Medtech Strategist has released an interesting podcast interview. Learn about Tamara Syrek Jensen's career at CMS, much of it in the Coverage Group, and the insights she brings to clients today as a Principal of Rubrum Advising.
(Note, she seems to say a couple times, CMS is where I am; but it's clear she was out-of-government at this interview and working with Lee Fleisher at Rubrum Consulting.)
Find the podcast here:
https://www.medtechstrategist.com/podcast-content
Look for Podcast #34. She's interviewed by Stephen Levin, edtior-in-chief.
Or find their YouTube audio channel here:
https://www.youtube.com/watch?v=dNK8ZhJZEYQ
Chat GPT listened in and reports for us:
In a candid Market Pathways interview, former CMS coverage chief Tamara Syrek Jensen argues that reimbursement bottlenecks are structural, not merely bureaucratic—spanning evidence, coding, payment, Medicare Advantage, and payer coordination—while urging earlier, honest, disciplined engagement among industry, CMS, and FDA.
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Tamara Syrek Jensen on CMS After 25 Years:
A Reimbursement Insider Explains What Industry Still Gets Wrong
Market Pathways’ interview with Tamara Syrek Jensen is valuable not because it offers a grand reimbursement fix, but because it strips away a few durable myths. Jensen, who spent roughly 25 years at CMS and the last decade leading the Coverage and Analysis Group, speaks with unusual directness about the agency’s constraints, the industry’s misconceptions, and the widening gap between regulatory success and payment success. The conversation, drawn from the San Diego Innovation Summit, is framed by Stephen Levin as a rare chance to hear a former CMS official speak frankly about Medicare reimbursement, parallel review, and the practical difficulties companies face in working with CMS.
The central point is one sophisticated readers already suspect but often understate: reimbursement is not “FDA, but slower.” Jensen emphasizes that payment is an ecosystem problem, not a single-agency problem. Coverage, coding, and payment remain the classic “three-legged stool,” but in her telling that stool has effectively become four-legged because Medicare Advantage now sits on top of the traditional fee-for-service architecture. Add private payers, the AMA, specialty societies, and MAC behavior, and the contrast with FDA becomes stark: regulation can be grueling, but it is still largely one-agency navigation; reimbursement is a distributed negotiation across multiple institutions, standards, and incentives.
That matters because Jensen rejects the cartoon version of CMS as simply the lagging “problem child” after FDA approval. She says CMS had been trying, including behind the scenes, to explore whether certain NCDs could be made much shorter and faster, closer to the timing of FDA action. But even a rapid coverage decision is insufficient if coding is absent or payment is effectively zero. Her point is not defensive so much as architectural: reimbursement failures are often compounded failures. A positive regulatory event does not automatically propagate into a usable reimbursement pathway, and companies that model it that way are modeling the wrong system.
For companies, Jensen’s most practical message may be cultural rather than procedural. She openly acknowledges that bias against industry has existed inside government, just as industry carries its own bias against CMS. But she also makes a sharper distinction: distrust is manageable, dishonesty is corrosive. Her formulation is memorable in its simplicity—“Just be honest”—and it comes with an implicit warning. When manufacturers tell CMS one story and FDA another, they are not just creating confusion; they are degrading the possibility of creative problem-solving. By contrast, she describes a more recent “paradigm shift” in which companies are more willing to admit evidentiary imperfection while still arguing that a technology benefits patients. That, she suggests, is the kind of conversation from which CED and TSET-type solutions can actually emerge.
Her comments on transparency are equally pointed. Jensen does not deny that CMS has historically been experienced as opaque. She more or less concedes the criticism, while arguing that openness—within legal limits—was necessary precisely because silence breeds mythology. If companies cannot get clear signals from the agency, they fill the void with stories about hostility, indifference, or hidden rules. Her preferred answer was repeated conversation, not because repeated meetings are efficient, but because they are trust-building. That is a notable stance from a former Coverage and Analysis Group leader: not that CMS could or should say yes more often, but that it needed to talk more clearly, earlier, and more often about why the answer might be yes, no, or not yet.
On substance, Jensen is especially strong on the question of what CMS is actually evaluating. She pushes back on the industry complaint that “reasonable and necessary” is too undefined to be operational. Her response is that the record is hardly empty: hundreds of NCDs already reveal the endpoints and evidentiary instincts CMS uses, especially as they relate to the Medicare population and its comorbidity burden. More interestingly, she warns that formalizing the standard too tightly could backfire. A rigid statutory or regulatory definition might deliver more certainty in theory while freezing out future technologies in practice. For an audience steeped in coverage policy, that is one of the interview’s more consequential arguments: ambiguity is frustrating, but some ambiguity may be the price of adaptability.
Her skepticism toward reimbursement legislation follows the same logic. Jensen does not dismiss legislative reform reflexively; she worries about implementability. She cites prior statutory efforts that failed because Congress wrote requirements CMS could not realistically operationalize. In the current debate over accelerated coverage concepts, her concern is that proposals can place the entire burden on government—pay first, sort out the evidence later—without symmetrical obligations on manufacturers to produce meaningful Medicare-relevant endpoints within a defined period. For Jensen, temporary coverage without credible downstream accountability is not a bridge but a drift state. That argument will resonate with readers who have watched enthusiasm for transitional coverage repeatedly collide with evidence generation problems in the real world.
The same realism shapes her criticism of parallel review. She does not dispute the idea; she disputes the physics. Early FDA-CMS collaboration is good, she says, but true parallelism is extraordinarily difficult when CDRH operates at a vastly different scale and under rigid review timelines while CMS coverage staff are far smaller in number and are trying to assess Medicare-specific value, not just safety and effectiveness. In one of the interview’s starkest operational details, she notes that the Coverage and Analysis Group had about 30 people, with only around 10 writing NCDs. For experts accustomed to discussing “alignment” at the policy level, this is the grounding reminder: some reimbursement problems are not conceptual failures but capacity mismatches.
What gives the episode extra relevance is timing. Syrek Jensen now speaks from outside government, having recently joined Rubrum Consulting, led by former CMS chief medical officer Lee Fleisher, and that shift gives her remarks both freedom and consequence. She is no longer explaining CMS from behind the seal; she is translating it from just beyond the door. The result is not a manifesto and not a grievance session. It is something rarer: a high-level reimbursement practitioner explaining that the system’s biggest problems are real, that many are structural, and that progress will depend less on rhetorical demands for “faster CMS” than on earlier evidence planning, more honest cross-agency engagement, and a better grasp of what Medicare is actually being asked to buy.
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Her Background
She describes her path as “organic” rather than planned. In her telling, she was a fun-loving undergraduate who later “grew up” and got serious. Her first job after college was on Capitol Hill, where she worked in policy; her boss sat on Ways and Means, which exposed her early to the legislative side of CMS and Medicare. From there, she decided to pursue law, but did it the hard way: she worked at CMS while attending law school at night.
Inside CMS, she says she then rose through a series of roles rather than following a master plan. She started as an analyst on conditions of participation, moved into a special assistant role for the Chief Medical Officer, gained a broad view of the agency, and eventually landed in the Coverage and Analysis Group, where she later became its leader. She also emphasizes the importance of informal mentors who guided her along the way.
The Most Surprising Three Remarks
1. Her direct statement that parallel review essentially “doesn’t work” in practice.
That is striking because parallel review is often discussed as a high-level policy solution, but she reduced it to operational reality: FDA’s device center has thousands of staff, while the Coverage and Analysis Group had about 30 people, with only about 10 writing NCDs. She said the idea is good, but the timing and staffing mismatch make true parallel review extremely hard to execute.
2. Her unusually candid admission that anti-industry bias at CMS was real — and that she herself probably had some of it.
Former officials almost never say that so plainly. She added that a major source of mistrust was when manufacturers told CMS one thing and FDA another, and she framed honesty as the key condition for productive engagement. That was a notably direct acknowledgment from a former top CMS coverage official.
3. Her remark that the “four years” in the accelerated-coverage style legislation was basically “a random number we made up.”
That is a remarkable thing to say out loud. More broadly, she argued that if government is required to cover a technology for four years, industry must carry a real burden to generate evidence, with consequences if it fails. That cuts against any simplistic “coverage first, evidence later” narrative.
Honorable mention: her blunt line that “the claim system is a yes system.” That is a very revealing description of why CMS is drawn to prepayment integrity tools like Wiser.
