1.Short title; sense of the
Congress
(a)This Act may be cited
as the Medicare Prescription Drug
Price Negotiation Act of 2007
.
(b)It is the sense of
the Congress that the Congress should enact, and the President should sign,
legislation to amend part D of title XVIII of the Social Security Act to
provide for fair prescription drug prices for Medicare beneficiaries.
1.This Act may be cited as the Medicare
Fair Prescription Drug Price Act of 2007
.
2.
(a)
(1)Section 1860D–11(i) of the
Social Security Act (42 U.S.C.
1395w–111(i)) is amended by striking the Secretary—
and all that
follows through may not require
and inserting the
Secretary may not require
.
(2)Nothing in the amendment made by paragraph (1) shall
be construed as doing any of the following:
(A)Preventing the
sponsor of a prescription drug plan or an MA organization offering an MA–PD
plan under part D of title XVIII of the Social Security Act from obtaining a
discount or reduction of the price for a covered part D drug.
(B)Affecting the authority
of the Secretary of Health and Human Services to ensure appropriate and
adequate access to covered part D drugs under prescription drug plans and under
MA–PD plans under such part, including compliance of such plans with formulary
requirements under section 1860D–4(b)(3) of the Social Security Act (42 U.S.C.
1395w–104(b)(3)).
(C)Limiting access by
individuals enrolled in such prescription drug plans and MA–PD plans to
community pharmacies.
(3)Section 1860D–11 of the
Social Security Act (42 U.S.C.
1395w–111) is amended by adding at the end the following new subsection:
(k)Efforts to
promote and ensure access to fair prices
(1)To the extent that the Secretary promotes and ensures
access to fair prices by engaging in any direct negotiations with a drug
manufacturer with respect to prices for covered part D drugs, the
Secretary—
(A)may only do so
utilizing the resources of the Department of Health and Human Services;
and
(B)may not enter into a
contract with any public or private entity or enter into an Interdepartmental
Agreement for the purpose of conducting such
negotiations.
.
(b)Section
1860D–11(k) of the Social
Security Act, as added by subsection (a)(3), is amended by adding at
the end the following new paragraph:
(2)Annual report
on efforts to promote and ensure access to fair pricesThe
Secretary shall submit to Congress an annual report on the efforts of the
Secretary to promote and ensure access to fair prices for prescription drugs
under this
part.
.
(c)The amendments made by this section shall take effect on the
date of enactment of this Act.
3.Greater transparency of
part D prices and information
(a)Access of congressional
support agencies to data on prescription drug plans and Medicare Advantage
plansSection 1860D–42 of the
Social Security Act (42 U.S.C. 1395w–152) is amended by adding at the end the
following new subsection:
(c)Providing part D data
to congressional support agencies
(1)Notwithstanding any
provision under this part that limits the use of prescription drug data
collected under this part and subject to the restriction under paragraph (6),
upon the request of a congressional support agency, the Secretary shall provide
such agency with the following data collected from, or related to, prescription
drug plans and MA–PD plans:
(A)Aggregate negotiated
price concessionsAggregate negotiated price concessions
described in section 1860D–2(d)(2) (as determined necessary and appropriate by
the congressional support agency to carry out the legislatively mandated duties
of the agency).
(B)Negotiated price
concessionsThe negotiated rebates, discounts, and other price
concessions (as currently reported pursuant to section 1860D–2(d)(2)).
(C)Data or a representative sample of data regarding drug
claims submitted under section 1860D–15(c)(1)(C) (as determined necessary and
appropriate by the congressional support agency to carry out the legislatively
mandated duties of the agency).
(D)The amount of reinsurance payments paid under section
1860D–15(a)(2), provided at the plan level.
(E)The amount of any adjustments of payments made under
subparagraph (B) or (C) of section 1860D–15(e)(2), provided at the plan
level.
(2)Prohibition on
disclosure of data by congressional support agencies
(A)Data provided to a
congressional support agency under this subsection shall not—
(i)be disclosed by such
agency in the performance of the agency’s duties in cases where such disclosure
by the Secretary would be prohibited under applicable Federal law, or where
such disclosure would result in the disclosure of trade secrets; and
(ii)be disclosed, reported,
or released by such agency in identifiable form.
(B)For purposes of subparagraph (A)(ii), the term
identifiable form
means any representation of information
described in subparagraphs (A) through (E) of paragraph (1) that permits
identification of a specific prescription drug plan, MA–PD plan, pharmacy
benefit manager, drug manufacturer, drug wholesaler, drug, or individual
enrolled in a prescription drug plan or an MA–PD plan under this part.
(3)Each congressional support agency shall adopt and maintain
reasonable safeguards to protect against the unauthorized disclosure of data
provided under this subsection. Such safeguards shall only permit the
congressional support agency to disclose the data to another agency or entity
if the agency or entity is—
(A)under a
subcontract with the congressional support agency to support any analysis
conducted by the congressional support agency with respect to such data;
and
(B)is subject to
the same data disclosure provisions and safeguards as the congressional support
agency is subject to under this paragraph and paragraph (2).
(4)Data provided under this subsection shall be exempt
from disclosure under section 552 of title 5, United States Code.
(5)Congressional support
agency definedIn this subsection, the term congressional
support agency
means—
(A)the Medicare Payment
Advisory Commission;
(B)the Congressional
Research Service;
(C)the Congressional Budget
Office; and
(D)the Government
Accountability Office.
(6)Restriction on
disclosure of price concessionsThe Secretary may only release
data on the negotiated price concessions described in paragraph (1)(B) to the
congressional support agency described in paragraph (5)(C).
(7)Nothing in this subsection shall be construed to
limit the ability of a congressional support agency to obtain information not
described in paragraph
(1).
.
(b)Study on market
competition and reports on limitations of data elements for studying the
prescription drug program
(1)Study and report on
market competition by the Congressional Budget Office
(A)The Director of the Congressional Budget Office shall
conduct a study on the effect of market competition on prices for drugs under
part D of title XVIII of the Social Security Act (42 U.S.C. 1395w–101 et seq.)
that includes a review of—
(i)the number and
extent of discounts and other price concessions received by prescription drug
plans and MA–PD plans for covered part D drugs under such part;
(ii)the
relationship between such discounts and price concessions and drug
utilization;
(iii)the
relationship between such discounts and price concessions and the
manufacturer’s best price (as defined in section 1927(c)(2)(B) of the Social
Security Act (42 U.S.C. 1396r–8(c)(2)(B)) for covered outpatient drugs;
and
(iv)the extent to
which the efforts of the Secretary of Health and Human Services (as reported by
the Secretary under section 1860D–11(k) of the Social Security Act, as added by
section 2(b)) to promote and ensure access to fair prices for prescription
drugs under such part have an effect upon payers in non-Medicare
markets.
(B)Not
later than 1 year after the date of enactment of this Act, the Director of the
Congressional Budget Office shall submit a report containing the results of the
study conducted under subparagraph (A).
(2)Reports on limitations
of data elements for studying the prescription drug programNot
later than 180 days after the date of enactment of this Act, the Medicare
Payment Advisory Commission and the Government Accountability Office shall each
submit a report to Congress commenting on the limitations on the usefulness of
the data described in subparagraphs (A) through (E) of section 1860D–42(c)(1),
as added by subsection (a), to inform Congress on negotiated prices for covered
part D drugs (as defined in section 1860D–2(e) of such Act (42 U.S.C.
1395w–102(e)) under the Medicare prescription drug program.
(c)Disclosure of drug
claims data to the State agency responsible for administering the state plan
under the medicaid programSection 1860D–42 of the Social
Security Act (42 U.S.C. 1395w–152), as amended by subsection (a), is amended by
adding at the end the following new subsection:
(d)Disclosure of drug
claims data to the State agency responsible for administering the state plan
under the medicaid programNotwithstanding any provision under
this part that limits the use of prescription drug data collected under this
part, upon the request of a State agency with responsibility for administering
the State plan under title XIX, the Secretary shall provide such State agency
with the data described in paragraph (1)(C) of subsection (c) with respect to
full-benefit dual eligible individuals (as defined in section 1935(c)(6)) who
are enrolled in the State plan. The provisions of paragraphs (2) and (3) of
subsection (c) shall apply to a State agency with respect to data provided
under this subsection in the same manner as such provisions apply to a
congressional support agency with respect to data provided under subsection
(c).
.
(d)Public disclosure of
data by the Secretary of Health and Human ServicesSection
1860D–42 of the Social Security Act (42 U.S.C. 1395w–152), as amended by
subsections (a) and (c), is amended by adding at the end the following new
subsection:
(e)Disclosure of
drug prices charged to enrollees
(1)The Secretary shall make available to the public, upon
request and in an electronic form determined appropriate by the Secretary, data
on the prices charged for each covered part D drug under each prescription drug
plan and MA–PD plan to individuals enrolled in the plan. Such data shall
reflect actual prices posted on the Internet website of the Centers for
Medicare & Medicaid Services and shall be made available in a manner that
permits linkage of the data to data contained in other public prescription drug
plan and MA–PD plan data files.
(2)Nominal fee
for data providedThe Secretary may charge a nominal fee for data
provided under paragraph (1) based on the cost of preparing and providing such
data.
.
(e)Dissemination of retail
drug pricesSection 1860D–4(k) of the Social Security Act (42
U.S.C. 1395w–104(k)) is amended—
(1)in the heading,
by striking pharmaceutical prices for equivalent drugs
and inserting prescription drug information at point of
sale
;
(2)by striking
In
general.—A PDP sponsor
and inserting
“Pharmaceutical prices for
equivalent drugs.—
(A)A PDP
sponsor
;
(3)by redesignating
paragraph (2) as subparagraph (B) and indenting appropriately;
(4)by redesignating
subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and indenting
appropriately;
(5)in clause (i), as
redesignated under paragraph (4)—
(A)by striking
subparagraph (B)
and inserting clause (ii)
;
and
(B)by striking
paragraph (1)
and inserting subparagraph (A)
;
and
(6)by adding at the end the
following new paragraph:
(2)Drug prices charged to
enrollees
(A)A PDP sponsor offering a prescription drug plan shall
provide that each pharmacy that dispenses a covered part D drug shall inform an
enrollee of the price charged for such drug under the prescription drug
plan.
(B)The information under subparagraph (A) shall be provided
at the time of purchase of the drug involved, including for purchases of
covered part D drugs by mail
order.
.
4.Prioritizing studies of
comparative clinical effectiveness of covered part D drugs
(a)
(1)The Secretary of Health and Human Services (in this
section referred to as the Secretary
) shall develop a
comprehensive prioritized list of comparative clinical effectiveness studies
that are most critical to building the evidence needed to advance value-based
purchasing of covered part D drugs (as defined in section 1860D–2(e) of the
Social Security Act (42 U.S.C. 1395w–102(e)) under the Medicare prescription
drug program under part D of title XVIII of such Act.
(2)
(A)In developing the list under paragraph (1), the Secretary
shall take into account—
(i)the work the Agency for
Healthcare Research and Quality has already done to identify needed comparative
clinical effectiveness and safety research on prescription drugs, including the
work identifying issues for which existing scientific evidence is insufficient
under subsection (a)(3)(A)(ii) of section 1013 of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. 299b–7);
(ii)the initial list of
medical conditions considered a priority for research that was developed in
response to the requirements of subsection (a)(2)(B) of such section
1013;
(iii)areas where patients
and doctors are most lacking the information needed to make the best decisions
regarding covered part D drugs, such as the areas where there is a large gap in
knowledge of drug therapies and areas that involve the most widely prescribed
covered part D drugs; and
(iv)any advice provided by
the advisory committee established under paragraph (3).
(B)Contents of
prioritized list
(i)Specification
of items, services, and methodologyThe prioritized list shall
specify the items and services to be evaluated, as well as the general
methodology that should be used to conduct each study identified as a priority
on the list, taking into consideration the full range of methodologies
available, from systematic reviews to clinical trials.
(ii)The studies included on the prioritized list may include
studies that compare a covered part D drug to any other drug (or biological
product), item, or service that is covered under the Medicare program.
(C)
(i)Not later than 1 year after the date of enactment of this
Act and subject to the requirements under clause (ii), the Secretary shall
submit to Congress a report that contains the following:
(I)The prioritized
list developed under paragraph (1) and plans for the conduct of studies
identified as a priority on such list.
(II)A summary of
the information described in clauses (i) through (iv) of subparagraph
(A).
(III)An explanation
of how the Secretary took into account the information described in such
clauses (i) through (iv) in developing the prioritized list and in preparing
the report.
(IV)The rationale for why
the Secretary included the studies identified as a priority on such
list.
(ii)Submission of
draft reportBefore submitting the report under clause (i), the
Secretary shall—
(I)submit to
Congress a draft version of the report;
(II)make such draft version
available to the public; and
(III)provide a 60-day period
for public comment on such draft version.
(D)The Secretary shall make the report submitted under
subparagraph (C)(i) available to the public.
(3)Establishment of
advisory committee
(A)The
Secretary shall establish an advisory committee for the purpose of providing
advice to the Secretary on setting priorities for comparative clinical
effectiveness studies across all agencies of the Department of Health and Human
Services. The Secretary shall make available to the public any advice provided
to the Secretary by the advisory committee.
(B)
(i)The advisory committee shall include a diverse range of
public and private clinical experts, stakeholders, and interests from the
following groups:
(I)The medical and
health industries.
(II)Patients and
representatives of patients.
(III)Researchers.
(IV)Government.
(ii)No majority
of membership from any one groupThe Secretary shall ensure that
the advisory committee does not have a majority of members from any one of the
groups described in subclauses (I) through (IV) of clause (i).
(C)The Advisory committee shall provide a substantial
opportunity for public comment by accepting oral and written comments from the
public prior to making any recommendations or providing any advice to the
Secretary.
(b)Nothing in this section shall be construed to limit
the authority of the Secretary—
(1)to prioritize comparative
clinical effectiveness research needs for procedures, devices, diagnostics, or
other medical interventions; or
(2)to conduct any study on
the list developed under subsection (a)(1) or any other study determined
appropriate by the Secretary.
(c)Authorization of
appropriationsThere are authorized to be appropriated such sums
as may be necessary to carry out this section.
5.Authorizing
consideration of comparative clinical effectiveness studies in developing and
reviewing formularies under the medicare prescription drug program
(a)Section
1860D–4(b)(3)(B) of the Social Security Act (42 U.S.C. 1395w–104(b)(3)(B)) is
amended—
(1)in clause (i), by striking
and
at the end;
(2)in clause (ii), by striking the period at
the end and inserting ; and
; and
(3)by adding at the end the following new
clause:
(iii)take into account
relevant comparative clinical effectiveness
studies.
.
(b)The amendments made by subsection (a) shall apply to plan
years beginning on or after January 1, 2007.
6.Sense of the
senate regarding the resource standard used to determine eligibility for
premium and cost-sharing subsidies under part D
(a)The Senate makes the following
findings:
(1)Currently,
beneficiaries enrolled in the Medicare part D prescription drug program must
satisfy a resource standard in order to be eligible for the low-income
subsidy.
(2)The resource standard
used to determine eligibility for the low-income subsidy has resulted in many
Medicare beneficiaries who are in financial need being disqualified from
receiving additional assistance.
(3)Under S. 1 from the 108th
Congress, as passed by the Senate, beneficiaries were not subjected to a
resource standard to qualify for additional assistance.
(b)It is the Sense of the
Senate that Congress should revisit the resource standard used to determine the
eligibility of individuals for premium and cost-sharing subsidies under section
1860D–14 of the Social Security Act (42 U.S.C. 1395w–114).
7.Sense of the
senate regarding pharmacy issues under part D
(a)
(1)Pharmacists play
a critical role in delivering prescription drugs to Medicare beneficiaries
enrolled in prescription drug plans and MA–PD plans under the Medicare part D
prescription drug program.
(2)Pharmacists have
encountered difficulties in providing services under their contracts with PDP
sponsors offering prescription drug plans and MA organizations offering MA–PD
plans under part D.
(b)It is the sense of the Senate that Congress should address
issues related to pharmacies under the Medicare part D prescription drug
program.
April 13, 2007
Reported with an amendment