[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2416 Introduced in Senate (IS)]
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117th CONGRESS
1st Session
S. 2416
To amend title XVIII of the Social Security Act to provide for
expedited coding and coverage of novel medical products, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 21, 2021
Mr. Burr (for himself, Mr. Bennet, Mr. Scott of South Carolina, and Mr.
Carper) introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to provide for
expedited coding and coverage of novel medical products, 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 ``New Opportunities for Value that
Extend Lives Act of 2021'' or the ``NOVEL Act of 2021''.
SEC. 2. EXPEDITED CODING OF NOVEL MEDICAL PRODUCTS.
Section 1874 of the Social Security Act (42 U.S.C. 1395kk) is
amended by adding at the end the following new subsection:
``(h) Expedited Coding of Novel Medical Products.--
``(1) In general.--On and after the date that is 180
calendar days after the date of enactment of this subsection,
in the case of a novel medical product, the Secretary shall
make modifications to the HCPCS code set at least once every
quarter.
``(2) Request.--Upon the written confidential request of a
manufacturer of a novel medical product, the Secretary shall
make a determination whether to assign a HCPCS code to such
product. Such request may occur on or after the date on which
the product receives a designation 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)).
``(3) Deadline for determination and notification.--
``(A) Complete request.--If the Secretary finds
that a manufacturer has submitted a complete request
under paragraph (2), the Secretary shall--
``(i) make a determination under such
paragraph with respect to the request by not
later than 180 calendar days after receiving
the request; and
``(ii) notify the manufacturer of the
determination by not later than 30 calendar
days after making such determination.
``(B) Incomplete request.--If the Secretary finds
that a manufacturer has submitted an incomplete request
under paragraph (2), the Secretary shall notify the
manufacturer of such finding by not later than 10
calendar days after receiving the request. Such
notification shall contain detailed instructions on how
the manufacturer can rectify any issue with the
request.
``(4) Monitoring utilization.--A HCPCS code assigned under
this subsection shall allow for the reliable monitoring of
utilization of the novel medical product as described in
paragraph (7).
``(5) Effective date of code assignment.--If the Secretary
makes a determination to assign a HCPCS code to a product under
paragraph (2), such code--
``(A) may be assigned within the first quarter
after the manufacturer files, with respect to such
product, a new drug application under section 505(b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(b)), a biological product license application under
section 351(a) of the Public Health Service Act (42
U.S.C. 262(a)), a premarket application under section
515(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e(c)), a report under section 510(k) of such
Act (21 U.S.C. 360k), or a request for classification
under section 513(f)(2) of such Act (21 U.S.C.
360c(f)(2)); and
``(B) may not take effect before the date the
product is approved, cleared, or licensed by the Food
and Drug Administration.
``(6) Trade secrets and confidential information.--No
information submitted under paragraph (2) 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.
``(7) Inpatient products.--The Secretary shall establish a
code modifier within the hospital inpatient prospective payment
system under section 1886(d) to track the utilization and, to
the extent practicable, outcomes of novel medical products that
are assigned a HCPCS code pursuant to the expedited coding
process under this subsection and are furnished by hospitals in
inpatient settings.
``(8) Authority.--
``(A) Incorporation into an existing process.--The
Secretary may, as determined appropriate, incorporate
the request process under this subsection into another
HCPCS code request process that the Secretary has in
place.
``(B) Waiver of elements of existing processes.--In
implementing this subsection, the Secretary may waive
such elements of other HCPCS code request processes
relating to advance planning as the Secretary
determines appropriate.
``(9) Definitions.--In this subsection:
``(A) Novel medical product defined.--The term
`novel medical product' means a drug, biological
product, or medical device--
``(i) that has not been assigned a HCPCS
code; and
``(ii) that has been designated as--
``(I) a breakthrough therapy under
section 506(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
356(a));
``(II) a breakthrough device under
section 515B of such Act (21 U.S.C.
360e-3); or
``(III) a regenerative advanced
therapy under section 506(g) of such
Act (21 U.S.C. 356(g)).
``(B) HCPCS defined.--The term `HCPCS' means the
Healthcare Common Procedure Coding System.''.
SEC. 3. COVERAGE DETERMINATIONS FOR NOVEL MEDICAL PRODUCTS.
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) Coverage pathway for novel medical products.--
``(A) In general.--The Secretary shall facilitate
an efficient coverage pathway to expedite a national
coverage decision for coverage with evidence
development process under this title for novel medical
products described in subparagraph (D). The Secretary
shall review such novel medical products for the
coverage process on an expedited basis, beginning as
soon as the Secretary assigns a HCPCS code to the
product pursuant to the expedited coding process under
section 1874(h).
``(B) Determination of coverage with evidence
development.--Such coverage pathway shall include, with
respect to such novel medical products, if the
Secretary determines coverage with evidence development
is appropriate, issuance of a national coverage
determination of coverage with evidence development for
a period up to, but not to exceed, 4 years from the
date of such determination.
``(C) Modernizing payment options for novel medical
products.--Not later than 4 years after issuing a
national coverage determination pursuant to this
paragraph, the Secretary shall submit to Congress and
to the manufacturer of the novel medical product a
report providing options for implementing alternative
payment models under this title for the class of
products to which the novel medical product belongs,
which may include the utilization of existing models in
the commercial health insurance market or any other
payment model deemed appropriate by the Secretary. Such
report shall include any recommendations for
legislation and administrative action as the Secretary
determines appropriate to facilitate such payment
arrangements.
``(D) Novel medical products described.--For
purposes of this paragraph, a novel medical product
described in this subparagraph is a novel medical
product, as defined in paragraph (9)(A) of section
1874(h), that is assigned a HCPCS code pursuant to the
expedited coding process under such section.
``(E) Clarification.--Nothing in this paragraph
shall prevent the Secretary from issuing a noncoverage
or a national coverage determination for a novel
medical product described in subparagraph (D).''.
SEC. 4. ENHANCING COORDINATION WITH THE FOOD AND DRUG ADMINISTRATION.
(a) Public Meeting.--
(1) In general.--Not later than 12 months after the date of
enactment of this Act, the Secretary of Health and Human
Services (in this section referred to 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 (as defined in section 1874(h)(9)(A) of the
Social Security Act, as added by section 2) on the market in
the United States.
(2) Attendees.--The public meeting shall include--
(A) 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;
(B) stakeholders with expertise in the research and
development of novel medical products, including
manufacturers of such products;
(C) representatives of commercial health insurance
payers;
(D) stakeholders with expertise in the
administration and use of novel medical products,
including physicians; and
(E) stakeholders representing patients and with
expertise in the utilization of patient experience data
in medical product development.
(3) Topics.--The public meeting shall include a discussion
of--
(A) the status of the drug and medical device
development pipeline related to the availability of
novel medical products;
(B) 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;
(C) 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;
(D) common differences in the data sets necessary
to determine the safety and effectiveness of a novel
medical product and the data sets 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));
(E) the availability of information for sponsors of
such novel medical products to meet each of those
requirements; and
(F) 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.
(4) Trade secrets and confidential information.--No
information discussed as a part of the public meeting under
this section 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.
(b) Improving Transparency of Criteria for Medicare Coverage.--
(1) Updating guidance.--Not later than 18 months after the
public meeting under subsection (a), the Secretary shall update
the final guidance entitled ``National Coverage Determinations
with Data Collection as a Condition of Coverage: Coverage with
Evidence Development'' to improve the availability and
coordination of information as described in subparagraphs (D)
through (F) of subsection (a)(3), and clarify novel medical
product clinical data requirements to meet the reasonable and
necessary requirements for coverage and payment under title
XVIII of the Social Security Act.
(2) Finalizing updated guidance.--Not later than 12 months
after issuing draft guidance under paragraph (1), the Secretary
shall finalize the updated guidance.
SEC. 5. REPORT ON CODING, COVERAGE, AND PAYMENT PROCESSES UNDER
MEDICARE FOR NEW MEDICAL PRODUCTS.
(a) In General.--Not later than 12 months after the date of
enactment of this Act, the Secretary of Health and Human Services 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 medical products
described in subsection (b). Such report shall include the following:
(1) A description of challenges in the coding, coverage,
and payment processes under the Medicare program for medical
products described in such subsection.
(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 the Social Security Act (42 U.S.C. 1396r
et seq.) into the Medicare program.
(b) Medical Products Described.--For purposes of subsection (a), a
medical product described in this subsection is a medical product,
including a drug, biological (including gene and cell therapy and gene
editing), 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)).
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