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
To require the use of prescription drug monitoring programs.
This Act may be cited as the
Prescription Drug Monitoring Act of 2021.
Requiring the use of prescription drug monitoring programs
In this section:
The term controlled substance has the meaning given the term in section 102 of the Controlled Substances Act (21 U.S.C. 802).
The term covered State means a State that receives funding under the Harold Rogers Prescription Drug Monitoring Program established under the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law 107–77; 115 Stat. 748), or under the controlled substance monitoring program under section 399O of the Public Health Service Act (42 U.S.C. 280g–3).
The term dispenser—
means a person licensed or otherwise authorized by a State to deliver a prescription drug product to a patient or an agent of the patient; and
does not include a person involved in oversight or payment for prescription drugs.
The term PDMP means a prescription drug monitoring program.
The term practitioner means a practitioner registered under section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) to prescribe, administer, or dispense controlled substances.
The term State means each of the several States and the District of Columbia.
Beginning 1 year after the date of enactment of this Act, each covered State shall require—
each prescribing practitioner within the covered State or their designee, who shall be licensed or registered healthcare professionals or other employees who report directly to the practitioner, to consult the PDMP of the covered State before initiating treatment with a prescription for a controlled substance listed in schedule II, III, or IV of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)), and every 3 months thereafter as long as the treatment continues;
the PDMP of the covered State to provide proactive notification to a practitioner when patterns indicative of controlled substance misuse, including opioid misuse, are detected;
each dispenser within the covered State to report each prescription for a controlled substance dispensed by the dispenser to the PDMP not later than 24 hours after the controlled substance is dispensed to the patient;
that the PDMP make available a quarterly de-identified data set and an annual report for public and private use, including use by healthcare providers, health plans and health benefits administrators, State agencies, and researchers, which shall, at a minimum, meet requirements established by the Attorney General, in coordination with the Secretary of Health and Human Services;
each State agency that administers the PDMP to—
proactively analyze data available through the PDMP; and
provide reports to law enforcement agencies and prescriber licensing boards describing any prescribing practitioner that repeatedly fall outside of expected norms or standard practices for the prescribing practitioner’s field; and
that the data contained in the PDMP of the covered State be made available to other States.
If a covered State fails to comply with subsection (a), the Attorney General or the Secretary of Health and Human Services may withhold grant funds from being awarded to the covered State under the Harold Rogers Prescription Drug Monitoring Program established under the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law 107–77; 115 Stat. 748), or under the controlled substance monitoring program under section 399O of the Public Health Service Act (42 U.S.C. 280g–3).