With more and more PBMs and insurers owning their own Specialty Pharmacies, independent Specialty Pharmacies are being unfairly excluded from restrictive networks. However, a recent decision helps level the playing field, at least partially. The Centers of Medicare & Medicaid Services (CMS) has found that Aetna violated the Federal Any Willing Provider Law (AWPL) after Aetna denied network admission to qualified pharmacies. CMS entered an “Order” compelling Aetna to modify its behavior.
The Federal AWPL obligates a Part D prescription drug plan to permit participation by any pharmacy that meets the plan terms and conditions. The Federal AWPL specifies that the standard terms and conditions must be “reasonable and relevant.” To comply with the statutory requirement, a Part D plan sponsor must offer standard terms and conditions for all Part D plans it offers. To comply with the “reasonable and relevant” requirement, the Part D plans must specifically identify the terms and conditions that apply to each and every plan. The Part D plan terms and conditions must “include language that obligates the Part D sponsor to include the pharmacy in the identified plan(s) upon the pharmacy’s acceptance of the terms and conditions.” In short, this is very good for independent specialty pharmacies.
After receiving complaints from the industry, CMS reviewed Aetna’s contracting process and evaluated Aetna’s compliance with the Federal AWPL. Aetna’s process included two documents, a Letter of Agreement (LOA) and a Definitive Agreement (DA). The LOA provided a list of payment rates that pharmacies would accept or deny, and Aetna would subsequently make network assignments based on the selected rates. Aetna maintained the exclusive decision as to which plans the applying pharmacy may participate. Also, Aetna’s LOA or DA did not contain language explicitly obligating Aetna to include a pharmacy in the network(s) of the plan(s) for which the pharmacy had accepted the terms and conditions. CMS found that Aetna violated the Federal AWPL. As a result, CMS Ordered Aetna to develop a Corrective Action Plan to bring its programs into compliance. Should CMS find that Aetna does not comply with the Federal AWPL, CMS may impose intermediate sanctions, civil monetary penalties or contract termination. Again, CMS’s Order has the potential to level the playing field.
CMS’s discipline of Aetna is relevant to Specialty Pharmacies wishing to gain access to Medicare Part D Specialty Pharmacy Networks. Based on the Federal AWPL and CMS’s reaffirmed commitment to these regulations, it is clear that Part D plans must provide the standard terms and conditions to a pharmacy seeking access to a specialty pharmacy network. Should the pharmacy accept those reasonable and relevant terms and conditions the Part D Plan must allow access to the pharmacy in the Specialty Pharmacy Network. Further, the act of refusing to provide the terms and conditions or failure of a Part D plan to contract with a pharmacy willing to accept the terms is a violation of the Federal AWPL. A Part D Plan that does not adhere to the Federal AWPL faces sanctions, civil monetary penalties or contract termination. These concepts are all relevant and material to independents seeking access to restricted pharmacy networks.
Is your specialty pharmacy being denied access to a Part D Plan’s Specialty Pharmacy Network? Frier Levitt’s attorneys work every day on behalf of Specialty Pharmacies around the country and understands your unique challenges. Contact us today.
