I 

114TH CONGRESS 

1ST SESSION H. R. 786 

To improve access, certainty, and innovation with respect to vaccines. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 5, 2015 

Mrs. ELLMERS (for herself and Mr. BUTTERFIELD) introduced the following 

bill; which was referred to the Committee on Energy and Commerce, and 

in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of 

such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To improve access, certainty, and innovation with respect 

to vaccines. 

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 ‘‘Vaccine Access, Cer5 tainty, and Innovation Act of 2015’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—DEVELOPMENT, LICENSURE, AND RECOMMENDATIONS 


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Sec. 101. Review of transparency and consistency of ACIP recommendation 

process. 

Sec. 102. Guidance on vaccine development. 

Sec. 103. Meetings between CDC and vaccine developers. 

Sec. 104. Modifications to priority review voucher program for tropical diseases. 

Sec. 105. Guidance on changes to an approved application for biological products. 

Sec. 106. Expediting the process for export certifications for vaccines. 

Sec. 107. NIH vaccine research. 

TITLE II—MEDICARE, MEDICAID, AND OTHER PROVISIONS 

Sec. 201. Requiring prompt updates to Medicare program upon issuance of 

ACIP recommendations. 

Sec. 202. GAO study and report on Medicare and Medicaid beneficiary access 

for vaccines. 

Sec. 203. Encouraging health plans to establish programs to increase adult immunization. 

1 TITLE I—DEVELOPMENT, LICEN2 SURE, AND RECOMMENDA3 TIONS 

4 SEC. 101. REVIEW OF TRANSPARENCY AND CONSISTENCY 

5 OF ACIP RECOMMENDATION PROCESS. 

6 (a) REVIEW.—The Director of the Centers for Dis7 ease Control and Prevention shall conduct a review of the 

8 transparency and consistency of the process used by the 

9 Advisory Committee on Immunization Practices in formu10 lating and issuing recommendations pertaining to vac11 cines. 

12 (b) CONSIDERATIONS.—The review under subsection 

13 (a) shall include assessment of— 

14 (1) the criteria used to evaluate new and exist15 ing vaccines; 

16 (2) the Grading of Recommendations, Assess17 ment, Development, and Evaluation (GRADE) apVerDate Sep 11 2014 01:11 Feb 13, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H786.IH H786

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1 proach to the review and analysis of scientific and 

2 economic data, including the scientific basis for such 

3 approach; and 

4 (3) the extent to which the processes used by 

5 the working groups of the Advisory Committee on 

6 Immunization Practices are transparent and con7 sistent. 

8 (c) STAKEHOLDERS.—In carrying out the review 

9 under subsection (a), the Director of the Centers for Dis10 ease Control and Prevention shall solicit input from vac11 cine stakeholders. 

12 (d) REPORT.—Not later than 1 year after the date 

13 of enactment of this Act, the Director of the Centers for 

14 Disease Control and Prevention shall submit to the appro15 priate committees of the Congress and make publicly 

16 available a report on the results of the review under sub17 section (a), including recommendations on improving the 

18 transparency and consistency of the process described in 

19 such subsection. 

20 (e) DEFINITION.—In this section, the term ‘‘Advisory 

21 Committee on Immunization Practices’’ means the advi22 sory committee on immunization practices established by 

23 the Secretary of Health and Human Services pursuant to 

24 section 222 of the Public Health Service Act (42 U.S.C. 


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1 217a), acting through the Director of the Centers for Dis2 ease Control and Prevention. 

3 SEC. 102. GUIDANCE ON VACCINE DEVELOPMENT. 

4 (a) ISSUANCE.—Not later than 2 years after the date 

5 of enactment of this Act, the Secretary of Health and 

6 Human Services shall issue final guidance to facilitate the 

7 use of accelerated and expedited pathways for the develop8 ment and licensure of vaccines to prevent— 

9 (1) emerging, re-emerging, or rare infectious 

10 diseases with respect to which the low prevalence or 

11 nature of the disease may render the existence or 

12 collection of clinical outcome data unlikely or im13 practical; and 

14 (2) infectious diseases with respect to which 

15 currently available vaccines are not addressing the 

16 full scope of public health needs. 

17 (b) CONSIDERATIONS.—In developing the guidance 

18 required by this section, the Secretary of Health and 

19 Human Services shall consider issues relating to clinical 

20 development strategies for diseases described in subsection 

21 (a), including the development and acceptability of novel 

22 clinical and surrogate endpoints, the use of novel or accel23 erated study designs, the use of observational real-world 

24 data, the use of novel adjuvants, the use of new tech25 nologies or approaches to collecting and monitoring paVerDate Sep 11 2014 01:11 Feb 13, 2015 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H786.IH H786

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1 tient-level data, and the demonstration of efficacy through 

2 studies in healthy volunteers for the purpose of licensure. 

3 SEC. 103. MEETINGS BETWEEN CDC AND VACCINE DEVEL4 OPERS. 

5 Section 310 of the Public Health Service Act (42 

6 U.S.C. 242o) is amended by adding at the end the fol7 lowing: 

8 ‘‘(c)(1) In this subsection, the term ‘vaccine devel9 oper’ means a nongovernmental entity engaged in— 

10 ‘‘(A) the development or production of a vac11 cine; and 

12 ‘‘(B) vaccine research. 

13 ‘‘(2)(A) Upon the submission of a written request by 

14 a vaccine developer, the Secretary, acting through the Di15 rector of the Centers for Disease Control and Prevention, 

16 shall convene a meeting of representatives of the vaccine 

17 developer and experts in immunization programs, epidemi18 ology, and other relevant areas, including such experts 

19 from the Food and Drug Administration and the National 

20 Vaccine Program, at which the Director (or the Director’s 

21 designee), for the purpose of informing the vaccine devel22 oper’s understanding of public health needs and priorities, 

23 shall provide the perspectives of the Centers for Disease 

24 Control and Prevention and other relevant Federal agen25 cies regarding— 


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1 ‘‘(i) public health needs, epidemiology, and im2 plementation considerations with regard to a vaccine 

3 developer’s potential vaccine profile; and 

4 ‘‘(ii) potential implications of such perspectives 

5 for the vaccine developer’s vaccine research and de6 velopment planning. 

7 ‘‘(B) The Director of the Centers for Disease Control 

8 and Prevention (or the Director’s designee) shall convene 

9 a meeting requested under subparagraph (A) not later 

10 than 90 business days after receipt of the request for the 

11 meeting. 

12 ‘‘(3)(A) Upon the submission of a written request by 

13 a vaccine developer, the Secretary, acting through the Di14 rector of the Centers for Disease Control and Prevention, 

15 shall provide to the vaccine developer any age-based dis16 ease epidemiological analyses or data that— 

17 ‘‘(i) are specified in the request; 

18 ‘‘(ii) have been published; 

19 ‘‘(iii) have been performed by or are in the pos20 session of the Centers; and 

21 ‘‘(iv) are not a trade secret or otherwise con22 fidential information subject to section 552(b)(4) of 

23 title 5, United States Code, or section 1905 of title 

24 18, United States Code. 


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1 ‘‘(B) The Secretary shall provide analyses requested 

2 by a vaccine manufacturer under subparagraph (A) not 

3 later than 90 business days after receipt of the request 

4 for the analyses. 

5 ‘‘(4) The Secretary shall promptly notify a vaccine 

6 developer if— 

7 ‘‘(A) the Secretary becomes aware of any 

8 change to information that was— 

9 ‘‘(i) shared by the Secretary with the vac10 cine developer during a meeting under para11 graph (2); or 

12 ‘‘(ii) provided by the Secretary to the vac13 cine developer in one or more analyses under 

14 paragraph (3); and 

15 ‘‘(B) the change may have implications for the 

16 vaccine developer’s vaccine research and develop17 ment.’’. 

18 SEC. 104. MODIFICATIONS TO PRIORITY REVIEW VOUCHER 

19 PROGRAM FOR TROPICAL DISEASES. 

20 Section 524 of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 360n) is amended— 

22 (1) in subsection (a)— 

23 (A) in paragraph (3)— 


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1 (i) in the matter before subparagraph 

2 (A), by striking ‘‘This term’’ and inserting 

3 ‘‘In this section, this term’’; and 

4 (ii) in subparagraph (R), by striking 

5 ‘‘designated by order of the Secretary’’ and 

6 inserting ‘‘designated by the Secretary pur7 suant to paragraph (4)’’; 

8 (B) by redesignating paragraph (4) as 

9 paragraph (5); and 

10 (C) by inserting after paragraph (3) the 

11 following: 

12 ‘‘(4) DESIGNATION OF OTHER INFECTIOUS DIS13 EASES AS TROPICAL DISEASES.— 

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

15 establish a process under which the Secretary— 

16 ‘‘(i) using a methodology that is made 

17 available to the public on the Internet site 

18 of the Food and Drug Administration, des19 ignates infectious diseases other than the 

20 diseases specified in subparagraphs (A) 

21 through (Q) of paragraph (3) to be trop22 ical diseases for purposes of this section; 

23 and 

24 ‘‘(ii) publishes on such Internet site a 

25 complete, updated list of the diseases that 


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1 are tropical diseases for purposes of this 

2 section. 

3 ‘‘(B) CONSIDERATIONS.—In designating 

4 an infectious disease as a tropical disease under 

5 subparagraph (A), the Secretary shall— 

6 ‘‘(i) consider the potential impact of 

7 the disease on the public health due to— 

8 ‘‘(I) the potential rate of spread 

9 of the disease; and 

10 ‘‘(II) the potential severity of the 

11 disease in terms of human morbidity 

12 and mortality; and 

13 ‘‘(ii) consult with experts in tropical 

14 infectious diseases, including the Centers 

15 for Disease Control and Prevention, the 

16 Food and Drug Administration, medical 

17 professionals, the clinical research commu18 nity, and the World Health Organization. 

19 ‘‘(C) REVIEW.—Every 5 years, or more 

20 frequently as determined necessary by the Sec21 retary, the Secretary shall review, provide modi22 fications to, and re-publish the list published 

23 under subparagraph (A) and any revisions 

24 made to the methodology for designation of dis25 eases under such subparagraph.’’; 


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1 (2) in subsection (b)— 

2 (A) in paragraph (2), by striking ‘‘The 

3 sponsor of a tropical disease’’ and inserting: 

4 ‘‘(A) IN GENERAL.—The sponsor of a trop5 ical disease’’; 

6 (B) by inserting after such paragraph 

7 (2)(A) the following: 

8 ‘‘(B) NOTIFICATION OF TRANSFER.—Each 

9 person to whom a priority review voucher is 

10 transferred shall notify the Secretary of such 

11 change in ownership of the voucher not later 

12 than 30 business days after such transfer.’’; 

13 (C) in paragraph (4), by striking ‘‘The 

14 sponsor of a human drug application’’ and in15 serting: 

16 ‘‘(A) IN GENERAL.—The sponsor of a 

17 human drug application’’; and 

18 (D) by inserting after paragraph (4)(A), as 

19 designated by subparagraph (D), the following: 

20 ‘‘(B) TRANSFER AFTER NOTICE.—The 

21 sponsor of a human drug application that pro22 vides notification of intent under subparagraph 

23 (A) may transfer the voucher after such notifi24 cation is provided, if such sponsor has not yet 

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1 scribed in the notification. Upon such a trans2 fer, notwithstanding subparagraph (A), such 

3 sponsor shall not remain legally committed to 

4 pay a user fee because of the sponsor’s notifica5 tion of intent under such subparagraph.’’; and 

6 (3) in subsection (c), by amending paragraph 

7 (2) to read as follows: 

8 ‘‘(2) FEE AMOUNT.—The amount of the pri9 ority review user fee shall be determined each fiscal 

10 year by the Secretary based on the difference be11 tween— 

12 ‘‘(A) the average cost incurred by the 

13 agency in the review of a human drug applica14 tion subject to priority review in the previous 

15 fiscal year; and 

16 ‘‘(B) the average cost incurred by the 

17 Food and Drug Administration in the review of 

18 a human drug application that is not subject to 

19 priority review in the previous fiscal year.’’. 

20 SEC. 105. GUIDANCE ON CHANGES TO AN APPROVED APPLI21 CATION FOR BIOLOGICAL PRODUCTS. 

22 Not later than 2 years after the date of enactment 

23 of this Act, the Secretary of Health and Human Services 

24 shall issue final guidance that— 


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1 (1) addresses changes in a licensed biological 

2 product or the labeling, production process, quality 

3 controls, equipment, facilities, or responsible per4 sonnel for such a product established in the applica5 tion for the product that was approved under section 

6 351 of the Public Health Service Act (42 U.S.C. 

7 262); 

8 (2) does not address such changes for specified 

9 biotechnology or specified synthetic biological prod10 ucts listed in section 601.2(c) of title 21 of the Code 

11 of Federal Regulation; and 

12 (3) updates and supersedes the guidance enti13 tled ‘‘Changes to an Approved Application: Biologi14 cal Products,’’ that was issued by the Food and 

15 Drug Administration in July, 1997. 

16 SEC. 106. EXPEDITING THE PROCESS FOR EXPORT CERTIFI17 CATIONS FOR VACCINES. 

18 Section 801(e)(4) of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 381(e)(4)) is amended— 

20 (1) in the matter following clause (ii) in sub21 paragraph (A), by striking ‘‘within 20 days of the 

22 receipt of a request for such certification’’ and in23 serting ‘‘within 20 business days of the receipt of a 

24 request for such certification, except that in the case 

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1 cation within 10 business days of the receipt of a re2 quest for such certification’’; and 

3 (2) in subparagraph (B), by striking ‘‘within 

4 the 20 days prescribed by subparagraph (A)’’ and 

5 inserting ‘‘within the period prescribed by subpara6 graph (A)’’. 

7 SEC. 107. NIH VACCINE RESEARCH. 

8 (a) IN GENERAL.—Subpart 6 of part C of title IV 

9 of the Public Health Service Act (42 U.S.C. 285f et seq.) 

10 is amended by adding at the end the following: 

11 ‘‘SEC. 447D. ADVANCEMENT OF VACCINE DEVELOPMENT. 

12 ‘‘In carrying out the general purpose described in sec13 tion 446, the Director of the Institute shall conduct or 

14 support translational science, research, and research train15 ing to advance the development of vaccines for the preven16 tion of diseases, including the advancement of vaccine de17 velopment programs into clinical trials.’’. 

18 (b) REVIEW OF NIH VACCINE RESEARCH.— 

19 (1) IN GENERAL.—Not later than one year 

20 after the date of enactment of this Act, the Director 

21 of the National Institutes of Health shall— 

22 (A) conduct a review on vaccine research 

23 being conducted or supported by the Institutes; 

24 and 


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1 (B) publish a report on the results of such 

2 review. 

3 (2) CONTENTS.—At a minimum, the report 

4 under paragraph (1)(B) shall— 

5 (A) describe intramural and extramural 

6 vaccine research and development programs 

7 that are being conducted or supported by the 

8 National Institutes of Health, including those 

9 that are translational or clinical phase studies; 

10 (B) provide a summary of funding alloca11 tions made to conduct or support the matters 

12 described in section 447D of the Public Health 

13 Service Act, as added by subsection (a), and 

14 identify projected funding needs with regard to 

15 future research or support with regard to these 

16 matters; and 

17 (C) identify funding and collaborations 

18 with the private sector through— 

19 (i) the Small Business Innovation Re20 search and Small Business Technology 

21 Transfer programs; and 

22 (ii) cooperative research and develop23 ment agreements. 


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1 TITLE II—MEDICARE, MEDICAID, 

2 AND OTHER PROVISIONS 

3 SEC. 201. REQUIRING PROMPT UPDATES TO MEDICARE 

4 PROGRAM UPON ISSUANCE OF ACIP REC5 OMMENDATIONS. 

6 In the case that the advisory committee on immuniza7 tion practices established by the Secretary of Health and 

8 Human Services pursuant to section 222 of the Public 

9 Health Service Act (42 U.S.C. 217a) issues a rec10 ommendation for a vaccine or an update to a recommenda11 tion for a vaccine that the Secretary is using under title 

12 XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) 

13 with respect to coverage of vaccines or immunizations 

14 under such title, the Secretary shall determine whether or 

15 not to update policies under such title with respect to such 

16 coverage on a date that is not later than 60 business days 

17 after the date on which such advisory committee issues 

18 such recommendation or update. 

19 SEC. 202. GAO STUDY AND REPORT ON MEDICARE AND 

20 MEDICAID BENEFICIARY ACCESS FOR VAC21 CINES. 

22 (a) STUDY.—The Comptroller General of the United 

23 States (in this section referred to as the ‘‘Comptroller 

24 General’’) shall conduct a study on the impact of reim25 bursement rates under the Medicare program under parts 


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1 B, C, and D of title XVIII of the Social Security Act and 

2 under the Medicaid program under title XIX of such Act 

3 on access by targeted individuals to vaccines recommended 

4 by the Advisory Committee on Immunization Practices of 

5 the Centers for Disease Control and Prevention. Such 

6 study shall include an analysis and determination of— 

7 (1) the reimbursement rates for vaccines under 

8 such parts of the Medicare program and under the 

9 Medicaid program, including those rates paid by a 

10 PDP sponsor under part D of title XVIII of such 

11 Act, Medicare Advantage organizations under part C 

12 of such title, and Medicaid managed care organiza13 tions (as defined in section 1903(m)(1)(A) of the 

14 Social Security Act (42 U.S.C. 1396b(m)(1)(A)); 

15 (2) the number of targeted individuals during 

16 the 3-year period prior to the study who were eligi17 ble for a vaccination recommended by the Advisory 

18 Committee on Immunization Practices of the Cen19 ters for Disease Control and Prevention; 

20 (3) the number of such targeted individuals who 

21 actually received a vaccination described in para22 graph (2), with a particular breakdown of adults, 

23 the elderly, and populations located in rural or un24 derserved communities; and 


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1 (4) the extent to which the reimbursement rates 

2 under such parts of the Medicare program and 

3 under the Medicaid program for vaccinations de4 scribed in paragraph (2) affect their use by physi5 cians or access for such targeted individuals. 

6 (b) TARGETED INDIVIDUALS.—For purposes of sub7 section (a), the term ‘‘targeted individual’’ means and in8 dividual who is— 

9 (1)(A) entitled to benefits under part A of title 

10 XVIII of the Social Security Act or enrolled in part 

11 B of such Act; or 

12 (B) eligible for medical assistance under title 

13 XIX of such Act; and 

14 (2) within a vulnerable population. 

15 (c) REPORT.—Not later than 2 years after the date 

16 of enactment of this Act, the Comptroller General shall 

17 submit to the appropriate committees of the Congress a 

18 report containing the results of the study conducted under 

19 subsection (a), including— 

20 (1) a summary of the findings of the study; and 

21 (2) recommendations based on the results of 

22 the study, including recommendations for such legis23 lative and administrative action as the Comptroller 

24 General determines appropriate. 


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1 SEC. 203. ENCOURAGING HEALTH PLANS TO ESTABLISH 

2 PROGRAMS TO INCREASE ADULT IMMUNIZA3 TION. 

4 (a) PRIVATE HEALTH PLANS.—Section 2718 of the 

5 Public Health Service Act (42 U.S.C. 300gg–18) is 

6 amended by adding at the end the following new sub7 section: 

8 ‘‘(f) PROGRAMS TO INCREASE ADULT IMMUNIZA9 TION.— 

10 ‘‘(1) IN GENERAL.—For purposes of this sec11 tion, for plan years beginning on or after the date 

12 of enactment of the Vaccine Access, Certainty, and 

13 Innovation Act of 2015, activities that improve 

14 health care quality described in subsection (a)(2) 

15 shall include programs to increase adult immuniza16 tion. 

17 ‘‘(2) ADMINISTRATION.—Not later than Decem18 ber 31, 2016, the Secretary shall establish standard19 ized methodologies, including definitions, for which 

20 activities, and in what regard such activities, con21 stitute programs to increase adult immunization in 

22 accordance with this subsection. The Secretary shall 

23 consult with relevant stakeholders in establishing 

24 such methodologies.’’. 

25 (b) MEDICARE ADVANTAGE AND PART D PLANS.— 

26 Section 1857(e) of the Social Security Act (42 U.S.C. 


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1 1395w–27(e)) is amended by adding at the end the fol2 lowing new paragraph: 

3 ‘‘(5) INCLUSION OF EXPENDITURES ON PRO4 GRAMS TO INCREASE ADULT IMMUNIZATION IN MIN5 IMUM MEDICAL LOSS RATIO CALCULATION.—For 

6 purposes of calculating the minimum medical loss 

7 ratio under paragraph (4), for plan years beginning 

8 at least 12 months after the date of enactment of 

9 this Act, the numerator shall include any expendi10 tures on programs to increase adult immunization.’’. 

Æ 


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