| 1 | 1 | | I |
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| 2 | 2 | | 118THCONGRESS |
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| 3 | 3 | | 2 |
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| 4 | 4 | | DSESSION H. R. 7312 |
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| 5 | 5 | | To provide for requirements for electronic-prescribing for controlled sub- |
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| 6 | 6 | | stances under group health plans and group and individual health insur- |
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| 7 | 7 | | ance coverage. |
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| 8 | 8 | | IN THE HOUSE OF REPRESENTATIVES |
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| 9 | 9 | | FEBRUARY9, 2024 |
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| 10 | 10 | | Ms. K |
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| 11 | 11 | | USTER(for herself, Mr. BALDERSON, and Ms. LETLOW) introduced the |
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| 12 | 12 | | following bill; which was referred to the Committee on Energy and Com- |
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| 13 | 13 | | merce, and in addition to the Committees on Education and the Work- |
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| 14 | 14 | | force, Ways and Means, and the Judiciary, for a period to be subse- |
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| 15 | 15 | | quently determined by the Speaker, in each case for consideration of such |
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| 16 | 16 | | provisions as fall within the jurisdiction of the committee concerned |
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| 17 | 17 | | A BILL |
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| 18 | 18 | | To provide for requirements for electronic-prescribing for |
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| 19 | 19 | | controlled substances under group health plans and |
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| 20 | 20 | | group and individual health insurance coverage. |
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| 21 | 21 | | Be it enacted by the Senate and House of Representa-1 |
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| 22 | 22 | | tives of the United States of America in Congress assembled, 2 |
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| 23 | 23 | | SECTION 1. SHORT TITLE. 3 |
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| 24 | 24 | | This Act may be cited as the ‘‘Electronic Prescribing 4 |
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| 25 | 25 | | for Controlled Substances Act’’ or the ‘‘EPCS 2.0 Act’’. 5 |
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| 26 | 26 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
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| 27 | 27 | | ssavage on LAPJG3WLY3PROD with BILLS 2 |
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| 28 | 28 | | •HR 7312 IH |
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| 29 | 29 | | SEC. 2. REQUIREMENTS FOR ELECTRONIC-PRESCRIBING 1 |
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| 30 | 30 | | FOR CONTROLLED SUBSTANCES UNDER 2 |
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| 31 | 31 | | GROUP HEALTH PLANS AND GROUP AND IN-3 |
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| 32 | 32 | | DIVIDUAL HEALTH INSURANCE COVERAGE. 4 |
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| 33 | 33 | | (a) P |
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| 34 | 34 | | UBLICHEALTHSERVICEACTAMENDMENT.— 5 |
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| 35 | 35 | | Section 2799A–7 of the Public Health Service Act (42 6 |
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| 36 | 36 | | U.S.C. 300gg–117) is amended by adding at the end the 7 |
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| 37 | 37 | | following new subsection: 8 |
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| 38 | 38 | | ‘‘(d) R |
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| 39 | 39 | | EQUIREMENTS FOR ELECTRONIC-PRE-9 |
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| 40 | 40 | | SCRIBING FORCONTROLLEDSUBSTANCES.— 10 |
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| 41 | 41 | | ‘‘(1) I |
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| 42 | 42 | | N GENERAL.—Except as provided pursu-11 |
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| 43 | 43 | | ant to paragraph (2), for plan years beginning on or 12 |
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| 44 | 44 | | after January 1, 2026, a group health plan and a 13 |
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| 45 | 45 | | health insurance issuer offering group or individual 14 |
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| 46 | 46 | | health insurance coverage, with respect to a partici-15 |
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| 47 | 47 | | pating provider, as defined in section 2799–1(a)(3), 16 |
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| 48 | 48 | | shall have in place policies, subject to paragraphs 17 |
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| 49 | 49 | | (4) and (5), that require any prescription for a 18 |
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| 50 | 50 | | schedule II, III, IV, or V controlled substance (as 19 |
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| 51 | 51 | | defined by section 202 of the Controlled Substances 20 |
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| 52 | 52 | | Act) covered by the plan or coverage that is trans-21 |
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| 53 | 53 | | mitted by such a participating provider for such a 22 |
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| 54 | 54 | | participant, beneficiary, or enrollee be electronically 23 |
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| 55 | 55 | | transmitted consistent with standards established 24 |
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| 56 | 56 | | under paragraph (3) of section 1860D–4(e) of the 25 |
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| 57 | 57 | | Social Security Act, under an electronic prescription 26 |
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| 58 | 58 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
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| 59 | 59 | | ssavage on LAPJG3WLY3PROD with BILLS 3 |
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| 60 | 60 | | •HR 7312 IH |
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| 61 | 61 | | drug program that meets requirements that are sub-1 |
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| 62 | 62 | | stantially similar (as jointly determined by the Sec-2 |
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| 63 | 63 | | retary, the Secretary of Labor, and the Secretary of 3 |
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| 64 | 64 | | the Treasury) to the requirements of paragraph (2) 4 |
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| 65 | 65 | | of such section 1860D–4(e). 5 |
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| 66 | 66 | | ‘‘(2) E |
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| 67 | 67 | | XCEPTION FOR CERTAIN CIR -6 |
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| 68 | 68 | | CUMSTANCES.—The Secretary, the Secretary of 7 |
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| 69 | 69 | | Labor, and the Secretary of the Treasury shall joint-8 |
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| 70 | 70 | | ly, through rulemaking, specify circumstances and 9 |
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| 71 | 71 | | processes by which the requirement under paragraph 10 |
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| 72 | 72 | | (1) may be waived, with respect to a schedule II, III, 11 |
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| 73 | 73 | | IV, or V controlled substance that is a prescription 12 |
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| 74 | 74 | | drug covered by a group health plan or group or in-13 |
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| 75 | 75 | | dividual health insurance coverage offered by a 14 |
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| 76 | 76 | | health insurance issuer, including in the case of— 15 |
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| 77 | 77 | | ‘‘(A) a prescription issued when the par-16 |
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| 78 | 78 | | ticipating provider and dispensing pharmacy are 17 |
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| 79 | 79 | | the same entity; 18 |
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| 80 | 80 | | ‘‘(B) a prescription issued that cannot be 19 |
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| 81 | 81 | | transmitted electronically under the most re-20 |
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| 82 | 82 | | cently implemented version of the National 21 |
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| 83 | 83 | | Council for Prescription Drug Programs 22 |
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| 84 | 84 | | SCRIPT Standard; 23 |
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| 85 | 85 | | ‘‘(C) a prescription issued by a partici-24 |
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| 86 | 86 | | pating provider who received a waiver (which 25 |
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| 87 | 87 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
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| 88 | 88 | | ssavage on LAPJG3WLY3PROD with BILLS 4 |
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| 89 | 89 | | •HR 7312 IH |
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| 90 | 90 | | may include a waiver obtained pursuant to sec-1 |
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| 91 | 91 | | tion 1860D–4(e)(7)(B)(iii) of the Social Secu-2 |
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| 92 | 92 | | rity Act) or a renewal thereof for a period of 3 |
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| 93 | 93 | | time as determined by the Secretary, the Sec-4 |
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| 94 | 94 | | retary of Labor, and the Secretary of the 5 |
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| 95 | 95 | | Treasury, not to exceed one year, from the re-6 |
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| 96 | 96 | | quirement to use electronic prescribing due to 7 |
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| 97 | 97 | | demonstrated economic hardship, technological 8 |
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| 98 | 98 | | limitations that are not reasonably within the 9 |
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| 99 | 99 | | control of the participating provider, or other 10 |
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| 100 | 100 | | exceptional circumstance demonstrated by the 11 |
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| 101 | 101 | | participating provider; 12 |
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| 102 | 102 | | ‘‘(D) a prescription issued by a partici-13 |
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| 103 | 103 | | pating provider under circumstances in which, 14 |
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| 104 | 104 | | notwithstanding the participating provider’s 15 |
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| 105 | 105 | | ability to submit a prescription electronically as 16 |
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| 106 | 106 | | required by this subsection, such participating 17 |
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| 107 | 107 | | provider reasonably determines that it would be 18 |
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| 108 | 108 | | impractical for the individual involved to obtain 19 |
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| 109 | 109 | | substances prescribed by electronic prescription 20 |
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| 110 | 110 | | in a timely manner, and such delay would ad-21 |
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| 111 | 111 | | versely impact the individual’s medical condition 22 |
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| 112 | 112 | | involved; 23 |
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| 114 | 114 | | ssavage on LAPJG3WLY3PROD with BILLS 5 |
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| 115 | 115 | | •HR 7312 IH |
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| 116 | 116 | | ‘‘(E) a prescription issued by a partici-1 |
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| 117 | 117 | | pating provider prescribing a drug under a re-2 |
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| 118 | 118 | | search protocol; 3 |
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| 119 | 119 | | ‘‘(F) a prescription issued by a partici-4 |
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| 120 | 120 | | pating provider for a drug for which the Food 5 |
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| 121 | 121 | | and Drug Administration requires a prescrip-6 |
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| 122 | 122 | | tion to contain elements that are not able to be 7 |
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| 123 | 123 | | included in electronic prescribing, such as a 8 |
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| 124 | 124 | | drug with risk evaluation and mitigation strate-9 |
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| 125 | 125 | | gies that include elements to assure safe use; 10 |
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| 126 | 126 | | ‘‘(G) a prescription issued for an individual 11 |
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| 127 | 127 | | who receives hospice care or for a resident of a 12 |
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| 128 | 128 | | nursing facility (as defined in section 1919(a) 13 |
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| 129 | 129 | | of the Social Security Act); 14 |
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| 130 | 130 | | ‘‘(H) a prescription issued under cir-15 |
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| 131 | 131 | | cumstances in which electronic prescribing is 16 |
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| 132 | 132 | | not available due to temporary technological or 17 |
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| 133 | 133 | | electrical failure, as specified jointly by the Sec-18 |
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| 134 | 134 | | retary, the Secretary of Labor, and the Sec-19 |
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| 135 | 135 | | retary of the Treasury through rulemaking; and 20 |
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| 136 | 136 | | ‘‘(I) a prescription issued by a partici-21 |
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| 137 | 137 | | pating provider allowing for the dispensing of a 22 |
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| 138 | 138 | | non-patient specific prescription pursuant to a 23 |
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| 139 | 139 | | standing order, approved protocol for drug ther-24 |
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| 140 | 140 | | apy, collaborative drug management, or com-25 |
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| 142 | 142 | | ssavage on LAPJG3WLY3PROD with BILLS 6 |
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| 143 | 143 | | •HR 7312 IH |
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| 144 | 144 | | prehensive medication management, in response 1 |
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| 145 | 145 | | to a public health emergency or other cir-2 |
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| 146 | 146 | | cumstances under which the participating pro-3 |
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| 147 | 147 | | vider may issue a non-patient specific prescrip-4 |
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| 148 | 148 | | tion. 5 |
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| 149 | 149 | | ‘‘(3) R |
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| 150 | 150 | | ULES OF CONSTRUCTION .— 6 |
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| 151 | 151 | | ‘‘(A) V |
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| 152 | 152 | | ERIFICATION.—Nothing in this sub-7 |
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| 153 | 153 | | section shall be construed as requiring a dis-8 |
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| 154 | 154 | | penser to verify that a participating provider, 9 |
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| 155 | 155 | | with respect to a prescription for a schedule II, 10 |
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| 156 | 156 | | III, IV, or V controlled substance that is a pre-11 |
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| 157 | 157 | | scription drug covered by a group health plan 12 |
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| 158 | 158 | | or group or individual health insurance cov-13 |
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| 159 | 159 | | erage offered by a health insurance issuer, has 14 |
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| 160 | 160 | | a waiver (or is otherwise exempt) under para-15 |
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| 161 | 161 | | graph (2) from the requirement under para-16 |
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| 162 | 162 | | graph (1). 17 |
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| 163 | 163 | | ‘‘(B) A |
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| 164 | 164 | | UTHORITY TO DISPENSE .—Nothing 18 |
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| 165 | 165 | | in this subsection shall be construed as affect-19 |
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| 166 | 166 | | ing the authority of a group health plan or 20 |
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| 167 | 167 | | group or individual health insurance coverage 21 |
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| 168 | 168 | | offered by a health insurance issuer to cover, or 22 |
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| 169 | 169 | | the authority of a dispenser to continue to dis-23 |
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| 170 | 170 | | pense, a prescription drug if the prescription 24 |
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| 171 | 171 | | for such drug is an otherwise valid written, 25 |
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| 173 | 173 | | ssavage on LAPJG3WLY3PROD with BILLS 7 |
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| 174 | 174 | | •HR 7312 IH |
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| 175 | 175 | | oral, or fax prescription that is consistent with 1 |
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| 176 | 176 | | applicable law. 2 |
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| 177 | 177 | | ‘‘(C) P |
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| 178 | 178 | | ATIENT CHOICE.—Nothing in this 3 |
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| 179 | 179 | | subsection shall be construed as affecting the 4 |
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| 180 | 180 | | ability of an individual who is a participant, 5 |
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| 181 | 181 | | beneficiary, or enrollee of a group health plan 6 |
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| 182 | 182 | | or group or individual health insurance cov-7 |
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| 183 | 183 | | erage offered by a health insurance issuer and 8 |
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| 184 | 184 | | who is prescribed a schedule II, III, IV, or V 9 |
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| 185 | 185 | | controlled substance that is a prescription drug 10 |
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| 186 | 186 | | covered by the plan or coverage to designate a 11 |
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| 187 | 187 | | particular dispenser to dispense a prescribed 12 |
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| 188 | 188 | | controlled substance to the extent consistent 13 |
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| 189 | 189 | | with the requirements under this subsection. 14 |
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| 190 | 190 | | ‘‘(4) R |
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| 191 | 191 | | EGULATIONS ON POLICY REQUIRE -15 |
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| 192 | 192 | | MENTS.—The Secretary, the Secretary of Labor, 16 |
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| 193 | 193 | | and the Secretary of the Treasury shall promulgate 17 |
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| 194 | 194 | | regulations specifying requirements for the policies 18 |
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| 195 | 195 | | established by group health plans and health insur-19 |
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| 196 | 196 | | ance issuers under paragraph (1). Such regulations 20 |
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| 197 | 197 | | shall include requirements for— 21 |
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| 198 | 198 | | ‘‘(A) a uniform process by which plans and 22 |
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| 199 | 199 | | issuers are required to set the e-prescribing re-23 |
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| 200 | 200 | | quirements; 24 |
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| 202 | 202 | | ssavage on LAPJG3WLY3PROD with BILLS 8 |
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| 203 | 203 | | •HR 7312 IH |
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| 204 | 204 | | ‘‘(B) a process by which plans and issuers 1 |
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| 205 | 205 | | are required to grant waivers and exceptions to 2 |
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| 206 | 206 | | participating providers pursuant to paragraph 3 |
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| 207 | 207 | | (2); and 4 |
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| 208 | 208 | | ‘‘(C) a mechanism for plans and issuers to 5 |
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| 209 | 209 | | recognize waivers issued to participating pro-6 |
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| 210 | 210 | | viders under part D of title XVIII of the Social 7 |
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| 211 | 211 | | Security Act, pursuant to paragraph (2)(C). 8 |
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| 212 | 212 | | ‘‘(5) P |
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| 213 | 213 | | ROHIBITIONS.—The policies established 9 |
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| 214 | 214 | | pursuant to paragraph (1) by a group health plan or 10 |
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| 215 | 215 | | health insurance issuer offering group or individual 11 |
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| 216 | 216 | | health insurance coverage may not— 12 |
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| 217 | 217 | | ‘‘(A) require dispensers of a schedule II, 13 |
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| 218 | 218 | | III, IV, or V controlled substance to confirm 14 |
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| 219 | 219 | | that the prescription for the controlled sub-15 |
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| 220 | 220 | | stance was electronically issued by a partici-16 |
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| 221 | 221 | | pating provider in accordance with such poli-17 |
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| 222 | 222 | | cies, as described in paragraph (1); 18 |
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| 223 | 223 | | ‘‘(B) require dispensers of such controlled 19 |
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| 224 | 224 | | substances to submit information or data be-20 |
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| 225 | 225 | | yond what is otherwise required to process a 21 |
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| 226 | 226 | | prescription drug claim in order to confirm a 22 |
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| 227 | 227 | | participating provider’s compliance with such 23 |
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| 228 | 228 | | policies; 24 |
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| 230 | 230 | | ssavage on LAPJG3WLY3PROD with BILLS 9 |
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| 231 | 231 | | •HR 7312 IH |
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| 232 | 232 | | ‘‘(C) reject, deny, or recoup reimbursement 1 |
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| 233 | 233 | | for a prescription drug claim based on the for-2 |
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| 234 | 234 | | mat in which the prescription was issued; or 3 |
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| 235 | 235 | | ‘‘(D) require a participating provider to 4 |
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| 236 | 236 | | use a specific vendor for electronic prescribing 5 |
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| 237 | 237 | | or a specific electronic prescribing product or 6 |
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| 238 | 238 | | system. 7 |
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| 239 | 239 | | ‘‘(6) A |
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| 240 | 240 | | TTESTATION OF COMPLIANCE .—Begin-8 |
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| 241 | 241 | | ning on January 1, 2026, each group health plan 9 |
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| 242 | 242 | | and health insurance issuer offering group or indi-10 |
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| 243 | 243 | | vidual health insurance coverage shall annually sub-11 |
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| 244 | 244 | | mit to the Secretary, the Secretary of Labor, and 12 |
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| 245 | 245 | | the Secretary of the Treasury an attestation of com-13 |
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| 246 | 246 | | pliance with the requirements of this subsection. 14 |
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| 247 | 247 | | ‘‘(7) C |
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| 248 | 248 | | ONSULTATION REQUIREMENT FOR RULE -15 |
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| 249 | 249 | | MAKING.—In promulgating regulations to carry out 16 |
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| 250 | 250 | | this subsection, the Secretary, the Secretary of the 17 |
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| 251 | 251 | | Labor, and the Secretary of the Treasury shall joint-18 |
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| 252 | 252 | | ly consult with dispensers of controlled substances, 19 |
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| 253 | 253 | | State insurance regulators, health insurance issuers 20 |
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| 254 | 254 | | offering group or individual health insurance cov-21 |
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| 255 | 255 | | erage, and health care practitioners.’’. 22 |
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| 256 | 256 | | (b) E |
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| 257 | 257 | | MPLOYEERETIREMENTINCOMESECURITYACT 23 |
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| 258 | 258 | | OF1974 AMENDMENT.—Section 722 of the Employee Re-24 |
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| 259 | 259 | | tirement Income Security Act of 1974 (29 U.S.C. 1185k) 25 |
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| 260 | 260 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
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| 261 | 261 | | ssavage on LAPJG3WLY3PROD with BILLS 10 |
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| 262 | 262 | | •HR 7312 IH |
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| 263 | 263 | | is amended by adding at the end the following new sub-1 |
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| 264 | 264 | | section: 2 |
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| 265 | 265 | | ‘‘(d) R |
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| 266 | 266 | | EQUIREMENTS FOR ELECTRONIC-PRE-3 |
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| 267 | 267 | | SCRIBING FORCONTROLLEDSUBSTANCES.— 4 |
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| 268 | 268 | | ‘‘(1) I |
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| 269 | 269 | | N GENERAL.—Except as provided pursu-5 |
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| 270 | 270 | | ant to paragraph (2), for plan years beginning on or 6 |
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| 271 | 271 | | after January 1, 2026, a group health plan and a 7 |
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| 272 | 272 | | health insurance issuer offering group health insur-8 |
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| 273 | 273 | | ance coverage, with respect to a participating pro-9 |
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| 274 | 274 | | vider, as defined in section 716(a)(3), shall have in 10 |
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| 275 | 275 | | place policies, subject to paragraphs (4) and (5), 11 |
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| 276 | 276 | | that require any prescription for a schedule II, III, 12 |
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| 277 | 277 | | IV, or V controlled substance (as defined by section 13 |
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| 278 | 278 | | 202 of the Controlled Substances Act) covered by 14 |
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| 279 | 279 | | the plan or coverage that is transmitted by such a 15 |
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| 280 | 280 | | participating provider for such a participant or bene-16 |
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| 281 | 281 | | ficiary be electronically transmitted consistent with 17 |
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| 282 | 282 | | standards established under paragraph (3) of section 18 |
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| 283 | 283 | | 1860D–4(e) of the Social Security Act, under an 19 |
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| 284 | 284 | | electronic prescription drug program that meets re-20 |
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| 285 | 285 | | quirements that are substantially similar (as jointly 21 |
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| 286 | 286 | | determined by the Secretary, the Secretary of 22 |
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| 287 | 287 | | Health and Human Services, and the Secretary of 23 |
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| 288 | 288 | | the Treasury) to the requirements of paragraph (2) 24 |
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| 289 | 289 | | of such section 1860D–4(e). 25 |
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| 291 | 291 | | ssavage on LAPJG3WLY3PROD with BILLS 11 |
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| 292 | 292 | | •HR 7312 IH |
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| 293 | 293 | | ‘‘(2) EXCEPTION FOR CERTAIN CIR -1 |
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| 294 | 294 | | CUMSTANCES.—The Secretary, the Secretary of 2 |
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| 295 | 295 | | Health and Human Services, and the Secretary of 3 |
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| 296 | 296 | | the Treasury shall jointly, through rulemaking, 4 |
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| 297 | 297 | | specify circumstances and processes by which the re-5 |
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| 298 | 298 | | quirement under paragraph (1) may be waived, with 6 |
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| 299 | 299 | | respect to a schedule II, III, IV, or V controlled sub-7 |
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| 300 | 300 | | stance that is a prescription drug covered by a group 8 |
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| 301 | 301 | | health plan or group health insurance coverage of-9 |
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| 302 | 302 | | fered by a health insurance issuer, including in the 10 |
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| 303 | 303 | | case of— 11 |
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| 304 | 304 | | ‘‘(A) a prescription issued when the par-12 |
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| 305 | 305 | | ticipating provider and dispensing pharmacy are 13 |
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| 306 | 306 | | the same entity; 14 |
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| 307 | 307 | | ‘‘(B) a prescription issued that cannot be 15 |
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| 308 | 308 | | transmitted electronically under the most re-16 |
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| 309 | 309 | | cently implemented version of the National 17 |
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| 310 | 310 | | Council for Prescription Drug Programs 18 |
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| 311 | 311 | | SCRIPT Standard; 19 |
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| 312 | 312 | | ‘‘(C) a prescription issued by a partici-20 |
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| 313 | 313 | | pating provider who received a waiver (which 21 |
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| 314 | 314 | | may include a waiver obtained pursuant to sec-22 |
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| 315 | 315 | | tion 1860D–4(e)(7)(B)(iii) of the Social Secu-23 |
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| 316 | 316 | | rity Act) or a renewal thereof for a period of 24 |
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| 317 | 317 | | time as determined by the Secretary, the Sec-25 |
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| 318 | 318 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
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| 319 | 319 | | ssavage on LAPJG3WLY3PROD with BILLS 12 |
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| 320 | 320 | | •HR 7312 IH |
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| 321 | 321 | | retary of Health and Human Services, and the 1 |
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| 322 | 322 | | Secretary of the Treasury, not to exceed one 2 |
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| 323 | 323 | | year, from the requirement to use electronic 3 |
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| 324 | 324 | | prescribing due to demonstrated economic hard-4 |
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| 325 | 325 | | ship, technological limitations that are not rea-5 |
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| 326 | 326 | | sonably within the control of the participating 6 |
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| 327 | 327 | | provider, or other exceptional circumstance 7 |
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| 328 | 328 | | demonstrated by the participating provider; 8 |
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| 329 | 329 | | ‘‘(D) a prescription issued by a partici-9 |
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| 330 | 330 | | pating provider under circumstances in which, 10 |
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| 331 | 331 | | notwithstanding the participating provider’s 11 |
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| 332 | 332 | | ability to submit a prescription electronically as 12 |
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| 333 | 333 | | required by this subsection, such participating 13 |
|---|
| 334 | 334 | | provider reasonably determines that it would be 14 |
|---|
| 335 | 335 | | impractical for the individual involved to obtain 15 |
|---|
| 336 | 336 | | substances prescribed by electronic prescription 16 |
|---|
| 337 | 337 | | in a timely manner, and such delay would ad-17 |
|---|
| 338 | 338 | | versely impact the individual’s medical condition 18 |
|---|
| 339 | 339 | | involved; 19 |
|---|
| 340 | 340 | | ‘‘(E) a prescription issued by a partici-20 |
|---|
| 341 | 341 | | pating provider prescribing a drug under a re-21 |
|---|
| 342 | 342 | | search protocol; 22 |
|---|
| 343 | 343 | | ‘‘(F) a prescription issued by a partici-23 |
|---|
| 344 | 344 | | pating provider for a drug for which the Food 24 |
|---|
| 345 | 345 | | and Drug Administration requires a prescrip-25 |
|---|
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| 347 | 347 | | ssavage on LAPJG3WLY3PROD with BILLS 13 |
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| 348 | 348 | | •HR 7312 IH |
|---|
| 349 | 349 | | tion to contain elements that are not able to be 1 |
|---|
| 350 | 350 | | included in electronic prescribing, such as a 2 |
|---|
| 351 | 351 | | drug with risk evaluation and mitigation strate-3 |
|---|
| 352 | 352 | | gies that include elements to assure safe use; 4 |
|---|
| 353 | 353 | | ‘‘(G) a prescription issued for an individual 5 |
|---|
| 354 | 354 | | who receives hospice care or for a resident of a 6 |
|---|
| 355 | 355 | | nursing facility (as defined in section 1919(a) 7 |
|---|
| 356 | 356 | | of the Social Security Act); 8 |
|---|
| 357 | 357 | | ‘‘(H) a prescription issued under cir-9 |
|---|
| 358 | 358 | | cumstances in which electronic prescribing is 10 |
|---|
| 359 | 359 | | not available due to temporary technological or 11 |
|---|
| 360 | 360 | | electrical failure, as specified jointly by the Sec-12 |
|---|
| 361 | 361 | | retary, the Secretary of Health and Human 13 |
|---|
| 362 | 362 | | Services, and the Secretary of the Treasury 14 |
|---|
| 363 | 363 | | through rulemaking; and 15 |
|---|
| 364 | 364 | | ‘‘(I) a prescription issued by a partici-16 |
|---|
| 365 | 365 | | pating provider allowing for the dispensing of a 17 |
|---|
| 366 | 366 | | non-patient specific prescription pursuant to a 18 |
|---|
| 367 | 367 | | standing order, approved protocol for drug ther-19 |
|---|
| 368 | 368 | | apy, collaborative drug management, or com-20 |
|---|
| 369 | 369 | | prehensive medication management, in response 21 |
|---|
| 370 | 370 | | to a public health emergency or other cir-22 |
|---|
| 371 | 371 | | cumstances under which the participating pro-23 |
|---|
| 372 | 372 | | vider may issue a non-patient specific prescrip-24 |
|---|
| 373 | 373 | | tion. 25 |
|---|
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| 375 | 375 | | ssavage on LAPJG3WLY3PROD with BILLS 14 |
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| 376 | 376 | | •HR 7312 IH |
|---|
| 377 | 377 | | ‘‘(3) RULES OF CONSTRUCTION .— 1 |
|---|
| 378 | 378 | | ‘‘(A) V |
|---|
| 379 | 379 | | ERIFICATION.—Nothing in this sub-2 |
|---|
| 380 | 380 | | section shall be construed as requiring a dis-3 |
|---|
| 381 | 381 | | penser to verify that a participating provider, 4 |
|---|
| 382 | 382 | | with respect to a prescription for a schedule II, 5 |
|---|
| 383 | 383 | | III, IV, or V controlled substance that is a pre-6 |
|---|
| 384 | 384 | | scription drug covered by a group health plan 7 |
|---|
| 385 | 385 | | or group or individual health insurance cov-8 |
|---|
| 386 | 386 | | erage offered by a health insurance issuer, has 9 |
|---|
| 387 | 387 | | a waiver (or is otherwise exempt) under para-10 |
|---|
| 388 | 388 | | graph (2) from the requirement under para-11 |
|---|
| 389 | 389 | | graph (1). 12 |
|---|
| 390 | 390 | | ‘‘(B) A |
|---|
| 391 | 391 | | UTHORITY TO DISPENSE .—Nothing 13 |
|---|
| 392 | 392 | | in this subsection shall be construed as affect-14 |
|---|
| 393 | 393 | | ing the authority of a group health plan or 15 |
|---|
| 394 | 394 | | group health insurance coverage offered by a 16 |
|---|
| 395 | 395 | | health insurance issuer to cover, or the author-17 |
|---|
| 396 | 396 | | ity of a dispenser to continue to dispense, a pre-18 |
|---|
| 397 | 397 | | scription drug if the prescription for such drug 19 |
|---|
| 398 | 398 | | is an otherwise valid written, oral, or fax pre-20 |
|---|
| 399 | 399 | | scription that is consistent with applicable law. 21 |
|---|
| 400 | 400 | | ‘‘(C) P |
|---|
| 401 | 401 | | ATIENT CHOICE.—Nothing in this 22 |
|---|
| 402 | 402 | | subsection shall be construed as affecting the 23 |
|---|
| 403 | 403 | | ability of an individual who is a participant or 24 |
|---|
| 404 | 404 | | beneficiary of a group health plan or group or 25 |
|---|
| 405 | 405 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
|---|
| 406 | 406 | | ssavage on LAPJG3WLY3PROD with BILLS 15 |
|---|
| 407 | 407 | | •HR 7312 IH |
|---|
| 408 | 408 | | individual health insurance coverage offered by 1 |
|---|
| 409 | 409 | | a health insurance issuer and who is prescribed 2 |
|---|
| 410 | 410 | | a schedule II, III, IV, or V controlled substance 3 |
|---|
| 411 | 411 | | that is a prescription drug covered by the plan 4 |
|---|
| 412 | 412 | | or coverage to designate a particular dispenser 5 |
|---|
| 413 | 413 | | to dispense a prescribed controlled substance to 6 |
|---|
| 414 | 414 | | the extent consistent with the requirements 7 |
|---|
| 415 | 415 | | under this subsection. 8 |
|---|
| 416 | 416 | | ‘‘(4) R |
|---|
| 417 | 417 | | EGULATIONS ON POLICY REQUIRE -9 |
|---|
| 418 | 418 | | MENTS.—The Secretary, the Secretary of Health 10 |
|---|
| 419 | 419 | | and Human Services, and the Secretary of the 11 |
|---|
| 420 | 420 | | Treasury shall promulgate regulations specifying re-12 |
|---|
| 421 | 421 | | quirements for the policies established by group 13 |
|---|
| 422 | 422 | | health plans and health insurance issuers under 14 |
|---|
| 423 | 423 | | paragraph (1). Such regulations shall include re-15 |
|---|
| 424 | 424 | | quirements for— 16 |
|---|
| 425 | 425 | | ‘‘(A) a uniform process by which plans and 17 |
|---|
| 426 | 426 | | issuers are required to set the e-prescribing re-18 |
|---|
| 427 | 427 | | quirements; 19 |
|---|
| 428 | 428 | | ‘‘(B) a process by which plans and issuers 20 |
|---|
| 429 | 429 | | are required to grant waivers and exceptions to 21 |
|---|
| 430 | 430 | | participating providers pursuant to paragraph 22 |
|---|
| 431 | 431 | | (2); and 23 |
|---|
| 432 | 432 | | ‘‘(C) a mechanism for plans and issuers to 24 |
|---|
| 433 | 433 | | recognize waivers issued to participating pro-25 |
|---|
| 434 | 434 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
|---|
| 435 | 435 | | ssavage on LAPJG3WLY3PROD with BILLS 16 |
|---|
| 436 | 436 | | •HR 7312 IH |
|---|
| 437 | 437 | | viders under part D of title XVIII of the Social 1 |
|---|
| 438 | 438 | | Security Act, pursuant to paragraph (2)(C). 2 |
|---|
| 439 | 439 | | ‘‘(5) P |
|---|
| 440 | 440 | | ROHIBITIONS.—The policies established 3 |
|---|
| 441 | 441 | | pursuant to paragraph (1) by a group health plan or 4 |
|---|
| 442 | 442 | | health insurance issuer offering group health insur-5 |
|---|
| 443 | 443 | | ance coverage may not— 6 |
|---|
| 444 | 444 | | ‘‘(A) require dispensers of a schedule II, 7 |
|---|
| 445 | 445 | | III, IV, or V controlled substance to confirm 8 |
|---|
| 446 | 446 | | that the prescription for the controlled sub-9 |
|---|
| 447 | 447 | | stance was electronically issued by a partici-10 |
|---|
| 448 | 448 | | pating provider in accordance with such poli-11 |
|---|
| 449 | 449 | | cies, as described in paragraph (1); 12 |
|---|
| 450 | 450 | | ‘‘(B) require dispensers of such controlled 13 |
|---|
| 451 | 451 | | substances to submit information or data be-14 |
|---|
| 452 | 452 | | yond what is otherwise required to process a 15 |
|---|
| 453 | 453 | | prescription drug claim in order to confirm a 16 |
|---|
| 454 | 454 | | participating provider’s compliance with such 17 |
|---|
| 455 | 455 | | policies; 18 |
|---|
| 456 | 456 | | ‘‘(C) reject, deny, or recoup reimbursement 19 |
|---|
| 457 | 457 | | for a prescription drug claim based on the for-20 |
|---|
| 458 | 458 | | mat in which the prescription was issued; or 21 |
|---|
| 459 | 459 | | ‘‘(D) require a participating provider to 22 |
|---|
| 460 | 460 | | use a specific vendor for electronic prescribing 23 |
|---|
| 461 | 461 | | or a specific electronic prescribing product or 24 |
|---|
| 462 | 462 | | system. 25 |
|---|
| 463 | 463 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
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| 464 | 464 | | ssavage on LAPJG3WLY3PROD with BILLS 17 |
|---|
| 465 | 465 | | •HR 7312 IH |
|---|
| 466 | 466 | | ‘‘(6) ATTESTATION OF COMPLIANCE .—Begin-1 |
|---|
| 467 | 467 | | ning on January 1, 2026, each group health plan 2 |
|---|
| 468 | 468 | | and health insurance issuer offering group health in-3 |
|---|
| 469 | 469 | | surance coverage shall annually submit to the Sec-4 |
|---|
| 470 | 470 | | retary, the Secretary of Health and Human Services, 5 |
|---|
| 471 | 471 | | and the Secretary of the Treasury an attestation of 6 |
|---|
| 472 | 472 | | compliance with the requirements of this subsection. 7 |
|---|
| 473 | 473 | | ‘‘(7) C |
|---|
| 474 | 474 | | ONSULTATION REQUIREMENT FOR RULE -8 |
|---|
| 475 | 475 | | MAKING.—In promulgating regulations to carry out 9 |
|---|
| 476 | 476 | | this subsection, the Secretary, the Secretary of 10 |
|---|
| 477 | 477 | | Health and Human Services, and the Secretary of 11 |
|---|
| 478 | 478 | | the Treasury shall jointly consult with dispensers of 12 |
|---|
| 479 | 479 | | controlled substances, State insurance regulators, 13 |
|---|
| 480 | 480 | | health insurance issuers offering group or individual 14 |
|---|
| 481 | 481 | | health insurance coverage, and health care practi-15 |
|---|
| 482 | 482 | | tioners.’’. 16 |
|---|
| 483 | 483 | | (c) I |
|---|
| 484 | 484 | | NTERNALREVENUECODE OF1986 AMEND-17 |
|---|
| 485 | 485 | | MENT.—Section 9822 of the Internal Revenue Code of 18 |
|---|
| 486 | 486 | | 1986 is amended by adding at the end the following new 19 |
|---|
| 487 | 487 | | subsection: 20 |
|---|
| 488 | 488 | | ‘‘(d) R |
|---|
| 489 | 489 | | EQUIREMENTS FOR ELECTRONIC-PRE-21 |
|---|
| 490 | 490 | | SCRIBING FORCONTROLLEDSUBSTANCES.— 22 |
|---|
| 491 | 491 | | ‘‘(1) I |
|---|
| 492 | 492 | | N GENERAL.—Except as provided pursu-23 |
|---|
| 493 | 493 | | ant to paragraph (2), for plan years beginning on or 24 |
|---|
| 494 | 494 | | after January 1, 2026, a group health plan, with re-25 |
|---|
| 495 | 495 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
|---|
| 496 | 496 | | ssavage on LAPJG3WLY3PROD with BILLS 18 |
|---|
| 497 | 497 | | •HR 7312 IH |
|---|
| 498 | 498 | | spect to a participating provider, as defined in sec-1 |
|---|
| 499 | 499 | | tion 9816(a)(3), shall have in place policies, subject 2 |
|---|
| 500 | 500 | | to paragraphs (4) and (5), that require any prescrip-3 |
|---|
| 501 | 501 | | tion for a schedule II, III, IV, or V controlled sub-4 |
|---|
| 502 | 502 | | stance (as defined by section 202 of the Controlled 5 |
|---|
| 503 | 503 | | Substances Act) covered by the plan that is trans-6 |
|---|
| 504 | 504 | | mitted by such a participating provider for such a 7 |
|---|
| 505 | 505 | | participant or beneficiary be electronically trans-8 |
|---|
| 506 | 506 | | mitted consistent with standards established under 9 |
|---|
| 507 | 507 | | paragraph (3) of section 1860D–4(e) of the Social 10 |
|---|
| 508 | 508 | | Security Act, under an electronic prescription drug 11 |
|---|
| 509 | 509 | | program that meets requirements that are substan-12 |
|---|
| 510 | 510 | | tially similar (as jointly determined by the Secretary, 13 |
|---|
| 511 | 511 | | the Secretary of Health and Human Services, and 14 |
|---|
| 512 | 512 | | the Secretary of Labor) to the requirements of para-15 |
|---|
| 513 | 513 | | graph (2) of such section 1860D–4(e). 16 |
|---|
| 514 | 514 | | ‘‘(2) E |
|---|
| 515 | 515 | | XCEPTION FOR CERTAIN CIR -17 |
|---|
| 516 | 516 | | CUMSTANCES.—The Secretary, the Secretary of 18 |
|---|
| 517 | 517 | | Health and Human Services, and the Secretary of 19 |
|---|
| 518 | 518 | | Labor shall jointly, through rulemaking, specify cir-20 |
|---|
| 519 | 519 | | cumstances and processes by which the requirement 21 |
|---|
| 520 | 520 | | under paragraph (1) may be waived, with respect to 22 |
|---|
| 521 | 521 | | a schedule II, III, IV, or V controlled substance that 23 |
|---|
| 522 | 522 | | is a prescription drug covered by a group health, in-24 |
|---|
| 523 | 523 | | cluding in the case of— 25 |
|---|
| 524 | 524 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
|---|
| 525 | 525 | | ssavage on LAPJG3WLY3PROD with BILLS 19 |
|---|
| 526 | 526 | | •HR 7312 IH |
|---|
| 527 | 527 | | ‘‘(A) a prescription issued when the par-1 |
|---|
| 528 | 528 | | ticipating provider and dispensing pharmacy are 2 |
|---|
| 529 | 529 | | the same entity; 3 |
|---|
| 530 | 530 | | ‘‘(B) a prescription issued that cannot be 4 |
|---|
| 531 | 531 | | transmitted electronically under the most re-5 |
|---|
| 532 | 532 | | cently implemented version of the National 6 |
|---|
| 533 | 533 | | Council for Prescription Drug Programs 7 |
|---|
| 534 | 534 | | SCRIPT Standard; 8 |
|---|
| 535 | 535 | | ‘‘(C) a prescription issued by a partici-9 |
|---|
| 536 | 536 | | pating provider who received a waiver (which 10 |
|---|
| 537 | 537 | | may include a waiver obtained pursuant to sec-11 |
|---|
| 538 | 538 | | tion 1860D–4(e)(7)(B)(iii) of the Social Secu-12 |
|---|
| 539 | 539 | | rity Act) or a renewal thereof for a period of 13 |
|---|
| 540 | 540 | | time as determined by the Secretary, the Sec-14 |
|---|
| 541 | 541 | | retary of Health and Human Services, and the 15 |
|---|
| 542 | 542 | | Secretary of Labor, not to exceed one year, 16 |
|---|
| 543 | 543 | | from the requirement to use electronic pre-17 |
|---|
| 544 | 544 | | scribing due to demonstrated economic hard-18 |
|---|
| 545 | 545 | | ship, technological limitations that are not rea-19 |
|---|
| 546 | 546 | | sonably within the control of the participating 20 |
|---|
| 547 | 547 | | provider, or other exceptional circumstance 21 |
|---|
| 548 | 548 | | demonstrated by the participating provider; 22 |
|---|
| 549 | 549 | | ‘‘(D) a prescription issued by a partici-23 |
|---|
| 550 | 550 | | pating provider under circumstances in which, 24 |
|---|
| 551 | 551 | | notwithstanding the participating provider’s 25 |
|---|
| 552 | 552 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
|---|
| 553 | 553 | | ssavage on LAPJG3WLY3PROD with BILLS 20 |
|---|
| 554 | 554 | | •HR 7312 IH |
|---|
| 555 | 555 | | ability to submit a prescription electronically as 1 |
|---|
| 556 | 556 | | required by this subsection, such participating 2 |
|---|
| 557 | 557 | | provider reasonably determines that it would be 3 |
|---|
| 558 | 558 | | impractical for the individual involved to obtain 4 |
|---|
| 559 | 559 | | substances prescribed by electronic prescription 5 |
|---|
| 560 | 560 | | in a timely manner, and such delay would ad-6 |
|---|
| 561 | 561 | | versely impact the individual’s medical condition 7 |
|---|
| 562 | 562 | | involved; 8 |
|---|
| 563 | 563 | | ‘‘(E) a prescription issued by a partici-9 |
|---|
| 564 | 564 | | pating provider prescribing a drug under a re-10 |
|---|
| 565 | 565 | | search protocol; 11 |
|---|
| 566 | 566 | | ‘‘(F) a prescription issued by a partici-12 |
|---|
| 567 | 567 | | pating provider for a drug for which the Food 13 |
|---|
| 568 | 568 | | and Drug Administration requires a prescrip-14 |
|---|
| 569 | 569 | | tion to contain elements that are not able to be 15 |
|---|
| 570 | 570 | | included in electronic prescribing, such as a 16 |
|---|
| 571 | 571 | | drug with risk evaluation and mitigation strate-17 |
|---|
| 572 | 572 | | gies that include elements to assure safe use; 18 |
|---|
| 573 | 573 | | ‘‘(G) a prescription issued for an individual 19 |
|---|
| 574 | 574 | | who receives hospice care or for a resident of a 20 |
|---|
| 575 | 575 | | nursing facility (as defined in section 1919(a) 21 |
|---|
| 576 | 576 | | of the Social Security Act); 22 |
|---|
| 577 | 577 | | ‘‘(H) a prescription issued under cir-23 |
|---|
| 578 | 578 | | cumstances in which electronic prescribing is 24 |
|---|
| 579 | 579 | | not available due to temporary technological or 25 |
|---|
| 580 | 580 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
|---|
| 581 | 581 | | ssavage on LAPJG3WLY3PROD with BILLS 21 |
|---|
| 582 | 582 | | •HR 7312 IH |
|---|
| 583 | 583 | | electrical failure, as specified jointly by the Sec-1 |
|---|
| 584 | 584 | | retary, the Secretary of Health and Human 2 |
|---|
| 585 | 585 | | Services, and the Secretary of Labor through 3 |
|---|
| 586 | 586 | | rulemaking; and 4 |
|---|
| 587 | 587 | | ‘‘(I) a prescription issued by a partici-5 |
|---|
| 588 | 588 | | pating provider allowing for the dispensing of a 6 |
|---|
| 589 | 589 | | non-patient specific prescription pursuant to a 7 |
|---|
| 590 | 590 | | standing order, approved protocol for drug ther-8 |
|---|
| 591 | 591 | | apy, collaborative drug management, or com-9 |
|---|
| 592 | 592 | | prehensive medication management, in response 10 |
|---|
| 593 | 593 | | to a public health emergency or other cir-11 |
|---|
| 594 | 594 | | cumstances under which the participating pro-12 |
|---|
| 595 | 595 | | vider may issue a non-patient specific prescrip-13 |
|---|
| 596 | 596 | | tion. 14 |
|---|
| 597 | 597 | | ‘‘(3) R |
|---|
| 598 | 598 | | ULES OF CONSTRUCTION .— 15 |
|---|
| 599 | 599 | | ‘‘(A) V |
|---|
| 600 | 600 | | ERIFICATION.—Nothing in this sub-16 |
|---|
| 601 | 601 | | section shall be construed as requiring a dis-17 |
|---|
| 602 | 602 | | penser to verify that a participating provider, 18 |
|---|
| 603 | 603 | | with respect to a prescription for a schedule II, 19 |
|---|
| 604 | 604 | | III, IV, or V controlled substance that is a pre-20 |
|---|
| 605 | 605 | | scription drug covered by a group health plan, 21 |
|---|
| 606 | 606 | | has a waiver (or is otherwise exempt) under 22 |
|---|
| 607 | 607 | | paragraph (2) from the requirement under 23 |
|---|
| 608 | 608 | | paragraph (1). 24 |
|---|
| 609 | 609 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
|---|
| 610 | 610 | | ssavage on LAPJG3WLY3PROD with BILLS 22 |
|---|
| 611 | 611 | | •HR 7312 IH |
|---|
| 612 | 612 | | ‘‘(B) AUTHORITY TO DISPENSE .—Nothing 1 |
|---|
| 613 | 613 | | in this subsection shall be construed as affect-2 |
|---|
| 614 | 614 | | ing the ability of a group health plan to cover, 3 |
|---|
| 615 | 615 | | or the ability of a dispenser to continue to dis-4 |
|---|
| 616 | 616 | | pense, a prescription drug if the prescription 5 |
|---|
| 617 | 617 | | for such drug is an otherwise valid written, 6 |
|---|
| 618 | 618 | | oral, or fax prescription that is consistence with 7 |
|---|
| 619 | 619 | | applicable laws and regulations. 8 |
|---|
| 620 | 620 | | ‘‘(C) P |
|---|
| 621 | 621 | | ATIENT CHOICE.—Nothing in this 9 |
|---|
| 622 | 622 | | subsection shall be construed as affecting the 10 |
|---|
| 623 | 623 | | ability of an individual who is a participant or 11 |
|---|
| 624 | 624 | | beneficiary of a group health plan and who is 12 |
|---|
| 625 | 625 | | prescribed a schedule II, III, IV, or V con-13 |
|---|
| 626 | 626 | | trolled substance that is a prescription drug 14 |
|---|
| 627 | 627 | | covered by the plan to designate a particular 15 |
|---|
| 628 | 628 | | dispenser to dispense a prescribed controlled 16 |
|---|
| 629 | 629 | | substance to the extent consistent with the re-17 |
|---|
| 630 | 630 | | quirements under this subsection. 18 |
|---|
| 631 | 631 | | ‘‘(4) R |
|---|
| 632 | 632 | | EGULATIONS ON POLICY REQUIRE -19 |
|---|
| 633 | 633 | | MENTS.—The Secretary, the Secretary of Health 20 |
|---|
| 634 | 634 | | and Human Services, and the Secretary of Labor 21 |
|---|
| 635 | 635 | | shall promulgate regulations specifying requirements 22 |
|---|
| 636 | 636 | | for the policies established by group health plans 23 |
|---|
| 637 | 637 | | under paragraph (1). Such regulations shall include 24 |
|---|
| 638 | 638 | | requirements for— 25 |
|---|
| 639 | 639 | | VerDate Sep 11 2014 22:16 Feb 22, 2024 Jkt 049200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\H7312.IH H7312 |
|---|
| 640 | 640 | | ssavage on LAPJG3WLY3PROD with BILLS 23 |
|---|
| 641 | 641 | | •HR 7312 IH |
|---|
| 642 | 642 | | ‘‘(A) a uniform process by which plans are 1 |
|---|
| 643 | 643 | | required to set the e-prescribing requirements; 2 |
|---|
| 644 | 644 | | ‘‘(B) a process by which plans are required 3 |
|---|
| 645 | 645 | | to grant waivers and exceptions to participating 4 |
|---|
| 646 | 646 | | providers pursuant to paragraph (2); and 5 |
|---|
| 647 | 647 | | ‘‘(C) a mechanism for plans to recognize 6 |
|---|
| 648 | 648 | | waivers issued to participating providers under 7 |
|---|
| 649 | 649 | | part D of title XVIII of the Public Health Serv-8 |
|---|
| 650 | 650 | | ice Act, pursuant to paragraph (2)(C). 9 |
|---|
| 651 | 651 | | ‘‘(5) P |
|---|
| 652 | 652 | | ROHIBITIONS.—The policies established 10 |
|---|
| 653 | 653 | | pursuant to paragraph (1) by a group health plan 11 |
|---|
| 654 | 654 | | may not— 12 |
|---|
| 655 | 655 | | ‘‘(A) require dispensers of a schedule II, 13 |
|---|
| 656 | 656 | | III, IV, or V controlled substance to confirm 14 |
|---|
| 657 | 657 | | that the prescription for the controlled sub-15 |
|---|
| 658 | 658 | | stance was electronically issued by a partici-16 |
|---|
| 659 | 659 | | pating provider in accordance with such poli-17 |
|---|
| 660 | 660 | | cies, as described in paragraph (1); 18 |
|---|
| 661 | 661 | | ‘‘(B) require dispensers of such controlled 19 |
|---|
| 662 | 662 | | substances to submit information or data be-20 |
|---|
| 663 | 663 | | yond what is otherwise required to process a 21 |
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| 664 | 664 | | prescription drug claim in order to confirm a 22 |
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| 665 | 665 | | participating provider’s compliance with such 23 |
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| 666 | 666 | | policies; 24 |
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| 668 | 668 | | ssavage on LAPJG3WLY3PROD with BILLS 24 |
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| 669 | 669 | | •HR 7312 IH |
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| 670 | 670 | | ‘‘(C) reject, deny, or recoup reimbursement 1 |
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| 671 | 671 | | for a prescription drug claim based on the for-2 |
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| 672 | 672 | | mat in which the prescription was issued; or 3 |
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| 673 | 673 | | ‘‘(D) require a participating provider to 4 |
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| 674 | 674 | | use a specific vendor for electronic prescribing 5 |
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| 675 | 675 | | or a specific electronic prescribing product or 6 |
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| 676 | 676 | | system. 7 |
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| 677 | 677 | | ‘‘(6) A |
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| 678 | 678 | | TTESTATION OF COMPLIANCE .—Begin-8 |
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| 679 | 679 | | ning on January 1, 2026, each group health plan 9 |
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| 680 | 680 | | shall annually submit to the Secretary, the Secretary 10 |
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| 681 | 681 | | of Health and Human Services, and the Secretary of 11 |
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| 682 | 682 | | Labor an attestation of compliance with the require-12 |
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| 683 | 683 | | ments of this subsection. 13 |
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| 684 | 684 | | ‘‘(7) C |
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| 685 | 685 | | ONSULTATION REQUIREMENT FOR RULE -14 |
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| 686 | 686 | | MAKING.—In promulgating regulations to carry out 15 |
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| 687 | 687 | | this subsection, the Secretary, the Secretary of 16 |
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| 688 | 688 | | Health and Human Services, and the Secretary of 17 |
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| 689 | 689 | | Labor shall jointly consult with dispensers of con-18 |
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| 690 | 690 | | trolled substances, State insurance regulators, health 19 |
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| 691 | 691 | | insurance issuers offering group or individual health 20 |
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| 692 | 692 | | insurance coverage, and health care practitioners.’’. 21 |
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| 693 | 693 | | (d) U |
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| 694 | 694 | | PDATE OFBIOMETRICCOMPONENT OFMULTI-22 |
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| 695 | 695 | | FACTORAUTHENTICATION.—Not later than 1 year after 23 |
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| 696 | 696 | | the date of enactment of this Act, the Attorney General 24 |
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| 697 | 697 | | shall finalize a regulation updating the requirements for 25 |
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| 699 | 699 | | ssavage on LAPJG3WLY3PROD with BILLS 25 |
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| 700 | 700 | | •HR 7312 IH |
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| 701 | 701 | | the biometric component of multifactor authentication 1 |
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| 702 | 702 | | with respect to electronic prescriptions of controlled sub-2 |
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| 703 | 703 | | stances, as required under section 2003(c) of the SUP-3 |
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| 704 | 704 | | PORT for Patients and Community Act (Public Law 115– 4 |
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| 705 | 705 | | 271). 5 |
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| 706 | 706 | | Æ |
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| 708 | 708 | | ssavage on LAPJG3WLY3PROD with BILLS |
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