U.S. House of Representatives lawmakers on Tuesday criticized the Trump administration's efforts to introduce formulary management tools such as step therapy into more parts of Medicare.
Republicans and Democrats on the House Energy & Commerce Committee's health subcommittee alleged that the Trump administration's efforts threaten patient access to needed drugs. Step therapy requires a patient to try a cheaper drug before a more expensive drug and prior authorization requires insurance to approve a prescription before it's issued.
"It is not defensible in my view," said Rep. Anna Eshoo (D-Calif.), who chairs the subcommittee. "I don't know who supports this thing."
Rep. Larry Buschon (R-Ind.), a physician and ranking member of the subcommittee, noted that the practices have been debated for 30 years. "At the end of the day it ultimately doesn't save any money," he said.
HHS released a proposed rule in November that gives Medicare Part D plans more flexibility to use step therapy. The proposed rule, which has yet to be finalized, will allow plans to apply step therapy and prior authorization to drugs in six protected classes.
The CMS is also considering allowing Medicare Advantage plans to adopt step therapy for certain drugs under Medicare Part B.
The Medicare Payment Advisory Commission has endorsed the proposal as a welcome tool to lower prescription drug spending. The commission said in comments to the rule that "new formulary flexibilities likely would not be sufficient to keep Part D financially sustainable into the future."
But some congressional lawmakers want to step back from step therapy. Rep. Raul Ruiz (D-Calif.), a physician, and Rep. Brad Wenstrup (R-Ohio) introduced the Safe Step Act last week that aims to create a clear process in which a patient or provider can get an exception from either step therapy or prior authorization.
"While I understand that step therapy can play an important role in reducing healthcare costs, it does not take into account a patient's medical history, like whether they tried the medication previously and failed under a different insurance plan," Ruiz said during the hearing Tuesday.
Total Medicare costs are expected to grow from 3.7% of the gross domestic product last year to 5.9% in 2038, according to the Social Security and Medicare trustees in a report issued last week.
James Mathews, MedPAC's executive director and the lone witness during Tuesday's hearing, defended the formulary management tool but said patients should have some protection.
"We do understand the circumstances of every patient is unique and we would not support putting patients through some of these things like step therapy when the clinician knows that they are not going to be effective for a given patient," he said.
Mathews added that the greater use of these tools must be accompanied by a "very robust and effective" system for filing grievances and appeals.