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115th Congress } { REPORT
HOUSE OF REPRESENTATIVES
2d Session } { 115-725
======================================================================
MEDICAID PARTNERSHIP 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
ADDITIONAL VIEWS
[To accompany H.R. 5801]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5801) to amend title XIX of the Social Security
Act to provide for requirements under the Medicaid program
relating to the use of qualified prescription drug monitoring
programs and prescribing certain controlled substances, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 5
Background and Need for Legislation.............................. 5
Committee Action................................................. 7
Committee Votes.................................................. 8
Oversight Findings and Recommendations........................... 8
New Budget Authority, Entitlement Authority, and Tax Expenditures 8
Congressional Budget Office Estimate............................. 8
Federal Mandates Statement....................................... 30
Statement of General Performance Goals and Objectives............ 30
Duplication of Federal Programs.................................. 30
Committee Cost Estimate.......................................... 30
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 31
Disclosure of Directed Rule Makings.............................. 31
Advisory Committee Statement..................................... 31
Applicability to Legislative Branch.............................. 31
Section-by-Section Analysis of the Legislation................... 31
Changes in Existing Law Made by the Bill, as Reported............ 32
Additional Views................................................. 37
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 ``Medicaid Providers Are Required To
Note Experiences in Record Systems to Help In-need Patients Act'' or
the ``Medicaid PARTNERSHIP Act''.
SEC. 2. REQUIREMENTS UNDER THE MEDICAID PROGRAM RELATING TO QUALIFIED
PRESCRIPTION DRUG MONITORING PROGRAMS AND
PRESCRIBING CERTAIN CONTROLLED SUBSTANCES.
Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is
amended by inserting after section 1943 the following new section:
``SEC. 1944. REQUIREMENTS RELATING TO QUALIFIED PRESCRIPTION DRUG
MONITORING PROGRAMS AND PRESCRIBING CERTAIN
CONTROLLED SUBSTANCES.
``(a) In General.--Beginning October 1, 2021, a State shall, subject
to subsection (d), require each covered provider to check the
prescription drug history of a covered individual being treated by the
covered provider through a qualified prescription drug monitoring
program described in subsection (b) before prescribing to such
individual a controlled substance.
``(b) Qualified Prescription Drug Monitoring Program Described.--A
qualified prescription drug monitoring program described in this
subsection is, with respect to a State, a prescription drug monitoring
program administered by the State that, at a minimum, satisfies each of
the following criteria:
``(1) The program facilitates access by a covered provider
to, at a minimum, the following information with respect to a
covered individual, in as close to real-time as possible:
``(A) Information regarding the prescription drug
history of a covered individual with respect to
controlled substances.
``(B) The number and type of controlled substances
prescribed to and filled for the covered individual
during at least the most recent 12-month period.
``(C) The name, location, and contact information (or
other identifying number selected by the State, such as
a national provider identifier issued by the National
Plan and Provider Enumeration System of the Centers for
Medicare & Medicaid Services) of each covered provider
who prescribed a controlled substance to the covered
individual during at least the most recent 12-month
period.
``(2) The program facilitates the integration of information
described in paragraph (1) into the workflow of a covered
provider, which may include the electronic system the covered
provider uses to prescribe controlled substances.
A qualified prescription drug monitoring program described in this
subsection, with respect to a State, may have in place, in accordance
with applicable State and Federal law, a data sharing agreement with
the State Medicaid program that allows the medical director and
pharmacy director of such program (and any designee of such a director
who reports directly to such director) to access the information
described in paragraph (1) in an electronic format. The State Medicaid
program under this title may facilitate reasonable and limited access,
as determined by the State and ensuring documented beneficiary
protections regarding the use of such data, to such qualified
prescription drug monitoring program for the medical director or
pharmacy director of any managed care entity (as defined under section
1932(a)(1)(B)) that has a contract with the State under section 1903(m)
or under section 1905(t)(3), or the medical director or pharmacy
director of any entity has a contract to manage the pharmaceutical
benefit with respect to individuals enrolled in the State plan (or
waiver of the State plan). All applicable State and Federal security
and privacy laws shall apply to the directors or designees of such
directors of any State Medicaid program or entity accessing a qualified
prescription drug monitoring program under this section.
``(c) Application of Privacy Rules Clarification.--The Secretary
shall clarify privacy requirements, including requirements under the
regulations promulgated pursuant to section 264(c) of the Health
Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note), related to the sharing of data under subsection (b) in the same
manner as the Secretary is required under subparagraph (J) of section
1860D-4(c)(5) to clarify privacy requirements related to the sharing of
data described in such subparagraph.
``(d) Ensuring Access.--In order to ensure reasonable access to
health care, the Secretary may waive the application of the requirement
under subsection (a), with respect to a State, in the case of natural
disasters and similar situations, and in the case of the provision of
emergency services (as defined for purposes of section 1860D-
4(c)(5)(D)(ii)(II)).
``(e) Reports.--
``(1) State reports.--Each State shall include in the annual
report submitted to the Secretary under section 1927(g)(3)(D),
beginning with such reports submitted for 2023, information
including, at a minimum, the following information for the most
recent 12-month period:
``(A) The percentage of covered providers (as
determined pursuant to a process established by the
State) who checked the prescription drug history of a
covered individual through a qualified prescription
drug monitoring program described in subsection (b)
before prescribing to such individual a controlled
substance.
``(B) Aggregate trends with respect to prescribing
controlled substances such as--
``(i) the number of pill counts and dosage
for controlled substances;
``(ii) the number and dosage of controlled
substances prescribed per covered individual;
and
``(iii) the types of controlled substances
prescribed, including the dates of such
prescriptions, the supplies authorized
(including the duration of such supplies), and
the period of validity of such prescriptions,
in different populations (such as individuals
who are elderly, individuals with disabilities,
and individuals who are enrolled under both
this title and title XVIII).
``(C) Whether or not the State requires (and a
detailed explanation as to why the State does or does
not require) pharmacists to check the prescription drug
history of a covered individual through a qualified
drug management program before dispensing a controlled
substance to such individual.
``(2) Report by cms.--Not later than October 1, 2023, the
Administrator of the Centers for Medicare & Medicaid Services
shall publish on the publicly available website of the Centers
for Medicare & Medicaid Services a report including the
following information:
``(A) Guidance for States on how States can increase
the percentage of covered providers who use qualified
prescription drug monitoring programs described in
subsection (b).
``(B) Best practices for how States and covered
providers should use such qualified prescription drug
monitoring programs to reduce the occurrence of abuse
of controlled substances.
``(f) Increase to Federal Matching Rate for Certain Expenditures
Relating to Qualified Prescription Drug Management Programs.--The
Secretary shall increase the Federal medical assistance percentage or
Federal matching rate that would otherwise apply to a State under
section 1903(a) for a calendar quarter occurring during the period
beginning October 1, 2018, and ending September 30, 2021, for
expenditures by the State for activities under the State plan (or
waiver of the State plan) to implement a prescription drug management
program that satisfies the criteria described in paragraphs (1) and (2)
of subsection (b) if the State (in this subsection referred to as the
`administering State') has in place agreements with all States that are
contiguous to such administering State that, when combined, enable
covered providers in all such contiguous States to access, through the
prescription drug management program, the information that is described
in subsection (b)(1) of covered individuals of such administering State
and that covered providers in such administering State are able to
access through such program. In no case shall an increase under this
subsection result in a Federal medical assistance percentage or Federal
matching rate that exceeds 100 percent.
``(g) Rule of Construction.--Nothing in this section prevents a State
from requiring pharmacists to check the prescription drug history of
covered individuals through a qualified drug management program before
dispensing controlled substances to such individuals.
``(h) Definitions.--In this section:
``(1) Controlled substance.--The term `controlled substance'
means a drug that is included in schedule II of section 202(c)
of the Controlled Substances Act and, at the option of the
State involved, a drug included in schedule III or IV of such
section.
``(2) Covered individual.--The term `covered individual'
means, with respect to a State, an individual who is enrolled
in the State plan (or under a waiver of such plan). Such term
does not include an individual who--
``(A) is receiving--
``(i) hospice or palliative care; or
``(ii) treatment for cancer;
``(B) is a resident of a long-term care facility, of
a facility described in section 1905(d), or of another
facility for which frequently abused drugs are
dispensed for residents through a contract with a
single pharmacy; or
``(C) the State elects to treat as exempted from such
term.
``(3) Covered provider.--
``(A) In general.--The term `covered provider' means,
subject to subparagraph (B), with respect to a State, a
health care provider who is participating under the
State plan (or waiver of the State plan) and licensed,
registered, or otherwise permitted by the State to
prescribe a controlled substance (or the designee of
such provider).
``(B) Exceptions.--
``(i) In general.--Beginning October 1, 2021,
for purposes of this section, such term does
not include a health care provider included in
any type of health care provider determined by
the Secretary to be exempt from application of
this section under clause (ii).
``(ii) Exceptions process.--Not later than
October 1, 2020, the Secretary, after
consultation with the National Association of
Medicaid Directors, national health care
provider associations, Medicaid beneficiary
advocates, and advocates for individuals with
rare diseases, shall determine, based on such
consultations, the types of health care
providers (if any) that should be exempted from
the definition of the term `covered provider'
for purposes of this section.''.
SEC. 3. GUIDANCE.
Not later than October 1, 2019, the Administrator of the Centers for
Medicare & Medicaid Services, in consultation with the Director of the
Centers for Disease Control and Prevention, shall issue guidance on
best practices on the uses of prescription drug monitoring programs
required of prescribers and on protecting the privacy of Medicaid
beneficiary information maintained in and accessed through prescription
drug monitoring programs.
SEC. 4. DEVELOPMENT OF MODEL STATE PRACTICES.
(a) In General.--Not later than October 1, 2020, the Secretary of
Health and Human Services shall develop and publish model practices to
assist State Medicaid program operations in identifying and
implementing strategies to utilize data sharing agreements described in
the matter following paragraph (2) of section 1944(b) of the Social
Security Act, as added by section 2, for the following purposes:
(1) Monitoring and preventing fraud, waste, and abuse.
(2) Improving health care for individuals enrolled in a State
plan under title XIX of such Act (or waiver of such plan) who--
(A) transition in and out of coverage under such
title;
(B) may have sources of health care coverage in
addition to coverage under such title; or
(C) pay for prescription drugs with cash.
(3) Any other purposes specified by the Secretary.
(b) Elements of Model Practices.--The model practices described in
subsection (a)--
(1) may include strategies for assisting States in allowing
the medical director or pharmacy director (or designees of such
a director) of managed care organizations or pharmaceutical
benefit managers to access information with respect to all
covered individuals served by such managed care organizations
or pharmaceutical benefit managers to access as a single data
set, in an electronic format; and
(2) shall include any appropriate beneficiary protections and
privacy guidelines.
(c) Consultation.--In developing model practices under this section,
the Secretary shall consult with the National Association of Medicaid
Directors, managed care entities (as defined in section 1932(a)(1)(B)
of the Social Security Act) with contracts with States pursuant to
section 1903(m) of such Act, pharmaceutical benefit managers,
physicians and other health care providers, beneficiary advocates, and
individuals with expertise in health care technology related to
prescription drug monitoring programs and electronic health records.
SEC. 5. REPORT BY COMPTROLLER GENERAL.
Not later than October 1, 2020, the Comptroller General of the United
States shall issue a report examining the operation of prescription
drug monitoring programs administered by States, including data
security and access standards used by such programs.
Purpose and Summary
H.R. 5801 was introduced on May 15, 2018, by Rep. Morgan
Griffith (R-VA). The bill requires Medicaid providers to check
a qualified prescription drug monitoring (PDMP) before
prescribing a schedule II controlled substance program and
encourages integration of the PDMP into a provider's clinical
workflow. The bill also establishes standard criteria that a
PDMP must meet to be counted as a qualified PDMP and requires
state Medicaid programs to report certain PDMP data to the
Centers for Medicare and Medicaid Services (CMS).
Background and Need for Legislation
Deaths due to overdoses of opioids and other drugs have
ravaged American communities. According to the Centers for
Disease Control and Prevention (CDC), on average, 1,000 people
are treated for opioid misuse in emergency departments per day,
an average of 115 Americans die per day, and opioid-related
overdoses have increased steadily since 1999.\1\
---------------------------------------------------------------------------
\1\Centers for Disease Control and Prevention. ``Drug Overdose
Death Data.'' December 19, 2017. Available at https://www.cdc.gov/
drugoverdose/data/statedeaths.html.
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While the impacts to Americans' health outcomes are
staggering, the opioid crisis has negatively impacted society
in numerous ways. The Centers for Disease Control and
Prevention note that life expectancy dropped in 2015 and 2016
and that one of the reasons was an increase in unintentional
injuries, a category that includes drug overdoses.\2\ The
opioid crisis has also resulted in a contraction in the labor
force by almost 1 million workers in the years between 1999 and
2015, which resulted in a loss of $702 billion in real
output.\3\ In 2015, the total economic burden of the opioid
epidemic was estimated to be $504 billion.\4\ While all states
were negatively impacted, there is geographic variation in the
burden. West Virginia had the greatest loss per person ($4,378)
and Nebraska had the lowest loss per person ($394).\4\ One
recent analysis found that the annual cost for private sector
employers for treating opioid addiction and overdoses has
increased more than eight-fold since 2004, and more than one in
five persons aged 55 to 64 had at least one opioid prescription
in 2016.\5\
---------------------------------------------------------------------------
\2\Dowell, D., Arias E., Kochanek K. et al. ``Contribution of
Opioid-Involved Poisoning to the Change in Life Expectancy in the
United States, 2000-2015.'' JAMA, September 2017. Available at https://
jamanetwork.com/journals/jama/fullarticle/2654372.
\3\American Action Forum. ``The Labor Force and Output Consequences
of the Opioid Crisis.'' March 27, 2018. Available at https://
www.americanactionforum.org/research/labor-force-output-consequences-
opioid-crisis/.
\4\American Enterprise Institute. ``The Geographic Variation in the
Cost of the Opioid Crisis''. Available at https://www.aei.org/wp-
content/uploads/2018/03/Geographic_Variation_in_Cost_of_
Opioid_Crisis.pdf.
\5\Kaiser Family Foundation, ``A Look at How the Opioid Crisis Has
Affected People with Employer Coverage,'' April 2018. Available online
at: https://www.kff.org/health-costs/press-release/analysis-cost-of-
treating-opioid-addiction-rose-rapidly-for-large-employers-as-the-
number-of-prescriptions-has-declined/.
---------------------------------------------------------------------------
Medicaid is the largest source of federal funding for
behavioral health services--mental health and substance use
disorder services--with nearly $71 billion in projected 2017
spending.\6\ As the Medicaid and CHIP Payment and Access
Commission (MACPAC) stated in 2017, ``the opioid epidemic,
which has reached most communities across the U.S.,
disproportionately affects Medicaid beneficiaries.''\7\ Of the
two million non-elderly Americans with opioid addiction,
Medicaid provides health coverage for an estimated 38 percent
of this population, which is the largest percentage of any
insurer type.\8\ Medicaid provides care to 4 in 10 adults with
opioid use disorder and compared to other insurance types,
provides a significantly higher percentage of inpatient and
outpatient substance use disorder treatment.\9\
---------------------------------------------------------------------------
\6\Government Accountability Office, ``Medicaid: States Fund
Services for Adults in Institutions for Mental Disease Using a Variety
of Strategies,'' GAO-17-652, August 2017. Available at https://
www.gao.gov/assets/690/686456.pdf.
\7\Medicaid and CHIP Payment and Access Commission, ``Medicaid and
the Opioid Epidemic,'' Chapter 2 in June 2017 Report to Congress on
Medicaid and CHIP. Available at: https://www.macpac.gov/wp-content/
uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf.
\8\Kaiser Family Foundation. ``Medicaid's Role in Addressing the
Opioid Epidemic.'' Available at https://www.kff.org/infographic/
medicaids-role-in-addressing-opioid-epidemic/.
\9\Kaiser Family Foundation. ``Medicaid's Role in Addressing the
Opioid Epidemic.'' Available at https://www.kff.org/infographic/
medicaids-role-in-addressing-opioid-epidemic/.
---------------------------------------------------------------------------
MACPAC found that ``Medicaid beneficiaries are prescribed
pain relievers at higher rates than those with other sources of
insurance. They also have a higher risk of overdose and other
negative outcomes, from both prescription opioids and illegal
opioids such as heroin and illicitly manufactured
fentanyl.''\10\ Not only are the number of Medicaid
beneficiaries with opioid misuse disproportionately high, so
too are the number of overdoses. Studies from North Carolina
and Washington indicate high rates of opioid-related deaths for
the Medicaid population (33 percent and 45 percent,
respectively).
---------------------------------------------------------------------------
\10\Medicaid and CHIP Payment and Access Commission, ``Medicaid and
the Opioid Epidemic,'' Chapter 2 in June 2017 Report to Congress on
Medicaid and CHIP. Available at: https://www.macpac.gov/wp-content/
uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf.
---------------------------------------------------------------------------
For treatment, Medicaid has several pharmacy and medical
benefits for treating opioid use disorder that vary by state. A
primary pharmaceutical treatment offered to patients with
opioid abuse and/or substance use disorder is medication-
assisted treatment (MAT). The Substance Abuse and Mental Health
Services Administration (SAMHSA) describes MAT as ``the use of
FDA-approved medications, in combination with counseling and
behavioral therapies, to provide a ``whole-patient'' approach
to the treatment of substance use disorders.''\11\
---------------------------------------------------------------------------
\11\See SAMHSA website. Available at: https://www.samhsa.gov/
medication-assisted-treatment.
---------------------------------------------------------------------------
Non-pharmaceutical treatment of opioid use disorder in
Medicaid occurs in inpatient, outpatient, residential, and
community-based settings. MACPAC's 2017 analysis found that
``Medicaid is responding to the opioid crisis by covering
treatment, innovating in the delivery of care, and working with
other state agencies to reduce misuse of prescription
opioids.''\12\ State Medicaid programs adopt strategies and
design their programs to meet the needs of their Medicaid
beneficiaries resulting in variations in covered treatment
services and settings. It is important state Medicaid programs
provide a continuum of care to serve the needs of Medicaid
beneficiaries.
---------------------------------------------------------------------------
\12\Medicaid and CHIP Payment and Access Commission, ``Medicaid and
the Opioid Epidemic,'' Chapter 2 in June 2017 Report to Congress on
Medicaid and CHIP. Available at: https://www.macpac.gov/wp-content/
uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf.
---------------------------------------------------------------------------
However, as MACPAC noted, ``there are gaps in the continuum
of care, and states vary in the extent to which they cover
needed treatment.''\13\ One of the barriers to appropriate
treatment consistently identified by Medicaid directors and
health policy experts is a statutory prohibition on federal
Medicaid matching funds for paying for care for certain
Medicaid beneficiaries in Institutions for Mental Diseases
(IMD). As MACPAC has explained, ``the Medicaid IMD exclusion
acts a barrier for individuals with an opioid use disorder to
receive residential treatment, which, depending on an
individual's treatment plan, may be the most appropriate
setting for care.''\14\ Given these and other findings, there
continues to be an opportunity for Congress and state Medicaid
programs to work to improve access to timely, high-quality
treatment across the continuum of care.
---------------------------------------------------------------------------
\13\Medicaid and CHIP Payment and Access Commission, ``Medicaid and
the Opioid Epidemic,'' Chapter 2 in June 2017 Report to Congress on
Medicaid and CHIP. Available at: https://www.macpac.gov/wp-content/
uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf.
\14\Medicaid and CHIP Payment and Access Commission, ``Medicaid and
the Opioid Epidemic,'' Chapter 2 in June 2017 Report to Congress on
Medicaid and CHIP. Available at: https://www.macpac.gov/wp-content/
uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf.
---------------------------------------------------------------------------
Prescription drug monitoring programs (PDMPs) are statewide
electronic databases that compile designated information on
specified prescription drugs dispensed within the states. Data
are made available to individuals or organizations as
authorized under state law. Currently, 49 states have a PDMP
program.\15\ The final state, Missouri, has begun work to
create a PDMP.\16\
---------------------------------------------------------------------------
\15\https://www.medicaid.gov/medicaid-chip-program-information/by-
topics/prescription-drugs/downloads/2016-dur-summary-report.pdf.
\16\https://governor.mo.gov/news/archive/governor-eric-greitens-
announces-statewide-prescription-drug-monitoring-program.
---------------------------------------------------------------------------
PDMPs reduce substance use disorder by preventing doctor or
pharmacy shopping and proactively identifying patients at-risk
of substance use disorder. Evidence from New York suggests that
PDMPs are associated with a 75 percent decrease in the number
of beneficiaries who got a prescription from more than one
prescriber and dispenser.\17\ To date, only 13 states\18\
require that prescribers access the patient history in the
database prior to prescribing restricted (controlled)
substances. However, researchers have found that ``mandatory
PDMP access laws are effective in reducing prescription drug
abuse, and in particular opioid abuse.''\19\
---------------------------------------------------------------------------
\17\PDMP Center of Excellence at Brandeis University. ``Mandating
PDMP participation by medical providers: Current Status and Experience
in Selected States.'', 2014. Available at http://
www.pdmpexcellence.org/content/mandating-medical-providerparticipation-
pdmps.
\18\CT, DE, KS, KY, MA, ND, NH, NY, PA, SC, VA, VT, WV: See page 35
of the DUR report. https://www.medicaid.gov/medicaid-chip-program-
information/by-topics/prescription-drugs/downloads/2016-dur-summary-
report.pdf.
\19\http://www.nber.org/papers/w23537 see page 2.
---------------------------------------------------------------------------
Committee Action
On April 11, 2018, the Subcommittee on Health held a
hearing on the discussion draft entitled ``Medicaid PARTNERSHIP
Act.'' The Subcommittee received testimony from:
Kimberly Brandt, Principal Deputy
Administrator for Operations, Centers for Medicare and
Medicaid Services, U.S. Department of Health and Human
Services;
Michael Botticelli, Executive Director,
Grayken Center for Addiction, Boston Medical Center;
Toby Douglas, Senior Vice President,
Medicaid Solutions, Centene Corporation;
David Guth, Chief Executive Officer,
Centerstone;
John Kravitz, Chief Information Officer,
Geisinger Health System; and,
Sam Srivastava, Chief Executive Officer,
Magellan Health.
On April 25, 2018, the Subcommittee on Health met in open
markup session and forwarded the discussion draft, without
amendment, to the full Committee by a record vote of 18 yeas
and 9 nays. On May 17, 2018, the full Committee on Energy and
Commerce met in open markup session and ordered H.R. 5801, as
amended, favorably reported to the House by a voice vote. H.R.
5801 is similar to the discussion draft forwarded by the
Subcommittee.
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. There were no record votes taken in connection with
ordering H.R. 5801 reported.
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held a hearing 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. 5801 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--
------------------------------------------------------------------------------------------------------------------------
2019-
2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2019-2023 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 the 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:
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
information 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 require
Medicaid providers to check the PDMP before prescribing a
schedule II controlled substance and to encourage states to
integrate PDMP data into a Medicaid provider's clinical
workflow.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 5801 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. 5801 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 Committee finds
that H.R. 5801 contains no directed rule makings.
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
``Medicaid Provider Are Required To Note Experiences in Record
Systems to Help In-need Patients Act'' or the ``Medicaid
PARTNERSHIP Act.''
Section 2. Requirements under the Medicaid program relating to
Qualified Prescription Drug Monitoring Programs and prescribing
certain controlled substances
Section 2 amends section 1943 of the Social Security Act by
requiring covered providers to use the state's Qualified
Prescription Drug Monitoring Program (Q-PDMP) to check covered
individuals' prescription drug history before prescribing a
schedule II controlled substance (states may add other
schedules) beginning October 1, 2021. A Q-PDMP will, at a
minimum, allow a covered provider to access in as close to real
time as possible:
1. prescription drug history,
2. controlled substances prescribed during at least the
most recent 12-month period, and
3. contact information of each covered provider who
prescribed a controlled substance to the covered individual
during at least the most recent 12-month period.
Exemptions are included for natural disasters and
emergencies as well as individuals in hospice, palliative care,
and long-term care facilities.
Section 2 requires that no later than 2023, each state
shall report to the Centers for Medicare and Medicaid Services,
at a minimum: 1) the process used to determine the percentage
of covered providers who are checking the Q-PDMP, 2) aggregate
trends such as the number of pill counts and dosage for
controlled substances, 3) types of controlled substances
prescribed, and 4) whether or not the state requires
pharmacists to check the Q-PDMP.
In addition, by 2023, CMS is required to publish all of the
aggregate state-level data from the state reports, a summary of
that data, and guidance for states on how states can increase
the percentage of covered providers who use the Q-PDMP. CMS
shall publish best practices for how states and covered
providers can use Q-PDMPs to reduce the abuse of controlled
substances.
Finally, section 2 requires the Secretary to increase the
federal matching rate for activities to implement the qualified
prescription drug monitoring program that occur beginning
October 1, 2018, and that end September 30, 2021. In addition,
a state must have in place agreements to share Q-PDMP data with
all contiguous states.\20\
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\20\While 19 states (39%) report that they also have access to
Border States PDMPs, thirty-six states (73%) indicated that they face a
range of barriers that hinder their ability to fully access and utilize
the database to curb abuse. This draft gives states an incentive to
help eliminate these barriers, which is critically important. States
that do have access to border-states' PDMP information: CT, ID, IL, IN,
KS, KY, LA, MA, MD, MI, MS, MT, ND, NV, NY, OH, TN, VA, VT.
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Section 3. Guidance
Section 3 requires the Administrator of CMS in consultation
with the Director of the Centers for Disease Control and
Prevention to issue guidance on best practices on the uses of
prescription drug monitoring programs required of prescribers
and on protecting the privacy of Medicaid beneficiary
information. The report is due no later than October 1, 2019.
Section 4. Development of model state practices
Section 4 requires the Secretary of Health and Human
Services to develop and publish model practices to assist state
Medicaid Program operations in identifying and implementing
strategies to utilize data sharing agreements with state
Medicaid programs or managed care organizations. The Secretary
should consult with the National Association of Medicaid
Directors, managed care entities, pharmaceutical benefit
managers, physicians and other health care providers,
beneficiary advocates, and individuals with expertise in health
care technology related to prescription drug monitoring
programs and electronic health records.
Section 5. Report by Comptroller General
Not later than October 1, 2020, the Comptroller General of
the United States shall issue a report examining the operation
of prescription drug monitoring programs administered by
states, including data security and access standards used by
such programs.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
TITLE XIX--GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS
* * * * * * *
SEC. 1944. REQUIREMENTS RELATING TO QUALIFIED PRESCRIPTION DRUG
MONITORING PROGRAMS AND PRESCRIBING CERTAIN
CONTROLLED SUBSTANCES.
(a) In General.--Beginning October 1, 2021, a State shall,
subject to subsection (d), require each covered provider to
check the prescription drug history of a covered individual
being treated by the covered provider through a qualified
prescription drug monitoring program described in subsection
(b) before prescribing to such individual a controlled
substance.
(b) Qualified Prescription Drug Monitoring Program
Described.--A qualified prescription drug monitoring program
described in this subsection is, with respect to a State, a
prescription drug monitoring program administered by the State
that, at a minimum, satisfies each of the following criteria:
(1) The program facilitates access by a covered
provider to, at a minimum, the following information
with respect to a covered individual, in as close to
real-time as possible:
(A) Information regarding the prescription
drug history of a covered individual with
respect to controlled substances.
(B) The number and type of controlled
substances prescribed to and filled for the
covered individual during at least the most
recent 12-month period.
(C) The name, location, and contact
information (or other identifying number
selected by the State, such as a national
provider identifier issued by the National Plan
and Provider Enumeration System of the Centers
for Medicare & Medicaid Services) of each
covered provider who prescribed a controlled
substance to the covered individual during at
least the most recent 12-month period.
(2) The program facilitates the integration of
information described in paragraph (1) into the
workflow of a covered provider, which may include the
electronic system the covered provider uses to
prescribe controlled substances.
A qualified prescription drug monitoring program described in
this subsection, with respect to a State, may have in place, in
accordance with applicable State and Federal law, a data
sharing agreement with the State Medicaid program that allows
the medical director and pharmacy director of such program (and
any designee of such a director who reports directly to such
director) to access the information described in paragraph (1)
in an electronic format. The State Medicaid program under this
title may facilitate reasonable and limited access, as
determined by the State and ensuring documented beneficiary
protections regarding the use of such data, to such qualified
prescription drug monitoring program for the medical director
or pharmacy director of any managed care entity (as defined
under section 1932(a)(1)(B)) that has a contract with the State
under section 1903(m) or under section 1905(t)(3), or the
medical director or pharmacy director of any entity has a
contract to manage the pharmaceutical benefit with respect to
individuals enrolled in the State plan (or waiver of the State
plan). All applicable State and Federal security and privacy
laws shall apply to the directors or designees of such
directors of any State Medicaid program or entity accessing a
qualified prescription drug monitoring program under this
section.
(c) Application of Privacy Rules Clarification.--The
Secretary shall clarify privacy requirements, including
requirements under the regulations promulgated pursuant to
section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note), related to
the sharing of data under subsection (b) in the same manner as
the Secretary is required under subparagraph (J) of section
1860D-4(c)(5) to clarify privacy requirements related to the
sharing of data described in such subparagraph.
(d) Ensuring Access.--In order to ensure reasonable access to
health care, the Secretary may waive the application of the
requirement under subsection (a), with respect to a State, in
the case of natural disasters and similar situations, and in
the case of the provision of emergency services (as defined for
purposes of section 1860D-4(c)(5)(D)(ii)(II)).
(e) Reports.--
(1) State reports.--Each State shall include in the
annual report submitted to the Secretary under section
1927(g)(3)(D), beginning with such reports submitted
for 2023, information including, at a minimum, the
following information for the most recent 12-month
period:
(A) The percentage of covered providers (as
determined pursuant to a process established by
the State) who checked the prescription drug
history of a covered individual through a
qualified prescription drug monitoring program
described in subsection (b) before prescribing
to such individual a controlled substance.
(B) Aggregate trends with respect to
prescribing controlled substances such as--
(i) the number of pill counts and
dosage for controlled substances;
(ii) the number and dosage of
controlled substances prescribed per
covered individual; and
(iii) the types of controlled
substances prescribed, including the
dates of such prescriptions, the
supplies authorized (including the
duration of such supplies), and the
period of validity of such
prescriptions, in different populations
(such as individuals who are elderly,
individuals with disabilities, and
individuals who are enrolled under both
this title and title XVIII).
(C) Whether or not the State requires (and a
detailed explanation as to why the State does
or does not require) pharmacists to check the
prescription drug history of a covered
individual through a qualified drug management
program before dispensing a controlled
substance to such individual.
(2) Report by CMS.--Not later than October 1, 2023,
the Administrator of the Centers for Medicare &
Medicaid Services shall publish on the publicly
available website of the Centers for Medicare &
Medicaid Services a report including the following
information:
(A) Guidance for States on how States can
increase the percentage of covered providers
who use qualified prescription drug monitoring
programs described in subsection (b).
(B) Best practices for how States and covered
providers should use such qualified
prescription drug monitoring programs to reduce
the occurrence of abuse of controlled
substances.
(f) Increase to Federal Matching Rate for Certain
Expenditures Relating to Qualified Prescription Drug Management
Programs.--The Secretary shall increase the Federal medical
assistance percentage or Federal matching rate that would
otherwise apply to a State under section 1903(a) for a calendar
quarter occurring during the period beginning October 1, 2018,
and ending September 30, 2021, for expenditures by the State
for activities under the State plan (or waiver of the State
plan) to implement a prescription drug management program that
satisfies the criteria described in paragraphs (1) and (2) of
subsection (b) if the State (in this subsection referred to as
the ``administering State'') has in place agreements with all
States that are contiguous to such administering State that,
when combined, enable covered providers in all such contiguous
States to access, through the prescription drug management
program, the information that is described in subsection (b)(1)
of covered individuals of such administering State and that
covered providers in such administering State are able to
access through such program. In no case shall an increase under
this subsection result in a Federal medical assistance
percentage or Federal matching rate that exceeds 100 percent.
(g) Rule of Construction.--Nothing in this section prevents a
State from requiring pharmacists to check the prescription drug
history of covered individuals through a qualified drug
management program before dispensing controlled substances to
such individuals.
(h) Definitions.--In this section:
(1) Controlled substance.--The term ``controlled
substance'' means a drug that is included in schedule
II of section 202(c) of the Controlled Substances Act
and, at the option of the State involved, a drug
included in schedule III or IV of such section.
(2) Covered individual.--The term ``covered
individual'' means, with respect to a State, an
individual who is enrolled in the State plan (or under
a waiver of such plan). Such term does not include an
individual who--
(A) is receiving--
(i) hospice or palliative care; or
(ii) treatment for cancer;
(B) is a resident of a long-term care
facility, of a facility described in section
1905(d), or of another facility for which
frequently abused drugs are dispensed for
residents through a contract with a single
pharmacy; or
(C) the State elects to treat as exempted
from such term.
(3) Covered provider.--
(A) In general.--The term ``covered
provider'' means, subject to subparagraph (B),
with respect to a State, a health care provider
who is participating under the State plan (or
waiver of the State plan) and licensed,
registered, or otherwise permitted by the State
to prescribe a controlled substance (or the
designee of such provider).
(B) Exceptions.--
(i) In general.--Beginning October 1,
2021, for purposes of this section,
such term does not include a health
care provider included in any type of
health care provider determined by the
Secretary to be exempt from application
of this section under clause (ii).
(ii) Exceptions process.--Not later
than October 1, 2020, the Secretary,
after consultation with the National
Association of Medicaid Directors,
national health care provider
associations, Medicaid beneficiary
advocates, and advocates for
individuals with rare diseases, shall
determine, based on such consultations,
the types of health care providers (if
any) that should be exempted from the
definition of the term ``covered
provider'' for purposes of this
section.
* * * * * * *
ADDITIONAL VIEWS
It is important to note that not all states have a PDMP
currently and/or may not meet certain requirements in the bill
for a ``qualified prescription drug monitoring program'' by the
date of enactment. In such an instance, State Medicaid Programs
would not be required, or indeed able, to meet the standard set
forth by the legislation. Therefore, in these instances, it is
the intention of this legislation that State Medicaid programs
should be held harmless due to factors outside of the State
Medicaid agency's control. In addition, Democratic members of
the Committee reiterate that nothing in the legislation shall
be taken as to dictate the timing, manner and form of the
system of mandated checks that a state may put in place for
their PDMPs.
Frank Pallone, Jr.,
Ranking Member.
[all]