The drug pricing plan released by President Trump takes a robust look at rising prescription drug prices, but several components of the blueprint—and the accompanying request for information (RFI) released by the Department of Health and Human Services several days late—could have a direct impacts on pharmacists.
"We're just very encouraged that the president was recognizing our top issues," said Kala Shankle, director of Regulatory Affairs and Policy at the National Community Pharmacist's Association (NCPA).
The drug pricing plan known as "American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs," and the subsequent request for information, both released in May, center around the idea of improving negotiations and lowering patient out-of-pocket drug costs.
"I think really what the administration is trying to do here is find a way to lower drug prices, lower list prices, but also meaningfully lower the patient or beneficiary's expense for pharmaceuticals," says Matt Brow, president of Avalere Health, a healthcare consulting firm.
But patients aren't the only stakeholder who could be impacted by the changes recommended in the plan. As the President takes aim at what he referred to as the "middle men" or pharmacy benefit managers (PBMs), pharmacists could see significant impacts as well.
The most meaningful of these impacts include:
1. Altering Pricing Incentives
The blueprint continues recent momentum to curb drug pricing by altering safe harbor provisions that are currently part of anti-kickback statutes.
FDA commissioner Scott Gottlieb questioned whether there was a need to re-examine the current safe harbor provisions for drug rebates in comments at a Food and Drug Law Institute conference in early May.
One of the proposals outlined in the blueprint furthers this idea by suggesting measures to restrict the use of rebates, including making changes to the safe harbor provisions for drug rebates in the Medicare Part D program.
"The administration has the ability to modify their previous guidance that established that safe harbor, so it think it's a very significant proposal for PBMs just given the ease with which the administration could implement it," says Lindsay Bealor Greenleaf, director at healthcare consulting firm ADVI.
The blueprint identifies this as a "further opportunity," though exactly how the safe harbor provisions could be altered isn't immediately clear. Greenleaf says the most extreme—and less likely—change would be to repeal it outright, eliminating a PBM's power to engage in rebating and discounting in Medicare Part D. A more realistic option, she said, is developing some type of policy that limits excessive rebates or discounts.
"That would have immediate impact on the PBM's business models," she said.
2. Weighing in on DIR fees
For the past two years in a row, retroactive pharmacy DIR fees have been identified as the top legislative and regulatory priority for NCPA members — and it appears Washington is taking notice.
Although there's no specific language about putting the DIR fees at the point of sale, Shankle says the President's blueprint and the RFI released by HHS do include broad language requesting more information about DIR fees in the industry. The request comes at the heels of another request for information issued by CMS as part of its 2019 Medicare Part D rule to examine assessing the fees at the point of sale.
"This administration continues to recognize that the system is broken and we've been saying that for a very long time, so again, it's very encouraging that the President is even requesting more information," Shankle says.
NCPA hopes the administration may even consider eliminating the fees.
"The blueprint and then the accompanying RFI that came out of HHS had some language in there about rebates and what it would look like if rebates were eliminated and no longer part of manufacturer contracts," Shankle says. "We're going to take that a step further and say, what about considering doing that for pharmacy DIR."
Brow said if PBMs were prohibited or limited in how they assessed DIR fees it could have a positive impact on pharmacies.
"That could make it possible potentially for more pharmacists, I think, to participate in-network and make it less meaningful or less of an incentive for the PBM to try to exclude pharmacists from network," he said.