TACT Act of 2023

I 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Timely Access to Clin- 4 ical Treatment Act of 2023’’ or the ‘‘TACT Act of 2023’’. 5 SEC. 2. PATIENT ACCESS TO ORAL MEDICATIONS. 6 (a) IN GENERAL.—Section 2719A of the Public 7 Health Service Act (42 U.S.C. 300gg–19a) is amended by 8 adding at the end the following new subsection: 9 ‘‘(f) ACCESS TO ORAL MEDICATIONS.— 10 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 4011 IH ‘‘(1) REQUIREMENTS FOR CONTRACTS BE- 1 TWEEN GROUP HEALTH PLANS OR HEALTH INSUR- 2 ANCE ISSUERS AND PHARMACIES.—If a group health 3 plan or a health insurance issuer offering group or 4 individual health insurance coverage covers or pro- 5 vides any benefits for oral medications (as defined in 6 paragraph (4)) and enters into a contract with a 7 pharmacy, whether directly or through an agent of 8 such plan or issuer (including a pharmacy benefits 9 manager) to dispense such medications to partici- 10 pants, beneficiaries, or enrollees of the plan or cov- 11 erage, such plan or issuer shall require, as condi- 12 tions of such contract, such pharmacy to carry out 13 the procedures described in paragraph (2). 14 ‘‘(2) PROCEDURES DESCRIBED.—For purposes 15 of paragraph (1), the procedures described in this 16 paragraph with respect to a participant, beneficiary, 17 or enrollee of the plan or coverage and a health care 18 provider who submits to such pharmacy a prescrip- 19 tion for an oral medication for such participant, ben- 20 eficiary, or enrollee are the following (as applicable): 21 ‘‘(A) PHARMACY CONFIRMATION OF ABIL- 22 ITY TO DISPENSE.—Not later than 24 hours 23 after receiving such prescription— 24 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 4011 IH ‘‘(i) confirm to such health care pro- 1 vider that such pharmacy received such 2 prescription; and 3 ‘‘(ii) inform such health care provider 4 as well as such plan or issuer whether such 5 pharmacy will dispense such oral medica- 6 tion to such participant, beneficiary, or en- 7 rollee by not later than 72 hours after re- 8 ceiving such prescription, including any 9 time for benefits verification, prior author- 10 ization, or any other administrative proce- 11 dure required by the agent of such plan or 12 issuer (including a pharmacy benefits man- 13 ager) prior to authorizing the pharmacy to 14 dispense the medication. 15 ‘‘(B) PHARMACY ABLE TO FILL PRESCRIP- 16 TION.—In the case that such pharmacy informs 17 such health care provider under subparagraph 18 (A)(ii) that such pharmacy is able to dispense 19 such oral medication to such participant, bene- 20 ficiary, or enrollee by the 72-hour deadline de- 21 scribed in such subparagraph, dispense such 22 oral medication to such participant, beneficiary, 23 or enrollee by such deadline. 24 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 4011 IH ‘‘(C) PHARMACY UNABLE TO FILL PRE- 1 SCRIPTION.—In the case that such pharmacy 2 informs such health care provider under sub- 3 paragraph (A)(ii) that such pharmacy is not 4 able to dispense such oral medication to such 5 participant, beneficiary, or enrollee by the 72- 6 hour deadline described in such subparagraph, 7 immediately provide a written notice to— 8 ‘‘(i) the prescribing physician or other 9 health care provider; 10 ‘‘(ii) the group health plan or a health 11 insurance issuer offering group or indi- 12 vidual health insurance coverage; and 13 ‘‘(iii) such participant, beneficiary, or 14 enrollee, 15 with a clear and understandable explanation of 16 such inability and of the option of such partici- 17 pant, beneficiary, or enrollee to be dispensed 18 such oral medication from any provider or phar- 19 macy described in subparagraph (C) of para- 20 graph (3), in accordance with the requirements 21 described in subparagraphs (A) and (B) of such 22 paragraph. 23 ‘‘(D) PHARMACY FAILURE TO COMMU- 24 NICATE.—If the pharmacy does not commu- 25 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 4011 IH nicate its ability to dispense as required by sub- 1 paragraph (A), or, after confirming that it will 2 dispense an oral medication under such sub- 3 paragraph, does not actually dispense such 4 medication by the 72-hour deadline described in 5 such paragraph, such pharmacy shall be 6 deemed to have confirmed that it is not able to 7 dispense such medication under subparagraph 8 (C). 9 ‘‘(3) REQUIREMENTS FOR GROUP HEALTH 10 PLANS AND HEALTH INSURANCE ISSUERS.— 11 ‘‘(A) PATIENT SELECTION OF ALTERNATE 12 PROVIDER OR PHARMACY.—If a group health 13 plan or a health insurance issuer offering group 14 or individual health insurance coverage (or its 15 agent, including a pharmacy benefits manager) 16 described in paragraph (1) enters into a con- 17 tract described in such paragraph, with a phar- 18 macy and such pharmacy, with respect to a 19 participant, beneficiary, or enrollee of the plan 20 or coverage and a health care provider who sub- 21 mits to such pharmacy a prescription for an 22 oral medication for such participant, bene- 23 ficiary, or enrollee, informs such health care 24 provider under subparagraph (A)(ii) of such 25 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 4011 IH paragraph that such pharmacy will not dispense 1 such oral medication to such participant, bene- 2 ficiary, or enrollee by the 72-hour deadline de- 3 scribed in such subparagraph (or in the case 4 that the participant, beneficiary, or enrollee has 5 not received the oral medication by the 72-hour 6 deadline), the plan or issuer— 7 ‘‘(i) shall authorize such participant, 8 beneficiary, or enrollee to select any pro- 9 vider or pharmacy described in subpara- 10 graph (C) to dispense such oral medication 11 to such participant, beneficiary, or enrollee 12 based on the written notice described in 13 paragraph (2)(C) or a certification by a 14 the prescribing physician or other health 15 professional that the participant, bene- 16 ficiary, or enrollee has not received the oral 17 medication by the 72-hour deadline; and 18 ‘‘(ii) in the case that the provider or 19 pharmacy selected under clause (i) does 20 not have a contract with such plan or 21 issuer to dispense such oral medication to 22 such participant, group health plan or a 23 health insurance issuer offering group or 24 individual health insurance coverage de- 25 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 4011 IH scribed in paragraph (1) shall cover the 1 medication and pay the provider or phar- 2 macy in accordance with the provisions of 3 subparagraph (B). 4 ‘‘(B) COVERAGE REQUIREMENTS FOR PRE- 5 SCRIPTIONS DISPENSED BY ALTERNATE PRO- 6 VIDER OR PHARMACY.—For prescriptions dis- 7 pensed by an alternate provider or pharmacy in 8 accordance with subparagraph (A) that does 9 not have a contract with a group health plan or 10 a health insurance issuer offering group or indi- 11 vidual health insurance coverage (or its agent, 12 including a pharmacy benefits manager) de- 13 scribed in paragraph (1) to dispense such oral 14 medication to such participant, such group 15 health plan or a health insurance issuer (or its 16 agent, including a pharmacy benefits manager) 17 shall cover the medication and pay the provider 18 or pharmacy subject to the following require- 19 ments— 20 ‘‘(i) such medication will be provided 21 without imposing any requirement under 22 the plan for prior authorization of the 23 medication or any limitation on coverage 24 that is more restrictive than the require- 25 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 4011 IH ments or limitations that apply to oral 1 medications received from participating 2 providers and pharmacies with respect to 3 such plan; 4 ‘‘(ii) the cost-sharing requirement (ex- 5 pressed as a copayment amount or coinsur- 6 ance rate) is not greater than the require- 7 ment that would apply if such services 8 were provided by a participating provider 9 or a participating pharmacy; 10 ‘‘(iii) such cost-sharing requirement is 11 calculated as if the total amount that 12 would have been charged for such services 13 by such participating provider or partici- 14 pating pharmacy were equal to the recog- 15 nized amount (as determined by the Sec- 16 retary) for such oral medications, plan, 17 and year; 18 ‘‘(iv) the group health plan pays to 19 such provider or pharmacy, respectively, 20 the amount by which the recognized 21 amount for such services and year involved 22 exceeds the cost-sharing amount for such 23 services (as determined in accordance with 24 clauses (ii) and (iii)) and year; 25 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 4011 IH ‘‘(v) any cost-sharing payments made 1 by the participant or beneficiary with re- 2 spect to such oral medication so furnished 3 shall be counted toward any in-network de- 4 ductible or out-of-pocket maximums ap- 5 plied under the plan (and such in-network 6 deductible and out-of-pocket maximums 7 shall be applied) in the same manner as if 8 such cost-sharing payments were made 9 with respect to oral medication furnished 10 by a participating provider or a partici- 11 pating pharmacy; and 12 ‘‘(vi) such medication will be provided 13 without regard to any other term or condi- 14 tion of such coverage (other than exclusion 15 or coordination of benefits, or an affiliation 16 or waiting period, permitted under section 17 2704 of this Act, including as incorporated 18 pursuant to section 715 of the Employee 19 Retirement Income Security Act of 1974 20 and section 9815 of this Act, and other 21 than applicable cost-sharing). 22 ‘‘(C) PROVIDER OR PHARMACY DE- 23 SCRIBED.—A provider or pharmacy described in 24 this subparagraph, with respect to a partici- 25 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 4011 IH pant, beneficiary, or enrollee of a group health 1 plan or group or individual health insurance 2 coverage described in paragraph (1) and a pre- 3 scription for an oral medication for such partic- 4 ipant, beneficiary or enrollee, is a provider or 5 pharmacy that— 6 ‘‘(i) is licensed by the State in which 7 such provider or pharmacy is located to 8 dispense such oral medication, if such a li- 9 cense is required by the State; 10 ‘‘(ii) is either located within a reason- 11 able distance (as determined by the Sec- 12 retary) of the residence of such partici- 13 pant, beneficiary, or enrollee, or is able to 14 deliver such oral medication to such partic- 15 ipant, beneficiary, or enrollee at such resi- 16 dence; and 17 ‘‘(iii) is able to dispense (and if appli- 18 cable, deliver), such oral medication to 19 such participant, beneficiary, or enrollee 20 within 48 hours of the date on which it re- 21 ceives the prescription. 22 For purposes of this section, a provider or 23 pharmacy described in this subparagraph in- 24 cludes a physician or other health care practi- 25 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 4011 IH tioner authorized to dispense oral medication to 1 such participant, beneficiary, or enrollee pursu- 2 ant to the law of the State in which the physi- 3 cian or other health care practitioner is located. 4 ‘‘(D) PRIOR AUTHORIZATION REQUIRE- 5 MENTS.—In the case of a group health plan or 6 a health insurance issuer offering group or indi- 7 vidual health insurance coverage that requires 8 prior authorization for an oral medication to be 9 dispensed to a participant, beneficiary, or en- 10 rollee of the plan or coverage, such plan or 11 issuer (or its agent, including a pharmacy bene- 12 fits manager) shall make a decision with respect 13 to a request for such a prior authorization by 14 not later than 72 hours after receiving such re- 15 quest. In the case that such plan or issuer (or 16 its agent, including a pharmacy benefits man- 17 ager) does not make a decision with respect to 18 a request for prior authorization for an oral 19 medication to be dispensed to a participant, 20 beneficiary, or enrollee of the plan or coverage 21 by the 72-hour deadline described in the pre- 22 vious sentence, such participant, beneficiary or 23 enrollee may select any pharmacy described in 24 subparagraph (C) to dispense such oral medica- 25 VerDate Sep 11 2014 01:05 Jul 12, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4011.IH H4011 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 4011 IH tion to such participant, beneficiary, or enrollee, 1 in accordance with the cost-sharing require- 2 ments described in subparagraph (B). 3 ‘‘(E) USE OF RELEVANT QUALITY MEAS- 4 URES UNDER INCENTIVE PAYMENT AND AD- 5 JUSTMENT SYSTEMS.—If a group health plan or 6 a health insurance issuer offering group or indi- 7 vidual health insurance coverage uses an incen- 8 tive payment and adjustment system (as de- 9 fined by the Secretary) in determining phar- 10 macy reimbursement payments for oral medica- 11 tions, such system shall only use quality meas- 12 ures that are relevant to the performance of 13 such pharmacy with respect to areas that the 14 pharmacy can impact based on the oral medica- 15 tions dispensed and managed by the pharmacy. 16 ‘‘(4) ORAL MEDICATION DEFINED.—In this 17 subsection, the term ‘oral medication’ means a drug 18 or biological (as defined in section 1 [Text truncated for display. 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