S.Amdt. 254Senate111th Congress (2009-2011)2nd degree
S.Amdt. 254
Sponsored by
Sen. Michael B. Enzi (R-WY)
Submitted February 4, 2009
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Senate amendment submitted
February 4, 2009
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Submitted
SA 254. Mr. ENZI submitted an amendment intended to be proposed to amendment SA 98 proposed by Mr. Inouye (for himself and Mr. Baucus) to the bill H.R. 1, making supplemental appropriations for job preservation and creation, infrastructure investment, energy efficiency and science, assistance to the unemployed, and State and local fiscal stabilization, for fiscal year ending September 30, 2009, and for other purposes; which was ordered to lie on the table; as follows: Beginning on page 263, strike line 11 and all that follows through line 21 on page 390, and insert the following: TITLE XIII--HEALTH INFORMATION TECHNOLOGY SEC. 13001. SHORT TITLE. This title may be cited as the ``Wired for Health Care Quality Act''. Subtitle A--Improving the Interoperability of Health Information Technology SEC. 13101. IMPROVING HEALTH CARE QUALITY, SAFETY, AND EFFICIENCY. (a) In General.--The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by adding at the end the following: ``TITLE XXX--HEALTH INFORMATION TECHNOLOGY AND QUALITY ``SEC. 3001. DEFINITIONS; REFERENCE. ``(a) In General.--In this title: ``(1) Entity.--The term `Entity' means the Health IT Standards Entity established under section 3003. ``(2) Health care provider.--The term `health care provider' means a hospital, skilled nursing facility, home health entity, nursing facility, licensed assisted-living facility, health care clinic, federally qualified health center, group practice (as defined in section 1877(h)(4) of the Social Security Act), a pharmacist, a pharmacy, a laboratory, a physician (as defined in section 1861(r) of the Social Security Act), a practitioner (as defined in section 1842(b)(18)(CC) of the Social Security Act), a health facility operated by or pursuant to a contract with the Indian Health Service, a rural health clinic, and any other category of facility or clinician determined appropriate by the Secretary. ``(3) Health information.--The term `health information' has the meaning given such term in section 1171(4) of the Social Security Act. ``(4) Health insurance plan.-- ``(A) In general.--The term `health insurance plan' means-- ``(i) a health insurance issuer (as defined in section 2791(b)(2)); ``(ii) a group health plan (as defined in section 2791(a)(1)); and ``(iii) a health maintenance organization (as defined in section 2791(b)(3)); or ``(iv) a safety net health plan. ``(B) Safety net health plan.--The term `safety net health plan' means a managed care organization, as defined in section 1932(a)(1)(B)(i) of the Social Security Act-- ``(i) that is exempt from or not subject to Federal income tax, or that is owned by an entity or entities exempt from or not subject to Federal income tax; and ``(ii) for which not less than 75 percent of the enrolled population receives benefits under a Federal health care program (as defined in section 1128B(f)(1) of the Social Security Act) or a health care plan or program which is funded, in whole or in part, by a State (other than a program for government employees). ``(C) References.--All references in this title to `health plan' shall be deemed to be references to `health insurance plan'. ``(5) Individually identifiable health information.--The term `individually identifiable health information' has the meaning given such term in section 1171 of the Social Security Act. ``(6) Laboratory.--The term `laboratory' has the meaning given such term in section 353. ``(7) National coordinator.--The term `National Coordinator' means the National Coordinator of Health Information Technology appointed pursuant to section 3002. ``(8) Policy committee.--The term `Policy Committee' means the Health Information Technology Policy Committee established under section 3004. ``(9) Qualified health information technology.--The term `qualified health information technology' means a computerized system (including hardware and software) that-- ``(A) protects the privacy and security of health information; ``(B) maintains and provides permitted access to health information in an electronic format; ``(C) with respect to individually identifiable health information maintained in a designated record set, preserves an audit trail of each individual that has gained access to such record set; ``(D) incorporates decision support to reduce medical errors and enhance health care quality; ``(E) complies with the standards and implementation specifications and certification criteria adopted by the Federal Government under section 3003; ``(F) has the ability to transmit and exchange information to other health information technology systems and, to the extent feasible, public health information technology systems; and ``(G) allows for the reporting of quality measures adopted under section 3010. ``(10) State.--The term `State' means each of the several States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. ``(b) References to Social Security Act.--Any reference in this section to the Social Security Act shall be deemed to be a reference to such Act as in effect on the date of enactment of this title. ``SEC. 3002. OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY. ``(a) Establishment.--There is established within the office of the Secretary, the Office of the National Coordinator for Health Information Technology. The National Coordinator shall be appointed by the Secretary in consultation with the President, and shall report directly to the Secretary. ``(b) Purpose.--The Office of the National Coordinator shall be responsible for-- ``(1) ensuring that key health information technology initiatives are coordinated across programs of the Department of Health and Human Services; ``(2) ensuring that health information technology policies and programs of the Department of Health and Human Services are coordinated with such policies and programs of other relevant Federal agencies (including Federal commissions and advisory committees) with a goal of avoiding duplication of efforts and of helping to ensure that each agency undertakes activities primarily within the areas of its greatest expertise and technical capability; ``(3) reviewing Federal health information technology investments to ensure that Federal health information technology programs are meeting the objectives of the strategic plan published by the Office of the National Coordinator for Health Information Technology to establish a nationwide interoperable health information technology infrastructure; ``(4) providing comments and advice regarding specific Federal health information technology programs, at the request of Office of Management and Budget; and ``(5) enhancing the use of health information technology to improve the quality of health care in the prevention and management of chronic disease and to address population health. ``(c) Role With Policy Committee and Entity.--The Office of the National Coordinator shall-- ``(1) serve as an ex officio member of the Policy Committee, and act as a liaison between the Federal Government and the Policy Committee; ``(2) serve as an ex officio member of the Entity and act as a liaison between the Federal Government and the Entity; and ``(3) serve as a liaison between the Entity and the Policy Committee. ``(d) Reports and Website.--The Office of the National Coordinator shall-- ``(1) develop, publish, and update as necessary a strategic plan for implementing a nationwide interoperable health information technology infrastructure; ``(2) maintain and frequently update an Internet website that-- ``(A) publishes the schedule for the assessment of standards and implementation specifications; ``(B) publishes the recommendations of the Policy Committee; ``(C) publishes the recommendations of the Entity; ``(D) publishes quality measures adopted pursuant to this title and the Wired for Health Care Quality Act; [[Page S1566]] ``(E) identifies sources of funds that will be made available to facilitate the purchase of, or enhance the utilization of, qualified health information technology systems, either through grants or technical assistance; and ``(F) publishes a plan for a transition of any functions of the Office of the National Coordinator that should be continued after September 30, 2014; ``(3) prepare a report on the lessons learned from major public and private health care systems that have implemented health information technology systems, including an explanation of whether the systems and practices developed by such systems may be applicable to and usable in whole or in part by other health care providers; and ``(4) assess the impact of health information technology in communities with health disparities and identify practices to increase the adoption of such technology by health care providers in such communities. ``(e) Rule of Construction.--Nothing in this section shall be construed as requiring the duplication of Federal efforts with respect to the establishment of the Office of the National Coordinator for Health Information Technology, regardless of whether such efforts are carried out before or after the date of the enactment of this title. ``(f) Authorization of Appropriations.--There is authorized to be appropriated to carry out this section, $5,000,000 for each of fiscal years 2009 and 2010. ``(g) Sunset.--The provisions of this section shall not apply after September 30, 2014. ``SEC. 3003. HEALTH INFORMATION TECHNOLOGY STANDARDS ENTITY. ``(a) Establishment.--The Secretary, through a grant, contract, or cooperative agreement, shall provide for the establishment of a public-private entity to be known as the `Health IT Standards Entity' (referred to in this title as the `Entity') to-- ``(1) set priorities and support the development, harmonization, and recognition of standards, implementation specifications, and certification criteria for the electronic exchange of health information (including for the reporting of quality data under section 3010); and ``(2) serve as a forum for the participation of a broad range of stakeholders with specific technical expertise in the development of standards, implementation specifications, and certification criteria to provide input on the effective implementation of health information technology systems. ``(b) Structure.--In providing for the establishment of the Entity pursuant to subsection (a), the Secretary shall ensure the following: ``(1) Diverse composition.--The Entity is initially composed of members representing the Federal Government, consumers and patient organizations, organizations with expertise in privacy, organizations with expertise in security, health care providers, health plans and other third party payers, information technology vendors, purchasers and employers, health informatics and entities engaged in research and academia, health information exchanges, organizations with expertise in infrastructure and technical standards, organizations with expertise in quality improvement, and other appropriate health entities. ``(2) Broad participation.--There is broad participation in the Entity by a variety of public and private stakeholders, either through membership in the Entity or through another means. ``(3) Published business plan; governance rules.--The Entity has a business plan and a published set of governance rules that will enable it to be self-sustaining and to fulfill the purposes stated in this section, and the Entity publishes such plan and such rules on an Internet website that it develops and maintains. ``(4) Chairperson; vice chairperson.--The Entity may designate one member to serve as the chairperson and one member to serve as the vice chairperson of the Entity. ``(5) Department membership.--The Secretary shall be a member of the Entity, and the National Coordinator shall act as a liaison among the Entity, the Community, and the Federal Government. ``(6) Balance among sectors.--In developing the procedures for conducting the activities of the Entity, the Entity shall act to ensure a balance among various sectors of the health care system so that no single sector unduly influences the actions of the Entity. ``(c) Standards and Implementation Specifications.-- ``(1) Activities of the entity.--In providing for the establishment of the Entity pursuant to subsection (a), the Secretary shall ensure the following: ``(A) Publication of schedule.--Not later than 90 days after the date on which the Entity is established, the Entity shall develop and publish a schedule for the assessment of standards and implementation specifications under this section, and update such schedule annually. ``(B) First year standards activity.--Consistent with the initial schedule published under subparagraph (A) and not later than 1 year after date on which the Entity is established, the Entity shall develop, harmonize, or recognize such standards and implementation specifications. ``(C) Subsequent standards activity.--The Entity shall review at least annually, and modify as appropriate, standards and implementation specifications that the Entity has previously developed, harmonized, or recognized, and continue to develop, harmonize, or recognize additional standards and implementation specifications, consistent with the updated schedule published pursuant to subparagraph (A). ``(D) Recognition of entity to make recommendations.--The Entity, in consultation with the Secretary, may recognize a private entity or entities for the purpose of developing, harmonizing, or updating standards and implementation specifications, consistent with this section, and making recommendations on such subjects to the Entity, in order to achieve uniform and consistent implementation of the standards and implementation specifications. ``(E) Standard testing pilot project.--The Entity may conduct, or, in consultation with the Secretary, may recognize a private entity or entities to conduct, a pilot project to test the standards and implementation specifications developed, harmonized, or recognized under this section in order to provide for the efficient implementation of such standards and implementation specifications. ``(2) Review.--The Secretary shall review the standards and implementation specifications described in paragraphs (1)(A) and (1)(B). ``(3) Publication.-- ``(A) Schedule.--The Secretary shall publish the schedules developed under paragraph (1)(A) in the Federal Register and on the Internet website of the Department of Health and Human Services. ``(B) Standards and implementation specifications.--All standards and implementation specifications developed, harmonized, or recognized by the Entity pursuant to this section shall be published in the Federal Register and on the Internet website of the Office of the National Coordinator. ``(4) Federal action.--Not later than 6 months after the issuance of a standard or implementation specification by the Entity under this subsection, the Secretary, the Secretary of Veterans Affairs, and the Secretary of Defense, in collaboration with representatives of other relevant Federal agencies as determined appropriate by the President, shall jointly review such standard or implementation specification. If appropriate, the President shall provide for the adoption by the Federal Government of any such standard or implementation specification. Such determination shall be published in the Federal Register and on the Internet website of the Office of the National Coordinator within 30 days after the date on which such determination is made. ``(d) Open and Public Process.--In providing for the establishment of the Entity pursuant to subsection (a), the Secretary shall ensure the following: ``(1) Consensus approach; open process.--The Entity shall use a consensus approach and a fair and open process to support the development, harmonization, and recognition of standards described in subsection (a)(1). ``(2) Participation of outside advisers.--The Entity shall ensure an adequate opportunity for the participation of outside advisors, including individuals with expertise in-- ``(A) health information privacy; ``(B) health information security; ``(C) health care quality and patient safety, including individuals with expertise in utilizing health information technology to improve healthcare quality and patient safety; ``(D) long-term care and aging services; and ``(E) data exchange and developing health information technology standards and new health information technology. ``(3) Open meetings.--Plenary and other regularly scheduled formal meetings of the Entity (or established subgroups thereof) shall be open to the public. ``(4) Publication of meeting notices and materials prior to meetings.--The Entity shall develop and maintains an Internet website on which it publishes, prior to each meeting, a meeting notice, a meeting agenda, and meeting materials. ``(5) Opportunity for public comment.--The Entity shall develop a process that allows for public comment during the process by which the Entity develops, harmonizes, or recognizes standards and implementation specifications. ``(6) Report.--Not later than 12 months after the date of enactment of this title, the Entity publishes a report on progress made in developing, harmonizing, and recognizing standards, implementation specifications, and certification criteria, and in achieving broad participation of stakeholders in its processes. ``(e) Certification.--In providing for the establishment of the Entity pursuant to subsection (a), the Secretary shall ensure that-- ``(1) the Entity, in consultation with the Secretary, may recognize a private entity or entities for the purpose of developing, updating, and recommending to the Entity criteria to certify that appropriate categories of health information technology products that claim to be in compliance with applicable standards and implementation specifications developed, harmonized, or recognized under this title have established such compliance; ``(2) the Entity, in consultation with the Secretary, reviews, and if appropriate, adopts such criteria; and ``(3) the Entity, in consultation with the Secretary, may recognize a private entity or [[Page S1567]] entities to conduct the certifications described under paragraph (1) using the criteria adopted under this subsection. ``(f) Rule of Construction.--Nothing in this section shall be construed as requiring the duplication of Federal efforts with respect to activities described in this section that are existing on the date of enactment of this title, including the establishment of an entity to support the development, harmonization, or recognition of standards, implementation specifications, and certification criteria, regardless of whether such efforts are carried out prior to or after such date of the enactment. ``(g) Flexibility.--The provisions of Public Law 92-463 (as amended) shall not apply to the Entity. ``(h) Requirement to Consider Recommendations.--In carrying out the activities described in this section, the Entity shall integrate the recommendations of the Policy Committee that are adopted by the Secretary under section 3004(c). ``(i) Authorization of Appropriations.--There are authorized to be appropriated to carry out this section, $2,000,000 for each of the fiscal years 2009 and 2010 to be available until expended. ``SEC. 3004. HEALTH INFORMATION TECHNOLOGY POLICY COMMITTEE. ``(a) Establishment.--There is established a committee to be known as the Health Information Technology Policy Committee to provide advice to the Secretary and the heads of any relevant Federal agencies concerning the policy considerations related to health information technology. ``(b) Purpose.--The Policy Committee shall-- ``(1) not later than 1 year after the date of enactment of this title, and semiannually thereafter, make recommendations concerning a policy framework for the development and adoption of a nationwide interoperable health information technology infrastructure; ``(2) not later than 1 year after the date of enactment of this title, and annually thereafter, make recommendations concerning national policies for adoption by the Federal Government, and voluntary adoption by private entities, to support the widespread adoption of health information technology, including-- ``(A) the protection of individually identifiable health information, including policies concerning the individual's ability to control the acquisition, uses, and disclosures of individually identifiable health information; ``(B) methods to protect individually identifiable health information from improper use and disclosures and methods to notify patients if their individually identifiable health information is wrongfully disclosed; ``(C) methods to facilitate secure access to such individual's individually identifiable health information; ``(D) methods, guidelines, and safeguards to facilitate secure access to patient information by a family member, caregiver, or guardian acting on behalf of a patient due to age-related and other disability, cognitive impairment, or dementia that prevents a patient from accessing the patient's individually identifiable health information; ``(E) the appropriate uses of a nationwide health information network including-- ``(i) the collection of quality data and public reporting; ``(ii) biosurveillance and public health; ``(iii) medical and clinical research; and ``(iv) drug safety; ``(F) fostering the public understanding of health information technology; ``(G) strategies to enhance the use of health information technology in preventing and managing chronic disease; ``(H) policies to take into account the input of employees and staff who are directly involved in patient care of such health care providers in the design, implementation, and use of health information technology systems; ``(I) other policies determined to be necessary by the Policy Committee; and ``(J) best practices in the communication of privacy protections and procedures to ensure comprehension by individuals with limited English proficiency and limited health literacy; and ``(3) serve as a forum for the participation of a broad range of stakeholders to provide input on improving the effective implementation of health information technology systems. ``(c) Publication.--All recommendations made by the Policy Committee pursuant to this section shall be published in the Federal Register and on the Internet website of the National Coordinator. The Secretary shall review all recommendations and determine which recommendations shall be adopted by the Federal Government and such determination shall be published on the Internet website of the Office of the National Coordinator within 30 days after the date of such adoption. ``(d) Membership.-- ``(1) In general.--The Policy Committee shall be composed of members to be appointed as follows: ``(A) 1 member shall be appointed by the Secretary. ``(B) 1 member shall be appointed by the Secretary of Veterans Affairs who shall represent the Department of Veterans Affairs. ``(C) 1 member shall be appointed by the Secretary of Defense who shall represent the Department of Defense. ``(D) 1 member shall be appointed by the majority leader of the Senate. ``(E) 1 member shall be appointed by the minority leader of the Senate. ``(F) 1 member shall be appointed by the Speaker of the House of Representatives. ``(G) 1 member shall be appointed by the minority leader of the House of Representatives. ``(H) Eleven members shall be appointed by the Comptroller General of whom-- ``(i) three members shall represent patients or consumers; ``(ii) one member shall represent health care providers; ``(iii) one member shall be from a labor organization representing health care workers; ``(iv) one member shall have expertise in privacy and security; ``(v) one member shall have expertise in improving the health of vulnerable populations; ``(vi) one member shall represent health plans or other third party payers; ``(vii) one member shall represent information technology vendors; ``(viii) one member shall represent purchasers or employers; and ``(ix) one member shall have expertise in health care quality measurement and reporting. ``(2) Chairperson and vice chairperson.--The Policy Committee shall designate one member to serve as the chairperson and one member to serve as the vice chairperson of the Policy Committee. ``(3) National coordinator.--The National Coordinator shall be a member of the Policy Committee and act as a liaison among the Policy Committee, the Entity, and the Federal Government. ``(4) Participation.--The members of the Policy Committee appointed under paragraph (1) shall represent a balance among various sectors of the health care system so that no single sector unduly influences the recommendations of the Policy Committee. ``(5) Terms.-- ``(A) In general.--The terms of members of the Policy Committee shall be for 3 years except that the Comptroller General shall designate staggered terms for the members first appointed. ``(B) Vacancies.--Any member appointed to fill a vacancy in the membership of the Policy Committee that occurs prior to the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member's term until a successor has been appointed. A vacancy in the Policy Committee shall be filled in the manner in which the original appointment was made. ``(6) Outside involvement.--The Policy Committee shall ensure an adequate opportunity for the participation of outside advisors, including individuals with expertise in-- ``(A) health information privacy and security; ``(B) improving the health of vulnerable populations; ``(C) health care quality and patient safety, including individuals with expertise in measurement and the use of health information technology to capture data to improve health care quality and patient safety; ``(D) long-term care and aging services; ``(E) medical and clinical research; and ``(F) data exchange and developing health information technology standards and new health information technology. ``(7) Quorum.--Ten members of the Policy Committee shall constitute a quorum for purposes of voting, but a lesser number of members may meet and hold hearings. ``(8) Failure of initial appointment.-- ``(A) Forfeiture of authority to appoint.--If, on the date that is 120 days after the date of enactment of this title, an official authorized under paragraph (1) to appoint one or more members of the Policy Committee has not appointed the full number of members that such paragraph authorizes such official to appoint-- ``(i) the number of members that such official is authorized to appoint shall be reduced to the number that such official has appointed as of that date; and ``(ii) the number prescribed in paragraph (7) as the quorum shall be reduced to the smallest whole number that is greater than one-half of the total number of members who have been appointed as of that date. ``(B) Transition rule.--With respect to an official authorized under paragraph (1) to appoint one or more members of the Policy Committee and who has not appointed the full number of members that such paragraph authorizes such official to appoint within the 120-day period described in subparagraph (A), upon a change in such official (resulting from the convening of a new Congress or the swearing in of a new President), a new 120-day period shall begin to run under such subparagraph with respect to the remaining members to be appointed by such official. ``(e) Federal Agencies.-- ``(1) Staff of other federal agencies.--Upon the request of the Policy Committee, the head of any Federal agency may detail, without reimbursement, any of the personnel of such agency to the Policy Committee to assist in carrying out the duties of the Policy Committee. Any such detail shall not interrupt or otherwise affect the civil service status or privileges of the Federal employee involved. ``(2) Technical assistance.--Upon the request of the Policy Committee, the head of a Federal agency shall provide such technical assistance to the Policy Committee as the [[Page S1568]] Policy Committee determines to be necessary to carry out its duties. ``(3) Other resources.--The Policy Committee shall have reasonable access to materials, resources, statistical data, and other information from the Library of Congress and agencies and elected representatives of the executive and legislative branches of the Federal Government. The chairperson or vice chairperson of the Policy Committee shall make requests for such access in writing when necessary. ``(f) Administrative Provisions.-- ``(1) FACA.--The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Policy Committee, except that the term provided for under section 14(a)(2) of such Act shall be not longer than 7 years. ``(2) Charter.-- ``(A) In general.--The Secretary shall file the Policy Committee charter prescribed by section 9(c) of the Federal Advisory Committee Act (5 U.S.C. App.) not later than 120 days after the date of enactment of this title. ``(B) Failure to file.--If the charter described in subparagraph (A) has not been filed by the date specified in such subparagraph, then the requirement under section 9(c) of the Federal Advisory Committee Act (5 U.S.C. App.) shall be deemed to have been met as of the day following the date specified in such subparagraph. ``(g) Sunset.--The provisions of this section shall not apply after September 30, 2014. ``(h) Authorization of Appropriations.--There is authorized to be appropriated to carry out this section, $2,000,000 for each of fiscal years 2009 and 2010. ``SEC. 3005. FEDERAL PURCHASING AND DATA COLLECTION. ``(a) Coordination of Federal Spending.-- ``(1) In general.--Except as provided in paragraph (2), not later than 2 years after the adoption by the President of a recommendation under section 3003(c)(8), a Federal agency shall not expend Federal funds for the purchase of any new health information technology or health information technology system for clinical care or for the electronic retrieval, storage, or exchange of health information if such technology or system is not consistent with applicable standards and implementation specifications adopted by the Federal Government under section 3003. ``(2) Exceptions.--The President may authorize an exception to the requirement in paragraph (1) as determined necessary by the Secretary for the efficient administration of the Federal agency involved or for economic reasons, including a case in which-- ``(A) the purchasing cycles involved preclude modifying specifications without significant costs; and ``(B) a new technology or system must interact with a separate older technology or system whose replacement or modification would impose significant costs. ``(3) Rule of construction.--Nothing in paragraph (1) shall be construed to restrict the purchase of minor (as determined by the Secretary) hardware or software components in order to modify, correct a deficiency in, or extend the life of existing hardware or software. ``(b) Voluntary Adoption.--Any standards and implementation specifications adopted by the Federal Government under section 3003(c)(8) shall be voluntary with respect to private entities. ``(c) Coordination of Federal Data Collection.--Not later than 3 years after the adoption by the Federal Government of a recommendation as provided for in section 3003(c)(8), all Federal agencies collecting health data in an electronic format for the purposes of quality reporting, surveillance, epidemiology, adverse event reporting, research, or for other purposes determined appropriate by the Secretary, shall comply with applicable standards and implementation specifications adopted under such subsection. The requirements of this subsection shall apply to the collection of health data pursuant to programs authorized or required by the Social Security Act only as authorized or required by such Act. ``(d) Electronic Submission.--The Secretary shall implement procedures to enable the Department of Health and Human Services to accept the electronic submission of data for activities described in this title and the Federal Food, Drug, and Cosmetic Act. ``SEC. 3006. QUALITY AND EFFICIENCY REPORTS. ``(a) Purpose.--The purpose of this section is to provide for the development of reports based on Federal health care data and private data that is publicly available or is provided by the entity making the request for the report in order to-- ``(1) improve the quality and efficiency of health care and advance health care research; ``(2) enhance the education and awareness of consumers for evaluating health care services; and ``(3) provide the public with reports on national, regional, and provider- and supplier-specific performance, which may be in a provider- or supplier-identifiable format. ``(b) Procedures for the Development of Reports.-- ``(1) In general.--Notwithstanding section 552(b)(6) or 552a(b) of title 5, United States Code, subject to paragraph (2)(A)(ii), not later than 12 months after the date of enactment of this section, the Secretary, in accordance with the purpose described in subsection (a), shall establish and implement procedures under which an entity may submit a request to a Quality Reporting Organization for the Organization to develop a report based on-- ``(A) Federal health care data disclosed to the Organization under subsection (c); ``(B) private data that is publicly available or is provided to the Organization by the entity making the request for the report; and ``(C) clinical data, when available, used to improve the quality of care, monitor chronic diseases and medical procedures, and includes the following characteristics: ``(i) Has multi-institutional data sources. ``(ii) Is national in scope. ``(iii) Has publicly available protocols that encompass common definitions, data collection, sampling size, methodology, and standardized reporting format. ``(iv) Has an external audit process to ensure adequacy and quality of data. ``(v) Is risk-adjusted to ensure appropriate data comparison. ``(2) Definitions.--In this section: ``(A) Federal health care data.-- ``(i) In general.--Subject to clause (ii), the term `Federal health care data' means-- ``(I) deidentified enrollment data and deidentified claims data maintained by the Secretary or entities under programs, contracts, grants, or memoranda of understanding administered by the Secretary; and ``(II) where feasible, other deidentified enrollment data and deidentified claims data maintained by the Federal Government or entities under contract with the Federal Government. ``(ii) Exception.--The term `Federal health care data' includes data relating to programs administered by the Secretary under the Social Security Act only to the extent that the disclosure of such data is authorized or required under such Act. ``(B) Quality reporting organization.--The term `Quality Reporting Organization' means an entity with a contract under subsection (d). ``(c) Access to Federal Health Care Data.-- ``(1) In general.--The procedures established under subsection (b)(1) shall provide for the secure disclosure of Federal health care data to each Quality Reporting Organization. ``(2) Update of information.--Not less than every 6 months, the Secretary shall update the information disclosed under paragraph (1) to Quality Reporting Organizations. ``(d) Quality Reporting Organizations.-- ``(1) In general.-- ``(A) Contracts.--Subject to subparagraph (B), the Secretary shall enter into a contract with up to 3 private entities to serve as Quality Reporting Organizations under which an entity shall-- ``(i) store the Federal health care data that is to be disclosed under subsection (c); and ``(ii) develop and release reports pursuant to subsection (e). ``(B) Additional contracts.--If the Secretary determines that reports are not being developed and released within 6 months of the receipt of the request for the report, the Secretary shall enter into contracts with additional private entities in order to ensure that such reports are developed and released in a timely manner. ``(2) Qualifications.--The Secretary shall enter into a contract with an entity under paragraph (1) only if the Secretary determines that the entity-- ``(A) has the research capability to conduct and complete reports under this section; ``(B) has in place-- ``(i) an information technology infrastructure to support the database of Federal health care data that is to be disclosed to the entity; and ``(ii) operational standards to provide security for such database; ``(C) has experience with, and expertise on, the development of reports on health care quality and efficiency; and ``(D) has a significant business presence in the United States. ``(3) Contract requirements.--Each contract with an entity under paragraph (1) shall contain the following requirements: ``(A) Ensuring beneficiary privacy.-- ``(i) HIPAA.--The entity shall meet the requirements imposed on a covered entity for purposes of applying part C of title XI and all regulatory provisions promulgated thereunder, including regulations (relating to privacy) adopted pursuant to the authority of the Secretary under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note). ``(ii) Other statutory protections.--The entity shall be required to refrain from disclosing data that could be withheld by the Secretary under section 552 of title 5, United States Code, or whose disclosure by the Secretary would violate section 552a of such title. ``(B) Proprietary information.--The entity shall provide assurances that the entity will not disclose any negotiated price concessions, such as discounts, direct or indirect subsidies, rebates, and direct or indirect remunerations, obtained by health care providers or suppliers or health care plans, or any other proprietary cost information. ``(C) Disclosure.--The entity shall disclose-- ``(i) any financial, reporting, or contractual relationship between the entity and any health care provider or supplier or health care plan; and ``(ii) if applicable, the fact that the entity is managed, controlled, or operated by any [[Page S1569]] health care provider or supplier or health care plan. ``(D) Component of another organization.--If the entity is a component of another organization-- ``(i) the entity shall maintain Federal health care data and reports separately from the rest of the organization and establish appropriate security measures to maintain the confidentiality and privacy of the Federal health care data and reports; and ``(ii) the entity shall not make an unauthorized disclosure to the rest of the organization of Federal health care data or reports in breach of such confidentiality and privacy requirement. ``(E) Termination or nonrenewal.--If a contract under this section is terminated or not renewed, the following requirements shall apply: ``(i) Confidentiality and privacy protections.--The entity shall continue to comply with the confidentiality and privacy requirements under this section with respect to all Federal health care data disclosed to the entity and each report developed by the entity. ``(ii) Disposition of data and reports.--The entity shall-- ``(I) return to the Secretary all Federal health care data disclosed to the entity and each report developed by the entity; or ``(II) if returning the Federal health care data and reports is not practicable, destroy the reports and Federal health care data. ``(4) Competitive procedures.--Competitive procedures (as defined in section 4(5) of the Federal Procurement Policy Act) shall be used to enter into contracts under paragraph (1). ``(5) Review of contract in the event of a merger or acquisition.--The Secretary shall review the contract with a Quality Reporting Organization under this section in the event of a merger or acquisition of the Organization in order to ensure that the requirements under this section will continue to be met. ``(e) Development and Release of Reports Based on Requests.-- ``(1) Request for a report.-- ``(A) Request.-- ``(i) In general.--The procedures established under subsection (b)(1) shall include a process for an entity to submit a request to a Quality Reporting Organization for a report based on Federal health care data and private data that is publicly available or is provided by the entity making the request for the report. Such request shall comply with the purpose described in subsection (a). ``(ii) Request for specific methodology.--The process described in clause (i) shall permit an entity making a request for a report to request that a specific methodology, including appropriate risk adjustment, be used by the Quality Reporting Organization in developing the report. The Organization shall work with the entity making the request to finalize the methodology to be used. ``(iii) Request for a specific qro.--The process described in clause (i) shall permit an entity to submit the request for a report to any Quality Reporting Organization. ``(B) Release to public.--The procedures established under subsection (b)(1) shall provide that at the time a request for a report is finalized under subparagraph (A) by a Quality Reporting Organization, the Organization shall make available to the public, through the Internet website of the Department of Health and Human Services and other appropriate means, a brief description of both the requested report and the methodology to be used to develop such report. ``(2) Development and release of report.-- ``(A) Development.-- ``(i) In general.--If the request for a report complies with the purpose described in subsection (a), the Quality Reporting Organization may develop the report based on the request. ``(ii) Requirement.--A report developed under clause (i) shall include a detailed description of the standards, methodologies, and measures of quality used in developing the report. ``(iii) Risk adjustment.--A Quality Reporting Organization shall ensure that the methodology used to develop a report under clause (i) shall include acceptable risk adjustment and case-mix adjustment developed in consultation with providers as described in clause (iv). ``(iv) Provider consultation.--During the development of the report under clause (i), the Quality Reporting Organization shall consult with a group of not more than 5 providers of the relevant specialty who are appointed by the providers' respective national associations, as to compliance with clauses (ii) and (iii). The comments of the consulted providers shall be included in the public release of the report. ``(B) Review of report by secretary.--Prior to a Quality Reporting Organization releasing a report under subparagraph (C), and within 30 days of receiving a request for such a release, the Secretary shall review the report to ensure that the report was delivered using a scientifically valid methodology including appropriate risk adjustment and case- mix adjustment, and determine that the report does not disclose-- ``(i) information whose disclosure by a covered entity, as such term is defined for purposes of the regulations issued under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, would violate such regulations; or ``(ii) information that could be withheld by the Department of Health and Human Services under section 552 of title 5, United States Code, or whose disclosure by the Department would violate section 552(a) of such title. ``(C) Release of report.-- ``(i) Release to entity making request.--If the Secretary finds that the report complies with the provisions described in subparagraph (B), the Quality Reporting Organization shall release the report to the entity that made the request for the report. ``(ii) Release to public.--The procedures established under subsection (b)(1) shall provide for the following: ``(I) Updated description.--At the time of the release of a report by a Quality Reporting Organization under clause (i), the entity shall make available to the public, through the Internet website of the Department of Health and Human Services and other appropriate means, an updated brief description of both the requested report and the methodology used to develop such report. ``(II) Complete report.--Not later than 1 year after the date of the release of a report under clause (i), the report shall be made available to the public through the Internet website of the Department of Health and Human Services and other appropriate means. ``(f) Annual Review of Reports and Termination of Contracts.-- ``(1) Annual review of reports.--The Comptroller General of the United States shall review reports released under subsection (e)(2)(C) to ensure that such reports comply with the purpose described in subsection (a) and annually submit a report to the Secretary on such review. ``(2) Termination of contracts.--The Secretary may terminate a contract with a Quality Reporting Organization if the Secretary determines that there is a pattern of reports being released by the Organization that do not comply with the purpose described in subsection (a). ``(g) Fees.-- ``(1) Fees for secretary.--The Secretary shall charge a Quality Reporting Organization a fee for-- ``(A) disclosing the data under subsection (c); and ``(B) conducting the review under subsection (e)(2)(B). The Secretary shall ensure that such fees are sufficient to cover the costs of the activities described in subparagraph (A) and (B). ``(2) Fees for qro.-- ``(A) In general.--Subject to subparagraphs (A) and (B), a Quality Reporting Organization may charge an entity making a request for a report a reasonable fee for the development and release of the report. ``(B) Discount for small entities.--In the case of an entity making a request for a report (including a not-for- profit) that has annual revenue that does not exceed $10,000,000, the Quality Reporting Organization shall reduce the reasonable fee charged to such entity under subparagraph (A) by an amount equal to 10 percent of such fee. ``(C) Increase for large entities that do not agree to release reports within 6 months.--In the case of an entity making a request for a report that is not described in subparagraph (B) and that does not agree to the report being released to the public under clause (ii)(II) of subsection (e)(2)(C) within 6 months of the date of the release of the report to the entity under clause (i) of such subsection, the Quality Reporting Organization shall increase the reasonable fee charged to such entity under subparagraph (A) by an amount equal to 10 percent of such fee. ``(D) Rule of construction.--Nothing in this paragraph shall be construed to effect the requirement that a report be released to the public under clause (ii)(II) of subsection (e)(2)(C)(ii)(II) by not later than 1 year after the date of the release of the report to the requesting entity under clause (i) of such subsection. ``(h) Regulations.--Not later than 6 months after the date of enactment of this section, the Secretary shall prescribe regulations to carry out this section. ``SEC. 3007. RESEARCH ACCESS TO HEALTH CARE DATA AND REPORTING ON PERFORMANCE. ``The Secretary shall permit researchers that meet criteria used to evaluate the appropriateness of the release data for research purpose (as established by the Secretary) to-- ``(1) have access to Federal health care data (as defined in section 3006(b)(2)(A)); and ``(2) report on the performance of health care providers and suppliers, including reporting in a provider- or supplier-identifiable format.''. (b) Coordination.--Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall submit a report (including recommendations) to the appropriate committees of Congress concerning the coordination of existing Federal health care quality initiatives. Subtitle B--Facilitating the Widespread Adoption of Interoperable Health Information Technology SEC. 13201. FACILITATING THE WIDESPREAD ADOPTION OF INTEROPERABLE HEALTH INFORMATION TECHNOLOGY. Title XXX of the Public Health Service Act, as added by section 13101, is amended by adding at the end the following: [[Page S1570]] ``SEC. 3008. FACILITATING THE WIDESPREAD ADOPTION OF INTEROPERABLE HEALTH INFORMATION TECHNOLOGY. ``(a) Competitive Grants for Adoption of Technology.-- ``(1) In general.--The Secretary may award competitive grants to eligible entities to facilitate the purchase and enhance the utilization of qualified health information technology systems to improve the quality and efficiency of health care. ``(2) Eligibility.--To be eligible to receive a grant under paragraph (1) an entity shall-- ``(A) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; ``(B) submit to the Secretary a strategic plan for the implementation of data sharing and interoperability standards and implementation specifications; ``(C) adopt the standards and implementation specifications adopted by the Federal Government under section 3003; ``(D) implement the measures adopted under section 3010 and report to the Secretary on such measures; ``(E) agree to notify individuals if their individually identifiable health information is wrongfully disclosed; ``(F) take into account the input of employees and staff who are directly involved in patient care of such health care providers in the design, implementation, and use of qualified health information technology systems; ``(G) demonstrate significant financial need; ``(H) provide matching funds in accordance with paragraph (4); and ``(I) be a-- ``(i) public or not for profit hospital; ``(ii) federally qualified health center (as defined in section 1861(aa)(4) of the Social Security Act); ``(iii) individual or group practice (or a consortium thereof); or ``(iv) another health care provider not described in clause (i) or (ii); that serves medically underserved communities. ``(3) Use of funds.--Amounts received under a grant under this subsection shall be used to-- ``(A) facilitate the purchase of qualified health information technology systems; ``(B) train personnel in the use of such systems; ``(C) enhance the utilization of qualified health information technology systems (which may include activities to increase the awareness among consumers of health care privacy protections); or ``(D) improve the prevention and management of chronic disease. ``(4) Matching requirement.--To be eligible for a grant under this subsection an entity shall contribute non-Federal contributions to the costs of carrying out the activities for which the grant is awarded in an amount equal to $1 for each $3 of Federal funds provided under the grant. ``(5) Preference in awarding grants.--In awarding grants under this subsection the Secretary shall give preference to-- ``(A) eligible entities that will improve the degree to which such entity will link the qualified health information system to local or regional health information plan or plans; and ``(B) with respect to awards made for the purpose of providing care in an outpatient medical setting, entities that organize their practices as a patient-centered medical home. ``(b) Competitive Grants for the Development of State Loan Programs to Facilitate the Widespread Adoption of Health Information Technology.-- ``(1) In general.--The Secretary may award competitive grants to States for the establishment of State programs for loans to health care providers to facilitate the purchase and enhance the utilization of qualified health information technology. ``(2) Establishment of fund.--To be eligible to receive a competitive grant under this subsection, a State shall establish a qualified health information technology loan fund (referred to in this subsection as a `State loan fund') and comply with the other requirements contained in this subsection. Amounts received under a grant under this subsection shall be deposited in the State loan fund established by the State. No funds authorized by other provisions of this title to be used for other purposes specified in this title shall be deposited in any such State loan fund. ``(3) Eligibility.--To be eligible to receive a grant under paragraph (1) a State shall-- ``(A) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; ``(B) submit to the Secretary a strategic plan in accordance with paragraph (4); ``(C) establish a qualified health information technology loan fund in accordance with paragraph (2); ``(D) require that health care providers receiving loans under the grant-- ``(i) link, to the extent practicable, the qualified health information system to a local or regional health information network; ``(ii) consult, as needed, with the Health Information Technology Resource Center established in section 914(d) to access the knowledge and experience of existing initiatives regarding the successful implementation and effective use of health information technology; ``(iii) agree to notify individuals if their individually identifiable health information is wrongfully disclosed; and ``(iv) take into account the input of employees and staff who are directly involved in patient care of such health care providers in the design and implementation and use of qualified health information technology systems; ``(E) require that health care providers receiving loans under the grant adopt the standards adopted by the Federal Government under section 3003; ``(F) require that health care providers receiving loans under the grant implement the measures adopted under section 3010 and report to the Secretary on such measures; and ``(G) provide matching funds in accordance with paragraph (8). ``(4) Strategic plan.-- ``(A) In general.--A State that receives a grant under this subsection shall annually prepare a strategic plan that identifies the intended uses of amounts available to the State loan fund of the State. ``(B) Contents.--A strategic plan under subparagraph (A) shall include-- ``(i) a list of the projects to be assisted through the State loan fund in the first fiscal year that begins after the date on which the plan is submitted; ``(ii) a description of the criteria and methods established for the distribution of funds from the State loan fund; ``(iii) a description of the financial status of the State loan fund and the short-term and long-term goals of the State loan fund; and ``(iv) a description of the strategies the State will use to address challenges in the adoption of health information technology due to limited broadband access. ``(5) Use of funds.-- ``(A) In general.--Amounts deposited in a State loan fund, including loan repayments and interest earned on such amounts, shall be used only for awarding loans or loan guarantees, or as a source of reserve and security for leveraged loans, the proceeds of which are deposited in the State loan fund established under paragraph (1). Loans under this section may be used by a health care provider to-- ``(i) facilitate the purchase of qualified health information technology systems; ``(ii) enhance the utilization of qualified health information technology systems (which may include activities to increase the awareness among consumers of health care of privacy protections and privacy rights); or ``(iii) train personnel in the use of such systems. ``(B) Limitation.--Amounts received by a State under this subsection may not be used-- ``(i) for the purchase or other acquisition of any health information technology system that is not a qualified health information technology system; ``(ii) to conduct activities for which Federal funds are expended under this title, or the amendments made by the Wired for Health Care Quality Act; or ``(iii) for any purpose other than making loans to eligible entities under this section. ``(6) Types of assistance.--Except as otherwise limited by applicable State law, amounts deposited into a State loan fund under this subsection may only be used for the following: ``(A) To award loans that comply with the following: ``(i) The interest rate for each loan shall be less than or equal to the market interest rate. ``(ii) The principal and interest payments on each loan shall commence not later than 1 year after the date on which the loan was awarded, and each loan shall be fully amortized not later than 10 years after such date. ``(iii) The State loan fund shall be credited with all payments of principal and interest on each loan awarded from the fund. ``(B) To guarantee, or purchase insurance for, a local obligation (all of the proceeds of which finance a project eligible for assistance under this subsection) if the guarantee or purchase would improve credit market access or reduce the interest rate applicable to the obligation involved. ``(C) As a source of revenue or security for the payment of principal and interest on revenue or general obligation bonds issued by the State if the proceeds of the sale of the bonds will be deposited into the State loan fund. ``(D) To earn interest on the amounts deposited into the State loan fund. ``(7) Administration of state loan funds.-- ``(A) Combined financial administration.--A State may (as a convenience and to avoid unnecessary administrative costs) combine, in accordance with State law, the financial administration of a State loan fund established under this subsection with the financial administration of any other revolving fund established by the State if not otherwise prohibited by the law under which the State loan fund was established. ``(B) Cost of administering fund.--Each State may annually use not to exceed 4 percent of the funds provided to the State under a grant under this subsection to pay the reasonable costs of the administration of the programs under this section, including the recovery of reasonable costs expended to establish a State loan fund which are incurred after the date of enactment of this title. [[Page S1571]] ``(C) Guidance and regulations.--The Secretary shall publish guidance and promulgate regulations as may be necessary to carry out the provisions of this subsection, including-- ``(i) provisions to ensure that each State commits and expends funds allotted to the State under this subsection as efficiently as possible in accordance with this title and applicable State laws; and ``(ii) guidance to prevent waste, fraud, and abuse. ``(D) Private sector contributions.-- ``(i) In general.--A State loan fund established under this subsection may accept contributions from private sector entities, except that such entities may not specify the recipient or recipients of any loan issued under this subsection. ``(ii) Availability of information.--A State shall make publicly available the identity of, and amount contributed by, any private sector entity under clause (i) and may issue letters of commendation or make other awards (that have no financial value) to any such entity. ``(8) Matching requirements.-- ``(A) In general.--The Secretary may not make a grant under paragraph (1) to a State unless the State agrees to make available (directly or through donations from public or private entities) non-Federal contributions in cash toward the costs of the State program to be implemented under the grant in an amount equal to not less than $1 for each $1 of Federal funds provided under the grant. ``(B) Determination of amount of non-federal contribution.--In determining the amount of non-Federal contributions that a State has provided pursuant to subparagraph (A), the Secretary may not include any amounts provided to the State by the Federal Government. ``(9) Preference in awarding grants.--The Secretary may give a preference in awarding grants under this subsection to States that adopt value-based purchasing programs to improve health care quality. ``(10) Reports.--The Secretary shall annually submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate, and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives, a report summarizing the reports received by the Secretary from each State that receives a grant under this subsection. ``(c) Competitive Grants for the Implementation of Regional or Local Health Information Technology Plans.-- ``(1) In general.--The Secretary may award competitive grants to eligible entities to implement regional or local health information plans to improve health care quality and efficiency through the electronic exchange of health information pursuant to the standards, implementation specifications and certification criteria, and other requirements adopted by the Secretary under section 3010. ``(2) Eligibility.--To be eligible to receive a grant under paragraph (1) an entity shall-- ``(A) demonstrate financial need to the Secretary; ``(B) demonstrate that one of its principal missions or purposes is to use information technology to improve health care quality and efficiency; ``(C) adopt bylaws, memoranda of understanding, or other charter documents that demonstrate that the governance structure and decisionmaking processes of such entity allow for participation on an ongoing basis by multiple stakeholders within a community, including-- ``(i) health care providers (including health care providers that provide services to low income and underserved populations); ``(ii) pharmacists or pharmacies; ``(iii) health plans; ``(iv) health centers (as defined in section 330(b)) and federally qualified health centers (as defined in section 1861(aa)(4) of the Social Security Act) and rural health clinics (as defined in section 1861(aa) of the Social Security Act), if such centers or clinics are present in the community served by the entity; ``(v) patient or consumer organizations; ``(vi) organizations dedicated to improving the health of vulnerable populations; ``(vii) employers; ``(viii) State or local health departments; and ``(ix) any other health care providers or other entities, as determined appropriate by the Secretary; ``(D) demonstrate the participation, to the extent practicable, of stakeholders in the electronic exchange of health information within the local or regional plan pursuant to subparagraph (C); ``(E) adopt nondiscrimination and conflict of interest policies that demonstrate a commitment to open, fair, and nondiscriminatory participation in the health information plan by all stakeholders; ``(F) adopt the standards and implementation specifications adopted by the Secretary under section 3003; ``(G) require that health care providers receiving such grants-- ``(i) implement the measures adopted under section 3010 and report to the Secretary on such measures; and ``(ii) take into account the input of employees and staff who are directly involved in patient care of such health care providers in the design, implementation, and use of health information technology systems; ``(H) agree to notify individuals if their individually identifiable health information is wrongfully disclosed; ``(I) facilitate the electronic exchange of health information within the local or regional area and among local and regional areas; ``(J) prepare and submit to the Secretary an application in accordance with paragraph (3); ``(K) agree to provide matching funds in accordance with paragraph (5); and ``(L) reduce barriers to the implementation of health information technology by providers. ``(3) Application.-- ``(A) In general.--To be eligible to receive a grant under paragraph (1), an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. ``(B) Required information.--At a minimum, an application submitted under this paragraph shall include-- ``(i) clearly identified short-term and long-term objectives of the regional or local health information plan; ``(ii) a technology plan that complies with the standards, implementation specifications, and certification criteria adopted under section 3003(c)(8) and that includes a descriptive and reasoned estimate of costs of the hardware, software, training, and consulting services necessary to implement the regional or local health information plan; ``(iii) a strategy that includes initiatives to improve health care quality and efficiency, including the use and reporting of health care quality measures adopted under section 3010; ``(iv) a plan that describes provisions to encourage the implementation of the electronic exchange of health information by all health care providers participating in the health information plan; ``(v) a plan to ensure the privacy and security of individually identifiable health information that is consistent with Federal and State law; ``(vi) a governance plan that defines the manner in which the stakeholders shall jointly make policy and operational decisions on an ongoing basis; ``(vii) a financial or business plan that describes-- ``(I) the sustainability of the plan; ``(II) the financial costs and benefits of the plan; and ``(III) the entities to which such costs and benefits will accrue; ``(viii) a description of whether the State in which the entity resides has received a grant under section 319D, alone or as a part of a consortium, and if the State has received such a grant, how the entity will coordinate the activities funded under such section 319D with the system under this section; and ``(ix) in the case of an applicant entity that is unable to demonstrate the participation of all stakeholders pursuant to paragraph (2)(C), the justification from the entity for any such nonparticipation. ``(4) Use of funds.--Amounts received under a grant under paragraph (1) shall be used to establish and implement a regional or local health information plan in accordance with this subsection. ``(5) Matching requirement.-- ``(A) In general.--The Secretary may not make a grant under this subsection to an entity unless the entity agrees that, with respect to the costs to be incurred by the entity in carrying out the infrastructure program for which the grant was awarded, the entity will make available (directly or through donations from public or private entities) non- Federal contributions toward such costs in an amount equal to not less than $1 for each $2 of Federal funds provided under the grant. ``(B) Determination of amount contributed.--Non-Federal contributions required under subparagraph (A) may be in cash or in kind, fairly evaluated, including equipment, technology, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions. ``(d) Reports.--Not later than 1 year after the date on which the first grant is awarded under this section, and annually thereafter during the grant period, an entity that receives a grant under this section shall submit to the Secretary a report on the activities carried out under the grant involved. Each such report shall include-- ``(1) a description of the financial costs and benefits of the project involved and of the entities to which such costs and benefits accrue; ``(2) an analysis of the impact of the project on health care quality and safety; ``(3) a description of any reduction in duplicative or unnecessary care as a result of the project involved; and ``(4) other information as required by the Secretary. ``(e) Requirement To Achieve Quality Improvement.--The Secretary shall annually evaluate the activities conducted under this section and shall, in awarding grants, implement the lessons learned from such evaluations in a manner so that awards made subsequent to each such evaluation are made in a manner that, in the determination of the Secretary, will result in the greatest improvement in quality measures under section [[Page S1572]] 3010. The Secretary shall ensure that such evaluation take into account differences in patient health status, patient characteristics, and geographic location, as appropriate. ``(f) Limitations.-- ``(1) Eligible entities.--An eligible entity may only receive 1 non-renewable grant under subsection (a) and one non-renewable grant under subsection (c). ``(2) Loan recipients.--A health care provider may only receive 1 non-renewable loan awarded or guaranteed with funds provided under subsection (b), ``(g) Authorization of Appropriations.-- ``(1) In general.--For the purpose of carrying out this section, there is authorized to be appropriated $139,000,000 for fiscal year 2009 and $139,000,000 for fiscal year 2010. ``(2) Availability.--Amounts appropriated under paragraph (1) shall remain available through fiscal year 2012. ``SEC. 3009. DEMONSTRATION PROGRAM TO INTEGRATE INFORMATION TECHNOLOGY INTO CLINICAL EDUCATION. ``(a) In General.--The Secretary may award grants to eligible entities or consortia under this section to carry out demonstration projects to develop academic curricula integrating qualified health information technology systems in the clinical education of health professionals or analyze clinical data sets from electronic health records to discover quality measures. Such awards shall be made on a competitive basis and pursuant to peer review. ``(b) Eligibility.--To be eligible to receive a grant under subsection (a), an entity or consortium shall-- ``(1) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; ``(2) be or include-- ``(A) a health professions school; ``(B) a school of public health; ``(C) a school of nursing; or ``(D) an institution with a graduate medical education program; ``(3) provide for the collection of data regarding the effectiveness of the demonstration project to be funded under the grant in improving the safety of patients and the efficiency of health care delivery; and ``(4) provide matching funds in accordance with subsection (d). ``(c) Use of Funds.-- ``(1) In general.--With respect to a grant under subsection (a), an eligible entity or consortium shall use amounts received under the grant in collaboration with 2 or more disciplines. ``(2) Limitation.--An eligible entity or consortium shall not award a grant under subsection (a) to purchase hardware, software, or services. ``(d) Matching Funds.-- ``(1) In general.--The Secretary may award a grant to an entity or consortium under this section only if the entity or consortium agrees to make available non-Federal contributions toward the costs of the program to be funded under the grant in an amount that is not less than $1 for each $2 of Federal funds provided under the grant. ``(2) Determination of amount contributed.--Non-Federal contributions under paragraph (1) may be in cash or in kind, fairly evaluated, including equipment or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such contributions. ``(e) Evaluation.--The Secretary shall take such action as may be necessary to evaluate the projects funded under this section and publish, make available, and disseminate the results of such evaluations on as wide a basis as is practicable. ``(f) Reports.--Not later than 1 year after the date of enactment of this title, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate, and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives a report that-- ``(1) describes the specific projects established under this section; and ``(2) contains recommendations for Congress based on the evaluation conducted under subsection (e). ``(g) Authorization of Appropriations.--There is authorized to be appropriated to carry out this section, $2,000,000 for each of fiscal years 2009 and 2010. ``(h) Sunset.--This provisions of this section shall not apply after September 30, 2012.''. Subtitle C--Improving the Quality of Health Care SEC. 13301. CONSENSUS PROCESS FOR THE ADOPTION OF QUALITY MEASURES FOR USE IN THE NATIONWIDE INTEROPERABLE HEALTH INFORMATION TECHNOLOGY INFRASTRUCTURE. Title XXX of the Public Health Service Act, as amended by section 13201, is further amended by adding at the end the following: ``SEC. 3010. FOSTERING DEVELOPMENT AND USE OF HEALTH CARE QUALITY MEASURES. ``(a) In General.--Only for purposes of activities conducted under this title, and excluding all programs authorized under the Social Security Act, the Secretary shall provide for the endorsement and use of health care quality measures (referred to in this title as `quality measures') for the purpose of measuring the quality and efficiency of health care that patients receive pursuant to programs authorized under this title. ``(b) Designation of, and Arrangement With, Organization.-- ``(1) In general.--Not later than 90 days after the date of enactment of this title, the Secretary shall designate, and have in effect an arrangement with, a single organization that meets the requirements of subsection (c) under which such organization shall promote the development of quality measures by a variety of quality measurement development organizations, including the Physician Consortium for Performance Improvement, the National Committee for Quality Assurance, and others, only for purposes of activities conducted under this title and provide the Secretary with advice and recommendations on the key elements and priorities of a national system for health care quality measurement for purposes of activities conducted under this title. ``(2) Responsibilities.--The responsibilities to be performed by the organization designated under paragraph (1) (in this title referred to as the `designated organization') shall include-- ``(A) establishing and managing an integrated strategy and process for setting priorities and goals in establishing quality measures only for purposes of activities conducted under this title; ``(B) coordinating and harmonizing the development and testing of such measures; ``(C) establishing standards for the development and testing of such measures; ``(D) endorsing national consensus quality measures; ``(E) recommending, in collaboration with multi-stakeholder groups, quality measures to the Secretary for adoption and use only for purposes of activities conducted under this title; ``(F) promoting the development and use of electronic health records that contain the functionality for automated collection, aggregation, and transmission of performance measurement information; and ``(G) providing recommendations and advice to the Entity regarding the integration of quality measures into the standards, implementation specification, and certification criteria adoption process outlined under section 3003 and the Policy Committee regarding national policies outlined under section 3004. ``(c) Requirements Described.--The requirements described in this subsection are the following: ``(1) Private entity.--The organization shall be a private nonprofit entity that is governed by a board of directors and an individual who is designated as president and chief executive officer. ``(2) Board membership.--The members of the board of directors of the entity shall include representatives of-- ``(A) health care providers or groups representing providers; ``(B) health plans or groups representing health plans; ``(C) patients or consumers enrolled in such plans or groups representing individuals enrolled in such plans; ``(D) health care purchasers and employers or groups representing purchasers or employers; and ``(E) organizations that develop health information technology standards and new health information technology. ``(3) Other membership requirements.--The membership of the board of directors of the entity shall be representative of individuals with experience with-- ``(A) urban health care issues; ``(B) safety net health care issues; ``(C) rural or frontier health care issues; ``(D) quality and safety issues; ``(E) State or local health programs; ``(F) individuals or entities skilled in the conduct and interpretation of biomedical, health services, and health economics research and with expertise in outcomes and effectiveness research and technology assessment; and ``(G) individuals or entities involved in the development and establishment of standards and certification for health information technology systems and clinical data. ``(4) Open and transparent.--With respect to matters related to the arrangement with the Secretary under subsection (a)(1), the organization shall conduct its business in an open and transparent manner, and provide the opportunity for public comment and ensure a balance among disparate stakeholders, so that no member organization unduly influences the work of the organization. ``(5) Voluntary consensus standards setting organizations.--The organization shall operate as a voluntary consensus standards setting organization as defined for purposes of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (Public Law 104-113) and Office of Management and Budget Revised Circular A-119 (published in the Federal Register on February 10, 1998). ``(6) Participation.--If the organization requires a fee for membership, the organization shall ensure that such fee is not a substantial barrier to participation in the entity's activities related to the arrangement with the Secretary. ``(d) Requirements for Measures.--The quality measures developed under this title only for purposes of activities conducted under this title shall comply with the following: ``(1) Measures.--The designated organization, in promoting the development of quality measures under this title, shall ensure that such measures-- ``(A) are evidence-based, reliable, and valid; [[Page S1573]] ``(B) include-- ``(i) measures of clinical processes and outcomes, patient experience, efficiency, and equity; and ``(ii) measures to assess effectiveness, timeliness, patient self-management, patient centeredness, and safety; and ``(C) include measures of underuse and overuse. ``(2) Priorities.--In carrying out its responsibilities under this section, the designated organization shall ensure that priority is given to-- ``(A) measures with the greatest potential impact for improving the performance and efficiency of care; ``(B) measures that may be rapidly implemented by group health plans, health insurance issuers, physicians, hospitals, nursing homes, long-term care providers, and other providers; ``(C) measures which may inform health care decisions made by consumers and patients; ``(D) measures that apply to multiple services furnished by different providers during an episode of care; ``(E) measures that can be integrated into the standards, implementation specifications, and the certification criteria adoption process described in section 3003; and ``(F) measures that may be integrated into the decision support function of qualified health information technology as defined by this title. ``(3) Risk adjustment.--The designated organization, in consultation with performance measure developers and other stakeholders, shall establish procedures to ensure that quality measures take into account differences in patient health status, patient characteristics, and geographic location, as appropriate. ``(4) Maintenance.--The designated organization, in consultation with owners and developers of quality measures, shall have in place protocols designed to ensure that such measures are current and reflect the most recent available evidence and clinical guidelines. ``(e) Grants for Performance Measure Development.--The Secretary, acting through the Agency for Healthcare Research and Quality, may award grants, in amounts not to exceed $50,000 each, to organizations to support the development and testing of quality measures that meet the standards established by the designated organization. ``(f) Adoption and Use of Quality Measures.--For purposes of carrying out activities authorized or required under this title to ensure the use of quality measures and to foster uniformity between health care quality measures utilized by private entities, the Secretary shall-- ``(1) select quality measures for adoption and use, from quality measures recommended by multi-stakeholder groups and endorsed by the designated organization; and ``(2) ensure that the standards and implementation specifications adopted under section 3003 integrate the quality measures endorsed, adopted, and utilized under this section. ``SEC. 3011. RELATIONSHIP WITH PROGRAMS UNDER THE SOCIAL SECURITY ACT. ``(a) In General.--For purposes of carrying out activities authorized or required under this title, the Secretary shall ensure that the quality measures not described in subsection (b) and adopted under this title-- ``(1) complement quality measures developed by the Secretary under programs administered by the Secretary under the Social Security Act, including programs under titles XVIII, XIX, and XXI of such Act; and ``(2) do not conflict with the needs, priorities, and activities of programs authorized or required under titles XVIII, XIX, and XXI of such Act, as set forth by the Administrator of the Centers for Medicare & Medicaid Services. ``(b) Adoption of Medicare, Medicaid, and SCHIP Measures.-- Where quality measures developed and endorsed through a multi-stakeholder consensus process under title XVIII, XIX, or XXI of the Social Security Act are available and appropriate, the Secretary shall adopt such measures for activities under this title. ``(c) Nonduplication of Social Security Act Reporting Requirements.--If a grantee under section 3008 reports on quality measures to the Secretary under title XVII, XIX, or XXI of the Social Security Act, such grantee is deemed to have met the quality reporting requirement under such section 3008, provided that such reporting is conducted utilizing a qualified health information technology system.''. Subtitle D--Privacy and Security SEC. 13401. PRIVACY AND SECURITY. Title XXX of the Public Health Service Act, as amended by section 13301, is further amended by adding at the end the following: ``SEC. 3012. PRIVACY AND SECURITY. ``(a) Privacy and Security of Personal Health Records.--Not later than 180 days after the date of enactment of this title, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate, the Committee on the Judiciary of the Senate, the Committee on the Judiciary of the House of Representatives, and the Committee on Energy and Commerce of the House of Representatives, a report containing recommendations for privacy and security protections for personal health records, including whether it is appropriate to apply any provisions of subpart E of part 164 of title 45, Code of Federal Regulations, to such records and the extent to which the implementation of separate privacy and security measures is necessary. In making such recommendations, the Secretary shall to the maximum extent practicable avoid the application of new regulations that would be inconsistent, or conflict, with privacy regulations that are in effect on the date of enactment of this title. ``(b) Definition.--In this section, the term `personal health record' means an electronic, cumulative record of health-related information concerning an individual that is often drawn from multiple sources, that is offered by an entity that is not a covered entity or a business associate acting pursuant to a business associate agreement under the Health Insurance Portability and Accountability Act of 1996 (and the regulations promulgated under such Act) and that is primarily intended to be used and managed by the individual. ``(c) Marketing.--For purposes of the regulations promulgated pursuant to part C of title XI of the Social Security Act and section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note), referred to in this title as the `HIPAA Privacy Rule', the term `marketing' means, in addition to the activities described in section 164.501 of the HIPAA Privacy Rule (45 C.F.R. 164.501) and any comparable provision in any amended or superseding rule, an arrangement whereby a covered entity, in exchange for remuneration, makes a communication described in clause (i), (ii), or (iii) of paragraph (1) of the definition of marketing in section 164.501 of the HIPAA Privacy Rule (45 C.F.R. 164.501) as in effect on the date of enactment of this title, except that the Secretary shall promulgate regulations establishing the terms and conditions under which covered entities may charge an appropriate fee for making such communications. This subsection shall become effective on the date that is 90 days after the date on which the Secretary has promulgated such regulations. ``(d) Right of Individuals to Electronic Access.--With respect to the right of access to inspect and obtain a copy of health information under the HIPAA Privacy Rule, effective not later than 180 days after the later of the date of enactment of this title or the issuance of guidance by the Secretary, any entity that maintains health information in an electronic form shall, to the extent readily producible, provide an individual access to that information in the form or format requested, and upon request, an electronic copy of such records. The Secretary shall issue such guidance as is necessary to implement this subsection. ``(e) Rights of Individuals Who Are Victims of Medical Fraud.--To the extent provided for under the HIPAA privacy regulations and under the conditions specified in such regulations, with respect to protected health information, an individual who is a victim of medical fraud or who believes that there is an error in their protected health information stored in an electronic format shall have the right-- ``(1) to have access to inspect and obtain a copy of protected health information about the individual, including the information fraudulently entered, in a designated record set; and ``(2) to have a covered entity amend protected health information or a record about the individual, including information fraudulently entered, in a designated electronic record set for as long as the protected health information is maintained in the designated electronic record set to ensure that fraudulent and inaccurate health information is not shared or re-reported. ``(f) Rule of Construction.--Nothing in this section shall be construed to supercede or otherwise limit the provisions of any contract that provides for the application of privacy protections that are greater than the privacy protections provided for under the regulations promulgated under section 264 of the Health Insurance Portability and Accountability Act of 1996. ``SEC. 3013. NOTICE OF PRIVACY PRACTICES. ``Not later than 1 year after the date of enactment of this title, and after notice and comment, the Secretary shall develop and disseminate a model summary notice of privacy practices for use with the privacy notice required under the HIPAA Privacy Rule. Such summary notice shall be suitable for printing on one page and shall include separate statements on any marketing uses for which authorization is sought, shall describe the right to object to such uses in an way that is easily understood, and shall otherwise describe the elements of the right to privacy and security in a clear and concise manner. Such summary notice shall be provided in a form separate from any other notice or consent requests. ``SEC. 3014. REPORTING. ``Not later than 180 days after the date of enactment of this title, and every year thereafter for the next 5 years, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate, the Committee on the Judiciary of the Senate, the Committee on the Judiciary of the House of Representatives, and the Committee on Energy and Commerce of the House of Representatives, a report on compliance and enforcement under the HIPAA Privacy Rule. Such report shall include-- ``(1) the number of complaints filed; ``(2) the resolution or disposition of each complaint; ``(3) the amount of civil money penalties imposed; [[Page S1574]] ``(4) the number of compliance reviews conducted and the outcome of each such review; ``(5) the number of subpoenas or closed cases; and ``(6) the Secretary's plan for improving compliance and enforcement in the coming year. ``SEC. 3015. NOTIFICATION OF PRIVACY BREACH. ``Not later than 1 year after the date of enactment of this title, and after notice and comment, the Secretary shall provide for the development of standards and protections and determine appropriate protocols regarding the notification trigger, methods, and contents of the notification by the entity responsible for the protected health information to an individual whose protected health information has been lost, stolen, or otherwise disclosed for an unauthorized purpose. Such notification shall be made within 60 days of the discovery that such information has been lost, stolen, or otherwise disclosed. The Secretary shall include exemptions to such standards and protection for law enforcement and national security purposes. The Secretary shall determine penalties to be imposed on entities that fail to comply with this section in accordance with sections 1176 and 1177 of the Social Security Act. ``SEC. 3016. ACCOUNTABILITY. ``(a) Subcontracting and Outsourcing Overseas.--In the event an entity subject to this title contracts with service providers that are not subject to this title, including service providers operating in a foreign country, such entity shall-- ``(1) take reasonable steps to select and retain third party service providers capable of maintaining appropriate safeguards for the security, privacy, and integrity of protected health information; and ``(2) require by contract that such service providers implement and maintain appropriate measures designed to meet the requirements of entities subject to this title. ``(b) Compliance Assistance.--The Secretary shall ensure there is a capacity to assist covered entities to determine the appropriate elements to be considered in arranging contracts with service providers who are not subject to this title. ``(c) Effective Date.--This section shall take effect on the date that is 30 days after the date on which the Secretary transmits to the Committee on Health, Education, Labor, and Pension of the Senate and the Committee on Energy and Commerce of the House of Representatives a statement that the Secretary has complied with the requirements of subsection (b).''. Subtitle E--Miscellaneous Provisions SEC. 13501. GAO STUDY. Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate, the Committee on the Judiciary of the Senate, the Committee on the Judiciary of the House of Representatives, and the Committee on Energy and Commerce of the House of Representatives, a report on the overall effectiveness and compliance of the efforts of the Secretary of Health and Human Services to implement health privacy safeguards provided for in this title, and any recommendations on how to improve effectiveness and compliance, if any. SEC. 13502. HEALTH INFORMATION TECHNOLOGY RESOURCE CENTER. Section 914 of the Public Health Service Act (42 U.S.C. 299b-3) is amended by adding at the end the following: ``(d) Health Information Technology Resource Center.-- ``(1) In general.--The Secretary, acting through the Director, shall develop a Health Information Technology Resource Center (referred to in this subsection as the `Center') to provide technical assistance and develop best practices to support and accelerate efforts to adopt, implement, and effectively use interoperable health information technology in compliance with sections 3003 and 3010. ``(2) Purposes.--The purposes of the Center are to-- ``(A) provide a forum for the exchange of knowledge and experience; ``(B) accelerate the transfer of lessons learned from existing public and private sector initiatives, including those currently receiving Federal financial support; ``(C) assemble, analyze, and widely disseminate evidence and experience related to the adoption, implementation, and effective use of interoperable health information technology; ``(D) provide for the establishment of regional and local health information networks to facilitate the development of interoperability across health care settings and improve the quality of health care; ``(E) provide for the development of solutions to barriers to the exchange of electronic health information; and ``(F) conduct other activities identified by the States, local, or regional health information networks, or health care stakeholders as a focus for developing and sharing best practices. ``(3) Support for activities.--To provide support for the activities of the Center, the Director shall modify the requirements, if necessary, that apply to the National Resource Center for Health Information Technology to provide the necessary infrastructure to support the duties and activities of the Center and facilitate information exchange across the public and private sectors. ``(4) Rule of construction.--Nothing in this subsection shall be construed to require the duplication of Federal efforts with respect to the establishment of the Center, regardless of whether such efforts were carried out prior to or after the enactment of this subsection. ``(e) Authorization of Appropriations.--There is authorized to be appropriated, such sums as may be necessary for each of fiscal years 2009 and 2010 to carry out this section.''. SEC. 13503. FACILITATING THE PROVISION OF TELEHEALTH SERVICES ACROSS STATE LINES. Section 330L of the Public Health Service Act (42 U.S.C. 254c-18) is amended to read as follows: ``SEC. 330L. TELEMEDICINE; INCENTIVE GRANTS REGARDING COORDINATION AMONG STATES. ``(a) Facilitating the Provision of Telehealth Services Across State Lines.--The Secretary may make grants to States that have adopted regional State reciprocity agreements for practitioner licensure, in order to expedite the provision of telehealth services across State lines. ``(b) Authorization of Appropriations.--For the purpose of carrying out subsection (a), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2009 and 2010.''. Beginning on page 648, strike line 1 and all that follows through line 9 on page 713. ______