[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4697 Introduced in House (IH)]
<DOC>
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)
introduced the following bill; which was referred to the Committee on
Energy 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
within 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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Prevent Drug Addiction Act of
2016''.
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 section, 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-related deaths.
``(d) Evaluations.--The Administrator shall develop a process to
evaluate the effectiveness of activities carried out by grantees under
this section at reducing addiction 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 training
requirements described in subsection (g)(3) during 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 described in paragraph (1)
shall comply with the 12-hour training requirement of subparagraph (B)
at least once during each 3-year period.
``(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 communications, 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, including
through such methods as Screening, Brief Intervention, 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 Osteopathic Association, the American
Psychiatric Association, the American Academy of Pain Management, the
American Pain Society, the American Academy of Pain Medicine, the
American Board of Pain Medicine, the American Society of Interventional
Pain Physicians, or any other organization that the Secretary
determines is appropriate for purposes of this subparagraph.''.
(b) Requirements for Participation in Opioid Treatment Programs.--
Effective July 1, 2017, a physician practicing in an opioid treatment
program shall 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 Administration shall fund the
enforcement of the requirements specified 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
prescribers 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 following:
``(i)(1) An opioid treatment program that is registered 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 subsection.
``(2) The program shall make acceptable arrangements for each
patient who is restricted, by Federal regulation or guideline or by the
determination of the program medical director, from having a take-home
dose of a controlled substance related to the treatment involved, to
receive a dose of that substance under appropriate supervision 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 Mortality Report.--
``(1) In general.--Not later than July 1, 2017, the
Secretary, acting through the Administrator, shall require that
a Model Opioid Treatment Program Mortality Report be completed
and submitted to the Administrator for each individual who dies
while receiving treatment in an opioid treatment program.
``(2) Requirement of states that receive funding for the
controlled substance monitoring 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 Administrator by submitting a Model Opioid
Treatment Program 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 toxicology reports
become available to such individual, as required by the
Secretary.
``(3) Development.--The Administrator, in consultation with
State and local medical examiners, prescribing physicians,
hospitals, and any other organization that the Administrator
determines appropriate, shall develop a Model Opioid Treatment
Program 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 implement, through the
National Center for Health Statistics, 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 uniform 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 determines 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 information with respect to such
deaths, including--
``(A) the particular drug formulation used at the
time of death;
``(B) the dosage level;
``(C) a description of the circumstances
surrounding the death in relation to the recommended
dosage involved;
``(D) a disclosure of whether the medication
involved can be traced back to a physician'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 Registry case reports as
required under the privacy standard for the de-
identification of health information pursuant to the
regulations contained in part 164 of title 45, Code of
Federal Regulations.
``(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 Disease Control and Prevention shall submit to the
Secretary a report, based on information contained in the Registry
described in subsection (b), concerning the number of methadone-related
deaths in the United States for the year for which the report is
submitted.''.
SEC. 6. DEVELOPMENT OF PRESCRIPTION DRUG ADDICTION PREVENTION AND
TREATMENT QUALITY 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 ADDICTION PREVENTION AND
TREATMENT QUALITY 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 Centers for Disease Control and Prevention, the
Administrator of the Substance Abuse and Mental Health Services
Administration, and the Director of the Centers for Medicare & Medicaid
Services, shall require the development and application of specific
prescription drug addiction prevention 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 requirements developed under
subsection (a) to all affected providers.
``(c) Types of Measures.--Quality measures developed 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 ADDICTION 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 program for at-risk
beneficiaries under which, subject 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
sponsor, 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 beneficiary for
prescription drug addiction to coverage for
addictive drugs under a prescription 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
prescription drug addiction.
``(ii) Initial notice.--An initial notice
described in this clause is a notice that
provides to the beneficiary--
``(I) notice that the PDP sponsor
has identified the beneficiary as
potentially being an at-risk
beneficiary for prescription drug
addiction;
``(II) information describing all
State and Federal public health
resources that are designed to address
prescription drug addiction to which
the beneficiary has access, including
mental health services and other
counseling services;
``(III) notice of, and information
about, the right of the beneficiary to
appeal such identification under
subsection (h) and the option of an
automatic escalation to external
review;
``(IV) a request for the
beneficiary to submit to the PDP
sponsor preferences for which
prescribers and pharmacies the
beneficiary would prefer the PDP
sponsor to select under subparagraph
(D) in the case that the beneficiary is
identified as an at-risk beneficiary
for prescription drug addiction as
described in clause (iii)(I);
``(V) an explanation of the meaning
and consequences of the identification
of the beneficiary as potentially being
an at-risk beneficiary for prescription
drug addiction, including an
explanation of the drug management
program established by the PDP sponsor
pursuant to subparagraph (A);
``(VI) clear instructions that
explain how the beneficiary can contact
the PDP sponsor in order to submit to
the PDP sponsor the preferences
described in subclause (IV) and any
other communications relating to the
drug management program for at-risk
beneficiaries established by the PDP
sponsor; and
``(VII) contact information for
other organizations that can provide
the beneficiary with assistance
regarding such drug management program
(similar to the information provided by
the Secretary in other standardized
notices provided to part D eligible
individuals enrolled in prescription
drug plans under this part).
``(iii) Second notice.--A second notice
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
addiction;
``(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
pharmacy 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 escalation
to external review;
``(V) that the beneficiary can, in
the case that the beneficiary has not
previously submitted to the PDP sponsor
preferences for which prescribers and
pharmacies the beneficiary would prefer
the PDP sponsor select under
subparagraph (D), submit such
preferences to the PDP sponsor; and
``(VI) that includes clear
instructions that explain how the
beneficiary can contact the PDP
sponsor.
``(iv) Timing of notices.--
``(I) In general.--Subject to
subclause (II), a second notice
described 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 provided to the beneficiary.
``(II) Exception.--In the case that
the PDP sponsor, in conjunction with
the Secretary, determines that concerns
identified through rulemaking by the
Secretary regarding 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 described in
subclause (II), the PDP sponsor may
provide such second notice on such
earlier date.
``(C) At-risk beneficiary for prescription drug
addiction.--
``(i) In general.--For purposes of this
paragraph, the term `at-risk beneficiary 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
described in section 10(f)(2)(A) of the
Prevent Drug Addiction Act of 2016; or
``(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 described.--An
exempted individual described 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
purposes 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 drug plan
offered by such sponsor, a PDP sponsor shall,
based on the preferences submitted to the PDP
sponsor by the beneficiary 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
prescriptions for such drugs for such
beneficiary; and
``(II) one or more pharmacies that
may dispense such drugs to such
beneficiary.
``(ii) Reasonable access.--In making the
selection under this subparagraph, a PDP
sponsor shall ensure that the beneficiary
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
addiction 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
preferences;
``(bb) select or change the
selection of a prescriber or
pharmacy for the beneficiary
based on such preferences; and
``(cc) inform the
beneficiary of such selection
or change of selection.
``(II) Exception.--In the case that
the PDP sponsor determines that a
change to the selection of a prescriber
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
regard to the preferences of the
beneficiary described in subclause (I).
``(iv) Confirmation.--Before selecting a
prescriber or pharmacy under this subparagraph,
a PDP sponsor must request 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 beneficiary 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
respect to such individual shall be subject to
reconsideration and appeal under subsection (h) and the
option of an automatic escalation to external review to
the extent provided by the Secretary.
``(F) Termination of identification.--
``(i) In general.--The Secretary shall
develop standards for the termination of
identification of an individual as an at-risk
beneficiary for prescription drug addiction
under this paragraph. Under such standards such
identification shall terminate as of the
earlier of--
``(I) the date the individual
demonstrates that the individual is no
longer likely, in the absence of the
restrictions under this paragraph, to
be an at-risk beneficiary for
prescription drug addiction described
in subparagraph (C)(i); or
``(II) the end of such maximum
period of identification as the
Secretary may specify.
``(ii) Rule of construction.--Nothing in
clause (i) shall be construed as preventing a
plan from identifying an individual as an at-
risk beneficiary for prescription drug
addiction under subparagraph (C)(i) after such
termination on the basis of additional
information on drug use occurring after the
date of notice of such termination.
``(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 addiction whose
access to coverage for addictive drugs under a
prescription drug plan has been limited by a PDP
sponsor under this paragraph, such PDP sponsor shall
disclose data, including any necessary individually
identifiable health information, in a form and manner
specified by the Secretary, about the decision to
impose such limitations and the limitations imposed by
the sponsor under this part.
``(I) Education.--The Secretary shall provide
education to enrollees in prescription drug plans of
PDP sponsors and providers regarding the drug
management program for at-risk beneficiaries described
in this paragraph, including education--
``(i) provided by Medicare administrative
contractors through the improper payment
outreach and education program described 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 Improvements for
Patients and Providers Act of 2008 (42 U.S.C.
1395b-3 note)) and materials 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:
``(v) The drug management program for at-
risk beneficiaries under subsection (c)(4).''.
(b) Utilization Management Programs.--Section 1860D-4(c) of the
Social Security Act (42 U.S.C. 1395w-104(c)), as amended by subsection
(a), is amended--
(1) in paragraph (1), by inserting after subparagraph (D)
the following new subparagraph:
``(E) A utilization management tool to prevent drug
addiction (as described in paragraph (5)(A)).''; and
(2) by adding at the end the following new paragraph:
``(5) Utilization management tool to prevent drug
addiction.--
``(A) In general.--A tool described in this
paragraph is any of the following:
``(i) A utilization tool designed to
prevent addiction to addictive drugs by
individuals and to prevent the diversion of
such drugs at pharmacies.
``(ii) Retrospective utilization review to
identify--
``(I) individuals that receive
addictive drugs at a frequency or in
amounts that are not clinically
appropriate; and
``(II) providers of services or
suppliers that may facilitate the
addiction to or diversion of addictive
drugs by beneficiaries.
``(iii) Consultation with the Contractor
described in subparagraph (B) to verify if an
individual enrolling in a prescription drug
plan offered by a PDP sponsor has been
previously identified by another PDP sponsor as
an individual described in clause (ii)(I).
``(B) Reporting.--A PDP sponsor offering 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 supplier
described in subparagraph (A)(ii)(II) that is
identified by such plan sponsor during the 30-
day period before such report is submitted; and
``(ii) the name and prescription records of
individuals described in paragraph (4)(C).''.
(c) Expanding Activities of Medicare Drug Integrity 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 contracts entered into
under this section with Medicare drug integrity contractors,
the Secretary shall authorize such contractors to directly
accept prescription 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 information to a contractor described in
paragraph (1) in order for such contractor to assist in the
determination described in such paragraph, the contractor
shall--
``(A) acknowledge to the PDP sponsor receipt 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 inform 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 entities.--
``(A) In general.--For purposes of carrying out
this subsection, subject to subparagraph (B), the
Secretary shall authorize MEDICs to respond to requests
for information from PDP sponsors, State prescription
drug monitoring programs, and other entities delegated
by PDP sponsors using available programs and systems in
the effort to prevent fraud, waste, and abuse.
``(B) HIPAA compliant information only.--
Information may only be disclosed by a MEDIC under
subparagraph (A) if the disclosure of such information
is permitted under the Federal regulations (concerning
the privacy of individually identifiable health
information) promulgated 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 Purposes 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 following new
subsection:
``(d) Treatment of Certain Complaints for Purposes of Quality or
Performance Assessment.--In conducting a quality or performance
assessment of a PDP sponsor, the Secretary shall develop or utilize
existing screening methods for reviewing and considering 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 management
program for at-risk beneficiaries.''.
(e) GAO Studies and Reports.--
(1) Studies.--The Comptroller General of the United States
shall conduct a study on each of the following:
(A) The implementation of the amendments made by
this section.
(B) The effectiveness of the at-risk beneficiaries
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 subsection (a)(1), including an analysis of--
(i) the impediments, if any, that impair
the ability of individuals described in
subparagraph (C) of such section 1860D-4(c)(4)
to access clinically appropriate levels of
prescription drugs; and
(ii) the types of--
(I) individuals who, in the
implementation of such section, are
determined to be individuals described
in such subparagraph; and
(II) prescribers and pharmacies
that are selected under subparagraph
(D) of such section.
(2) Reports.--Not later than January 1, 2017, the
Comptroller General of the United States shall begin work, with
respect to each study described 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 described 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 Commerce of the
House of Representatives.
(C) The Committee on Finance of the Senate.
(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.
(2) Stakeholder meetings prior to effective date.--
(A) In general.--Not later than January 1, 2017,
the Secretary shall convene stakeholders, including
individuals entitled to benefits 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 described in this
subparagraph are the topics of--
(i) ensuring affordability and
accessibility to prescription drugs for
enrollees in prescription drug plans of PDP
sponsors who are at-risk beneficiaries for
prescription drug addiction (as defined in
paragraph (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 an at-
risk beneficiary for prescription drug
addiction under such paragraph (similar to the
processes established under the Medicare
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 described
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 determining
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 program for at-
risk beneficiaries under such paragraph (4),
the responsibilities of such PDP sponsor with
respect to the implementation of such program.
(C) Rulemaking.--The Secretary shall promulgate
regulations based on the input gathered pursuant to
subparagraph (A).
<all>