TCET COMMENT (BRUCE QUINN) 8-2023

 

CMS should be commended for the hard work and breadth of planning in the TCET proposal and associated documents. Here, I provide some comments from the perspective of an MD PhD who works full time on the topic of Medicare and innovation, as a consultant to medtech and genomic companies.

1. Yes, there can be problems with coverage.
1. As a consultant, I often see cases that are the services that collided with legacy rules or confusing delays in decision-making. I can validate that there certainly are novel products that collide with substantial problems, and being able to elevate and solve these problems, when possible, should be a core capability of the innovation system at CMS. For example, there have been devices that achieve NTAP status for substantial benefit yet there NTAP expires (or OPPS pass through) before the LCD process is finished.
2. Breakthrough devices are not “one single device” in a category.
1. The discussion on 41642 is a little confusing about the first device to get breakthrough coverage, and in past discussions I have heard CMS say that FDA allows only 1 breakthrough device per category. In fact, FDA gives breakthrough status on a rolling basis to device applicants UNTIL a product is FDA approved. All the devices have “breakthrough” review status. For example, a CSF Alzheimer test from Fujirebio and one from Roche both had breakthrough status, which is awarded during review. Eventually, both devices were also authorized. CMS should avoid stating that single unique products are the only form of breakthrough review status.
3. Whether two devices are in “the same category” will not always be clear.
1. CMS discusses the application of TCET NCDs (presumably with CED) to families of products. Often the family of products is unambiguous, such as the several beta-amyloid-PET tracers or the several anti-beta-amyloid monoclonal drugs.
2. But there may be other cases where it is less clear that various devices (inside and outside of TCET) which are related but distinguished by some tech features, fall in the same category or not.
4. Diagnostics should be eligible for breakthrough device status.
1. Varous versions of MCIT were also ambiguous or unclear about diagnostics. FDA classes diagnostics as devices and has numerous diagnostics under breakthrough review. CMS refers to “special contractors” for diagnostics, but the MOLDX program (it would be helpful for readers to name it) applies only in about half of states. The MOLDX program, and other LCDs, can also be quite slow, sometimes releasing a draft LCD based on a two-year-old request letter. In such cases, sometimes TCET could be a better choice.
5. Planning versus implementation.
1. The documents reflect a great deal of thought and good planning. However, CMS policy watchers may still be concerned about implementation. Parallel Review was announced with great fanfare within the memory of many policy experts, but yielded little, and there are many features of TCET that have wide overlap with events during the Parallel Review process. CMS announced it would keep an annual running tally of NCDs on a “wait list” for review, yet, the tally was updated once or twice and then forgotten about (last updated 2020). https://www.cms.gov/files/document/ncd-wait-list.pdf Stakeholders will be watching whether CMS actually effectively executes repeatedly on TCET, a goal where it fell short with Parallel Review.
6. Economics and Microeconomics of TCET and CED
1. While CMS does not make decisions on a cost-effectiveness basis, CED still has major economics. The IDEAS studies provided about 16,000 Alzheimer PET scans, which at $3000 each (scan and tracer), involved $48M. If we rephrase the question and goal, if CMS or HHS or “the government” wanted to know more about the clinical utility of PET scans in dementia, a fraction of the same tax dollars could have been spent at NIH in a large rigorous and data-rich trial.
2. The dollar value of CED relative to the cost of a trial will have a huge impact on the viability of CED. For example, if CMS covers $30,000 Alzheimer drugs, with per patient sponsor trial costs of $3000 per patient, that may be a highly viable research project. On the other hand, if CMS covers a genetic test for $80, and the sponsor trial costs are also $3000 per patient, the “CED” value is really “budget dust” compared to the trial cost.
3. CMS should require at least an internal estimate of per patient study costs. Some physicians in management, for example, those with an MBA, would probably do this spontaneously while participating in the project. However, this should be a requirement of the internal phases of planning CED, at least back of envelope calculations so policy participants have some reality check on what they are proposing and the “value of information” or VOI.

Bruce Quinn (MD PhD MBA)

Los Angeles