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HR 4872 Subtitle B—School-Based Health Clinics SEC. 2511. SCHOOL-BASED HEALTH CLINICS. (a) INGENERAL.—Part Q of title III (42 U.S.C. 280h et seq.) is amended by adding at the end the following: ‘‘SEC. 399Z–1. SCHOOL-BASED HEALTH CLINICS. ‘‘(a) PROGRAM.—The Secretary shall establish a school-based health clinic Program consisting of awarding grants to eligible entities to support the operation of school-based health clinics (referred to in this section as ‘SBHCs’). ‘‘(b) ELIGIBILITY.—To be eligible for a grant under this section, an entity shall—

PAGE 1006 HR 4872 ‘‘(1) be an SBHC (as defined in subsection {l}(4)); and ‘‘(2) submit an application at such time, in such manner, and containing such information as the Secretary may require, including at a minimum— ‘‘(A) evidence that the applicant meets all criteria necessary to be designated as an SBHC; ‘‘(B) evidence of local need for the services to be provided by the SBHC; ‘‘(C) an assurance that— ‘‘(i) SBHC services will be provided in accordance with Federal, State, and local laws governing— ‘‘{l} obtaining parental or guardian consent; and ‘‘{ll} patient privacy and student records, including section 264 of the Health Insurance Portability and Accountability Act of 1996 and section 444 of the General Education Provisions Act; ‘‘(ii) the SBHC has established and maintains collaborative relationships with other health care providers in the catchment area of the SBHC;

PAGE 1007 HR 4872 (iii) the SBHC will provide on-site access during the academic day when school is in session and has an established network of support and access to services with backup health providers when the school or SBHC is closed; ‘‘(iv) the SBHC will be integrated into the school environment and will coordinate health services with appropriate school personnel and other community providers colocated at the school; and ‘‘(v) the SBHC sponsoring facility assumes all responsibility for the SBHC administration, operations, and oversight; and ‘‘(D) such other information as the Secretary may require. ‘‘(c) USE OFFUNDS.— Funds awarded under a grant under this section may be used for ‘‘(1) providing training related to the provision of comprehensive primary health services and additional health services;

PAGE 1008 HR 4872 ‘‘(2) the management and operation of SBHC programs; and ‘‘(3) the payment of salaries for health professionals and other appropriate SBHC personnel. ‘‘(d) CONSIDERATION OF NEED.— In determining the amount of a grant under this section, the Secretary shall take into consideration— ‘‘(1) the financial need of the SBHC; ‘‘(2) State, local, or other sources of funding provided to the SBHC; and ‘‘(3) other factors as determined appropriate by the Secretary. ‘‘(e) PREFERENCES.—In awarding grants under this section, the Secretary shall give preference to SBHCs that have a demonstrated record of service to the following: ‘‘(1) A high percentage of medically underserved children and adolescents. ‘‘(2) Communities or populations in which children and adolescents have difficulty accessing health and mental health services. ‘‘(3) Communities with high percentages of children and adolescents who are uninsured, underinsured, or eligible for medical assistance under Federal or State health benefits programs (including titles XIX and XXI of the Social Security Act).

PAGE 1009 HR 4872 ‘‘(f) MATCHINGREQUIREMENT.—The Secretary may award a grant to an SBHC only if the SBHC agrees to provide, from non-Federal sources, an amount equal to 20 percent of the amount of the grant (which may be provided in cash or in kind) to carry out the activities supported by the grant. ‘‘(g) SUPPLEMENT, NOTSUPPLANT.—The Secretary may award a grant to an SBHC under this section only if the SBHC demonstrates to the satisfaction of the Secretary that funds received through the grant will be expended only to supplement, and not supplant, non-Federal and Federal funds otherwise available to the SBHC for operation of the SBHC (including each activity described in paragraph (1) or (2) of subsection (c)). ‘‘(h) PAYOR OF LAST RESORT.—The Secretary may award a grant to an SBHC under this section only if the SBHC demonstrates to the satisfaction of the Secretary that funds received through the grant will not be expended for any activity to the extent that payment has been made, or can reasonably be expected to be made ‘‘(1) under any insurance policy; ‘‘(2) under any Federal or State health benefits program (including titles XIX and XXI of the Social Security Act); or

PAGE 1010 HR 4872 ‘‘(3) by an entity which provides health services on a prepaid basis. ‘‘(i) REGULATIONS REGARDING REIMBURSEMENT FOR HEALTH SERVICES. The Secretary shall issue regulations regarding the reimbursement for health services provided by SBHCs to individuals eligible to receive such services through the program under this section, including reimbursement under any insurance policy or any Federal or State health benefits program (including titles XIX and XXI of the Social Security Act). ‘‘(j) TECHNICALASSISTANCE.—The Secretary shall provide (either directly or by grant or contract) technical and other assistance to SBHCs to assist such SBHCs to meet the requirements of this section. Such assistance may include fiscal and program management assistance, training in fiscal and program management, operational and administrative support, and the provision of information to the SBHCs of the variety of resources available under this title and how those resources can be best used to meet the health needs of the communities served by the SBHCs. ‘‘(k) EVALUATION; REPORT.—The Secretary shall— ‘‘(1) develop and implement a plan for evaluating SBHCs and monitoring quality performances under the awards made under this section; and

PAGE 1010 HR 4872 ‘‘(3) by an entity which provides health services on a prepaid basis. ‘‘(i) REGULATIONS REGARDING REIMBURSEMENT FOR HEALTH SERVICES. The Secretary shall issue regulations regarding the reimbursement for health services provided by SBHCs to Individuals eligible to receive such services through the program under this section, including reimbursement under any insurance policy or any Federal or State health benefits program (including titles XIX and XXI of the Social Security Act). ‘‘(j) TECHNICALASSISTANCE.—The Secretary shall provide (either directly or by grant or contract) technical and other assistance to SBHCs to assist such SBHCs to meet the requirements of this section. Such assistance may include fiscal and program management assistance, training in fiscal and program management, operational and administrative support, and the provision of information to the SBHCs of the variety of resources available under this title and how those resources can be best used to meet the health needs of the communities served by the SBHCs. ‘‘(k) EVALUATION; REPORT.—The Secretary shall— ‘‘(1) develop and implement a plan for evaluating SBHCs and monitoring quality performances

PAGE 1011 HR 4872 ‘‘(2) submit to the Congress on an annual basis a report on the program under this section. ‘‘(l) DEFINITIONS.—In this section: ‘‘(1) COMPREHENSIVE PRIMARY HEALTH SERVICES.—The term ‘comprehensive primary health services’ means the core services offered by SBHCs, which shall include the following: ‘‘(A) PHYSICAL.—Comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic medical conditions and referrals to, and follow-up for, specialty care. ‘‘(B) MENTAL HEALTH.—Mental health assessments, crisis intervention, counseling, treatment, and referral to a continuum of services including emergency psychiatric care, community support programs, inpatient care, and outpatient programs. ‘‘(C) OPTIONAL SERVICES.—Additional services, which may include oral health, social, and age-appropriate health education services, including nutritional counseling. ‘‘(2) MEDICALLY UNDERSERVED CHILDREN AND ADOLESCENTS.—The term ‘medically underserved children and adolescents’ means a population of children and adolescents who are residents of an area designated by the Secretary as an area with a shortage of personal health services and health infrastructure for such children and adolescents.

PAGE 1012 HR 4872 ‘‘(3) SCHOOL-BASED HEALTH CLINIC.—The term ‘school-based health clinic’ means a health clinic that— ‘‘(A) is located in, or is adjacent to, a school facility of a local educational agency; ‘‘(B) is organized through school, community, and health provider relationships; ‘‘(C) is administered by a sponsoring facility; and ‘‘(D) provides, at a minimum, comprehensive primary health services during school hours to children and adolescents by health professionals in accordance with State and local laws and regulations, established standards, and community practice. ‘‘(4) SPONSORING FACILITY.—The term ‘sponsoring facility’ is— ‘‘(A) a hospital; ‘‘(B) a public health department; ‘‘(C) a community health center; ‘‘(D) a nonprofit health care agency; ‘‘(E) a local educational agency; or

PAGE 1013 HR 4872 ‘‘(F) a program administered by the Indian Health Service or the Bureau of Indian Affairs or operated by an Indian tribe or a tribal organization under the Indian Self-Determination and Education Assistance Act, a Native Hawaiian entity, or an urban Indian program under title V of the Indian Health Care Improvement Act. ‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—For purposes of carrying out this section, there are authorizedto be appropriated $50,000,000 for fiscal year 2010 and such sums as may be necessary for each of the fiscal years 2011 through 2014.’’ (b) EFFECTIVEDATE.—The Secretary of Health and Human Services shall begin awarding grants under section 399Z–1 of the Public Health Service Act, as added by subsection (b), not later than July 1, 2010, without regard to whether or not final regulations have been issued under section 399Z–1(h) of such Act. Subtitle C—National Medical Device Registry SEC. 2521. NATIONAL MEDICAL DEVICE REGISTRY.

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(a) REGISTRY.— ‘‘(1) IN GENERAL.—Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended— ‘‘(A) by redesignating subsection (g) as subsection (h); and ‘‘(B) by inserting after subsection (f) the following: ‘‘National Medical Device Registry ‘‘(g)(1) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that ‘‘(A) is or has been used in or on a patient; and ‘‘(B) is ‘‘(i) a class III device; or ‘‘(ii) a class II device that is implantable, life-supporting, or life-sustaining. ‘‘(2) In developing the registry, the Secretary shall, in consultation with the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, the head of the Office of the National Coordinator for Health Information Technology, and the Secretary of Veterans Affairs, determine the best methods for—

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‘‘(A) including in the registry, in a manner consistent with subsection (f), appropriate information to identify each device described in paragraph (1) by type, model, and serial number or other unique identifier; ‘‘(B) validating methods for analyzing patient safety and outcomes data from multiple sources and for linking such data with the information included in the registry as described in subparagraph (A), including, to the extent feasible, use of— ‘‘(i) data provided to the Secretary under other provisions of this chapter; and ‘‘(ii) information from public and private sources identified under paragraph (3); ‘‘(C) integrating the activities described in this subsection with ‘‘(i) activities under paragraph (3) of section 505(k) (relating to active postmarket risk identification); ‘‘(ii) activities under paragraph (4) of section 505(k) (relating to advanced analysis of drug safety data); and ‘‘(iii) other postmarket device surveillance activities of the Secretary authorized by this chapter; and

PAGE 1016 HR 4872 ‘‘(D) providing public access to the data and analysis collected or developed through the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists. ‘‘(3)(A) To facilitate analyses of postmarket safety and patient outcomes for devices described in paragraph (1), the Secretary shall, in collaboration with public, academic, and **private entities, develop methods to— ‘‘(i) obtain access to disparate sources of patient safety and outcomes data, including— ‘‘{l} Federal health-related electronic data (such as data from the Medicare program under title XVIII of the Social Security Act or from the health systems of the Department of Veterans Affairs); ‘‘{II} private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); and ‘‘{III} other data as the Secretary deems necessary to permit postmarket assessment of device safety and effectiveness; and

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‘‘(ii) link data obtained under clause (i) with information in the registry. ‘‘(B) In this paragraph, the term ‘data’ refers to information respecting a device described in paragraph (1), including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary. ‘‘(4) Not later than 36 months after the date of the enactment of this subsection, the Secretary shall promulgate regulations for establishment and operation of the registry under paragraph (1). Such regulations— ‘‘(A)(i) in the case of devices that are described in paragraph (1) and sold on or after the date of the enactment of this subsection, shall require manufacturers of such devices to submit information to the registry, including, for each such device, the type, model, and serial number or, if required under subsection (f), other unique device identifier; and ‘‘(ii) in the case of devices that are described in paragraph (1) and sold before such date, may require manufacturers of such devices to submit such information to the registry, if deemed necessary by the Secretary to protect the public health;

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‘‘(B) shall establish procedures— ‘‘(i) to permit linkage of information submitted pursuant to subparagraph (A) with patient safety and outcomes data obtained under paragraph (3); and ‘‘(ii) to permit analyses of linked data; ‘‘(C) may require device manufacturers to submit such other information as is necessary to facilitate postmarket assessments of device safety and effectiveness and notification of device risks; ‘‘(D) shall establish requirements for regular and timely reports to the Secretary, which shall be included in the registry, concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative safety and outcomes trends; and ‘‘(E) shall establish procedures to permit public access to the information in the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scentists.

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‘‘(5) To carry out this subsection, there are authorized to be appropriated such sums as may be necessary for fiscal years 2010 and 2011.’’. (2) EFFECTIVE DATE.—The Secretary of Health and Human Services shall establish and begin implementation of the registry under section 519 (g) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1), by not later than the date that is 36 months after the date of the enactment of this Act, without regard to whether or not final regulations to establish and operate the registry have been promulgated by such date.

(3) CONFORMING AMENDMENT.—Section 303 (f)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333 (f)(1)(B)(ii)) is amended by striking ‘‘519(g)’’ and inserting ‘‘519(h)’’. (b) ELECTRONIC EXCHANGE AND USE INCERTIFIED ELECTRONIC HEALTH RECORDS OF UNIQUE DEVICE IDENTIFIERS.— (1) RECOMMENDATIONS.—The HIT Policy Committee established under section 3002 of the Public Health Service Act (42 U.S.C. 300jj–12) shall recommend to the head of the Office of the National Coordinator for Health Information Technology standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each device described in section 519(g)(1) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).

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(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA. —The Secretary of the Health Human Services, acting through the head of the Office of the National Coordinator for Health Information Technology, shall adopt standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each device described in paragraph (1), if such an identifier is required by section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device.