Tell Congress How New Drug Model Would Affect Patients

Several lawsuits have been filed requesting a halt to Centers for Medicare & Medicaid Services' implementation of the drug payment demonstration, arguing that the regulatory process was not followed. Here is where the cases currently stand:

• The U.S. District Court for the Southern District of New York issued a preliminary injunction on Regeneron’s lawsuit, exempting Eylea injections from the rule. This injunction stays in place until lifted. Regeneron published a statement on the ruling on Jan.1. 

• A ruling from the U.S. District Court of the Northern District of California on Biotechnology Innovation Organization’s lawsuit further delays CMS’ implementation of the Most Favored Nation Drug Model until at least Jan. 26, giving providers additional time before reimbursement rates change. Judge Vince Chhabria wrote: "The plaintiffs have demonstrated that they are very likely — indeed virtually certain — to prevail on their claim that the government violated the APA's notice and comment requirements."

• Another U.S. District Court ruling in Maryland granted the Pharmaceutical Research and Manufacturers of America’s request for a temporary restraining order. That ruling delayed the drug model’s scheduled Jan. 1 start date to give the judge more time to review the case.

These rulings are likely a deadly blow to the demonstration. The California court ordered the U.S. Department of Health and Human Services to undertake the normal public comment process, which would push the rule to the Biden administration. Because the rule is not officially withdrawn and a new administration will control its fate, it is critical to let policymakers know the effects this rule would have to you and your patients.

What Can You Do?

The Academy is conducting a multipronged campaign to halt implementation of the Most Favored Nation Drug Model. You can support our efforts by taking the following actions: 

• Use the Academy’s advocacy tool to submit comments to CMS on how the model will affect your practice and patients. You can customize your response to provide policymakers with specific details of how the demonstration will affect your ability to provide sight-saving care to your patients, especially as your practices are struggling to recover from the COVID-19 public health emergency.
• Use the Academy’s advocacy tool to encourage your lawmakers to act to halt CMS’ implementation of the model.

Enlist Patients to Help Us Halt Implementation

Hearing the patients’ perspective is a powerful tool in the advocacy effort, and your patients can be helpful allies to encourage Congress to halt implementation of the Most Favored Nation demonstration. It is important that lawmakers fully understand how patients could be affected if the model is implemented. To help amplify our message, the Academy has developed a toolkit for practices to download and provide to patients to get them engaged in our advocacy efforts.

Your practice may want to make copies of these resources to share with patients. They include:

• A fact sheet that practices can use to engage patients
• A form that patients can sign to authorize practices to send a message to Congress on their behalf through the Academy’s advocacy tool
• A patient campaign on the Academy’s advocacy tool that practices can set up on a tablet or computer for patients to send a message to their elected officials

Contact the Academy’s grassroots coordinator, Dash Delan at ddelan@aao.org, for assistance in using these patient engagement resources.