Wednesday, August 7, 2019

CMS Drops CED from CAR-T Coverage; Covers FDA Label and NCCN Indications

On February 15, 2019, CMS released a draft coverage policy for CAR-T therapies, which would have required elaborate Coverage with Evidence Development restrictions (here, here).  The NCD was targeted for finalization on May 16, 2019, but CMS delayed the finalization indefinitely via a brief press release (here).

On August 7, almost three months delayed, CMS released a final NCD (press release here, NCD here.)

Most notably, the decisional part of the NCD has been shortened from 1800 words to only 150 words. 

CAR-T therapies will be covered on FDA indications and compendium (e.g. NCCN) endorsed indications.   This essentially minimizes the role of this NCD as an impactful coverage document, since major cancer drugs would generally be covered on FDA indications and NCCN indications by local contractors (MACs) anyway. 


Criteria for cancer compendia indications were established by CMS regulation 42 CFR 414.930, 2009.   Specific compendia at any given time are updated regularly by CMS in program documents.  Based on current program documents (here), at 50.4.5, NCCN indications I and 2A are always medically accepted; NCCN 3 is not accepted; I believe NCCN 2B is at discretion.

Trade Journals

  • The first CAR-T approval was in mid 2017 (here).
  • Boston STAT here.
  • WaPo here.
  • BioSpace here.
  • MedCity News here.
  • EndPoints here.
  • ASCO Post here.
  • American Society of Hematology press release here.

Press Release Provided by CMS

The press release is titled, "Trump Administration Makes CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries Nationwide."   Opening, "the Centers for Medicare & Medicaid Services (CMS), under the leadership of President Trump and Secretary Azar, finalized the decision to cover FDA-approved Chimeric Antigen Receptor T-cell, or “CAR T-cell” therapy, which is a form of cancer treatment..."  (On the rising use of President Trump's name in routine Medicare press releases, here.)

In contrast, a very recent press release regarding an NCD on acupuncture in back pain made no reference to either Pres. Trump or Secr. Azar (here).