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Some doctors have been prescribing opioids to Medicare Part D drug plan beneficiaries to relieve their cancer pain -- even though they didn't actually have cancer, according to (OIG) at HHS.

The report noted 7,552 prescription fills for transmucosal immediate-release fentanyl (TIRF) dispensed to 810 beneficiaries who did not have a cancer diagnosis in their Medicare claims history to support a medically accepted indication for use. And for 65 of those beneficiaries, the plans kept approving the prescriptions even after they had been disallowed.

"As a result, plan sponsors paid $86.2 million in unallowable Medicare Part D total costs," the authors wrote in the report, which was issued last month.

Another few thousand prescriptions were questionable, such as the 2,023 prescription fills for TIRF drugs for 176 beneficiaries whose most recent cancer diagnosis in their Medicare claims history was more than 1 year before the drugs were dispensed -- totaling $19.7 million in paid claims. "Although we did not determine these [prescription drug events] to be unallowable, they were at high risk of being unallowable," the report said.

In its introduction, the OIG noted that it has been tracking opioid use in the Medicare program during the opioid crisis "and has identified providers with questionable prescribing practices and beneficiaries at serious risk of misuse or overdose of opioids." Because improper off-label drug use can harm beneficiaries, it audited Medicare Part D plan sponsors' data on prescription drug events (PDEs, i.e., prescription fills) submitted to the Centers for Medicare & Medicaid Services (CMS) to determine compliance with Medicare requirements.

The audit included 45,776 prescriptions for TIRF drugs dispensed to 5,034 beneficiaries from July 2015 through December 2019, for which the Medicare Part D total cost was $513.9 million. In addition to examining whether the patients receiving the drugs had a cancer diagnosis, the researchers also "selected a judgmental sample of 51 beneficiaries who did not have a cancer diagnosis in their Medicare claims history and reviewed plan sponsor documentation to determine why TIRF drugs were approved."

They also scrutinized medical records from 28 of those patients' other providers who did not prescribe TIRF drugs, trying to find any evidence for a cancer diagnosis.

The investigators found that TIRF prescriptions were approved for patients without a cancer diagnosis "because plan sponsors' prior authorization processes were not adequate. Specifically, these authorization processes did not always require verification of the diagnosis or followup to confirm that the beneficiaries had a cancer diagnosis. In addition, during its assessments, CMS determined PDEs to be allowable for beneficiaries who did not have a cancer diagnosis because CMS relied on plan sponsors' prior authorization documentation."

Approving TIRF prescriptions for patients without a cancer diagnosis can lead to substance abuse, the report authors warned. "During our audit period, 446 beneficiaries who did not have a cancer diagnosis to support the use of TIRF drugs had at least one Medicare claim indicating an opioid overdose or opioid misuse during the time they were receiving TIRF drugs."

The authors made five recommendations to address this problem:

• Delete the PDEs related to the $86,247,325 of unallowable Medicare Part D total costs
• Identify and delete any unallowable PDEs related to the $19,704,602 of Medicare Part D total costs for beneficiaries whose most recent Medicare claim with a cancer diagnosis was for services provided more than 1 year before the TIRF drugs were dispensed
• Ensure that plan sponsors obtain sufficient information during the prior authorization process so that TIRF drugs are dispensed only to beneficiaries with a medically accepted indication of breakthrough cancer pain
• Expand the required PDE data elements to include diagnosis codes to enable plan sponsors to confirm that TIRF drugs are prescribed for a medically accepted indication
• Conduct data analysis and follow up on information that is inconsistent between the Medicare claims data and prior authorization information obtained for TIRF drug prescriptions

However, CMS didn't agree with most of the OIG recommendations, the authors noted. "CMS stated that it did not concur with our first and second recommendations because our determination of the amount of unallowable costs was not based on the applicable statute, regulations, or guidance."

And regarding the third recommendation, "CMS stated that we did not determine whether prior authorizations had been obtained from prescribing providers confirming that a medication was for a medically accepted indication, nor what clinical information was provided by prescribers via the prior authorization process," the report noted.

"CMS also stated that it disagrees with the position that every Medicare Part D claim without a corresponding cancer diagnosis, or a recent cancer diagnosis, demonstrates that a TIRF drug was used for a nonmedically accepted indication," they continued. "CMS stated that, although it disagrees with our methodology, it continues to take misuse of TIRF drugs seriously and is therefore undertaking an additional TIRF audit using a methodology aligned with legal requirements for plan sponsors."

The authors said they appreciated the additional TIRF audit for prescriptions without a medically accepted indication but pushed back on CMS's response: "Our audit methodology was based on the medically accepted indication requirements as defined in the [Social Security] Act. We maintain that it is not reasonable for a beneficiary to be prescribed TIRF drugs for breakthrough cancer pain without having had a cancer diagnosis."

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