II 109th CONGRESS 2d Session S. 3897 IN THE SENATE OF THE UNITED STATES September 14, 2006 Mr. Grassley (for himself and Mr. Baucus) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend titles XI and XVIII of the Social Security Act to provide for the sharing of certain data collected by the Centers for Medicare & Medicaid Services with certain agencies, research centers and organizations, and congressional support agencies.

1.

Short title

This Act may be cited as the Medicare Data Access and Research Act.

2.

Findings

Congress makes the following findings: (1)The new Medicare drug benefit under part D of title XVIII of the Social Security Act is delivered through private prescription drug plans. Private plans submit administrative and beneficiary level data to the Centers for Medicare & Medicaid Services as a condition of participation and payment in the new Medicare drug program. (2)Data from the new Medicare drug benefit can be linked with hospital, ambulatory care, and other data to create a new comprehensive resource for the study of drug safety and effectiveness of medical care in older adults and low-income, disabled, and vulnerable populations. With appropriate protections for privacy, this data should be available to the Food and Drug Administration, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, and the National Institutes of Health, and university-based research centers and other research organizations interested in furthering the public health through research on the safety, effectiveness, and quality of health care services provided under the Medicare program under title XVIII of the Social Security Act. (3)Timely and ready access to certain data from the new Medicare drug benefit will allow congressional support agencies to inform and advise Congress on the cost, scope, and impact of the new benefit and assess its quality.

3.

Drug and health care data release

(a)

In general

Title XI of the Social Security Act (42 U.S.C. 1301 et seq.) is amended by inserting after section 1121 the following new sections:

1121A.

Drug and health care claims data release

(a)

In general

Notwithstanding any provision under part D of title XVIII that limits the use of prescription drug data collected under such part, for the purpose of improving the public’s health, the Secretary, acting through the Centers for Medicare & Medicaid Services, shall— (1)enter into data release agreements on an annual basis with the agencies described in subsection (b) to provide access to relevant data submitted by prescription drug plans and MA–PD plans under part D of title XVIII, excluding negotiated price concessions under such part (such as discounts, direct or indirect subsidies, rebates, and direct or indirect remunerations), and linked to hospital, physician, and other relevant medical claims, utilization, and diagnostic data collected under titles XVIII and XIX, including data from the uniform reporting systems established under section 1121(a); and (2)permit agencies described in such subsection to link data provided under this section with other relevant health data, including survey data, vital statistics, and disease registries, as needed by the agency in order to accomplish its research objectives. (b)

Agencies described

The agencies described in this subsection are as follows: (1)The Food and Drug Administration. (2)The Centers for Disease Control and Prevention. (3)The Agency for Healthcare Research and Quality. (4)The National Institutes of Health. (c)

Use of the data provided

Data provided under a data release agreement under subsection (a)(1) shall only be used for the following purposes: (1)

FDA

In the case of the Food and Drug Administration, to enhance post marketing surveillance by— (A)studying patterns of drug and vaccine utilization over time after a drug has been placed on the market; (B)studying health risks associated with such utilization, particularly with respect to improving the speed of risk identification in order to mitigate or resolve such risks; (C)studying drug utilization in order to promote consumer education that would allow consumers and health care providers to make informed product choices and informed drug compliance choices; and (D)performing such other functions, consistent with the purposes of this section and the Agency’s mission, as are determined appropriate by the Secretary. (2)

CDC

In the case of the Centers for Disease Control and Prevention, to— (A)improve surveillance of clinical outbreaks and emerging threats; (B)study immunization rates; (C)study outcomes of specific diseases; (D)develop and monitor the use of preventive screening protocols using claims data; (E)study drug and medical utilization in order to promote consumer education and treatment for specific public health risks; and (F)perform such other functions, consistent with the purposes of this section and the Agency’s mission, as are determined appropriate by the Secretary. (3)

AHRQ

In the case of the Agency for Healthcare Research and Quality, to— (A)carry out the Agency’s research obligations under section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003; (B)conduct research consistent with the Agency’s mission to improve the quality, safety, efficiency, and effectiveness of health care; and (C)perform such other functions, consistent with the purposes of this section and such mission, as are determined appropriate by the Secretary. (4)

NIH

In the case of the National Institutes of Health, to— (A)help prevent, detect, diagnose, and treat disease and disabilities; and (B)perform such other functions, consistent with the purposes of this section and the Agency’s mission, as are determined appropriate by the Secretary. (d)

Timeframe for data release

A data release agreement entered into under this section shall provide for the release of information as needed by the Agency for the uses described in subsection (c). (e)

Data release procedures

(1)

Determining appropriate level and elements of data for release

(A)

In general

The Secretary shall establish a process to determine the appropriate level and elements of data to be released to an Agency under this section in order to ensure that the Agency, and researchers within the Agency, are able to conduct meaningful analyses while maintaining the confidentiality of the data provided under the data release agreement. (B)

Relationship to procedures for release to private researchers

The process established under subparagraph (A) may be analogous to the process used by the Centers for Medicare & Medicaid Services for the release of data to private researchers. (2)

Agency feedback on analyses conducted

The Secretary shall establish a process for Agencies that are provided data under a data release agreement under this section to provide the results of the analyses conducted using such data to the Centers for Medicare & Medicaid Services for use in the administration and assessment of programs administered by the Centers for Medicare & Medicaid Services, including the program under part D of title XVIII. (3)

Review of data procedures

The Secretary shall establish a process to review and update the following: (A)The processes established under paragraphs (1)(A) and (2). (B)Procedures for transmission and retention of data released under this section. (f)

Notification of inaccuracies discovered in data provided

The Secretary shall establish procedures to ensure that an Agency that is provided data under this section notifies the Secretary of any inaccuracies discovered in the data by the Agency within a reasonable time of such discovery. (g)

Report

The Secretary shall include (beginning with 2007), as part of the annual report submitted to Congress under section 1875(b), an evaluation of the data release agreements entered into under subsection (a)(1), including a description of the reports and analyses conducted by agencies using data provided under such an agreement. (h)

Authorization of appropriations

There are authorized to be appropriated such sums as are necessary to carry out the purposes of this section.

1121B.

Research center and organization drug and health care data use

(a)

In general

Notwithstanding any provision under part D of title XVIII that limits the use of prescription drug data collected under such part, for the purpose of improving the public’s health, the Secretary shall— (1)enter into data use agreements with the research centers and organizations described in subsection (b) to provide access to relevant data submitted by prescription drug plans and MA–PD plans under part D of title XVIII, excluding negotiated price concessions under such part (such as discounts, direct or indirect subsidies, rebates, and direct or indirect remunerations), and linked to hospital, physician, and other relevant medical claims, utilization, and diagnostic data collected under titles XVIII and XIX, including data from the uniform reporting systems established under section 1121(a); (2)permit research centers and organizations described in such subsection to link data provided under this section with other relevant health data, including survey data, vital statistics, and disease registries, as needed by the research center or organization in order to accomplish its research objectives; and (3)prepare the linked sets of data described in paragraph (1) for release not later than July 1, 2007. (b)

Research centers and organizations described

The research centers and organizations described in this subsection are as follows: (1)A University-based research center. (2)Any other research center or organization— (A)whose primary mission is to conduct public health research; and (B)which the Secretary determines can appropriately conduct analyses consistent with the purposes of this section. (c)

Use of data and penalties

(1)

Use of data

(A)

In general

Data provided to a research center or organization under a data use agreement under this section shall be used solely for purposes of research on the safety, effectiveness, and quality of, disparities in, and related aspects of health care use by individuals entitled to, or enrolled for, benefits under part A of title XVIII, or enrolled for benefits under part B of such title, conducted for the purpose of developing and providing generalizable knowledge to inform the public health through scientific publication and other forms of public dissemination. (B)

Approval by Review Board for the Protection of Human Subjects

Such use shall be approved by a review board for the protection of human subjects. (C)

Review process

The Secretary shall establish a review process to ensure that— (i)data use agreements under this section include a detailed description of how the data is to be used under the agreement; and (ii)such use is consistent with the purposes described in subparagraph (A). (2)

Penalties

(A)

In general

A research center or organization who knowingly or intentionally uses data provided under a data use agreement under this section for any purpose other than the purposes described in paragraph (1)(A) shall be subject, in addition to any other penalties that may be prescribed by law, to— (i)a civil money penalty of not less than $25,000 for each infraction; and (ii)disqualification from receipt of any data under this section for not less than 2 years. (B)

Procedure

The provisions of section 1128A (other than subsections (a) and (b) and the second sentence of subsection (f)) shall apply to a civil money penalty under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). (d)

Release of data

(1)

In general

A data use agreement entered into under subsection (a)(1) shall provide for the release of information according to a schedule approved by the Secretary under the criteria developed in accordance with paragraph (2). (2)

Criteria for approving research applications

(A)

Development

The Secretary, in consultation with health services researchers and academicians, shall develop criteria for the approval of a data use agreement under this section. (B)

Criteria

The criteria developed under subparagraph (A) shall include the following requirements: (i)The research center or organization has well-documented scientific expertise, a record of scholarship on the topic of the proposed study, and a likelihood of successful publication, as demonstrated by a prior record of relevant publication by key staff and other evidence of appropriate scientific qualifications of the proposed research team. (ii)The research center or organization demonstrates a credible capability to conduct and complete the proposed study, including experience with scientific investigations using similar types of data. (iii)The research center or organization demonstrates the public health importance of the proposed study, and the potential of such study to provide public knowledge needed to improve the safety, use, and outcomes of treatments, the administration of the program under title XVIII, and the care provided to individuals entitled to, or enrolled for, benefits under part A of title XVIII, or enrolled for benefits under part B of such title. (iv)The research center or organization develops a data management plan that describes in detail the measures that will be implemented to safeguard the data and protect the privacy of individuals entitled to, or enrolled for, benefits under part A of title XVIII, or enrolled for benefits under part B of such title, including any proposed data linkages. (v)The research center or organization enters into an agreement under which the research center or organization agrees to— (I)place detailed results of the proposed study in the public domain through publication in a reasonable timeframe, not to exceed 1 year after completion of such study, including a thorough description of the methodology used to conduct the study; (II)make available to the public, without charge, any product or tool developed using the data provided under this section; and (III)not sell such data to other entities or create commercial data products (such as data extracts or analytical files) using such data. (vi)The research center or organization and the proposed research team provide assurances that such team is independent from the sources of funding or any other party and has the right to independently and freely publish the scientific findings of the study. (vii)Such other requirements, consistent with the purposes of this section, as the Secretary determines appropriate. (3)

Timely review and action on requests

The Secretary shall provide for timely review of, and action on, requests for a data use agreement under this section, taking into consideration the reasonable needs of the research center or organization. (4)

Public disclosure

The Secretary shall make available to the public the criteria used to grant or deny data use agreements under the criteria developed under paragraph (2)(A). (e)

Feedback by research center or organization

(1)

Notification of inaccuracies discovered in data provided

The Secretary shall establish procedures to ensure that a research center or organization that is provided data under this section notifies the Secretary of any inaccuracies discovered in the data by the center or organization within a reasonable time of such discovery. (2)

Feedback on data collection

The Secretary shall permit researchers to provide feedback on the collection of data with respect to the programs administered by the Centers for Medicare & Medicaid Services and make recommendations with respect to the collection of additional data elements with respect to such programs. (f)

Confidentiality

(1)

Determining appropriate level of data to be provided

The Secretary shall establish a process to determine the appropriate level of data to be provided to a research center or organization under this section in order to ensure that the center or organization, and researchers within the center or organization, are able to conduct meaningful analyses while maintaining the confidentiality of the data provided under the data use agreement. (2)

Safeguards to protect confidentiality of data provided

(A)

In general

The Secretary shall establish safeguards to protect the confidentiality of data after it is provided to a research center or organization under this section. Such safeguards shall not provide for greater disclosure by the research center or organization than is permitted under any of the following: (i)The Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. (ii)Sections 552 or 552a of title 5, United States Code, with regard to the privacy of individually identifiable beneficiary health information. (B)

Confidentiality of physicians and medical practices

The safeguards established under subparagraph (A) shall ensure that the data provided to a research center or organization under this section that identifies individual physicians or medical practices is not released by the research center or organization, or otherwise made public. (g)

Report

The Secretary shall include (beginning with 2007), as part of the annual report submitted to Congress under section 1875(b), an evaluation of the agreements entered into under subsection (a). (h)

Reasonable fee

The Secretary may charge a research center or organization a reasonable fee based on the cost of preparing and providing data to such center or organization under this section.

. (b)

Criteria development and publication

The Secretary shall develop and publish the criteria required under section 1121B(d)(2)(A) of the Social Security Act, as added by subsection (a), not later than 180 days after the date of enactment of this Act.

4.

Access to data on prescription drug plans and Medicare Advantage plans

(a)

In general

Section 1875 of the Social Security Act (42 U.S.C. 1395ll) is amended— (1)in the heading, by inserting to Congress; providing information to congressional support agencies after and recommendations; and (2)by adding at the end the following new subsection: (c)

Providing information to congressional support agencies

(1)

In general

Notwithstanding any provision under part D that limits the use of prescription drug data collected under such part, upon the request of a congressional support agency, the Secretary shall provide such agency with information submitted to, or compiled by, the Secretary under part D (subject to the restriction on disclosure under paragraph (2)), including— (A)only with respect to congressional support agencies that make official baseline spending projections, conduct oversight studies mandated by Congress, or make official recommendations on the program under this title to Congress— (i)aggregate negotiated prices for drugs covered under prescription drug plans and MA–PD plans; and (ii)bid information (described in section 1860D–11(b)(2)(C)) submitted by such plans; and (B)access to drug event data submitted by such plans under section 1860D–15(d)(2)(A), except, with respect to data that reveals prices negotiated with drug manufacturers, such data shall only be available to congressional support agencies that make official baseline spending projections, conduct oversight studies mandated by Congress, or make official recommendations on the program under this title to Congress. (2)

Restriction on data disclosure

(A)

In general

Data provided to a congressional support agency under this subsection shall not be disclosed, reported, or released in identifiable form. (B)

Identifiable form

For purposes of subparagraph (A), the term identifiable form means any representation of information that permits identification of a specific prescription drug plan, MA–PD plan, pharmacy benefit manager, drug manufacturer, drug wholesaler, or individual enrolled in a prescription drug plan or an MA–PD plan under part D. (3)

Timing

The Secretary shall release data under this subsection in a timeframe that enables congressional support agencies to complete congressional requests. (4)

Use of the data provided

Data provided to a congressional support agency under this subsection shall only be used by such agency for carrying out the functions and activities of the agency mandated by Congress. (5)

Confidentiality

The Secretary shall establish safeguards to protect the confidentiality of data released under this subsection. Such safeguards shall not provide for greater disclosure than is permitted under any of the following: (A)The Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. (B)Sections 552 or 552a of title 5, United States Code, with regard to the privacy of individually identifiable beneficiary health information. (6)

Definitions

In this subsection: (A)

Congressional support agency

The term Congressional support agency means— (i)the Medicare Payment Advisory Commission; (ii)the Congressional Research Service; (iii)the Congressional Budget Office; and (iv)the Government Accountability Office. (B)

MA–PD plan

The term MA–PD plan has the meaning given such term in section 1860D–1(a)(3)(C). (C)

Prescription drug plan

The term prescription drug plan has the meaning given such term in section 1860D–41(a)(14). . (b)

Conforming amendment

Section 1805(b)(2) of the Social Security Act (42 U.S.C. 1395b–6(b)(2)) is amended by adding at the end the following new subparagraph: (D)

Part D

Specifically, the Commission shall review payment policies with respect to the Voluntary Prescription Drug Benefit Program under part D, including— (i)the factors affecting expenditures; (ii)payment methodologies; and (iii)their relationship to access and quality of care for Medicare beneficiaries. .