[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4011 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 4011

   To amend title XXVII of the Public Health Service Act to improve 
      patient access to oral medications, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 12, 2023

  Mr. Bilirakis (for himself and Ms. Sewell) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend title XXVII of the Public Health Service Act to improve 
      patient access to oral medications, 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 ``Timely Access to Clinical Treatment 
Act of 2023'' or the ``TACT Act of 2023''.

SEC. 2. PATIENT ACCESS TO ORAL MEDICATIONS.

    (a) In General.--Section 2719A of the Public Health Service Act (42 
U.S.C. 300gg-19a) is amended by adding at the end the following new 
subsection:
    ``(f) Access to Oral Medications.--
            ``(1) Requirements for contracts between group health plans 
        or health insurance issuers and pharmacies.--If a group health 
        plan or a health insurance issuer offering group or individual 
        health insurance coverage covers or provides any benefits for 
        oral medications (as defined in paragraph (4)) and enters into 
        a contract with a pharmacy, whether directly or through an 
        agent of such plan or issuer (including a pharmacy benefits 
        manager) to dispense such medications to participants, 
        beneficiaries, or enrollees of the plan or coverage, such plan 
        or issuer shall require, as conditions of such contract, such 
        pharmacy to carry out the procedures described in paragraph 
        (2).
            ``(2) Procedures described.--For purposes of paragraph (1), 
        the procedures described in this paragraph with respect to a 
        participant, beneficiary, or enrollee of the plan or coverage 
        and a health care provider who submits to such pharmacy a 
        prescription for an oral medication for such participant, 
        beneficiary, or enrollee are the following (as applicable):
                    ``(A) Pharmacy confirmation of ability to 
                dispense.--Not later than 24 hours after receiving such 
                prescription--
                            ``(i) confirm to such health care provider 
                        that such pharmacy received such prescription; 
                        and
                            ``(ii) inform such health care provider as 
                        well as such plan or issuer whether such 
                        pharmacy will dispense such oral medication to 
                        such participant, beneficiary, or enrollee by 
                        not later than 72 hours after receiving such 
                        prescription, including any time for benefits 
                        verification, prior authorization, or any other 
                        administrative procedure required by the agent 
                        of such plan or issuer (including a pharmacy 
                        benefits manager) prior to authorizing the 
                        pharmacy to dispense the medication.
                    ``(B) Pharmacy able to fill prescription.--In the 
                case that such pharmacy informs such health care 
                provider under subparagraph (A)(ii) that such pharmacy 
                is able to dispense such oral medication to such 
                participant, beneficiary, or enrollee by the 72-hour 
                deadline described in such subparagraph, dispense such 
                oral medication to such participant, beneficiary, or 
                enrollee by such deadline.
                    ``(C) Pharmacy unable to fill prescription.--In the 
                case that such pharmacy informs such health care 
                provider under subparagraph (A)(ii) that such pharmacy 
                is not able to dispense such oral medication to such 
                participant, beneficiary, or enrollee by the 72-hour 
                deadline described in such subparagraph, immediately 
                provide a written notice to--
                            ``(i) the prescribing physician or other 
                        health care provider;
                            ``(ii) the group health plan or a health 
                        insurance issuer offering group or individual 
                        health insurance coverage; and
                            ``(iii) such participant, beneficiary, or 
                        enrollee,
                with a clear and understandable explanation of such 
                inability and of the option of such participant, 
                beneficiary, or enrollee to be dispensed such oral 
                medication from any provider or pharmacy described in 
                subparagraph (C) of paragraph (3), in accordance with 
                the requirements described in subparagraphs (A) and (B) 
                of such paragraph.
                    ``(D) Pharmacy failure to communicate.--If the 
                pharmacy does not communicate its ability to dispense 
                as required by subparagraph (A), or, after confirming 
                that it will dispense an oral medication under such 
                subparagraph, does not actually dispense such 
                medication by the 72-hour deadline described in such 
                paragraph, such pharmacy shall be deemed to have 
                confirmed that it is not able to dispense such 
                medication under subparagraph (C).
            ``(3) Requirements for group health plans and health 
        insurance issuers.--
                    ``(A) Patient selection of alternate provider or 
                pharmacy.--If a group health plan or a health insurance 
                issuer offering group or individual health insurance 
                coverage (or its agent, including a pharmacy benefits 
                manager) described in paragraph (1) enters into a 
                contract described in such paragraph, with a pharmacy 
                and such pharmacy, with respect to a participant, 
                beneficiary, or enrollee of the plan or coverage and a 
                health care provider who submits to such pharmacy a 
                prescription for an oral medication for such 
                participant, beneficiary, or enrollee, informs such 
                health care provider under subparagraph (A)(ii) of such 
                paragraph that such pharmacy will not dispense such 
                oral medication to such participant, beneficiary, or 
                enrollee by the 72-hour deadline described in such 
                subparagraph (or in the case that the participant, 
                beneficiary, or enrollee has not received the oral 
                medication by the 72-hour deadline), the plan or 
                issuer--
                            ``(i) shall authorize such participant, 
                        beneficiary, or enrollee to select any provider 
                        or pharmacy described in subparagraph (C) to 
                        dispense such oral medication to such 
                        participant, beneficiary, or enrollee based on 
                        the written notice described in paragraph 
                        (2)(C) or a certification by a the prescribing 
                        physician or other health professional that the 
                        participant, beneficiary, or enrollee has not 
                        received the oral medication by the 72-hour 
                        deadline; and
                            ``(ii) in the case that the provider or 
                        pharmacy selected under clause (i) does not 
                        have a contract with such plan or issuer to 
                        dispense such oral medication to such 
                        participant, group health plan or a health 
                        insurance issuer offering group or individual 
                        health insurance coverage described in 
                        paragraph (1) shall cover the medication and 
                        pay the provider or pharmacy in accordance with 
                        the provisions of subparagraph (B).
                    ``(B) Coverage requirements for prescriptions 
                dispensed by alternate provider or pharmacy.--For 
                prescriptions dispensed by an alternate provider or 
                pharmacy in accordance with subparagraph (A) that does 
                not have a contract with a group health plan or a 
                health insurance issuer offering group or individual 
                health insurance coverage (or its agent, including a 
                pharmacy benefits manager) described in paragraph (1) 
                to dispense such oral medication to such participant, 
                such group health plan or a health insurance issuer (or 
                its agent, including a pharmacy benefits manager) shall 
                cover the medication and pay the provider or pharmacy 
                subject to the following requirements--
                            ``(i) such medication will be provided 
                        without imposing any requirement under the plan 
                        for prior authorization of the medication or 
                        any limitation on coverage that is more 
                        restrictive than the requirements or 
                        limitations that apply to oral medications 
                        received from participating providers and 
                        pharmacies with respect to such plan;
                            ``(ii) the cost-sharing requirement 
                        (expressed as a copayment amount or coinsurance 
                        rate) is not greater than the requirement that 
                        would apply if such services were provided by a 
                        participating provider or a participating 
                        pharmacy;
                            ``(iii) such cost-sharing requirement is 
                        calculated as if the total amount that would 
                        have been charged for such services by such 
                        participating provider or participating 
                        pharmacy were equal to the recognized amount 
                        (as determined by the Secretary) for such oral 
                        medications, plan, and year;
                            ``(iv) the group health plan pays to such 
                        provider or pharmacy, respectively, the amount 
                        by which the recognized amount for such 
                        services and year involved exceeds the cost-
                        sharing amount for such services (as determined 
                        in accordance with clauses (ii) and (iii)) and 
                        year;
                            ``(v) any cost-sharing payments made by the 
                        participant or beneficiary with respect to such 
                        oral medication so furnished shall be counted 
                        toward any in-network deductible or out-of-
                        pocket maximums applied under the plan (and 
                        such in-network deductible and out-of-pocket 
                        maximums shall be applied) in the same manner 
                        as if such cost-sharing payments were made with 
                        respect to oral medication furnished by a 
                        participating provider or a participating 
                        pharmacy; and
                            ``(vi) such medication will be provided 
                        without regard to any other term or condition 
                        of such coverage (other than exclusion or 
                        coordination of benefits, or an affiliation or 
                        waiting period, permitted under section 2704 of 
                        this Act, including as incorporated pursuant to 
                        section 715 of the Employee Retirement Income 
                        Security Act of 1974 and section 9815 of this 
                        Act, and other than applicable cost-sharing).
                    ``(C) Provider or pharmacy described.--A provider 
                or pharmacy described in this subparagraph, with 
                respect to a participant, beneficiary, or enrollee of a 
                group health plan or group or individual health 
                insurance coverage described in paragraph (1) and a 
                prescription for an oral medication for such 
                participant, beneficiary or enrollee, is a provider or 
                pharmacy that--
                            ``(i) is licensed by the State in which 
                        such provider or pharmacy is located to 
                        dispense such oral medication, if such a 
                        license is required by the State;
                            ``(ii) is either located within a 
                        reasonable distance (as determined by the 
                        Secretary) of the residence of such 
                        participant, beneficiary, or enrollee, or is 
                        able to deliver such oral medication to such 
                        participant, beneficiary, or enrollee at such 
                        residence; and
                            ``(iii) is able to dispense (and if 
                        applicable, deliver), such oral medication to 
                        such participant, beneficiary, or enrollee 
                        within 48 hours of the date on which it 
                        receives the prescription.
                For purposes of this section, a provider or pharmacy 
                described in this subparagraph includes a physician or 
                other health care practitioner authorized to dispense 
                oral medication to such participant, beneficiary, or 
                enrollee pursuant to the law of the State in which the 
                physician or other health care practitioner is located.
                    ``(D) Prior authorization requirements.--In the 
                case of a group health plan or a health insurance 
                issuer offering group or individual health insurance 
                coverage that requires prior authorization for an oral 
                medication to be dispensed to a participant, 
                beneficiary, or enrollee of the plan or coverage, such 
                plan or issuer (or its agent, including a pharmacy 
                benefits manager) shall make a decision with respect to 
                a request for such a prior authorization by not later 
                than 72 hours after receiving such request. In the case 
                that such plan or issuer (or its agent, including a 
                pharmacy benefits manager) does not make a decision 
                with respect to a request for prior authorization for 
                an oral medication to be dispensed to a participant, 
                beneficiary, or enrollee of the plan or coverage by the 
                72-hour deadline described in the previous sentence, 
                such participant, beneficiary or enrollee may select 
                any pharmacy described in subparagraph (C) to dispense 
                such oral medication to such participant, beneficiary, 
                or enrollee, in accordance with the cost-sharing 
                requirements described in subparagraph (B).
                    ``(E) Use of relevant quality measures under 
                incentive payment and adjustment systems.--If a group 
                health plan or a health insurance issuer offering group 
                or individual health insurance coverage uses an 
                incentive payment and adjustment system (as defined by 
                the Secretary) in determining pharmacy reimbursement 
                payments for oral medications, such system shall only 
                use quality measures that are relevant to the 
                performance of such pharmacy with respect to areas that 
                the pharmacy can impact based on the oral medications 
                dispensed and managed by the pharmacy.
            ``(4) Oral medication defined.--In this subsection, the 
        term `oral medication' means a drug or biological (as defined 
        in section 1861(t) of the Social Security Act) that is used for 
        a medically accepted indication that is dispensed as an 
        outpatient and taken by mouth.''.
    (b) Conforming Amendment.--Section 2719A(e) of the Public Health 
Service Act (42 U.S.C. 300gg-19a(e)) is amended by inserting ``(other 
than subsection (f))'' after ``The provisions of this section''.
    (c) GAO Report and Recommendations.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Comptroller General of the United 
        States shall submit to the Chair and Ranking Member of the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Chair and Ranking Member of the Committee on 
        Energy and Commerce of the House of Representatives a report on 
        the effects of the implementation of subsection (f) of section 
        2719A of the Public Health Service Act (as added by subsection 
        (a)) on the timely access of patients to oral medications (as 
        defined in subsection (f)(4) of such section), together with 
        such recommendations as the Comptroller General determines are 
        appropriate.
            (2) Items included.--The report submitted under paragraph 
        (1) shall include--
                    (A) a comparison of the amount of time between the 
                date on which a prescription is written and the date on 
                which a patient receives an oral medication before and 
                after the implementation of subsection (f) of section 
                2719A of the Public Health Service Act;
                    (B) an assessment of the effects on patient health 
                outcomes, including morbidity and mortality;
                    (C) an evaluation of costs to patients, health 
                insurance issuers, physicians, and other healthcare 
                providers; and
                    (D) a risk assessment with mitigation 
                recommendations on any actual or potential fraud, waste 
                and abuse relating to the implementation of such 
                subsection.
    (d) Effective Date.--The amendments made by this section shall 
apply with respect to plan years beginning on or after January 1, 2024.
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