I 

118TH CONGRESS 

2D SESSION H. R. 7312 

To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 9, 2024 

Ms. KUSTER (for herself, Mr. BALDERSON, and Ms. LETLOW) introduced the 

following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce, Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To provide for requirements for electronic-prescribing for 

controlled substances under group health plans and 

group and individual health insurance coverage. 

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 ‘‘Electronic Prescribing 

5 for Controlled Substances Act’’ or the ‘‘EPCS 2.0 Act’’. 


ssavage on LAPJG3WLY3PROD with BILLS
2 

•HR 7312 IH

1 SEC. 2. REQUIREMENTS FOR ELECTRONIC-PRESCRIBING 

2 FOR CONTROLLED SUBSTANCES UNDER 

3 GROUP HEALTH PLANS AND GROUP AND IN4 DIVIDUAL HEALTH INSURANCE COVERAGE. 

5 (a) PUBLIC HEALTH SERVICE ACT AMENDMENT.— 

6 Section 2799A–7 of the Public Health Service Act (42 

7 U.S.C. 300gg–117) is amended by adding at the end the 

8 following new subsection: 

9 ‘‘(d) REQUIREMENTS FOR ELECTRONIC-PRE10 SCRIBING FOR CONTROLLED SUBSTANCES.— 

11 ‘‘(1) IN GENERAL.—Except as provided pursu12 ant to paragraph (2), for plan years beginning on or 

13 after January 1, 2026, a group health plan and a 

14 health insurance issuer offering group or individual 

15 health insurance coverage, with respect to a partici16 pating provider, as defined in section 2799–1(a)(3), 

17 shall have in place policies, subject to paragraphs 

18 (4) and (5), that require any prescription for a 

19 schedule II, III, IV, or V controlled substance (as 

20 defined by section 202 of the Controlled Substances 

21 Act) covered by the plan or coverage that is trans22 mitted by such a participating provider for such a 

23 participant, beneficiary, or enrollee be electronically 

24 transmitted consistent with standards established 

25 under paragraph (3) of section 1860D–4(e) of the 

26 Social Security Act, under an electronic prescription 


ssavage on LAPJG3WLY3PROD with BILLS
3 

•HR 7312 IH

1 drug program that meets requirements that are sub2 stantially similar (as jointly determined by the Sec3 retary, the Secretary of Labor, and the Secretary of 

4 the Treasury) to the requirements of paragraph (2) 

5 of such section 1860D–4(e). 

6 ‘‘(2) EXCEPTION FOR CERTAIN CIR7 CUMSTANCES.—The Secretary, the Secretary of 

8 Labor, and the Secretary of the Treasury shall joint9 ly, through rulemaking, specify circumstances and 

10 processes by which the requirement under paragraph 

11 (1) may be waived, with respect to a schedule II, III, 

12 IV, or V controlled substance that is a prescription 

13 drug covered by a group health plan or group or in14 dividual health insurance coverage offered by a 

15 health insurance issuer, including in the case of— 

16 ‘‘(A) a prescription issued when the par17 ticipating provider and dispensing pharmacy are 

18 the same entity; 

19 ‘‘(B) a prescription issued that cannot be 

20 transmitted electronically under the most re21 cently implemented version of the National 

22 Council for Prescription Drug Programs 

23 SCRIPT Standard; 

24 ‘‘(C) a prescription issued by a partici25 pating provider who received a waiver (which 


ssavage on LAPJG3WLY3PROD with BILLS
4 

•HR 7312 IH

1 may include a waiver obtained pursuant to sec2 tion 1860D–4(e)(7)(B)(iii) of the Social Secu3 rity Act) or a renewal thereof for a period of 

4 time as determined by the Secretary, the Sec5 retary of Labor, and the Secretary of the 

6 Treasury, not to exceed one year, from the re7 quirement to use electronic prescribing due to 

8 demonstrated economic hardship, technological 

9 limitations that are not reasonably within the 

10 control of the participating provider, or other 

11 exceptional circumstance demonstrated by the 

12 participating provider; 

13 ‘‘(D) a prescription issued by a partici14 pating provider under circumstances in which, 

15 notwithstanding the participating provider’s 

16 ability to submit a prescription electronically as 

17 required by this subsection, such participating 

18 provider reasonably determines that it would be 

19 impractical for the individual involved to obtain 

20 substances prescribed by electronic prescription 

21 in a timely manner, and such delay would ad22 versely impact the individual’s medical condition 

23 involved; 


ssavage on LAPJG3WLY3PROD with BILLS
5 

•HR 7312 IH

1 ‘‘(E) a prescription issued by a partici2 pating provider prescribing a drug under a re3 search protocol; 

4 ‘‘(F) a prescription issued by a partici5 pating provider for a drug for which the Food 

6 and Drug Administration requires a prescrip7 tion to contain elements that are not able to be 

8 included in electronic prescribing, such as a 

9 drug with risk evaluation and mitigation strate10 gies that include elements to assure safe use; 

11 ‘‘(G) a prescription issued for an individual 

12 who receives hospice care or for a resident of a 

13 nursing facility (as defined in section 1919(a) 

14 of the Social Security Act); 

15 ‘‘(H) a prescription issued under cir16 cumstances in which electronic prescribing is 

17 not available due to temporary technological or 

18 electrical failure, as specified jointly by the Sec19 retary, the Secretary of Labor, and the Sec20 retary of the Treasury through rulemaking; and 

21 ‘‘(I) a prescription issued by a partici22 pating provider allowing for the dispensing of a 

23 non-patient specific prescription pursuant to a 

24 standing order, approved protocol for drug ther25 apy, collaborative drug management, or comVerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312

ssavage on LAPJG3WLY3PROD with BILLS
6 

•HR 7312 IH

1 prehensive medication management, in response 

2 to a public health emergency or other cir3 cumstances under which the participating pro4 vider may issue a non-patient specific prescrip5 tion. 

6 ‘‘(3) RULES OF CONSTRUCTION.— 

7 ‘‘(A) VERIFICATION.—Nothing in this sub8 section shall be construed as requiring a dis9 penser to verify that a participating provider, 

10 with respect to a prescription for a schedule II, 

11 III, IV, or V controlled substance that is a pre12 scription drug covered by a group health plan 

13 or group or individual health insurance cov14 erage offered by a health insurance issuer, has 

15 a waiver (or is otherwise exempt) under para16 graph (2) from the requirement under para17 graph (1). 

18 ‘‘(B) AUTHORITY TO DISPENSE.—Nothing 

19 in this subsection shall be construed as affect20 ing the authority of a group health plan or 

21 group or individual health insurance coverage 

22 offered by a health insurance issuer to cover, or 

23 the authority of a dispenser to continue to dis24 pense, a prescription drug if the prescription 

25 for such drug is an otherwise valid written, 


ssavage on LAPJG3WLY3PROD with BILLS
7 

•HR 7312 IH

1 oral, or fax prescription that is consistent with 

2 applicable law. 

3 ‘‘(C) PATIENT CHOICE.—Nothing in this 

4 subsection shall be construed as affecting the 

5 ability of an individual who is a participant, 

6 beneficiary, or enrollee of a group health plan 

7 or group or individual health insurance cov8 erage offered by a health insurance issuer and 

9 who is prescribed a schedule II, III, IV, or V 

10 controlled substance that is a prescription drug 

11 covered by the plan or coverage to designate a 

12 particular dispenser to dispense a prescribed 

13 controlled substance to the extent consistent 

14 with the requirements under this subsection. 

15 ‘‘(4) REGULATIONS ON POLICY REQUIRE16 MENTS.—The Secretary, the Secretary of Labor, 

17 and the Secretary of the Treasury shall promulgate 

18 regulations specifying requirements for the policies 

19 established by group health plans and health insur20 ance issuers under paragraph (1). Such regulations 

21 shall include requirements for— 

22 ‘‘(A) a uniform process by which plans and 

23 issuers are required to set the e-prescribing re24 quirements; 


ssavage on LAPJG3WLY3PROD with BILLS
8 

•HR 7312 IH

1 ‘‘(B) a process by which plans and issuers 

2 are required to grant waivers and exceptions to 

3 participating providers pursuant to paragraph 

4 (2); and 

5 ‘‘(C) a mechanism for plans and issuers to 

6 recognize waivers issued to participating pro7 viders under part D of title XVIII of the Social 

8 Security Act, pursuant to paragraph (2)(C). 

9 ‘‘(5) PROHIBITIONS.—The policies established 

10 pursuant to paragraph (1) by a group health plan or 

11 health insurance issuer offering group or individual 

12 health insurance coverage may not— 

13 ‘‘(A) require dispensers of a schedule II, 

14 III, IV, or V controlled substance to confirm 

15 that the prescription for the controlled sub16 stance was electronically issued by a partici17 pating provider in accordance with such poli18 cies, as described in paragraph (1); 

19 ‘‘(B) require dispensers of such controlled 

20 substances to submit information or data be21 yond what is otherwise required to process a 

22 prescription drug claim in order to confirm a 

23 participating provider’s compliance with such 

24 policies; 


ssavage on LAPJG3WLY3PROD with BILLS
9 

•HR 7312 IH

1 ‘‘(C) reject, deny, or recoup reimbursement 

2 for a prescription drug claim based on the for3 mat in which the prescription was issued; or 

4 ‘‘(D) require a participating provider to 

5 use a specific vendor for electronic prescribing 

6 or a specific electronic prescribing product or 

7 system. 

8 ‘‘(6) ATTESTATION OF COMPLIANCE.—Begin9 ning on January 1, 2026, each group health plan 

10 and health insurance issuer offering group or indi11 vidual health insurance coverage shall annually sub12 mit to the Secretary, the Secretary of Labor, and 

13 the Secretary of the Treasury an attestation of com14 pliance with the requirements of this subsection. 

15 ‘‘(7) CONSULTATION REQUIREMENT FOR RULE16 MAKING.—In promulgating regulations to carry out 

17 this subsection, the Secretary, the Secretary of the 

18 Labor, and the Secretary of the Treasury shall joint19 ly consult with dispensers of controlled substances, 

20 State insurance regulators, health insurance issuers 

21 offering group or individual health insurance cov22 erage, and health care practitioners.’’. 

23 (b) EMPLOYEE RETIREMENT INCOME SECURITY ACT

24 OF 1974 AMENDMENT.—Section 722 of the Employee Re25 tirement Income Security Act of 1974 (29 U.S.C. 1185k) 


ssavage on LAPJG3WLY3PROD with BILLS
10 

•HR 7312 IH

1 is amended by adding at the end the following new sub2 section: 

3 ‘‘(d) REQUIREMENTS FOR ELECTRONIC-PRE4 SCRIBING FOR CONTROLLED SUBSTANCES.— 

5 ‘‘(1) IN GENERAL.—Except as provided pursu6 ant to paragraph (2), for plan years beginning on or 

7 after January 1, 2026, a group health plan and a 

8 health insurance issuer offering group health insur9 ance coverage, with respect to a participating pro10 vider, as defined in section 716(a)(3), shall have in 

11 place policies, subject to paragraphs (4) and (5), 

12 that require any prescription for a schedule II, III, 

13 IV, or V controlled substance (as defined by section 

14 202 of the Controlled Substances Act) covered by 

15 the plan or coverage that is transmitted by such a 

16 participating provider for such a participant or bene17 ficiary be electronically transmitted consistent with 

18 standards established under paragraph (3) of section 

19 1860D–4(e) of the Social Security Act, under an 

20 electronic prescription drug program that meets re21 quirements that are substantially similar (as jointly 

22 determined by the Secretary, the Secretary of 

23 Health and Human Services, and the Secretary of 

24 the Treasury) to the requirements of paragraph (2) 

25 of such section 1860D–4(e). 


ssavage on LAPJG3WLY3PROD with BILLS
11 

•HR 7312 IH

1 ‘‘(2) EXCEPTION FOR CERTAIN CIR2 CUMSTANCES.—The Secretary, the Secretary of 

3 Health and Human Services, and the Secretary of 

4 the Treasury shall jointly, through rulemaking, 

5 specify circumstances and processes by which the re6 quirement under paragraph (1) may be waived, with 

7 respect to a schedule II, III, IV, or V controlled sub8 stance that is a prescription drug covered by a group 

9 health plan or group health insurance coverage of10 fered by a health insurance issuer, including in the 

11 case of— 

12 ‘‘(A) a prescription issued when the par13 ticipating provider and dispensing pharmacy are 

14 the same entity; 

15 ‘‘(B) a prescription issued that cannot be 

16 transmitted electronically under the most re17 cently implemented version of the National 

18 Council for Prescription Drug Programs 

19 SCRIPT Standard; 

20 ‘‘(C) a prescription issued by a partici21 pating provider who received a waiver (which 

22 may include a waiver obtained pursuant to sec23 tion 1860D–4(e)(7)(B)(iii) of the Social Secu24 rity Act) or a renewal thereof for a period of 

25 time as determined by the Secretary, the SecVerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312

ssavage on LAPJG3WLY3PROD with BILLS
12 

•HR 7312 IH

1 retary of Health and Human Services, and the 

2 Secretary of the Treasury, not to exceed one 

3 year, from the requirement to use electronic 

4 prescribing due to demonstrated economic hard5 ship, technological limitations that are not rea6 sonably within the control of the participating 

7 provider, or other exceptional circumstance 

8 demonstrated by the participating provider; 

9 ‘‘(D) a prescription issued by a partici10 pating provider under circumstances in which, 

11 notwithstanding the participating provider’s 

12 ability to submit a prescription electronically as 

13 required by this subsection, such participating 

14 provider reasonably determines that it would be 

15 impractical for the individual involved to obtain 

16 substances prescribed by electronic prescription 

17 in a timely manner, and such delay would ad18 versely impact the individual’s medical condition 

19 involved; 

20 ‘‘(E) a prescription issued by a partici21 pating provider prescribing a drug under a re22 search protocol; 

23 ‘‘(F) a prescription issued by a partici24 pating provider for a drug for which the Food 

25 and Drug Administration requires a prescripVerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312

ssavage on LAPJG3WLY3PROD with BILLS
13 

•HR 7312 IH

1 tion to contain elements that are not able to be 

2 included in electronic prescribing, such as a 

3 drug with risk evaluation and mitigation strate4 gies that include elements to assure safe use; 

5 ‘‘(G) a prescription issued for an individual 

6 who receives hospice care or for a resident of a 

7 nursing facility (as defined in section 1919(a) 

8 of the Social Security Act); 

9 ‘‘(H) a prescription issued under cir10 cumstances in which electronic prescribing is 

11 not available due to temporary technological or 

12 electrical failure, as specified jointly by the Sec13 retary, the Secretary of Health and Human 

14 Services, and the Secretary of the Treasury 

15 through rulemaking; and 

16 ‘‘(I) a prescription issued by a partici17 pating provider allowing for the dispensing of a 

18 non-patient specific prescription pursuant to a 

19 standing order, approved protocol for drug ther20 apy, collaborative drug management, or com21 prehensive medication management, in response 

22 to a public health emergency or other cir23 cumstances under which the participating pro24 vider may issue a non-patient specific prescrip25 tion. 


ssavage on LAPJG3WLY3PROD with BILLS
14 

•HR 7312 IH

1 ‘‘(3) RULES OF CONSTRUCTION.— 

2 ‘‘(A) VERIFICATION.—Nothing in this sub3 section shall be construed as requiring a dis4 penser to verify that a participating provider, 

5 with respect to a prescription for a schedule II, 

6 III, IV, or V controlled substance that is a pre7 scription drug covered by a group health plan 

8 or group or individual health insurance cov9 erage offered by a health insurance issuer, has 

10 a waiver (or is otherwise exempt) under para11 graph (2) from the requirement under para12 graph (1). 

13 ‘‘(B) AUTHORITY TO DISPENSE.—Nothing 

14 in this subsection shall be construed as affect15 ing the authority of a group health plan or 

16 group health insurance coverage offered by a 

17 health insurance issuer to cover, or the author18 ity of a dispenser to continue to dispense, a pre19 scription drug if the prescription for such drug 

20 is an otherwise valid written, oral, or fax pre21 scription that is consistent with applicable law. 

22 ‘‘(C) PATIENT CHOICE.—Nothing in this 

23 subsection shall be construed as affecting the 

24 ability of an individual who is a participant or 

25 beneficiary of a group health plan or group or 


ssavage on LAPJG3WLY3PROD with BILLS
15 

•HR 7312 IH

1 individual health insurance coverage offered by 

2 a health insurance issuer and who is prescribed 

3 a schedule II, III, IV, or V controlled substance 

4 that is a prescription drug covered by the plan 

5 or coverage to designate a particular dispenser 

6 to dispense a prescribed controlled substance to 

7 the extent consistent with the requirements 

8 under this subsection. 

9 ‘‘(4) REGULATIONS ON POLICY REQUIRE10 MENTS.—The Secretary, the Secretary of Health 

11 and Human Services, and the Secretary of the 

12 Treasury shall promulgate regulations specifying re13 quirements for the policies established by group 

14 health plans and health insurance issuers under 

15 paragraph (1). Such regulations shall include re16 quirements for— 

17 ‘‘(A) a uniform process by which plans and 

18 issuers are required to set the e-prescribing re19 quirements; 

20 ‘‘(B) a process by which plans and issuers 

21 are required to grant waivers and exceptions to 

22 participating providers pursuant to paragraph 

23 (2); and 

24 ‘‘(C) a mechanism for plans and issuers to 

25 recognize waivers issued to participating proVerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312

ssavage on LAPJG3WLY3PROD with BILLS
16 

•HR 7312 IH

1 viders under part D of title XVIII of the Social 

2 Security Act, pursuant to paragraph (2)(C). 

3 ‘‘(5) PROHIBITIONS.—The policies established 

4 pursuant to paragraph (1) by a group health plan or 

5 health insurance issuer offering group health insur6 ance coverage may not— 

7 ‘‘(A) require dispensers of a schedule II, 

8 III, IV, or V controlled substance to confirm 

9 that the prescription for the controlled sub10 stance was electronically issued by a partici11 pating provider in accordance with such poli12 cies, as described in paragraph (1); 

13 ‘‘(B) require dispensers of such controlled 

14 substances to submit information or data be15 yond what is otherwise required to process a 

16 prescription drug claim in order to confirm a 

17 participating provider’s compliance with such 

18 policies; 

19 ‘‘(C) reject, deny, or recoup reimbursement 

20 for a prescription drug claim based on the for21 mat in which the prescription was issued; or 

22 ‘‘(D) require a participating provider to 

23 use a specific vendor for electronic prescribing 

24 or a specific electronic prescribing product or 

25 system. 


ssavage on LAPJG3WLY3PROD with BILLS
17 

•HR 7312 IH

1 ‘‘(6) ATTESTATION OF COMPLIANCE.—Begin2 ning on January 1, 2026, each group health plan 

3 and health insurance issuer offering group health in4 surance coverage shall annually submit to the Sec5 retary, the Secretary of Health and Human Services, 

6 and the Secretary of the Treasury an attestation of 

7 compliance with the requirements of this subsection. 

8 ‘‘(7) CONSULTATION REQUIREMENT FOR RULE9 MAKING.—In promulgating regulations to carry out 

10 this subsection, the Secretary, the Secretary of 

11 Health and Human Services, and the Secretary of 

12 the Treasury shall jointly consult with dispensers of 

13 controlled substances, State insurance regulators, 

14 health insurance issuers offering group or individual 

15 health insurance coverage, and health care practi16 tioners.’’. 

17 (c) INTERNAL REVENUE CODE OF 1986 AMEND18 MENT.—Section 9822 of the Internal Revenue Code of 

19 1986 is amended by adding at the end the following new 

20 subsection: 

21 ‘‘(d) REQUIREMENTS FOR ELECTRONIC-PRE22 SCRIBING FOR CONTROLLED SUBSTANCES.— 

23 ‘‘(1) IN GENERAL.—Except as provided pursu24 ant to paragraph (2), for plan years beginning on or 

25 after January 1, 2026, a group health plan, with reVerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312

ssavage on LAPJG3WLY3PROD with BILLS
18 

•HR 7312 IH

1 spect to a participating provider, as defined in sec2 tion 9816(a)(3), shall have in place policies, subject 

3 to paragraphs (4) and (5), that require any prescrip4 tion for a schedule II, III, IV, or V controlled sub5 stance (as defined by section 202 of the Controlled 

6 Substances Act) covered by the plan that is trans7 mitted by such a participating provider for such a 

8 participant or beneficiary be electronically trans9 mitted consistent with standards established under 

10 paragraph (3) of section 1860D–4(e) of the Social 

11 Security Act, under an electronic prescription drug 

12 program that meets requirements that are substan13 tially similar (as jointly determined by the Secretary, 

14 the Secretary of Health and Human Services, and 

15 the Secretary of Labor) to the requirements of para16 graph (2) of such section 1860D–4(e). 

17 ‘‘(2) EXCEPTION FOR CERTAIN CIR18 CUMSTANCES.—The Secretary, the Secretary of 

19 Health and Human Services, and the Secretary of 

20 Labor shall jointly, through rulemaking, specify cir21 cumstances and processes by which the requirement 

22 under paragraph (1) may be waived, with respect to 

23 a schedule II, III, IV, or V controlled substance that 

24 is a prescription drug covered by a group health, in25 cluding in the case of— 


ssavage on LAPJG3WLY3PROD with BILLS
19 

•HR 7312 IH

1 ‘‘(A) a prescription issued when the par2 ticipating provider and dispensing pharmacy are 

3 the same entity; 

4 ‘‘(B) a prescription issued that cannot be 

5 transmitted electronically under the most re6 cently implemented version of the National 

7 Council for Prescription Drug Programs 

8 SCRIPT Standard; 

9 ‘‘(C) a prescription issued by a partici10 pating provider who received a waiver (which 

11 may include a waiver obtained pursuant to sec12 tion 1860D–4(e)(7)(B)(iii) of the Social Secu13 rity Act) or a renewal thereof for a period of 

14 time as determined by the Secretary, the Sec15 retary of Health and Human Services, and the 

16 Secretary of Labor, not to exceed one year, 

17 from the requirement to use electronic pre18 scribing due to demonstrated economic hard19 ship, technological limitations that are not rea20 sonably within the control of the participating 

21 provider, or other exceptional circumstance 

22 demonstrated by the participating provider; 

23 ‘‘(D) a prescription issued by a partici24 pating provider under circumstances in which, 

25 notwithstanding the participating provider’s 


ssavage on LAPJG3WLY3PROD with BILLS
20 

•HR 7312 IH

1 ability to submit a prescription electronically as 

2 required by this subsection, such participating 

3 provider reasonably determines that it would be 

4 impractical for the individual involved to obtain 

5 substances prescribed by electronic prescription 

6 in a timely manner, and such delay would ad7 versely impact the individual’s medical condition 

8 involved; 

9 ‘‘(E) a prescription issued by a partici10 pating provider prescribing a drug under a re11 search protocol; 

12 ‘‘(F) a prescription issued by a partici13 pating provider for a drug for which the Food 

14 and Drug Administration requires a prescrip15 tion to contain elements that are not able to be 

16 included in electronic prescribing, such as a 

17 drug with risk evaluation and mitigation strate18 gies that include elements to assure safe use; 

19 ‘‘(G) a prescription issued for an individual 

20 who receives hospice care or for a resident of a 

21 nursing facility (as defined in section 1919(a) 

22 of the Social Security Act); 

23 ‘‘(H) a prescription issued under cir24 cumstances in which electronic prescribing is 

25 not available due to temporary technological or 


ssavage on LAPJG3WLY3PROD with BILLS
21 

•HR 7312 IH

1 electrical failure, as specified jointly by the Sec2 retary, the Secretary of Health and Human 

3 Services, and the Secretary of Labor through 

4 rulemaking; and 

5 ‘‘(I) a prescription issued by a partici6 pating provider allowing for the dispensing of a 

7 non-patient specific prescription pursuant to a 

8 standing order, approved protocol for drug ther9 apy, collaborative drug management, or com10 prehensive medication management, in response 

11 to a public health emergency or other cir12 cumstances under which the participating pro13 vider may issue a non-patient specific prescrip14 tion. 

15 ‘‘(3) RULES OF CONSTRUCTION.— 

16 ‘‘(A) VERIFICATION.—Nothing in this sub17 section shall be construed as requiring a dis18 penser to verify that a participating provider, 

19 with respect to a prescription for a schedule II, 

20 III, IV, or V controlled substance that is a pre21 scription drug covered by a group health plan, 

22 has a waiver (or is otherwise exempt) under 

23 paragraph (2) from the requirement under 

24 paragraph (1). 


ssavage on LAPJG3WLY3PROD with BILLS
22 

•HR 7312 IH

1 ‘‘(B) AUTHORITY TO DISPENSE.—Nothing 

2 in this subsection shall be construed as affect3 ing the ability of a group health plan to cover, 

4 or the ability of a dispenser to continue to dis5 pense, a prescription drug if the prescription 

6 for such drug is an otherwise valid written, 

7 oral, or fax prescription that is consistence with 

8 applicable laws and regulations. 

9 ‘‘(C) PATIENT CHOICE.—Nothing in this 

10 subsection shall be construed as affecting the 

11 ability of an individual who is a participant or 

12 beneficiary of a group health plan and who is 

13 prescribed a schedule II, III, IV, or V con14 trolled substance that is a prescription drug 

15 covered by the plan to designate a particular 

16 dispenser to dispense a prescribed controlled 

17 substance to the extent consistent with the re18 quirements under this subsection. 

19 ‘‘(4) REGULATIONS ON POLICY REQUIRE20 MENTS.—The Secretary, the Secretary of Health 

21 and Human Services, and the Secretary of Labor 

22 shall promulgate regulations specifying requirements 

23 for the policies established by group health plans 

24 under paragraph (1). Such regulations shall include 

25 requirements for— 


ssavage on LAPJG3WLY3PROD with BILLS
23 

•HR 7312 IH

1 ‘‘(A) a uniform process by which plans are 

2 required to set the e-prescribing requirements; 

3 ‘‘(B) a process by which plans are required 

4 to grant waivers and exceptions to participating 

5 providers pursuant to paragraph (2); and 

6 ‘‘(C) a mechanism for plans to recognize 

7 waivers issued to participating providers under 

8 part D of title XVIII of the Public Health Serv9 ice Act, pursuant to paragraph (2)(C). 

10 ‘‘(5) PROHIBITIONS.—The policies established 

11 pursuant to paragraph (1) by a group health plan 

12 may not— 

13 ‘‘(A) require dispensers of a schedule II, 

14 III, IV, or V controlled substance to confirm 

15 that the prescription for the controlled sub16 stance was electronically issued by a partici17 pating provider in accordance with such poli18 cies, as described in paragraph (1); 

19 ‘‘(B) require dispensers of such controlled 

20 substances to submit information or data be21 yond what is otherwise required to process a 

22 prescription drug claim in order to confirm a 

23 participating provider’s compliance with such 

24 policies; 


ssavage on LAPJG3WLY3PROD with BILLS
24 

•HR 7312 IH

1 ‘‘(C) reject, deny, or recoup reimbursement 

2 for a prescription drug claim based on the for3 mat in which the prescription was issued; or 

4 ‘‘(D) require a participating provider to 

5 use a specific vendor for electronic prescribing 

6 or a specific electronic prescribing product or 

7 system. 

8 ‘‘(6) ATTESTATION OF COMPLIANCE.—Begin9 ning on January 1, 2026, each group health plan 

10 shall annually submit to the Secretary, the Secretary 

11 of Health and Human Services, and the Secretary of 

12 Labor an attestation of compliance with the require13 ments of this subsection. 

14 ‘‘(7) CONSULTATION REQUIREMENT FOR RULE15 MAKING.—In promulgating regulations to carry out 

16 this subsection, the Secretary, the Secretary of 

17 Health and Human Services, and the Secretary of 

18 Labor shall jointly consult with dispensers of con19 trolled substances, State insurance regulators, health 

20 insurance issuers offering group or individual health 

21 insurance coverage, and health care practitioners.’’. 

22 (d) UPDATE OF BIOMETRIC COMPONENT OF MULTI23 FACTOR AUTHENTICATION.—Not later than 1 year after 

24 the date of enactment of this Act, the Attorney General 

25 shall finalize a regulation updating the requirements for 


ssavage on LAPJG3WLY3PROD with BILLS
25 

•HR 7312 IH

1 the biometric component of multifactor authentication 

2 with respect to electronic prescriptions of controlled sub3 stances, as required under section 2003(c) of the SUP4 PORT for Patients and Community Act (Public Law 115– 

5 271). 

Æ 


ssavage on LAPJG3WLY3PROD with BILLS