Appeal type: Drugs
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Bupivacaine Hydrochloride (HCL) Powder from an out-
of-network (OON) infusion provider. 
 You asked the Plan to pre-approve Bupivacaine HCL Powder from an OON infusion provider. You say that 
you are concerned that switching from the enrollee's current non-plan participating infusion provider to a plan-
participating infusion provider will result in lower quality services and expose her to safety risks. You say that 
most in-network pharmacies and clinics are not able to/not equipped to do specialty compounding. You say 
that, if they are able to do compounding, they generally are not able to do sterile compounding for intrathecal 
pain pumps. The Plan denied your request. The Plan says their plan-participating compounding pharmacy has 
earned The Joint commission's Gold Seal of Approval for Home Care Accreditation for the 25th year in 2021. 
The Plan says that the compounded drugs are compounded by pharmacists and the home infusion services are 
provided in the home setting by registered nurses. The Plan says that the plan-participating provider is a safe 
and medically acceptable alternative to the non-plan participating infusion service provided. 
 
Medicare rules generally allow plans to restrict enrollees to using plan providers as long as there are plan 
providers available to meet the enrollees needs. The enrollees contract with the Plan says that, with few 
exceptions, enrollees must use contract providers for care.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve Bupivacaine HCL Powder from an 
OON infusion provider. Our reviewer says that the criteria for coverage of OON care have not been met. Our 
physician reviewer found the enrollee is not currently receiving any active treatment and/or medical 
management of his/her condition that makes it medically necessary for this enrollee to continue care with the 
out-of-network provider as requested. There is not anything unique about the enrollee's condition that would 
make it medically necessary for him/ her to continue care with the out of network provider. The plan has shown 
that they have in-network specialists who has the qualifications and expertise necessary to meet the current 
medical Standards of Care required for treatment of the enrollee's condition. The enrollee's medical 
management and/or follow-up care can be safely transitioned to an in-network specialist at this time. The Plan's 
denial is medically justified on the basis that it is offering adequate care to meet the enrollee's medical needs 
through referral to an in-Plan participating infusion provider. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Bupivacaine HCL Powder from an OON infusion provider have not been met. 
Therefore, we decided that the Plan does not have to pre-approve Bupivacaine Hydrochloride (HCL) Powder 
from an out-of-network (OON) infusion provider.