[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 786 Introduced in House (IH)]

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.

    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 ``Vaccine Access, Certainty, and 
Innovation Act of 2015''.

SEC. 2. TABLE OF CONTENTS.

    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

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.

          TITLE I--DEVELOPMENT, LICENSURE, AND RECOMMENDATIONS

SEC. 101. REVIEW OF TRANSPARENCY AND CONSISTENCY OF ACIP RECOMMENDATION 
              PROCESS.

    (a) Review.--The Director of the Centers for Disease Control and 
Prevention shall conduct a review of the transparency and consistency 
of the process used by the Advisory Committee on Immunization Practices 
in formulating and issuing recommendations pertaining to vaccines.
    (b) Considerations.--The review under subsection (a) shall include 
assessment of--
            (1) the criteria used to evaluate new and existing 
        vaccines;
            (2) the Grading of Recommendations, Assessment, 
        Development, and Evaluation (GRADE) approach to the review and 
        analysis of scientific and economic data, including the 
        scientific basis for such approach; and
            (3) the extent to which the processes used by the working 
        groups of the Advisory Committee on Immunization Practices are 
        transparent and consistent.
    (c) Stakeholders.--In carrying out the review under subsection (a), 
the Director of the Centers for Disease Control and Prevention shall 
solicit input from vaccine stakeholders.
    (d) Report.--Not later than 1 year after the date of enactment of 
this Act, the Director of the Centers for Disease Control and 
Prevention shall submit to the appropriate committees of the Congress 
and make publicly available a report on the results of the review under 
subsection (a), including recommendations on improving the transparency 
and consistency of the process described in such subsection.
    (e) Definition.--In this section, the term ``Advisory Committee on 
Immunization Practices'' means the advisory committee on immunization 
practices established by the Secretary of Health and Human Services 
pursuant to section 222 of the Public Health Service Act (42 U.S.C. 
217a), acting through the Director of the Centers for Disease Control 
and Prevention.

SEC. 102. GUIDANCE ON VACCINE DEVELOPMENT.

    (a) Issuance.--Not later than 2 years after the date of enactment 
of this Act, the Secretary of Health and Human Services shall issue 
final guidance to facilitate the use of accelerated and expedited 
pathways for the development and licensure of vaccines to prevent--
            (1) emerging, re-emerging, or rare infectious diseases with 
        respect to which the low prevalence or nature of the disease 
        may render the existence or collection of clinical outcome data 
        unlikely or impractical; and
            (2) infectious diseases with respect to which currently 
        available vaccines are not addressing the full scope of public 
        health needs.
    (b) Considerations.--In developing the guidance required by this 
section, the Secretary of Health and Human Services shall consider 
issues relating to clinical development strategies for diseases 
described in subsection (a), including the development and 
acceptability of novel clinical and surrogate endpoints, the use of 
novel or accelerated study designs, the use of observational real-world 
data, the use of novel adjuvants, the use of new technologies or 
approaches to collecting and monitoring patient-level data, and the 
demonstration of efficacy through studies in healthy volunteers for the 
purpose of licensure.

SEC. 103. MEETINGS BETWEEN CDC AND VACCINE DEVELOPERS.

    Section 310 of the Public Health Service Act (42 U.S.C. 242o) is 
amended by adding at the end the following:
    ``(c)(1) In this subsection, the term `vaccine developer' means a 
nongovernmental entity engaged in--
            ``(A) the development or production of a vaccine; and
            ``(B) vaccine research.
    ``(2)(A) Upon the submission of a written request by a vaccine 
developer, the Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall convene a meeting of 
representatives of the vaccine developer and experts in immunization 
programs, epidemiology, and other relevant areas, including such 
experts from the Food and Drug Administration and the National Vaccine 
Program, at which the Director (or the Director's designee), for the 
purpose of informing the vaccine developer's understanding of public 
health needs and priorities, shall provide the perspectives of the 
Centers for Disease Control and Prevention and other relevant Federal 
agencies regarding--
            ``(i) public health needs, epidemiology, and implementation 
        considerations with regard to a vaccine developer's potential 
        vaccine profile; and
            ``(ii) potential implications of such perspectives for the 
        vaccine developer's vaccine research and development planning.
    ``(B) The Director of the Centers for Disease Control and 
Prevention (or the Director's designee) shall convene a meeting 
requested under subparagraph (A) not later than 90 business days after 
receipt of the request for the meeting.
    ``(3)(A) Upon the submission of a written request by a vaccine 
developer, the Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall provide to the vaccine 
developer any age-based disease epidemiological analyses or data that--
            ``(i) are specified in the request;
            ``(ii) have been published;
            ``(iii) have been performed by or are in the possession of 
        the Centers; and
            ``(iv) are not a trade secret or otherwise confidential 
        information subject to section 552(b)(4) of title 5, United 
        States Code, or section 1905 of title 18, United States Code.
    ``(B) The Secretary shall provide analyses requested by a vaccine 
manufacturer under subparagraph (A) not later than 90 business days 
after receipt of the request for the analyses.
    ``(4) The Secretary shall promptly notify a vaccine developer if--
            ``(A) the Secretary becomes aware of any change to 
        information that was--
                    ``(i) shared by the Secretary with the vaccine 
                developer during a meeting under paragraph (2); or
                    ``(ii) provided by the Secretary to the vaccine 
                developer in one or more analyses under paragraph (3); 
                and
            ``(B) the change may have implications for the vaccine 
        developer's vaccine research and development.''.

SEC. 104. MODIFICATIONS TO PRIORITY REVIEW VOUCHER PROGRAM FOR TROPICAL 
              DISEASES.

    Section 524 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360n) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (3)--
                            (i) in the matter before subparagraph (A), 
                        by striking ``This term'' and inserting ``In 
                        this section, this term''; and
                            (ii) in subparagraph (R), by striking 
                        ``designated by order of the Secretary'' and 
                        inserting ``designated by the Secretary 
                        pursuant to paragraph (4)'';
                    (B) by redesignating paragraph (4) as paragraph 
                (5); and
                    (C) by inserting after paragraph (3) the following:
            ``(4) Designation of other infectious diseases as tropical 
        diseases.--
                    ``(A) In general.--The Secretary shall establish a 
                process under which the Secretary--
                            ``(i) using a methodology that is made 
                        available to the public on the Internet site of 
                        the Food and Drug Administration, designates 
                        infectious diseases other than the diseases 
                        specified in subparagraphs (A) through (Q) of 
                        paragraph (3) to be tropical diseases for 
                        purposes of this section; and
                            ``(ii) publishes on such Internet site a 
                        complete, updated list of the diseases that are 
                        tropical diseases for purposes of this section.
                    ``(B) Considerations.--In designating an infectious 
                disease as a tropical disease under subparagraph (A), 
                the Secretary shall--
                            ``(i) consider the potential impact of the 
                        disease on the public health due to--
                                    ``(I) the potential rate of spread 
                                of the disease; and
                                    ``(II) the potential severity of 
                                the disease in terms of human morbidity 
                                and mortality; and
                            ``(ii) consult with experts in tropical 
                        infectious diseases, including the Centers for 
                        Disease Control and Prevention, the Food and 
                        Drug Administration, medical professionals, the 
                        clinical research community, and the World 
                        Health Organization.
                    ``(C) Review.--Every 5 years, or more frequently as 
                determined necessary by the Secretary, the Secretary 
                shall review, provide modifications to, and re-publish 
                the list published under subparagraph (A) and any 
                revisions made to the methodology for designation of 
                diseases under such subparagraph.'';
            (2) in subsection (b)--
                    (A) in paragraph (2), by striking ``The sponsor of 
                a tropical disease'' and inserting:
                    ``(A) In general.--The sponsor of a tropical 
                disease'';
                    (B) by inserting after such paragraph (2)(A) the 
                following:
                    ``(B) Notification of transfer.--Each person to 
                whom a priority review voucher is transferred shall 
                notify the Secretary of such change in ownership of the 
                voucher not later than 30 business days after such 
                transfer.'';
                    (C) in paragraph (4), by striking ``The sponsor of 
                a human drug application'' and inserting:
                    ``(A) In general.--The sponsor of a human drug 
                application''; and
                    (D) by inserting after paragraph (4)(A), as 
                designated by subparagraph (D), the following:
                    ``(B) Transfer after notice.--The sponsor of a 
                human drug application that provides notification of 
                intent under subparagraph (A) may transfer the voucher 
                after such notification is provided, if such sponsor 
                has not yet submitted the human drug application 
                described in the notification. Upon such a transfer, 
                notwithstanding subparagraph (A), such sponsor shall 
                not remain legally committed to pay a user fee because 
                of the sponsor's notification of intent under such 
                subparagraph.''; and
            (3) in subsection (c), by amending paragraph (2) to read as 
        follows:
            ``(2) Fee amount.--The amount of the priority review user 
        fee shall be determined each fiscal year by the Secretary based 
        on the difference between--
                    ``(A) the average cost incurred by the agency in 
                the review of a human drug application subject to 
                priority review in the previous fiscal year; and
                    ``(B) the average cost incurred by the Food and 
                Drug Administration in the review of a human drug 
                application that is not subject to priority review in 
                the previous fiscal year.''.

SEC. 105. GUIDANCE ON CHANGES TO AN APPROVED APPLICATION FOR BIOLOGICAL 
              PRODUCTS.

    Not later than 2 years after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue final guidance 
that--
            (1) addresses changes in a licensed biological product or 
        the labeling, production process, quality controls, equipment, 
        facilities, or responsible personnel for such a product 
        established in the application for the product that was 
        approved under section 351 of the Public Health Service Act (42 
        U.S.C. 262);
            (2) does not address such changes for specified 
        biotechnology or specified synthetic biological products listed 
        in section 601.2(c) of title 21 of the Code of Federal 
        Regulation; and
            (3) updates and supersedes the guidance entitled ``Changes 
        to an Approved Application: Biological Products,'' that was 
        issued by the Food and Drug Administration in July, 1997.

SEC. 106. EXPEDITING THE PROCESS FOR EXPORT CERTIFICATIONS FOR 
              VACCINES.

    Section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(e)(4)) is amended--
            (1) in the matter following clause (ii) in subparagraph 
        (A), by striking ``within 20 days of the receipt of a request 
        for such certification'' and inserting ``within 20 business 
        days of the receipt of a request for such certification, except 
        that in the case of a vaccine the Secretary shall issue such 
        certification within 10 business days of the receipt of a 
        request for such certification''; and
            (2) in subparagraph (B), by striking ``within the 20 days 
        prescribed by subparagraph (A)'' and inserting ``within the 
        period prescribed by subparagraph (A)''.

SEC. 107. NIH VACCINE RESEARCH.

    (a) In General.--Subpart 6 of part C of title IV of the Public 
Health Service Act (42 U.S.C. 285f et seq.) is amended by adding at the 
end the following:

``SEC. 447D. ADVANCEMENT OF VACCINE DEVELOPMENT.

    ``In carrying out the general purpose described in section 446, the 
Director of the Institute shall conduct or support translational 
science, research, and research training to advance the development of 
vaccines for the prevention of diseases, including the advancement of 
vaccine development programs into clinical trials.''.
    (b) Review of NIH Vaccine Research.--
            (1) In general.--Not later than one year after the date of 
        enactment of this Act, the Director of the National Institutes 
        of Health shall--
                    (A) conduct a review on vaccine research being 
                conducted or supported by the Institutes; and
                    (B) publish a report on the results of such review.
            (2) Contents.--At a minimum, the report under paragraph 
        (1)(B) shall--
                    (A) describe intramural and extramural vaccine 
                research and development programs that are being 
                conducted or supported by the National Institutes of 
                Health, including those that are translational or 
                clinical phase studies;
                    (B) provide a summary of funding allocations made 
                to conduct or support the matters described in section 
                447D of the Public Health Service Act, as added by 
                subsection (a), and identify projected funding needs 
                with regard to future research or support with regard 
                to these matters; and
                    (C) identify funding and collaborations with the 
                private sector through--
                            (i) the Small Business Innovation Research 
                        and Small Business Technology Transfer 
                        programs; and
                            (ii) cooperative research and development 
                        agreements.

           TITLE II--MEDICARE, MEDICAID, AND OTHER PROVISIONS

SEC. 201. REQUIRING PROMPT UPDATES TO MEDICARE PROGRAM UPON ISSUANCE OF 
              ACIP RECOMMENDATIONS.

    In the case that the advisory committee on immunization practices 
established by the Secretary of Health and Human Services pursuant to 
section 222 of the Public Health Service Act (42 U.S.C. 217a) issues a 
recommendation for a vaccine or an update to a recommendation for a 
vaccine that the Secretary is using under title XVIII of the Social 
Security Act (42 U.S.C. 1395 et seq.) with respect to coverage of 
vaccines or immunizations under such title, the Secretary shall 
determine whether or not to update policies under such title with 
respect to such coverage on a date that is not later than 60 business 
days after the date on which such advisory committee issues such 
recommendation or update.

SEC. 202. GAO STUDY AND REPORT ON MEDICARE AND MEDICAID BENEFICIARY 
              ACCESS FOR VACCINES.

    (a) Study.--The Comptroller General of the United States (in this 
section referred to as the ``Comptroller General'') shall conduct a 
study on the impact of reimbursement rates under the Medicare program 
under parts B, C, and D of title XVIII of the Social Security Act and 
under the Medicaid program under title XIX of such Act on access by 
targeted individuals to vaccines recommended by the Advisory Committee 
on Immunization Practices of the Centers for Disease Control and 
Prevention. Such study shall include an analysis and determination of--
            (1) the reimbursement rates for vaccines under such parts 
        of the Medicare program and under the Medicaid program, 
        including those rates paid by a PDP sponsor under part D of 
        title XVIII of such Act, Medicare Advantage organizations under 
        part C of such title, and Medicaid managed care organizations 
        (as defined in section 1903(m)(1)(A) of the Social Security Act 
        (42 U.S.C. 1396b(m)(1)(A));
            (2) the number of targeted individuals during the 3-year 
        period prior to the study who were eligible for a vaccination 
        recommended by the Advisory Committee on Immunization Practices 
        of the Centers for Disease Control and Prevention;
            (3) the number of such targeted individuals who actually 
        received a vaccination described in paragraph (2), with a 
        particular breakdown of adults, the elderly, and populations 
        located in rural or underserved communities; and
            (4) the extent to which the reimbursement rates under such 
        parts of the Medicare program and under the Medicaid program 
        for vaccinations described in paragraph (2) affect their use by 
        physicians or access for such targeted individuals.
    (b) Targeted Individuals.--For purposes of subsection (a), the term 
``targeted individual'' means and individual who is--
            (1)(A) entitled to benefits under part A of title XVIII of 
        the Social Security Act or enrolled in part B of such Act; or
            (B) eligible for medical assistance under title XIX of such 
        Act; and
            (2) within a vulnerable population.
    (c) Report.--Not later than 2 years after the date of enactment of 
this Act, the Comptroller General shall submit to the appropriate 
committees of the Congress a report containing the results of the study 
conducted under subsection (a), including--
            (1) a summary of the findings of the study; and
            (2) recommendations based on the results of the study, 
        including recommendations for such legislative and 
        administrative action as the Comptroller General determines 
        appropriate.

SEC. 203. ENCOURAGING HEALTH PLANS TO ESTABLISH PROGRAMS TO INCREASE 
              ADULT IMMUNIZATION.

    (a) Private Health Plans.--Section 2718 of the Public Health 
Service Act (42 U.S.C. 300gg-18) is amended by adding at the end the 
following new subsection:
    ``(f) Programs to Increase Adult Immunization.--
            ``(1) In general.--For purposes of this section, for plan 
        years beginning on or after the date of enactment of the 
        Vaccine Access, Certainty, and Innovation Act of 2015, 
        activities that improve health care quality described in 
        subsection (a)(2) shall include programs to increase adult 
        immunization.
            ``(2) Administration.--Not later than December 31, 2016, 
        the Secretary shall establish standardized methodologies, 
        including definitions, for which activities, and in what regard 
        such activities, constitute programs to increase adult 
        immunization in accordance with this subsection. The Secretary 
        shall consult with relevant stakeholders in establishing such 
        methodologies.''.
    (b) Medicare Advantage and Part D Plans.--Section 1857(e) of the 
Social Security Act (42 U.S.C. 1395w-27(e)) is amended by adding at the 
end the following new paragraph:
            ``(5) Inclusion of expenditures on programs to increase 
        adult immunization in minimum medical loss ratio calculation.--
        For purposes of calculating the minimum medical loss ratio 
        under paragraph (4), for plan years beginning at least 12 
        months after the date of enactment of this Act, the numerator 
        shall include any expenditures on programs to increase adult 
        immunization.''.
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