The most dramatic of CMS’s potential changes is the proposal regarding reimbursement of therapies administered in general practice. From calendar year (CY) 2024, CMS proposes to: stop paying separately for skin substitutes in medical practices. Instead, payment for skin replacements would be wrapped in payment for the associated administrative procedure — which could have dramatic implications for Medicare payment in such physician offices.
For the setting up of the hospital’s outpatient clinic, CMS’s proposals are less drastic. CMS is not proposing any changes for CY 2024. For CY 2023, CMS is proposing to continue its existing reimbursement policy, which associates skin replacement reimbursements with high/low payment categories based on the cost of the product. However, CMS is proposing to retire a special C code — C1849 — that the agency passed in 2021 to describe certain synthetic skin substitutes, and CMS is also proposing certain other changes that will affect skin substitutes being used. delivered in outpatient hospital settings. In addition, it is unclear whether CMS will be allowed to make additional regulatory changes in the coming years, especially given that CMS’s proposed rules contain language that suggests the ultimate goal of CMS is to ensure greater uniformity in payment policies for both the hospital’s outpatient clinic as well as the physician’s healthcare facilities. .
For both the doctor’s office and hospital outpatient settings, CMS also proposes changes to the code set used for skin replacements. Historically, skin substitutes have usually been given Q codes. However, from CY 2024, CMS proposes to switch to using A codes, including converting existing Q codes to A codes. While CMS’s proposal would make the transition to A codes automatic for most skin substitutes, if an HCT/P skin substitute currently has a Q code, CMS would require an application for a revised code, which would necessarily require a letter of recommendation from the tissue reference group of the Food and Drug Administration (FDA).
If finalized, CMS’s various skin replacement proposals would represent a huge change in the way Medicare treats this class of regenerative drugs, especially in physician offices. Industry members, patients, healthcare providers and other stakeholders have the opportunity to submit comments on CMS’s skin replacement proposals. Both CMS’s physician’s office and the hospital’s outpatient clinic have a response time of 60 days, and stakeholder feedback may affect whether CMS completes its proposals, makes changes, or withdraws or delays implementation of the proposed changes.
CMS is requesting comments on the proposed Medicare physician reimbursement schedule through September 6, and on the proposed outpatient prospective payment system through September 13, 2022. If you have questions about the reimbursement of regenerative medicine products, or if you have a comment about the If you would like to submit any proposals discussed above, please contact one of the authors of this warning or the Hogan Lovells attorney with whom you usually work.
This article is the thirteenth in our 2022 series, “Trends in Cell, Tissue and Gene Therapies,” which aims to help you stay on top of the wide range of legal and regulatory issues affecting businesses. active in regenerative medicine. From clinical trials to obtaining patents to scaling production, our global team will discuss emerging issues arising in all parts of the world, including unique deal closings, lawsuits and inspections for CTGT companies.