OptumRx: Important Update - Compounded Drugs - Prohibited Activities

Author: Angie Shirley/Wednesday, May 20, 2015/Categories: APCI Choice

Compounded Drugs - Prohibited Activities:

  • Ownership or partial ownership in a pharmacy by a physician or other prescriber of Prescription Drug Products
  • Compensation, either monetary or in-kind, either paid to or received from, any healthcare provider for referrals for prescribing  a particular Compounded Drug or to a particular pharmacy
  • Use of Form 1099 contractors to market pharmacy or particular Compounded Drug
  • Submitting Compounded Drug Claims with ingredients manufactured or distributed from a non-FDA registered manufacturing facility and/or wholesaler not FDA registered or with no distribution locations within the USA
  • Submitting Compounded Drug Claims with ingredients that include as a component the National Drug Code (“NDC”) for a repackaged drug or a drug imported from another country without FDA approval
  • Delivering Covered Prescription Services, including Compounded Drugs, by Mailing , unless specifically permitted to do so within the Agreement, Plan Specifications, Amendment or in writing
  • Advertising for obtaining Compounded Drugs delivered by Mailing unless specifically permitted to do so within the Agreement, Plan Specifications, Amendment or in writing
  • Submitting a claim for a Compounded Drug when a manufactured Drug Product  with an identical or similar formulation is available on the market
  • Submitting an NDC that is not the NDC for the raw, bulk chemical, or Drug Product ingredient used in the Compounded Drug
  • Splitting the days supply or quantity of the Compounded Drug Claims to less than a thirty (30) day supply to circumvent Prior Authorization, dollar amount thresholds, quantity or Benefit Plan limits
  • Splitting the days supply or quantity of the Compounded Drug Claims to less than a thirty (30) day supply in order to gain additional reimbursement or Member Cost Share
  • Refusing to dispense the Compounded Drug medication because  of dispute over reimbursement
  • Charging the Member more than the Cost Share provided by the POS System, including charging for non-covered ingredients
  • Waiving Member Cost Share Amounts provided by the POS System
  • Not using the NDC of the lowest cost AWP available on the market in the Compounded Drug
  • Pharmacy is registered as a §503B entity with the FDA
  • Violating any Federal, State, or Local law regarding compounding, marketing, or dispensing compounded medications
  • Acting as a central fill pharmacy for a pharmacy not contracted with OptumRx
  • Dispensing compound drugs to a patient for the first time without verifying physician/member relationship
  • Dispensing compound drugs without literature on file that supports the clinical/therapeutic value of the compound ingredients
  • Dispensing or distributing  compounded drugs  which are not based on valid prescriptions for individually-identified patients 

2015 Pharmacy Manual can be found at the following:

http://learn.optumrx.com/pharmacymanual

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