Last month, Dr. Ryan Mathis updated us on the legal initiative around CAMP (skin sub/CTP) pricing. The case, filed in the district court of the Northern District of Texas, was dismissed — not because the companies lost on the merits, but because the judge said they had to go through Medicare’s administrative process first, likely through providers affected by the rule. The deadline for the CAMPs Initiative to appeal the court’s decision was May 11, 2026. Here’s an update about what happened by Dr. Mathis.
–Caroline
After taking the maximum time permitted to file an appeal, on May 11, 2026, the CAMPs Initiative appealed the U.S. District Court for the Northern District of Texas’s decision dismissing its case. The case is officially titled CAMPs Initiative v. HHS, case number 26-10449 in the Fifth Circuit.Opus 4.7. The appeal, which will be heard by the U.S. Court of Appeals for the Fifth Circuit, based in New Orleans, will prolong this case further, potentially adding uncertainty for healthcare providers and manufacturers of skin substitutes alike.
This appeal follows the March 12, 2026 district court dismissal of the CAMPs Initiative’s case challenging the Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) final rule’s provisions regarding skin substitute reimbursement. In its decision, the court dismissed the case because the plaintiff, or a proxy, did not first present its claims to the Department of Health and Human Services (HHS) or the Centers for Medicare & Medicaid Services (CMS) before filing suit. This is a jurisdictional requirement for claims arising from the Medicare Act.
In the appeal, the CAMPs Initiative will likely raise similar arguments as it did in the district court – namely, that this “channeling” or “exhaustion” requirement should not apply to it because it has no adequate administrative process for its claims to be heard as it is not an entity that submits Medicare claims, and that it does not have an adequate proxy who can present its claims to HHS/CMS.
Here are the key points:
- This case will take a long time (possibly years) to resolve. This appeal will likely take months. Assuming this case proceeds normally, in a few weeks, the Fifth Circuit will issue an order that will commence briefing on the case. Under a normal briefing schedule, this case will be ready for decision by late summer/early fall 2026. If the parties request an extension to submit their briefs, which are relatively common and are typically granted, the case may not be ready for decision until later in the fall. Appeals courts don’t have deadlines.
- Here are the possible eventual outcomes:
- The government wins the appeal. If that happens, the case is probably over. CAMPs could theoretically ask the full Fifth Circuit to rehear it, or ask the Supreme Court to take it up, but both of those are uncommon. In this scenario, the 2026 payment policy for skin substitutes stays in place (until CMS changes it).
- CAMPs wins the appeal. However, that doesn’t overturn the current pricing. If CAMPS wins the appeal, they just win the right to have the case heard. At that point, the case goes back down to the Texas trial court, which would then have to decide the actual question: whether CMS’s payment policy violates the Medicare law, the Administrative Procedure Act (which governs how federal agencies make rules), or the Constitution. That trial court decision would itself take months and could be appealed all over again, restarting the cycle.
The reality is that skin substitute pricing is not going to change any time soon as a result of this court case. Medicare payment rules, however, often change annually. Every year, CMS issues new payment rules via the Medicare Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (OPPS) rules. The 2027 rules are in development right now. Whatever CMS does in those future rules could change the legal landscape — perhaps making the current lawsuit moot, requiring new legal arguments, or potentially triggering a brand-new lawsuit. So even tracking this single case isn’t enough; the underlying payment policy is a moving target.
Ryan Mathis, MD
Director of Global Medical Policy, Kerecis
