[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2326 Introduced in Senate (IS)]
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116th CONGRESS
1st Session
S. 2326
To amend titles XI and 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 30, 2019
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 titles XI and 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 2019'' or the ``NOVEL Act of 2019''.
SEC. 2. EXPEDITED CODING OF NOVEL MEDICAL PRODUCTS.
Section 1174(b)(2)(B) of the Social Security Act (42 U.S.C. 1320d-
3(b)(2)(B)) is amended by adding at the end the following new clauses:
``(iii) Expedited coding of novel medical
products.--
``(I) In general.--Notwithstanding
paragraph (1), in the case of a novel
medical product (as defined in clause
(iv)), the Secretary shall make
modifications to the HCPCS code set at
least once every quarter.
``(II) 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)).
``(III) Deadline for determination;
notification.--The Secretary shall--
``(aa) not later than 180
calendar days after receiving
the request of a manufacturer
under subclause (II), make a
determination under such
subclause with respect to the
request; and
``(bb) not later than 30
calendar days after making such
determination, notify the
manufacturer of the
determination.
``(IV) Monitoring utilization and
outcomes.--A HCPCS code assigned under
this clause shall allow for the
reliable monitoring of utilization and
outcomes of the novel medical product
as described in clause (vi).
``(V) Effective date of code
assignment.--If the Secretary makes a
determination to assign a HCPCS code to
a product under subclause (II), such
code--
``(aa) 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
``(bb) may not take effect
before the date the product is
approved, cleared, or licensed
by the Food and Drug
Administration.
``(VI) Trade secrets and
confidential information.--No
information submitted under subclause
(II) 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.
``(iv) Novel medical product defined.--For
purposes of this subparagraph, 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
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)).
``(v) HCPCS defined.--For purposes of this
subparagraph, the term `HCPCS' means the
Healthcare Common Procedure Coding System.
``(vi) 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 outcomes of novel medical products that are
assigned a HCPCS code pursuant to the expedited
coding process under clause (iii) and are
furnished by hospitals in inpatient
settings.''.
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 under clause (iii)(V)(aa) of section
1174(b)(2)(B).
``(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 such
national coverage determination, the Secretary shall
submit to Congress and to the manufacturer of the novel
medical product a report providing options for
alternative payment models under this title for the
novel medical product or class of such products, which
may include the utilization of existing models in the
commercial health insurance market. 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 clause (iv) of section
1174(b)(2)(B), that is assigned a HCPCS code pursuant
to the expedited coding process under clause (iii) of
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.''.
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
the enactment of this Act, 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 1174(b)(2)(B)(iv) 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) 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));
(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 of Health
and Human Services 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) subsection (a)(3),
and clarify novel medical product clinical data requirements to
meet 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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