Medicare Prescription Drug Emergency Guarantee Act of 2006 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to assure uninterrupted access to medicines under the Medicare prescription drug program.
Requires each prescription drug plan sponsor offering a prescription drug plan, and each Medicare Advantage organization offering an Medicare Advantage-Prescription Drug Plan (MA-PD plan), to: (1) provide minimum standard transition coverage; (2) furnish each enrollee with annual notices of any changes in formulary or other restrictions or drug coverage limitations; and (3) require application of intermediate sanctions to protect against fraud and abuse.
Amends SSA: (1) title XVIII part C (Medicare+Choice) to allow changes of enrollment in prescription drug plans and MA-PD plans to be made once each year outside the annual coordinated election period, or twice a year; and (2) title XIX (Medicaid) to prohibit conditioning Medicaid eligibility on enrollment in Medicare part D or any other creditable coverage.
Directs the Medicare Payment Advisory Commission (MEDPAC) to study and report to Congress on the extent to which full-benefit dual eligible individuals were enrolled (by assignment or otherwise) in the most appropriate part D prescription drug plans.
Directs the Secretary of Health and Human Services to reimburse covered third parties during 2006 for 100% of covered part D drugs which a prescription drug plan or MA-PD plan enrollee reasonably expected would have been covered but were not because the enrollee was unable to access on a timely basis prescription drug benefits to which he or she was entitled. Directs the Secretary to establish a process for recovering such reimbursed costs from prescription drug plans and MA-PD plans if they should have incurred them.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4685 Introduced in House (IH)]
109th CONGRESS
2d Session
H. R. 4685
To amend titles XVIII and XIX of the Social Security Act to assure
uninterrupted access to necessary medicines under the Medicare
prescription drug program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 1, 2006
Mr. Dingell (for himself, Mr. Rangel, Mr. Spratt, Mr. Waxman, Mr. Brown
of Ohio, Mr. Stark, Ms. Pelosi, Mr. Markey, Mrs. Capps, Mr. Boucher,
Ms. Schakowsky, Ms. DeGette, Mr. Pallone, Ms. Solis, Ms. Baldwin, Mr.
Gene Green of Texas, Mr. Gordon, Mr. Allen, Mr. Inslee, Mr. Cleaver,
Ms. Slaughter, Mr. Emanuel, Mr. Neal of Massachusetts, Mr. Delahunt,
Mr. Doggett, Mr. Conyers, Ms. Matsui, Mr. Berman, Mr. Larson of
Connecticut, Mr. Cardin, Mr. McNulty, Mr. Holden, Mr. Owens, Ms.
Herseth, and Mrs. McCarthy) 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 titles XVIII and XIX of the Social Security Act to assure
uninterrupted access to necessary medicines under the Medicare
prescription drug program.
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
Prescription Drug Emergency Guarantee Act of 2006''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents
Sec. 2. Protections to provide for uninterrupted access to medicines
Sec. 3. Required application of intermediate sanctions to protect
against fraud and abuse
Sec. 4. Changes of enrollment in prescription drug plans and MA-PD
plans allowed twice during year
Sec. 5. Prohibiting additional restrictions or limitations on coverage
during year
Sec. 6. MedPAC study on appropriate enrollment of dual eligible
individuals
Sec. 7. Prohibition on conditioning Medicaid eligibility on enrollment
in Medicare part D coverage or other
creditable coverage
Sec. 8. Reimbursement of third parties for 2006 transition costs
SEC. 2. PROTECTIONS TO PROVIDE FOR UNINTERRUPTED ACCESS TO MEDICINES.
(a) Minimum Standard Transition Coverage.--
(1) In general.--Section 1860D-4(b) of the Social Security
Act (42 U.S.C. 1395w-104(b)) is amended by adding at the end
the following new paragraph:
``(4) Uninterrupted access to medicines.--
``(A) Minimum standard transition coverage.--A PDP
sponsor offering a prescription drug plan under this
part or an MA-PD plan under part C shall provide
minimum standard transition coverage in accordance with
subparagraph (B).
``(B) Requirements.--The minimum standard
transition coverage under this subparagraph, with
respect to a part D eligible individual who is enrolled
in a prescription drug plan (or an individual who is
presumed to be such an individual pursuant to
subparagraph (F)) who presents a prescription for a
drug at a pharmacy, is the following:
``(i) Guaranteed initial supply, regardless
of coverage limitations or restrictions.--In
the case that the PDP sponsor of such plan uses
a formulary that does not cover the drug or
otherwise imposes a restriction on the coverage
of the drug (such as through the application of
a preferred status, usage restriction, step
therapy, prior authorization or a quantity
limits) and during the period in which such
individual has been enrolled in such plan the
individual has not previously sought coverage
under the plan for such drug the plan shall
provide for the following:
``(I) Minimum supply of
prescription drug.--The plan must
provide for coverage for at least a 60-
day supply (or a 90-day supply in the
case of an individual who is a resident
of a long-term care facility) of the
drug, or, if less, a supply of the drug
that is the full amount of the
prescription.
``(II) Information on formulary,
prescription drug plans, and appeal
rights.--The plan must provide the
individual with a standard notice
developed by the Secretary that informs
the individual about the limitations
and restrictions of the coverage of the
drug, that describes the rights of the
individual with respect to requesting a
determination under subsection (g)(2)
or an appeal of such a determination
under subsection (h), that describes
any ability of the individual to change
the election of such plan under section
1860D-1(b)(1)(B), and that informs the
individual about sources of information
on prescription drug plans to make such
a change in plans.
``(III) Refills during pending
appeal.--In the case of such an
individual who brings an appeal under
subsection (h), with respect to the
prescription drug involved, an
additional supply of the drug (for the
amount of days provided to the
individual under subclause (I)) during
the period ending on the date on which
a final determination is made on the
appeal.
``(ii) Guaranteed supply when unable to
verify plan enrollment.--In the case that the
pharmacy is unable to locate or verify the
individual's enrollment in such plan through a
reasonable effort:
``(I) Minimum supply of
prescription drug.--The plan must
provide for coverage for at least a 60-
day supply (or a 90-day supply in the
case of an individual who is a resident
of a long-term care facility) of the
drug, or, if less, a supply of the drug
that is the full amount of the
prescription.
``(II) Refills.--The plan must
provide an additional 60-day supply (or
a 90-day supply in the case of an
individual who is a resident of a long-
term care facility) of the drug, or if
less, a supply of the drug that is the
full amount of the prescription, if the
pharmacy continues to be unable to
locate the individual's enrollment
through such reasonable efforts when a
prescription is presented on or after
the date that a prescription refill is
appropriate.
``(C) Reimbursements.--
``(i) Reimbursements to pharmacies.--
``(I) In general.--If a pharmacy
provides prescription drugs for which
the minimum standard transition
coverage is required under subparagraph
(B), the Secretary shall reimburse the
pharmacy for the costs incurred in
providing the prescription drugs,
including acquisition costs, dispensing
costs, and other overhead costs. The
Secretary shall provide prompt payment
(consistent with the provisions of
section 1842(c)(2)) of such
reimbursements from the Medicare
Prescription Drug Account under section
1860D-16 of the Social Security Act (42
U.S.C. 1395w-116). Such reimbursements
shall be deemed to be payments from
such Account under subsection (b) of
such section.
``(II) Sanctions for fraudulent
claims.--In the case of a pharmacy that
knowingly provides to the Secretary
false information in connection with a
claim for reimbursement under subclause
(I), the Secretary may impose a civil
money penalty in an amount not to
exceed $10,000 for each such claim. The
provisions of section 1128A (other than
subsections (a) and (b) and the second
sentence of subsection (f)) shall apply
to a civil money penalty under the
previous sentence in the same manner as
such provisions apply to a penalty or
proceeding under section 1128A(a).
``(ii) Recovery from plans of pharmacy
reimbursements.--The Secretary shall establish
a process for recovering the reimbursements
made to pharmacies under clause (i) from
prescription drug plans and MA-PD plans if the
Secretary determines that such plans should
have incurred such costs. Amounts recovered
pursuant to the preceding sentence shall be
deposited in the Medicare Prescription Drug
Account.
``(iii) Application of intermediate
sanctions.--In the case of a failure of a
prescription drug plan under this part or an
MA-PD plan under part C to provide for the
minimum coverage required under subparagraph
(B), the failure shall be treated as a failure
to provide medically necessary items and
services under section 1857(g)(1)(A), as
applied by section 1860D-12(b)(3)(E), and the
Secretary shall impose intermediate sanctions
under such section 1857(g).
``(D) Cost-sharing.--The cost-sharing for a
prescription filled pursuant to subparagraph (B) for an
individual shall be in accordance with the prescription
drug plan in which the individual attests to be
enrolled and the class of individual (such as subsidy-
eligible individuals) to which the individual so
attests.
``(E) Refunds to individuals with inappropriate
charges.--If the Secretary determines, in accordance
with a method determined by the Secretary, that an
individual was inappropriately charged for a
prescription drug dispensed to such individual under
this part or part C, the Secretary shall--
``(i) reduce payments to the sponsor of the
prescription drug plan under section 1860D-15
or to the organization offering the MA-PD plan
under section 1853 that inappropriately charged
the individual by an amount equal to the amount
the individual was inappropriately charged; and
``(ii) refund such amount to the individual
within 30 days of the date of the determination
that the individual was inappropriately
charged.
``(F) Presumptive eligibility.--
``(i) Subsidy-eligible individuals.--For
purposes of this paragraph, an individual shall
be presumed to be a dual eligible individual or
subsidy-eligible individual if the individual
self attests to being such an individual,
respectively.
``(ii) Plan enrollment.--For purposes of
this paragraph, an individual shall be presumed
to be enrolled in a prescription drug plan
under this part or an MA-PD plan under part C
if the individual self attests to being
enrolled under such plan.
``(iii) Individual liable for costs of
false attestation.--
``(I) In general.--If the
Secretary, as the result of
verification activities conducted by
the Secretary, determines after a fair
hearing that an individual has
knowingly made a false self-attestation
described in clause (i) or (ii) or in
subparagraph (D), the Secretary may,
subject to subclause (II), seek
recovery from the individual for the
full amount of the cost of benefits
provided to the individual under this
paragraph as a result of such self
attestation.
``(II) Exception.--The Secretary
shall at its discretion not seek
recovery under subclause (I) if the
Secretary determines that it would not
be cost-effective to do so.
``(III) Reimbursements to federal
government.--Any amounts recovered by
the Secretary in accordance with this
clause shall be returned to the
prescription drug plan or MA-PD plan if
the Secretary has previously recovered
payment from such plan.
``(iv) Requirements for self attestation.--
The Secretary shall promulgate requirements for
self attestations under this subparagraph, but
the failure of the Secretary to promulgate such
requirements shall not preclude the
applications of the previous provisions of this
subparagraph.''.
(2) Effective date.--The amendment made by paragraph (1)
shall take effect on the date of the enactment of this Act, but
shall apply to prescription drugs dispensed on and after
January 1, 2006.
(b) Notice for Change in Formulary and Other Restrictions or
Limitations on Coverage.--
(1) In general.--Section 1860D-4(a) of such Act (42 U.S.C.
1395w-104(a)) is amended by adding at the end the following new
paragraph:
``(5) Annual notice of changes in formulary and other
restrictions or limitations on coverage.--Each PDP sponsor
offering a prescription drug plan (and each MA organization
offering an MA-PD plan) shall furnish to each enrollee at the
time of each annual coordinated election period (referred to in
section 1860D-1(b)(1)(B)(iii)) for a plan year a notice of any
changes in the formulary or other restrictions or limitations
on coverage of a covered part D drug under the plan that will
take effect for the plan year.''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to annual coordinated election periods beginning
after the date of the enactment of this Act.
(c) Standardized Forms and Procedures for Reconsiderations and
Appeals.--
(1) In general.--Section 1860D-4 of such Act (42 U.S.C.
1395w-104) is amended by adding at the end the following new
subsection:
``(l) Standardized Forms and Procedures for Reconsiderations and
Appeals.--
``(1) Standard enrollee notice.--The Secretary shall
develop a standard notice to be distributed by a prescription
drug plan (or an MA-PD plan) to an enrollee when a covered part
D drug prescribed for the enrollee is not covered, or the
coverage of such drug is otherwise restricted, by the plan.
``(2) Standardized process for reconsiderations and
appeals.--The Secretary shall require prescription drug plans
and MA-PD plans to follow the same standardized process for
reconsiderations and redeterminations under subsections (g) and
(h). Such process shall require that determinations regarding
medical necessity are based on professional medical judgement,
the medical condition of the enrollee, the treating physician's
recommendation, and other medical evidence.''.
(2) Effective date.--The Secretary of Health and Human
Services shall provide for the standard notice and the
standardized process, and the application of such notice and
process, under the amendment made by paragraph (1) by not later
than January 1, 2007.
SEC. 3. REQUIRED APPLICATION OF INTERMEDIATE SANCTIONS TO PROTECT
AGAINST FRAUD AND ABUSE.
(a) In General.--Section 1860D-12(b)(3)(E) of the Social Security
Act (42 U.S.C. 1395w-112(b)(3)(E)) is amended by inserting ``and the
reference to `may provide' in section 1857(g)(1) is deemed a reference
to `shall provide''' after ``this part''.
(b) Application to MA-PD Plans.--Section 1857(g)(1) of such Act (42
U.S.C. 1395w-27(g)(1)) is amended by inserting ``(or in the case of an
MA-PD plan or a prescription drug plan under part D, the Secretary
shall provide)'' after ``may provide''.
SEC. 4. CHANGES OF ENROLLMENT IN PRESCRIPTION DRUG PLANS AND MA-PD
PLANS ALLOWED TWICE DURING YEAR.
(a) Additional Election Permitted Once Each Year Outside of Annual
Coordinated Election Period.--Section 1851(e)(4) of the Social Security
Act (42 U.S.C. 1395w-21(e)(4)) is amended by inserting ``once every
year, and in addition,'' after ``make a new election under this
section''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect as of the date of the enactment of this Act.
SEC. 5. PROHIBITING ADDITIONAL RESTRICTIONS OR LIMITATIONS ON COVERAGE
DURING YEAR.
(a) In General.--Section 1860D-4(b)(4) of the Social Security Act
(42 U.S.C. 1395w-104(b)(4)) is amended by inserting after subparagraph
(F) the following new subparagraph:
``(G) Prohibiting additional restrictions or
limitations on coverage during year.--A prescription
drug plan and an MA-PD plan may only impose a
restriction or limitation on the coverage of a covered
part D drug (such as through the application of a
formulary, preferred status, usage restriction, step
therapy, prior authorization, or a quantity limitation)
only at the beginning of a plan year, except in the
case that the Commissioner of Food and Drugs issues a
clinical warning during a year that imposes such a
restriction or limitation on the drug.''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect on the date of the enactment of this Act and shall apply to
the removal of a drug or a change in the status of such drug on and
after such date.
SEC. 6. MEDPAC STUDY ON APPROPRIATE ENROLLMENT OF DUAL ELIGIBLE
INDIVIDUALS.
(a) Study.--The Medicare Payment Advisory Commission shall conduct
a study to determine the extent to which full-benefit dual eligible
individuals (as defined in section 1935(c)(6) of the Social Security
Act (42 U.S.C. 1396u5(c)(6)) were enrolled (by assignment or otherwise)
in the most appropriate prescription drug plans under part D of title
XVIII of such Act for such individuals.
(b) Report.--The Commission shall submit a report to Congress on
the study under subsection (a) not later than February 1, 2007.
SEC. 7. PROHIBITION ON CONDITIONING MEDICAID ELIGIBILITY ON ENROLLMENT
IN MEDICARE PART D COVERAGE OR OTHER CREDITABLE COVERAGE.
(a) In General.--Section 1935 of the Social Security Act (42 U.S.C.
1396v) is amended by adding at the end the following new subsection:
``(f) Prohibition on Conditioning Medicaid Eligibility on
Enrollment in Medicare Part D Coverage or Other Creditable Coverage.--
``(1) In general.--A State shall not condition eligibility
for medical assistance under the State plan for a part D
eligible individual (as defined in section 1860D-1(a)(3)(A))
who is enrolled in creditable prescription drug coverage
described in any of subparagraphs (C) through (H) of section
1860D-13(b)(4) on the individual's enrollment in a prescription
drug plan under part D of title XVIII or an MA-PD plan under
part C of such title.
``(2) Coordination of benefits with part d for other
individuals.--Nothing in this subsection shall be construed as
prohibiting a State from coordinating medical assistance under
the State plan with benefits under part D of title XVIII for
individuals not described in paragraph (1).''.
(b) Treatment of State Plan Amendments, Redetermination of
Eligibility.--In the case of a State that, as of the date of the
enactment of this Act, has an approved amendment to its State plan
under title XIX of the Social Security Act with a provision that
conflicts with section 1935(f) of such Act (as added by subsection
(a)), such provision is, as of such date of enactment, null and void.
The State shall redetermine any applications for medical assistance
that have been denied solely on the basis of such a State plan
amendment not later than December 31, 2006. Such redetermination shall
be effective as of the date of the individual's application for medical
assistance.
SEC. 8. REIMBURSEMENT OF THIRD PARTIES FOR 2006 TRANSITION COSTS.
(a) Reimbursement.--
(1) In general.--Notwithstanding section 1935(d) of the
Social Security Act (42 U.S.C. 1396u-5(d) or any other
provision of law, the Secretary of Health and Human Services
shall reimburse covered third parties for 100 percent of the
costs incurred by the covered third party during 2006 for
covered part D drugs for part D eligible individuals who are
enrolled in a prescription drug plan under part D of title
XVIII of such Act (or an MA-PD plan under part C of such title)
which the individual reasonably expected would have been
covered under such part but were not because the individual was
unable to access on a timely basis prescription drug benefits
to which the individual was entitled under such part. Such
payments shall be made from the Medicare Prescription Drug
Account under section 1860D-16 of the Social Security Act (42
U.S.C. 1395w-116) and shall be deemed to be payments from such
Account under subsection (b) of such section. The provisions of
clauses (ii) through (iv) of subparagraph (F) of paragraph (4)
of section 1860D-4(b) of the Social Security Act, as added by
section 2(a), shall apply under this paragraph in the same
manner as they apply under such paragraph (4).
(2) Sanctions for fraudulent claims.--The provisions of
subclause (II) of section 1860D-4(b)(4)(C)(i) of the Social
Security Act, as added by section 2(a), shall apply to a
covered third party with respect to a claim for reimbursement
under paragraph (1) in the same manner that such provisions
apply to a pharmacy in connection with a claim for
reimbursement under subclause (I) of such section 1860D-
4(b)(4)(C)(i).
(3) Retroactive application to beginning of 2006.--The
costs incurred by a third party which may be reimbursed under
paragraph (1) shall include costs incurred during the period
beginning on January 1, 2006, and before the date of enactment
of this Act.
(b) Recovery of Costs From Plans by Secretary.--The Secretary of
Health and Human Services shall establish a process for recovering the
costs described in subsection (a)(1) from prescription drug plans and
MA-PD plans if the Secretary determines that such plans should have
incurred such costs. Amounts recovered pursuant to the preceding
sentence shall be deposited in the Medicare Prescription Drug Account
described in subsection (a)(1).
(c) Definitions.--For purposes of this section:
(1) Covered part d drug.--The term ``covered part D drug''
has the meaning given such term under section 1860D-2(e) of the
Social Security Act (42 U.S.C. 1395w-102(e)).
(2) Covered third party.--The term ``covered third party''
means any individual or party (such as a State, charity, or
family member of the part D eligible individual involved) other
than a party that is obligated under part D of title XVIII of
the Social Security Act to incur the costs involved. Such term
shall not include a pharmaceutical company or an assistance
program sponsored or assisted (in whole or in part) by such
company.
(3) MA-PD plan.--The term ``MA-PD plan'' has the meaning
given such term under section 1860D-41(a)(14) of the Social
Security Act (42 U.S.C. 1395w-151(a)(14)).
(4) Part d eligible individual.--The term ``part D eligible
individual'' has the meaning given such term under section
1860D-1(a)(3)(A) of the Social Security Act (42 U.S.C. 1394w-
101(a)(3)(A)).
(5) Prescription drug plan.--The term ``prescription drug
plan'' has the meaning given such term under section 1860D-
1(a)(3)(C) of the Social Security Act (42 U.S.C. 1394w-
101(a)(3)(C)).
(6) State.--The term ``State'' includes the District of
Columbia.
<all>
Introduced in House
Introduced in House
Sponsor introductory remarks on measure. (CR E55-56)
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 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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