Last year, Novitas issued a draft LCD for oncology that primarily deferred coverage judgements to compendia like NCCN. They finalized a far longer, more confusing version of the LCD this past June, withdrew it in July, and reissued it as "draft" in July. It's accompanied by an extremely long and confusing billing article. See my July blog about the "re-issue" here.
ACLA, in a press release, flags some of the public comments, including one by a multi-stakeholder group and one by ACLA itself. Stakeholders quarrel with the deferral of coverage decisions (unless made in a one-off way for a few tests), to the NCCN and other guidelines.
See the ACLA press release here. It has a number of links in it. These include the multi stakholder letter, the ACLA letter, and its supplement.
The comment letters are worth reading but frankly, I'm surprised they all just take the very long, verbose, repetitive, and confusing policy and article "on its face" and try to respond rationally to it.
For the AMP response, not yet posted, check here.
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Open Meeting Transcripts Available.
See the LCD open meeting page here. See the transcript (and audio) listing here. 30,000 words.
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NCCN Compendia for Drugs - As a Model
If you wanted to use compendia as a guide to coverage (more a floor than a ceiling, though), there's an excellent precedent. SSA 1861(t)(2) refers to cancer compendia, and CMS rulemaking provides process guidance. See the CMS webpage here. The regulatory discussion, in 2009, was just a few pages long here, The process in regulation at 414.930, is here, just a few paragraphs long. They're written in a few paragraphs of normal, clear professional English. (For NCCN's request letter to be endorsed, 10pp, here. For CMS's review of it, here.)
AI Corner #1.
Here is a summary by ChatGPT of the multi-stakeholder letter.
The letter, dated September 8, 2023, is addressed to Dr. Patrick Mann and Dr. Alicia Campbell regarding concerns about the draft local coverage determinations (LCDs) for "Genetic Testing for Oncology" by Novitas and First Coast Service Options. The letter highlights fears that the LCDs, if finalized as drafted, would limit Medicare beneficiaries' access to genetic testing for cancer, potentially violating Social Security Act and Medicare Program Integrity Manual requirements. Concerns include default non-coverage for tests not in knowledgebases, ICD-10 code issues, documentation requests, and restrictions on hereditary cancer syndrome testing.
The letter requests collaboration with stakeholders to address these concerns and ensure access to essential genetic tests for cancer diagnosis and management. Signed by numerous healthcare organizations.
AI Corner #2
A summary by ChatGPT in the style of Lewis Black. Here.
