Healthcare has never had a shortage of ideas.
What it lacks is alignment.
For years, teams built strong digital tools, clinicians wanted better ways to support patients, and regulators focused on safety – but reimbursement, regulation, and real-world use rarely moved together.
The recent launch of CMS ACCESS and FDA TEMPO is one of the clearest signs yet that this is beginning to change.
Get the latest news about MedTech and SaMD from our experts.
ACCESS - CMS finally designs payment around how chronic care really works
ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) is a CMS Innovation Center model focused on people living with chronic conditions.
It starts from a simple reality:
Chronic care is continuous. It does not fit into short, episodic encounters.
Instead of mainly paying for visits or procedures, ACCESS provides recurring payments to care organizations that take responsibility for managing chronic conditions over time. Payments are tied to whether patients actually improve, not how many services were delivered.
What ACCESS changes in practice:
- Care teams are incentivized to stay engaged with patients between visits
- Preventive action is rewarded, not just reacting to problems
- Digital tools are expected to be part of care delivery, not optional extras
ACCESS is voluntary and runs for many years, which matters. It gives organizations time to build, test, adjust, and mature care models without the pressure of short pilots that end just as they start working.
Most importantly, ACCESS puts accountability where it belongs: on outcomes.
TEMPO - FDA opens a smarter door to real-world use
Shortly after ACCESS, the FDA introduced TEMPO (Technology-Enabled Meaningful Patient Outcomes).
TEMPO exists because the FDA recognizes a real issue:
- Digital health tools do not learn best in labs or artificial pilots. They learn in real care, with real patients.
Under TEMPO, selected digital health devices can be used within the ACCESS model even if they are not yet fully FDA-cleared – under strict oversight and enforcement discretion.
What TEMPO is (and is not):
- It is not deregulation
- It is not skipping FDA review
- It is a controlled pathway to gather real-world evidence earlier
Manufacturers participating in TEMPO must collect and share data on safety, performance, and patient outcomes. That data is meant to support future regulatory decisions while patients benefit sooner.
This is a major shift in mindset:
Evidence is not delayed until after adoption. Evidence is generated during adoption.
Why FDA ACCESS and CMS TEMPO together actually work
ACCESS solves one half of the problem: reimbursement.
TEMPO solves another: timing and evidence generation.
Together they create a loop:
- ACCESS creates demand for meaningful, tech-enabled chronic care
- TEMPO allows appropriate tools to be used while learning from real-world use
- Real-world data flows back into regulatory and clinical decision-making
This is a major shift in mindset:
Evidence is not delayed until after adoption. Evidence is generated during adoption.
This is especially important for chronic conditions where:
- Progress is slow and incremental
- Engagement matters just as much as intervention
- Outcomes only make sense when measured over time
How different groups can benefit - in very practical terms
For care organizations and providers
This is a chance to redesign how chronic care is delivered.
To benefit from ACCESS:
- Build care models that extend beyond the clinic
- Invest in systems that track outcomes consistently
- Partner with digital health vendors that support daily patient engagement
ACCESS rewards teams that prevent deterioration, catch issues early, and support patients continuously. It favors thoughtful care design over high throughput.
Get the latest news about MedTech and SaMD from our experts.
For digital health and MedTech companies
TEMPO + ACCESS may be one of the most realistic paths to scale in Medicare without waiting years.
To benefit:
- Focus on chronic conditions prioritized by ACCESS
- Design products that clearly improve measurable outcomes
- Prepare to collect real-world safety and performance data from day one
This is not the place for “nice-to-have” apps. Tools need to show real clinical and operational value in everyday use.
Companies that succeed here will not only gain evidence, but credibility.
For founders and product teams
This is a moment to rethink roadmaps.
Instead of:
- “Let’s get cleared first, then worry about reimbursement”
The mindset becomes:
- “Let’s design for outcomes, evidence, and reimbursement together”
Teams that align regulatory strategy, reimbursement logic, and product design early will be far better positioned than those treating these as separate workstreams.
For patients
This shift matters most for them.
ACCESS and TEMPO together mean:
- Support outside the clinic
- Care that adapts as life changes
- Tools that help day to day, not just during appointments
It moves healthcare closer to how people actually live.
What to do now if you want to be ready
This is not something to react to in two years.
Steps that make sense now:
- Map how your solution or care model fits outcome-based payment
- Identify what real-world data you can capture reliably
- Strengthen clinical, regulatory, and data collaboration early
- Design for long-term engagement, not short pilots
ACCESS and TEMPO favor teams that are prepared, not rushed.
Why this moment is bigger than two programs
Regulators and payers rarely move in lockstep.
This time, they did.
ACCESS and TEMPO signal something important:
Healthcare is starting to reward solutions that work in real life, over time, for real people.
That doesn’t lower the bar.
It finally aligns it with reality.
If you care about chronic care, digital health, or how innovation truly reaches patients, this is not just policy news.
It’s a structural shift worth understanding – and using wisely.