Sunday, July 31, 2022

Pacific Edge Bio Issues Press Release about Novitas Cancer LCD

A few weeks ago (June 9), I issued a blog about a novel new LCD for cancer biomarkers at Novitas - here.   The LCD primarily acts to refer coverage of cancer biomarkers to outside guidelines and databases.  About the same time (June 12), I issued a blog about "Medicare test coverage without any articles."  (For example, someone would ask me, "Company A says its test is covered, and it bills under Novitas, but I can't find any statement anywhere.")  Here.  Of course, searches are always imperfect, and the only answer with a null search is that, "the rules were hard to find."  

Usually, when I get these requests and can't find a MAC published article, I submit a FOIA request to the MAC for any internal documents or correspondence about covering and pricing the test of interest.

Press Release about LCD

Here we have a press release (August 1, 2022) from Pacific Edge Bio, about how the new Novitas LCD would impact its coverage.  Bottom line: They say the impact might be negative.  Here.   

Here are some procedural comments, by Pacific Edge, about its current experience with the US LCD revision process at Novitas:

...Having consulted with our US-based advisers and industry experts, Pacific Edge believes the proposed changes are unlikely to survive the ongoing review process in their current form. The consensus view we received was that the proposed changes to the LCD are contrary to US legal requirements and precedent....

What does Pacific Edge think of the LCD and LCA?

Pacific Edge believes the proposed LCD and LCA will not survive in their current form because:

  • They do not meet the statutory requirements for an LCD.
  • They do not comply with CMS’ requirements for the development of LCDs.
  • Their new approach of using knowledge bases as a determinant for CMS coverage is not well supported within the draft LCD.
  • The proposed LCD and LCA are insufficient to allow stakeholders to understand whether tests are covered and would inappropriately restrict coverage for tests.

What is Pacific Edge doing to change the Novitas proposal?

Pacific Edge has presented in person to Novitas and has made a detailed submission comprehensively setting out its concerns and the drawbacks of this new approach. It is also sharing insight with other biotech companies that could be similarly affected by the new approach to make their concerns known to Novitas before the end of the consultation period, and engaging with industry advocates.

If the draft LCD was first published in June, why did Pacific Edge only notify the NZX and ASX and call a trading halt on Friday 29 July 2022?

In June the draft proposals did not appear to affect Pacific Edge since there was no indication that coverage for Cxbladder under its existing LCD was changing. Additionally, Cxbladder was not explicitly mentioned in the proposed LCD.....(continues)

On July 28, 2022, Novitas posted a comment period extension (here) with the following elaboration:

Posted: 7/28/2022 NOVITAS

Note Posted on MCD 07/28/2022: 

As communicated on our website on 07/25/2022, the Comment Period End Date has been extended for this Proposed LCD to 09/06/2022. The original Comment Period End Date was 07/23/2022, which displayed on the CMS MCD from 6/9/2022 through 07/28/2022. The extension is due to changes being made to the related draft article. 

Please refer to the Related Local Coverage Documents section at the bottom of this Proposed LCD for changes made to the draft article (DA59125, Billing and Coding: Genetic Testing for Oncology) The changes are indicated on the document note at the top of the document.


I've been meaning to write a blog (or vlog) about precedents for using guidelines for LCDs.   

For example, the NGS MAC article A56199 for BRCA testing simply points, in a short statement, to the current NCCN guideline.  The MOLDX and NOVITAS MACs have LCDs for pharmacogenetics primarily simply point to the FDA guidance on PGx genes and the CPIC guidance and reviews on PGx genes (L38337).   Then, there is this new proposal for Novitas which ties cancer biomarker coverage to NCCN (and a couple other) guidelines.   MOLDX recently finalized a hereditary cancer testing LCD L38966 which has a heavy emphasis on a reference to outside guidelines, as well.

Other times, efforts to tie LCD coverage to guidelines has flopped and quickly.  In May 2016, Noridian posted an LCD that simply tied breast cancer gene expression tests (eg Oncotype, Mammaprint) to "current ASCO guidelines."  This LCD was proposed and withdrawn in a time cycle of just a few weeks.  Here.  

CMS guides Contractors to weight guidelines in their LCDs, along with RCT evidence.   CMS has made national decisions that block coverage of future products that CMS has never reviewed, as discussed recently by Selkoe here.