"In addition, the patient is receiving #90 Hydrocodone, 10mg/acetaminophen 650mg each month from a different provider with five refills while receiving #90 Hydrocodone 7.5mg/acetaminophen 750mg also with five refills within one week from a different provider. The patient appears to be taking 4.2 gm of acetaminophen per day which is over the FDA maximum recommended dose due to risk of hepatic toxicity."
Not only was the patient using multiple prescribers for multiple substances, the letter said, but because each product was within the FDA maximal dosing limit so normal formulary management tools would not be triggered.
The CMS letter discusses other issues with current Part D drug plan distribution practices:
- Patterns of scheduled maintenance opioid therapy (both long and short duration medications) that repeat from month to month, from different providers, need to be investigated to ensure patient safety and prevent overutilization.
- Schedule III narcotics, unlike Schedule II narcotics, are not required to be rewritten each month allowing up to five refills and can more easily pose a threat of recurrent overprescribing—daily acetaminophen exposure can be dangerous, and the intent of each prescriber above was to provide a lower quantity of a hydrocodone/acetaminophen containing product, and to that end, a limited quantity of opioid exposure.
- The FDA daily maximum dose of 4gm of acetaminophen across all scheduled substances should be implemented by plans, and
- Sponsors should develop effective DUR programs, which include case management, outreach to providers, and if necessary, beneficiary-level controls to prevent overutilization of opioid therapy and ensure beneficiary safety.