The concept of "innovative technology" is a constantly moving target. Today, technologies become more advanced at an increasingly faster rate while the threat of becoming obsolete is exacerbated with new technology that comes to market. This is especially true within the MedTech industry, where innovation can significantly impact patients' lives.

As the definition of what makes a device truly unique, novel, and innovative continuously shifts, so too does the approach to laying out a pathway for providing reimbursement. How should products be evaluated in this context? What do manufacturers of today's medical technologies need to prove to be deemed worthy of receiving reimbursement?

These are questions that are becoming more challenging to answer as more devices come to market — difficult enough to the extent that even the Centers for Medicare & Medicaid Services (CMS) remains unsure of how to address the status of these devices entirely. After expressing concerns that covered devices were potentially receiving their coverage without maintaining adequate evidence that their benefits exceeded related risks to Medicare patients, CMS repealed its previous Medicare Coverage of Innovative Technology (MCIT) program in November 2021 after months of deliberation.¹

In place of the MCIT program is the newly proposed Transitional Coverage for Emerging Technologies (TCET) program; a pathway to payment that CMS introduced in June 2023² with the intention of balancing multiple considerations when making coverage determinations (including facilitating access to technologies earlier and more safely, reducing uncertainty about coverage through earlier evaluation of technologies, and encouraging manufacturers to produce better evidence development of data if evidence gaps are found to exist). There’s also a legislative bill that's currently working its way through the Congress and Senate, which resembles the MCIT program.

Manufacturers of innovative technologies that have strong alignment with Medicare or beneficiaries of Medicare should already be preparing for potential reimbursement connected through either the MCIT or TCET programs as CMS protocols become finalized.

There’s legitimate confusion surrounding both MCIT and TCET legislation. However, there’s also a significant advantage to understanding each program enough to simply consider reimbursement – even if it's for temporary coverage – if maximum and legitimate reimbursement is going to be attained. Now is the time for all stakeholders to understand the current developments for novel device market access through these pathways.

An evolving pathway to reimbursement

Nearly two decades have passed since the initial ideas about providing accelerated coverage and reimbursement for new, novel, and disruptive medical technologies have been brought to the table. These thoughts have undergone various stages of iterations and have resulted in a lot of “alphabet soup” in terms of acronyms, but most of the planning has resembled some form of the MCIT and TCET programs.

The overarching similarities to Medicare coverage for innovative emerging technologies is that there are going to be formal statutory mechanisms that ensure patients are eligible for new medical devices or diagnostics that come to market and that they have access to them during the initial years without major out-of-pocket costs, even though the normal trajectory is that manufacturers must generate compelling evidence before any technologies are formally covered.

When comparing the prospects of TCET to the intentions of MCIT, there are five key elements that differentiate the two programs:

1. CMS officials are proposing that if TCET becomes a formal program, it would only apply to breakthrough technologies – including certain devices, diagnostics, and digital interventions – that are designated within specific Medicare benefit categories. However, the expectation is that the vast majority of products that would come to market would be eligible.

2. There’s no automatic enrollment into the TCET program. It will be the individual responsibility of each manufacturer to attain approval by the Food & Drug Administration (FDA) and then to contact Medicare to participate in the program.

3. CMS officials have said that they may conduct an evidence review to evaluate any new device technologies after they’ve received FDA clearance to determine if they are clinically beneficial for patients to warrant reimbursement coverage.

4. Prior to regulatory approval, manufacturers can connect with CMS to discuss any potential evidence gaps (such as those related to study design, the types of patients who are enrolled, or the magnitude of outcomes being measured) to preemptively address concerns before products reach the market.

5. When the MCIT program was originally conceived, there was discussion about how manufacturers could acquire temporary coverage after regulatory approval while an evaluation occurred to determine whether to award permanent coverage. The TCET program will, however, reportedly create a uniform coverage policy for Medicare patients and other Medicare-eligible recipients about how products (or a group of products) and services will be covered long term. For manufacturers that are adequately positioned, this approach establishes a road map for what’s needed related to commercialization to ensure that the product continues to be covered and reimbursed.

Implications of likely legislative next steps

It appears that the legislative and administrative interest in the TCET program is much stronger than these matters have been in the past. Today’s manufacturers will be best served by preparing themselves as if the most restrictive and onerous of any proposals will be those that make it to market.

Pragmatically, manufacturers should assume that the TCET framework will cause everyone to think more critically about the potential value of enrolling any product or technology into the program and to place more emphasis on post-market evidence development.

With very few exceptions, most of today’s breakthrough devices and technologies are not fully articulated technologies at the time that they’re developed, regardless of how innovative they might project to be given their potential to benefit patients and providers. As such, manufacturers are often relying on good faith efforts to develop the best evidence to prove therapeutic benefits for today’s Medicare patients.

Proactive evaluation of devices and technologies is something that all manufacturers are strongly encouraged to invest in moving forward. Contact IQVIA MedTech to learn more about how we can partner with you to navigate your market access journey.

Look for our second entry in this series, as we discuss critical precommercial implications of TCET-MCIT with our colleagues from IQVIA’s Regulatory Strategy team.

References

1. CMS Newsroom. CMS Repeals MCIT/R&N Rule; Will Consider Other Coverage Pathways to Enhance Access to Innovative Medical Devices. 2021. Accessed online: https://www.cms.gov/newsroom/press-releases/cms-repeals-mcitrn-rule-will-consider-other-coverage-pathways-enhance-access-innovative-medical

2. CMS Newsroom. Notice with Comment - Transitional Coverage for Emerging Technologies (CMS-3421-NC). 2023. Accessed online: https://www.cms.gov/newsroom/fact-sheets/notice-comment-transitional-coverage-emerging-technologies-cms-3421-nc#:~:text=The%20TCET%20pathway%20is%20intended,potential%20benefits%20and%20harms%20of