President-elect Joe Biden has pledged to “marshal the forces of science” in his administration. Undoubtedly he needs to start by bolstering the credibility of the Food and Drug Administration and the Centers for Disease Control and Prevention.
But a third health agency, central to the lives of older Americans, low-income families and the disabled, is sorely in need of his attention. Science has also been under assault at the Centers for Medicare & Medicaid Services, which provides federal health insurance to more than 130 million Americans at a cost of more than $1 trillion, nearly twice the Pentagon’s budget.
C.M.S. does more than just write checks for medical care. Its scientists and analysts determine which treatments should be offered — I am the chairman of the committee that advises Medicare on those decisions — and how best to care for the patients it serves.
Unfortunately, the Trump White House has steadily eviscerated the agency’s dispassionate approaches to making those determinations.
Recently, for instance, the Trump administration set in motion a plan to strip C.M.S. of its ability to assess for itself whether new medical devices approved by the F.D.A. are appropriate for the older patients it covers. This is important because the benefits and risks of such devices and procedures, which range from implantable hips and cardiac stents to digital apps and laboratory tests, can vary widely based on patient age and disability.
The proposed rule requires Medicare to pay for any new device so long as the F.D.A. labels it a “breakthrough.” And that word does not mean what you think it does.
The F.D.A. calls a device a “breakthrough” when it is expected — though not yet proved — to be helpful to patients with serious conditions. The designation has nothing to do with how the device works in older patients, or even if it was studied in that population at all. The proposed rule would also require Medicare to cover any new drug or device if at least one commercial insurer covers it for its members, even if its members are young and healthy.
Already, companies seldom generate enough data on their products for C.M.S. to assess their value for its patients. In 2019, for instance, data was insufficient in just under half of new F.D.A. drug approvals to assess benefits or side effects in older patients. The proposed rule would drain the last remaining motivation that companies have to study their treatments in the patients who are likely to ultimately receive them.
C.M.S. scientists and analysts do more than evaluate new treatments. They also test alternative ways to organize and pay for patient care. The agency has found, for example, that enrolling people at risk of diabetes in gym sessions reduced how often they were hospitalized. But some seemingly obvious ways to improve health care don’t work: C.M.S. also found it could not reduce hospitalizations for cancer patients by paying their doctors to actively manage their patients’ care.
The fact that so many promising ideas don’t work as expected is the reason C.M.S. needs to double down on evaluations of how medical care is delivered to its patients.
This administration has gone in the other direction. Just before the election, the White House conjured up a plan to send older people a $200 prescription drug discount card in the mail. Research has already demonstrated that if you give people money to buy prescription drugs, they will buy more of them. The pharmaceutical industry knows this, too. That’s why it hands out coupons worth billions of dollars.
These same studies also show that when people are indiscriminately given cash for medicines — instead of only those who need that money the most — it costs much more overall than it saves. No wonder the discount card giveaway would have cost around $8 billion. Fortunately, the president has yet to follow through with it.
In another troubling development, the administration announced on Nov. 20 that it would run an experiment in which reimbursements to physicians will be cut for dozens of high-cost drugs they administer in the office, such as chemotherapies and treatments for inflammatory diseases.
C.M.S. financial analysts warned that the cuts will lead many Medicare patients to lose access to these important treatments. Scientists should evaluate this prediction by including a comparison group of patients whose doctors would not receive a cut in payment. But the agency administrator made it clear that she didn’t believe the warning. No comparison group is planned. That is no way to evaluate whether our nation’s vulnerable would be helped or hurt by this significant policy change.
Another example of a poorly designed experiment involved taking Medicaid coverage away from able-bodied people who are not working or going to school, under an ill-founded theory that doing so would inspire them to seek employment. Such a study is best done narrowly, so that any harms are minimized. Instead, the administration invited multiple states in 2018 to test the outcome.
A Harvard study found that a work requirement in Arkansas led to a rise in the number of uninsured people and no significant changes in employment. Thousands of Medicaid beneficiaries in Michigan and New Hampshire were set to lose their coverage before work requirements in those states were ended. Given those results, the overall program should have been canceled. The administration broadened it.
Through its reliance on scientific evaluation of what it should pay for, and how, C.M.S. has remained financially viable for more than half a century. As the new president plans to fix the damage done by the current president, this vital agency demands his attention.
Peter B. Bach is a physician at Memorial Sloan Kettering Cancer Center. He served as a senior adviser to the administrator of the Centers for Medicare and Medicaid Services in 2005 and 2006.
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