ACP calls for increased oversight and regulation of PBMs, including gag clause ban

The American College of Physicians (ACP) says its time to improve transparency and take a closer look at the role of pharmacy benefit managers in order to stem the high cost of prescription drugs.

The ACP, the country’s largest medical specialty organization which represents internists, also called for addressing issues in Medicare and Medicaid in two new policy papers on mitigating rising prescription costs published today in the Annals of Internal Medicine. It made policy recommendations in a paper on public health plans and in a paper on pharmacy benefit managers (PBMs).

The recommendations are intended to increase transparency in how drugs are priced, lower out-of-pocket costs for patients and improve access to affordable medications, ACP officials said.

“The U.S. pays more for prescription drugs than any other developed country—putting a great strain on our patients,” said Robert McLean, M.D., ACP's president. “As physicians, we have a responsibility to address issues that create obstacles to care for our patients, including skyrocketing prescription drug costs.”

In an accompanying editorial, the authors note that many of ACP’s policy recommendations are currently debated in Congress as lawmakers look for ways to curb prescription drug spending.

In its position paper, the ACP called for the following changes to PBMs:

  • A ban on “gag clauses” that prevent pharmacies from sharing information with consumers, as well as changes to improve transparency, standards and regulation for PBMs.
  • Increased oversight and regulation of PBMs, including mergers and consolidation with the PBM market that could reduce competition, resulting in more costs being passed to patients.
  • Requiring health plans, PBMs and pharmaceutical companies to report the amount paid for prescription drugs, the aggregate amount of rebates and non-propriety pricing information to the Department of Health and Human Services (HHS) and making it publicly available.

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The ACP also recommended the following five changes to address issues in public health plans, including the Medicare and Medicaid programs:

  • Modify the Medicare Part D low-income subsidy (LIS) program cost-sharing and copayment structures to encourage the use of lower-cost generic or biosimilar drugs, such as eliminating cost-sharing for generic drugs for LIS enrollees.
  • Place annual out-of-pocket spending caps for Medicare Part D beneficiaries who reach the catastrophic phase of coverage.
  • Adopt Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries.
  • Minimize the financial impact on the federal government of prescription drug misclassification in the Medicaid Drug Rebate Program (MDRP).
  • Encourage further study of payment models in federal health care programs, including methods to align payment for prescription drugs administered in-office in a way that would reduce incentives to prescribe higher-priced drugs when lower-cost and similarly effective drugs are available.

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Physicians see directly how the high price of prescription drugs hurts patients, including their ability to afford necessary medications like insulin and anticancer therapies, the editorial said.

“Internists have seen first-hand the how the increasing costs of prescription drugs have impacted patients,” said McLean. “Not all patients can afford the expensive out-of-pocket costs for vital drugs, and the high price tag can cause patients to not adhere to their medications, take incorrect doses to make their supply last longer or forgo the medication they need altogether. It’s more important than ever to continue advocating for policies that make prescription drugs more affordable and accessible to patients, and ensure they are not boxed out of the care they need.”