[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5394 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 5394

 To require the Secretary of Health and Human Services to establish a 
     new program which ensures meaningful access to claims data by 
    clinician-led clinical data registries, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 28, 2021

  Mr. Bucshon (for himself and Ms. Schrier) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
  in addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
 To require the Secretary of Health and Human Services to establish a 
     new program which ensures meaningful access to claims data by 
    clinician-led clinical data registries, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This part may be cited as the ``Meaningful Access to Federal Health 
Plan Claims Data Act of 2021''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) Clinician-led clinical data registries serve an 
        important role in promoting, facilitating, and conducting 
        medical research and improving quality of healthcare by 
        providing timely and actionable feedback to practitioners on 
        their performance in relation to other practitioners and best 
        clinical practices.
            (2) Clinician-led clinical data registries are hindered in 
        their ability to promote medical research and quality 
        improvement by their lack of meaningful access to claims data.
            (3) While the Centers for Medicare & Medicaid Services has 
        established programs for providing access to claims data, those 
        programs fail to provide clinician-led clinical data registries 
        with meaningful access to such data.
            (4) Ensuring clinician-led clinical data registries 
        meaningful access to claims data will enable such entities to 
        better track patient outcomes over time, expand their ability 
        to assess the safety and effectiveness of medical treatments, 
        and provide them with the information necessary to assess the 
        cost-effectiveness of therapies.

SEC. 3. ENSURING MEANINGFUL ACCESS TO CLAIMS DATA BY CLINICIAN-LED 
              CLINICAL DATA REGISTRIES.

    (a) Ensuring Meaningful Access to Claims Data.--
            (1) Establishment of a new program.--
            (2) Establishment of a new program.--The Secretary shall 
        establish a new program (separate from any existing data access 
        programs, including, without limitation, the Centers for 
        Medicare & Medicaid Services Qualified Entity (in this section, 
        referred to as ``QE'') Program (42 U.S.C. 1395kk(e), 1395kk-2) 
        (in this section, referred to as the ``Medicare Data Sharing 
        for Performance Measurement Program'') and the Research Data 
        Assistance Center (in this section, referred to as the 
        ``ResDAC'') process) under which the Secretary shall, at the 
        request of a clinician-led clinical data registry, provide 
        timely, broad, and continuous access to a database of claims 
        data to such clinician-led clinical data registry for purposes 
        of research, quality of care measurement and reporting to 
        health care providers, linking such data with clinical data and 
        performing risk-adjusted, scientifically valid analyses and 
        research to support quality improvement or patient safety, and 
        other purposes and uses described herein or approved by the 
        Secretary. Access to a database of claims data pursuant to this 
        subsection shall not be more restrictive than access to data 
        provided under the QE Program or the ResDAC process.
            (3) Streamlined application process.--
                    (A) Initial and recertification application.--Prior 
                to gaining access to a database of claims data under 
                the program established in subsection (a), a clinician-
                led clinical data registry shall submit to the 
                Secretary an application demonstrating that it is 
                qualified (as determined by the Secretary) to use 
                claims data. Upon the Secretary's approval of a 
                clinician-led clinical data registry's application 
                described in this subparagraph, the Secretary shall 
                provide access to a database of claims data to such 
                clinician-led clinical data registry for a period of at 
                least 5 years. After the expiration of the time period 
                described in this subparagraph, the clinician-led 
                clinical data registry shall reapply to access the 
                database of claims data under the program established 
                in subsection (a).
                    (B) Process.--The Secretary shall establish a 
                streamlined initial application and recertification 
                application process under which the Secretary shall 
                approve or deny the clinician-led clinical data 
                registry's application described in subparagraph (2)(A) 
                within 60 calendar days after receiving the application 
                unless the Secretary demonstrates a compelling reason 
                for needing additional time to complete the process. If 
                the clinician-led clinical data registry's application 
                described in subparagraph (2)(A) is denied, the 
                Secretary shall provide the reason(s) for denial.
            (4) Appeal rights.--
                    (A) Opportunity to appeal.--The Secretary shall 
                develop and maintain a process by which clinician-led 
                clinical data registries may appeal--
                            (i) the Secretary's decision to deny the 
                        clinician-led clinical data registry's 
                        application described in subparagraph (2)(A); 
                        and
                            (ii) the Secretary's failure to approve or 
                        deny the clinician-led clinical data registry's 
                        application described in subparagraph (2)(A) 
                        within a reasonable timeframe established by 
                        the Secretary.
                    (B) Deadline for decision.--The Secretary shall 
                render a decision with respect to an appeal filed by a 
                clinician-led clinical data registry pursuant to 
                subparagraph (A) in a timely manner, not to exceed 60 
                calendar days after the Secretary receives the 
                clinician-led clinical data registry's request for an 
                appeal. Notice of such decision shall be provided to 
                the clinician-led clinical data registry filing the 
                appeal before the conclusion of such 60-day period.
            (5) Broad and timely access to data.--The Secretary shall 
        structure its database of claims data to allow for various data 
        set queries, including, but not limited to, provider-specific 
        claims data, clinical specialty-specific claims data, state-
        specific claims data, and nationwide claims data. The Secretary 
        shall promptly make available to a clinician-led clinical data 
        registry access to claims data requested by such clinician-led 
        clinical data registry within a reasonable timeframe, not to 
        exceed 30 calendar days, after the Secretary approves the 
        request from the clinician-led clinical data registry.
    (b) Permissible Uses of Claims Data.--Clinician-led clinical data 
registries may--
            (1) make available to the public reports evaluating the 
        performance of providers of services and suppliers using the 
        claims data provided to such clinician-led clinical data 
        registry under subsection (a) in combination with registry 
        data;
            (2) use claims data received under subsection (a) combined 
        with registry data to conduct additional non-public analyses 
        and provide or charge an access fee for such analyses to 
        authorized users for non-public use;
            (3) provide or charge an access fee for data sets that link 
        claims data received under subsection (a) with registry data to 
        authorized users for non-public use; and
            (4) provide or charge an access fee for claims data 
        received under subsection (a) to authorized users for non-
        public use.
    (c) Fees.--
            (1) Claims data provided to clinician-led clinical data 
        registries.--Claims data shall be provided to a clinician-led 
        clinical data registry under subsection (a) at a reasonable fee 
        based on the cost of providing such data to the clinician-led 
        clinical data registry. Such fee shall be based at least in 
        part on the number of patients included in the claims data 
        provided to such clinician-led clinical data registry. Any fee 
        collected pursuant to the preceding sentence shall be deposited 
        in the Centers for Medicare & Medicaid Services Program 
        Management Account.
            (2) Analyses and data provided to authorized users.--
        Clinician-led clinical data registries may charge a reasonable, 
        cost-based fee for providing to authorized users claims data, 
        data sets linking claims data with registry data, or analyses 
        described in subsection (b).
    (d) Protection of Information.--
            (1) Privacy, security, and disclosure laws.--The Secretary 
        shall provide access to a database of claims data pursuant to 
        subsection (a) in accordance with applicable information, 
        privacy, security, and disclosure laws, including, without 
        limitation, the Health Insurance Portability and Accountability 
        Act of 1996, Public Law 104-191, as amended by the Privacy and 
        Security provisions set forth in Section 13400 of the Health 
        Information Technology for Economic and Clinical Health Act, 
        Public Law 111-5, the regulations promulgated thereunder 
        codified at 45 CFR Parts 160 and 164, and subparagraphs (A) 
        through (B) of section 105(a)(3) of the Medicare Access and 
        CHIP Reauthorization Act of 2015 (42 U.S.C. 1395kk-2(a)(3)).
            (2) Prohibition on using analyses or data for marketing 
        purposes.--An authorized user shall not use analyses or data 
        provided or sold under paragraphs (2) through (4) of subsection 
        (b) for marketing purposes.
            (3) No redisclosure of analyses or data.--An authorized 
        user in receipt of an analysis or datum provided or sold under 
        paragraphs (2) through (4) of subsection (b) shall comply with 
        section 105(a)(5) of Medicare Access and CHIP Reauthorization 
        Act of 2015 (42 U.S.C. 1395kk-2(a)(5)).
            (4) Opportunity for providers of services and suppliers to 
        review.--Prior to a clinician-led clinical data registry using, 
        providing, or charging an access fee for claims data, data sets 
        linking claims data with registry data, or analyses described 
        in subsection (b), to the extent that such data, data sets, or 
        analyses would individually identify a provider of services or 
        supplier who is not being provided or sold such data, data 
        sets, or analyses, such clinician-led clinical data registry 
        shall confidentially make available such data, data sets, or 
        analyses to such provider of services or supplier and provide 
        such provider of services or supplier with the opportunity to 
        appeal and correct errors.
    (e) Data Use Agreement.--A clinician-led clinical data registry and 
an authorized user shall enter into a data use agreement regarding the 
use or disclosure of any claims data or data sets that link claims data 
with registry data that the clinician-led clinical data registry is 
providing or charging an access fee to the authorized user under 
paragraphs (3) through (4) of subsection (b). Such agreement shall 
include the requirements and prohibitions described in section 
105(a)(4) of the Medicare Access and CHIP Reauthorization Act of 2015 
(42 U.S.C. 1395kk-2(a)(4)).
    (f) Assessment for a Breach.--
            (1) In general.--In the case of a breach of a data use 
        agreement, the Secretary shall impose an assessment on the 
        clinician-led clinical data registry and the authorized user.
            (2) Assessment.--The assessment under subsection (f)(1) 
        shall be in an amount up to $100 for each individual entitled 
        to, or enrolled for, benefits under part A of title XVIII of 
        the Social Security Act or enrolled for benefits under part B 
        of such title for whom the clinician-led clinical data registry 
        provided data on to the authorized user.
            (3) Deposit of amounts collected.--Any amounts collected 
        pursuant to this subsection shall be deposited in the Federal 
        Supplementary Medical Insurance Trust Fund under section 1841 
        of the Social Security Act (42 U.S.C. 1395t).
    (g) Discovery or Admission as Evidence.--Claims data released to a 
clinician-led clinical data registry under subsection (a) shall not be 
subject to discovery or admission as evidence in judicial or 
administrative proceedings without consent of the applicable provider 
of services or supplier.

SEC. 4. REPORT TO CONGRESS.

    Not later than 2 years after the date of enactment of this Act, and 
annually thereafter, the Secretary shall submit to Congress a report on 
the extent to which clinician-led clinical data registries are afforded 
meaningful access to claims data.

SEC. 5. DEFINITIONS.

    In this Act:
            (1) Authorized user.--The term ``authorized user'' shall 
        have the meaning ascribed to it in section 105(a)(9)(A) of the 
        Medicare Access and CHIP Reauthorization Act of 2015 (42 U.S.C. 
        1395kk-2(a)(9)(A)), as well as a government agency or other 
        governmental entity, researchers, entities that seek data for 
        purposes of complying with regulations or other requirements of 
        the Federal Food and Drug Administration, and other entities 
        approved by the Secretary.
            (2) Claims data.--The term ``claims data'' shall have the 
        meaning ascribed to the term ``data'' in section 105(b)(1)(B) 
        of the Medicare Access and CHIP Reauthorization Act of 2015 (42 
        U.S.C. 1395kk-2(b)(1)(B)).
            (3) Clinician-led clinical data registry.--The term 
        ``clinician-led clinical data registry'' shall have the meaning 
        ascribed to it in section 4005(b) of the 21st Century Cures 
        Act.
            (4) Data use agreement.--The term ``data use agreement'' 
        means an agreement described in subsection (e) of section 3.
            (5) Non-public use.--The term ``non-public use'' means for 
        the purposes of--
                    (A) promoting, facilitating, and conducting medical 
                research; assisting providers of services and suppliers 
                to improve patient safety and to develop and 
                participate in quality and patient care improvement 
                activities, including developing new models of care;
                    (B) assisting clinician-led clinical data 
                registries in developing and reporting quality measures 
                to health care providers quality measures;
                    (C) educating a government agency or other 
                governmental entity; and
                    (D) supporting clinical trials and other activities 
                necessary to comply with pre- or post-market approval 
                or adverse event reporting requirements or conditions 
                imposed by the Federal Food and Drug Administration; 
                and other purposes approved by the Secretary.
            (6) Provider of services.--The term ``provider of 
        services'' shall have the meaning ascribed to it in section 
        1861(u) of the Social Security Act (42 U.S.C. 1395x(u)).
            (7) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Humans Services.
            (8) Supplier.--The term ``supplier'' shall have the meaning 
        ascribed to it in section 1861(d) of the Social Security Act 
        (42 U.S.C. 1395x(d)).

SEC. 6. REGULATIONS.

    The Secretary shall promulgate not later than 1 year after the 
enactment of this Act, final regulations to implement the provisions of 
the preceding sections of this Act.

SEC. 7. COVERAGE OF PROMISING NEW TECHNOLOGIES UNDER THE MEDICARE 
              PROGRAM.

    (a) Non-Exclusion of Items and Services Furnished Under Access With 
Data Collection.--Section 1862(a)(1) of the Social Security Act (42 
U.S.C. 1395y(a)(1)) is amended--
            (1) in subparagraph (O), by striking at the end ``and'';
            (2) in subparagraph (P), by striking the semicolon at the 
        end and inserting ``, and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(Q)(i) in the case of items and services for 
                which evidence is promising but not definitive to 
                determine that the items and services are reasonable 
                and necessary for the diagnosis or treatment of illness 
                of injury or to improve the functioning of a malformed 
                body member, which are not reasonable and necessary for 
                evidence collection to determine that the reasonable 
                and necessary standard in subparagraph (A) is met; and
                    ``(ii) for purposes of this subparagraph, evidence 
                collection may include--
                            ``(I) evidence of appropriateness, impact 
                        on quality of life, effectiveness, safety or 
                        other outcomes as determined by the Secretary; 
                        and
                            ``(II) evidence derived from real world 
                        data repositories, patient registries, cohort 
                        studies, randomized controlled trials, or other 
                        studies as determined by the Secretary;
                    ``(iii) the evidence collection described in clause 
                (ii) shall be evidence collection approved by the 
                Secretary acting through the Administrator of the 
                Centers for Medicare & Medicaid Services in 
                collaboration with the Director of the Agency for 
                Healthcare Research and Quality as meeting the 
                priorities of this title as set forth under Section 
                1142;
                    ``(iv) such evidence collection shall be time-
                limited to a period of no more than 5 years, unless the 
                Secretary deems that extension is needed to address 
                remaining gaps in evidence;
                    ``(v) such evidence collection shall be accessible, 
                include outcomes relevant to patients, and have 
                transparent governance; and
                    ``(vi) such evidence collection shall be referred 
                to as `Access with Data Collection'.''.
    (b) Effective Date.--The amendments made by this section shall 
apply to items and services furnished after December 31, 2021.
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