I 118THCONGRESS 2 DSESSION H. R. 7312 To provide for requirements for electronic-prescribing for controlled sub- stances under group health plans and group and individual health insur- ance coverage. IN THE HOUSE OF REPRESENTATIVES FEBRUARY9, 2024 Ms. K USTER(for herself, Mr. BALDERSON, and Ms. LETLOW) introduced the following bill; which was referred to the Committee on Energy and Com- merce, and in addition to the Committees on Education and the Work- force, Ways and Means, and the Judiciary, for a period to be subse- quently 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. 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 ‘‘Electronic Prescribing 4 for Controlled Substances Act’’ or the ‘‘EPCS 2.0 Act’’. 5 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 2 •HR 7312 IH SEC. 2. REQUIREMENTS FOR ELECTRONIC-PRESCRIBING 1 FOR CONTROLLED SUBSTANCES UNDER 2 GROUP HEALTH PLANS AND GROUP AND IN-3 DIVIDUAL HEALTH INSURANCE COVERAGE. 4 (a) P UBLICHEALTHSERVICEACTAMENDMENT.— 5 Section 2799A–7 of the Public Health Service Act (42 6 U.S.C. 300gg–117) is amended by adding at the end the 7 following new subsection: 8 ‘‘(d) R EQUIREMENTS FOR ELECTRONIC-PRE-9 SCRIBING FORCONTROLLEDSUBSTANCES.— 10 ‘‘(1) I N GENERAL.—Except as provided pursu-11 ant to paragraph (2), for plan years beginning on or 12 after January 1, 2026, a group health plan and a 13 health insurance issuer offering group or individual 14 health insurance coverage, with respect to a partici-15 pating provider, as defined in section 2799–1(a)(3), 16 shall have in place policies, subject to paragraphs 17 (4) and (5), that require any prescription for a 18 schedule II, III, IV, or V controlled substance (as 19 defined by section 202 of the Controlled Substances 20 Act) covered by the plan or coverage that is trans-21 mitted by such a participating provider for such a 22 participant, beneficiary, or enrollee be electronically 23 transmitted consistent with standards established 24 under paragraph (3) of section 1860D–4(e) of the 25 Social Security Act, under an electronic prescription 26 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 3 •HR 7312 IH drug program that meets requirements that are sub-1 stantially similar (as jointly determined by the Sec-2 retary, the Secretary of Labor, and the Secretary of 3 the Treasury) to the requirements of paragraph (2) 4 of such section 1860D–4(e). 5 ‘‘(2) E XCEPTION FOR CERTAIN CIR -6 CUMSTANCES.—The Secretary, the Secretary of 7 Labor, and the Secretary of the Treasury shall joint-8 ly, through rulemaking, specify circumstances and 9 processes by which the requirement under paragraph 10 (1) may be waived, with respect to a schedule II, III, 11 IV, or V controlled substance that is a prescription 12 drug covered by a group health plan or group or in-13 dividual health insurance coverage offered by a 14 health insurance issuer, including in the case of— 15 ‘‘(A) a prescription issued when the par-16 ticipating provider and dispensing pharmacy are 17 the same entity; 18 ‘‘(B) a prescription issued that cannot be 19 transmitted electronically under the most re-20 cently implemented version of the National 21 Council for Prescription Drug Programs 22 SCRIPT Standard; 23 ‘‘(C) a prescription issued by a partici-24 pating provider who received a waiver (which 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 4 •HR 7312 IH may include a waiver obtained pursuant to sec-1 tion 1860D–4(e)(7)(B)(iii) of the Social Secu-2 rity Act) or a renewal thereof for a period of 3 time as determined by the Secretary, the Sec-4 retary of Labor, and the Secretary of the 5 Treasury, not to exceed one year, from the re-6 quirement to use electronic prescribing due to 7 demonstrated economic hardship, technological 8 limitations that are not reasonably within the 9 control of the participating provider, or other 10 exceptional circumstance demonstrated by the 11 participating provider; 12 ‘‘(D) a prescription issued by a partici-13 pating provider under circumstances in which, 14 notwithstanding the participating provider’s 15 ability to submit a prescription electronically as 16 required by this subsection, such participating 17 provider reasonably determines that it would be 18 impractical for the individual involved to obtain 19 substances prescribed by electronic prescription 20 in a timely manner, and such delay would ad-21 versely impact the individual’s medical condition 22 involved; 23 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 5 •HR 7312 IH ‘‘(E) a prescription issued by a partici-1 pating provider prescribing a drug under a re-2 search protocol; 3 ‘‘(F) a prescription issued by a partici-4 pating provider for a drug for which the Food 5 and Drug Administration requires a prescrip-6 tion to contain elements that are not able to be 7 included in electronic prescribing, such as a 8 drug with risk evaluation and mitigation strate-9 gies that include elements to assure safe use; 10 ‘‘(G) a prescription issued for an individual 11 who receives hospice care or for a resident of a 12 nursing facility (as defined in section 1919(a) 13 of the Social Security Act); 14 ‘‘(H) a prescription issued under cir-15 cumstances in which electronic prescribing is 16 not available due to temporary technological or 17 electrical failure, as specified jointly by the Sec-18 retary, the Secretary of Labor, and the Sec-19 retary of the Treasury through rulemaking; and 20 ‘‘(I) a prescription issued by a partici-21 pating provider allowing for the dispensing of a 22 non-patient specific prescription pursuant to a 23 standing order, approved protocol for drug ther-24 apy, collaborative drug management, or com-25 VerDate 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 prehensive medication management, in response 1 to a public health emergency or other cir-2 cumstances under which the participating pro-3 vider may issue a non-patient specific prescrip-4 tion. 5 ‘‘(3) R ULES OF CONSTRUCTION .— 6 ‘‘(A) V ERIFICATION.—Nothing in this sub-7 section shall be construed as requiring a dis-8 penser to verify that a participating provider, 9 with respect to a prescription for a schedule II, 10 III, IV, or V controlled substance that is a pre-11 scription drug covered by a group health plan 12 or group or individual health insurance cov-13 erage offered by a health insurance issuer, has 14 a waiver (or is otherwise exempt) under para-15 graph (2) from the requirement under para-16 graph (1). 17 ‘‘(B) A UTHORITY TO DISPENSE .—Nothing 18 in this subsection shall be construed as affect-19 ing the authority of a group health plan or 20 group or individual health insurance coverage 21 offered by a health insurance issuer to cover, or 22 the authority of a dispenser to continue to dis-23 pense, a prescription drug if the prescription 24 for such drug is an otherwise valid written, 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 7 •HR 7312 IH oral, or fax prescription that is consistent with 1 applicable law. 2 ‘‘(C) P ATIENT CHOICE.—Nothing in this 3 subsection shall be construed as affecting the 4 ability of an individual who is a participant, 5 beneficiary, or enrollee of a group health plan 6 or group or individual health insurance cov-7 erage offered by a health insurance issuer and 8 who is prescribed a schedule II, III, IV, or V 9 controlled substance that is a prescription drug 10 covered by the plan or coverage to designate a 11 particular dispenser to dispense a prescribed 12 controlled substance to the extent consistent 13 with the requirements under this subsection. 14 ‘‘(4) R EGULATIONS ON POLICY REQUIRE -15 MENTS.—The Secretary, the Secretary of Labor, 16 and the Secretary of the Treasury shall promulgate 17 regulations specifying requirements for the policies 18 established by group health plans and health insur-19 ance issuers under paragraph (1). Such regulations 20 shall include requirements for— 21 ‘‘(A) a uniform process by which plans and 22 issuers are required to set the e-prescribing re-23 quirements; 24 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 8 •HR 7312 IH ‘‘(B) a process by which plans and issuers 1 are required to grant waivers and exceptions to 2 participating providers pursuant to paragraph 3 (2); and 4 ‘‘(C) a mechanism for plans and issuers to 5 recognize waivers issued to participating pro-6 viders under part D of title XVIII of the Social 7 Security Act, pursuant to paragraph (2)(C). 8 ‘‘(5) P ROHIBITIONS.—The policies established 9 pursuant to paragraph (1) by a group health plan or 10 health insurance issuer offering group or individual 11 health insurance coverage may not— 12 ‘‘(A) require dispensers of a schedule II, 13 III, IV, or V controlled substance to confirm 14 that the prescription for the controlled sub-15 stance was electronically issued by a partici-16 pating provider in accordance with such poli-17 cies, as described in paragraph (1); 18 ‘‘(B) require dispensers of such controlled 19 substances to submit information or data be-20 yond what is otherwise required to process a 21 prescription drug claim in order to confirm a 22 participating provider’s compliance with such 23 policies; 24 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 9 •HR 7312 IH ‘‘(C) reject, deny, or recoup reimbursement 1 for a prescription drug claim based on the for-2 mat in which the prescription was issued; or 3 ‘‘(D) require a participating provider to 4 use a specific vendor for electronic prescribing 5 or a specific electronic prescribing product or 6 system. 7 ‘‘(6) A TTESTATION OF COMPLIANCE .—Begin-8 ning on January 1, 2026, each group health plan 9 and health insurance issuer offering group or indi-10 vidual health insurance coverage shall annually sub-11 mit to the Secretary, the Secretary of Labor, and 12 the Secretary of the Treasury an attestation of com-13 pliance with the requirements of this subsection. 14 ‘‘(7) C ONSULTATION REQUIREMENT FOR RULE -15 MAKING.—In promulgating regulations to carry out 16 this subsection, the Secretary, the Secretary of the 17 Labor, and the Secretary of the Treasury shall joint-18 ly consult with dispensers of controlled substances, 19 State insurance regulators, health insurance issuers 20 offering group or individual health insurance cov-21 erage, and health care practitioners.’’. 22 (b) E MPLOYEERETIREMENTINCOMESECURITYACT 23 OF1974 AMENDMENT.—Section 722 of the Employee Re-24 tirement Income Security Act of 1974 (29 U.S.C. 1185k) 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 10 •HR 7312 IH is amended by adding at the end the following new sub-1 section: 2 ‘‘(d) R EQUIREMENTS FOR ELECTRONIC-PRE-3 SCRIBING FORCONTROLLEDSUBSTANCES.— 4 ‘‘(1) I N GENERAL.—Except as provided pursu-5 ant to paragraph (2), for plan years beginning on or 6 after January 1, 2026, a group health plan and a 7 health insurance issuer offering group health insur-8 ance coverage, with respect to a participating pro-9 vider, as defined in section 716(a)(3), shall have in 10 place policies, subject to paragraphs (4) and (5), 11 that require any prescription for a schedule II, III, 12 IV, or V controlled substance (as defined by section 13 202 of the Controlled Substances Act) covered by 14 the plan or coverage that is transmitted by such a 15 participating provider for such a participant or bene-16 ficiary be electronically transmitted consistent with 17 standards established under paragraph (3) of section 18 1860D–4(e) of the Social Security Act, under an 19 electronic prescription drug program that meets re-20 quirements that are substantially similar (as jointly 21 determined by the Secretary, the Secretary of 22 Health and Human Services, and the Secretary of 23 the Treasury) to the requirements of paragraph (2) 24 of such section 1860D–4(e). 25 VerDate Sep 11 2014 22:18 Feb 22, 2024 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 11 •HR 7312 IH ‘‘(2) EXCEPTION FOR CERTAIN CIR -1 CUMSTANCES.—The Secretary, the Secretary of 2 Health and Human Services, and the Secretary of 3 the Treasury shall jointly, through rulemaking, 4 specify circumstances and processes by which the re-5 quirement under paragraph (1) may be waived, with 6 respect to a schedule II, III, IV, or V controlled sub-7 stance that is a prescription drug covered by a group 8 health plan or group health insurance coverage of-9 fered by a health insurance issuer, including in the 10 case of— 11 ‘‘(A) a prescription issued when the par-12 ticipating provider and dispensing pharmacy are 13 the same entity; 14 ‘‘(B) a prescription issued that cannot be 15 transmitted electronically under the most re-16 cently implemented version of the National 17 Council for Prescription Drug Programs 18 SCRIPT Standard; 19 ‘‘(C) a prescription issued by a partici-20 pating provider who received a waiver (which 21 may include a waiver obtained pursuant to sec-22 tion 1860D–4(e)(7)(B)(iii) of the Social Secu-23 rity Act) or a renewal thereof for a period of 24 time as determined by the Secretary, the Sec-25 VerDate 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 retary of Health and Human Services, and the 1 Secretary of the Treasury, not to exceed one 2 year, from the requirement to use electronic 3 prescribing due to demonstrated economic hard-4 ship, technological limitations that are not rea-5 sonably within the control of the participating 6 provider, or other exceptional circumstance 7 demonstrated by the participating provider; 8 ‘‘(D) a prescription issued by a partici-9 pating provider under circumstances in which, 10 notwithstanding the participating provider’s 11 ability to submit a prescription electronically as 12 required by this subsection, such participating 13 provider reasonably determines that it would be 14 impractical for the individual involved to obtain 15 substances prescribed by electronic prescription 16 in a timely manner, and such delay would ad-17 versely impact the individual’s medical condition 18 involved; 19 ‘‘(E) a prescription issued by a partici-20 pating provider prescribing a drug under a re-21 search protocol; 22 ‘‘(F) a prescription issued by a partici-23 pating provider for a drug for which the Food 24 and Drug Administration requires a prescrip-25 VerDate 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 tion to contain elements that are not able to be 1 included in electronic prescribing, such as a 2 drug with risk evaluation and mitigation strate-3 gies that include elements to assure safe use; 4 ‘‘(G) a prescription issued for an individual 5 who receives hospice care or for a resident of a 6 nursing facility (as defined in section 1919(a) 7 of the Social Security Act); 8 ‘‘(H) a prescription issued under cir-9 cumstances in which electronic prescribing is 10 not available due to temporary technological or 11 electrical failure, as specified jointly by the Sec-12 retary, the Secretary of Health and Human 13 Services, and the Secretary of the Treasury 14 through rulemaking; and 15 ‘‘(I) a prescription issued by a partici-16 pating provider allowing for the dispensing of a 17 non-patient specific prescription pursuant to a 18 standing order, approved protocol for drug ther-19 apy, collaborative drug management, or com-20 prehensive medication management, in response 21 to a public health emergency or other cir-22 cumstances under which the participating pro-23 vider may issue a non-patient specific prescrip-24 tion. 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 14 •HR 7312 IH ‘‘(3) RULES OF CONSTRUCTION .— 1 ‘‘(A) V ERIFICATION.—Nothing in this sub-2 section shall be construed as requiring a dis-3 penser to verify that a participating provider, 4 with respect to a prescription for a schedule II, 5 III, IV, or V controlled substance that is a pre-6 scription drug covered by a group health plan 7 or group or individual health insurance cov-8 erage offered by a health insurance issuer, has 9 a waiver (or is otherwise exempt) under para-10 graph (2) from the requirement under para-11 graph (1). 12 ‘‘(B) A UTHORITY TO DISPENSE .—Nothing 13 in this subsection shall be construed as affect-14 ing the authority of a group health plan or 15 group health insurance coverage offered by a 16 health insurance issuer to cover, or the author-17 ity of a dispenser to continue to dispense, a pre-18 scription drug if the prescription for such drug 19 is an otherwise valid written, oral, or fax pre-20 scription that is consistent with applicable law. 21 ‘‘(C) P ATIENT CHOICE.—Nothing in this 22 subsection shall be construed as affecting the 23 ability of an individual who is a participant or 24 beneficiary of a group health plan or group or 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 15 •HR 7312 IH individual health insurance coverage offered by 1 a health insurance issuer and who is prescribed 2 a schedule II, III, IV, or V controlled substance 3 that is a prescription drug covered by the plan 4 or coverage to designate a particular dispenser 5 to dispense a prescribed controlled substance to 6 the extent consistent with the requirements 7 under this subsection. 8 ‘‘(4) R EGULATIONS ON POLICY REQUIRE -9 MENTS.—The Secretary, the Secretary of Health 10 and Human Services, and the Secretary of the 11 Treasury shall promulgate regulations specifying re-12 quirements for the policies established by group 13 health plans and health insurance issuers under 14 paragraph (1). Such regulations shall include re-15 quirements for— 16 ‘‘(A) a uniform process by which plans and 17 issuers are required to set the e-prescribing re-18 quirements; 19 ‘‘(B) a process by which plans and issuers 20 are required to grant waivers and exceptions to 21 participating providers pursuant to paragraph 22 (2); and 23 ‘‘(C) a mechanism for plans and issuers to 24 recognize waivers issued to participating pro-25 VerDate 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 viders under part D of title XVIII of the Social 1 Security Act, pursuant to paragraph (2)(C). 2 ‘‘(5) P ROHIBITIONS.—The policies established 3 pursuant to paragraph (1) by a group health plan or 4 health insurance issuer offering group health insur-5 ance coverage may not— 6 ‘‘(A) require dispensers of a schedule II, 7 III, IV, or V controlled substance to confirm 8 that the prescription for the controlled sub-9 stance was electronically issued by a partici-10 pating provider in accordance with such poli-11 cies, as described in paragraph (1); 12 ‘‘(B) require dispensers of such controlled 13 substances to submit information or data be-14 yond what is otherwise required to process a 15 prescription drug claim in order to confirm a 16 participating provider’s compliance with such 17 policies; 18 ‘‘(C) reject, deny, or recoup reimbursement 19 for a prescription drug claim based on the for-20 mat in which the prescription was issued; or 21 ‘‘(D) require a participating provider to 22 use a specific vendor for electronic prescribing 23 or a specific electronic prescribing product or 24 system. 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 17 •HR 7312 IH ‘‘(6) ATTESTATION OF COMPLIANCE .—Begin-1 ning on January 1, 2026, each group health plan 2 and health insurance issuer offering group health in-3 surance coverage shall annually submit to the Sec-4 retary, the Secretary of Health and Human Services, 5 and the Secretary of the Treasury an attestation of 6 compliance with the requirements of this subsection. 7 ‘‘(7) C ONSULTATION REQUIREMENT FOR RULE -8 MAKING.—In promulgating regulations to carry out 9 this subsection, the Secretary, the Secretary of 10 Health and Human Services, and the Secretary of 11 the Treasury shall jointly consult with dispensers of 12 controlled substances, State insurance regulators, 13 health insurance issuers offering group or individual 14 health insurance coverage, and health care practi-15 tioners.’’. 16 (c) I NTERNALREVENUECODE OF1986 AMEND-17 MENT.—Section 9822 of the Internal Revenue Code of 18 1986 is amended by adding at the end the following new 19 subsection: 20 ‘‘(d) R EQUIREMENTS FOR ELECTRONIC-PRE-21 SCRIBING FORCONTROLLEDSUBSTANCES.— 22 ‘‘(1) I N GENERAL.—Except as provided pursu-23 ant to paragraph (2), for plan years beginning on or 24 after January 1, 2026, a group health plan, with re-25 VerDate 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 spect to a participating provider, as defined in sec-1 tion 9816(a)(3), shall have in place policies, subject 2 to paragraphs (4) and (5), that require any prescrip-3 tion for a schedule II, III, IV, or V controlled sub-4 stance (as defined by section 202 of the Controlled 5 Substances Act) covered by the plan that is trans-6 mitted by such a participating provider for such a 7 participant or beneficiary be electronically trans-8 mitted consistent with standards established under 9 paragraph (3) of section 1860D–4(e) of the Social 10 Security Act, under an electronic prescription drug 11 program that meets requirements that are substan-12 tially similar (as jointly determined by the Secretary, 13 the Secretary of Health and Human Services, and 14 the Secretary of Labor) to the requirements of para-15 graph (2) of such section 1860D–4(e). 16 ‘‘(2) E XCEPTION FOR CERTAIN CIR -17 CUMSTANCES.—The Secretary, the Secretary of 18 Health and Human Services, and the Secretary of 19 Labor shall jointly, through rulemaking, specify cir-20 cumstances and processes by which the requirement 21 under paragraph (1) may be waived, with respect to 22 a schedule II, III, IV, or V controlled substance that 23 is a prescription drug covered by a group health, in-24 cluding in the case of— 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 19 •HR 7312 IH ‘‘(A) a prescription issued when the par-1 ticipating provider and dispensing pharmacy are 2 the same entity; 3 ‘‘(B) a prescription issued that cannot be 4 transmitted electronically under the most re-5 cently implemented version of the National 6 Council for Prescription Drug Programs 7 SCRIPT Standard; 8 ‘‘(C) a prescription issued by a partici-9 pating provider who received a waiver (which 10 may include a waiver obtained pursuant to sec-11 tion 1860D–4(e)(7)(B)(iii) of the Social Secu-12 rity Act) or a renewal thereof for a period of 13 time as determined by the Secretary, the Sec-14 retary of Health and Human Services, and the 15 Secretary of Labor, not to exceed one year, 16 from the requirement to use electronic pre-17 scribing due to demonstrated economic hard-18 ship, technological limitations that are not rea-19 sonably within the control of the participating 20 provider, or other exceptional circumstance 21 demonstrated by the participating provider; 22 ‘‘(D) a prescription issued by a partici-23 pating provider under circumstances in which, 24 notwithstanding the participating provider’s 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 20 •HR 7312 IH ability to submit a prescription electronically as 1 required by this subsection, such participating 2 provider reasonably determines that it would be 3 impractical for the individual involved to obtain 4 substances prescribed by electronic prescription 5 in a timely manner, and such delay would ad-6 versely impact the individual’s medical condition 7 involved; 8 ‘‘(E) a prescription issued by a partici-9 pating provider prescribing a drug under a re-10 search protocol; 11 ‘‘(F) a prescription issued by a partici-12 pating provider for a drug for which the Food 13 and Drug Administration requires a prescrip-14 tion to contain elements that are not able to be 15 included in electronic prescribing, such as a 16 drug with risk evaluation and mitigation strate-17 gies that include elements to assure safe use; 18 ‘‘(G) a prescription issued for an individual 19 who receives hospice care or for a resident of a 20 nursing facility (as defined in section 1919(a) 21 of the Social Security Act); 22 ‘‘(H) a prescription issued under cir-23 cumstances in which electronic prescribing is 24 not available due to temporary technological or 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 21 •HR 7312 IH electrical failure, as specified jointly by the Sec-1 retary, the Secretary of Health and Human 2 Services, and the Secretary of Labor through 3 rulemaking; and 4 ‘‘(I) a prescription issued by a partici-5 pating provider allowing for the dispensing of a 6 non-patient specific prescription pursuant to a 7 standing order, approved protocol for drug ther-8 apy, collaborative drug management, or com-9 prehensive medication management, in response 10 to a public health emergency or other cir-11 cumstances under which the participating pro-12 vider may issue a non-patient specific prescrip-13 tion. 14 ‘‘(3) R ULES OF CONSTRUCTION .— 15 ‘‘(A) V ERIFICATION.—Nothing in this sub-16 section shall be construed as requiring a dis-17 penser to verify that a participating provider, 18 with respect to a prescription for a schedule II, 19 III, IV, or V controlled substance that is a pre-20 scription drug covered by a group health plan, 21 has a waiver (or is otherwise exempt) under 22 paragraph (2) from the requirement under 23 paragraph (1). 24 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 22 •HR 7312 IH ‘‘(B) AUTHORITY TO DISPENSE .—Nothing 1 in this subsection shall be construed as affect-2 ing the ability of a group health plan to cover, 3 or the ability of a dispenser to continue to dis-4 pense, a prescription drug if the prescription 5 for such drug is an otherwise valid written, 6 oral, or fax prescription that is consistence with 7 applicable laws and regulations. 8 ‘‘(C) P ATIENT CHOICE.—Nothing in this 9 subsection shall be construed as affecting the 10 ability of an individual who is a participant or 11 beneficiary of a group health plan and who is 12 prescribed a schedule II, III, IV, or V con-13 trolled substance that is a prescription drug 14 covered by the plan to designate a particular 15 dispenser to dispense a prescribed controlled 16 substance to the extent consistent with the re-17 quirements under this subsection. 18 ‘‘(4) R EGULATIONS ON POLICY REQUIRE -19 MENTS.—The Secretary, the Secretary of Health 20 and Human Services, and the Secretary of Labor 21 shall promulgate regulations specifying requirements 22 for the policies established by group health plans 23 under paragraph (1). Such regulations shall include 24 requirements for— 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 23 •HR 7312 IH ‘‘(A) a uniform process by which plans are 1 required to set the e-prescribing requirements; 2 ‘‘(B) a process by which plans are required 3 to grant waivers and exceptions to participating 4 providers pursuant to paragraph (2); and 5 ‘‘(C) a mechanism for plans to recognize 6 waivers issued to participating providers under 7 part D of title XVIII of the Public Health Serv-8 ice Act, pursuant to paragraph (2)(C). 9 ‘‘(5) P ROHIBITIONS.—The policies established 10 pursuant to paragraph (1) by a group health plan 11 may not— 12 ‘‘(A) require dispensers of a schedule II, 13 III, IV, or V controlled substance to confirm 14 that the prescription for the controlled sub-15 stance was electronically issued by a partici-16 pating provider in accordance with such poli-17 cies, as described in paragraph (1); 18 ‘‘(B) require dispensers of such controlled 19 substances to submit information or data be-20 yond what is otherwise required to process a 21 prescription drug claim in order to confirm a 22 participating provider’s compliance with such 23 policies; 24 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 24 •HR 7312 IH ‘‘(C) reject, deny, or recoup reimbursement 1 for a prescription drug claim based on the for-2 mat in which the prescription was issued; or 3 ‘‘(D) require a participating provider to 4 use a specific vendor for electronic prescribing 5 or a specific electronic prescribing product or 6 system. 7 ‘‘(6) A TTESTATION OF COMPLIANCE .—Begin-8 ning on January 1, 2026, each group health plan 9 shall annually submit to the Secretary, the Secretary 10 of Health and Human Services, and the Secretary of 11 Labor an attestation of compliance with the require-12 ments of this subsection. 13 ‘‘(7) C ONSULTATION REQUIREMENT FOR RULE -14 MAKING.—In promulgating regulations to carry out 15 this subsection, the Secretary, the Secretary of 16 Health and Human Services, and the Secretary of 17 Labor shall jointly consult with dispensers of con-18 trolled substances, State insurance regulators, health 19 insurance issuers offering group or individual health 20 insurance coverage, and health care practitioners.’’. 21 (d) U PDATE OFBIOMETRICCOMPONENT OFMULTI-22 FACTORAUTHENTICATION.—Not later than 1 year after 23 the date of enactment of this Act, the Attorney General 24 shall finalize a regulation updating the requirements for 25 VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS 25 •HR 7312 IH the biometric component of multifactor authentication 1 with respect to electronic prescriptions of controlled sub-2 stances, as required under section 2003(c) of the SUP-3 PORT for Patients and Community Act (Public Law 115– 4 271). 5 Æ VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6301 E:\BILLS\H7312.IH H7312 ssavage on LAPJG3WLY3PROD with BILLS