US Codex
Pub. L.
Notes

Title II — Medicare Provisions to Address the Opioid Crisis

115th Congress · Approved Oct 24, 2018 · 132 Stat. 3894

TITLE II Medicare Provisions to Address the Opioid Crisis

SEC. 2001. Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder and Other Substance Use Disorders.

(a)
In General.— Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—
(1)
in paragraph (2)(B)—
(A)
in clause (i), in the matter preceding subclause (I), by striking “ clause (ii)” and inserting “ clause (ii) and paragraph (6)(C)”; and
(B)
in clause (ii), in the heading, by striking “ for home dialysis therapy”;
(2)
in paragraph (4)(C)—
(A)
in clause (i), by striking “ paragraph (6)” and inserting “ paragraphs (5), (6), and (7)”; and
(B)
in clause (ii)(X), by inserting “ or telehealth services described in paragraph (7)” before the period at the end; and
(3)
by adding at the end the following new paragraph:

“(7) Treatment of substance use disorder services furnished through telehealth.—The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after July 1, 2019, to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder, as determined by the Secretary, at an originating site described in paragraph (4)(C)(ii) (other than an originating site described in subclause (IX) of such paragraph).”

(b)
Implementation.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) may implement the amendments made by this section by interim final rule.
(c)
Report.—
(1)
In general.— Not later than 5 years after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the impact of the implementation of the amendments made by this section with respect to telehealth services under section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) on—
(A)
the utilization of health care items and services under title XVIII of such Act (42 U.S.C. 1395 et seq.) related to substance use disorders, including emergency department visits; and
(B)
health outcomes related to substance use disorders, such as opioid overdose deaths.
(2)
Funding.— For purposes of carrying out paragraph (1), in addition to funds otherwise available, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $3,000,000 to the Centers for Medicare & Medicaid Services Program Management Account to remain available until expended.

SEC. 2002. Comprehensive Screenings for Seniors.

(a)
Initial Preventive Physical Examination.— Section 1861(ww) of the Social Security Act (42 U.S.C. 1395x(ww)) is amended—
(1)
in paragraph (1)—
(A)
by striking “ paragraph (2) and” and inserting “ paragraph (2),”; and
(B)
by inserting “ and the furnishing of a review of any current opioid prescriptions (as defined in paragraph (4)),” after “ upon the agreement with the individual,”; and
(2)
in paragraph (2)—
(A)
by redesignating subparagraph (N) as subparagraph (O); and
(B)
by inserting after subparagraph (M) the following new subparagraph:

“(N) Screening for potential substance use disorders.”

; and

(3)
by adding at the end the following new paragraph:

“(4) For purposes of paragraph (1), the term ‘a review of any current opioid prescriptions’ means, with respect to an individual determined to have a current prescription for opioids—

“(A) a review of the potential risk factors to the individual for opioid use disorder;

“(B) an evaluation of the individual’s severity of pain and current treatment plan;

“(C) the provision of information on non-opioid treatment options; and

“(D) a referral to a specialist, as appropriate.”

(b)
Annual Wellness Visit.— Section 1861(hhh)(2) of the Social Security Act (42 U.S.C. 1395x(hhh)(2)) is amended—
(1)
by redesignating subparagraph (G) as subparagraph (I); and
(2)
by inserting after subparagraph (F) the following new subparagraphs:

“(G) Screening for potential substance use disorders and referral for treatment as appropriate.

“(H) The furnishing of a review of any current opioid prescriptions (as defined in subsection (ww)(4)).”

(c)
Rule of Construction.— Nothing in the amendments made by subsection (a) or (b) shall be construed to prohibit separate payment for structured assessment and intervention services for substance abuse furnished to an individual on the same day as an initial preventive physical examination or an annual wellness visit.
(d)
Effective Date.— The amendments made by this section shall apply to examinations and visits furnished on or after January 1, 2020.

SEC. 2003. Every Prescription Conveyed Securely.

(a)
In General.— Section 1860D–4(e) of the Social Security Act (42 U.S.C. 1395w–104(e)) is amended by adding at the end the following:

“(7) Requirement of e-prescribing for controlled substances.—

“(A) In general.—Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, or V controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph (2).

“(B) Exception for certain circumstances.—The Secretary shall, through rulemaking, specify circumstances and processes by which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of—

“(i) a prescription issued when the practitioner and dispensing pharmacy are the same entity;

“(ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard;

“(iii) a prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner;

“(iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved;

“(v) a prescription issued by a practitioner prescribing a drug under a research protocol;

“(vi) a prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use;

“(vii) a prescription issued by a practitioner—

“(I) for an individual who receives hospice care under this title; and

“(II) that is not covered under the hospice benefit under this title; and

“(viii) a prescription issued by a practitioner for an individual who is—

“(I) a resident of a nursing facility (as defined in section 1919(a)); and

“(II) dually eligible for benefits under this title and title XIX.

“(C) Dispensing.—

(i) Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A).

“(ii) Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense covered part D drugs from otherwise valid written, oral, or fax prescriptions that are consistent with laws and regulations.

“(iii) Nothing in this paragraph shall be construed as affecting the ability of an individual who is being prescribed a covered part D drug to designate a particular pharmacy to dispense the covered part D drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph.

“(D) Enforcement.—The Secretary shall, through rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A).”

(b)
Effective Date.— The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021.
(c)
Update of Biometric Component of Multifactor Authentication.— Not later than 1 year after the date of enactment of this Act, the Attorney General shall update the requirements for the biometric component of multifactor authentication with respect to electronic prescriptions of controlled substances.

SEC. 2004. Requiring Prescription Drug Plan Sponsors under Medicare to Establish Drug Management Programs for At-Risk Beneficiaries.

Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)) is amended—
(1)
in paragraph (1), by inserting after subparagraph (E) the following new subparagraph:

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

; and

(2)
in paragraph (5)(A), by inserting “ (and for plan years beginning on or after January 1, 2022, a PDP sponsor shall)” after “ A PDP sponsor may”.

SEC. 2005. Medicare Coverage of Certain Services Furnished by Opioid Treatment Programs.

(a)
Coverage.— Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended—
(1)
in subparagraph (FF), by striking at the end “ and”;
(2)
in subparagraph (GG), by inserting at the end “ and”; and
(3)
by adding at the end the following new subparagraph:

“(HH) opioid use disorder treatment services (as defined in subsection (jjj)).”

(b)
Opioid Use Disorder Treatment Services and Opioid Treatment Program Defined.— Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection:

“(jjj) Opioid Use Disorder Treatment Services; Opioid Treatment Program.—

“(1) Opioid use disorder treatment services.—The term ‘opioid use disorder treatment services’ means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including—

“(A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for use in the treatment of opioid use disorder;

“(B) dispensing and administration of such medications, if applicable;

“(C) substance use counseling by a professional to the extent authorized under State law to furnish such services;

“(D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law);

“(E) toxicology testing, and

“(F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation).

“(2) Opioid treatment program.—The term ‘opioid treatment program’ means an entity that is an opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that—

“(A) is enrolled under section 1866(j);

“(B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program;

“(C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and

“(D) meets such additional conditions as the Secretary may find necessary to ensure—

“(i) the health and safety of individuals being furnished services under such program; and

“(ii) the effective and efficient furnishing of such services.”

(c)
Payment.—
(1)
In general.— Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended—
(A)
by striking “ and (bb)” and inserting “ (bb)”; and
(B)
by inserting before the semicolon at the end the following “ , and (cc) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary”.
(2)
Payment determination.— Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

“(w) Opioid Use Disorder Treatment Services.—

“(1) In general.—The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program.

“(2) Considerations.—The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code.

“(3) Annual updates.—The Secretary shall provide an update each year to the bundled payment amounts under this subsection.”

(d)
Including Opioid Treatment Programs as Medicare Providers.— Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is amended—
(1)
in paragraph (1), by striking at the end “ and”;
(2)
in paragraph (2), by striking the period at the end and inserting “ ; and”; and
(3)
by adding at the end the following new paragraph:

“(3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section).”

SEC. 2006. Encouraging Appropriate Prescribing under Medicare for Victims of Opioid Overdose.

Section 1860D–4(c)(5)(C) of the Social Security Act (42 U.S.C. 1395w–104(c)(5)(C)) is amended—
(1)
in clause (i), in the matter preceding subclause (I), by striking “ For purposes” and inserting “ Except as provided in clause (v), for purposes”; and
(2)
by adding at the end the following new clause:

“(v) Treatment of enrollees with a history of opioid-related overdose.—

“(I) In general.—For plan years beginning not later than January 1, 2021, a part D eligible individual who is not an exempted individual described in clause (ii) and who is identified under this clause as a part D eligible individual with a history of opioid-related overdose (as defined by the Secretary) shall be included as a potentially at-risk beneficiary for prescription drug abuse under the drug management program under this paragraph.

“(II) Identification and notice.—For purposes of this clause, the Secretary shall—

“(aa) identify part D eligible individuals with a history of opioid-related overdose (as so defined); and

“(bb) notify the PDP sponsor of the prescription drug plan in which such an individual is enrolled of such identification.”

SEC. 2007. Automatic Escalation to External Review under a Medicare Part D Drug Management Program for At-Risk Beneficiaries.

(a)
In General.— Section 1860D–4(c)(5) of the Social Security Act (42 U.S.C. 1395ww–10(c)(5)) is amended—
(1)
in subparagraph (B), in each of clauses (ii)(III) and (iii)(IV), by striking “ and the option of an automatic escalation to external review” and inserting “ , including notice that if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution”; and
(2)
in subparagraph (E), by striking “ and the option” and all that follows and inserting the following: “ and if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution.”.
(b)
Effective Date.— The amendments made by subsection (a) shall apply beginning not later January 1, 2021.

SEC. 2008. Suspension of Payments by Medicare Prescription Drug Plans and Ma–pd Plans Pending Investigations of Credible Allegations of Fraud by Pharmacies.

(a)
In General.— Section 1860D–12(b) of the Social Security Act (42 U.S.C. 1395w–112(b)) is amended by adding at the end the following new paragraph:

“(7) Suspension of payments pending investigation of credible allegations of fraud by pharmacies.—

“(A) In general.—Section 1862(o)(1) shall apply with respect to a PDP sponsor with a contract under this part, a pharmacy, and payments to such pharmacy under this part in the same manner as such section applies with respect to the Secretary, a provider of services or supplier, and payments to such provider of services or supplier under this title. A PDP sponsor shall notify the Secretary regarding the imposition of any payment suspension pursuant to the previous sentence, such as through the secure internet website portal (or other successor technology) established under section 1859(i).

“(B) Rule of construction.—Nothing in this paragraph shall be construed as limiting the authority of a PDP sponsor to conduct postpayment review.”

(b)
Application to MA–PD Plans.— Section 1857(f)(3) of the Social Security Act (42 U.S.C. 1395w–27(f)(3)) is amended by adding at the end the following new subparagraph:

“(D) Suspension of payments pending investigation of credible allegations of fraud by pharmacies.—Section 1860D–12(b)(7).”

(c)
Conforming Amendment.— Section 1862(o)(3) of the Social Security Act (42 U.S.C. 1395y(o)(3)) is amended by inserting “ , section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)),” after “ this subsection”.
(d)
Clarification Relating to Credible Allegation of Fraud.— Section 1862(o) of the Social Security Act (42 U.S.C. 1395y(o)) is amended by adding at the end the following new paragraph:

“(4) Credible allegation of fraud.—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.”

(e)
Effective Date.— The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2020.