State Comprehensive Mental Health Services Plan Act of 1986

(Measure passed House, amended)

Title I: Drug Exports - Drug Exports Amendments Act of 1986 - Amends the Federal Food, Drug, and Cosmetic Act to permit the export of certain drugs and products (including biological products) intended for human or animal use even though such drugs and products have not been approved or licensed for use in the United States.

Prohibits the export of drugs denied approval on the basis of safety and efficacy or whose manufacture in the United States has been determined to be contrary to U.S. health and safety.

Sets forth other restrictions on the export of such drugs.

Lists the countries to which such drugs may be exported. Sets forth requirements on which changes to such list shall be based. Grants the Secretary of Health and Human Services and the Secretary of Agriculture certain regulatory and enforcement powers.

Amends the Public Health Service Act to allow the Secretary of Health and Human Services to conduct biomedical research for the identification, control, treatment, and prevention of diseases (including tropical diseases) which do not occur in the United States.

Title II: National Commission to Prevent Infant Mortality - National Commission to Prevent Infant Mortality Act of 1986 - Establishes the National Commission to Prevent Infant Mortality (Commission).

States the duties of the Commission, which include: (1) identifying and examining Federal, State, local, and private resources which affect infant mortality; (2) identifying barriers to the health care needed to prevent high infant mortality; and (3) reviewing and carrying forward appropriate recommendations that promote the health status of childbearing women and their infants.

Directs the Commission to: (1) recommend a national policy designed to improve the current approach to preventing infant mortality; (2) recommend specific changes needed in Federal laws and programs; and (3) present such recommendations to the President, the Speaker of the House, and the Majority Leader of the Senate within one year of enactment of this Act.

Sets forth the powers of the Commission. States that the provisions of the Federal Advisory Committee Act shall not apply to the Commission.

Provides for the termination of the Commission. Authorizes appropriations.

Title III: Vaccine Compensation - National Childhood Vaccine Injury Act of 1986 - Part A: Vaccines - Subtitle I: National Vaccine Program - Amends the Public Health Service Act to establish in the Department of Health and Human Services a National Vaccine Program to: (1) direct vaccine research and development within the Federal Government; (2) ensure the production and procurement of safe and effective vaccines; (3) direct the distribution and use of vaccines; and (4) coordinate governmental and nongovernmental activities. Requires the Director of the Program to report to specified congressional committees.

Establishes the National Vaccine Advisory Committee to recommend: (1) ways to encourage the availability of an adequate supply of vaccines; and (2) research priorities.

Authorizes appropriations for FY 1987 through 1991.

Subtitle 2: National Vaccine Injury Compensation Program - Part A: Program Requirements - Establishes the National Vaccine Injury Compensation Program as an alternative remedy to judicial action for specified vaccine-related injuries.

Prescribes the contents of any petition for compensation.

Grants U.S. district courts authority to determine eligibility and compensation. Requires the district court in which the petition is filed to designate a special master to serve as an adjunct to the court. Sets forth the responsibilities of the court.

Lists factors to be considered when determining the amount of a compensation award. Sets forth a table of injuries deemed vaccine-related for compensation purposes. Permits the Secretary of Health and Human Services to: (1) promulgate regulations to revise such table; and (2) recommend changes to the vaccines covered by the table.

Limits awards for actual and projected pain and suffering and emotional distress to $250,000. Prohibits awards for punitive damages.

Establishes the Advisory Commission on Childhood Vaccines to: (1) advise the Secretary on the implementation of the Program; (2) recommend changes to the Vaccine Injury Table; and (3) recommend research priorities.

Part B: Additional Remedies - Sets forth procedures under which the person who filed a petition for compensation under the program may elect to file a civil action for damages.

Provides that no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death: (1) resulting from unavoidable side effects; or (2) solely due to the manufacturer's failure to provide direct warnings. Provides that a manufacturer may be held liable where: (1) such manufacturer engaged in the fraudulent or intentional withholding of information; or (2) such manufacturer failed to exercise due care. Permits punitive damages in such civil actions under certain circumstances.

Part C: Assuring a Safer Childhood Vaccination Program in the United States - Requires each health care provider who administers a vaccine listed in the Vaccine Injury Table to record certain information with respect to each such vaccine. Requires each health care provider and vaccine manufacturer to report certain information to the Secretary.

Requires the Secretary to develop certain vaccine information materials for distribution to the legal representatives of any child receiving a vaccine listed in the Vaccine Injury Table.

Directs the Secretary to promote the development of safer childhood vaccines.

Sets forth recordkeeping and reporting requirements for vaccine manufacturers. Imposes civil and criminal penalties for destroying, altering, or concealing any such report or record.

Part D: General Provisions - Allows any person to commence a civil action against the Secretary where the Secretary allegedly has failed to perform a duty under this Act. Provides for judicial review of the Secretary's regulatory actions in a court of appeals of the United States.

Allows the Secretary to provide licensing for unpatented vaccines for naturally occurring human infectious diseases under certain circumstances.

Requires the Secretary to conduct studies on pertussis, rubella, and radiculoneuritis vaccines and publish the results of such studies.

Directs the Secretary to study the risks to children associated with each vaccine listed in the Vaccine Injury Table and establish guidelines respecting the administration of such vaccines. Directs the Secretary to periodically review and revise such guidelines.

Directs the Secretary to review the warnings, use instructions, and precautionary information presently used by manufacturers of vaccines listed in the Vaccine Injury Table. Directs the Secretary to require manufacturers to revise and reissue any warning, instruction, or information found inadequate.

Grants the Secretary recall authority with respect to any licensed virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other licensed product which presents a danger to public health. Establishes civil penalties for recall violations.

Directs the Secretary to make annual reports to specified congressional committees on the impact this Act has on the supply of vaccines.

Part E: Miscellaneous - Provides that certain Federal provisions designed to reduce paperwork shall not apply to information required to carry out this Act.

Title IV: Encouraging Good Faith Professional Review Activities - Health Care Quality Improvement Act of 1986 - Part A: Promotion of Professional Review Activities - Provides protection from liability under Federal and State laws for members of a professional review body and their staffs who, in the reasonable belief that the action was in the furtherance of quality health care, warranted by the facts known, and after a reasonable effort to obtain the facts, take actions which adversely affect the clinical privileges or professional society membership of a physician. Provides such protection to those who provide information to professional review bodies.

Sets forth certain standards for professional review actions, including: (1) a notice requirement when professional review action is proposed by a health care entity; and (2) specified hearing requirements. Allows the court to award the payment of reasonable attorneys' fees and costs to a prevailing defendant or plaintiff.

Allows the Secretary of Health and Human Services to establish voluntary guidelines to assist the professional review bodies.

Part B: Reporting of Information - Requires any entity (including an insurance company) making a payment in a medical malpractice action to report certain information to the Secretary and to State licensing boards, including: (1) the name of the physician or health care practitioner; (2) the amount of payment; (3) the name of any hospital with which the physician or health care practitioner is associated; and (4) a description of the acts and injuries upon which the claim was based. Establishes civil penalties for the failure to report such information.

Directs the Secretary to study whether information respecting small payments should continue to be reported, and transmit the results of such study to the Congress.

Requires each Board of Medical Examiners which revokes or suspends a physician's license for reasons relating to the physician's professional competence or conduct to report such information to the Secretary.

Requires each health care entity which takes a professional review action that adversely affects the clinical privileges of a physician to report such information to the Board of Medical Examiners. Allows health care entities to report professional review actions taken against health care practitioners who are not physicians.

Requires each health care entity which takes a professional review action that adversely affects the clinical privileges of a physician to report such information to the Board of Medical Examiners. Allows health care entities to report professional review actions taken against health care practitioners who are not physicians.

Specifies sanctions to be taken against health care entities and Boards of Medical Examiners which fail to comply with such requirements.

Requires hospitals to request certain information from the Secretary regarding staff physicians and health care practitioners (or physicians and health care practitioners being considered for staff positions).

Requires the Secretary to provide: (1) for the disclosure of such information to the physician or health care practitioner; and (2) procedures to correct inaccurate information.

Directs the Secretary to make such information available to: (1) State licensing boards; (2) hospitals; and (3) other health care entities.

Part C: Definitions and Reports - Defines certain terms for the purposes of this Act.

Requires the Secretary to report to the Congress annually on the implementation of this Act.

Directs the Secretary to seek to enter into a memorandum of understanding with: (1) the Secretary of Defense and the Administrator of Veterans Affairs to apply the provisions of this Act to hospitals and other facilities and health care providers under their jurisdiction; and (2) the Administrator of Drug Enforcement to provide information respecting physicians and other practitioners whose registration to dispense controlled substances has been revoked or suspended under the Controlled Substances Act. Requires the Secretary to report to the Congress on such memoranda.

Title V: State Comprehensive Mental Health Services Plan - State Comprehensive Mental Health Services Plan Act of 1986 - Amends title XIX (Block Grants) of the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants to States for the development of State comprehensive mental health services plans. Authorizes appropriations for FY 1988 and 1989.

Sets forth the requirements for such plans, which include: (1) establishing and implementing a community-based system of care for chronically mentally ill individuals; (2) describing the services to be provided to such individuals; (3) providing activities to reduce the rate of hospitalization of such individuals; and (4) providing case management services to such individuals.

Requires the Secretary to reduce a State's allotment where such State fails to meet a required plan development or implementation goal.

Directs the Secretary to develop a model plan for the development of a community-based system of care for chronically mentally ill individuals.

Requires States to establish State mental health service planning councils.

Authorizes the Secretary to make grants for demonstration projects to provide services for homeless chronically mentally ill individuals. Increases the authorized appropriations for FY 1988 for such grants.

Title VI: Geriatric Training - Amends the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants and enter into contracts to provide support for geriatric training programs to train physicians and dentists who plan to teach geriatric medicine or geriatric dentistry. Authorizes appropriations.

Title VII: Health Planning - Repeals title XV (National Health Planning and Development) of the Public Health Service Act.

Title VIII: Health Maintenance Organizations - Health Maintenance Organization Amendments of 1986 - Amends title XIII (Health Maintenance Organizations) of the Public Health Service Act to repeal provisions authorizing assistance for feasibility surveys, planning, and initial development of health maintenance organizations (HMOs).

Limits initial operating loan assistance to entities with existing loan eligibility as of October 1, 1985.

Eliminates loans and loan guarantees for the acquisition and construction of ambulatory care facilities.

Limits the authority of the Secretary of Health and Human Services to borrow through the loan guarantee fund to obligations made before October 1, 1985.

Repeals the requirements for: (1) health system agency review of Federal support of HMO activities; (2) periodic demonstration of compliance with Federal requirements by HMOs; and (3) certain financial reports.

Requires updates of the digest of State HMO laws to be made annually (presently required quarterly).

Authorizes appropriations for FY 1987 through 1989 to meet the obligations of the loan fund.

Includes organ transplants as part of the basic coverage if such transplants were required to be included in the basic health services on April 15, 1985.

Requires the Secretary of Health and Human Services to conduct a study to assess the operation and impact of the provisions of title XIII (Health Maintenance Organizations) of the Public Health Service Act and transmit the results to the Congress.

Allows health maintenance organizations to provide psychiatric health care.

Title IX: Alzheimer's Disease and Related Dementias Services Research - Part A: General Provisions - Alzheimer's Disease and Related Dementias Services Research Act of 1986 - Expresses the findings of Congress.

Part B: Council on Alzheimer's Disease Establishment - Establishes in the Department of Health and Human Services the Council on Alzheimer's Disease to: (1) coordinate research done by and through the Department on Alzheimer's disease and related dementias; (2) establish a mechanism for the sharing of information among employees of the Department involved in program serving the elderly; (3) identify the most promising areas of research; (4) establish mechanisms to use the results of Alzheimer's research; and (5) assist in developing and coordinating research plans.

Requires the Council to transmit specified reports to the Congress.

Part C: Advisory Panel on Alzheimer's Disease - Establishes the Advisory Panel on Alzheimer's Disease to assist the Secretary of Health and Human Services and the Council on Alzheimer's Disease.

Requires the Panel to report annually to the Congress. Authorizes appropriations for FY 1988 through 1991.

Part D: Awards for Leadership and Excellence in Alzheimer's Disease and Related Dementias - Requires the Director of the National Institute on Aging to make awards to researchers for leadership and excellence in Alzheimer's disease and related dementias research. Authorizes appropriations.

Part E: Research Relating to Services for Individuals with Alzheimer's Disease and Related Dementias and Their Families - Subpart 1: Responsibilities of the National Institute on Aging - Requires the Director to conduct research relevant to appropriate services for individuals wth Alzheimer's disease and related dementias and their families. Requires the Director to prepare and transmit to the Chairman of the Council a plan for such research. Requires the Director to disseminate the results of such research to appropriate professional entities and the public. Authorizes appropriations for FY 1988 through 1991.

Subpart 2: Responsibilities of the National Institute of Mental Health - Requires the Director of the National Institute of Mental Health to conduct research relevant to appropriate services for individuals with Alzheimer's disease and related dementias and their families. Requires the Director to prepare and transmit to the Chairman of the Council a plan for such research. Requires the Director to disseminate the results of such research to appropriate professional entities and the public. Authorizes appropriations for FY 1988 through 1991.

Subpart 3: Responsibilities of the National Center for Health Services Research and Health Care Technology Assessment - Requires the Director of the National Center for Health Center Research and Health Care Technology Assessment to conduct research relevant to appropriate services for individuals with Alzheimer's disease and related dementias and their families. Requires the Director to prepare and transmit to the Chairman of the Council a plan for such research. Requires the Director to disseminate the results of such research to appropriate professional entities and the public. Authorizes appropriations for FY 1988 through 1991.

Subpart 4: Responsibilities of the Health Care Financing Administration - Requires the Administrator of the National Health Care Financing Administration to conduct research relevant to appropriate services for individuals with Alzheimer's disease and related dementias and their families. Requires the Administrator to prepare and transmit to the Chairman of the Council a plan for such research. Requires the Administrator to disseminate the results of such research to appropriate professional entities and the public. Authorizes appropriations for FY 1988 through 1991.

Part F: Dissemination - Requires the Director of the National Institute on Aging to establish the Clearinghouse on Alzheimer's Disease to disseminate information concerning services available for individuals with Alzheimer's disease and related dementias and their families.

Requires the Director to make a grant to a national organization representing individuals with Alzheimer's disease and related dementias to: (1) establish a central computerized information system to compile, translate, and disseminate information concerning initiatives regarding services for individuals with Alzheimer's disease and related dementias; and (2) establish a national toll-free telephone line to make such information available.

Authorizes appropriations for FY 1988 through 1991.

Part G: Educational Activities - Directs the Secretary of Health and Human Services to develop a mechanism to ensure that Alzheimer's disease and related dementias information is provided promptly to the Commissioner of Social Security and that such information is provided to personnel of the Social Security Administration.

Requires the Director of the National Institute on Aging to conduct education and information dissemination activities concerning: (1) the special problems of individuals with Alzheimer's disease and their families; and (2) Alzheimer's disease and related dementias for public safety and transportation personnel. Authorizes appropriations for FY 1988 through 1991.