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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