Addiction Prevention and Responsible Opioid Practices Act

I 116TH CONGRESS 2D SESSION H. R. 7701 To establish programs related to prevention of prescription opioid misuse, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JULY 21, 2020 Mr. CARTWRIGHT introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, Education and Labor, and Ways and Means, for a pe- riod to be subsequently determined by the Speaker, in each case for con- sideration of such provisions as fall within the jurisdiction of the com- mittee concerned 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 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 7701 IH SEC. 2. FEDERAL LICENSURE OF PHARMACEUTICAL REP- 1 RESENTATIVES WHO PROMOTE CERTAIN 2 OPIOIDS. 3 Subchapter E of chapter V of the Federal Food, 4 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 5 amended by adding at the end the following: 6 ‘‘SEC. 569E. FEDERAL LICENSURE OF PHARMACEUTICAL 7 REPRESENTATIVES WHO PROMOTE CERTAIN 8 OPIOIDS. 9 ‘‘(a) IN GENERAL.—The Secretary, in consultation 10 with the Attorney General, shall establish a licensure pro- 11 gram for pharmaceutical representatives described in sub- 12 section (b). 13 ‘‘(b) LICENSURE PROGRAM.— 14 ‘‘(1) REQUIREMENT.—Beginning on July 1, 15 2021, no individual described in paragraph (2) may 16 engage in the marketing or promoting of opioid 17 drugs unless such individual is licensed under this 18 section. 19 ‘‘(2) INDIVIDUALS REQUIRED TO OBTAIN LI- 20 CENSURE.—An individual required to obtain a li- 21 cense under this section is any individual who, on 22 behalf of a drug manufacturer, engaged, on more 23 than 15 days in a calendar year, in the marketing 24 or promotion to health care professionals, including 25 educational or sales communications, meetings or 26 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 7701 IH paid events, and the provision of goods, gifts, and 1 samples, of any opioid drug (other than methadone) 2 that is listed in schedule II of section 202(c) of the 3 Controlled Substances Act. 4 ‘‘(3) LICENSURE PERIOD.—Each license issued 5 under this section shall be valid for 3 years, and 6 may be renewed for additional 3-year periods. 7 ‘‘(c) REQUIREMENTS.—An individual required to ob- 8 tain a license under this section shall— 9 ‘‘(1) submit to the Secretary, at such time and 10 in such manner as the Secretary may require— 11 ‘‘(A) such information as the Secretary 12 may require; and 13 ‘‘(B) a registration fee in the amount of 14 $3,000; 15 ‘‘(2) certify that such individual has completed 16 training on ethics, pharmaceutical marketing regula- 17 tions, the ‘CDC Guidelines for Prescribing Opioids 18 for Chronic Pain’, published by the Centers for Dis- 19 ease Control and Prevention in 2016 (or any suc- 20 cessor document) or the ‘FDA Blueprint for Pre- 21 scriber Education for Extended-Release and Long- 22 Acting Opioid Analgesics’, and applicable Federal 23 laws pertaining to drug marketing, labeling, and 24 clinical trials, as the Secretary may require; 25 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 7701 IH ‘‘(3) certify that such individual will not engage 1 in any illegal, fraudulent, misleading, or other decep- 2 tive marketing of schedule II opioid drugs; and 3 ‘‘(4) file with the Secretary annual reports dis- 4 closing the names of providers visited and any drug 5 samples or gifts such individual gives any such pro- 6 vider. 7 ‘‘(d) MANUFACTURER REPORTING REQUIRE- 8 MENTS.—The manufacturer who employs or contracts 9 with any individual required to obtain a license under this 10 section shall include in reports required under section 11 1128G of the Social Security Act the name of each such 12 licensed individual that provides payments or other trans- 13 fers of value required to be reported under such section 14 1128G that relates to an opioid drug that is listed in 15 schedule II of the Controlled Substances Act.’’. 16 SEC. 3. WITHDRAWAL OF APPROVAL OF CERTAIN OPIOIDS. 17 (a) IN GENERAL.—Notwithstanding any other provi- 18 sion of law, any ultra-high-dose opioid shall be considered 19 a drug that presents an imminent hazard to the public 20 health within the meaning of section 505(e) of the Federal 21 Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), and 22 the Secretary of Health and Human Services shall sus- 23 pend the approval of such drug, in accordance with such 24 section 505(e). 25 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 7701 IH (b) DEFINITION.—In this section, the term ‘‘ultra- 1 high-dose opioid’’ means an opioid drug for which the 2 daily dosage provided for in the approved label exceeds 3 the morphine milligram equivalents per day outlined in the 4 report entitled ‘‘CDC Guidelines for Prescribing Opioids 5 for Chronic Pain’’, published by the Centers for Disease 6 Control and Prevention in 2016 (or any successor docu- 7 ment). 8 SEC. 4. CONTINUING MEDICAL EDUCATION AND PRESCRIP- 9 TION DRUG MONITORING PROGRAM REG- 10 ISTRATION FOR PRESCRIBERS. 11 Section 303 of the Controlled Substances Act (21 12 U.S.C. 823) is amended— 13 (1) by redesignating subsection (k) as sub- 14 section (l); and 15 (2) by inserting after subsection (j) the fol- 16 lowing: 17 ‘‘(k)(1) The Attorney General shall not register, or 18 renew the registration of, a practitioner under subsection 19 (f) who is licensed under State law to prescribe controlled 20 substances in schedule II, III, or IV, unless the practi- 21 tioner submits to the Attorney General, for each such reg- 22 istration or renewal request, a written certification that— 23 ‘‘(A)(i) the practitioner has, during the 1-year 24 period preceding the registration or renewal request, 25 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 7701 IH completed a training program described in para- 1 graph (2); or 2 ‘‘(ii) the practitioner, during the applicable reg- 3 istration period, will not prescribe such controlled 4 substances in amounts in excess of a 72-hour supply 5 (for which no refill is available); and 6 ‘‘(B) the practitioner has registered with the 7 prescription drug monitoring program of the State 8 in which the practitioner practices, if the State has 9 such program. 10 ‘‘(2) A training program described in this paragraph 11 is a training program that— 12 ‘‘(A) follows the best practices for pain manage- 13 ment, as described in the ‘Guideline for Prescribing 14 Opioids for Chronic Pain’ as published by the Cen- 15 ters for Disease Control and Prevention in 2016, or 16 any successor thereto, or the ‘FDA Blueprint for 17 Prescriber Education for Extended-Release and 18 Long-Acting Opioid Analgesics’ as published by the 19 Food and Drug Administration in 2017, or any suc- 20 cessor thereto; 21 ‘‘(B) includes information on— 22 ‘‘(i) recommending non-opioid and non- 23 pharmacological therapy; 24 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 7701 IH ‘‘(ii) establishing treatment goals and eval- 1 uating patient risks; 2 ‘‘(iii) prescribing the lowest dose and few- 3 est number of pills considered effective; 4 ‘‘(iv) addictive and overdose risks of 5 opioids; 6 ‘‘(v) diagnosing and managing substance 7 use disorders, including linking patients to evi- 8 dence-based treatment; 9 ‘‘(vi) identifying narcotics-seeking behav- 10 iors; and 11 ‘‘(vii) using prescription drug monitoring 12 programs; and 13 ‘‘(C) is approved by the Secretary.’’. 14 SEC. 5. REPORT ON PRESCRIBER EDUCATION COURSES 15 FOR MEDICAL AND DENTAL STUDENTS. 16 Each school of medicine, school of osteopathic medi- 17 cine, and school of dentistry participating in a program 18 under title IV of the Higher Education Act of 1965 (20 19 U.S.C. 1070a et seq.), as a condition for such participa- 20 tion, shall submit an annual report to the Secretary of 21 Education and the Secretary of Health and Human Serv- 22 ices on any prescriber education courses focused specifi- 23 cally on pain management and responsible opioid pre- 24 scribing practices that such school requires students to 25 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 7701 IH take, and whether such courses are consistent with the 1 most recently published version of the ‘‘Guideline for Pre- 2 scribing Opioids for Chronic Pain’’ of the Centers for Dis- 3 ease Control and Prevention or the ‘‘FDA Blueprint for 4 Prescriber Education for Extended-Release and Long-Act- 5 ing Opioid Analgesics’’, as published by the Food and 6 Drug Administration in 2017. The Secretary of Education 7 and the Secretary of Health and Human Services shall 8 compile the reports submitted by such schools and submit 9 an annual summary of such reports to Congress. 10 SEC. 6. REQUIREMENTS UNDER PRESCRIPTION DRUG MON- 11 ITORING PROGRAMS. 12 (a) IN GENERAL.—Beginning 1 year after the date 13 of enactment of this Act, each State that receives funding 14 under any of the programs described in subsection (c) 15 shall— 16 (1) require practitioners, or their designees, in 17 the State to consult the database of the prescription 18 drug monitoring program before writing prescrip- 19 tions for controlled substances (as such term is de- 20 fined in section 102 of the Controlled Substances 21 Act (21 U.S.C. 802)) in schedule II, III, or IV 22 under section 202 of such Act (21 U.S.C. 812); 23 (2) require dispensers of controlled substances 24 in schedule II, III, or IV, or their designees, to input 25 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 7701 IH data into the database of the prescription drug mon- 1 itoring program within 24 hours of filling a quali- 2 fying prescription, as required by the Attorney Gen- 3 eral and the Secretary of Health and Human Serv- 4 ices, including patient identifier information, the na- 5 tional drug code of the dispensed drug, date of dis- 6 pensing the drug, quantity and dosage of the drug 7 dispensed, form of payment, Drug Enforcement Ad- 8 ministration registration number of the practitioner, 9 Drug Enforcement Administration registration num- 10 ber of the dispenser; 11 (3) allow practitioners and dispensers to des- 12 ignate other appropriate individuals to act as agents 13 of such practitioners and dispensers for purposes of 14 obtaining and inputing data from the database for 15 purposes of complying with paragraphs (1) and (2), 16 as applicable; 17 (4) provide informational materials for practi- 18 tioners and dispensers to identify and refer patients 19 with possible substance use disorders to professional 20 treatment specialists; 21 (5) establish formal data sharing agreements to 22 foster electronic connectivity with the prescription 23 drug monitoring programs of each State (if such 24 State has such a program) with which the State 25 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 7701 IH shares a border, to facilitate the exchange of infor- 1 mation through an established technology architec- 2 ture that ensures common data standards, privacy 3 protection, and secure and streamlined information 4 sharing; 5 (6) authorize direct access to the State’s data- 6 base of the prescription drug monitoring program to 7 all State law enforcement agencies, State boards re- 8 sponsible for the licensure, regulation, or discipline 9 of practitioners, pharmacists, or other persons au- 10 thorized to prescribe, administer, or dispense con- 11 trolled substances; and 12 (7) in order to enhance accountability in pre- 13 scribing and dispensing patterns, not fewer than 4 14 times per year, proactively provide informational re- 15 ports on aggregate trends and individual outliers, 16 based on information available through the State 17 prescription drug monitoring program to— 18 (A) the State entities and persons de- 19 scribed in paragraph (6); and 20 (B) the Medicaid agency and the depart- 21 ment of public health of the State. 22 (b) TRANSPARENCY IN PRESCRIBING PRACTICES AND 23 INTERVENTION FOR HIGH PRESCRIBERS.— 24 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 7701 IH (1) STATE REPORTING REQUIREMENT.—Each 1 State that receives funding under any of the pro- 2 grams described in subsection (c) shall, twice per 3 year, submit to the Secretary of Health and Human 4 Services and the Administrator of the Drug Enforce- 5 ment Administration— 6 (A) a list of all practitioners and dis- 7 pensers who, in the applicable reporting period, 8 have prescribed or dispensed schedule II, III, or 9 IV opioids in the State; 10 (B) the amount of schedule II, III, or IV 11 opioids that were prescribed and dispensed by 12 each individual practitioner and dispenser de- 13 scribed in subparagraph (A); and 14 (C) any additional information that the 15 Secretary and Administrator may require to 16 support surveillance and evaluation of trends in 17 prescribing or dispensing of schedule II, III, or 18 IV opioids, or to identify possible non-medical 19 use and diversion of such substances. 20 (2) ANNUAL REPORT.—Not later than 1 year 21 after the date of enactment of this Act, and annually 22 thereafter, the Secretary of Health and Human 23 Services, in consultation with the Administrator of 24 the Drug Enforcement Administration, the Secretary 25 VerDate Sep 11 2014 00:06 Aug 09, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H7701.IH H7701 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 7701 IH of Defense, the Secretary of Veterans Affairs, and 1 the Director of the Indian Health Service, shall sub- 2 mit to Congress, and make public, a rep [Text truncated for display. 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