Ensuring Patient Access to Critical Breakthrough Products Act of 2021
This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.)
The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period. The Centers for Medicare & Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary.
The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4043 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 4043
To amend title XVIII of the Social Security Act to ensure prompt
coverage of breakthrough devices under the Medicare program, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 22, 2021
Ms. DelBene (for herself, Mrs. Walorski, Mr. Cardenas, Mr. Bilirakis,
Ms. Sewell, and Mr. Upton) introduced the following bill; which was
referred to the Committee on Ways and Means, and in addition to the
Committee on Energy and Commerce, for a period to be subsequently
determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to ensure prompt
coverage of breakthrough devices under the Medicare program, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Ensuring Patient Access to Critical
Breakthrough Products Act of 2021''.
SEC. 2. COVERAGE AND PAYMENT FOR BREAKTHROUGH DEVICES UNDER THE
MEDICARE PROGRAM.
(a) In General.--Part E of title XVIII of the Social Security Act
(42 U.S.C. 1395x et seq.) is amended by adding at the end the following
new section:
``SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES.
``(a) Breakthrough Devices.--For purposes of this section, the term
`breakthrough device' means a medical device that is a device (as
defined in section 201 of the Federal Food, Drug, and Cosmetic Act) and
that is--
``(1) provided with review priority by the Secretary under
subsection (d)(5) of section 515 of such Act; and
``(2) approved or cleared pursuant to section 510(k),
513(f), or 515 of such Act for use in treating an indication on
or after March 15, 2019.
Such term also includes a breakthrough device that is a specified
breakthrough device (as defined in subsection (e)(1)(B)) approved or
cleared pursuant to section 510(k), 513(f), or 515 of such Act for use
in treating an indication on or after March 15, 2019.
``(b) Coverage.--
``(1) Transitional coverage.--
``(A) In general.--During the transitional coverage
period (as defined in subparagraph (B)) a breakthrough
device shall be--
``(i) deemed to be reasonable and necessary
for purposes of section 1862(a)(1)(A);
``(ii) deemed to be approved for an
additional payment under section 1886(d)(5)(K)
(other than with respect to the cost criterion
under clause (ii)(I) of such section);
``(iii) deemed to be approved for pass-
through payment under section 1833(t)(6) and
section 1833(i) (other than with respect to the
cost criterion under section
1833(t)(6)(A)(iv)); and
``(iv) insofar as such breakthrough device
may be furnished in a setting for which payment
is made under an applicable payment system
described in subparagraphs (D) through (I) of
subsection (c)(4), deemed eligible for an
additional payment or payment adjustment, as
the case may be, pursuant to subsection (d)(3)
when furnished in a setting for which payment
is made under such an applicable payment system
during such transitional coverage period.
``(B) Transitional coverage period defined.--As
used in this section, the term `transitional coverage
period' means, with respect to a breakthrough device,
the period that--
``(i) begins on the date of the approval
under section 515 of the Federal Food, Drug,
and Cosmetic Act or of the clearance under
section 510(k) of such Act, as applicable, of
such device by the Secretary for the indication
described in subsection (a)(1); and
``(ii) ends on the last day of the 4-year
period that begins on the date that the
Secretary, pursuant to subsection (c)(2),
updates the relevant applicable payment system
(as defined in subsection (c)(4)) to recognize
the unique temporary or permanent code or codes
assigned under subsection (c)(1) to such
breakthrough device, except as provided in
subsections (d)(1)(B) and (d)(2)(B).
``(C) Data used to meet the ntap and pass-through
cost criteria.--In determining whether a breakthrough
device qualifies for an additional payment under
section 1886(d)(5)(K) or for pass-through payment under
section 1833(t)(6) or section 1833(i), the Secretary
shall use the most recently available data and
information on the costs of such breakthrough device,
which may include list prices and invoice prices
charged for such breakthrough device.
``(2) Process for regular coverage.--For purposes of the
application of section 1862(a)(1)(A) to a breakthrough device
furnished after the transitional coverage period (as defined in
paragraph (1)(B)) for such device, the Secretary shall
establish a process for the coverage of such breakthrough
devices under this title after such period as follows:
``(A) Identification of additional evidence.--
``(i) In general.--With respect to a
breakthrough device, not later than 1 year
after the date of the approval of such device
under section 515 of the Federal Food, Drug,
and Cosmetic Act or of the clearance of such
device under section 510(k) of such Act, as
applicable, the Secretary shall identify
whether any additional data or evidence is
required with respect to any indications for
such device for purposes of the application of
such section 1862(a)(1)(A) to such device for
such indications.
``(ii) Non-duplication of data requests.--
In carrying out clause (i) with respect to a
breakthrough device, the Secretary shall ensure
that data or evidence identified--
``(I) does not duplicate data
required to be collected by the Food
and Drug Administration with respect to
such breakthrough device;
``(II) minimizes the administrative
burdens of data collection and
reporting on providers of services,
suppliers, and manufacturers of
breakthrough devices; and
``(III) is not otherwise
unnecessary or redundant.
``(B) Proposal for coverage after the transitional
coverage period.--Not later than 2 years after the date
of the approval or clearance of a breakthrough device
by the Food and Drug Administration, the Secretary
shall develop a proposal for coverage under this title
of such breakthrough device for such indications as the
Secretary determines to be appropriate, based on the
data and evidence collected under subparagraph (A), for
such devices furnished after the transitional coverage
period under paragraph (1) for such device. If the
Secretary does not, on a date that is before the end of
such two-year period, take action to modify the
indications for which coverage of a breakthrough device
may be provided under this title after such period, for
purposes of section 1862(a)(1)(A) coverage under this
title of such breakthrough device shall be made for all
indications for which such device is approved under
section 515 of the Federal Food, Drug, and Cosmetic Act
or cleared under section 510(k) of such Act.
``(3) Rules of construction.--Nothing in this section shall
be construed to--
``(A) affect the ability of the manufacturer of a
breakthrough device to seek approval for pass-through
payment status under section 1833(t)(6) or to seek
approval for an additional payment under section
1886(d)(5)(K) insofar as such breakthrough device does
not qualify for transitional coverage under paragraph
(1); or
``(B) affect the application and approval process
for pass-through payment status under section
1833(t)(6) or for an additional payment under section
1886(d)(5)(K) in the case of a medical device that is
not approved by the Food and Drug Administration as a
breakthrough device.
``(c) Coding.--
``(1) Prompt assignment.--Not later than three months after
the date of approval or clearance of a breakthrough device by
the Food and Drug Administration, the Secretary shall assign a
unique temporary or permanent code or codes for purposes of
coverage and payment for such breakthrough device under the
applicable payment systems (described in paragraph (4)).
``(2) Updates.--
``(A) IPPS.--The Secretary shall provide for
semiannual updates under the applicable payment system
described in paragraph (4)(A) (relating to the
inpatient hospital prospective payment system) to
recognize the code or codes assigned under paragraph
(1).
``(B) OPPS.--The Secretary shall provide for
quarterly updates under the applicable payment system
described in paragraph (4)(B) (relating to the
outpatient hospital prospective payment system) to
recognize the code or codes assigned under paragraph
(1).
``(C) Other payment systems.--The Secretary shall
provide for semiannual or quarterly updates, as the
case may be, under the applicable payment systems
described in subparagraphs (C) through (K) of paragraph
(4) to recognize the code or codes assigned under
paragraph (1).
``(3) Transparency.--The process for the assignment of a
code or codes under this subsection shall provide for public
notice and a meaningful opportunity for public comment from
affected parties.
``(4) Applicable payment systems described.--For purposes
of this subsection, the term `applicable payment systems'
means--
``(A) with respect to inpatient hospital services,
the prospective payment system for inpatient hospital
services established under section 1886(d);
``(B) with respect to outpatient hospital services,
the prospective payment system for covered OPD services
established under section 1833(t);
``(C) with respect to ambulatory surgical center
services, the fee schedule for such services
established under 1833(i);
``(D) with respect to physicians' services, the
physician fee schedules established under section 1848;
``(E) with respect to covered items of durable
medical equipment, the applicable fee schedules
established under section 1834;
``(F) with respect to diagnostic laboratory tests,
the payment amounts under section 1834A and the fee
schedules establish under section 1848, as the case may
be;
``(G) with respect to inpatient hospital services
furnished by rehabilitation facilities, the prospective
payment system established under section 1886(j);
``(H) with respect to inpatient hospital services
furnished by long-term care hospitals, the prospective
payment system under section 1886(m);
``(I) with respect to inpatient hospital services
furnished by psychiatric hospitals and psychiatric
units, the prospective payment system under section
1886(s);
``(J) with respect to home health services, the
prospective payment system under section 1895; and
``(K) with respect to items and services, or a
provider of services or supplier, not described in
subparagraphs (A) through (K), the payment system
established under this title for such items and
services when furnished by such provider of services or
supplier.
``(d) Payment.--
``(1) Inpatient hospital prospective payment system: deemed
eligibility for breakthrough payment.--The Secretary shall deem
each breakthrough device as approved for an additional payment
under section 1886(d)(5)(K) for the 4-year period that begins--
``(A) except as provided in subparagraph (B), on
the date that the Secretary, pursuant to subsection
(c)(2)(A), updates the payment system under section
1886(d) to recognize the unique temporary or permanent
code or codes assigned under subsection (c)(1) to such
breakthrough device; or
``(B) in the case of a device that has not received
approval or clearance as a breakthrough device by the
Food and Drug Administration before such payment system
is updated under subsection (c)(2)(A) to recognize the
unique temporary or permanent code or codes assigned
under subsection (c)(1) to such device, on the date of
such approval or clearance.
Nothing in this paragraph shall be construed to affect the
authority of the Secretary to use claims data to establish new
diagnosis or procedure codes for breakthrough devices or to
identify appropriate diagnosis-related groups for the
assignment of breakthrough devices under annual rulemaking to
carry out section 1886(d)(5)(K).
``(2) Outpatient prospective payment system: deemed
eligibility for pass-through payment.--The Secretary shall deem
each breakthrough device as approved for pass-through payment
under section 1833(t)(6) (including for purposes of section
1833(i)(2)(D)) during the 4-year period that begins--
``(A) except as provided in subparagraph (B), on
the date that the Secretary, pursuant to subsection
(c)(2)(B), updates the payment system under section
1833(t) to recognize the unique temporary or permanent
code or codes assigned under subsection (c)(1) to such
breakthrough device; or
``(B) in the case of a device that has not received
approval or clearance as a breakthrough device by the
Food and Drug Administration before such payment system
is updated under subsection (c)(2)(B) to recognize the
unique temporary or permanent code or codes assigned
under subsection (c)(1) to such device, on the date of
such approval or clearance.
Nothing in this paragraph shall be construed to affect the
authority of the Secretary to use claims data to establish new
ambulatory payment classification groups for breakthrough
devices or to revise such groups to take into account
breakthrough devices under annual rulemaking to carry out
section 1833(t).
``(3) Other payment systems.--
``(A) In general.--In the case of breakthrough
device that is furnished and for which payment may be
made under the payment system established under section
1834, 1834A, 1848, 1886(j), 1886(m), 1886(s), or 1895
or any other provision of this title (other than
sections 1833(i), 1833(t), and 1886(d)), the Secretary
shall provide for an additional payment for such
breakthrough device under such applicable payment
system or an adjustment to such applicable payment
system, as the case may be. The payment basis for such
additional payment or adjustment, as the case may be,
shall equal an amount that the Secretary determines
covers the costs of such breakthrough device.
``(B) Cost information.--In determining the costs
of a breakthrough device for purposes of determining an
additional payment or payment adjustment under
subparagraph (A), the Secretary shall use the most
recently available data and information on the costs of
such breakthrough device, which may include list prices
and invoice prices charged for such breakthrough
device.
``(C) Rule of construction.--Nothing in this
paragraph shall be construed to affect the authority of
the Secretary to use claims data to establish new or
modify existing ambulatory payment classification
groups, diagnosis-related groups, level II HCPCS codes
or such other groups or codes as the Secretary may
establish under the annual rulemaking authority under
the provisions referred to in subparagraph (A).
``(D) Clinical diagnostic laboratory tests.--An
additional payment or payment adjustment under
subparagraph (A) for a breakthrough device under the
applicable payment system established in section 1834A
may be in the form of an increase to the amount
determined for the breakthrough device using cross-
walking under section 1834A(c)(1)(A), an extension of
the initial period of payment applicable to advance
diagnostic laboratory tests under section
1834A(d)(1)(A), and in such other form or manner as the
Secretary determines reflects the costs for such
breakthrough device under the relevant provisions of
section 1834A.
``(4) Payment for breakthrough devices after the
transitional coverage period.--Payment for a breakthrough
device that is furnished after the conclusion of the
transitional coverage period under subsection (b)(1) for such
device shall be made pursuant to the applicable payment system
involved, taking into account the additional evidence and data
collected under subsection (b)(2).
``(e) Special Rules for Certain Breakthrough Devices.--
``(1) Coverage of specified breakthrough devices.--
``(A) In general.--Subject to the succeeding
provisions of this subsection and notwithstanding any
other provision of law, the Secretary shall provide for
coverage and payment pursuant to this section of a
specified breakthrough device (as defined in
subparagraph (B)).
``(B) Specified breakthrough device defined.--In
this section, the term `specified breakthrough device'
means a breakthrough device with respect to which no
Medicare benefit category exists.
``(2) Period of transitional coverage.--
``(A) In general.--Subject to subparagraph (C), the
provisions of subsection (b)(1) (relating to the
transitional coverage period and payment for
breakthrough devices, including the use of the most
recently available data and information on costs) shall
apply to a specified breakthrough device in the same
manner as such provisions apply to a breakthrough
device. The Secretary may use methodologies under
existing payment systems established under this title,
may provide for appropriate adjustments to such
methodologies, or may establish a new payment
methodology under this title, to provide for payment
for a specified breakthrough device to ensure the
payment basis for such payment covers costs of the
specified breakthrough device are covered by such
payment.
``(B) Report.--
``(i) In general.--With respect to each
specified breakthrough device, the Secretary
shall submit to Congress a report on the
coverage of and payment for such specified
breakthrough device under this section that
includes the following information:
``(I) The manner in which coverage
is provided and payment is made for the
specified breakthrough device,
including how such device was
classified (such as an item of durable
medical equipment or otherwise) and the
payment methodology the Secretary
applied with respect to such device.
``(II) The impact of the
availability of the specified
breakthrough device to Medicare
beneficiaries, including impacts on the
quality of patient care, patient
outcomes, and patient experience.
``(III) The impact of the
availability of the specified
breakthrough device to Medicare
beneficiaries on program expenditures
under this title.
``(IV) Such other information as
the Secretary determines to be
appropriate.
``(ii) Deadline.--
``(I) In general.--Except as
provided in subclause (II), the
Secretary shall submit a report
required under this subparagraph no
later than the end of the transitional
period of coverage and payment
applicable to such specified
breakthrough device.
``(II) Extension to generate
additional data.--If the Secretary
determines that additional data or
evidence is required to complete a
report required under this subparagraph
with respect to a specified
breakthrough device, the deadline under
this clause may be extended for an
additional two years.
``(C) Additional period of transitional coverage to
develop additional data.--Insofar as the Secretary
determines that additional data or evidence is required
to complete a report required under subparagraph (B)
with respect to a specified breakthrough device, the
transitional coverage period of coverage and payment
for such device shall be extended by the lesser of--
``(i) two years; or
``(ii) the amount of additional time
required for the submission of the report with
respect to such device.
``(3) Coverage and payment after the transitional period.--
The Secretary may continue to provide for coverage of and
payment for a specified breakthrough device after the end of
the transitional period of coverage and payment for
breakthrough devices through the national coverage
determination process if the Secretary determines that the
specified breakthrough device--
``(A) improves the quality of care and patient
outcomes;
``(B) improves the delivery of care; or
``(C) reduces spending under this title without
reducing the quality of care.''.
(b) Conforming Amendments.--
(1) Inpatient prospective payment system.--Section
1886(d)(5)(K) of the Social Security Act (42 U.S.C.
1395ww(d)(5)(K)) is amended by adding at the end the following
new clause:
``(x) Effective for discharges occurring on or
after October 1, 2019, in the case of a new medical
service or technology that is a breakthrough device (as
defined in section 1899C(a)), the additional payment
established for such breakthrough device under this
subparagraph shall be made for the 4-year period
applicable to such breakthrough device under section
1899C(d)(1). In determining the amount of the
additional payment for a breakthrough device under this
subparagraph during such 4-year period, the Secretary
shall apply section 412.88(b) of title 42, Code of
Federal Regulations, as in effect on the date of the
enactment of this clause, except as if the reference in
such section to `65 percent' were a reference to `65
percent (or such greater percent specified by the
Secretary)'.''.
(2) Outpatient prospective payment system.--Section
1833(t)(6)(C) of such Act (42 U.S.C. 1395l(t)(6)(C)) is amended
by adding at the end the following new clause:
``(iii) Special rule for breakthrough
devices.--Notwithstanding clause (i) or (ii),
or any other provision of this paragraph to the
contrary, in the case of a breakthrough device
(as defined in section 1899C(a)) that is
furnished on or after January 1, 2020, payment
under this paragraph for such breakthrough
device shall be made for the 4-year period
applicable to such breakthrough device under
section 1899C(d)(2). The provisions of this
clause shall also apply for purposes of
transitional pass-through payment under section
1833(i)(2)(D).''.
(c) Effective Date.--This section, and the amendments made by this
section, shall take effect on the date of the enactment of this Act
and, unless otherwise specified in this section (or in an amendment
made by this section), shall apply to breakthrough devices (as defined
in section 1899C(a) of the Social Security Act, as added by subsection
(a)), approved or cleared on or after July 1, 2019, or, in the case of
a specified breakthrough device (as defined in such section as so
added), approved or cleared on or after December 1, 2018.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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