Increasing the Safety of Prescription Drug Use Act of 2013

Summary: Increasing the Safety of Prescription Drug Use Act of 2013 - Amends the Public Health Service Act, with respect to state databases for controlled substance monitoring programs, to require the state to: (1) ensure that its database is interoperable with other such programs and electronic health records and provides updated patient information available to a practitioner; (2) require practitioners to use database information to help determine whether to prescribe or renew a prescription for a controlled substance; and (3) require dispensers, where permitted, to enter patient data required by the Secretary of Health and Human Services (HHS) into the database, including concerning methadone dispensed. Imposes confidentiality protections regarding patient information in the database. Requires health care practitioners and dispensers who participate in or are employed by a federal or federally funded health care program, and federally qualified health centers, to use the databases of the controlled substance monitoring programs if they are available to the practitioner or dispenser. Directs the Secretary to award grants to carry out a pilot project to develop a standardized peer review process and methodology to review and evaluate prescribing and pharmacy dispensing patterns.  Establishes a grant program to facilitate training to increase the capacity of health care providers to conduct patient screening and brief interventions. Requires health care providers who participate in or are employed by a federal health care program, and federally qualified health centers, to 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. Requires the Secretary to award grants to states for: (1) evaluating the prospect of review by health professions boards of prescribing authorities of providers, and (2) development of continuing education criteria and review processes that allow health professions boards or state agencies to certify appropriate education and training for informed and safe prescribing of opioids and other drugs in schedules II and III of the Controlled Substances Act. Requires practitioners who register or renew a registration to dispense or conduct research with controlled substances in schedules II, III, IV, or V to certify that they have completed continuing medical education regarding prescription drug abuse (in the case of first-time registration) and regarding medical understanding of the proper use of all drugs listed in all of the controlled substances schedules (in the case of renewals). Directs the Attorney General to require a practitioner so registered to conduct patient screening for potential drug misuse or abuse before prescribing a schedule II or III drug, according to standards established by the state licensing body. Requires the Secretary to: (1) review naloxone to consider whether it should cease to be a prescription-only drug 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; and (2) convene or coordinate an interagency working group to encourage states and local governments to increase opportunities for disposal of opiates and to reduce opportunities for abuse, as by establishing opioid dispensing limits at hospital emergency departments. Directs the Comptroller General (GAO) to review prescription drug abuse programs and policies in federal agencies and best practices with respect to prescription drug abuse programs of the states.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Increasing the Safety of 
Prescription Drug Use Act of 2013''.

SEC. 2. PRESCRIPTION DRUG MONITORING PROGRAM.

    (a) Controlled Substance Monitoring Program.--Section 399O of the 
Public Health Service Act (42 U.S.C. 243g-3) is amended--
            (1) 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.''; and
            (2) 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.''.
    (b) 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.
    (c) 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.

SEC. 3. PILOT PROJECT.

    (a) 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.
    (b) 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.
    (c) Requirements.--A State receiving a grant under this section 
shall--
            (1) 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
            (2) 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.
    (d) 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).

SEC. 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:

``SEC. 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.''.

SEC. 5. PRESCRIPTION DRUG ABUSE TRAINING AND SCREENING PROGRAMS.

    (a) 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).
    (b) 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--
            (1) in the case of a practitioner registering for the first 
        time, with respect to prescription drug abuse; and
            (2) 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).
    (c) 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.

SEC. 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.

SEC. 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.

SEC. 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.