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115th Congress } { Rept. 115-762
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
======================================================================
COMBATING OPIOID ABUSE FOR CARE IN HOSPITALS ACT OF 2018
_______
June 19, 2018.--Committed to the Committee of the Whole House on the
State of the Union and Ordered to be printed
_______
Mr. Brady of Texas, from the Committee on Ways and Means, submitted the
following
R E P O R T
[To accompany H.R. 5774]
[Including cost estimate of the Congressional Budget Office]
The Committee on Ways and Means, to whom was referred the
bill (H.R. 5774) to require the Secretary of Health and Human
Services to develop guidance on pain management and opioid use
disorder prevention for hospitals receiving payment under part
A of the Medicare program, provide for opioid quality measures
development, and provide for a technical expert panel on
reducing surgical setting opioid use and data collection on
perioperative opioid use, and for other purposes, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
I. SUMMARY AND BACKGROUND............................................5
A. Purpose and Summary................................... 5
B. Background and Need for Legislation................... 6
C. Legislative History................................... 6
II. EXPLANATION OF THE BILL...........................................7
A. Combatting Opioid Abuse for Care in Hospitals Act..... 7
III.VOTES OF THE COMMITTEE............................................9
IV. BUDGET EFFECTS OF THE BILL.......................................10
A. Committee Estimate of Budgetary Effects............... 10
B. Statement Regarding New Budget Authority and Tax
Expenditures Budget Authority........................ 10
C. Cost Estimate Prepared by the Congressional Budget
Office............................................... 10
V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE.......18
A. Committee Oversight Findings and Recommendations...... 18
B. Statement of General Performance Goals and Objectives. 18
C. Information Relating to Unfunded Mandates............. 18
D. Congressional Earmarks, Limited Tax Benefits, and
Limited Tariff Benefits.............................. 18
E. Duplication of Federal Programs....................... 18
F. Disclosure of Directed Rule Makings................... 18
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED............19
A. Text of Existing Law Amended or Repealed by the Bill,
as Reported.......................................... 19
B. Changes in Existing Law Proposed by the Bill, as
Reported............................................. 19
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 ``Combating Opioid Abuse for Care in
Hospitals Act of 2018'' or the ``COACH Act of 2018''.
SEC. 2. DEVELOPING GUIDANCE ON PAIN MANAGEMENT AND OPIOID USE DISORDER
PREVENTION FOR HOSPITALS RECEIVING PAYMENT UNDER
PART A OF THE MEDICARE PROGRAM.
(a) In General.--Not later than January 1, 2019, the Secretary of
Health and Human Services (in this section referred to as the
``Secretary'') shall develop and publish on the public website of the
Centers for Medicare & Medicaid Services guidance for hospitals
receiving payment under part A of title XVIII of the Social Security
Act (42 U.S.C. 1395c et seq.) on pain management strategies and opioid
use disorder prevention strategies with respect to individuals entitled
to benefits under such part.
(b) Consultation.--In developing the guidance described in subsection
(a), the Secretary shall consult with relevant stakeholders,
including--
(1) medical professional organizations;
(2) providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x));
(3) health care consumers or groups representing such
consumers; and
(4) other entities determined appropriate by the Secretary.
(c) Contents.--The guidance described in subsection (a) shall
include, with respect to hospitals and individuals described in such
subsection, the following:
(1) Best practices regarding evidence-based screening and
practitioner education initiatives relating to screening and
treatment protocols for opioid use disorder, including--
(A) methods to identify such individuals at-risk of
opioid use disorder, including risk stratification;
(B) ways to prevent, recognize, and treat opioid
overdoses; and
(C) resources available to such individuals, such as
opioid treatment programs, peer support groups, and
other recovery programs.
(2) Best practices for such hospitals to educate
practitioners furnishing items and services at such hospital
with respect to pain management and substance use disorders,
including education on--
(A) the adverse effects of prolonged opioid use;
(B) non-opioid, evidence-based, non-pharmacological
pain management treatments;
(C) monitoring programs for individuals who have been
prescribed opioids; and
(D) the prescribing of naloxone along with an initial
opioid prescription.
(3) Best practices for such hospitals to make such
individuals aware of the risks associated with opioid use
(which may include use of the notification template described
in paragraph (4)).
(4) A notification template developed by the Secretary, for
use as appropriate, for such individuals who are prescribed an
opioid that--
(A) explains the risks and side effects associated
with opioid use (including the risks of addiction and
overdose) and the importance of adhering to the
prescribed treatment regimen, avoiding medications that
may have an adverse interaction with such opioid, and
storing such opioid safely and securely;
(B) highlights multimodal and evidence-based non-
opioid alternatives for pain management;
(C) encourages such individuals to talk to their
health care providers about such alternatives;
(D) provides for a method (through signature or
otherwise) for such an individual, or person acting on
such individual's behalf, to acknowledge receipt of
such notification template;
(E) is worded in an easily understandable manner and
made available in multiple languages determined
appropriate by the Secretary; and
(F) includes any other information determined
appropriate by the Secretary.
(5) Best practices for such hospital to track opioid
prescribing trends by practitioners furnishing items and
services at such hospital, including--
(A) ways for such hospital to establish target
levels, taking into account the specialties of such
practitioners and the geographic area in which such
hospital is located, with respect to opioids prescribed
by such practitioners;
(B) guidance on checking the medical records of such
individuals against information included in
prescription drug monitoring programs;
(C) strategies to reduce long-term opioid
prescriptions; and
(D) methods to identify such practitioners who may be
over-prescribing opioids.
(6) Other information the Secretary determines appropriate,
including any such information from the Opioid Safety
Initiative established by the Department of Veterans Affairs or
the Opioid Overdose Prevention Toolkit published by the
Substance Abuse and Mental Health Services Administration.
SEC. 3. REQUIRING THE REVIEW OF QUALITY MEASURES RELATING TO OPIOIDS
AND OPIOID USE DISORDER TREATMENTS FURNISHED UNDER
THE MEDICARE PROGRAM AND OTHER FEDERAL HEALTH CARE
PROGRAMS.
(a) In General.--Section 1890A of the Social Security Act (42 U.S.C.
1395aaa-1) is amended by adding at the end the following new
subsection:
``(g) Technical Expert Panel Review of Opioid and Opioid Use Disorder
Quality Measures.--
``(1) In general.--Not later than 180 days after the date of
the enactment of this subsection, the Secretary shall establish
a technical expert panel for purposes of reviewing quality
measures relating to opioids and opioid use disorders,
including care, prevention, diagnosis, health outcomes, and
treatment furnished to individuals with opioid use disorders.
The Secretary may use the entity with a contract under section
1890(a) and amend such contract as necessary to provide for the
establishment of such technical expert panel.
``(2) Review and assessment.--Not later than 1 year after the
date the technical expert panel described in paragraph (1) is
established (and periodically thereafter as the Secretary
determines appropriate), the technical expert panel shall--
``(A) review quality measures that relate to opioids
and opioid use disorders, including existing measures
and those under development;
``(B) identify gaps in areas of quality measurement
that relate to opioids and opioid use disorders, and
identify measure development priorities for such
measure gaps; and
``(C) make recommendations to the Secretary on
quality measures with respect to opioids and opioid use
disorders for purposes of improving care, prevention,
diagnosis, health outcomes, and treatment, including
recommendations for revisions of such measures, need
for development of new measures, and recommendations
for including such measures in the Merit-Based
Incentive Payment System under section 1848(q), the
alternative payment models under section 1833(z)(3)(C),
the shared savings program under section 1899, the
quality reporting requirements for inpatient hospitals
under section 1886(b)(3)(B)(viii), the hospital value-
based purchasing program under section 1886(o), and
under other value-based purchasing programs under this
title.
``(3) Consideration of measures by secretary.--The Secretary
shall consider--
``(A) using opioid and opioid use disorder measures
(including measures used under the Merit-Based
Incentive Payment System under section 1848(q),
measures recommended under paragraph (2)(C), and other
such measures identified by the Secretary) in
alternative payment models under section 1833(z)(3)(C)
and in the shared savings program under section 1899;
and
``(B) using opioid measures described in subparagraph
(A), as applicable, in the quality reporting
requirements for inpatient hospitals under section
1886(b)(3)(B)(viii), in the hospital value-based
purchasing program under section 1886(o), and under
other value-based purchasing programs under this title.
``(4) Prioritization of measure development.--The Secretary
shall prioritize for measure development the gaps in quality
measures identified under paragraph (2)(B).''.
(b) Expedited Endorsement Process for Opioid Measures.--Section
1890(b)(2) of the Social Security Act (42 U.S.C. 1395aaa(b)(2)) is
amended by adding at the end the following new flush sentence:
``Such endorsement process shall, as determined practicable by
the entity, provide for an expedited process with respect to
the endorsement of such measures relating to opioids and opioid
use disorders.''.
SEC. 4. TECHNICAL EXPERT PANEL ON REDUCING SURGICAL SETTING OPIOID USE;
DATA COLLECTION ON PERIOPERATIVE OPIOID USE.
(a) Technical Expert Panel on Reducing Surgical Setting Opioid Use.--
(1) In general.--Not later than 6 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall convene a technical expert panel, including
medical and surgical specialty societies and hospital
organizations, to provide recommendations on reducing opioid
use in the inpatient and outpatient surgical settings and on
best practices for pain management, including with respect to
the following:
(A) Approaches that limit patient exposure to opioids
during the perioperative period, including pre-surgical
and post-surgical injections, and that identify such
patients at risk of opioid use disorder pre-operation.
(B) Shared decision making with patients and families
on pain management, including recommendations for the
development of an evaluation and management code for
purposes of payment under the Medicare program under
title XVIII of the Social Security Act that would
account for time spent on shared decision making.
(C) Education on the safe use, storage, and disposal
of opioids.
(D) Prevention of opioid misuse and abuse after
discharge.
(E) Development of a clinical algorithm to identify
and treat at-risk, opiate-tolerant patients and reduce
reliance on opiodes for acute pain during the
perioperative period.
(2) Report.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall submit to Congress
and make public a report containing the recommendations
developed under paragraph (1) and recommendations for broader
implementation of pain management protocols that limit the use
of opioids in the perioperative setting and upon discharge from
such setting.
(b) Data Collection on Perioperative Opioid Use.--Not later than 1
year after the date of the enactment of this Act, the Secretary of
Health and Human Services shall submit to Congress a report that
contains the following:
(1) The diagnosis-related group codes identified by the
Secretary as having the highest volume of surgeries.
(2) With respect to each of such diagnosis-related group
codes so identified, a determination by the Secretary of the
data that is both available and reported on opioid use
following such surgeries, such as with respect to--
(A) surgical volumes, practices, and opioid
prescribing patterns;
(B) opioid consumption, including--
(i) perioperative days of therapy;
(ii) average daily dose at the hospital,
including dosage greater than 90 milligram
morphine equivalent;
(iii) post-discharge prescriptions and other
combination drugs that are used before
intervention and after intervention;
(iv) quantity and duration of opioid
prescription at discharge; and
(v) quantity consumed and number of refills;
(C) regional anesthesia and analgesia practices,
including pre-surgical and post-surgical injections;
(D) naloxone reversal;
(E) post-operative respiratory failure;
(F) information about storage and disposal; and
(G) such other information as the Secretary may
specify.
(3) Recommendations for improving data collection on
perioperative opioid use, including an analysis to identify
barriers to collecting, reporting, and analyzing the data
described in paragraph (2), including barriers related to
technological availability.
SEC. 5. REQUIRING THE POSTING AND PERIODIC UPDATE OF OPIOID PRESCRIBING
GUIDANCE FOR MEDICARE BENEFICIARIES.
(a) In General.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall post on the public
website of the Centers for Medicare & Medicaid Services all guidance
published by the Department of Health and Human Services on or after
January 1, 2016, relating to the prescribing of opioids and applicable
to opioid prescriptions for individuals entitled to benefits under part
A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.)
or enrolled under part B of such title of such Act (42 U.S.C. 1395j et
seq.).
(b) Update of Guidance.--
(1) Periodic update.--The Secretary shall, in consultation
with the entities specified in paragraph (2), periodically (as
determined appropriate by the Secretary) update guidance
described in subsection (a) and revise the posting of such
guidance on the website described in such subsection.
(2) Consultation.--The entities specified in this paragraph
are the following:
(A) Medical professional organizations.
(B) Providers and suppliers of services (as such
terms are defined in section 1861 of the Social
Security Act (42 U.S.C. 1395x)).
(C) Health care consumers or groups representing such
consumers.
(D) Other entities determined appropriate by the
Secretary.
I. SUMMARY AND BACKGROUND
A. Purpose and Summary
The bill, H.R. 5774, the ``Combatting Opioid Abuse for Care
in Hospitals (COACH) Act of 2018'' as ordered reported by the
Committee on Ways and Means on May 16, 2018, focuses on
preventing opioid overuse by improving education for providers
and beneficiaries. It realigns incentives to expand evidence-
based, high-quality health care that reduces reliance on
opioids for pain management.
This legislation requires the Centers for Medicare &
Medicaid Services (CMS) to develop and publish a toolkit by
January 1, 2019, that provides best practices to hospitals for
reducing opioid use. This toolkit will include a template
notice of opioid risks for patients who are prescribed opioids
in a hospital setting. The toolkit will also include best
practices regarding evidence-based provider education for pain
management and screening at-risk individuals and those with
opioid use disorders. Among other guidance, the toolkit will
include best practices for patient education and tracking
opioid prescribing trends within a hospital setting. This
guidance will be developed in consultation with relevant
stakeholders.
Additionally, within 180 days of enactment, the Department
of Health and Human Services (HHS) is required to convene at
least two Technical Expert Panels (TEPs). The first TEP is
required to review quality measures related to opioids and
opioid use disorders and identify gaps in such measures,
prioritize such measures for development in gap areas, and make
recommendations for adopting such measures under physician and
hospital quality reporting programs. The legislation requires,
as practicable, the creation of a fast-track endorsement
process for such measures by the National Quality Forum (NQF).
Within one year of the TEP's establishment, the Secretary will
report on the quality measures (and gaps), including those
related to care, prevention, diagnosis, health outcomes, and
treatment furnished to individuals with opioid use disorders.
The second TEP is required to make recommendations on best
practices for pain management and reducing opioid use within
the surgical setting; it also must analyze post-surgical opioid
prescribing. HHS must report to Congress based on the TEP's
work, while also describing the available data on perioperative
opioid use, as well as identifying barriers to data collection
and recommendations to improve data collection. HHS will
publish the recommendations under the report (or reports) to
Congress within one year of enactment.
Finally, within 180 days of enactment, the Secretary will
publish on the CMS website all opioid prescribing guidance
published after January 1, 2016, applicable to Medicare
beneficiaries. CMS is required to periodically update the
posted guidance in consultation with medical professional
organizations, providers and suppliers of services, health care
consumers, and other stakeholder organizations the Secretary
identifies.
B. Background and Need for Legislation
Currently, while there is some guidance available through
HHS and other entities aimed at helping health care providers
reduce the prevalence of opioid use disorders, it is
incomplete. There is no guidance that comprehensively addresses
screening for opioid use disorder, provider and beneficiary
education regarding opioid risks and non-opioid pain management
alternatives, and best practices for tracking trends in opioid
prescribing. In particular, CMS has not made available opioid
guidance for Medicare beneficiaries in a hospital setting and
has not published such guidance in one location that is easily
accessible to beneficiaries and providers.
Presently, Medicare reimbursement to providers
participating in the Medicare Merit-Based Incentive Program
System (MIPS) for physicians, alternative payment models,
shared savings programs, hospital inpatient quality reporting,
and hospital value-based purchasing are based on quality
ratings and measures with little or no impact on reducing
opioid use and abuse.
Lastly, more than 80 percent of Americans who undergo low-
risk inpatient surgery receive opioids, and the majority of
those patients have opioids that go unused after surgery.
Ensuring appropriate use of opioids post-surgery, specific to
patients' conditions and needs, is critical.
C. Legislative History
Background
H.R. 5774 was introduced on May 11, 2018, and was referred
to the Committee on Ways and Means and additionally the
Committee on Energy and Commerce.
Committee hearings
On January 17, 2018, the Subcommittee on Oversight held a
hearing on the current landscape and CMS actions to prevent
opioid misuse.
On February 6, 2018, the Subcommittee on Health held a
hearing on removing barriers to prevent and treat opioid abuse
and dependence in Medicare.
On April 12, 2018, the Subcommittee on Human Resources held
a hearing on local perspectives on the jobs gap that discussed
problems the opioid epidemic is creating in finding qualified
workers.
On April 25, 2018, the Subcommittee on Trade held a hearing
on stopping the flow of synthetic opioids in the international
mail system.
Committee action
The Committee on Ways and Means marked up H.R. 5774, the
``Combatting Opioid Abuse for Care in Hospitals (COACH) Act of
2018,'' on May 16, 2018, and ordered the bill, as amended,
favorably reported (with a quorum being present) by voice vote.
II. EXPLANATION OF THE BILL
A. Combatting Opioid Abuse for Care in Hospitals (COACH) Act of 2018
PRESENT LAW
There are no requirements in current law for CMS to develop
and provide best practices on opioids to hospitals
participating in Medicare, to publish such guidance on the CMS
website, to assess opioid quality measures and consider such
measures for adoption, or to study perioperative opioid
prescribing best practices and data.
REASONS FOR CHANGE
The purposes of this legislation is to prevent opioid
misuse by improving education for providers and beneficiaries
and to realign incentives to expand evidence-based, high-
quality health care that reduces reliance on opioids for pain
management.
EXPLANATION OF PROVISIONS
Section 1: Short Title: This section states the short title
as the ``Combatting Opioid Abuse for Care in Hospitals (COACH)
Act of 2018.''
Section 2: Developing Guidance on Pain Management and
Opioid Use Disorder Prevention for Hospitals Receiving Payment
under Part A of the Medicare Program
Toolkit Creation for Hospitals Receiving Part A Medicare
Payment: Requires CMS to develop a toolkit that provides best
practices to Medicare participating hospitals for reducing
opioid use by January 1, 2019, and to post the guidance that is
developed on the CMS website.
Stakeholder Consultation: CMS is required to develop this
guidance in consultation with medical professional
organizations, providers and suppliers of services (including
hospitals), health care consumers (including patient advocacy
organizations), and other stakeholder organizations identified
by the Secretary of HHS.
Contents of Toolkit: The toolkit is intended to provide a
number of resources for hospitals to adopt. The toolkit will
include the following resources:
1. Best practices regarding evidence-based provider
education;
2. Best practices for provider education including
treatment for pain management and prevention of drug diversion
through proper storage and disposal;
3. Best practices for patient education;
4. Creation of a clearly worded notification template for
hospital staff to better inform patients prescribed opioids of
potential risks and non-opioid pain management alternatives;
5. Best practices for tracking and controlling opioid
prescribing trends within a hospital setting; and
6. Best practices from opioid toolkits developed by other
federal agencies, including the Department of Veterans Affairs
and the Substance Abuse and Mental Health Services
Administration (SAMHSA).
Section 3: Requiring the Review of Quality Measures
Relating to Opioids and Opioid Use Disorder Treatments
Furnished Under the Medicare Program and Other Federal Health
Care Programs
Technical Expert Panel Review of Opioid and Opioid Use
Disorder Quality Measures: Within 180 days, the Secretary is
required to convene a TEP to review quality measures related to
opioids and opioid use disorders including care, prevention,
diagnosis, health outcomes, and treatments furnished to
individuals with opioid use disorder. The Secretary may elect
to establish the TEP through a contract with the consensus-
based entity (i.e., NQF).
Review and Assessments: Within one year of the TEP's
creation, the TEP will review existing measures related to
opioids as well as those under development, and identify gaps
in areas of quality measurement and establish priorities for
development of opioid measures in gap areas; and make
recommendations to the Secretary regarding revisions to
existing measures, development of new measures, and
recommendations for adoption of such measures. The TEP should
be mindful of administrative burden on providers when
undergoing this assessment and making recommendations.
Consideration of Measures by Secretary: The Secretary is
required to consider the adoption of measures identified by the
TEP, as well as those used under the Merit-Based Incentive
Payment System (MIPS) for physicians, for adoption in
alternative payment models, shared savings programs, hospital
inpatient quality reporting, and the hospital value-based
purchasing program. The Committee also expects the Secretary to
avoid creating undue administrative burden and consider methods
to offset burden by streamlining or reducing measures unrelated
to opioids. The Secretary cannot recommend additional quality
measures for adoption in post-acute care quality reporting and
value-based purchasing
Prioritization of Measure Development for Expedited
Endorsement: The Secretary is required to prioritize measures
for expedited endorsement and the consensus-based entity is
required, as practicable, to expedite the process for endorsing
opioid-related quality measures. The Committee also expects
that measures that do not have sufficient reliability,
validity, or evidence behind them should not be endorsed, but
instead should be rejected.
Section 4: Technical Expert Panel on Reducing Surgical
Setting Opioid Use; Data Collection on Perioperative Opioid Use
Technical Expert Panel on Reducing Surgical Setting Opioid
Use: Within six months, the Secretary is required to convene a
TEP consisting of medical and surgical specialty societies,
which may also encompass non-physician therapy societies, and
hospital organizations to provide recommendations on best
practices for pain management in surgical settings.
Recommendations are required to include approaches to limit
patient exposure to opioids (such approaches may include pre-
and post-surgical injections), consideration of creating a code
to pay for shared decision-making, and development of a
clinical algorithm to identify patients at-risk of or suffering
from opioid use disorder.
TEP Recommendations: Within one year of enactment, the
Secretary is required to issue a public report on
recommendations for broad implementation of pain management
protocols that limit the use of opioids in the perioperative
setting.
Secretary Report: Within one year of enactment, the
Secretary is required to issue a report analyzing perioperative
opioid prescribing data for high-volume surgeries.
Specifically, the Secretary is required to analyze the quantity
and duration of opioid prescriptions; opioid-related surgical
complications (such as the need for naloxone reversal
associated with these surgeries); and will include
recommendations to improve data and remove barriers to data
collection.
Section 5: Requiring the Posting of Periodic Updates of
Opioid Prescribing Guidance for Medicare Beneficiaries
Within 180 days of enactment, the Secretary is required to
publish on the CMS website all opioid prescribing guidance
published after January 1, 2016 applicable to Medicare
beneficiaries. CMS is required to periodically update the
posted guidance in consultation with medical professional
organizations, providers and suppliers of services, health care
consumers, and other stakeholder organizations identified by
the Secretary.
EFFECTIVE DATE
Developing Guidance on Pain Management and Opioid Use
Disorder Prevention for Hospitals Receiving Payment under Part
A of the Medicare Program: By January 1, 2019, CMS is required
to have completed and published a hospital toolkit on the CMS
website.
Requiring the Review of Quality Measures Relating to
Opioids and Opioid Use Disorder Treatments Furnished Under the
Medicare Program and Other Federal Health Care Programs: The
Secretary is required to establish the Technical Expert Panel
within 180 days of enactment and to publish recommendations
within one year of the TEP's creation.
Technical Expert Panel on Reducing Surgical Setting Opioid
Use; Data Collection on Perioperative Opioid Use: The Secretary
is required to establish the Technical Expert Panel within six
months of enactment and to publish recommendations within one
year of enactment.
Requiring the Posting of Periodic Updates of Opioid
Prescribing Guidance for Medicare Beneficiaries: The Secretary
is required to publish opioid prescribing guidance applicable
to Medicare beneficiaries within 180 days of enactment and
periodically update the posted guidance thereafter.
III. VOTES OF THE COMMITTEE
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, the following statement is made
concerning the vote of the Committee on Ways and Means in its
consideration of H.R. 5774, the COACH Act of 2018, on May 16,
2018.
The Chairman's amendment in the nature of a substitute was
adopted by a voice vote (with a quorum being present).
The bill, H.R. 5774, was ordered favorably reported as
amended by voice vote (with a quorum being present).
IV. BUDGET EFFECTS OF THE BILL
A. Committee Estimate of Budgetary Effects
In compliance with clause 3(d) of rule XIII of the Rules of
the House of Representatives, the following statement is made
concerning the effects on the budget of the bill, H.R. 5774, as
reported. The Committee agrees with the estimate prepared by
the Congressional Budget Office (CBO), which is included below.
B. Statement Regarding New Budget Authority and Tax Expenditures Budget
Authority
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee states that the
bill involves no new or increased budget authority. The
Committee states further that the bill involves no new or
increased tax expenditures.
C. Cost Estimate Prepared by the Congressional Budget Office
In compliance with clause 3(c)(3) of rule XIII of the Rules
of the House of Representatives, requiring a cost estimate
prepared by the CBO, the following statement by CBO is
provided.
U.S. Congress,
Congressional Budget Office,
Washington, DC, June 6, 2018.
Hon. Kevin Brady,
Chairman, Committee on Ways and Means,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for the opioid-related
legislation ordered to be reported on May 16, 2018.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Tom Bradley.
Sincerely,
Mark P. Hadley
(For Keith Hall, Director).
Enclosure.
Opioid Legislation
Summary: On May 16, 2018, the House Committee on Ways and
Means ordered seven bills to be reported related to the
nation's response to the opioid epidemic. Generally, the bills
would:
Expand Medicare coverage of treatment for
opioid use disorder;
Give Medicare providers and health plans
additional tools to curtail inappropriate prescribing
and use of opioids;
Require the completion of studies and
reports related to opioid use and misuse in Medicare;
and
Require the United States Postal Service and
Customs and Border Protection (CBP) to reduce illegal
shipment of opioids across international borders.
Because the bills are related, CBO is publishing a single
comprehensive document that includes estimates for each piece
of legislation.
CBO estimates that enacting four of the bills would affect
direct spending; therefore, pay-as-you-go procedures apply for
those bills. None of the bills would affect revenues.
CBO estimates that although enacting one bill of the seven
included in this document (H.R. 5776) would increase net direct
spending and on-budget deficits over the four consecutive 10-
year periods beginning in 2029, those effects would not exceed
the threshold established by the Congress for long-term costs.
CBO estimates that none of the remaining bills would increase
net direct spending or on-budget deficits in any of the four
consecutive 10-year periods beginning in 2029.
None of the bills contain intergovernmental or private-
sector mandates as defined in the Unfunded Mandates Reform Act
(UMRA).
Estimated cost to the Federal Government: The estimates in
this document do not include the effects of interactions among
the bills. If all seven 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 those differences would be small. The effects of
this legislation fall within functions 550 (health), 570
(Medicare), and 750 (administration of justice).
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
Table 1 lists the four bills included in this estimate that
would affect direct spending.
H.R. 5676, the Stop Excessive Narcotics in our Retirement
Communities Protection Act of 2018, would allow prescription
drug plans to suspend payments to pharmacies while fraud
investigations are pending. CBO expects that enacting the
legislation would reduce payments by those plans to pharmacies
and result in lower premiums for benefits under Medicare's Part
D. CBO estimates that the reduction in premiums would lower
federal spending for Part D by $9 million over the 2019-2028
period.
TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
------------------------------------------------------------------------------------------------------------------------
2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2019-2023 2019-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
INCREASES OR DECREASES (-) IN DIRECT SPENDING
H.R. 5676, Stop Excessive
Narcotics in our Retirement
Communities Protection Act of
2018:
Budget Authority........... 0 0 -1 -1 -1 -1 -1 -1 -1 -1 -1 -4 -9
Outlays.................... 0 0 -1 -1 -1 -1 -1 -1 -1 -1 -1 -4 -9
H.R. 5773, Preventing Addiction
for Susceptible Seniors Act of
2018:a
Budget Authority........... 0 0 0 -6 -7 -7 -7 -8 -9 -9 -11 -20 -64
Outlays.................... 0 0 0 -6 -7 -7 -7 -8 -9 -9 -11 -20 -64
H.R. 5776, the Medicare and
Opioid Safe Treatment Act of
2018:a
Budget Authority........... 0 8 0 20 20 25 30 30 35 35 40 73 243
Outlays.................... 0 2 4 22 20 25 30 30 35 35 40 73 243
H.R. 5788, Securing the
International Mail Against
Opioids Act of 2018:a
Budget Authority........... 0 0 * * * * * * * * * * *
Outlays.................... 0 0 * * * * * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000
aThis bill also would affect spending subject to appropriation.
H.R. 5773, the Preventing Addiction for Susceptible Seniors
Act of 2018, 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. 5773 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.
Two provisions of H.R. 5773 would have no significant
budgetary effect; they are described later in this document.
H.R. 5776, the Medicare and Opioid Safe Treatment Act of
2018, would appropriate $8 million in 2019, which would be
available until expended, for Federally Qualified Health
Centers and Rural Health Clinics to support training in the
treatment of opioid use disorder. CBO expects that $8 million
would be spent between 2019 and 2021.
H.R. 5776 also would expand the availability of medication-
assisted treatment (MAT) for Medicare beneficiaries with opioid
use disorder. The bill would allow treatment programs certified
by the Substance Abuse and Mental Health Services
Administration (SAMHSA) to become Medicare-participating
providers.\1\ H.R. 5776 also would direct the Secretary of HHS
to create a new schedule of bundled payments for MAT through
certified programs and grant the Secretary considerable
discretion for defining bundles and establishing payment rates.
---------------------------------------------------------------------------
\1\MAT combines behavioral therapy and pharmaceutical treatment for
substance use disorders. Under current law, methadone (an opioid used
to treat and manage dependence on other drugs, such as heroin) can be
dispensed only by SAMHSA-certified treatment programs, which do not
participate in Medicare. Other drugs used in MAT, including
buprenorphine and naltrexone, can be dispensed more widely.
---------------------------------------------------------------------------
CBO projects that, beginning in 2021, about 3,000 Medicare
beneficiaries who would not be treated for opioid abuse under
current law would newly enroll each year in treatment offered
by SAMHSA-certified programs and that the annual cost per
participant would range from about $6,000 to about $10,000,
depending largely on the medications dispensed and the period
for which beneficiaries adhered to the protocol. CBO's
projection of the number of beneficiaries who would receive
treatment takes into consideration the number of beneficiaries
estimated to have opioid-use disorder, the number already
receiving some form of treatment, and the availability of
providers to treat those who newly enroll in MAT. To develop a
per capita treatment cost, CBO analyzed rates for MAT paid by
other payers, as well as Medicare spending for health care
services typically used by people receiving MAT. CBO estimates
that the new MAT benefit would increase direct spending by $235
million over the 2019-2028 period.
CBO estimates that enacting H.R. 5776 would increase net
Medicare spending by $243 million over the 2019-2028 period.
(If enacted, H.R. 5776 would also affect spending subject to
appropriation; CBO has not completed an estimate of that
amount.)
H.R. 5788, the Securing the International Mail Against
Opioids Act of 2018, would establish a new fee for certain
items mailed to the United States from overseas, beginning
January 1, 2020. Initially, the fee for most such items would
be one dollar, but the amount could be adjusted annually
thereafter. Using information provided by CBP, CBO estimates
that about $100 million in new fees would be collected over the
2020-2028 period. The collections would be divided equally
between CBP and the Postal Service and spent by those agencies
on activities related to the processing of inbound mail. CBO
estimates that the net effect on federal spending in each year
would be insignificant. (If enacted, H.R. 5788 would also
affect spending subject to appropriation; those effects are
described below.)
Spending subject to appropriation: For this document, CBO
has grouped bills with spending that would be subject to
appropriation into three general categories:
Bills with provisions that would have no
budgetary effect;
Bills with provisions for which CBO has
estimated an authorization of appropriations (see Table
2); 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 three of the bills
have provisions that would not significantly affect direct
spending, revenues, or spending subject to appropriation.
H.R. 5773, the Preventing Addiction for Susceptible Seniors
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 that Section 3 of H.R. 5773 would not significantly
affect direct spending for Part D.
Section 5 of that bill 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
provision, CBO estimates that its enactment would not
significantly affect direct spending for Part D.
Section 6 of that bill 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.
H.R. 5775, the Providing Reliable Options for Patients and
Educational Resources 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.
The bill also would require Medicare Advantage plans and
prescription drug plans to provide information regarding safe
disposal of controlled substances in home health risk
assessments and medication therapy management programs,
respectively. In CBO's estimation, neither proposal would have
a budgetary effect because those activities would not impose
significant administrative costs on plans or federal agencies.
In addition, H.R. 5775 would restrict the use of certain
pain-related questions on the Hospital Consumer Assessment of
Healthcare Providers and Systems (HCAHPS) survey, which is
administered by the Centers for Medicare & Medicaid Services
(CMS). The survey is one measure used in CMS's Hospital Value-
Based Purchasing (VBP) Program, which adjusts payments to acute
care hospitals on the basis of the quality of care they provide
to Medicare beneficiaries. Because the VBP program is funded by
reducing base payments to all hospitals, CBO estimates that
changing the HCAHPS survey would not affect the total amount
paid by Medicare.
H.R. 5776, the Medicare and Opioid Safe Treatment Act of
2018, in section 3, would require CMS, beginning on January 1,
2020, to review and possibly modify payments made through
Medicare's Hospital Outpatient Prospective Payment System for
certain opioid and nonopioid pain management treatments and
technologies. CMS could revise payments if the Secretary of HHS
determined that there was a financial incentive to use opioids
in place of nonopioid medications. The budget neutrality
requirement under current law would apply to such revisions,
and the rest of the payment rates within the system would be
subject to offsetting adjustments. Because the changes would be
made in a budget-neutral manner, CBO estimates that this
provision would have no budgetary effect.
Section 6 of H.R. 5776 would explicitly authorize the
Center for Medicare and Medicaid Innovation (CMMI) to test
approaches for expanding beneficiaries' awareness of
psychological services and to help those beneficiaries curtail
use of hospital-based mental health or behavioral health
services. Because CMMI already has that authority, CBO
estimates that enacting the legislation would not affect
federal spending.
Estimated Authorizations. Table 2 shows CBO's estimates of
the authorization of appropriations for provisions in four
bills. For those estimates, CBO assumes that appropriated funds
would be available to implement those provisions.
H.R. 5723, the Expanding Oversight of Opioid Prescribing
and Payment Act of 2018, would require the Medicare Payment
Advisory Commission to report to the Congress on payments for
pain treatment, incentives for prescribing opioids in inpatient
and outpatient settings, and documented tracking of opioid use
from Medicare claims data. CBO estimates that producing such a
report would cost less than $500,000 over the 2019-2023 period.
TABLE 2.--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. 5723, Expanding Oversight of Opioid Prescribing
and Payment Act of 2018:
Estimated Authorization Level.................... 0 * 0 0 0 0 *
Estimated Outlays................................ 0 * 0 0 0 0 *
H.R. 5773, Preventing Addiction for Susceptible
Seniors Act of 2018:a
Estimated Authorization Level.................... 0 2 2 2 2 2 9
Estimated Outlays................................ 0 2 2 2 2 2 9
H.R. 5776, Medicare and Opioid Safe Treatment Act of
2018:a
Estimated Authorization Level.................... 0 1 0 0 0 0 1
Estimated Outlays................................ 0 1 0 0 0 0 1
H.R. 5788, Securing the International Mail Against
Opioids Act of 2018:a
Estimated Authorization Level.................... 0 100 0 0 0 0 100
Estimated Outlays................................ 0 40 40 20 0 0 100
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between zero and $500,000
aThis bill also would affect mandatory spending.
H.R. 5773, the Preventing Addiction for Susceptible Seniors
Act of 2018, 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. 5773 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. 5773 would cost approximately
$9 million over the 2019-2023 period.
H.R. 5776, the Medicare and Opioid Safe Treatment Act of
2018, would direct the Secretary of HHS to report to the
Congress on the availability of supplemental benefits to pay
for treatment or prevention of substance abuse among enrollees
in Medicare Advantage plans. The Secretary also would report on
coverage of and payment for pain treatment and substance use
disorders under Medicare. CBO estimates that producing those
reports would cost $1 million over five years.
H.R. 5788, the Securing the International Mail Against
Opioids Act of 2018, would direct the Postal Service, CBP, and
other federal agencies to collaborate to develop technology to
detect opioids and other drugs that enter the United States in
the mail. Using information provided by CBP, CBO estimates that
it would cost roughly $100 million over the 2019-2021 period to
deploy drug detection systems at international mail facilities.
Other Authorizations. CBO has determined that provisions in
two bills--H.R. 5774, Combating Opioid Abuse for Care in
Hospitals Act of 2018; and H.R. 5776, the Medicare and Safe
Opioid Treatment Act of 2018--would increase authorization
levels, but has not completed estimates of amounts. Any
spending that would result from those authorizations would be
subject to future appropriation action.
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. Four of the bills discussed in this document contain
direct spending and are subject to pay-as-you-go procedures.
Details about the amount of direct spending in those bills can
be found in Table 1.
Increase in long-term direct spending and deficits: CBO
estimates that although enacting H.R. 5776, the Medicare and
Opioid Safe Treatment Act of 2018, would increase net direct
spending and on-budget deficits over the four consecutive 10-
year periods beginning in 2029, those effects would not exceed
the threshold established by the Congress for long-term costs
($2.5 billion for net direct spending and $5 billion for on-
budget deficits). CBO estimates that none of the remaining
bills would increase net direct spending or on-budget deficits
in any of the four consecutive 10-year periods beginning in
2029.
Mandates: None of the bills contains intergovernmental or
private-sector mandates as defined in UMRA.
Previous CBO estimate: On June 6, 2018, CBO issued an
estimate for 59 opioid-related bills ordered reported by the
House Committee on Energy and Commerce on May 9 and May 17,
2018. Several of those bills contain provisions that are
identical or similar to those in the legislation ordered
reported by the Committee on Ways and Means, and for those
provisions, CBO's estimates are the same.
In particular, several sections in H.R. 5773, the
Preventing Addiction for Susceptible Seniors Act of 2018,
contain provisions that are identical or similar to those in
five bills listed in the other estimate:
Section 2, which would require prescription drug
plans to implement drug management programs, is identical to a
provision in H.R. 5675.
Section 3, regarding electronic prior
authorization for prescriptions under Medicare's Part D, is
similar to a provision in H.R. 4841.
Section 4, which would mandate the creation of a
new Internet portal to allow various stakeholders to exchange
information, is identical to a provision in H.R. 5715.
Section 5, which would expand medication therapy
management, is the same as a provision in H.R. 5684.
Section 6, regarding prescriber notification, is
identical to H.R. 5716.
In addition, in this estimate, a provision related to
Medicare beneficiary education in section 2 of H.R. 5775, the
Providing Reliable Options for Patients and Educational
Resources Act of 2018, is the same as a provision in H.R. 5686,
the Medicare Clear Health Options in Care for Enrollees Act of
2018, in CBO's estimate for the Committee on Energy and
Commerce.
Estimate prepared by: Federal costs, Medicare: Philippa
Haven, Lori Housman, Jamease Kowalczyk, Lara Robillard, Sarah
Sajewski, Colin Yee, and Rebecca Yip; U.S. Postal Service and
Customs and Border Protection: Mark Grabowicz; Mandates: Andrew
Laughlin; Fact Checking: Zachary Byrum and Kate Kelly.
Estimate reviewed by: Tom Bradley, Chief, Health Systems
and Medicare Cost Estimates Unit; Kim P. Cawley, Chief, Natural
Resources Cost Estimates Unit; Susan Willie, Chief, Mandates
Unit; Leo Lex, Deputy Assistant Director for Budget Analysis;
Theresa A. Gullo, Assistant Director for Budget Analysis.
V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE
A. Committee Oversight Findings and Recommendations
With respect to clause 3(c)(1) of rule XIII of the Rules of
the House of Representatives, the Committee made findings and
recommendations that are reflected in this report.
B. Statement of General Performance Goals and Objectives
With respect to clause 3(c)(4) of rule XIII of the Rules of
the House of Representatives, the Committee advises that the
bill contains no measure that authorizes funding, so no
statement of general performance goals and objectives for which
any measure authorizes funding is required.
C. Information Relating to Unfunded Mandates
This information is provided in accordance with section 423
of the Unfunded Mandates Reform Act of 1995 (Pub. L. No. 104-
4).
The Committee has determined that the bill does not contain
Federal mandates on the private sector. The Committee has
determined that the bill does not impose a Federal
intergovernmental mandate on State, local, or tribal
governments.
D. Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits
With respect to clause 9 of rule XXI of the Rules of the
House of Representatives, the Committee has carefully reviewed
the provisions of the bill, and states that the provisions of
the bill do not contain any congressional earmarks, limited tax
benefits, or limited tariff benefits within the meaning of the
rule.
E. Duplication of Federal Programs
In compliance with Sec. 3(g)(2) of H. Res. 5 (114th
Congress), the Committee states that no provision of the bill
establishes or reauthorizes: (1) a program of the Federal
Government known to be duplicative of another Federal program;
(2) a program included in any report from the Government
Accountability Office to Congress pursuant to section 21 of
Public Law 111-139; or (3) a program related to a program
identified in the most recent Catalog of Federal Domestic
Assistance, published pursuant to the Federal Program
Information Act (Pub. L. No. 95-220, as amended by Pub. L. No.
98-169).
F. Disclosure of Directed Rule Makings
In compliance with Sec. 3(i) of H. Res. 5 (114th Congress),
the following statement is made concerning directed rule
makings: The Committee estimates that the bill requires no
directed rule makings within the meaning of such section.
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED
In compliance with clause 3(e)(1)(B) of rule XIII of the
Rules of the House of Representatives, changes in existing law
proposed by the bill, as reported, are shown as follows
(existing law proposed to be omitted is enclosed in black
brackets, new matter is printed in italic, existing law in
which no change is proposed is shown in roman):
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 XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part E--Miscellaneous Provisions
* * * * * * *
contract with a consensus-based entity regarding performance
measurement
Sec. 1890. (a) Contract.--
(1) In general.--For purposes of activities conducted
under this Act, the Secretary shall identify and have
in effect a contract with a consensus-based entity,
such as the National Quality Forum, that meets the
requirements described in subsection (c). Such contract
shall provide that the entity will perform the duties
described in subsection (b).
(2) Timing for first contract.--As soon as
practicable after the date of the enactment of this
subsection, the Secretary shall enter into the first
contract under paragraph (1).
(3) Period of contract.--A contract under paragraph
(1) shall be for a period of 4 years (except as may be
renewed after a subsequent bidding process).
(4) Competitive procedures.--Competitive procedures
(as defined in section 4(5) of the Office of Federal
Procurement Policy Act (41 U.S.C. 403(5))) shall be
used to enter into a contract under paragraph (1).
(b) Duties.--The duties described in this subsection are the
following:
(1) Priority setting process.--The entity shall
synthesize evidence and convene key stakeholders to
make recommendations, with respect to activities
conducted under this Act, on an integrated national
strategy and priorities for health care performance
measurement in all applicable settings. In making such
recommendations, the entity shall--
(A) ensure that priority is given to
measures--
(i) that address the health care
provided to patients with prevalent,
high-cost chronic diseases;
(ii) with the greatest potential for
improving the quality, efficiency, and
patient-centeredness of health care;
and
(iii) that may be implemented rapidly
due to existing evidence, standards of
care, or other reasons; and
(B) take into account measures that--
(i) may assist consumers and patients
in making informed health care
decisions;
(ii) address health disparities
across groups and areas; and
(iii) address the continuum of care a
patient receives, including services
furnished by multiple health care
providers or practitioners and across
multiple settings.
(2) Endorsement of measures.--The entity shall
provide for the endorsement of standardized health care
performance measures. The endorsement process under the
preceding sentence shall consider whether a measure--
(A) is evidence-based, reliable, valid,
verifiable, relevant to enhanced health
outcomes, actionable at the caregiver level,
feasible to collect and report, and responsive
to variations in patient characteristics, such
as health status, language capabilities, race
or ethnicity, and income level; and
(B) is consistent across types of health care
providers, including hospitals and physicians.
Such endorsement process shall, as determined
practicable by the entity, provide for an expedited
process with respect to the endorsement of such
measures relating to opioids and opioid use disorders.
(3) Maintenance of measures.--The entity shall
establish and implement a process to ensure that
measures endorsed under paragraph (2) are updated (or
retired if obsolete) as new evidence is developed.
(5) Annual report to congress and the secretary;
secretarial publication and comment.--
(A) Annual report.--By not later than March 1
of each year (beginning with 2009), the entity
shall submit to Congress and the Secretary a
report containing the following:
(i) A description of--
(I) the implementation of
quality measurement initiatives
under this Act and the
coordination of such
initiatives with quality
initiatives implemented by
other payers;
(II) the recommendations made
under paragraph (1);
(III) the performance by the
entity of the duties required
under the contract entered into
with the Secretary under
subsection (a);
(IV) gaps in endorsed quality
measures, which shall include
measures that are within
priority areas identified by
the Secretary under the
national strategy established
under section 399HH of the
Public Health Service Act, and
where quality measures are
unavailable or inadequate to
identify or address such gaps;
(V) areas in which evidence
is insufficient to support
endorsement of quality measures
in priority areas identified by
the Secretary under the
national strategy established
under section 399HH of the
Public Health Service Act and
where targeted research may
address such gaps; and
(VI) the matters described in
clauses (i) and (ii) of
paragraph (7)(A).
(ii) An itemization of financial
information for the fiscal year ending
September 30 of the preceding year,
including--
(I) annual revenues of the
entity (including any
government funding, private
sector contributions, grants,
membership revenues, and
investment revenue);
(II) annual expenses of the
entity (including grants paid,
benefits paid, salaries or
other compensation, fundraising
expenses, and overhead costs);
and
(III) a breakdown of the
amount awarded per contracted
task order and the specific
projects funded in each task
order assigned to the entity.
(iii) Any updates or modifications of
internal policies and procedures of the
entity as they relate to the duties of
the entity under this section,
including--
(I) specifically identifying
any modifications to the
disclosure of interests and
conflicts of interests for
committees, work groups, task
forces, and advisory panels of
the entity; and
(II) information on external
stakeholder participation in
the duties of the entity under
this section (including
complete rosters for all
committees, work groups, task
forces, and advisory panels
funded through government
contracts, descriptions of
relevant interests and any
conflicts of interest for
members of all committees, work
groups, task forces, and
advisory panels, and the total
percentage by health care
sector of all convened
committees, work groups, task
forces, and advisory panels.
(B) Secretarial review and publication of
annual report.--Not later than 6 months after
receiving a report under subparagraph (A) for a
year, the Secretary shall--
(i) review such report; and
(ii) publish such report in the
Federal Register, together with any
comments of the Secretary on such
report.
(6) Review and endorsement of episode grouper under
the physician feedback program.--The entity shall
provide for the review and, as appropriate, the
endorsement of the episode grouper developed by the
Secretary under section 1848(n)(9)(A). Such review
shall be conducted on an expedited basis.
(7) Convening multi-stakeholder groups.--
(A) In general.--The entity shall convene
multi-stakeholder groups to provide input on--
(i) the selection of quality and
efficiency measures described in
subparagraph (B), from among--
(I) such measures that have
been endorsed by the entity;
and
(II) such measures that have
not been considered for
endorsement by such entity but
are used or proposed to be used
by the Secretary for the
collection or reporting of
quality and efficiency
measures; and
(ii) national priorities (as
identified under section 399HH of the
Public Health Service Act) for
improvement in population health and in
the delivery of health care services
for consideration under the national
strategy established under section
399HH of the Public Health Service Act.
(B) Quality measures.--
(i) In general.--Subject to clause
(ii), the quality and efficiency
measures described in this subparagraph
are quality and efficiency measures--
(I) for use pursuant to
sections 1814(i)(5)(D),
1833(i)(7), 1833(t)(17),
1848(k)(2)(C), 1866(k)(3),
1881(h)(2)(A)(iii),
1886(b)(3)(B)(viii),
1886(j)(7)(D), 1886(m)(5)(D),
1886(o)(2), 1886(s)(4)(D), and
1895(b)(3)(B)(v);
(II) for use in reporting
performance information to the
public; and
(III) for use in health care
programs other than for use
under this Act.
(ii) Exclusion.--Data sets (such as
the outcome and assessment information
set for home health services and the
minimum data set for skilled nursing
facility services) that are used for
purposes of classification systems used
in establishing payment rates under
this title shall not be quality and
efficiency measures described in this
subparagraph.
(C) Requirement for transparency in
process.--
(i) In general.--In convening multi-
stakeholder groups under subparagraph
(A) with respect to the selection of
quality and efficiency measures, the
entity shall provide for an open and
transparent process for the activities
conducted pursuant to such convening.
(ii) Selection of organizations
participating in multi-stakeholder
groups.--The process described in
clause (i) shall ensure that the
selection of representatives comprising
such groups provides for public
nominations for, and the opportunity
for public comment on, such selection.
(D) Multi-stakeholder group defined.--In this
paragraph, the term ``multi-stakeholder group''
means, with respect to a quality and efficiency
measure, a voluntary collaborative of
organizations representing a broad group of
stakeholders interested in or affected by the
use of such quality and efficiency measure.
(8) Transmission of multi-stakeholder input.--Not
later than February 1 of each year (beginning with
2012), the entity shall transmit to the Secretary the
input of multi-stakeholder groups provided under
paragraph (7).
(c) Requirements Described.--The requirements described in
this subsection are the following:
(1) Private nonprofit.--The entity is a private
nonprofit entity governed by a board.
(2) Board membership.--The members of the board of
the entity include--
(A) representatives of health plans and
health care providers and practitioners or
representatives of groups representing such
health plans and health care providers and
practitioners;
(B) health care consumers or representatives
of groups representing health care consumers;
and
(C) representatives of purchasers and
employers or representatives of groups
representing purchasers or employers.
(3) Entity membership.--The membership of the entity
includes persons who have experience with--
(A) urban health care issues;
(B) safety net health care issues;
(C) rural and frontier health care issues;
and
(D) health care quality and safety issues.
(4) Open and transparent.--With respect to matters
related to the contract with the Secretary under
subsection (a), the entity conducts its business in an
open and transparent manner and provides the
opportunity for public comment on its activities.
(5) Voluntary consensus standards setting
organization.--The entity operates as a voluntary
consensus standards setting organization as defined for
purposes of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (Public Law 104-
113) and Office of Management and Budget Revised
Circular A-119 (published in the Federal Register on
February 10, 1998).
(6) Experience.--The entity has at least 4 years of
experience in establishing national consensus
standards.
(7) Membership fees.--If the entity requires a
membership fee for participation in the functions of
the entity, such fees shall be reasonable and adjusted
based on the capacity of the potential member to pay
the fee. In no case shall membership fees pose a
barrier to the participation of individuals or groups
with low or nominal resources to participate in the
functions of the entity.
(d) Funding.--(1) For purposes of carrying out this section,
the Secretary shall provide for the transfer, from the Federal
Hospital Insurance Trust Fund under section 1817 and the
Federal Supplementary Medical Insurance Trust Fund under
section 1841 (in such proportion as the Secretary determines
appropriate), of $10,000,000 to the Centers for Medicare &
Medicaid Services Program Management Account for each of fiscal
years 2009 through 2013. Amounts transferred under the
preceding sentence shall remain available until expended.
(2) For purposes of carrying out this section and section
1890A (other than subsections (e) and (f)), the Secretary shall
provide for the transfer, from the Federal Hospital Insurance
Trust Fund under section 1817 and the Federal Supplementary
Medical Insurance Trust Fund under section 1841, in such
proportion as the Secretary determines appropriate, to the
Centers for Medicare & Medicaid Services Program Management
Account of $5,000,000 for fiscal year 2014, $30,000,000 for
each of fiscal years 2015 through 2017, and $7,500,000 for each
of fiscal years 2018 and 2019. Amounts transferred under the
preceding sentence shall remain available until expended. For
purposes of carrying out this section and section 1890A (other
than subsections (e) and (f)), the Secretary shall provide for
the transfer, from the Federal Hospital Insurance Trust Fund
under section 1817 and the Federal Supplementary Medical
Insurance Trust Fund under section 1841, in such proportion as
the Secretary determines appropriate, to the Centers for
Medicare & Medicaid Services Program Management Account of
$5,000,000 for fiscal year 2014 and $30,000,000 for each of
fiscal years 2015 through 2017. Amounts transferred under the
preceding sentence shall remain available until expended.
Amounts transferred for each of fiscal years 2018 and 2019
shall be in addition to any unobligated funds transferred for a
preceding fiscal year that are available under the preceding
sentence.
(e) Annual Report by Secretary to Congress.--By not later
than March 1 of each year (beginning with 2019), the Secretary
shall submit to Congress a report containing the following:
(1) A comprehensive plan that identifies the quality
measurement needs of programs and initiatives of the
Secretary and provides a strategy for using the entity
with a contract under subsection (a) and any other
entity the Secretary has contracted with or may
contract with to perform work associated with section
1890A to help meet those needs, specifically with
respect to the programs under this title and title XIX.
In years after the first plan under this paragraph is
submitted, the requirements of this paragraph may be
met by providing an update to the plan.
(2) The amount of funding provided under subsection
(d) for purposes of carrying out this section and
section 1890A that has been obligated by the Secretary,
the amount of funding provided that has been expended,
and the amount of funding provided that remains
unobligated.
(3) With respect to the activities described under
this section or section 1890A, a description of how the
funds described in paragraph (2) have been obligated or
expended, including how much of that funding has been
obligated or expended for work performed by the
Secretary, the entity with a contract under subsection
(a), and any other entity the Secretary has contracted
with to perform work.
(4) A description of the activities for which the
funds described in paragraph (2) were used, including
task orders and activities assigned to the entity with
a contract under subsection (a), activities performed
by the Secretary, and task orders and activities
assigned to any other entity the Secretary has
contracted with to perform work related to carrying out
section 1890A.
(5) The amount of funding described in paragraph (2)
that has been obligated or expended for each of the
activities described in paragraph (4).
(6) Estimates for, and descriptions of, obligations
and expenditures that the Secretary anticipates will be
needed in the succeeding two year period to carry out
each of the quality measurement activities required
under this section and section 1890A, including any
obligations that will require funds to be expended in a
future year.
quality measurement
Sec. 1890A. (a) Multi-stakeholder Group Input Into Selection
of Quality Measures.--The Secretary shall establish a pre-
rulemaking process under which the following steps occur with
respect to the selection of quality and efficiency measures
described in section 1890(b)(7)(B):
(1) Input.--Pursuant to section 1890(b)(7), the
entity with a contract under section 1890 shall convene
multi-stakeholder groups to provide input to the
Secretary on the selection of quality and efficiency
measures described in subparagraph (B) of such
paragraph.
(2) Public availability of measures considered for
selection.--Not later than December 1 of each year
(beginning with 2011), the Secretary shall make
available to the public a list of quality and
efficiency measures described in section 1890(b)(7)(B)
that the Secretary is considering under this title.
(3) Transmission of multi-stakeholder input.--
Pursuant to section 1890(b)(8), not later than February
1 of each year (beginning with 2012), the entity shall
transmit to the Secretary the input of multi-
stakeholder groups described in paragraph (1).
(4) Consideration of multi-stakeholder input.--The
Secretary shall take into consideration the input from
multi-stakeholder groups described in paragraph (1) in
selecting quality and efficiency measures described in
section 1890(b)(7)(B) that have been endorsed by the
entity with a contract under section 1890 and measures
that have not been endorsed by such entity.
(5) Rationale for use of quality measures.--The
Secretary shall publish in the Federal Register the
rationale for the use of any quality and efficiency
measure described in section 1890(b)(7)(B) that has not
been endorsed by the entity with a contract under
section 1890.
(6) Assessment of impact.--Not later than March 1,
2012, and at least once every three years thereafter,
the Secretary shall--
(A) conduct an assessment of the quality and
efficiency impact of the use of endorsed
measures described in section 1890(b)(7)(B);
and
(B) make such assessment available to the
public.
(b) Process for Dissemination of Measures Used by the
Secretary.--
(1) In general.--The Secretary shall establish a
process for disseminating quality and efficiency
measures used by the Secretary. Such process shall
include the following:
(A) The incorporation of such measures, where
applicable, in workforce programs, training
curricula, and any other means of dissemination
determined appropriate by the Secretary.
(B) The dissemination of such quality and
efficiency measures through the national
strategy developed under section 399HH of the
Public Health Service Act.
(2) Existing methods.--To the extent practicable, the
Secretary shall utilize and expand existing
dissemination methods in disseminating quality and
efficiency measures under the process established under
paragraph (1).
(c) Review of Quality Measures Used by the Secretary.--
(1) In general.--The Secretary shall--
(A) periodically (but in no case less often
than once every 3 years) review quality and
efficiency measures described in section
1890(b)(7)(B); and
(B) with respect to each such measure,
determine whether to--
(i) maintain the use of such measure;
or
(ii) phase out such measure.
(2) Considerations.--In conducting the review under
paragraph (1), the Secretary shall take steps to--
(A) seek to avoid duplication of measures
used; and
(B) take into consideration current
innovative methodologies and strategies for
quality and efficiency improvement practices in
the delivery of health care services that
represent best practices for such quality and
efficiency improvement and measures endorsed by
the entity with a contract under section 1890
since the previous review by the Secretary.
(d) Rule of Construction.--Nothing in this section shall
preclude a State from using the quality and efficiency measures
identified under sections 1139A and 1139B.
(e) Development of Quality Measures.--The Administrator of
the Center for Medicare & Medicaid Services shall through
contracts develop quality measures (as determined appropriate
by the Administrator) for use under this Act. In developing
such measures, the Administrator shall consult with the
Director of the Agency for Healthcare Research and Quality.
(f) Hospital Acquired Conditions.--The Secretary shall, to
the extent practicable, publicly report on measures for
hospital-acquired conditions that are currently utilized by the
Centers for Medicare & Medicaid Services for the adjustment of
the amount of payment to hospitals based on rates of hospital-
acquired infections.
(g) Technical Expert Panel Review of Opioid and Opioid Use
Disorder Quality Measures.--
(1) In general.--Not later than 180 days after the
date of the enactment of this subsection, the Secretary
shall establish a technical expert panel for purposes
of reviewing quality measures relating to opioids and
opioid use disorders, including care, prevention,
diagnosis, health outcomes, and treatment furnished to
individuals with opioid use disorders. The Secretary
may use the entity with a contract under section
1890(a) and amend such contract as necessary to provide
for the establishment of such technical expert panel.
(2) Review and assessment.--Not later than 1 year
after the date the technical expert panel described in
paragraph (1) is established (and periodically
thereafter as the Secretary determines appropriate),
the technical expert panel shall--
(A) review quality measures that relate to
opioids and opioid use disorders, including
existing measures and those under development;
(B) identify gaps in areas of quality
measurement that relate to opioids and opioid
use disorders, and identify measure development
priorities for such measure gaps; and
(C) make recommendations to the Secretary on
quality measures with respect to opioids and
opioid use disorders for purposes of improving
care, prevention, diagnosis, health outcomes,
and treatment, including recommendations for
revisions of such measures, need for
development of new measures, and
recommendations for including such measures in
the Merit-Based Incentive Payment System under
section 1848(q), the alternative payment models
under section 1833(z)(3)(C), the shared savings
program under section 1899, the quality
reporting requirements for inpatient hospitals
under section 1886(b)(3)(B)(viii), the hospital
value-based purchasing program under section
1886(o), and under other value-based purchasing
programs under this title.
(3) Consideration of measures by secretary.--The
Secretary shall consider--
(A) using opioid and opioid use disorder
measures (including measures used under the
Merit-Based Incentive Payment System under
section 1848(q), measures recommended under
paragraph (2)(C), and other such measures
identified by the Secretary) in alternative
payment models under section 1833(z)(3)(C) and
in the shared savings program under section
1899; and
(B) using opioid measures described in
subparagraph (A), as applicable, in the quality
reporting requirements for inpatient hospitals
under section 1886(b)(3)(B)(viii), in the
hospital value-based purchasing program under
section 1886(o), and under other value-based
purchasing programs under this title.
(4) Prioritization of measure development.--The
Secretary shall prioritize for measure development the
gaps in quality measures identified under paragraph
(2)(B).
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