Lower Costs, More Cures Act of 2019
This bill establishes and modifies several requirements to address prescription drug prices under Medicare.
The bill generally
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3129 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
1st Session
S. 3129
To provide for certain reforms with respect to the Medicare program
under title XVIII of the Social Security Act, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 19, 2019
Mr. Crapo (for himself, Mr. Enzi, Mr. Burr, Mr. Barrasso, Mr. Tillis,
and Mr. Risch) introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To provide for certain reforms with respect to the Medicare program
under title XVIII of the Social Security Act, 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.
This Act may be cited as the ``Lower Costs, More Cures Act of
2019''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--MEDICARE PARTS B AND D
Subtitle A--Medicare Part B Provisions
Sec. 101. Improvements to Medicare site-of-service transparency.
Sec. 102. Requiring manufacturers of certain single-dose container or
single-use package drugs payable under part
B of the Medicare program to provide
refunds with respect to discarded amounts
of such drugs.
Sec. 103. Providing for variation in payment for certain drugs covered
under part B of the Medicare program.
Sec. 104. Establishment of maximum add-on payment for drugs and
biologicals.
Sec. 105. Treatment of drug administration services furnished by
certain excepted off-campus outpatient
departments of a provider.
Sec. 106. Payment for biosimilar biological products during initial
period.
Sec. 107. Education on biological and biosimilar products.
Sec. 108. GAO study and report on average sales price.
Subtitle B--Medicare Part D Provisions
Sec. 111. Medicare part D benefit redesign.
Sec. 112. Transitional coverage and retroactive Medicare part D
coverage for certain low-income
beneficiaries.
Sec. 113. Allowing the offering of additional prescription drug plans
under Medicare part D.
Sec. 114. Allowing certain enrollees of prescription drug plans and MA-
PD plans under the Medicare program to
spread out cost-sharing under certain
circumstances.
Sec. 115. Establishing a monthly cap on beneficiary incurred costs for
insulin products and supplies under a
prescription drug plan or MA-PD plan.
Sec. 116. Growth rate of Medicare part D out-of-pocket cost threshold.
Sec. 117. Requiring prescription drug plan sponsors to include real-
time benefit information as part of such
sponsor's electronic prescription program
under the Medicare program.
Sec. 118. Requiring prescription drug plans and MA-PD plans to report
potential fraud, waste, and abuse to the
Secretary of HHS.
Sec. 119. Establishment of pharmacy quality measures under Medicare
part D.
TITLE II--DRUG PRICE TRANSPARENCY
Sec. 201. Reporting on explanation for drug price increases.
Sec. 202. Public disclosure of drug discounts.
Sec. 203. Requiring certain manufacturers to report drug pricing
information with respect to drugs under the
Medicare program.
Sec. 204. Making prescription drug marketing sample information
reported by manufacturers available to
certain individuals and entities.
Sec. 205. Providing the Medicare Payment Advisory Commission and
Medicaid and CHIP Payment and Access
Commission with access to certain drug
payment information, including certain
rebate information.
Sec. 206. Sense of the Senate regarding the need to expand commercially
available drug pricing comparison
platforms.
TITLE III--REVENUE PROVISIONS
Sec. 301. Permanent extension of reduction in medical expense deduction
floor.
Sec. 302. Safe harbor for high deductible health plans without
deductible for insulin.
Sec. 303. Inclusion of certain over-the-counter medical products as
qualified medical expenses.
TITLE IV--MISCELLANEOUS
Sec. 401. Improving coordination between the Food and Drug
Administration and the Centers for Medicare
& Medicaid Services.
Sec. 402. Patient consultation in Medicare national and local coverage
determinations in order to mitigate
barriers to inclusion of such perspectives.
Sec. 403. MedPAC report on shifting coverage of certain Medicare part B
drugs to Medicare part D.
Sec. 404. Requirement that direct-to-consumer advertisements for
prescription drugs and biological products
include truthful and non-misleading pricing
information.
Sec. 405. Chief Pharmaceutical Negotiator at the Office of the United
States Trade Representative.
TITLE I--MEDICARE PARTS B AND D
Subtitle A--Medicare Part B Provisions
SEC. 101. IMPROVEMENTS TO MEDICARE SITE-OF-SERVICE TRANSPARENCY.
Section 1834(t) of the Social Security Act (42 U.S.C. 1395m(t)) is
amended--
(1) in paragraph (1)--
(A) in the heading, by striking ``In general'' and
inserting ``Site payment'';
(B) in the matter preceding subparagraph (A)--
(i) by striking ``or to'' and inserting ``,
to'';
(ii) by inserting ``, or to a physician for
services furnished in a physician's office''
after ``surgical center under this title''; and
(iii) by inserting ``(or 2021 with respect
to a physician for services furnished in a
physician's office)'' after ``2018''; and
(C) in subparagraph (A)--
(i) by striking ``and the'' and inserting
``, the''; and
(ii) by inserting ``, and the physician fee
schedule under section 1848 (with respect to
the practice expense component of such payment
amount)'' after ``such section'';
(2) by redesignating paragraphs (2) through (4) as
paragraphs (3) through (5), respectively; and
(3) by inserting after paragraph (1) the following new
paragraph:
``(2) Physician payment.--Beginning in 2021, the Secretary
shall expand the information included on the Internet website
described in paragraph (1) to include--
``(A) the amount paid to a physician under section
1848 for an item or service for the settings described
in paragraph (1); and
``(B) the estimated amount of beneficiary liability
applicable to the item or service.''.
SEC. 102. REQUIRING MANUFACTURERS OF CERTAIN SINGLE-DOSE CONTAINER OR
SINGLE-USE PACKAGE DRUGS PAYABLE UNDER PART B OF THE
MEDICARE PROGRAM TO PROVIDE REFUNDS WITH RESPECT TO
DISCARDED AMOUNTS OF SUCH DRUGS.
Section 1847A of the Social Security Act (42 U.S.C. 1395-3a) is
amended by adding at the end the following new subsection:
``(h) Refund for Certain Discarded Single-Dose Container or Single-
Use Package Drugs.--
``(1) Secretarial provision of information.--
``(A) In general.--For each calendar quarter
beginning on or after July 1, 2021, the Secretary
shall, with respect to a refundable single-dose
container or single-use package drug (as defined in
paragraph (8)), report to each manufacturer (as defined
in subsection (c)(6)(A)) of such refundable single-dose
container or single-use package drug the following for
the calendar quarter:
``(i) Subject to subparagraph (C),
information on the total number of units of the
billing and payment code of such drug, if any,
that were discarded during such quarter, as
determined using a mechanism such as the JW
modifier used as of the date of enactment of
this subsection (or any such successor modifier
that includes such data as determined
appropriate by the Secretary).
``(ii) The refund amount that the
manufacturer is liable for pursuant to
paragraph (3).
``(B) Determination of discarded amounts.--For
purposes of subparagraph (A)(i), with respect to a
refundable single-dose container or single-use package
drug furnished during a quarter, the amount of such
drug that was discarded shall be determined based on
the amount of such drug that was unused and discarded
for each drug on the date of service.
``(C) Exclusion of units of packaged drugs.--The
total number of units of the billing and payment code
of a refundable single-dose container or single-use
package drug of a manufacturer furnished during a
calendar quarter for purposes of subparagraph (A)(i),
and the determination of the estimated total allowed
charges for the drug in the quarter for purposes of
paragraph (3)(A)(ii), shall not include such units that
are packaged into the payment amount for an item or
service and are not separately payable.
``(2) Manufacturer requirement.--For each calendar quarter
beginning on or after July 1, 2021, the manufacturer of a
refundable single-dose container or single-use package drug
shall, for such drug, provide to the Secretary a refund that is
equal to the amount specified in paragraph (3) for such drug
for such quarter.
``(3) Refund amount.--
``(A) In general.--The amount of the refund
specified in this paragraph is, with respect to a
refundable single-dose container or single-use package
drug of a manufacturer assigned to a billing and
payment code for a calendar quarter beginning on or
after July 1, 2021, an amount equal to the estimated
amount (if any) by which--
``(i) the product of--
``(I) the total number of units of
the billing and payment code for such
drug that were discarded during such
quarter (as determined under paragraph
(1)); and
``(II)(aa) in the case of a
refundable single-dose container or
single-use package drug that is a
single source drug or biological, the
amount determined for such drug under
subsection (b)(4); or
``(bb) in the case of a refundable
single-dose container or single-use
package drug that is a biosimilar
biological product, the average sales
price determined under subsection
(b)(8)(A); exceeds
``(ii) an amount equal to the applicable
percentage (as defined in subparagraph (B)) of
the estimated total allowed charges for such
drug during the quarter.
``(B) Applicable percentage defined.--
``(i) In general.--For purposes of
subparagraph (A)(ii), the term `applicable
percentage' means--
``(I) subject to subclause (II), 10
percent; and
``(II) if applicable, in the case
of a refundable single-dose container
or single-use package drug described in
clause (ii), a percentage specified by
the Secretary pursuant to such clause.
``(ii) Treatment of drugs that have unique
circumstances.--In the case of a refundable
single-dose container or single-use package
drug that has unique circumstances involving
similar loss of product as that described in
paragraph (8)(B), the Secretary, through notice
and comment rulemaking, may increase the
applicable percentage otherwise applicable
under clause (i)(I) as determined appropriate
by the Secretary.
``(4) Frequency.--Amounts required to be refunded pursuant
to paragraph (2) shall be paid in regular intervals (as
determined appropriate by the Secretary).
``(5) Refund deposits.--Amounts paid as refunds pursuant to
paragraph (2) shall be deposited into the Federal Supplementary
Medical Insurance Trust Fund established under section 1841.
``(6) Enforcement.--
``(A) Audits.--
``(i) Manufacturer audits.--Each
manufacturer of a refundable single-dose
container or single-use package drug that is
required to provide a refund under this
subsection shall be subject to periodic audit
with respect to such drug and such refunds by
the Secretary.
``(ii) Provider audits.--The Secretary
shall conduct periodic audits of claims
submitted under this part with respect to
refundable single-dose container or single-use
package drugs in accordance with the authority
under section 1833(e) to ensure compliance with
the requirements applicable under this
subsection.
``(B) Civil money penalty.--
``(i) In general.--The Secretary shall
impose a civil money penalty on a manufacturer
of a refundable single-dose container or
single-use package drug who has failed to
comply with the requirement under paragraph (2)
for such drug for a calendar quarter in an
amount equal to the sum of--
``(I) the amount that the
manufacturer would have paid under such
paragraph with respect to such drug for
such quarter; and
``(II) 25 percent of such amount.
``(ii) Application.--The provisions of
section 1128A (other than subsections (a) and
(b)) shall apply to a civil money penalty under
this subparagraph in the same manner as such
provisions apply to a penalty or proceeding
under section 1128A(a).
``(7) Implementation.--The Secretary shall implement this
subsection through notice and comment rulemaking.
``(8) Definition of refundable single-dose container or
single-use package drug.--
``(A) In general.--Except as provided in
subparagraph (B), in this subsection, the term
`refundable single-dose container or single-use package
drug' means a single source drug or biological (as
defined in section 1847A(c)(6)(D)) or a biosimilar
biological product (as defined in section
1847A(c)(6)(H)) for which payment is established under
this part and that is furnished from a single-dose
container or single-use package.
``(B) Exclusions.--The term `refundable single-dose
container or single-use package drug' does not
include--
``(i) a drug or biological that is either a
radiopharmaceutical or an imaging agent;
``(ii) a drug or biological for which
dosage and administration instructions approved
by the Commissioner of Food and Drugs require
filtration during the drug preparation process,
prior to dilution and administration, and
require that any unused portion of such drug
after the filtration process be discarded after
the completion of such filtration process; or
``(iii) a drug or biological approved by
the Food and Drug Administration on or after
the date of enactment of this subsection and
with respect to which payment has been made
under this part for less than 18 months.''.
SEC. 103. PROVIDING FOR VARIATION IN PAYMENT FOR CERTAIN DRUGS COVERED
UNDER PART B OF THE MEDICARE PROGRAM.
(a) In General.--Section 1847A(b) of the Social Security Act (42
U.S.C. 1395w-3a(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by inserting after ``or
106 percent'' the following: ``(or, for a multiple
source drug (other than autologous cellular
immunotherapy) furnished on or after January 1, 2021,
the applicable percent specified in paragraph (9)(A)
for the drug and quarter involved)''; and
(B) in subparagraph (B) of paragraph (1), by
inserting after ``106 percent'' the following: ``(or,
for a single source drug or biological (other than
autologous cellular immunotherapy) furnished on or
after January 1, 2021, the applicable percent specified
in paragraph (9)(A) for the drug or biological and
quarter involved)''; and
(2) by adding at the end the following new paragraph:
``(9) Application of variable percentages based on
percentile ranking of per beneficiary allowed charges.--
``(A) Applicable percent to be applied.--
``(i) In general.--Subject to clause (ii),
with respect to a drug or biological furnished
in a calendar quarter beginning on or after
January 1, 2021, if the Secretary determines
that the percentile rank of a drug or
biological under subparagraph (B)(i)(III), with
respect to per beneficiary allowed charges for
all such drugs or biologicals, is--
``(I) at least equal to the 85th
percentile, the applicable percent for
the drug for such quarter under this
subparagraph is 104 percent;
``(II) at least equal to the 70th
percentile, but less than the 85th
percentile, such applicable percent is
106 percent;
``(III) at least equal to the 50th
percentile, but less than the 70th
percentile, such applicable percent is
108 percent; or
``(IV) less than the 50th
percentile, such applicable percent is
110 percent.
``(ii) Cases where data not sufficiently
available to compute per beneficiary allowed
charges.--Subject to clause (iii), in the case
of a drug or biological furnished for which the
amount of payment is determined under
subparagraph (A) or (B) of paragraph (1) and
not under subsection (c)(4), for calendar
quarters during a period in which data are not
sufficiently available to compute a per
beneficiary allowed charges for the drug or
biological, the applicable percent is 106
percent.
``(B) Determination of percentile rank of per
beneficiary allowed charges of drugs.--
``(i) In general.--With respect to a
calendar quarter beginning on or after January
1, 2021, for drugs and biologicals for which
the amount of payment is determined under
subparagraph (A) or (B) of paragraph (1),
except for drugs or biologicals for which data
are not sufficiently available, the Secretary
shall--
``(I) compute the per beneficiary
allowed charges (as defined in
subparagraph (C)) for each such drug or
biological;
``(II) adjust such per beneficiary
allowed charges for the quarter, to the
extent provided under subparagraph (D);
and
``(III) arrange such adjusted per
beneficiary allowed charges for all
such drugs or biologicals from high to
low and rank such drugs or biologicals
by percentile of such per beneficiary
allowed charges.
``(ii) Frequency.--The Secretary shall make
the computations under clause (i)(I) every 6
months (or, if necessary, as determined by the
Secretary, every 9 or 12 months) and such
computations shall apply to succeeding calendar
quarters until a new computation has been made.
``(iii) Applicable data period.--For
purposes of this paragraph, the term
`applicable data period' means the most recent
period for which the data necessary for making
the computations under clause (i) are
available, as determined by the Secretary.
``(C) Per beneficiary allowed charges defined.--In
this paragraph, the term `per beneficiary allowed
charges' means, with respect to a drug or biological
for which the amount of payment is determined under
subparagraph (A) or (B) of paragraph (1)--
``(i) the allowed charges for the drug or
biological for which payment is so made for the
applicable data period, as estimated by the
Secretary; divided by
``(ii) the number of individuals for whom
any payment for the drug or biological was made
under paragraph (1) for the applicable data
period, as estimated by the Secretary.
``(D) Adjustment to reflect changes in average
sales price.--In applying this paragraph for a
particular calendar quarter, the Secretary shall adjust
the per beneficiary allowed charges for a drug or
biological by multiplying such per beneficiary allowed
charges under subparagraph (C) for the applicable data
period by the ratio of--
``(i) the average sales price for the drug
or biological for the most recent calendar
quarter used under subsection (c)(5)(B); to
``(ii) the average sales price for the drug
or biological for the calendar quarter (or the
weighted average for the quarters involved)
included in the applicable data period.''.
(b) Application of Judicial Review Provisions.--Section 1847A(g) of
the Social Security Act is amended--
(1) by striking ``and'' at the end of paragraph (4);
(2) by striking the period at the end of paragraph (5) and
inserting ``; and''; and
(3) by adding at the end the following new paragraph:
``(6) the determination of per beneficiary allowed charges
of drugs or biologicals and ranking of such charges under
subsection (b)(9).''.
SEC. 104. ESTABLISHMENT OF MAXIMUM ADD-ON PAYMENT FOR DRUGS AND
BIOLOGICALS.
(a) In General.--Section 1847A of the Social Security Act (42
U.S.C. 1395w-3a), as amended by section 103, is amended--
(1) in subsection (b)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``paragraph (7)'' and
inserting ``paragraphs (7) and (10)''; and
(B) by adding at the end the following new
paragraph:
``(10) Maximum add-on payment amount.--
``(A) In general.--In determining the payment
amount under the provisions of subparagraph (A), (B),
or (C) of paragraph (1) of this subsection, subsection
(c)(4)(A)(ii), or subsection (d)(3)(C) for a drug or
biological furnished on or after January 1, 2021, if
the applicable add-on payment (as defined in
subparagraph (B)) for each drug or biological on a
claim for a date of service exceeds the maximum add-on
payment amount specified under subparagraph (C) for the
drug or biological, then the payment amount otherwise
determined for the drug or biological under those
provisions, as applicable, shall be reduced by the
amount of such excess.
``(B) Applicable add-on payment defined.--In this
paragraph, the term `applicable add-on payment' means
the following amounts, determined without regard to the
application of subparagraph (A):
``(i) In the case of a multiple source
drug, an amount equal to the difference
between--
``(I) the amount that would
otherwise be applied under paragraph
(1)(A); and
``(II) the amount that would be
applied under such paragraph if `100
percent' were substituted for the
applicable percent (as defined in
paragraph (9)) for such drug.
``(ii) In the case of a single source drug
or biological, an amount equal to the
difference between--
``(I) the amount that would
otherwise be applied under paragraph
(1)(B); and
``(II) the amount that would be
applied under such paragraph if `100
percent' were substituted for the
applicable percent (as defined in
paragraph (9)) for such drug or
biological.
``(iii) In the case of a biosimilar
biological product, the amount otherwise
determined under paragraph (8)(B).
``(iv) In the case of a drug or biological
during the initial period described in
subsection (c)(4)(A), an amount equal to the
difference between--
``(I) the amount that would
otherwise be applied under subsection
(c)(4)(A)(ii); and
``(II) the amount that would be
applied under such subsection if `100
percent' were substituted, as
applicable, for--
``(aa) `103 percent' in
subclause (I) of such
subsection; or
``(bb) any percent in
excess of 100 percent applied
under subclause (II) of such
subsection.
``(v) In the case of a drug or biological
to which subsection (d)(3)(C) applies, an
amount equal to the difference between--
``(I) the amount that would
otherwise be applied under such
subsection; and
``(II) the amount that would be
applied under such subsection if `100
percent' were substituted, as
applicable, for--
``(aa) any percent in
excess of 100 percent applied
under clause (i) of such
subsection; or
``(bb) `103 percent' in
clause (ii) of such subsection.
``(C) Maximum add-on payment amount specified.--For
purposes of subparagraph (A), the maximum add-on
payment amount specified in this subparagraph is--
``(i) with respect to a drug or biological
(other than autologous or allogeneric cellular
immunotherapy)--
``(I) for each of 2021 through
2028, $1,000; and
``(II) for a subsequent year, the
amount specified in this subparagraph
for the preceding year increased by the
percentage increase in the consumer
price index for all urban consumers
(all items; United States city average)
for the 12-month period ending with
June of the previous year; or
``(ii) with respect to a drug or biological
consisting of autologous or allogeneric
cellular immunotherapy--
``(I) for each of 2021 through
2028, $2,000; and
``(II) for a subsequent year, the
amount specified in this subparagraph
for the preceding year increased by the
percentage increase in the consumer
price index for all urban consumers
(all items; United States city average)
for the 12-month period ending with
June of the previous year.
Any amount determined under this subparagraph that is
not a multiple of $10 shall be rounded to the nearest
multiple of $10.''; and
(2) in subsection (c)(4)(A)(ii), by striking ``in the
case'' and inserting ``subject to subsection (b)(10), in the
case''.
(b) Conforming Amendments Relating to Separately Payable Drugs.--
(1) OPPS.--Section 1833(t)(14) of the Social Security Act
(42 U.S.C. 1395l(t)(14)) is amended--
(A) in subparagraph (A)(iii)(II), by inserting ``,
subject to subparagraph (I)'' after ``are not
available''; and
(B) by adding at the end the following new
subparagraph:
``(I) Application of maximum add-on payment for
separately payable drugs and biologicals.--In
establishing the amount of payment under subparagraph
(A) for a specified covered outpatient drug that is
furnished as part of a covered OPD service (or group of
services) on or after January 1, 2021, if such payment
is determined based on the average price for the year
established under section 1847A pursuant to clause
(iii)(II) of such subparagraph, the provisions of
subsection (b)(10) of section 1847A shall apply to the
amount of payment so established in the same manner as
such provisions apply to the amount of payment under
section 1847A.''.
(2) ASC.--Section 1833(i)(2)(D) of the Social Security Act
(42 U.S.C. 1395l(i)(2)(D)) is amended--
(A) by moving clause (v) 6 ems to the left;
(B) by redesignating clause (vi) as clause (vii);
and
(C) by inserting after clause (v) the following new
clause:
``(vi) If there is a separate payment under
the system described in clause (i) for a drug
or biological furnished on or after January 1,
2021, the provisions of subsection (t)(14)(I)
shall apply to the establishment of the amount
of payment for the drug or biological under
such system in the same manner in which such
provisions apply to the establishment of the
amount of payment under subsection
(t)(14)(A).''.
SEC. 105. TREATMENT OF DRUG ADMINISTRATION SERVICES FURNISHED BY
CERTAIN EXCEPTED OFF-CAMPUS OUTPATIENT DEPARTMENTS OF A
PROVIDER.
Section 1833(t)(16) of the Social Security Act (42 U.S.C.
1395l(t)(16)) is amended by adding at the end the following new
subparagraph:
``(G) Special payment rule for drug administration
services furnished by an excepted department of a
provider.--
``(i) In general.--In the case of a covered
OPD service that is a drug administration
service (as defined by the Secretary) furnished
by a department of a provider described in
clause (ii) or (iv) of paragraph (21)(B), the
payment amount for such service furnished on or
after January 1, 2021, shall be the same
payment amount (as determined in paragraph
(21)(C)) that would apply if the drug
administration service was furnished by an off-
campus outpatient department of a provider (as
defined in paragraph (21)(B)).
``(ii) Application without regard to budget
neutrality.--The reductions made under this
subparagraph--
``(I) shall not be considered an
adjustment under paragraph (2)(E); and
``(II) shall not be implemented in
a budget neutral manner.''.
SEC. 106. PAYMENT FOR BIOSIMILAR BIOLOGICAL PRODUCTS DURING INITIAL
PERIOD.
Section 1847A(c)(4) of the Social Security Act (42 U.S.C. 1395w-
3a(c)(4)) is amended--
(1) in each of subparagraphs (A) and (B), by redesignating
clauses (i) and (ii) as subclauses (I) and (II), respectively,
and moving such subclauses 2 ems to the right;
(2) by redesignating subparagraphs (A) and (B) as clauses
(i) and (ii) and moving such clauses 2 ems to the right;
(3) by striking ``unavailable.--In the case'' and inserting
``unavailable.--
``(A) In general.--Subject to subparagraph (B), in
the case''; and
(4) by adding at the end the following new subparagraph:
``(B) Limitation on payment amount for biosimilar
biological products during initial period.--In the case
of a biosimilar biological product furnished on or
after July 1, 2020, in lieu of applying subparagraph
(A) during the initial period described in such
subparagraph with respect to the biosimilar biological
product, the amount payable under this section for the
biosimilar biological product is the lesser of the
following:
``(i) The amount determined under clause
(ii) of such subparagraph for the biosimilar
biological product.
``(ii) The amount determined under
subsection (b)(1)(B) for the reference
biological product.''.
SEC. 107. EDUCATION ON BIOLOGICAL AND BIOSIMILAR PRODUCTS.
(a) In General.--The Secretary of Health and Human Services shall
advance education and awareness among health care providers regarding
biological products, including biosimilar biological products and
interchangeable biosimilar biological products, as appropriate,
including by developing or improving continuing education programs that
advance the education of such providers on the prescribing of, and
relevant clinical considerations with respect to, biological products,
including biosimilar biological products and interchangeable biosimilar
biological products.
(b) Application Under the Medicare Merit-Based Incentive Payment
System.--Section 1848(q)(5)(C) of the Social Security Act (42 U.S.C.
1395w-4(q)(5)(C)) is amended by adding at the end the following new
clause:
``(iv) Clinical medical education program
on biosimilar biological products.--Completion
of a clinical medical education program
developed or improved under section 107(a) of
the Lower Costs, More Cures Act of 2019 by a
MIPS eligible professional during a performance
period shall earn such eligible professional
one-half of the highest potential score for the
performance category described in paragraph
(2)(A)(iii) for such performance period. A MIPS
eligible professional may only count the
completion of such a program for purposes of
such category one time during the eligible
professional's lifetime.''.
SEC. 108. GAO STUDY AND REPORT ON AVERAGE SALES PRICE.
(a) Study.--
(1) In general.--The Comptroller General of the United
States (in this section referred to as the ``Comptroller
General'') shall conduct a study on spending for applicable
drugs under part B of title XVIII of the Social Security Act.
(2) Applicable drugs defined.--In this section, the term
``applicable drugs'' means drugs and biologicals--
(A) for which reimbursement under such part B is
based on the average sales price of the drug or
biological; and
(B) that account for the largest percentage of
total spending on drugs and biologicals under such part
B (as determined by the Comptroller General, but in no
case less than 25 drugs or biologicals).
(3) Requirements.--The study under paragraph (1) shall
include an analysis of the following:
(A) The extent to which each applicable drug is
paid for--
(i) under such part B for Medicare
beneficiaries; or
(ii) by private payers in the commercial
market.
(B) Any change in Medicare spending or Medicare
beneficiary cost-sharing that would occur if the
average sales price of an applicable drug was based
solely on payments by private payers in the commercial
market.
(C) The extent to which drug manufacturers provide
rebates, discounts, or other price concessions to
private payers in the commercial market for applicable
drugs, which the manufacturer includes in its average
sales price calculation, for--
(i) formulary placement;
(ii) utilization management considerations;
or
(iii) other purposes.
(D) Barriers to drug manufacturers providing such
price concessions for applicable drugs.
(E) Other areas determined appropriate by the
Comptroller General.
(b) Report.--Not later than 2 years after the date of the enactment
of this Act, the Comptroller General shall submit to Congress a report
on the study conducted under subsection (a), together with
recommendations for such legislation and administrative action as the
Secretary determines appropriate.
Subtitle B--Medicare Part D Provisions
SEC. 111. MEDICARE PART D BENEFIT REDESIGN.
(a) Benefit Structure Redesign.--Section 1860D-2(b) of the Social
Security Act (42 U.S.C. 1395w-102(b)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
inserting ``for a year preceding 2022 and for
costs above the annual deductible specified in
paragraph (1) and up to the annual out-of-
pocket threshold specified in paragraph (4)(B)
for 2022 and each subsequent year'' after
``paragraph (3)'';
(ii) in clause (i), by inserting after ``25
percent'' the following: ``(or, for 2022 and
each subsequent year, 15 percent)''; and
(iii) in clause (ii), by inserting ``(or,
for 2022 and each subsequent year, 15
percent)'' after ``25 percent'';
(B) in subparagraph (C)--
(i) in clause (i), in the matter preceding
subclause (I), by inserting ``for a year
preceding 2022,'' after ``paragraph (4),''; and
(ii) in clause (ii)(III), by striking ``and
each subsequent year'' and inserting ``and
2021''; and
(C) in subparagraph (D)--
(i) in clause (i)--
(I) in the matter preceding
subclause (I), by inserting ``for a
year preceding 2022,'' after
``paragraph (4),''; and
(II) in subclause (I)(bb), by
striking ``a year after 2018'' and
inserting ``each of years 2018 through
2021''; and
(ii) in clause (ii)(V), by striking ``2019
and each subsequent year'' and inserting ``each
of years 2019 through 2021'';
(2) in paragraph (3)(A)--
(A) in the matter preceding clause (i), by
inserting ``for a year preceding 2022,'' after ``and
(4),''; and
(B) in clause (ii), by striking ``for a subsequent
year'' and inserting ``for each of years 2007 through
2021''; and
(3) in paragraph (4)--
(A) in subparagraph (A)--
(i) in clause (i)--
(I) by redesignating subclauses (I)
and (II) as items (aa) and (bb),
respectively, and indenting
appropriately;
(II) in the matter preceding item
(aa), as redesignated by subclause (I),
by striking ``is equal to the greater
of--'' and inserting ``is equal to--
``(I) for a year preceding 2022,
the greater of--'';
(III) by striking the period at the
end of item (bb), as redesignated by
subclause (I), and inserting ``; and'';
and
(IV) by adding at the end the
following:
``(II) for 2022 and each succeeding
year, $0.''; and
(ii) in clause (ii)--
(I) by striking ``clause (i)(I)''
and inserting ``clause (i)(I)(aa)'';
and
(II) by adding at the end the
following new sentence: ``The Secretary
shall continue to calculate the dollar
amounts specified in clause (i)(I)(aa),
including with the adjustment under
this clause, after 2021 for purposes of
section 1860D-14(a)(1)(D)(iii).'';
(B) in subparagraph (B)--
(i) in clause (i)--
(I) in subclause (V), by striking
``or'' at the end;
(II) in subclause (VI)--
(aa) by striking ``for a
subsequent year'' and inserting
``for 2021''; and
(bb) by striking the period
at the end and inserting a
semicolon; and
(III) by adding at the end the
following new subclauses:
``(VII) for 2022, is equal to
$3,100; or
``(VIII) for a subsequent year, is
equal to the amount specified in this
subparagraph for the previous year,
increased by the annual percentage
increase described in paragraph (6) for
the year involved.''; and
(ii) in clause (ii), by striking ``clause
(i)(II)'' and inserting ``clause (i)'';
(C) in subparagraph (C)(i), by striking ``and for
amounts'' and inserting ``and for a year preceding 2022
for amounts''; and
(D) in subparagraph (E), by striking ``In
applying'' and inserting ``For each of 2011 through
2021, in applying''.
(b) Decreasing Reinsurance Payment Amount.--Section 1860D-15(b)(1)
of the Social Security Act (42 U.S.C. 1395w-115(b)(1)) is amended--
(1) by striking ``equal to 80 percent'' and inserting
``equal to--
``(A) for a year preceding 2022, 80 percent'';
(2) in subparagraph (A), as added by paragraph (1), by
striking the period at the end and inserting ``; and''; and
(3) by adding at the end the following new subparagraph:
``(B) for 2022 and each subsequent year, the sum
of--
``(i) an amount equal to 20 percent of the
allowable reinsurance costs (as specified in
paragraph (2)) attributable to that portion of
gross covered prescription drug costs as
specified in paragraph (3) incurred in the
coverage year after such individual has
incurred costs that exceed the annual out-of-
pocket threshold specified in section 1860D-
2(b)(4)(B) with respect to applicable drugs (as
defined in section 1860D-14B(g)(2)); and
``(ii) an amount equal to 30 percent of the
allowable reinsurance costs (as specified in
paragraph (2)) attributable to that portion of
gross covered prescription drug costs as
specified in paragraph (3) incurred in the
coverage year after such individual has
incurred costs that exceed the annual out-of-
pocket threshold specified in section 1860D-
2(b)(4)(B) with respect to covered part D drugs
that are not applicable drugs (as so
defined).''.
(c) Manufacturer Discount Program.--
(1) In general.--Part D of title XVIII of the Social
Security Act is amended by inserting after section 1860D-14A
(42 U.S.C. 1495w-114) the following new section:
``SEC. 1860D-14B. MANUFACTURER DISCOUNT PROGRAM.
``(a) Establishment.--The Secretary shall establish a manufacturer
discount program (in this section referred to as the `program'). Under
the program, the Secretary shall enter into agreements described in
subsection (b) with manufacturers and provide for the performance of
the duties described in subsection (c). The Secretary shall establish a
model agreement for use under the program by not later than January 1,
2021, in consultation with manufacturers, and allow for comment on such
model agreement.
``(b) Terms of Agreement.--
``(1) In general.--
``(A) Agreement.--An agreement under this section
shall require the manufacturer to provide applicable
beneficiaries access to discounted prices for
applicable drugs of the manufacturer that are dispensed
on or after January 1, 2022.
``(B) Provision of discounted prices at the point-
of-sale.--The discounted prices described in
subparagraph (A) shall be provided to the applicable
beneficiary at the pharmacy or by the mail order
service at the point-of-sale of an applicable drug.
``(2) Provision of appropriate data.--Each manufacturer
with an agreement in effect under this section shall collect
and have available appropriate data, as determined by the
Secretary, to ensure that it can demonstrate to the Secretary
compliance with the requirements under the program.
``(3) Compliance with requirements for administration of
program.--Each manufacturer with an agreement in effect under
this section shall comply with requirements imposed by the
Secretary or a third party with a contract under subsection
(d)(3), as applicable, for purposes of administering the
program, including any determination under subparagraph (A) of
subsection (c)(1) or procedures established under such
subsection (c)(1).
``(4) Length of agreement.--
``(A) In general.--An agreement under this section
shall be effective for an initial period of not less
than 12 months and shall be automatically renewed for a
period of not less than 1 year unless terminated under
subparagraph (B).
``(B) Termination.--
``(i) By the secretary.--The Secretary may
provide for termination of an agreement under
this section for a knowing and willful
violation of the requirements of the agreement
or other good cause shown. Such termination
shall not be effective earlier than 30 days
after the date of notice to the manufacturer of
such termination. The Secretary shall provide,
upon request, a manufacturer with a hearing
concerning such a termination, and such hearing
shall take place prior to the effective date of
the termination with sufficient time for such
effective date to be repealed if the Secretary
determines appropriate.
``(ii) By a manufacturer.--A manufacturer
may terminate an agreement under this section
for any reason. Any such termination shall be
effective, with respect to a plan year--
``(I) if the termination occurs
before January 30 of a plan year, as of
the day after the end of the plan year;
and
``(II) if the termination occurs on
or after January 30 of a plan year, as
of the day after the end of the
succeeding plan year.
``(iii) Effectiveness of termination.--Any
termination under this subparagraph shall not
affect discounts for applicable drugs of the
manufacturer that are due under the agreement
before the effective date of its termination.
``(iv) Notice to third party.--The
Secretary shall provide notice of such
termination to a third party with a contract
under subsection (d)(3) within not less than 30
days before the effective date of such
termination.
``(5) Effective date of agreement.--An agreement under this
section shall take effect on a date determined appropriate by
the Secretary, which may be at the start of a calendar quarter.
``(c) Duties Described.--The duties described in this subsection
are the following:
``(1) Administration of program.--Administering the
program, including--
``(A) the determination of the amount of the
discounted price of an applicable drug of a
manufacturer;
``(B) the establishment of procedures under which
discounted prices are provided to applicable
beneficiaries at pharmacies or by mail order service at
the point-of-sale of an applicable drug;
``(C) the establishment of procedures to ensure
that, not later than the applicable number of calendar
days after the dispensing of an applicable drug by a
pharmacy or mail order service, the pharmacy or mail
order service is reimbursed for an amount equal to the
difference between--
``(i) the negotiated price of the
applicable drug; and
``(ii) the discounted price of the
applicable drug;
``(D) the establishment of procedures to ensure
that the discounted price for an applicable drug under
this section is applied before any coverage or
financial assistance under other health benefit plans
or programs that provide coverage or financial
assistance for the purchase or provision of
prescription drug coverage on behalf of applicable
beneficiaries as the Secretary may specify; and
``(E) providing a reasonable dispute resolution
mechanism to resolve disagreements between
manufacturers, applicable beneficiaries, and the third
party with a contract under subsection (d)(3).
``(2) Monitoring compliance.--
``(A) In general.--The Secretary shall monitor
compliance by a manufacturer with the terms of an
agreement under this section.
``(B) Notification.--If a third party with a
contract under subsection (d)(3) determines that the
manufacturer is not in compliance with such agreement,
the third party shall notify the Secretary of such
noncompliance for appropriate enforcement under
subsection (e).
``(3) Collection of data from prescription drug plans and
ma-pd plans.--The Secretary may collect appropriate data from
prescription drug plans and MA-PD plans in a timeframe that
allows for discounted prices to be provided for applicable
drugs under this section.
``(d) Administration.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall provide for the implementation of this section, including
the performance of the duties described in subsection (c).
``(2) Limitation.--In providing for the implementation of
this section, the Secretary shall not receive or distribute any
funds of a manufacturer under the program.
``(3) Contract with third parties.--The Secretary shall
enter into a contract with one or more third parties to
administer the requirements established by the Secretary in
order to carry out this section. At a minimum, the contract
with a third party under the preceding sentence shall require
that the third party--
``(A) receive and transmit information between the
Secretary, manufacturers, and other individuals or
entities the Secretary determines appropriate;
``(B) receive, distribute, or facilitate the
distribution of funds of manufacturers to appropriate
individuals or entities in order to meet the
obligations of manufacturers under agreements under
this section;
``(C) provide adequate and timely information to
manufacturers, consistent with the agreement with the
manufacturer under this section, as necessary for the
manufacturer to fulfill its obligations under this
section; and
``(D) permit manufacturers to conduct periodic
audits, directly or through contracts, of the data and
information used by the third party to determine
discounts for applicable drugs of the manufacturer
under the program.
``(4) Performance requirements.--The Secretary shall
establish performance requirements for a third party with a
contract under paragraph (3) and safeguards to protect the
independence and integrity of the activities carried out by the
third party under the program under this section.
``(5) Administration.--Chapter 35 of title 44, United
States Code, shall not apply to the program under this section.
``(e) Enforcement.--
``(1) Audits.--Each manufacturer with an agreement in
effect under this section shall be subject to periodic audit by
the Secretary.
``(2) Civil money penalty.--
``(A) In general.--The Secretary shall impose a
civil money penalty on a manufacturer that fails to
provide applicable beneficiaries discounts for
applicable drugs of the manufacturer in accordance with
such agreement for each such failure in an amount the
Secretary determines is commensurate with the sum of--
``(i) the amount that the manufacturer
would have paid with respect to such discounts
under the agreement, which will then be used to
pay the discounts which the manufacturer had
failed to provide; and
``(ii) 25 percent of such amount.
``(B) Application.--The provisions of section 1128A
(other than subsections (a) and (b)) shall apply to a
civil money penalty under this paragraph in the same
manner as such provisions apply to a penalty or
proceeding under section 1128A(a).
``(f) Clarification Regarding Availability of Other Covered Part D
Drugs.--Nothing in this section shall prevent an applicable beneficiary
from purchasing a covered part D drug that is not on the formulary of
the prescription drug plan or MA-PD plan that the applicable
beneficiary is enrolled in.
``(g) Definitions.--In this section:
``(1) Applicable beneficiary.--The term `applicable
beneficiary' means an individual who, on the date of dispensing
a covered part D drug--
``(A) is enrolled in a prescription drug plan or an
MA-PD plan;
``(B) is not enrolled in a qualified retiree
prescription drug plan; and
``(C) has incurred costs for covered part D drugs
in the year that are equal to or exceed the annual
deductible specified in section 1860D-2(b)(1) for such
year.
``(2) Applicable drug.--The term `applicable drug' means,
with respect to an applicable beneficiary, a covered part D
drug--
``(A) approved under a new drug application under
section 505(c) of the Federal Food, Drug, and Cosmetic
Act or, in the case of a biologic product, licensed
under section 351 of the Public Health Service Act
(including a product licensed under subsection (k) of
such section); and
``(B)(i) if the PDP sponsor of the prescription
drug plan or the MA organization offering the MA-PD
plan uses a formulary, which is on the formulary of the
prescription drug plan or MA-PD plan that the
applicable beneficiary is enrolled in;
``(ii) if the PDP sponsor of the prescription drug
plan or the MA organization offering the MA-PD plan
does not use a formulary, for which benefits are
available under the prescription drug plan or MA-PD
plan that the applicable beneficiary is enrolled in; or
``(iii) is provided through an exception or appeal.
``(3) Applicable number of calendar days.--The term
`applicable number of calendar days' means--
``(A) with respect to claims for reimbursement
submitted electronically, 14 days; and
``(B) with respect to claims for reimbursement
submitted otherwise, 30 days.
``(4) Discounted price.--
``(A) In general.--The term `discounted price'
means, with respect to an applicable drug of a
manufacturer furnished during a year to an applicable
beneficiary, 90 percent of the negotiated price of such
drug.
``(B) Clarification.--Nothing in this section shall
be construed as affecting the responsibility of an
applicable beneficiary for payment of a dispensing fee
for an applicable drug.
``(C) Special case for claims spanning
deductible.--In the case where the entire amount of the
negotiated price of an individual claim for an
applicable drug with respect to an applicable
beneficiary does not fall at or above the annual
deductible specified in section 1860D-2(b)(1) for the
year, the manufacturer of the applicable drug shall
provide the discounted price under this section on only
the portion of the negotiated price of the applicable
drug that falls at or above such annual deductible.
``(5) Manufacturer.--The term `manufacturer' means any
entity which is engaged in the production, preparation,
propagation, compounding, conversion, or processing of
prescription drug products, either directly or indirectly by
extraction from substances of natural origin, or independently
by means of chemical synthesis, or by a combination of
extraction and chemical synthesis. Such term does not include a
wholesale distributor of drugs or a retail pharmacy licensed
under State law.
``(6) Negotiated price.--The term `negotiated price' has
the meaning given such term in section 1860D-2(d)(1)(B), except
that such negotiated price shall not include any dispensing fee
for an applicable drug.
``(7) Qualified retiree prescription drug plan.--The term
`qualified retiree prescription drug plan' has the meaning
given such term in section 11860D-22(a)(2).''.
(2) Sunset of medicare coverage gap discount program.--
Section 1860D-14A of the Social Security Act (42 U.S.C. 1395-
114a) is amended--
(A) in subsection (a), in the first sentence, by
striking ``The Secretary'' and inserting ``Subject to
subsection (h), the Secretary''; and
(B) by adding at the end the following new
subsection:
``(h) Sunset of Program.--
``(1) In general.--The program shall not apply to
applicable drugs dispensed on or after January 1, 2022, and,
subject to paragraph (2), agreements under this section shall
be terminated as of such date.
``(2) Continued application for applicable drugs dispensed
prior to sunset.--The provisions of this section (including all
responsibilities and duties) shall continue to apply after
January 1, 2022, with respect to applicable drugs dispensed
prior to such date.''.
(3) Inclusion of actuarial value of manufacturer discounts
in bids.--Section 1860D-11 of the Social Security Act (42
U.S.C. 1395w-111) is amended--
(A) in subsection (b)(2)(C)(iii)--
(i) by striking ``assumptions regarding the
reinsurance'' and inserting ``assumptions
regarding--
``(I) the reinsurance''; and
(ii) by adding at the end the following:
``(II) for 2022 and each subsequent
year, the manufacturer discounts
provided under section 1860D- 14B
subtracted from the actuarial value to
produce such bid; and''; and
(B) in subsection (c)(1)(C)--
(i) by striking ``an actuarial valuation of
the reinsurance'' and inserting ``an actuarial
valuation of--
``(i) the reinsurance'';
(ii) in clause (i), as added by clause (i)
of this subparagraph, by adding ``and'' at the
end; and
(iii) by adding at the end the following:
``(ii) for 2022 and each subsequent year,
the manufacturer discounts provided under
section 1860D-14B;''.
(4) Clarification regarding exclusion of manufacturer
discounts from troop.--Section 1860D-2(b)(4) of the Social
Security Act (42 U.S.C. 1395w-102(b)(4)) is amended--
(A) in subparagraph (C), by inserting ``and subject
to subparagraph (F)'' after ``subparagraph (E)''; and
(B) by adding at the end the following new
subparagraph:
``(F) Clarification regarding exclusion of
manufacturer discounts.--In applying subparagraph (A),
incurred costs shall not include any manufacturer
discounts provided under section 1860D-14B.''.
(d) Determination of Allowable Reinsurance Costs.--Section 1860D-
15(b) of the Social Security Act (42 U.S.C. 1395w-115(b)) is amended--
(1) in paragraph (2)--
(A) by striking ``Costs.--For purposes'' and
inserting ``Costs.--
``(A) In general.--Subject to subparagraph (B), for
purposes''; and
(B) by adding at the end the following new
subparagraph:
``(B) Inclusion of manufacturer discounts on
applicable drugs.--For purposes of applying
subparagraph (A), the term `allowable reinsurance
costs' shall include the portion of the negotiated
price (as defined in section 1860D-14B(g)(6)) of an
applicable drug (as defined in section 1860D-14(g)(2))
that was paid by a manufacturer under the manufacturer
discount program under section 1860D-14B.''; and
(2) in paragraph (3)--
(A) in the first sentence, by striking ``For
purposes'' and inserting ``Subject to paragraph (2)(B),
for purposes''; and
(B) in the second sentence, by inserting ``or, in
the case of an applicable drug, by a manufacturer''
after ``by the individual or under the plan''.
(e) Updating Risk Adjustment Methodologies To Account for Part D
Modernization Redesign.--Section 1860D-15(c) of the Social Security Act
(42 U.S.C. 1395w-115(c)) is amended by adding at the end the following
new paragraph:
``(3) Updating risk adjustment methodologies to account for
part d modernization redesign.--The Secretary shall update the
risk adjustment model used to adjust bid amounts pursuant to
this subsection as appropriate to take into account changes in
benefits under this part pursuant to the amendments made by
section 121 of the Lower Costs, More Cures Act of 2019.''.
(f) Conditions for Coverage of Drugs Under This Part.--Section
1860D-43 of the Social Security Act (42 U.S.C. 1395w-153) is amended--
(1) in subsection (a)--
(A) in paragraph (2), by striking ``and'' at the
end;
(B) in paragraph (3), by striking the period at the
end and inserting a semicolon; and
(C) by adding at the end the following new
paragraphs:
``(4) participate in the manufacturer discount program
under section 1860D-14B;
``(5) have entered into and have in effect an agreement
described in subsection (b) of such section 1860D-14B with the
Secretary; and
``(6) have entered into and have in effect, under terms and
conditions specified by the Secretary, a contract with a third
party that the Secretary has entered into a contract with under
subsection (d)(3) of such section 1860D-14B.'';
(2) by striking subsection (b) and inserting the following:
``(b) Effective Date.--Paragraphs (1) through (3) of subsection (a)
shall apply to covered part D drugs dispensed under this part on or
after January 1, 2011, and before January 1, 2022, and paragraphs (4)
through (6) of such subsection shall apply to covered part D drugs
dispensed on or after January 1, 2022.''; and
(3) in subsection (c), by striking paragraph (2) and
inserting the following:
``(2) the Secretary determines that in the period beginning
on January 1, 2011, and ending on December 31, 2011 (with
respect to paragraphs (1) through (3) of subsection (a)), or
the period beginning on January 1, 2022, and ending December
31, 2022 (with respect to paragraphs (4) through (6) of such
subsection), there were extenuating circumstances.''.
(g) Conforming Amendments.--
(1) Section 1860D-2 of the Social Security Act (42 U.S.C.
1395w-102) is amended--
(A) in subsection (a)(2)(A)(i)(I), by striking ``,
or an increase in the initial'' and inserting ``or for
a year preceding 2022 an increase in the initial'';
(B) in subsection (c)(1)(C)--
(i) in the subparagraph heading, by
striking ``at initial coverage limit''; and
(ii) by inserting ``for a year preceding
2022 or the annual out-of-pocket threshold
specified in subsection (b)(4)(B) for the year
for 2022 and each subsequent year'' after
``subsection (b)(3) for the year'' each place
it appears; and
(C) in subsection (d)(1)(A), by striking ``or an
initial'' and inserting ``or for a year preceding 2022,
an initial''.
(2) Section 1860D-4(a)(4)(B)(i) of the Social Security Act
(42 U.S.C. 1395w-104(a)(4)(B)(i)) is amended by striking ``the
initial'' and inserting ``for a year preceding 2022, the
initial''.
(3) Section 1860D-14(a) of the Social Security Act (42
U.S.C. 1395w-114(a)) is amended--
(A) in paragraph (1)--
(i) in subparagraph (C), by striking ``The
continuation'' and inserting ``For a year
preceding 2022, the continuation'';
(ii) in subparagraph (D)(iii), by striking
``1860D-2(b)(4)(A)(i)(I)'' and inserting
``1860D-2(b)(4)(A)(i)(I)(aa)''; and
(iii) in subparagraph (E), by striking
``The elimination'' and inserting ``For a year
preceding 2022, the elimination''; and
(B) in paragraph (2)--
(i) in subparagraph (C), by striking ``The
continuation'' and inserting ``For a year
preceding 2022, the continuation''; and
(ii) in subparagraph (E)--
(I) by inserting ``for a year
preceding 2022,'' after ``subsection
(c)''; and
(II) by striking ``1860D-
2(b)(4)(A)(i)(I)'' and inserting
``1860D-2(b)(4)(A)(i)(I)(aa)''.
(4) Section 1860D-21(d)(7) of the Social Security Act (42
U.S.C. 1395w-131(d)(7)) is amended by striking ``section 1860D-
2(b)(4)(B)(i)'' and inserting ``section 1860D-2(b)(4)(C)(i)''.
(5) Section 1860D-22(a)(2)(A) of the Social Security Act
(42 U.S.C. 1395w-132(a)(2)(A)) is amended--
(A) by striking ``the value of any discount'' and
inserting the following: ``the value of--
``(i) for years prior to 2022, any
discount'';
(B) in clause (i), as inserted by subparagraph (A)
of this paragraph, by striking the period at the end
and inserting ``; and''; and
(C) by adding at the end the following new clause:
``(ii) for 2022 and each subsequent year,
any discount provided pursuant to section
1860D-14B.''.
(6) Section 1860D-41(a)(6) of the Social Security Act (42
U.S.C. 1395w-151(a)(6)) is amended--
(A) by inserting ``for a year before 2022'' after
``1860D-2(b)(3)''; and
(B) by inserting ``for such year'' before the
period.
(h) Effective Date.--The amendments made by this section shall
apply to plan year 2022 and subsequent plan years.
SEC. 112. TRANSITIONAL COVERAGE AND RETROACTIVE MEDICARE PART D
COVERAGE FOR CERTAIN LOW-INCOME BENEFICIARIES.
Section 1860D-14 of the Social Security Act (42 U.S.C. 1395w-114)
is amended--
(1) by redesignating subsection (e) as subsection (f); and
(2) by adding after subsection (d) the following new
subsection:
``(e) Limited Income Newly Eligible Transition Program.--
``(1) In general.--Beginning not later than January 1,
2021, the Secretary shall carry out a program to provide
transitional coverage for covered part D drugs for LI NET
eligible individuals in accordance with this subsection.
``(2) LI net eligible individual defined.--For purposes of
this subsection, the term `LI NET eligible individual' means a
part D eligible individual who--
``(A) meets the requirements of clauses (ii) and
(iii) of subsection (a)(3)(A); and
``(B) has not yet enrolled in a prescription drug
plan or an MA-PD plan, or, who has so enrolled, but
with respect to whom coverage under such plan has not
yet taken effect.
``(3) Transitional coverage.--For purposes of this
subsection, the term `transitional coverage' means, with
respect to an LI NET eligible individual--
``(A) immediate access to covered part D drugs at
the point-of-sale during the period that begins on the
first day of the month such individual is determined to
meet the requirements of clauses (ii) and (iii) of
subsection (a)(3)(A) and ends on the date that coverage
under a prescription drug plan or MA-PD plan takes
effect with respect to such individual; and
``(B) in the case of an LI NET eligible individual
who is a full-benefit dual eligible individual (as
defined in section 1935(c)(6)) or a recipient of
supplemental security income benefits under title XVI,
retroactive coverage (in the form of reimbursement of
the amounts that would have been paid under this part
had such individual been enrolled in a prescription
drug plan or MA-PD plan) of covered part D drugs
purchased by such individual during the period that--
``(i) begins on the date that is the later
of--
``(I) the date that such individual
was first eligible for a low-income
subsidy under this part; or
``(II) the date that is 36 months
prior to the date such individual
enrolls in a prescription drug plan or
MA-PD plan; and
``(ii) ends on the date that coverage under
such plan takes effect.
``(4) Program administration.--
``(A) Single point of contact.--The Secretary
shall, to the extent feasible, administer the program
under this subsection through a contract with a single
program administrator.
``(B) Benefit design.--The Secretary shall ensure
that the transitional coverage provided to LI NET
eligible individuals under this subsection--
``(i) provides access to all covered part D
drugs under an open formulary;
``(ii) permits all pharmacies determined by
the Secretary to be in good standing to process
claims under the program;
``(iii) is consistent with such
requirements as the Secretary considers
necessary to improve patient safety and ensure
appropriate dispensing of medication; and
``(iv) meets such other requirements as the
Secretary may establish.
``(5) Relationship to other provisions of this title;
waiver authority.--
``(A) In general.--The following provisions shall
not apply with respect to the program under this
subsection:
``(i) Paragraphs (1) and (3)(B) of section
1860D-4(a) (dissemination of general
information; availability of information on
changes in formulary through the internet).
``(ii) Subparagraphs (A) and (B) of section
1860D-4(b)(3) (development and revision by a
pharmacy and therapeutic committee; formulary
development).
``(iii) Paragraphs (1)(C) and (2) of
section 1860D-4(c) (medication therapy
management program).
``(B) Waiver authority.--The Secretary may waive
such other requirements of title XI and this title as
may be necessary to carry out the purposes of the
program established under this subsection.''.
SEC. 113. ALLOWING THE OFFERING OF ADDITIONAL PRESCRIPTION DRUG PLANS
UNDER MEDICARE PART D.
(a) Rescinding and Issuance of New Guidance.--Not later than one
year after the date of the enactment of this Act, the Secretary of
Health and Human Services (in this section referred to as the
``Secretary'') shall--
(1) rescind sections of any sub-regulatory guidance that
limit the number of prescription drug plans in each PDP region
that may be offered by a PDP sponsor under part D of title
XVIII of the Social Security Act (42 U.S.C. 1395w-101 et seq.);
and
(2) issue new guidance specifying that a PDP sponsor may
offer up to 4 (or a greater number if determined appropriate by
the Secretary) prescription drug plans in each PDP region,
except in cases where the PDP sponsor may offer up to 2
additional plans in a PDP region pursuant to section 1860D-
11(d)(4) of the Social Security Act (42 U.S.C. 1395w-
111(d)(4)), as added by subsection (b).
(b) Offering of Additional Plans.--Section 1860D-11(d) of the
Social Security Act (42 U.S.C. 1395w-111(d)) is amended by adding at
the end the following new paragraph:
``(4) Offering of additional plans.--
``(A) In general.--For plan year 2022 and each
subsequent plan year, a PDP sponsor may offer up to 2
additional prescription drug plans in a PDP region (in
addition to any limit established by the Secretary
under this part) provided that the PDP sponsor complies
with subparagraph (B) with respect to at least one such
prescription drug plan.
``(B) Requirements.--In order to be eligible to
offer up to 2 additional plans in a PDP region pursuant
to subparagraph (A), a PDP sponsor must ensure that,
with respect to at least one such prescription drug
plan, the sponsor or any entity that provides pharmacy
benefits management services under a contract with any
such sponsor or plan does not receive direct or
indirect remuneration, as defined in section 423.308 of
title 42, Code of Federal Regulations (or any successor
regulation), unless at least 25 percent of the
aggregate reductions in price or other remuneration
received by the PDP sponsor or entity from drug
manufacturers with respect to the plan and plan year--
``(i) are reflected at the point-of-sale to
the enrollee; or
``(ii) are used to reduce total beneficiary
cost-sharing estimated by the PDP sponsor for
prescription drug coverage under the plan in
the annual bid submitted by the PDP sponsor
under section 1860D-11(b).
``(C) Definition of reductions in price.--For
purposes of subparagraph (B), the term `reductions in
price' refers only to collectible amounts, as
determined by the Secretary, which excludes amounts
which after adjudication and reconciliation with
pharmacies and manufacturers are duplicate in nature,
contrary to other contractual clauses, or otherwise
ineligible (such as due to beneficiary disenrollment or
coordination of benefits).''.
(c) Rule of Construction.--Nothing in the provisions of, or
amendments made by, this section shall be construed as limiting the
ability of the Secretary to increase any limit otherwise applicable on
the number of prescription drug plans that a PDP sponsor may offer, at
the discretion of the PDP sponsor, in a PDP region under part D of
title XVIII of the Social Security Act (42 U.S.C. 1395w-101 et seq.).
SEC. 114. ALLOWING CERTAIN ENROLLEES OF PRESCRIPTION DRUG PLANS AND MA-
PD PLANS UNDER THE MEDICARE PROGRAM TO SPREAD OUT COST-
SHARING UNDER CERTAIN CIRCUMSTANCES.
(a) Standard Prescription Drug Coverage.--Section 1860D-2(b)(2) of
the Social Security Act (42 U.S.C. 1395w-102(b)(2)), as amended by
section 111, is amended--
(1) in subparagraph (A), by striking ``Subject to
subparagraphs (C) and (D)'' and inserting ``Subject to
subparagraphs (C), (D), and (E)''; and
(2) by adding at the end the following new subparagraph:
``(E) Enrollee option regarding spreading cost-
sharing.--
``(i) In general.--The Secretary shall
establish by regulation a process under which,
with respect to plan year 2022 and subsequent
plan years, a prescription drug plan or an MA-
PD plan shall, in the case of a part D eligible
individual enrolled with such plan for such
plan year with respect to whom the plan
projects that the dispensing of a covered part
D drug to such individual will result in the
individual incurring costs within a 30-day
period that are equal to a significant
percentage (as specified by the Secretary
pursuant to such regulation) of the annual out-
of-pocket threshold specified in paragraph
(4)(B) for such plan year, provide such
individual with the option to make the
coinsurance payment required under subparagraph
(A) for such costs in the form of equal monthly
installments over the remainder of such plan
year.
``(ii) Significant percentage
limitations.--In specifying a significant
percentage pursuant to the regulation
established by the Secretary under clause (i),
the Secretary shall not specify a percentage
that is less than 30 percent or greater than
100 percent.''.
(b) Alternative Prescription Drug Coverage.--Section 1860D-2(c) of
the Social Security Act (42 U.S.C. 1395w-102(c)) is amended by adding
at the end the following new paragraph:
``(4) Same enrollee option regarding spreading cost-
sharing.--For plan year 2022 and subsequent plan years, the
coverage provides the enrollee option regarding spreading cost-
sharing described in and required under subsection
(b)(2)(E).''.
SEC. 115. ESTABLISHING A MONTHLY CAP ON BENEFICIARY INCURRED COSTS FOR
INSULIN PRODUCTS AND SUPPLIES UNDER A PRESCRIPTION DRUG
PLAN OR MA-PD PLAN.
(a) In General.--Section 1860D-2 of the Social Security Act (42
U.S.C. 1395w-102), as amended by sections 111 and 114, is amended--
(1) in subsection (b)(2)--
(A) in subparagraph (A), by striking ``and (E)''
and inserting ``(E), and (F)'';
(B) in subparagraph (B), by striking ``and (D)''
and inserting ``(D), and (F)''; and
(C) by adding at the end the following new
subparagraph:
``(F) Cap on incurred costs for insulin products
and supplies.--
``(i) In general.--The coverage provides
benefits, for costs above the annual deductible
specified in paragraph (1) and up to the annual
out-of-pocket threshold described in paragraph
(4)(B) and with respect to a month (beginning
with January of 2022), with cost sharing that
is equal to $0 for a specified covered part D
drug (as defined in clause (iii)) furnished to
an individual who has incurred costs during
such month with respect to specified covered
part D drugs equal to--
``(I) for months occurring in 2022,
$50; or
``(II) for months occurring in a
subsequent year, the amount applicable
under this clause for months occurring
in the year preceding such subsequent
year, increased by the annual
percentage increase specified in
paragraph (6) for such subsequent year
and rounded to the nearest dollar.
``(ii) Application.--The provisions of
clauses (i) through (iii) of paragraph (4)(C)
shall apply with respect to the determination
of the incurred costs for specified covered
part D drugs for purposes of clause (i) in the
same manner as such provisions apply with
respect to the determination of incurred costs
for covered part D drugs for purposes of
paragraph (4)(A).
``(iii) Specified covered part d drug.--For
purposes of this subparagraph, the term
`specified covered part D drug' means a covered
part D drug that is--
``(I) insulin; or
``(II) a medical supply associated
with the injection of insulin (as
defined in regulations of the Secretary
promulgated pursuant to subsection
(e)(1)(B)).''; and
(2) in subsection (c), by adding at the end the following
new paragraph:
``(5) Same protection with respect to expenditures for
insulin and certain medical supplies.--The coverage provides
the coverage required under subsection (b)(2)(F).''.
(b) Conforming Amendments.--
(1) In general.--Section 1860D-14(a)(1)(D) of the Social
Security Act (42 U.S.C. 1395w-114(a)(1)(D)), as amended by
section 111, is amended--
(A) in clause (ii), by striking ``section 1860D-
2(b)(2)'' and inserting ``section 1860D-2(b)(2)(A)'';
and
(B) in clause (iii), by striking ``section 1860D-
2(b)(2)'' and inserting ``section 1860D-2(b)(2)(A)''.
(2) Effective date.--The amendments made by paragraph (1)
shall apply with respect to plan year 2022 and each subsequent
plan year.
SEC. 116. GROWTH RATE OF MEDICARE PART D OUT-OF-POCKET COST THRESHOLD.
(a) Providing Medicare Part D Beneficiaries With Certain 2020
Offset Payments.--Section 1860D-2(b)(4) of the Social Security Act (42
U.S.C. 1395w-102(b)(4)) is amended by adding at the end the following
new subparagraph:
``(F) 2020 offset payments.--
``(i) In general.--Subject to clause (iv),
the Secretary shall provide for payment from
the Medicare Prescription Drug Account as
follows:
``(I) In the case of a specified
individual (as defined in clause
(ii)(I)) who as of the last day of a
calendar quarter in 2020 has incurred
costs for covered part D drugs so that
the individual has exceeded the annual
out-of-pocket threshold applied under
subparagraph (B)(i)(V) for 2020,
payment to the individual by not later
than 15th day of the third month
following the end of such quarter of
the amount by which such threshold so
applied exceeded the target threshold
for 2020.
``(II) In the case of a specified
individual who is not described in
subclause (I) and who as of the last
day of 2020 has incurred costs for
covered part D drugs so that the
individual has exceeded the target
threshold for 2020, payment to the
individual by not later than December
31, 2021, of the amount by which such
incurred costs exceeded the target
threshold for 2020.
``(ii) Definitions.--For purposes of this
subparagraph:
``(I) Specified individual.--The
term `specified individual' means an
individual who--
``(aa) is enrolled in a
prescription drug plan or an
MA- PD plan;
``(bb) is not enrolled in a
qualified retiree prescription
drug plan; and
``(cc) is not entitled to
an income-related subsidy under
section 1860D-14(a).
``(II) Target threshold for 2020.--
The term `target threshold for 2020'
means the annual out-of-pocket
threshold that would have been applied
under subparagraph (B)(i) for 2020 if
such threshold had been determined in
accordance with subclause (IV) of such
subparagraph instead of subclause (V)
of such subparagraph.
``(iii) Notification.--In the case of any
specified individual who during 2020 has
incurred costs for covered part D drugs so that
the individual has exceeded the target
threshold for 2020, the Secretary shall, not
later than September 30, 2021, provide to such
individual a notification informing such
individual of such individual's right to a
payment described in clause (i) and the
estimated timing of such payment.
``(iv) Clarification.--The Secretary shall
provide only 1 payment under this subparagraph
with respect to any individual.
``(v) Implementation.--The Secretary may
implement this subparagraph by program
instruction or otherwise.''.
(b) Reduced Growth Rate for 2021 of Medicare Part D Out-of-Pocket
Cost Threshold.--Section 1860D-2(b)(4)(B)(i) of the Social Security Act
(42 U.S.C. 1395w-102(b)(4)(B)(i)) is amended--
(1) in subclause (V), by striking at the end ``or'';
(2) by redesignating subclause (VI) as subclause (VIII);
and
(3) by inserting after subclause (V) the following new
subclauses:
``(VI) for 2021, is equal to the
amount that would have been applied
under this subparagraph for 2020 if
such amount had been determined in
accordance with subclause (IV) instead
of subclause (V), increased by the
lesser of--
``(aa) the annual
percentage increase described
in paragraph (7) for 2021, plus
2 percentage points; or
``(bb) the annual
percentage increase described
in paragraph (6) for 2021;
``(VII) for 2022, is equal to the
amount that would have been applied
under this subparagraph for 2022 if the
amendments made by section 1101(d)(1)
of the Health Care and Education
Reconciliation Act of 2010 and by
section 135 of the Lower Costs, More
Cures Act of 2019 had not been enacted;
or''.
SEC. 117. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS TO INCLUDE REAL-
TIME BENEFIT INFORMATION AS PART OF SUCH SPONSOR'S
ELECTRONIC PRESCRIPTION PROGRAM UNDER THE MEDICARE
PROGRAM.
Section 1860D-4(e)(2) of the Social Security Act (42 U.S.C. 1395w-
104(e)(2)) is amended--
(1) in subparagraph (D), by striking ``To the extent'' and
inserting ``Except as provided in subparagraph (F), to the
extent''; and
(2) by adding at the end the following new subparagraph:
``(F) Real-time benefit information.--
``(i) In general.--Not later than January
1, 2021, the program shall implement real-time
benefit tools that are capable of integrating
with a prescribing health care professional's
electronic prescribing or electronic health
record system for the transmission of formulary
and benefit information in real time to
prescribing health care professionals. With
respect to a covered part D drug, such tools
shall be capable of transmitting such
information specific to an individual enrolled
in a prescription drug plan. Such information
shall include the following:
``(I) A list of any clinically
appropriate alternatives to such drug
included in the formulary of such plan.
``(II) Cost-sharing information for
such drug and such alternatives,
including a description of any variance
in cost-sharing based on the pharmacy
dispensing of such drug or such
alternatives.
``(III) Information relating to
whether such drug is included in the
formulary of such plan and any prior
authorization or other utilization
management requirements applicable to
such drug and such alternatives so
included.
``(ii) Electronic transmission.--The
provisions of subclauses (I) and (II) of clause
(ii) of subparagraph (E) shall apply to an
electronic transmission described in clause (i)
in the same manner as such provisions apply
with respect to an electronic transmission
described in clause (i) of such subparagraph.
``(iii) Special rule for 2021.--The program
shall be deemed to be in compliance with clause
(i) for 2021 if the program complies with the
provisions of section 423.160(b)(7) of title
42, Code of Federal Regulations (or a successor
regulation), for such year.
``(iv) Rule of construction.--Nothing in
this subparagraph shall be construed as to
allow a real-time benefits tool to steer an
individual, without the consent of the
individual, to a particular pharmacy or
pharmacy setting over their preferred pharmacy
setting nor prohibit the designation of a
preferred pharmacy under such tool.''.
SEC. 118. REQUIRING PRESCRIPTION DRUG PLANS AND MA-PD PLANS TO REPORT
POTENTIAL FRAUD, WASTE, AND ABUSE TO THE SECRETARY OF
HHS.
Section 1860D-4 of the Social Security Act (42 U.S.C. 1395w-104) is
amended by adding at the end the following new subsection:
``(p) Reporting Potential Fraud, Waste, and Abuse.--Beginning
January 1, 2021, the PDP sponsor of a prescription drug plan shall
report to the Secretary, as specified by the Secretary--
``(1) any substantiated or suspicious activities (as
defined by the Secretary) with respect to the program under
this part as it relates to fraud, waste, and abuse; and
``(2) any steps made by the PDP sponsor after identifying
such activities to take corrective actions.''.
SEC. 119. ESTABLISHMENT OF PHARMACY QUALITY MEASURES UNDER MEDICARE
PART D.
Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-
104(c)) is amended by adding at the end the following new paragraph:
``(8) Application of pharmacy quality measures.--
``(A) In general.--A PDP sponsor that implements
incentive payments to a pharmacy or price concessions
paid by a pharmacy based on quality measures shall use
measures established or approved by the Secretary under
subparagraph (B) with respect to payment for covered
part D drugs dispensed by such pharmacy.
``(B) Standard pharmacy quality measures.--The
Secretary shall establish or approve standard quality
measures from a consensus and evidence-based
organization for payments described in subparagraph
(A). Such measures shall focus on patient health
outcomes and be based on proven criteria measuring
pharmacy performance.
``(C) Effective date.--The requirement under
subparagraph (A) shall take effect for plan years
beginning on or after January 1, 2023, or such earlier
date specified by the Secretary if the Secretary
determines there are sufficient measures established or
approved under subparagraph (B) to meet the requirement
under subparagraph (A).''.
TITLE II--DRUG PRICE TRANSPARENCY
SEC. 201. REPORTING ON EXPLANATION FOR DRUG PRICE INCREASES.
(a) In General.--Title XI of the Social Security Act (42 U.S.C.
1301 et seq.) is amended by inserting after section 1128K the following
new section:
``SEC. 1128L. DRUG PRICE REPORTING.
``(a) Definitions.--In this section:
``(1) Manufacturer.--The term `manufacturer' means the
person--
``(A) that holds the application for a drug
approved under section 505 of the Federal Food, Drug,
and Cosmetic Act or licensed under section 351 of the
Public Health Service Act; or
``(B) who is responsible for setting the wholesale
acquisition cost for the drug.
``(2) Qualifying drug.--The term `qualifying drug' means
any drug that is approved under subsection (c) or (j) of
section 505 of the Federal Food, Drug, and Cosmetic Act or
licensed under subsection (a) or (k) of section 351 of this
Act--
``(A) that has a wholesale acquisition cost of $100
or more, adjusted for inflation occurring after the
date of enactment of this section, for a month's supply
or a typical course of treatment that lasts less than a
month, and is--
``(i) subject to section 503(b)(1) of the
Federal Food, Drug, and Cosmetic Act;
``(ii) administered or otherwise dispensed
to treat a disease or condition affecting more
than 200,000 persons in the United States; and
``(iii) not a vaccine; and
``(B) for which, during the previous calendar year,
at least 1 dollar of the total amount of sales were for
individuals enrolled under the Medicare program under
title XVIII or under a State Medicaid plan under title
XIX or under a waiver of such plan.
``(3) Wholesale acquisition cost.--The term `wholesale
acquisition cost' has the meaning given that term in section
1847A(c)(6)(B).
``(b) Report.--
``(1) Report required.--The manufacturer of a qualifying
drug shall submit a report to the Secretary--
``(A) for each increase in the price of a
qualifying drug that results in an increase in the
wholesale acquisition cost of that drug that is equal
to--
``(i) 10 percent or more within a single
calendar year beginning on or after January 1,
2019; or
``(ii) 25 percent or more within three
consecutive calendar years for which the first
such calendar year begins on or after January
1, 2019; and
``(B) in the case that the qualifying drug is first
covered under title XVIII with respect to an applicable
year, if the estimated cost or spending under such
title per individual or per user of such drug (as
estimated by the Secretary) for such applicable year
(or per course of treatment in such applicable year, as
defined by the Secretary) is at least $26,000.
``(2) Report deadline.--Each report described in paragraph
(1) shall be submitted to the Secretary--
``(A) in the case of a report with respect to an
increase in the price of a qualifying drug that occurs
during the period beginning on January 1, 2019, and
ending on the day that is 60 days after the date of
enactment of this section, not later than 90 days after
such date of enactment;
``(B) in the case of a report with respect to an
increase in the price of a qualifying drug that occurs
after the period described in subparagraph (A), not
later than 30 days prior to the planned effective date
of such price increase for such qualifying drug; and
``(C) in the case of a report with respect to a
qualifying drug that meets the criteria described in
paragraph (1)(B), not later than 30 days after such
drug meets such criteria.
``(c) Contents.--A report under subsection (b), consistent with the
standard for disclosures described in section 213.3(d) of title 12,
Code of Federal Regulations (as in effect on the date of enactment of
this section), shall, at a minimum, include--
``(1) with respect to the qualifying drug--
``(A) the percentage by which the manufacturer will
raise the wholesale acquisition cost of the drug within
the calendar year or three consecutive calendar years
as described in subsection (b)(1)(A) or (b)(1)(B), if
applicable, and the effective date of such price
increase;
``(B) an explanation for, and description of, each
price increase for such drug that will occur during the
calendar year period described in subsection (b)(1)(A)
or the three consecutive calendar year period described
in subsection (b)(1)(B), as applicable;
``(C) if known and different from the manufacturer
of the qualifying drug, the identity of--
``(i) the sponsor or sponsors of any
investigational new drug applications under
section 505(i) of the Federal Food, Drug, and
Cosmetic Act for clinical investigations with
respect to such drug, for which the full
reports are submitted as part of the
application--
``(I) for approval of the drug
under section 505 of such Act; or
``(II) for licensure of the drug
under section 351 of the Public Health
Service Act; and
``(ii) the sponsor of an application for
the drug approved under such section 505 of the
Federal Food, Drug, and Cosmetic Act or
licensed under section 351 of the Public Health
Service Act;
``(D) a description of the history of the
manufacturer's price increases for the drug since the
approval of the application for the drug under section
505 of the Federal Food, Drug, and Cosmetic Act or the
issuance of the license for the drug under section 351
of the Public Health Service Act, or since the
manufacturer acquired such approved application or
license, if applicable;
``(E) the current wholesale acquisition cost of the
drug;
``(F) the total expenditures of the manufacturer
on--
``(i) materials and manufacturing for such
drug; and
``(ii) acquiring patents and licensing for
such drug;
``(G) the percentage of total expenditures of the
manufacturer on research and development for such drug
that was derived from Federal funds;
``(H) the total expenditures of the manufacturer on
research and development for such drug that is
necessary to demonstrate that it meets applicable
statutory standards for approval under section 505 of
the Federal Food, Drug, and Cosmetic Act or licensure
under section 351 of the Public Health Service Act, as
applicable;
``(I) the total expenditures of the manufacturer on
pursuing new or expanded indications or dosage changes
for such drug under section 505 of the Federal Food,
Drug, and Cosmetic Act or section 351 of the Public
Health Service Act;
``(J) the total expenditures of the manufacturer on
carrying out postmarket requirements related to such
drug, including under section 505(o)(3) of the Federal
Food, Drug, and Cosmetic Act;
``(K) the total revenue and the net profit
generated from the qualifying drug for each calendar
year since the approval of the application for the drug
under section 505 of the Federal Food, Drug, and
Cosmetic Act or the issuance of the license for the
drug under section 351 of the Public Health Service
Act, or since the manufacturer acquired such approved
application or license; and
``(L) the total costs associated with marketing and
advertising for the qualifying drug;
``(2) with respect to the manufacturer--
``(A) the total revenue and the net profit of the
manufacturer for each of the 1-year period described in
subsection (b)(1)(A) or the 3-year period described in
subsection (b)(1)(B), as applicable;
``(B) all stock-based performance metrics used by
the manufacturer to determine executive compensation
for each of the 1-year period described in subsection
(b)(1)(A) or the 3-year period described in subsection
(b)(1)(B), as applicable; and
``(C) any additional information the manufacturer
chooses to provide related to drug pricing decisions,
such as total expenditures on--
``(i) drug research and development; or
``(ii) clinical trials, including on drugs
that failed to receive approval by the Food and
Drug Administration; and
``(3) such other related information as the Secretary
considers appropriate and as specified by the Secretary through
notice-and-comment rulemaking.
``(d) Information Provided.--The manufacturer of a qualifying drug
that is required to submit a report under subsection (b), shall ensure
that such report and any explanation for, and description of, each
price increase described in subsection (c)(1)(B) shall be truthful, not
misleading, and accurate.
``(e) Civil Monetary Penalty.--Any manufacturer of a qualifying
drug that fails to submit a report for the drug as required by this
section, following notification by the Secretary to the manufacturer
that the manufacturer is not in compliance with this section, shall be
subject to a civil monetary penalty of $75,000 for each day on which
the violation continues.
``(f) False Information.--Any manufacturer that submits a report
for a drug as required by this section that knowingly provides false
information in such report is subject to a civil monetary penalty in an
amount not to exceed $75,000 for each item of false information.
``(g) Public Posting.--
``(1) In general.--Subject to paragraph (3), the Secretary
shall post each report submitted under subsection (b) on the
public website of the Department of Health and Human Services
the day the price increase of a qualifying drug is scheduled to
go into effect.
``(2) Format.--In developing the format in which reports
will be publicly posted under paragraph (1), the Secretary
shall consult with stakeholders, including beneficiary groups,
and shall seek feedback from consumer advocates and readability
experts on the format and presentation of the content of such
reports to ensure that such reports are--
``(A) user-friendly to the public; and
``(B) written in plain language that consumers can
readily understand.
``(3) Protected information.--Nothing in this section shall
be construed to authorize the public disclosure of information
submitted by a manufacturer that is prohibited from disclosure
by applicable laws concerning the protection of trade secrets,
commercial information, and other information covered under
such laws.
``(h) Annual Report to Congress.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall submit to Congress, and post on the public website of the
Department of Health and Human Services in a way that is user-
friendly to the public and written in plain language that
consumers can readily understand, an annual report--
``(A) summarizing the information reported pursuant
to this section;
``(B) including copies of the reports and
supporting detailed economic analyses submitted
pursuant to this section;
``(C) detailing the costs and expenditures incurred
by the Department of Health and Human Services in
carrying out this section; and
``(D) explaining how the Department of Health and
Human Services is improving consumer and provider
information about drug value and drug price
transparency.
``(2) Protected information.--Nothing in this subsection
shall be construed to authorize the public disclosure of
information submitted by a manufacturer that is prohibited from
disclosure by applicable laws concerning the protection of
trade secrets, commercial information, and other information
covered under such laws.''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect on the date of enactment of this Act.
SEC. 202. PUBLIC DISCLOSURE OF DRUG DISCOUNTS.
Section 1150A of the Social Security Act (42 U.S.C. 1320b-23) is
amended--
(1) in subsection (c), in the matter preceding paragraph
(1), by inserting ``(other than as permitted under subsection
(e))'' after ``disclosed by the Secretary''; and
(2) by adding at the end the following new subsection:
``(e) Public Availability of Certain Information.--
``(1) In general.--In order to allow the comparison of
PBMs' ability to negotiate rebates, discounts, direct and
indirect remuneration fees, administrative fees, and price
concessions and the amount of such rebates, discounts, direct
and indirect remuneration fees, administrative fees, and price
concessions that are passed through to plan sponsors, beginning
January 1, 2020, the Secretary shall make available on the
Internet website of the Department of Health and Human Services
the information with respect to the second preceding calendar
year provided to the Secretary on generic dispensing rates (as
described in paragraph (1) of subsection (b)) and information
provided to the Secretary under paragraphs (2) and (3) of such
subsection that, as determined by the Secretary, is with
respect to each PBM.
``(2) Availability of data.--In carrying out paragraph (1),
the Secretary shall ensure the following:
``(A) Confidentiality.--The information described
in such paragraph is displayed in a manner that
prevents the disclosure of information, with respect to
an individual drug or an individual plan, on rebates,
discounts, direct and indirect remuneration fees,
administrative fees, and price concessions.
``(B) Class of drug.--The information described in
such paragraph is made available by class of drug,
using an existing classification system, but only if
the class contains such number of drugs, as specified
by the Secretary (but not fewer than three drugs), to
ensure confidentiality of proprietary information or
other information that is prevented to be disclosed
under subparagraph (A).''.
SEC. 203. REQUIRING CERTAIN MANUFACTURERS TO REPORT DRUG PRICING
INFORMATION WITH RESPECT TO DRUGS UNDER THE MEDICARE
PROGRAM.
(a) In General.--Section 1847A of the Social Security Act (42
U.S.C. 1395w-3a) is amended--
(1) in subsection (b)--
(A) in paragraph (2)(A), by inserting ``or
subsection (f)(2), as applicable'' before the period at
the end;
(B) in paragraph (3), in the matter preceding
subparagraph (A), by inserting ``or subsection (f)(2),
as applicable,'' before ``determined by''; and
(C) in paragraph (6)(A), in the matter preceding
clause (i), by inserting ``or subsection (f)(2), as
applicable,'' before ``determined by''; and
(2) in subsection (f)--
(A) by striking ``For requirements'' and inserting
the following:
``(1) In general.--For requirements''; and
(B) by adding at the end the following new
paragraph:
``(2) Manufacturers without a rebate agreement under title
xix.--
``(A) In general.--If the manufacturer of a drug or
biological described in subparagraph (C), (E), or (G)
of section 1842(o)(1) or in section 1881(b)(14)(B) that
is payable under this part has not entered into and
does not have in effect a rebate agreement described in
subsection (b) of section 1927, for calendar quarters
beginning on or after January 1, 2020, such
manufacturer shall report to the Secretary the
information described in subsection (b)(3)(A)(iii) of
such section 1927 with respect to such drug or
biological in a time and manner specified by the
Secretary. For purposes of applying this paragraph, a
drug or biological described in the previous sentence
includes items, services, supplies, and products that
are payable under this part as a drug or biological.
``(B) Audit.--Information reported under
subparagraph (A) is subject to audit by the Inspector
General of the Department of Health and Human Services.
``(C) Verification.--The Secretary may survey
wholesalers and manufacturers that directly distribute
drugs described in subparagraph (A), when necessary, to
verify manufacturer prices and manufacturer's average
sales prices (including wholesale acquisition cost) if
required to make payment reported under subparagraph
(A). The Secretary may impose a civil monetary penalty
in an amount not to exceed $100,000 on a wholesaler,
manufacturer, or direct seller, if the wholesaler,
manufacturer, or direct seller of such a drug refuses a
request for information about charges or prices by the
Secretary in connection with a survey under this
subparagraph or knowingly provides false information.
The provisions of section 1128A (other than subsections
(a) (with respect to amounts of penalties or additional
assessments) and (b)) shall apply to a civil money
penalty under this subparagraph in the same manner as
such provisions apply to a penalty or proceeding under
section 1128A(a).
``(D) Confidentiality.--Notwithstanding any other
provision of law, information disclosed by
manufacturers or wholesalers under this paragraph
(other than the wholesale acquisition cost for purposes
of carrying out this section) is confidential and shall
not be disclosed by the Secretary in a form which
discloses the identity of a specific manufacturer or
wholesaler or prices charged for drugs by such
manufacturer or wholesaler, except--
``(i) as the Secretary determines to be
necessary to carry out this section (including
the determination and implementation of the
payment amount), or to carry out section 1847B;
``(ii) to permit the Comptroller General of
the United States to review the information
provided; and
``(iii) to permit the Director of the
Congressional Budget Office to review the
information provided.''.
(b) Enforcement.--Section 1847A of such Act (42 U.S.C. 1395w-3a) is
further amended--
(1) in subsection (d)(4)--
(A) in subparagraph (A), by striking ``In general''
and inserting ``Misrepresentation'';
(B) in subparagraph (B), by striking ``subparagraph
(B)'' and inserting ``subparagraph (A), (B), or (C)'';
(C) by redesignating subparagraph (B) as
subparagraph (D); and
(D) by inserting after subparagraph (A) the
following new subparagraphs:
``(B) Failure to provide timely information.--If
the Secretary determines that a manufacturer described
in subsection (f)(2) has failed to report on
information described in section 1927(b)(3)(A)(iii)
with respect to a drug or biological in accordance with
such subsection, the Secretary shall apply a civil
money penalty in an amount of $10,000 for each day the
manufacturer has failed to report such information and
such amount shall be paid to the Treasury.
``(C) False information.--Any manufacturer required
to submit information under subsection (f)(2) that
knowingly provides false information is subject to a
civil money penalty in an amount not to exceed $100,000
for each item of false information. Such civil money
penalties are in addition to other penalties as may be
prescribed by law.''; and
(2) in subsection (c)(6)(A), by striking the period at the
end and inserting ``, except that, for purposes of subsection
(f)(2), the Secretary may, if the Secretary determines
appropriate, exclude repackagers of a drug or biological from
such term.''.
(c) Manufacturers With a Rebate Agreement.--
(1) In general.--Section 1927(b)(3)(A) of the Social
Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is amended by adding
at the end the following new sentence: ``For purposes of
applying clause (iii), a drug or biological described in the
flush matter following such clause includes items, services,
supplies, and products that are payable under this part as a
drug or biological.''.
(2) Technical amendment.--Section 1927(b)(3)(A)(iii) of the
Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)(iii)) is
amended by striking ``section 1881(b)(13)(A)(ii)'' and
inserting ``section 1881(b)(14)(B)''.
(d) Report.--Not later than January 1, 2021, the Inspector General
of the Department of Health and Human Services shall assess and submit
to Congress a report on the accuracy of average sales price information
submitted by manufacturers under section 1847A of the Social Security
Act (42 U.S.C. 1395w-3a). Such report shall include any recommendations
on how to improve the accuracy of such information.
SEC. 204. MAKING PRESCRIPTION DRUG MARKETING SAMPLE INFORMATION
REPORTED BY MANUFACTURERS AVAILABLE TO CERTAIN
INDIVIDUALS AND ENTITIES.
(a) In General.--Section 1128H of the Social Security Act (42
U.S.C. 1320a-7i) is amended--
(1) by redesignating subsection (b) as subsection (e); and
(2) by inserting after subsection (a) the following new
subsections:
``(b) Data Sharing Agreements.--
``(1) In general.--The Secretary shall enter into
agreements with the specified data sharing individuals and
entities described in paragraph (2) under which--
``(A) upon request of such an individual or entity,
as applicable, the Secretary makes available to such
individual or entity the information submitted under
subsection (a) by manufacturers and authorized
distributors of record; and
``(B) such individual or entity agrees to not
disclose publicly or to another individual or entity
any information that identifies a particular
practitioner or health care facility.
``(2) Specified data sharing individuals and entities.--For
purposes of paragraph (1), the specified data sharing
individuals and entities described in this paragraph are the
following:
``(A) Oversight agencies.--Health oversight
agencies (as defined in section 164.501 of title 45,
Code of Federal Regulations), including the Centers for
Medicare & Medicaid Services, the Office of the
Inspector General of the Department of Health and Human
Services, the Government Accountability Office, the
Congressional Budget Office, the Medicare Payment
Advisory Commission, and the Medicaid and CHIP Payment
and Access Commission.
``(B) Researchers.--Individuals who conduct
scientific research (as defined in section 164.501 of
title 45, Code of Federal Regulations) in relevant
areas as determined by the Secretary.
``(C) Payers.--Private and public health care
payers, including group health plans, health insurance
coverage offered by health insurance issuers, Federal
health programs, and State health programs.
``(3) Exemption from freedom of information act.--Except as
described in paragraph (1), the Secretary may not be compelled
to disclose the information submitted under subsection (a) to
any individual or entity. For purposes of section 552 of title
5, United States Code (commonly referred to as the Freedom of
Information Act), this paragraph shall be considered a statute
described in subsection (b)(3)(B) of such section.
``(c) Penalties.--
``(1) Data sharing agreements.--Subject to paragraph (3),
any specified data sharing individual or entity described in
subsection (b)(2) that violates the terms of a data sharing
agreement the individual or entity has with the Secretary under
subsection (b)(1) shall be subject to a civil money penalty of
not less than $1,000, but not more than $10,000, for each such
violation. Such penalty shall be imposed and collected in the
same manner as civil money penalties under subsection (a) of
section 1128A are imposed and collected under that section.
``(2) Failure to report.--Subject to paragraph (3), any
manufacturer or authorized distributor of record of an
applicable drug under subsection (a) that fails to submit
information required under such subsection in a timely manner
in accordance with rules or regulations promulgated to carry
out such subsection shall be subject to a civil money penalty
of not less than $1,000, but not more than $10,000, for each
such failure. Such penalty shall be imposed and collected in
the same manner as civil money penalties under subsection (a)
of section 1128A are imposed and collected under that section.
``(3) Limitation.--The total amount of civil money
penalties imposed under paragraph (1) or (2) with respect to a
year and an individual or entity described in paragraph (1) or
a manufacturer or distributor described in paragraph (2),
respectively, shall not exceed $150,000.
``(d) Drug Sample Distribution Information.--
``(1) In general.--Not later than January 1 of each year
(beginning with 2021), the Secretary shall maintain a list
containing information related to the distribution of samples
of applicable drugs. Such list shall provide the following
information with respect to the preceding year:
``(A) The name of the manufacturer or authorized
distributor of record of an applicable drug for which
samples were requested or distributed under this
section.
``(B) The quantity and class of drug samples
requested.
``(C) The quantity and class of drug samples
distributed.
``(2) Public availability.--The Secretary shall make the
information in such list available to the public on the
Internet website of the Food and Drug Administration.''.
(b) FDA Maintenance of Information.--The Food and Drug
Administration shall maintain information available to affected
reporting companies to ensure their ability to fully comply with the
requirements of section 1128H of the Social Security Act.
(c) Prohibition on Distribution of Samples of Opioids.--Section
503(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(d))
is amended--
(1) by moving the margin of paragraph (4) 2 ems to the
left; and
(2) by adding at the end the following:
``(5) No person may distribute a drug sample of a drug that is--
``(A) an applicable drug (as defined in section 1128H(e) of
the Social Security Act);
``(B) a controlled substance (as defined in section 102 of
the Controlled Substances Act) for which the findings required
under section 202(b)(2) of such Act have been made; and
``(C) approved under section 505 for use in the management
or treatment of pain (other than for the management or
treatment of a substance use disorder).''.
(d) MedPAC Report.--Not later than 3 years after the date of the
enactment of this Act, the Medicare Payment Advisory Commission shall
conduct a study on the impact of drug samples on provider prescribing
practices and health care costs and may, as the Commission deems
appropriate, make recommendations on such study.
SEC. 205. PROVIDING THE MEDICARE PAYMENT ADVISORY COMMISSION AND
MEDICAID AND CHIP PAYMENT AND ACCESS COMMISSION WITH
ACCESS TO CERTAIN DRUG PAYMENT INFORMATION, INCLUDING
CERTAIN REBATE INFORMATION.
(a) Access to Certain Part D Payment Data.--Section 1860D-15(f) of
the Social Security Act (42 U.S.C. 1395w-115(f)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (A)(ii), by striking ``and'' at
the end;
(B) in subparagraph (B), by striking the period at
the end and inserting ``; and''; and
(C) by inserting at the end the following new
subparagraph:
``(C) by the Executive Director of the Medicare
Payment Advisory Commission for purposes of monitoring,
making recommendations, and analysis of the program
under this title and by the Executive Director of the
Medicaid and CHIP Payment and Access Commission for
purposes of monitoring, making recommendations, and
analysis of the Medicaid program established under
title XIX and the Children's Health Insurance Program
under title XXI.''; and
(2) by adding at the end the following new paragraph:
``(3) Additional restrictions on disclosure of
information.--The Executive Directors described in paragraph
(2)(C) shall not disclose any of the following information
disclosed to such Executive Directors or obtained by such
Executive Directors pursuant to such paragraph, with respect to
a prescription drug plan offered by a PDP sponsor or an MA-PD
plan offered by an MA organization:
``(A) The specific amounts or the identity of the
source of any rebates, price concessions, or other
forms of direct or indirect remuneration under such
prescription drug plan or such MA-PD plan.
``(B) Information submitted with the bid submitted
under section 1860D-11 by such PDP sponsor or section
1854 by such MA organization.
``(C) In the case of such information from
prescription drug event records, in a form that would
not be permitted under section 423.505(m) of title 42,
Code of Federal Regulations, or any successor
regulation, if made by the Centers for Medicare &
Medicaid Services.''.
(b) Access to Certain Rebate and Payment Data Under Medicare and
Medicaid.--Section 1927(b)(3)(D) of the Social Security Act (42 U.S.C.
1396r-8(b)(3)(D)) is amended--
(1) in the matter before clause (i), by striking
``subsection (a)(6)(A)(ii)'' and inserting ``subsection
(a)(6)(A)'';
(2) in clause (v), by striking ``and'' at the end;
(3) in clause (vi), by striking the period at the end and
inserting ``, and'';
(4) by inserting after clause (vi) the following new
clause:
``(vii) to permit the Executive Director of
the Medicare Payment Advisory Commission and
the Executive Director of the Medicaid and CHIP
Payment and Access Commission to review the
information provided.'';
(5) in the matter at the end, by striking ``1860D-
4(c)(2)(E)'' and inserting ``1860D-4(c)(2)(G)''; and
(6) by adding at the end the following new sentence: ``Any
information disclosed to the Executive Director of the Medicare
Payment Advisory Commission or the Executive Director of the
Medicaid and CHIP Payment and Access Commission pursuant to
this subparagraph shall not be disclosed by either such
Executive Director in a form which discloses the identity of a
specific manufacturer or wholesaler or prices charged for drugs
by such manufacturer or wholesaler.''.
SEC. 206. SENSE OF THE SENATE REGARDING THE NEED TO EXPAND COMMERCIALLY
AVAILABLE DRUG PRICING COMPARISON PLATFORMS.
It is the sense of the Senate that--
(1) commercially available drug pricing comparison
platforms can, at no cost, help patients find the lowest price
for their medications at their local pharmacy;
(2) such platforms should be integrated, to the maximum
extent possible, in the health care delivery ecosystem; and
(3) pharmacy benefit managers should work to disclose
generic and brand name drug prices to such platforms to ensure
that--
(A) patients can benefit from the lowest possible
price available to them; and
(B) overall drug prices can be reduced as more
educated purchasing decisions are made based on price
transparency.
TITLE III--REVENUE PROVISIONS
SEC. 301. PERMANENT EXTENSION OF REDUCTION IN MEDICAL EXPENSE DEDUCTION
FLOOR.
(a) In General.--Section 213(a) of the Internal Revenue Code of
1986 is amended by striking ``10 percent'' and inserting ``7.5
percent''.
(b) Conforming Amendments.--
(1) Section 213 of such Code is amended by striking
subsection (f).
(2) Section 56(b)(1) of such Code is amended by striking
subparagraph (B) and by redesignating subparagraphs (C), (D),
(E), and (F), as subparagraphs (B), (C), (D), and (E),
respectively.
(c) Effective Date.--The amendment made by this section shall apply
to taxable years ending after December 31, 2018.
SEC. 302. SAFE HARBOR FOR HIGH DEDUCTIBLE HEALTH PLANS WITHOUT
DEDUCTIBLE FOR INSULIN.
(a) In General.--Section 223(c)(2)(C) of the Internal Revenue Code
of 1986 is amended by inserting ``or for insulin or any device for the
delivery of insulin'' before the period at the end.
(b) Effective Date.--The amendment made by this section shall apply
to months beginning after the date of the enactment of this Act.
SEC. 303. INCLUSION OF CERTAIN OVER-THE-COUNTER MEDICAL PRODUCTS AS
QUALIFIED MEDICAL EXPENSES.
(a) HSAs.--Section 223(d)(2) of the Internal Revenue Code of 1986
is amended--
(1) by striking the last sentence of subparagraph (A) and
inserting the following: ``For purposes of this subparagraph,
amounts paid for menstrual care products shall be treated as
paid for medical care.''; and
(2) by adding at the end the following new subparagraph:
``(D) Menstrual care product.--For purposes of this
paragraph, the term `menstrual care product' means a
tampon, pad, liner, cup, sponge, or similar product
used by individuals with respect to menstruation or
other genital-tract secretions.''.
(b) Archer MSAs.--Section 220(d)(2)(A) of such Code is amended by
striking the last sentence and inserting the following: ``For purposes
of this subparagraph, amounts paid for menstrual care products (as
defined in section 223(d)(2)(D)) shall be treated as paid for medical
care.''.
(c) Health Flexible Spending Arrangements and Health Reimbursement
Arrangements.--Section 106 of such Code is amended by striking
subsection (f) and inserting the following new subsection:
``(f) Reimbursements for Menstrual Care Products.--For purposes of
this section and section 105, expenses incurred for menstrual care
products (as defined in section 223(d)(2)(D)) shall be treated as
incurred for medical care.''.
(d) Effective Dates.--
(1) Distributions from savings accounts.--The amendment
made by subsections (a) and (b) shall apply to amounts paid
after December 31, 2019.
(2) Reimbursements.--The amendment made by subsection (c)
shall apply to expenses incurred after December 31, 2019.
TITLE IV--MISCELLANEOUS
SEC. 401. IMPROVING COORDINATION BETWEEN THE FOOD AND DRUG
ADMINISTRATION AND THE CENTERS FOR MEDICARE & MEDICAID
SERVICES.
(a) In General.--
(1) Public meeting.--
(A) In general.--Not later than 12 months after the
date of the enactment of this Act, the Secretary of
Health and Human Services (referred to in this section
as the ``Secretary'') shall convene a public meeting
for the purposes of discussing and providing input on
improvements to coordination between the Food and Drug
Administration and the Centers for Medicare & Medicaid
Services in preparing for the availability of novel
medical products described in subsection (c) on the
market in the United States.
(B) Attendees.--The public meeting shall include--
(i) representatives of relevant Federal
agencies, including representatives from each
of the medical product centers within the Food
and Drug Administration and representatives
from the coding, coverage, and payment offices
within the Centers for Medicare & Medicaid
Services;
(ii) stakeholders with expertise in the
research and development of novel medical
products, including manufacturers of such
products;
(iii) representatives of commercial health
insurance payers;
(iv) stakeholders with expertise in the
administration and use of novel medical
products, including physicians; and
(v) stakeholders representing patients and
with expertise in the utilization of patient
experience data in medical product development.
(C) Topics.--The public meeting shall include a
discussion of--
(i) the status of the drug and medical
device development pipeline related to the
availability of novel medical products;
(ii) the anticipated expertise necessary to
review the safety and effectiveness of such
products at the Food and Drug Administration
and current gaps in such expertise, if any;
(iii) the expertise necessary to make
coding, coverage, and payment decisions with
respect to such products within the Centers for
Medicare & Medicaid Services, and current gaps
in such expertise, if any;
(iv) trends in the differences in the data
necessary to determine the safety and
effectiveness of a novel medical product and
the data necessary to determine whether a novel
medical product meets the reasonable and
necessary requirements for coverage and payment
under title XVIII of the Social Security Act
pursuant to section 1862(a)(1)(A) of such Act
(42 U.S.C. 1395y(a)(1)(A));
(v) the availability of information for
sponsors of such novel medical products to meet
each of those requirements; and
(vi) the coordination of information
related to significant clinical improvement
over existing therapies for patients between
the Food and Drug Administration and the
Centers for Medicare & Medicaid Services with
respect to novel medical products.
(D) Trade secrets and confidential information.--No
information discussed as a part of the public meeting
under this paragraph shall be construed as authorizing
the Secretary to disclose any information that is a
trade secret or confidential information subject to
section 552(b)(4) of title 5, United States Code.
(2) Improving transparency of criteria for medicare
coverage.--
(A) Draft guidance.--Not later than 18 months after
the public meeting under paragraph (1), the Secretary
shall update the final guidance titled ``National
Coverage Determinations with Data Collection as a
Condition of Coverage: Coverage with Evidence
Development'' to address any opportunities to improve
the availability and coordination of information as
described in clauses (iv) through (vi) of paragraph
(1)(C).
(B) Final guidance.--Not later than 12 months after
issuing draft guidance under subparagraph (A), the
Secretary shall finalize the updated guidance to
address any such opportunities.
(b) Report on Coding, Coverage, and Payment Processes Under
Medicare for Novel Medical Products.--Not later than 12 months after
the date of the enactment of this Act, the Secretary shall publish a
report on the Internet website of the Department of Health and Human
Services regarding processes under the Medicare program under title
XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect
to the coding, coverage, and payment of novel medical products
described in subsection (c). Such report shall include the following:
(1) A description of challenges in the coding, coverage,
and payment processes under the Medicare program for novel
medical products.
(2) Recommendations to--
(A) incorporate patient experience data (such as
the impact of a disease or condition on the lives of
patients and patient treatment preferences) into the
coverage and payment processes within the Centers for
Medicare & Medicaid Services;
(B) decrease the length of time to make national
and local coverage determinations under the Medicare
program (as those terms are defined in subparagraph (A)
and (B), respectively, of section 1862(l)(6) of the
Social Security Act (42 U.S.C. 1395y(l)(6)));
(C) streamline the coverage process under the
Medicare program and incorporate input from relevant
stakeholders into such coverage determinations; and
(D) identify potential mechanisms to incorporate
novel payment designs similar to those in development
in commercial insurance plans and State plans under
title XIX of such Act (42 U.S.C. 1396 et seq.) into the
Medicare program.
(c) Novel Medical Products Described.--For purposes of this
section, a novel medical product described in this subsection is a
medical product, including a drug, biological (including gene and cell
therapy), or medical device, that has been designated as a breakthrough
therapy under section 506(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356(a)), a breakthrough device under section 515B of
such Act (21 U.S.C. 360e-3), or a regenerative advanced therapy under
section 506(g) of such Act (21 U.S.C. 356(g)).
SEC. 402. PATIENT CONSULTATION IN MEDICARE NATIONAL AND LOCAL COVERAGE
DETERMINATIONS IN ORDER TO MITIGATE BARRIERS TO INCLUSION
OF SUCH PERSPECTIVES.
Section 1862(l) of the Social Security Act (42 U.S.C. 1395y(l)) is
amended by adding at the end the following new paragraph:
``(7) Patient consultation in national and local coverage
determinations.--The Secretary may consult with patients and
organizations representing patients in making national and
local coverage determinations.''.
SEC. 403. MEDPAC REPORT ON SHIFTING COVERAGE OF CERTAIN MEDICARE PART B
DRUGS TO MEDICARE PART D.
(a) Study.--The Medicare Payment Advisory Commission (in this
section referred to as the ``Commission'') shall conduct a study on
shifting coverage of certain drugs and biologicals for which payment is
currently made under part B of title XVIII of the Social Security Act
(42 U.S.C. 1395j et seq.) to part D of such title (42 U.S.C. 1395w-21
et seq.). Such study shall include an analysis of--
(1) differences in program structures and payment methods
for drugs and biologicals covered under such parts B and D,
including effects of such a shift on program spending,
beneficiary cost-sharing liability, and utilization management
techniques for such drugs and biologicals; and
(2) the feasibility and policy implications of shifting
coverage of drugs and biologicals for which payment is
currently made under such part B to such part D.
(b) Report.--
(1) In general.--Not later than June 30, 2021, the
Commission shall submit to Congress a report containing the
results of the study conducted under subsection (a).
(2) Contents.--The report under paragraph (1) shall include
information, and recommendations as the Commission deems
appropriate, regarding--
(A) formulary design under such part D;
(B) the ability of the benefit structure under such
part D to control total spending on drugs and
biologicals for which payment is currently made under
such part B;
(C) changes to the bid process under such part D,
if any, that may be necessary to integrate coverage of
such drugs and biologicals into such part D;
(D) any other changes to the program that Congress
should consider in determining whether to shift
coverage of such drugs and biologicals from such part B
to such part D; and
(E) the feasibility and policy implications of
creating a methodology to preserve the healthcare
provider's ability to take title of the drug, including
a methodology under which--
(i) prescription drug plans negotiate
reimbursement rates and other arrangements with
drug manufacturers on behalf of a wholesaler;
(ii) wholesalers purchase the drugs from
the manufacturers at the negotiated rate and
ship them through distributors to physicians to
administer to patients;
(iii) physicians and hospitals purchase the
drug from the wholesaler via the distributor;
(iv) after administering the drug, the
physician submits a claim to the MAC for their
drug administration fee;
(v) to be reimbursed for the purchase of
the drug from the distributor, the physician
furnishes the claim for the drug itself to the
wholesaler and the wholesaler would refund the
cost of the drug to the physician; and
(vi) the wholesaler passes this claim to
the PDP to receive reimbursement.
SEC. 404. REQUIREMENT THAT DIRECT-TO-CONSUMER ADVERTISEMENTS FOR
PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS INCLUDE
TRUTHFUL AND NON-MISLEADING PRICING INFORMATION.
Part A of title XI of the Social Security Act is amended by adding
at the end the following new section:
``SEC. 1150C. REQUIREMENT THAT DIRECT-TO-CONSUMER ADVERTISEMENTS FOR
PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS INCLUDE
TRUTHFUL AND NON-MISLEADING PRICING INFORMATION.
``(a) In General.--The Secretary shall require that each direct-to-
consumer advertisement for a prescription drug or biological product
for which payment is available under title XVIII or XIX includes an
appropriate disclosure of truthful and non-misleading pricing
information with respect to the drug or product.
``(b) Determination by CMS.--The Secretary, acting through the
Administrator of the Centers for Medicare & Medicaid Services, shall
determine the components of the requirement under subsection (a), such
as the forms of advertising, the manner of disclosure, the price point
listing, and the price information for disclosure.''.
SEC. 405. CHIEF PHARMACEUTICAL NEGOTIATOR AT THE OFFICE OF THE UNITED
STATES TRADE REPRESENTATIVE.
(a) In General.--Section 141 of the Trade Act of 1974 (19 U.S.C.
2171) is amended--
(1) in subsection (b)(2)--
(A) by striking ``and one Chief Innovation and
Intellectual Property Negotiator'' and inserting ``one
Chief Innovation and Intellectual Property Negotiator,
and one Chief Pharmaceutical Negotiator'';
(B) by striking ``or the Chief Innovation and
Intellectual Property Negotiator'' and inserting ``the
Chief Innovation and Intellectual Property Negotiator,
or the Chief Pharmaceutical Negotiator''; and
(C) by striking ``and the Chief Innovation and
Intellectual Property Negotiator'' and inserting ``the
Chief Innovation and Intellectual Property Negotiator,
and the Chief Pharmaceutical Negotiator''; and
(2) in subsection (c), by adding at the end the following
new paragraph:
``(7) The principal function of the Chief Pharmaceutical
Negotiator shall be to conduct trade negotiations and to
enforce trade agreements relating to United States
pharmaceutical products and services. The Chief Pharmaceutical
Negotiator shall be a vigorous advocate on behalf of United
States pharmaceutical interests. The Chief Pharmaceutical
Negotiator shall perform such other functions as the United
States Trade Representative may direct.''.
(b) Compensation.--Section 5314 of title 5, United States Code, is
amended by striking ``Chief Innovation and Intellectual Property
Negotiator, Office of the United States Trade Representative.'' and
inserting the following:
``Chief Innovation and Intellectual Property Negotiator,
Office of the United States Trade Representative.
``Chief Pharmaceutical Negotiator, Office of the United
States Trade Representative.''.
(c) Report Required.--Not later than the date that is one year
after the appointment of the first Chief Pharmaceutical Negotiator
pursuant to paragraph (2) of section 141(b) of the Trade Act of 1974,
as amended by subsection (a), and annually thereafter, the United
States Trade Representative shall submit to the Committee on Finance of
the Senate and the Committee on Ways and Means of the House of
Representatives a report describing in detail--
(1) enforcement actions taken by the United States Trade
Representative during the 1-year period preceding the
submission of the report to ensure the protection of United
States pharmaceutical products and services; and
(2) other actions taken by the United States Trade
Representative to advance United States pharmaceutical products
and services.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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