Addiction Prevention and Responsible Opioid Practices Act

II 116TH CONGRESS 2D SESSION S. 4242 To establish programs related to prevention of prescription opioid misuse, and for other purposes. IN THE SENATE OF THE UNITED STATES JULY 21, 2020 Mr. DURBIN introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To establish programs related to prevention of prescription opioid misuse, 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 the ‘‘Addiction Prevention 4 and Responsible Opioid Practices Act’’. 5 SEC. 2. EXCISE TAX ON OPIOID PAIN RELIEVERS. 6 (a) IN GENERAL.—Subchapter E of chapter 32 of the 7 Internal Revenue Code of 1986 is amended by adding at 8 the end the following new section: 9 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 4242 IS ‘‘SEC. 4192. OPIOID PAIN RELIEVERS. 1 ‘‘(a) IN GENERAL.—There is hereby imposed on the 2 manufacturer or producer of any taxable active opioid a 3 tax equal to the amount determined under subsection (b). 4 ‘‘(b) AMOUNT DETERMINED.—The amount deter- 5 mined under this subsection with respect to a manufac- 6 turer or producer for a calendar year is 1 cent per milli- 7 gram of taxable active opioid in the production or manu- 8 facturing quota determined for such manufacturer or pro- 9 ducer for the calendar year under section 306 of the Con- 10 trolled Substances Act (21 U.S.C. 826). 11 ‘‘(c) TAXABLE ACTIVE OPIOID.—For purposes of this 12 section— 13 ‘‘(1) IN GENERAL.—The term ‘taxable active 14 opioid’ means any controlled substance (as defined 15 in section 102 of the Controlled Substances Act (21 16 U.S.C. 802), as in effect on the date of the enact- 17 ment of this section) manufactured in the United 18 States which is opium, an opiate, or any derivative 19 thereof. 20 ‘‘(2) EXCLUSIONS.— 21 ‘‘(A) OTHER INGREDIENTS.—In the case 22 of a product that includes a taxable active 23 opioid and another ingredient, subsection (a) 24 shall apply only to the portion of such product 25 that is a taxable active opioid. 26 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 4242 IS ‘‘(B) DRUGS USED IN ADDICTION TREAT- 1 MENT.—The term ‘taxable active opioid’ shall 2 not include any controlled substance (as so de- 3 fined) which is used exclusively for the treat- 4 ment of opioid addiction as part of a medica- 5 tion-assisted treatment.’’. 6 (b) CLERICAL AMENDMENTS.— 7 (1) The heading of subchapter E of chapter 32 8 of the Internal Revenue Code of 1986 is amended by 9 striking ‘‘Medical Devices’’ and inserting 10 ‘‘Other Medical Products’’. 11 (2) The table of subchapters for chapter 32 of 12 such Code is amended by striking the item relating 13 to subchapter E and inserting the following new 14 item: 15 ‘‘SUBCHAPTER E. OTHER MEDICAL PRODUCTS’’. (3) The table of sections for subchapter E of 16 chapter 32 of such Code is amended by adding at 17 the end the following new item: 18 ‘‘Sec. 4192. Opioid pain relievers.’’. (c) EFFECTIVE DATE.—The amendments made by 19 this section shall apply to calendar years beginning after 20 the date of the enactment of this Act. 21 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 4242 IS SEC. 3. OPIOID CONSUMER ABUSE REDUCTION PROGRAM. 1 (a) OPIOID TAKE-BACK PROGRAM.—Section 302 of 2 the Controlled Substances Act (21 U.S.C. 822) is amend- 3 ed by adding at the end the following: 4 ‘‘(h)(1) The Attorney General shall establish a na- 5 tional take-back program for the safe and environmentally 6 responsible disposal of controlled substances. 7 ‘‘(2) In establishing the take-back program required 8 under paragraph (1), the Attorney General— 9 ‘‘(A) shall consult with the Secretary and the 10 Administrator of the Environmental Protection 11 Agency; and 12 ‘‘(B) may coordinate with States, law enforce- 13 ment agencies, water resource management agencies, 14 manufacturers, practitioners, pharmacists, public 15 health entities, transportation and incineration serv- 16 ice contractors, and other entities and individuals, as 17 appropriate. 18 ‘‘(3) The take-back program established under para- 19 graph (1)— 20 ‘‘(A) shall— 21 ‘‘(i) ensure appropriate geographic dis- 22 tribution so as to provide— 23 ‘‘(I) reasonably convenient and equi- 24 table access to permanent take-back loca- 25 tions, including not less than 1 disposal 26 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 4242 IS site for every 25,000 residents and not less 1 than 1 physical disposal site per town, city, 2 county, or other unit of local government, 3 where possible; and 4 ‘‘(II) periodic collection events and 5 mail-back programs, including public no- 6 tice of such events and programs, as a sup- 7 plement to the permanent take-back loca- 8 tions described in subclause (I), particu- 9 larly in areas in which the provision of ac- 10 cess to such locations at the level described 11 in that subclause is not possible; 12 ‘‘(ii) establish a process for the accurate 13 cataloguing and reporting of the quantities of 14 controlled substances collected; and 15 ‘‘(iii) include a public awareness campaign 16 and education of practitioners and pharmacists; 17 and 18 ‘‘(B) may work in coordination with State and 19 locally implemented public and private take-back 20 programs. 21 ‘‘(4) From time to time, beginning in the second cal- 22 endar year that begins after the date of enactment of this 23 subsection, the Secretary of the Treasury shall transfer 24 from the general fund of the Treasury an amount equal 25 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 4242 IS to one-half of the total amount of taxes collected under 1 section 4192 of the Internal Revenue Code of 1986 to the 2 Attorney General to carry out this subsection. Amounts 3 transferred under this subparagraph shall remain avail- 4 able until expended.’’. 5 (b) FUNDING OF SUBSTANCE ABUSE PROGRAMS.— 6 From time to time, beginning in the second calendar year 7 that begins after the date of enactment of this Act, the 8 Secretary of the Treasury shall transfer from the general 9 fund of the Treasury an amount equal to one-half of the 10 total amount of taxes collected under section 4192 of the 11 Internal Revenue Code of 1986, as added by this Act, to 12 the Director of the Center for Substance Abuse Treatment 13 of the Substance Abuse and Mental Health Services Ad- 14 ministration for programs of the Center, including the 15 Block Grants for Prevention and Treatment of Substance 16 Abuse program under subpart II of part B of title XIX 17 of the Public Health Service Act (42 U.S.C. 300x–21 et 18 seq.) and Programs of Regional and National Significance. 19 Amounts transferred under this subsection shall remain 20 available until expended. 21 SEC. 4. GAO STUDY. 22 Not later than 1 year after the date of enactment 23 of this Act, the Comptroller General of the United States 24 shall— 25 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 4242 IS (1) conduct a study examining the coverage of- 1 fered under commercial health insurance plans and 2 reimbursement rates under the Medicare program 3 and State Medicaid plans with respect to— 4 (A) substance use disorder treatment serv- 5 ices, as compared to other health services, and 6 how any disparity identified under this para- 7 graph may contribute to differences in salary 8 and turnover among substance abuse disorder 9 providers; and 10 (B) rates of coverage or reimbursement, as 11 applicable, for substance abuse disorder services 12 provided via telehealth, as compared to such 13 services provided in-person; and 14 (2) provide recommendations with respect to 15 addressing any disparities identified under subpara- 16 graph (A) or (B) of paragraph (1) in order to bol- 17 ster retention of substance abuse disorder providers 18 and the provision of substance abuse disorder serv- 19 ices. 20 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 8 •S 4242 IS SEC. 5. EXPANDING ACCESS TO SUBSTANCE USE DISORDER 1 AND MENTAL HEALTH SERVICES FURNISHED 2 THROUGH TELEHEALTH UNDER THE MEDI- 3 CARE PROGRAM. 4 Section 1834(m)(7) of the Social Security Act (42 5 U.S.C. 1395m(m)(7)) is amended— 6 (1) in the paragraph heading, by inserting 7 ‘‘AND MENTAL HEALTH SERVICES’’ after ‘‘SUB- 8 STANCE USE DISORDER SERVICES’’; 9 (2) by inserting ‘‘or, on or after the first day 10 after the end of the public health emergency de- 11 scribed in section 1135(g)(1)(B), to an eligible tele- 12 health individual for purposes of diagnosis of a sub- 13 stance use disorder or diagnosis or treatment of a 14 mental health disorder, as determined by the Sec- 15 retary,’’ after ‘‘as determined by the Secretary,’’. 16 SEC. 6. ENSURING PARITY FOR MENTAL HEALTH AND AD- 17 DICTION TREATMENT SERVICES. 18 Title V of the Public Health Service Act (42 U.S.C. 19 290ll et seq.) is amended— 20 (1) in part K, by redesignating section 550 (42 21 U.S.C. 290ee–10), relating to sobriety treatment 22 and recovery teams, as section 553 and transferring 23 such section to appear after section 552 in part D; 24 and 25 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 9 •S 4242 IS (2) by adding at the end of such part D the fol- 1 lowing: 2 ‘‘SEC. 554. COMPLIANCE WITH MENTAL HEALTH AND AD- 3 DICTION TREATMENT PARITY. 4 ‘‘(a) IN GENERAL.—The Secretary, in coordination 5 with the Secretary of Labor, shall award grants to, or 6 enter into cooperative agreements with, States to ensure 7 that health insurance issuers in the State comply with sec- 8 tion 2726. 9 ‘‘(b) USE OF GRANT.—A State shall use amounts re- 10 ceived under a grant or cooperative agreement under this 11 section to— 12 ‘‘(1) establish clear guidelines for parity compli- 13 ance for mental health and substance use disorder 14 benefits; 15 ‘‘(2) ensure parity compliance during public 16 health emergencies with best practices for delivering 17 evidence-based mental health and substance use dis- 18 order treatment, including to ensure virtual, video, 19 internet, telephonic, and other remote services are 20 appropriately covered, including alignment with au- 21 thorities, flexibilities, and coverage promulgated by 22 the Centers for Medicare & Medicaid Services; 23 ‘‘(3) engage with health insurance issuers to en- 24 sure that they comply with the guidelines promul- 25 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 10 •S 4242 IS gated and other provisions of section 2726, including 1 through audits, market conduct examinations, secret 2 shopper programs, or other means; 3 ‘‘(4) share information with other States who 4 receive grants under this section; 5 ‘‘(5) submit a report to the Secretary and the 6 Secretary of Labor on information, actions, rec- 7 ommendations, and such other information as such 8 secretaries may require; and 9 ‘‘(6) publicly post a summary of the report sub- 10 mitted under paragraph (6) on the websites of the 11 Department of Health and Human Services and the 12 Department of Labor. 13 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 14 are authorized to be appropriated to carry out this section 15 $10,000,000 for each of fiscal years 2021 through 2025.’’. 16 SEC. 7. FEDERAL LICENSURE OF PHARMACEUTICAL REP- 17 RESENTATIVES WHO PROMOTE CERTAIN 18 OPIOIDS. 19 Subchapter E of chapter V of the Federal Food, 20 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 21 amended by adding at the end the following: 22 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 11 •S 4242 IS ‘‘SEC. 569E. FEDERAL LICENSURE OF PHARMACEUTICAL 1 REPRESENTATIVES WHO PROMOTE CERTAIN 2 OPIOIDS. 3 ‘‘(a) IN GENERAL.—The Secretary, in consultation 4 with the Attorney General, shall establish a licensure pro- 5 gram for pharmaceutical representatives described in sub- 6 section (b). 7 ‘‘(b) LICENSURE PROGRAM.— 8 ‘‘(1) REQUIREMENT.—Beginning on July 1, 9 2021, no individual described in paragraph (2) may 10 engage in the marketing or promoting of opioid 11 drugs unless such individual is licensed under this 12 section. 13 ‘‘(2) INDIVIDUALS REQUIRED TO OBTAIN LI- 14 CENSURE.—An individual required to obtain a li- 15 cense under this section is any individual who, on 16 behalf of a drug manufacturer, engaged, on more 17 than 15 days in a calendar year, in the marketing 18 or promotion to health care professionals, including 19 educational or sales communications, meetings or 20 paid events, and the provision of goods, gifts, and 21 samples, of any opioid drug (other than methadone) 22 that is listed in schedule II of section 202(c) of the 23 Controlled Substances Act. 24 VerDate Sep 11 2014 03:51 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4242.IS S4242 pbinns on DSKJLVW7X2PROD with BILLS 12 •S 4242 IS ‘‘(3) LICENSURE PERIOD.—Each license issued 1 under this section shall be valid for 3 years, and 2 may be renewed for additional 3-year periods. 3 ‘‘(c) REQUIREMENTS.—An individual required to ob- 4 tain a license under this section shall— 5 ‘‘(1) submit to the Secretary, at such time and 6 in such manner as the Secretary may require— 7 ‘‘(A) such information as the Secretary 8 may require; and 9 ‘‘(B) a registration fee in the amount of 10 $3,000; 11 ‘‘(2) certify that such individual has completed 12 training on ethics, pharmaceutical marketing regula- 13 tions, the ‘CDC Guidelines for Prescribing Opioids 14 for Chronic Pain’, published by the Centers for Dis- 15 ease Control and Prevention in 2016 (or any suc- 16 cessor document) or the ‘FDA Blueprint for Pre- 17 scriber Education for Extended-Release and Long- 18 Acting Opioid Analgesics’, and applicable Federal 19 laws pertaining to drug marketing, labeling, and 20 clinical trials, as the Secretary may require; 21 ‘‘(3) certify that such individual will not engage 22 in a [Text truncated for display. 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