Center for Medicare Advocacy and Florida Health Justice Project Sue to Obtain “Off-label” Part D Prescription Drug Coverage for BeneficiaryPosted in Media, Press Release
April 16, 2018
For Immediate Release
On April 6, 2018 the Center for Medicare Advocacy and Florida Health Justice Project filed a lawsuit in the United States District Court for the Southern District of Florida on behalf of a 49-year-old Florida resident seeking Medicare coverage for the “off-label” (non-FDA-approved) use of a critically needed medication (Dobson v. Azar, 4:18-cv-10038-JLK).
Donald Dobson needs Dronabinol to control his debilitating nausea and vomiting. His symptoms result from severe pain after multiple surgeries he required due to a workplace injury. After numerous medications failed to provide relief, Mr. Dobson’s doctor prescribed Dronabinol, which significantly relieved his nausea and vomiting and allowed him to resume many activities of a normal life. However, when Mr. Dobson became eligible for Medicare Part D, his plan denied coverage because his particular use of the medication is not FDA-approved. After exhausting Medicare’s appeal system, Mr. Dobson is now seeking help in federal court as his only hope to receive this critically important and medically necessary treatment for his debilitating symptoms.
Kata Kertesz, an attorney with the Center for Medicare Advocacy said, “The Medicare agency is using an overly narrow interpretation of the law to deny coverage of a drug that it does not dispute is medically necessary for Mr. Dobson. The doctor prescribed this medication because it is the only one that has worked to control Mr. Dobson’s symptoms. But, he cannot afford it without Medicare Part D coverage.”
Mr. Dobson’s Medicare Part D plan should cover the Dronabinol because his use of the drug is supported by one of the “compendia” of medically-accepted indications listed in the Medicare law. Medicare looks to the compendia for acceptable off-label uses of medications, and the symptoms of nausea and vomiting are listed in an entry for Dronabinol. “Mr. Dobson’s position is strongly supported by another recent federal case about a beneficiary who gained Part D coverage of the same medication for very similar symptoms,” said Ms. Kertesz. “However, the Medicare agency is using an inappropriately restrictive reading of the law to claim that coverage cannot be granted for Mr. Dobson.” (See, Tangney v. Burwell, 186 F. Supp. 3d 45 (D. Mass. 2016)).
Miriam Harmatz, Co-Executive Director of the Florida Health Justice Project, stated, “this is an important case, and we hope there will be a clear ruling by the court that’s consistent with Tangney and a Florida Medicaid case, Edmonds v. Levine, 417 F. Supp. 2d 1323 (S.D. Fla. 2006). This will both ensure that Mr. Dobson gets the medication he desperately needs, and help ensure appropriate application of the law governing off label uses in other cases.”
- The complaint is available at: https://www.medicareadvocacy.org/wp-content/uploads/2018/04/Dobson-Complaint-Filed.pdf
The Center for Medicare Advocacy (www.medicareadvocacy.org) is a national, nonprofit, non-partisan law organization that works to advance access to comprehensive Medicare coverage and quality health care for older people and people with disabilities through legal analysis, education, and advocacy.
The Florida Health Justice Project, (www.floridahealthjustice.org) is a new Florida non-profit that works to ensure access to necessary health care for low-income Floridians.