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114th Congress  }                                        {      Report
                        HOUSE OF REPRESENTATIVES
 2d Session     }                                        {     114-801

======================================================================



 
                 NATIONAL CLINICAL CARE COMMISSION ACT

                                _______
                                

 November 14, 2016.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 1192]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1192) to amend the Public Health Service Act to 
foster more effective implementation and coordination of 
clinical care for people with pre-diabetes, diabetes, and the 
chronic diseases and conditions that result from diabetes, 
having considered the same, report favorably thereon with 
amendments and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     4
Background and Need for Legislation..............................     4
Hearings.........................................................     4
Committee Consideration..........................................     4
Committee Votes..................................................     5
Committee Oversight Findings.....................................     5
Statement of General Performance Goals and Objectives............     5
New Budget Authority, Entitlement Authority, and Tax Expenditures     5
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     5
Committee Cost Estimate..........................................     5
Congressional Budget Office Estimate.............................     5
Federal Mandates Statement.......................................     5
Duplication of Federal Programs..................................     5
Disclosure of Directed Rule Makings..............................     6
Advisory Committee Statement.....................................     6
Applicability to Legislative Branch..............................     6
Section-by-Section Analysis of the Legislation...................     6
Changes in Existing Law Made by the Bill, as Reported............     6

    The amendments are as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``National Clinical Care Commission 
Act''.

SEC. 2. ESTABLISHMENT OF THE NATIONAL CLINICAL CARE COMMISSION.

  Part P of title III of the Public Health Service Act (42 U.S.C. 280g 
et seq.) is amended by adding at the end the following new section:

``SEC. 399V-7. NATIONAL CLINICAL CARE COMMISSION.

  ``(a) Establishment.--There is hereby established, within the 
Department of Health and Human Services, a National Clinical Care 
Commission (in this section referred to as the `Commission') to 
evaluate, and recommend solutions regarding better coordination and 
leveraging of, programs within the Department and other Federal 
agencies that relate in any way to supporting appropriate clinical care 
(such as any interactions between physicians and other health care 
providers and their patients related to treatment and care management) 
for individuals with--
          ``(1) a complex metabolic or autoimmune disease;
          ``(2) a disease resulting from insulin deficiency or insulin 
        resistance; or
          ``(3) complications caused by any such disease.
  ``(b) Membership.--
          ``(1) In general.--The Commission shall be composed of the 
        following voting members:
                  ``(A) The heads (or their designees) of the following 
                Federal agencies and departments:
                          ``(i) The Centers for Medicare & Medicaid 
                        Services.
                          ``(ii) The Agency for Healthcare Research and 
                        Quality.
                          ``(iii) The Centers for Disease Control and 
                        Prevention.
                          ``(iv) The Indian Health Service.
                          ``(v) The Department of Veterans Affairs.
                          ``(vi) The National Institutes of Health.
                          ``(vii) The Food and Drug Administration.
                          ``(viii) The Health Resources and Services 
                        Administration.
                          ``(ix) The Department of Defense.
                  ``(B) Twelve additional voting members appointed 
                under paragraph (2).
                  ``(C) Such additional voting members as may be 
                appointed by the Secretary, at the Secretary's 
                discretion, from among the heads (or their designees) 
                of governmental or nongovernmental entities that impact 
                clinical care of individuals with any of the diseases 
                and complications described in subsection (a).
          ``(2) Additional members.--The Commission shall include 
        additional voting members appointed by the Secretary, in 
        consultation with national medical societies and patient 
        advocacy organizations with expertise in the care and 
        epidemiology of any of the diseases and complications described 
        in subsection (a), including one or more such members from each 
        of the following categories:
                  ``(A) Clinical endocrinologists.
                  ``(B) Physician specialties (other than as described 
                in subparagraph (A)) that play a role in diseases and 
                complications described in subsection (a), such as 
                cardiologists, nephrologists, and eye care 
                professionals.
                  ``(C) Primary care physicians.
                  ``(D) Non-physician health care professionals, such 
                as certified diabetes educators, registered dieticians 
                and nutrition professionals, nurses, nurse 
                practitioners, and physician assistants.
                  ``(E) Patient advocates.
                  ``(F) National experts in the duties listed under 
                subsection (c).
                  ``(G) Health care providers furnishing services to a 
                patient population that consists of a high percentage 
                (as specified by the Secretary) of individuals who are 
                enrolled in a State plan under title XIX of the Social 
                Security Act or who are not covered under a health plan 
                or health insurance coverage.
          ``(3) Chairperson.--The voting members of the Commission 
        shall select a chairperson from the members appointed under 
        paragraph (2) from the category under paragraph (2)(A).
          ``(4) Meetings.--The Commission shall meet at least twice, 
        and not more than 4 times, a year.
          ``(5) Board terms.--Members of the Commission appointed 
        pursuant to subparagraph (B) or (C) of paragraph (1), including 
        the chairperson, shall serve for a 3-year term. A vacancy on 
        the Commission shall be filled in the same manner as the 
        original appointments.
  ``(c) Duties.--The Commission shall--
          ``(1) evaluate programs of the Department of Health and Human 
        Services regarding the utilization of diabetes screening 
        benefits, annual wellness visits, and other preventive health 
        benefits that may reduce the incidence of the diseases and 
        complications described in subsection (a), including explaining 
        problems regarding such utilization and related data collection 
        mechanisms;
          ``(2) identify current activities and critical gaps in 
        Federal efforts to support clinicians in providing integrated, 
        high-quality care to individuals with any of the diseases and 
        complications described in subsection (a);
          ``(3) make recommendations regarding the coordination of 
        clinically-based activities that are being supported by the 
        Federal Government with respect to the diseases and 
        complications described in subsection (a);
          ``(4) make recommendations regarding the development and 
        coordination of federally funded clinical practice support 
        tools for physicians and other health care professionals in 
        caring for and managing the care of individuals with any of the 
        diseases and complications described in subsection (a), 
        specifically with regard to implementation of new treatments 
        and technologies;
          ``(5) evaluate programs described in subsection (a) that are 
        in existence as of the date of the enactment of this section 
        and determine if such programs are meeting the needs identified 
        in paragraph (2) and, if such programs are determined as not 
        meeting such needs, recommend programs that would be more 
        appropriate;
          ``(6) recommend, with respect to the diseases and 
        complications described in subsection (a), clinical pathways 
        for new technologies and treatments, including future data 
        collection activities, that may be developed and then used to 
        evaluate--
                  ``(A) various care models and methods; and
                  ``(B) the impact of such models and methods on 
                quality of care as measured by appropriate care 
                parameters (such as A1C, blood pressure, and 
                cholesterol levels);
          ``(7) evaluate and expand education and awareness activities 
        provided to physicians and other health care professionals 
        regarding clinical practices for the prevention of the diseases 
        and complications described in subsection (a);
          ``(8) review and recommend appropriate methods for outreach 
        and dissemination of educational resources that--
                  ``(A) regard the diseases and complications described 
                in subsection (a);
                  ``(B) are funded by the Federal Government; and
                  ``(C) are intended for health care professionals and 
                the public; and
          ``(9) carry out other activities, such as activities relating 
        to the areas of public health and nutrition, that the 
        Commission deems appropriate with respect to the diseases and 
        complications described in subsection (a).
  ``(d) Operating Plan.--
          ``(1) Initial plan.--Not later than 90 days after its first 
        meeting, the Commission shall submit to the Secretary and the 
        Congress an operating plan for carrying out the activities of 
        the Commission as described in subsection (c). Such operating 
        plan may include--
                  ``(A) a list of specific activities that the 
                Commission plans to conduct for purposes of carrying 
                out the duties described in each of the paragraphs in 
                subsection (c);
                  ``(B) a plan for completing the activities;
                  ``(C) a list of members of the Commission and other 
                individuals who are not members of the Commission who 
                will need to be involved to conduct such activities;
                  ``(D) an explanation of Federal agency involvement 
                and coordination needed to conduct such activities;
                  ``(E) a budget for conducting such activities;
                  ``(F) a plan for evaluating the value and potential 
                impact of the Commission's work and recommendations, 
                including the possible continuation of the Commission 
                for the purposes of overseeing their implementation; 
                and
                  ``(G) other information that the Commission deems 
                appropriate.
          ``(2) Updates.--The Commission shall periodically update the 
        operating plan under paragraph (1) and submit such updates to 
        the Secretary and the Congress.
  ``(e) Final Report.--By not later than 3 years after the date of the 
Commission's first meeting, the Commission shall submit to the 
Secretary and the Congress a final report containing all of the 
findings and recommendations required by this section. Not later than 
120 days after the submission of the final report, the Secretary shall 
review the plan required by subsection (d)(1)(F) and submit to the 
Congress a recommendation on whether the Commission should be 
reauthorized to operate after fiscal year 2019.
  ``(f) Sunset.--The Commission shall terminate at the end of fiscal 
year 2019.''.

    Amend the title so as to read:
    A bill to amend the Public Health Service Act to foster 
more effective implementation and coordination of clinical care 
for people with a complex metabolic or autoimmune disease, a 
disease resulting from insulin deficiency or insulin 
resistance, or complications caused by such a disease, and for 
other purposes.

                          Purpose and Summary

    H.R. 1192 was introduced on March 2, 2015, by Rep. Pete 
Olson (R-TX). H.R. 1192 establishes a clinical care commission 
to evaluate and recommend solutions regarding better 
coordinating and leveraging of Federal programs related to 
complex metabolic or autoimmune disorders, a disease resulting 
from insulin deficiency or resistance, or complications caused 
by any such disease.

                  Background and Need for Legislation

    Metabolic disorders take a large toll on human health each 
year. Complications from these disorders can lead to 
catastrophic health outcomes, such as limb amputation and 
kidney failure, and the treatment of metabolic disorders and 
their complications costs billions of dollars each year.
    There are numerous programs across the Federal government 
related to metabolic disorders. Some focus on prevention, while 
others focus on the treatment of such conditions. Improving 
such efforts, including the coordination among Federal 
activities related to metabolic disorders, provides an 
opportunity to reduce costs while enhancing health outcomes.

                                Hearings

    The Subcommittee on Health held a hearing on H.R. 1192 on 
September 8, 2016. The hearing was entitled ``Examining 
Legislation to Improve Public Health'' and witnesses included 
the following:
           Sonja L. Banks, President and COO, Sickle 
        Cell Disease Association of America, Inc.;
           General Arthur Dean, Chairman and CEO, 
        Community Anti-Drug Coalitions of America;
           Jonathan Leffert, President-Elect, American 
        Association of Clinical Endocrinologists;
           Brad Marino, Chair, Pediatric Congenital 
        Heart Association; and
           R. Sean Morrison, Director, National 
        Palliative Care Research Center.

                        Committee Consideration

    On September 12 and 13, 2016, the Subcommittee on Health 
met in open markup session and forwarded H.R. 1192 to the full 
Committee, as amended, by a voice vote.
    On September 20 and 21, 2016, the full Committee on Energy 
and Commerce met in open markup session and ordered H.R. 1192 
reported to the House, without amendment, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 1192 reported

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held a hearing and made 
findings that are reflected in this report.

         Statement of General Performance Goals and Objectives

    This legislation establishes a clinical care commission to 
evaluate and recommend solutions regarding better coordinating 
and leveraging of Federal programs that relate to complex 
metabolic or autoimmune disorders, a disease resulting from 
insulin deficiency or resistance, or complications caused by 
any such disease.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
1192 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 1192 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974. At the 
time this report was filed, the estimate was not available.

                  Congressional Budget Office Estimate

    At the time this report was filed, the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 1974 
was not available.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 1192 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 1192 
specifically directs to be completed no rule making within the 
meaning of 5 U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 provides that the Act may be cited as the 
``National Clinical Care Commission Act''.

Section 2. Establishment of the National Clinical Care Commission

    Section 2 establishes a National Clinical Care Commission 
within the Department of Health and Human Services. The 
Commission will evaluate and recommend solutions regarding 
better coordination and leveraging of programs within the 
Department of Health and Human Services and other Federal 
agencies that relate to supporting appropriate clinical care 
for individuals with a complex metabolic or autoimmune disease, 
a disease resulting from insulin deficiency or resistance, or 
complications by any such disease.
    The Commission will sunset at the end of fiscal year 2019.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT




           *       *       *       *       *       *       *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *



PART P--ADDITIONAL PROGRAMS

           *       *       *       *       *       *       *


SEC. 399V-7. NATIONAL CLINICAL CARE COMMISSION.

  (a) Establishment.--There is hereby established, within the 
Department of Health and Human Services, a National Clinical 
Care Commission (in this section referred to as the 
``Commission'') to evaluate, and recommend solutions regarding 
better coordination and leveraging of, programs within the 
Department and other Federal agencies that relate in any way to 
supporting appropriate clinical care (such as any interactions 
between physicians and other health care providers and their 
patients related to treatment and care management) for 
individuals with--
          (1) a complex metabolic or autoimmune disease;
          (2) a disease resulting from insulin deficiency or 
        insulin resistance; or
          (3) complications caused by any such disease.
  (b) Membership.--
          (1) In general.--The Commission shall be composed of 
        the following voting members:
                  (A) The heads (or their designees) of the 
                following Federal agencies and departments:
                          (i) The Centers for Medicare & 
                        Medicaid Services.
                          (ii) The Agency for Healthcare 
                        Research and Quality.
                          (iii) The Centers for Disease Control 
                        and Prevention.
                          (iv) The Indian Health Service.
                          (v) The Department of Veterans 
                        Affairs.
                          (vi) The National Institutes of 
                        Health.
                          (vii) The Food and Drug 
                        Administration.
                          (viii) The Health Resources and 
                        Services Administration.
                          (ix) The Department of Defense.
                  (B) Twelve additional voting members 
                appointed under paragraph (2).
                  (C) Such additional voting members as may be 
                appointed by the Secretary, at the Secretary's 
                discretion, from among the heads (or their 
                designees) of governmental or nongovernmental 
                entities that impact clinical care of 
                individuals with any of the diseases and 
                complications described in subsection (a).
          (2) Additional members.--The Commission shall include 
        additional voting members appointed by the Secretary, 
        in consultation with national medical societies and 
        patient advocacy organizations with expertise in the 
        care and epidemiology of any of the diseases and 
        complications described in subsection (a), including 
        one or more such members from each of the following 
        categories:
                  (A) Clinical endocrinologists.
                  (B) Physician specialties (other than as 
                described in subparagraph (A)) that play a role 
                in diseases and complications described in 
                subsection (a), such as cardiologists, 
                nephrologists, and eye care professionals.
                  (C) Primary care physicians.
                  (D) Non-physician health care professionals, 
                such as certified diabetes educators, 
                registered dieticians and nutrition 
                professionals, nurses, nurse practitioners, and 
                physician assistants.
                  (E) Patient advocates.
                  (F) National experts in the duties listed 
                under subsection (c).
                  (G) Health care providers furnishing services 
                to a patient population that consists of a high 
                percentage (as specified by the Secretary) of 
                individuals who are enrolled in a State plan 
                under title XIX of the Social Security Act or 
                who are not covered under a health plan or 
                health insurance coverage.
          (3) Chairperson.--The voting members of the 
        Commission shall select a chairperson from the members 
        appointed under paragraph (2) from the category under 
        paragraph (2)(A).
          (4) Meetings.--The Commission shall meet at least 
        twice, and not more than 4 times, a year.
          (5) Board terms.--Members of the Commission appointed 
        pursuant to subparagraph (B) or (C) of paragraph (1), 
        including the chairperson, shall serve for a 3-year 
        term. A vacancy on the Commission shall be filled in 
        the same manner as the original appointments.
  (c) Duties.--The Commission shall--
          (1) evaluate programs of the Department of Health and 
        Human Services regarding the utilization of diabetes 
        screening benefits, annual wellness visits, and other 
        preventive health benefits that may reduce the 
        incidence of the diseases and complications described 
        in subsection (a), including explaining problems 
        regarding such utilization and related data collection 
        mechanisms;
          (2) identify current activities and critical gaps in 
        Federal efforts to support clinicians in providing 
        integrated, high-quality care to individuals with any 
        of the diseases and complications described in 
        subsection (a);
          (3) make recommendations regarding the coordination 
        of clinically-based activities that are being supported 
        by the Federal Government with respect to the diseases 
        and complications described in subsection (a);
          (4) make recommendations regarding the development 
        and coordination of federally funded clinical practice 
        support tools for physicians and other health care 
        professionals in caring for and managing the care of 
        individuals with any of the diseases and complications 
        described in subsection (a), specifically with regard 
        to implementation of new treatments and technologies;
          (5) evaluate programs described in subsection (a) 
        that are in existence as of the date of the enactment 
        of this section and determine if such programs are 
        meeting the needs identified in paragraph (2) and, if 
        such programs are determined as not meeting such needs, 
        recommend programs that would be more appropriate;
          (6) recommend, with respect to the diseases and 
        complications described in subsection (a), clinical 
        pathways for new technologies and treatments, including 
        future data collection activities, that may be 
        developed and then used to evaluate--
                  (A) various care models and methods; and
                  (B) the impact of such models and methods on 
                quality of care as measured by appropriate care 
                parameters (such as A1C, blood pressure, and 
                cholesterol levels);
          (7) evaluate and expand education and awareness 
        activities provided to physicians and other health care 
        professionals regarding clinical practices for the 
        prevention of the diseases and complications described 
        in subsection (a);
          (8) review and recommend appropriate methods for 
        outreach and dissemination of educational resources 
        that--
                  (A) regard the diseases and complications 
                described in subsection (a);
                  (B) are funded by the Federal Government; and
                  (C) are intended for health care 
                professionals and the public; and
          (9) carry out other activities, such as activities 
        relating to the areas of public health and nutrition, 
        that the Commission deems appropriate with respect to 
        the diseases and complications described in subsection 
        (a).
  (d) Operating Plan.--
          (1) Initial plan.--Not later than 90 days after its 
        first meeting, the Commission shall submit to the 
        Secretary and the Congress an operating plan for 
        carrying out the activities of the Commission as 
        described in subsection (c). Such operating plan may 
        include--
                  (A) a list of specific activities that the 
                Commission plans to conduct for purposes of 
                carrying out the duties described in each of 
                the paragraphs in subsection (c);
                  (B) a plan for completing the activities;
                  (C) a list of members of the Commission and 
                other individuals who are not members of the 
                Commission who will need to be involved to 
                conduct such activities;
                  (D) an explanation of Federal agency 
                involvement and coordination needed to conduct 
                such activities;
                  (E) a budget for conducting such activities;
                  (F) a plan for evaluating the value and 
                potential impact of the Commission's work and 
                recommendations, including the possible 
                continuation of the Commission for the purposes 
                of overseeing their implementation; and
                  (G) other information that the Commission 
                deems appropriate.
          (2) Updates.--The Commission shall periodically 
        update the operating plan under paragraph (1) and 
        submit such updates to the Secretary and the Congress.
  (e) Final Report.--By not later than 3 years after the date 
of the Commission's first meeting, the Commission shall submit 
to the Secretary and the Congress a final report containing all 
of the findings and recommendations required by this section. 
Not later than 120 days after the submission of the final 
report, the Secretary shall review the plan required by 
subsection (d)(1)(F) and submit to the Congress a 
recommendation on whether the Commission should be reauthorized 
to operate after fiscal year 2019.
  (f) Sunset.--The Commission shall terminate at the end of 
fiscal year 2019.

           *       *       *       *       *       *       *


                                  [all]