TACT Act of 2021

I 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 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 Can- 4 cer Treatment Act of 2021’’ or the ‘‘TACT Act of 2021’’. 5 SEC. 2. PATIENT ACCESS TO ANTI-CANCER ORAL MEDICA- 6 TIONS. 7 (a) IN GENERAL.—Section 2719A of the Public 8 Health Service Act (42 U.S.C. 300gg–19A) is amended 9 by adding at the end the following new subsection: 10 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 3258 IH ‘‘(f) ACCESS TO ANTI-CANCER ORAL MEDICA- 1 TIONS.— 2 ‘‘(1) REQUIREMENTS FOR CONTRACTS BE- 3 TWEEN GROUP HEALTH PLANS OR HEALTH INSUR- 4 ANCE ISSUERS AND PHARMACIES.—If a group health 5 plan or a health insurance issuer offering group or 6 individual health insurance coverage covers or pro- 7 vides any benefits for anti-cancer oral medications 8 (as defined in paragraph (4)) and enters into a con- 9 tract with a pharmacy, whether directly or through 10 an agent of such plan or issuer (including a phar- 11 macy benefit manager), to dispense such medications 12 to participants, beneficiaries, or enrollees of the plan 13 or coverage, such plan or issuer shall require, as 14 conditions of such contract, such pharmacy to carry 15 out the procedures described in paragraph (2). 16 ‘‘(2) PROCEDURES DESCRIBED.—For purposes 17 of paragraph (1), the procedures described in this 18 paragraph with respect to a participant, beneficiary, 19 or enrollee of the plan or coverage and a health care 20 provider who submits to such pharmacy a prescrip- 21 tion for an anti-cancer oral medication for such par- 22 ticipant, beneficiary, or enrollee are the following (as 23 applicable): 24 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 3258 IH ‘‘(A) PHARMACY CONFIRMATION OF ABIL- 1 ITY TO DISPENSE.—Not later than 24 hours 2 after receiving such prescription— 3 ‘‘(i) confirm to such health care pro- 4 vider that such pharmacy received such 5 prescription; and 6 ‘‘(ii) inform such health care provider, 7 as well as such plan or issuer, whether 8 such pharmacy will dispense such anti-can- 9 cer oral medication to such participant, 10 beneficiary, or enrollee by not later than 11 72 hours after receiving such prescription, 12 including any time for benefits verification, 13 prior authorization, or any other adminis- 14 trative procedure required by the agent of 15 such plan or issuer (including a pharmacy 16 benefit manager) prior to authorizing the 17 pharmacy to dispense the medication. 18 ‘‘(B) PHARMACY ABLE TO FILL PRESCRIP- 19 TION.—In the case that such pharmacy informs 20 such health care provider in writing under sub- 21 paragraph (A)(ii) that such pharmacy is able to 22 dispense such anti-cancer oral medication to 23 such participant, beneficiary, or enrollee by the 24 72-hour deadline described in such subpara- 25 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 3258 IH graph, dispense such anti-cancer oral medica- 1 tion to such participant, beneficiary, or enrollee 2 by such deadline. 3 ‘‘(C) PHARMACY UNABLE TO FILL PRE- 4 SCRIPTION.—In the case that such pharmacy 5 informs such health care provider under sub- 6 paragraph (A)(ii) that such pharmacy is not 7 able to dispense such anti-cancer oral medica- 8 tion to such participant, beneficiary, or enrollee 9 by the 72-hour deadline described in such sub- 10 paragraph, immediately provide a written notice 11 to— 12 ‘‘(i) the prescribing physician or other 13 health care provider; 14 ‘‘(ii) the group health plan or a health 15 insurance issuer offering group or indi- 16 vidual health insurance coverage; and 17 ‘‘(iii) such participant, beneficiary, or 18 enrollee; 19 with a clear and understandable explanation of 20 such inability and of the option of such partici- 21 pant, beneficiary, or enrollee to be dispensed 22 such anti-cancer oral medication from any pro- 23 vider or pharmacy described in paragraph 24 (3)(C), in accordance with the cost-sharing re- 25 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 3258 IH quirements described in subparagraphs (A) and 1 (B) of such paragraph. 2 ‘‘(D) PHARMACY FAILURE TO COMMU- 3 NICATE.—If the pharmacy does not commu- 4 nicate its ability to dispense as required by sub- 5 paragraph (A), or, after confirming that it will 6 dispense an anti-cancer oral medication under 7 such subparagraph, does not actually dispense 8 such medication by the 72-hour deadline de- 9 scribed in such paragraph, such pharmacy shall 10 be deemed to have confirmed that it is not able 11 to dispense such medication under subpara- 12 graph (C). 13 ‘‘(3) REQUIREMENTS FOR GROUP HEALTH 14 PLANS AND HEALTH INSURANCE ISSUERS.— 15 ‘‘(A) PATIENT SELECTION OF ALTERNATE 16 PROVIDER OR PHARMACY.—If a group health 17 plan or a health insurance issuer offering group 18 or individual health insurance coverage (or its 19 agent, including a pharmacy benefits manager) 20 described in paragraph (1) enters into a con- 21 tract described in such paragraph, with a phar- 22 macy and such pharmacy, with respect to a 23 participant, beneficiary, or enrollee of the plan 24 or coverage and health care provider who sub- 25 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 3258 IH mits to such pharmacy a prescription for an 1 anti-cancer oral medication for such partici- 2 pant, beneficiary, or enrollee, informs such 3 health care provider under subparagraph (A)(ii) 4 of such paragraph that such pharmacy will not 5 dispense such anti-cancer oral medication to 6 such participant, beneficiary, or enrollee by the 7 72-hour deadline described in such subpara- 8 graph (or in the case that the participant, bene- 9 ficiary, or enrollee has not received the anti- 10 cancer oral medication by the 72-hour dead- 11 line), the plan or issuer— 12 ‘‘(i) shall authorize such participant, 13 beneficiary, or enrollee to select any pro- 14 vider or pharmacy described in subpara- 15 graph (C) to dispense such anti-cancer oral 16 medication to such participant, beneficiary, 17 or enrollee based on the written noticed de- 18 scribed in paragraph (2)(C) or a certifi- 19 cation by the prescribing physician or 20 other health professional that the partici- 21 pant, beneficiary, or enrollee has not re- 22 ceived the anti-cancer oral medication by 23 the 72-hour deadline; and 24 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 3258 IH ‘‘(ii) in the case the provider or phar- 1 macy selected under clause (i) does not 2 have a contract with such plan or issuer to 3 dispense such anti-cancer oral medication 4 to such participant, group health plan or 5 health insurance issuer offering group or 6 individual health insurance coverage de- 7 scribed in paragraph (1) shall cover the 8 medication and pay the provider or phar- 9 macy in accordance with the provisions of 10 subparagraph (B). 11 ‘‘(B) COVERAGE REQUIREMENTS FOR PRE- 12 SCRIPTIONS DISPENSED BY ALTERNATE PRO- 13 VIDER OR PHARMACY.—For prescriptions dis- 14 pensed by an alternate provider or pharmacy in 15 accordance with subparagraph (A) that does 16 not have a contract with a group health plan or 17 a health insurance issuer offering group or indi- 18 vidual health insurance coverage (or its agent, 19 including a pharmacy benefits manager) de- 20 scribed in paragraph (1) to dispense such anti- 21 cancer oral medication to such participant, such 22 group health plan or a health insurance issuer 23 (or its agent, including a pharmacy benefits 24 manager) shall cover the medication and pay 25 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 8 •HR 3258 IH the provider or pharmacy subject the following 1 requirements— 2 ‘‘(i) such medication will be provider 3 without imposing any requirement under 4 the plan for prior authorization of the 5 medication or any limitation on coverage 6 that is more restrictive than the require- 7 ments or limitations that apply to anti-can- 8 cer oral medications received from partici- 9 pating providers and pharmacies with re- 10 spect to such plan; 11 ‘‘(ii) the cost-sharing requirement (ex- 12 pressed as a copayment amount or coinsur- 13 ance rate) is not greater than the require- 14 ment that would apply if such services 15 were provided by a participating provider 16 or a participating pharmacy; 17 ‘‘(iii) such cost-sharing requirement is 18 calculated as if the total amount that 19 would have been charged for such services 20 by such participating provider or partici- 21 pating pharmacy were equal to the recog- 22 nized amount (as determined by the Sec- 23 retary) for such anti-cancer oral medica- 24 tions, plan, and year; 25 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 9 •HR 3258 IH ‘‘(iv) the group health plan pays to 1 such provider or pharmacy, respectively, 2 the amount by which the recognized 3 amount for such services and year involved 4 exceeds the cost-sharing amount for such 5 services (as determined in accordance with 6 clauses (ii) and (iii)) and year; 7 ‘‘(v) any cost-sharing payments made 8 by the participant or beneficiary with re- 9 spect to such anti-cancer oral medication 10 so furnished shall be counted toward any 11 in-network deductible or out-of-pocket 12 maximums applied under the plan (and 13 such in-network deductible and out-of- 14 pocket maximums shall be applied) in the 15 same manner as if such cost-sharing pay- 16 ments were made with respect to anti-can- 17 cer oral medication furnished by a partici- 18 pating provider or a participating phar- 19 macy; and 20 ‘‘(vi) such medication will be provided 21 without regard to any other term or condi- 22 tion of such coverage (other than exclusion 23 or coordination of benefits, or an affiliation 24 or waiting period, permitted under section 25 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 10 •HR 3258 IH 2704 of this Act, including as incorporated 1 pursuant to section 715 of the Employee 2 Retirement Income Security Act of 1974 3 and section 9815 of this Act, and other 4 than applicable cost-sharing). 5 ‘‘(C) PROVIDER OR PHARMACY DE- 6 SCRIBED.—A provider or pharmacy described in 7 this subparagraph, with respect to a partici- 8 pant, beneficiary, or enrollee of a group health 9 plan or group or individual health insurance 10 coverage described in paragraph (1) and a pre- 11 scription for an anticancer oral medication for 12 such participant, beneficiary or enrollee, is a 13 provider or pharmacy that— 14 ‘‘(i) is licensed by the State in which 15 such provider or pharmacy is located to 16 dispense such anti-cancer oral medication, 17 if such a license is required by the State; 18 ‘‘(ii) is either located within a reason- 19 able distance (as determined by the Sec- 20 retary) of the residence of such partici- 21 pant, beneficiary, or enrollee, or is able to 22 deliver such anti-cancer oral medication to 23 such participant, beneficiary, or enrollee at 24 such residence; and 25 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 11 •HR 3258 IH ‘‘(iii) is able to dispense (and if appli- 1 cable, deliver), such anti-cancer oral medi- 2 cation to such participant, beneficiary, or 3 enrollee within 48 hours of the date on 4 which it receives the prescription. 5 For purposes of this section, a provider or 6 pharmacy described in this subparagraph in- 7 cludes a physician or other health care practi- 8 tioner authorized to dispense anti-cancer oral 9 medication to such participant, beneficiary, or 10 enrollee pursuant to the law of the State in 11 which the physician or other health care practi- 12 tioner is located. 13 ‘‘(D) PRIOR AUTHORIZATION REQUIRE- 14 MENTS.—In the case of a group health plan or 15 a health insurance issuer offering group or indi- 16 vidual health insurance coverage that requires 17 prior authorization for an anti-cancer oral 18 medication to be dispensed to a participant, 19 beneficiary, or enrollee of the plan or coverage, 20 such plan or issuer (or its agent , including a 21 pharmacy benefits manager) shall make a deci- 22 sion with respect to a request for such a prior 23 authorization by not later than 72 hours after 24 receiving such request. In the case that such 25 VerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258 pbinns on DSKJLVW7X2PROD with BILLS 12 •HR 3258 IH plan or issuer (or its agent, including a phar- 1 macy benefits manager) does not make a deci- 2 sion with respect to a request for prior author- 3 ization for an anticancer oral medication to be 4 dispensed to a participant, beneficiary, or en- 5 rollee of the plan or coverage by the 72-hour 6 deadline described in the previous sentence, 7 such participant, beneficiary or enrollee may se- 8 lect any pharmacy described in subparagraph 9 (C) to dispense such anticancer oral medication 10 to such participant, beneficiary, or enrollee, in 11 accordance with the cost-sharing requirements 12 described in subparagraph (B) but only if the 13 prescription for such anti-cancer oral medica- 14 tion meets the clinical guidelines set forth by 15 the National Comprehensive Cancer Network. 16 ‘‘(4) ANTI-CANCER ORAL MEDICATION DE- 17 FINED.—In this subsection, the term ‘anti-cancer 18 oral medication’ means a drug or biological (as de- 19 fined in section 1861(t) of the Social Security Act) 2 [Text truncated for display. 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