OPINION:
President Trump’s new administration has the opportunity to address a critical but little-known aspect of our country’s health care system: Medicare Administrative Contractors, which are restricting access to critical diagnostic testing for cancer patients.
Most Americans are familiar with insurers such as Blue Cross Blue Shield or United Healthcare. Less familiar are MACs, a network of private health care insurers contracted by the Centers for Medicare and Medicaid Services to act as intermediaries between health care providers and Medicare beneficiaries.
During my tenure as surgeon general of the United States, we realized that our nation’s health insurance program needed desperate reform. Thanks to President Bush’s leadership, we embarked on an administrativewide effort to overhaul Medicare for the first time in the program’s history.
Ultimately, we were successful. The passage of the Medicare Prescription Drug, Improvement and Modernization Act set into motion the greatest advancement in health care coverage for America’s senior citizens. This included creating the MAC system to improve claim processing.
At the time, President Bush said, “With this law, we are providing more access to comprehensive exams, disease screenings and other preventative care so that seniors across this land can live better and healthier lives.”
He was right. Since then, MACs have processed millions of claims, ensured Medicare dollars are spent appropriately and safeguarded the compliance of Medicare regulations. However, more attention is needed to the far-ranging implications of coverage determinations made by MACs.
CMS has very clear definitions for assessing the useful testing types that should be covered benefits, termed “medical necessity and reasonableness.” In line with the 21st Century Cures Act, to determine whether a diagnostic test meets the CMS definitions, a MAC can perform an informal review of the evidence and alert the laboratory that the test meets the definition and is covered. Otherwise, the MAC can follow a more formalized process and issue a local coverage determination that outlines evidence supporting the test and criteria for the covered benefit.
The standards for determining whether a test meets the CMS definitions vary across and within MACs, creating significant access barriers to new diagnostic tests. These decisions are, in theory, applicable only within the issuing MAC’s jurisdiction. However, when a company brings a new test to the market, it works with the MAC of the jurisdiction where the laboratory is located to get the test covered and into the hands of medical professionals who incorporate it as part of the standard of care.
A single MAC decision can have national access implications for many novel, advanced diagnostic tests that a single laboratory offers. While this may seem efficient and effective, it has created complications for patients and health care providers.
Two recent examples illustrate the problem with MACs. In March 2023, Palmetto GBA, a large MAC that covers most of the southeastern U.S., published an article on the CMS website that limited Medicare coverage for blood tests that organ recipients receive to monitor for rejection. Almost overnight, testing volume dropped, and Palmetto followed up with an even more confusing local coverage determination that threatened access to a critical test many Medicare recipients relied upon.
Without access to this test, organ recipients began to worry that they would have to get painful biopsies to ensure their bodies weren’t rejecting the donated organ. Some kidney recipients feared they would have to go back on dialysis for the rest of their lives.
Fortunately, after much public outcry, CMS stepped in and ensured that Palmetto did not move forward with its proposed local coverage determination. After filing a Freedom of Information Act request in early 2024, it became public that the decision to deny coverage ran counter to the advice of expert clinicians who work with MACs to advise the process.
Yet another MAC is threatening access to critical testing for a different cohort of Medicare recipients. In June 2022, Novitas, a MAC covering portions of the Midwest and Mid-Atlantic regions of the U.S., proposed a local coverage determination for all genetic tests for use in oncology. In July 2023, Novitas instituted its final version. Still, it was an entirely different length, included topics not covered in the original proposal and was rife with inconsistent standards for clinical evidence. After outcry over this bait and switch, Novitas released a ‘new’ draft local coverage determination, which observers noted is ostensibly identical to the original proposal, and recently finalized the decision.
Cancer patients and clinicians are standing by while Novitas attempts to correct course. Their final coverage determination has sweeping consequences and impacts the availability of tests for various cancers, including melanoma, squamous cell carcinoma and bladder cancer. Even worse, Novitas’ local coverage determination inexplicably includes tests from labs outside their jurisdiction.
The episodes with Palmetto and Novitas expose the flaws in the MAC coverage determination process and have nationwide implications. America’s cancer patients cannot stand by while decisions based on flawed and incomplete evidence are made without public input.
CMS needs to step in and ensure that Novitas’ local coverage determination, as written, is not implemented. Meanwhile, fixing the MAC system should be at the top of the list for a new administration that has focused on changing how Washington operates. President Bush said each generation has a duty to strengthen Medicare, which is now this generation’s turn.
• Richard Carmona, MD, MPH, FACS, was the 17th surgeon general of the United States and currently serves as a distinguished laureate professor at the University of Arizona.
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