RELEASE: REP. HILL AWARDS GOLDEN FLEECE TO CMS FOR IMPROPERLY ADMINISTERING DANGEROUS DRUGS
WASHINGTON, D.C., August 31, 2023
WASHINGTON, D.C. – Rep. French Hill (AR-02) named the Centers for Medicare and Medicaid Services (CMS) as the latest recipient of his Golden Fleece Award for their lack of monitoring the practices of Medicare plan sponsors who improperly approved and dispensed transmucosal immediate-release fentanyl (TIRF) drugs, resulting in Medicare recipients receiving these dangerous and addictive pain management drugs when they were not clinically appropriate.
Rep Hill said, “Due to the CMS's lack of oversight of Medicare plan sponsors, they spent more than $100 million giving Medicare beneficiaries unnecessary pain-management medications that put patients who received these dangerous drugs at an increased risk of developing substance use disorders. For their negligence, I am naming the Centers for Medicare and Medicaid Services as the latest recipient of my Golden Fleece Award.”
In a letter to CMS Administrator Chiquita Brooks-LaSure, Rep. Hill writes:
Dear Ms. Brooks-LaSure:
I write today to inform you that the Centers for Medicare and Medicaid Services (CMS) is this month’s recipient of my Golden Fleece Award for improper approval and dispensing of transmucosal immediate-release fentanyl (TIRF) drugs. The Office of the Inspector General for the U.S. Department of Health and Human Services (HHS OIG) found that plan sponsors and CMS did not ensure that all TIRF drugs were dispensed in accordance with Medicare requirements, resulting in nearly $106 million in improper payments.
Transmucosal immediate-release fentanyl (TIRF) drugs are high-potency, prescription opioid pain relievers that are FDA-approved solely to manage breakthrough pain in adult cancer patients who are already tolerant to around-the-clock opioid therapy for their persistent cancer pain. TIRF drugs are Schedule II controlled substances that are 100 times more potent than morphine and possess a high potential for abuse.
The HHS OIG report found that “[p]lan sponsors and CMS did not ensure that all TIRF drugs were dispensed in accordance with Medicare requirements.” Not only did plan sponsors routinely approve TIRF drugs for beneficiaries who lacked a cancer diagnosis in their Medicare claims history but they also approved and dispensed TIRF drugs for beneficiaries whose last cancer diagnosis claim was more than a year old and even for some who had previously been determined to be unallowable to receive these therapies “because breakthrough cancer pain is the only medically accepted indication for Medicare reimbursement of TIRF drugs.”
After finding these practices, the HHS OIG report recommended CMS identify and delete the record data for individuals who improperly received TIRF drugs, strengthen plan sponsors’ prior authorization processes, and include diagnosis codes to confirm that patients receiving prescriptions have medically accepted indicators. In particular, the report divulged, “that when physicians did not answer questions in sufficient detail to determine whether beneficiaries were actively being treated for cancer, plan sponsor staff did not obtain additional or clarifying information.”
At a time when healthcare costs continue to skyrocket and our citizens suffer from opioid abuse and substance dependency, it is important that CMS does not exacerbate the burdens in affording healthcare and maintaining safe, healthy habits for Medicare recipients. In the middle of an ongoing opioid use crisis, your agency’s negligence to oversee Medicare plan sponsors and their prior authorization processes has compounded this problem and put more Americans at risk to develop substance use disorders. We need to protect Americans from these dangerous drugs unless they are absolutely clinically appropriate and, in the same turn, ensure that beneficiaries are receiving high-quality care without paying for unnecessary and potentially even harmful therapies.
I am committed to ensuring effective practices at our Nation’s federal agencies. Should you require any additional authority from Congress to address these concerns, I urge you to notify us as soon as possible. I would also welcome any technical assistance you could provide to Congress to correct statutory issues that may have contributed to this problem. Thank you for your consideration and I look forward to working with you to address this important issue.
Member of Congress