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CMS Plan to Restrict Sale of Pain Drugs Opposed by AMA

Cheryl Clark, for HealthLeaders Media, March 6, 2012

"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.

Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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3 comments on "CMS Plan to Restrict Sale of Pain Drugs Opposed by AMA"


rrpostal (12/4/2012 at 4:42 PM)
Oh my. I work for medicare and this is going to swamp us in people screaming for their meds. "Cutting people off" from their relatively safe and regulated medication is not the proper way to combat addiction. People will resort to crime and illicit drugs. The amount of medicare patients on pain meds is astounding, but hardly a huge cost issue, which is what I'd rather they worry about. If someone is going to be getting stoned on opiates, I'd much rather they do it at their pharmacy than the street corner.

RICK (3/7/2012 at 10:46 AM)
CMS = Constant Mental Struggle. Just more proof that CMS stinks.

B S (3/6/2012 at 9:36 AM)
Of course this is all about patient safety - that's why the Government Accountability Office (A financial and budgeting entity) triggered the action.