Prescription Drug Monitoring Act of 2021

II 117TH CONGRESS 1ST SESSION S. 889 To require the use of prescription drug monitoring programs. IN THE SENATE OF THE UNITED STATES MARCH 22, 2021 Ms. KLOBUCHAR (for herself, Mr. PORTMAN, Mr. KING, and Mr. MANCHIN) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require the use of prescription drug monitoring programs. 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 ‘‘Prescription Drug 4 Monitoring Act of 2021’’. 5 SEC. 2. REQUIRING THE USE OF PRESCRIPTION DRUG 6 MONITORING PROGRAMS. 7 (a) DEFINITIONS.—In this section: 8 (1) CONTROLLED SUBSTANCE.—The term 9 ‘‘controlled substance’’ has the meaning given the 10 VerDate Sep 11 2014 00:57 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S889.IS S889 kjohnson on DSK79L0C42PROD with BILLS 2 •S 889 IS term in section 102 of the Controlled Substances 1 Act (21 U.S.C. 802). 2 (2) COVERED STATE.—The term ‘‘covered 3 State’’ means a State that receives funding under 4 the Harold Rogers Prescription Drug Monitoring 5 Program established under the Departments of 6 Commerce, Justice, and State, the Judiciary, and 7 Related Agencies Appropriations Act, 2002 (Public 8 Law 107–77; 115 Stat. 748), or under the con- 9 trolled substance monitoring program under section 10 399O of the Public Health Service Act (42 U.S.C. 11 280g–3). 12 (3) DISPENSER.—The term ‘‘dispenser’’— 13 (A) means a person licensed or otherwise 14 authorized by a State to deliver a prescription 15 drug product to a patient or an agent of the pa- 16 tient; and 17 (B) does not include a person involved in 18 oversight or payment for prescription drugs. 19 (4) PDMP.—The term ‘‘PDMP’’ means a pre- 20 scription drug monitoring program. 21 (5) PRACTITIONER.—The term ‘‘practitioner’’ 22 means a practitioner registered under section 303(f) 23 of the Controlled Substances Act (21 U.S.C. 823(f)) 24 VerDate Sep 11 2014 00:57 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S889.IS S889 kjohnson on DSK79L0C42PROD with BILLS 3 •S 889 IS to prescribe, administer, or dispense controlled sub- 1 stances. 2 (6) STATE.—The term ‘‘State’’ means each of 3 the several States and the District of Columbia. 4 (b) REQUIREMENTS.—Beginning 1 year after the 5 date of enactment of this Act, each covered State shall 6 require— 7 (1) each prescribing practitioner within the cov- 8 ered State or their designee, who shall be licensed or 9 registered healthcare professionals or other employ- 10 ees who report directly to the practitioner, to consult 11 the PDMP of the covered State before initiating 12 treatment with a prescription for a controlled sub- 13 stance listed in schedule II, III, or IV of section 14 202(c) of the Controlled Substances Act (21 U.S.C. 15 812(c)), and every 3 months thereafter as long as 16 the treatment continues; 17 (2) the PDMP of the covered State to provide 18 proactive notification to a practitioner when patterns 19 indicative of controlled substance misuse, including 20 opioid misuse, are detected; 21 (3) each dispenser within the covered State to 22 report each prescription for a controlled substance 23 dispensed by the dispenser to the PDMP not later 24 VerDate Sep 11 2014 00:57 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S889.IS S889 kjohnson on DSK79L0C42PROD with BILLS 4 •S 889 IS than 24 hours after the controlled substance is dis- 1 pensed to the patient; 2 (4) that the PDMP make available a quarterly 3 de-identified data set and an annual report for pub- 4 lic and private use, including use by healthcare pro- 5 viders, health plans and health benefits administra- 6 tors, State agencies, and researchers, which shall, at 7 a minimum, meet requirements established by the 8 Attorney General, in coordination with the Secretary 9 of Health and Human Services; 10 (5) each State agency that administers the 11 PDMP to— 12 (A) proactively analyze data available 13 through the PDMP; and 14 (B) provide reports to law enforcement 15 agencies and prescriber licensing boards de- 16 scribing any prescribing practitioner that re- 17 peatedly fall outside of expected norms or 18 standard practices for the prescribing practi- 19 tioner’s field; and 20 (6) that the data contained in the PDMP of the 21 covered State be made available to other States. 22 (c) NONCOMPLIANCE.—If a covered State fails to 23 comply with subsection (a), the Attorney General or the 24 Secretary of Health and Human Services may withhold 25 VerDate Sep 11 2014 00:57 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S889.IS S889 kjohnson on DSK79L0C42PROD with BILLS 5 •S 889 IS grant funds from being awarded to the covered State 1 under the Harold Rogers Prescription Drug Monitoring 2 Program established under the Departments of Com- 3 merce, Justice, and State, the Judiciary, and Related 4 Agencies Appropriations Act, 2002 (Public Law 107–77; 5 115 Stat. 748), or under the controlled substance moni- 6 toring program under section 399O of the Public Health 7 Service Act (42 U.S.C. 280g–3). 8 Æ VerDate Sep 11 2014 00:57 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S889.IS S889 kjohnson on DSK79L0C42PROD with BILLS