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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Timely Access to Can5 cer Treatment Act of 2021’’ or the ‘‘TACT Act of 2021’’. 

6 SEC. 2. PATIENT ACCESS TO ANTI-CANCER ORAL MEDICA7 TIONS. 

8 (a) IN GENERAL.—Section 2719A of the Public 

9 Health Service Act (42 U.S.C. 300gg–19A) is amended 

10 by adding at the end the following new subsection: 


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1 ‘‘(f) ACCESS TO ANTI-CANCER ORAL MEDICA2 TIONS.— 

3 ‘‘(1) REQUIREMENTS FOR CONTRACTS BE4 TWEEN GROUP HEALTH PLANS OR HEALTH INSUR5 ANCE ISSUERS AND PHARMACIES.—If a group health 

6 plan or a health insurance issuer offering group or 

7 individual health insurance coverage covers or pro8 vides any benefits for anti-cancer oral medications 

9 (as defined in paragraph (4)) and enters into a con10 tract with a pharmacy, whether directly or through 

11 an agent of such plan or issuer (including a phar12 macy benefit manager), to dispense such medications 

13 to participants, beneficiaries, or enrollees of the plan 

14 or coverage, such plan or issuer shall require, as 

15 conditions of such contract, such pharmacy to carry 

16 out the procedures described in paragraph (2). 

17 ‘‘(2) PROCEDURES DESCRIBED.—For purposes 

18 of paragraph (1), the procedures described in this 

19 paragraph with respect to a participant, beneficiary, 

20 or enrollee of the plan or coverage and a health care 

21 provider who submits to such pharmacy a prescrip22 tion for an anti-cancer oral medication for such par23 ticipant, beneficiary, or enrollee are the following (as 

24 applicable): 


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1 ‘‘(A) PHARMACY CONFIRMATION OF ABIL2 ITY TO DISPENSE.—Not later than 24 hours 

3 after receiving such prescription— 

4 ‘‘(i) confirm to such health care pro5 vider that such pharmacy received such 

6 prescription; and 

7 ‘‘(ii) inform such health care provider, 

8 as well as such plan or issuer, whether 

9 such pharmacy will dispense such anti-can10 cer oral medication to such participant, 

11 beneficiary, or enrollee by not later than 

12 72 hours after receiving such prescription, 

13 including any time for benefits verification, 

14 prior authorization, or any other adminis15 trative procedure required by the agent of 

16 such plan or issuer (including a pharmacy 

17 benefit manager) prior to authorizing the 

18 pharmacy to dispense the medication. 

19 ‘‘(B) PHARMACY ABLE TO FILL PRESCRIP20 TION.—In the case that such pharmacy informs 

21 such health care provider in writing under sub22 paragraph (A)(ii) that such pharmacy is able to 

23 dispense such anti-cancer oral medication to 

24 such participant, beneficiary, or enrollee by the 

25 72-hour deadline described in such subparaVerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258

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1 graph, dispense such anti-cancer oral medica2 tion to such participant, beneficiary, or enrollee 

3 by such deadline. 

4 ‘‘(C) PHARMACY UNABLE TO FILL PRE5 SCRIPTION.—In the case that such pharmacy 

6 informs such health care provider under sub7 paragraph (A)(ii) that such pharmacy is not 

8 able to dispense such anti-cancer oral medica9 tion to such participant, beneficiary, or enrollee 

10 by the 72-hour deadline described in such sub11 paragraph, immediately provide a written notice 

12 to— 

13 ‘‘(i) the prescribing physician or other 

14 health care provider; 

15 ‘‘(ii) the group health plan or a health 

16 insurance issuer offering group or indi17 vidual health insurance coverage; and 

18 ‘‘(iii) such participant, beneficiary, or 

19 enrollee; 

20 with a clear and understandable explanation of 

21 such inability and of the option of such partici22 pant, beneficiary, or enrollee to be dispensed 

23 such anti-cancer oral medication from any pro24 vider or pharmacy described in paragraph 

25 (3)(C), in accordance with the cost-sharing reVerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258

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1 quirements described in subparagraphs (A) and 

2 (B) of such paragraph. 

3 ‘‘(D) PHARMACY FAILURE TO COMMU4 NICATE.—If the pharmacy does not commu5 nicate its ability to dispense as required by sub6 paragraph (A), or, after confirming that it will 

7 dispense an anti-cancer oral medication under 

8 such subparagraph, does not actually dispense 

9 such medication by the 72-hour deadline de10 scribed in such paragraph, such pharmacy shall 

11 be deemed to have confirmed that it is not able 

12 to dispense such medication under subpara13 graph (C). 

14 ‘‘(3) REQUIREMENTS FOR GROUP HEALTH

15 PLANS AND HEALTH INSURANCE ISSUERS.— 

16 ‘‘(A) PATIENT SELECTION OF ALTERNATE

17 PROVIDER OR PHARMACY.—If a group health 

18 plan or a health insurance issuer offering group 

19 or individual health insurance coverage (or its 

20 agent, including a pharmacy benefits manager) 

21 described in paragraph (1) enters into a con22 tract described in such paragraph, with a phar23 macy and such pharmacy, with respect to a 

24 participant, beneficiary, or enrollee of the plan 

25 or coverage and health care provider who subVerDate Sep 11 2014 01:56 Jul 01, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3258.IH H3258

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1 mits to such pharmacy a prescription for an 

2 anti-cancer oral medication for such partici3 pant, beneficiary, or enrollee, informs such 

4 health care provider under subparagraph (A)(ii) 

5 of such paragraph that such pharmacy will not 

6 dispense such anti-cancer oral medication to 

7 such participant, beneficiary, or enrollee by the 

8 72-hour deadline described in such subpara9 graph (or in the case that the participant, bene10 ficiary, or enrollee has not received the anti11 cancer oral medication by the 72-hour dead12 line), the plan or issuer— 

13 ‘‘(i) shall authorize such participant, 

14 beneficiary, or enrollee to select any pro15 vider or pharmacy described in subpara16 graph (C) to dispense such anti-cancer oral 

17 medication to such participant, beneficiary, 

18 or enrollee based on the written noticed de19 scribed in paragraph (2)(C) or a certifi20 cation by the prescribing physician or 

21 other health professional that the partici22 pant, beneficiary, or enrollee has not re23 ceived the anti-cancer oral medication by 

24 the 72-hour deadline; and 


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1 ‘‘(ii) in the case the provider or phar2 macy selected under clause (i) does not 

3 have a contract with such plan or issuer to 

4 dispense such anti-cancer oral medication 

5 to such participant, group health plan or 

6 health insurance issuer offering group or 

7 individual health insurance coverage de8 scribed in paragraph (1) shall cover the 

9 medication and pay the provider or phar10 macy in accordance with the provisions of 

11 subparagraph (B). 

12 ‘‘(B) COVERAGE REQUIREMENTS FOR PRE13 SCRIPTIONS DISPENSED BY ALTERNATE PRO14 VIDER OR PHARMACY.—For prescriptions dis15 pensed by an alternate provider or pharmacy in 

16 accordance with subparagraph (A) that does 

17 not have a contract with a group health plan or 

18 a health insurance issuer offering group or indi19 vidual health insurance coverage (or its agent, 

20 including a pharmacy benefits manager) de21 scribed in paragraph (1) to dispense such anti22 cancer oral medication to such participant, such 

23 group health plan or a health insurance issuer 

24 (or its agent, including a pharmacy benefits 

25 manager) shall cover the medication and pay 


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1 the provider or pharmacy subject the following 

2 requirements— 

3 ‘‘(i) such medication will be provider 

4 without imposing any requirement under 

5 the plan for prior authorization of the 

6 medication or any limitation on coverage 

7 that is more restrictive than the require8 ments or limitations that apply to anti-can9 cer oral medications received from partici10 pating providers and pharmacies with re11 spect to such plan; 

12 ‘‘(ii) the cost-sharing requirement (ex13 pressed as a copayment amount or coinsur14 ance rate) is not greater than the require15 ment that would apply if such services 

16 were provided by a participating provider 

17 or a participating pharmacy; 

18 ‘‘(iii) such cost-sharing requirement is 

19 calculated as if the total amount that 

20 would have been charged for such services 

21 by such participating provider or partici22 pating pharmacy were equal to the recog23 nized amount (as determined by the Sec24 retary) for such anti-cancer oral medica25 tions, plan, and year; 


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1 ‘‘(iv) the group health plan pays to 

2 such provider or pharmacy, respectively, 

3 the amount by which the recognized 

4 amount for such services and year involved 

5 exceeds the cost-sharing amount for such 

6 services (as determined in accordance with 

7 clauses (ii) and (iii)) and year; 

8 ‘‘(v) any cost-sharing payments made 

9 by the participant or beneficiary with re10 spect to such anti-cancer oral medication 

11 so furnished shall be counted toward any 

12 in-network deductible or out-of-pocket 

13 maximums applied under the plan (and 

14 such in-network deductible and out-of15 pocket maximums shall be applied) in the 

16 same manner as if such cost-sharing pay17 ments were made with respect to anti-can18 cer oral medication furnished by a partici19 pating provider or a participating phar20 macy; and 

21 ‘‘(vi) such medication will be provided 

22 without regard to any other term or condi23 tion of such coverage (other than exclusion 

24 or coordination of benefits, or an affiliation 

25 or waiting period, permitted under section 


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1 2704 of this Act, including as incorporated 

2 pursuant to section 715 of the Employee 

3 Retirement Income Security Act of 1974 

4 and section 9815 of this Act, and other 

5 than applicable cost-sharing). 

6 ‘‘(C) PROVIDER OR PHARMACY DE7 SCRIBED.—A provider or pharmacy described in 

8 this subparagraph, with respect to a partici9 pant, beneficiary, or enrollee of a group health 

10 plan or group or individual health insurance 

11 coverage described in paragraph (1) and a pre12 scription for an anticancer oral medication for 

13 such participant, beneficiary or enrollee, is a 

14 provider or pharmacy that— 

15 ‘‘(i) is licensed by the State in which 

16 such provider or pharmacy is located to 

17 dispense such anti-cancer oral medication, 

18 if such a license is required by the State; 

19 ‘‘(ii) is either located within a reason20 able distance (as determined by the Sec21 retary) of the residence of such partici22 pant, beneficiary, or enrollee, or is able to 

23 deliver such anti-cancer oral medication to 

24 such participant, beneficiary, or enrollee at 

25 such residence; and 


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1 ‘‘(iii) is able to dispense (and if appli2 cable, deliver), such anti-cancer oral medi3 cation to such participant, beneficiary, or 

4 enrollee within 48 hours of the date on 

5 which it receives the prescription. 

6 For purposes of this section, a provider or 

7 pharmacy described in this subparagraph in8 cludes a physician or other health care practi9 tioner authorized to dispense anti-cancer oral 

10 medication to such participant, beneficiary, or 

11 enrollee pursuant to the law of the State in 

12 which the physician or other health care practi13 tioner is located. 

14 ‘‘(D) PRIOR AUTHORIZATION REQUIRE15 MENTS.—In the case of a group health plan or 

16 a health insurance issuer offering group or indi17 vidual health insurance coverage that requires 

18 prior authorization for an anti-cancer oral 

19 medication to be dispensed to a participant, 

20 beneficiary, or enrollee of the plan or coverage, 

21 such plan or issuer (or its agent , including a 

22 pharmacy benefits manager) shall make a deci23 sion with respect to a request for such a prior 

24 authorization by not later than 72 hours after 

25 receiving such request. In the case that such 


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1 plan or issuer (or its agent, including a phar2 macy benefits manager) does not make a deci3 sion with respect to a request for prior author4 ization for an anticancer oral medication to be 

5 dispensed to a participant, beneficiary, or en6 rollee of the plan or coverage by the 72-hour 

7 deadline described in the previous sentence, 

8 such participant, beneficiary or enrollee may se9 lect any pharmacy described in subparagraph 

10 (C) to dispense such anticancer oral medication 

11 to such participant, beneficiary, or enrollee, in 

12 accordance with the cost-sharing requirements 

13 described in subparagraph (B) but only if the 

14 prescription for such anti-cancer oral medica15 tion meets the clinical guidelines set forth by 

16 the National Comprehensive Cancer Network. 

17 ‘‘(4) ANTI-CANCER ORAL MEDICATION DE18 FINED.—In this subsection, the term ‘anti-cancer 

19 oral medication’ means a drug or biological (as de20 fined in section 1861(t) of the Social Security Act) 

21 that is used in an anti-cancer chemotherapeutic regi22 men for a medically accepted indication, including 

23 any related supportive care drugs and biologicals 

24 that are dispensed as an outpatient and taken by the 

25 mouth.’’. 


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1 (b) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply with respect to plan years begin3 ning on or after January 1, 2022. 

4 (c) GAO REPORT AND RECOMMENDATIONS.— 

5 (1) IN GENERAL.—Not later than 2 years after 

6 the date of enactment of this Act, the Comptroller 

7 General of the United States shall submit to the 

8 Chair and Ranking Member of the Committee on 

9 Health, Education, Labor and Pensions of the Sen10 ate and the Chair and Ranking Member of the Com11 mittee on Energy and Commerce of the House of 

12 Representatives a report on the effects of the imple13 mentation of subsection (f) of section 2719A of the 

14 Public Health Service Act (as added by subsection 

15 (a)) on the timely access of patients to anti-cancer 

16 oral medications (as defined in subsection (f)(4) of 

17 such section), together with such recommendations 

18 as the Comptroller General determines are appro19 priate. 

20 (2) ITEMS INCLUDED.—The report submitted 

21 under paragraph (1) shall include— 

22 (A) a comparison of the amount of time 

23 between the date on which a prescription is 

24 written and the date on which a patient receives 

25 an anti-cancer oral medication before and after 


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1 the implementation of subsection (f) of section 

2 2719A of the Public Health Service Act; 

3 (B) an assessment of the effects on patient 

4 health outcomes, including morbidity and mor5 tality; 

6 (C) an evaluation of costs to patients, 

7 health insurance issuers, physicians, and other 

8 healthcare providers; and 

9 (D) a risk assessment with mitigation rec10 ommendations on any actual or potential fraud, 

11 waste and abuse relating to the implementation 

12 of such subsection. 

Æ 


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