Pub. L. 108-173, tit. IX, subtit. D, sec. 938
PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES; ADVANCE BENEFICIARY NOTICES.
SEC. 938. PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES; ADVANCE BENEFICIARY NOTICES.(a) In General.—Section 1869 (42 U.S.C. 1395ff(b)), as amended by section 933(d)(2)(B), is further amended by adding at the end the following new subsection:“(h) Prior Determination Process for Certain Items and Services.—“(1) Establishment of process.—“(A) In general.—With respect to a medicare administrative contractor that has a contract under section 1874A that provides for making payments under this title with respect to physicians’ services (as defined in section 1848(j)(3)), the Secretary shall establish a prior determination process that meets the requirements of this subsection and that shall be applied by such contractor in the case of eligible requesters.“(B) Eligible requester.—For purposes of this subsection, each of the following shall be an eligible requester:“(i) A participating physician, but only with respect to physicians’ services to be furnished to an individual who is entitled to benefits under this title and who has consented to the physician making the request under this subsection for those physicians’ services.“(ii) An individual entitled to benefits under this title, but only with respect to a physicians’ service for which the individual receives, from a physician, an advance beneficiary notice under section 1879(a).“(2) Secretarial flexibility.—The Secretary shall establish by regulation reasonable limits on the physicians’ services for which a prior determination of coverage may be requested under this subsection. In establishing such limits, the Secretary may consider the dollar amount involved with respect to the physicians’ service, administrative costs and burdens, and other relevant factors.“(3) Request for prior determination.—“(A) In general.—Subject to paragraph (2), under the process established under this subsection an eligible requester may submit to the contractor a request for a determination, before the furnishing of a physicians’ service, as to whether the physicians’ service is covered under this title consistent with the applicable requirements of section 1862(a)(1)(A) (relating to medical necessity).“(B) Accompanying documentation.—The Secretary may require that the request be accompanied by a description of the physicians’ service, supporting documentation relating to the medical necessity for the physicians’ service, and any other appropriate documentation. In the case of a request submitted by an eligible requester who is described in paragraph (1)(B)(ii), the Secretary may require that the request also be accompanied by a copy of the advance beneficiary notice involved.“(4) Response to request.—“(A) In general.—Under such process, the contractor shall provide the eligible requester with written notice of a determination as to whether—“(i) the physicians’ service is so covered;“(ii) the physicians’ service is not so covered; or117 STAT. 2414“(iii) the contractor lacks sufficient information to make a coverage determination with respect to the physicians’ service.“(B) Contents of notice for certain determinations.—“(i) Noncoverage.—If the contractor makes the determination described in subparagraph (A)(ii), the contractor shall include in the notice a brief explanation of the basis for the determination, including on what national or local coverage or noncoverage determination (if any) the determination is based, and a description of any applicable rights under subsection (a).“(ii) Insufficient information.—If the contractor makes the determination described in subparagraph (A)(iii), the contractor shall include in the notice a description of the additional information required to make the coverage determination.“(C) Deadline to respond.—Such notice shall be provided within the same time period as the time period applicable to the contractor providing notice of initial determinations on a claim for benefits under subsection (a)(2)(A).“(D) Informing beneficiary in case of physician request.—In the case of a request by a participating physician under paragraph (1)(B)(i), the process shall provide that the individual to whom the physicians’ service is proposed to be furnished shall be informed of any determination described in subparagraph (A)(ii) (relating to a determination of non-coverage) and the right (referred to in paragraph (6)(B)) to obtain the physicians’ service and have a claim submitted for the physicians’ service.“(5) Binding nature of positive determination.—If the contractor makes the determination described in paragraph (4)(A)(i), such determination shall be binding on the contractor in the absence of fraud or evidence of misrepresentation of facts presented to the contractor.“(6) Limitation on further review.—“(A) In general.—Contractor determinations described in paragraph (4)(A)(ii) or (4)(A)(iii) (relating to pre-service claims) are not subject to further administrative appeal or judicial review under this section or otherwise.“(B) Decision not to seek prior determination or negative determination does not impact right to obtain services, seek reimbursement, or appeal rights.—Nothing in this subsection shall be construed as affecting the right of an individual who—“(i) decides not to seek a prior determination under this subsection with respect to physicians’ services; or“(ii) seeks such a determination and has received a determination described in paragraph (4)(A)(ii),from receiving (and submitting a claim for) such physicians’ services and from obtaining administrative or judicial review respecting such claim under the other applicable provisions of this section. Failure to seek a prior determination under this subsection with respect to physicians’ 117 STAT. 2415 service shall not be taken into account in such administrative or judicial review.“(C) No prior determination after receipt of services.—Once an individual is provided physicians’ services, there shall be no prior determination under this subsection with respect to such physicians’ services.”.(b) Effective Date; Sunset; Transition.—(1) Effective date.—The Secretary shall establish the prior determination process under the amendment made by subsection (a) in such a manner as to provide for the acceptance of requests for determinations under such process filed not later than 18 months after the date of the enactment of this Act.(2) Sunset.—Such prior determination process shall not apply to requests filed after the end of the 5-year period beginning on the first date on which requests for determinations under such process are accepted.(3) Transition.—During the period in which the amendment made by subsection (a) has become effective but contracts are not provided under section 1874A of the Social Security Act with medicare administrative contractors, any reference in section 1869(g) of such Act (as added by such amendment) to such a contractor is deemed a reference to a fiscal intermediary or carrier with an agreement under section 1816, or contract under section 1842, respectively, of such Act.(4) Limitation on application to sgr.—For purposes of applying section 1848(f)(2)(D) of the Social Security Act (42 U.S.C. 1395w–4(f)(2)(D)), the amendment made by subsection (a) shall not be considered to be a change in law or regulation.(c) Provisions Relating to Advance Beneficiary Notices; Report on Prior Determination Process.—(1) Data collection.—The Secretary shall establish a process for the collection of information on the instances in which an advance beneficiary notice (as defined in paragraph (5)) has been provided and on instances in which a beneficiary indicates on such a notice that the beneficiary does not intend to seek to have the item or service that is the subject of the notice furnished.(2) Outreach and education.—The Secretary shall establish a program of outreach and education for beneficiaries and providers of services and other persons on the appropriate use of advance beneficiary notices and coverage policies under the medicare program.(3) GAO report on use of advance beneficiary notices.—Not later than 18 months after the date on which section 1869(h) of the Social Security Act (as added by subsection (a)) takes effect, the Comptroller General of the United States shall submit to Congress a report on the use of advance beneficiary notices under title XVIII of such Act. Such report shall include information concerning the providers of services and other persons that have provided such notices and the response of beneficiaries to such notices.(4) GAO report on use of prior determination process.—Not later than 36 months after the date on which section 1869(h) of the Social Security Act (as added by subsection (a)) takes effect, the Comptroller General of the United States shall submit to Congress a report on the use of the 117 STAT. 2416 prior determination process under such section. Such report shall include—(A) information concerning—(i) the number and types of procedures for which a prior determination has been sought;(ii) determinations made under the process;(iii) the percentage of beneficiaries prevailing;(iv) in those cases in which the beneficiaries do not prevail, the reasons why such beneficiaries did not prevail; and(v) changes in receipt of services resulting from the application of such process;(B) an evaluation of whether the process was useful for physicians (and other suppliers) and beneficiaries, whether it was timely, and whether the amount of information required was burdensome to physicians and beneficiaries; and(C) recommendations for improvements or continuation of such process.(5) Advance beneficiary notice defined.—In this subsection, the term “advance beneficiary notice” means a written notice provided under section 1879(a) of the Social Security Act (42 U.S.C. 1395pp(a)) to an individual entitled to benefits under part A or enrolled under part B of title XVIII of such Act before items or services are furnished under such part in cases where a provider of services or other person that would furnish the item or service believes that payment will not be made for some or all of such items or services under such title.