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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3018 Introduced in Senate (IS)]

<DOC>

117th CONGRESS
  1st Session
                                S. 3018

     To amend title XVIII of the Social Security Act to establish 
   requirements with respect to the use of prior authorization under 
           Medicare Advantage plans, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            October 20, 2021

   Mr. Marshall (for himself, Ms. Sinema, Mr. Thune, and Mr. Brown) 
introduced the following bill; which was read twice and referred to the 
                          Committee on Finance

_______________________________________________________________________

                                 A BILL

 
     To amend title XVIII of the Social Security Act to establish 
   requirements with respect to the use of prior authorization under 
           Medicare Advantage plans, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Improving Seniors' Timely Access to 
Care Act of 2021''.

SEC. 2. ESTABLISHING REQUIREMENTS WITH RESPECT TO THE USE OF PRIOR 
              AUTHORIZATION UNDER MEDICARE ADVANTAGE PLANS.

    (a) In General.--Section 1852 of the Social Security Act (42 U.S.C. 
1395w-22) is amended by adding at the end the following new subsection:
    ``(o) Prior Authorization Requirements.--
            ``(1) In general.--Beginning with the second plan year 
        beginning after the date of the enactment of this subsection, 
        in the case of a Medicare Advantage plan that imposes any prior 
        authorization requirement with respect to any applicable item 
        or service (other than a covered part D drug) during a plan 
        year, such plan shall--
                    ``(A) establish the electronic prior authorization 
                program described in paragraph (2) and issue real-time 
                decisions with respect to prior authorization requests 
                for items and services identified by the Secretary 
                under subparagraph (C)(ii) of such paragraph;
                    ``(B) meet the transparency requirements specified 
                in paragraph (3); and
                    ``(C) meet the beneficiary protection standards 
                specified pursuant to paragraph (4).
            ``(2) Electronic prior authorization program.--
                    ``(A) In general.--For purposes of paragraph 
                (1)(A), the electronic prior authorization program 
                described in this paragraph is a program that provides 
                for the secure electronic transmission of--
                            ``(i) a prior authorization request from a 
                        health care professional to a Medicare 
                        Advantage plan with respect to an applicable 
                        item or service to be furnished to an 
                        individual, including such clinical information 
                        necessary to evidence medical necessity; and
                            ``(ii) a response, in accordance with this 
                        paragraph, from such plan to such professional.
                    ``(B) Electronic transmission.--
                            ``(i) Exclusions.--For purposes of this 
                        paragraph, a facsimile, a proprietary payer 
                        portal that does not meet standards specified 
                        by the Secretary, or an electronic form shall 
                        not be treated as an electronic transmission 
                        described in subparagraph (A).
                            ``(ii) Standards.--
                                    ``(I) In general.--In order to 
                                ensure appropriate clinical outcome for 
                                individuals, for purposes of this 
                                paragraph, an electronic transmission 
                                described in subparagraph (A) shall 
                                comply with technical standards adopted 
                                by the Secretary in consultation with 
                                standard-setting organizations 
                                determined appropriate by the 
                                Secretary, health care professionals, 
                                Medicare Advantage organizations, and 
                                health information technology software 
                                vendors. In adopting such standards 
                                with respect to which an electronic 
                                transmission described in subparagraph 
                                (A) shall comply, the Secretary shall 
                                ensure that such transmissions support 
                                attachments containing applicable 
                                clinical information and shall 
                                prioritize the adoption of standards 
                                that support integration with 
                                interoperable health information 
                                technology certified under a program of 
                                voluntary certification kept or 
                                recognized by the National Coordinator 
                                for Health Information Technology 
                                consistent with section 3001(c)(5) of 
                                the Public Health Service Act.
                                    ``(II) Transaction standard.--The 
                                Secretary shall include in the 
                                standards adopted under subclause (I) a 
                                standard with respect to the 
                                transmission of attachments described 
                                in such subclause, and data elements 
                                and operating rules for such 
                                transmission, consistent with health 
                                care industry standards.
                    ``(C) Real-time decisions.--
                            ``(i) In general.--The program described in 
                        subparagraph (A) shall provide for real-time 
                        decisions (as defined by the Secretary in 
                        accordance with clause (iv)) by a Medicare 
                        Advantage plan with respect to prior 
                        authorization requests for applicable items and 
                        services identified by the Secretary pursuant 
                        to clause (ii) for a plan year if such requests 
                        contain all documentation described in 
                        paragraph (3)(A)(ii)(II) required by such plan.
                            ``(ii) Identification of requests.--For 
                        purposes of clause (i) and with respect to a 
                        period of 2 plan years, the Secretary shall 
                        identify, not later than the date on which the 
                        initial announcement described in section 
                        1853(b)(1)(B)(i) for the first plan year of 
                        such period is required to be announced, 
                        applicable items and services for which prior 
                        authorization requests are routinely approved, 
                        and shall update the identification of such 
                        items and services for each subsequent period 
                        of 2 plan years.
                            ``(iii) Data collection and consultation 
                        with relevant eligible professional 
                        organizations and relevant stakeholders.--The 
                        Secretary shall use the information described 
                        in paragraph (3)(A) (if available) and shall 
                        issue a request for information from Medicare 
                        Advantage plans, providers, suppliers, 
                        beneficiary advocacy organizations, consumer 
                        organizations, and other stakeholders for 
                        purposes of identifying requests for a period 
                        under clause (ii).
                            ``(iv) Definition of real-time decision.--
                                    ``(I) In general.--In establishing 
                                the definition of a real-time decision 
                                for purposes of clause (i), the 
                                Secretary shall take into account 
                                current medical practice, technology, 
                                health care industry standards, and 
                                other relevant information and factors 
                                to ensure the accurate and timely 
                                furnishing of items and services to 
                                individuals.
                                    ``(II) Update.--The Secretary shall 
                                update, not less often than once every 
                                2 years, the definition of a real-time 
                                decision for purposes of clause (i), 
                                taking into account changes in medical 
                                practice, changes in technology, 
                                changes in health care industry 
                                standards, and other relevant 
                                information, such as the information 
                                submitted by Medicare Advantage plans 
                                under paragraph (3)(A)(i), and factors 
                                to ensure the accurate and timely 
                                furnishing of items and services to 
                                individuals.
                            ``(v) Implementation.--The Secretary shall 
                        use notice and comment rulemaking, which may 
                        include use of the annual call letter process 
                        under this part, for each of the following:
                                    ``(I) Establishing the definition 
                                of a `real-time decision' for purposes 
                                of clause (i).
                                    ``(II) Updating such definition 
                                pursuant to clause (iv)(II).
                                    ``(III) Identifying applicable 
                                items or services pursuant to clause 
                                (ii) for the initial period of 2 plan 
                                years as described in such clause.
                                    ``(IV) Updating the identification 
                                of such items and services for each 
                                subsequent period of 2 plan years as 
                                described in such clause.
            ``(3) Transparency requirements.--
                    ``(A) In general.--For purposes of paragraph 
                (1)(B), the transparency requirements specified in this 
                paragraph are, with respect to a Medicare Advantage 
                plan, the following:
                            ``(i) The plan, annually and in a manner 
                        specified by the Secretary, shall submit to the 
                        Secretary the following information:
                                    ``(I) A list of all applicable 
                                items and services that are described 
                                in subsection (a)(1)(B) that are 
                                subject to a prior authorization 
                                requirement under the plan.
                                    ``(II) The percentage of prior 
                                authorization requests approved during 
                                the previous plan year by the plan in 
                                an initial determination with respect 
                                to each such item and service.
                                    ``(III) The percentage of such 
                                requests that were initially denied and 
                                that were subsequently appealed in any 
                                manner, and the percentage of such 
                                appealed requests that were overturned, 
                                with respect to each such item and 
                                service, broken down by each stage of 
                                appeal (including judicial review). The 
                                plan may include information regarding 
                                the number of initial denials due to 
                                request submissions that did not meet 
                                clinical evidence standards.
                                    ``(IV) The percentage of such 
                                requests that were denied and the 
                                percentage of the total number of 
                                denied requests that were denied as a 
                                result of decision support technology 
                                or other clinical decision-making 
                                tools.
                                    ``(V) The average and the median 
                                amount of time (in hours) that elapsed 
                                during the previous plan year between 
                                the submission of such a request to the 
                                plan and a determination by the plan 
                                with respect to such request for each 
                                such item and service, excluding any 
                                such requests that did not contain all 
                                information required to be submitted by 
                                the plan.
                                    ``(VI) A list that includes a 
                                description of each occurrence during 
                                the previous plan year in which the 
                                plan made a determination to approve or 
                                deny an item or service in the case 
                                where a provider furnished an 
                                additional or differing item or service 
                                during the peroperative period of a 
                                surgical or otherwise invasive 
                                procedure that such provider determined 
                                was medically necessary.
                                    ``(VII) A disclosure and 
                                description of any software decision-
                                making tools the plan utilizes in 
                                making determinations with respect to 
                                such requests.
                                    ``(VIII) Such other information as 
                                the Secretary determines appropriate.
                            ``(ii) The plan shall provide--
                                    ``(I) to each provider or supplier 
                                who seeks to enter into a contract with 
                                such plan to furnish applicable items 
                                and services under such plan, the list 
                                described in clause (i)(I) and any 
                                policies or procedures used by the plan 
                                for making determinations with respect 
                                to prior authorization requests;
                                    ``(II) to each such provider and 
                                supplier who does enter into such a 
                                contract, access to the criteria used 
                                by the plan for making such 
                                determinations, including an 
                                itemization of the medical or other 
                                documentation required to be submitted 
                                by a provider or supplier with respect 
                                to such a request, except to the extent 
                                that provision of access to such 
                                criteria would disclose proprietary 
                                information of such plan; and
                                    ``(III) to each beneficiary subject 
                                to prior authorization under the plan, 
                                access to the criteria used by the plan 
                                for making such determinations, except 
                                to the extent that provision of access 
                                to such criteria would disclose 
                                proprietary information of such plan.
                    ``(B) Regulations.--The Secretary shall, through 
                notice and comment rulemaking, provide guidance to 
                Medicare Advantage plans regarding--
                            ``(i) the establishment of criteria 
                        described in subparagraph (A)(ii)(II) and 
                        access to such criteria by providers and 
                        suppliers in accordance with such subparagraph; 
                        and
                            ``(ii) access to such criteria by 
                        beneficiaries in accordance with subparagraph 
                        (A)(ii)(III).
                    ``(C) Medpac report.--Not later than 3 years after 
                the date information is first submitted under 
                subparagraph (A)(i), the Medicare Payment Advisory 
                Commission shall submit to Congress a report on such 
                information that includes a descriptive analysis of the 
                use of prior authorization. As appropriate, the 
                Commission should report on statistics including the 
                frequency of appeals and overturned decisions. The 
                Commission shall provide recommendations, as 
                appropriate, on any improvement that should be made to 
                the electronic prior authorization programs of Medicare 
                Advantage plans.
            ``(4) Beneficiary protection standards.--The Secretary of 
        Health and Human Services shall, through notice and comment 
        rulemaking, specify requirements with respect to the use of 
        prior authorization by Medicare Advantage plans for applicable 
        items and services to ensure--
                    ``(A) that such plans adopt transparent prior 
                authorization programs developed in consultation with 
                providers and suppliers with contracts in effect with 
                such plans for furnishing such items and services under 
                such plans that allow for the modification of prior 
                authorization requirements based on the performance of 
                such providers and suppliers with respect to adherence 
                to evidence-based medical guidelines and other quality 
                criteria;
                    ``(B) that such plans conduct annual reviews of 
                such items and services for which prior authorization 
                requirements are imposed under such plans through a 
                process that takes into account input from providers 
                and suppliers with such contracts in effect and is 
                based on analysis of past prior authorization requests 
                and current coverage and clinical criteria;
                    ``(C) continuity of care for individuals 
                transitioning to, or between, coverage under such plans 
                in order to minimize any disruption to ongoing 
                treatment attributable to prior authorization 
                requirements under such plans;
                    ``(D) that such plans make timely prior 
                authorization determinations, provide rationales for 
                denials, and ensure requests are reviewed by qualified 
                medical personnel; and
                    ``(E) that such plans provide information on the 
                appeals process to the beneficiary when denying any 
                request for prior authorization with respect to an item 
                or service.
            ``(5) Applicable item or service.--For purposes of this 
        subsection, the term `applicable item or service' means, with 
        respect to a Medicare Advantage plan, any item or service for 
        which benefits are available under such plan, other than a 
        covered part D drug.
            ``(6) Report to congress.--Not later than the end of the 
        second plan year beginning on or after the date of the 
        enactment of this subsection, and biennially thereafter through 
        the date that is 10 years after such date of enactment, the 
        Secretary shall submit to Congress a report containing an 
        evaluation of the implementation of the requirements of this 
        subsection, an analysis of an issues in implementing such 
        requirements faced by Medicare Advantage plans, and a 
        description of the information submitted under paragraph 
        (3)(A)(i) with respect to--
                    ``(A) in the case of the first such report, such 
                second plan year; and
                    ``(B) in the case of a subsequent report, the 2 
                full plan years preceding the date of the submission of 
                such report.''.
    (b) Determination Clarification.--Section 1852(g)(1)(A) of the 
Social Security Act (42 U.S.C. 1395w-22(g)(1)(A)) is amended by 
inserting ``(including any decision made with respect to a prior 
authorization request for such service)'' after ``section''.
                                 <all>
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