II 

118TH CONGRESS 

1ST SESSION S. 2666 

To amend the Public Health Service Act, the Employee Retirement Income 

Security Act of 1974, and the Internal Revenue Code of 1986 to provide 

for requirements for electronic-prescribing for controlled substances under 

group health plans and group and individual health insurance coverage. 

IN THE SENATE OF THE UNITED STATES 

JULY 27, 2023 

Ms. HASSAN (for herself and Mr. MULLIN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal 

Revenue Code of 1986 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’’. 


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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, 2025, 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 paragraph (4), 

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

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

20 202 of the Controlled Substances Act) covered under 

21 the plan or coverage that is transmitted by such a 

22 health care practitioner for such a participant, bene23 ficiary, or enrollee be electronically transmitted in 

24 accordance with such standards, consistent with 

25 standards established under paragraph (3) of section 

26 1860D–4(e) of the Social Security Act, under an 


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1 electronic prescription drug program that meets re2 quirements that are substantially similar (as jointly 

3 determined by the Secretary, Secretary of the Treas4 ury, and Secretary of Labor) to the requirements of 

5 paragraph (2) of such section 1860D–4(e). 

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

8 Treasury, and Secretary of Labor shall jointly, 

9 through rulemaking, specify circumstances and proc10 esses by which the requirement under paragraph (1) 

11 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 described in any of 

17 clauses (i) through (vi) of section 1860D– 

18 4(e)(7)(B) of the Social Security Act; 

19 ‘‘(B) 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 ‘‘(C) a prescription issued under cir24 cumstances in which electronic prescribing is 

25 not available due to temporary technological or 


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1 electrical failure, as specified jointly by the Sec2 retary, Secretary of the Treasury, and Sec3 retary of Labor through rulemaking; and 

4 ‘‘(D) a prescription issued by a practi5 tioner allowing for the dispensing of a non-pa6 tient specific prescription pursuant to a stand7 ing order, approved protocol for drug therapy, 

8 collaborative drug management, or comprehen9 sive medication management, in response to a 

10 public health emergency or other circumstances 

11 under which the practitioner may issue a non12 patient specific prescription. 

13 ‘‘(3) RULES OF CONSTRUCTION.— 

14 ‘‘(A) VERIFICATION.—Nothing in this sub15 section shall be construed as requiring a dis16 penser to verify that a health care practitioner, 

17 with respect to a prescription for a schedule II, 

18 III, IV, or V controlled substance that is a pre19 scription drug covered under a group health 

20 plan or group or individual health insurance 

21 coverage offered by a health insurance issuer, 

22 has a waiver (or is otherwise exempt) under 

23 paragraph (2) from the requirement under 

24 paragraph (1). 


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

2 in this subsection shall be construed as affect3 ing the authority of a group health plan or 

4 group or individual health insurance coverage 

5 offered by a health insurance issuer to cover, or 

6 the authority of a dispenser to continue to dis7 pense, a prescription drug if the prescription 

8 for such drug is an otherwise valid written, 

9 oral, or fax prescription that is consistent with 

10 applicable law. 

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

12 subsection shall be construed as affecting the 

13 ability of an individual who is a participant, 

14 beneficiary, or enrollee of a group health plan 

15 or group or individual health insurance cov16 erage offered by a health insurance issuer and 

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

18 controlled substance that is a prescription drug 

19 covered under the plan or coverage to designate 

20 a particular pharmacy to dispense a prescribed 

21 controlled substance to the extent consistent 

22 with the requirements under this subsection. 

23 ‘‘(4) PROHIBITIONS.—The policies established 

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


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1 health insurance issuer offering group or individual 

2 health insurance coverage may not— 

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

4 III, IV, or V controlled substance to confirm 

5 that the prescription for the controlled sub6 stance was electronically issued by a health care 

7 practitioner in accordance with such policies, as 

8 described in paragraph (1); 

9 ‘‘(B) require dispensers of such controlled 

10 substances to submit information or data be11 yond what is otherwise required to process a 

12 prescription drug claim in order to confirm a 

13 practitioner’s compliance with such policies; or 

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

15 for a prescription drug claim based on the for16 mat in which the prescription was issued. 

17 ‘‘(5) CONSULTATION REQUIREMENT FOR RULE18 MAKING.—In promulgating regulations to carry out 

19 this subsection, the Secretary, Secretary of the 

20 Treasury, and Secretary of Labor shall jointly con21 sult with dispensers of controlled substances, State 

22 insurance regulators, 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) 


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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, 2025, 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 paragraph (4), that require 

12 any prescription for a schedule II, III, IV, or V con13 trolled substance (as defined by section 202 of the 

14 Controlled Substances Act) covered under the plan 

15 or coverage that is transmitted by such a health care 

16 practitioner for such a participant or beneficiary be 

17 electronically transmitted in accordance with such 

18 standards, consistent with standards established 

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

20 Social Security Act, under an electronic prescription 

21 drug program that meets requirements that are sub22 stantially similar (as jointly determined by the Sec23 retary, Secretary of the Treasury, and Secretary of 

24 Labor) to the requirements of paragraph (2) of such 

25 section 1860D–4(e). 


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

3 Treasury, and Secretary of Health and Human 

4 Services shall jointly, through rulemaking, specify 

5 circumstances and processes by which the require6 ment under paragraph (1) may be waived, with re7 spect 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 described in any of 

13 clauses (i) through (vi) of section 1860D– 

14 4(e)(7)(B) of the Social Security Act; 

15 ‘‘(B) a prescription issued for an individual 

16 who receives hospice care or for a resident of a 

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

18 of the Social Security Act); 

19 ‘‘(C) a prescription issued under cir20 cumstances in which electronic prescribing is 

21 not available due to temporary technological or 

22 electrical failure, as specified jointly by the Sec23 retary, Secretary of the Treasury, and Sec24 retary of Health and Human Services through 

25 rulemaking; and 


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1 ‘‘(D) a prescription issued by a practi2 tioner allowing for the dispensing of a non-pa3 tient specific prescription pursuant to a stand4 ing order, approved protocol for drug therapy, 

5 collaborative drug management, or comprehen6 sive medication management, in response to a 

7 public health emergency or other circumstances 

8 under which the practitioner may issue a non9 patient specific prescription. 

10 ‘‘(3) RULES OF CONSTRUCTION.— 

11 ‘‘(A) VERIFICATION.—Nothing in this sub12 section shall be construed as requiring a dis13 penser to verify that a health care practitioner, 

14 with respect to a prescription for a schedule II, 

15 III, IV, or V controlled substance that is a pre16 scription drug covered under a group health 

17 plan or group or individual health insurance 

18 coverage offered by a health insurance issuer, 

19 has a waiver (or is otherwise exempt) under 

20 paragraph (2) from the requirement under 

21 paragraph (1). 

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

23 in this subsection shall be construed as affect24 ing the authority of a group health plan or 

25 group health insurance coverage offered by a 


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1 health insurance issuer to cover, or the author2 ity of a dispenser to continue to dispense, a pre3 scription drug if the prescription for such drug 

4 is an otherwise valid written, oral, or fax pre5 scription that is consistent with applicable law. 

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

7 subsection shall be construed as affecting the 

8 ability of an individual who is a participant or 

9 beneficiary of a group health plan or group or 

10 individual health insurance coverage offered by 

11 a health insurance issuer and who is prescribed 

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

13 that is a prescription drug covered under the 

14 plan or coverage to designate a particular phar15 macy to dispense a prescribed controlled sub16 stance to the extent consistent with the require17 ments under this subsection. 

18 ‘‘(4) PROHIBITIONS.—The policies established 

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

20 health insurance issuer offering group health insur21 ance coverage may not— 

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

23 III, IV, or V controlled substance to confirm 

24 that the prescription for the controlled sub25 stance was electronically issued by a health care 


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1 practitioner in accordance with such policies, as 

2 described in paragraph (1); 

3 ‘‘(B) require dispensers of such controlled 

4 substances to submit information or data be5 yond what is otherwise required to process a 

6 prescription drug claim in order to confirm a 

7 practitioner’s compliance with such policies; or 

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

9 for a prescription drug claim based on the for10 mat in which the prescription was issued. 

11 ‘‘(5) CONSULTATION REQUIREMENT FOR RULE12 MAKING.—In promulgating regulations to carry out 

13 this subsection, the Secretary, Secretary of the 

14 Treasury, and Secretary of Health and Human 

15 Services shall jointly consult with dispensers of con16 trolled substances, State insurance regulators, and 

17 health care practitioners.’’. 

18 (c) INTERNAL REVENUE CODE OF 1986 AMEND19 MENT.—Section 9822 of the Internal Revenue Code of 

20 1986 is amended by adding at the end the following new 

21 subsection: 

22 ‘‘(d) REQUIREMENTS FOR ELECTRONIC-PRE23 SCRIBING FOR CONTROLLED SUBSTANCES.— 

24 ‘‘(1) IN GENERAL.—Except as provided pursu25 ant to paragraph (2), for plan years beginning on or 


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1 after January 1, 2025, a group health plan, with re2 spect to a participating provider, as defined in sec3 tion 9816(a)(3), shall have in place policies, subject 

4 to paragraph (4), that require any prescription for 

5 a schedule II, III, IV, or V controlled substance (as 

6 defined by section 202 of the Controlled Substances 

7 Act) covered under the plan that is transmitted by 

8 such a health care practitioner for such a participant 

9 or beneficiary be electronically transmitted in ac10 cordance with such standards, consistent with stand11 ards established under paragraph (3) of section 

12 1860D–4(e) of the Social Security Act, under an 

13 electronic prescription drug program that meets re14 quirements that are substantially similar (as jointly 

15 determined by the Secretary, Secretary of the Treas16 ury, and Secretary of Labor) to the requirements of 

17 paragraph (2) of such section 1860D–4(e). 

18 ‘‘(2) EXCEPTION FOR CERTAIN CIR19 CUMSTANCES.—The Secretary, Secretary of Health 

20 and Human Services, and Secretary of Labor shall 

21 jointly, through rulemaking, specify circumstances 

22 and processes by which the requirement under para23 graph (1) may be waived, with respect to a schedule 

24 II, III, IV, or V controlled substance that is a preVerDate Sep 11 2014 01:22 Aug 17, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2666.IS S2666

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1 scription drug covered by a group health, including 

2 in the case of— 

3 ‘‘(A) a prescription described in any of 

4 clauses (i) through (vi) of section 1860D– 

5 4(e)(7)(B) of the Social Security Act; 

6 ‘‘(B) a prescription issued for an individual 

7 who receives hospice care or for a resident of a 

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

9 of the Social Security Act); 

10 ‘‘(C) a prescription issued under cir11 cumstances in which electronic prescribing is 

12 not available due to temporary technological or 

13 electrical failure, as specified jointly by the Sec14 retary, Secretary of Health and Human Serv15 ices, and Secretary of Labor through rule16 making; and 

17 ‘‘(D) a prescription issued by a practi18 tioner allowing for the dispensing of a non-pa19 tient specific prescription pursuant to a stand20 ing order, approved protocol for drug therapy, 

21 collaborative drug management, or comprehen22 sive medication management, in response to a 

23 public health emergency or other circumstances 

24 under which the practitioner may issue a non25 patient specific prescription. 


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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 health care practitioner, 

5 with respect to a prescription for a schedule II, 

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

8 plan, has a waiver (or is otherwise exempt) 

9 under paragraph (2) from the requirement 

10 under paragraph (1). 

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

12 in this subsection shall be construed as affect13 ing the ability of a group health plan to cover, 

14 or the ability of a dispenser to continue to dis15 pense, a prescription drug if the prescription 

16 for such drug is an otherwise valid written, 

17 oral, or fax prescription that is consistence with 

18 applicable laws and regulations. 

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

20 subsection shall be construed as affecting the 

21 ability of an individual who is a participant or 

22 beneficiary of a group health plan and who is 

23 prescribed a schedule II, III, IV, or V con24 trolled substance that is a prescription drug 

25 covered under the plan to designate a particular 


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1 pharmacy to dispense a prescribed controlled 

2 substance to the extent consistent with the re3 quirements under this subsection. 

4 ‘‘(4) PROHIBITIONS.—The policies established 

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

6 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 health care 

11 practitioner in accordance with such policies, as 

12 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 practitioner’s compliance with such policies; or 

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

19 for a prescription drug claim based on the for20 mat in which the prescription was issued. 

21 ‘‘(5) CONSULTATION REQUIREMENT FOR RULE22 MAKING.—In promulgating regulations to carry out 

23 this subsection, the Secretary, Secretary of Health 

24 and Human Services, and Secretary of Labor shall 

25 jointly consult with dispensers of controlled subVerDate Sep 11 2014 01:22 Aug 17, 2023 Jkt 039200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S2666.IS S2666

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1 stances, State insurance regulators, and health care 

2 practitioners.’’. 

Æ 


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