Title: NOVEL Act of 2019
Policy area: Health

Summary:
New Opportunities for Value that Extend Lives Act of 2019 or the NOVEL Act of 2019  This bill establishes a process for expediting the assignment of Healthcare Common Procedure Coding System (HCPCS) codes to medical products that have been designated as a breakthrough product or regenerative advanced therapy by the Food and Drug Administration; it also establishes a process for determining coverage under Medicare of such breakthrough products that have been assigned HCPCS codes.

[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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