At the end of December, Congress passed the $1.7T budget bill, which makes for a 1700 page PDF. It's HR 2617, home page here, final PDF format here.
Most of the Medicare details show up around page 1175, Title IV, Subtitles A-D with various Medicare extenders and provisions.
E.g. 4121 provides coverage for marriage and family therapist services, 4136 relates to disposable negative pressure wound care devices. Section 4114 delays PAMA lab test pricing by a year. Section 4127 requires OIG to report on "Safe harbor for contingency management," e.g. where drug treatment patients receive a reward like a Starbucks card for showing up for drug counseling and whether that is a program kickback. See also a March 2022 OIG Advisory Opinion #22-04 on this.
Genomeweb has an open access article highlighting top line budgets ($6.6B FDA [half user fees], $47B NIH, $9B CDC.
But to understand more, you'll also want to see the 800-page Congressional Record document issued on December 20 (pp 58553-59323), the "Explanatory Statement" of additional instructions from Congress. Here you'll find actions that various stakeholders are noting in press releases, but which may not always be explicit in HR 2617.
Below the break, I'm clipping a number of paragraphs related to AHQR and CMS.
Topics include:
AHRQ, budget $373M. Items mentioned here:
- Antimicrobial resistance.
- Primary care research.
- Diagnostic error research ($20M).
- Grief care.
- Heart disease research.
- Maternal health.
- Long COVID ($10M).
- Organ availability.
- Disabilities.
- Sepsis ($750K; pediatrics, maternal, nursing home, rehab, pandemic, total public costs).
- Bundled payment for AD diagnostics (PET, Amyvid, radiopharmaceuticals.)
- Not mentioned, proteomics for hospital-based CSF tests also bundled under CLFS rules.
- Cardiac CT access.
- CT colonography (encouraged to consider).
- Diabetes technology (CMS & FDA uncoordinated).
- E&M policies.
- Rural hospital closures.
- Sepsis - CMS and CDC to develop new (or use existing) measures, cf. measures adopted in NY State.
- New public reports re sepsis care data.
- TCET - Transitional Coverage for Emerging Technologies. Report in FY2024 to Congress.
- WGS - Whole genome sequence, guidance for state officials, Medicaid. Includes WGS, WES, gene panels.
https://www.congress.gov/congressional-record/volume-168/issue-198/senate-section/article/S8553-2
Agency for Healthcare Research and Quality (AHRQ)
The agreement includes $373,500,000 for AHRQ. Within the
total, the agreement includes the following amounts:
------------------------------------------------------------------------
FY 2023
Budget Activity Agreement
------------------------------------------------------------------------
Health Costs, Quality, and Outcomes:
Prevention/Care Management............................ $11,542,000
Health Information Technology (IT).................... 16,349,000
Patient Safety Research............................... 89,615,000
Health Services Research, Data, and Dissemination..... 101,103,000
Long COVID............................................ 10,000,000
Medical Expenditure Panel Survey........................ 71,791,000
Program Management...................................... 73,100,000
------------------------------------------------------------------------
Antimicrobial Resistance (AMR).--The agreement directs AHRQ
to work with other HHS agencies to provide the annual
briefing described under the section of the explanatory
statement dealing with the Office of the Secretary within 30
days of enactment of this Act and every succeeding annual
appropriations act.
Center for Primary Care Research.--The agreement continues
$2,000,000 for this activity.
Diagnostic Errors.--The agreement includes $20,000,000 to
fund research, testing, and solutions to avoid diagnostic
error and to support Diagnostic Safety Centers of Excellence
to disseminate related findings. Funding provided will
support eight centers, with each center focusing on specific
conditions, populations, or settings of diagnostic safety as
noted in the fiscal year 2023 budget request.
Grief and Bereavement Care.--The agreement notes that more
Americans are experiencing grief and loss as a result of the
COVID-19 pandemic. The agreement includes $1,000,000 to fund
an evidence review and technical expert panel to assess the
feasibility of developing consensus-based quality standards
for high quality bereavement and grief care. AHRQ is
directed, in consultation with stakeholders including the
National Quality Forum (NQF), the Patient-Centered Outcomes
Research Institute (PCORI), and community-based providers
including hospice programs, to establish an evidence-base on
what constitutes high-quality grief and bereavement care.
Heart Disease Research.--Heart disease is the leading cause
of death for Americans. Understanding how to reduce the rate
of cardiac events and to control the metabolic processes that
lead to such events is needed. The agreement supports AHRQ
studying and assessing the current evidence for lipid control
and cardiovascular event reduction. In addition, the
agreement directs AHRQ to assess the current evidence on the
costs and benefits--including the costs to the Federal
Treasury--of angioplasties conducted in non-emergency
situations and make recommendations based on its findings
within 180 days of enactment of this Act.
Improving Maternal Health.--The agreement urges AHRQ to
fund research to understand the complex challenges of
ensuring safe and healthy pregnancies and childbirth,
particularly for underserved women who are at substantially
higher risk of complication and death.
Long COVID Research.--The agreement includes $10,000,000
for health-systems research on how best to deliver patient-
centered, coordinated care to those living with Long COVID,
including the development and implementation of new models of
care to help treat the complexity of symptoms those with Long
COVID experience.
Organ Availability.--The agreement urges AHRQ to evaluate
innovative approaches to enhance the availability of organs,
otherwise encourage donation, and further improve the organ
transplantation process, including through consultation with
other Federal agencies.
People with Disabilities.--The agreement includes $750,000
for AHRQ to work with stakeholders to develop a research
agenda and report for dissemination on health promotion,
disease prevention, and intervention strategies for people
with disabilities.
Sepsis.--To better understand the disease burden of sepsis,
the agreement includes $750,000 and directs AHRQ to conduct a
comprehensive set of studies that calculate the morbidity,
readmissions, and mortality related to sepsis with respect to
pediatrics, maternal sepsis, nursing home care, and
rehabilitation, and the association of pandemic-related
changes in the healthcare system on the burden of sepsis. The
study should also examine the annual financial costs of
sepsis in the United States.
Centers for Medicare & Medicaid Services (CMS)
program management
Alzheimer's Disease (AD) Diagnostics.--CMS' bundled payment
policy for advance radiopharmaceuticals in the hospital
outpatient setting can make these diagnostic imaging services
cost prohibitive for many hospitals and doctors, especially
those providing care to racial and ethnic minorities, and
patients in rural areas. The agreement directs CMS to review
the utilization of AD diagnostics and consider potential
modifications that could make access to advanced imaging for
AD more equitable.
Cardiac Computed Tomography (CT).--The agreement notes that
unstable and low Medicare payments for cardiac CT services is
contributing to significant disparity in access to services
among minority populations and encourages CMS to address this
inequity.
Certified Community Behavioral Health Clinics (CCBHC).--The
agreement continues to encourage CMS to work with SAMHSA to
review and update the Department's approach to CCBHC
certification activities. The agreement directs CMS and
SAMHSA to provide an update on the review and implementation
of the CCBHC expansion included in the Bipartisan Safer
Communities Act within 90 days of the date of enactment of
this Act.
[[Page S8890]]
Computed Tomography (CT) Colonography.--The agreement
encourages CMS to consider existing evidence to determine
whether CMS should cover CT Colonography as a Medicare-
covered colorectal cancer screening test under section
1861(pp)(1) of the Social Security Act.
Diabetes Technology.--The agreement is concerned about
access to new technologies to treat diabetes and notes that
CMS and FDA have not coordinated their efforts regarding
these technologies, leading to a lack of certainty and
predictability regarding coverage and payment policies. The
agreement expects the report on this issue as requested in
Public Law 117-103.
Evaluation and Management Services (E/M).--The agreement
requests an update in the fiscal year 2024 Congressional
Justification on a process to evaluate E/M services more
regularly and comprehensively.
Rural Hospital Closures.--The agreement notes that 135
rural hospitals have closed in the past decade and many
others are vulnerable to closure. The agreement directs CMS
to provide feedback to the Committees on Appropriations, the
Senate Committee on Finance, and the House Committee on
Energy and Commerce on providing appropriate relief for
struggling hospitals in rural and under-served communities.
Sepsis.--The agreement directs CMS, in collaboration with
CDC, to use the measure development process to develop new or
identify existing hospital quality measures for adult and
pediatric sepsis that could be implemented through notice and
comment rulemaking. This process should take into account the
adult and pediatric measures that were successfully adopted
and implemented in New York State. CMS should consult with
the CDC to determine if CDC's National Healthcare Safety
Network (NHSN) could include Adult Sepsis Event
surveillance and early identification of sepsis, perhaps
leveraging new data interoperability standards. CMS, in
coordination with the CDC, shall also develop new or
identify existing processes to publicly report
quantitative and qualitative information regarding sepsis
care that may be reported through the NHSN and may track
hospital implementation of quality improvement measures
for adult and pediatric sepsis care.
Transitional Coverage for Emerging Technologies.--The
agreement requests an update in the fiscal year 2024
Congressional Justification on this program and related CMS
resources.
Whole Genome Sequencing.--The agreement notes a growing
body of evidence that whole genome sequencing (WGS), whole
exome sequencing, and gene panel testing can save lives and
money when used to diagnose infants and children suspected of
having a rare genetic disease. The agreement urges CMS to
develop guidance for state health officials on best practices
for incorporating these technologies into their Medicaid and
CHIP programs as a first-line diagnostic for children who are
suspected of having rare genetic diseases in the inpatient
setting. This guidance should also include advice for States
on how to encourage and incentivize managed care
organizations to cover these diagnostic tools for this
population. The agreement requests a report within 180 days
of enactment on steps taken to develop such guidance.
Additionally, the agreement understands that there are
undiagnosed diseases that do not require hospital inpatient
care and urges CMS to issue guidance on the Early and
Periodic Screening, Diagnostic and Treatment Benefit on the
usage of WGS, whole exome sequencing, and gene panel testing.