IN THE SENATE OF THE UNITED STATES
July 13, 2016
Ms. Klobuchar (for herself, Mr. Manchin, and Mr. King) 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 and to facilitate information sharing among States.
This Act may be cited as the
Prescription Drug Monitoring Act of 2016.
In this Act:
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 the controlled substance monitoring program under section 399O of the Public Health Service Act (42 U.S.C. 280g–3).
The term dispenser—
means 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.
Prescription drug monitoring program requirements
Beginning 2 years 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; and
that the PDMP make available a quarterly de-identified data set and an annual report for public and private use, which shall, at a minimum, meet requirements established by the Attorney General, in coordination with the Secretary of Health and Human Services.
If a covered State fails to comply with subsection (a), the Attorney General or the Secretary of Health and Human Services, as appropriate, 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 the controlled substance monitoring program under section 399O of the Public Health Service Act (42 U.S.C. 280g–3).
Sharing PDMP information among States
Beginning 2 years after the date of enactment of this Act, each covered State shall make the data contained in the PDMP of the covered State available to other States through the data-sharing single technology solution established under subsection (b).
Data-Sharing Single technology solution
The Attorney General, in coordination with the Secretary of Health and Human Services, shall award, on a competitive basis, a grant to an eligible entity to establish and maintain an inter-State data-sharing single hub to facilitate the sharing of PDMP data among States and the accessing of such data by practitioners.
The data-sharing single hub established under paragraph (1)—
allow States to retain ownership of the data submitted by the States;
provide a source of de-identified data that can be used for statistical, research, or educational purposes;
allow State authorized users to access data from a PDMP of a covered State without requiring a user fee; and
conform with the standards of the Prescription Monitoring Information Exchange; and
distribute, in whole or in part, any PDMP data without the express written consent of the PDMP State authority; and
limit, in whole or in part, distribution of PDMP data as approved by the PDMP State authority.
Authorization of appropriations
There are authorized to be appropriated to the Attorney General $2,000,000 for fiscal years 2017 through 2020 to carry out this subsection.