Home Infusion Pharmacy vs Specialty Pharmacy, Medicare Part D
We have a few patients that are using standard drugs (Vancomycin) and some drugs that are considered specialty drugs (Cancidas). The specialty drug is being denied stating "not a specialty pharmacy" So my question is: Can a home infusion pharmacy also be a specialty Pharmacy for part D?
Submitted by: Steve Magliacane, Community Surgical Infusion
Response Summary
There were 7 Listserv responses to Steve’s question. In summary, many of the responses attempted to address the difference between a Home Infusion Pharmacy and Specialty Pharmacy. The question asked was “Can a Home Infusion Pharmacy also be a Specialty Pharmacy for Medicare Part D?”
Bruce Rodman, VP Health Information Policy, National Home Infusion Association addressed the question in the following manner:
Below is the CMS requirement for Part D plans on this subject, from page 26 of the Prescription Drug Benefit Manual, Chapter 5 which CMS published in final form on March 9, 2007.
I think there are some key sentences included that home infusion providers can point out to a Part D plan attempting to limit distribution of specialty drugs:
"Part D sponsors may not require network pharmacies to qualify as a "specialty" pharmacy in order to dispense any drug that requires special attention if the network pharmacy is capable of appropriately dispensing the particular Part D drug or drugs in question."
"...Part D sponsors may not restrict access based solely on the placement of a Part D drug in a "specialty/high cost" tier because this tier placement alone is not indicative of any special requirements associated with such drug."
"Requiring pharmacies to accept different reimbursement rates for certain "specialty" drugs is inconsistent with standard industry practice and use of such different reimbursement rates may not be used to subvert the convenient access standards."
50.3 - Specialty Pharmacy Access
Part D sponsors may not restrict access to certain Part D drugs to "specialty" pharmacies within their Part D network in such a manner that contravenes the convenient access protections described in section 50.1. Specifically, Part D sponsors may not restrict access to Part D drugs by limiting distribution through a subset of network pharmacies, except when necessary to meet FDA limited distribution requirements or to ensure the appropriate dispensing of Part D drugs that require extraordinary special handling, provider coordination, or patient education when such extraordinary requirements cannot be met by a network pharmacy. Therefore, Part D sponsors may not restrict access based solely on the placement of a Part D drug in a "specialty/high cost" tier because this tier placement alone is not indicative of any special requirements associated with such drug.
Part D sponsors may specify, on a drug-by-drug basis, reasonable requirements for network pharmacies to ensure appropriate handling and dispensing of a particular Part D drug that requires special attention. These drug-by-drug requirements should only apply to special handling and dispensing that may be required for a particular "specialty" drug and not to reimbursement or other standard contracting terms and conditions. Requiring pharmacies to accept different reimbursement rates for certain "specialty" drugs is inconsistent with standard industry practice and use of such different reimbursement rates may not be used to subvert the convenient access standards.
In addition, Part D sponsors may not require network pharmacies to qualify as a "specialty" pharmacy in order to dispense any drug that requires special attention if the network pharmacy is capable of appropriately dispensing the particular Part D drug or drugs in question. The convenient access standards dictate that "specialty" pharmacies be used to supplement network pharmacy access when necessary and not otherwise restrict it.
The full manual is found at:
http://www.cms.hhs.gov/PrescriptionDrugCovContra/12_PartDManuals.asp#TopOfPa
Rock-Pond Analysis
We thank Bruce for providing some meaningful information to assist providers in dealing with Medicare Part D plans and high end “Specialty Drugs”. There certainly have been attempts to distinguish the differences between Home Infusion Therapy and Specialty Pharmacy Services. The following definition generally applies: Home Infusion Therapy services are those organizations that provide a broad range of intravenous therapies including Total Parenteral Nutrition, Antibiotics, Pain Management, Chemotherapy and Hydration within limited geographical service areas. Specialty Pharmacies provide a limited number of specialty drugs frequently to chronic populations and service many states from a single service site. Today, there are many organizations that provide both service components.