ChatGPT 3.5 rewrites my MolDx LCD's Blog

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https://www.discoveriesinhealthpolicy.com/2023/08/busy-day-at-moldx-new-draft-lcd-for.html

On Thursday, August 31, 2023, MOLDX, a medical diagnostics organization, had a busy day announcing new draft and final Local Coverage Determinations (LCDs) related to various genetic and molecular tests for different medical conditions.

New Draft LCDs:

1. Advanced Prostate: MOLDX introduced a new draft LCD related to gene expression profile (GEP) tests for decision-making in castration-resistant and metastatic prostate cancers. This LCD is a revised version based on a letter from Dr. Davincioni of Decipher/Veracyte from February 2022. Unlike previous versions that focused on early diagnosis and management, this LCD is intended for patients facing multiple therapy options of varying severity. It aims to help physicians make informed treatment choices. The LCD doesn't specify covered or non-covered tests, but it is associated with billing article DA59462, listing 81479 as a potentially covered code. Notably, the Veracyte Decipher collaboration with Duke University was highlighted in the field.

2. Lung Nodules: Another draft LCD, DL39654, discusses molecular biomarkers for risk stratification of indeterminate pulmonary nodules following bronchoscopy. While it appears to be related to tests like the Veracyte Percepta test, it is framed for patients post-bronchoscopy. The LCD differentiates between "first generation" and "second generation" Percepta tests. The billing article DA59476 provides complementary information and lists 81479 as a possible billing code. Additionally, an LCD for the "XL2" test from Biodesix is mentioned for cases of incidental lung nodules.

3. Thyroid Nodules: LCD DL39646 addresses risk stratification for thyroid nodules based on a letter from Veracyte (Dr. Gerrard) from January 2022. It applies to patients with Bethesda III or IV indeterminate nodules or Bethesda V nodules where molecular testing can aid in decision-making. The LCD emphasizes the importance of avoiding unnecessary thyroid surgeries and highlights the potential benefits of molecular tests in guiding clinical decisions. A billing article (DA59470) provides information on covered codes, including 81479 and 81546 (Veracyte GSC Genomic Sequencing Classifier).

New Final LCD:

MOLDX released a new final LCD concerning Rheumatoid Arthritis (RA). LCD L39424 was based on a letter from SCIPHER, discussing the PRISM-RA test. The original draft in October 2022 stated that molecular biomarker tests for guiding therapy selection in RA were non-covered. However, the final LCD now offers limited coverage based on new evidence and specific criteria. Patients with a history of failure or contraindication to first-line DMARD treatments considering alternate therapies (TNF, JAK, etc.) are eligible for coverage. The LCD references the appropriate validation and design of the test. The billing article (A59529) mentions 81599 as a possible billing code. A detailed "response to comments" document (A59519) accompanies this change in coverage status.

Coordination and Comment:

This batch of draft and final LCDs demonstrated better coordination in terms of posting, likely to speed up the finalization of drafts. The draft LCDs are open for comments from August 31 to October 14.

Convergent Evolution of LCD Text:

LCDs for indeterminate nodules (such as those in the lung and thyroid) show a trend toward using similar language for coverage and performance rules. These rules often emphasize that tests must be appropriately designed for the target population.

Challenges for Academics and Publications:

Despite efforts to document and publish payor policies, the lack of specific coverage details in LCDs or articles poses challenges for policy experts. While databases like DEX can provide some information, they often lack coverage dates and historical records, limiting the ability of academics and consultants to analyze coverage issues systematically.

PAMA Impact:

The widespread use of "unlisted codes" for billing for genetic and molecular tests can potentially bypass the pricing system established by the CMS and Congress, potentially affecting the effectiveness of the PAMA (Protecting Access to Medicare Act) pricing system. This is particularly significant as genomics plays an increasing role in laboratory spending.

Overall, this day marked significant activity in the realm of genetic and molecular diagnostic testing policies, reflecting ongoing developments in medical technology and healthcare coverage.