Thursday, October 28, 2021

Brief Blog; Novitas Finalizes PGx LCD; Tracks Close to MolDx

MolDx and PGx

Over a year ago, the MolDx MAC adopted a broad pharmacogenetics policy that keyed Medicare coverage to current FDA PGx recommendations and current recommendations of the consortium CPIC.

Novitas Follows MolDx

In June 2021, the Novitas and FCSO MACs (which operate in tandem) proposed PGx coverage on generally similar terms to MolDx.

Novitas LCD Finalized

On October 28, 2021, the Novitas/FCSO PGx LCDs were finalized with minimal changes, along with final "billing & coding" articles and responses to public comments.  The new policies are effective December 12.


The policies should be seen in light of the 2019 "Operation Double Helix," which found hundreds of millions of dollars of allegedly improper genetics payments, primarily in the Novitas and FCSO MACs.  

In addition, the policies should be seen in light of a Novitas general genomics coverage and non coverage article released earlier in October -  which I covered in a blog here.  It's A58917.  The Q&A document with this final LCD specifically notes that A58917 is the governing coding article.

Redline of Draft and Final LCD

I did a redline comparison of the draft and final LCDs, which showed few if any really significant changes.  The basic template remains coverage under CPIC and FDA criteria on a rolling basis.  New text requires the ordering physician use the tests in management and be experienced in the use of the genetics tests ordered, a requirement also found in the October general anti-fraud article I just cited (here).

The LCD authors (in the comment Q&A) make clear they prefer any LCD comments to be submitted with full-text articles, not just citation or PMID numbers.  Many groups, from Mayo to CAP/AMP, submitted comments.

The billing article (39pp) includes many pages of tables copied from CPIC/FDA guidelines.


It's really, really, really fast for any MAC on any topic to propose an LCD in June and finalize by October.  LCD finalization usually takes closer to a year, even longer.

Cloud File

I include Cloud Files in a zip file of the draft and final PGx LCD, a redline comparison document, the Q&A PDF and the final Coding and Billing PDF.   Find the Zip file open access here (For the Q&A comments, use file "Landscape.")

I've also posted current versions of all the links here.


The blue states all follow MolDx rules.   The purple states are under Novitas or FCSO (Florida); these two MACs are in a complicated multi entity ownership structure related to Florida BCBS.  The remaining two MACs (upper midwest + northeast) are the National Govt Services or NGS MACs.

The map also makes clear why the MolDx rate always "wins" in the annual gapfill process, where the determinative price is the median price and with 28 states, the MolDx price is always the 25th or median position.

click to enlarge


A number of commenters pointed out that pharmacists or genetic counselors should be able to order PGx testing; Novitas responded that this falls outside current Medicare law and regulations.

I've assumed that FCSO MAC documents released on the same day on the Medicare Coverage Database are in sync with concurrent and identically titled Novitas documents; I haven't checked.

See a subscription article at Genomeweb on 23andMe's acquisition of telemed/pharmacy firm Lemonaid to complement 23andMe's PGx services (here). Also gains capabilities in primary care and disease management.