[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3258 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 3258

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 14, 2021

  Ms. Sewell (for herself and Mr. Bilirakis) 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 anti-cancer 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 Cancer Treatment 
Act of 2021'' or the ``TACT Act of 2021''.

SEC. 2. PATIENT ACCESS TO ANTI-CANCER 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 Anti-Cancer 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 
        anti-cancer 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 
        benefit 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 anti-cancer 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 anti-cancer 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 benefit 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 in writing under subparagraph (A)(ii) that 
                such pharmacy is able to dispense such anti-cancer oral 
                medication to such participant, beneficiary, or 
                enrollee by the 72-hour deadline described in such 
                subparagraph, dispense such anti-cancer 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 anti-cancer 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 anti-
                cancer oral medication from any provider or pharmacy 
                described in paragraph (3)(C), in accordance with the 
                cost-sharing 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 anti-cancer 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 
                health care provider who submits to such pharmacy a 
                prescription for an anti-cancer 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 anti-cancer 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 anti-cancer 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 anti-cancer oral medication to 
                        such participant, beneficiary, or enrollee 
                        based on the written noticed described in 
                        paragraph (2)(C) or a certification by the 
                        prescribing physician or other health 
                        professional that the participant, beneficiary, 
                        or enrollee has not received the anti-cancer 
                        oral medication by the 72-hour deadline; and
                            ``(ii) in the case the provider or pharmacy 
                        selected under clause (i) does not have a 
                        contract with such plan or issuer to dispense 
                        such anti-cancer oral medication to such 
                        participant, group health plan or 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 anti-cancer 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 the following 
                requirements--
                            ``(i) such medication will be provider 
                        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 anti-cancer 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 anti-
                        cancer 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 
                        anti-cancer 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 anti-cancer 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 anticancer 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 anti-cancer 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 anti-cancer oral 
                        medication to such participant, beneficiary, or 
                        enrollee at such residence; and
                            ``(iii) is able to dispense (and if 
                        applicable, deliver), such anti-cancer 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 
                anti-cancer 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 anti-
                cancer 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 anticancer 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 anticancer oral 
                medication to such participant, beneficiary, or 
                enrollee, in accordance with the cost-sharing 
                requirements described in subparagraph (B) but only if 
                the prescription for such anti-cancer oral medication 
                meets the clinical guidelines set forth by the National 
                Comprehensive Cancer Network.
            ``(4) Anti-cancer oral medication defined.--In this 
        subsection, the term `anti-cancer oral medication' means a drug 
        or biological (as defined in section 1861(t) of the Social 
        Security Act) that is used in an anti-cancer chemotherapeutic 
        regimen for a medically accepted indication, including any 
        related supportive care drugs and biologicals that are 
        dispensed as an outpatient and taken by the mouth.''.
    (b) Effective Date.--The amendments made by this section shall 
apply with respect to plan years beginning on or after January 1, 2022.
    (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 anti-cancer 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 anti-cancer 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.
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