New Opportunities for Value that Extend Lives Act of 2021
Bill: S.2416 | Sponsor: Sen. Burr, Richard (R-NC)
Policy area: Health

Summary:
New Opportunities for Value that Extend Lives Act of 2021 or the NOVEL Act of 2021  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.

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)).
                                 <all>