"Last week, CMS and the FDA announced coordinated efforts to widen access to technology-enabled care for Medicare beneficiaries with certain chronic conditions." (Orrick)
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CMS and FDA uaveiled separate but coordinated efforts last week, to catalyze advanced informatics applied to everyday health care. The ACCESS program will support use of such services, like remote physiological monitoring, by paying for improvements in clinical outcomes like weight and blood pressure.
The TEMPO program will provide structured and monitored waivers to certain kinds of e-health technologies, in particular in the context of the Medicare ACCESS program.
You can google 50 news articles in a second, but here are three law firm-based reviews I found helpful. Further below, I use AI to summarize a 70-minute panel, and, to investigate how the CMS press release about the panel, differed from the actual transcript of the panel.
JD SUPRA - MCDERMOTT
Jeffrey Davis reviews the two programs.
https://www.jdsupra.com/legalnews/access-tempo-the-2-door-entryway-to-1472276/
At ORRICK, another joint review of ACCESS and TEMPO. By Joseph, Ravitz, Sherer, and Johson (the author list itself sounds like a law firm...)
https://www.orrick.com/en/Insights/2025/12/CMS-and-FDA-Announce-Initiatives-to-Expand-Access-to-Digital-Health-Technologies
At Hyman Phelps, see an article by Jennifer Newberger on ACCESS and TEMPO:
https://www.thefdalawblog.com/2025/12/you-better-move-fast-acess-to-tempo/
MedTechDive also reviews ACCESS and TEMPO together on December 10:
https://www.medtechdive.com/news/fda-digital-health-pilot-cms-tempo/807374/
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For an original CMS document, see the CMS newsroom, December 5, writing;
Readout: CMS Convenes Leaders Across Government, Clinician Societies, Digital Health Industry to Discuss Innovation Center ACCESS Model
https://www.cms.gov/newsroom/press-releases/readout-cms-convenes-leaders-across-government-clinician-societies-digital-health-industry-discuss
See a one-hour video of the panelists:
https://www.youtube.com/watch?v=vM1guSugkQU
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Finally, see an entirely separate but also very innovative program, MAHA ELEVATE, discussed in detail by Trey Rawles here.
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AI CORNER
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Chat GPT 5.2 summarizes the YouTube video. Then, it compares the original video with the CMS press release about the meeting.
What the panel actually did (vs. the press-release version)
The 70-minute event was essentially a three-leg argument for a coordinated CMS+FDA “on-ramp” for digital, technology-enabled chronic care in Original Medicare:
Infrastructure (Health Tech Ecosystem: interoperability, identity, provider directory)
Payment (CMMI ACCESS: outcome-aligned payments; “pay for improvement/control, not app usage”)
Regulatory sandbox (FDA TEMPO: time-bounded enforcement discretion + structured real-world data capture)
What made it interesting for experts is the way speakers repeatedly framed the problem as not “we lack tech,” but we lack (a) scalable payment rails and (b) regulatory clarity for tools that operate between traditional visit-based medicine and continuously measured home-life medicine.
1) Amy Gleason: the “Ecosystem” pitch is about trust infrastructure, not just APIs
Gleason’s segment is less about ACCESS than about CMS trying to finish the last 20% of interoperability that regulation hasn’t delivered: “it should work on paper” but doesn’t in real workflows. Her “sticky” focus was trust:
National Provider Directory as routing infrastructure (apps know where to query).
Modern digital identity (medicare.gov identity layer; “trust that the person asking is who they say they are”).
The rhetorical “47 patient portals” anecdote is doing policy work: it reframes interoperability as consumer experience failure, not vendor compliance.
The important subtext: CMS is positioning itself as an enabler of an app ecosystem (patient-chosen apps, QR/smart health cards, conversational AI layer) rather than a single CMS-owned solution. It’s “voluntary, fast, months not years,” with “pledges” and working groups—a deliberate contrast with the historically slow regulatory path.
2) Dr. Oz: ACCESS as a cost-curve play with a “make it a business” posture
Oz makes two notable policy claims:
The macro problem is health spending growing ~8–9% vs GDP, and he links that to information/transparency and patient empowerment (market-like behavior).
He explicitly says CMS wants innovators to make money building solutions—but only if outcomes move. This is unusually direct language in a CMS forum.
He then sketches ACCESS as a 10-year voluntary model providing an “on-ramp” for digital health in Original Medicare, explicitly tying it to rural policy and workforce scarcity. The subtext: ACCESS is being sold as Medicare modernization and as an industrial policy lever (“open for business”), while still needing OACT-friendly “savings” logic.
3) Jim O’Neill: HHS AI Strategy 1.0 + “regulatory clarity” + data visibility
O’Neill’s remarks are the clearest “whole-of-HHS” frame:
Internal AI adoption: custom LLM(s) deployed to 65,000 employees, explicitly framed as productivity and speed (fraud, claims adjudication, grant reviews, FDA review acceleration).
External vision: three pillars—reimbursement pathways, regulatory clarity, and R&D targeting.
His most pointed (and controversial) line for experts is the claim that a “key pillar” is visibility into de-identified patient data for payers/patients/providers to create a continuous improvement feedback loop. That’s a strong signal about real-world data as policy infrastructure, and it implicitly nudges debates about governance, consent, and secondary use.
He also explicitly name-checks TEMPO before FDA speaks, making clear it’s meant to be fast access + controlled learning.
4) ACCESS model mechanics (Jacob Shiff): outcome-aligned payments + referral rails + public outcomes
Shiff’s 10 minutes are the “operational kernel,” and there are a few design choices experts will notice:
Outcome-aligned payment: predictable payments with full earn-out when patients improve relative to baseline (BP, pain symptoms, etc.).
Tracks: grouped conditions for integrated care (signals intent to avoid “one app per diagnosis” fragmentation).
Care modality flexibility: virtual/asynchronous/in-person—explicit anti-micromanagement stance (“not micromanaging practice of medicine”).
Cost sharing: participants may collect or forego beneficiary cost-sharing (a lever to reduce friction; also a potential competitive variable).
Provider/supplier enrollment + HIPAA covered entity + clinical director: a “we’re not letting fly-by-night apps bill Medicare” posture.
Referral + co-management payment: referring clinicians can refer without 1:1 contracting; there’s a new co-management payment (no beneficiary cost sharing) for documented review/coordination. This is a practical attempt to avoid the classic failure mode: “specialty digital program runs parallel to primary care and nobody gets paid to integrate it.”
Big signal: CMS intends to maintain a directory of participants including risk-adjusted outcomes. That’s not just payment; it’s a market-making transparency tool (and it tees up methodological fights about risk adjustment, gaming, and measure selection).
He also claims demand: 250+ tech-enabled organizations submitted intent-to-apply within ~2–3 days. Whether that holds up is a later question, but it’s being used to argue “the ecosystem is ready.”
5) The society panel: it’s about workforce, data usability, and measurement sanity
This panel (AMA, ACC, APA) is less “rah rah digital” than “here’s where digital fails in clinic.” Three threads dominated:
A. Burnout is not only paperwork; it’s data overload + low-value measurement
AMA’s Whyte: clinicians don’t need “more data,” they need better data (continuous, personalized, outcome-linked). He also warns against being held accountable for outcomes clinicians can’t plausibly influence (food insecurity example).
B. Behavioral health: outcomes are “hard,” but we already have usable proxies
APA’s Trestman: acknowledges no biological equivalent of A1c yet, but argues that consistent use of PHQ-9 / GAD-7 can operationalize outcomes and—crucially—motivate patients when they see trend lines. He frames this as measurement-informed care that empowers patients, not just reporting burden.
C. Cardiology: the bottleneck isn’t biomarkers; it’s scaling programs into low-margin/rural systems
ACC’s Bhatt: home BP monitoring programs work, but don’t scale due to payment + implementation costs, especially in net-zero margin settings. She emphasizes “baseline” and personalization (your normal vs population normal), and repeatedly ties ACCESS to “creating a mechanism” to collect data and intervene where there’s currently zero access.
Notable “flash round” moment:
Whyte picks sleep as the under-measured outcome that matters and is increasingly measurable via wearables—but immediately ties it to the practical chain: fidelity → reimbursement → EHR integration → payer acceptance. That’s a neat encapsulation of the “payment/regulatory rails” theme.
Bhatt wants a metric for “patient feels like a partner in care” (not mere engagement). That’s conceptually important because ACCESS is outcome-aligned, but the panel is warning that relationships and agency are key mediators—hard to capture, easy to ignore, and easy to accidentally harm with poorly designed incentives.
Trestman says the key isn’t a new measure; it’s turning data into usable, integrated information at point of care.
The panel’s “success state” predictions converge: more care shifts to home/ambulatory, clinicians get time back, and patients feel “seen.”
6) TEMPO (FDA): the genuinely novel piece—enforcement discretion + real-world data under ACCESS
Traficant’s TEMPO description is the sharpest new policy mechanism in the event:
For certain digital health devices that would typically require FDA premarket authorization but don’t yet have it, TEMPO allows manufacturers to request FDA enforcement discretion when deployed within ACCESS, under a risk mitigation + monitoring + reporting plan negotiated with FDA.
ACCESS becomes a controlled deployment environment that generates real-world performance data that may support future FDA marketing authorization.
Requires enhanced consent: beneficiaries are told it’s an FDA pilot and that certain data will be shared with FDA (within privacy/security standards).
In plain English: TEMPO is a regulatory sandbox tightly coupled to a CMS payment model, with RWE as the bridge. For experts, the questions this tees up are immediate: scope (which devices), boundary conditions on “discretion,” what data is “ordinarily reported” vs incremental TEMPO data, and how consent + governance will be operationalized at scale.
The through-line: ACCESS is a payment model; TEMPO is an RWE-enabled regulatory ramp; the Ecosystem is the trust plumbing
The event’s key move is that CMS and FDA are trying to make digital chronic care in Original Medicare legible and financeable while keeping a safety narrative:
Outcome-aligned reimbursement to avoid “paying for churn.”
Transparency (risk-adjusted outcomes) to foster competition and referrals.
Regulatory discretion under monitored conditions to speed access without pretending safety review is optional.
If you want, I can also produce a second version as (a) a one-page “expert memo” with policy implications + likely implementation failure modes, or (b) a short set of “watch items” (e.g., measure selection/risk adjustment, consent + data governance, how co-management payments interact with existing RPM/CCM, and what kinds of devices TEMPO will actually include).
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What do you see in the whole 70 minute video, that isn't summarized in the CMS press release about the video.
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The CMS press release is a tight, curated “what happened + what it is” summary; the 70-minute panel is the operating logic, governance posture, and (importantly) the frictions that the press release deliberately smooths over.
What the press release does (and why it feels “about the same”)
It’s basically a single narrative arc:
That’s it: announce, legitimate, de-risk, invite. It’s not trying to teach anyone how this will behave in the wild.
What the panel adds that the press release largely omits
The panel isn’t just longer—it contains different types of information:
1) The “platform” backstory (Health Tech Ecosystem)
In the panel, ACCESS is positioned as the payment engine for a broader digital plumbing agenda (interoperability infrastructure, patient-facing ecosystem). The press release only gestures at “modernizing the digital health ecosystem.” (Centers for Medicare & Medicaid Services)
2) Implementation mechanics (how ACCESS actually functions)
The panel version (and the supporting CMS model materials) gets into what sophisticated readers care about:
The press release stays at the “model exists” layer. (Centers for Medicare & Medicaid Services)
3) The measurement politics (what counts as an “outcome,” and what clinicians will tolerate)
The society panel spends real time on: data quality vs data volume, clinician burnout from measurement, behavioral health measurement pragmatics (PHQ-9/GAD-7 style tools), and even “what outcome we wish we could measure” (e.g., sleep as a health signal; “patient-as-partner” sentiment).
None of that appears in the press release because it’s not message discipline—it’s the actual tension that will shape uptake.
4) The regulatory posture is more candid (TEMPO as a sandbox)
The press release: “FDA discussed TEMPO…collecting, monitoring, reporting real-world performance data.” (Centers for Medicare & Medicaid Services)
The panel (and FDA’s own release / CMS FAQ): TEMPO is explicitly a risk-based enforcement discretion pathway for certain digital health devices that would typically require premarket authorization, paired with real-world data generation and enhanced consent in a controlled context. (U.S. Food and Drug Administration)
That’s a materially different “feel”: not just coordination, but a deliberately engineered regulatory/payment coupled experiment.
The practical punchline
If you’re an engaged expert, the press release tells you what CMS wants the world to repeat.
The panel tells you how CMS/HHS/FDA think this will work, where the adoption bottlenecks are (measurement burden, data integration, rural capacity, workforce constraints), and what their regulatory/payment theory of change is—i.e., how ACCESS + TEMPO is supposed to create an evidence-generating flywheel rather than a one-off demo. (Centers for Medicare & Medicaid Services)
