Medicare has different standards than the FDA. That’s how it should be

Who among us is looking forward to getting older in 2024? Not senators (most of whom are 65 and older), the two leading presidential candidates (100% of whom are over 75), or the eight Cabinet members who are already more than 65 (growing to 10 in February). Members of the U.S. House of Representatives are younger (averaging 58 years of age), but even so, many are already over 65.

But as someone who worked on Capitol Hill, for the White House, and for the Department of Health and Human Services, I am amazed that Washington’s aging movers and shakers offer so little support for the one federal agency with a mission to take care of us as we get older: the Centers for Medicare and Medicaid Services.

CMS is the only federal agency whose goal is to make sure we don’t get harmed by medical products that aren’t proven to benefit people over 65. Or 75. Or even 80. Thanks to Baby Boomers, there are more of us than ever before.

With all the senior citizens running our government, you’d think they would be glad when Medicare tries to ensure that treatments are proven safe and effective for people over 65.

Instead, lobbyists appear to have convinced many policymakers and the public to demand that Medicare should pay for all drugs and medical devices that the FDA approves. For example, in 2023 Rep. Cathy McMorris Rodgers, chair of the energy and commerce committee, referred to CMS coverage policies as “unacceptable” and blamed them for ”standing in the way or slowing down patient access to treatments and cures.” Meanwhile, more than 90 members of Congress signed letters to CMS, arguing that it should not create barriers to drugs that the FDA has approved — something that would involve enormous costs, potentially without any benefit and could in fact harm older Americans.

There is a growing disconnect between how the FDA interprets its mission to approve medical products that are proven “safe and effective” and Medicare’s statutory mission to pay only for treatments that are “reasonable and necessary.” That disconnect goes well beyond recent controversies regarding Alzheimer’s drugs.

Medicare requires proven safety and effectiveness for patients over 65 compared with other available treatments. In contrast, the FDA has the authority to approve treatments that are not quite as safe or not quite as effective as other, less expensive treatments — because the FDA’s standards do not consider cost at all. And the FDA doesn’t require evidence that people over 65 will benefit. That means that the FDA can (and does!) approve products that may be more likely to harm than help older patients.

Outrage can be engaging when criticizing government programs, but the facts are more enlightening. The FDA frequently approves medical products for adults of all ages that have not been tested on any people over 70 and tested on just a few people over 65. In fact, the FDA is the only U.S. public health agency that simply recommends, rather than requires, diversity in clinical trials — and the companies that pay for the research rarely achieve that goal.

That can be harmful to many Medicare patients, especially the more than one-third who are over 75. Older people metabolize drugs differently, so the drugs may accumulate dangerously in a patient’s body. They also tend to take numerous medications, and those medications may interact with new treatments in ways that are harmful. And as people age, they tend to become more frail, and thus more likely to be harmed rather than helped by medical products that are safer for younger adults (or even for 65-year-olds).

As a scientist who is on Medicare, I see both sides of the argument. Of course, I’d like Medicare to pay for everything that could help keep us healthy or cure a serious disease, but the disconnect between FDA decisions and Medicare decisions is enshrined in statues that are interpreted by policymakers. Since FDA approval is based on studies paid for by drug or device companies, rather than taxpayers, the FDA says it can’t require the research to include people of color or older patients. However, the agency could approve treatments only for the types of patients that were studied. If a company only studied white adults under the age of 65, for example, its product should only be approved for those types of patients. Isn’t that what labeling is supposed to do?

Since no company would want to lose so many potential customers or be branded as discriminatory, that would create the incentive that the companies apparently need to ensure that their medical products are safe and effective for all adults and that Medicare provides coverage for all patients that the company proves are likely to benefit.

In most countries, national health plans are the gatekeepers that examine whether treatments are safe, effective, reasonable, and necessary. But the U.S. has two major gatekeepers that do not always agree because their responsibilities are different. Meanwhile, lack of older patients in clinical trials continues to be a major shortcoming facing FDA approval decisions. As one of the millions of Americans who depend on both agencies, I am grateful that Medicare is doing what is necessary to keep us as healthy as possible while also staying solvent despite spiraling healthcare costs.

Diana Zuckerman, Ph.D., is president of the National Center for Health Research, a nonprofit think tank that does not accept funding from any sources with financial ties to its work.