```

[House Report 114-553]
[From the U.S. Government Publishing Office]

114th Congress    }                                     {       Report
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                     {      114-553

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

 
             CO-PRESCRIBING TO REDUCE OVERDOSES ACT OF 2016

                                _______
                                

  May 10, 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. 3680]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 3680) to provide for the Secretary of Health and 
Human Services to carry out a grant program for co-prescribing 
opioid overdose reversal drugs, having considered the same, 
report favorably thereon with an amendment and recommend that 
the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     3
Background and Need for Legislation..............................     3
Hearings.........................................................     4
Committee Consideration..........................................     4
Committee Votes..................................................     4
Committee Oversight Findings.....................................     4
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.......................................     7
Duplication of Federal Programs..................................     7
Disclosure of Directed Rule Makings..............................     7
Advisory Committee Statement.....................................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............     8

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Co-Prescribing to Reduce Overdoses Act 
of 2016''.

SEC. 2. OPIOID OVERDOSE REVERSAL DRUGS PRESCRIBING GRANT PROGRAM.

  (a) Establishment.--
          (1) In general.--Not later than six months after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services may establish, in accordance with this section, a 
        five-year opioid overdose reversal drugs prescribing grant 
        program (in this Act referred to as the ``grant program'').
          (2) Maximum grant amount.--A grant made under this section 
        may not be for more than $200,000 per grant year.
          (3) Eligible entity.--For purposes of this section, the term 
        ``eligible entity'' means a federally qualified health center 
        (as defined in section 1861(aa) of the Social Security Act (42 
        U.S.C. 1395x(aa)), an opioid treatment program under part 8 of 
        title 42, Code of Federal Regulations, any practitioner 
        dispensing narcotic drugs pursuant to section 303(g) of the 
        Controlled Substances Act (21 U.S.C. 823(g)), or any other 
        entity that the Secretary deems appropriate.
          (4) Prescribing.--For purposes of this section and section 3, 
        the term ``prescribing'' means, with respect to an opioid 
        overdose reversal drug, such as naloxone, the practice of 
        prescribing such drug--
                  (A) in conjunction with an opioid prescription for 
                patients at an elevated risk of overdose;
                  (B) in conjunction with an opioid agonist approved 
                under section 505 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355) for the treatment of 
                opioid abuse disorder;
                  (C) to the caregiver or a close relative of patients 
                at an elevated risk of overdose from opioids; or
                  (D) in other circumstances, as identified by the 
                Secretary, in which a provider identifies a patient is 
                at an elevated risk for an intentional or unintentional 
                drug overdose from heroin or prescription opioid 
                therapies.
  (b) Application.--To be eligible to receive a grant under this 
section, an eligible entity shall submit to the Secretary of Health and 
Human Services, in such form and manner as specified by the Secretary, 
an application that describes--
          (1) the extent to which the area to which the entity will 
        furnish services through use of the grant is experiencing 
        significant morbidity and mortality caused by opioid abuse;
          (2) the criteria that will be used to identify eligible 
        patients to participate in such program; and
          (3) how such program will work to try to identify State, 
        local, or private funding to continue the program after 
        expiration of the grant.
  (c) Use of Funds.--An eligible entity receiving a grant under this 
section may use the grant for any of the following activities, but may 
use not more than 20 percent of the grant funds for activities 
described in paragraphs (4) and (5):
          (1) To establish a program for prescribing opioid overdose 
        reversal drugs, such as naloxone.
          (2) To train and provide resources for health care providers 
        and pharmacists on the prescribing of opioid overdose reversal 
        drugs, such as naloxone.
          (3) To establish mechanisms and processes for tracking 
        patients participating in the program described in paragraph 
        (1) and the health outcomes of such patients.
          (4) To purchase opioid overdose reversal drugs, such as 
        naloxone, for distribution under the program described in 
        paragraph (1).
          (5) To offset the co-pays and other cost sharing associated 
        with opioid overdose reversal drugs, such as naloxone, to 
        ensure that cost is not a limiting factor for eligible 
        patients.
          (6) To conduct community outreach, in conjunction with 
        community-based organizations, designed to raise awareness of 
        prescribing practices, and the availability of opioid overdose 
        reversal drugs, such as naloxone.
          (7) To establish protocols to connect patients who have 
        experienced a drug overdose with appropriate treatment, 
        including medication assisted treatment and appropriate 
        counseling and behavioral therapies.
  (d) Evaluations by Recipients.--As a condition of receipt of a grant 
under this section, an eligible entity shall, for each year for which 
the grant is received, submit to the Secretary of Health and Human 
Services information on appropriate outcome measures specified by the 
Secretary to assess the outcomes of the program funded by the grant, 
including--
          (1) the number of prescribers trained;
          (2) the number of prescribers who have co-prescribed an 
        opioid overdose reversal drug, such as naloxone, to at least 
        one patient;
          (3) the total number of prescriptions written for opioid 
        overdose reversal drugs, such as naloxone;
          (4) the percentage of patients at elevated risk who received 
        a prescription for an opioid overdose reversal drug, such as 
        naloxone;
          (5) the number of patients reporting use of an opioid 
        overdose reversal drug, such as naloxone; and
          (6) any other outcome measures that the Secretary deems 
        appropriate.
  (e) Reports by Secretary.--For each year of the grant program under 
this section, the Secretary of Health and Human Services shall submit 
to the appropriate committees of the House of Representatives and of 
the Senate a report aggregating the information received from the grant 
recipients for such year under subsection (d) and evaluating the 
outcomes achieved by the programs funded by grants made under this 
section.

SEC. 3. PROVIDING INFORMATION TO PRESCRIBERS IN CERTAIN FEDERAL HEALTH 
                    CARE AND MEDICAL FACILITIES ON BEST PRACTICES FOR 
                    PRESCRIBING OPIOID OVERDOSE REVERSAL DRUGS.

  (a) In General.--Not later than 180 days after the date of enactment 
of this Act, the Secretary of Health and Human Services (in this 
section referred to as the ``Secretary'') may, as appropriate, provide 
information to prescribers within Federally qualified health centers 
(as defined in paragraph (4) of section 1861(aa) of the Social Security 
Act (42 U.S.C. 1395x(aa))), and the health care facilities of the 
Indian Health Service, on best practices for prescribing opioid 
overdose reversal drugs, such as naloxone, for patients receiving 
chronic opioid therapy, patients being treated for opioid use 
disorders, and other patients that a provider identifies as having an 
elevated risk of overdose from heroin or prescription opioid therapies.
  (b) Not Establishing a Medical Standard of Care.--The information on 
best practices provided under this section shall not be construed as 
constituting or establishing a medical standard of care for prescribing 
opioid overdose reversal drugs, such as naloxone, for patients 
described in subsection (a).
  (c) No Authorization of Any Additional Appropriations.--The Secretary 
shall carry out this section through funds otherwise appropriated and 
nothing in this section shall be construed as authorizing the 
appropriations of additional funds to carry out this section.
  (d) Elevated Risk of Overdose Defined.--In this section, the term 
``elevated risk of overdose'' has the meaning given such term by the 
Secretary, which--
          (1) may be based on the criteria provided in the Opioid 
        Overdose Toolkit published by the Substance Abuse and Mental 
        Health Services Administration (SAMHSA); and
          (2) may include patients on a first course opioid treatment, 
        patients using extended-release and long-acting opioid 
        analgesics, and patients with a respiratory disease or other 
        co-morbidities.

SEC. 4. AUTHORIZATION OF APPROPRIATIONS.

  There is authorized to be appropriated to carry out this Act 
$5,000,000 for the period of fiscal years 2017 through 2021.

SEC. 5. CUT-GO COMPLIANCE.

  Subsection (f) of section 319D of the Public Health Service Act (42 
U.S.C. 247d-4) is amended by inserting before the period at the end the 
following: ``(except such dollar amount shall be reduced by $5,000,000 
for fiscal year 2018)''.

                          Purpose and Summary

    H.R. 3680, the ``Co-Prescribing to Reduce Overdoses Act of 
2016,'' was introduced by Rep. John Sarbanes (D-MD) on October 
1, 2015. This legislation directs the Secretary of Health and 
Human Services to carry out a grant program for co-prescribing 
opioid overdose reversal drugs.

                  Background and Need for Legislation

    In 1999, there were 6.1 overdose deaths per 100,000 
Americans involving opioid analgesics and heroin. By 2014, that 
number doubled to 14.7 overdose deaths. The rate of overdose 
for individuals aged 24 to 34 nearly tripled going from 8.1 
overdose deaths per 100,000 to 23.1 overdose deaths.\1\ 
Naloxone is an opioid antagonist that can prevent opioid 
overdose deaths by binding to the opioid receptors in the body 
and preventing the overdose. The World Health Organization 
estimated that if naloxone was more widely available in the 
United States, 20,000 overdose deaths could be prevented 
annually.\2\ This legislation is a first step in promoting 
wider access of naloxone or other opioid overdose reversal 
drugs that may come to market.
---------------------------------------------------------------------------
    \1\http://www.cdc.gov/nchs/data/hus/hus15.pdf.
    \2\http://www.reuters.com/article/us-health-who-naloxone-
idUSKBN0IO12420141104.
---------------------------------------------------------------------------

                                Hearings

    The Subcommittee on Health held a hearing on H.R. 3680 on 
October 8, 2015. The Subcommittee received testimony from:
           Mr. Michael Botticelli, Director, National 
        Drug Control Policy, Executive Office of the President;
           Dr. Richard Frank, Assistant Secretary for 
        Planning and Evaluation, Department of Health and Human 
        Services;
           Mr. Jack Riley, Deputy Administrator, Drug 
        Enforcement Administration;
           Dr. Allen Anderson, President, American 
        Orthopaedic Society for Sports Medicine;
           Dr. Paul Halverson, Dean, Indiana 
        University, Richard M. Fairbanks School of Public 
        Health;
           Dr. Kenneth Katz, Lehigh Valley Health 
        Network, Department of Emergency Medicine, Section of 
        Medical Toxicology;
           Dr. Chapman Sledge, Chief Medical Officer, 
        Cumberland Heights; and,
           Dr. Robert Corey Waller, Chair, Legislative 
        Advocacy Committee, American Society of Addiction 
        Medicine.

                        Committee Consideration

    On April 20, 2016, the Subcommittee on Health met in open 
markup session and forwarded H.R. 3680, as amended, to the full 
Committee by a voice vote. On April 26, 27, and 28, 2016, the 
full Committee on Energy and Commerce met in open markup 
session and ordered H.R. 3680 reported to the House, as 
amended, 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. 3680 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

    The goal of this legislation is to provide grants to states 
to encourage the co-prescribing of opioid overdose reversal 
drugs for individuals identified as being at risk for overdose.

   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. 
3680 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. 3680 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.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

H.R. 3680--Co-Prescribing To Reduce Overdoses Act of 2015

    Summary: H.R. 3680 would authorize the Secretary of Health 
and Human Services (MIS) to establish a grant program to 
provide funds to eligible entities to develop guidelines and to 
provide resources for prescribing drugs that reverse opioid 
overdoses. The bill also would authorize the Secretary of MS to 
provide information to prescribers and health care facilities 
of the Indian Health Service on best practices for prescribing 
certain drugs to patients with an elevated risk of opioid use 
disorders. Additionally, H.R. 3680 would reduce amounts 
authorized to be appropriated for certain existing activities 
related to bioterrorism and public health emergencies by the 
Centers for Disease Control and Prevention (CDC). Assuming 
appropriation actions consistent with the bill, CB0 estimates 
that implementing H.R. 3680 would reduce net discretionary 
costs by $1 million over the 2017-2021 period.
    Pay-as-you-go procedures do not apply because enacting H.R. 
3680 would not affect direct spending or revenues. CB0 
estimates that enacting H.R. 3680 would not increase net direct 
spending or on-budget deficits in any of the four consecutive 
10-year periods beginning in 2027.
    H.R. 3680 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA) 
and would not affect the budgets of state, local, or tribal 
governments.
    Estimated cost to the Federal Government: The estimated 
budgetary effect of H.R. 3680 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                      By fiscal year, in millions of dollars--
                                                                   ---------------------------------------------
                                                                     2017   2018   2019   2020   2021  2017-2021
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION
 
Health and Human Services:
    Authorization Level...........................................      1      1      1      1      1         5
    Estimated Outlays.............................................      *      1      1      1      1         4
Centers for Disease Control and Prevention:
    Authorization Level...........................................      0     -5      0      0      0        -5
    Estimated Outlays.............................................      0     -2     -2     -1      *        -5
    Total Changes:
        Authorization Level.......................................      1     -4      1      1      1         0
        Estimated Outlays.........................................      *     -1     -1      *      1        -1
----------------------------------------------------------------------------------------------------------------
Notes: * = between -$500,000 and $500,000; details may not add to totals because of rounding.

    Basis of estimate: For this estimate, CB0 assumes that H.R. 
3680 will be enacted near the end of fiscal year 2016 and that 
spending will follow historical patterns for similar programs.

Health and Human Services

    The bill would require the Secretary of HHS to award grants 
to states to develop guidelines for prescribing drugs that help 
reverse opioid overdoses and to other eligible entities to 
establish and support programs for prescribing such drugs. The 
bill would authorize the appropriation of $5 million over the 
2017-2021 period for those purposes. Assuming availability of 
appropriated funds, CB0 estimates that implementing the grant 
program would cost of $4 million over the 2017-2021 period.

Centers for Disease Control and Prevention

    Under current law, an authorization of appropriation of 
$138 million exists for 2018 for CDC activities related to 
bioterrorism and public health emergencies. H.R. 3680 would 
reduce the authorized amount by $5 million in 2018. Assuming 
future appropriations are reduced accordingly, CBO estimates 
that implementing this provision would result in $5 million 
less in discretionary outlays for those activities over 2017-
2021 period.
    Pay-As-You-Go considerations: None.
    Increase in long-term direct spending and deficits: CBO 
estimates that enacting H.R. 3680 would not increase net direct 
spending or on-budget deficits in any of the four consecutive 
10-year periods beginning in 2027.
    Intergovernmental and private-sector impact: H.R. 3680 
contains no intergovernmental or private-sector mandates as 
defined in UMRA. Any costs incurred by states or local 
governments that apply for grants authorized by the bill would 
be incurred voluntarily as a condition of federal assistance.
    Estimate prepared by: Federal costs: Ellen Werble; Impact 
on state, local, and tribal governments: Leo Lex; Impact on the 
private sector: Amy Petz.
    Estimate approved by: Holly Harvey; Deputy Assistant 
Director for Budget Analysis.

                       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. 3680 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. 3680 
specifically directs to be completed 0 rule makings 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 states that the legislation may be cited as the 
``Co-Prescribing to Reduce Overdoses Act of 2016.''

Section 2. Opioid overdose reversal drugs prescribing grant program

    Section 2 directs the Secretary of Health and Human 
Services to establish a five-year opioid overdose reversal 
drugs prescribing grant program.
    Rural health care clinics, federally qualified health 
centers, eligible opioid treatment programs, or physicians who 
dispense or prescribe certain drugs under DATA 2000, or any 
other entity that the Secretary deems appropriate would be 
eligible under the grant program.
    Additionally, this section defines prescribing of an opioid 
overdose reversal drug to mean in conjunction with an opioid 
prescription for patients at increased risk for overdose, in 
conjunction with an opioid agonist such as methadone used for 
treatment of an opioid use disorder, to the caregiver or close 
relative of someone at risk of overdose, or in circumstances as 
defined by the Secretary.
    To be eligible to receive a grant under this section, the 
potential grantee must describe the following: the mortality 
and morbidity in the area the grantee will be providing 
services that is a result of opioid abuse, the criteria to 
identify eligible patients for participation, and how the 
program will work to identify other sources of funding to 
continue the program after the grant expires.
    Grants awarded by the Secretary under this section may be 
used to establish a program for prescribing and training, to 
provide resources for health care providers and pharmacists on 
the prescribing of opioid overdose reversal drugs, to establish 
ways to track patients' health outcomes in the program, to 
purchase opioid overdose reversal drugs, to offset the copays 
or cost sharing to these drugs, to conduct community outreach, 
or to establish protocols to connect patients who have 
experienced a drug overdose with appropriate treatment.
    All grants awarded under this section will be evaluated on 
six criteria: the number of prescribers trained, the number of 
prescribers who have co-prescribed an opioid overdose reversal 
drug, the total number of prescriptions written, the percentage 
of patients at an elevated risk who received a prescription for 
an overdose reversal drug, the number of patients reporting 
using the drug, and any other outcome measures the Secretary 
deems appropriate.
    Finally, this section mandates a report from the Secretary 
for each year of the grant program on the outcomes achieved by 
the grants funded.

Section 3. Providing information to prescribers in certain federal 
        health care and medical facilities on best practices for 
        prescribing naloxone

    This section authorizes the Secretary to provide 
information to prescribers in federally qualified health 
centers and Indian Health Service facilities on best practices 
for prescribing naloxone. This section does not establish a 
medical standard of care, and there is no additional 
authorization of appropriation for this section to be carried 
out.
    This section also elucidates the term ``elevated risk of 
overdose'' which meaning may be based on the Opioid Overdose 
Toolkit published by the Substance Abuse and Mental Health 
Services Administration and may include patients on a first 
course opioid treatment, those using extended-release or long 
acting opioids, or patients with respiratory disease or other 
comorbidities.

Section 4. Authorization of appropriations

    Section 4 authorizes an appropriation of $5,000,000 for the 
period of fiscal years 2017 to 2021.

Section 5. Cut-Go compliance

    Section 5 reduces the authorization of Section 319D of the 
Public Health Service Act by $5,000,000 for fiscal year 2018 to 
bring the legislation into compliance with Cut-Go. This 
reduction in authorization is equal to the authorization of 
appropriations in section 4.

         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 B--Federal-State Cooperation

           *       *       *       *       *       *       *

SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND PREVENTION.

  (a) Facilities; Capacities.--
          (1) Findings.--Congress finds that the Centers for 
        Disease Control and Prevention has an essential role in 
        defending against and combatting public health threats 
        domestically and abroad and requires secure and modern 
        facilities, and expanded and improved capabilities 
        related to bioterrorism and other public health 
        emergencies, sufficient to enable such Centers to 
        conduct this important mission.
          (2) Facilities.--
                  (A) In general.--The Director of the Centers 
                for Disease Control and Prevention may design, 
                construct, and equip new facilities, renovate 
                existing facilities (including laboratories, 
                laboratory support buildings, scientific 
                communication facilities, transshipment 
                complexes, secured and isolated parking 
                structures, office buildings, and other 
                facilities and infrastructure), and upgrade 
                security of such facilities, in order to better 
                conduct the capacities described in section 
                319A, and for supporting public health 
                activities.
                  (B) Multiyear contracting authority.--For any 
                project of designing, constructing, equipping, 
                or renovating any facility under subparagraph 
                (A), the Director of the Centers for Disease 
                Control and Prevention may enter into a single 
                contract or related contracts that collectively 
                include the full scope of the project, and the 
                solicitation and contract shall contain the 
                clause ``availability of funds'' found at 
                section 52.232-18 of title 48, Code of Federal 
                Regulations.
          (3) Improving the capacities of the centers for 
        disease control and prevention.--The Secretary shall 
        expand, enhance, and improve the capabilities of the 
        Centers for Disease Control and Prevention relating to 
        preparedness for and responding effectively to 
        bioterrorism and other public health emergencies. 
        Activities that may be carried out under the preceding 
        sentence include--
                  (A) expanding or enhancing the training of 
                personnel;
                  (B) improving communications facilities and 
                networks, including delivery of necessary 
                information to rural areas;
                  (C) improving capabilities for public health 
                surveillance and reporting activities, taking 
                into account the integrated system or systems 
                of public health alert communications and 
                surveillance networks under subsection (b); and
                  (D) improving laboratory facilities related 
                to bioterrorism and other public health 
                emergencies, including increasing the security 
                of such facilities.
  (b) National Communications and Surveillance Networks.--
          (1) In general.--The Secretary, directly or through 
        awards of grants, contracts, or cooperative agreements, 
        shall provide for the establishment of an integrated 
        system or systems of public health alert communications 
        and surveillance networks between and among--
                  (A) Federal, State, and local public health 
                officials;
                  (B) public and private health-related 
                laboratories, hospitals, poison control 
                centers, and other health care facilities; and
                  (C) any other entities determined appropriate 
                by the Secretary.
          (2) Requirements.--The Secretary shall ensure that 
        networks under paragraph (1) allow for the timely 
        sharing and discussion, in a secure manner, of 
        essential information concerning bioterrorism or 
        another public health emergency, or recommended methods 
        for responding to such an attack or emergency, allowing 
        for coordination to maximize all-hazards medical and 
        public health preparedness and response and to minimize 
        duplication of effort.
          (3) Standards.--Not later than one year after the 
        date of the enactment of the Public Health Security and 
        Bioterrorism Preparedness and Response Act of 2002, the 
        Secretary, in cooperation with health care providers 
        and State and local public health officials, shall 
        establish any additional technical and reporting 
        standards (including standards for interoperability) 
        for networks under paragraph (1) and update such 
        standards as necessary.
  (c) Modernizing Public Health Situational Awareness and 
Biosurveillance.--
          (1) In general.--Not later than 2 years after the 
        date of enactment of the Pandemic and All-Hazards 
        Preparedness Reauthorization Act of 2013, the 
        Secretary, in collaboration with State, local, and 
        tribal public health officials, shall establish a near 
        real-time electronic nationwide public health 
        situational awareness capability through an 
        interoperable network of systems to share data and 
        information to enhance early detection of rapid 
        response to, and management of, potentially 
        catastrophic infectious disease outbreaks, novel 
        emerging threats, and other public health emergencies 
        that originate domestically or abroad. Such network 
        shall be built on existing State situational awareness 
        systems or enhanced systems that enable such 
        connectivity.
          (2) Strategy and implementation plan.--Not later than 
        180 days after the date of enactment of the Pandemic 
        and All-Hazards Preparedness Reauthorization Act of 
        2013, the Secretary shall submit to the appropriate 
        committees of Congress a coordinated strategy and an 
        accompanying implementation plan that identifies and 
        demonstrates the measurable steps the Secretary will 
        carry out to--
                  (A) develop, implement, and evaluate the 
                network described in paragraph (1), utilizing 
                the elements described in paragraph (3);
                  (B) modernize and enhance biosurveillance 
                activities; and
                  (C) improve information sharing, 
                coordination, and communication among disparate 
                biosurveillance systems supported by the 
                Department of Health and Human Services.
          (3) Elements.--The network described in paragraph (1) 
        shall include data and information transmitted in a 
        standardized format from--
                  (A) State, local, and tribal public health 
                entities, including public health laboratories;
                  (B) Federal health agencies;
                  (C) zoonotic disease monitoring systems;
                  (D) public and private sector health care 
                entities, hospitals, pharmacies, poison control 
                centers or professional organizations in the 
                field of poison control, community health 
                centers, health centers and clinical 
                laboratories, to the extent practicable and 
                provided that such data are voluntarily 
                provided simultaneously to the Secretary and 
                appropriate State, local, and tribal public 
                health agencies; and
                  (E) such other sources as the Secretary may 
                deem appropriate.
          (4) Rule of construction.--Paragraph (3) shall not be 
        construed as requiring separate reporting of data and 
        information from each source listed.
          (5) Required activities.--In establishing and 
        operating the network described in paragraph (1), the 
        Secretary shall--
                  (A) utilize applicable interoperability 
                standards as determined by the Secretary, and 
                in consultation with the Office of the National 
                Coordinator for Health Information Technology, 
                through a joint public and private sector 
                process;
                  (B) define minimal data elements for such 
                network;
                  (C) in collaboration with State, local, and 
                tribal public health officials, integrate and 
                build upon existing State, local, and tribal 
                capabilities, ensuring simultaneous sharing of 
                data, information, and analyses from the 
                network described in paragraph (1) with State, 
                local, and tribal public health agencies; and
                  (D) in collaboration with State, local, and 
                tribal public health officials, develop 
                procedures and standards for the collection, 
                analysis, and interpretation of data that 
                States, regions, or other entities collect and 
                report to the network described in paragraph 
                (1).
          (6) Consultation with the national biodefense science 
        board.--In carrying out this section and consistent 
        with section 319M, the National Biodefense Science 
        Board shall provide expert advice and guidance, 
        including recommendations, regarding the measurable 
        steps the Secretary should take to modernize and 
        enhance biosurveillance activities pursuant to the 
        efforts of the Department of Health and Human Services 
        to ensure comprehensive, real-time, all-hazards 
        biosurveillance capabilities. In complying with the 
        preceding sentence, the National Biodefense Science 
        Board shall--
                  (A) identify the steps necessary to achieve a 
                national biosurveillance system for human 
                health, with international connectivity, where 
                appropriate, that is predicated on State, 
                regional, and community level capabilities and 
                creates a networked system to allow for two-way 
                information flow between and among Federal, 
                State, and local government public health 
                authorities and clinical health care providers;
                  (B) identify any duplicative surveillance 
                programs under the authority of the Secretary, 
                or changes that are necessary to existing 
                programs, in order to enhance and modernize 
                such activities, minimize duplication, 
                strengthen and streamline such activities under 
                the authority of the Secretary, and achieve 
                real-time and appropriate data that relate to 
                disease activity, both human and zoonotic; and
                  (C) coordinate with applicable existing 
                advisory committees of the Director of the 
                Centers for Disease Control and Prevention, 
                including such advisory committees consisting 
                of representatives from State, local, and 
                tribal public health authorities and 
                appropriate public and private sector health 
                care entities and academic institutions, in 
                order to provide guidance on public health 
                surveillance activities.
  (d) State and Regional Systems To Enhance Situational 
Awareness in Public Health Emergencies.--
          (1) In general.--To implement the network described 
        in subsection (c), the Secretary may award grants to 
        States or consortia of States to enhance the ability of 
        such States or consortia of States to establish or 
        operate a coordinated public health situational 
        awareness system for regional or Statewide early 
        detection of, rapid response to, and management of 
        potentially catastrophic infectious disease outbreaks 
        and public health emergencies, in collaboration with 
        appropriate public health agencies, sentinel hospitals, 
        clinical laboratories, pharmacies, poison control 
        centers, other health care organizations, and animal 
        health organizations within such States.
          (2) Eligibility.--To be eligible to receive a grant 
        under paragraph (1), the State or consortium of States 
        shall submit to the Secretary an application at such 
        time, in such manner, and containing such information 
        as the Secretary may require, including an assurance 
        that the State or consortium of States will submit to 
        the Secretary--
                  (A) reports of such data, information, and 
                metrics as the Secretary may require;
                  (B) a report on the effectiveness of the 
                systems funded under the grant; and
                  (C) a description of the manner in which 
                grant funds will be used to enhance the 
                timelines and comprehensiveness of efforts to 
                detect, respond to, and manage potentially 
                catastrophic infectious disease outbreaks and 
                public health emergencies.
          (3) Use of funds.--A State or consortium of States 
        that receives an award under this subsection--
                  (A) shall establish, enhance, or operate a 
                coordinated public health situational awareness 
                system for regional or Statewide early 
                detection of, rapid response to, and management 
                of potentially catastrophic infectious disease 
                outbreaks and public health emergencies;
                  (B) may award grants or contracts to entities 
                described in paragraph (1) within or serving 
                such State to assist such entities in improving 
                the operation of information technology 
                systems, facilitating the secure exchange of 
                data and information, and training personnel to 
                enhance the operation of the system described 
                in subparagraph (A); and
                  (C) may conduct a pilot program for the 
                development of multi-State telehealth network 
                test beds that build on, enhance, and securely 
                link existing State and local telehealth 
                programs to prepare for, monitor, respond to, 
                and manage the events of public health 
                emergencies, facilitate coordination and 
                communication among medical, public health, and 
                emergency response agencies, and provide 
                medical services through telehealth initiatives 
                within the States that are involved in such a 
                multi-State telehealth network test bed.
          (4) Limitation.--Information technology systems 
        acquired or implemented using grants awarded under this 
        section must be compliant with--
                  (A) interoperability and other technological 
                standards, as determined by the Secretary; and
                  (B) data collection and reporting 
                requirements for the network described in 
                subsection (c).
          (5) Independent evaluation.--Not later than 3 years 
        after the date of enactment of the Pandemic and All-
        Hazards Preparedness Reauthorization Act of 2013, the 
        Government Accountability Office shall conduct an 
        independent evaluation, and submit to the Secretary and 
        the appropriate committees of Congress a report 
        concerning the activities conducted under this 
        subsection and subsection (c).
  (e) Telehealth Enhancements for Emergency Response.--
          (1) Evaluation.--The Secretary, in consultation with 
        the Federal Communications Commission and other 
        relevant Federal agencies, shall--
                  (A) conduct an inventory of telehealth 
                initiatives in existence on the date of 
                enactment of the Pandemic and All-Hazards 
                Preparedness Act, including--
                          (i) the specific location of network 
                        components;
                          (ii) the medical, technological, and 
                        communications capabilities of such 
                        components;
                          (iii) the functionality of such 
                        components; and
                          (iv) the capacity and ability of such 
                        components to handle increased volume 
                        during the response to a public health 
                        emergency;
                  (B) identify methods to expand and 
                interconnect the regional health information 
                networks funded by the Secretary, the State and 
                regional broadband networks funded through the 
                rural health care support mechanism pilot 
                program funded by the Federal Communications 
                Commission, and other telehealth networks;
                  (C) evaluate ways to prepare for, monitor, 
                respond rapidly to, or manage the events of, a 
                public health emergency through the enhanced 
                use of telehealth technologies, including 
                mechanisms for payment or reimbursement for use 
                of such technologies and personnel during 
                public health emergencies;
                  (D) identify methods for reducing legal 
                barriers that deter health care professionals 
                from providing telemedicine services, such as 
                by utilizing State emergency health care 
                professional credentialing verification 
                systems, encouraging States to establish and 
                implement mechanisms to improve interstate 
                medical licensure cooperation, facilitating the 
                exchange of information among States regarding 
                investigations and adverse actions, and 
                encouraging States to waive the application of 
                licensing requirements during a public health 
                emergency;
                  (E) evaluate ways to integrate the practice 
                of telemedicine within the National Disaster 
                Medical System; and
                  (F) promote greater coordination among 
                existing Federal interagency telemedicine and 
                health information technology initiatives.
          (2) Report.--Not later than 12 months after the date 
        of enactment of the Pandemic and All-Hazards 
        Preparedness Act, the Secretary shall prepare and 
        submit a report to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on 
        Energy and Commerce of the House of Representatives 
        regarding the findings and recommendations pursuant to 
        subparagraphs (A) through (F) of paragraph (1).
  (f) Authorization of Appropriations.--There are authorized to 
be appropriated to carry out this section, $138,300,000 for 
each of fiscal years 2014 through 2018 (except such dollar 
amount shall be reduced by $5,000,000 for fiscal year 2018).
  (g) Definition.--For purposes of this section the term 
``biosurveillance'' means the process of gathering near real-
time biological data that relates to human and zoonotic disease 
activity and threats to human or animal health, in order to 
achieve early warning and identification of such health 
threats, early detection and prompt ongoing tracking of health 
events, and overall situational awareness of disease activity.

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