There's a notable gap in new federal rules requiring insurers to streamline decisions on whether they'll cover treatments ordered by doctors: They don't apply to drugs.
Why it matters: Drugs account for a significant share of prior authorization requests, and patients and doctors argue that the new rules, as is, won't increase access to needed treatments.
The Biden administration says it wants to improve the coverage request process for physician-administered drugs, but it's still figuring out how to navigate the systems that insurers have in place to cover medications.
Driving the news: Patient advocates and the health industry applauded rules released earlier this month that require federally funded insurers to act faster on prior authorization requests, give a reason for coverage denials, and update electronic systems that facilitate prior authorizations.
But the rules only apply to medical items and services.
Lawmakers have started to probe insurers' use of prior authorization to deny necessary care, and Congress may revive legislation to codify the administration's prior authorization changes and further expedite insurer approvals.
What happened: Providers have been pushing the administration to address prior authorization of drugs for nearly a year. But the Centers for Medicare and Medicaid Services decided not to because standards and technical systems can differ depending on whether drugs are administered in a physician's office or a hospital or picked up at a pharmacy.
Where it stands: Past laws and regulations have already put some guardrails around prior authorizations for drugs, especially for those covered through prescription drug benefits.
Medicare prescription drug plans have to offer electronic prior authorization and respond to urgent requests within 24 hours and regular inquiries within 72 hours.
Medicare Advantage plans have to follow the same response timeframes for drugs administered in a doctor's office or hospital. State Medicaid programs have similar rules for outpatient drugs.
But the decision to exclude drugs from the latest prior authorization revamp means other new protections, like standards around electronic information-sharing and reporting, won't apply to cancer drugs and other kinds of specialty care that patients receive in a doctor's office or hospital.
According to KFF, 99% of Medicare Advantage enrollees are in plans that require prior authorization for medical benefit drugs.
Zoom in: Michael Lai, a Maryland ophthalmologist, said almost all of his patients who come in with insurance other than traditional Medicare require prior authorization for the injections needed to treat their retinal conditions.
"None of it is solved by the latest CMS rule," said Lai, who spearheads federal affairs for the American Society of Retina Specialists.
Leaving physician-administered drugs out of the new rules will hurt vulnerable patients, said Andrea Preisler, who handles administrative simplification policy for the American Hospital Association.
"It just really compounds barriers to care that these patients face," she said.
AHA believes applying the new finalized policy to medical benefit drugs is technologically feasible and would be a good start to improving patient access to medications, Preisler said.
What's next: CMS is "actively pursuing policy opportunities related to prior authorization for drugs covered under the medical benefit," a spokesperson said.
CMS wouldn't comment on when that work will begin.
AHIP, the trade group for health insurers, said last year in a letter to CMS that it "agrees with having future discussions" on extending information-sharing policies to drugs.
Drug-related prior authorizations are far more common than those for medical services, and that could present challenges for managing access to information, AHIP said.
Our thought bubble: CMS seems committed to further changes, but the Biden administration already has a packed drug policy agenda. Prior authorization 2.0 could take a back seat to other priorities, like Medicare drug price negotiations.
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