Tag: Drug Pricing

FTC Releases Controversial Interim Staff Report on PBMs’ Purported Impact on Drug Prices

At an Open Commission Meeting on August 1, 2024, the Federal Trade Commission (FTC) presented a report prepared by its staff entitled Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.

Although characterized as “interim,” the report posits the following observations about pharmacy benefit managers (PBMs):

  • “PBMs have gained significant power over prescription drug access and prices through increased concentration and vertical integration.”
  • “Increased concentration and vertical integration may have enabled PBMs to lessen competition, disadvantage rivals, and inflate drug costs.”
  • “The largest PBMs’ outsized bargaining leverage may operate to the disadvantage of smaller unaffiliated pharmacies.”
  • “PBM and brand drug manufacturer rebate contracts may impair or block less expensive competing products, including generic and biosimilar drugs.”
  • “PBMs lead to higher prices” (a conclusion based on only two case studies).

Commissioner Melissa Holyoak, in dissenting from the release of the report, stated that “the Report was plagued by process irregularities and concerns over the substance—or lack thereof—of the original order. In fact, the politicized nature of the process appears to have led to the departure of at least one senior leader at the Commission.” Commissioner Holyoak added that “[e]ven if the Report’s assertions of increasing concentration are accurate, increased concentration ‘does not prove that competition in that market has declined.’ Though the Report baldly asserts that PBMs ‘have gained significant power over prescription drug access and prices,’ the Report does not present empirical evidence that demonstrates PBMs have market power—i.e., ‘the ability to raise price profitably by restricting output.”’

Commissioner Andrew N. Ferguson, although concurring in the release of the report, was likewise critical of the process and its findings. In particular, Commissioner Ferguson found the report to be “especially unusual” in that it “relies, throughout, in large part on public information that was not collected from the PBMs or their affiliates during the 6(b) process.” Furthermore, Commissioner Ferguson was critical of the finding, based on only two case-study drugs, that PBMs lead to higher prices and pleaded with the FTC “to determine whether these findings are representative of market dynamics for other drugs.” He added that “[w]e need to understand whether any anticompetitive or unfair or deceptive acts or practices on the part of PBMs or any other market participants are contributing to these prices.”

©2024 Epstein Becker & Green, P.C. All rights reserved.
For more on PBMs, visit the NLR Biotech Food Drug section

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify a regulatory provision that had previously protected certain pharmaceutical manufacturer rebates from criminal prosecution and financial penalties under the federal Anti-Kickback Statute.

Specifically, the Proposed Rule would exclude from “safe harbor” protection rebates and other discounts on prescription pharmaceutical products offered by pharmaceutical manufacturers to Medicare Part D plan sponsors or Medicaid Managed Care Organizations (MCOs), unless the price reduction is required by law (such as rebates required under the Medicaid Drug Rebate Program). The proposed exclusion would apply to rebates offered directly to Part D plan sponsors and Medicaid MCOs, as well as those negotiated by or paid through a pharmacy benefit manager (PBM). HHS stated that it does not intend for the revisions in this Proposed Rule to negatively impact protection of prescription pharmaceutical product discounts offered to other entities such as wholesalers, hospitals, physicians, pharmacies and third-party payors in other federal health care programs. The proposed effective date of this regulatory modification is January 1, 2020, although HHS has sought comments regarding whether this allows sufficient time for parties to restructure existing arrangements.

In addition, the Proposed Rule would add two new regulatory safe harbors for:

  • Certain price reductions that are fully passed through to the dispensing pharmacy and applied to the price charged to the member at the point-of-sale; and

  • Fixed fee payments from manufacturers to PBMs for the services that PBMs provide those manufacturers. In order to be protected, the fees would have to be for services that relate to the PBM’s arrangements with health plans (e.g., services that rely on data collected from health plan customers).

These new safe harbors would become effective 60 days after HHS publishes a final rule.

The potential implications of the Proposed Rule extend beyond the context of federal Anti-Kickback Statute compliance to drug reimbursement in the United States more broadly. The proposals will likely be subject to significant public debate and legal scrutiny.

The Proposed Rule is scheduled to be published in the Federal Register on February 6, 2019, and public comments on the proposals would be due 60 days later. The Proposed Rule can be found here and the HHS Factsheet is available here.

 

© 2019 McDermott Will & Emery