When speaking last month at the White House, Oracle founder Larry Ellison said that the newly announced ‘Stargate’ – an artificial intelligence infrastructure project – will pave the way to the United States developing a ‘cancer vaccine.” Well, as my grandmother used to say, “From his mouth to God’s ears.”
In the past, such advances have led our country to longer, healthier lives, to save premature babies, and irradicate devastating diseases. Innovators should be rewarded for propelling the future of care and treatment options for the millions of Americans. Instead, the unfortunate reality is that innovators now stand to be punished due to outdated policies governing Medicare administered by third party middlemen with financial incentive to deny access to innovative diagnostic testing.
Crucially, finding a way to eradicate cancers, one of our planet’s most devastating diseases, will be in vain without advancements in diagnostic testing. However, this comes with an urgent caveat -- this future will not be fulfilled if healthcare middlemen continue to have their way.
The 68 million Americans covered by Medicare (including me) have their claims processed by private insurers known as Medicare Administrative Contractors (MACs). Last month, two of those MACs – Novitas Solutions and First Coast Service Options (FCSO) – issued a Local Coverage Determination (LCD) which ended the coverage of nine groundbreaking cancer diagnostic tests. It’s a warning shot across the bow to precision medicine and investment in innovation.
These decisions must not stand. Early detection is a critical step of prevention, especially for cancer patients. Tests like these allow doctors to intervene and understand their patients’ care far earlier into their diagnosis, enabling them to develop more personalized and cost-efficient treatment plans that, most importantly, improve outcomes. When such care is delayed or inaccessible, there are often greater problems associated with treatment, such as more intensive intervention options like biopsies or radiation therapy or potentially missed and undertreated disease. This comes alongside higher costs of care and, unsettlingly, a lower chance of survival.
There also must be high alert for “regulatory mission creep.” That’s why the 21st Century Cures Act included additional guidelines on the MACs’ LCD process and determination timeline. MACs delaying their decision and blatantly diverting from the Cures Act is a flagrant breaking of the law that has become the norm for MACs – not an exception – and certainly not an exemption.
Cancer patients are not the only ones negatively impacted by these actions. In 2023, the MAC Palmetto GBA, published an article to the CMS website, changing the coverage of two tests for organ transplant patients --one of which could predict rejection problems with transplanted organs weeks or even months ahead of clinical signs of damage.
Luckily, CMS stepped in and coverage for the blood tests was restored. That was not without struggle and hardships for patients and their loved ones. In the process, it also came to light that the MAC ignored the recommendations of medical experts when making the decision to deny coverage.
The bad news is that CMS is limiting access to cutting-edge diagnostics for those on Medicare. This negligence is unacceptable. It is regulatory malpractice. CMS and MACs must be held accountable and reduce uncertainty for patients, healthcare providers, and innovators alike instead of allowing critical coverage decisions to cause greater uncertainty in the future of American healthcare. Additional Congressional oversight should push CMS and their MAC henchmen to reexamine their coverage decisions that impact seniors’ access to novel healthcare and increase taxpayer burden.
If we are to more fully and rapidly realize a world where we can detect cancer, organ failure, and a host of diseases before they occur, we must establish the foundations and incentives to develop testing and treatments. This is the goal of Mr. Ellison’s Stargate initiative – and it is one worth pursuing aggressively.
Peter J. Pitts is president and co-founder of the Center for Medicine in the Public Interest and a former associate commissioner of the U.S. Food and Drug Administration.
