Health Professions Reauthorization Act of 1988

(Measure passed House, amended)

Title I: Revision and Extension of Programs with Respect to Health Research and Teaching Facilities and Training of Professional Health Personnel - Health Professions Reauthorization Act of 1988 - Amends title VII (Health Research and Teaching Facilities and Training of Professional Health Personnel) of the Public Health Service Act to set ceilings for FY 1989 through 1991 on the total principal amount of new loans made and installments paid to borrowers covered by Federal loan insurance. Extends from September 30, 1991, to September 30, 1994, the cutoff date for the making of new loans. Requires that the total principal amount of Federal loan insurance available be granted without regard to any apportionment or other similar limitation.

Directs the Secretary of Health and Human Services, in providing loan insurance certificates, to give priority to lenders that agree to make loans at interest rates below the prevailing rates or otherwise under terms more favorable to the student than the terms generally available.

Expands eligibility for the loans to include individuals in a postdoctoral program or residency of at least one year in certain fields. Places a limit on the total amount of the loans made to such an individual in any academic year.

Requires interest on federally insured student loans under title VII to be compounded not more frequently than semiannually. (Current law requires the interest to be compounded semiannually.)

Prohibits provisions relating to the eligibility of student borrowers from being construed to limit the authority of any school to make allowances for students with special circumstances.

Allows a lender to assign its insurance rights to a public entity in the business of purchasing student loans.

Declares that lenders as well as holders are required to exercise reasonable care in the making of loans and substantial effort in collection.

Requires a lender, subject to exception, to prosecute an action for default.

Directs the Secretary to make or deny payment within 60 days of notification of entry of judgment.

Declares that provisions dealing with standards regarding loan collection may not be construed to require schools to reimburse the student loan fund for loans that became uncollectable prior to 1983.

Reduces the required interest rate on the loans from nine percent to five percent.

Adds to the list of periods excluded from the ten-year repayment period any time during which the borrower is pursuing a full-time course of study at certain types of schools.

Requires, if a school terminates a loan fund, a capital distribution. (Current law requires a capital distribution between September 30, 1991, and December 31, 1991.)

Directs the Secretary to establish a program in which allied health personnel and allied health professions students would agree, in consideration of payment by the Federal Government of portions of the principal and interest of educational loans, to serve as an allied health professional in specified agencies or settings for not less than two years. Specifies the percentages to be paid for each of three years of service. Makes provisions of the National Health Service Corps Loan Repayment Program apply to this program. Authorizes appropriations for FY 1989 through 1991.

Requires scholarships under provisions relating to first-year students in exceptional financial need to cover not less than 50 percent of tuition and educational expenses and 100 percent of the monthly stipend. Authorizes appropriations for FY 1989 through 1991.

Authorizes appropriations for capitation grants for schools of public health for FY 1989 through 1991. Repeals provisions of the Public Health Service Act dealing with capitation grants for such schools, effective October 1, 1991.

Authorizes appropriations for project grants to establish, maintain, or improve departments of family medicine for FY 1989 through 1991.

Reduces from six to four the number of individuals who must be enrolled in first-year positions in internship or medical residency training programs in area health education centers.

Authorizes appropriations for FY 1989 through 1991 for area health education center programs.

Directs the Secretary to enter into contracts for developing and operating health education and training centers to improve the supply, distribution, quality, and efficiency of personnel providing health services: (1) in the United States along the border with Mexico; and (2) to any population group having serious unmet health care needs.

Directs the Secretary to designate the geographic area in which each health education and training center will operate. Mandates that each applicant agree to establish an advisory group, develop a plan for carrying out the center's purpose, and be responsible for the evaluation of the program.

Directs the Secretary to make available 50 percent of the amounts appropriated for allocation to border centers.

Authorizes appropriations for contracts for border and other health education and training centers for FY 1989 through 1991.

Authorizes appropriations for FY 1989 through 1991 for: (1) programs for physician assistants; (2) grants for training, traineeships, and fellowships in general internal medicine and general pediatrics; (3) residency programs in the general practice of dentistry; and (4) training and education relating to family medicine.

Authorizes the Secretary to make grants and enter into contracts for a residency program or an advanced educational program in general dentistry, and for traineeships and fellowships for participants in such a program who are in financial need.

Allows grants and contracts for health professions educational assistance to individuals from disadvantaged backgrounds to be used for stipends for education at any public or private nonprofit health or educational entity. (Current law limits stipends to use for health professions education at a school of medicine, osteopathy, or dentistry.) Authorizes appropriations for educational assistance to individuals from disadvantaged backgrounds for FY 1989 through 1991.

Authorizes the Secretary to make grants and enter into contracts for: (1) residency programs in primary care for podiatric physicians, providing financial assistance in the form of traineeships; (2) education and training of faculty and residents to teach geriatrics, providing financial assistance in the form of traineeships or fellowships; and (3) recruiting students who reside in areas having shortages of podiatric manpower, and to operate clinical training programs in such areas.

Authorizes appropriations for FY 1989 through 1991 for two-year schools of medicine, interdisciplinary training, curriculum development training and recruitment relating to podiatric medicine, and training to teach geriatrics.

Requires that any grants approved, under provisions relating to the areas of family medicine, internal medicine, pediatrics, or dentistry, for a third or subsequent fiscal year be for at least 20 percent of the average grant to that grantee in the consecutively preceding fiscal years.

Requires grant applications in internal medicine, pediatrics, or dentistry to be submitted to peer review groups. Directs the Secretary, acting through the Administrator of the Health Resources and Services Administration, to establish peer review groups as necessary. Prohibits approval of an application unless a peer review group has recommended approval.

Directs the Secretary to make available with respect to Hispanic individuals at least ten percent of amounts appropriated to carry out provisions relating to scholarships for first-year students of exceptional financial need, programs for physician assistants, educational assistance to individuals from disadvantaged backgrounds, and allied health personnel.

Requires that studies mandated by current law of health professionals by specialty and geographic location include studies of the number, supply, and requirements for: (1) health professionals who are members of minority groups, including Hispanics; and (2) health professionals to serve minority groups, including Hispanics.

Directs the Secretary to conduct a study and report to the Congress regarding Hispanics in medically underserved areas and: (1) health care provided by individuals unable to communicate in the most appropriate language and cultural context; and (2) reliance on allied health personnel as the primary source of health care.

Authorizes the Secretary to make grants and enter into contracts with schools of public health for projects for: (1) public health and preventive medicine; (2) health promotion and disease prevention; and (3) increasing the enrollment of individuals from disadvantaged backgrounds. Requires applications to be recommended for approval by a peer review group. Authorizes appropriations for FY 1989 through 1991.

Reduces and makes equal for all programs, regardless of their level of minority enrollment, the number of students who must complete a graduate program in health administration during the year the grant is received in order for the program to be eligible for the grant. Authorizes appropriations for FY 1989 through 1991.

Authorizes appropriations for FY 1989 through 1991 for traineeships for students in graduate programs in health administration, hospital administration, or health policy analysis and planning.

Increases by one the number of appointees to the National Advisory Council on Health Professions Education and mandates inclusion on the Council of a representative of a graduate program in clinical psychology. Adds such programs to the list of schools and training centers which must promise not to discriminate on the basis of sex in order to receive a grant, loan guarantee, or interest subsidy payment under title VII of the Public Health Service Act.

Authorizes appropriations for FY 1989 through 1991 for public health traineeships and training in preventive medicine.

Replaces provisions relating to advanced financial distress assistance to health professions schools with provisions authorizing the Secretary to make grants and enter into contracts to assist schools with regard to health care needs, diagnosis, treatment, and prevention relating to acquired immune deficiency syndrome (AIDS). Authorizes appropriations for FY 1989 through 1991.

Directs the Secretary to conduct annually a program to determine the proficiency of individuals who do not meet criteria established in specified provisions for determining the qualifications of laboratory technicians and technologists.

Requires the Comptroller General to: (1) conduct a study regarding the practices and policies of the States in licensing by endorsement physicians who are graduates of schools of medicine outside the United States; and (2) complete the study within nine months of enactment of this Act and submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.

Directs the Secretary to identify and notify entities that would be appropriate applicants for grants under provisions relating to two-year schools of medicine.

Prohibits any program of research under the Public Health Service Act which was carried out, or was appropriate to be carried out, by an agency other than the Health Resources and Services Administration in FY 1987 from being carried out by such Administration for each of the FY 1989 through 1991.

Directs the Secretary to solicit applications for grants under provisions relating to family medicine, internal medicine, pediatrics, and dentistry at least twice a year, if unobligated appropriations are sufficient with respect to a second solicitation. Requires a preliminary review of applications for technical sufficiency, with an opportunity to submit a timely second application.

Directs the Secretary to establish and implement a program in which health professionals agree to conduct, at the National Institutes of Health (NIH), research with respect to acquired immune deficiency syndrome (AIDS) in return for payment by the Federal Government of not more than $20,000 of their educational loans for each year of service. Limits eligibility for the agreements to those who: (1) have substantial educational loans relative to income; and (2) were not employed by the NIH during the one-year peiod before enactment of this Act. Makes provisions of the Public Health Service Act relating to the National Health Service Corps Loan Repayment Program, except as inconsistent, apply to the program. Authorizes appropriations for FY 1989 through 1991.

Requires that certain funds appropriated for National Research Service Awards be made available to the Secretary, acting through the Administrator of the Health Resources and Services Administration. (Current law does not specify to whom the funds are to be made available.)

Directs the Secretary, for each of the FY 1989 through 1991, to make available from amounts appropriated after enactment of this Act, a certain amount for a grant to a hospital in a specified location for enhancement of quality care.

Declares that, with respect to Federal regulations for lenders, provisions relating to the Federal program of insured loans to graduate students in health professions schools may not be construed to preclude the applicability of such regulations to the Student Loan Marketing Association or any other entity in the business of purchasing student loans.

Title II: Waiver of Liability for Certain Sale of Facility Under Program of Construction and Modernization of Medical Facilities - Declares that, if the Secretary of Health and Human Services certifies compliance with conditions of this title, provisions of the Public Health Service Act imposing liability in the nature of recovery by the Government of funds provided for the construction or modernization of medical facilities shall not apply to the sale of a specified facility in San Juan County, Utah, on November 26, 1986.

Sets forth the conditions which must be met, including that: (1) the transferor county, a political subdivision of the State of Utah, establish, in accordance with specified regulations, and administer an irrevocable trust to satisfy, with respect to such facility, its obligation under Federal laws and regulations to provide for adequate facilities to furnish needed services for persons unable to pay; and (2) the transferee corporation agree to satisfy, at the described facility, the obligation of the county to provide such services for persons unable to pay.

Directs the Secretary to make such determination with 12 months after enactment of this Act and to certify the determination to the Congress.

Directs the Secretary to monitor compliance and, if conditions are not met or either party fails to carry out its duties, to ensure that proceedings are commenced to recover the amounts as provided by current law.

Title III: Medical Device Improvements - Medical Device Improvements Act of 1988 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require any hospital, ambulatory surgical facility, or nursing home which receives or otherwise becomes aware of information that reasonably suggests that a medical device may have caused or contributed to the death of a patient to promptly report the information to the Secretary of Health and Human Services (HHS) and, if the identity of the manufacturer is known, to the manufacturer of the device. Requires, whenever a facility becomes aware of information suggesting that a medical device may have caused a life-threatening illness or injury, or when a medical device malfunctions in a way likely to cause death or serious illness, that the information be reported to the manufacturer of the device. Provides that if the identity of the manufacturer is undeterminable, the facility must report the information to the Secretary.

Requires facilities to submit to the Secretary quarterly summaries of the reports made to manufacturers respecting device malfunctions. Requires summaries to contain information for the purpose of determining reporting compliance by manufacturers.

Treats facilities as having received or otherwise become aware of information with respect to a medical device when an employee becomes aware of such information in the course of duties.

Limits disclosure of the identity of a facility making a report, the device which was the subject of a report, or the device manufacturer.

Shields individuals and entities from liability in private civil actions with respect to the content of reports, unless the individual or entity had knowledge of the falsity of the information. Prohibits a report, or the fact that such a report has been made, from being admitted into evidence or otherwise used in an action other than one brought to enforce the FDCA.

Prohibits facilities from taking any adverse personnel action against an employee or practitioner for making a report.

Imposes civil penalties on facilities failing to make required reports.

Directs the Secretary to conduct a study of compliance with the provisions of this Act and of the cost-effectiveness of the requirements and their implementation and any recommendations for improving the requirements. Requires that the results be reported to the Congress.

Provides that the penalty provisions of this Act may not apply to certain facilities, depending on whether or not there has been substantial compliance with this Act.

Directs the Secretary to conduct education and information programs for a one-year period for facilities and manufacturers of devices regarding the requirements of this Act.

Directs the Comptroller General to: (1) conduct a study three years after enactment of this Act of compliance by facilities, of actions taken by manufacturers in response to reports made under this Act, and of the cost effectiveness of such requirements; and (2) submit a report to specified congressional committees.

Directs the Secretary to amend certain regulations to require distributors of medical devices to establish and maintain records and make reports under the FDCA. Requires reporting distributors to submit copies to device manufacturers.

Authorizes the Secretary to waive certain requirements in applications for premarket approval of class III devices in certain circumstances.

Directs the Secretary: (1) upon determining that a requirement has been met for a device, to make that determination for all devices of the same type in the absence of good cause that such determination should not be made; and (2) to include in the consumer safety and effectiveness information a statement describing the basis upon which the determination was made.

Defines "substantial equivalence" for purposes of classifying devices, as requiring: (1) the same intended use and the same technological characteristics; or (2) the same intended use but different technological characteristics and evidence demonstrating the device is as safe and effective as comparable devices currently sold in interstate commerce. Provides that technological characteristics shall be considered different from those of another device if there is a significant change in materials, design, energy source, or other features.

Directs the Secretary to promulgate regulations requiring device manufacturers to prepare a detailed summary of any clinical data (including adverse health effects) required by the Secretary in making the determination that the device is substantially equivalent to another device.

Requires certain certifications by a manufacturer who reports to the Secretary that a device is not a class III device because it is substantially equivalent to another device meeting certain criteria.

Directs the Secretary, within five years, to: (1) require manufacturers of devices which are subject to revision of classification to submit a description of and citation to any known adverse safety or effectiveness information respecting the devices which has not previously been submitted; and (2) require manufacturers to submit adverse safety and effectiveness data.

Requires the Secretary to publish a notice for each class III device which was commercially distributed before the date of the enactment of this Act, and for which no final regulation has been promulgated, revising the classification into class I unless the notice requires the device to remain in class III or revises the classification so that it is classified into class II. Sets forth criteria for the Secretary to apply in determining whether to revise the classification of a device or to require a device to remain in class III. Sets forth publication, notice, comment, and petition provisions regarding classification revisions by the Secretary. Provides for judicial review of classifications.

Revises existing standards to designate as class II devices those devices for which it can be determined whether or not a performance standard is appropriate rather than requiring a performance standard as under current law.

Revises the standard for classification of class III devices (devices requiring premarket approval) to provide that a device must be so classified if insufficient information exists to determine that class I or class II controls will assure safety and effectiveness.

Revises the evidence required for reclassification of a class III device.

Revises procedures for establishing performance standards for devices.

Directs the Secretary to file a civil action upon determining that: (1) a device intended for human use presents an unreasonable risk of substantial harm to the public health; (2) there are reasonable grounds to beleive that the risk was not caused by failure to exercise due care, and that the device was properly designed and manufactured with reference to the state of the art; (3) notification would not, by itself, be sufficient to eliminate such risk; and (4) the person responsible for the unreasonable risk has not submitted to the Secretary a satisfactory plan, or has made insufficient progress in carrying out a plan to eliminate the risk.

Provides that no device shall be considered to present an unreasonable risk of substantial harm to the public health solely on the basis that it was designed and manufactured subsequent to the device and incorporated safer features.

Directs that any order entered in a civil action requiring repair or replacement of a device or providing a refund shall be subject to a reasonable allowance for use unless the device was intended to be implanted into the human body.

Permits an individual availing himself of a remedy under this Act to be charged a reasonable allowance for use. Specifies that for purposes of an order issued under this Act, "expenses actually incurred" does not include any expense covered under a health insurance policy or health benefit plan.

Provides that field repairs or removals of devices (recalls) must be reported to the Secretary if they are taken to eliminate a risk to health or to remedy a violation of the Federal Food, Drug, and Cosmetic Act.

Provides that requirements applicable to manufacturers are extended to those who remanufacture medical devices. Excludes routine service from the definition of remanufacture.

Requires the Secretary to plan education and training activities to minimize the exposure of people to health hazards associated with medical devices.

Makes it discretionary rather than mandatory to refer petitions for classifying new devices in class I or class II to a panel. Revises other panel procedures.

Removes the requirement that the Secretary afford all interested persons an informal hearing before a performance standard may be amended.

Transfers provisions of the Public Health Service Act relating to electronic product radiation control to the FDCA.

Provides that the regulation of medical devices used to deliver electro-convulsive therapy is not affected by this Act.