In a recent interview, Food and Drug Administration Commissioner Marty Makary declared that Medicare should automatically cover FDA-designated breakthrough devices — a rare and refreshing commonsense reform in a health care system riddled with red tape and inefficiency. Aligning reimbursement with FDA approvals will allow for better patient care by unlocking faster access to lifesaving treatments, unleash private-sector innovation, and help lower long-term costs.
It’s no secret that the U.S. needs a more efficient, market-responsive health care system, and Makary’s suggestion offers a simple and effective way out. The only flaw is that his proposal doesn’t go far enough. If the FDA has thoroughly reviewed and approved a medical treatment or device as safe and effective, then Medicare should reimburse for it.
Right now, the Centers for Medicare and Medicaid Services often withholds coverage for reimbursement long after a device or treatment has cleared FDA approval — some of the most rigorous regulatory hurdles in the world. This delay disrupts the natural flow of the market by discouraging private investment and hindering access to proven technologies. Though this process is rooted in an effort to control short-term costs, in practice, it contributes to higher long-term spending through avoidable complications and repeat procedures.
The crisis is made worse by its proliferation. Private insurers look to CMS for guidance. And when CMS drags its feet, the private market tends to follow. The result: patients, providers and entrepreneurs left in limbo — and a distorted market that discourages exactly the kind of innovations in which we should be investing.
There is no shortage of compelling examples that underscore the consequences of this flawed approach, spanning everything from surgical innovation to transformative pharmaceuticals.
Take ConMed’s BioBrace, a collagen-based bioinductive implant designed to reinforce soft tissue following orthopedic procedures such as rotator cuff, ACL, and Achilles repairs and/or reconstructions. Clinical studies demonstrate that it significantly reduces re-tear rates and supports more durable recoveries.
Yet despite FDA clearance and strong clinical validation, CMS has not issued a dedicated reimbursement code for this technology, resulting in inconsistent coverage. CMS typically considers such devices to be covered under existing bundled codes, making separate reimbursement difficult to obtain. The perverse outcome? Surgeons are discouraged from using a device that measurably improves outcomes, simply because its use may be unprofitable for a hospital or ambulatory surgical center. Because some surgeons have ownership or equity stakes, they may avoid using products without separate reimbursement since they are financially disincentivized, and as a result, patient care — which should be the system’s foremost concern — is too often compromised.
Theradaptive, a biotechnology firm born out of research at the Walter Reed Army Institute of Research, could serve as a model for a better approach. Its platform delivers regenerative proteins directly into bone and tissue defects — a stark improvement over systemic biologics that can cause off-target side effects. Their breakthrough device OsteoAdapt has earned three FDA Breakthrough Device designations and secured Defense Department support for human trials to repair spinal and trauma-related injuries. This technology holds immense promise for complex reconstructive surgeries, particularly for veterans and trauma patients. It is covered by CMS under its Category B designation, allowing it to be leveraged for complex reconstructive surgeries, which can be particularly transformative for veterans and trauma patients. This could serve as a model for other devices: Once a company has a category B designation, they can receive automatic coverage after approval, streamlining the process.
The issue of coverage has been especially widely felt with the recent surge in demand for GLP-1 medications like Wegovy and Ozempic. Initially approved for diabetes, these drugs have demonstrated powerful benefits for cardiovascular health and obesity-related conditions yet still face significant coverage barriers. Despite an FDA expansion in March 2024 that allows Wegovy to reduce major adverse cardiovascular events in overweight or obese adults, CMS still refuses to cover them for weight loss. Under the finalized 2026 Medicare Part D rule, GLP-1s remain reimbursable only for diabetes — not for obesity — leaving an estimated 7.5 million beneficiaries locked out. Yet numerous studies show that covering these drugs for their proven weight loss potential could stave off downstream spending of billions in avoidable future care such as heart attack, stroke, or diabetes complications.
This kind of bureaucratic inertia hurts everyone. Skimping on cutting-edge treatments today leads to more expensive consequences tomorrow: complications, re-operations, emergency care, and long-term disability. It’s penny wise, pound foolish, and worst of all, the American taxpayer ultimately foots the bill.
Beyond the dollars, there’s a bigger principle at stake: When the government micromanages access to innovation, the market breaks down. Investors hesitate to fund companies with unclear reimbursement prospects. Entrepreneurs are forced to shift focus away from high-need populations. Patients wait — or go without. And once again, Washington ends up being the bottleneck to progress.
Aligning CMS reimbursement with FDA approvals won’t fix the health care model. But it would begin to reintroduce predictability and practicality into a system that has for too long been short on both. Particularly when it comes to breakthrough technologies and treatments, this move would give private-sector innovators the confidence to invest, create a clearer path to market, and allow doctors and patients to make treatment decisions based on clinical need, not payment models.
It’s long past time for policymakers to recognize that innovation is not a cost center — it’s a cost saver. Let the market work. Let private capital flow. Let surgeons deliver on their promise to provide patients with the best possible care. And most importantly, let patients benefit from the incredible outcomes American medicine is already capable of delivering.
Steve Forbes is chairman and editor-in-chief of Forbes Media.
Correction: This essay has been updated to clarify OsteoAdapt’s CMS coverage status under its Category B designation.
Source: Steve Forbes: CMS must cover FDA-approved medical devices and treatments
