Class Action Alleges HHS Secretary Failed to Warn Medicare Beneficiaries About Drug Coverage Changes

New to ClassAction.org? Read our Newswire Disclaimer

Two Medicare beneficiaries allege in a proposed class action that Secretary of the Department of Health and Human Services (HHS) Xavier Becerra violated their constitutional rights when he failed to notify them that their health plan would no longer cover the injectable drug Stelara.

Want to stay in the loop on class actions that matter to you? Sign up for ClassAction.org’s free weekly newsletter here.

According to the 35-page lawsuit, Becerra determined that, effective October 15, 2021, Stelara would no longer be covered by Medicare Part B, a facet of the federal health insurance program that pays for certain injectable medications administered in physicians’ offices or other outpatient clinical settings, among other items and services.

The plaintiffs—both of whom require Stelara to manage their respective conditions—say that it was only after they had received multiple scheduled injections from their providers throughout 2021 and 2022 that they learned the drug was no longer covered by Medicare Part B.

The complaint contends that one plaintiff, a 72-year-old woman who needs Stelara to treat otherwise debilitating symptoms of a severe form of psoriatic arthritis, had to look at her quarterly Medicare summary notice to find out that she would have to pay out-of-pocket for her last two injections, costing approximately $58,000 each.

Per the suit, these changes in coverage terms occurred because regional Medicare Administrative Contractors (MACs) determined that the drug is “usually self-administered by the patient” and added it to the Self-Administered Drug Exclusion List (SAD List). Drugs that MACs find to be self-administered by more than half of all Medicare beneficiaries are excluded from Part B coverage, the complaint explains.

The case claims that Becerra has violated the due process clause of the Constitution’s Fifth Amendment by failing to ensure that Medicare Part B beneficiaries receive “timely, adequate” notice of the change in Medicare coverage terms of a drug when it is added to the SAD List.

By failing to provide patients with adequate and timely warning of non-coverage, the defendant has deprived them of an opportunity to make an informed decision about how to proceed, the filing argues.

For instance, adequately informed beneficiaries could determine whether their Medicare Part D plan, which covers medically necessary drugs, provides coverage for the drug in question, and request a formulary exception if it does not, the case says. Proper forewarning would also allow patients time to make other arrangements to receive the drug or discuss alternative medications with their physician, the complaint shares.

The lawsuit also takes issue with Becerra’s alleged failure to waive financial liability for affected beneficiaries who were furnished a drug that had been added to the SAD List “when they did not know and could not reasonably have been expected to know that Part B would not cover the drugs.”

Finally, the complaint accuses Becerra of violating Section 504 of the Rehabilitation Act by failing to ensure that beneficiaries who cannot self-administer medications added to the SAD List due to a disability can continue to receive Medicare-covered administration by qualified healthcare professionals.

For example, the second plaintiff, an 84-year-old man who uses Stelara to control symptoms of Crohn’s disease, cannot self-administer the drug because his Parkinson’s disease has impaired his motor dexterity and coordination, the case says. The plaintiff has now been forced to rely on a friend to inject the medication for him, the suit shares.

The lawsuit looks to represent any Medicare beneficiaries who have received or receive coverage of a “Part B drug” that has been or will be added to the SAD List by the Medicare Administrative Contractor responsible for administering their claims and who have been or will be denied coverage of the drug on the grounds that it is self-administered. The suit also seeks to cover anyone who cannot self-administer the Part B medication they require because of a disability.

Get class action lawsuit news sent to your inbox – sign up for ClassAction.org’s free weekly newsletter here.