Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to establish a safe pharmacy access program under which a prescription drug plan (PDP) sponsor (or a Medicare Advantage (MA) organization offering an MA-PD plan) shall have in place procedures designed to prevent fraud and abuse in the dispensing of certain controlled substances under Medicare part D.
Allows a PDP sponsor to suspend payments and clean claim notifications to a pharmacy pending an investigation of a credible allegation of fraud against the pharmacy, unless the Secretary determines there is a good cause not to suspend payments.
Directs the Secretary of Health and Human Services (HHS), under contracts entered into under the Medicare integrity program with Medicare drug integrity contractors (MEDICs), to authorize such MEDICs to obtain prescription and medical records directly from entities such as pharmacies, PDPs, and physicians. Requires a MEDIC to acknowledge receipt of a PDP sponsor referral of information for investigation, report back to the sponsor the investigation results within 45 days, and share them with appropriate agencies.
Requires electronic transmission (e-prescribing) of prescriptions for certain covered Medicare part D controlled substances.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3392 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 3392
To amend title XVIII of the Social Security Act to provide for a PDP
safety program to prevent fraud and abuse in the dispensing of
controlled substances under part D of the Medicare program, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 30, 2013
Mr. Bilirakis (for himself and Mr. Ben Ray Lujan of New Mexico)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committee on Ways and
Means, 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 amend title XVIII of the Social Security Act to provide for a PDP
safety program to prevent fraud and abuse in the dispensing of
controlled substances under part D of the Medicare program, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Medicare Part D
Patient Safety and Drug Abuse Prevention Act of 2013''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Establishing PDP safety program to prevent fraud and abuse in
Medicare prescription drug plans.
Sec. 3. Part D suspension of claims payment.
Sec. 4. Improving activities of Medicare Drug Integrity Contractors
(MEDICs).
Sec. 5. Requiring e-prescribing for coverage of covered part D
controlled substances.
SEC. 2. ESTABLISHING PDP SAFETY PROGRAM TO PREVENT FRAUD AND ABUSE IN
MEDICARE PRESCRIPTION DRUG PLANS.
(a) PDP Safety Program.--Section 1860D-4(c) of the Social Security
Act (42 U.S.C. 1395w-104(c)) is amended--
(1) in paragraph (1)(D)--
(A) by inserting ``, designed to'' after
``program''; and
(B) by inserting ``, that includes the procedures
described in paragraph (4)'' after ``waste''; and
(2) by adding at the end the following:
``(4) Safe pharmacy access program.--
``(A) PDP sponsor procedures.--A PDP sponsor (or an
MA organization offering an MA-PD plan) shall have in
place procedures designed--
``(i) to identify an individual who has
obtained coverage for a covered part D drug
that is a frequently abused schedule II, III,
IV, or V controlled substance, as determined in
accordance with utilization guidelines
established by the Secretary and the sponsor
(or MA organization), and to notify such
individuals that they have been so identified;
``(ii) to contract with pharmacies
authorized to dispense such controlled
substances to create a safe pharmacy network
that meets the criteria specified in
subparagraph (C);
``(iii) taking into account the location of
the individual's residence (or residences),
work site, mobility, and other relevant
factors, to limit coverage to schedule II, III,
IV, or V controlled substances for some or all
classes of covered part D drugs for an
individual identified under clause (i) (or
under subparagraph (B)) to drugs dispensed by
one or more pharmacies contracted with under
clause (ii);
``(iv) to provide to the Secretary the
name, and other information that the Secretary
may require, of individuals so identified and
of the fact of such individual's disenrollment
(if any) from the plan of the sponsor (or the
MA-PD plan offered by the MA organization);
``(v) to provide for an appeals process
whereby an individual so identified may appeal
such identification on the basis that the
identification was not appropriate;
``(vi) to provide for a process whereby an
individual so identified may petition for the
termination of such identification on the basis
that the limitation on coverage is no longer
necessary to prevent fraud and abuse by the
individual; and
``(vii) to provide that coverage shall be
provided for a schedule II, III, IV, or V
controlled substance only if it prescribed in
accordance with an electronic prescribing
program under subsection (e), except in such
exceptional circumstances as the Secretary may
permit.
``(B) Sharing information for subsequent plan
enrollments.--The Secretary shall share information,
with respect to the identity of an individual
identified under subparagraph (A)(i) who disenrolls
from a plan under subparagraph (A)(iv), with a PDP
sponsor (or MA organization) that subsequently enrolls
such individual under another plan in order that the
provisions of subparagraph (A)(iii) would apply under
such subsequent enrollment.
``(C) Safe pharmacy network criteria.--The criteria
specified in this subparagraph for a safe pharmacy
network are the following:
``(i) The pharmacies in the network are
able to properly monitor the usage of schedule
II, III, IV, and V controlled substances.
``(ii) Such pharmacies and network meet
such other drug safety criteria as the
Secretary or the PDP sponsor (or MA
organization) determines to be appropriate,
such as use of a State prescription drug
monitoring program, if such a program is
available in the State.''.
(b) Dual Eligibles.--Section 1860D-1(b)(3)(D) of the Social
Security Act (42 U.S.C. 1395w-101(b)(3)(D)) is amended by inserting ``,
subject to such limits as the Secretary may establish for individuals
identified pursuant to section 1860D-4(c)(4)(A)(i)'' after ``the
Secretary''.
(c) Effective Date.--The amendments made by this section shall
apply with respect to plan years beginning after the date that is 8
months after the date of the enactment of this Act.
SEC. 3. PART D SUSPENSION OF CLAIMS PAYMENT.
Amend 1860D-12(b)(4) of the Social Security Act (42 U.S.C. 1395w-
112(b)(4)) is amended by adding at the end the following new
subparagraph:
``(H) Suspension of payments pending investigation
of credible allegations of fraud by pharmacies.--
``(i) In general.--A PDP sponsor may
suspend payments and clean claim notifications
to a pharmacy pending an investigation of a
credible allegation of fraud (as defined in
clause (ii)) against the pharmacy, unless the
Secretary determines there is a good cause not
to suspend payments.
``(ii) Credible allegation of fraud
defined.--In this subparagraph, the term
`credible allegation of fraud' includes--
``(I) a complaint made on the
Medicare fraud hotline;
``(II) detection of potential fraud
through the analysis of claims data;
``(III) detection of potential
fraud through identification of
inappropriate dispensing through
audits, civil false claims cases, and
law enforcement investigations; and
``(IV) claims referred to Medicare
drug integrity contractors (MEDICs).
``(iii) Rule of construction.--Nothing in
this subparagraph shall be construed as limited
the authority of a PDP sponsor to conduct post-
claim payment review.''.
SEC. 4. IMPROVING ACTIVITIES OF MEDICARE DRUG INTEGRITY CONTRACTORS
(MEDICS).
(a) In General.--Section 1893 of the Social Security Act (42 U.S.C.
1395ddd) is amended by adding at the end the following new subsection:
``(j) Improving Activities of Medicare Drug Integrity Contractors
(MEDICs).--
``(1) Access to in general.--Under contracts entered into
under this section (each in this subsection referred to as a
`MEDIC contract') with Medicare drug integrity contractors
(each in this subsection referred to as a `MEDIC'), the
Secretary shall authorize MEDICs to directly obtain
prescription and medical records from entities such as
pharmacies, PDP and physicians.
``(2) Requirement for acknowledgment of referrals.--If a
PDP sponsor refers information to a MEDIC for investigation,
under the MEDIC contract the MEDIC must acknowledge receipt of
the referral and must report back to the sponsor the result of
the MEDIC's investigation within 45 days of the date of the
referral and share such results with appropriate agencies, such
as law enforcement officials and State licensing authority.
``(3) Uniform annual report criteria.--In order to assess
the performance of MEDICs, the Secretary shall develop a
uniform reporting criteria for the annual reporting of the
results of investigations by MEDICs to the Secretary and to
Congress. Each such annual report shall include information on
the number of referrals for investigation made to a MEDIC, the
average time required for investigation, the results of the
investigation, and the number of results that were referred to
the Inspector General of the Department of Health and Human
Services and to State licensing officials for further
investigations.''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect on the date of the enactment of this Act and shall apply as
quickly as possible to MEDIC contracts, including MEDIC contracts
entered into before such date of enactment.
SEC. 5. REQUIRING E-PRESCRIBING FOR COVERAGE OF COVERED PART D
CONTROLLED SUBSTANCES.
(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.--Except in such emergent circumstances as the
Secretary may specify, coverage shall not be provided 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 unless the prescription for the drug has been
transmitted electronically in accordance with an electronic
prescription drug program that meets the requirements of
paragraph (2).''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to coverage of drugs prescribed on or after January 1, 2015.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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.
Referred to the Subcommittee on Health.
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