I 
114TH CONGRESS 
2D SESSION 
H. R. 4697 
To provide for increased Federal oversight of prescription opioid treatment 
and assistance to States in reducing opioid addiction, diversion, and deaths. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 3, 2016 
Ms. ESTY (for herself, Mr. COSTELLO of Pennsylvania, and Mr. KNIGHT) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committees on Ways and 
Means and the Judiciary, for a period to be subsequently determined by 
the Speaker, in each case for consideration of such provisions as fall with-
in the jurisdiction of the committee concerned 
A BILL 
To provide for increased Federal oversight of prescription 
opioid treatment and assistance to States in reducing 
opioid addiction, diversion, and deaths. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Prevent Drug Addic-
tion Act of 2016’’. 
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SEC. 2. CONSUMER EDUCATION CAMPAIGN. 
Part A of title V of the Public Health Service Act 
(42 U.S.C. 290aa et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 506C. CONSUMER EDUCATION CAMPAIGN. 
‘‘(a) IN GENERAL.—The Administrator shall award 
grants to States and nonprofit entities for the purpose of 
conducting culturally sensitive consumer education about 
opioid addiction, including methadone addiction. Such 
education shall include information on the dangers of 
opioid addiction, how to prevent opioid addiction including 
through safe disposal of prescription medications and 
other safety precautions, and detection of early warning 
signs of addiction. 
‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 
under subsection (a), an entity shall— 
‘‘(1) be a State or nonprofit entity; and 
‘‘(2) submit to the Administrator an application 
at such time, in such manner, and containing such 
information as the Administrator may require. 
‘‘(c) PRIORITY.—In awarding grants under this sec-
tion, the Administrator shall give priority to applicants 
that are States or communities with a high incidence of 
addiction to methadone and other opioids, and opioid-re-
lated deaths. 
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‘‘(d) EVALUATIONS.—The Administrator shall de-
velop a process to evaluate the effectiveness of activities 
carried out by grantees under this section at reducing ad-
diction to methadone and other opioids. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
$15,000,000 for each of fiscal years 2017 through 2021.’’. 
SEC. 3. PRACTITIONER EDUCATION. 
(a) EDUCATION REQUIREMENTS.— 
(1) REGISTRATION
CONSIDERATION.—Section 
303(f) of the Controlled Substances Act (21 U.S.C. 
823(f)) is amended by inserting after paragraph (5) 
the following: 
‘‘(6) The applicant’s compliance with the train-
ing requirements described in subsection (g)(3) dur-
ing any previous period in which the applicant has 
been subject to such training requirements.’’. 
(2) TRAINING REQUIREMENTS.—Section 303(g) 
of the Controlled Substances Act (21 U.S.C. 823(g)) 
is amended by adding at the end the following: 
‘‘(3)(A) To be registered to prescribe or otherwise 
dispense methadone or other opioids, a practitioner de-
scribed in paragraph (1) shall comply with the 12-hour 
training requirement of subparagraph (B) at least once 
during each 3-year period. 
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‘‘(B) The training requirement of this subparagraph 
is that the practitioner has completed not less than 12 
hours of training (through classroom situations, seminars 
at professional society meetings, electronic communica-
tions, or otherwise) with respect to— 
‘‘(i) the treatment and management of opioid- 
dependent patients; 
‘‘(ii) pain management treatment guidelines; 
and 
‘‘(iii) early detection of opioid addiction, includ-
ing through such methods as Screening, Brief Inter-
vention, and Referral to Treatment (SBIRT), 
that is provided by the American Society of Addiction 
Medicine, the American Academy of Addiction Psychiatry, 
the American Medical Association, the American Osteo-
pathic Association, the American Psychiatric Association, 
the American Academy of Pain Management, the Amer-
ican Pain Society, the American Academy of Pain Medi-
cine, the American Board of Pain Medicine, the American 
Society of Interventional Pain Physicians, or any other or-
ganization that the Secretary determines is appropriate 
for purposes of this subparagraph.’’. 
(b) REQUIREMENTS FOR PARTICIPATION IN OPIOID 
TREATMENT PROGRAMS.—Effective July 1, 2017, a phy-
sician practicing in an opioid treatment program shall 
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comply with the requirements of section 303(g)(3) of the 
Controlled Substances Act (as added by subsection (a)) 
with respect to required minimum training at least once 
during each 3-year period. 
(c) DEFINITION.—In this section, the term ‘‘opioid 
treatment program’’ has the meaning given such term in 
section 8.2 of title 42, Code of Federal Regulations (or 
any successor regulation). 
(d) FUNDING.—The Drug Enforcement Administra-
tion shall fund the enforcement of the requirements speci-
fied in section 303(g)(3) of the Controlled Substances Act 
(as added by subsection (a)) through the use of a portion 
of the licensing fees paid by controlled substance pre-
scribers under the Controlled Substances Act (21 U.S.C. 
801 et seq.). 
SEC. 4. OPERATION OF OPIOID TREATMENT PROGRAMS. 
Section 303 of the Controlled Substances Act (21 
U.S.C. 823) is amended by adding at the end the fol-
lowing: 
‘‘(i)(1) An opioid treatment program that is reg-
istered under this section, and that closes for business on 
any weekday or weekend day, including a Federal or State 
holiday, shall comply with the requirements of this sub-
section. 
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‘‘(2) The program shall make acceptable arrange-
ments for each patient who is restricted, by Federal regu-
lation or guideline or by the determination of the program 
medical director, from having a take-home dose of a con-
trolled substance related to the treatment involved, to re-
ceive a dose of that substance under appropriate super-
vision during the closure. 
‘‘(3) The Administrator of the Substance Abuse and 
Mental Health Services Administration shall issue a notice 
that references regulations on acceptable arrangements 
under this subsection, or shall promulgate regulations on 
such acceptable arrangements.’’. 
SEC. 5. MORTALITY REPORTING. 
Part A of title V of the Public Health Service Act 
(42 U.S.C. 290aa et seq.), as amended by section 3, is 
further amended by adding at the end the following: 
‘‘SEC. 506D. MORTALITY REPORTING. 
‘‘(a) MODEL OPIOID TREATMENT PROGRAM MOR-
TALITY REPORT.— 
‘‘(1) IN
GENERAL.—Not later than July 1, 
2017, the Secretary, acting through the Adminis-
trator, shall require that a Model Opioid Treatment 
Program Mortality Report be completed and sub-
mitted to the Administrator for each individual who 
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dies while receiving treatment in an opioid treatment 
program. 
‘‘(2) REQUIREMENT OF STATES THAT RECEIVE 
FUNDING FOR THE CONTROLLED SUBSTANCE MONI-
TORING
PROGRAM.—As a condition for receiving 
funds under section 399O, each State shall require 
that any individual who signs a death certificate 
where an opioid drug is detected in the body of the 
deceased, or where such drug is otherwise associated 
with the death, report such death to the Adminis-
trator by submitting a Model Opioid Treatment Pro-
gram Mortality Report described in paragraph (3). 
Such report shall be submitted to the Administrator 
on or before the later of— 
‘‘(A) 90 days after the date of signing the 
death certificate; or 
‘‘(B) as soon as practicable after the date 
on which the necessary postmortem and toxi-
cology reports become available to such indi-
vidual, as required by the Secretary. 
‘‘(3) DEVELOPMENT.—The Administrator, in 
consultation with State and local medical examiners, 
prescribing physicians, hospitals, and any other or-
ganization that the Administrator determines appro-
priate, shall develop a Model Opioid Treatment Pro-
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gram Mortality Report to be used under paragraphs 
(1) and (2). 
‘‘(b) NATIONAL OPIOID DEATH REGISTRY.— 
‘‘(1) IN
GENERAL.—Not later than July 1, 
2017, the Administrator shall establish and imple-
ment, through the National Center for Health Sta-
tistics, a National Opioid Death Registry (referred 
to in this subsection as the ‘Registry’) to track 
opioid-related deaths and information related to such 
deaths. 
‘‘(2) CONSULTATION.—In establishing the uni-
form reporting criteria for the Registry, the Director 
of the Centers for Disease Control and Prevention 
shall consult with the Administrator, State and local 
medical examiners, prescribing physicians, hospitals, 
and any other organization that the Director deter-
mines is appropriate for purposes of this subsection. 
‘‘(3) REQUIREMENTS.—The registry shall be 
designed as a uniform reporting system for opioid- 
related deaths and shall require the reporting of in-
formation with respect to such deaths, including— 
‘‘(A) the particular drug formulation used 
at the time of death; 
‘‘(B) the dosage level; 
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‘‘(C) a description of the circumstances 
surrounding the death in relation to the rec-
ommended dosage involved; 
‘‘(D) a disclosure of whether the medica-
tion involved can be traced back to a physi-
cian’s prescription; 
‘‘(E) a disclosure of whether the individual 
was in an opioid treatment program at the time 
of death; 
‘‘(F) the age and sex of the individual; and 
‘‘(G) other nonpersonal information such 
as that included in filed National Association of 
Medical Examiners Pediatric Toxicology Reg-
istry case reports as required under the privacy 
standard for the de-identification of health in-
formation pursuant to the regulations contained 
in part 164 of title 45, Code of Federal Regula-
tions. 
‘‘(4) AUTHORIZATION.—There is authorized to 
be appropriated $5,000,000 for each of fiscal years 
2017 through 2021 to carry out this subsection. 
‘‘(c) REPORT
ON REGISTRY INFORMATION.—Not 
later than the January 1 of the first fiscal year beginning 
2 years after the date of enactment of this section, and 
each January 1 thereafter, the Director of the Centers for 
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Disease Control and Prevention shall submit to the Sec-
retary a report, based on information contained in the 
Registry described in subsection (b), concerning the num-
ber of methadone-related deaths in the United States for 
the year for which the report is submitted.’’. 
SEC. 6. DEVELOPMENT OF PRESCRIPTION DRUG ADDIC-
TION PREVENTION AND TREATMENT QUAL-
ITY MEASURES ACROSS EACH RELEVANT 
PROVIDER SETTING. 
Subpart I of part D of title IX of the Public Health 
Service Act (42 U.S.C. 299b–31 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 932. DEVELOPMENT OF PRESCRIPTION DRUG ADDIC-
TION PREVENTION AND TREATMENT QUAL-
ITY MEASURES ACROSS EACH RELEVANT 
PROVIDER SETTING. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Agency for Healthcare Research and 
Quality and in consultation with the Director of the Cen-
ters for Disease Control and Prevention, the Adminis-
trator of the Substance Abuse and Mental Health Services 
Administration, and the Director of the Centers for Medi-
care & Medicaid Services, shall require the development 
and application of specific prescription drug addiction pre-
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vention and treatment quality measures for each relevant 
health care provider setting, as identified by the Director. 
‘‘(b) DISSEMINATION.—Not later than April 1, 2017, 
the Secretary shall disseminate the quality measure re-
quirements developed under subsection (a) to all affected 
providers. 
‘‘(c) TYPES OF MEASURES.—Quality measures devel-
oped under this section may be structure-oriented (such 
as the required presence of a hospital-based treatment 
program), process-oriented (such as requiring patients to 
be informed of the addictive qualities of the medication 
being prescribed), or outcome-oriented (such as assessing 
family satisfaction with care).’’. 
SEC. 7. PROGRAMS TO PREVENT PRESCRIPTION DRUG AD-
DICTION UNDER MEDICARE PART D. 
(a) DRUG MANAGEMENT PROGRAM
FOR AT-RISK 
BENEFICIARIES.— 
(1) IN GENERAL.—Section 1860D–4(c) of the 
Social Security Act (42 U.S.C. 1395w–10(c)) is 
amended by adding at the end the following: 
‘‘(4) DRUG MANAGEMENT PROGRAM FOR AT- 
RISK BENEFICIARIES.— 
‘‘(A) AUTHORITY TO ESTABLISH.—A PDP 
sponsor may establish a drug management pro-
gram for at-risk beneficiaries under which, sub-
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ject to subparagraph (B), the PDP sponsor 
may, in the case of an at-risk beneficiary for 
prescription drug addiction who is an enrollee 
in a prescription drug plan of such PDP spon-
sor, limit such beneficiary’s access to coverage 
for addictive drugs under such plan to addictive 
drugs that are prescribed for such beneficiary 
by a prescriber selected under subparagraph 
(D), and dispensed for such beneficiary by a 
pharmacy selected under such subparagraph. 
‘‘(B) REQUIREMENT FOR NOTICES.— 
‘‘(i) IN
GENERAL.—A PDP sponsor 
may not limit the access of an at-risk ben-
eficiary for prescription drug addiction to 
coverage for addictive drugs under a pre-
scription drug plan until such sponsor— 
‘‘(I) provides to the beneficiary 
an initial notice described in clause 
(ii) and a second notice described in 
clause (iii); and 
‘‘(II) verifies with the providers 
of the beneficiary that the beneficiary 
is an at-risk beneficiary for prescrip-
tion drug addiction. 
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‘‘(ii) INITIAL NOTICE.—An initial no-
tice described in this clause is a notice that 
provides to the beneficiary— 
‘‘(I) notice that the PDP sponsor 
has identified the beneficiary as po-
tentially being an at-risk beneficiary 
for prescription drug addiction; 
‘‘(II) information describing all 
State and Federal public health re-
sources that are designed to address 
prescription drug addiction to which 
the beneficiary has access, including 
mental health services and other coun-
seling services; 
‘‘(III) notice of, and information 
about, the right of the beneficiary to 
appeal such identification under sub-
section (h) and the option of an auto-
matic escalation to external review; 
‘‘(IV) a request for the bene-
ficiary to submit to the PDP sponsor 
preferences for which prescribers and 
pharmacies the beneficiary would pre-
fer the PDP sponsor to select under 
subparagraph (D) in the case that the 
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(similar to the information provided 
by the Secretary in other standardized 
notices provided to part D eligible in-
dividuals enrolled in prescription drug 
plans under this part). 
‘‘(iii) SECOND NOTICE.—A second no-
tice described in this clause is a notice that 
provides to the beneficiary notice— 
‘‘(I) that the PDP sponsor has 
identified the beneficiary as an at-risk 
beneficiary for prescription drug ad-
diction; 
‘‘(II) that such beneficiary is 
subject to the requirements of the 
drug management program for at-risk 
beneficiaries established by such PDP 
sponsor for such plan; 
‘‘(III) of the prescriber and phar-
macy selected for such individual 
under subparagraph (D); 
‘‘(IV) of, and information about, 
the beneficiary’s right to appeal such 
identification under subsection (h) 
and the option of an automatic esca-
lation to external review; 
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‘‘(V) that the beneficiary can, in 
the case that the beneficiary has not 
previously submitted to the PDP 
sponsor preferences for which pre-
scribers and pharmacies the bene-
ficiary would prefer the PDP sponsor 
select under subparagraph (D), sub-
mit such preferences to the PDP 
sponsor; and 
‘‘(VI) that includes clear instruc-
tions that explain how the beneficiary 
can contact the PDP sponsor. 
‘‘(iv) TIMING OF NOTICES.— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), a second notice de-
scribed in clause (iii) shall be provided 
to the beneficiary on a date that is 
not less than 60 days after an initial 
notice described in clause (ii) is pro-
vided to the beneficiary. 
‘‘(II) EXCEPTION.—In the case 
that the PDP sponsor, in conjunction 
with the Secretary, determines that 
concerns 
identified 
through 
rule-
making by the Secretary regarding 
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the health or safety of the beneficiary 
or regarding significant drug diversion 
activities require the PDP sponsor to 
provide a second notice described in 
clause (iii) to the beneficiary on a 
date that is earlier than the date de-
scribed in subclause (II), the PDP 
sponsor may provide such second no-
tice on such earlier date. 
‘‘(C) AT-RISK
BENEFICIARY
FOR
PRE-
SCRIPTION DRUG ADDICTION.— 
‘‘(i) IN
GENERAL.—For purposes of 
this paragraph, the term ‘at-risk bene-
ficiary for prescription drug addiction’ 
means a part D eligible individual who is 
not an exempted individual described in 
clause (ii) and— 
‘‘(I) who is identified through the 
use of guidelines developed by the 
Secretary in consultation with PDP 
sponsors and other stakeholders de-
scribed in section 10(f)(2)(A) of the 
Prevent Drug Addiction Act of 2016; 
or 
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‘‘(II) with respect to whom the 
PDP sponsor of a prescription drug 
plan, upon enrolling such individual in 
such plan, received notice from the 
Secretary that such individual was 
identified under this paragraph to be 
an at-risk beneficiary for prescription 
drug addiction under the prescription 
drug plan in which such individual 
was most recently previously enrolled 
and such identification has not been 
terminated under subparagraph (F). 
‘‘(ii) 
EXEMPTED
INDIVIDUAL
DE-
SCRIBED.—An exempted individual de-
scribed in this clause is an individual 
who— 
‘‘(I) receives hospice care under 
this title; or 
‘‘(II) the Secretary elects to treat 
as an exempted individual for pur-
poses of clause (i). 
‘‘(D) SELECTION OF PRESCRIBERS.— 
‘‘(i) IN
GENERAL.—With respect to 
each at-risk beneficiary for prescription 
drug addiction enrolled in a prescription 
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drug plan offered by such sponsor, a PDP 
sponsor shall, based on the preferences 
submitted to the PDP sponsor by the ben-
eficiary pursuant to clauses (ii)(IV) and 
(iii)(V) of subparagraph (B), select— 
‘‘(I) one or more individuals who 
are authorized to prescribe addictive 
drugs (referred to in this paragraph 
as ‘prescribers’) who may write pre-
scriptions for such drugs for such 
beneficiary; and 
‘‘(II) one or more pharmacies 
that may dispense such drugs to such 
beneficiary. 
‘‘(ii) REASONABLE ACCESS.—In mak-
ing the selection under this subparagraph, 
a PDP sponsor shall ensure that the bene-
ficiary continues to have reasonable access 
to drugs described in subparagraph (G), 
taking into account geographic location, 
beneficiary preference, affordability, and 
reasonable travel time. 
‘‘(iii) BENEFICIARY PREFERENCES.— 
‘‘(I) IN GENERAL.—If an at-risk 
beneficiary for prescription drug ad-
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diction submits preferences for which 
in-network prescribers and pharmacies 
the beneficiary would prefer the PDP 
sponsor select in response to a notice 
under subparagraph (B), the PDP 
sponsor shall— 
‘‘(aa) 
review 
such 
pref-
erences; 
‘‘(bb) select or change the 
selection of a prescriber or phar-
macy for the beneficiary based on 
such preferences; and 
‘‘(cc) inform the beneficiary 
of such selection or change of se-
lection. 
‘‘(II) EXCEPTION.—In the case 
that the PDP sponsor determines that 
a change to the selection of a pre-
scriber or pharmacy under item (bb) 
by the PDP sponsor is contributing or 
would contribute to prescription drug 
addiction or drug diversion by the 
beneficiary, the PDP sponsor may 
change the selection of a prescriber or 
pharmacy for the beneficiary without 
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regard to the preferences of the bene-
ficiary described in subclause (I). 
‘‘(iv) CONFIRMATION.—Before select-
ing a prescriber or pharmacy under this 
subparagraph, a PDP sponsor must re-
quest and receive confirmation from the 
prescriber or pharmacy acknowledging and 
accepting that the beneficiary involved is in 
the drug management program for at-risk 
beneficiaries. 
‘‘(E) TERMINATIONS AND APPEALS.—The 
identification of an individual as an at-risk ben-
eficiary for prescription drug addiction under 
this paragraph, a coverage determination made 
under a drug management program for at-risk 
beneficiaries, and the selection of a prescriber 
or pharmacy under subparagraph (D) with re-
spect to such individual shall be subject to re-
consideration and appeal under subsection (h) 
and the option of an automatic escalation to ex-
ternal review to the extent provided by the Sec-
retary. 
‘‘(F) TERMINATION OF IDENTIFICATION.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall develop standards for the termination 
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‘‘(G) ADDICTIVE DRUG.—For purposes of 
this subsection, the term ‘addictive drug’ means 
a drug that is determined by the Secretary to 
be addictive or frequently diverted and that is— 
‘‘(i) a Controlled Drug Substance in 
Schedule CII–CIV; 
‘‘(ii) within the same class or category 
of drugs as a Controlled Drug Substance 
in Schedule CII–CIV; or 
‘‘(iii) within another class or category 
of drugs that the Secretary determines, in 
consultation with the Inspector General of 
the Department of Health and Human 
Services, is at high risk for diversion or 
addiction. 
‘‘(H) DATA DISCLOSURE.—In the case of 
an at-risk beneficiary for prescription drug ad-
diction whose access to coverage for addictive 
drugs under a prescription drug plan has been 
limited by a PDP sponsor under this para-
graph, such PDP sponsor shall disclose data, 
including any necessary individually identifiable 
health information, in a form and manner spec-
ified by the Secretary, about the decision to im-
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pose such limitations and the limitations im-
posed by the sponsor under this part. 
‘‘(I) EDUCATION.—The Secretary shall 
provide education to enrollees in prescription 
drug plans of PDP sponsors and providers re-
garding the drug management program for at- 
risk beneficiaries described in this paragraph, 
including education— 
‘‘(i) provided by Medicare administra-
tive contractors through the improper pay-
ment outreach and education program de-
scribed in section 1874A(h); and 
‘‘(ii) through current education efforts 
(such as State health insurance assistance 
programs described in subsection (a)(1)(A) 
of section 119 of the Medicare Improve-
ments for Patients and Providers Act of 
2008 (42 U.S.C. 1395b–3 note)) and ma-
terials directed toward such enrollees.’’. 
(2) INFORMATION
FOR
CONSUMERS.—Section 
1860D–4(a)(1)(B) of the Social Security Act (42 
U.S.C. 1395w–104(a)(1)(B)) is amended by adding 
at the end the following: 
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‘‘(v) The drug management program 
for at-risk beneficiaries under subsection 
(c)(4).’’. 
(b) UTILIZATION MANAGEMENT PROGRAMS.—Sec-
tion 1860D–4(c) of the Social Security Act (42 U.S.C. 
1395w–104(c)), as amended by subsection (a), is amend-
ed— 
(1) in paragraph (1), by inserting after sub-
paragraph (D) the following new subparagraph: 
‘‘(E) A utilization management tool to pre-
vent drug addiction (as described in paragraph 
(5)(A)).’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(5) UTILIZATION MANAGEMENT TOOL TO PRE-
VENT DRUG ADDICTION.— 
‘‘(A) IN
GENERAL.—A tool described in 
this paragraph is any of the following: 
‘‘(i) A utilization tool designed to pre-
vent addiction to addictive drugs by indi-
viduals and to prevent the diversion of 
such drugs at pharmacies. 
‘‘(ii) Retrospective utilization review 
to identify— 
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‘‘(I) individuals that receive ad-
dictive drugs at a frequency or in 
amounts that are not clinically appro-
priate; and 
‘‘(II) providers of services or sup-
pliers that may facilitate the addiction 
to or diversion of addictive drugs by 
beneficiaries. 
‘‘(iii) Consultation with the Con-
tractor described in subparagraph (B) to 
verify if an individual enrolling in a pre-
scription drug plan offered by a PDP 
sponsor has been previously identified by 
another PDP sponsor as an individual de-
scribed in clause (ii)(I). 
‘‘(B) REPORTING.—A PDP sponsor offer-
ing a prescription drug plan in a State shall 
submit to the Secretary and the Medicare drug 
integrity contractor with which the Secretary 
has entered into a contract under section 1893 
with respect to such State a report, on a 
monthly basis, containing information on— 
‘‘(i) any provider of services or sup-
plier described in subparagraph (A)(ii)(II) 
that is identified by such plan sponsor dur-
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ing the 30-day period before such report is 
submitted; and 
‘‘(ii) 
the 
name 
and 
prescription 
records of individuals described in para-
graph (4)(C).’’. 
(c) EXPANDING ACTIVITIES OF MEDICARE DRUG IN-
TEGRITY CONTRACTORS (MEDICS).—Section 1893 of the 
Social Security Act (42 U.S.C. 1395ddd) is amended by 
adding at the end the following new subsection: 
‘‘(j) EXPANDING ACTIVITIES OF MEDICARE DRUG 
INTEGRITY CONTRACTORS (MEDICS).— 
‘‘(1) ACCESS
TO
INFORMATION.—Under con-
tracts entered into under this section with Medicare 
drug integrity contractors, the Secretary shall au-
thorize such contractors to directly accept prescrip-
tion and necessary medical records from entities 
such as pharmacies, prescription drug plans, and 
physicians with respect to an individual in order for 
such contractors to provide information relevant to 
the determination of whether such individual is an 
at-risk beneficiary for prescription drug addiction, as 
defined in section 1860D–4(c)(4)(C). 
‘‘(2) REQUIREMENT
FOR
ACKNOWLEDGMENT 
OF REFERRALS.—If a PDP sponsor refers informa-
tion to a contractor described in paragraph (1) in 
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order for such contractor to assist in the determina-
tion described in such paragraph, the contractor 
shall— 
‘‘(A) acknowledge to the PDP sponsor re-
ceipt of the referral; and 
‘‘(B) in the case that any PDP sponsor 
contacts the contractor requesting to know the 
determination by the contractor of whether or 
not an individual has been determined to be an 
individual described such paragraph, shall in-
form such PDP sponsor of such determination 
on a date that is not later than 15 days after 
the date on which the PDP sponsor contacts 
the contractor. 
‘‘(3) MAKING DATA AVAILABLE TO OTHER EN-
TITIES.— 
‘‘(A) IN GENERAL.—For purposes of car-
rying out this subsection, subject to subpara-
graph (B), the Secretary shall authorize MED-
ICs to respond to requests for information from 
PDP sponsors, State prescription drug moni-
toring programs, and other entities delegated by 
PDP sponsors using available programs and 
systems in the effort to prevent fraud, waste, 
and abuse. 
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‘‘(B) HIPAA COMPLIANT
INFORMATION 
ONLY.—Information may only be disclosed by a 
MEDIC under subparagraph (A) if the disclo-
sure of such information is permitted under the 
Federal regulations (concerning the privacy of 
individually identifiable health information) pro-
mulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act of 
1996 (42 U.S.C. 1320d–2 note).’’. 
(d) TREATMENT OF CERTAIN COMPLAINTS FOR PUR-
POSES OF QUALITY OR PERFORMANCE ASSESSMENT.— 
Section 1860D–42 of the Social Security Act (42 U.S.C. 
1395w–152) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(d) TREATMENT
OF CERTAIN COMPLAINTS
FOR 
PURPOSES
OF
QUALITY
OR
PERFORMANCE
ASSESS-
MENT.—In conducting a quality or performance assess-
ment of a PDP sponsor, the Secretary shall develop or 
utilize existing screening methods for reviewing and con-
sidering complaints that are received from enrollees in a 
prescription drug plan offered by such PDP sponsor and 
that are complaints regarding the lack of access by the 
individual to prescription drugs due to a drug manage-
ment program for at-risk beneficiaries.’’. 
(e) GAO STUDIES AND REPORTS.— 
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(1) STUDIES.—The Comptroller General of the 
United States shall conduct a study on each of the 
following: 
(A) The implementation of the amend-
ments made by this section. 
(B) The effectiveness of the at-risk bene-
ficiaries for prescription drug addiction drug 
management programs authorized by section 
1860D–4(c)(4) of the Social Security Act (42 
U.S.C. 1395w–10(c)(4)), as added by sub-
section (a)(1), including an analysis of— 
(i) the impediments, if any, that im-
pair the ability of individuals described in 
subparagraph (C) of such section 1860D– 
4(c)(4) to access clinically appropriate lev-
els of prescription drugs; and 
(ii) the types of— 
(I) individuals who, in the imple-
mentation of such section, are deter-
mined to be individuals described in 
such subparagraph; and 
(II) prescribers and pharmacies 
that are selected under subparagraph 
(D) of such section. 
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(2) REPORTS.—Not later than January 1, 
2017, the Comptroller General of the United States 
shall begin work, with respect to each study de-
scribed in paragraph (1), on a report that describes 
the result of such study. Upon the completion of 
each such report, such Comptroller General shall 
submit the report to each of the committees de-
scribed in paragraph (3). 
(3) COMMITTEES DESCRIBED.—The committees 
described in this paragraph are the following: 
(A) The Committee on Ways and Means of 
the House of Representatives. 
(B) The Committee on Energy and Com-
merce of the House of Representatives. 
(C) The Committee on Finance of the Sen-
ate. 
(D) The Committee on Health, Education, 
Labor, and Pensions of the Senate. 
(E) The Special Committee on Aging of 
the Senate. 
(f) EFFECTIVE DATE.— 
(1) IN GENERAL.—The amendments made by 
this section shall apply to prescription drug plans for 
plan years beginning on or after January 1, 2018. 
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(2) STAKEHOLDER MEETINGS PRIOR TO EFFEC-
TIVE DATE.— 
(A) IN GENERAL.—Not later than January 
1, 2017, the Secretary shall convene stake-
holders, including individuals entitled to bene-
fits under part A of title XVIII of the Social 
Security Act or enrolled under part B of such 
title of such Act, advocacy groups representing 
such individuals, clinicians, plan sponsors, and 
entities delegated by plan sponsors, for input 
regarding the topics described in subparagraph 
(B). 
(B) TOPICS DESCRIBED.—The topics de-
scribed in this subparagraph are the topics of— 
(i) ensuring affordability and accessi-
bility to prescription drugs for enrollees in 
prescription drug plans of PDP sponsors 
who are at-risk beneficiaries for prescrip-
tion drug addiction (as defined in para-
graph (4)(C) of section 1860D–4(c) of the 
Social Security Act (42 U.S.C. 1395w– 
10(c)), as added by subsection (a)(1)); 
(ii) the use of an expedited appeals 
process under which such an enrollee may 
appeal an identification of such enrollee as 
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an at-risk beneficiary for prescription drug 
addiction under such paragraph (similar to 
the processes established under the Medi-
care Advantage program under part C of 
title XVIII of the Social Security Act that 
allow an automatic escalation to external 
review of claims submitted under such 
part); 
(iii) the types of enrollees that should 
be treated as exempted individuals, as de-
scribed in clause (ii) of such paragraph; 
(iv) the manner in which terms and 
definitions in paragraph (4) of such section 
1860D–4(c) should be applied, such as the 
use of clinical appropriateness in deter-
mining whether an enrollee is an at-risk 
beneficiary for prescription drug addiction 
as defined in subparagraph (C) of such 
paragraph (4); 
(v) the information to be included in 
the notices described in subparagraph (B) 
of such section and the standardization of 
such notices; and 
(vi) with respect to a PDP sponsor 
that establishes a drug management pro-
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gram for at-risk beneficiaries under such 
paragraph (4), the responsibilities of such 
PDP sponsor with respect to the imple-
mentation of such program. 
(C) RULEMAKING.—The Secretary shall 
promulgate regulations based on the input 
gathered pursuant to subparagraph (A). 
Æ 
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