Sec. 107. Expanding claims data availability to improve care
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Section 1874(e) of the Social Security Act ( 42 U.S.C. 1395kk(e) ) is amended by adding at the end the following new paragraphs: To the extent consistent with applicable information, privacy, security, and disclosure laws, beginning July 1, 2014, notwithstanding paragraph (4)(B) (other than clause
(iii)of such paragraph) and the second sentence of paragraph (4)(D), a qualified entity may, as determined appropriate by the Secretary, do any or all of the following: Use the combined data described in paragraph (4)(B)(iii) to conduct analyses, other than for reports described in paragraph (4), for entities described in subparagraph
(B)for non-public uses, as determined appropriate by the Secretary, such as for the purposes described in subclause (II). The purposes described in this subclause are assisting providers of services and suppliers in developing and participating in quality and patient care improvement activities (including developing new models of care), population health management, and disease monitoring, and the purposes described in subparagraph (C). Provide or sell such analyses to entities described in subparagraph (B). Provide entities described in clauses (i), (ii), (v), and
(vi)of subparagraph
(B)with access to the combined data described in paragraph (4)(B)(iii) through a qualified data enclave (as defined in subparagraph (F)) that is maintained by the qualified entity, or through an approved alternative method (as defined in subparagraph (G)), in order for entities described in such clauses to conduct analyses for non-public uses, such as for the purposes described in clause (i)(II) (but excluding the purposes described in subparagraph (C)). For the purpose of subparagraph
(A)clauses
(i)and (ii), the entities described in this subparagraph are the following: A provider of services. A supplier. Subject to subparagraph (C), an employer (as defined in section 3(5) of the Employee Retirement Insurance Security Act of 1974). A health insurance issuer (as defined in section 2791 of the Public Health Service Act) that provides data under paragraph (4)(B)(iii). A medical society or hospital association. Other entities approved by the Secretary (other than an employer (as so defined) and a health insurance issuer (as so defined)). Any analyses provided or sold under this paragraph to an employer (as so defined) may only be used by such employer for purposes of providing health insurance to employees and retirees of the employer. Except as provided in clause (ii), an analysis provided or sold under this paragraph shall not contain information that individually identifies a patient. An analysis that is provided or sold under this paragraph to a provider of services or supplier may contain data that individually identifies a patient of such provider or supplier but only with respect to items and services furnished by such provider or supplier to such patient. Prior to a qualified entity providing or selling an analysis under this paragraph to an entity described in subparagraph (B), 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 an opportunity for such provider or supplier to review and submit corrections to such analysis. An entity described in subparagraph
(B)that is provided or sold analyses under this paragraph, or an entity described in subparagraph (A)(iii) that receives data under this paragraph through a qualified data enclave or an approved alternative method, shall not redisclose or make public such analyses, such data, or analyses using such data. For purposes of this paragraph, the term qualified data enclave means a data enclave that the Secretary determines meets the following: The data enclave is a virtual private network or comparable mechanism. Subject to the requirements described in clause
(ii)and such other requirements as the Secretary may specify, the data enclave is capable of providing access to the combined data described in subparagraph (A)(iii). The requirements described in this clause are the following: A qualified data enclave shall preclude any entity that obtains access to the data from removing or extracting the data from such enclave. Subject to the succeeding sentence, the enclave shall preclude access to data that individually identifies a patient, including data on the patient's name and date of birth and such other data as the Secretary shall specify. Such data enclave may provide providers of services and suppliers with access to such individually identifiable patient data but only with respect to items and services furnished by such provider or supplier to such patient. Access to data in the enclave shall not be provided to any entity unless the qualified entity and the entity have entered into a data use agreement, the terms of which contain the requirements of this paragraph and paragraph
(6)and such other terms the Secretary may specify. For purposes of this paragraph, the term approved alternative method means a method of providing access to the data described in subparagraph (A)(iii) (other than through a qualified data enclave) to entities described in such paragraph that the Secretary determines meets the following: The method is as secure as a qualified data enclave. The method meets the requirements applicable to a qualified data enclave under subclauses
(II)and
(III)of subparagraph (F)(ii). The method meets other requirements determined appropriate by the Secretary. Any qualified entity that provides or sells analyses pursuant to subparagraph (A)(ii), or provides access to a data through an approved data enclave or an approved alternative method, shall annually submit to the Secretary a report that includes— 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; a description of the topics and purposes of such analyses; information on the entities who obtained access to data pursuant to subparagraph (A)(iii), the uses of the data, and the total amount of fees received for providing such access; and other information determined appropriate by the Secretary. A data use agreement under this subsection shall provide for civil monetary penalties (as determined appropriate by the Secretary) for a breach of such agreement. . Section 1874(e) of the Social Security Act ( 42 U.S.C. 1395kk(e) ) is amended— in the subsection heading, by striking Medicare ; and in paragraph (3)— by inserting after the first sentence the following new sentence: Effective July 1, 2014, if the Secretary determines appropriate, the data described in this paragraph may also include standardized extracts (as determined by the Secretary) of claims data under titles XIX and XXI for assistance provided under such titles for one or more specified geographic areas and time periods requested by a qualified entity. ; and in the last sentence, by inserting or under titles XIX or XXI before the period at the end. Section 1848(m)(3)(E) of the Social Security Act ( 42 U.S.C. 1395w–4(m)(3)(E) ) is amended by adding at the end the following new clause: To the extent consistent with applicable information, privacy, security, and disclosure laws, and subject to other requirements as the Secretary may specify, beginning July 1, 2014, the Secretary shall, if requested by a qualified clinical data registry under this subparagraph, subject to subclauses
(II)and (III), provide data as described in section 1874(e)(3) (in a form and manner determined to be appropriate) to such registry for purposes of linking such data with clinical data and performing analyses and research to support quality improvement or patient safety. A qualified clinical data registry may not publicly report any data made available under subclause
(I)(or any analyses or research described in such subclause) that individually identifies a provider of services, supplier, or individual unless the registry obtains the consent of such provider, supplier, or individual prior to such reporting. The data described in subclause
(I)shall be made available to qualified clinical data registries at a fee equal to the cost of making such data available. Any fee collected pursuant to the preceding sentence shall be deposited in the Centers for Medicare & Medicaid Services Program Management Account. . Section 1874(e)(4)(A) of the Social Security Act ( 42 U.S.C. 1395kk(e)(4)(A) ) is amended, in the second sentence— by inserting , for periods prior to July 1, 2014, after deposited ; and by inserting the following before the period at the end: , and, beginning July 1, 2014, into the Centers for Medicare & Medicaid Services Program Management Account .
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- 42 USC 1395w–4(m)(3)(E)
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