US Codex
Pub. L.
Notes

Title I — Prevention and Education

114th Congress · Approved Jul 22, 2016 · 130 Stat. 695

TITLE I Prevention and Education

SEC. 101. Task Force on Pain Management.

(a)
Definitions.— In this section:
(1)
Secretary.— The term “Secretary” means the Secretary of Health and Human Services.
(2)
Task force.— The term “task force” means the Pain Management Best Practices Inter-Agency Task Force convened under subsection (b).
(b)
Inter-Agency Task Force.— Not later than 2 years after the date of enactment of this Act, the Secretary, in cooperation with the Secretary of Veterans Affairs and the Secretary of Defense, shall convene a Pain Management Best Practices Inter-Agency Task Force.
(c)
Membership.— The task force shall be comprised of—
(1)
representatives of—
(A)
the Department of Health and Human Services and relevant agencies within the Department of Health and Human Services;
(B)
the Department of Veterans Affairs;
(C)
the Department of Defense; and
(D)
the Office of National Drug Control Policy;
(2)
currently licensed and practicing physicians, dentists, and nonphysician prescribers;
(3)
currently licensed and practicing pharmacists and pharmacies;
(4)
experts in the fields of pain research and addiction research, including adolescent and young adult addiction research;
(5)
representatives of—
(A)
pain management professional organizations;
(B)
the mental health treatment community;
(C)
the addiction treatment community, including individuals in recovery from substance use disorder;
(D)
pain advocacy groups, including patients;
(E)
veteran service organizations;
(F)
groups with expertise on overdose reversal, including first responders;
(G)
State medical boards; and
(H)
hospitals;
(6)
experts on the health of, and prescription opioid use disorders in, members of the Armed Forces and veterans; and
(7)
experts in the field of minority health.
(d)
Representation.— The Secretary shall ensure that the membership of the task force includes individuals representing rural and underserved areas.
(e)
Duties.— The task force shall—
(1)
identify, review, and, as appropriate, determine whether there are gaps in or inconsistencies between best practices for pain management (including chronic and acute pain) developed or adopted by Federal agencies;
(2)
not later than 1 year after the date on which the task force is convened under subsection (b), propose updates to best practices and recommendations on addressing gaps or inconsistencies identified under paragraph (1), as appropriate, and submit to relevant Federal agencies and the general public such proposed updates and recommendations, taking into consideration—
(A)
existing pain management research and other relevant research;
(B)
recommendations from relevant conferences and existing relevant evidence-based guidelines;
(C)
ongoing efforts at the State and local levels and by medical professional organizations to develop improved pain management strategies, including consideration of differences within and between classes of opioids, the availability of opioids with abuse deterrent technology, and pharmacological, nonpharmacological, and medical device alternatives to opioids to reduce opioid monotherapy in appropriate cases;
(D)
the management of high-risk populations who receive opioids in the course of medical care, other than for pain management;
(E)
the 2016 Guideline for Prescribing Opioids for Chronic Pain issued by the Centers for Disease Control and Prevention; and
(F)
private sector, State, and local government efforts related to pain management and prescribing pain medication;
(3)
provide the public with at least 90 days to submit comments on any proposed updates and recommendations under paragraph (2); and
(4)
develop a strategy for disseminating information about best practices for pain management (including chronic and acute pain) to stakeholders, if appropriate.
(f)
Limitation.— The task force shall not have rulemaking authority.
(g)
Sunset.— The task force under this section shall sunset after 3 years.

SEC. 102. Awareness Campaigns.

(a)
In General.— The Secretary of Health and Human Services, in coordination with the heads of other departments and agencies, shall, as appropriate, through existing programs and activities, advance the education and awareness of the public (including providers, patients, and consumers) and other appropriate entities regarding the risk of abuse of prescription opioids if such drugs are not taken as prescribed.
(b)
Topics.— The education and awareness campaigns under subsection (a) shall address—
(1)
the dangers of opioid abuse;
(2)
the prevention of opioid abuse, including through safe disposal of prescription medications and other safety precautions; and
(3)
the detection of early warning signs of addiction.
(c)
Other Requirements.— The education and awareness campaigns under subsection (a) shall, as appropriate—
(1)
take into account any association between prescription opioid abuse and heroin use;
(2)
emphasize—
(A)
the similarities between heroin and prescription opioids; and
(B)
the effects of heroin and prescription opioids on the human body; and
(3)
bring greater public awareness to the dangerous effects of fentanyl when mixed with heroin or abused in a similar manner.

SEC. 103. Community-Based Coalition Enhancement Grants to Address Local Drug Crises.

(a)
Definitions.— In this section:
(1)
Administrator.— The term “Administrator” means the Administrator of the Substance Abuse and Mental Health Services Administration.
(2)
Director.— The term “Director” means the Director of the Office of National Drug Control Policy.
(3)
Drug-free communities act of 1997.— The term “Drug-Free Communities Act of 1997” means chapter 2 of the National Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.).
(4)
Eligible entity.— The term “eligible entity” means an organization that—
(A)
on or before the date of submitting an application for a grant under this section, receives or has received a grant under the Drug-Free Communities Act of 1997; and
(B)
has documented, using local data, rates of abuse of opioids or methamphetamines at levels that are—
(i)
significantly higher than the national average as determined by the Secretary (including appropriate consideration of the results of the Monitoring the Future Survey published by the National Institute on Drug Abuse and the National Survey on Drug Use and Health published by the Substance Abuse and Mental Health Services Administration); or
(ii)
higher than the national average, as determined by the Secretary (including appropriate consideration of the results of the surveys described in clause (i)), over a sustained period of time.
(5)
Emerging drug abuse issue.— The term “emerging drug abuse issue” means a substance use disorder within an area involving—
(A)
a sudden increase in demand for particular drug abuse treatment services relative to previous demand; and
(B)
a lack of resources in the area to address the emerging problem.
(6)
Local drug crisis.— The term “local drug crisis” means, with respect to the area served by an eligible entity—
(A)
a sudden increase in the abuse of opioids or methamphetamines, as documented by local data;
(B)
the abuse of prescription medications, specifically opioids or methamphetamines, that is significantly higher than the national average, over a sustained period of time, as documented by local data; or
(C)
a sudden increase in opioid-related deaths, as documented by local data.
(7)
Opioid.— The term “opioid” means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.
(b)
Program Authorized.— The Director, in coordination with the Administrator, may make grants to eligible entities to implement comprehensive community-wide strategies that address local drug crises and emerging drug abuse issues within the area served by the eligible entity.
(c)
Application.—
(1)
In general.— An eligible entity seeking a grant under this section shall submit an application to the Director at such time, in such manner, and accompanied by such information as the Director may require.
(2)
Criteria.— As part of an application for a grant under this section, the Director shall require an eligible entity to submit a detailed, comprehensive, multisector plan for addressing the local drug crisis or emerging drug abuse issue within the area served by the eligible entity.
(d)
Use of Funds.— An eligible entity shall use a grant received under this section—
(1)
for programs designed to implement comprehensive community-wide prevention strategies to address the local drug crisis in the area served by the eligible entity, in accordance with the plan submitted under subsection (c)(2);
(2)
to obtain specialized training and technical assistance from the organization funded under section 4 of Public Law 107–82 (21 U.S.C. 1521 note); and
(3)
for programs designed to implement comprehensive community-wide strategies to address emerging drug abuse issues in the community.
(e)
Supplement Not Supplant.— An eligible entity shall use Federal funds received under this section only to supplement the funds that would, in the absence of those Federal funds, be made available from other Federal and non-Federal sources for the activities described in this section, and not to supplant those funds.
(f)
Evaluation.— A grant under this section shall be subject to the same evaluation requirements and procedures as the evaluation requirements and procedures imposed on the recipient of a grant under the Drug-Free Communities Act of 1997, and may also include an evaluation of the effectiveness at reducing abuse of opioids or methamphetamines.
(g)
Limitation on Administrative Expenses.— Not more than 8 percent of the amounts made available to carry out this section for a fiscal year may be used to pay for administrative expenses.
(h)
Delegation Authority.— The Director may enter into an interagency agreement with the Administrator to delegate authority for the execution of grants and for such other activities as may be necessary to carry out this section.
(i)
Authorization of Appropriations.— For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2017 through 2021.

SEC. 104. Information Materials and Resources to Prevent Addiction Related to Youth Sports Injuries.

(a)
Report.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall, not later than 24 months after the date of the enactment of this section, make publicly available on the appropriate website of the Department of Health and Human Services a report determining the extent to which informational materials and resources described in subsection (c) are available to teenagers and adolescents who play youth sports, families of such teenagers and adolescents, nurses, youth sports groups, and relevant health care provider groups.
(b)
Development of Informational Materials and Resources.— The Secretary may, for purposes of preventing substance use disorder in teenagers and adolescents who are injured playing youth sports and are subsequently prescribed an opioid, not later than 12 months after the report is made publicly available under subsection (a), and taking into consideration the findings of such report and in coordination with relevant health care provider groups, facilitate the development of informational materials and resources described in subsection (c) for teenagers and adolescents who play youth sports, families of such teenagers and adolescents, nurses, youth sports groups, and relevant health care provider groups.
(c)
Materials and Resources Described.— For purposes of this section, the informational materials and resources described in this subsection are informational materials and resources with respect to youth sports injuries for which opioids are potentially prescribed, including materials and resources focused on the risks associated with opioid use and misuse, treatment options for such injuries that do not involve the use of opioids, and how to seek treatment for addiction.
(d)
No Additional Funds.— No additional funds are authorized to be appropriated for the purpose of carrying out this section. This section shall be carried out using amounts otherwise available for such purpose.

SEC. 105. Assisting Veterans with Military Emergency Medical Training to Meet Requirement for Becoming Civilian Health Care Professionals.

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 314 the following:

“SEC. 315. ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL TRAINING TO MEET REQUIREMENTS FOR BECOMING CIVILIAN HEALTH CARE PROFESSIONALS.

“(a) Program.—

“(1) In general.—The Secretary may establish a program, in consultation with the Secretary of Labor, consisting of awarding demonstration grants to States to streamline State requirements and procedures in order to assist veterans who held certain military occupational specialties related to medical care or who have completed certain medical training while serving in the Armed Forces of the United States to meet certification, licensure, and other requirements applicable to civilian health care professions (such as emergency medical technician, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician assistant professions) in the State.

“(2) Consultation and collaboration.—In determining the eligible military occupational specialties or training courses and the assistance required as described in paragraph (1), the Secretary shall consult with the Secretary of Defense, the Secretary of Veterans Affairs, and the Assistant Secretary of Labor for Veterans’ Employment and Training, and shall collaborate with the initiatives carried out under section 4114 of title 38, United States Code, and sections 1142 through 1144 of title 10, United States Code.

“(b) Use of Funds.—Amounts received as a demonstration grant under this section shall be used to—

“(1) prepare and implement a plan to streamline State requirements and procedures as described in subsection (a), including by—

“(A) determining the extent to which the requirements for the education, training, and skill level of civilian health care professions (such as emergency medical technicians, paramedics, licensed practical nurses, registered nurses, physical therapy assistants, or physician assistants) in the State are equivalent to requirements for the education, training, and skill level of veterans who served in medical related fields while a member of the Armed Forces of the United States; and

“(B) identifying methods, such as waivers, for veterans who served in medical related fields while a member of the Armed Forces of the United States to forgo or meet any such equivalent State requirements; and

“(2) if necessary to meet workforce shortages or address gaps in education, training, or skill level to meet certification, licensure or other requirements applicable to becoming a civilian health care professional (such as an emergency medical technician, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician assistant professions) in the State, develop or expand career pathways at institutions of higher education to support veterans in meeting such requirements.

“(c) Report.—Upon the completion of the demonstration program under this section, the Secretary shall submit to Congress a report on the program.

“(d) Funding.—No additional funds are authorized to be appropriated for the purpose of carrying out this section. This section shall be carried out using amounts otherwise available for such purpose.

“(e) Sunset.—The demonstration program under this section shall not exceed 5 years.”

SEC. 106. Fda Opioid Action Plan.

(a)
In General.—
(1)
New drug application.—
(A)
In general.— Subject to subparagraph (B), prior to the approval pursuant to an application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) of a new drug that is an opioid, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall refer the application to an advisory committee of the Food and Drug Administration to seek recommendations from such advisory committee.
(B)
Public health exemption.— A referral to an advisory committee under subparagraph (A) is not required with respect to a new opioid drug or drugs if the Secretary—
(i)
finds that such a referral is not in the interest of protecting and promoting public health;
(ii)
finds that such a referral is not necessary based on a review of the relevant scientific information; and
(iii)
submits a notice containing the rationale for such findings to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(2)
Pediatric opioid labeling.— The Secretary shall convene the Pediatric Advisory Committee of the Food and Drug Administration to seek recommendations from such Committee regarding a framework for the inclusion of information in the labeling of drugs that are opioids relating to the use of such drugs in pediatric populations before the Secretary approves any labeling or change to labeling for any drug that is an opioid intended for use in a pediatric population.
(3)
Sunset.— The requirements of paragraphs (1) and (2) shall cease to be effective on October 1, 2022.
(b)
Prescriber Education.— Not later than 1 year after the date of the enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, as part of the Food and Drug Administration’s evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, and in consultation with relevant stakeholders, shall develop recommendations regarding education programs for prescribers of opioids pursuant to section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), including recommendations on—
(1)
which prescribers should participate in such programs; and
(2)
how often participation in such programs is necessary.
(c)
Guidance on Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.— Not later than 18 months after the end of the period for public comment on the draft guidance entitled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products” issued by the Center for Drug Evaluation and Research of the Food and Drug Administration in March 2016, the Commissioner of Food and Drugs shall publish in the Federal Register a final version of such guidance.

SEC. 107. Improving Access to Overdose Treatment.

(a)
Grants for Reducing Overdose Deaths.— Part D of title V of the Public Health Service Act (42 U.S.C. 290dd et seq.) is amended by adding at the end the following:

“SEC. 544. GRANTS FOR REDUCING OVERDOSE DEATHS.

“(a) Establishment.—

“(1) In general.—The Secretary shall award grants to eligible entities to expand access to drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.

“(2) Maximum grant amount.—A grant awarded under this section may not be for more than $200,000 per grant year.

“(3) Eligible entity.—For purposes of this section, the term ‘eligible entity’ means a Federally qualified health center (as defined in section 1861(aa) of the Social Security Act), an opioid treatment program under part 8 of title 42, Code of Federal Regulations, any practitioner dispensing narcotic drugs pursuant to section 303(g) of the Controlled Substances Act, or any other entity that the Secretary deems appropriate.

“(4) Prescribing.—For purposes of this section, the term ‘prescribing’ means, with respect to a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, the practice of prescribing such drug or device—

“(A) in conjunction with an opioid prescription for patients at an elevated risk of overdose;

“(B) in conjunction with an opioid agonist approved under section 505 of the Federal Food, Drug, and Cosmetic Act for the treatment of opioid use disorder;

“(C) to the caregiver or a close relative of patients at an elevated risk of overdose from opioids; or

“(D) in other circumstances in which a provider identifies a patient is at an elevated risk for an intentional or unintentional drug overdose from heroin or prescription opioid therapies.

“(b) Application.—To be eligible to receive a grant under this section, an eligible entity shall submit to the Secretary, in such form and manner as specified by the Secretary, an application that describes—

“(1) the extent to which the area to which the entity will furnish services through use of the grant is experiencing significant morbidity and mortality caused by opioid abuse;

“(2) the criteria that will be used to identify eligible patients to participate in such program; and

“(3) a plan for sustaining the program after Federal support for the program has ended.

“(c) Use of Funds.—An eligible entity receiving a grant under this section may use amounts under the grant for any of the following activities, but may use not more than 20 percent of the grant funds for activities described in paragraphs (3) and (4):

“(1) To establish a program for prescribing a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.

“(2) To train and provide resources for health care providers and pharmacists on the prescribing of drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.

“(3) To purchase drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, for distribution under the program described in paragraph (1).

“(4) To offset the co-payments and other cost sharing associated with drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.

“(5) To establish protocols to connect patients who have experienced a drug overdose with appropriate treatment, including medication-assisted treatment and appropriate counseling and behavioral therapies.

“(d) Evaluations by Recipients.—As a condition of receipt of a grant under this section, an eligible entity shall, for each year for which the grant is received, submit to the Secretary an evaluation of activities funded by the grant which contains such information as the Secretary may reasonably require.

“(e) Reports by the Secretary.—Not later than 5 years after the date on which the first grant under this section is awarded, the Secretary shall submit to the appropriate committees of the House of Representatives and of the Senate a report aggregating the information received from the grant recipients for such year under subsection (d) and evaluating the outcomes achieved by the programs funded by grants awarded under this section.

“(f) Authorization of Appropriations.—There is authorized to be appropriated to carry out this section, $5,000,000 for the period of fiscal years 2017 through 2021.”

(b)
Improving Access to Overdose Treatment.—
(1)
Information on best practices.— Not later than 180 days after the date of enactment of this Act:
(A)
The Secretary of Health and Human Services may provide information to prescribers within Federally qualified health centers (as defined in paragraph (4) of section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa))), and the health care facilities of the Indian Health Service, on best practices for prescribing or co-prescribing a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.
(B)
The Secretary of Defense may provide information to prescribers within Department of Defense medical facilities on best practices for prescribing or co-prescribing a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.
(C)
The Secretary of Veterans Affairs may provide information to prescribers within Department of Veterans Affairs medical facilities on best practices for prescribing or co-prescribing a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.
(2)
Rule of construction.— Nothing in this subsection should be construed to establish or contribute to a medical standard of care.

SEC. 108. Nih Opioid Research.

(a)
In General.— The Director of the National Institutes of Health (referred to in this section as the “NIH”) may intensify and coordinate fundamental, translational, and clinical research of the NIH with respect to—
(1)
the understanding of pain;
(2)
the discovery and development of therapies for chronic pain; and
(3)
the development of alternatives to opioids for effective pain treatments.
(b)
Priority and Direction.— The prioritization and direction of the Federally funded portfolio of pain research studies shall consider recommendations made by the Interagency Pain Research Coordinating Committee in concert with the Pain Management Best Practices Inter-Agency Task Force, and in accordance with the National Pain Strategy, the Federal Pain Research Strategy, and the NIH-Wide Strategic Plan for Fiscal Years 2016–2020, the latter of which calls for the relative burdens of individual diseases and medical disorders to be regarded as crucial considerations in balancing the priorities of the Federal research portfolio.

SEC. 109. National All Schedules Prescription Electronic Reporting Reauthorization.

(a)
Amendment to Purpose.— Paragraph (1) of section 2 of the National All Schedules Prescription Electronic Reporting Act of 2005 (Public Law 109–60) is amended to read as follows:

“(1) foster the establishment of State-administered controlled substance monitoring systems in order to ensure that health care providers have access to the accurate, timely prescription history information that they may use as a tool for the early identification of patients at risk for addiction in order to initiate appropriate medical interventions and avert the tragic personal, family, and community consequences of untreated addiction; and”

(b)
Amendments to Controlled Substance Monitoring Program.— Section 399O of the Public Health Service Act (42 U.S.C. 280g–3) is amended—
(1)
in subsection (a)(1)—
(A)
in the matter preceding subparagraph (A), by inserting “ , in consultation with the Administrator of the Substance Abuse and Mental Health Services Administration and Director of the Centers for Disease Control and Prevention,” after “ the Secretary”;
(B)
in subparagraph (A), by striking “ or”;
(C)
in subparagraph (B), by striking the period at the end and inserting “ ; or”; and
(D)
by adding at the end the following:

“(C) to maintain an existing State-controlled substance monitoring program.”

(2)
by amending subsection (b) to read as follows:

“(b) Minimum Requirements.—The Secretary shall maintain and, as appropriate, supplement or revise (after publishing proposed additions and revisions in the Federal Register and receiving public comments thereon) minimum requirements for criteria to be used by States for purposes of clauses (ii), (v), (vi), and (vii) of subsection (c)(1)(A).”

(3)
in subsection (c)—
(A)
in paragraph (1)(B)—
(i)
in the matter preceding clause (i), by striking “ (a)(1)(B)” and inserting “ (a)(1)(B) or (a)(1)(C)”;
(ii)
in clause (i), by striking “ program to be improved” and inserting “ program to be improved or maintained”;
(iii)
by redesignating clauses (iii) and (iv) as clauses (iv) and (v), respectively;
(iv)
by inserting after clause (ii), the following:

“(iii) a plan to apply the latest advances in health information technology, to the extent practicable, in order to incorporate prescription drug monitoring program data directly into the workflow of prescribers and dispensers to ensure timely access to patients’ controlled prescription drug history;”

(v)
in clause (iv) (as so redesignated), by striking “ ; and” and inserting the following: “ and at least one health information technology system such as electronic health records, health information exchanges, or e-prescribing systems;”;
(vi)
in clause (v) (as so redesignated)—
(I)
by striking “ public health” and inserting “ public health or safety”; and
(II)
by striking the period and inserting “ ; and”; and
(vii)
by adding at the end the following:

“(vi) information, where applicable, on how the controlled substance monitoring program jointly works with the applicant’s respective State substance abuse agency to ensure information collected and maintained by the controlled substance monitoring program is used to inform the provision of clinically appropriate substance use disorder services to individuals in need.”

(B)
in paragraph (3)—
(i)
by striking “ If a State that submits” and inserting the following:

“(A) In general.—If a State that submits”

(ii)
by inserting before the period at the end “ and include timelines for full implementation of such interoperability. The State shall also describe the manner in which it will achieve interoperability between its monitoring program and health information technology systems, as allowable under State law, and include timelines for the implementation of such interoperability”; and
(iii)
by adding at the end the following:

“(B) Monitoring of efforts.—The Secretary shall monitor State efforts to achieve interoperability, as described in subparagraph (A).”

; and

(C)
in paragraph (5)—
(i)
by striking “ implement or improve” and inserting “ establish, improve, or maintain”; and
(ii)
by adding at the end the following: “ The Secretary shall redistribute any funds that are so returned among the remaining grantees under this section in accordance with the formula described in subsection (a)(2)(B).”;
(4)
in subsection (d)—
(A)
in the matter preceding paragraph (1)—
(i)
by striking “ In implementing or improving” and all that follows through “ (a)(1)(B)” and inserting “ In establishing, improving, or maintaining a controlled substance monitoring program under this section, a State shall comply, or with respect to a State that applies for a grant under subparagraph (B) or (C) of subsection (a)(1)”; and
(ii)
by striking “ public health” and inserting “ public health or safety”; and
(B)
by adding at the end the following:

“(5) The State shall report on interoperability with the controlled substance monitoring program of Federal agencies, where appropriate, interoperability with health information technology systems such as electronic health records, health information exchanges, and e-prescribing, where appropriate, and whether or not the State provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient.”

(5)
in subsections (e), (f)(1), and (g), by striking “ implementing or improving” each place it appears and inserting “ establishing, improving, or maintaining”;
(6)
in subsection (f)—
(A)
in paragraph (1)—
(i)
in subparagraph (B), by striking “ misuse of a schedule II, III, or IV substance” and inserting “ misuse of a controlled substance included in schedule II, III, or IV of section 202(c) of the Controlled Substances Act”; and
(ii)
in subparagraph (D)—
(I)
by inserting “ a State substance abuse agency,” after “ State health department,”; and
(II)
by striking “ such department, program, or administration” each place it appears and inserting “ such department, program, agency, or administration” in each such place; and
(B)
by adding at the end the following:

“(3) Evaluation and reporting.—Subject to subsection (g), a State receiving a grant under subsection (a) shall provide the Secretary with aggregate data to enable the Secretary—

“(A) to evaluate the success of the State’s program in achieving its purposes; or

“(B) to prepare and submit the report to Congress required by subsection (k)(2).

“(4) Research by other entities.—A department, program, agency, or administration receiving nonidentifiable information under paragraph (1)(D) may make such information available to other entities for research purposes.”

(7)
by striking subsection (k);
(8)
by redesignating subsections (h) through (j) as subsections (i) through (k), respectively;
(9)
in subsections (c)(1)(A)(iv) and (d)(4), by striking “ subsection (h)” each place it appears and inserting “ subsection (i)”;
(10)
by inserting after subsection (g) the following:

“(h) Education and Access to the Monitoring System.—A State receiving a grant under subsection (a) shall take steps to—

“(1) facilitate prescriber and dispenser use of the State’s controlled substance monitoring system, to the extent practicable; and

“(2) educate prescribers and dispensers on the benefits of the system.”

(11)
in subsection (k)(2)(A), as so redesignated—
(A)
in clause (ii), by striking “ or affected” and inserting “ , established or strengthened initiatives to ensure linkages to substance use disorder services, or affected”; and
(B)
in clause (iii), by striking “ including an assessment” and inserting “ and between controlled substance monitoring programs and health information technology systems, including an assessment”;
(12)
in subsection (l)(1), by striking “ establishment, implementation, or improvement” and inserting “ establishment, improvement, or maintenance”;
(13)
in subsection (m)(8), by striking “ and the District of Columbia” and inserting “ , the District of Columbia, and any commonwealth or territory of the United States”; and
(14)
by amending subsection (n) to read as follows:

“(n) Authorization of Appropriations.—To carry out this section, there are authorized to be appropriated, $10,000,000 for each of fiscal years 2017 through 2021.”

SEC. 110. Opioid Overdose Reversal Medication Access and Education Grant Programs.

(a)
In General.— Part D of title V of the Public Health Service Act (42 U.S.C. 290dd et seq.), as amended by section 107, is further amended by adding at the end the following:

“SEC. 545. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND EDUCATION GRANT PROGRAMS.

“(a) Grants to States.—The Secretary shall make grants to States to—

“(1) implement strategies for pharmacists to dispense a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, as appropriate, pursuant to a standing order;

“(2) encourage pharmacies to dispense opioid overdose reversal medication pursuant to a standing order;

“(3) develop or provide training materials that persons authorized to prescribe or dispense a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose may use to educate the public concerning—

“(A) when and how to safely administer such drug or device; and

“(B) steps to be taken after administering such drug or device; and

“(4) educate the public concerning the availability of drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose without a person-specific prescription.

“(b) Certain Requirement.—A grant may be made under this section only if the State involved has authorized standing orders to be issued for drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.

“(c) Preference in Making Grants.—In making grants under this section, the Secretary may give preference to States that have a significantly higher rate of opioid overdoses than the national average, and that—

“(1) have not implemented standing orders regarding drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose;

“(2) authorize standing orders to be issued that permit community-based organizations, substance abuse programs, or other nonprofit entities to acquire, dispense, or administer drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; or

“(3) authorize standing orders to be issued that permit police, fire, or emergency medical services agencies to acquire and administer drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.

“(d) Grant Terms.—

“(1) Number.—A State may not receive more than one grant under this section at a time.

“(2) Period.—A grant under this section shall be for a period of 3 years.

“(3) Limitation.—A State may use not more than 20 percent of a grant under this section for educating the public pursuant to subsection (a)(4).

“(e) Applications.—To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may reasonably require, including detailed proposed expenditures of grant funds.

“(f) Reporting.—A State that receives a grant under this section shall, at least annually for the duration of the grant, submit a report to the Secretary evaluating the progress of the activities supported through the grant. Such reports shall include information on the number of pharmacies in the State that dispense a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose under a standing order, and other information as the Secretary determines appropriate to evaluate the use of grant funds.

“(g) Definitions.—In this section the term ‘standing order’ means a document prepared by a person authorized to prescribe medication that permits another person to acquire, dispense, or administer medication without a person-specific prescription.

“(h) Authorization of Appropriations.—

“(1) In general.—To carry out this section, there are authorized to be appropriated $5,000,000 for the period of fiscal years 2017 through 2019.

“(2) Administrative costs.—Not more than 3 percent of the amounts made available to carry out this section may be used by the Secretary for administrative expenses of carrying out this section.”

(b)
Technical Clarification.— Effective as if included in the enactment of the Children’s Health Act of 2000 (Public Law 106–310), section 3405(a) of such Act (114 Stat. 1221) is amended by striking “ Part E of title III” and inserting “ Part E of title III of the Public Health Service Act”.