[House Report 115-724]
[From the U.S. Government Publishing Office]


115th Congress }                                          { REPORT
                        HOUSE OF REPRESENTATIVES
  2d Session   }                                          { 115-724

======================================================================
 
               OVERDOSE PREVENTION AND PATIENT SAFETY ACT

                                _______
                                

 June 12, 2018.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 5795]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 5795) to amend the Public Health Service Act to 
protect the confidentiality of substance use disorder patient 
records, having considered the same, report favorably thereon 
with an amendment and recommend that the bill as amended do 
pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     4
Background and Need for Legislation..............................     5
Committee Action.................................................     7
Committee Votes..................................................     8
Oversight Findings and Recommendations...........................    11
New Budget Authority, Entitlement Authority, and Tax Expenditures    11
Congressional Budget Office Estimate.............................    11
Federal Mandates Statement.......................................    33
Statement of General Performance Goals and Objectives............    33
Duplication of Federal Programs..................................    33
Committee Cost Estimate..........................................    33
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......    34
Disclosure of Directed Rule Makings..............................    34
Advisory Committee Statement.....................................    34
Applicability to Legislative Branch..............................    34
Section-by-Section Analysis of the Legislation...................    34
Changes in Existing Law Made by the Bill, as Reported............    36
Dissenting Views.................................................    40

    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 ``Overdose Prevention and Patient Safety 
Act''.

SEC. 2. CONFIDENTIALITY AND DISCLOSURE OF RECORDS RELATING TO SUBSTANCE 
                    USE DISORDER.

  (a) Conforming Changes Relating to Substance Use Disorder.--
Subsections (a) and (h) of section 543 of the Public Health Service Act 
(42 U.S.C. 290dd-2) are each amended by striking ``substance abuse'' 
and inserting ``substance use disorder''.
  (b) Disclosures to Covered Entities Consistent With HIPAA.--Paragraph 
(2) of section 543(b) of the Public Health Service Act (42 U.S.C. 
290dd-2(b)) is amended by adding at the end the following:
                  ``(D) To a covered entity or to a program or activity 
                described in subsection (a), for the purposes of 
                treatment, payment, and health care operations, so long 
                as such disclosure is made in accordance with HIPAA 
                privacy regulation. Any redisclosure of information so 
                disclosed may only be made in accordance with this 
                section.''.
  (c) Disclosures of De-identified Health Information to Public Health 
Authorities.--Paragraph (2) of section 543(b) of the Public Health 
Service Act (42 U.S.C. 290dd-2(b)), as amended by subsection (b), is 
further amended by adding at the end the following:
                  ``(E) To a public health authority, so long as such 
                content does not include any individually identifiable 
                health information and meets the standards established 
                in section 164.514 of title 45, Code of Federal 
                Regulations (or successor regulations) for creating de-
                identified information.''.
  (d) Definitions.--Subsection (b) of section 543 of the Public Health 
Service Act (42 U.S.C. 290dd-2) is amended by adding at the end the 
following:
          ``(3) Definitions.--For purposes of this subsection:
                  ``(A) Covered entity.--The term `covered entity' has 
                the meaning given such term for purposes of HIPAA 
                privacy regulation.
                  ``(B) Health care operations.--The term `health care 
                operations' has the meaning given such term for 
                purposes of HIPAA privacy regulation.
                  ``(C) HIPAA privacy regulation.--The term `HIPAA 
                privacy regulation' has the meaning given such term 
                under section 1180(b)(3) of the Social Security Act.
                  ``(D) Individually identifiable health information.--
                The term `individually identifiable health information' 
                has the meaning given such term for purposes of HIPAA 
                privacy regulation.
                  ``(E) Payment.--The term `payment' has the meaning 
                given such term for purposes of HIPAA privacy 
                regulation.
                  ``(F) Public health authority.--The term `public 
                health authority' has the meaning given such term for 
                purposes of HIPAA privacy regulation.
                  ``(G) Treatment.--The term `treatment' has the 
                meaning given such term for purposes of HIPAA privacy 
                regulation.''.
  (e) Use of Records in Criminal, Civil, or Administrative 
Investigations, Actions, or Proceedings.--Subsection (c) of section 543 
of the Public Health Service Act (42 U.S.C. 290dd-2) is amended to read 
as follows:
  ``(c) Use of Records in Criminal, Civil, or Administrative 
Contexts.--Except as otherwise authorized by a court order under 
subsection (b)(2)(C) or by the consent of the patient, a record 
referred to in subsection (a) may not--
          ``(1) be entered into evidence in any criminal prosecution or 
        civil action before a Federal or State court;
          ``(2) form part of the record for decision or otherwise be 
        taken into account in any proceeding before a Federal agency;
          ``(3) be used by any Federal, State, or local agency for a 
        law enforcement purpose or to conduct any law enforcement 
        investigation of a patient; or
          ``(4) be used in any application for a warrant.''.
  (f) Penalties.--Subsection (f) of section 543 of the Public Health 
Service Act (42 U.S.C. 290dd-2) is amended to read as follows:
  ``(f) Penalties.--The provisions of sections 1176 and 1177 of the 
Social Security Act shall apply to a violation of this section to the 
extent and in the same manner as such provisions apply to a violation 
of part C of title XI of such Act. In applying the previous sentence--
          ``(1) the reference to `this subsection' in subsection (a)(2) 
        of such section 1176 shall be treated as a reference to `this 
        subsection (including as applied pursuant to section 543(f) of 
        the Public Health Service Act)'; and
          ``(2) in subsection (b) of such section 1176--
                  ``(A) each reference to `a penalty imposed under 
                subsection (a)' shall be treated as a reference to `a 
                penalty imposed under subsection (a) (including as 
                applied pursuant to section 543(f) of the Public Health 
                Service Act)'; and
                  ``(B) each reference to `no damages obtained under 
                subsection (d)' shall be treated as a reference to `no 
                damages obtained under subsection (d) (including as 
                applied pursuant to section 543(f) of the Public Health 
                Service Act)'.''.
  (g) Antidiscrimination.--Section 543 of the Public Health Service Act 
(42 U.S.C. 290dd-2) is amended by adding at the end the following:
  ``(i) Antidiscrimination.--
          ``(1) In general.--No entity shall discriminate against an 
        individual on the basis of information received by such entity 
        pursuant to a disclosure made under subsection (b) in--
                  ``(A) admission or treatment for health care;
                  ``(B) hiring or terms of employment;
                  ``(C) the sale or rental of housing; or
                  ``(D) access to Federal, State, or local courts.
          ``(2) Recipients of federal funds.--No recipient of Federal 
        funds shall discriminate against an individual on the basis of 
        information received by such recipient pursuant to a disclosure 
        made under subsection (b) in affording access to the services 
        provided with such funds.''.
  (h) Notification in Case of Breach.--Section 543 of the Public Health 
Service Act (42 U.S.C. 290dd-2), as amended by subsection (g), is 
further amended by adding at the end the following:
  ``(j) Notification in Case of Breach.--
          ``(1) Application of hitech notification of breach 
        provisions.--The provisions of section 13402 of the HITECH Act 
        (42 U.S.C. 17932) shall apply to a program or activity 
        described in subsection (a), in case of a breach of records 
        described in subsection (a), to the same extent and in the same 
        manner as such provisions apply to a covered entity in the case 
        of a breach of unsecured protected health information.
          ``(2) Definitions.--In this subsection, the terms `covered 
        entity' and `unsecured protected health information' have the 
        meanings given to such terms for purposes of such section 
        13402.''.
  (i) Sense of Congress.--It is the sense of the Congress that any 
person treating a patient through a program or activity with respect to 
which the confidentiality requirements of section 543 of the Public 
Health Service Act (42 U.S.C. 290dd-2) apply should access the 
applicable State-based prescription drug monitoring program as a 
precaution against substance use disorder.
  (j) Regulations.--
          (1) In general.--The Secretary of Health and Human Services, 
        in consultation with appropriate Federal agencies, shall make 
        such revisions to regulations as may be necessary for 
        implementing and enforcing the amendments made by this section, 
        such that such amendments shall apply with respect to uses and 
        disclosures of information occurring on or after the date that 
        is 12 months after the date of enactment of this Act.
          (2) Easily understandable notice of privacy practices.--Not 
        later than 1 year after the date of enactment of this Act, the 
        Secretary of Health and Human Services, in consultation with 
        appropriate experts, shall update section 164.520 of title 45, 
        Code of Federal Regulations, so that covered entities provide 
        notice, written in plain language, of privacy practices 
        regarding patient records referred to in section 543(a) of the 
        Public Health Service Act (42 U.S.C. 290dd-2(a)), including--
                  (A) a statement of the patient's rights, including 
                self-pay patients, with respect to protected health 
                information and a brief description of how the 
                individual may exercise these rights (as required by 
                paragraph (b)(1)(iv) of such section 164.520); and
                  (B) a description of each purpose for which the 
                covered entity is permitted or required to use or 
                disclose protected health information without the 
                patient's written authorization (as required by 
                paragraph (b)(2) of such section 164.520).
  (k) Development and Dissemination of Model Training Programs for 
Substance Use Disorder Patient Records.--
          (1) Initial programs and materials.--Not later than 1 year 
        after the date of the enactment of this Act, the Secretary of 
        Health and Human Services (referred to in this subsection as 
        the ``Secretary''), in consultation with appropriate experts, 
        shall identify the following model programs and materials (or 
        if no such programs or materials exist, recognize private or 
        public entities to develop and disseminate such programs and 
        materials):
                  (A) Model programs and materials for training health 
                care providers (including physicians, emergency medical 
                personnel, psychiatrists, psychologists, counselors, 
                therapists, nurse practitioners, physician assistants, 
                behavioral health facilities and clinics, care 
                managers, and hospitals, including individuals such as 
                general counsels or regulatory compliance staff who are 
                responsible for establishing provider privacy policies) 
                concerning the permitted uses and disclosures, 
                consistent with the standards and regulations governing 
                the privacy and security of substance use disorder 
                patient records promulgated by the Secretary under 
                section 543 of the Public Health Service Act (42 U.S.C. 
                290dd-2), as amended by this section, for the 
                confidentiality of patient records.
                  (B) Model programs and materials for training 
                patients and their families regarding their rights to 
                protect and obtain information under the standards and 
                regulations described in subparagraph (A).
          (2) Requirements.--The model programs and materials described 
        in subparagraphs (A) and (B) of paragraph (1) shall address 
        circumstances under which disclosure of substance use disorder 
        patient records is needed to--
                  (A) facilitate communication between substance use 
                disorder treatment providers and other health care 
                providers to promote and provide the best possible 
                integrated care;
                  (B) avoid inappropriate prescribing that can lead to 
                dangerous drug interactions, overdose, or relapse; and
                  (C) notify and involve families and caregivers when 
                individuals experience an overdose.
          (3) Periodic updates.--The Secretary shall--
                  (A) periodically review and update the model programs 
                and materials identified or developed under paragraph 
                (1); and
                  (B) disseminate such updated programs and materials 
                to the individuals described in paragraph (1)(A).
          (4) Input of certain entities.--In identifying, reviewing, or 
        updating the model programs and materials under this 
        subsection, the Secretary shall solicit the input of relevant 
        stakeholders.
  (l) Rules of Construction.--Nothing in this Act or the amendments 
made by this Act shall be construed to limit--
          (1) a patient's right, as described in section 164.522 of 
        title 45, Code of Federal Regulations, or any successor 
        regulation, to request a restriction on the use or disclosure 
        of a record referred to in section 543(a) of the Public Health 
        Service Act (42 U.S.C. 290dd-2(a)) for purposes of treatment, 
        payment, or health care operations; or
          (2) a covered entity's choice, as described in section 
        164.506 of title 45, Code of Federal Regulations, or any 
        successor regulation, to obtain the consent of the individual 
        to use or disclose a record referred to in such section 543(a) 
        to carry out treatment, payment, or health care operation.
  (m) Sense of Congress.--It is the sense of the Congress that--
          (1) patients have the right to request a restriction on the 
        use or disclosure of a record referred to in section 543(a) of 
        the Public Health Service Act (42 U.S.C. 290dd-2(a)) for 
        treatment, payment, or health care operations; and
          (2) covered entities should make every reasonable effort to 
        the extent feasible to comply with a patient's request for a 
        restriction regarding such use or disclosure.

                          Purpose and Summary

    H.R. 5795, the Overdose Prevention and Patient Safety Act, 
was introduced on May 15, 2018, by Rep. Earl Blumenauer (D-OR) 
and Rep. Markwayne Mullin (R-OK). The bill permits substance 
use disorder (SUD) treatment records to be shared between 
covered entities in accordance with the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996, for the 
purposes of treatment, payment, and healthcare operations. In 
order to protect individuals seeking and receiving SUD 
treatment, the bill enhances the protections on the disclosure 
of SUD treatment records to non-covered entities by, except for 
authorization by court order or by consent of the patient, 
prohibiting the use of these records in any criminal, civil, or 
administrative investigations, actions, or proceedings. The 
legislation increases the penalties in the event of unlawful 
disclosure of SUD treatment records and establishes breach 
notification requirements in accordance with the Health 
Information Technology for Economic and Clinical Health 
(HITECH) Act. Finally, in the case of any entity legally or 
illegally in receipt of SUD treatment information, H.R. 5795 
prohibits the entity from discriminating against an individual 
in admission or treatment for healthcare; hiring or terms of 
employment; the sale or rental of housing; and access to 
Federal, State, or local courts. All recipients of Federal 
funds are also prohibited from using SUD treatment records as 
the basis of discriminating against an individual.

                  Background and Need for Legislation

    Federal confidentiality law and regulations (42 C.F.R. Part 
2, or Part 2) were enacted in the 1970s after Congress 
recognized that the fear of prosecution and the stigma 
associated with SUD and fear of prosecution decreased the 
likelihood patients would enter into treatment.\1\\2\
---------------------------------------------------------------------------
    \1\Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment 
and Rehabilitation Act of 1970, P.L. 91-61
    \2\Drug Abuse Office and Treatment Act of 1972, P.L. 92-255
---------------------------------------------------------------------------
    Part 2 regulations impose more restrictions on the 
disclosure of substance use disorder treatment records than 
most other Federal and State health privacy laws, including the 
Standards for Privacy of Individually Identifiable Health 
Information (Privacy Rule) under HIPAA.\3\ The HIPAA Privacy 
Rule sets national standards for the protection of health 
information and applies broadly to identifiable health 
information that is created or received by payers and providers 
of health care. It also applies to the business associates of 
these covered entities that provide specific services (e.g., 
claims processing, data management) for covered entities to 
help them operate and meet their responsibilities to patients. 
Under the HIPAA Privacy Rule, health information may be used or 
disclosed by covered entities (health providers, payers, and 
clearinghouses) for the purposes of treatment, payment, and 
other healthcare operations--including case management, care 
coordination, and outcomes evaluation. The Privacy Rule also 
outlines other various circumstances under which covered 
entities may use or disclose health information.
---------------------------------------------------------------------------
    \3\Health Insurance Portability and Accountability Act of 1996, 
P.L. 104-191
---------------------------------------------------------------------------
    Compared to the HIPAA Privacy Rule, Part 2 is much narrower 
in scope and permits fewer uses and disclosures of patient 
information without express written consent. Under Part 2, any 
information regarding:

        the identity, diagnosis, prognosis, or treatment of any 
        patient which are maintained in connection with the 
        performance of any program or activity relating to 
        substance abuse education, prevention, training, 
        treatment, rehabilitation, or research, which is 
        conducted, regulated, or directly or indirectly 
        assisted by any department or agency of the United 
        States

is confidential.\4\ This information may be disclosed only with 
the patient's written consent, pursuant to a court order, or if 
the disclosure falls within one of a few statutory exceptions. 
The regulations apply to holders, recipients, and seekers of 
this information.
---------------------------------------------------------------------------
    \4\42 U.S.C. Sec. 290dd-2. Confidentiality of records.
---------------------------------------------------------------------------
    Part 2 also places very strict limitations on the 
redisclosure of such records. Anyone who receives such 
information from a SUD treatment program may not redisclose it 
without consent or as otherwise authorized by the regulations 
and may not use it except for certain purposes. Part 2 
technically applies only to Federally assisted organizations 
and individual practitioners that specialize in providing SUD 
treatment or referral for treatment. However, with few 
exceptions, most of the nation's alcohol and drug treatment 
programs receive Federal funding.
    According to the Substance Abuse and Mental Health Services 
Administration (SAMHSA), individuals with mental and substance 
abuse disorders die decades earlier than the average person--
mostly from untreated chronic illnesses that are aggravated by 
poor health habits. SAMHSA has made clear that integrating 
mental health, substance abuse, and primary care services 
produces the best outcomes and proves the most effective 
approach to caring for people with multiple healthcare 
needs.\5\ However, Part 2 serves as a barrier for initiatives 
that promote enhanced access and care continuity, such as 
health information exchanges, integrated care networks, health 
homes, and accountable care organizations. In addition, Part 2 
is not uniformly applied to all providers treating patients 
with SUD. Patient information maintained in connection with the 
Veterans' Health Administration is not subject to Part 2. For-
profit treatment providers that do not receive any Federal 
assistance do not have to comply with Part 2. Buprenorphine 
prescribers may or may not be subject to Part 2 depending on 
whether the provider considers itself as an entity that 
specifically provides SUD diagnosis, treatment, or referral for 
treatment.\6\
---------------------------------------------------------------------------
    \5\SAMHSA-HRSA Center for Integrated Health Solutions. ``What is 
integrated care?'' 2016. Available at http://
www.integration.samhsa.gov/resource/what-is-integrated-care.
    \6\American Psychiatric Association. ``Final Rule: 42 CFR Part 2, 
Confidentiality of Substance Use Disorder Patient Records.'' 2017. 
Available at https://www.psychiatry.org/psychiatrists/practice/
practice-management/hipaa/42-cfr-part-2.
---------------------------------------------------------------------------
    Because of disparities between HIPAA and Part 2, the health 
provider community has become increasingly frustrated with the 
restrictions that Part 2 places on their ability to improve the 
coordination and quality of care by sharing SUD treatment 
records. Access to a patient's entire medical record, including 
addiction records, ensures that health providers and 
organizations have all the information necessary for safe, 
effective, high quality treatment, and care coordination that 
addresses all of a patient's unique health needs. Failure to 
integrate services and supports can lead to risks and dangers 
to individual patients, such as dangerous drug interactions\7\ 
and problems related to medication adherence. Obtaining 
multiple consents from a patient can often be challenging and 
creates barriers to whole person, integrated approaches to 
care.
---------------------------------------------------------------------------
    \7\McCance-Katz EF, Sullivan L, Nallani S, Drug Interactions of 
Clinical Importance among the Opioids, Methadone and Buprenorphine, and 
other Frequently Prescribed Medications: A Review. Am J Addict. 19: 4-
16 (2010). Available at https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC3334287/.
---------------------------------------------------------------------------
    SAMHSA revised the Part 2 regulations in 1987 and in 2017. 
The most recently released final regulations and supplemental 
notice of proposed rulemaking were an attempt to align Part 2 
with the HIPAA Privacy Rule to the extent feasible under 
current law by making it easier to share these records within 
accountable care organizations and health information 
exchanges. Under the newly-created general designation process 
promulgated under final regulations, a patient may consent to 
share his or her information with an intermediary, such as a 
health information exchange (HIE), accountable care 
organization (ACO), or other integrated care setting.\8\ 
However, a recipient of this information within an HIE or ACO 
with a treating provider relationship is prohibited from re-
disclosing that information to another provider in the same HIE 
or ACO without additional patient consent, rendering the 
process unworkable in practice.\9\ SAMHSA has stated that the 
agency is encouraged that Congress is reviewing the issue and 
has made clear that any further changes to Part 2 would require 
a change to the underlying statute.\10\
---------------------------------------------------------------------------
    \8\42 CFR Sec. 2.31(a)(4)(iii)(B). Consent requirements.
    \9\United States Congress. House Energy and Commerce Committee, 
Subcommittee on Health. Improving the Coordination and Quality of 
Substance Use Disorder Treatment. May 8, 2018. 115th Congress, 2nd 
session. (2018) (statement of Gerald (Jud) E. DeLoss, Greensfelder 
Hemker & Gale P.C.). Available at https://docs.house.gov/meetings/IF/
IF14/20180508/108271/HHRG-115-IF14-Wstate-DeLossG-20180508.pdf.
    \10\McKance-Katz, Elinore F. (Substance Abuse and Mental Health 
Services Administration) Letter to the Honorable Markwayne Mullin. 
March 19, 2018. Available at https://docs.house.gov/meetings/IF/IF14/
20180321/108049/HHRG-115-IF14-20180321-SD100.pdf.
---------------------------------------------------------------------------

                            Committee Action

    On March 21 and 22, 2108, the Subcommittee on Health held a 
hearing on H.R. 3545, Overdose Prevention and Patient Safety 
Act, which was similar to H.R. 5795. The hearing was entitled 
``Combatting the Opioid Crisis: Prevention and Public Health 
Solutions.'' The Subcommittee received testimony from:
           Scott Gottlieb, MD, Commissioner, Food and 
        Drug Administration;
           Anne Schuchat, MD (RADM, USPHS), Acting 
        Director, Centers for Disease Control and Prevention;
           Christopher M. Jones, PharmD, MPH, Director, 
        National Mental Health and Substance Use Policy 
        Laboratory, Substance Abuse and Mental Health Services 
        Administration;
           Sue Thau, Public Policy Consultant, 
        Community Anti- Drug Coalitions of America;
           Cartier Esham, Executive Vice President, 
        Emerging Companies, Biotechnology Innovation 
        Organization;
           Jeffrey Francer, Senior Vice President and 
        General Counsel, Association for Accessible Medicines;
           John W. Holaday, PhD, Chairman and Co-
        Founder, DisposeRx;
           Eric C. Strain, MD, Director, Center for 
        Substance Abuse Treatment and Research, Johns Hopkins 
        University School of Medicine;
           Kenneth J. Martz, PsyD MBA, Special Projects 
        Consultant, Gaudenzia, Inc.;
           Brad Bauer, Senior Vice President of New 
        Business Development and Customer Relationship 
        Management, Appriss Health;
           William Banner, MD, PhD, Medical Director, 
        Oklahoma Center for Poison and Drug Information; Board 
        President, American Association of Poison Control 
        Centers;
           Michael E. Kilkenny, MD, MS, Physician 
        Director, Cabell-Huntington Health Department of West 
        Virginia;
           Jessica Hulsey Nickel, Founder, President 
        and CEO, Addiction Policy Forum;
           Ryan Hampton, Recovery Advocate, Facing 
        Addiction;
           Carlene Deal-Smith, Peer Support Specialist, 
        Presbyterian Medical Services;
           Mark Rosenberg, DO, MBA, FACEP, FAAHPM, 
        Chairman of Emergency Medicine and Chief Innovation 
        Officer, St. Joseph's Healthcare System; Board of 
        Directors, American College of Emergency Physicians;
           Stacy Bohlen, CEO, National Indian Health 
        Board; and
           Alexis Horan, Vice President of Government 
        Relations, Clean Slate Centers.
    In addition, on May 8, 2018, the Subcommittee on Health 
held a hearing on a discussion draft entitled ``Overdose 
Prevention and Patient Safety Act,'' which was similar to H.R. 
5795. The hearing was entitled ``Improving the Coordination and 
Quality of Substance Use Disorder Treatment.'' The Subcommittee 
received testimony from:
           Earl Blumenauer (D-OR), Member, U.S. House 
        of Representatives;
           Gerald (Jud) E. DeLoss, Officer, 
        Greensfelder, Hemker and Gale, P.C;
           Jeremiah Gardner, Manager of Public Affairs 
        and Advocacy, Hazelden Betty Ford Foundation;
           Dustin McKee, Director of Policy, National 
        Alliance on Mental Illness of Ohio;
           H. Westley Clark, M.D., J.D., M.P.H., Dean's 
        Executive Professor, Public Health Program, Santa Clara 
        University; and
           Patty McCarthy Metcalf, Executive Director, 
        Faces and Voices of Recovery.
    On May 17, 2018, the full Committee on Energy and Commerce 
met in open markup session and ordered H.R. 5795, as amended, 
favorably reported to the House by a record vote of 35 yeas and 
17 nays.

                            Committee Votes

    Clause 3(b) of rule XIII requires the Committee to list the 
record votes on the motion to report legislation and amendments 
thereto. The following reflects the record votes taken during 
the Committee consideration:


                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee held hearings and made findings that 
are reflected in this report.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 5795 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

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

                                     U.S. Congress,
                               Congressional Budget Office,
                                      Washington, DC, June 6, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed document with cost estimates for the 
opioid-related legislation ordered to be reported on May 9 and 
May 17, 2018.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Tom Bradley 
and Chad Chirico.
            Sincerely,
                                             Mark P. Hadley
                                        (For Keith Hall, Director).
    Enclosure.

Opioid Legislation

    Summary: On May 9 and May 17, 2018, the House Committee on 
Energy and Commerce ordered 59 bills to be reported related to 
the nation's response to the opioid epidemic. Generally, the 
bills would:
           Provide grants to facilities and providers 
        that treat people with substance use disorders,
           Direct various agencies within the 
        Department of Health and Human Services (HHS) to 
        explore nonopioid approaches to treating pain and to 
        educate providers about those alternatives,
           Modify requirements under Medicaid and 
        Medicare for prescribing controlled substances,
           Expand Medicaid coverage for substance abuse 
        treatment, and
           Direct the Food and Drug Administration 
        (FDA) to modify its oversight of opioid drugs and other 
        medications that are used to manage pain.
    Because of the large number of related bills ordered 
reported by the Committee, CBO is publishing a single 
comprehensive document that includes estimates for each piece 
of legislation.
    CBO estimates that enacting 20 of the bills would affect 
direct spending, and 2 of the bills would affect revenues; 
therefore, pay-as-you-go procedures apply for those bills.
    CBO estimates that enacting H.R. 4998, the Health Insurance 
for Former Foster Youth Act, would increase net direct spending 
by more than $2.5 billion and on-budget deficits by more than 
$5 billion in at least one of the four consecutive 10-year 
periods beginning in 2029. None of the remaining 58 bills 
included in this estimate would increase net direct spending by 
more than $2.5 billion or on-budget deficits by more than $5 
billion in any of the four consecutive 10-year periods 
beginning in 2029.
    One of the bills reviewed for this document, H.R. 5795, 
would impose both intergovernmental and private-sector mandates 
as defined in the Unfunded Mandates Reform Act (UMRA). CBO 
estimates that the costs of those mandates on public and 
private entities would fall below the thresholds in UMRA ($80 
million and $160 million, respectively, in 2018, adjusted 
annually for inflation). Five bills, H.R. 5228, H.R. 5333, H.R. 
5554, H.R. 5687, and H.R. 5811, would impose private-sector 
mandates as defined in UMRA. CBO estimates that the costs of 
the mandates in three of the bills (H.R. 5333, H.R. 5554, and 
H.R. 5811) would not exceed the UMRA threshold for private 
entities. Because CBO is uncertain how federal agencies would 
implement new authority granted in the other two bills, H.R. 
5228 and H.R. 5687, CBO cannot determine whether the costs of 
those mandates would exceed the UMRA threshold.
    Estimated cost to the Federal Government: The estimates in 
this document do not include the effects of interactions among 
the bills. If all 59 bills were combined and enacted as one 
piece of legislation, the budgetary effects would be different 
from the sum of the estimates in this document, although CBO 
expects that any such differences would be small. The costs of 
this legislation fall within budget functions 550 (health), 570 
(Medicare), 750 (administration of justice), and 800 (general 
government).
    Basis of estimate: For this estimate, CBO assumes that all 
of the legislation will be enacted late in 2018 and that 
authorized and estimated amounts will be appropriated each 
year. Outlays for discretionary programs are estimated based on 
historical spending patterns for similar programs.

Uncertainty

    CBO aims to produce estimates that generally reflect the 
middle of a range of the most likely budgetary outcomes that 
would result if the legislation was enacted. Because data on 
the utilization of mental health and substance abuse treatment 
under Medicaid and Medicare is scarce, CBO cannot precisely 
predict how patients or providers would respond to some policy 
changes or what budgetary effects would result. In addition, 
several of the bills would give the Department of Health and 
Human Services (HHS) considerable latitude in designing and 
implementing policies. Budgetary effects could differ from 
those provided in CBO's analyses depending on those decisions.

Direct spending and revenues

    Table 1 lists the 22 bills of the 59 ordered to be reported 
that would affect direct spending or revenues.

                                             TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING AND REVENUES
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         By fiscal year, in millions of dollars--
                                ------------------------------------------------------------------------------------------------------------------------
                                   2018     2019     2020     2021     2022     2023     2024     2025     2026     2027     2028   2019-2023  2019-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      INCREASES OR DECREASES (-) IN DIRECT SPENDING
 
Legislation Primarily Affecting
 Medicaid:
    H.R. 1925, At-Risk Youth           0        *        5        5        5       10       10       10       10       10       10        25          75
     Medicaid Protection Act of
     2017......................
    H.R. 4998, Health Insurance        0        0        0        0        0        *       10       21       33       46       61         *         171
     for Former Foster Youth
     Act.......................
    H.R. 5477, Rural                   0       13       35       58       68       83       27        9        3        3        3       256         301
     Development of Opioid
     Capacity Services Act.....
    H.R. 5583, a bill to amend         0        *        *        *        *        *        *        *        *        *        *         *           *
     title XI of the Social
     Security Act to require
     States to annually report
     on certain adult health
     quality measures, and for
     other purposes............
    H.R. 5797, IMD CARE Act....        0       38      158      251      265      279        0        0        0        0        0       991         991
    H.R. 5799, Medicaid DRUG           0        *        *        1        1        1        1        1        1        1        1         2           5
     Improvement Acta..........
    H.R. 5801 Medicaid                 0        *        *        *        *        *        *        *        *        *        *         *           *
     Providers Are Required To
     Note Experiences in Record
     Systems to Help In-Need
     Patients (PARTNERSHIP)
     Acta......................
    H.R. 5808, Medicaid                0        *       -1       -1       -1       -1       -2       -2       -2       -2       -2        -4         -13
     Pharmaceutical Home Act of
     2018a.....................
    H.R. 5810, Medicaid Health         0       94       58       62       56       52       48       43       38       32       25       323         509
     HOME Act..................
Legislation Primarily Affecting
 Medicare:
    H.R. 3528, Every                   0        0        0      -24      -35      -33      -30      -33      -32      -31      -32       -92        -250
     Prescription Conveyed
     Securely Act..............
    H.R. 4841, Standardizing           0        0        0        *        *        *        *        *        *        *        *         *           *
     Electronic Prior
     Authorization for Safe
     Prescribing Act of 2018...
    H.R. 5603, Access to               0        2        *        *        *        1        1        1        2        2        2         3          11
     Telehealth Services for
     Opioid Use Disorders Act..
    H.R. 5605, Advancing High          0        0        0       15       26       24       23       23       10        1        *        65         122
     Quality Treatment for
     Opioid Use Disorders in
     Medicare Act..............
    H.R. 5675, a bill to amend         0        0        0       -6       -7       -7       -7       -8       -9       -9      -11       -20         -64
     title XVIII of the Social
     Security Act to require
     prescription drug plan
     sponsors under the
     Medicare program to
     establish drug management
     programs for at-risk
     beneficiaries.............
    H.R. 5684, Protecting              0        0        0        *        *        *        *        *        *        *        *         *           *
     Seniors From Opioid Abuse
     Act.......................
    H.R. 5796, Responsible             0       10       25       50       10        5        0        0        0        0        0       100         100
     Education Achieves Care
     and Healthy Outcomes for
     Users' Treatment Act of
     2018......................
    H.R. 5798, Opioid Screening        0        0        *        1        1        1        1        1        1        1        1         2           5
     and Chronic Pain
     Management Alternatives
     for Seniors Act...........
    H.R. 5804, Post-Surgical           0        0       25       30       25       20       10        5        0        0        0       100         115
     Injections as an Opioid
     Alternative Acta..........
    H.R. 5809, Postoperative           0        0        0        0       10       15       20       25       30       35       45        25         180
     Opioid Prevention Act of
     2018......................
Legislation Primarily Affecting
 the Food and Drug
 Administration:
    H.R. 5333, Over-the-Counter        0        0        *        *        *        *        *        *        *        *        *         *           *
     Monograph Safety,
     Innovation, and Reform Act
     of 2018a..................
 
                                                         INCREASES OR DECREASES (-) IN REVENUESb
 
    H.R. 5752, Stop Illicit            0        *        *        *        *        *        *        *        *        *        *         *          *
     Drug Importation Act of
     2018......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000. Budget authority is equivalent to outlays.
aThis bill also would affect spending subject to appropriation.
bOne additional bill, H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, would have a negligible effect on revenues.

    Legislation Primarily Affecting Medicaid. The following 
nine bills would affect direct spending for the Medicaid 
program.
    H.R. 1925, the At-Risk Youth Medicaid Protection Act of 
2017, would require states to suspend, rather than terminate, 
Medicaid eligibility for juvenile enrollees (generally under 21 
years of age) who become inmates of public correctional 
institutions. States also would have to redetermine those 
enrollees' Medicaid eligibility before their release and 
restore their coverage upon release if they qualify for the 
program. States would be required to process Medicaid 
applications submitted by or on behalf of juveniles in public 
correctional institutions who were not enrolled in Medicaid 
before becoming inmates and ensure that Medicaid coverage is 
provided when they are released if they are found to be 
eligible. On the basis of an analysis of juvenile incarceration 
trends and of the per enrollee spending for Medicaid foster 
care children, who have a similar health profile to 
incarcerated juveniles, CBO estimates that implementing the 
bill would cost $75 million over the 2019-2028 period.
    H.R. 4998, the Health Insurance for Former Foster Youth 
Act, would require states to provide Medicaid coverage to 
adults up to age 25 who had aged out of foster care in any 
state. Under current law, such coverage is mandatory only if 
the former foster care youth has aged out in the state in which 
the individual applies for coverage. The policy also would 
apply to former foster children who had been in foster care 
upon turning 14 years of age but subsequently left foster care 
to enter into a legal guardianship with a kinship caregiver. 
The provisions would take effect respect for foster youth who 
turn 18 on or after January 1, 2023. On the basis of spending 
for Medicaid foster care children and data from the Census 
Bureau regarding annual migration rates between states, CBO 
estimates that implementing the bill would cost $171 million 
over the 2019-2028 period.
    H.R. 5477, the Rural Development of Opioid Capacity 
Services Act, would direct the Secretary of HHS to conduct a 
five-year demonstration to increase the number and ability of 
providers participating in Medicaid to provide treatment for 
substance use disorders. On the basis of an analysis of federal 
and state spending for treatment of substance use disorders and 
the prevalence of such disorders, CBO estimates that enacting 
the bill would increase direct spending by $301 million over 
the 2019-2028 period.
    H.R. 5583, a bill to amend title XI of the Social Security 
Act to require States to annually report on certain adult 
health quality measures, and for other purposes, would require 
states to include behavioral health indicators in their annual 
reports on the quality of care under Medicaid. Although the 
bill would add a requirement for states, CBO estimates that its 
enactment would not have a significant budgetary effect because 
most states have systems in place for reporting such measures 
to the federal government.
    H.R. 5797, the IMD CARE Act, would expand Medicaid coverage 
for people with opioid use disorder who are in institutions for 
mental disease (IMDs) for up to 30 days per year. Under a 
current-law policy known as the IMD exclusion, the federal 
government generally does not make matching payments to state 
Medicaid programs for most services provided by IMDs to adults 
between the ages of 21 and 64. Recent administrative changes 
have made federal financing for IMDs available in limited 
circumstances, but the statutory prohibition remains in place. 
CBO analyzed several data sets, primarily those collected by 
the Substance Abuse and Mental Health Services Administration 
(SAMHSA), to estimate current federal spending under Medicaid 
for IMD services and to estimate spending under H.R. 5797. 
Using that analysis, CBO estimates that enacting H.R. 5797 
would increase direct spending by $991 million over the 2019-
2028 period.
    H.R. 5799, the Medicaid DRUG Improvement Act, would require 
state Medicaid programs to implement additional reviews of 
opioid prescriptions, monitor concurrent prescribing of opioids 
and certain other drugs, and monitor use of antipsychotic drugs 
by children. CBO estimates that the bill would increase direct 
spending by $5 million over 2019-2028 period to cover the 
administrative costs of complying with those requirements. On 
the basis of stakeholder feedback, CBO expects that the bill 
would not have a significant effect on Medicaid spending for 
prescription drugs because many of the bill's requirements 
would duplicate current efforts to curb opioid and 
antipsychotic drug use. (If enacted, H.R. 5799 also would 
affect spending subject to appropriation; CBO has not completed 
an estimate of that amount.)
    H.R. 5801, the Medicaid Providers Are Required To Note 
Experiences in Record Systems to Help-In-Need Patients 
(PARTNERSHIP) Act, would require providers who are permitted to 
prescribe controlled substances and who participate in Medicaid 
to query prescription drug monitoring programs (PDMPs) before 
prescribing controlled substances to Medicaid patients. PDMPs 
are statewide electronic databases that collect data on 
controlled substances dispensed in the state. The bill also 
would require PDMPs to comply with certain data and system 
criteria, and it would provide additional federal matching 
funds to certain states to help cover administrative costs. On 
the basis of a literature review and stakeholder feedback, CBO 
estimates that the net budgetary effect of enacting H.R. 5801 
would be insignificant. Costs for states to come into 
compliance with the systems and administrative requirements 
would be roughly offset by savings from small reductions in the 
number of controlled substances paid for by Medicaid under the 
proposal. (If enacted, H.R. 5801 also would affect spending 
subject to appropriation; CBO has not completed an estimate of 
that amount.)
    H.R. 5808, the Medicaid Pharmaceutical Home Act of 2018, 
would require state Medicaid programs to operate pharmacy 
programs that would identify people at high risk of abusing 
controlled substances and require those patients to use a 
limited number of providers and pharmacies. Although nearly all 
state Medicaid programs currently meet such a requirement, a 
small number of high-risk Medicaid beneficiaries are not now 
monitored. Based on an analysis of information about similar 
state and federal programs, CBO estimates that net Medicaid 
spending under the bill would decrease by $13 million over the 
2019-2028 period. That amount represents a small increase in 
administrative costs and a small reduction in the number of 
controlled substances paid for by Medicaid under the proposal. 
(If enacted, H.R. 5808 also would affect spending subject to 
appropriation; CBO has not completed an estimate of that 
amount.)
    H.R. 5810, the Medicaid Health HOME Act, would allow states 
to receive six months of enhanced federal Medicaid funding for 
programs that coordinate care for people with substance use 
disorders. Based on enrollment and spending data from states 
that currently participate in Medicaid's Health Homes program, 
CBO estimates that the expansion would cost approximately $469 
million over the 2019-2028 period. The bill also would require 
states to cover all FDA-approved drugs used in medication-
assisted treatment for five years, although states could seek a 
waiver from that requirement. (Medication-assisted treatment 
combines behavioral therapy and pharmaceutical treatment for 
substance use disorders.) Under current law, states already 
cover most FDA-approved drugs used in such programs in some 
capacity, although a few exclude methadone dispensed by opioid 
treatment programs. CBO estimates that a small share of those 
states would begin to cover methadone if this bill was enacted 
at a federal cost of about $39 million over the 2019-2028 
period. In sum, CBO estimates that the enacting H.R. 5810 would 
increase direct spending by $509 million over the 2019-2028 
period.
    Legislation Primarily Affecting Medicare. The following ten 
bills would affect direct spending for the Medicare program.
    H.R. 3528, the Every Prescription Conveyed Securely Act, 
would require prescriptions for controlled substances covered 
under Medicare Part D to be transmitted electronically, 
starting on January 1, 2021. Based on CBO's analysis of 
prescription drug spending, spending for controlled substances 
is a small share of total drug spending. CBO also assumes a 
small share of those prescriptions would not be filled because 
they are not converted to an electronic format. Therefore, CBO 
expects that enacting H.R. 3528 would reduce the number of 
prescriptions filled and estimates that Medicare spending be 
reduced by $250 million over the 2019-2028 period.
    H.R. 4841, the Standardizing Electronic Prior Authorization 
for Safe Prescribing Act of 2018, would require health care 
professionals to submit prior authorization requests 
electronically, starting on January 1, 2021, for drugs covered 
under Medicare Part D. Taking into account that many 
prescribers already use electronic methods to submit such 
requests, CBO estimates that enacting H.R. 4841 would not 
significantly affect direct spending for Part D.
    H.R. 5603, the Access to Telehealth Services for Opioid Use 
Disorders Act, would permit the Secretary of HHS to lift 
current geographic and other restrictions on coverage of 
telehealth services under Medicare for treatment of substance 
use disorders or co-occurring mental health disorders. Under 
the bill, the Secretary of HHS would be directed to encourage 
other payers to coordinate payments for opioid use disorder 
treatments and to evaluate the extent to which the 
demonstration reduces hospitalizations, increases the use of 
medication-assisted treatments, and improves the health 
outcomes of individuals with opioid use disorders during and 
after the demonstration. Based on current use of Medicare 
telehealth services for treatment of substance use disorders, 
CBO estimates that expanding that coverage would increase 
direct spending by $11 million over the 2019-2028 period.
    H.R. 5605, the Advancing High Quality Treatment for Opioid 
Use Disorders in Medicare Act, would establish a five-year 
demonstration program to increase access to treatment for 
opioid use disorder. The demonstration would provide incentive 
payments and funding for care management services based on 
criteria such as patient engagement, use of evidence-based 
treatments, and treatment length and intensity. Under the bill, 
the Secretary of HHS would be directed to encourage other 
payers to coordinate payments for opioid use disorder 
treatments and to evaluate the extent to which the 
demonstration reduces hospitalizations, increases the use of 
medication-assisted treatments, and improves the health 
outcomes of individuals with opioid use disorders during and 
after the demonstration. Based on historical utilization of 
opioid use disorder treatments and projected spending on 
incentive payments and care management fees, CBO estimates that 
increased use of treatment services and the demonstration's 
incentive payments would increase direct spending by $122 
million over the 2019-2028 period.
    H.R. 5675, a bill to amend title XVIII of the Social 
Security Act to require prescription drug plan sponsors under 
the Medicare program to establish drug management programs for 
at-risk beneficiaries, would require Part D prescription drug 
plans to provide drug management programs for Medicare 
beneficiaries who are at risk for prescription drug abuse. 
(Under current law, Part D plans are permitted but not required 
to establish such programs as of 2019.) Based on an analysis of 
the number of plans currently providing those programs, CBO 
estimates that enacting H.R. 5675 would lower federal spending 
by $64 million over the 2019-2028 period by reducing the number 
of prescriptions filled and Medicare's payments for controlled 
substances.
    H.R. 5684, the Protecting Seniors From Opiod Abuse Act, 
would expand medication therapy management programs under 
Medicare Part D to include beneficiaries who are at risk for 
prescription drug abuse. Because relatively few beneficiaries 
would be affected by this bill, CBO estimates that its 
enactment would not significantly affect direct spending for 
Part D.
    H.R. 5796, the Responsible Education Achieves Care and 
Healthy Outcomes for Users' Treatment Act of 2018, would allow 
the Secretary of HHS to award grants to certain organizations 
that provide technical assistance and education to high-volume 
prescribers of opioids. The bill would appropriate $100 million 
for fiscal year 2019. Based on historical spending patterns for 
similar activities, CBO estimates that implementing H.R. 5796 
would cost $100 million over the 2019-2028 period.
    H.R. 5798, the Opioid Screening and Chronic Pain Management 
Alternatives for Seniors Act, would add an assessment of 
current opioid prescriptions and screening for opioid use 
disorder to the Welcome to Medicare Initial Preventive Physical 
Examination. Based on historical use of the examinations and 
pain management alternatives, CBO expects that enacting the 
bill would increase use of pain management services and 
estimates that direct spending would increase by $5 million 
over the 2019-2028 period.
    H.R. 5804, the Post-Surgical Injections as an Opioid 
Alternative Act, would freeze the Medicare payment rate for 
certain analgesic injections provided in ambulatory surgical 
centers (ASCs). (For injections identified by specific billing 
codes, Medicare would pay the 2016 rate, which is higher than 
the current rate, during the 2020-2024 period.) Based on 
current utilization in the ASC setting, CBO estimates that 
enacting the legislation would increase direct spending by 
about $115 million over the 2019-2028 period. (If enacted, H.R. 
5804 also would affect spending subject to appropriation; see 
Table 3.)
    H.R. 5809, the Postoperative Opioid Prevention Act of 2018, 
would create an additional payment under Medicare for nonopioid 
analgesics. Under current law, certain new drugs and devices 
may receive an additional payment--separate from the bundled 
payment for a surgical procedure--in outpatient hospital 
departments and ambulatory surgical centers. The bill would 
allow nonopioid analgesics to qualify for a five-year period of 
additional payments. Based on its assessment of current 
spending for analgesics and on the probability of new nonopioid 
analgesics coming to market, CBO estimates that H.R. 5809 would 
increase direct spending by about $180 million over the 2019-
2028 period.
    Legislation Primarily Affecting the Food and Drug 
Administration. One bill related to the FDA would affect direct 
spending.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would change the way that 
the FDA regulates the marketing of over-the-counter (OTC) 
medicines, and it would authorize that agency to grant 18 
months of exclusive market protection for certain qualifying 
OTC drugs, thus delaying the entry of other versions of the 
same qualifying OTC product. Medicaid currently provides some 
coverage for OTC medicines, but only if a medicine is the least 
costly alternative in its drug class. On the basis of 
stakeholder feedback, CBO expects that delaying the 
availability of additional OTC versions of a drug would not 
significantly affect the average net price paid by Medicaid. As 
a result, CBO estimates that enacting H.R. 5333 would have a 
negligible effect on the federal budget. (If enacted, H.R. 5333 
also would affect spending subject to appropriation; see Table 
3.)
    Legislation with Revenue Effects. Two bills would affect 
revenues. However, CBO estimates that one bill, H.R. 5228, the 
Stop Counterfeit Drugs by Regulating and Enhancing Enforcement 
Now Act, would have only a negligible effect.
    H.R. 5752, the Stop Illicit Drug Importation Act of 2018, 
would amend the Federal, Food, Drug, and Cosmetic Act (FDCA) to 
strengthen the FDA's seizure powers and enhance its authority 
to detain, refuse, seize, or destroy illegal products offered 
for import. The legislation would subject more people to 
debarment under the FDCA and thus increase the potential for 
violations, and subsequently, the assessment of civil 
penalties, which are recorded in the budget as revenues. CBO 
estimates that those collections would result in an 
insignificant increase in revenues. Because H.R. 5752 would 
prohibit the importation of drugs that are in the process of 
being scheduled, it also could reduce amounts collected in 
customs duties. CBO anticipates that the result would be a 
negligible decrease in revenues. With those results taken 
together, CBO estimates, enacting H.R. 5752 would generate an 
insignificant net increase in revenues over the 2019-2028 
period.

Spending subject to appropriation

    For this document, CBO has grouped bills with spending that 
would be subject to appropriation into four general categories:
           Bills that would have no budgetary effect,
           Bills with provisions that would authorize 
        specified amounts to be appropriated (see Table 2),
           Bills with provisions for which CBO has 
        estimated an authorization of appropriations (see Table 
        3), and
           Bills with provisions that would affect 
        spending subject to appropriation for which CBO has not 
        yet completed an estimate.
    No Budgetary Effect. CBO estimates that 6 of the 59 bills 
would have no effect on direct spending, revenues, or spending 
subject to appropriation.
    H.R. 3192, the CHIP Mental Health Parity Act, would require 
all Children's Health Insurance Program (CHIP) plans to cover 
mental health and substance abuse treatment. In addition, 
states would not be allowed to impose financial or utilization 
limits on mental health treatment that are lower than limits 
placed on physical health treatment. Based on information from 
the Centers for Medicare and Medicaid Services, CBO estimates 
that enacting the bill would have no budgetary effect because 
all CHIP enrollees are already in plans that meet those 
requirements.
    H.R. 3331, a bill to amend title XI of the Social Security 
Act to promote testing of incentive payments for behavioral 
health providers for adoption and use of certified electronic 
health record technology, would give the Center for Medicare 
and Medicaid Innovation (CMMI) explicit authorization to test a 
program offering incentive payments to behavioral health 
providers that adopt and use certified electronic health record 
technology. Because it is already clear to CMMI that it has 
that authority, CBO estimates that enacting the legislation 
would not affect federal spending.
    H.R. 5202, the Ensuring Patient Access to Substance Use 
Disorder Treatments Act of 2018, would clarify permission for 
pharmacists to deliver controlled substances to providers under 
certain circumstances. Because this provision would codify 
current practice, CBO estimates that H.R. 5202 would not affect 
direct spending or revenues during the 2019-2028 period.
    H.R. 5685, the Medicare Opioid Safety Education Act of 
2018, would require the Secretary of HHS to include information 
on opioid use, pain management, and nonopioid pain management 
treatments in future editions of Medicare & You, the program's 
handbook for beneficiaries, starting on January 1, 2019. 
Because H.R. 5685 would add information to an existing 
administrative document, CBO estimates that enacting the bill 
would have no budgetary effect.
    H.R. 5686, the Medicare Clear Health Options in Care for 
Enrollees Act of 2018, would require prescription drug plans 
that provide coverage under Medicare Part D to furnish 
information to beneficiaries about the risks of opioid use and 
the availability of alternative treatments for pain. CBO 
estimates that enacting the bill would not affect direct 
spending because the required activities would not impose 
significant administrative costs.
    H.R. 5716, the Commit to Opioid Medical Prescriber 
Accountability and Safety for Seniors Act, would require the 
Secretary of HHS on an annual basis to identify high 
prescribers of opioids and furnish them with information about 
proper prescribing methods. Because HHS already has the 
capacity to meet those requirements, CBO estimates that 
enacting that provision would not impose additional 
administrative costs on the agency.
    Specified Authorizations. Table 2 lists the ten bills that 
would authorize specified amounts to be appropriated over the 
2019-2023 period. Spending from those authorized amounts would 
be subject to appropriation.

          TABLE 2.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH SPECIFIED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
                                                                By fiscal year, in millions of dollars--
                                                      ----------------------------------------------------------
                                                        2018    2019    2020    2021    2022    2023   2019-2023
----------------------------------------------------------------------------------------------------------------
                                 INCREASES IN SPENDING SUBJECT TO APPROPRIATION
 
H.R. 4684, Ensuring Access to Quality Sober Living
 Act:
    Authorization Level..............................       0       3       0       0       0       0         3
    Estimated Outlays................................       0       1       2       *       *       *         3
 
H.R. 5102, Substance Use Disorder Workforce Loan
 Repayment Act of 2018:
    Authorization Level..............................       0      25      25      25      25      25       125
    Estimated Outlays................................       0       9      19      23      25      25       100
 
H.R. 5176, Preventing Overdoses While in Emergency
 Rooms Act of 2018:
    Authorization Level..............................       0      50       0       0       0       0        50
    Estimated Outlays................................       0      16      26       6       2       1        50
 
H.R. 5197, Alternatives to Opioids (ALTO) in the
 Emergency Department Act:
    Authorization Level..............................       0      10      10      10       0       0        30
    Estimated Outlays................................       0       3       8      10       7       2        30
 
H.R. 5261, Treatment, Education, and Community Help
 to Combat Addiction Act of 2018:
    Authorization Level..............................       0       4       4       4       4       4        20
    Estimated Outlays................................       0       1       3       4       4       4        16
 
H.R. 5327, Comprehensive Opioid Recovery Centers Act
 of 2018:
    Authorization Level..............................       0      10      10      10      10      10        50
    Estimated Outlays................................       0       3       8      10      10      10        41
 
H.R. 5329, Poison Center Network Enhancement Act of
 2018:
    Authorization Level..............................       0      30      30      30      30      30       151
    Estimated Outlays................................       0      12      25      29      29      29       125
 
H.R. 5353, Eliminating Opioid-Related Infectious
 Diseases Act of 2018:
    Authorization Level..............................       0      40      40      40      40      40       200
    Estimated Outlays................................       0      15      34      38      39      40       166
 
H.R. 5580, Surveillance and Testing of Opioids to
 Prevent Fentanyl Deaths Act of 2018:
    Authorization Level..............................      30      30      30      30      30       0       120
    Estimated Outlays................................       0      11      25      29      29      19       113
 
H.R. 5587, Peer Support Communities of Recovery Act:
    Authorization Level..............................       0      15      15      15      15      15        75
    Estimated Outlays................................       0       5      13      14      15      15       62
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between zero and $500,000.

    H.R. 4684, the Ensuring Access to Quality Sober Living Act, 
would direct the Secretary of HHS to develop and disseminate 
best practices for organizations that operate housing designed 
for people recovering from substance use disorders. The bill 
would authorize a total of $3 million over the 2019-2021 period 
for that purpose. Based on historical spending patterns for 
similar activities, CBO estimates that implementing H.R. 4684 
would cost $3 million over the 2019-2023 period.
    H.R. 5102, the Substance Use Disorder Workforce Loan 
Repayment Act of 2018, would establish a loan repayment program 
for mental health professionals who practice in areas with few 
mental health providers or with high rates of death from 
overdose and would authorize $25 million per year over the 
2019-2028 period for that purpose. Based on historical spending 
patterns for similar activities, CBO estimates that 
implementing H.R. 5102 would cost $100 million over the 2019-
2023 period; the remaining amounts would be spent in years 
after 2023.
    H.R. 5176, the Preventing Overdoses While in Emergency 
Rooms Act of 2018, would require the Secretary of HHS to 
develop protocols and a grant program for health care providers 
to address the needs of people who survive a drug overdose, and 
it would authorize $50 million in 2019 for that purpose. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5176 would cost $50 million 
over the 2019-2023 period.
    H.R. 5197, the Alternatives to Opioids (ALTO) in the 
Emergency Department Act, would direct the Secretary of HHS to 
carry out a demonstration program for hospitals and emergency 
departments to develop alternative protocols for pain 
management that limit the use of opioids and would authorize 
$10 million annually in grants for fiscal years 2019 through 
2021. Based on historical spending patterns for similar 
programs, CBO estimates that implementing H.R. 5197 would cost 
$30 million over the 2019-2023 period.
    H.R. 5261, the Treatment, Education, and Community Help to 
Combat Addiction Act of 2018, would direct the Secretary of HHS 
to designate regional centers of excellence to improve the 
training of health professionals who treat substance use 
disorders. The bill would authorize $4 million annually for 
grants to those programs over the 2019-2023 period. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5261 would cost $16 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    H.R. 5327, the Comprehensive Opioid Recovery Centers Act of 
2018, would direct the Secretary of HHS to award grants to at 
least 10 providers that offer treatment services for people 
with opioid use disorder, and it would authorize $10 million 
per year over the 2019-2023 period for that purpose. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5327 would cost $41 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    H.R. 5329, the Poison Center Network Enhancement Act of 
2018, would reauthorize the poison control center toll-free 
number, national media campaign, and grant program under the 
Public Health Service Act. Among other actions, H.R. 5329 would 
increase the share of poison control center funding that could 
be provided by federal grants. The bill would authorize a total 
of about $30 million per year over the 2019-2023 period. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5329 would cost $125 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    H.R 5353, the Eliminating Opioid Related Infectious 
Diseases Act of 2018, would amend Public Health Service Act by 
broadening the focus of surveillance and education programs 
from preventing and treating hepatitis C virus to preventing 
and treating infections associated with injection drug use. It 
would authorize $40 million per year over 2019-2023 period for 
that purpose. Based on historical spending patterns for similar 
activities, CBO estimates that implementing H.R. 5353 would 
cost $166 million over the 2019-2023 period; the remaining 
amounts would be spent in years after 2023.
    H.R. 5580, the Surveillance and Testing of Opioids to 
Prevent Fentanyl Deaths Act of 2018, would establish a grant 
program for public health laboratories that conduct testing for 
fentanyl and other synthetic opioids. It also would direct the 
Centers for Disease Control and Prevention to expand its drug 
surveillance program, with a particular focus on collecting 
data on fentanyl. The bill would authorize a total of $30 
million per year over the 2018-2022 period for those 
activities. Based on historical spending patterns for similar 
activities, CBO estimates that implementing H.R. 5580 would 
cost $113 million over the 2019-2023 period; the remaining 
amounts would be spent in years after 2023.
    H.R. 5587, Peer Support Communities of Recovery Act, would 
direct the Secretary of HHS to award grants to nonprofit 
organizations that support community-based, peer-delivered 
support, including technical support for the establishment of 
recovery community organizations, independent, nonprofit groups 
led by people in recovery and their families. The bill would 
authorize $15 million per year for the 2019-2023 period. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5587 would cost $62 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    Estimated Authorizations. Table 3 shows CBO's estimates of 
the appropriations that would be necessary to implement 19 of 
the bills. Spending would be subject to appropriation of those 
amounts.
    H.R. 449, the Synthetic Drug Awareness Act of 2018, would 
require the Surgeon General to report to the Congress on the 
health effects of synthetic psychoactive drugs on children 
between the ages of 12 and 18. Based on spending patterns for 
similar activities, CBO estimates that implementing H.R. 449 
would cost approximately $1 million over the 2019-2023 period.
    H.R. 4005, the Medicaid Reentry Act, would direct the 
Secretary of HHS to convene a group of stakeholders to develop 
and report to the Congress on best practices for addressing 
issues related to health care faced by those returning from 
incarceration to their communities. The bill also would require 
the Secretary to issue a letter to state Medicaid directors 
about relevant demonstration projects. Based on an analysis of 
anticipated workload, CBO estimates that implementing H.R. 4005 
would cost less than $500,000 over the 2018-2023 period.
    H.R. 4275, the Empowering Pharmacists in the Fight Against 
Opioid Abuse Act, would require the Secretary of HHS to develop 
and disseminate materials for training pharmacists, health care 
practitioners, and the public about the circumstances under 
which a pharmacist may decline to fill a prescription. Based on 
historical spending patterns for similar activities, CBO 
estimates that costs to the federal government for the 
development and distribution of those materials would not be 
significant.

          TABLE 3.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH ESTIMATED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
                                                              By fiscal year, in millions of dollars--
                                                   -------------------------------------------------------------
                                                     2018   2019     2020     2021     2022     2023   2019-2023
----------------------------------------------------------------------------------------------------------------
                                 INCREASES IN SPENDING SUBJECT TO APPROPRIATION
 
H.R. 449, Synthetic Drug Awareness Act of 2018:
    Estimated Authorization Level.................      0       *        *        *        0        0         1
    Estimated Outlays.............................      0       *        *        *        0        0         1
 
H.R. 4005, Medicaid Reentry Act:
    Estimated Authorization Level.................      *       *        0        0        0        0         *
    Estimated Outlays.............................      *       *        0        0        0        0         *
 
H.R. 4275, Empowering Pharmacists in the Fight
 Against Opioid Abuse Act:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5009, Jessie's Law:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5041, Safe Disposal of Unused Medication Act:      0       *        *        *        *        *         *
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5272, Reinforcing Evidence-Based Standards
 Under Law in Treating Substance Abuse Act of
 2018:
    Estimated Authorization Level.................      0       1        1        1        1        1         4
    Estimated Outlays.............................      0       1        1        1        1        1         4
 
H.R. 5333, Over-the-Counter Monograph Safety,
 Innovation, and Reform Act of 2018:a
    Food and Drug Administration:
        Collections from fees:
            Estimated Authorization Level.........      0     -22      -22      -26      -35      -42      -147
            Estimated Outlays.....................      0     -22      -22      -26      -35      -42      -147
        Spending of fees:
            Estimated Authorization Level.........      0      22       22       26       35       42       147
            Estimated Outlays.....................      0       6       17       30       44       41       137
        Net effect on FDA:
            Estimated Authorization Level.........      0       0        0        0        0        0         0
            Estimated Outlays.....................      0     -17       -6        4        9        *       -10
    Government Accountability Office:
        Estimated Authorization Level.............      0       0        0        0        0        *         *
        Estimated Outlays.........................      0       0        0        0        0        *         *
    Total, H.R. 5333:
        Estimated Authorization Level.............      0       0        0        0        0        *         *
        Estimated Outlays.........................      0     -17       -6        4        9        *       -10
 
H.R. 5473, Better Pain Management Through Better
 Data Act of 2018:
    Estimated Authorization Level.................      0       *        *        *        *        0         1
    Estimated Outlays.............................      0       *        *        *        *        *         1
 
H.R. 5483, Special Registration for Telemedicine
 Clarification Act of 2018:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5554, Animal Drug and Animal Generic Drug
 User Fee Amendments of 2018:
    Collections from fees:
        Animal drug fees..........................      0     -30      -31      -32      -33      -34      -159
        Generic animal drug fees..................      0     -18      -19      -19      -20      -21       -97
            Total, Estimated Authorization Level..      0     -49      -50      -51      -53      -55      -257
            Total, Estimated Outlays..............      0     -40      -50      -51      -53      -55      -257
    Spending of fees:
        Animal drug fees..........................      0      30       31       32       33       34       159
        Generic animal drug fees..................      0      18       19       19       20       21        97
            Total, Estimated Authorization Level..      0      49       50       51       53       55       257
            Total, Estimated Outlays..............      0      39       47       51       52       54       243
    Net changes in fees:
        Estimated Authorization Level.............      0       0        0        0        0        0         0
        Estimated Outlays.........................      0     -10       -3        *        *        *       -14
    Other effects:
        Estimated Authorization Level.............      0       3        1        1        1        1         6
        Estimated Outlays.........................      0       2        1        1        1        1         6
    Total, H.R. 5554:
        Estimated Authorization Level.............      0       3        1        1        1        1         6
        Estimated Outlays.........................      0      -8       -2        1        *        *        -8
 
H.R. 5582, Abuse Deterrent Access Act of 2018:
    Estimated Authorization Level.................      0       0        *        0        0        0         *
    Estimated Outlays.............................      0       0        *        0        0        0         *
 
H.R. 5590, Opioid Addiction Action Plan Act:
    Estimated Authorization Level.................      *       *        *        *        *        *         2
    Estimated Outlays.............................      *       *        *        *        *        *         2
 
H.R. 5687, Securing Opioids and Unused Narcotics
 with Deliberate Disposal and Packaging Act of
 2018:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *         *
 
H.R. 5715, Strengthening Partnerships to Prevent
 Opioid Abuse Act:
    Estimated Authorization Level.................      0       2        2        2        2        2         9
    Estimated Outlays.............................      0       2        2        2        2        2         9
 
H.R. 5789, a bill to require the Secretary of
 Health and Human Services to issue guidance to
 improve care for infants with neonatal abstinence
 syndrome and their mothers, and to require the
 Comptroller General of the United States to
 conduct a study on gaps in Medicaid coverage for
 pregnant and postpartum women with substance use
 disorder:
    Estimated Authorization Level.................      0       2        0        0        0        0         2
    Estimated Outlays.............................      0       2        0        0        0        0         2
 
H.R. 5795, Overdose Prevention and Patient Safety
 Act:
    Estimated Authorization Level.................      0       1        0        0        0        0         1
    Estimated Outlays.............................      0       1        0        0        0        0         1
 
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act:
    Estimated Authorization Level.................      0       1        0        0        0        0         1
    Estimated Outlays.............................      0       *        *        0        0        0         1
 
H.R. 5804, Post-Surgical Injections as an Opioid
 Alternative Act:a
    Estimated Authorization Level.................      0       0        0        0        1        1         1
    Estimated Outlays.............................      0       0        0        0        1        1         1
 
H.R. 5811, a bill to amend the Federal Food, Drug,
 and Cosmetic Act with respect to postapproval
 study requirements for certain controlled
 substances, and for other purposes:
    Estimated Authorization Level.................      0       *        *        *        *        *         *
    Estimated Outlays.............................      0       *        *        *        *        *        *
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000.
aThis bill also would affect mandatory spending (see Table 1).

    H.R. 5009, Jessie's Law, would require HHS, in 
collaboration with outside experts, to develop best practices 
for displaying information about opioid use disorder in a 
patient's medical record. HHS also would be required to develop 
and disseminate written materials annually to health care 
providers about what disclosures could be made while still 
complying with federal laws that govern health care privacy. 
Based on spending patterns for similar activities, CBO 
estimates that implementing H.R. 5009 would have an 
insignificant effect on spending over the 2019-2023 period.
    H.R. 5041, the Safe Disposal of Unused Medication Act, 
would require hospice programs to have written policies and 
procedures for the disposal of controlled substances after a 
patient's death. Certain licensed employees of hospice programs 
would be permitted to assist in the disposal of controlled 
substances that were lawfully dispensed. Using information from 
the Department of Justice (DOJ), CBO estimates that 
implementing the bill would cost less than $500,000 over the 
2019-2023 period.
    H.R. 5272, the Reinforcing Evidence-Based Standards Under 
Law in Treating Substance Abuse Act of 2018, would require the 
newly established National Mental Health and Substance Use 
Policy Laboratory to issue guidance to applicants for SAMHSA 
grants that support evidence-based practices. Using information 
from HHS about the historical cost of similar activities, CBO 
estimates that enacting this bill would cost approximately $4 
million over the 2019-2023 period.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would change the FDA's 
oversight of the commercial marketing of OTC medicines and 
authorize the collection and spending of fees through 2023 to 
cover the costs of expediting the FDA's administrative 
procedures for certain regulatory activities relating to OTC 
products. Under H.R. 5333, CBO estimates, the FDA would assess 
about $147 million in fees over the 2019-2023 period that could 
be collected and made available for obligation only to the 
extent and in the amounts provided in advance in appropriation 
acts. Because the FDA could spend those fees, CBO estimates 
that the estimated budget authority for collections and 
spending would offset each other exactly in each year, although 
CBO expects that spending initially would lag behind 
collections. Assuming appropriation action consistent with the 
bill, CBO estimates that implementing H.R. 5333 would reduce 
net discretionary outlays by $10 million over the 2019-2023 
period, primarily because of that lag. The bill also would 
require the Government Accountability Office to study exclusive 
market protections for certain qualifying OTC drugs authorized 
by the bill--a provision that CBO estimates would cost less 
than $500,000. (If enacted, H.R. 5333 also would affect 
mandatory spending; see Table 1.)
    H.R. 5473, the Better Pain Management Through Better Data 
Act of 2018, would require that the FDA conduct a public 
meeting and issue guidance to industry addressing data 
collection and labeling for medical products that reduce pain 
while enabling the reduction, replacement, or avoidance of oral 
opioids. Using information from the agency, CBO estimates that 
implementing H.R. 5473 would cost about $1 million over the 
2019-2023 period.
    H.R. 5483, the Special Registration for Telemedicine 
Clarification Act of 2018, would direct DOJ, within one year of 
the bill's enactment, to issue regulations concerning the 
practice of telemedicine (for remote diagnosis and treatment of 
patients). Using information from DOJ, CBO estimates that 
implementing the bill would cost less than $500,000 over the 
2019-2023 period.
    H.R. 5554, the Animal Drug and Animal Generic Drug User Fee 
Amendments of 2018, would authorize the FDA to collect and 
spend fees to cover the cost of expedited approval for the 
development and marketing of certain drugs for use in animals. 
The legislation would extend through fiscal year 2023, and make 
several changes to, the FDA's existing approval processes and 
fee programs for brand-name and generic veterinary drugs, which 
expire at the end of fiscal year 2018. CBO estimates that 
implementing H.R. 5554 would reduce net discretionary outlays 
by $8 million over the 2019-2023 period, primarily because the 
spending of fees lags somewhat behind their collection.
    Fees authorized under the bill would supplement funds 
appropriated to cover the FDA's cost of reviewing certain 
applications and investigational submissions for brand-name and 
generic drugs for use in animals. Those fees could be collected 
and made available for obligation only to the extent and in the 
amounts provided in advance in appropriation acts. Under H.R. 
5554, CBO estimates, the FDA would assess about $257 million in 
fees over the 2019-2023 period. Because the FDA could spend 
those funds, CBO estimates that budget authority for 
collections and spending would offset each other exactly in 
each year. CBO estimates that the delay between collecting and 
spending fees under the reauthorized programs would reduce net 
discretionary outlays by $14 million over the 2019-2023 period, 
assuming appropriation actions consistent with the bill.
    Enacting H.R. 5554 would increase the FDA's workload 
because the legislation would expand eligibility for 
conditional approval for certain drugs. The agency's 
administrative costs also would increase because of regulatory 
activities required by a provision concerning petitions for 
additives intended for use in animal food. H.R. 5554 also would 
require the FDA to publish guidance or produce regulations on a 
range of topics, transmit a report to the Congress, and hold 
public meetings. CBO expects that the costs associated with 
those activities would not be covered by fees, and it estimates 
that implementing such provisions would cost $6 million over 
the 2019-2023 period.
    H.R. 5582, the Abuse Deterrent Access Act of 2018, would 
require the Secretary of HHS to report to the Congress on 
existing barriers to access to ``abuse-deterrent opioid 
formulations'' by Medicare Part C and D beneficiaries. Such 
formulations make the drugs more difficult to dissolve for 
injection, for example, and thus can impede their abuse. 
Assuming the availability of appropriated funds and based on 
historical spending patterns for similar activities, CBO 
estimates that implementing the legislation would cost less 
than $500,000 over the 2019-2023 period.
    H.R. 5590, the Opioid Addiction Action Plan Act, would 
require the Secretary of HHS to develop an action plan by 
January 1, 2019, for increasing access to medication-assisted 
treatment among Medicare and Medicaid enrollees. The bill also 
would require HHS to convene a stakeholder meeting and issue a 
request for information within three months of enactment, and 
to submit a report to the Congress by June 1, 2019. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5590 would cost approximately 
$2 million over the 2019-2023 period.
    H.R. 5687, the Securing Opioids and Unused Narcotics with 
Deliberate Disposal and Packaging Act of 2018, would permit the 
FDA to require certain packaging and disposal technologies, 
controls, or measures to mitigate the risk of abuse and misuse 
of drugs. Based on information from the FDA, CBO estimates that 
implementing H.R. 5687 would not significantly affect spending 
over the 2019-2023 period. This bill would also require that 
the GAO study the effectiveness and use of packaging 
technologies for controlled substances--a provision that CBO 
estimates would cost less than $500,000.
    H.R. 5715, the Strengthening Partnerships to Prevent Opioid 
Abuse Act, would require the Secretary of HHS to establish a 
secure Internet portal to allow HHS, Medicare Advantage plans, 
and Medicare Part D plans to exchange information about fraud, 
waste, and abuse among providers and suppliers no later than 
two years after enactment. H.R. 5715 also would require 
organizations with Medicare Advantage contracts to submit 
information on investigations related to providers suspected of 
prescribing large volumes of opioids through a process 
established by the Secretary no later than January 2021. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5715 would cost approximately 
$9 million over the 2019-2023 period.
    H.R. 5789, a bill to require the Secretary of Health and 
Human Services to issue guidance to improve care for infants 
with neonatal abstinence syndrome and their mothers, and to 
require the Comptroller General of the United States to conduct 
a study on gaps in Medicaid coverage for pregnant and 
postpartum women with substance use disorder, would direct the 
Secretary of HHS to issue guidance to states on best practices 
under Medicaid and CHIP for treating infants with neonatal 
abstinence syndrome. H.R. 5789 also would direct the Government 
Accountability Office to study Medicaid coverage for pregnant 
and postpartum women with substance use disorders. Based on 
inforation from HHS and historical spending patterns for 
similar activities, CBO estimates that enacting H.R. 5789 would 
cost approximately $2 million over the 2019-2023 period.
    H.R. 5795, the Overdose Prevention and Patient Safety Act, 
would amend the Public Health Service Act so that requirements 
pertaining to the confidentiality and disclosure of medical 
records relating to substance use disorders align with the 
provisions of the Health Insurance Portability and 
Accountability Act of 1996. The bill would require the Office 
of the Secretary of HHS to issue regulations prohibiting 
discrimination based on data disclosed from such medical 
records, to issue regulations requiring covered entities to 
provide written notice of privacy practices, and to develop 
model training programs and materials for health care providers 
and patients and their families. Based on spending patterns for 
similar activities, CBO estimates that implementing H.R. 5795 
would cost approximately $1 million over the 2019-2023 period.
    H.R. 5800, Medicaid IMD ADDITIONAL INFO Act, would direct 
the Medicaid and CHIP Payment and Access Commission to study 
institutions for mental diseases in a representative sample of 
states. Based on information from the commission about the cost 
of similar work, CBO estimates that implementing H.R. 5800 
would cost about $1 million over the 2019-2023 period.
    H.R. 5804, the Post-Surgical Injections as an Opioid 
Alternative Act, would freeze the Medicare payment rate for 
certain analgesic injections provided in ambulatory surgical 
centers. The bill also would mandate two studies of Medicare 
coding and payments arising from enactment of this legislation. 
Based on the cost of similar activities, CBO estimates that 
those reports would cost $1 million over the 2019-2023 period. 
(If enacted, H.R. 5804 also would affect mandatory spending; 
see Table 1.)
    H.R. 5811, a bill to amend the Federal Food, Drug, and 
Cosmetic Act with respect to postapproval study requirements 
for certain controlled substances, and for other purposes, 
would allow the FDA to require that pharmaceutical 
manufacturers study certain drugs after they are approved to 
assess any potential reduction in those drugs' effectiveness 
for the conditions of use prescribed, recommended, or suggested 
in labeling. CBO anticipates that implementing H.R. 5811 would 
not significantly affect the FDA's costs over the 2019-2023 
period.
    Other Authorizations. The following nine bills would 
increase authorization levels, but CBO has not completed 
estimates of amounts. All authorizations would be subject to 
future appropriation action.
           H.R. 4284, Indexing Narcotics, Fentanyl, and 
        Opioids Act of 2017
           H.R. 5002, Advancing Cutting Edge Research 
        Act
           H.R. 5228, Stop Counterfeit Drugs by 
        Regulating and Enhancing Enforcement Now Act (see Table 
        1 for an estimate of the revenue effects of H.R. 5228)
           H.R. 5752, Stop Illicit Drug Importation Act 
        of 2018 (see Table 1 for an estimate of the revenue 
        effects of H.R. 5752)
           H.R. 5799, Medicaid DRUG Improvement Act 
        (see Table 1 for an estimate of the direct spending 
        effects of H.R. 5799)
           H.R. 5801, Medicaid Providers and 
        Pharmacists Are Required to Note Experiences in Record 
        Systems to Help In-Need Patients (PARTNERSHIP) Act (see 
        Table 1 for an estimate of the direct spending effects 
        of H.R. 5801)
           H.R. 5806, 21st Century Tools for Pain and 
        Addiction Treatments Act
           H.R. 5808, Medicaid Pharmaceutical Home Act 
        of 2018 (see Table 1 for an estimate of the direct 
        spending effects of H.R. 5808)
           H.R. 5812, Creating Opportunities that 
        Necessitate New and Enhanced Connections That Improve 
        Opioid Navigation Strategies Act (CONNECTIONS) Act
    Pay-As-You-Go considerations: The Statutory Pay-As-You-Go 
Act of 2010 establishes budget-reporting and enforcement 
procedures for legislation affecting direct spending or 
revenues. Twenty-two of the bills discussed in this document 
contain direct spending or revenues and are subject to pay-as-
you-go procedures. Details about the amount of direct spending 
and revenues in those bills can be found in Table 1.
    Increase in long-term direct spending and deficits: CBO 
estimates that enacting H.R. 4998, the Health Insurance for 
Former Foster Youth Act, would increase net direct spending by 
more than $2.5 billion and on-budget deficits by more than $5 
billion in at least one of the four consecutive 10-year periods 
beginning in 2029.
    CBO estimates that none of the remaining 58 bills included 
in this estimate would increase net direct spending by more 
than $2.5 billion or on-budget deficits by more than $5 billion 
in any of the four consecutive 10-year periods beginning in 
2029.
    Mandates: One of the 59 bills included in this document, 
H.R. 5795, would impose both intergovernmental and private-
sector mandates as defined in UMRA. CBO estimates that the 
costs of that bill's mandates on public and private entities 
would fall below UMRA's thresholds ($80 million and $160 
million, respectively, for public- and private-sector entities 
in 2018, adjusted annually for inflation).
    In addition, five bills would impose private-sector 
mandates as defined in UMRA. CBO estimates that the costs of 
the mandates in three of those bills (H.R. 5333, H.R. 5554, and 
H.R. 5811) would fall below the UMRA threshold. Because CBO 
does not know how federal agencies would implement new 
authority granted in the other two of those five bills, H.R. 
5228 and 5687, CBO cannot determine whether the costs of their 
mandates would exceed the threshold.
    For large entitlement grant programs, including Medicaid 
and CHIP, UMRA defines an increase in the stringency of 
conditions on states or localities as an intergovernmental 
mandate if the affected governments lack authority to offset 
those costs while continuing to provide required services. 
Because states possess significant flexibility to alter their 
responsibilities within Medicaid and CHIP, the requirements 
imposed by various bills in the markup on state administration 
of those programs would not constitute mandates as defined in 
UMRA.

Mandates Affecting Public and Private Entities

    H.R. 5795, the Overdose Prevention and Patient Safety Act, 
would impose intergovernmental and private-sector mandates by 
requiring entities that provide treatment for substance use 
disorders to notify patients of their privacy rights and also 
to notify patients in the event that the confidentiality of 
their records is breached. In certain circumstances, H.R. 5795 
also would prohibit public and private entities from denying 
entry to treatment on the basis of information in patient 
health records. Those requirements would either supplant or 
narrowly expand responsibilities under existing law, and 
compliance with them would not impose significant additional 
costs. CBO estimates that the costs of the mandates would fall 
below the annual thresholds established in UMRA.

Mandates Affecting Private Entities

    Five bills included in this document would impose private-
sector mandates:
    H.R. 5228, the Stop Counterfeit Drugs by Regulating and 
Enhancing Enforcement Now Act, would require drug distributors 
to cease distributing any drug that the Secretary of HHS 
determines might present an imminent or substantial hazard to 
public health. CBO cannot determine what drugs could be subject 
to such an order nor can it determine how private entities 
would respond. Consequently, CBO cannot determine whether the 
aggregate cost of the mandate would exceed the annual threshold 
for private-sector mandates.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would require developers 
and manufacturers of OTC drugs to pay certain fees to the FDA. 
CBO estimates that about $30 million would be collected each 
year, on average, for a total of $147 million over the 2019-
2023 period. Those amounts would not exceed the annual 
threshold for private-sector mandates in any year during that 
period.
    H.R. 5554, the Animal Drug and Animal Generic Drug User Fee 
Amendments of 2018, would require developers and manufacturers 
of brand-name and generic veterinary drugs to pay application, 
product, establishment, and sponsor fees to the FDA. CBO 
estimates that about $51 million would be collected annually, 
on average, for a total of $257 million over the 2019-2023 
period. Those amounts would not exceed the annual threshold for 
private-sector mandates in any year during that period.
    H.R. 5687, the Securing Opioids and Unused Narcotics with 
Deliberate Disposal and Packaging Act of 2018, would permit the 
Secretary of HHS to require drug developers and manufacturers 
to implement new packaging and disposal technology for certain 
drugs. Based on information from the agency, CBO expects that 
the Secretary would use the new regulatory authority provided 
in the bill; however, it is uncertain how or when those 
requirements would be implemented. Consequently, CBO cannot 
determine whether the aggregate cost of the mandate would 
exceed the annual threshold for private entities.
    H.R. 5811, a bill to amend the Federal Food, Drug, and 
Cosmetic Act with respect to postapproval study requirements 
for certain controlled substances, and for other purposes, 
would expand an existing mandate that requires drug developers 
to conduct postapproval studies or clinical trials for certain 
drugs. Under current law, in certain instances, the FDA can 
require studies or clinical trials after a drug has been 
approved. H.R. 5811 would permit the FDA to use that authority 
if the reduction in a drug's effectiveness meant that its 
benefits no longer outweighed its costs. CBO estimates that the 
incremental cost of the mandate would fall below the annual 
threshold established in UMRA because of the small number of 
drugs affected and the narrow expansion of the authority that 
exists under current law.
    None of the remaining 53 bills included in this document 
would impose an intergovernmental or private-sector mandate.
    Previous CBO estimate: On June 6, 2018, CBO issued an 
estimate for seven opioid-related bills ordered reported by the 
House Committee on Ways and Means on May 16, 2018. Two of those 
bills contain provisions that are identical or similar to the 
legislation ordered reported by the Committee on Energy and 
Commerce, and for those provisions, CBO's estimates are the 
same.
    In particular, five bills listed in this estimate contain 
provisions that are identical or similar to those in several 
sections of H.R. 5773, the Preventing Addiction for Susceptible 
Seniors Act of 2018:
       H.R. 5675, which would require prescription drug 
plans to implement drug management programs, is identical to 
section 2 of H.R. 5773.
       H.R. 4841, regarding electronic prior 
authorization for prescriptions under Medicare's Part D, is 
similar to section 3 of H.R. 5773.
       H.R. 5715, which would mandate the creation of a 
new Internet portal to allow various stakeholders to exchange 
information, is identical to section 4 of H.R. 5773.
       H.R. 5684, which would expand medication therapy 
management, is the same as section 5 of H.R. 5773.
       H.R. 5716, regarding prescriber notification, is 
identical to section 6 of H.R. 5773.
    In addition, in this estimate, a provision related to 
Medicare beneficiary education in H.R. 5686, the Medicare Clear 
Health Options in Care for Enrollees Act of 2018, is the same 
as a provision in section 2 of H.R. 5775, the Providing 
Reliable Options for Patients and Educational Resources Act of 
2018, in CBO's estimate for the Committee on Ways and Means.
    Estimate prepared by: Federal Costs: Rebecca Yip (Centers 
for Disease Control and Prevention), Mark Grabowicz (Drug 
Enforcement Agency), Julia Christensen, Ellen Werble (Food and 
Drug Administration), Emily King, Andrea Noda, Lisa Ramirez-
Branum, Robert Stewart (Medicaid and Children's Health 
Insurance Program), Philippa Haven, Lara Robillard, Colin Yee, 
Rebecca Yip (Medicare), Philippa Haven (National Institutes of 
Health), Alice Burns, Andrea Noda (Office of the Secretary of 
the Department of Health and Human Services), Philippa Haven, 
Lori Housman, Emily King (Substance Abuse and Mental Health 
Services Administration, Health Resources and Services 
Administration); Federal Revenues: Jacob Fabian, Peter Huether, 
and Cecilia Pastrone; Fact Checking: Zachary Byrum and Kate 
Kelly; Mandates: Andrew Laughlin.
    Estimate reviewed by: Tom Bradley, Chief Health Systems and 
Medicare Cost Estimates Unit; Chad M. Chirico, Chief Low-Income 
Health Programs and Prescription Drugs Cost Estimates Unit; 
Sarah Masi, Special Assistant for Health; Susan Willie, Chief, 
Mandates Unit; Leo Lex, Deputy Assistant Director for Budget 
Analysis; Theresa A. Gullo, 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.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to improve 
the treatment SUD by permitting the use and disclosure of 
relevant treatment information for the purposes of treatment, 
payment, and health care operations between covered entities.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 5795 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, 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.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 5795 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                  Disclosure of Directed Rule Makings

    Pursuant to section 3(i) of H. Res. 5, the following 
directed rule makings are contained in H.R. 5795:
     The Secretary of Health and Human Services, in 
consultation with appropriate Federal agencies, shall make such 
revisions to regulations as may be necessary for implementing 
and enforcing the amendments made by the legislation with 
respect to uses and disclosures of information occurring on or 
after the date that is 12 months after the date of enactment of 
the legislation.
     Not later than 1 year after the date of enactment 
of the legislation, the Secretary of Health and Human Services, 
in consultation with appropriate experts, shall update section 
164.520 of title 45, Code of Federal Regulations, so that 
covered entities provide notice, written in plain language, of 
privacy practices regarding patient records referred to in 
section 543(a) of the Public Health Service Act (42 U.S.C. 
290dd-2(a)).

                      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 
``Overdose Prevention and Patient Safety Act.''

Section 2. Confidentiality and disclosure of records relating to 
        substance use disorder

    Subsection (a) changes the term ``substance abuse'' to 
``substance use disorder.''
    Subsection (b) allows for the sharing of patient records 
referred to in section 543(a) of the Public Health Service Act, 
among covered entities for the purposes of treatment, payment, 
and health care operations.
    Subsection (c) allows for the sharing of patient records 
referred to in section 543(a) of the Public Health Service Act, 
with a public health authority so long as the information is 
de-identified.
    Subsection (d) defines covered entity, health care 
operations, HIPAA privacy regulation, individually identifiable 
health information, payment, public health authority, and 
treatment.
    Except as otherwise authorized by patient consent or a 
court order, subsection (e) prohibits patient records referred 
to in section 543(a) of the Public Health Service Act from 
being entered into evidence in any criminal prosecution or 
civil action before a Federal or State court; to be used as 
part of the record for decision in any proceeding before a 
Federal agency; to be used by any Federal, State, or local 
agency for a law enforcement purpose or law enforcement 
investigation of a patient; or to be used in the application of 
a warrant.
    Subsection (f) aligns the penalties under section 543 of 
the Public Health Service Act with the penalties under sections 
1176 and 1177 of the Social Security Act.
    Subsection (g) prohibits discrimination against an 
individual on the basis of their patient records referred to in 
section 543(a) of the Public Health Service Act in admission or 
treatment for healthcare; hiring or terms of employment; the 
sale or rental of housing; and access to Federal, State, or 
local courts. Subsection (g) also prohibits recipients of 
Federal funds from discriminating against an individual on the 
basis of their patient records referred to in section 543(a) of 
the Public Health Service Act.
    Subsection (h) establishes breach notification requirements 
of section 13402 of the HITECH Act in the case of a data breach 
of information referred to in section 543(a) of the Public 
Health Service Act.
    Subsection (i) states that it is the sense of Congress that 
any person treating a patient through a program or activity 
with respect to which the requirements of section 543 of the 
Public Health Service Act apply should access the applicable 
State-based prescription drug monitoring program as a 
precaution against substance use disorder.
    Subsection (j) requires the Secretary of Health and Human 
Services, in consultation with appropriate Federal agencies, to 
make revisions to regulations as may be necessary for 
implementing and enforcing the amendments made by the 
legislation. The Secretary of Health and Human Services must 
update Federal regulations so that covered entities provide 
notice, written in plain language, of privacy practices 
regarding patient records referred to in section 543(a) of the 
Public Health Service Act.
    Subsection (k) requires the Secretary of Health and Human 
Services to create model programs and materials to train health 
care providers on the permitted uses and disclosures of patient 
records referred to in section 543(a) of the Public Health 
Service Act. The Secretary must also create model programs and 
materials for teaching patients and their families their rights 
to protect and obtain information under section 543 of the 
Public Health Service Act.
    Subsection (l) states that nothing in this legislation 
shall be construed to limit a patient's right to request a 
restriction on the use or disclosure of a record referred to in 
section 543(a) of the Public Health Service Act for purposes of 
treatment, payment, or health care operations. Subsection (l) 
also states that nothing in this legislation shall be construed 
to limit a covered entity's choice to obtain the consent of the 
individual to use or disclose such record to carry out 
treatment, payment, or health care operations.
    Subsection (m) states that it is the sense of Congress that 
patients have the right to request a restriction on the use or 
disclosure of a record referred to in section 543(a) of the 
Public Health Service Act for treatment, payment, or health 
care operations, and that covered entities should make every 
reasonable effort to the extent feasible to comply with a 
patient's request for a restriction regarding such use or 
disclosure.

         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 (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, and existing law in which no 
change is proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT




           *       *       *       *       *       *       *
TITLE V--SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION

           *       *       *       *       *       *       *



Part D--Miscellaneous Provisions Relating to Substance Abuse and Mental 
Health

           *       *       *       *       *       *       *



SEC. 543. CONFIDENTIALITY OF RECORDS.

  (a) Requirement.--Records of the identity, diagnosis, 
prognosis, or treatment of any patient which are maintained in 
connection with the performance of any program or activity 
relating to [substance abuse] substance use disorder education, 
prevention, training, treatment, rehabilitation, or research, 
which is conducted, regulated, or directly or indirectly 
assisted by any department or agency of the United States 
shall, except as provided in subsection (e), be confidential 
and be disclosed only for the purposes and under the 
circumstances expressly authorized under subsection (b).
  (b) Permitted Disclosure.--
          (1) Consent.--The content of any record referred to 
        in subsection (a) may be disclosed in accordance with 
        the prior written consent of the patient with respect 
        to whom such record is maintained, but only to such 
        extent, under such circumstances, and for such purposes 
        as may be allowed under regulations prescribed pursuant 
        to subsection (g).
          (2) Method for disclosure.--Whether or not the 
        patient, with respect to whom any given record referred 
        to in subsection (a) is maintained, gives written 
        consent, the content of such record may be disclosed as 
        follows:
                  (A) To medical personnel to the extent 
                necessary to meet a bona fide medical 
                emergency.
                  (B) To qualified personnel for the purpose of 
                conducting scientific research, management 
                audits, financial audits, or program 
                evaluation, but such personnel may not 
                identify, directly or indirectly, any 
                individual patient in any report of such 
                research, audit, or evaluation, or otherwise 
                disclose patient identities in any manner.
                  (C) If authorized by an appropriate order of 
                a court of competent jurisdiction granted after 
                application showing good cause therefor, 
                including the need to avert a substantial risk 
                of death or serious bodily harm. In assessing 
                good cause the court shall weigh the public 
                interest and the need for disclosure against 
                the injury to the patient, to the physician-
                patient relationship, and to the treatment 
                services. Upon the granting of such order, the 
                court, in determining the extent to which any 
                disclosure of all or any part of any record is 
                necessary, shall impose appropriate safeguards 
                against unauthorized disclosure.
                  (D) To a covered entity or to a program or 
                activity described in subsection (a), for the 
                purposes of treatment, payment, and health care 
                operations, so long as such disclosure is made 
                in accordance with HIPAA privacy regulation. 
                Any redisclosure of information so disclosed 
                may only be made in accordance with this 
                section.
                  (E) To a public health authority, so long as 
                such content does not include any individually 
                identifiable health information and meets the 
                standards established in section 164.514 of 
                title 45, Code of Federal Regulations (or 
                successor regulations) for creating de-
                identified information.
          (3) Definitions.--For purposes of this subsection:
                  (A) Covered entity.--The term ``covered 
                entity'' has the meaning given such term for 
                purposes of HIPAA privacy regulation.
                  (B) Health care operations.--The term 
                ``health care operations'' has the meaning 
                given such term for purposes of HIPAA privacy 
                regulation.
                  (C) HIPAA privacy regulation.--The term 
                ``HIPAA privacy regulation'' has the meaning 
                given such term under section 1180(b)(3) of the 
                Social Security Act.
                  (D) Individually identifiable health 
                information.--The term ``individually 
                identifiable health information'' has the 
                meaning given such term for purposes of HIPAA 
                privacy regulation.
                  (E) Payment.--The term ``payment'' has the 
                meaning given such term for purposes of HIPAA 
                privacy regulation.
                  (F) Public health authority.--The term 
                ``public health authority'' has the meaning 
                given such term for purposes of HIPAA privacy 
                regulation.
                  (G) Treatment.--The term ``treatment'' has 
                the meaning given such term for purposes of 
                HIPAA privacy regulation.
  [(c) Use of Records in Criminal Proceedings.--Except as 
authorized by a court order granted under subsection (b)(2)(C), 
no record referred to in subsection (a) may be used to initiate 
or substantiate any criminal charges against a patient or to 
conduct any investigation of a patient.]
  (c) Use of Records in Criminal, Civil, or Administrative 
Contexts.--Except as otherwise authorized by a court order 
under subsection (b)(2)(C) or by the consent of the patient, a 
record referred to in subsection (a) may not--
          (1) be entered into evidence in any criminal 
        prosecution or civil action before a Federal or State 
        court;
          (2) form part of the record for decision or otherwise 
        be taken into account in any proceeding before a 
        Federal agency;
          (3) be used by any Federal, State, or local agency 
        for a law enforcement purpose or to conduct any law 
        enforcement investigation of a patient; or
          (4) be used in any application for a warrant.
  (d) Application.--The prohibitions of this section continue 
to apply to records concerning any individual who has been a 
patient, irrespective of whether or when such individual ceases 
to be a patient.
  (e) Nonapplicability.--The prohibitions of this section do 
not apply to any interchange of records--
          (1) within the Uniformed Services or within those 
        components of the Department of Veterans Affairs 
        furnishing health care to veterans; or
          (2) between such components and the Uniformed 
        Services.
The prohibitions of this section do not apply to the reporting 
under State law of incidents of suspected child abuse and 
neglect to the appropriate State or local authorities.
  [(f) Penalties.--Any person who violates any provision of 
this section or any regulation issued pursuant to this section 
shall be fined in accordance with title 18, United States 
Code.]
  (f) Penalties.--The provisions of sections 1176 and 1177 of 
the Social Security Act shall apply to a violation of this 
section to the extent and in the same manner as such provisions 
apply to a violation of part C of title XI of such Act. In 
applying the previous sentence--
          (1) the reference to ``this subsection'' in 
        subsection (a)(2) of such section 1176 shall be treated 
        as a reference to ``this subsection (including as 
        applied pursuant to section 543(f) of the Public Health 
        Service Act)''; and
          (2) in subsection (b) of such section 1176--
                  (A) each reference to ``a penalty imposed 
                under subsection (a)'' shall be treated as a 
                reference to ``a penalty imposed under 
                subsection (a) (including as applied pursuant 
                to section 543(f) of the Public Health Service 
                Act)''; and
                  (B) each reference to ``no damages obtained 
                under subsection (d)'' shall be treated as a 
                reference to ``no damages obtained under 
                subsection (d) (including as applied pursuant 
                to section 543(f) of the Public Health Service 
                Act)''.
  (g) Regulations.--Except as provided in subsection (h), the 
Secretary shall prescribe regulations to carry out the purposes 
of this section. Such regulations may contain such definitions, 
and may provide for such safeguards and procedures, including 
procedures and criteria for the issuance and scope of orders 
under subsection (b)(2)(C), as in the judgment of the Secretary 
are necessary or proper to effectuate the purposes of this 
section, to prevent circumvention or evasion thereof, or to 
facilitate compliance therewith.
  (h) Application to Department of Veterans Affairs.--The 
Secretary of Veterans Affairs, acting through the Chief Medical 
Director, shall, to the maximum feasible extent consistent with 
their responsibilities under title 38, United States Code, 
prescribe regulations making applicable the regulations 
prescribed by the Secretary of Health and Human Services under 
subsection (g) of this section to records maintained in 
connection with the provision of hospital care, nursing home 
care, domiciliary care, and medical services under such title 
38 to veterans suffering from [substance abuse] substance use 
disorder. In prescribing and implementing regulations pursuant 
to this subsection, the Secretary of Veterans Affairs shall, 
from time to time, consult with the Secretary of Health and 
Human Services in order to achieve the maximum possible 
coordination of the regulations, and the implementation 
thereof, which they each prescribe.
  (i) Antidiscrimination.--
          (1) In general.--No entity shall discriminate against 
        an individual on the basis of information received by 
        such entity pursuant to a disclosure made under 
        subsection (b) in--
                  (A) admission or treatment for health care;
                  (B) hiring or terms of employment;
                  (C) the sale or rental of housing; or
                  (D) access to Federal, State, or local 
                courts.
          (2) Recipients of federal funds.--No recipient of 
        Federal funds shall discriminate against an individual 
        on the basis of information received by such recipient 
        pursuant to a disclosure made under subsection (b) in 
        affording access to the services provided with such 
        funds.
  (j) Notification in Case of Breach.--
          (1) Application of hitech notification of breach 
        provisions.--The provisions of section 13402 of the 
        HITECH Act (42 U.S.C. 17932) shall apply to a program 
        or activity described in subsection (a), in case of a 
        breach of records described in subsection (a), to the 
        same extent and in the same manner as such provisions 
        apply to a covered entity in the case of a breach of 
        unsecured protected health information.
          (2) Definitions.--In this subsection, the terms 
        ``covered entity'' and ``unsecured protected health 
        information'' have the meanings given to such terms for 
        purposes of such section 13402.

           *       *       *       *       *       *       *


                            DISSENTING VIEWS

    H.R. 5795 could greatly harm efforts to combat the opioid 
epidemic. Confronting this tragic epidemic requires identifying 
strategies that promote more people with opioid use disorder 
(OUD) to enter and remain in treatment. Failure to do so leaves 
individuals and communities at increased risks of fatal and 
non-fatal overdoses, as people continue to seek out illicit 
opioids as part of their addiction. Unfortunately, H.R. 5795 
increases the odds that fewer individuals with OUD enter and 
remain in treatment due to the weaker privacy protections 
afforded to a patient's substance use disorder (SUD) records 
under this bill.
    Ensuring strong privacy protection is critical to 
maintaining individuals' trust in the health care system and 
willingness to obtain needed health services. These protections 
are especially important where very sensitive information is 
concerned. Information that may be contained in SUD treatment 
records is particularly sensitive because disclosure of SUD 
information has tangible vulnerabilities that are not the same 
as other medical conditions.
    H.R. 5795 would dramatically reduce the privacy protection 
provided to individuals with SUD. Unlike current law, H.R. 5795 
would allow a patient's SUD treatment records from Part 2 
programs to be disclosed and redisclosed without patient 
consent for purposes of treatment, payment, and health care 
operations (TPO) by Part 2 programs and covered entities, 
including health care providers, health insurers, and health 
care clearinghouses. That means that such records can be shared 
between these health care organizations, even in instances when 
a patient objects to such disclosures out of concern that 
negative consequences could result.
    By eliminating the patient consent requirement under 42 CFR 
Part 2 (Part 2) for TPO purposes, H.R. 5795 could result in 
individuals not seeking or remaining in treatment because they 
worry about the negative consequences that could result. 
According to the Substance Abuse and Mental Health Services 
Administration (SAMHSA), those negative consequences can 
include loss of employment, loss of housing, loss of child 
custody, discrimination by medical professionals and insurers, 
arrest, prosecution, and incarceration. Unlike other medical 
conditions, a person cannot be incarcerated for having a heart 
attack, legally fired for having cancer, or denied visitation 
with children due to severe acne.
    Such concerns led patient and provider groups to submit 
testimony and letters to this Committee expressing grave 
concerns with this legislation. For example, the South Carolina 
Association of Opioid Dependence explained, ``[e]ven with the 
growing awareness that substance use disorders are a disease, 
the unfortunate truth is that persons with a SUD are still 
actively discriminated against. This stigma and discrimination 
is heightened for individuals using Medication Assisted 
Treatments (MAT), such as treatment with methadone and 
buprenorphine (best known as Suboxone), to address their OUD. 
Every day in South Carolina we see examples of discriminatory 
practices towards the persons we serve. Such as a patient 
getting dropped by his Primary Care Physician's office and cut 
off from needed medications for his medical conditions when the 
physician found out the patient is receiving methadone for an 
OUD. Or a baby being taken away from a new mother because she 
is on methadone for an OUD despite longstanding compliance with 
her treatment and abstinence from illegal drug-use.''\1\
---------------------------------------------------------------------------
    \1\South Carolina Association for the Treatment of Opioid 
Dependence, Letter to Chairman Greg Walden and Ranking Member Frank 
Pallone RE: Opposition to H.R. 3545--``Overdose Prevention and Patient 
Safety Act'' and Support for Other Legislative Proposals to Preserve 
Confidentiality and Coordinate Care, Apr. 17, 2018.
---------------------------------------------------------------------------
    Another group, Raise the Bottom Addiction Treatment, one of 
two Medication Assisted Treatment facilities in Idaho, 
explained in expressing their opposition to this legislation 
``[o]ur patients come from every walk of life, including 
professionals and executives within our community. Their 
anonymity and privacy is of the utmost importance because their 
careers, families, and livelihood often depend on it. Knowing 
that people may seek treatment without fear of backlash and/or 
discrimination is often a deciding factor when considering 
entering treatment. To undo this protection will deeply affect 
one's ability and willingness to seek help. In Ada County 
alone, we suffered 8 deaths in the first 15 days of January due 
to overdose and suicide. Not only can the members of our 
community not afford to lose their right to confidentiality, 
but we as a nation cannot afford to move backwards in our fight 
to combat this opiate crisis.''\2\
---------------------------------------------------------------------------
    \2\Raise the Bottom Addiction Treatment, Letter to Chairman Greg 
Walden and Ranking Member Frank Pallone RE: Opposition to H.R. 3545--
``Overdose Prevention and Patient Safety Act'' and Support for Other 
Legislative Proposals to Preserve Confidentiality and Coordinate Care, 
May 17, 2018.
---------------------------------------------------------------------------
    Recent headlines also present the serious risk faced by 
individuals with OUD when their disease status is disclosed. In 
a recent opinion piece in the New York Daily News by Dr. 
Jessica Gregg, an associate professor of medicine at Oregon 
Health and Science University, and medical director of the 
Oregon Health and Science University (OHSU) addiction medicine 
Extension for Community Health Care Outcomes (ECHO) clinic, she 
relayed the story of how a nursing facility decided that a 
patient's opioid addiction made her ``too complicated'' and 
refused to provide her care to recover from an infection.\3\ In 
short, she wrote, quote: ``in a health-care setting, the 
problem with stigma associated with drug addiction isn't just 
that it hurts people's feelings, or that it is shaming, or that 
it is unjust--though all of these things are true.\4\ The 
problem with stigma is that patients with drug addiction get 
much, much worse care.''\5\
---------------------------------------------------------------------------
    \3\New York Daily News, The crippling stigma of drug addiction, May 
5, 2018, (http://www.nydailynews.com/opinion/crippling-stigma-drug-
addiction-article-1.3971945?outputType= amp&_twitter_impression=true)
    \4\Id.
    \5\Id.
---------------------------------------------------------------------------
    These concerns are exacerbated because of the continuing 
occurrence of data breaches and privacy violations. A recent 
survey by the Ponemon Institute of health IT practitioners 
found that half of health care organizations governed by Health 
Insurance Portability and Accountability Act (HIPAA) lost or 
exposed patient data at some point in the past year.\6\ In 
addition, the Breach Barometer Report by Protenus found that 
5.6 million patient records were exposed in 2017.\7\ A recent 
prominent example of such disclosures was resolved a few months 
ago when Aetna agreed to pay millions of dollars to remedy 
privacy violations that revealed some of their members' HIV 
status to many unauthorized entities through the clear window 
of envelopes. As a recent commentary in Baker Hostetler's Data 
Privacy Monitor notes, ``concern over data breaches often focus 
primarily on financial harms to the affected individuals, but 
the Aetna settlement serves as an important reminder that 
certain non-financial harms can be even more detrimental to 
those affected.''\8\ Members of the Aetna class action lawsuit 
reported damaged relationships with family or friends, loss of 
housing, extreme emotional distress and anxiety, and workplace 
issues.
---------------------------------------------------------------------------
    \6\Politico Pro DataPoint on Health Care, Survey, Half of HIPAA 
Organizations Lost or Exposed Data, Mar. 21, 2018.
    \7\Protenus, Inc., Brach Barometer Report: Year in Review 5.6M 
Patient Records Breached in 2017, as Healthcare Struggles to 
Comprehensively and Proactively Detect Health Data Breaches, 2017.
    \8\Baker Hostetler Data Privacy Monitor, Aetna Agrees to Pay $17 
million and Implement Best-Practices Policy to Settle Claims of HIV-
related Privacy Violations, Jan. 25, 2018, (https://
www.dataprivacymonitor.com/data-breaches/aetna-agrees-to-pay-17-
million-and-implement-best-practices-policy-to-settle-claims-of-hiv-
related-privacy-violations/).
---------------------------------------------------------------------------
    While H.R. 5795 attempts to address the concerns about this 
legislation through the addition of provisions such as the 
antidiscrimination section that makes it illegal for lawful 
holders of these records to discriminate in certain ways based 
on such records, they are not enough. Such additions cannot 
compensate for the risk of stigma, discrimination, and negative 
health and life outcomes that could result from a roll back of 
Part 2's critical privacy protections. They also cannot 
compensate for the incomplete protection individuals with SUD 
are provided by federal civil rights statutes, such as the Fair 
Housing Act and the Americans with Disabilities Act. For 
example, individuals with SUD who are not in long-term recovery 
are not afforded all the protections provided by these laws.
    Instead of increasing the uptake and retention of treatment 
by individuals with SUD, H.R. 5795 could erect a barrier to 
such individuals' willingness to take such action. As a result, 
H.R. 5795 could harm our efforts to respond to the opioid 
crisis. The stakes of taking any action that could result in 
any individual with an OUD, not seeking or remaining in 
treatment, should be rejected. As such, amid the worst opioid 
epidemic in U.S. history, I strongly oppose H.R. 5795 and 
believe it should be rejected.
    Congress should heed the advice of the conferees that 
negotiated the confidentiality statute that first created Part 
2. Those members stated: ``The conferees wish to stress their 
conviction that the strictest adherence to . . . 
[confidentiality of substance use disorder patient records] is 
absolutely essential to the success of all drug abuse 
prevention programs. Every patient and former patient must be 
assured that his [or her] right to privacy will be protected. 
Without that assurance, fear of public disclosure of drug abuse 
or of records that will attach for life will discourage 
thousands from seeking the treatment they must have if this 
tragic national problem is to be overcome.'' As the U.S. faces 
the current national drug abuse problem--the scale of which our 
country has never seen--maintaining the heightened privacy 
protections of Part 2 remains vital to ensuring all individuals 
with substance use disorder can seek treatment for their 
substance use disorder with confidence that their right to 
privacy will be protected.

                                        Frank Pallone, Jr.,
                                                    Ranking Member.

                                  [all]