I 115th CONGRESS 1st Session H. R. 2445 IN THE HOUSE OF REPRESENTATIVES May 16, 2017 Mrs. Blackburn 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 provide for a prior authorization process under the Medicare program for certain high cost durable medical equipment, prosthetics, orthotics, and supplies.

1. Short title This Act may be cited as the DMEPOS Access and Transparency Act of 2017 or the DATA Act of 2017 . 2. Prior authorization process for certain high cost durable medical equipment, prosthetics, orthotics, and supplies under the medicare program Section 1834(a)(15) of the Social Security Act ( 42 U.S.C. 1395m(a)(15) ) is amended— (1) in the paragraph heading, by striking items and inserting items; prior authorization process for certain high cost durable medical equipment, prosthetics, orthotics, and supplies ; and (2) by adding at the end the following new subparagraphs: (D) Prior authorization process for certain high cost durable medical equipment, prosthetics, orthotics, and supplies (i) In general Not later than 1 year after the date of the enactment of this subparagraph, the Secretary shall develop and implement a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies. A claim for an item of durable medical equipment, a prosthetic, an orthotic, or a supply that has received prior approval through the prior authorization process shall be exempt from subsequent pre- and post-payment audits and only subject to audits for systematic fraud and abuse. (ii) Consideration of factors The Secretary shall consider the following factors in developing and implementing the prior authorization process under this subparagraph: (I) Beneficiary access to timely care. (II) Alignment with the best practices of commercial managed care plans and Medicare Advantage plans under part C that have expertise in prior authorization processes. (III) Implementation of standard medical necessity evaluation prior authorization requests for physician and hospital referral agents and non-physician practitioners. (IV) Accounting for same day delivery expectations by providing for expedited emergency review for certain items. (iii) Implementation The Secretary shall promulgate a regulation to carry out the prior authorization process under this subparagraph. The regulation shall— (I) ensure that stakeholders participate in the development of the process; and (II) place priority on prior authorization of items that are subject to a high number of contractor audits. (E) Prior authorization process for home respiratory therapy (i) In general In the case of home respiratory therapy (as defined in clause (v)) furnished on or after January 1, 2019, the Secretary shall establish and implement a process under which the Secretary shall determine, in advance of furnishing such therapy to an individual, whether payment for such therapy may not be made under this title because such therapy is not covered under this title or because of the application of section 1862(a)(1). (ii) Elements of process Under the process described in clause (i), with respect to home respiratory therapy for an individual, the following shall apply: (I) In order to obtain a prior authorization under such process, the prescribing practitioner (as defined by the Secretary) prescribing such therapy for such individual shall submit, for such therapy and individual— (aa) a prescription; (bb) in the case of home respiratory therapy that is oxygen or oxygen equipment, a certificate of medical necessity; and (cc) a prior authorization form that includes the information described in subclause (II). A prescription described in item (aa) with respect to such therapy is not required under this subclause if a certificate of medical necessity described in item (bb) with respect to such therapy is provided and if such certificate contains a narrative description that includes the elements for a prescription, as set forth by the Secretary. (II) The Secretary shall provide a prior authorization form (initially on paper and, not later than 3 years after the date of the enactment of this subparagraph, in an electronic format) for prescribing practitioners (as so defined by the Secretary) to complete when requesting a prior authorization under this subparagraph. The form shall constitute the complete request for information to determine medical necessity and require the prescribing practitioner (as so defined by the Secretary) to provide each of the following: (aa) The date that the individual was seen by a prescribing practitioner (as so defined by the Secretary) within the appropriate timeframes for certification of the need for the therapy. (bb) The result of the original blood gas, saturation test results, or sleep study results, as applicable. (cc) A statement that the individual needs or is using the therapy. (III) The Secretary shall respond to the prescribing practitioner (as so defined by the Secretary) making the prior authorization request within 72 hours (3 calendar days) of receiving the request. For hospital discharges, in the case of home respiratory therapy consisting of equipment or supplies, the Secretary shall establish an expedited review process to allow for the equipment or supplies to be delivered on the same day it is ordered. (IV) The Secretary shall communicate the response to the prescribing practitioner (as so defined by the Secretary) making the prior authorization request and to the supplier designated on the certificate of medical necessity. (V) A prior authorization approved under the process shall be deemed to constitute medical necessity for coverage and payment under this title but shall not eliminate the proof of delivery documentation requirement under section 424.57(c)(12) of title 42, Code of Federal Regulations. (VI) A supplier of home respiratory therapy shall not be required to provide such therapy if a prior authorization request under this subparagraph for such therapy has not been approved. (iii) Effect of prior authorization The approval of a prior authorization request under this subparagraph shall constitute a finding of medical necessity. The Secretary may not subject claims with such a prior authorization to pre- or post-payment audit for the purpose of determining medical necessity or improper payment reviews as they relate to documenting medical necessity. (iv) Implementation The Secretary may carry out this subparagraph through notice and comment rulemaking or by interim final rule with comment period. In establishing and implementing the process under this subparagraph, the Secretary shall consult with stakeholders through formal and informal mechanisms. (v) Home respiratory therapy defined For purposes of this subparagraph, the term home respiratory therapy means— (I) equipment, supplies, and services for home oxygen, home sleep, and mechanical ventilation; and (II) any other equipment, supply, or service specified by the Secretary by regulation. .