IMAGING PROVISIONS.

SEC. 135. IMAGING PROVISIONS.(a) Accreditation Requirement.—(1) Accreditation requirement.—Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by inserting after subsection (d) the following new subsection:“(e) Accreditation Requirement for Advanced Diagnostic Imaging Services.—“(1) In general.—“(A) In general.—Beginning with January 1, 2012, with respect to the technical component of advanced diagnostic imaging services for which payment is made under the fee schedule established under section 1848(b) and 122 STAT. 2533 that are furnished by a supplier, payment may only be made if such supplier is accredited by an accreditation organization designated by the Secretary under paragraph (2)(B)(i).“(B) Advanced diagnostic imaging services defined.—In this subsection, the term ‘advanced diagnostic imaging services’ includes—“(i) diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography); and“(ii) such other diagnostic imaging services, including services described in section 1848(b)(4)(B) (excluding X-ray, ultrasound, and fluoroscopy), as specified by the Secretary in consultation with physician specialty organizations and other stakeholders.“(C) Supplier defined.—In this subsection, the term ‘supplier’ has the meaning given such term in section 1861(d).“(2) Accreditation organizations.—“(A) Factors for designation of accreditation organizations.—The Secretary shall consider the following factors in designating accreditation organizations under subparagraph (B)(i) and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph (C):“(i) The ability of the organization to conduct timely reviews of accreditation applications.“(ii) Whether the organization has established a process for the timely integration of new advanced diagnostic imaging services into the organization’s accreditation program.“(iii) Whether the organization uses random site visits, site audits, or other strategies for ensuring accredited suppliers maintain adherence to the criteria described in paragraph (3).“(iv) The ability of the organization to take into account the capacities of suppliers located in a rural area (as defined in section 1886(d)(2)(D)).“(v) Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation.“(vi) Such other factors as the Secretary determines appropriate.“(B) Designation.—Not later than January 1, 2010, the Secretary shall designate organizations to accredit suppliers furnishing the technical component of advanced diagnostic imaging services. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C).“(C) Review and modification of list of accreditation organizations.—“(i) In general.—The Secretary shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify 122 STAT. 2534 the list of accreditation organizations designated under subparagraph (B).“(ii) Special rule for accreditations done prior to removal from list of designated accreditation organizations.—In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph (B), any supplier that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect.“(3) Criteria for accreditation.—The Secretary shall establish procedures to ensure that the criteria used by an accreditation organization designated under paragraph (2)(B) to evaluate a supplier that furnishes the technical component of advanced diagnostic imaging services for the purpose of accreditation of such supplier is specific to each imaging modality. Such criteria shall include—“(A) standards for qualifications of medical personnel who are not physicians and who furnish the technical component of advanced diagnostic imaging services;“(B) standards for qualifications and responsibilities of medical directors and supervising physicians, including standards that recognize the considerations described in paragraph (4);“(C) procedures to ensure that equipment used in furnishing the technical component of advanced diagnostic imaging services meets performance specifications;“(D) standards that require the supplier have procedures in place to ensure the safety of persons who furnish the technical component of advanced diagnostic imaging services and individuals to whom such services are furnished;“(E) standards that require the establishment and maintenance of a quality assurance and quality control program by the supplier that is adequate and appropriate to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by such supplier; and“(F) any other standards or procedures the Secretary determines appropriate.“(4) Recognition in standards for the evaluation of medical directors and supervising physicians.—The standards described in paragraph (3)(B) shall recognize whether a medical director or supervising physician—“(A) in a particular specialty receives training in advanced diagnostic imaging services in a residency program;“(B) has attained, through experience, the necessary expertise to be a medical director or a supervising physician;122 STAT. 2535“(C) has completed any continuing medical education courses relating to such services; or“(D) has met such other standards as the Secretary determines appropriate.“(5) Rule for accreditations made prior to designation.—In the case of a supplier that is accredited before January 1, 2010, by an accreditation organization designated by the Secretary under paragraph (2)(B) as of January 1, 2010, such supplier shall be considered to have been accredited by an organization designated by the Secretary under such paragraph as of January 1, 2012, for the remaining period such accreditation is in effect.”.(2) Conforming amendments.—(A) In general.—Section 1862(a) of the Social Security Act (42 U.S.C. 1395y(a)) is amended—(i) in paragraph (21), by striking “or” at the end;(ii) in paragraph (22), by striking the period at the end and inserting “; or”; and(iii) by inserting after paragraph (22) the following new paragraph:“(23) which are the technical component of advanced diagnostic imaging services described in section 1834(e)(1)(B) for which payment is made under the fee schedule established under section 1848(b) and that are furnished by a supplier (as defined in section 1861(d)), if such supplier is not accredited by an accreditation organization designated by the Secretary under section 1834(e)(2)(B).”.(B) Effective date.—The amendments made by this paragraph shall apply to advanced diagnostic imaging services furnished on or after January 1, 2012.(b) Demonstration Project To Assess the Appropriate Use of Imaging Services.—(1) Conduct of demonstration project.—(A) In general.—The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall conduct a demonstration project using the models described in paragraph (2)(E) to collect data regarding physician compliance with appropriateness criteria selected under paragraph (2)(D) in order to determine the appropriateness of advanced diagnostic imaging services furnished to Medicare beneficiaries.(B) Advanced diagnostic imaging services.—In this subsection, the term “advanced diagnostic imaging services” has the meaning given such term in section 1834(e)(1)(B) of the Social Security Act, as added by subsection (a).(C) Authority to focus demonstration project.—The Secretary may focus the demonstration project with respect to certain advanced diagnostic imaging services, such as services that account for a large amount of expenditures under the Medicare program, services that have recently experienced a high rate of growth, or services for which appropriateness criteria exists.(2) Implementation and design of demonstration project.—(A) Implementation and duration.—122 STAT. 2536(i) Implementation.—The Secretary shall implement the demonstration project under this subsection not later than January 1, 2010.(ii) Duration.—The Secretary shall conduct the demonstration project under this subsection for a 2-year period.(B) Application and selection of participating physicians.—(i) Application.—Each physician that desires to participate in the demonstration project under this subsection shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.(ii) Selection.—The Secretary shall select physicians to participate in the demonstration project under this subsection from among physicians submitting applications under clause (i). The Secretary shall ensure that the physicians selected—(I) represent a wide range of geographic areas, demographic characteristics (such as urban, rural, and suburban), and practice settings (such as private and academic practices); and(II) have the capability to submit data to the Secretary (or an entity under a subcontract with the Secretary) in an electronic format in accordance with standards established by the Secretary.(C) Administrative costs and incentives.—The Secretary shall—(i) reimburse physicians for reasonable administrative costs incurred in participating in the demonstration project under this subsection; and(ii) provide reasonable incentives to physicians to encourage participation in the demonstration project under this subsection.(D) Use of appropriateness criteria.—(i) In general.—The Secretary, in consultation with medical specialty societies and other stakeholders, shall select criteria with respect to the clinical appropriateness of advanced diagnostic imaging services for use in the demonstration project under this subsection.(ii) Criteria selected.—Any criteria selected under clause (i) shall—(I) be developed or endorsed by a medical specialty society; and(II) be developed in adherence to appropriateness principles developed by a consensus organization, such as the AQA alliance.(E) Models for collecting data regarding physician compliance with selected criteria.—Subject to subparagraph (H), in carrying out the demonstration project under this subsection, the Secretary shall use each of the following models for collecting data regarding physician compliance with appropriateness criteria selected under subparagraph (D):(i) A model described in subparagraph (F).(ii) A model described in subparagraph (G).122 STAT. 2537(iii) Any other model that the Secretary determines to be useful in evaluating the use of appropriateness criteria for advanced diagnostic imaging services.(F) Point of service model described.—A model described in this subparagraph is a model that—(i) uses an electronic or paper intake form that—(I) contains a certification by the physician furnishing the imaging service that the data on the intake form was confirmed with the Medicare beneficiary before the service was furnished;(II) contains standardized data elements for diagnosis, service ordered, service furnished, and such other information determined by the Secretary, in consultation with medical specialty societies and other stakeholders, to be germane to evaluating the effectiveness of the use of appropriateness criteria selected under subparagraph (D); and(III) is accessible to physicians participating in the demonstration project under this subsection in a format that allows for the electronic submission of such form; and(ii) provides for feedback reports in accordance with paragraph (3)(B).(G) Point of order model described.—A model described in this subparagraph is a model that—(i) uses a computerized order-entry system that requires the transmittal of relevant supporting information at the time of referral for advanced diagnostic imaging services and provides automated decision-support feedback to the referring physician regarding the appropriateness of furnishing such imaging services; and(ii) provides for feedback reports in accordance with paragraph (3)(B).(H) Limitation.—In no case may the Secretary use prior authorization—(i) as a model for collecting data regarding physician compliance with appropriateness criteria selected under subparagraph (D) under the demonstration project under this subsection; or(ii) under any model used for collecting such data under the demonstration project.(I) Required contracts and performance standards for certain entities.—(i) In general.—The Secretary shall enter into contracts with entities to carry out the model described in subparagraph (G).(ii) Performance standards.—The Secretary shall establish and enforce performance standards for such entities under the contracts entered into under clause (i), including performance standards with respect to—(I) the satisfaction of Medicare beneficiaries who are furnished advanced diagnostic imaging services by a physician participating in the demonstration project;122 STAT. 2538(II) the satisfaction of physicians participating in the demonstration project;(III) if applicable, timelines for the provision of feedback reports under paragraph (3)(B); and(IV) any other areas determined appropriate by the Secretary.(3) Comparison of utilization of advanced diagnostic imaging services and feedback reports.—(A) Comparison of utilization of advanced diagnostic imaging services.—The Secretary shall consult with medical specialty societies and other stakeholders to develop mechanisms for comparing the utilization of advanced diagnostic imaging services by physicians participating in the demonstration project under this subsection against—(i) the appropriateness criteria selected under paragraph (2)(D); and(ii) to the extent feasible, the utilization of such services by physicians not participating in the demonstration project.(B) Feedback reports.—The Secretary shall, in consultation with medical specialty societies and other stakeholders, develop mechanisms to provide feedback reports to physicians participating in the demonstration project under this subsection. Such feedback reports shall include—(i) a profile of the rate of compliance by the physician with appropriateness criteria selected under paragraph (2)(D), including a comparison of—(I) the rate of compliance by the physician with such criteria; and(II) the rate of compliance by the physician’s peers (as defined by the Secretary) with such criteria; and(ii) to the extent feasible, a comparison of—(I) the rate of utilization of advanced diagnostic imaging services by the physician; and(II) the rate of utilization of such services by the physician’s peers (as defined by the Secretary) who are not participating in the demonstration project.(4) Conduct of demonstration project and waiver.—(A) Conduct of demonstration project.—Chapter 35 of title 44, United States Code, shall not apply to the conduct of the demonstration project under this subsection.(B) Waiver.—The Secretary may waive such provisions of titles XI and XVIII of the Social Security Act (42 U.S.C. 1301 et seq.; 1395 et seq.) as may be necessary to carry out the demonstration project under this subsection.(5) Evaluation and report.—(A) Evaluation.—The Secretary shall evaluate the demonstration project under this subsection to—(i) assess the timeliness and efficacy of the demonstration project;(ii) assess the performance of entities under a contract entered into under paragraph (2)(I)(i);(iii) analyze data—122 STAT. 2539(I) on the rates of appropriate, uncertain, and inappropriate advanced diagnostic imaging services furnished by physicians participating in the demonstration project;(II) on patterns and trends in the appropriateness and inappropriateness of such services furnished by such physicians;(III) on patterns and trends in national and regional variations of care with respect to the furnishing of such services; and(IV) on the correlation between the appropriateness of the services furnished and image results; and(iv) address—(I) the thresholds used under the demonstration project to identify acceptable and outlier levels of performance with respect to the appropriateness of advanced diagnostic imaging services furnished;(II) whether prospective use of appropriateness criteria could have an effect on the volume of such services furnished;(III) whether expansion of the use of appropriateness criteria with respect to such services to a broader population of Medicare beneficiaries would be advisable;(IV) whether, under such an expansion, physicians who demonstrate consistent compliance with such appropriateness criteria should be exempted from certain requirements;(V) the use of incident-specific versus practice-specific outlier information in formulating future recommendations with respect to the use of appropriateness criteria for such services under the Medicare program; and(VI) the potential for using methods (including financial incentives), in addition to those used under the models under the demonstration project, to ensure compliance with such criteria.(B) Report.—Not later than 1 year after the completion of the demonstration project under this subsection, the Secretary shall submit to Congress a report containing the results of the evaluation of the demonstration project conducted under subparagraph (A), together with recommendations for such legislation and administrative action as the Secretary determines appropriate.(6) Funding.—The Secretary shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund established under section 1841 of the Social Security Act (42 U.S.C. 1395t) of $10,000,000, for carrying out the demonstration project under this subsection (including costs associated with administering the demonstration project, reimbursing physicians for administrative costs and providing incentives to encourage participation under paragraph (2)(C), entering into contracts under paragraph (2)(I), and evaluating the demonstration project under paragraph (5)).(c) GAO Study and Reports on Accreditation Requirement for Advanced Diagnostic Imaging Services.—122 STAT. 2540(1) Study.—(A) In general.—The Comptroller General of the United States (in this subsection referred to as the “Comptroller General”) shall conduct a study, by imaging modality, on—(i) the effect of the accreditation requirement under section 1834(e) of the Social Security Act, as added by subsection (a); and(ii) any other relevant questions involving access to, and the value of, advanced diagnostic imaging services for Medicare beneficiaries.(B) Issues.—The study conducted under subparagraph (A) shall examine the following:(i) The impact of such accreditation requirement on the number, type, and quality of imaging services furnished to Medicare beneficiaries.(ii) The cost of such accreditation requirement, including costs to facilities of compliance with such requirement and costs to the Secretary of administering such requirement.(iii) Access to imaging services by Medicare beneficiaries, especially in rural areas, before and after implementation of such accreditation requirement.(iv) Such other issues as the Secretary determines appropriate.(2) Reports.—(A) Preliminary report.—Not later than March 1, 2013, the Comptroller General shall submit a preliminary report to Congress on the study conducted under paragraph (1).(B) Final report.—Not later than March 1, 2014, the Comptroller General shall submit a final report to Congress on the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.