Friday, December 30, 2022

Congressional Budget Guidance to CMS: Sepsis, WGS, Alzheimer's, TCET, More

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).
Turning to CMS, special topics include:
  • 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.
Clipped below.

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 


       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 


       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.