December 2023
Congressional Action Needed to Avert Medicare Physician Payment Cut
Physicians once again are facing a payment cut of 3.37% beginning on January 1, 2024, as a result of the budget neutrality adjustments finalized in the calendar year (CY) 2024 Medicare Physician Fee Schedule (MPFS) final rule and the expiration of 1.25% of the payment increase provided by the Consolidated Appropriations Act of 2023. ASH sent a letter to congressional leadership, recognizing and supporting current actions Congress has taken while urging Congress to take further action to prevent this cut and stabilize physician payment. In the letter, ASH also highlighted current legislation, the Strengthening Medicare for Patients and Providers Act (H.R. 2474), and additional legislation aimed at addressing various challenges in physician payment. ASH will continue to monitor the pay cuts and advocate for greater stability in the Medicare physician payment system.
ASH Submits Feedback on NHLBI Strategic Vision Refresh
In December, ASH submitted comments on the National Heart, Lung, and Blood Institute’s (NHLBI) request for feedback on the refresh of its Strategic Vision to address emerging scientific opportunities. The Society’s comments focused on the institute’s focus area of women’s health through the lifespan, given ASH’s priority on maternal health and hematology, and included thoughts on the challenges or barriers that need to be addressed to support progress in this area. Click here to read all of ASH’s comments on the Strategic Vision refresh.
FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease
On December 8, 2023, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. The use of innovative cell-based gene therapies as a possible curative treatment can target diseases and improve public health. Casgevy is the first FDA-approved therapy utilizing CRISPR/Cas9, a type of genome editing technology. Patients’ hematopoietic (blood) stem cells are modified by genome editing using CRISPR/Cas9 technology. Lyfgenia is a cell-based gene therapy. Lyfgenia uses a lentiviral vector (gene delivery vehicle) for genetic modification of blood stem cells, which are then delivered back to the patient.
ASH Submits Comments to FDA on LDT Proposed Rule
In late September, the U.S. Food & Drug Administration (FDA) released a proposed rule to classify in vitro diagnostics (IVDs), and more specifically laboratory developed tests (LDTs), as medical devices. ASH provided comments on the rule’s potential impact; notably how the change in classification may impact access to health care and stifle innovation. ASH also recommended that the FDA first conduct a market scan, potentially by creating an LDT registry, before making policy changes to the current oversight mechanisms.
ASH Supports Legislation to Increase Awareness of Iron Deficiency
In late December, ASH joined several other organizations in supporting the Iron Deficiency Education and Awareness (IDEA) Act (H.R. 6746), which was introduced by Representative Yadira Caraveo (D-CO) on December 13. The legislation aims to improve public health by raising awareness and urging regular testing for iron deficiency, particularly among women. A quote from 2023 ASH President Dr. Robert Brodsky was included in the statement issued by Representative Caraveo upon introduction of the legislation.
ASH Comments on FDA’s Draft Guidance on Graft-versus-Host Diseases
In late November, ASH sent comments to the U.S. Food and Drug Administration (FDA) regarding the Agency’s Draft Guidance on Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment. The guidance is intended to provide sponsors developing prevention or treatments for acute and chronic Graft-Versus Host Disease (aGVHD and cGVHD) with best practices to design clinical trials for successful applications. ASH commended the Agency for releasing the guide that will be helpful to hematologists and their patients, and provided specific recommendations to strengthen the draft.
2024 Medicare Physician Fee Schedule Final Rule
On November 2, the Centers for Medicare & Medicaid Services (CMS) released a final rule that updates payment policies for the 2024 Medicare Physician Fee Schedule. The agency finalized policies, supported by ASH, that implement several significant changes including payment for HCPCS code G2211, an add-on for services associated with complex patient care, and payment for dental services inextricably linked to other covered services used to treat cancer prior to or during chemotherapy services, chimeric antigen receptor T-cell therapy, and the use of high-dose bone modifying agents (antiresorptive therapy).
The conversion factor for 2024 is set to decrease by approximately 3.37% from $33.89 to $32.74. Without Congressional action, CMS does not have the authority to mitigate or eliminate this cut. ASH submitted comments on how continued cuts to physician payment affect the specialty of hematology and continues to work with Congress and other stakeholders to reform physician payment policy.
Additionally, CMS will continue to pay for telehealth services at the non-facility rate for telehealth services performed in the Medicare beneficiary’s home. This will apply to telemedicine services delivered to Medicare beneficiaries until December 31, 2024, unless Congress passes legislation extending or permanently waiving the originating site requirement. In addition, the agency finalized the use of virtual supervision using real-time audio-video telehealth services through the end of 2024. ASH advocated for the continuation of telehealth services and is pleased to see this in the final rule. A more detailed analysis of the final rule is now available for review.
FDA Grants Accelerated Approval to Pirtobrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
ASH Clinical News
The December issue of ASH Clinical News examines the judicial system’s growing presence in health care policy, precipitated in part by the COVID-19 pandemic. More and more, the courts are questioning the public health decisions made by expert agencies, a trend that could have far-reaching consequences for health care in the U.S.
NHLBI Announces Availability of Administrative Supplements to Promote Research Continuity and Retention
To help overcome faculty attrition and minimize workforce loss, the National Heart, Lung, and Blood Institute (NHLBI) offers supplemental funding opportunities to eligible early-stage investigators facing critical life events. These supplements provide up to $70,000 in direct costs for up to one year to support research projects during critical life events, such as childbirth, adoption, and primary caregiving responsibilities for an ailing spouse, child, partner, or a member of the immediate family during the project period. The funding can help sustain the investigator’s research by supporting additional personnel, computational services, and supplies and equipment. Additional information about NHLBI’s supplements can be found here and information about the availability of supplements at other institutes within the National Institutes of Health (NIH) may be found here.
President Biden Appoints W. Kimryn Rathmell, MD, PhD, as NCI Director
On November 17, President Biden appointed W. Kimryn Rathmell, MD, PhD, to serve as the 17th director of the National Cancer Institute (NCI). Dr. Rathmell, who officially began her service as NCI Director on December 18, is a renowned physician-scientist and expert in the understanding and treatment of kidney cancer. She comes to NCI from Vanderbilt University Medical Center, where she served as the Hugh Jackson professor of medicine and chair of the Department of Medicine. At NCI, she succeeds Monica A. Bertagnolli, MD, who was recently confirmed as Director of the National Institutes of Health (NIH).
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