According to a eye-catching new article at Genomeweb, dated January 27, 2025, Novitas has delayed implementation of its new LCD for oncology, "to give the incoming presidential administration time to fully review the proposed changes."
I have never seen this before, at the LCD level. The mechanism is, the "notice date" of the LCD is still the same, January 9 to February 22, but, a new date has been added, an "effective date," which is pushed out to April 24, 2025.
Interpace is cited as a moving party.
- Genomeweb here:
- Interpace Announcement here:
- LCD with novel date for "implementation" in late April versus the "end of notice period" in February.
- https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39367&ver=28&contractorName=all&contractorNumber=all&updatePeriod=1129&sortBy=id&bc=13
- - Novitas January 9 text about Pancragen (direct excerpt from LCD):
- SIDEBAR: https://brucedocumentblog.blogspot.com/2025/01/novitas-lcd-january-2025-pancragen.html
- My original blog about January 9, 2025, release of LCD:
click to enlarge |
Press Release
The Interpace press release states,
Interpace Diagnostics®, a subsidiary of Interpace Biosciences®, (“Interpace” or the “Company”) (OTCQX: IDXG) today announced notification that the Centers for Medicare & Medicaid Services (CMS) directed its Medicare Administrative Contractors, Novitas and First Coast Service Options, Inc., to delay implementation of the Genetic Testing for Oncology Local Coverage Determination (LCD) (L39365), from February 23, 2025, to April 24, 2025.
This change of effective date will allow the incoming Trump administration time to fully review the proposed policy changes, re-evaluate for themselves the supporting clinical evidence for the PancraGEN® assay, and fully assess the negative impact on patient care if the currently proposed LCD comes into effect.
.....We are thrilled that this extension decision also supports the dozens of employees who meticulously process specimens and otherwise would have lost their jobs.
....Further review and evaluation of the clinical validation and utility of PancraGEN demonstrates the incoming Trump administration’s commitment to proven, cost-effective patient care.”
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Theory
Theory
Could it be that DJT is postponing any and all LCDs, only coincidentally the Novitas one containing Interpace? No sign of that yet. Eg Another recent LCD still has its original normal implementation date.
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How could this help Interpace?
While the whole LCD is delayed until April, I've only seen a press release from Interpace. So, it's not clear if the WH is asking Novitas to reconsider all aspects of the LCD - including many other tests - or only Interpace Pancragen. And, what are the logistics? If Novitas views Pancragen more favorably, could it simply rewrite & release those new paragraphs of the LCD? Or, would that violate public comment regulations? If the latter, would Novitas need to rewrite those paragraphs, reissue the whole LCD as a new draft and then finalize the re-write in summer or later?
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In addition to Mehmet Oz MD as Administrator of CMS, Becker's reported Stephanie Carlton RN as his chief of staff, Chris Klomb as head of Medicare ("Center for Medicare,") and Abe Sutton as head of CMMI. Carlton is ex-McKinsey, Klomp CEO of a healthcare IT firm, Sutton worked in the first DJT WH then got a JD from Harvard.