. "(b)(1) 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 appropriated $10,000,000 for each of the fiscal years 1988 and 1989.

Regulations. 42 USC 300X-10.

Appropriation authorization.

STATE C O M P R E H E N S IV E MENTAL HEALTH SERVICES PLANS

"SEC. 1920C. (a) For each fiscal year, beginning with fiscal year 42 USC 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 numbers 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 mentally ill individuals in order to enable such individuals to function outside of inpatient institutions to the maximum extent of their capabilities. "(5) The 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.

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 100 STAT. 3796

Homeless P®"^**^'

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 provision 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 phasing in of the provision of such services by the end of fiscal year 1992. "(g) The State plan shall provide for the establishment and 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 development 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 USC 300X-12.

Ante, p. 3794.

-

.

"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 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 subsection (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.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/323

 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 consultation 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 homeless 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 further 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 Grants. with, schools of medicine, schools of osteopathy, teaching hospitals, Contracts. Schools and colleges. Education. Physicians. Dentists.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/324

 100 STAT. 3798

PUBLIC LAW 99-660—NOV. 14, 1986

and graduate medical education programs, for the purpose of providing support for geriatric medicine training projects to train physicians 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 services, 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 paragraph (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 dentistry or at hospital departments of dentistry. Fellowships. "(B) A one-year or two-year internal medicine or family medicine 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 medicine; 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 osteopathy, 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 Training; 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—

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Page:United States Statutes at Large Volume 100 Part 5.djvu/325

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3799

H -

"(i) offers post-doctoral training in the specialties of dentistry, 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) REPEAL.—Title XV of the Public Health Service Act is repealed effective January 1, 1987. Qo) FUNDS.—The repeal made by subsection (a) shall not affect any funds obligated for the purposes of title XV of the Public Health Service Act before January 1, 1987.

TITLE VIII—HEALTH MAINTENANCE ORGANIZATIONS

a

Effective date, 42 USC 300k-l et H^usc 300k-i note. .-,;i Health Maintenance 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 FEASIBILITY 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-

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