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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\
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\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\
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\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.
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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\
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\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.
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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\
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\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.
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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/).
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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]
