ÎÚÑ»´«Ã½

ASH continues to advocate for issues impacting physician practice including workforce, coding issues, coverage and reimbursement, prior authorization, telehealth, and drug shortage issues. During 2023, ASH was very busy working with Congress and the Biden Administration on these issues and the following overview provides information on advocacy highlights that occurred in 2023.

Medical Workforce

• The Senate Health ÎÚÑ»´«Ã½ Labor and Pensions Committee issued a Request for Information about potential legislative solutions to health workforce shortages. ASH’s The Senate Health ÎÚÑ»´«Ã½ Labor and Pensions Committee issued a Request for Information about potential legislative solutions to health workforce shortages. ASH’s response highlighted the myriad of challenges contributing to the workforce issues in hematology, especially classical hematology, and recommended different legislative proposals and action to address these challenges, including support for the Sickle Cell Care Expansion Act. This legislation aims to incentivize physicians to conduct research related to SCD and to treat individuals living with SCD by expanding the National Health Service Corps loan repayment and scholarship program.  highlighted the myriad of challenges contributing to the workforce issues in hematology, especially classical hematology, and recommended different legislative proposals and action to address these challenges, including support for the Sickle Cell Care Expansion Act. This legislation aims to incentivize physicians to conduct research related to SCD and to treat individuals living with SCD by expanding the National Health Service Corps loan repayment and scholarship program.

Physician Fee Schedule Code Changes for CAR T-Cell Therapy

• ASH’s advisors on the American Medical Association (AMA) Current Procedural Terminology (CPT) and Relative Value Scale Update Committees (RUC), Drs. Sam Silver, Jamile Shammo, Chancellor Donald, and Amar Kelkar, were involved with advisors from the American Society of Clinical Oncology, the American Society for Transplantation and Cellular Therapy, and the College of American Pathologists, to present their case to request Chimeric antigen receptor T-cell therapy (CAR T-cell) code changes. The application was successful, and there are now four Category I CPT codes for reporting services for CAR T-cell therapy.
• This change allowed for the codes to be assigned work and practice expense values through the AMA’s RUC survey process. As such, ASH and the other collaborating organizations prepared and fielded a RUC survey of their respective society members to assist with determining relative value units (RVUs) for each of the Category I CPT codes. In late September, the RUC survey findings were presented, and we were successful in obtaining RVUs that appropriately value the work and practice expense involved with CAR T-cell therapy. The Category I codes will be available for use on January 1, 2025. This is a major win for ASH advocacy related to reimbursement policy for ASH members who administer and oversee CAR T-cell therapy.

Duffy Null Coding Proposal

• On May 19, ASH submitted a letter to the Centers for Disease Control and Prevention’s ICD-10 Coordination and Maintenance Committee to request the creation of new ICD-10 codes to describe the Duffy phenotype. ASH requested specific Z codes to help document the Duffy status for individuals in a consistent and longitudinal manner. (Z codes can be used to designate other reasons for healthcare encounters.) New ICD-10 codes for Duffy null will be critical for proper reimbursement, accurate documentation, appropriate clinical care and management, and augmented ability to conduct research. Dr. Maureen Achebe, ASH’s representative, presented the coding request at the September 12–13 ICD-10 Coordination and Maintenance Committee meeting. ASH hopes that a decision on the new Z code request will be made by 2024.

Medicare Coverage for Allogeneic Hematopoietic Stem Cell Transplantation

• In March, ASH and the American Society for Transplantation and Cellular Therapy (ASTCT) sent a letter to Medicare Administrative Contractor (MAC), National Government Services (NGS), in support of the MAC’s proposed local coverage determination (LCD) to expand coverage for allogeneic stem cell transplant for Medicare beneficiaries with primary refractory or relapsed Hodgkin and non-Hodgkin lymphomas with B-cell or T-cell origin. ASH and ASTCT have been working collaboratively to have similar LCDs active in all MAC jurisdictions. Currently, nine out of the eleven MAC jurisdictions have active LCDs allowing coverage for allogeneic stem cell transplant.
• On July 6, ASH, the American Society for Transplantation and Cellular Therapy, the National Marrow Donor Program, the Center for International Blood and Marrow Transplant Research, and the Blood and Marrow Transplant Clinical Trials Network submitted comments to CMS on a national coverage analysis (NCA) for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS). This NCA is in response to the organizations’ original request to the agency in October, 2021. In the comments, the organizations summarized evidence to stress the importance of coverage of HSCT for individuals with MDS without the coverage with evidence development requirement.
  • CMS issued its  on Allogeneic HSCT for MDS on December 7. The proposal expands coverage for allogeneic HSCT using only bone marrow or peripheral blood stem cell products for Medicare patients with MDS designated as high-risk or very high-risk with a score of ≥ 4.5 points according to criteria specified by the International Prognostic Scoring System-Revised. Coverage for other patients not specified by the criteria will be determined by local Medicare Administrative Contractors.

Regulations on Prior Authorization

• ASH submitted comments to the Centers for Medicare and Medicaid Services (CMS) on two proposed rules related to Medicare Advantage Plans and changes to the prior authorization (PA) process.
  • ASH’s February 3 comments on CMS’s Medicare Advantage (MA) and Part D rule outlined support for proposals that allow for a 90-day transition period when beneficiaries switch to a different MA plan; require compliance with local and national coverage determinations; establish coverage criteria that is not more restrictive than traditional Medicare and that is based on widely used treatment guidelines and published literature; and establish a utilization management committee.
  • ASH’s March 9 comments on the Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations proposed rule stressed the importance of user-friendly, streamlined electronic systems for prior authorization that are available to physicians, as well as nurses and other staff. ASH also suggested that the PA process use accurate and current clinical criteria for approvals or denials, and that CMS should consider exempting certain treatments and services from the PA process that have a proven history of success based on current clinical criteria and standards of practice. Additionally, ASH recommended shorter turn-around times for standard and urgent/expedited PA requests.

Regulations on Medicare Coverage and Reimbursement

• In February, ASH submitted comments to CMS regarding the need for coverage and payment of dental services related to the care of hematologic diseases and disorders. This request was submitted to CMS for their consideration of inclusion in the Calendar Year 2024 Physician Fee Schedule proposed rule.
• On May 25, ASH submitted comments on the CMS Fiscal Year 2024 Hospice Wage Index and Payment Rate Update proposed rule. ASH provided comments on the request for information on hospice utilization explaining that there is a lack of utilization of hospice services for patients with hematologic malignancies. ASH also recommended the creation of an innovative reimbursement model for palliative transfusions () and that CMS develop educational materials for referring providers regarding the high-level hospice benefit.
• ASH submitted comments on the Medicare Hospital Inpatient Rule on June 6 and focused comments on support for a proposal to add a health equity adjustment to the Value Based Purchasing program to encourage hospitals to provide high quality care to Medicare/Medicaid dual eligible beneficiaries. ASH is very supportive as members believe that incenting hospitals to provide equitable care to dual eligible patients is a step in the right direction for a fair and equitable healthcare system.
• On June 20, ASH submitted comments to the HHS Office of the National Coordinator for Health Information Technology regarding its proposed rule on Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing. ASH focused its comments on supporting the development of standards for decision support interventions and predictive models and the need to establish effective guardrails to ensure the safety of the patient, protect physicians’ decision-making processes, and uphold physician autonomy. ASH also commented on the rule’s request for information on certification criteria to support complementary and interoperable workflows between physicians and pharmacies.
• On September 11, ASH submitted comments on CMS’ Calendar Year 2024 Physician Fee Schedule. Of great interest to ASH is the proposed regulatory change to reflect the telehealth extensions Congress authorized in the Consolidated Appropriations Act of 2023 to pay for telehealth services billed for patients receiving care in their homes, using the appropriate place of service code, at the non-facility rate. Additionally, ASH supports the CMS proposal to create new services to address health-related social needs, including community health integration, social determinants of health risk assessment, and principal illness navigation services, which could potentially be billed by hematologists. Finally, ASH supports several changes to payment for dental services, including coverage of dental services for patients receiving CAR-T therapy and chemotherapy, and also recommended coverage for individuals who have sickle cell disease.
• ASH provided comments to CMS on September 11 regarding the Calendar Year 2024 Hospital Outpatient Prospective Payment Rule. ASH focused its comments on a proposal to maintain a buffer stock of essential medicines to help mitigate drug shortages by providing an additional payment to hospitals for maintaining this stock.

Legislation on Medicare Coverage and Reimbursement

• On June 22, the Improving Access to Transfusion Care for Hospice Patients Act () was reintroduced in the U.S. Senate by Senators Jacky Rosen (D-NV), John Barrasso (R-WY), and Tammy Baldwin (D-WI). This bipartisan bill aims to increase access to palliative blood transfusions for patients receiving end-of-life care through the Medicare hospice benefit by establishing a demonstration program to provide a separate payment for blood transfusions in addition to the daily reimbursement rate for hospice care services.
  • ASH strongly supports this legislation and the creation of similarly innovative reimbursement models, as recommended in the ASH Statement in Support of Palliative Blood Transfusions in Hospice Setting
  • A quote from ASH President Dr. Robert Brodsky was included in the  issued by Senators Rosen, Barrasso, and Baldwin following reintroduction of the legislation.
• The Society expressed support for the CONNECT for Health Act (S. 2016/H.R. 4189), legislation that would increase patient access to telehealth services. The bill would permanently remove geographic restrictions that limit where patients can access telehealth, add homes and other clinically appropriate originating sites, and allow rural health clinics and federally qualified health centers to serve as distant sites.
• ASH sent a letter to House and Senate leadership on December 5, urging Congress to pass legislation that would eliminate the 3.37% cut to the Medicare Physician Fee Schedule conversion factor, before it goes into effect on January 1, 2024. ASH also highlighted current legislation, the Strengthening Medicare for Patients and Providers Act (H.R. 2474), and a discussion draft of the Provider Reimbursement Stability Act, aimed at addressing physician payment challenges. ASH members on the Committee on Practice advocated for physician payment reform during its spring Capitol Hill Day, and during the ASH Annual Meeting, sent an alert out to all members encouraging them to write legislators about the need to mitigate the cuts as well as reform the Medicare physician payment system.

Advocacy to Address Drug Shortages

• As drug shortages continue to reach an all-time high in the United States, especially for hematologic therapies, ASH continues to update the Hematologic Drug Shortage Information webpage to keep members apprised of shortages and actively work with Congress, federal agencies, and other stakeholders to ensure access to safe and effective hematologic drugs.
  • In late May, the lead from FDA’s Office of Drug Shortages met with the Committee on Government Affairs to discuss the impact of ongoing hematologic drug shortages, FDA’s efforts to prevent and mitigate shortages, and how ASH could help support the Agency.
  • Over the summer, the Society activated the ASH Grassroots Network to contact their elected officials about the devastating impact of the shortages and encourage action.
  • In late August, ASH sent a letter to Representative Cathy McMorris Rodgers (R-WA), Chair of the House Energy & Commerce Committee, recommending changes to draft legislation entitled Stop Drug Shortages Act. ASH also sent a letter to Congressional leaders in early September about the need for timely and comprehensive action on drug shortages, including those that impact hematology care.