I 113th CONGRESS 1st Session H. R. 3705 IN THE HOUSE OF REPRESENTATIVES December 11, 2013 Mr. Paulsen (for himself and Mr. Matheson ) 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 amend title XVIII of the Social Security Act to establish appropriateness requirements for certain advanced diagnostic imaging services, and for other purposes.

1. Short title This Act may be cited as the Excellence in Diagnostic Imaging Utilization Act of 2013 . 2. Appropriateness requirements for certain advanced diagnostic imaging services (a) In general Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following new subsection: (p) Appropriateness requirements for certain advanced diagnostic imaging services (1) In general (A) In general Beginning with January 1, 2015, with respect to applicable advanced diagnostic imaging services furnished in an outpatient setting and for which payment is made under— (i) the technical or professional component of the fee schedule established under section 1848(b); or (ii) the prospective payment system for hospital outpatient department services under section 1833(t), payment for such services may only be made if the requirements of this subsection are met. (B) Applicable advanced diagnostic imaging services For purposes of this subsection, the term applicable advanced diagnostic imaging services means advanced diagnostic imaging services (as defined in subsection (e)(1)(B)) for which defined appropriate use criteria (and related guidelines) have been— (i) developed or endorsed by national professional medical specialty societies; and (ii) selected by the Secretary for purposes of this subsection in consultation with national professional medical specialty societies and other stakeholders. (C) Construction in instances of multiple applicable appropriate use criteria Nothing in this subsection shall be construed as preventing the Secretary, in the case that there are multiple appropriate use criteria (and related guidelines) that are applicable to a particular advanced diagnostic imaging service (or a specific set of clinical indications), from selecting more than one criterion (or more than one guideline) under subparagraph (B)(ii)(II). (D) Periodic revision The Secretary may periodically revise the list of applicable advanced diagnostic imaging services under this paragraph. (2) Development and maintenance of imaging appropriateness registries by medical specialty societies (A) In general Not later than April 1, 2014, the Secretary shall qualify registries that are developed and maintained by national professional medical specialty societies. (B) Requirements Registries qualified under subparagraph (A) shall meet the following requirements: (i) The registry shall document— (I) the use of an approved electronic clinical decision support tool (as described in paragraph (3)) in connection with the ordering and performance of an applicable advanced diagnostic imaging service; (II) whether orders for applicable advanced diagnostic imaging services were consistent with related appropriate use criteria (including an appropriateness score where available from the approved electronic clinical decision support tool); (III) the clinical indication for the applicable advanced diagnostic imaging services ordered; and (IV) in situations where an order for an applicable advanced diagnostic imaging service is not consistent with the related appropriate use criteria, the rationale of the ordering or furnishing supplier or provider (as the case may be) for such inconsistency. (ii) The registry shall be structured to allow access to data for future research, provide a centralized analysis of the data submitted, including the impact on utilization changes for applicable advanced diagnostic services, and provide connections with existing medical society registries. (iii) The registry shall generate reports on at least a quarterly basis providing feedback to suppliers and providers that order and furnish applicable advanced diagnostic imaging services on the ordering activity of the supplier or provider and related appropriate use criteria metrics. (C) Multiple qualified registries In the case where more than one registry is developed under this paragraph, the Secretary shall ensure that each registry receives standardized data such that the data may be combined and compared across registries. (D) Periodic updating The Secretary shall periodically update the list of registries qualified under this paragraph. (3) Listing of qualified suppliers of approved electronic clinical decision support tools (A) In general Not later than July 1, 2014, the Secretary shall publish a list of qualified suppliers of approved electronic clinical decision support tools, in accordance with the provisions of this paragraph. (B) Standards (i) In general The Secretary, in consultation with the medical specialty societies described in paragraph (2)(A), shall establish standards for the approval of electronic clinical decision support tools provided by qualified suppliers. (ii) Standards The standards established under clause (i) shall include the ability of such tool to— (I) use only standards and guidelines developed by national medical specialty societies; (II) capture the clinical indication for the applicable advanced diagnostic imaging services ordered, selected from the related appropriate use criteria; (III) accurately deliver to the ordering clinician appropriate use criteria (and related guidelines) for applicable advanced diagnostic imaging services, regardless of the physician specialty (if any) from which the criteria or guidelines originated or to which the criteria or guidelines are directed; (IV) in the case where there are multiple standards or guidelines applicable to a particular service or a specific set of clinical indications, indicate the standards or guidelines that are being applied; (V) determine the appropriateness of orders for such services; (VI) submit standardized data to one or more registries qualified under paragraph (2) that is sufficient for such registries to meet their documentation obligations under that paragraph; (VII) be regularly and timely updated; (VIII) generate a unique electronic identifier (referred to in this subsection as a Clinical Decision Support Number ) that documents the fact that the clinical decision support tool was consulted by the ordering supplier or provider in connection with the ordering of an applicable advanced diagnostic imaging service; and (IX) perform other functions determined to be necessary by the Secretary in consultation with the medical specialty societies described in paragraph (2)(A). (C) Design An approved electronic clinical decision support tool under this paragraph— (i) may use a web-based portal, or be imbedded into an electronic health record system or other health information technology tool; and (ii) shall meet the privacy and security standards under the regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996. (D) Usage and convenient access requirements The Secretary shall only include in the list published under this paragraph approved electronic clinical decision support tools provided by suppliers who— (i) attest that they have obtained permission to incorporate appropriate use criteria (and related guidelines) developed by national medical specialty societies; and (ii) demonstrate that they can provide convenient access to such a tool via a secure web-based portal at no cost to— (I) suppliers and providers who order and furnish applicable advanced diagnostic imaging services under this title; and (II) the Federal government. (E) Periodic updating The Secretary shall periodically update the list of qualified suppliers of approved electronic clinical decision support tools that meet the standards established under subparagraph (B) and the other requirements of this paragraph. (4) Consultation requirement The Secretary shall require that, as a condition of participation in the program under this title, suppliers and providers who order an applicable advanced diagnostic imaging service shall agree to consult an approved electronic clinical decision support tool listed pursuant to paragraph (3) in connection with such order. (5) Payment for services contingent upon registry submission (A) In general With respect to an applicable advanced diagnostic imaging service, payment for the technical or professional component of such service under the fee schedule established under section 1848(b) or under the prospective payment system for hospital outpatient department services under section 1833(t) may only be made if the documentation accompanying any such claim for payment demonstrates that an approved electronic clinical decision support tool listed pursuant to paragraph (3) was consulted and the required information was submitted to a registry qualified under paragraph (2). (B) Demonstration of compliance Compliance with the requirements under subparagraph (A) may be demonstrated by the inclusion of a Clinical Decision Support Number with the claim for payment. (6) Exemptions (A) Significant hardship exemption The Secretary may, on a case-by-case basis, exempt a supplier or provider to whom this subsection would otherwise apply if the Secretary determines, subject to annual renewal, that compliance with this subsection would result in a significant hardship, such as in the case of a supplier or provider who lacks access to an electronic records system or high-speed Internet access. (B) Emergency services exemption Applicable advanced diagnostic imaging services ordered emergently as part of an emergency medical evaluation shall not be subject to the requirements of this subsection. (C) Clarification of inapplicability to inpatient services Advanced diagnostic imaging services ordered for inpatients and for which payment is made under part A are not subject to the requirements of this subsection. (7) Limitations The Secretary may not utilize the authority provided under this subsection to— (A) impose any requirement that a supplier or provider obtain approval to order an advanced diagnostic imaging service before performing such service or any other requirement for prior authorization with respect to such service; or (B) use approved electronic clinical decision support tools to make claims payment determinations under this title. (8) Rulemaking regarding patient safety The Secretary shall promulgate regulations to address situations in which a supplier or provider, prior to performing an applicable advanced diagnostic imaging service for an individual, reasonably believes that the service ordered, if performed, would pose a safety risk to the individual and that a different imaging service is more appropriate under the circumstances. Such regulations shall define circumstances in which the supplier or provider may change the order to an imaging service the supplier or provider determines is more appropriate. . (b) Compliance with appropriateness registry treated as satisfactory quality reporting Section 1848(m)(3) of the Social Security Act ( 42 U.S.C. 1395w–4(m)(3) ) is amended— (1) by redesignating subparagraph (F) as subparagraph (H); and (2) by inserting after subparagraph (E) the following new subparagraphs: (F) Satisfactory reporting measures through participation in imaging appropriateness registry (i) In general For 2015 and subsequent years, the Secretary shall treat an eligible professional described in clause (ii) as satisfactorily submitting data on quality measures under subparagraph (A) if, instead of reporting measures under subsection (k)(2)(C), the eligible professional provides evidence, in a form and manner specified by the Secretary, demonstrating that the registry submission requirements under section 1833(p)(5) have been complied with with respect to not less than 90 percent of claims for applicable advanced diagnostic imaging services (as defined in section 1833(p)(1)(B)) submitted by the eligible professional in the year. (ii) Eligible professional described For purposes of clause (i), an eligible professional described in this clause is an eligible professional who furnishes the technical or professional component of applicable advanced diagnostic imaging services (as so defined). (G) Satisfactory reporting measures through participation in imaging appropriateness registry (i) In general For 2015 and subsequent years, the Secretary shall treat an eligible professional described in clause (ii) as satisfactorily submitting data on quality measures under subparagraph (A) if, in lieu of reporting measures under subsection (k)(2)(C), the eligible professional provides evidence, in a form and manner specified by the Secretary, demonstrating that they have complied with the consultation requirements under section 1833(p)(4) with respect to not less than 90 percent of claims for applicable advanced diagnostic imaging services (as so defined) submitted by the eligible professional in the year. (ii) Eligible professional described For purposes of clause (i), an eligible professional described in this clause is an eligible professional who orders applicable advanced diagnostic imaging services (as so defined). . (c) Conforming amendment Section 1833(t)(16) of the Social Security Act ( 42 U.S.C. 1395l(t)(16) ) is amended by adding at the end the following new subparagraph: (E) Application of appropriateness requirements for certain advanced diagnostic imaging services For provisions relating to the application of appropriateness requirements for certain advanced diagnostic imaging services, see section 1834(p). .