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Increasing the Safety of Prescription Drug Use Act of 2015

Introduced on 3/3/15 by Tom Udall [D-NM] and referred to the Committee on Health, Education, Labor, and Pensions. Cosponsor was Al Franken [D-MN]. Related bills are S.480 and S. 1455.

Purpose: To reduce prescription drug misuse and abuse.

TITLE I—HHS Programs

SEC. 101. Amendment to purpose.

Amends section 2 of the National All Schedules Prescription Electronic Reporting Act of 2005 (Public Law 109–60) to include law enforcement, regulatory, and licensing authority access to prescription monitoring programs to track the prescription history of prescribers for the purposes of investigating drug diversion and prescribing and dispensing practices of errant prescribers or pharmacists.

SEC. 102. Prescription drug monitoring program.

Provides for additional grants to maintain and operate existing prescription monitoring programs. Grants to establish and implement State prescription monitoring programs, and make improvements to existing programs are continued.

Works on improving interoperability between different states including timelines for full implementation of such interoperability and allowing for monitoring of interoperability.

The State shall ensure that the database is interoperable with the controlled substance monitoring program of other States and other Federal agencies, is interoperable with electronic health records and e-prescribing, provides automatic, real-time or daily information about a patient when a practitioner requests information about such patient. The state shall report on the interoperability of its program.

Practitioners are required to use State database information to help determine whether to prescribe or renew a prescription for a controlled substance.

Dispensers are required, where permitted, to enter data required by the Secretary, including the name of the patient, the date, and prescription dose, into the database for a controlled substance. Notwithstanding section 543 and any other provision of law, the data required to be entered shall include information with respect to methadone that is dispensed to a patient.

The State shall ensure that anyone getting patient information through the database may use such information only to carry out official duties with regard to the patient. No information in a database established or maintained through a grant may be used to conduct a criminal investigation or substantiate any criminal charges against a patient or conduct any investigation of a patient relating to methadone use.

States receiving grants shall provide the Secretary with aggregate data and other information determined by the Secretary to be necessary to enable the Secretary to evaluate the success of the State’s program and to prepare the report to Congress.

A State receiving a grant shall take steps to facilitate prescriber and dispenser use and educate them on the benefits of the system both to them and society.

$7,000,000 of appropriations is authorized for each of fiscal years 2016 through 2020 to carry out this section.

Health care practitioners in federal programs such as Indian Health Service, VA, DoD, FBOP, Medicare, a State Medicaid plan, the Children’s Health Insurance Program, and Federally qualified health centers, shall use the databases of the controlled substance monitoring programs if such databases are available.

SEC. 103. Pilot project.

The Secretary of HHA shall award grants to one or more States to carry out a 1-year pilot project to develop a standardized peer review process to review and evaluate prescribing and pharmacy dispensing patterns, through a review of prescription drug monitoring programs. The methodology shall be to identify and investigate questionable or inappropriate prescribing and dispensing patterns of controlled substances which shall be shared with the appropriate State health profession board.

SEC. 104. Prescription drug and other controlled substance abuse prevention.

Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following:

“SEC. 399V–6. Prescription drug and other controlled substance abuse prevention.

The Secretary shall award 5-year grants to continuing education entities, such as health profession boards and other professional education organizations to facilitate training to increase the capacity of health care providers to conduct patient screening and brief interventions to prevent the abuse of prescription drugs and other controlled substances.

Expansion of prescribing authority to advance practice nurses and physician assistants—The Secretary shall award grants to States for the purpose of evaluating this expansion in order to control the abuse of prescription drugs or other controlled substances with respect to specific drugs and other controlled substances, as appropriate.

SEC. 105. Prescription drug abuse training and screening programs.

(a) Continuing education development grants to States for training for informed and safe prescribing of opioids and other scheduled drugs.

(b) Training requirements for registration with DEA.—A practitioner who registers or renews a registration shall certify completion of continuing medical education with respect to prescription drug abuse and medical understanding of the proper use of all scheduled drugs.

(c) Screening program.—The Attorney General shall require that a practitioner conduct patient screening for potential drug misuse or abuse before prescribing a scheduled drug according to standards established by the applicable State licensing body.

SEC. 106. FDA review of naloxone.

The Secretary of HHS shall conduct a review of naloxone to consider whether it should cease to be subject to 21 U.S.C. 353(b)(1) and be available as a behind-the-counter drug, in order to increase access.

SEC. 107. Prescription drug disposal.

Encourages States and local governments to increase opportunities for disposal of opiates, such as frequent “take-back programs” and fixed medicine disposal sites at law enforcement public buildings, and to reduce opportunities for abuse of opiates, such as establishing opioid dispensing limits at hospital emergency departments.

SEC. 108. GAO report.

The Comptroller General shall review prescription drug abuse programs and best practices and issue a report to Congress on its findings and recommendations on ways to reduce prescription drug abuse.


TITLE II—TREAT Act  (Identical to S.1455)

 “Recovery Enhancement for Addiction Treatment Act” or the “TREAT Act”.

Amends the Controlled Substances Act to increase the number of patients that a qualifying practitioner dispensing narcotic drugs for maintenance or detoxification treatment is initially allowed to treat from 30 to 100 patients per year.

Allows a qualifying physician, after one year, to request approval to treat an unlimited number of patients under specified conditions, including that he or she: (1) agrees to fully participate in the Prescription Drug Monitoring Program of the state in which the practitioner is licensed, (2) practices in a qualified practice setting, and (3) has completed at least 24 hours of training regarding treatment and management of opiate-dependent patients for substance use disorders provided by specified organizations.

Revises the definition of a “qualifying practitioner” to include: (1) a physician who holds a board certification from the American Board of Addiction Medicine; and (2) a nurse practitioner or physician’s assistant who is licensed under state law to prescribe schedule III, IV, or V medications for pain, who has specified training or experience that demonstrates specialization in the ability to treat opiate-dependent patients, who practices under the supervision of, or prescribes opioid addiction therapy in collaboration with, a licensed physician who holds an active waiver to prescribe schedule III, IV, or V narcotic medications for opioid addiction therapy, and who practices in a qualified practice setting.

Directs the Comptroller General to initiate an evaluation of the effectiveness of this Act, including an evaluation of: (1) changes in the availability and use of medication-assisted treatment for opioid addiction, (2) the quality of medication-assisted treatment programs, (3) diversion of opioid addiction treatment medication, and (4) changes in state or local policies and legislation relating to opioid addiction treatment.


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