• Nation’s Ophthalmologists Issue Statement on Trump Administration’s Last-Minute Part B Drug Rules

    Most Favored Nation Model may block patient access to needed treatments.

    On Nov. 20, the Trump administration announced a demonstration to test an innovative way for Medicare to pay no more for high cost, physician-administered Medicare Part B drugs than the lowest price charged in other similar countries. Known as the Most Favored Nation (MFN) Model, the plan will be implemented starting Jan. 1, 2021.

    While the American Academy of Ophthalmology supports the goal of reforming the Medicare Part B drug payment system, we fear that the Most Favored Nation Model Interim Final Rule may prevent beneficiaries from getting timely access to needed treatments.

    Because the administration decided to bypass the standard proposed rule and comment process, the rule has not benefited the robust stakeholder feedback that’s imperative to ensuring policy changes don’t have a detrimental impact on patients and providers. The pandemic has already made access to these treatments challenging for beneficiaries, as many surgical practices are still experiencing significant disruptions.

    The model was never officially proposed. The U.S. Department of Health and Human Services (HHS) has used a tactic reserved for emergencies to bypass ​the public notice-and-comment process. Instead of going through the public process of rulemaking, HHS is using an interim final rule, which does not need to be preceded by a proposed rule and takes effect immediately upon publication in the Federal Register.​ In addition, we question the timing of this rule, released as final at the last possible moment and set to be implemented in 60-days. The sweeping policy changes as a result of this rule would begin under the Biden administration.

    We appreciate that the Centers for Medicare & Medicaid Services attempted to “keep doctors whole” with a fair administrative fee for handling and storing these complex biologics, but the mandatory and universal nature of the demonstration has us concerned that our smaller practices and those serving rural beneficiaries may face substantial challenges in accessing these drugs under the program.