II 

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. 

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 2019’’ or the ‘‘NOVEL 

6 Act of 2019’’. 


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

3 Section 1174(b)(2)(B) of the Social Security Act (42 

4 U.S.C. 1320d–3(b)(2)(B)) is amended by adding at the 

5 end the following new clauses: 

6 ‘‘(iii) EXPEDITED CODING OF NOVEL

7 MEDICAL PRODUCTS.— 

8 ‘‘(I) IN GENERAL.—Notwith9 standing paragraph (1), in the case of 

10 a novel medical product (as defined in 

11 clause (iv)), the Secretary shall make 

12 modifications to the HCPCS code set 

13 at least once every quarter. 

14 ‘‘(II) REQUEST.—Upon the writ15 ten confidential request of a manufac16 turer of a novel medical product, the 

17 Secretary shall make a determination 

18 whether to assign a HCPCS code to 

19 such product. Such request may occur 

20 on or after the date on which the 

21 product receives a designation as a 

22 breakthrough therapy under section 

23 506(a) of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 356(a)), 

25 a breakthrough device under section 

26 515B of such Act (21 U.S.C. 360e– 


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1 3), or a regenerative advanced therapy 

2 under section 506(g) of such Act (21 

3 U.S.C. 356(g)). 

4 ‘‘(III) DEADLINE FOR DETER5 MINATION; NOTIFICATION.—The Sec6 retary shall— 

7 ‘‘(aa) not later than 180 cal8 endar days after receiving the re9 quest of a manufacturer under 

10 subclause (II), make a deter11 mination under such subclause 

12 with respect to the request; and 

13 ‘‘(bb) not later than 30 cal14 endar days after making such de15 termination, notify the manufac16 turer of the determination. 

17 ‘‘(IV) MONITORING UTILIZATION

18 AND OUTCOMES.—A HCPCS code as19 signed under this clause shall allow 

20 for the reliable monitoring of utiliza21 tion and outcomes of the novel med22 ical product as described in clause 

23 (vi). 

24 ‘‘(V) EFFECTIVE DATE OF CODE

25 ASSIGNMENT.—If the Secretary makes 


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1 a determination to assign a HCPCS 

2 code to a product under subclause 

3 (II), such code— 

4 ‘‘(aa) may be assigned with5 in the first quarter after the 

6 manufacturer files, with respect 

7 to such product, a new drug ap8 plication under section 505(b) of 

9 the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 355(b)), 

11 a biological product license appli12 cation under section 351(a) of 

13 the Public Health Service Act 

14 (42 U.S.C. 262(a)), a premarket 

15 application under section 515(c) 

16 of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 

18 360e(c)), a report under section 

19 510(k) of such Act (21 U.S.C. 

20 360k), or a request for classifica21 tion under section 513(f)(2) of 

22 such Act (21 U.S.C. 360c(f)(2)); 

23 and 

24 ‘‘(bb) may not take effect 

25 before the date the product is apVerDate Sep 11 2014 00:53 Aug 08, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2326.IS S2326

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1 proved, cleared, or licensed by 

2 the Food and Drug Administra3 tion. 

4 ‘‘(VI) TRADE SECRETS AND CON5 FIDENTIAL INFORMATION.—No infor6 mation submitted under subclause (II) 

7 shall be construed as authorizing the 

8 Secretary to disclose any information 

9 that is a trade secret or confidential 

10 information subject to section 

11 552(b)(4) of title 5, United States 

12 Code. 

13 ‘‘(iv) NOVEL MEDICAL PRODUCT DE14 FINED.—For purposes of this subpara15 graph, the term ‘novel medical product’ 

16 means a drug, biological product, or med17 ical device— 

18 ‘‘(I) that has not been assigned a 

19 HCPCS code; and 

20 ‘‘(II) that has been designated as 

21 a breakthrough therapy under section 

22 506(a) of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 356(a)), 

24 a breakthrough device under section 

25 515B of such Act (21 U.S.C. 360e– 


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1 3), or a regenerative advanced therapy 

2 under section 506(g) of such Act (21 

3 U.S.C. 356(g)). 

4 ‘‘(v) HCPCS DEFINED.—For pur5 poses of this subparagraph, the term 

6 ‘HCPCS’ means the Healthcare Common 

7 Procedure Coding System. 

8 ‘‘(vi) INPATIENT PRODUCTS.—The 

9 Secretary shall establish a code modifier 

10 within the hospital inpatient prospective 

11 payment system under section 1886(d) to 

12 track the utilization and outcomes of novel 

13 medical products that are assigned a 

14 HCPCS code pursuant to the expedited 

15 coding process under clause (iii) and are 

16 furnished by hospitals in inpatient set17 tings.’’. 

18 SEC. 3. COVERAGE DETERMINATIONS FOR NOVEL MEDICAL 

19 PRODUCTS. 

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

21 1395y(l)) is amended by adding at the end the following 

22 new paragraph: 

23 ‘‘(7) COVERAGE PATHWAY FOR NOVEL MEDICAL

24 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 under clause (iii)(V)(aa) of section 

11 1174(b)(2)(B). 

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 such national cov24 erage determination, the Secretary shall submit 

25 to Congress and to the manufacturer of the 


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1 novel medical product a report providing op2 tions for alternative payment models under this 

3 title for the novel medical product or class of 

4 such products, which may include the utilization 

5 of existing models in the commercial health in6 surance market. Such report shall include any 

7 recommendations for legislation and adminis8 trative action as the Secretary determines ap9 propriate to facilitate such payment arrange10 ments. 

11 ‘‘(D) NOVEL MEDICAL PRODUCTS DE12 SCRIBED.—For purposes of this paragraph, a 

13 novel medical product described in this subpara14 graph is a novel medical product, as defined in 

15 clause (iv) of section 1174(b)(2)(B), that is as16 signed a HCPCS code pursuant to the expe17 dited coding process under clause (iii) of such 

18 section. 

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

20 paragraph shall prevent the Secretary from 

21 issuing a noncoverage or a national coverage 

22 determination for a novel medical product.’’. 

23 SEC. 4. ENHANCING COORDINATION WITH THE FOOD AND 

24 DRUG ADMINISTRATION. 

25 (a) PUBLIC MEETING.— 


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

2 after the date of the enactment of this Act, the Sec3 retary shall convene a public meeting for the pur4 poses of discussing and providing input on improve5 ments to coordination between the Food and Drug 

6 Administration and the Centers for Medicare & Med7 icaid Services in preparing for the availability of 

8 novel medical products (as defined in section 

9 1174(b)(2)(B)(iv) of the Social Security Act, as 

10 added by section 2) on the market in the United 

11 States. 

12 (2) ATTENDEES.—The public meeting shall in13 clude— 

14 (A) representatives of relevant Federal 

15 agencies, including representatives from each of 

16 the medical product centers within the Food 

17 and Drug Administration and representatives 

18 from the coding, coverage, and payment offices 

19 within the Centers for Medicare & Medicaid 

20 Services; 

21 (B) stakeholders with expertise in the re22 search and development of novel medical prod23 ucts, including manufacturers of such products; 

24 (C) representatives of commercial health 

25 insurance payers; 


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1 (D) stakeholders with expertise in the ad2 ministration and use of novel medical products, 

3 including physicians; and 

4 (E) stakeholders representing patients and 

5 with expertise in the utilization of patient expe6 rience data in medical product development. 

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

8 a discussion of— 

9 (A) the status of the drug and medical de10 vice development pipeline related to the avail11 ability of novel medical products; 

12 (B) the anticipated expertise necessary to 

13 review the safety and effectiveness of such prod14 ucts at the Food and Drug Administration and 

15 current gaps in such expertise, if any; 

16 (C) the expertise necessary to make cod17 ing, coverage, and payment decisions with re18 spect to such products within the Centers for 

19 Medicare & Medicaid Services, and current gaps 

20 in such expertise, if any; 

21 (D) trends in the differences in the data 

22 necessary to determine the safety and effective23 ness of a novel medical product and the data 

24 necessary to determine whether a novel medical 

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1 quirements for coverage and payment under 

2 title XVIII of the Social Security Act pursuant 

3 to section 1862(a)(1)(A) of such Act (42 U.S.C. 

4 1395y(a)(1)(A)); 

5 (E) the availability of information for 

6 sponsors of such novel medical products to meet 

7 each of those requirements; and 

8 (F) the coordination of information related 

9 to significant clinical improvement over existing 

10 therapies for patients between the Food and 

11 Drug Administration and the Centers for Medi12 care & Medicaid Services with respect to novel 

13 medical products. 

14 (4) TRADE SECRETS AND CONFIDENTIAL IN15 FORMATION.—No information discussed as a part of 

16 the public meeting under this section shall be con17 strued as authorizing the Secretary to disclose any 

18 information that is a trade secret or confidential in19 formation subject to section 552(b)(4) of title 5, 

20 United States Code. 

21 (b) IMPROVING TRANSPARENCY OF CRITERIA FOR

22 MEDICARE COVERAGE.— 

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

24 months after the public meeting under subsection 

25 (a), the Secretary of Health and Human Services 


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1 shall update the final guidance entitled ‘‘National 

2 Coverage Determinations with Data Collection as a 

3 Condition of Coverage: Coverage with Evidence De4 velopment’’ to improve the availability and coordina5 tion of information as described in subparagraphs 

6 (D) through (F) subsection (a)(3), and clarify novel 

7 medical product clinical data requirements to meet 

8 reasonable and necessary requirements for coverage 

9 and payment under title XVIII of the Social Secu10 rity Act. 

11 (2) FINALIZING UPDATED GUIDANCE.—Not 

12 later than 12 months after issuing draft guidance 

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

14 updated guidance. 

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

16 PROCESSES UNDER MEDICARE FOR NEW 

17 MEDICAL PRODUCTS. 

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

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

20 and Human Services shall publish a report on the internet 

21 website of the Department of Health and Human Services 

22 regarding processes under the Medicare program under 

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

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


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1 of medical products described in subsection (b). Such re2 port shall include the following: 

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

4 coverage, and payment processes under the Medicare 

5 program for medical products described in such sub6 section. 

7 (2) Recommendations to— 

8 (A) incorporate patient experience data 

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

10 the lives of patients and patient treatment pref11 erences) into the coverage and payment proc12 esses within the Centers for Medicare & Med13 icaid Services; 

14 (B) decrease the length of time to make 

15 national and local coverage determinations 

16 under the Medicare program (as those terms 

17 are defined in subparagraph (A) and (B), re18 spectively, of section 1862(l)(6) of the Social 

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

20 (C) streamline the coverage process under 

21 the Medicare program and incorporate input 

22 from relevant stakeholders into such coverage 

23 determinations; and 

24 (D) identify potential mechanisms to incor25 porate novel payment designs similar to those 


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1 in development in commercial insurance plans 

2 and State plans under title XIX of the Social 

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

4 Medicare program. 

5 (b) MEDICAL PRODUCTS DESCRIBED.—For purposes 

6 of subsection (a), a medical product described in this sub7 section is a medical product, including a drug, biological 

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

9 medical device, that has been designated as a break10 through therapy under section 506(a) of the Federal 

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

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

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

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

Æ 


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