CMS heavily regulates these insurers' plans. One such regulation requires insurers to cover "all or substantially all" drugs in six protected classes: antiretrovirals, antineoplastics, antidepressants, anticonvulsants, antipsychotics and immunosuppressants.
It's no mystery why these drug classes are "protected." These medicines treat illnesses like HIV/AIDS, cancer, bipolar disorder, epilepsy and schizophrenia—all of which often require multiple treatments specifically tailored to individual patients. The wrong medication can prove life threatening.
A patient who has just received a kidney transplant will need a unique combination of immunosuppressants that works well with her body. Since there isn't a one size fits all drug cocktail for immunosuppression, it's of the utmost importance that patients have access to all possible treatment options.
The Trump administration ignored this basic scientific truth when constructing its Part D model. Beginning in 2022, the model would waive requirements regarding the protected classes. For five of the six protected classes, insurers would be required to cover only one drug per class. Antiretrovirals used to treat HIV/AIDS would be subject to the change in 2023—by which time there will be no protected classes left.
This change is intended to reduce program spending, since insurers would use their newly restrictive plan formularies to steer patients toward cheaper drugs. But it wouldn't have any impact on patient out-of-pocket spending. It is a cruel, heartless policy, which is bad medical practice.
As a physician I can say with certainty that the risks to patients' health far outweigh any financial benefits gained by the government and private insurers.
Say you're a senior who, after months of trial and error, has finally found a prescription drug regimen that effectively treats your seizures. Under the Trump administration's model, starting next year, your Part D plan might no longer cover that prescription. Instead, it might only cover a single anticonvulsant—one that caused severe side effects when you tried it previously.
A pharmacy manager counts out the correct number of antibiotic pills to fill a prescription. Now a nasty fork in the road lies ahead. You either discontinue your drug regimen and let your health deteriorate—or you go broke trying to pay for your current prescription out-of-pocket.
By shelving this planned model, the Biden administration can ensure that seniors never have to choose between their health and their finances.
The Biden administration could further help patients by implementing one of the few good ideas that came out of the Trump years—the so-called rebate rule.
Currently, huge corporations known as pharmacy benefit managers, or PBMs, help insurance companies decide which medicines to include in their Part D plans. These PBMs have enormous influence—and they use it to extract rebates and discounts from drug manufacturers. It's estimated that in 2018, drug companies offered $166 billion in these rebates and discounts.
However, when a patient pays for her medication at the pharmacy, she doesn't receive the rebate. PBMs and the insurers they serve are not obligated to pass along savings to patients in the form of lower out-of-pocket costs.
The rebate rule would make it illegal for middlemen to accept rebates—unless those middlemen share the savings directly with patients at the point of sale. This would reduce patients' out-of-pocket spending and help them afford their prescriptions.
The Biden administration recently delayed the rebate rule until March, until it can conduct a sweeping review of the Trump White House's last-minute changes. The desire to review the previous administration's largely disastrous changes makes sense—but this is one of the few reforms that President Biden ought to implement.
Trump's attack on the six protected classes is a disaster in the making. The new administration should waste no time in revoking this policy.
Howard Dean, a physician, served as governor of Vermont from 1991 to 2003 and chair of the Democratic National Committee from 2005 to 2009. He was a Democratic Party presidential candidate in 2004.
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