59–006 

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: 


SSpencer on DSK4SPTVN1PROD with REPORTS
2 

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; 


SSpencer on DSK4SPTVN1PROD with REPORTS
3 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
4 

1http://www.cdc.gov/nchs/data/hus/hus15.pdf. 

2http://www.reuters.com/article/us-health-who-naloxone-idUSKBN0IO12420141104. 

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. 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
5 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
6 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
7 

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 participaVerDate Sep 11 2014 06:43 May 11, 2016 Jkt 059006 PO 00000 Frm 00007 Fmt 6659 Sfmt 6602 E:\HR\OC\HR553.XXX HR553

SSpencer on DSK4SPTVN1PROD with REPORTS
8 

tion, 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): 


SSpencer on DSK4SPTVN1PROD with REPORTS
9 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
10 

(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 AllHazards 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— 


SSpencer on DSK4SPTVN1PROD with REPORTS
11 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
12 

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— 


SSpencer on DSK4SPTVN1PROD with REPORTS
13 

(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 AllHazards 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
14 

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. 

* * * * * * * 

Æ 


SSpencer on DSK4SPTVN1PROD with REPORTS