Matt’s Act

I 116TH CONGRESS 2D SESSION H. R. 7722 To limit the price of insulin drugs accessible for participants, beneficiaries, and enrollees enrolled in group or individual health insurance coverage and group health plans and for uninsured individuals who have diabetes, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JULY 22, 2020 Mr. FORTENBERRY (for himself and Ms. CRAIG) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee con- cerned A BILL To limit the price of insulin drugs accessible for participants, beneficiaries, and enrollees enrolled in group or individual health insurance coverage and group health plans and for uninsured individuals who have diabetes, and for other purposes. 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 ‘‘Matt’s Act’’. 4 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 7722 IH SEC. 2. INSULIN NET PRICE PROTECTION. 1 (a) PUBLISHING OF NET PRICE BY MANUFACTUR- 2 ERS.— 3 (1) IN GENERAL.—A manufacturer of an insu- 4 lin drug shall, on a quarterly basis, publish on the 5 internet website of such manufacturer the average 6 net price of each such insulin drug for the preceding 7 calendar quarter. 8 (2) ENFORCEMENT.—In the case that a manu- 9 facturer of an insulin drug fails to comply with para- 10 graph (1), a Federal agency or program may not 11 make payment for such insulin drug of such until 12 such manufacturer complies with such paragraph. 13 (b) NET PRICE FOR INSULIN DRUGS FOR CERTAIN 14 INDIVIDUALS.— 15 (1) APPLICATION TO PHSA PLANS.—Subpart 1 16 of part A of the Public Health Service Act (42 17 U.S.C. 300gg et seq.) is amended by adding at the 18 end the following new section: 19 ‘‘SEC. 2730. NET PRICE FOR INSULIN DRUGS. 20 ‘‘(a) AVAILABILITY OF NET PRICE.—With respect to 21 plan years beginning on and after January 1, 2021, a 22 health insurance issuer offering group or individual health 23 insurance coverage shall provide a participant, beneficiary, 24 or enrollee who has diabetes access to an insulin drug at— 25 ‘‘(1) the lesser of— 26 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 7722 IH ‘‘(A) the 10 percent of the average net 1 price for such drug published pursuant to sec- 2 tion 2(a) of Matt’s Act, plus the average 3 charges for distribution and dispensing de- 4 scribed in subsection (c) for such drug; 5 ‘‘(B) the coinsurance amount for an insu- 6 lin drug under the health insurance coverage 7 under which such an individual is a participant, 8 beneficiary, or enrollee would otherwise be re- 9 sponsible notwithstanding this section; or 10 ‘‘(C) $20; or 11 ‘‘(2) $0, in the case such a participant, bene- 12 ficiary, or enrollee is enrolled in a high deductible 13 health plan (as defined in section 223(c)(2) of the 14 Internal Revenue Code of 1986). 15 ‘‘(b) WAIVER OF DEDUCTIBLE.—In applying sub- 16 section (a), such a participant, beneficiary, or enrollee 17 shall have access to an insulin drug without regard to a 18 deductible. 19 ‘‘(c) CHARGES FOR DISTRIBUTING AND DIS- 20 PENSING.— 21 ‘‘(1) IN GENERAL.—For purposes of subsection 22 (a), charges for distribution and dispensing de- 23 scribed in this subsection— 24 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 7722 IH ‘‘(A) are charges associated with the trans- 1 actions, with respect to an insulin drug, be- 2 tween wholesalers, distributors, retailers, and 3 pharmacies; and 4 ‘‘(B) may not exceed 10 percent of the av- 5 erage net price of such an insulin drug. 6 ‘‘(2) REPORTING REQUIREMENT FOR PLANS.— 7 In the case that a health insurance issuer offering 8 group or individual health insurance coverage 9 charges a participant, beneficiary, or enrollee for av- 10 erage charges for distribution and dispensing pursu- 11 ant to subsection (a)(1), the health insurance issuer 12 shall submit to the Inspector General of the Depart- 13 ment of Health and Human Services information 14 with respect to such charges and the amount of the 15 charges. 16 ‘‘(3) REPORT TO CONGRESS BY INSPECTOR 17 GENERAL.—Beginning January 1, 2022, and annu- 18 ally thereafter, the Inspector General shall review 19 the charges described in paragraph (2) and submit 20 to Congress a report on such on review. 21 ‘‘(d) DEFINITIONS.—In this section: 22 ‘‘(1) INSULIN.— 23 ‘‘(A) IN GENERAL.—The term ‘insulin’ 24 means a prescription drug containing insulin 25 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 7722 IH that is approved by the Food and Drug Admin- 1 istration to improve glycemic control in patients 2 with diabetes mellitus (and may include any 3 medical supplies included with such drug or as- 4 sociated with the injection of such drug). 5 ‘‘(B) EXCLUSION.—Such term does not in- 6 clude any medical supplies that provides for the 7 monitoring of insulin levels. 8 ‘‘(2) LIST PRICE.—The term ‘list price’ has the 9 meaning given the term wholesale acquisition cost in 10 section 1847A(c)(6)(B) of the Social Security Act. 11 ‘‘(3) NET PRICE.—The term ‘net price’ means, 12 with respect to prescription drug coverage under 13 group or individual health insurance coverage of- 14 fered by a health insurance issuer, the list price of 15 the drug net all rebates, discounts, concessions, and 16 other adjustments applied to the cost paid by the 17 health insurance issuer, or by any other entity that 18 provides pharmacy benefit management services 19 under a contract with any such health insurance 20 issuer, regardless of whether such adjustments are 21 prospective or retrospective. 22 ‘‘(4) PRESCRIPTION DRUG.—The term ‘pre- 23 scription drug’ mean a drug, as defined in section 24 201(g) of the Federal Food, Drug, and Cosmetic 25 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 7722 IH Act, that is subject to section 503(b)(1) of such 1 Act.’’. 2 (2) APPLICATION TO ERISA PLANS.—Subpart A 3 of part 7 of the Employee Retirement Income Secu- 4 rity Act of 1974 (29 U.S.C. 1185 et seq.) is amend- 5 ed by adding at the end the following new section 6 (and amending the table of contents accordingly): 7 ‘‘SEC. 704. NET PRICE FOR INSULIN DRUGS. 8 ‘‘(a) AVAILABILITY OF NET PRICE.—With respect to 9 plan years beginning on and after January 1, 2021, a 10 group health plan shall provide a participant, beneficiary, 11 or enrollee who has diabetes access to an insulin drug at— 12 ‘‘(1) the lesser of— 13 ‘‘(A) the 10 percent of the average net 14 price for such drug published pursuant to sec- 15 tion 2(a) of Matt’s Act, plus the average 16 charges for distribution and dispensing de- 17 scribed in subsection (c) for such drug; 18 ‘‘(B) the coinsurance amount for an insu- 19 lin drug under the group health plan which 20 such an individual is a participant, beneficiary, 21 or enrollee would otherwise be responsible not- 22 withstanding this section; or 23 ‘‘(C) $20; or 24 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 7722 IH ‘‘(2) $0, in the case such a participant, bene- 1 ficiary, or enrollee is enrolled in a high deductible 2 health plan (as defined in section 223(c)(2) of the 3 Internal Revenue Code of 1986). 4 ‘‘(b) WAIVER OF DEDUCTIBLE.—In applying sub- 5 section (a), such a participant, beneficiary, or enrollee 6 shall have access to an insulin drug without regard to a 7 deductible. 8 ‘‘(c) CHARGES FOR DISTRIBUTING AND DIS- 9 PENSING.— 10 ‘‘(1) IN GENERAL.—For purposes of subsection 11 (a), charges for distribution and dispensing de- 12 scribed in this subsection— 13 ‘‘(A) are charges associated with the trans- 14 actions, with respect to an insulin drug, be- 15 tween wholesalers, distributors, retailers, and 16 pharmacies; and 17 ‘‘(B) may not exceed 10 percent of the av- 18 erage net price of such an insulin drug. 19 ‘‘(2) REPORTING REQUIREMENT FOR PLANS.— 20 In the case that a group health plan charges a par- 21 ticipant, beneficiary, or enrollee for average charges 22 for distribution and dispensing pursuant to sub- 23 section (a)(1), the group health plan shall submit to 24 the Inspector General of the Department of Health 25 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 7722 IH and Human Services information with respect to 1 such charges and the amount of the charges. 2 ‘‘(3) REPORT TO CONGRESS BY INSPECTOR 3 GENERAL.—Beginning January 1, 2022, and annu- 4 ally thereafter, the Inspector General shall review 5 the charges described in paragraph (2) and submit 6 to Congress a report on such on review. 7 ‘‘(d) DEFINITIONS.—In this section: 8 ‘‘(1) INSULIN.— 9 ‘‘(A) IN GENERAL.—The term ‘insulin’ 10 means a prescription drug containing insulin 11 that is approved by the Food and Drug Admin- 12 istration to improve glycemic control in patients 13 with diabetes mellitus (and may include any 14 medical supplies included with such drug or as- 15 sociated with the injection of such drug). 16 ‘‘(B) EXCLUSION.—Such term does not in- 17 clude any medical supplies that provides for the 18 monitoring of insulin levels. 19 ‘‘(2) LIST PRICE.—The term ‘list price’ has the 20 meaning given the term wholesale acquisition cost in 21 section 1847A(c)(6)(B) of the Social Security Act. 22 ‘‘(3) NET PRICE.—The term ‘net price’ means, 23 with respect to prescription drug coverage under a 24 group health plan, the list price of the drug net all 25 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 7722 IH rebates, discounts, concessions, and other adjust- 1 ments applied to the cost paid by the group health 2 plan, or by any other entity that provides pharmacy 3 benefit management services under a contract with 4 any such group health plan, regardless of whether 5 such adjustments are prospective or retrospective. 6 ‘‘(4) PRESCRIPTION DRUG.—The term ‘pre- 7 scription drug’ mean a drug, as defined in section 8 201(g) of the Federal Food, Drug, and Cosmetic 9 Act, that is subject to section 503(b)(1) of such 10 Act.’’. 11 (3) UNINSURED INDIVIDUALS.— 12 (A) IN GENERAL.—Beginning on and after 13 January 1, 2021, a pharmacy shall provide to 14 any individual who has diabetes and is not en- 15 rolled in any health plan access to an insulin 16 drug at the average net price for such drug 17 published pursuant to subsection (a), plus the 18 average charges for the distribution and dis- 19 pensing described in subparagraph (C) for such 20 drug. 21 (B) REVIEW OF CHARGES.—Beginning 22 January 1, 2022, and annually thereafter, the 23 Inspector General of the Department of Health 24 and Human Services shall review the amount of 25 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 7722 IH charges paid by an individual described in sub- 1 paragraph (A) and submit to Congress a report 2 on such review. 3 (C) CHARGES FOR DISTRIBUTING AND DIS- 4 PENSING.—For purposes of subparagraph (A), 5 charges for distribution and dispensing de- 6 scribed in this subsection— 7 (i) are charges associated with the 8 transactions, with respect to an insulin 9 drug, between wholesalers, distributors, re- 10 tailers, and pharmacies; and 11 (ii) may not exceed 10 percent of the 12 average net price of such an insulin drug. 13 (D) DEFINITIONS.—In this section: 14 (i) INSULIN.— 15 (I) IN GENERAL.—The term ‘‘in- 16 sulin’’ means a prescription drug con- 17 taining insulin that is approved by the 18 Food and Drug Administration to im- 19 prove glycemic control in patients with 20 diabetes mellitus (and may include 21 any medical supplies included with 22 such drug or associated with the in- 23 jection of such drug). 24 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 7722 IH (II) EXCLUSION.—Such term 1 does not include any medical supplies 2 that provides for the monitoring of in- 3 sulin levels. 4 (ii) LIST PRICE.—The term ‘‘list 5 price’’ has the meaning given the term 6 wholesale acquisition cost in section 7 1847A(c)(6)(B) of the Social Security Act 8 (42 U.S.C. 1395w–3a(c)(6)(B)). 9 (iii) NET PRICE.—The term ‘‘net 10 price’’ means, with respect to prescription 11 drug coverage under a group health plan, 12 the list price of the drug net all rebates, 13 discounts, concessions, and other adjust- 14 ments applied to the cost paid by the 15 group health plan, or by any other entity 16 that provides pharmacy benefit manage- 17 ment services under a contract with any 18 such group health plan, regardless of 19 whether such adjustments are prospective 20 or retrospective. 21 (iv) PRESCRIPTION DRUG.—The term 22 ‘‘prescription drug’’ mean a drug, as de- 23 fined in section 201(g) of the Federal 24 Food, Drug, and Cosmetic Act (21 U.S.C. 25 VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 7722 IH 321(g)), that is subject to section 1 503(b)(1) of such Act (21 U.S.C. 2 353(b)(1)). 3 Æ VerDate Sep 11 2014 04:25 Aug 10, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\H7722.IH H7722 kjohnson on DSK79L0C42PROD with BILLS