II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘New Opportunities for 

5 Value that Extend Lives Act of 2021’’ or the ‘‘NOVEL 

6 Act of 2021’’. 


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1 SEC. 2. EXPEDITED CODING OF NOVEL MEDICAL PROD2 UCTS. 

3 Section 1874 of the Social Security Act (42 U.S.C. 

4 1395kk) is amended by adding at the end the following 

5 new subsection: 

6 ‘‘(h) EXPEDITED CODING OF NOVEL MEDICAL

7 PRODUCTS.— 

8 ‘‘(1) IN GENERAL.—On and after the date that 

9 is 180 calendar days after the date of enactment of 

10 this subsection, in the case of a novel medical prod11 uct, the Secretary shall make modifications to the 

12 HCPCS code set at least once every quarter. 

13 ‘‘(2) REQUEST.—Upon the written confidential 

14 request of a manufacturer of a novel medical prod15 uct, the Secretary shall make a determination 

16 whether to assign a HCPCS code to such product. 

17 Such request may occur on or after the date on 

18 which the product receives a designation as a break19 through therapy under section 506(a) of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), 

21 a breakthrough device under section 515B of such 

22 Act (21 U.S.C. 360e–3), or a regenerative advanced 

23 therapy under section 506(g) of such Act (21 U.S.C. 

24 356(g)). 

25 ‘‘(3) DEADLINE FOR DETERMINATION AND NO26 TIFICATION.— 


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1 ‘‘(A) COMPLETE REQUEST.—If the Sec2 retary finds that a manufacturer has submitted 

3 a complete request under paragraph (2), the 

4 Secretary shall— 

5 ‘‘(i) make a determination under such 

6 paragraph with respect to the request by 

7 not later than 180 calendar days after re8 ceiving the request; and 

9 ‘‘(ii) notify the manufacturer of the 

10 determination by not later than 30 cal11 endar days after making such determina12 tion. 

13 ‘‘(B) INCOMPLETE REQUEST.—If the Sec14 retary finds that a manufacturer has submitted 

15 an incomplete request under paragraph (2), the 

16 Secretary shall notify the manufacturer of such 

17 finding by not later than 10 calendar days after 

18 receiving the request. Such notification shall 

19 contain detailed instructions on how the manu20 facturer can rectify any issue with the request. 

21 ‘‘(4) MONITORING UTILIZATION.—A HCPCS 

22 code assigned under this subsection shall allow for 

23 the reliable monitoring of utilization of the novel 

24 medical product as described in paragraph (7). 


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1 ‘‘(5) EFFECTIVE DATE OF CODE ASSIGN2 MENT.—If the Secretary makes a determination to 

3 assign a HCPCS code to a product under paragraph 

4 (2), such code— 

5 ‘‘(A) may be assigned within the first 

6 quarter after the manufacturer files, with re7 spect to such product, a new drug application 

8 under section 505(b) of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 355(b)), a 

10 biological product license application under sec11 tion 351(a) of the Public Health Service Act 

12 (42 U.S.C. 262(a)), a premarket application 

13 under section 515(c) of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 360e(c)), a 

15 report under section 510(k) of such Act (21 

16 U.S.C. 360k), or a request for classification 

17 under section 513(f)(2) of such Act (21 U.S.C. 

18 360c(f)(2)); and 

19 ‘‘(B) may not take effect before the date 

20 the product is approved, cleared, or licensed by 

21 the Food and Drug Administration. 

22 ‘‘(6) TRADE SECRETS AND CONFIDENTIAL IN23 FORMATION.—No information submitted under 

24 paragraph (2) shall be construed as authorizing the 

25 Secretary to disclose any information that is a trade 


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1 secret or confidential information subject to section 

2 552(b)(4) of title 5, United States Code. 

3 ‘‘(7) INPATIENT PRODUCTS.—The Secretary 

4 shall establish a code modifier within the hospital in5 patient prospective payment system under section 

6 1886(d) to track the utilization and, to the extent 

7 practicable, outcomes of novel medical products that 

8 are assigned a HCPCS code pursuant to the expe9 dited coding process under this subsection and are 

10 furnished by hospitals in inpatient settings. 

11 ‘‘(8) AUTHORITY.— 

12 ‘‘(A) INCORPORATION INTO AN EXISTING

13 PROCESS.—The Secretary may, as determined 

14 appropriate, incorporate the request process 

15 under this subsection into another HCPCS code 

16 request process that the Secretary has in place. 

17 ‘‘(B) WAIVER OF ELEMENTS OF EXISTING

18 PROCESSES.—In implementing this subsection, 

19 the Secretary may waive such elements of other 

20 HCPCS code request processes relating to ad21 vance planning as the Secretary determines ap22 propriate. 

23 ‘‘(9) DEFINITIONS.—In this subsection: 

24 ‘‘(A) NOVEL MEDICAL PRODUCT DE25 FINED.—The term ‘novel medical product’ 


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1 means a drug, biological product, or medical de2 vice— 

3 ‘‘(i) that has not been assigned a 

4 HCPCS code; and 

5 ‘‘(ii) that has been designated as— 

6 ‘‘(I) a breakthrough therapy 

7 under section 506(a) of the Federal 

8 Food, Drug, and Cosmetic Act (21 

9 U.S.C. 356(a)); 

10 ‘‘(II) a breakthrough device 

11 under section 515B of such Act (21 

12 U.S.C. 360e–3); or 

13 ‘‘(III) a regenerative advanced 

14 therapy under section 506(g) of such 

15 Act (21 U.S.C. 356(g)). 

16 ‘‘(B) HCPCS DEFINED.—The term 

17 ‘HCPCS’ means the Healthcare Common Pro18 cedure Coding System.’’. 

19 SEC. 3. COVERAGE DETERMINATIONS FOR NOVEL MEDICAL 

20 PRODUCTS. 

21 Section 1862(l) of the Social Security Act (42 U.S.C. 

22 1395y(l)) is amended by adding at the end the following 

23 new paragraph: 

24 ‘‘(7) COVERAGE PATHWAY FOR NOVEL MEDICAL

25 PRODUCTS.— 


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1 ‘‘(A) IN GENERAL.—The Secretary shall 

2 facilitate an efficient coverage pathway to expe3 dite a national coverage decision for coverage 

4 with evidence development process under this 

5 title for novel medical products described in 

6 subparagraph (D). The Secretary shall review 

7 such novel medical products for the coverage 

8 process on an expedited basis, beginning as 

9 soon as the Secretary assigns a HCPCS code to 

10 the product pursuant to the expedited coding 

11 process under section 1874(h). 

12 ‘‘(B) DETERMINATION OF COVERAGE WITH

13 EVIDENCE DEVELOPMENT.—Such coverage 

14 pathway shall include, with respect to such 

15 novel medical products, if the Secretary deter16 mines coverage with evidence development is 

17 appropriate, issuance of a national coverage de18 termination of coverage with evidence develop19 ment for a period up to, but not to exceed, 4 

20 years from the date of such determination. 

21 ‘‘(C) MODERNIZING PAYMENT OPTIONS

22 FOR NOVEL MEDICAL PRODUCTS.—Not later 

23 than 4 years after issuing a national coverage 

24 determination pursuant to this paragraph, the 

25 Secretary shall submit to Congress and to the 


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1 manufacturer of the novel medical product a re2 port providing options for implementing alter3 native payment models under this title for the 

4 class of products to which the novel medical 

5 product belongs, which may include the utiliza6 tion of existing models in the commercial health 

7 insurance market or any other payment model 

8 deemed appropriate by the Secretary. Such re9 port shall include any recommendations for leg10 islation and administrative action as the Sec11 retary determines appropriate to facilitate such 

12 payment arrangements. 

13 ‘‘(D) NOVEL MEDICAL PRODUCTS DE14 SCRIBED.—For purposes of this paragraph, a 

15 novel medical product described in this subpara16 graph is a novel medical product, as defined in 

17 paragraph (9)(A) of section 1874(h), that is as18 signed a HCPCS code pursuant to the expe19 dited coding process under such section. 

20 ‘‘(E) CLARIFICATION.—Nothing in this 

21 paragraph shall prevent the Secretary from 

22 issuing a noncoverage or a national coverage 

23 determination for a novel medical product de24 scribed in subparagraph (D).’’. 


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1 SEC. 4. ENHANCING COORDINATION WITH THE FOOD AND 

2 DRUG ADMINISTRATION. 

3 (a) PUBLIC MEETING.— 

4 (1) IN GENERAL.—Not later than 12 months 

5 after the date of enactment of this Act, the Sec6 retary of Health and Human Services (in this sec7 tion referred to as the ‘‘Secretary’’) shall convene a 

8 public meeting for the purposes of discussing and 

9 providing input on improvements to coordination be10 tween the Food and Drug Administration and the 

11 Centers for Medicare & Medicaid Services in pre12 paring for the availability of novel medical products 

13 (as defined in section 1874(h)(9)(A) of the Social 

14 Security Act, as added by section 2) on the market 

15 in the United States. 

16 (2) ATTENDEES.—The public meeting shall in17 clude— 

18 (A) representatives of relevant Federal 

19 agencies, including representatives from each of 

20 the medical product centers within the Food 

21 and Drug Administration and representatives 

22 from the coding, coverage, and payment offices 

23 within the Centers for Medicare & Medicaid 

24 Services; 


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1 (B) stakeholders with expertise in the re2 search and development of novel medical prod3 ucts, including manufacturers of such products; 

4 (C) representatives of commercial health 

5 insurance payers; 

6 (D) stakeholders with expertise in the ad7 ministration and use of novel medical products, 

8 including physicians; and 

9 (E) stakeholders representing patients and 

10 with expertise in the utilization of patient expe11 rience data in medical product development. 

12 (3) TOPICS.—The public meeting shall include 

13 a discussion of— 

14 (A) the status of the drug and medical de15 vice development pipeline related to the avail16 ability of novel medical products; 

17 (B) the anticipated expertise necessary to 

18 review the safety and effectiveness of such prod19 ucts at the Food and Drug Administration and 

20 current gaps in such expertise, if any; 

21 (C) the expertise necessary to make cod22 ing, coverage, and payment decisions with re23 spect to such products within the Centers for 

24 Medicare & Medicaid Services, and current gaps 

25 in such expertise, if any; 


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1 (D) common differences in the data sets 

2 necessary to determine the safety and effective3 ness of a novel medical product and the data 

4 sets necessary to determine whether a novel 

5 medical product meets the reasonable and nec6 essary requirements for coverage and payment 

7 under title XVIII of the Social Security Act 

8 pursuant to section 1862(a)(1)(A) of such Act 

9 (42 U.S.C. 1395y(a)(1)(A)); 

10 (E) the availability of information for 

11 sponsors of such novel medical products to meet 

12 each of those requirements; and 

13 (F) the coordination of information related 

14 to significant clinical improvement over existing 

15 therapies for patients between the Food and 

16 Drug Administration and the Centers for Medi17 care & Medicaid Services with respect to novel 

18 medical products. 

19 (4) TRADE SECRETS AND CONFIDENTIAL IN20 FORMATION.—No information discussed as a part of 

21 the public meeting under this section shall be con22 strued as authorizing the Secretary to disclose any 

23 information that is a trade secret or confidential in24 formation subject to section 552(b)(4) of title 5, 

25 United States Code. 


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1 (b) IMPROVING TRANSPARENCY OF CRITERIA FOR

2 MEDICARE COVERAGE.— 

3 (1) UPDATING GUIDANCE.—Not later than 18 

4 months after the public meeting under subsection 

5 (a), the Secretary shall update the final guidance en6 titled ‘‘National Coverage Determinations with Data 

7 Collection as a Condition of Coverage: Coverage with 

8 Evidence Development’’ to improve the availability 

9 and coordination of information as described in sub10 paragraphs (D) through (F) of subsection (a)(3), 

11 and clarify novel medical product clinical data re12 quirements to meet the reasonable and necessary re13 quirements for coverage and payment under title 

14 XVIII of the Social Security Act. 

15 (2) FINALIZING UPDATED GUIDANCE.—Not 

16 later than 12 months after issuing draft guidance 

17 under paragraph (1), the Secretary shall finalize the 

18 updated guidance. 

19 SEC. 5. REPORT ON CODING, COVERAGE, AND PAYMENT 

20 PROCESSES UNDER MEDICARE FOR NEW 

21 MEDICAL PRODUCTS. 

22 (a) IN GENERAL.—Not later than 12 months after 

23 the date of enactment of this Act, the Secretary of Health 

24 and Human Services shall publish a report on the internet 

25 website of the Department of Health and Human Services 


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1 regarding processes under the Medicare program under 

2 title XVIII of the Social Security Act (42 U.S.C. 1395 

3 et seq.) with respect to the coding, coverage, and payment 

4 of medical products described in subsection (b). Such re5 port shall include the following: 

6 (1) A description of challenges in the coding, 

7 coverage, and payment processes under the Medicare 

8 program for medical products described in such sub9 section. 

10 (2) Recommendations to— 

11 (A) incorporate patient experience data 

12 (such as the impact of a disease or condition on 

13 the lives of patients and patient treatment pref14 erences) into the coverage and payment proc15 esses within the Centers for Medicare & Med16 icaid Services; 

17 (B) decrease the length of time to make 

18 national and local coverage determinations 

19 under the Medicare program (as those terms 

20 are defined in subparagraph (A) and (B), re21 spectively, of section 1862(l)(6) of the Social 

22 Security Act (42 U.S.C. 1395y(l)(6))); 

23 (C) streamline the coverage process under 

24 the Medicare program and incorporate input 


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1 from relevant stakeholders into such coverage 

2 determinations; and 

3 (D) identify potential mechanisms to incor4 porate novel payment designs similar to those 

5 in development in commercial insurance plans 

6 and State plans under title XIX of the Social 

7 Security Act (42 U.S.C. 1396r et seq.) into the 

8 Medicare program. 

9 (b) MEDICAL PRODUCTS DESCRIBED.—For purposes 

10 of subsection (a), a medical product described in this sub11 section is a medical product, including a drug, biological 

12 (including gene and cell therapy and gene editing), or 

13 medical device, that has been designated as a break14 through therapy under section 506(a) of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), a 

16 breakthrough device under section 515B of such Act (21 

17 U.S.C. 360e–3), or a regenerative advanced therapy under 

18 section 506(g) of such Act (21 U.S.C. 356(g)). 

Æ 


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