42 USC 1395kk-2 - Expanding availability of Medicare data

U.S Code last checked for updates: Feb 22, 2025

§ 1395kk–2.

Expanding availability of Medicare data

(a)

Expanding uses of Medicare data by qualified entities

(1)

Additional analyses

(A)

In general

(B)

Limitations with respect to analyses

(i)

Employers

(ii)

Health insurance issuers

(2)

Access to certain data

(A)

Access

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),1

 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)

Purposes described

(C)

Medicare claims data must be provided at no cost

(3)

Protection of information

(A)

In general

(B)

Information on patients of the provider of services or supplier

(C)

Prohibition on using analyses or data for marketing purposes

(4)

Data use agreement

(5)

No redisclosure of analyses or data

(A)

In general

(B)

Permitted redisclosure

(6)

(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 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)

Assessment

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)

Deposit of amounts collected

(8)

Annual reports

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)

Definitions

In this subsection and subsection (b):

(A)

Authorized user

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)

Provider of services

(C)

Qualified entity

(D)

Secretary

(E)

Supplier

(b)

Access to Medicare data by qualified clinical data registries to facilitate quality improvement

(1)

Access

(A)

In general

(B)

Data described

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)

Fee

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

cite as: 42 USC 1395kk-2