---
kind: "section"
citation: "42 U.S.C. § 1395kk–2"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1395kk–2"
heading: "Expanding availability of Medicare data"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1395kk-2"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XVIII — Health Insurance for Aged and Disabled"
  - "Part E — Miscellaneous Provisions"
---

# §1395kk–2. Expanding availability of Medicare data

- (a) **Expanding uses of Medicare data by qualified entities—**
  - (1) **Additional analyses—**
    - (A) **In general—** Subject to [subparagraph (B)](#a-1-B), to the extent consistent with applicable information, privacy, security, and disclosure laws ([including](/usc/42/1301.md?p=b) [paragraph (3)](#a-3)), notwithstanding [paragraph (4)(B)](/usc/42/1874.md) of section 1874(e) of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395kk(e)](/usc/42/1395kk.md?p=e)) and the second sentence of [paragraph (4)(D)](/usc/42/1395kk.md?p=e-4-D) of such section, beginning July 1, 2016, a qualified entity may use the combined data described in [paragraph (4)(B)(iii)](/usc/42/1395kk.md?p=e-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](/usc/42/1301.md?p=a-6)) and provide or sell such analyses to authorized users for non-public use ([including](/usc/42/1301.md?p=b) for the purposes of assisting providers of services and [suppliers](/usc/42/1395x.md?p=d) to develop and participate in quality and patient care improvement activities, [including](/usc/42/1301.md?p=b) developing new models of care).
    - (B) **Limitations with respect to analyses—**
      - (i) **Employers—** Any analyses provided or sold under [subparagraph (A)](#a-1-A) to an employer described in [paragraph (9)(A)(iii)](#a-9-A-iii) may only be used by such employer for purposes of providing health insurance to employees and retirees of the employer.
      - (ii) **Health insurance issuers—** A qualified entity may not provide or sell an analysis to a health insurance issuer described in [paragraph (9)(A)(iv)](#a-9-A-iv) unless the issuer is providing the qualified entity with data under section 1874(e)(4)(B)(iii) of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395kk(e)(4)(B)(iii)](/usc/42/1395kk.md?p=e-4-B-iii)).
  - (2) **Access to certain data—**
    - (A) **Access—** To the extent consistent with applicable information, privacy, security, and disclosure laws ([including](/usc/42/1301.md?p=b) [paragraph (3)](#a-3)), notwithstanding [paragraph (4)(B)](/usc/42/1874.md) of section 1874(e) of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395kk(e)](/usc/42/1395kk.md?p=e)) and the second sentence of [paragraph (4)(D)](/usc/42/1395kk.md?p=e-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)](#a-9-A-i), [(ii)](#a-9-A-ii), and [(v)](#a-9-A-v) of paragraph (9)(A) for non-public use, [including](/usc/42/1301.md?p=b) for the purposes described in [subparagraph (B)](#a-2-B); or
      - (ii) subject to [subparagraph (C)](#a-2-C), provide Medicare claims data to authorized users described in clauses [(i)](#a-2-A-i), [(ii)](#a-2-A-ii), and (v),[^1] of [paragraph (9)(A)](#a-9-A) for non-public use, [including](/usc/42/1301.md?p=b) for the purposes described in [subparagraph (B)](#a-2-B).
    - (B) **Purposes described—** The purposes described in this subparagraph are assisting providers of services and [suppliers](/usc/42/1395x.md?p=d) in developing and participating in quality and patient care improvement activities, [including](/usc/42/1301.md?p=b) developing new models of care.
    - (C) **Medicare claims data must be provided at no cost—** A qualified entity may not charge a fee for providing the data under [subparagraph (A)(ii)](#a-2-A-ii).
  - (3) **Protection of information—**
    - (A) **In general—** Except as provided in [subparagraph (B)](#a-3-B), an analysis or data that is provided or sold under paragraph [(1)](#a-1) or [(2)](#a-2) shall not contain information that individually identifies a patient.
    - (B) **Information on patients of the provider of services or supplier—** 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](/usc/42/1395x.md?p=u) or [supplier](/usc/42/1395x.md?p=d) under paragraph [(1)](#a-1) or [(2)](#a-2) may contain information that individually identifies a patient of such provider or [supplier](/usc/42/1395x.md?p=d), [including](/usc/42/1301.md?p=b) with respect to items and services furnished to the patient by other providers of services or [suppliers](/usc/42/1395x.md?p=d).
    - (C) **Prohibition on using analyses or data for marketing purposes—** An authorized user shall not use an analysis or data provided or sold under paragraph [(1)](#a-1) or [(2)](#a-2) for marketing purposes.
  - (4) **Data use agreement—** A qualified entity and an authorized user described in clauses [(i)](#a-9-A-i), [(ii)](#a-9-A-ii), and [(v)](#a-9-A-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)](#a-2). Such agreement shall describe the requirements for privacy and security of the data and, as determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6), 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](/usc/42/1301.md?p=a-6), that the user shall comply with as if it were acting in the capacity of such a covered entity.
  - (5) **No redisclosure of analyses or data—**
    - (A) **In general—** Except as provided in [subparagraph (B)](#a-5-B), an authorized user that is provided or sold an analysis or data under paragraph [(1)](#a-1) or [(2)](#a-2) shall not redisclose or make public such analysis or data or any analysis using such data.
    - (B) **Permitted redisclosure—** A [provider of services](/usc/42/1395x.md?p=u) or [supplier](/usc/42/1395x.md?p=d) that is provided or sold an analysis or data under paragraph [(1)](#a-1) or [(2)](#a-2) may, as determined by the [Secretary](/usc/42/1301.md?p=a-6), 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) **Opportunity for providers of services and suppliers to review—** Prior to a qualified entity providing or selling an analysis to an authorized user under [paragraph (1)](#a-1), to the extent that such analysis would individually identify a [provider of services](/usc/42/1395x.md?p=u) or [supplier](/usc/42/1395x.md?p=d) who is not being provided or sold such analysis, such qualified entity shall provide such provider or [supplier](/usc/42/1395x.md?p=d) with the opportunity to appeal and correct errors in the manner described in section 1874(e)(4)(C)(ii) of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395kk(e)(4)(C)(ii)](/usc/42/1395kk.md?p=e-4-C-ii)).
  - (7) **Assessment for a breach—**
    - (A) **In general—** In the case of a breach of a data use agreement under this section or section 1874(e) of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395kk(e)](/usc/42/1395kk.md?p=e)), the [Secretary](/usc/42/1301.md?p=a-6) shall impose an assessment on the qualified entity both in the case of—
      - (i) an agreement between the [Secretary](/usc/42/1301.md?p=a-6) and a qualified entity; and
      - (ii) an agreement between a qualified entity and an authorized user.
    - (B) **Assessment—** The assessment under [subparagraph (A)](#a-7-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](/usc/42/1397j.md?p=20) Security Act [[42 U.S.C. 1395c](/usc/42/1395c.md) et seq.] or enrolled for benefits under part B of such title [[42 U.S.C. 1395j](/usc/42/1395j.md) et seq.]—
      - (i) in the case of an agreement described in [subparagraph (A)(i)](#a-7-A-i), for whom the [Secretary](/usc/42/1301.md?p=a-6) provided data on to the qualified entity under [paragraph (2)](#a-2); and
      - (ii) in the case of an agreement described in [subparagraph (A)(ii)](#a-7-A-ii), for whom the qualified entity provided data on to the authorized user under [paragraph (2)](#a-2).
    - (C) **Deposit of amounts collected—** Any amounts collected pursuant to this paragraph shall be deposited in Federal[^2] Supplementary Medical Insurance Trust Fund under section 1841 of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395t](/usc/42/1395t.md)).
  - (8) **Annual reports—** Any qualified entity that provides or sells an analysis or data under paragraph [(1)](#a-1) or [(2)](#a-2) shall annually submit to the [Secretary](/usc/42/1301.md?p=a-6) a report that [includes](/usc/42/1301.md?p=b)—
    - (A) a summary of the analyses provided or sold, [including](/usc/42/1301.md?p=b) 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)](#a-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](/usc/42/1301.md?p=a-6).
  - (9) **Definitions—** In this subsection and [subsection (b)](#b):
    - (A) **Authorized user—** The term “authorized user” means the following:
      - (i) A [provider of services](/usc/42/1395x.md?p=u).
      - (ii) A [supplier](/usc/42/1395x.md?p=d).
      - (iii) An employer (as defined in [section 1002(5) of title 29](/usc/29/1002.md?p=5)).
      - (iv) A health insurance issuer (as defined in [section 300gg–91 of this title](/usc/42/300gg–91.md)).
      - (v) A medical society or [hospital](/usc/42/1395x.md?p=e) association.
      - (vi) Any entity not described in clauses [(i)](#a-9-A-i) through [(v)](#a-9-A-v) that is approved by the [Secretary](/usc/42/1301.md?p=a-6) (other than an employer or health insurance issuer not described in clauses [(iii)](#a-9-A-iii) and [(iv)](#a-9-A-iv), respectively, as determined by the [Secretary](/usc/42/1301.md?p=a-6)).
    - (B) **Provider of services—** The term “[provider of services](/usc/42/1395x.md?p=u)” has the meaning given such term in section 1861(u) of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395x(u)](/usc/42/1395x.md?p=u)).
    - (C) **Qualified entity—** The term “qualified entity” has the meaning given such term in section 1874(e)(2) of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395kk(e)](/usc/42/1395kk.md?p=e)).[^3]
    - (D) **Secretary—** The term “[Secretary](/usc/42/1301.md?p=a-6)” means the [Secretary](/usc/42/1301.md?p=a-6) of Health and Human Services.
    - (E) **Supplier—** The term “[supplier](/usc/42/1395x.md?p=d)” has the meaning given such term in section 1861(d) of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395x(d)](/usc/42/1395x.md?p=d)).
- (b) **Access to Medicare data by qualified clinical data registries to facilitate quality improvement—**
  - (1) **Access—**
    - (A) **In general—** To the extent consistent with applicable information, privacy, security, and disclosure laws, beginning July 1, 2016, the [Secretary](/usc/42/1301.md?p=a-6) shall, at the request of a qualified clinical data registry under section 1848(m)(3)(E) of the [Social](/usc/42/1397j.md?p=20) Security Act ([42 U.S.C. 1395w–4(m)(3)(E)](/usc/42/1395w–4.md?p=m-3-E)), provide the data described in [subparagraph (B)](#b-1-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](/usc/42/1395x.md?p=u) or [supplier](/usc/42/1395x.md?p=d) shall only be conducted with the opportunity of such provider or [supplier](/usc/42/1395x.md?p=d) to appeal and correct errors in the manner described in [subsection (a)(6)](#a-6).
    - (B) **Data described—** The data described in this subparagraph is—
      - (i) claims data under the Medicare program under title XVIII of the [Social](/usc/42/1397j.md?p=20) Security Act [[42 U.S.C. 1395](/usc/42/1395.md) et seq.]; and
      - (ii) if the [Secretary](/usc/42/1301.md?p=a-6) determines appropriate, claims data under the Medicaid program under title XIX of such Act [[42 U.S.C. 1396](/usc/42/1396.md) et seq.] and the [State](/usc/42/1395x.md?p=x) Children’s Health Insurance Program under title XXI of such Act [[42 U.S.C. 1397aa](/usc/42/1397aa.md) et seq.].
  - (2) **Fee—** Data described in [paragraph (1)(B)](#b-1-B) shall be provided to a qualified clinical data registry under [paragraph (1)](#b-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.

## Footnotes

[^1]: So in original. The comma probably should not appear.
[^2]: So in original. Probably should be preceded by “the”.
[^3]: So in original. Probably should be “1395kk(e)(2)).”

## Source credit

(Pub. L. 114–10, title I, § 105, Apr. 16, 2015, 129 Stat. 133.)

## Notes

### 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.
