Monday, November 21, 2016

PAMA Section 218: Imaging Appropriate Use Criteria

PAMA as a whole:

https://www.gpo.gov/fdsys/pkg/PLAW-113publ93/html/PLAW-113publ93.htm



PAMA Section 218/Appropriate Use Criteria (Clipped; becomes SSA 1834(q)):


    (b) Promoting Evidence-Based Care.--
            (1) In general.--Section 1834 of the Social Security Act (42 
        U.S.C. 1395m), as amended by subsection (a), is amended by 
        adding at the end the following new subsection:

    ``(q) Recognizing Appropriate Use Criteria for Certain Imaging 
Services.--
            ``(1) Program established.--
                    ``(A) In general.--The Secretary shall establish a 
                program to promote the use of appropriate use criteria 
                (as defined in subparagraph (B)) for applicable imaging 
                services (as defined in subparagraph (C)) furnished in 
                an applicable setting (as defined in subparagraph (D)) 
                by ordering professionals and furnishing professionals 
                (as defined in subparagraphs (E) and (F), respectively).
                    ``(B) Appropriate use criteria defined.--In this 
                subsection, the term `appropriate use criteria' means 
                criteria, only developed or endorsed by national 
                professional medical specialty societies or other 
                provider-led entities, to assist ordering professionals 
                and furnishing professionals in making the most 
                appropriate treatment decision for a specific clinical 
                condition for an individual. To the extent feasible, 
                such criteria shall be evidence-based.
                    ``(C) Applicable imaging service defined.--In this 
                subsection, the term `applicable imaging service' means 
                an advanced diagnostic imaging service (as defined in 
                subsection (e)(1)(B)) for which the Secretary 
                determines--
                          ``(i) one or more applicable appropriate use 
                      criteria specified under paragraph (2) apply;
                          ``(ii) there are one or more qualified 
                      clinical decision support mechanisms listed under 
                      paragraph (3)(C); and
                          ``(iii) one or more of such mechanisms is 
                      available free of charge.
                    ``(D) Applicable setting defined.--In this 
                subsection, the term `applicable setting' means a 
                physician's office, a hospital outpatient department 
                (including an emergency department), an ambulatory 
                surgical center, and any other provider-led outpatient 
                setting determined appropriate by the Secretary.
                    ``(E) Ordering professional defined.--In this 
                subsection, the term `ordering professional' means a 
                physician (as defined in section 1861(r)) or a 
                practitioner described in section 1842(b)(18)(C) who 
                orders an applicable imaging service.
                    ``(F) Furnishing professional defined.--In this 
                subsection, the term `furnishing professional' means a 
                physician (as defined in section 1861(r)) or a 
                practitioner described in section 1842(b)(18)(C) who 
                furnishes an applicable imaging service.
            ``(2) Establishment of applicable appropriate use 
        criteria.--

[[Page 128 STAT. 1066]]

                    
                ``(A) <<NOTE: Deadline. Regulations. Consultation.>>  In 
                general.--Not later than November 15, 2015, the 
                Secretary shall through rulemaking, and in consultation 
                with physicians, practitioners, and other stakeholders, 
                specify applicable appropriate use criteria for 
                applicable imaging services only from among appropriate 
                use criteria developed or endorsed by national 
                professional medical specialty societies or other 
                provider-led entities.
                    ``(B) Considerations.--In specifying applicable 
                appropriate use criteria under subparagraph (A), the 
                Secretary shall take into account whether the criteria--
                          ``(i) have stakeholder consensus;
                          ``(ii) are scientifically valid and evidence 
                      based; and
                          ``(iii) are based on studies that are 
                      published and reviewable by stakeholders.
                    ``(C) <<NOTE: Review. Deadline.>>  Revisions.--The 
                Secretary shall review, on an annual basis, the 
                specified applicable appropriate use criteria to 
                determine if there is a need to update or revise (as 
                appropriate) such specification of applicable 
                appropriate use criteria and make such updates or 
                revisions through rulemaking.
                    ``(D) Treatment of multiple applicable appropriate 
                use criteria.--In the case where the Secretary 
                determines that more than one appropriate use criterion 
                applies with respect to an applicable imaging service, 
                the Secretary shall apply one or more applicable 
                appropriate use criteria under this paragraph for the 
                service.
            ``(3) Mechanisms for consultation with applicable 
        appropriate use criteria.--
                    ``(A) Identification of mechanisms to consult with 
                applicable appropriate use criteria.--
                          ``(i) In general.--The Secretary shall specify 
                      qualified clinical decision support mechanisms 
                      that could be used by ordering professionals to 
                      consult with applicable appropriate use criteria 
                      for applicable imaging services.
                          ``(ii) Consultation.--The Secretary shall 
                      consult with physicians, practitioners, health 
                      care technology experts, and other stakeholders in 
                      specifying mechanisms under this paragraph.
                          ``(iii) Inclusion of certain mechanisms.--
                      Mechanisms specified under this paragraph may 
                      include any or all of the following that meet the 
                      requirements described in subparagraph (B)(ii):
                                    ``(I) Use of clinical decision 
                                support modules in certified EHR 
                                technology (as defined in section 
                                1848(o)(4)).
                                    ``(II) Use of private sector 
                                clinical decision support mechanisms 
                                that are independent from certified EHR 
                                technology, which may include use of 
                                clinical decision support mechanisms 
                                available from medical specialty 
                                organizations.
                                    ``(III) Use of a clinical decision 
                                support mechanism established by the 
                                Secretary.
                    ``(B) Qualified clinical decision support 
                mechanisms.--

[[Page 128 STAT. 1067]]

                          ``(i) In general.--For purposes of this 
                      subsection, a qualified clinical decision support 
                      mechanism is a mechanism that the Secretary 
                      determines meets the requirements described in 
                      clause (ii).
                          ``(ii) Requirements.--The requirements 
                      described in this clause are the following:
                                    ``(I) The mechanism makes available 
                                to the ordering professional applicable 
                                appropriate use criteria specified under 
                                paragraph (2) and the supporting 
                                documentation for the applicable imaging 
                                service ordered.
                                    ``(II) In the case where there is 
                                more than one applicable appropriate use 
                                criterion specified under such paragraph 
                                for an applicable imaging service, the 
                                mechanism indicates the criteria that it 
                                uses for the service.
                                    ``(III) The mechanism determines the 
                                extent to which an applicable imaging 
                                service ordered is consistent with the 
                                applicable appropriate use criteria so 
                                specified.
                                    ``(IV) The mechanism generates and 
                                provides to the ordering professional a 
                                certification or documentation that 
                                documents that the qualified clinical 
                                decision support mechanism was consulted 
                                by the ordering professional.
                                    ``(V) The mechanism is updated on a 
                                timely basis to reflect revisions to the 
                                specification of applicable appropriate 
                                use criteria under such paragraph.
                                    ``(VI) The mechanism meets privacy 
                                and security standards under applicable 
                                provisions of law.
                                    ``(VII) The mechanism performs such 
                                other functions as specified by the 
                                Secretary, which may include a 
                                requirement to provide aggregate 
                                feedback to the ordering professional.
                    ``(C) <<NOTE: Deadlines.>>  List of mechanisms for 
                consultation with applicable appropriate use criteria.--
                          ``(i) <<NOTE: Publication.>>  Initial list.--
                      Not later than April 1, 2016, the Secretary shall 
                      publish a list of mechanisms specified under this 
                      paragraph.
                          ``(ii) Periodic updating of list.--The 
                      Secretary shall identify on an annual basis the 
                      list of qualified clinical decision support 
                      mechanisms specified under this paragraph.
            ``(4) Consultation with applicable appropriate use 
        criteria.--
                    ``(A) Consultation by ordering professional.--
                Beginning <<NOTE: Effective date.>> with January 1, 
                2017, subject to subparagraph (C), with respect to an 
                applicable imaging service ordered by an ordering 
                professional that would be furnished in an applicable 
                setting and paid for under an applicable payment system 
                (as defined in subparagraph (D)), an ordering 
                professional shall--
                          ``(i) consult with a qualified decision 
                      support mechanism listed under paragraph (3)(C); 
                      and

[[Page 128 STAT. 1068]]

                          ``(ii) provide to the furnishing professional 
                      the information described in clauses (i) through 
                      (iii) of subparagraph (B).
                    ``(B) <<NOTE: Effective date.>>  Reporting by 
                furnishing professional.--Beginning with January 1, 
                2017, subject to subparagraph (C), with respect to an 
                applicable imaging service furnished in an applicable 
                setting and paid for under an applicable payment system 
                (as defined in subparagraph (D)), payment for such 
                service may only be made if the claim for the service 
                includes the following:
                          ``(i) Information about which qualified 
                      clinical decision support mechanism was consulted 
                      by the ordering professional for the service.
                          ``(ii) Information regarding--
                                    ``(I) whether the service ordered 
                                would adhere to the applicable 
                                appropriate use criteria specified under 
                                paragraph (2);
                                    ``(II) whether the service ordered 
                                would not adhere to such criteria; or
                                    ``(III) whether such criteria was 
                                not applicable to the service ordered.
                          ``(iii) The national provider identifier of 
                      the ordering professional (if different from the 
                      furnishing professional).
                    ``(C) Exceptions.--The provisions of subparagraphs 
                (A) and (B) and paragraph (6)(A) shall not apply to the 
                following:
                          ``(i) Emergency services.--An applicable 
                      imaging service ordered for an individual with an 
                      emergency medical condition (as defined in section 
                      1867(e)(1)).
                          ``(ii) Inpatient services.--An applicable 
                      imaging service ordered for an inpatient and for 
                      which payment is made under part A.
                          ``(iii) Significant hardship.--An applicable 
                      imaging service ordered by an ordering 
                      professional who the Secretary may, on a case-by-
                      case basis, exempt from the application of such 
                      provisions if the Secretary determines, subject to 
                      annual renewal, that consultation with applicable 
                      appropriate use criteria would result in a 
                      significant hardship, such as in the case of a 
                      professional who practices in a rural area without 
                      sufficient Internet access.
                    ``(D) Applicable payment system defined.--In this 
                subsection, the term `applicable payment system' means 
                the following:
                          ``(i) The physician fee schedule established 
                      under section 1848(b).
                          ``(ii) The prospective payment system for 
                      hospital outpatient department services under 
                      section 1833(t).
                          ``(iii) The ambulatory surgical center payment 
                      systems under section 1833(i).
            ``(5) Identification of outlier ordering professionals.--
                    ``(A) <<NOTE: Effective date. Determination.>>  In 
                general.--With respect to applicable imaging services 
                furnished beginning with 2017, the Secretary shall 
                determine, on an annual basis, no more than five percent

[[Page 128 STAT. 1069]]

                of the total number of ordering professionals who are 
                outlier ordering professionals.
                    ``(B) Outlier ordering professionals.--The 
                determination of an outlier ordering professional 
                shall--
                          ``(i) be based on low adherence to applicable 
                      appropriate use criteria specified under paragraph 
                      (2), which may be based on comparison to other 
                      ordering professionals; and
                          ``(ii) include data for ordering professionals 
                      for whom prior authorization under paragraph 
                      (6)(A) applies.
                    ``(C) Use of two years of data.--The Secretary shall 
                use two years of data to identify outlier ordering 
                professionals under this paragraph.
                    ``(D) Process.--The Secretary shall establish a 
                process for determining when an outlier ordering 
                professional is no longer an outlier ordering 
                professional.
                    ``(E) Consultation with stakeholders.--The Secretary 
                shall consult with physicians, practitioners and other 
                stakeholders in developing methods to identify outlier 
                ordering professionals under this paragraph.
            ``(6) Prior authorization for ordering professionals who are 
        outliers.--
                    ``(A) <<NOTE: Effective date.>>  In general.--
                Beginning January 1, 2020, subject to paragraph (4)(C), 
                with respect to services furnished during a year, the 
                Secretary shall, for a period determined appropriate by 
                the Secretary, apply prior authorization for applicable 
                imaging services that are ordered by an outlier ordering 
                professional identified under paragraph (5).
                    ``(B) Appropriate use criteria in prior 
                authorization.--In applying prior authorization under 
                subparagraph (A), the Secretary shall utilize only the 
                applicable appropriate use criteria specified under this 
                subsection.
                    ``(C) Funding.--For purposes of carrying out this 
                paragraph, the Secretary shall provide for the transfer, 
                from the Federal Supplementary Medical Insurance Trust 
                Fund under section 1841, of $5,000,000 to the Centers 
                for Medicare & Medicaid Services Program Management 
                Account for each of fiscal years 2019 through 2021. 
                Amounts transferred under the preceding sentence shall 
                remain available until expended.
            ``(7) Construction.--Nothing in this subsection shall be 
        construed as granting the Secretary the authority to develop or 
        initiate the development of clinical practice guidelines or 
        appropriate use criteria.''.
            (2) 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 appropriate use criteria for 
                certain imaging services.--For provisions relating to 
                the application of appropriate use criteria for certain 
                imaging services, see section 1834(q).''.
            (3) Report on experience of imaging appropriate use criteria 
        program.--Not later than 18 months after the date of the 
        enactment of this Act, the Comptroller General of the United 
        States shall submit to Congress a report that includes

[[Page 128 STAT. 1070]]

        a description of the extent to which appropriate use criteria 
        could be used for other services under part B of title XVIII of 
        the Social Security Act (42 U.S.C. 1395j et seq.), such as 
        radiation therapy and clinical diagnostic laboratory services.

....SEC. 219. USING FUNDING FROM TRANSITIONAL FUND FOR SUSTAINABLE 
                        GROWTH RATE (SGR) REFORM.

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