1. Short title
This Act may be cited as the “Increasing the Safety of Prescription Drug Use Act of 2013”.
Increasing the Safety of Prescription Drug Use Act of 2013
A BILL
To reduce prescription drug misuse and abuse.
2. Prescription drug monitoring program
Controlled substance monitoring program— Section 399O of the Public Health Service Act (42 U.S.C. 243g–3) is amended—
in subsection (e), by adding at the end the following:
“(5) The State shall—
“(A) ensure that the database—
“(i) is interoperable with the controlled substance monitoring program of other States and other Federal agencies and across appropriate State agencies, including health agencies, as determined by the Secretary;
“(ii) is interoperable with electronic health records and e-prescribing, where appropriate; and
“(iii) provides automatic, real-time or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient;
“(B) require practitioners to use State database information to help determine whether to prescribe or renew a prescription for a controlled substance; and
“(C) require dispensers, or their designees, 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.
“(6) Notwithstanding section 543 and any other provision of law, the data required to be entered under paragraph (5)(C) shall include information with respect to methadone that is dispensed to a patient, if applicable.
“(7) The State shall ensure that—
“(A) any person who receives patient information through the database may disclose and use such information only to carry out the official duties of that person with regard to the patient; and
“(B) notwithstanding subsection (f)(1)(B), no information kept in accordance with a database developed or maintained through a grant under this section may be used to conduct a criminal investigation or substantiate any criminal charges against a patient or to conduct any investigation of a patient relating to methadone use of the patient.”
in subsection (n), by striking “To carry out this section” and all that follows through the period at the end and inserting “There are authorized to be appropriated for fiscal years 2014 through 2018 such sums as may be necessary to carry out this section.”.
Confidentiality of records— Section 543(a) of the Public Health Service Act (42 U.S.C. 290dd–2(a)) is amended by inserting “or, with respect to methadone, as required under section 399O(e)(6)” before the period at the end.
Requirements for Federal health care programs— Health care practitioners (as defined in paragraph (7) of section 399O(m) of the Public Health Service Act (42 U.S.C. 280g–3(m))) and dispensers (as defined in paragraph (4) of such section) who participate in or are employed by a Federal health care program or federally funded health care program, including the Indian Health Service, the Department of Veterans Affairs, the Department of Defense, the Federal Bureau of Prisons, the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), a State Medicaid plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), the Children's Health Insurance Program under title XXI of the Social Security Act (42 U.S.C. 1397aa et seq.), and Federally qualified health centers, shall use the databases of the controlled substance monitoring programs under section 399O of the Public Health Service Act (42 U.S.C. 280g–3), if such databases are available to the practitioner or dispenser.
3. Pilot project
In general— The Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall award grants to one or more States to carry out a 1-year pilot project to develop a standardized peer review process and methodology to review and evaluate prescribing and pharmacy dispensing patterns, through a review of prescription drug monitoring programs (referred to in this section as “PDMP”) in the States receiving such grants.
Methodology— The recipients of a grant under this section shall develop a systematic, standardized methodology to identify and investigate questionable or inappropriate prescribing and dispensing patterns of substances on schedule II or III under section 202 of the Controlled Substances Act (21 U.S.C. 812). Such peer review methodology and prescribing and dispensing patterns shall be shared with the appropriate State health profession board.
Requirements— A State receiving a grant under this section shall—
with respect to controlled substances for which a prescriber is required to have a license issued by the Drug Enforcement Administration in order to prescribe such controlled substances, make the information with respect to such controlled substances from the PDMP available to State regulation and licensing boards; and
with respect to any other controlled substances, may make the information with respect to such controlled substances from the PDMP available to State regulation and licensing boards.
Subgrantees— A quality improvement organization with which the Secretary has entered into a contract under part B of title XI of the Social Security Act may serve as the subgrantee under this subsection to develop peer review processes as described in subsection (a).
4. Prescription drug and other controlled substance abuse prevention
Part P of title III of the Public Health Service Act (42 U.S.C. 280g) is amended by adding at the end the following:
“399V–6. Prescription drug and other controlled substance abuse prevention
“(a) Training grants
“(1) In general—The Secretary shall award 5-year grants to eligible entities to facilitate training in order to increase the capacity of health care providers to conduct patient screening and brief interventions, such as in health care settings to prevent the abuse of prescription drugs and other controlled substances. The grant program under this section may be coordinated with the Screening Brief Intervention and Referral to Treatment grant program of the Substance Abuse and Mental Health Services Administration, or other appropriate program.
“(2) Eligible entities—In this subsection, the term “eligible entity” includes—
“(A) States;
“(B) continuing education entities, such as health profession boards or health accrediting bodies; and
“(C) other appropriate health or professional education organizations or institutions.
“(b) Federal health care workers—Health care providers who participate in or are employed by a Federal health care program, including the Indian Health Service, the Department of Veterans Affairs, the Department of Defense, the Federal Bureau of Prisons, the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), a State Medicaid plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), the State Children's Health Insurance Program under title XXI of the Social Security Act (42 U.S.C. 1397aa et seq.), and Federally qualified health centers, shall screen patients for abuse of prescription drugs or other controlled substances, conduct brief interventions, and provide referrals for known or suspected abuse of prescription drugs or other controlled substances, as appropriate.
“(c) Expansion of prescribing authority—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall award grants to States for the purpose of evaluating the prospect of the health professions board of such States reviewing and expanding prescribing authorities of providers, such as advance practice nurses and physician's assistants, in order to control the abuse of prescription drugs or other controlled substances with respect to specific drugs and other controlled substances, as appropriate.”
5. Prescription drug abuse training and screening programs
Continuing education grants— The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall award grants to States to develop continuing education criteria and review processes that allow State health profession boards or State agencies to certify appropriate education and training for informed and safe prescribing of opioids and other drugs on schedule II and III under section 202 of the Controlled Substances Act (21 U.S.C. 812).
Registration with DEA— A practitioner who registers or renews a registration under section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) shall, at the time of registering, certify to the Attorney General that such practitioner has completed continuing medical education—
in the case of a practitioner registering for the first time, with respect to prescription drug abuse; and
in the case of a practitioner renewing a registration, with respect to medical understanding of the proper use of all drugs listed in the schedules under section 202 of the Controlled Substances Act (21 U.S.C. 812).
Screening program— The Attorney General shall require that a practitioner registered under section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) conduct patient screening for potential drug misuse or abuse before prescribing a drug listed on schedule II or III under section 202 of the Controlled Substances Act (21 U.S.C. 812), according to standards established by the applicable State licensing body.
6. FDA review of naloxone
The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall conduct a review of naloxone to consider whether naloxone should cease to be subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) and be available as a behind-the-counter drug, in order to increase access of such drug to community-based organizations and street outreach organizations.
7. Prescription drug disposal
The Secretary of Health and Human Services shall convene or coordinate with an existing entity an interagency working group to encourage 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.
8. GAO report
The Comptroller General of the United States shall review prescription drug abuse programs and policies in Federal agencies and best practices with respect to prescription drug abuse programs of the States and, not later than 18 months after the date of enactment of this Act, shall issue a report to Congress on its findings and recommendations on ways to reduce prescription drug abuse.