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Retail Pharmacies Are Rising to the COVID-19 Challenge

March 23, 2020

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.

CMS Part D Guidance

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.

Congressional Action

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).

State-Specific Measures

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.

California Medi-Cal

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:

  • 100-Day Supply: Medi-Cal allows up to a 100-day supply per dispensing of a covered drug. Quantity per dispensing utilization control limitations on certain opioid-containing medications may be overridden through approval of a Treatment Authorization Request (TAR)/Service Authorization Request (SAR).
  • Six-Prescription (6 Rx) Limit: For Medi-Cal FFS recipients impacted by COVID-19, pharmacies are advised to submit a TAR/SAR using the special handling of “Six Prescription Limit” and incorporate the statement “Patient impacted by COVID-19” within the Miscellaneous Information field on the TAR/SAR. If a pharmacy receives a real-time claim denial for frequency limitation, the pharmacy is advised to submit a TAR/SAR using the special handling of “Exceeded Billing Frequency Limit” and incorporate the statement “Patient impacted by COVID-19” within the Miscellaneous Information field on the TAR/SAR.
  • Utilization Management: Utilization limits on quantity, frequency, and duration of medications dispensed to Medi-Cal beneficiaries may be waived by means of an approved TAR/SAR if there is a documented medical necessity to do so. Pharmacies are advised to incorporate the statement “Patient impacted by COVID-19” within the Miscellaneous Information field on the TAR/SAR.
  • Emergency Supply of Medications: Pharmacy providers are required to supply a minimum of 72 hours of prescribed medications in an emergency and may provide the emergency supply without an approved TAR/SAR. Providers must incorporate the following statement within the general emergency statement: “Patient impacted by COVID-19.”
  • DHCS has informed its pharmacy TAR/SAR staff to be flexible if they receive calls and/or inquires relative to prescriptions and COVID-19 concerns.

Alabama Medicaid

The Alabama Medicaid agency took various actions that affect pharmacies.

  • It is modifying the recipient signature requirement for services provided during the state of emergency effective March 16. Recipient signatures are not required in cases where the provider has discontinued signature capture due to health concerns surrounding COVID-19. Documentation of services provided to the recipient must be maintained by the provider. This action will be effective for one month, expiring on April 16, 2020, and will be reevaluated for a continuance as needed.
  • It is allowing a universal prior authorization (PA) number for all medications when claims deny for Early Refill (ER). The pharmacist should use clinical judgment when determining if the universal PA number is utilized. 

New York Medicaid

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.

Texas Board of Pharmacy

The TX Board of Pharmacy has temporarily suspended certain rule requirements as of March 20:

  • The annual inventory notarization requirement.
  • The requirement to have in-person contact for patient counseling; instead it will allow patient counseling to be performed by telephonic consultation.
  • The requirement to obtain an inspection within the last renewal period in order to renew a Class A-S, Class B, Class C-S, or Class E-S pharmacy license.
  • Various requirements regarding the pilot program for automated systems in order to allow for remote automated dispensing.
  • The requirement to maintain documentation of a current certification in the American Heart Association's Basic Cardiac Life Support for Health-Care Providers or its equivalent in order to provide immunization or vaccination under written protocol of a physician.

Georgia Board of Pharmacy

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. 

Coronavirus COVID-19 Task Force

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.

Contacts

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following:

Washington, DC
Michele Buenafe
Joyce Cowan
Kathleen McDermott
Scott Memmott
Andrew Ruskin
Albert Shay
Howard Young
Jacob Harper
Ariel Landa-Seiersen
Dani Elks

Houston
Donna Clark
Greg Etzel
Susan Feigin Harris
Scott McBride
Kathleen Rubinstein, Senior Health Policy Analyst
Summer Swallow
Banee Pachuca
Sydney Reed 

San Francisco
Reece Hirsch

Los Angeles
Brian Jazaeri

Boston
Mark Stein

Chicago
Lauren Groebe