Cell Therapy Preparation Billing: The Collection Cost Inside the Product Payment

Separate billing for cell therapy preparation does not earn a separate Medicare payment when the work is required to manufacture an autologous cell-based immunotherapy or gene therapy. Patient-specific collection and processing belong inside the product payment. If you work at the collection site or in the billing office, you may know whether a separate Medicare charge describes work the manufacturer already needed to make the patient’s treatment.

What Medicare Includes in the Product Payment

The Centers for Medicare & Medicaid Services’ 2026 payment-policy summary continues the existing CAR T-cell approach and extends it to autologous cell-based immunotherapy and gene therapy. For physician and hospital outpatient claims, required preparation goes into the product payment, while giving the patient the finished therapy is paid separately. The preparation payment follows what the work is for: making the patient’s treatment.

That matters because these services take real staff time and resources. Commenters argued that collection, laboratory processing and dose preparation were clinician-ordered, medically necessary work deserving separate reimbursement. CMS kept them in the product payment. We see the problem when a practice seeks another Medicare payment for that same work. Real work, duplicate payment: if Medicare pays the extra preparation charge as well as the product claim, taxpayers pay again for a manufacturing step already covered.

From Collection to the Finished Therapy

An autologous therapy starts with the patient’s own cells and returns the finished treatment to that same patient. CMS describes collection through apheresis, including leukapheresis, or through surgical removal, biopsy or other methods. The material travels at very low temperatures to a manufacturing site, where the steps may include genetic engineering, activation, cell expansion and quality testing.

For CAR T-cell therapy, the patient’s T-cells are collected through leukapheresis and genetically engineered to recognize a protein on cancerous cells. The finished product then returns to the healthcare provider or treatment facility for administration. Collection supplies the starting material for that product, which is why the collection-site work belongs in the manufacturing account even when it happens away from the factory.

CMS identifies manufacturing labor, raw materials, tissue procurement and quality-related activity as major contributors to the cost of these therapies. A manufacturer agreement can describe who performs part of that work and what the manufacturer pays for it. For an insider, the useful connection is between that assigned service, the patient’s collection record and any separate charge sent to Medicare.

Preparation Codes and the Administration Claim

The CAR T-cell preparation codes describe work included in the product payment. In its final rule’s payment discussion, CMS traces that treatment to its earlier hospital outpatient policy and the physician payment policy that followed.

Hospital outpatient payment has included this preparation in the product payment since 2019. The 2025 Physician Fee Schedule continued that approach: CPT codes 38225 for collection, 38226 for transport preparation and 38227 for receipt and preparation for administration are not separately payable. It separately paid CPT code 38228 for administering the CAR T-cell therapy.

For the collection-site biller, those preparation codes identify work paid for through the product. The broader infusion billing questions about administration time and drug quantity concern the work of delivering treatment. Here, the question is whether the claimed preparation belongs to manufacturing the product Medicare pays for.

Cell therapy preparation can also start in a procedure room. CMS identifies surgical biopsy, tumor harvest and tumor resection as ways to obtain the starting material, and applies the policy to procurement and processing required by the product’s manufacturing and release specifications.

For someone who knows why the biopsy was ordered, that purpose is central to the billing question. A procedure described as diagnostic on a claim may have supplied the material the manufacturer required for the therapy. We examine the order and clinical record alongside the manufacturing requirements and the charge, so the case follows what the procedure actually did for that patient.

When the Manufacturer Pays the Collection Site

A manufacturer can pay a collection site for the patient-specific work needed to make its product. The rule discusses payments for cell collection and local processing performed on the manufacturer’s behalf. For the employee who sees that payment and a separate Medicare preparation charge, the question is concrete: what work did each payment cover?

Collection and infusion can happen at different facilities. Commenters told CMS that the provider collecting the cells may differ from the provider that administers and bills for the finished product. A collection-site employee may therefore see the preparation work and the manufacturer’s payment without seeing the product claim at the other facility. We connect those parts of the treatment and payment story with you.

Those practice billing economics involve the product purchase, the manufacturer’s service payment and the Medicare claim. CMS kept its preparation-payment policy while changing course on its proposed treatment of manufacturer service fees in average sales price reporting. How the manufacturer accounts for its service payment is a different question from whether the collection site can charge Medicare separately for that work.

The Records Behind a Separate Preparation Charge

You may know the manufacturer’s assigned preparation because you performed it, invoiced it or handled the payment. That knowledge can connect the agreement to the work behind a separate Medicare charge. We develop the billing evidence with you, following the service the manufacturer required through the collection site’s records and into the claim.

The Medicare claim shows what the site asked for, while payment records show what the government paid. We examine both with the work records to determine whether Medicare was charged separately for a manufacturing step already included in the product payment. The connection matters most when the clinical staff, finance staff and billing staff each know a different part of the transaction.

A physician practice fraud inquiry also follows who chose the billing treatment and what they knew about it. Your knowledge of an instruction, an internal billing concern or the response to that concern can connect the payment discrepancy to the decision behind it. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

When You Know What the Collection Payment Covered

If you work in collection, laboratory operations, finance or billing and know how preparation became a separate Medicare charge, speak to our Whistleblower Experts about the preparation billed to Medicare. We build the case with you around the manufacturer’s requirements, the services performed and the billing decisions, bringing in health care billing fraud whistleblower lawyers who understand cell therapy preparation and Medicare payment. We stay beside you to turn that inside knowledge into your strongest Medicare whistleblower case.