[Senate Report 118-121]
[From the U.S. Government Publishing Office]
Calendar No. 265
118th Congress} { Report
SENATE
1st Session } { 118-121
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THE BETTER MENTAL HEALTH CARE, LOWER-COST DRUGS, AND EXTENDERS ACT
_______
December 7, 2023.--Ordered to be printed
_______
Mr. Wyden, from the Committee on Finance, submitted the following
R E P O R T
[To accompany S. 3430]
The Committee on Finance, having considered an original
bill (S. 3430) to amend titles XVIII and XIX of the Social
Security Act to expand the mental health care workforce and
services, reduce prescription drug costs, and extend certain
expiring provisions under Medicare and Medicaid, and for other
purposes, reports favorably thereon without amendment and
recommends that the bill do pass.
CONTENTS
Page
I. LEGISLATIVE BACKGROUND...........................................1
II. EXPLANATION OF THE BILL..........................................8
III. BUDGET EFFECTS OF THE BILL......................................36
IV. VOTES OF THE COMMITTEE..........................................37
V. REGULATORY IMPACT AND OTHER MATTERS.............................37
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED...........38
I. LEGISLATIVE BACKGROUND
The Committee on Finance, having considered S. 3430, a bill
to amend titles XVIII and XIX of the Social Security Act to
expand mental health care workforce and services, reduce
prescription drug costs, and extend certain expiring provisions
under Medicare and Medicaid, and for other purposes, reports
favorably thereon that the bill as modified by the Committee do
pass.
Background on Medicare and Medicaid Mental Health Care and Prescription
Drug Coverage
Medicare is a federal program that provides health
insurance coverage for individuals aged 65 and older, certain
individuals under the age of 65 who have disabilities, and
those with end-stage renal disease (ESRD). Medicare also pays
for certain services for individuals dually eligible for both
Medicare and Medicaid. Medicare consists of four parts: Part A
covers inpatient hospital and other facility-based services;
Part B covers physician visits and other outpatient-based care,
including physician-administered prescription drugs; Part C, or
Medicare Advantage (MA), covers the same Part A and Part B
services (and some supplemental services) through private
insurance companies; and Part D covers prescription drugs
through private prescription drug plan sponsors. Medicare pays
for health care services and items that are ``reasonable and
necessary.''
Traditional Medicare covers certain mental health services
delivered in inpatient and outpatient settings. Medicare Part A
covers inpatient mental health services furnished in a distinct
psychiatric unit of a general hospital. Medicare Part A also
allows a beneficiary to receive up to 190 days of mental health
care services furnished in a psychiatric hospital during their
lifetime. Medicare Part B covers a range of outpatient mental
health services that can be provided in different settings,
including a physician's office, hospital outpatient department,
or community mental health center. These services include
psychotherapy, family counseling, annual depression screening,
psychiatric evaluation, medication management, partial
hospitalization, outpatient substance use disorder services,
among other services. Part B covers mental health services
provided by psychiatrists and other physicians, clinical
psychologists, clinical social workers, clinical nurse
specialists, nurse practitioners, and physician assistants.
Starting on January 1, 2024, Medicare Part B will also cover
mental health services delivered by marriage and family
therapists and mental health counselors. Medicare Advantage
plans are required to cover the same set of mental health
services covered under traditional Medicare.
Medicare provides a voluntary outpatient prescription drug
benefit, known as the Part D program, in which beneficiaries
can receive covered, medically necessary outpatient drugs
prescribed by a physician or other qualified clinician. The
Part D program uses private insurers offering prescription drug
plans (PDPs) to provide prescription drug benefits to
beneficiaries. Insurers bear risk for enrollees' drug spending
and, in general, the federal government subsidizes about 75% of
total premium costs. Insurers manage costs, typically through
contracts with pharmacy benefit managers (PBMs) that use
formularies to negotiate rebates from drug manufacturers, pay
pharmacies for dispensing drugs to beneficiaries, and develop
networks of preferred pharmacies.
Medicaid is a joint federal-state program that finances the
delivery of primary and acute medical services, as well as
long-term services and supports, for a diverse low-income
population. Each state has a Medicaid state plan that describes
how the state will administer its program. The benefits covered
under Medicaid include both mandatory and optional services.
Mandatory services include inpatient hospital services,
outpatient hospital services, and a range of services for
infants and children under the early and periodic screening,
diagnostic, and treatment (EPSDT) benefit. Optional services
include certain non-mandatory categories of services, which may
include certain types of residential treatment, therapy, and
counseling services as well as prescription drugs.
State Medicaid programs are required to cover medically
necessary mental health services for adults provided in
hospitals, rural health clinics, nursing homes, home health
settings, and physician offices. Medicaid programs have the
option of covering additional mental health services for
adults, including prescription drugs; medication management;
case management; occupational, physical, or speech therapies;
clinic services; licensed clinical social worker services; and
peer support services. Medicaid programs also have the option
to cover services delivered in institutions for mental diseases
(IMD) for specific subpopulations for specific lengths of time,
as well as health services in school-based settings, including
services provided by mental health counselors. Infants and
children covered under Medicaid access mental health services
necessary to correct or ameliorate a mental health condition
under the mandatory EPSDT benefit.
Every state Medicaid program offers an outpatient
prescription drug benefit. State Medicaid programs receive
federal funding for drugs manufactured by companies that
participate in the Medicaid Drug Rebate Program. Covered
outpatient drugs are generally dispensed at the pharmacy
counter, though they may also include physician-administered
drugs. State Medicaid programs reimburse statutorily defined
retail community pharmacies for covered outpatient drugs
dispensed to Medicaid beneficiaries. The payment to retail
community pharmacies has two components: (1) an amount to cover
the cost of acquiring the drug (ingredient cost); and (2) an
amount for the pharmacist's professional services in filling a
prescription (dispensing fee).
Background on the Need to Expand Mental Health Care and Address
Pharmacy Benefit Manager Practices under Medicare and Medicaid
Nearly one in four U.S. adults, or 59.3 million people,
live with a mental illness.\1\ Nearly 22 million adults with a
substance use disorder (SUD) also had a co-occurring mental
health condition.\2\ While private insurance and Medicare
covers the majority of adults, more Medicaid beneficiaries
experience mental illness (30%) than people with private health
insurance (21%) or those who are uninsured (20%).\3\ About one
in five adult Medicaid beneficiaries have a substance use
disorder, compared to 16% of adults with private health
insurance.\4\ Young Americans are experiencing significant
mental health challenges, with one in three teenage girls
reporting
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\1\Highlights for the 2022 National Survey on Drug Use and Health,
Substance Abuse and Mental Health Services Administration, November
2023, available at https://www.samhsa.gov/data/sites/default/files/
reports/rpt42731/2022-nsduh-main-highlights.pdf.
\2\Id.
\3\Demographics and Health Insurance Coverage of Nonelderly Adults
with Mental Illness and Substance Use Disorder in 2020, Heather
Saunders and Robin Rudowitz, Kaiser Family Foundation, June 2022,
available at https://www.kff.org/mental-health/issue-brief/
demographics-and-health-insurance-coverage-of-nonelderly-adults-with-
mental-illness-and-substance-use-disorders-in-2020/.
\4\Id.
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having seriously contemplated suicide in 2021.\5\ Mental health
conditions have been exacerbated by the COVID-19 pandemic,
which contributed to increased isolation and loneliness, grief,
and financial insecurity. At the same time, behavioral health
providers have reported increasing demand with decreasing staff
sizes.
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\5\U.S. Teen Girls Experiencing Increased Sadness and Violence,
Centers for Disease Control and Prevention, February 2023, available at
https://www.cdc.gov/media/releases/2023/p0213-yrbs.html.
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Despite the prevalence of behavioral health conditions in
the U.S., nearly half of adults with mental illness do not
receive treatment, often due to barriers to comprehensive and
affordable mental health care.\6\
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\6\Highlights for the 2022 National Survey on Drug Use and Health,
Substance Abuse and Mental Health Services Administration, November
2023, available at https://www.samhsa.gov/data/sites/default/files/
reports/rpt42731/2022-nsduh-main-highlights.pdf.
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In addition, delayed access to mental health care can be
exacerbated by inaccurate provider directories published by
health plans. Health plan provider directories serve two
purposes: (1) to assist consumers who are choosing a plan; and
(2) to assist consumers who are seeking specific health care
providers. Currently, MA organizations are required by
regulation to maintain accurate provider directories. However,
CMS audits have found that MA provider directories were
inaccurate about 50% of the time.\7\
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\7\Online Provider Directory Review Report, Round 3, 2018, Online
Provider Directory Review Report, Round 2, 2018, Online Provider
Directory Review Report, Round 1, 2017, Centers for Medicare and
Medicaid Services (CMS).
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Escalating costs of prescription drugs are placing pressure
on federal health care programs and the individuals they serve.
The Office of the Inspector General of the Department of Health
and Human Services (HHS) finds that Medicare and Medicaid
account for 41% of total national spending on prescription
drugs.\8\ Between 2018 and 2021, gross Medicare Part D spending
on prescription drugs increased from $166 billion to $216
billion, with spending on the top 10 drugs increasing from $22
billion to $48 billion.\9\ Medicaid has also experienced
increases in prescription drug spending net of rebates over the
same time frame.\10\
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\8\Drug Spending, U.S. Department of Health and Human Services
Office of the Inspector General, November 2023, available at https://
oig.hhs.gov/reports-and-publications/featured-topics/drug-spending/
index.asp.
\9\A Small Number of Drugs Account for a Large Share of Medicare
Part D Spending, Juliette Cubanski and Tricia Neuman, Kaiser Family
Foundation, July 2023, available at https://www.kff.org/medicare/issue-
brief/a-small-number-of-drugs-account-for-a-large-share-of-medicare-
part-d-spending/.
\10\Trends in Medicaid Drug Spending and Rebates, available at
https://www.macpac.gov/
publication/trends-in-medicaid-drug-spending-and-rebates/
#::text=In%20FY%202021%2C%
20Medicaid%20spent,percent%20of%20Medicaid%20benefit%20spending.
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Finance Committee investigations as well as other research
have found that entities within the prescription drug supply
chain may be contributing to price increases for federal health
programs and patients at the pharmacy counter through a complex
network of financial relationships.11}12 Middlemen
like PBMs negotiate discounts on behalf of payers, like the
federal government, states, and PDP and MA plans, as well as on
behalf of patients, yet PBM discounts are not always passed on
to payers or patients at the pharmacy counter. In Medicare,
seniors' cost sharing is often based on an amount that more
closely approximates the list price of a drug, not the PBM's
net price that includes discounts. Several state Medicaid
programs have found some PBMs mark up the price of drugs paid
by Medicaid--costing one state more than $200 million a
year.\13\
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\11\A Tangled Web: An Examination of the Drug Supply and Payment
Chains, Minority Staff of the U.S. Senate Committee on Finance, June
2018, available at https://www.finance.senate.gov/imo/media/doc/
A%20Tangled%20Web.pdf.
\12\A Tangled Web: An Examination of the Drug Supply and Payment
Chains, Minority Staff of the U.S. Senate Committee on Finance, June
2018, available at https://www.finance.senate.gov/imo/media/doc/
A%20Tangled%20Web.pdf.
\13\Pharmacy Benefit Managers, Rebates, and Drug Prices: Conflicts
of Interest in the Market for Prescription Drugs, Joanna Shepherd, The
Yale Law and Policy Review, January 2019, available at https://
papers.ssrn.com/sol3/papers.cfm?abstract_id=3313828.
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Experts have noted that payments from drug manufacturers to
PBMs may create conflicts of interest between PBMs and their
health plan clients. Furthermore, linking PBM payment to a
drug's list price could create incentives for PBMs to drive
utilization of higher-priced drugs, rather than lower-priced,
clinically equivalent alternatives, to achieve higher rebates
and higher administrative fees.14}15
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\14\Perverse Incentives: Why Everyone Prefers High Drug Prices--
Except for Those Who Pay the Bills, Robin Feldman, Harvard Journal on
Legislation, 2020, available at https://repository.uchastings.edu/cgi/
viewcontent.cgi?article=2773&context=faculty_scholarship.
\15\Pharmacy Benefit Tactics Drive Up Drug Prices, Limit Access,
Contribute to Health Risks, Purchaser Business Group on Health,
December 2022, available at https://www.pbgh.org/wp-content/uploads/
2022/12/Pharmacy-Benefit-Tactics-Drive-Up-Drug-Prices-Limit-Access-
Contribute-to-Health-Risks.pdf.
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Evidence suggests that some PBMs also engage in a practice
known as ``spread pricing,'' which occurs when PBMs charge
their health plan clients a higher amount than what the PBM
actually reimburses the pharmacy for the same dispensed drug--
with the PBM retaining the difference.\16\ Across markets, PBM
clients often lack line of sight into the extent of such
spreads. Spread pricing has been widely documented in Medicaid.
For example, a 2018 audit of Ohio's Medicaid program found that
PBMs were charging the state an average 9% spread across all
drugs, with some spreads in excess of 30% for certain
generics.\17\ Similar behavior has been documented in other
state Medicaid programs, prompting several state lawmakers and
regulators to intervene.\18\ Spread pricing is less common in
Medicare Part D.\19\
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\16\Costs and Savings under Federal Policy Approaches to Address
Medicaid Prescription Drug Spending, Rachel Garfield, Rachel Dolan, and
Elizabeth Williams, Kaiser Family Foundation, June 22, 2021, available
at https://www.kff.org/medicaid/issue-brief/costs-and-savings-under-
federal-policy-approaches-to-address-medicaid-prescription-drug-
spending.
\17\Ohio Cracks Down on PBM Contracts After Audit Shows Egregious
Spread Pricing in Medicaid, Rose Meltzer, Fierce Healthcare, August 16,
2018, available at https://www.fiercehealthcare.com/regulatory/ohio-
takes-action-after-finding-pbms-engaged-egregious-spread-pricing-
medicaid.
\18\Arkansas, Delaware, Georgia, Kentucky, Louisiana, Maine,
Michigan, Minnesota, New York, Oklahoma, and Virginia have all passed
laws seeking to curb spread pricing.
\19\Medicare Part D: Use of Pharmacy Benefit Managers and Efforts
to Manage Drug Expenditures and Utilization., GAO, July 2019, available
at https://www.gao.gov/assets/gao-19-498.pdf.
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Senate Finance Committee's Work to Improve Access to Mental Health Care
and Address Pharmacy Benefit Manager Practices under Medicare
and Medicaid
In 2021, Finance Committee Chairman Ron Wyden and Ranking
Member Mike Crapo launched a bipartisan process to examine
behavioral health care needs and assess factors contributing to
gaps in mental health care. Chairman Wyden and Ranking Member
Crapo sent a letter to all Committee members asking for data-
driven policy proposals designed to improve access to
behavioral health care services for individuals enrolled in
Medicare, Medicaid, the Children's Health Insurance Program
(CHIP), and the Affordable Care Act (ACA) marketplaces. In
September 2021, the Finance Committee requested information
from public- and private-sector health care stakeholders to
help the Committee better understand how to address mental
health challenges. The Committee received over 300 responses
from organizations and more than 200 responses from individuals
on issues related to the workforce, parity, telehealth, care
integration and coordination, and youth mental health.
In addition, the Finance Committee held a series of mental
health care hearings to analyze system inadequacies and
identify potential policy solutions. From 2021 through 2023,
the Finance Committee held five hearings on mental health,
including ``Mental Health Care in America: Addressing Root
Causes and Identifying Policy Solutions,'' ``Protecting Youth
Mental Health: Part I--An Advisory and Call to Action,''
``Protecting Youth Mental Health: Part II--Identifying and
Addressing Barriers to Care,'' ``Behavioral Health Care When
Americans Need It: Ensuring Parity and Care Integration,'' and
``Barriers to Mental Health Care: Improving Provider Directory
Accuracy to Reduce the Prevalence of Ghost Networks.'' At these
hearings, the Committee heard testimony from experts and
impacted individuals including the United States Surgeon
General, physician leaders, mental health advocates, patients,
and the Government Accountability Office (GAO).
After gathering input on how to address gaps in mental
health care, the Committee released five bipartisan mental
health discussion drafts on workforce, telehealth, youth mental
health, primary care and behavioral health care integration,
and mental and physical health parity. These drafts included 47
provisions.
On May 3, 2023, Chairman Wyden released findings of a
secret shopper study conducted by the committee majority
staff.\20\ This report was part of the Finance Committee's
efforts to understand the prevalence of ghost networks, which
are inaccurate health provider directories that can prevent
Americans from obtaining health care, including mental health
care. In reviewing directories from 12 MA plans in a total of 6
states and calling 10 providers from each plan, 33% of provider
directory information was inaccurate, non-working numbers, or
unreturned calls. Staff could only make appointments for an
initial mental health visit 18% of the time.
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\20\Majority Study Findings: Medicare Advantage Plan Directories
Haunted by Ghost Networks, U.S. Senate Committee on Finance, May 3,
2023, available at https://www.finance.senate.gov/imo/media/doc/
050323%20Ghost%20Network%20Hearing%20-
%20Secret%20Shopper%20Study%20Report.pdf.
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Congress enacted several provisions from the Finance
Committee's bipartisan mental health care drafts in subsequent
legislative packages. The Bipartisan Safer Communities Act,
enacted in June 2022, included provisions from the Committee's
drafts to improve the mental health of children and adolescents
and bolster the workforce. Specifically, the bill expanded the
certified community behavioral health clinic (CCBHC)
demonstration model, authorized for up to eight states in the
Protecting Access to Medicare Act of 2014 and subsequently
expanded by Congress to include all interested states. It also
required the Centers for Medicare and Medicaid Services (CMS)
to issue guidance, provide technical assistance, and award
planning grants to states to expand mental health through
schools using Medicaid dollars; to conduct comprehensive and
regular oversight of states' implementation of Medicaid's EPSDT
benefit to strengthen children's access to comprehensive mental
health care services; and to provide guidance to states on how
they can increase access to behavioral health services through
telehealth under Medicaid and CHIP.
The Consolidated Appropriations Act, 2023, enacted in
December 2022, also included a number of mental health
provisions developed through the bipartisan Committee process,
including: establishing Medicare coverage for marriage and
family therapist (MFT) and mental health counselor services;
adding 200 additional Medicare-funded graduate medical
education (GME) residency positions and dedicating 100 of these
residency slots to psychiatry specialties; increasing Medicare
payments for crisis psychotherapy services when they are
provided by a mobile unit; requiring states to provide justice-
involved youth Medicaid coverage for 30 days prior to their
release; increasing flexibility for states to allow youth to
maintain Medicaid/CHIP coverage when they are detained in jail
settings prior to adjudication; implementing stronger
requirements on Medicaid health plans to publish searchable and
updated directories of the health providers in their networks;
and directing GAO to study whether mental health and substance
use disorder benefits are covered at parity with physical
health services in MA and mental health and substance use
disorder services in traditional Medicare.
Over the past eight years, the Finance Committee has worked
to bring more transparency to prescription drug pricing and
predatory practices within a highly complex prescription drug
supply chain. In 2015, then-Ranking Member Ron Wyden and senior
Finance Committee member (and then-Chairman of the Judiciary
Committee) Chuck Grassley conducted an 18-month investigation
into the pricing of Sovaldi and Harvoni, Gilead's breakthrough
hepatitis C drugs. In 2018, then-Ranking Member Wyden released
``A Tangled Web: Examination of the Drug Supply and Payment
Chains,'' a report which examined how financial arrangements
between different entities in the pharmaceutical delivery
system have continually pushed drug prices higher. In 2021,
then-Chairman Grassley and then-Ranking Member Wyden released
``Insulin: Examining the Factors Behind the Rising Cost of a
Century Old Drug,'' a report based on an investigation into how
contracts and financial transactions between insulin
manufacturers and PBMs influence prescription drug prices and
drug spending.
In addition, the Finance Committee held a series of
hearings on prescription drug pricing and the supply chain. In
2019, the Committee held three hearings, including a hearing in
which executives from the nation's five largest PBMs testified.
On March 30, 2023, Chairman Wyden and Ranking Member Crapo
convened a hearing entitled ``Pharmacy Benefit Managers and the
Prescription Drug Supply Chain: Impact on Patients and
Taxpayers,'' building on the Committee's years-long
consideration of practices across the prescription drug supply
chain. Witnesses at these hearings provided testimony that
demonstrated PBMs have become highly concentrated and
vertically integrated with pharmacy and health plan businesses,
enabling certain PBM practices to raise drug prices, patient
out-of-pocket costs, and total drug spending across federal
health programs under the Committee's jurisdiction. In
addition, testimony revealed PBM market concentration has
allowed PBMs to engage in predatory contracting with community
pharmacies that can undermine the financial viability and
competitiveness of community pharmacies.
On April 20, 2023, Chairman Wyden and Ranking Member Crapo
released the ``Bipartisan Framework for Reducing Prescription
Drug Costs by Modernizing the Supply Chain and Ensuring
Meaningful Relief at the Pharmacy Counter.'' The framework
outlined four key challenges facing federal prescription drug
programs, including: (1) misaligned incentives that drive up
drug prices and costs; (2) insufficient transparency that
distorts the market; (3) hurdles to pharmacy access; and (4)
behind-the-scenes practices that impede market competition and
increase costs throughout the pharmaceutical supply chain. The
framework also identified potential legislative solutions to
modernize and enhance federal prescription drug programs and to
help address these concerns.
On July 26, 2023, the Finance Committee held a markup of
the ``Modernizing and Ensuring PBM Accountability Act'' that
contained bipartisan provisions addressing PBM practices that
increased spending under the Medicare and Medicaid program.
This Act was voted favorably out of the Committee on a 26-1
vote.
Background on Congressional Extensions of Provisions of the Medicare
and Medicaid Programs That Expire
Congress has enacted multiple, separate health care
provisions that modify the Medicare and Medicaid program yet
that have not been made permanent. One reason for not making
provisions permanent is that while these health care programs
are essential for patients, health care providers, and other
stakeholders, modifications can be expensive to enact on a
permanent basis. As result, Congress has on numerous occasions
acted to extend certain statutory provisions that would
otherwise expire. According to the Congressional Research
Service, the Senate Finance Committee has jurisdiction over at
least 10 temporary health care provisions that fall under the
Medicare and Medicaid programs that expire in 2023 or on
January 19, 2024.\21\
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\21\Health Care-Related Expiring Provisions of the 118th Congress,
First Session, Katherine Kehres and Phoenix Voorhies, Congressional
Research Service, June 2023, available at https://www.crs.gov/reports/
pdf/R47604/R47604.pdf.
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On November 6, 2023, Finance Committee Chairman Wyden
released a Chairman's Mark entitled the ``Better Mental Health
Care, Lower-Cost Drugs, and Extenders Act'' that contained
bipartisan provisions addressing mental health care,
prescription drug costs that are higher as result of PBM
practices, and health extenders. The provisions, in addition to
further proposals and modifications contained in the November
8, 2023, Modification to the Chairman's Mark, comprise the
reported bill described below.
II. EXPLANATION OF THE BILL
SECTION 1. SHORT TITLE; TABLE OF CONTENTS
This section sets out the name of the bill--the ``Better
Mental Health Care, Lower-Cost Drugs, and Extenders Act''--and
lists the Table of Contents of the legislation.
TITLE 1--EXPANDING MENTAL HEALTH CARE WORKFORCE AND SERVICES UNDER
MEDICARE AND MEDICAID
SECTION 101. EXPANDING ELIGIBILITY FOR INCENTIVES UNDER THE MEDICARE
HEALTH PROFESSIONAL SHORTAGE AREA BONUS PROGRAM TO PRACTITIONERS
FURNISHING MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES
Current Law
On a quarterly basis, Medicare makes incentive payments to
physicians for Part B professional services delivered to
Medicare beneficiaries within a Health Resources and Services
Administration (HRSA)-designated health professional shortage
area (HPSA). The Medicare statute sets these bonus payments at
10%, the amount paid by the program to the physician for
qualifying services. Under current law, only physicians are
eligible for bonuses. Additionally, only psychiatrists can
receive bonus payments for professional services furnished
within a geographic mental health HPSA that is not also a
primary medical care HPSA.
Provision
The provision would extend eligibility for HPSA bonuses to
certain mental health and substance use disorder services
furnished in mental health HPSAs by applicable non-physician
health care professionals, including: (1) physician assistants,
nurse practitioners, or clinical nurse specialists; (2)
clinical social workers; (3) clinical psychologists; (4)
marriage and family therapists; and (5) mental health
counselors.
The provision would also increase bonus payments from 10%
to 15% for mental health and substance use disorder services
furnished in mental health HPSAs by eligible providers. These
provisions would apply to services furnished on or after
January 1, 2026.
SECTION 102. IMPROVED ACCESS TO MENTAL HEALTH SERVICES UNDER THE
MEDICARE PROGRAM
Current Law
Medicare covers certain behavioral health services, which
include mental health and substance use disorder services,
furnished by licensed or certified clinical social workers
(CSW) for the diagnosis and treatment of mental health illness.
CSWs bill for such services under Part B. Medicare does not
currently cover health behavior assessment and intervention
services provided by CSWs, although CMS included a proposal to
enable CSWs and certain other non-physician practitioners to
bill the program for these services in the ``Calendar Year (CY)
2024 Medicare Physician Fee Schedule Proposed Rule,'' published
on July 13, 2023.
Medicare pays for eligible skilled nursing facility (SNF)
care under Medicare Part A through a prospective payment system
(PPS), which excluded psychiatrists' and psychologists'
services when the SNF PPS methodology was implemented, but did
include clinical social worker services. Because of this, SNF
patients are unable to receive Medicare-compensated care from
CSWs who bill under Medicare Part B. The prohibition of
additional payments under Part B is due to potential double-
billing from what is paid to SNFs by Medicare in the SNF PPS.
Provision
The provision would, beginning January 1, 2026, modify the
definition of clinical social worker services covered under
Medicare Part B to include services for health behavior
assessment and intervention, identified by specific current and
successor Healthcare Common Procedure Coding System (HCPCS)
codes, furnished in an outpatient setting. The provision would
also exclude clinical social worker services from the Part A
Medicare SNF PPS. The provision would ensure that the required
payment adjustment in Section 1888(e)(4)(G)(iii) of the Social
Security Act (SSA) applies for the furnished CSW services that
are removed from the SNF PPS per diem payment bundle,
preventing provider double-billing.
SECTION 103. CLARIFYING COVERAGE OF OCCUPATIONAL THERAPY UNDER THE
MEDICARE PROGRAM
Current Law
No current law.
Provision
Within one year of enactment, the provision would require
the HHS Secretary to provide education and outreach to
stakeholders about the availability of substance use disorder
or mental health disorder services furnished by occupational
therapists to Medicare beneficiaries.
SECTION 104. MEDICARE INCENTIVES FOR BEHAVIORAL HEALTH INTEGRATION WITH
PRIMARY CARE
Current Law
Medicare, under Medicare Part B, covers eligible care
management for behavioral health conditions (e.g., depression,
anxiety, or another mental health condition) and pays health
care providers using the Psychiatric Collaborative Care Model,
a set of integrated behavioral health services that include
care management support such as care planning for behavioral
health conditions, ongoing assessment, medication support,
counseling, and other treatments.
Provision
Beginning in 2026, this provision would increase the
payment amount under the Medicare physician fee schedule (MPFS)
for certain behavioral health integration services (identified
in the legislation by specific service codes), and then phase
down that increase in 2027 and 2028. For 2026, the payment for
the codes would be 175% of the MPFS amount; for 2027, the
payment would be 150%; and for 2028, it would be 125%. The
increase and phase-down in payments under this provision would
not be included in the MPFS's budget neutrality calculations.
SECTION 105. ESTABLISHMENT OF MEDICARE INCIDENT TO MODIFIER FOR MENTAL
HEALTH SERVICES FURNISHED THROUGH TELEHEALTH
Current Law
During the coronavirus public health emergency (PHE), the
Coronavirus Aid, Relief, and Economic Security Act (CARES, Pub.
L. 116-136) gave the HHS Secretary authority to modify or waive
many of the statutory restrictions on Medicare telehealth
services. The Secretary used these flexibilities to expand
access to behavioral health services (substance use disorder
and mental health services) delivered via telehealth, including
for services furnished incident to care provided by a physician
or non-physician practitioner. Subsequently, the Consolidated
Appropriations Act, 2021 (Pub. L. 116-260) made this new
modification permanent.
Provision
This provision would direct the Secretary to establish
requirements within two years of enactment of this Act related
to the use of a code or modifier identifying claims for certain
telehealth services furnished by auxiliary personnel incident
to a physician's or non-physician practitioner's services.
SECTION 106. GUIDANCE ON FURNISHING BEHAVIORAL HEALTH SERVICES VIA
TELEHEALTH TO INDIVIDUALS WITH LIMITED ENGLISH PROFICIENCY UNDER
MEDICARE PROGRAM
Current Law
No current law.
Provision
This provision would require the HHS Secretary to issue and
disseminate guidance on best practices (1) for providers to
work with interpreters to furnish behavioral health services
via video-based and audio-only telehealth, when video-based
telehealth is not an option; (2) on integrating the use of
video platforms that enable multi-person video calls into
behavioral health services furnished via telehealth; (3) on
teaching patients, especially those with limited English
proficiency, to use video-based telehealth platforms; and (4)
for providing patient materials, communications, and
instructions in multiple languages, including text message
appointment reminders and prescription information.
SECTION 107. ENSURING TIMELY COMMUNICATION REGARDING TELEHEALTH AND
INTERSTATE LICENSURE REQUIREMENTS
Current Law
No current law.
Provision
This provision would require the HHS Secretary to provide
information on licensure requirements for furnishing telehealth
services under Medicare and Medicaid, including updates to
guidance and other information that clarifies the extent to
which licenses through the interstate license compact pathway
can qualify as valid and full licenses for the purposes of
meeting licensure requirements under Titles XVIII and XIX of
the SSA.
SECTION 108. FACILITATING ACCESSIBILITY FOR BEHAVIORAL HEALTH SERVICES
FURNISHED THROUGH TELEHEALTH
Current Law
No current law.
Provision
This provision would require the HHS Secretary to provide
updates to guidance to facilitate the accessibility of
behavioral health services furnished through telehealth for the
visually and hearing impaired.
SECTION 109. REQUIRING ENHANCED AND ACCURATE LISTS OF (REAL) HEALTH
PROVIDERS ACT
Current Law
Section 1852(c)(1)(C) requires MA Organizations to disclose
in a clear, accurate, and standardized form the number, mix,
and distribution of plan providers. Under its statutory
authority, CMS requires MA organizations to provide enrollees
with plan directories by October 15th each year, within 10 days
of enrollment, and at the request of an enrollee. MA
organizations are required to include printable and searchable
copies of plan directories listing providers on plan websites
and maintain a publicly accessible standards-based Application
Programming Interface that must provide a complete and accurate
directory of the MA plan's network of contracted providers. CMS
guidelines state that MA plans should contact contracted
providers on a quarterly basis to update provider directory
information including the ability to accept new patients,
street address, phone number, and any other changes that affect
availability to patients. Directories must be updated within 30
days of the plan receiving information requiring update.
MA plans vary with respect to whether, or the extent to
which, they cover out-of-network care. When out-of-network care
is covered, the enrollee is generally required to pay higher
cost sharing for going out-of-network.
Provision
These provisions would require that beginning in plan year
(PY) 2026, each network-based MA plan would be responsible for
maintaining an accurate provider directory on a public website
and would meet the requirements described below.
These provisions would require MA plans to pay for covered
items or services when delivered by a provider listed in the
directory as in-network, but who was actually out-of-network
when the appointment was made. MA plans would be required to
submit annual reports of their provider directory accuracy. The
accuracy of the plan directory would be reported on the plan's
directory and to the HHS Secretary. The Comptroller General of
the United States would be required to submit a study of this
information submitted under this provision and related issues.
The HHS Secretary would be required to hold a public
stakeholder meeting on best practices for maintaining accurate
provider directories, issue guidance to MA Organizations on
best practices, and issue guidance to providers on when to
update their information in the National Plan and Provider
Enumeration System.
I. Accurate Plan Provider Directory Requirements
This provision would amend Section 1852(c), requiring
network-based MA plans to maintain an accurate provider
directory on a publicly available website. Network-based plan
has the meaning given in Section 1852(d)(5)(C) except that it
includes private fee-for-service plans as determined by the
Secretary. Each network-based MA plan would be required to
verify provider directory information for each provider listed
in such directory, at least every 90 days or in the case of a
hospital or other facility the HHS Secretary can specify a
lesser frequency that is in no case less than once every 12
months. MA plans would be required to note in the directory
providers whose information could not be verified, to remove
providers listed in a directory within five business days if
the organization determines the provider is no longer
participating in the network, and meet other requirements as
specified by the HHS Secretary. Provider directories would be
required to include information that the enrollee may need to
access covered benefits from a contracted provider. The section
provides examples of what directory information could include
(such as provider name, specialty, contact information, primary
office or facility address, whether the provider is accepting
new patients, accommodations for people with disabilities,
cultural and linguistic capabilities, and telehealth
capabilities) but leaves the determination to the HHS
Secretary.
This provision would amend Section 1852(d) requiring MA
plans beginning in plan year 2026 to ensure that if an enrollee
received care from an out-of-network provider that was listed
on the date the appointment was made as an in-network provider
in the plan's directory, the MA organization would be cover
that out of network care, as long as it was a covered item or
service, and ensure that the enrollee was only responsible for
in-network cost sharing. This provision amends Section
1852(d)(1)(C) to require MA plans to cover services furnished
upon reliance on incorrect provider directory information on an
out of network basis. For plan year 2026, MA plans would notify
enrollees of their cost-sharing protections on an explanation
of benefits, annual notifications provided prior to the annual,
coordinated election period under 1851(e)(3), and on the plan's
provider directory.
II. Accountability and Transparency for Accurate Plan
Provider Directories
This provision would amend Section 1857(e) to require MA
contracts beginning plan year 2026 to conduct and submit to the
HHS Secretary annual reports of their provider directory
accuracy, including provider specialties with high inaccuracy
rates (such as providers specializing in mental health) as
determined by the HHS Secretary for each plan. The HHS
Secretary, in specifying methodologies that MA plans can use to
estimate the accuracy of the provider directory information and
their accuracy scores, would consider availability of various
data sources, administrative burden on plans and providers, and
the relative importance of certain directory information on
access to care. Beginning in plan year 2027, the HHS Secretary
would be required to post on the CMS website the provider
directory accuracy scores, in a machine-readable format and
plans would be required to disclose the accuracy scores on its
plan directory. The HHS Secretary would be required to
implement provider directory accuracy analyses through the
rulemaking process and would be permitted to waive these
requirements for low enrollment MA plans, as defined by the
Secretary. To implement these requirements, $1,000,000 to
remain available until expended would be appropriated to CMS
Program Management Account, out of the General Fund of the U.S.
Treasury.
By not later than January 15, 2031, the Comptroller General
of the United States would be required to submit a study of the
implementation of: (1) the requirement that in-network cost
sharing amounts apply to care furnished by an out-of-network
provider if the provider choice was based on incorrect
directory information; (2) provider response rates to plan
outreach methods; and (3) the requirement that MA organizations
conduct and submit provider directory accuracy analyses (both
overall and among providers specializing in mental health or
substance disorder treatment).
III. Stakeholder Engagement and CMS Guidance to Improve
Plan Provider Directories
Not later than 3 months after enactment, the HHS Secretary
would be required to hold a public stakeholder meeting on
maintaining accurate provider directories for MA plans,
including approaches for reducing administrative burden such as
data standardization and best practices to maintain provider
directory information. Participants of the meeting shall
include representatives from the Medicare program, Office of
the National Coordinator for Health Information Technology,
health care providers, companies that specialize in relevant
technologies, health insurers, and patient advocates.
Not later than 12 months after enactment, the HHS Secretary
would be required to issue guidance to MA Organizations on
mainlining accurate provider directories for such plans taking
into consideration comments submitted during the public
stakeholder meeting. The guidance may include the following
topics as determined appropriate by the Secretary: best
practices for MA organizations on how to work with providers to
maintain the accuracy of provider directories and reduce
provider and MA organization burden with respect to maintaining
the accuracy of provider directories; information on data sets
and data sources with information that could be used by MA
organizations to maintain accurate provider directories;
approaches for utilizing data sources maintained by MA
organizations and publicly available data sets to maintain
accurate provider directories; and information to be included
in the provider directory that may be useful for Medicare
beneficiaries to assess plan networks when selecting a plan and
accessing providers participating in plan networks during the
plan year.
Not later than 12 months after enactment, the HHS Secretary
would be required to issue guidance to Part B participating
providers on when to update their information in the National
Plan and Provider Enumeration System.
SECTION 110. GUIDANCE TO STATES ON STRATEGIES UNDER MEDICAID AND CHIP
TO INCREASE MENTAL HEALTH AND SUBSTANCE USE DISORDER CARE PROVIDER
CAPACITY
Current Law
In general, Medicaid state plans must allow program
enrollees to obtain services from any willing and qualified
provider that chooses to offer such services. States are
generally responsible for determining which providers meet
program qualification criteria including licensed clinicians
and non-licensed providers such as peer support specialists.
Providers who meet these federal and state requirements may
enter into agreements with state Medicaid agencies to provide
Medicaid-covered services to individuals enrolled in the
Medicaid program.
Section 1003 of the Substance Use-Disorder Prevention That
Promotes Opioid Recovery and Treatment for Patients and
Communities Act (SUPPORT Act; Pub. L. 115-271) established a
time-limited competitive demonstration project to increase the
treatment capacity of Medicaid substance use disorder (SUD)
providers and inform best practices through specified
activities, including improved reimbursement, recruitment,
training, and technical assistance.
Provision
This provision would require the HHS Secretary to issue
state guidance within 18 months of the enactment of this Act on
strategies to increase the capacity of mental health (MH) and
SUD providers under Medicaid and CHIP, with a focus on
improving MH/SUD provider capacity in rural and underserved
areas.
SECTION 111. GUIDANCE TO STATES ON SUPPORTING MENTAL HEALTH SERVICES
AND SUBSTANCE USE DISORDER CARE FOR CHILDREN AND YOUTH
Current Law
EPSDT services are a required benefit for nearly all
children (under age 21) who are enrolled in Medicaid, and for
targeted low-income children under the State CHIP Medicaid
expansion programs.\22\ EPSDT covers comprehensive health
screenings, including assessments of children's physical and
mental health development, and all federally allowable,
medically necessary treatment to correct problems identified
through screenings (including services to treat any identified
MH and/or SUD condition), even if the specific treatment needed
is not otherwise covered under a given state's Medicaid plan.
---------------------------------------------------------------------------
\22\While EPSDT is not a required benefit for separate CHIP
programs, many states also offer this benefit under their separate CHIP
plans.
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While MH and SUD services are not specifically defined
categories of Medicaid benefits, the program covers many MH/SUD
benefits under other service categories, and states have the
flexibility to cover MH/SUD services under several different
statutory authorities (e.g., state plan, waiver authorities,
and other authorities for Medicaid payment). For separate CHIP
programs, Title XXI of the SSA requires states to cover a wide-
array of MH/SUD services necessary to prevent, diagnose, and
treat mental health conditions and substance use disorders.
Provision
Within one year after enactment of this Act, the provision
would require the HHS Secretary, in consultation with (1) the
CMS Administrator, (2) the Assistant Secretary for the
Administration for Children and Families (ACF), (3) the
Assistant Secretary for Mental Health and Substance Use, and
(4) the Director of the Office of National Drug Control Policy
to release state guidance regarding opportunities to improve
the design, implementation, screening for and access to a
continuum of culturally competent, developmentally appropriate,
and trauma-informed Medicaid and CHIP MH/SUD services for at-
risk children and youth, as defined, as well as other special
populations such as youth in foster care and those with
intellectual or developmental disabilities.
SECTION 112. RECURRING ANALYSIS AND PUBLICATION OF MEDICAID HEALTH CARE
DATA RELATED TO MENTAL HEALTH SERVICES
Current Law
The SUPPORT Act requires the HHS Secretary to publish a
report on the prevalence of SUDs and the SUD treatment services
provided to Medicaid enrollees based on federally required
state submissions of Transformed Medicaid Statistical
Information System (T-MSIS) data. CMS is required to issue
annual updates that include certain specified information not
later than January 1st for each calendar year through 2024.
Provision
The provision would require the HHS Secretary to publish to
a publicly available website with specified information on the
prevalence of MH conditions and MH treatment services provided
to Medicaid enrollees, based on federally required state
submissions of T-MSIS (or a successor system) data. The first
publication of Medicaid MH data would be required to be made
available within 18 months of this Act's enactment, and
biennially thereafter. The provision would also require CMS to
permanently continue to issue annual updates of the SUPPORT Act
SUD Databook.
SECTION 113. GUIDANCE TO STATES ON SUPPORTING MENTAL HEALTH SERVICES OR
SUBSTANCE USE DISORDER CARE INTEGRATION WITH PRIMARY CARE IN MEDICAID
AND CHIP
Current Law
CMS has issued guidance to encourage states to adopt
strategies that promote the integration of physical and MH or
SUD care delivery under existing Medicaid and CHIP authorities,
payment methodologies, and integrated care models. This
approach is being undertaken in an attempt to more effectively
identify enrollee health care needs and connect enrollees with
appropriate treatment.\23\
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\23\Leveraging Medicaid, CHIP, and Other Federal Programs in the
Delivery of Behavioral Health Services for Children and Youth, Daniel
Tsai, CMCS Informational Bulletin, August 18, 2022, available at
https://www.medicaid.gov/sites/default/files/2022-08/
bhccib08182022.pdf.
---------------------------------------------------------------------------
Provision
The provision would require the HHS Secretary to conduct an
analysis of Medicaid and CHIP clinical outcomes associated with
various integrated care models and payment methodologies,
within 18 months of the enactment of this Act. Within 12 months
of completing this analysis, the HHS Secretary would be
required to issue state guidance on supporting the integration
of Medicaid and CHIP MH care or SUD care with primary care that
meets specified requirements.
SECTION 114. MEDICAID STATE OPTION RELATING TO INMATES WITH A SUBSTANCE
USE DISORDER PENDING DISPOSITION OF CHARGES
Current Law
The federal Medicaid statute includes the inmate payment
exclusion which generally prohibits the use of federal Medicaid
funds to pay for the health care of an inmate of a public
institution. CMS sub-regulatory guidance clarifies that
Medicaid's definition of an inmate of a public institution does
not distinguish between individuals who are detained in a
public institution pending disposition of charges and those who
are incarcerated post-sentencing.
Section 5122 of the Consolidated Appropriations Act, 2023
(CAA 2023; Pub. L. 117-328) permits states to receive federal
payment for certain specified Medicaid services provided to
``eligible juveniles'' during the period in which such
enrollees are inmates of a public institution pending
disposition of charges, beginning January 1, 2025.
Provision
The provision would modify the Medicaid statute, as amended
in CAA 2023, to permit states to receive federal payment, for a
period not to exceed 7 days, for medical assistance for
individuals with an SUD who are inmates of a public institution
pending disposition of charges, who were assessed to confirm an
SUD diagnosis while incarcerated, and whose eligibility for
medical assistance is suspended by the state during the period
the individual is an inmate of such a public institution. The
provision would be effective beginning January 1, 2026.
SECTION 115. DEFINING CERTIFIED COMMUNITY BEHAVIORAL HEALTH CLINICS
(CCBHCS) WITHIN THE MEDICAID PROGRAM
Current Law
Section 223 of the Protecting Access to Medicare Act of
2014 (Pub. L. 113-93) authorized a Medicaid demonstration
program which established CCBHCs.\24\ CCBHCs are facilities
operated by nonprofit, governmental, or tribal entities that
offer a comprehensive range of behavioral health services. The
HHS Secretary was required to publish criteria relating to
staffing, care coordination, and other clinic requirements for
States to use to certify clinics.\25\ States participating in
the CCBHC demonstration program receive the enhanced federal
medical assistance percentage (E-FMAP; i.e., the federal
reimbursement rate used for the State CHIP for CCBHC services
provided to Medicaid enrollees during the applicable
demonstration period. In addition, the CCBHCs in these states
receive greater Medicaid payment rates for the services
provided to Medicaid enrollees through a prospective payment
system (PPS) methodology. There are currently eight states
participating in the demonstration with varying expirations.
The Bipartisan Safer Communities Act of 2022 (Pub. L. 117-159)
authorized the HHS Secretary to select up to 10 additional
states for the Medicaid demonstration program beginning July 1,
2024, and every two years after that.
---------------------------------------------------------------------------
\24\The Consolidated Appropriations Act of 2018 (Pub. L. 115-141)
authorized a CCBHC expansion grant program which was further funded by
additional laws passed in 2021 and 2022. Expansion grants provide
supplemental funds directly to clinics in order to increase access and
improve the quality of their behavioral health services.
\25\ HHS issued the original CCBHC certification criteria in 2015,
which outlined standards for staffing, provider credentialing, training
requirements, linguistic competence, timely access, among others. In
March 2023, HHS issued updated criteria which was informed by public
input and includes updates to the standards related to developments in
the field.
---------------------------------------------------------------------------
CCBHCs can be supported by a Medicaid demonstration program
for states and/or discretionary grant funding for clinics from
the Substance Abuse and Mental Health Services Administration
(SAMHSA). States that are not part of the CCBHC Medicaid
demonstration program are able to make Medicaid payments to
CCBHCs, but these states are not required to pay CCBHCs through
a PPS. In addition, only states participating in the Medicaid
demonstration program are eligible for the E-FMAP for CCBHC
services.
Provision
Section 115 would amend Section 1905 of the SSA (42 U.S.C.
Sec. 1396d) to add CCBHC services to the list of Medicaid
optional service categories under traditional Medicaid. The
provision would add a definition of CCBHC services which would
include the same services that CCBHCs are required to provide
in the demonstration program (e.g., crisis mental health
services, targeted case management, psychiatric
rehabilitation). A CCBHC would be defined as an organization
that furnishes CCBHC services, is legally authorized to furnish
such services under State law, agrees to furnish data as
required as a condition of certification, and has been
certified by a State to meet the criteria issued by the HHS
Secretary as of January 1, 2024, and any subsequent updates to
those criteria, regardless of whether the state is
participating in the Medicaid demonstration program.\26\ The
effective date for this provision would be January 1, 2024.
---------------------------------------------------------------------------
\26\There is bracketed text providing the following examples of the
data states would need to furnish: ``encounter data, clinical outcomes
data, quality data, and such other data as the State or Secretary may
require.''
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TITLE II--REDUCING PRESCRIPTION DRUG COSTS UNDER MEDICARE AND MEDICAID
SECTION 201. ASSURING PHARMACY ACCESS AND CHOICE FOR MEDICARE
BENEFICIARIES
Current Law
Under SSA Section 1860D-4(b) ((42 U.S.C. Sec. 1395w-
104(b)), Part D plans must contract with an adequate network of
brick-and-mortar pharmacies each year in order to provide easy
access for plan enrollees. Plan sponsors often contract with
PBMs to contract with pharmacies and maintain pharmacy networks
on the plan's behalf. Under 1860D-4(b)(A), plan sponsors must
contract with any willing pharmacy that agrees to accept their
pharmacy network terms and conditions. Under current
regulations and program guidance, such terms and conditions
must be reasonable and relevant, including with respect to
reimbursement.\27\ However, pharmacy contract terms and drug
reimbursement vary among Part D plans.
---------------------------------------------------------------------------
\27\42 C.F.R. Sec. 423.505; Medicare Prescription Drug Benefit
Manual, Chapter 5, Section 50.
---------------------------------------------------------------------------
Chapter 5 of the Medicare Prescription Drug Benefit Manual
indicates that CMS generally defers to the relevant parties to
resolve disputes regarding Part D's any willing pharmacy
requirements, although the agency issued program guidance in
2015 highlighting reports from pharmacies raising ``several
issues''' with plan sponsors' approach to compliance.\28\\29\
The guidance did not outline any substantive changes or
increases in enforcement with respect to the relevant
requirements.
---------------------------------------------------------------------------
\28\Ibid.
\29\Compliance with Any Willing Pharmacy (AWP) Requirements, Amy K.
Larrick, CMS, August 13, 2015, available at https://www.hhs.gov/
guidance/sites/default/files/hhs-guidance-
documents/anywillingpharmacyguidance_166.pdf.
---------------------------------------------------------------------------
In recent years, CMS has also noted a sharp rise in
pharmacy fees and other price concessions that plan sponsors
and PBMs extracted from retail pharmacies after the point of
sale and reported as Direct and Indirect Remuneration (DIR).
Part D pharmacy DIR includes administrative fees, network
access fees, and fees for not meeting plan quality metrics.
Part D plan sponsors may provide incentive payments to
pharmacies for meeting specified goals, but CMS data indicate
that extracted fees, or penalties, far outpace additional
compensation to pharmacies. According to CMS, pharmacy fees are
the fastest-growing category of DIR, accounting for nearly 5%
of gross Part D drug costs ($9.5 billion) in 2020, compared to
0.01% ($8.9 million) in 2010.\30\ The increase in fees, as well
as their post-point of sale nature, have made it difficult for
pharmacies to accurately predict their total reimbursement for
dispensing a covered drug, with some pharmacies expressing
concerns that reimbursement on certain drugs can drop below
pharmacy acquisition costs.
---------------------------------------------------------------------------
\30\Medicare Program: Contract Year 2023 Policy and Technical
Changes to the Medicare Advantage and Medicare Prescription Drug
Benefit Programs, 87 Federal Register p. 1413, CMS, May 2022, available
at https://www.federalregister.gov/d/2022-09375/p-1413.
---------------------------------------------------------------------------
In May 2022, CMS issued a final rule, effective in 2024, to
help address the uncertainties in pharmacy reimbursement caused
by PBM fees. The rule changes the definition of ``negotiated
price'' to include the lowest possible reimbursement that a
network pharmacy will receive in total for dispensing a
drug.\31\ Some pharmacies have expressed concerns that
implementation of this rule could lead to further reductions in
overall reimbursement from PBMs working on behalf of Part D
plans.\32\
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\31\Id.
\32\A New World Order of Drastically Lower Pharmacy Reimbursement
Series--Part 1: Lower Net Pharmacy Reimbursement Following CMS Final
Rule on DIR Fees, Jonathan Levitt, Frier Levitt, June 2022, available
at https://www.frierlevitt.com/articles/a-new-world-order-of-
drastically-lower-pharmacy-reimbursement-series-part-1-lower-net-
pharmacy-reimbursement-following-cms-final-rule-on-dir-fees.
---------------------------------------------------------------------------
After a plan has developed an adequate network, Part D plan
sponsors (except those offering the Part D defined standard
benefit) may contract with select pharmacies to create a
second, preferred pharmacy network. Part D sponsors may
institute lower copayments or coinsurance for enrollee
prescriptions filled in preferred pharmacies, but such cost-
sharing reductions may not increase Medicare payments to the
Part D plan. CMS does not apply any willing pharmacy
requirements to the designation of preferred network
pharmacies, and program guidance permits plans to increase cost
sharing for non-preferred network pharmacies in order to meet
the requisite actuarial tests while reducing cost sharing for
preferred network pharmacies.\33\ A number of large Part D
plans include no independent pharmacies in their preferred
networks.\34\
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\33\42 C.F.R. Sec. 423.505; Medicare Prescription Drug Benefit
Manual, Chapter 5, Section 50.
\34\Small Pharmacies Walk Away from Medicare Part D's 2023
Preferred Networks, Adam Fein, Drug Channels, December 2022, available
at https://www.drugchannels.net/2022/12/small-pharmacies-walk-away-
from.html.
---------------------------------------------------------------------------
Provisions
I. Reasonable and Relevant Codification
These provisions would amend SSA Section 1860D-4(b)(1) by
requiring plan sponsors to contract with any willing pharmacy
that meets their standard contract terms and conditions, and by
requiring that such contract terms and conditions be reasonable
and relevant. No later than January 1, 2025, the HHS Secretary
would be required to request information on such contract terms
and conditions, as well as contracting practices between
pharmacies and Part D plans/PBMs, including with respect to
information on reimbursement and dispensing fees. No later than
January 1, 2028, the HHS Secretary would establish standards
for reasonable and relevant contract terms and conditions
through notice-and-comment rulemaking.
II. Essential Retail Pharmacies
These provisions would also amend Section 1860D-4(b)(1)(C)
(42 U.S.C. Sec. 1395w-104(b)(1)(C)), which governs convenient
access to Part D pharmacies. Effective starting in 2028, a plan
sponsor offering preferred pharmacy networks would be required
to contract with at least:
80% of essential retail pharmacies in the
plan's service area that are independent community
pharmacies, and
50% of essential retail pharmacies in such
plan's service area that are not independent community
pharmacies.
An independent community pharmacy would be defined as a
retail pharmacy with fewer than four locations that is not
affiliated with any person or entity other than its owners.
Franchises and pharmacies associated with pharmacy services
administrative organizations that meet the relevant
requirements can qualify as independent community pharmacies
under this provision.
An essential retail pharmacy would be defined as a pharmacy
that: (1) is not an affiliate of a PBM or plan sponsor;\35\ (2)
is located in a medically underserved area; and (3) is
designated as an essential retail pharmacy by the HHS Secretary
for the year. The HHS Secretary would designate essential
retail pharmacies each plan year based in part on information
submitted by plan sponsors about affiliate pharmacies. The HHS
Secretary would issue a list of essential retail pharmacies
prior to the start of a plan year. The HHS Secretary could
revoke a designation in certain cases, such as when a pharmacy
no longer meets the requirements.
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\35\Affiliate.--The term ``affiliate'' means any entity that is
owned by, controlled by, or related under a common ownership structure
with a pharmacy benefit manager or PDP sponsor or that acts as a
contractor or agent to such pharmacy benefit manager or PDP sponsor, if
such contractor or agent performs any of the functions described in
item (cc).
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Starting in 2028, total reimbursement for a covered drug
dispensed by an essential retail pharmacy that is an
independent community pharmacy could not be lower than the
average National Average Drug Acquisition Cost\36\ (NADAC) for
such drug for retail community pharmacies. If there were no
NADAC data for retail community pharmacies available, the NADAC
for applicable non-retail pharmacies or the Wholesale
Acquisition Cost (WAC) would be used to determine the
reimbursement floor for such pharmacies.
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\36\The National Average Drug Acquisition Cost (NADAC) is a
Medicaid price measure that is based on survey of pharmacy acquisition
costs and represents the average acquisition cost.
---------------------------------------------------------------------------
III. Allegations of Violations
These provisions would amend SSA Section 1860D-4(b)(1) (42
U.S.C. Sec. 1395w-104(b)(1)) to require the HHS Secretary, no
later than January 1, 2028, to establish a process enabling a
pharmacy to submit an allegation, via a standardized template,
that a plan sponsor was in violation of: (1) standards for
reasonable and relevant contract terms and conditions; or (2)
protections for essential retail pharmacies that are
independent pharmacies. The provisions would allow a pharmacy
to submit allegations of violations related to reasonable and
relevant standards once per contract per plan year, with the
ability to submit an additional allegation within a single plan
year in the event of a substantive change in the terms or
conditions offered under such contract. Essential retail
pharmacies that are independent pharmacies would be permitted
to submit allegations of reimbursement violations on a
quarterly basis.
A plan sponsor accused of such violations would have to
provide relevant documents or materials to the HHS Secretary
upon request, and could not limit the ability of a pharmacy to
submit such information to the HHS Secretary. If the HHS
Secretary determined that a pharmacy submitted frivolous
allegations on a routine basis, the HHS Secretary could
temporarily prohibit such pharmacy from using the allegation
process.
Civil penalties would apply for violations of the statute.
In addition, a plan sponsor that underpaid a pharmacy would be
required to provide full reimbursement.
These provisions would also amend SSA Section 1860D-12(b)
(42 U.S.C. 1395w-112) to require that each contract between a
Part D plan and a PBM include a written agreement that the PBM
reimburse the sponsor for any amounts related to violations of
contract terms and essential retail pharmacy protections that
were related to responsibilities such plan delegated to the
PBM.
These provisions would provide $250 million in funding to
carry out these provisions, beginning in 2024, to remain
available until expended.
IV. Oversight of Pharmacy Access Requirements
This provision would direct the Secretary to brief Congress
and to compile and publish periodic reports, beginning no later
than 90 days after the date of enactment of this legislation,
through plan year 2027, on the following topics related to
implementation of the Pharmacy DIR rule that takes effect in
2024, as well as related to statutory, regulatory, and sub-
regulatory requirements and standards:
Monitoring of changes to contract terms and
conditions offered to pharmacies for network or
preferred network participation;
HHS enforcement or oversight activities
related to regulatory and sub-regulatory requirements
regarding Part D's any willing pharmacy provisions; and
HHS plans, strategies, or initiatives to
address or mitigate concerns related to convenient
pharmacy access.
SECTION 202. ENSURING ACCURATE PAYMENTS TO PHARMACIES UNDER MEDICAID
Current Law
State Medicaid programs reimburse statutorily defined
retail community pharmacies (RCPs) for covered outpatient drugs
dispensed to Medicaid beneficiaries based on two components:
(1) the cost of the medicine (the ingredient cost) and (2) a
payment for the cost to the pharmacy of administering and
filling a prescription (the professional dispensing fee). State
Medicaid programs, subject to CMS approval, determine pharmacy
ingredient payment rates, as well as professional dispensing
fees.
The Deficit Reduction Act of 2005 (DRA, Pub. L. 109-171)
amended SSA Section 1927 by adding a new subsection (f) that
required the HHS Secretary to retain a contractor to survey
RCPs. To implement the survey, CMS contracted for the NADAC
survey. NADAC is a monthly survey of RCP acquisition costs paid
for most covered outpatient drugs. CMS, through a contractor,
surveys a national random sample of RCPs monthly and has been
publishing NADAC data since November 2013. RCP participation in
NADAC is voluntary, but to provide an accurate national
estimate of average acquisition costs, it is important that the
sample is representative of all geographic areas and different
pharmacy types such as independent and chain pharmacies.
The NADAC survey excludes specialty and mail-order
pharmacies, as well as a number of other non-retail community
pharmacies. According to a 2020 HHS OIG report, ``60 percent of
drugs categorized as specialty drugs with Medicaid
reimbursement in 2018 did not have NADAC data available,''
limiting states' ability to set accurate payment rates for
these products.\37\ OIG recommended that CMS provide states
with acquisition cost data for these products, but the agency
cited its lack of clear statutory authority to conduct a NADAC-
like survey of specialty pharmacies in responding to the
recommendation.
---------------------------------------------------------------------------
\37\States Could Do More to Oversee Spending and Contain Medicaid
Costs for Specialty Drugs, Suzanne Murrin, HHS OIG, December 2020,
available at https://oig.hhs.gov/oei/reports/OEI-03-17-00430.pdf.
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As of last year, the three largest specialty pharmacies
were all PBM affiliates and accounted for a combined 65% of
prescription revenue for pharmacy-dispensed specialty
drugs.\38\ A September 2023 Nephron Research study found that
``expansion of specialty pharmacy is now the leading driver of
PBM profit growth,'' accounting for an estimated 39% of gross
profits for PBMs in 2023, up from just 16% in 2012.\39\ A
number of studies have pointed to vertical integration in the
sector as a potential source of substantial markups on
otherwise low-cost specialty drugs in Part D.
---------------------------------------------------------------------------
\38\ DCI's Top 15 Specialty Pharmacies of 2022: Five Key Trends
About Today's Marketplace, Adam Fein, Drug Channels, April 2023,
available at https://www.drugchannels.net/2023/04/dcis-top-15-
specialty-pharmacies-of.html.
\39\Trends in Profitability and Compensation of PBMs and PBM
Contracting Entities, Eric Percher, Nephron Research, September 2023,
available at https://nephronresearch.bluematrix.com/sellside/
AttachmentViewer.action?encrypt=1c65fc0e-f558-4f1d-891f-
21c196a9f1ad&fileId=7276_04a77b17-d298-48a2-bd15-
1c5ed22a6984&isPdf=false.
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Provision
This provision would require the HHS Secretary to survey
RCPs' drug prices to determine national average drug
acquisition costs. Specifically, the HHS Secretary would be
required to conduct a monthly survey to determine NADACs for
covered outpatient drugs that represent a nationwide average of
consumer purchase prices, net of all discounts and rebates (to
the extent discount and rebate information is available). RCPs
that receive payment related to the dispensing of covered
outpatient drugs to individuals receiving benefits under
Medicaid would be required to respond to the survey. The HHS
Secretary would be authorized to use a vendor to conduct the
survey. Information on national drug acquisition prices
obtained through the NADAC survey would be publicly available,
as would other specified information on the NADAC survey.
These provisions would also require the HHS Secretary to
survey drug prices at applicable non-retail pharmacies to
determine NADAC benchmarks for such pharmacies that are
separate from benchmarks used for RCPs. Applicable non-retail
pharmacies that receive payment related to the dispensing of
covered outpatient drugs to individuals receiving benefits
under Medicaid would also be required to respond to the survey.
An ``applicable non-retail pharmacy'' would be a state-
licensed pharmacy that is not an RCP, including mail order and
specialty pharmacies. The following pharmacies would not be
considered applicable non-retail pharmacies: nursing home,
long-term care facility, hospital, clinic, charitable or not-
for-profit, government, and low-dispensing (defined by the HHS
Secretary) pharmacies. By January 1, 2025, the HHS Secretary,
would be required to consult with appropriate stakeholders and
issue guidance defining applicable non-retail pharmacies. In
addition, under the guidance promulgated to define non-retail
pharmacies, the HHS Secretary would be required to establish
pharmacy type indicators to distinguish between different non-
retail pharmacies, such as mail order and specialty pharmacies.
Applicable non-retail pharmacies may be identified by multiple
pharmacy type indicators.
To receive federal financial participation on prescription
drugs, state Medicaid programs must require pharmacies in the
state to respond to the monthly NADAC surveys. States would be
prohibited from using survey data from applicable non-retail
pharmacy prices to develop or inform reimbursement rates for
RCPs.
National drug acquisition prices would be made publicly
available as well as other information on the survey such as
the monthly response rate, identification of noncompliant
pharmacies, the sampling frame and the number of pharmacies
sampled monthly. In addition, price concessions to pharmacies
including discounts, rebates, and other price concessions would
be made public, if that information may be released publicly,
and to the extent the HHS Secretary has collected the
information through the NADAC survey during the survey period.
The HHS Secretary in consultation with the OIG would be
required to enforce pharmacy compliance with the NADAC survey
through establishing appropriate civil monetary penalties
(CMPs). CMPs may be assessed for each violation or survey non-
response and on each non-compliant pharmacy until compliance is
completed.
OIG would be required to conduct appropriate periodic
studies of the NADAC survey data, including substantial
variations in acquisition costs or other applicable costs, as
well as how internal transfer prices and related party
transactions may influence costs reported by pharmacies. As
appropriate, OIG would be required to update Congress
periodically on the results of these studies without disclosing
trade secrets and other proprietary information.
OIG would receive an appropriation of $5 million for FY
2024 that would be available until expended to carry out
oversight of the NADAC survey. The HHS Secretary would receive
a $9-million appropriation for Fiscal Year (FY) 2024 and for
each fiscal year thereafter to conduct the NADAC survey.
These provisions would be effective on the first day of the
first quarter 18 months after this provision's enactment date.
SECTION 203. PROTECTING SENIORS FROM EXCESSIVE COST SHARING FOR CERTAIN
MEDICINES
Current Law
Under Part D's standard benefit, enrollees incur 100% of
covered drug costs during the deductible phase, after which
point they incur 25% cost sharing until reaching the out-of-
pocket threshold. Currently, beneficiaries face 5% cost sharing
beyond the out-of-pocket threshold, but this obligation will
sunset after plan year 2023. Plans participating in the program
can opt to provide either the standard benefit, an actuarially
equivalent benefit, or an enhanced benefit.
Most Part D plans charge a mix of flat copayments and
coinsurance (cost sharing calculated as a percentage of a
drug's price), although adoption of the latter has grown in
recent years. Cost-sharing levels tend to vary across formulary
tiers. For specialty-tier drugs, for instance, all plans charge
coinsurance (between 25% and 33%), and a sizable share of plans
apply coinsurance to medications on their non-preferred tiers
(charging up to 50%), whereas all plans adopt flat copays for
generic and preferred generic tiers.\40\
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\40\Key Facts About Medicare Part D Enrollment and Costs in 2023,
Juliette Cubanski and Anthony Damico, Kaiser Family Foundation, July
2023, available at https://www.kff.org/medicare/issue-brief/key-facts-
about-medicare-part-d-enrollment-and-costs-in-2023.
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While the Part D statute requires plans to provide
enrollees with ``access to negotiated prices'' for covered
drugs, ``tak[ing] into account negotiated price concessions,
such as discounts, direct or indirect subsidies, rebates, and
direct or indirect remunerations,'' most plans choose not to
include manufacturer rebates in calculating these prices, which
typically form the basis for beneficiary cost sharing.\41\ As
summarized by the GAO, ``[R]ebates do not lower individual
beneficiary payments for drugs, as these are based on the gross
cost of the drug before accounting for rebates.''\42\ CMS has
finalized regulations, effective beginning next year, that will
require plan sponsors to incorporate price concessions from
pharmacies into the Part D negotiated price, thus reducing
beneficiary cost sharing at the point of sale, but this rule
does not extend to rebates furnished by manufacturers.
---------------------------------------------------------------------------
\41\42 U.S.C. Sec. 1395w-102(d)(1).
\42\Medicare Part D: CMS Should Monitor Effects of Rebates on Plan
Formularies and Beneficiary Spending, GAO, September 2023, available at
https://www.gao.gov/assets/gao-23-105270.pdf.
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Manufacturer rebates refer to post-sale price concessions
paid by drug makers to plans, often through their PBMs.
According to a GAO analysis of CMS data, for 2021,
manufacturers paid $48.6 billion in rebates, compared with
$16.8 billion in 2014, representing a 189% increase.\43\\44\ A
recent MedPAC analysis of 2020 data suggests manufacturers
rebate approximately 22% of Part D spending back to plan
sponsors and PBMs, in addition to the mandatory discounts that
the statute requires drug manufacturers to provide on branded
drugs and biosimilars.\45\ That said, rebate volume varies
significantly across therapeutic classes.
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\43\Ibid.
\44\Drug Pricing's $268 billion non-event, 46 brooklyn, January
2020, available at https://www.46brooklyn.com/research/2020/1/21/2018-
medicare-part-d-data-review-sxfn7.
\45\Analysis of Part D data on drug rebates and discounts, Tara
Hayes, Shinobu Suzuki, and Rachel Schmidt, MedPAC, September 2022,
available at https://www.medpac.gov/wp-content/uploads/2021/10/DIR-
Slides-MedPAC-29-Sept-2022.pdf.
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Rebate growth has a range of implications for
beneficiaries, plan sponsors, and other stakeholders across the
prescription drug supply chain. With respect to cost sharing,
MedPAC noted in its June 2023 report to Congress that ``the
subset of enrollees who use rebated drugs may pay
disproportionately high cost sharing relative to the net
benefit cost of their medicines,'' and that ``for about 8% of
gross spending aggregated across all phases of the Part D
benefit (9% of brand spending), the cost-sharing amounts set by
plan sponsors exceeded net drug costs after deducting
rebates.''\46\ GAO found that for 79 of the 100 most highly
rebated Part D drugs, beneficiaries paid more, on net, than
their plan sponsors.\47\ A Journal of the American Medical
Association (JAMA) analysis concluded that rebate growth was
associated with a $13 average increase in Medicare beneficiary
cost sharing per prescription between 2014 and 2018.\48\
---------------------------------------------------------------------------
\46\June 2023 Report to Congress, MedPAC, June 2023, available at
https://www.medpac.gov/wp-content/uploads/2023/06/
Jun23_Ch2_MedPAC_Report_To_Congress_SEC.pdf.
\47\Id.
\48\Association of Branded Prescription Drug Rebate Size and
Patient Out-of-Pocket Costs in a Nationally Representative Sample,
2007-2018, Kai Yeung, Stacie Dusetzina, and Anirban Basu, JAMA Open
Network, June 2021, available at https://jamanetwork.com/journals/
jamanetworkopen/fullarticle/2780950.
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Manufacturer rebates also influence formulary design and
coverage decisions, often to the advantage of products with
higher list prices, as more than 92% of rebate volume in Part D
is provided ``for providing manufacturers with formulary access
and tier placement.'' GAO's analysis indicates frequent use of
rebate agreements as a means of blocking coverage or
preferential placement for biosimilars and other products with
lower list prices. Plan sponsors generally direct the majority
of rebate revenue to reduce premiums for enrollees and premium
subsidies for the program, although MedPAC notes in its June
2023 report that data from the 2020 Medicare Current
Beneficiary Survey indicate that more beneficiaries report out-
of-pocket costs as the most important factor in choosing a plan
than any other feature, including premiums.
Provision
Starting in 2028, these provisions would amend SSA Section
1860D-2(b) to base post-deductible enrollee coinsurance for
certain covered Part D drugs (``discount-eligible drugs'') on
their net prices, inclusive of projected manufacturer rebates,
rather than their Part D negotiated prices or other list price
derivatives. The HHS Secretary would publish a list of
discount-eligible drugs in advance of the relevant plan year.
``Discount-eligible drugs'' would be defined as Part D
drugs that are on a plan's formulary, are subject to a
coinsurance amount (other than recommended vaccines or
insulin), and:
1. Are in the following categories and classes: anti-
inflammatories that are inhaled corticosteroids;
bronchodilators, anticholinergic agents;
bronchodilators, sympathomimetic agents; respiratory
tract agents; anticoagulants; and cardiovascular
agents; and
2. For which aggregate manufacturer price concessions
to Part D plan sponsors/PBMs, in aggregate, are equal
to or exceed 50% of aggregate Part D gross costs.
The ``net price'' would be defined as the Part D negotiated
price, net of all approximate price concessions that were not
already reflected in the negotiated price for a plan year.
``Approximate price concessions'' would be defined as the
amount of price concessions that Part D sponsors prospectively
expect to receive from manufacturers for a plan year. Each
year, plan sponsors would provide the HHS Secretary with: (1)
approximate price concessions and net prices for each discount-
eligible drug; and (2) a written explanation of the methodology
used to calculate such approximate price concessions and net
prices.
Plans would be compliant with rules under these provisions
when net price calculations are consistent with:
1. A ``drug-specific threshold'' (set at 20% for 2028
through 2032), which would be the maximum percentage by
which approximate price concessions for a specific
discount-eligible drug could vary from the actual price
concessions a plan received for such a drug, according
to DIR reporting for the applicable plan year; and
2. An ``aggregate threshold'' (set at 15% for 2028
through 2032), which would be the maximum percentage by
which total approximate price concessions for all
discount-eligible drugs could vary from the actual
price concessions for all such discount-eligible drugs,
in the aggregate, according to DIR reporting for the
applicable plan year.
Beginning in 2033, the HHS Secretary could adjust these
thresholds, taking into account historical variations in
expected and actual drug price concessions, factors that could
result in price concession uncertainty or variation in a given
plan year, sponsor behavioral responses, effects of precise
price concession disclosures, beneficiary out-of-pocket costs,
expenditures under Part D, and other factors. The HHS Secretary
would be required to publish any threshold adjustments prior to
the start of the applicable plan year.
The HHS Secretary would perform audits, as determined
appropriate, in order to monitor compliance. A plan sponsor
that violated the requirements could be subject to civil
monetary penalties.
Additionally, beginning in 2028, Part D plans would be
required to limit post-deductible enrollee cost sharing for any
covered Part D drug included in their formulary to the net
price for such drug, inclusive of manufacturer rebates.
Enforcement would occur retroactively, as needed, based on a
comparison between cost-sharing amounts for covered Part D
drugs under a plan and the net prices for such drugs under said
plan, as evidenced through DIR reporting. Plans found to be in
violation of this requirement could face civil penalties.
This provision would also direct the GAO to conduct a study
and publish a report (along with subsequent reports, as
determined appropriate), once relevant data becomes available,
on certain effects and behavioral responses related to the
implementation of the cost-sharing provisions specified in this
section, including:
Effects on enrollee cost sharing,
utilization and adherence, formulary coverage and
placement, and utilization management with respect to
affected covered Part D drugs (discount-eligible drugs
and covered Part D drugs for which, prior to
implementation of these provisions, cost sharing
exceeded net price for some beneficiaries), along with
any effects on beneficiary premiums.
Changes to pharmacy reimbursement
methodologies and levels, if any, with respect to
discount-eligible drugs.
Changes in manufacturer rebating levels
(relative to gross costs) for discount-eligible drugs.
Other behavioral responses by PDP sponsors,
enrollees, manufacturers, pharmacies, or other entities
related to the implementation of these provisions.
Other issues determined appropriate by the
Comptroller General.
TITLE III--MEDICAID EXPIRING PROVISIONS
SECTION 301. DELAYING CERTAIN DISPROPORTIONATE SHARE HOSPITAL PAYMENT
REDUCTIONS UNDER THE MEDICAID PROGRAM
Current Law
SSA Section 1923 requires states to make Medicaid
disproportionate share hospital (DSH) payments to hospitals
treating large numbers of low-income patients. Each state
receives an annual DSH allotment, which is the maximum amount
of federal matching funds that each state is permitted to claim
for Medicaid DSH payments. The ACA included a provision
directing the HHS Secretary to make aggregate reductions in
Medicaid DSH allotments for FY 2014 through FY 2020, but
subsequent laws have amended the Medicaid DSH reductions by
eliminating the reductions or delaying them. Under current law,
the aggregate reductions to the Medicaid DSH allotments equal
$8.0 billion for part of FY 2024 (i.e., November 18, 2023
through September 30, 2024) and $8.0 billion for each fiscal
year from FY 2025 through FY 2027, which totals $32.0 billion.
In FY 2028, DSH allotments are to rebound to the pre-reduced
levels, with annual inflation adjustments for FY 2024 to FY
2027.\49\
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\49\The Continuing Appropriations Act, 2024, and Other Extensions
Act (Pub. L. 118-15) amended the Medicaid DSH reductions by eliminating
the reductions from September 30, 2023 through November 17, 2023. The
Further Continuing Appropriations and Other Extensions Act (Pub. L.
118-22) amended the Medicaid DSH reductions by eliminating the
reductions from November 17, 2023 until January 20, 2024.
---------------------------------------------------------------------------
Provision
The provision would further amend the Medicaid DSH
reductions under SSA Section 1923(f)(7) (42 U.S.C. Sec. 1396r-
4(f)(7)(A)) by eliminating the reductions for FY 2024 and FY
2025. The reductions for FY 2026 and FY 2027 would be
unchanged. The aggregate reduction amount from FY 2024 to FY
2027 would decrease from $32.0 billion under current law to
$16.0 billion.
SECTION 302. EXTENSION OF STATE OPTION TO PROVIDE MEDICAL ASSISTANCE
FOR CERTAIN INDIVIDUALS WHO ARE PATIENTS IN CERTAIN INSTITUTIONS FOR
MENTAL DISEASES
Current Law
Medicaid's institutions for mental diseases (IMD) exclusion
limits the circumstances under which federal Medicaid funding
to states is available for inpatient behavioral health care. In
addition to the other authorities available to states to allow
Medicaid coverage for a period of time for eligible individuals
who are patients in an eligible IMD, Section 5052 of the
SUPPORT Act added a new Section 1915(l) of the SSA. Section
1915(l) provided a new state option to make Medicaid coverage
available to eligible individuals who were patients in an
eligible IMD. This coverage was authorized from October 1, 2019
through September 30, 2023 and available to patients for no
more than a 30-day period (whether or not consecutive days)
during any 12-month period.\50\ To participate in the state
option, states were required to comply with a maintenance of
effort (MOE) requirement and requirements regarding coverage of
certain services and transitions of care, among others. Only
two states were participating in this state option as of
September 30, 2023: South Dakota and Tennessee.
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\50\For more information about the SUPPORT Act state option, see
CRS Insight IN12212, Expiration of 1915(l) Medicaid State Plan Option.
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Provision
The provision would amend SSA Section 1915(l)(1) to remove
the September 30, 2023, expiration date of the state option to
make the state option permanent. The provision would also amend
the MOE requirement to broaden the type of expenditures
relevant to the MOE standard, among other things. In addition,
the provision would add a requirement that states commence an
assessment of the availability of treatment at each level of
care for Medicaid enrollees.
TITLE IV--MEDICARE EXPIRING PROVISIONS AND PROVIDER PAYMENT CHANGES
SECTION 401. EXTENSION OF FUNDING FOR QUALITY MEASURE ENDORSEMENT,
INPUT, AND SELECTION
Current Law
Under SSA Section 1890, the HHS Secretary is required to
have a contract with a consensus-based entity (CBE) to carry
out specified duties related to health care performance
measurement. These duties include, among others, convening
multi-stakeholder groups to provide input on the selection of
measures, making recommendations on a national strategy for
health care performance measurement, endorsing new health care
performance measures, maintaining existing health care
performance measures, and submitting annual reports to
Congress.
SSA Section 1890A requires the HHS Secretary establish a
pre-rulemaking process to select quality measures for use in
the Medicare program. As part of this process, the HHS
Secretary makes available to the public measures under
consideration for use in Medicare quality programs and broadly
disseminates the quality measures that are selected to be used.
Simultaneously, the CBE gathers input from multiple
stakeholders and annually transmits that input to the HHS
Secretary. Until recently, the National Quality Forum (NQF)
held this contract and fulfilled this requirement through its
Measure Applications Partnership (MAP), an entity that convened
multi-stakeholder groups to provide input into the selection of
quality measures for use in Medicare and other federal
programs. The MAP published annual reports with recommendations
for selection of quality measures in February of each calendar
year, with the first report published in February of 2012. On
February 8, 2023, CMS awarded the CBE contract to Battelle
Memorial Institute, which carries out this work under its
Partnership for Quality Measurement (PQM).
The Consolidated Appropriations Act, 2021 (Pub. L. 116-260)
most recently extended mandatory funding for quality measure
endorsement, input, and selection through September 30, 2023.
The law appropriated $26 million for FY 2021, $20 million for
FY 2022, and $20 million for FY 2023.
Provision
The provision would amend Section 1890(d)(2) of the SSA (42
U.S.C. Sec. 1395aaa(d)(2)) to provide for the transfer of $20
million for FY 2024 from the Medicare Hospital Insurance (HI)
and Supplementary Medical Insurance (SMI) Trust Funds, to carry
out Section 1890 and Section 1890A activities. Amounts
transferred shall remain available until expended.
SECTION 402. EXTENSION OF FUNDING OUTREACH AND ASSISTANCE FOR LOW-
INCOME PROGRAMS
Current Law
Beginning in FY 2009, Section 119 of the Medicare
Improvements for Patients and Providers Act (MIPPA; Pub. L.
110-275) provided mandatory funding for outreach and assistance
to low-income Medicare beneficiaries through State Health
Insurance Assistance Programs (SHIPs), Area Agencies on Aging
(AAAs), and Aging and Disability Resource Centers (ADRCs). This
funding includes assistance to those who may be eligible for
the Low-Income Subsidy program, Medicare Savings Program, and
the Medicare Part D Prescription Drug Program. This funding is
in addition to annual discretionary funding for SHIPs, AAAs,
and ADRCs. MIPPA also provided mandatory funding to an entity
to help inform older Americans about benefits available under
Federal and State Programs. The funds are awarded through a
competitive process. The grant is currently awarded to the
National Council on Aging, which operates the National Center
for Benefits and Outreach Enrollment. The National Center for
Benefits and Outreach Enrollment assists organizations to
enroll older adults and individuals with disabilities into
benefit programs that they may be eligible for, such as
Medicare, Medicaid, the Supplemental Security Income program,
and the Supplemental Nutrition Assistance Program, among
others. MIPPA funding was extended multiple times, most
recently in the Consolidated Appropriations Act, 2021 (Pub. L.
116-260) through FY 2023. The HHS Secretary is required to
transfer specified amounts for MIPPA program activities from
the Medicare HI and SMI Trust Funds to the CMS.
Provision
The provision would amend specified subsections of MIPPA
Section 119 (42 U.S.C. Sec. 1395b-3 note) to extend authority
for these programs through September 30, 2024. For FY 2024, it
would provide the same funding levels as FY 2023, for a total
of $50 million annually to be transferred from the Medicare HI
and SMI Trust Funds in the following amounts: SHIPs, $15
million; AAAs, $15 million; ADRCs, $5 million; and grant
funding to coordinate efforts to inform older Americans about
benefits available under federal and state programs, $15
million.
SECTION 403. EXTENSION OF THE WORK GEOGRAPHIC INDEX FLOOR UNDER THE
MEDICARE PROGRAM
Current Law
Medicare payments for services of physicians and certain
nonphysician practitioners are made on the basis of a fee
schedule (SSA Sec. 1848(e)(1)(E), U.S.C. Sec. 1395w-
4(e)(1)(E)). The Medicare physician fee schedule (MPFS) is
adjusted geographically for three categories of inputs to
reflect differences in the cost of resources needed to produce
physician services: physician work, practice expense, and
medical malpractice insurance. The geographic adjustments are
indices--known as Geographic Practice Cost Indices (GPCIs)--
that reflect how each area compares to the national average in
a ``market basket'' of goods. A value of 1.0 represents the
average across all areas. These indices are used to calculate
the payment rate under the MPFS.
Since January 1, 2004, several laws have established a
``floor'' on the physician work GPCI where the index has been
increased to 1.0 for all geographic regions in which the
calculation of the GPCI would have been less than 1.0. The
current authority is scheduled to expire on December 31,
2023.\51\
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\51\The Further Continuing Appropriations and Other Extensions Act
(Pub. L. 118-22) extended the floor value of 1.0 for the physician work
geographic index used in the calculation of payments under the Medicare
physician fee schedule through January 19, 2024.
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Provision
The provision would extend the floor value of 1.0 for the
physician work geographic index used in the calculation of
payments under the Medicare physician fee schedule through
December 31, 2024.
SECTION 404. EXTENSION OF MEDICARE APM PAYMENT INCENTIVES
Current Law
The Medicare Access and CHIP Reauthorization Act of 2015
(MACRA; Pub. L. 114-10) introduced a new merit-based incentive
payment system (MIPS) based on fee-for-service payments and put
in place processes for developing, evaluating, and adopting
alternative payment models (APMs) designed to incentivize
improvements in the quality and efficiency of care. Advanced
Alternative Payment Models (AAPMs), APMs that include certain
features related to quality measures and financial risk,
provide a number of incentives for clinicians who meet the
requisite payment- or patient-based thresholds to become
Qualifying APM Participants (QPs).
Specifically, under amendments included in the Consolidated
Appropriations Act, 2023, for performance year 2023, an
eligible professional must either receive at least 50% of
Medicare Part B payments through an AAPM entity or see at least
35% of Medicare patients through such an entity in order to
become a QP. Meeting these thresholds for performance year 2023
qualifies a QP for an APM Incentive Payment, to be paid out in
payment year 2025, as a lump-sum amount equal to 3.5% of the
estimated aggregate payment amounts for covered professional
services furnished by the clinician during the preceding year.
Under current law, QPs will not receive an APM Incentive
Payment in payment year 2026 on the basis of performance year
2024, although beginning in 2026, the statute provides for an
annual MPFS conversion factor update of 0.75% for QPs.
Additionally, starting with performance year 2024, the relevant
thresholds for QP eligibility will increase, requiring a larger
share of Part B payments or patients through AAPM entities in
order to qualify as a QP.
Provision
This provision would provide for a 1.75% APM Incentive
Payment for QPs for payment year 2026 (based on performance
year 2024) and would extend the QP payment and patient
thresholds in place with respect to payment year 2025 through
payment year 2026 (based on performance year 2024).
SECTION 405. PAYMENT RATES FOR DURABLE MEDICAL EQUIPMENT UNDER THE
MEDICARE PROGRAM
Current Law
Medicare pays for certain durable medical equipment,
prosthetics, orthotics, and supplies (DMEPOS) either through
(a) statutorily defined fee schedules, (b) competitive bidding
in selected urban areas, or (c) adjustments to the fee schedule
amounts based on data from competitive bidding; the adjustment
decreases the payments relative to unadjusted payments. The
CARES Act temporarily increased the adjusted DME fee schedule
amounts for certain geographic areas (areas other than rural or
noncontiguous areas), basing them on a blend of (higher)
unadjusted fee schedule amounts and (lower) amounts adjusted by
competitive bidding data; prior to the CARES Act, the payments
for areas other than rural or noncontiguous areas were based
entirely on the lower amounts adjusted by competitive bidding
data. The CARES Act specified a weighting scheme calling for
the payments to be based 25% on the higher unadjusted rates,
and 75% on the lower adjusted rates (hereafter, referred to as
the 25/75 blend), through the duration of the COVID-19 public
health emergency. The Consolidated Appropriations Act, 2023
(Pub. L. 117-328) extended the
25/75 blend through December 31, 2023.
Provision
The provision would extend by one year (through December
31, 2024) the 25/75 blend payment that applies to areas other
than rural or noncontiguous areas. The provision prohibits the
HHS Secretary from applying the pre-CARES act payment (i.e.,
the lower payment based entirely on the fee schedule amounts
adjusted by competitive bidding data) in areas other than rural
or noncontiguous areas prior January 1, 2025. The HHS Secretary
may implement the provision through program instructions or
otherwise.
SECTION 406. EXTENDING THE INDEPENDENCE AT HOME MEDICAL PRACTICE
DEMONSTRATION PROGRAM UNDER THE MEDICARE PROGRAM
Current Law
The Affordable Care Act (ACA; Pub. L. 111-148) created the
Independence at Home (IAH) demonstration under the Medicare
program to test a payment incentive and service delivery model
that uses home-based primary care teams and is designed to
reduce expenditures and improve health outcomes in the care of
certain chronically ill Medicare beneficiaries. Qualifying IAH
medical practices are legal entities comprised of an individual
physician or nurse practitioner, or group of physicians and
nurse practitioners, that use a team-based approach to carry
out care plans that are tailored to individual beneficiaries'
chronic conditions. Such teams could include physicians,
nurses, physician assistants, pharmacists, and other health and
social services staff, as appropriate. Practice staff are to
have experience providing home-based primary care services to
applicable beneficiaries. The practice staff is required to
make in-home visits and to be available 24 hours per day, 7
days per week to implement care plans. Subject to meeting
performance standards on quality measures, qualifying IAH
medical practices may be eligible for sharing savings, based on
the extent to which actual expenditures for a year for the
applicable beneficiaries enrolled by an IAH practice are less
than the estimated annual spending target and the resulting
incentive payment.
The CMS Innovation Center (CMMI) initially selected a total
of 15 individual practices to launch the IAH demonstration in
2012; however, the number of participating practices with IAH
agreements has varied over the years. The demonstration was
originally scheduled to end on September 30, 2017, but has been
extended twice (Bipartisan Budget Act of 2018, Pub. L. 115-123,
Section 50301, and the Consolidated Appropriations Act of 2021,
Pub. L. 116-260, Division CC, Section 105), such that
agreements with IAH medical practices under the demonstration
program are set to end no later than December 31, 2023.
For purposes of administering and carrying out the
demonstration program, the Consolidated Appropriations Act of
2021 provided $9.0 million to CMS from the Medicare HI and the
SMI Trust Funds, in proportions determined appropriate by the
HHS Secretary. The funding was made available for FY 2021, and
available until expended.
Provision
The provision would extend the IAH demonstration program
through December 31, 2025. Further, for purposes of
administering and carrying out the demonstration program, the
provision would provide $3.0 million from the Medicare HI and
SMI Trust Funds (in proportions determined appropriate by the
HHS Secretary) for FY 2024, to be available until expended.
SECTION 407. INCREASE IN SUPPORT FOR PHYSICIANS AND OTHER PROFESSIONALS
IN ADJUSTING TO MEDICARE PAYMENT CHANGES
Current Law
In 2020, payments to physicians and non-physician
practitioners under the Medicare physician fee schedule (MPFS)
were subject to many changes due to a combination of statutory,
technical, and circumstantial factors including the impact of
questions about the application of sequestration and PAYGO
requirements, the redefinition of certain medical codes, and
the uncertainty of the impact of the COVID-19 pandemic on
health care professionals. The Consolidated Appropriations Act,
2021 (Pub. L. 116-260) established a 3.75% increase in MPFS
payments to support physicians and other professionals for
services furnished in 2021. The Protecting Medicare and
American Farmers from Sequester Cuts Act (Pub. L. 117-71)
extended the increase through 2022 at the reduced level of
3.0%. The Consolidated Appropriations Act, 2023 (Pub. L. 117-
328) extended the increase through 2023 at 2.5% and through
2024 at 1.25%.
Provision
The provision would replace the statutory increase of 1.25%
for MPFS services furnished in 2024 with 2.50% for that year.
SECTION 408. REVISED PHASE-IN OF MEDICARE CLINICAL LABORATORY TEST
PAYMENT CHANGES
Current Law
Payments for outpatient clinical laboratory services are
paid under the Medicare Clinical Laboratory Fee Schedule
(CLFS). The Protecting Access to Medicare Act of 2014 (PAMA,
Pub. L. 113-93) mandated a different method for determining
clinical laboratory payments based on reported private
insurance payment amounts and required the CMS to phase-in CLFS
payments during the transition. Prior to the passage of PAMA,
private insurance CLFS payment rates had generally been lower
than Medicare payments. The applicable reporting period used to
calculate the new rates and the date of implementation of the
phase-in payments have been modified several times since PAMA
was enacted.
Current law establishes that (1) ``no reporting is required
for clinical laboratory payments during the period beginning
January 1, 2020, and ending December 31, 2023''; (2)
``reporting is required during the period beginning January 1,
2024, and ending March 31, 2024''; and (3) reporting is
required every three years thereafter. Correspondingly,
reductions in CLFS payments based on the phase-in of the new
methodology are to be limited; for 2023, there are no
reductions in payments compared to those received in the
previous year, while reductions are limited to 15% for each
Medicare clinical laboratory payment in 2024 through 2026.\52\
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\52\The Further Continuing Appropriations and Other Extensions Act
(Pub. L. 118-22) extended the moratorium on the reporting and
collecting of private insurance payments for clinical laboratory
services through December 31, 2024 and extended the zero-percent cap on
payment reductions through December 31, 2024.
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Provision
The provision would continue to limit reductions in CLFS
payments by extending the moratorium on the reporting and
collecting of private insurance payments for clinical
laboratory services through December 31, 2024 and by extending
the zero-percent cap on payment reductions through 2024.
Reductions in CLFS payments in 2025 through 2027 would be
limited to 15 percent.
SECTION 409. EXTENSION OF ADJUSTMENT TO CALCULATION OF HOSPICE CAP
AMOUNT UNDER MEDICARE
Current Law
The Medicare hospice benefit covers a broad set of
palliative care services in the management of a terminal
illness. These services are furnished to Medicare beneficiaries
with a life expectancy of six months or less, as determined by
a physician. For conditions unrelated to a terminal illness,
Medicare continues to cover items and services outside of the
hospice benefit.
Payment for hospice care is based on one of four
prospectively determined rates (which correspond to four
different levels of care) for each day a beneficiary is under
the care of a Medicare-certified hospice agency. The four rate
categories are routine home care, continuous home care,
inpatient respite care, and general inpatient care. Payment
rates are adjusted to reflect differences in area wage levels,
using the hospital wage index. Annual payments to a hospice
agency are limited by two caps. The first limits the number of
days of inpatient care a hospice agency may provide to not more
than 20% of total patient care days in a single year (42 Code
of Federal Regulations (C.F.R.) Sec. 418.108(d)). The second,
as required under law (SSA Sec. 1814(i)(2)(B)), limits a
hospice agency's average annual payment per beneficiary. The
latter cap is currently, for FY 2024, set at $33,494.01. If a
hospice agency's total payments exceed its total number of
Medicare patients, multiplied by the FY 2024 absolute dollar
limit, then the hospice must repay the difference.
Unlike the daily base payment rates, the hospice aggregate
cap is not adjusted for geographic differences in costs. The
average annual payment cap amount is adjusted for increases or
decreases in medical care expenditures. As required by Section
1814(i)(2)(B) of the SSA, the average annual payment cap,
through FY 2032, is indexed to the general hospice base payment
update, rather than using the Consumer Price Index for all
urban consumers (CPI-U) for medical care expenditures. The CPI-
U is published by the U.S. Bureau of Labor Statistics. Federal
law mandates that the average annual hospice payment cap after
FY 2032 be adjusted to reflect the percentage increase or
decrease in the medical care expenditure category of the CPI-U.
Provision
The provision would amend Section 1814 of the SSA,
extending the update of the Medicare hospice average annual
payment cap using the general hospice base payment update
(rather than indexing it to the CPI-U) through FY 2033. This
policy allows the hospice payment rate and the aggregate
hospice cap to grow using a common inflationary index.
TITLE V--OFFSETS
SECTION 501. MEDICAID IMPROVEMENT FUND
Current Law
Section 7002(b) of the Supplemental Appropriations Act of
2008 (Pub. L. 110-252) added SSA Section 1941, requiring the
HHS Secretary to establish the Medicaid Improvement Fund (MIF).
SSA Section 1941 authorized the HHS Secretary to use the MIF
``to improve the management of the Medicaid program by the
Centers for Medicare and Medicaid Services, including oversight
of contracts and contractors and evaluation of demonstration
projects.'' Pub. L. 110-252 authorized $100 million to be
available for expenditures in FY 2014 and $150 million for FY
2015 through FY 2018.
Multiple pieces of legislation have amended SSA Section
1941 to adjust the amount of money available to the MIF.\53\
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\53\The Continuing Appropriations Act, 2024, and Other Extensions
Act (Pub. L. 118-15) amended SSA Section 1941 to reduce availability to
the MIF for FY 2028 and thereafter from $7,000,000,000 to
$6,357,117,810. The Further Continuing Appropriations and Other
Extensions Act (Pub. L. 118-22) amended SSA Section 1941 to reduce
funding availability to the MIF for FY 2028 and thereafter from
$6,357,117,810 to $5,796,117,810.
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Provision
This provision would amend SSA Section 1941 (42 U.S.C.
Sec. 1396w-1(b)(3)(A)) by reducing funding available to the MIF
for FY 2028 and thereafter from $6,357,117,810 to $561,000,000.
SECTION 502. MEDICARE IMPROVEMENT FUND
Current Law
MIPPA added SSA Section 1898 (42 U.S.C Sec. 1395iii), which
authorized the HHS Secretary to establish the Medicare
Improvement Fund. The amounts in the Medicare Improvement Fund
are available to the HHS Secretary ``to make improvements under
the original Medicare fee-for-service program under parts A and
B . . . including adjustments to payments for items and
services furnished by providers of services and suppliers under
such original Medicare fee-for-service program.'' Funding for
the Medicare Improvement Fund is made available from the HI
Trust Fund and the SMI Trust Fund in the amount determined
appropriate by the HHS Secretary. Many subsequent laws have
modified the amount in the fund, but to date, none of the
monies have been expended. Most recently, the Consolidated
Appropriations Act, 2023 (Pub. L. 117-328) modified Section
1898 to make $180,000,000 available in the Medicare Improvement
Fund during and after FY 2022.\54\
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\54\The Further Continuing Appropriations and Other Extensions Act
(Pub. L. 118-22) changed the amount available in the Medicare
Improvement Fund for services furnished during and after FY 2022 to
$466,795,056.
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Provision
This provision would change the amount available in the
Medicare Improvement Fund for services furnished during and
after FY 2022 to $936,000,000.
III. BUDGET EFFECTS OF THE BILL
A. COMMITTEE ESTIMATES
In compliance with paragraph 11(a) of rule XXVI of the
Standing Rules of the Senate and section 308(a)(1) of the
Congressional Budget and Impoundment Control Act of 1974, as
amended (the ``Budget Act''), the following statement is made
concerning the estimated budget effects of the revenue
provisions of the Better Mental Health Care, Lower-Cost Drugs,
and Extenders Act, as reported. The spending effects of the
bill will be included in the statement from the Congressional
Budget Office that will be provided separately, as described in
Part C below.
B. BUDGET AUTHORITY AND TAX EXPENDITURES
In compliance with section 308(a)(1) of the Budget Act, the
Committee states that the extent to which the provisions of the
bill as reported involve new or increased budget authority or
affect levels of tax expenditures will be included in the
statement from the Congressional Budget Office that will be
provided separately, as described in Part C below.
C. CONSULTATION WITH CONGRESSIONAL BUDGET OFFICE
In accordance with section 403 of the Budget Act, the
Committee advises that the Congressional Budget Office has not
submitted a statement on the bill. The statement from the
Congressional Budget Office will be provided separately.
IV. VOTES OF THE COMMITTEE
In compliance with paragraph 7(b) of rule XXVI of the
Standing Rules of the Senate, the Committee states that, with a
majority present, the Better Mental Health Care, Lower-Cost
Drugs, and Extenders Act, was ordered favorably reported on
November 8, 2023, by a roll call vote of 26 ayes and 0 nays.
The vote was as follows:
Ayes: Wyden, Stabenow, Cantwell, Menendez, Carper, Cardin
(proxy), Brown (proxy), Bennet (proxy), Casey, Warner,
Whitehouse, Hassan, Cortez Masto, Warren, Crapo, Grassley
(proxy), Cornyn (proxy), Thune (proxy), Scott (proxy), Cassidy
(proxy), Lankford, Daines, Young (proxy), Barrasso (proxy),
Tillis, and Blackburn.
Nays: None.
Not Voting: Johnson.
V. REGULATORY IMPACT AND OTHER MATTERS
A. REGULATORY IMPACT
Pursuant to paragraph 11(b) of rule XXVI of the Standing
Rules of the Senate, the Committee makes the following
statement concerning the regulatory impact that might be
incurred in carrying out the provisions of the bill.
Impact on individuals and businesses, personal privacy and paperwork
The bill includes various provisions relating to coverage
and payment of services provided under the Medicare and
Medicaid programs that are not expected to impose additional
administrative requirements or regulatory burdens on
individuals, providers, or businesses beyond those normally
necessary under the Medicare and Medicaid programs. In carrying
out other provisions of the bill, MA plans and individuals and
businesses across the drug supply chain will be subject to new
administrative requirements.
MA plans will be required to conduct annual reports on
accuracy of their provider directories and submit those reports
to the HHS Secretary, and to notify consumers of the cost-
sharing protections for services based on reliance on incorrect
provider directory information. Across the drug supply chain,
Part D plans and the PBMs they contract with will be required
to report information about rebates they receive from
manufacturers and pharmacies will be required to report
acquisition cost information. Pharmacies, on a voluntary basis,
will be enabled to file complaints with the HHS Secretary with
respect to PBM adherence to the codification of regulatory
requirements that PBMs are required to follow. Part D plans and
PBMs may have to report information related to such complaints
to the HHS Secretary.
The provisions of the bill do not impact personal privacy.
B. UNFUNDED MANDATES STATEMENT
The Committee adopts as its own the estimate of federal
mandates prepared by the Director of the Congressional Budget
Office pursuant of section 423 of the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4), which will be provided separately.
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED
In the opinion of the Committee, it is necessary in order
to expedite the business of the Senate, to dispense with the
requirements of paragraph 12 of rule XXVI of the Standing Rules
of the Senate (relating to the showing of changes in existing
law made by the bill as reported by the Committee).
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