Inappropriate prescribing means that, after consideration of all the facts and circumstances of a particular situation identified through investigation or other information or actions taken by MA organizations and Part D plan sponsors, there is an established pattern of potential fraud, waste, and abuse related to prescribing of opioids, as reported by the plan sponsors. Beneficiaries with cancer and sickle-cell disease, as well as those patients receiving hospice and long term care (LTC) services are excluded, when determining inappropriate prescribing. Plan sponsors may consider any number of factors including, but not limited to the following:
(1) Documentation of a patient's medical condition.
(2) Identified instances of patient harm or death.
(3) Medical records, including claims (if available).
(4) Concurrent prescribing of opioids with an opioid potentiator in a manner that increases risk of serious patient harm.
(5) Levels of morphine milligram equivalent (MME) dosages prescribed.
(6) Absent clinical indication or documentation in the care management plan or in a manner that may indicate diversion.
(7) State-level prescription drug monitoring program (PDMP) data.
(8) Geography, time, and distance between a prescriber and the patient.
(9) Refill frequency and factors associated with increased risk of opioid overdose.
42 CFR § 422.500
Scope. This subpart sets forth application requirements for entities seeking a contract as a Medicare organization offering an MA plan, including MA organizations offering a specialized MA plan for special needs individuals. MA organizations offering prescription drug plans must, in addition to the requirements of this part, follow the requirements of part 423 of this chapter specifically related to the prescription drug benefit.