Public Law 115–271: To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes.

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“(nn)

Juvenile; Eligible Juvenile; Public Institution.—

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Not later than the date that is 180 days after the date of the enactment of this subsection, the Secretary shall, in consultation, as appropriate, with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, conduct a 54-month demonstration project for the purpose described in paragraph (2) under which the Secretary shall—

The purpose described in this paragraph is for each State selected under paragraph (4) to increase the treatment capacity of providers participating under the State plan (or a waiver of such plan) to provide substance use disorder treatment or recovery services under such plan (or waiver) through the following activities:

“(C)

“(D)

“(B)

Selection.—

“(C)

Activities described.—

“(B)

Selection.—

“(C)

Applications.—

“(A)

State reports.—

“(B)

CMS reports.—

During the period of the demonstration project under this subsection, the Secretary shall, in collaboration with States selected under paragraph (4), facilitate data sharing and the development of best practices between such States and States that were not so selected.

There is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 to the Centers for Medicare & Medicaid Services for purposes of implementing this subsection. Such amount shall remain available until expended.”

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“(oo)

Drug Review and Utilization Requirements.—

by “of section 1903(i)(10)(B)” and “of section 1902(a)(54)”;

by “, by not later than January 1, 1993,”;

by after “gross overuse,” the following: “excessive utilization,”; and

by “or inappropriate or medically unnecessary care” and “inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization”; and

by after “gross overuse,” the following: “excessive utilization,”; and

by “or inappropriate or medically unnecessary care” and “inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization”.

“(4)

Special rule relating to substance use disorder health homes.—

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“(ee)

Medication-Assisted Treatment.—

“(2)

Counseling and services.—

the mechanisms through which States may provide such coverage, including through existing statutory authority or through waivers;

the populations to which States have provided such coverage;

the payment models, including any alternative payment models, used by States to pay providers of such services; and

where available, information on Federal and State spending under Medicaid for peer support services.

improving access to behavioral health services;

improving early detection, and preventing worsening, of behavioral health disorders;

reducing chronic and comorbid conditions; and

reducing overall health costs.

utilization rates;

costs;

avoidable inpatient admissions and readmissions;

quality of care; and

patient, family, and provider satisfaction.

a medicaid managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act (42 U.S.C. 1396u–2(a)(1)(B))), including the number of such individuals who received such assistance through a prepaid inpatient health plan or a prepaid ambulatory health plan;132 STAT. 3922

a fee-for-service payment model; or

an alternative payment model, to the extent available.

“(B)

“(C)

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“(4)

“(B)

Exception for certain circumstances.—

“(C)

Dispensing.—

With respect to plan years beginning on or after January 1, 2022, a drug management program for at-risk beneficiaries described in paragraph (5).”

“(1)

Opioid use disorder treatment services.—

“(2)

Opioid treatment program.—

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“(w)

Opioid Use Disorder Treatment Services.—

“(II)

Identification and notice.—

Section 1860D–12(b)(7).”

In carrying out this subsection, section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for a credible allegation of fraud.”

the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable;

the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for the development of non-addictive medical products intended to treat pain or addiction;

the evidentiary standards and the development of opioid-sparing data for inclusion in the labeling of medical products intended to treat acute or chronic pain; and

the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive medical products intended to treat pain or addiction.

how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary—

the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence;

the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain, including—

the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section.

the term “” means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and

the term “” means reducing, , or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain.132 STAT. 3934

consult with stakeholders, which may include conducting a public meeting of medical professional societies (including any State-based societies), health care providers, State medical boards, medical specialties including pain medicine specialty societies, patient groups, pharmacists, academic or medical research entities, and other entities with experience in health care, as appropriate;

collaborate with the Director of the Centers for Disease Control and Prevention, as applicable and appropriate, and other Federal agencies with relevant expertise as appropriate; and

provide for a notice and comment period consistent with section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)) for the submission of comments by the public.

update the guidelines under subsection (a), informed by public input described in subsection (b); and

submit to the committees specified in subsection (c) and post on the public website of the Food and Drug Administration an updated report under such subsection.

are intended to help inform clinical decisionmaking by prescribers and patients; and

are not intended to be used for the purposes of restricting, limiting, delaying, or denying coverage for, or access to, a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.132 STAT. 3935

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In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include—

(A)

Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate and practicable.

The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs and in consultation with the U.S. Customs and Border Protection, shall develop and periodically update a mutually agreed upon list of the controlled substances that the Secretary will refer to U.S. Customs and Border Protection, unless the Secretary and U.S. Customs and Border Protection agree otherwise, when such substances are offered for import via international mail and appear to violate the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law. The Secretary shall transfer controlled substances on such list to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.).

Not later than 9 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Secretary of Homeland Security, shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the implementation of this section.

Section 301(cc) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) —

Section 306(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) —

(A)

(B)

by “, then such article shall be refused admission” “or (5) such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses (1) through (5) shall be refused admission”;

by “If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission.” before “With respect to an article of food, if importation”; and

by “Clause (2) of the third sentence” and all that follows through the period at the end and the following: “Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission 132 STAT. 3940 of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act.”.

is amended

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adding

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in clause (i) by “and” at the end; and

by at the end the following:.

is amended

in paragraph (1)—

in paragraph (2)—

a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies;

an evaluation of existing reference standards with respect to controlled substance disposal products and packaging technologies, including any such standards established by a standards development organization, and how such standards should be considered in ensuring effectiveness of such products and technologies;

identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act 132 STAT. 3942 (21 U.S.C. 801 et seq.), are made available to the public and any barriers to the use of such disposal products;

identification of ways in which packaging technologies are made available to the public and any barriers to the use of such technologies;

a description of current Federal oversight, if any, of site-of-use, in-home controlled substance disposal products, including—

a description of current Federal oversight, if any, of controlled substance packaging technologies, including—

recommendations, as appropriate, on—

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in subparagraph (A) by—

in clause (i) of subparagraph (B), by before the semicolon “, or new effectiveness information”;

in subparagraph (C) by “safety information” and “safety or new effectiveness information”; and

in subparagraph (E) by “safety information” and “safety or new effectiveness information”.

is amended

is amended

in subclause (I), by “or” at the end; and

by subclause (II) to read as follows:.

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the average frequency with which qualifying practitioners see their patients;

the average frequency with which patients receive counseling, including the rates by which such counseling is provided by such a qualifying practitioner directly, or by referral;

the frequency of toxicology testing, including the average frequency with which random toxicology testing is administered;

the average monthly patient caseload for each type of qualifying practitioner;

the treatment retention rates for patients;

overdose and mortality rates; and

any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner.

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circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act (21 U.S.C. 829) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and

other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances.

pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and

other health care practitioners and the public on a pharmacist’s ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)).

is amended

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The Comptroller General of the United States (in this section referred to as the “Comptroller General”) shall conduct a study on the requirements applicable to, and challenges of, hospice programs with regard to the management and disposal of controlled substances in the home of an individual.

In conducting the study under paragraph (1), the Comptroller General shall include—

“(2)

Regulations.—

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Attorney General

authorized collector

covered grant

eligible collector

identify, stop, and report suspicious orders; or

maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (21 U.S.C. 823) or any successor law or associated regulation.

is amended

by subsections (f), (g), and (h) as subsections (g), (h), and (i), respectively;

by after subsection (e) the following:; and

by after subsection (i), as so redesignated, the following:.

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in subsection (a)—

in subsection (c)—

(B)

is amended

in subsection (a)—

in subsection (b), in the first sentence, by “production” and “manufacturing”;

in subsection (c), by “October” and “December”; and

by at the end the following:.

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adding

In this subsection, the term “” has the meaning given that term in section 102 of the Controlled Substances Act, as amended by this chapter.

Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report on the reporting of suspicious orders, which shall include—

Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date that is 5 years after the date of enactment of this Act, the Attorney General shall submit to Congress a report providing, for the previous year—

Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States, in consultation with the Administrator of the Drug Enforcement Administration, shall submit to Congress a report on the reporting of suspicious orders, which shall include an evaluation of the utility of real-time reporting of potential suspicious orders of opioids on a national level using computerized algorithms, including the extent to which such algorithms—

With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y).

Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State—

“(i)

For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent.

For purposes of this paragraph:

“(iii)

a primary plan to the program under this title; or

for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and”

“(i)

In general.—

“(ii)

Special rules.—

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in subparagraph (C)(i), by “brand name” and “listed”; and

by clause (ii) of subparagraph (C) to read as follows:;132 STAT. 3961

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by “2 generic drug applicants” and “2 or more generic drug applicants”; and

by “or an agreement between 2 biosimilar biological product applicants regarding the 1-year period referred to in section 351(k)(6)(A) of the Public Health Service Act as it applies to the biosimilar biological product applications with which the agreement is concerned” and “, an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product”; and

by “Not later than January 1, 2013” and the following:; and

by at the end the following:; and

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the number of such institutions in the State;

the facility type of such institutions in the State; and

any coverage limitations under each such State plan (or waiver) on scope, duration, or frequency of such services.132 STAT. 3963

such services provided at such institution;

the process, including any timeframe, used by such institution to clinically assess and reassess such individuals; and

the discharge process used by such institution, including any care continuum of relevant services or facilities provided or used in such process.

any Federal waiver that each such State has for such institutions and the Federal statutory authority for such waiver; and

any other Medicaid funding sources used by each such State for funding such institutions, such as supplemental payments.

representative sample of States

State

institution for mental diseases

is amended

by paragraphs (5), (6), (7), and (8) as paragraphs (6), (7), (8), and (9), respectively; and

by after paragraph (4) the following new paragraph:.

Section 2103(a) of the Social Security Act (42 U.S.C. 1397cc(a)) , in the matter before paragraph (1), by “paragraphs (5), (6), and (7)” and “paragraphs (5), (6), (7), and (8)”.

Section 2110(a) of the Social Security Act (42 U.S.C. 1397jj(a)) —

Section 2110(b)(5)(A)(i) of the Social Security Act (42 U.S.C. 1397jj(b)(5)(A)(i)) by “subsection (c)(5)” and “subsection (c)(6)”.

to ease the health care-related transition of an individual who is an inmate of a public institution from the public institution to the community, including best practices for ensuring continuity of health insurance coverage or coverage under the State Medicaid plan under title XIX of the Social Security Act, as applicable, and relevant social services; and

to carry out, with respect to such an individual, such health care-related transition not later than 30 days after such individual is released from the public institution.

“SEC. 1944.

42 USC

1396w–3a.

REQUIREMENTS RELATING TO QUALIFIED PRESCRIPTION DRUG MONITORING PROGRAMS AND PRESCRIBING CERTAIN CONTROLLED SUBSTANCES.

A qualified prescription drug monitoring program described in this subsection, with respect to a State, may have in place, in accordance with applicable State and Federal law, a data-sharing agreement with the State Medicaid program that allows the medical director and pharmacy director of such program (and any designee of such a director who reports directly to such director) to access the information described in paragraph (1) in an electronic format. The State Medicaid program under this title may facilitate reasonable and limited access, as determined by the State and ensuring documented beneficiary protections regarding the use of such data, 132 STAT. 3968 to such qualified prescription drug monitoring program for the medical director or pharmacy director of any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under section 1903(m) or under section 1905(t)(3), or the medical director or pharmacy director of any entity that has a contract to manage the pharmaceutical benefit with respect to individuals enrolled in the State plan (or under a waiver of the State plan). All applicable State and Federal security and privacy laws shall apply to the directors or designees of such directors of any State Medicaid program or entity accessing a qualified prescription drug monitoring program under this section.

“(e)

Reports.—

“(f)

Increase to FMAP and Federal Matching Rates for Certain Expenditures Relating to Qualified Prescription Drug Monitoring Programs.—

“(h)

Definitions.—

Monitoring and preventing fraud, waste, and abuse.

Improving health care for individuals enrolled in a State plan under title XIX of such Act (or under a waiver of such plan) who—132 STAT. 3971

Any other purposes specified by the Secretary.

shall include strategies for assisting States in allowing the medical director or pharmacy director (or designees of such a director) of managed care organizations or pharmaceutical benefit managers to access information with respect to all covered individuals served by such managed care organizations or pharmaceutical benefit managers to access as a single data set, in an electronic format; and

shall include any appropriate beneficiary protections and privacy guidelines.

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Providing, for the adoption and use of certified EHR technology (as defined in section 1848(o)(4)) to improve the quality and coordination of care through the electronic documentation and exchange of health information, incentive payments to behavioral health providers (such as psychiatric hospitals (as defined in section 1861(f)), community mental health centers (as defined in section 1861(ff)(3)(B)), hospitals that participate in a State plan under title XIX or a waiver of such plan, treatment facilities that participate in such a State plan or such a waiver, mental health or substance use disorder providers that participate in such a State plan or such a waiver, clinical psychologists (as defined in section 1861(ii)), nurse practitioners (as defined in section 1861(aa)(5)) with respect to the provision of psychiatric services, and clinical social workers (as defined in section 1861(hh)(1))).”

“(d)

“(a)

Implementation of 4-Year Demonstration Program.—

132 STAT. 3980

“(b)

Program Design.—

“(c)

Participants; Opioid Use Disorder Care Teams.—

“(d)

Participation of Applicable Beneficiaries.—

“(e)

Payments.—

“(g)

Evaluation.—

“(h)

Funding.—

eligible entity

an organization—

(ii)

an entity that is a quality improvement entity with a contract under part B of title XI of the Social Security Act (42 U.S.C. 1320c et seq.).

outlier prescriber of opioids

prescriber

“(i)

In general.—

“(ii)

Electronic transmission.—

“(i)

Program Integrity Transparency Measures.—

“(5)

Communicating plan corrective actions against opioids over-prescribers.—

“(ii)

Identification of outlier prescribers of opioids.—

“(iii)

Contents of notification.—

“(iv)

Modifications and expansions.—

“(v)

Additional requirements for persistent outlier prescribers.—

“(22)

Review and revisions of payments for non-opioid alternative treatments.—

132 STAT. 3993

“(3)

Additional payments for certain fqhcs with physicians or other practitioners receiving data 2000 waivers.—

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medication-assisted treatments for opioid use, substance use disorder counseling, peer recovery support services, or other forms of substance use disorder treatments (whether furnished in an inpatient or outpatient setting); and

non-opioid alternatives for the treatment of pain.

Evidence-based treatments and technologies for chronic or acute pain, including such treatments that are covered, not covered, or have limited coverage under such title.

Evidence-based treatments and technologies that monitor substance use withdrawal and prevent overdoses of opioids.

Evidence-based treatments and technologies that treat substance use disorders.

Items and services furnished by practitioners through a multi-disciplinary treatment model for pain management, including the patient-centered medical home.

Items and services furnished to beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, or have comorbidities and require consultation or management of pain with one or more specialists in pain management, mental health, or addiction treatment.

Barriers inhibiting individuals entitled to benefits under part A or enrolled under part B of such title from accessing treatments and technologies described in subparagraphs (A) through (E) of paragraph (1).

Costs and benefits associated with potential expansion of coverage under such title to include items and services not covered under such title that may be used for the treatment of pain, such as acupuncture, therapeutic massage, and items and services furnished by integrated pain management programs.

Pain management guidance published by the Federal Government that may be relevant to coverage determinations or other coverage requirements under title XVIII of the Social Security Act.

methods to identify such individuals at-risk of opioid use disorder, including risk stratification;

ways to prevent, recognize, and treat opioid overdoses; and

resources available to such individuals, such as opioid treatment programs, peer support groups, and other recovery programs.

the adverse effects of prolonged opioid use;

non-opioid, evidence-based, non-pharmacological pain management treatments;

monitoring programs for individuals who have been prescribed opioids; and

the prescribing of naloxone along with an initial opioid prescription.

explains the risks and side effects associated with opioid use (including the risks of addiction and overdose) and the importance of adhering to the prescribed treatment regimen, avoiding medications that may have an adverse interaction with such opioid, and storing such opioid safely and securely;

highlights multimodal and evidence-based non-opioid alternatives for pain management;

encourages such individuals to talk to their health care providers about such alternatives;

provides for a method (through signature or otherwise) for such an individual, or person acting on such individual’s behalf, to acknowledge receipt of such notification template;

is worded in an easily understandable manner and made available in multiple languages determined appropriate by the Secretary; and

includes any other information determined appropriate by the Secretary.132 STAT. 4001

ways for such hospital to establish target levels, taking into account the specialties of such practitioners and the geographic area in which such hospital is located, with respect to opioids prescribed by such practitioners;

guidance on checking the medical records of such individuals against information included in prescription drug monitoring programs;

strategies to reduce long-term opioid prescriptions; and

methods to identify such practitioners who may be over-prescribing opioids.

“(2)

Review and assessment.—

“(3)

Consideration of measures by secretary.—

“(5)

Prioritization of measure endorsement.—

Approaches that limit patient exposure to opioids during the perioperative period, including pre-surgical and post-surgical injections, and that identify such patients at risk of opioid use disorder pre-operation.

Shared decision making with patients and families on pain management, including a review of payment to ensure payment under the Medicare program under title XVIII of the Social Security Act accounts for time spent on shared decision making.

Education on the safe use, storage, and disposal of opioids.132 STAT. 4003

Prevention of opioid misuse and abuse after discharge.

Development of a clinical algorithm to identify and treat at-risk, opiate-tolerant patients and reduce reliance on opioids for acute pain during the perioperative period.

surgical volumes, practices, and opioid prescribing patterns;

opioid consumption, including—

regional anesthesia and analgesia practices, including pre-surgical and post-surgical injections;

naloxone reversal;

post-operative respiratory failure;

information about storage and disposal; and

such other information as the Secretary may specify.

Medical professional organizations.

Providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act (42 U.S.C. 1395x)).

Health care consumers or groups representing such consumers.

Other entities determined appropriate by the Secretary.

“(vi)

“(n)

Provision of Information Relating to the Safe Disposal of Certain Prescription Drugs.—

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inserting

adding

“(XII)

is amended

in subparagraph (A), by at the end the following new clauses:; and

in subparagraph (B), by “, physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, or certified nurse-midwife” after “physician”.