Medicare Payment Proposal Updates for Cell and Gene Therapies: Coding and Reimbursement Implications for CY 2027
2027 Proposed ASC and HOPD Payment Updates for Cell and Gene Therapies
The 2027 proposed ambulatory surgical center (ASC) and hospital outpatient department (HOPD) rule largely preserves separate payment for high-cost cell and gene therapies in HOPDs while introducing broader outpatient payment changes—especially a major proposed 340B reimbursement cut, new drug-reporting modifier requirements, and site-of-care policy changes that could affect outpatient provider economics.
Separate Payment for Cell and Gene Therapies Continues in HOPDs
For 2027, the most important cell- and gene-therapy policy is actually a continuation of prior outpatient policy rather than a brand-new reimbursement framework. CMS proposes to continue excluding qualifying cell and gene therapies from comprehensive APC packaging when those products are not integral, ancillary, supportive, dependent, or adjunctive to the primary service. In practical terms, that means qualifying therapies would remain separately payable in the HOPD setting rather than being bundled into a single comprehensive outpatient payment. CMS also indicates it would continue adding newly created product-specific HCPCS codes to the exclusion list when new qualifying therapies enter the market.
The proposed exclusion list includes several established and newer advanced therapies, including Yescarta, Kymriah, Provenge, Tecartus, Breyanzi, Abecma, CARVYKTI, Skysona, Lenmeldy, CASGEVY, Luxturna, Zolgensma, Ryoncil, and Hemgenix. For manufacturers and outpatient hospitals, this continued policy remains critical because it reduces the financial disincentive to furnish very high-cost therapies in the outpatient setting.
The Biggest New 2027 Proposal: 340B Drug Payment Cuts
The most significant new reimbursement proposal in the 2027 HOPD rule is CMS’s plan to pay most 340B-acquired drugs at ASP minus 33.4 percent. CMS says this proposed rate is based on results from its 2026 OPPS drug acquisition cost survey. If finalized, this would be a major change for hospitals that acquire separately payable drugs under the 340B program, including facilities that may administer advanced biologics and cell or gene therapies in outpatient departments.
CMS also proposes to implement this 340B policy in a budget-neutral manner by increasing OPPS payment for non-drug items and services by an estimated 8.44 percent. At the same time, CMS proposes to increase the separate “340B remedy offset” reduction for affected hospitals from 0.5 percent to 3 percent beginning in 2027 to continue recouping prior non-drug payment increases associated with the 2018–2022 340B remedy. That means hospitals subject to the policy could see a complicated mix of lower payment for many 340B drugs, higher payment for non-drug OPPS services generally, and an additional downward adjustment tied to the remedy offset.
New Modifier Requirements for Drug Claims
Operationally, CMS proposes new billing expectations that outpatient hospitals will need to build into charge capture and claims systems. Beginning January 1, 2027, hospitals subject to the 340B adjustment would report modifier JG for 340B-acquired drugs, modifier TB for certain exempt 340B drug situations and informational reporting, and a new proposed modifier XX for drugs that were not acquired through the 340B program. For manufacturers, these modifier proposals matter because they could affect claims accuracy, reimbursement predictability, audit risk, and hospital readiness to bill high-cost therapies correctly.
Broader Drug Payment Policies Still Matter
CMS proposes a general 2027 packaging threshold of $140 for drugs, biologicals, and therapeutic radiopharmaceuticals under OPPS, while continuing separate payment above that threshold unless a product is otherwise policy-packaged. CMS also proposes to continue pass-through payment for qualifying drugs and biologicals under existing methodology, generally ASP plus 6 percent when ASP is available. These are not cell- and gene-therapy-specific changes, but they remain relevant for provider sites managing high-cost product reimbursement and transitional payment strategy.
Practical Takeaways for Manufacturers and Outpatient Providers
For manufacturers, the key 2027 takeaway is that CMS is not backing away from separate HOPD payment for qualifying cell and gene therapies, which remains favorable for outpatient access. The more immediate risk lies in the proposed 340B payment methodology, which could materially affect hospital economics and potentially influence provider behavior, contracting discussions, and site-of-care strategy.
For hospitals and billing teams, priority actions should include confirming that each applicable therapy’s HCPCS code remains on the C-APC exclusion list, modeling the financial impact of the proposed 340B rate and 3 percent remedy offset, and preparing systems for the proposed JG/TB/XX modifier workflow.
Resources
Disclaimer: The coding guidance and regulatory requirements described in this article are provided for general informational purposes. Coding logic and reimbursement mechanics vary by payer and setting. Hospitals and manufacturers should consult with compliance, legal, and coding counsel prior to implementing changes.
