Discoveries in Health Policy: CMS CLFS Experts (July 25-26): Links to Transcript, Video, and a Chat GPT Analysis

I gave the entire transcript to Chat GPT and asked it to open. I have preserved my prompts as I wrote them. Note that at first, it gave a shallow summary, then a better one. Then, I asked it what evidence it saw in the transcript, for how panelists made pragmatic decisions between "crosswalk" and "gapfill".

PROMPT #1

Please provide a summary of this transcript. A ten-person advisory expert panel advises CMS (Medicare) on how to price about 100 new tests. Primarily by the "crosswalk" method to a smilar test, if none available, then by "gapfill." Do not try to summarize the individual decisions, as there are >100 of them.

The transcript from the CMS CLFS FACA Advisory Panel meeting outlines the process and discussions involved in pricing new lab tests for Medicare. The ten-person expert panel advises CMS on pricing approximately 100 new tests using primarily the "crosswalk" method, which involves comparing a new test to an existing similar test to set a price. If a comparable test is not available, the "gap fill" method is used, where the price is determined based on the cost of resources and technology used for the test.
The panel's recommendations are based on subcommittees' reviews, public comments, and supporting information. Each new test is reviewed for its methodology, resources, and indications, with the panel voting on whether to use a crosswalk or gap fill approach. The process includes public input, and final decisions are made after considering preliminary recommendations and additional comments.
For a detailed summary, specific test decisions were not included as the content involves over 100 individual decisions and discussions. Instead, the focus is on the general procedure and methodology applied by the panel in making their pricing recommendations.

PROMPT #2

Could you write a description of the meeting that is about twice as long, going into additional highlights and factors.

The CMS CLFS FACA Advisory Panel meeting held on July 25-26, 2024, focused on establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes for the upcoming calendar year. The ten-person expert panel, consisting of members with extensive backgrounds in various medical and scientific fields, provided recommendations to the CMS on how to price approximately 100 new laboratory tests. These recommendations were primarily based on the "crosswalk" method and, when necessary, the "gap fill" method.

Key Highlights:

Meeting Structure and Process:
- The meeting began with introductions and housekeeping items, led by Rashida Arthur, the designated federal officer. The process was virtual, allowing broader participation.
- Two subcommittees were established: the Molecular Pathology Genomic Sequencing (MOG) Subcommittee and the Chemistry, Hematology, Immunology, and Microbiology (CHIMP) Subcommittee. These groups aimed to streamline discussions and leverage panel members' expertise efficiently.
Crosswalk Method:
- The crosswalk method involves comparing the new test to an existing test with similar methodology, resources, and clinical utility. If a suitable comparable test was found, the panel recommended using its established price for the new test.
- For example, the test code 0445U, related to Alzheimer’s disease, was crosswalked to 0358U due to similar descriptors and methodologies, ensuring consistent pricing based on established precedents.
Gap Fill Method:
- When no comparable test was available, the gap fill method was employed. This method involves determining the payment amount based on the resources and technology required for the new test. This method takes longer as it involves gathering cost data from multiple sources.
Public and Panel Input:
- The meeting allowed for real-time public comments and responses to questions from the panel, ensuring a transparent and inclusive process.
- Discussions often included detailed questions about the specifics of the tests, such as the methodologies used, the type of specimens analyzed, and the clinical relevance of the tests.
Technical Clarifications:
- The panel frequently sought technical clarifications to ensure accurate recommendations. For instance, there were detailed discussions on whether certain tests measured qualitative versus quantitative results and how these differences impacted resource use and pricing.
Complexity of Test Categories:
- The panel reviewed tests across various categories, such as molecular pathology, immunology, and microbiology. Each category had unique considerations, reflecting the diversity and complexity of modern diagnostic testing.
- The use of advanced technologies like liquid chromatography-tandem mass spectrometry (LC-MS/MS) and multiplex assays highlighted the evolving nature of laboratory diagnostics.
Voting and Decision Making:
- Each test was individually discussed, followed by panel voting on the recommended pricing method. Votes were cast electronically, and results were immediately shared.
- Some tests required additional follow-up or were moved to the end of the agenda for further discussion, ensuring thorough consideration of all options.

Additional Factors Considered:

Methodological Consistency: Ensuring that similar tests were priced consistently to avoid discrepancies and ensure fairness in pricing across the board.
Resource Utilization: Evaluating the resources required for each test, including equipment, reagents, and labor, to accurately reflect the cost in the pricing recommendation.
Clinical Utility: Considering the clinical importance and utility of the tests in patient care, influencing the prioritization and pricing decisions.
Technological Advances: Acknowledging the rapid advancements in diagnostic technologies and how they impact the complexity and cost of new tests.

Conclusion:

The CMS CLFS FACA Advisory Panel meeting was a meticulous and inclusive process aimed at ensuring fair and accurate pricing for new and revised laboratory tests. By leveraging the expertise of the panel members, incorporating public input, and thoroughly evaluating each test's methodology and clinical relevance, the panel provided CMS with well-founded recommendations for the upcoming year.

PROMPT #3

That was excellent! Thanks for the additional insight and color. One of the persistent topics is how to decide if a crosswalk is "close enough" to use, or whether to turf the decision to the gapfill process instead. This was discussed in the panel discussion segment about process, noting there were no objective rules for a "comparable" test. Could you review the whole document and draw any insights into how the panel approached the practical or pragmatic decision of whether a crosswalk was "close enough to use" or whether no such close crosswalk existed, forcing a referral to gapfill instead. How did panelists pragmatically handle this dilemma, as suggested by their transcribed thinking and remarks.

The CMS CLFS FACA Advisory Panel meeting highlighted several discussions around the challenge of determining whether a crosswalk is "close enough" to use or if the decision should be deferred to the gap fill process. This decision-making process lacks objective rules, and the panel often relies on practical and pragmatic considerations, as evidenced by their transcribed remarks and thought processes.

Key Insights from the Panel's Approach:

Criteria for Comparability:
- The panel frequently debated what makes a test "comparable" enough to justify a crosswalk. Factors such as intended use, methodology, number of targets, and resources required were considered. For instance, panelists discussed whether tests with similar methodologies but different targets could still be crosswalked effectively.
Information and Documentation:
- A recurring theme was the necessity of detailed information from sponsors. Panelists emphasized the need for comprehensive descriptions of assays, methodologies, resources, and outcome reports to make informed decisions. When such information was lacking, it often led to recommending the gap fill method due to insufficient data to establish a direct crosswalk .
Examples of Decision-Making:
- For complex assays, such as next-generation sequencing for colorectal cancer, the lack of a direct comparable test led to a recommendation for gap fill.
- In cases where a test had a similar methodology and specimen type but differed in complexity or number of analytes, the panel might opt for a crosswalk with a multiplier to account for these differences.
Consistency and Precedent:
- The panel aimed to maintain consistency in their recommendations year over year. This was particularly important for tests that had undergone similar reviews in previous years. Consistent application of crosswalks helps in maintaining fairness and predictability in pricing decisions.
Panel Discussions and Votes:
- The panel’s discussions often involved multiple options for crosswalks, with detailed justifications for each. When no clear crosswalk was identified, and no substantial input was received from labs or stakeholders, the gap fill method was recommended. This approach ensures that the pricing process remains rigorous and justified even in the absence of direct comparability .

Practical Handling of the Dilemma:

The panel's pragmatic handling of the crosswalk versus gap fill dilemma is illustrated by their reliance on detailed comparisons and thorough discussions. They consider:

The specific methodologies and technologies used in the tests.
The intended clinical use and outcome measures.
The completeness and quality of the information provided by test developers.
Historical decisions and established precedents to ensure consistency.

In conclusion, the panel's approach to deciding whether a crosswalk is "close enough" involves a detailed examination of each test's characteristics, a reliance on thorough documentation, and an emphasis on maintaining consistency. When faced with insufficient information or clear differences in methodology, the panel pragmatically opts for the gap fill method to ensure fair and accurate pricing decisions

Thursday, July 25, 2024

CMS CLFS Experts (July 25-26): Links to Transcript, Video, and a Chat GPT Analysis

Key Highlights:

Additional Factors Considered:

Conclusion:

Key Insights from the Panel's Approach:

Practical Handling of the Dilemma: