Medical devices are something of an orphan sister to the glamour of drugs, but they include some of the genuine miracles of modern medicine, particularly for seniors: Pacemakers, artificial joints, insulin pumps, and CT, MRI, and radiotherapy machines are just a few examples. The United States is currently the global leader in medical device innovation, and it is one of the few major industries that both boasts a net trade surplus and is a job creator. The sector employs 400,000 Americans directly and is indirectly responsible for almost 2 million more that supply and support the highly skilled workforce.
On Jan. 12, in the waning days of the Trump administration, the federal Centers for Medicare & Medicaid Services (CMS) announced a new coverage pathway, the Medicare Coverage of Innovative Technology (MCIT) initiative, for FDA-designated "breakthrough" medical devices. The initiative would provide national Medicare coverage immediately when the FDA authorizes marketing of breakthrough medical devices, making it easier for seniors who are covered by Medicare to get access to critical products that meet the definition:
A breakthrough device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition and must also meet at least one part of a second criterion, such as by being a 'breakthrough technology; or offering a treatment option when no other cleared or approved alternatives exist.
The most recent device to receive this designation is a headband that treats chronic vertigo by applying localized mechanical stimulation to the inner ear.
That new coverage pathway is both good medicine and good business. However, the policy, once hailed as a "significant" tailwind for the medical device industry and which was supposed to take effect on March 17, has been delayed by the Biden administration's CMS, at least until December. The announcement of the delay expressed concerns that MCIT "could be problematic in ensuring these devices are demonstrating value and do not have additional risks for Medicare beneficiaries."
But CMS' explanation is troubling. The first of those concerns is customarily resolved by physicians and their patients, while the second is addressed by the FDA's rigorous review and approval process. By definition, breakthrough devices address unmet medical needs.
The delay in the MCIT rule, and the possibility that it could even be completely rescinded in the coming weeks or months, threatens access to breakthrough medical treatments our seniors need.
Seniors with chronic conditions are some of the most vulnerable members of society. Many of them rely solely on Medicare to cover their health care costs, while some Medicare beneficiaries also qualify for coverage through Medicaid. In either case, the wait for breakthrough technologies can last years. Only seniors with supplemental or private health insurance, or those willing and able to pay out of pocket, can access these technologies.
Approving and adopting the MCIT would make a life-changing difference for millions of seniors whose illnesses could be better managed if Medicare covered medical devices used for important new treatments and diagnostics at an earlier point in time.
New medical technologies that receive breakthrough designation must still undergo the FDA's rigorous review process, the global gold standard for medical-device safety and efficacy. The MCIT rule would make these technologies available sooner once they are approved by the FDA. The coverage would be temporary (four years), allowing time for CMS to collect real-world data to understand the impacts of the potentially critical technologies on patients.
Seniors deserve to have access to the best treatments that could help to improve and prolong their lives, and the MCIT would be a life-altering policy change for many. Sound public policy with bipartisan congressional support would promote innovation and streamline access to critical technologies for patients with no other alternatives. We need it now.
Henry Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was a research associate at the National Institutes for Health and the founding director of the FDA's Office of Biotechnology. Erik Paulsen represented Minnesota's 3rd Congressional District in the U.S. House of Representatives from 2009 to 2019 and currently serves as a strategic consultant for Total Spectrum and on the board of Cardiovascular Systems Inc.