§1395kk–2 — Title 42 The Public Health and Welfare | U.S. Code

Summary

Beginning July 1, 2016, approved groups called “qualified entities” may use combined Medicare data and analyses they make from it to do extra, private studies and sell or give those studies to authorized users for non-public uses. The goal is to help health care providers improve care and build new care models. Employers who buy these analyses may only use them to provide health insurance to their workers and retirees. Health insurers may only get analyses if they first give data to the qualified entity. Raw Medicare claims data can be given to certain users for non-public use, but the qualified entity cannot charge for providing the raw claims data. The data and analyses must not identify individual patients, except a provider or supplier may get patient-identifying information only about their own patients (this can include services by other providers). Buyers cannot use the data for marketing. Qualified entities and users must sign an agreement that explains privacy, security, and limits on linking the data to other personal information; if the user is not covered by HIPAA rules, the agreement must list the rules they must follow as if they were. Providers who would be identified in an analysis must get a chance to appeal and fix errors before the analysis is shared. If a data-use agreement is breached, the Secretary will charge the qualified entity up to $100 for each affected Medicare beneficiary; money collected goes into the Supplementary Medical Insurance Trust Fund under section 1841. Qualified entities must send the Secretary an annual report listing what analyses they sold or shared, who bought them, fees collected, topics, uses, and other details. Authorized users include providers, suppliers, employers, health insurers, medical societies or hospital associations, and other groups approved by the Secretary. The Secretary must also give Medicare (and, if chosen, Medicaid and CHIP) claims data to approved clinical registries on request to link with clinical outcomes for quality research; those registries pay a fee that covers the cost and the fee goes to the CMS Program Management Account.

Title 42, §1395kk–2

The Public Health and Welfare — Source: USLM XML via OLRC

(a)(1)(A)Subject to subparagraph (B), to the extent consistent with applicable information, privacy, security, and disclosure laws (including paragraph (3)), notwithstanding paragraph (4)(B) of section 1874(e) of the Social Security Act (42 U.S.C. 1395kk(e)) and the second sentence of paragraph (4)(D) of such section, beginning July 1, 2016, a qualified entity may use the combined data described in paragraph (4)(B)(iii) of such section received by such entity under such section, and information derived from the evaluation described in such paragraph (4)(D), to conduct additional non-public analyses (as determined appropriate by the Secretary) and provide or sell such analyses to authorized users for non-public use (including for the purposes of assisting providers of services and suppliers to develop and participate in quality and patient care improvement activities, including developing new models of care).

(B)(i)Any analyses provided or sold under subparagraph (A) to an employer described in paragraph (9)(A)(iii) may only be used by such employer for purposes of providing health insurance to employees and retirees of the employer.

(ii)A qualified entity may not provide or sell an analysis to a health insurance issuer described in paragraph (9)(A)(iv) unless the issuer is providing the qualified entity with data under section 1874(e)(4)(B)(iii) of the Social Security Act (42 U.S.C. 1395kk(e)(4)(B)(iii)).

(2)(A)To the extent consistent with applicable information, privacy, security, and disclosure laws (including paragraph (3)), notwithstanding paragraph (4)(B) of section 1874(e) of the Social Security Act (42 U.S.C. 1395kk(e)) and the second sentence of paragraph (4)(D) of such section, beginning July 1, 2016, a qualified entity may—

(i)provide or sell the combined data described in paragraph (4)(B)(iii) of such section to authorized users described in clauses (i), (ii), and (v) of paragraph (9)(A) for non-public use, including for the purposes described in subparagraph (B); or

(ii)subject to subparagraph (C), provide Medicare claims data to authorized users described in clauses (i), (ii), and (v),11 So in original. The comma probably should not appear. of paragraph (9)(A) for non-public use, including for the purposes described in subparagraph (B).

(B)The purposes described in this subparagraph are assisting providers of services and suppliers in developing and participating in quality and patient care improvement activities, including developing new models of care.

(C)A qualified entity may not charge a fee for providing the data under subparagraph (A)(ii).

(3)(A)Except as provided in subparagraph (B), an analysis or data that is provided or sold under paragraph (1) or (2) shall not contain information that individually identifies a patient.

(B)To the extent consistent with applicable information, privacy, security, and disclosure laws, an analysis or data that is provided or sold to a provider of services or supplier under paragraph (1) or (2) may contain information that individually identifies a patient of such provider or supplier, including with respect to items and services furnished to the patient by other providers of services or suppliers.

(C)An authorized user shall not use an analysis or data provided or sold under paragraph (1) or (2) for marketing purposes.

(4)A qualified entity and an authorized user described in clauses (i), (ii), and (v) of paragraph (9)(A) shall enter into an agreement regarding the use of any data that the qualified entity is providing or selling to the authorized user under paragraph (2). Such agreement shall describe the requirements for privacy and security of the data and, as determined appropriate by the Secretary, any prohibitions on using such data to link to other individually identifiable sources of information. If the authorized user is not a covered entity under the rules promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996, the agreement shall identify the relevant regulations, as determined by the Secretary, that the user shall comply with as if it were acting in the capacity of such a covered entity.

(5)(A)Except as provided in subparagraph (B), an authorized user that is provided or sold an analysis or data under paragraph (1) or (2) shall not redisclose or make public such analysis or data or any analysis using such data.

(B)A provider of services or supplier that is provided or sold an analysis or data under paragraph (1) or (2) may, as determined by the Secretary, redisclose such analysis or data for the purposes of performance improvement and care coordination activities but shall not make public such analysis or data or any analysis using such data.

(6)Prior to a qualified entity providing or selling an analysis to an authorized user under paragraph (1), to the extent that such analysis would individually identify a provider of services or supplier who is not being provided or sold such analysis, such qualified entity shall provide such provider or supplier with the opportunity to appeal and correct errors in the manner described in section 1874(e)(4)(C)(ii) of the Social Security Act (42 U.S.C. 1395kk(e)(4)(C)(ii)).

(7)(A)In the case of a breach of a data use agreement under this section or section 1874(e) of the Social Security Act (42 U.S.C. 1395kk(e)), the Secretary shall impose an assessment on the qualified entity both in the case of—

(i)an agreement between the Secretary and a qualified entity; and

(ii)an agreement between a qualified entity and an authorized user.

(B)The assessment under subparagraph (A) shall be 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 [42 U.S.C. 1395c et seq.] or enrolled for benefits under part B of such title [42 U.S.C. 1395j et seq.]—

(i)in the case of an agreement described in subparagraph (A)(i), for whom the Secretary provided data on to the qualified entity under paragraph (2); and

(ii)in the case of an agreement described in subparagraph (A)(ii), for whom the qualified entity provided data on to the authorized user under paragraph (2).

(C)Any amounts collected pursuant to this paragraph shall be deposited in Federal 22 So in original. Probably should be preceded by “the”. Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C. 1395t).

(8)Any qualified entity that provides or sells an analysis or data under paragraph (1) or (2) shall annually submit to the Secretary a report that includes—

(A)a summary of the analyses provided or sold, including the number of such analyses, the number of purchasers of such analyses, and the total amount of fees received for such analyses;

(B)a description of the topics and purposes of such analyses;

(C)information on the entities who received the data under paragraph (2), the uses of the data, and the total amount of fees received for providing, selling, or sharing the data; and

(D)other information determined appropriate by the Secretary.

(9)In this subsection and subsection (b):

(A)The term “authorized user” means the following:

(i)A provider of services.

(ii)A supplier.

(iii)An employer (as defined in section 1002(5) of title 29).

(iv)A health insurance issuer (as defined in section 300gg–91 of this title).

(v)A medical society or hospital association.

(vi)Any entity not described in clauses (i) through (v) that is approved by the Secretary (other than an employer or health insurance issuer not described in clauses (iii) and (iv), respectively, as determined by the Secretary).

(B)The term “provider of services” has the meaning given such term in section 1861(u) of the Social Security Act (42 U.S.C. 1395x(u)).

(C)The term “qualified entity” has the meaning given such term in section 1874(e)(2) of the Social Security Act (42 U.S.C. 1395kk(e)).33 So in original. Probably should be “1395kk(e)(2)).”

(D)The term “Secretary” means the Secretary of Health and Human Services.

(E)The term “supplier” has the meaning given such term in section 1861(d) of the Social Security Act (42 U.S.C. 1395x(d)).

(b)(1)(A)To the extent consistent with applicable information, privacy, security, and disclosure laws, beginning July 1, 2016, the Secretary shall, at the request of a qualified clinical data registry under section 1848(m)(3)(E) of the Social Security Act (42 U.S.C. 1395w–4(m)(3)(E)), provide the data described in subparagraph (B) (in a form and manner determined to be appropriate) to such qualified clinical data registry for purposes of linking such data with clinical outcomes data and performing risk-adjusted, scientifically valid analyses and research to support quality improvement or patient safety, provided that any public reporting of such analyses or research that identifies a provider of services or supplier shall only be conducted with the opportunity of such provider or supplier to appeal and correct errors in the manner described in subsection (a)(6).

(B)The data described in this subparagraph is—

(i)claims data under the Medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]; and

(ii)if the Secretary determines appropriate, claims data under the Medicaid program under title XIX of such Act [42 U.S.C. 1396 et seq.] and the State Children’s Health Insurance Program under title XXI of such Act [42 U.S.C. 1397aa et seq.].

(2)Data described in paragraph (1)(B) shall be provided to a qualified clinical data registry under paragraph (1) at a fee equal to the cost of providing such data. Any fee collected pursuant to the preceding sentence shall be deposited in the Centers for Medicare & Medicaid Services Program Management Account.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (a)(4), is Pub. L. 104–191, Aug. 21, 1996, 110 Stat. 1936. For complete classification of this Act to the Code, see

Short Title

of 1996

Amendments

note set out under section 201 of this title and Tables. The Social Security Act, referred to in subsecs. (a)(7)(B) and (b)(1)(B), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles XVIII, XIX, and XXI of the Act are classified generally to this subchapter and subchapters XIX (§ 1396 et seq.) and XXI (§ 1397aa et seq.) of this chapter, respectively. Parts A and B of title XVIII of the Act are classified generally to parts A (§ 1395c et seq.) and B (§ 1395j et seq.) of this subchapter, respectively. For complete classification of this Act to the Code, see section 1305 of this title and Tables. Codification Section is comprised of section 105 of Pub. L. 114–10. Subsecs. (c) and (d) of section 105 of Pub. L. 114–10 amended section 1395kk of this title. Section was enacted as part of the Medicare Access and CHIP Reauthorization Act of 2015, and not as part of the Social Security Act which comprises this chapter.

§1395kk–2 Expanding availability of Medicare data