H. R. 6—36 
‘‘(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 deter-
mines are appropriate (but in no event to include meals 
or transportation). 
‘‘(2) OPIOID TREATMENT PROGRAM.—The term ‘opioid treat-
ment 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 pro-
gram; 
‘‘(C) is accredited by an accrediting body approved by 
the Substance Abuse and Mental Health Services Adminis-
tration; and 
‘‘(D) meets such additional conditions as the Secretary 
may find necessary to ensure— 
‘‘(i) the health and safety of individuals being fur-
nished 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 deter-
mined appropriate by the Secretary, that no duplicative pay-
ments 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 deter-
mine appropriate. In developing such bundles, the Secretary 
may consider payment rates paid to opioid treatment programs
H. R. 6—37 
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 para-
graph (1) of such section).’’. 
SEC. 2006. ENCOURAGING APPROPRIATE PRESCRIBING UNDER MEDI-
CARE 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 pur-
poses 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 indi-
vidual 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
H. R. 6—38 
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 INVESTIGA-
TIONS OF CREDIBLE ALLEGATIONS OF FRAUD BY PHAR-
MACIES. 
(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 pursu-
ant 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 para-
graph 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.—Sec-
tion 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 pursu-
ant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud 
hotline tip (as defined by the Secretary) without further evi-
dence 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.
H. R. 6—39 
TITLE III—FDA AND CONTROLLED 
SUBSTANCE PROVISIONS 
Subtitle A—FDA Provisions 
CHAPTER 1—IN GENERAL 
SEC. 3001. CLARIFYING FDA REGULATION OF NON-ADDICTIVE PAIN 
PRODUCTS. 
(a) PUBLIC MEETINGS.—Not later than one year after the date 
of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’), acting 
through the Commissioner of Food and Drugs, shall hold not less 
than one public meeting to address the challenges and barriers 
of developing non-addictive medical products intended to treat acute 
or chronic pain or addiction, which may include— 
(1) 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; 
(2) 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; 
(3) 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 
(4) 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. 
(b) GUIDANCE.—Not less than one year after the public meetings 
are conducted under subsection (a) the Secretary shall issue one 
or more final guidance documents, or update existing guidance 
documents, to help address challenges to developing non-addictive 
medical products to treat pain or addiction. Such guidance docu-
ments shall include information regarding— 
(1) 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— 
(A) may apply the eligibility criteria under such sec-
tions 506 and 515B to non-addictive medical products 
intended to treat pain or addiction;