I was asked to send this out to all the State Pharmacy Associations – that pharmacies do not have to have the patient sign for their prescription for CMS audit purposes at this time.

Stay safe!

Kelly Valente, PharmD, MS, BCACP

Commander, USPHS

Regional Pharmacist

CMS Boston

Drug and Health Plan Operations

Office of Program Operations and Local Engagement

Phone Number: 617-565-1271

Date: March 20, 2020

To: All Part D Plan Sponsors

From: Alec Alexander, Deputy Administrator and Director, Center for Program Integrity

Subject: Minimizing Face-to-Face Contact for Medication Delivery or Dispensing

On January 31, 2020, the Secretary of Health and Human Services (“HHS”) declared a public

health emergency under section 319 of the Public Health Service Act (42 U.S.C. 247d) in

response to a novel coronavirus known as SARS-CoV-2 (“coronavirus”). On March 13, 2020,

the President of the United States declared a national emergency based on the spread of this

coronavirus.

CMS encourages Part D sponsors to work with their first tier, downstream, and related entities to

identify means of ensuring that medication is delivered to patients without requiring face-to-face

contact, which could result in transmission of the coronavirus. Medicare Part D regulations

require Part D sponsors and their first tier, downstream, and related entities to make their books

and records available to HHS to permit audits, including the review of any information needed to

determine compliance with Part D requirements. These audits can include a review of

documentation of medication delivery or dispensing, including evidence of the patient’s

signature. However, requiring a patient signature for receipt of medication could undermine

current public health efforts to combat the spread of the coronavirus. We are making clear that

HHS does not require and will not audit for patient signatures as proof of delivery for any

medications, including for controlled substances. Part D sponsors should work with pharmacy

benefit managers and other entities to continue to utilize tools at their disposal to make sure

beneficiaries are receiving controlled substances appropriately.

If you have any questions or need additional information, please contact us via email at

CPIMedicarePartD_data@cms.hhs.gov.

RIPA is encouraging pharmacies to take steps to keep their staff and customers save. While appropriate PPE would be ideal, we are aware of ongoing shortages of PPE, and the need for alternative steps to help prevent the spread of the virus. Part of that would be to take mitigation steps to avoid close contact, like preferred use of the drive thru, delivery , curbside pickup etc using line spacers etc. The DOH has called for most businesses to take steps to limit gatherings > 10 people or more. Each organization / company is handling this a little differently. I would remind pharmacists that pharmacies are licensed under the license of the pharmacist in charge (PIC) whom is ultimately responsible for the safe operation of their pharmacy.

If PICs believe that their pharmacy “owners”/employers are unwilling to support a workplace is safe for them or their patients, (including but not limited to staffing issues) then I would encourage pharmacists and technicians to voice their complaints directly with the DOH/BOP. They can email the DOH complaint line @ DOH.ecomplaint@health.ri.gov.