Title: Reducing Medically Unnecessary Delays in Care Act of 2022
Policy area: Health

Summary:
Reducing Medically Unnecessary Delays in Care Act of 2022
This bill requires Medicare coverage decisions, including prior authorization requirements and adverse coverage decisions, to be based on written clinical criteria that is developed in consultation with physicians.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8078 Introduced in House (IH)]

<DOC>






117th CONGRESS
  2d Session
                                H. R. 8078

To ensure that prior authorization medical decisions under Medicare are 
                       determined by physicians.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 15, 2022

    Mr. Green of Tennessee introduced the following bill; which was 
  referred to the Committee on Ways and Means, and in addition to the 
   Committee on Energy and Commerce, 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 ensure that prior authorization medical decisions under Medicare are 
                       determined by physicians.

    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 ``Reducing Medically Unnecessary 
Delays in Care Act of 2022''.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) Adverse determination.--The term ``adverse 
        determination'' means a decision by a medicare administrative 
        contractor, Medicare Advantage plan, or prescription drug plan 
        that administers prior authorization programs under the 
        Medicare program under title XVIII of the Social Security Act 
        or such plan that the health care services furnished or 
        proposed to be furnished to an individual entitled to benefits 
        or enrolled under the Medicare program are not medically 
        necessary, or are experimental or investigational; and benefit 
        coverage under such program or plan for such services is 
        therefore denied, reduced, or terminated.
            (2) Authorization.--The term ``authorization'' means a 
        determination by a medicare administrative contractor, Medicare 
        Advantage plan, or prescription drug plan that administers 
        prior authorization programs under the Medicare program under 
        title XVIII of the Social Security Act or such plan that a 
        health care service has been reviewed and, based on the 
        information provided, satisfies the utilization review entity's 
        requirements for medical necessity and appropriateness and that 
        payment will be made under the Medicare program under title 
        XVIII of the Social Security Act or such plan for that health 
        care service.
            (3) Clinical criteria.--The term ``clinical criteria'' 
        means the written policies, written screening procedures, drug 
        formularies, or lists of covered drugs, decision rules, 
        decision abstracts, clinical protocols, practice guidelines, 
        and medical protocols used by a medicare administrative 
        contractor, Medicare Advantage plan, or prescription drug plan 
        to determine the necessity and appropriateness of health care 
        services.
            (4) Final adverse determination.--The term ``final adverse 
        determination'' means an adverse determination that has been 
        upheld by a medicare administrative contractor, Medicare 
        Advantage plan, or prescription drug plan at the completion of 
        the contractor's appeals process.
            (5) Health care service.--The term ``health care service'' 
        means a health care item, service, procedure, treatment, or 
        prescription drug provided by a facility licensed in the State 
        involved or provided by a doctor of medicine, a doctor of 
        osteopathy, or a health care professional licensed in such 
        State.
            (6) Medically necessary health care service.--The term 
        ``medically necessary health care services'' means health care 
        services that a prudent physician would provide to a patient 
        for the purpose of preventing, diagnosing, or treating an 
        illness, injury, disease, or its symptoms in a manner that is--
                    (A) in accordance with generally accepted standards 
                of medical practice;
                    (B) clinically appropriate in terms of type, 
                frequency, extent, site, and duration; and
                    (C) not primarily for the economic benefit of the 
                health plans and purchasers or for the convenience of 
                the patient, treating physician, or other health care 
                provider.
            (7) Medicare administrative contractor.--The term 
        ``medicare administrative contractor'' means a medicare 
        administrative contractor with a contract under section 1874A 
        of the Social Security Act (42 U.S.C. 1395kk-1).
            (8) Medicare advantage plan.--The term ``Medicare Advantage 
        plan'' means a Medicare Advantage plan under part C of title 
        XVIII of the Social Security Act.
            (9) Preauthorization.--The term ``Preauthorization''--
                    (A) means the process by which a medicare 
                administrative contractor, Medicare Advantage plan, or 
                prescription drug plan determines the medical necessity 
                or medical appropriateness of health care services for 
                which benefits are otherwise provided under the 
                Medicare program under title XVIII of the Social 
                Security Act or such plan prior to the rendering of 
                such health care services, including preadmission 
                review, pretreatment review, utilization, and case 
                management; and
                    (B) includes any requirement that a patient or 
                health care provider notify the Centers for Medicare & 
                Medicaid Services prior to providing a health care 
                service.
            (10) Prescription drug plan.--The term ``prescription drug 
        plan'' means a prescription drug plan under part D of title 
        XVIII of the Social Security Act.

SEC. 3. CONTRACT REQUIREMENTS FOR PRIOR AUTHORIZATION MEDICAL DECISIONS 
              FOR MEDICARE ADMINISTRATIVE CONTRACTORS, MEDICARE 
              ADVANTAGE PLANS, AND PRESCRIPTION DRUG PLANS.

    Any contract that applies on or after the date that is 90 days 
after the date of the enactment of this Act, between the Secretary of 
Health and Human Services and a medicare administrative contractor 
under section 1874A of the Social Security Act, a Medicare Advantage 
organization under section 1857 of such Act with respect to the 
offering of a Medicare Advantage plan, or a PDP sponsor under section 
1860D-12 of such Act with respect to the offering of a prescription 
drug plan shall require such medicare administrative contractor, 
Medicare Advantage plan, or prescription drug plan, respectively, to 
comply with each of the following requirements:
            (1) Medical necessity.--Any restriction, preauthorization, 
        adverse determination, or final adverse determination that the 
        medicare administrative contractor, Medicare Advantage plan, or 
        prescription drug plan, respectively, places on the provision 
        of a health care service for the purposes of coverage or 
        payment of such service under the Medicare program under title 
        XVIII of such Act, or under such plan, shall be based on the 
        medical necessity or appropriateness of such service and on 
        written clinical criteria.
            (2) Evidence-based standards.--If no independently 
        developed evidence-based standards exist for a particular 
        health care service, the medicare administrative contractor, 
        Medicare Advantage plan, or prescription drug plan, 
        respectively, may not deny coverage of the health care service 
        based solely on the grounds that the health care service does 
        not meet an evidence-based standard.
            (3) Input from physicians.--Prior to establishing, or 
        substantially or materially altering, written clinical criteria 
        for purpose of preauthorization review, the medicare 
        administrative contractor, Medicare Advantage plan, or 
        prescription drug plan, respectively, shall obtain input from 
        actively practicing physicians within the service area where 
        the written clinical criteria are to be employed. Such 
        physicians must represent major areas of specialty and be 
        certified by the boards of the American Board of Medical 
        Specialties. The medicare administrative contractor, Medicare 
        Advantage plan, or prescription drug plan shall seek input from 
        physicians who are not employees of the medicare administrative 
        contractor, Medicare Advantage plan, or prescription drug plan.
            (4) Written clinical criteria.--The medicare administrative 
        contractor, Medicare Advantage plan, or prescription drug plan, 
        respectively, shall apply written clinical criteria for the 
        purpose of preauthorization review consistently. Such written 
        clinical criteria must--
                    (A) be based on nationally recognized standards;
                    (B) be developed in accordance with the current 
                standards of national accreditation entities;
                    (C) reflect community standards of care; ensure 
                quality of care and access to needed health care 
                services;
                    (D) be evidence-based;
                    (E) be sufficiently flexible to allow deviations 
                from norms when justified on case-by-case bases; and
                    (F) be evaluated and updated if necessary at least 
                annually.
            (5) Website posting.--The medicare administrative 
        contractor, Medicare Advantage plan, or prescription drug plan, 
        respectively, shall make any current preauthorization 
        requirements and restrictions readily accessible on its website 
        to subscribers, health care providers, and the general public. 
        This includes the written clinical criteria. Such requirements 
        must be described in detail but also in easily understandable 
        language.
            (6) Notice required for new requirements or restrictions.--
        If the medicare administrative contractor, Medicare Advantage 
        plan, or prescription drug plan, respectively, decides to 
        implement a new preauthorization requirement or restriction, or 
        amend an existing requirement or restriction, the medicare 
        administrative contractor, Medicare Advantage plan, or 
        prescription drug plan shall provide contracted health care 
        providers written notice of the new or amended requirement or 
        amendment no less than 60 days before the requirement or 
        restriction is implemented and shall ensure that the new or 
        amended requirement has been updated on the medicare 
        administrative contractor, Medicare Advantage plan, or 
        prescription drug plan's website.
            (7) Availability of determinations.--The medicare 
        administrative contractor, Medicare Advantage plan, or 
        prescription drug plan, respectively, utilizing 
        preauthorization shall make statistics available regarding 
        preauthorization approvals and denials for coverage or payment 
        of health care services under the Medicare program under title 
        XVIII of the Social Security Act or such plan on their website 
        in a readily accessible format. The medicare administrative 
        contractor, Medicare Advantage plan, or prescription drug plan 
        shall include categories for--
                    (A) physician specialty;
                    (B) medication or diagnostic test/procedure;
                    (C) indication offered; and
                    (D) reason for denial.
            (8) Determinations made by physicians.--The medicare 
        administrative contractor, Medicare Advantage plan, or 
        prescription drug plan, respectively, shall ensure that all 
        preauthorizations and adverse determinations are made by a 
        physician who possesses a current and valid non-restricted 
        license to practice medicine in a State, and must be board 
        certified or eligible in the same specialty as the health care 
        provider who typically manages the medical condition or disease 
        or provides the health care service. The physician must make 
        the adverse determination under the clinical direction of one 
        of the medicare administrative contractor's, Medicare Advantage 
        plan's, or prescription drug plan's medical directors who is 
        responsible for the provision of health care services and who 
        is licensed in such State.
                                 <all>