Aided by ingenuity and growing regulatory flexibility, retail pharmacies across the country are finding ways to serve their customers while reducing face-to-face contact. Protocols may vary by state.
Social distancing has become part of our daily existence in the United States as communities across the country fight to “flatten the curve” and prevent rampant community spread of the coronavirus (COVID-19). Retail pharmacies and an increasing number of pharmacy regulators and payors are doing their part to reduce unnecessary interaction and wait times among customers by offering home delivery of prescriptions, relaxing signature requirements, and permitting 90-day refills, consistent with drug utilization review safety protocols.
The federal government, including Congress and the Centers for Medicare & Medicaid Services (CMS), and state pharmacy boards and Medicaid agencies are showing flexibility during the emergency period to facilitate these changes to avoid unnecessary customer and pharmacy worker contact. Most pharmacy benefit managers (PBMs) are also showing increased contract flexibility by allowing retail pharmacies to mail prescription drugs directly to customers’ homes, although contractual provisions often prohibit or limit retail pharmacies’ ability to serve as mail order pharmacies.
The following government actions illustrate the various agency efforts to assist retail pharmacies to reduce face-to-face contact and help flatten the curve. This list is not complete. We recommend you periodically review your state board of pharmacy and Medicaid program websites to determine if the agencies have taken actions to provide pharmacies with greater flexibility during the COVID-19 pandemic.
On March 10, CMS issued a memorandum to Part D sponsors (among others) notifying them that they may relax “refill too soon” edits and authorize a maximum extended supply of medications to reduce face-to-face contact. The memo also permitted Part D sponsors to relax any plan-imposed policies that may discourage mail or home delivery by retail pharmacies. Part D sponsors are permitted to waive prior authorization requirements to Part D drugs used to treat or prevent COVID-19.
This guidance was reiterated in a March 20 memorandum sent by CMS’s Center for Program Integrity to all Part D sponsors, titled “Minimizing Face-to-Face Contact for Medication Delivery or Dispensing,” encouraging Part D sponsors to identify means of ensuring that medication is delivered to patients without requiring face-to-face contact. In particular, CMS’s instruction recognizes that “requiring a patient signature for receipt of medication could undermine current public health efforts to combat the spread of the coronavirus.”
CMS then emphasized that the US Department of Health and Human Services (HHS) “does not require and will not audit for patient signatures as proof of delivery for any medications, including for controlled substances.” Note, however, that the ultimate decision to waive the signature requirement may rest with the PBM, so pharmacies should check with their PBMs for additional guidance.
Although not finalized as of this writing, as part of Phase 3 of the government’s coronavirus relief package, both Senate and House bills contain language permitting a 90-day prescription fill for Medicare Part D and Medicare Advantage Plan enrollees, as long as such a fill is not inconsistent with a “safety edit” or drug utilization review (DUR).
Both state boards of pharmacy and state Medicaid programs are implementing state-specific relief measures in response to the public health challenge. Below is a summary of the actions taken by several states, but pharmacies should check the website of their state board of pharmacy and Medicaid agency for specific guidance.
The California Department of Health Care Services (DHCS) is issuing guidance to Medi-Cal providers governing the Medi-Cal fee-for-service (FFS) pharmacy benefit, and reminds Medi-Cal pharmacy providers of the following existing Medi-Cal FFS pharmacy policies:
The Alabama Medicaid agency took various actions that affect pharmacies.
For the duration of its emergency declaration, the New York Department of Health has encouraged pharmacies to dispense a 90-day supply for most medications and to deliver medications to quarantined individuals. Pharmacies that choose to provide delivery to quarantined individuals may confirm receipt of the medications by the member through a phone call, text, or email, in lieu of getting a signature. Such confirmation should be documented and retrievable upon audit.
The TX Board of Pharmacy has temporarily suspended certain rule requirements as of March 20:
On March 13, the Georgia Board of Pharmacy issued a revised policy that specifically addresses emergency refill dispensing of prescription drugs (excluding controlled substances), temporary recognition of nonresident licensure, and temporary pharmacy facilities.
For our clients, we have formed a multidisciplinary Coronavirus COVID-19 Task Force to help guide you through the broad scope of legal issues brought on by this public health challenge. We also have launched a resource page to help keep you on top of developments as they unfold. If you would like to receive a daily digest of all new updates to the page, please subscribe now to receive our COVID-19 alerts.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following:
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Michele Buenafe
Kathleen McDermott
Scott Memmott
Albert Shay
Howard Young
Jacob Harper
Ariel Landa-Seiersen
Greg Etzel
Scott McBride
Banee Pachuca
Sydney Reed
Reece Hirsch
Mark Stein