On July 25, 2024, CMS held its annual expert advisory panel for pricing new lab codes. In addition to handling over 100 agenda items, CMS gave the panel a half hour in the afternoon to discuss the CMS pricing process as a whole.
I'll provide my own notes, and then I'll include a "news article" written by ChatGPT from an auto transcript.
This blog is limited to the process-discussion-half-hour - for the whole day, here.
Panelist Remarks Included...
Here are some viewpoints of the panelists that I captured:
- The public comment presentations in June are very helpful – it’s frustrating that “half” of codes lack a presentation in that forum.
- Companies present elaborate and useful info packets to AMA, but they dead-end there and are not part of the crosswalk process. Could the companies/AMA/CMS facilitate sharing, at least as an option?
- The panelists would like to have patient result reports for each test.
- Inclusion of an FDA instructions for use would help.
- One frustrating scenario is when a test in one year (000XU) is sent to gapfill, and the next summer a very similar code is created (00XXU). The new code can’t be crosswalked to 000XU, but it’s a similar code and for consistency the price should be the same. Under today’s rules, 00XXU will get sent to gapfill in the next year, a waste of gapfill resources and potentially a source of price inconsistency.
- It seems unfair to price two tests differently, one with 10 markers, one with 20, when they output the same result with the same accuracy.
- There was discussion that the PLA codebook has no structure, and with >500 codes, that’s confusing and makes crosswalk searches unreliable.
- What does “appropriate crosswalk” mean? Intended use? Method? Number of analytes? CMS noted that both creating such rules – and the lack of the rules – is problematic.
- When public stakeholders align on a pricing proposal, that’s impressive and helpful.
a. In September, explanations of proposed prices by CMS are very short, making it hard to craft a public response that meets CMS concerns and CMS thinking.b. It’s hard to know where the line is for “appropriateness” of fit as crosswalk, but on one side of the invisible line, you crosswalk, on the other side, you gapfill.c. CMS is highly dependent on the code text, which is inconsistent among codes, as the panel noted. I had a client pulled into CMS meetings to explain that two terms (in similar PLA codes) were well known synonyms, and it was a long difficult communication.d. Pricing outliers can occur (errors high or low) which may or may not be propagated by irregular future crosswalks. For example, a PLA company might go out of business and provide no info, so its code is wildly underpriced, but endorsed by the fee scheduele. PLA codes are canceled at a rate of 3-5 per quarter, what happens to a code crosswalked to a canceled code? Does it carry on at the ghost price, or become unpriced?
CMS Public Meeting on
Pricing New Lab Test Codes:
Insights from the Panel Discussion
Written by ChatGPT 4 via auto transcript at otter.ai
In a lively and informative session, the Centers for Medicare & Medicaid Services (CMS) facilitated a panel discussion to delve into the complexities of the rate-setting process for new lab test codes. The session aimed to gather expert feedback and improve the transparency and efficiency of the pricing process.
The discussion, led by Sarah Harding and Sarah Shirey-Lasso, addressed several key questions that have emerged from public comments over the years. These questions focused on the challenges and potential improvements in setting payment rates for lab tests. The conversation was intended to be informal, allowing panelists to freely share their experiences and suggestions.
Challenges in Crosswalking and Gap Filling
The panelists highlighted several difficulties in the current process. A recurring theme was the lack of detailed information from test sponsors. A seasoned panelist noted, "The number one challenge is when sponsors don't provide any information, and we're left to figure out comparability in terms of method, intended use, or number of targets."
This sentiment was echoed by other panelists, one of whom expressed frustration with the incomplete information provided by some sponsors. "Half of them don't show up for the public meeting in June, which makes it difficult to make informed decisions," she said.
The Need for Detailed Reports and Consistent Guidelines
The panelists agreed that detailed reports and consistent guidelines are crucial for effective crosswalking and rate setting. A panelist suggested that requiring submission of detailed assay reports and methodologies should be considered. "It's very difficult to do this work well without those kinds of details," she emphasized.
The panel also discussed the importance of having clear guidelines on what constitutes comparability. "Some guidelines around what crosswalking actually means would be helpful,"a panelist pointed out. She highlighted the inconsistencies in how different specialties develop and describe codes, making it challenging to find comparable tests.
Coordination with AMA and Improved Communication
Another panelist shared her recent experience from both sides of the process—submitting codes to the American Medical Association (AMA) and serving on the CMS panel. She stressed the need for better coordination between AMA and CMS. "If there was a way for those responsible for submitting codes to get a message from CMS outlining the next steps and the importance of providing detailed information, it would make a significant difference," she said.
The panelists suggested that CMS should facilitate the sharing of supplemental materials, such as instruction for use (IFU) documents and other relevant reports, to aid in the evaluation process.
The Role of Analytical and Clinical Information
A significant point of discussion was the distinction between analytical and clinically reported information. A speaker raised the issue of what should be considered for crosswalking—what's reported out clinically versus what's done analytically. "Payers tend to want to pay for the clinically important information," she noted. This distinction is crucial in determining the value and comparability of new tests.
Looking Ahead: Potential Policy Changes
The panelists concluded by discussing the potential for developing specific criteria for determining comparability. This would involve defining what makes tests comparable in terms of intended use, method, and reporting. While acknowledging the challenges, they expressed optimism about improving the process through better guidelines and more detailed information from sponsors.
In closing, CMS officials thanked the panelists for their valuable insights and emphasized the agency's commitment to refining the rate-setting process. The discussion provided a clear roadmap for future improvements, aiming to balance the needs of innovation with fair and sustainable pricing.
Conclusion
The CMS public meeting on pricing new lab test codes highlighted the complexities and challenges of the current process. The panelists' insights underscored the need for detailed information, clear guidelines, and better coordination with the AMA. As CMS continues to refine its methodologies, the feedback from this discussion will play a crucial role in shaping the future of lab test pricing policies.
