COVID-19.  We all know what it is by now – no need to explain further.  For specific information about COVID-19 from the experts, please visit the CDC website, Coronavirus Disease 2019 (COVID-19).

In this blog, we will cover regulations and actions your Pharmacy can take to help your staff, patients, and community stay healthy.  We will also share links to various websites with relevant information for Pharmacy.

COVID-19 and HIPAA

For the most part, the HIPAA Rules remain the same, and if you were compliant before COVID-19, you are compliant now. The Office of Civil Rights (the entity who enforces HIPAA) released a Bulletin covering the areas that pharmacies and other covered entities need to have policies for when it comes to complying with the uses and disclosures related to COVID-19 (and any other infectious disease).  Specifically, the Bulletin covers the areas in the table below – we have also added the specific policies and procedures in the HIPAATrack program that address these issues:

Area Mentioned in BulletinAssociate Policy and procedure
TreatmentUses and Disclosures to Carry out Treatment, Payment and Health Care Operations
Public Health ActivitiesUses and Disclosures for Public Health Activities
Disclosures to Family, Friends, and Others Involved in an Individual’s Care and for NotificationUses and Disclosures for Individuals Involved in the Patient’s Care and Notification Purpose
Disclosures to Prevent a Serious and  Imminent ThreatUses and Disclosures to Avert a Serious Threat to Health or Safety
Disclosures to the Media and Others not involved in the Care of the Patient/NotificationUses and Disclosures Requiring Authorization
Minimum NecessaryMinimum Necessary Requirements

On 3/17/2020, the OCR announced its intention to exercise enforcement discretion for telehealth.  In the announcement, the OCR states it “will exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency.”

The OCR releases a second bulletin on 3/15/2020 that addressed some limited waiver of penalties and sanctions for HIPAA covered entities that are hospitals.

CMS RELEASED INFORMATION ON MEDICARE ADVANTAGE AND PART D

On March 10, CMS released guidance on COVID-19 for The Medicare Advantage and Part D Plans.  In the guidance, they state several obligations and permissible “flexibilities” that the Advantage and Part D Plans may take related to COVID-19.  These include:

  • Waiving the cost of Testing
  • Paying for treatment at non-contracted facilities as if they were in-network
  • Paying for telehealth services
  • Relaxing “Refill-Too-Soon” Edits and Maximum Days Supplies
  • Reimbursing Enrollees for prescriptions obtained from Out-of-Network Pharmacies
  • Permitting Home Mail Delivery
  • Waiving of Prior Authorizations for drugs designed to treat or prevent COVID-19
  • Covering Vaccine if and when available

USP <795>, <797> and <800> COMPLIANCE AND COMPOUNDING

Another area Pharmacies need to be aware of is the requirement for the use of Personal Protective Equipment (PPE) for compound preparations and the handling of hazardous drugs.  If your State (or other entity) is requiring compliance with the PPE requirements in these standards, it is important to understand how they will be enforcing these requirements during this time of low and no availability and what recommendations they have to extend your supply.  As an example, the Iowa State Board of Pharmacy released some guidance on what Pharmacies should do when there is a shortage of PPE.

The FDA has also issued guidance on the compounding of alcohol-based hand sanitizer for public use.  Essentially, the FDA will not take action against any State-licensed Pharmacy that produces alcohol-based hand sanitizer.  You can find the guidance here.

GENERAL PHARMACY ITEMS

Before closing out this blog, we want to list actions that you may take to maintain a clean and safe Pharmacy environment for your patients and staff.  These are recommendations based on information released by various Boards of Pharmacy and Departments of Health.

  • Maintain a clean waiting, drop-off, pick-up and consulting areas in your Pharmacy
    • Use a cleaner from the list you can find here.
    • Clean at least hourly and after you have patients showing potential symptoms
    • Remove coffee service, magazines or other complimentary items (and other high touch items that need frequent cleaning)
  • Maintain appropriate social distancing:
    • 3 feet for individuals not showing symptoms
    • 6 feet for individuals showing symptoms
  • Use alcohol-based hand sanitizers at the pick-up, drop-off and consulting counters so people can sanitize their hands after using common pens, keypads, and other items
  • Provide gloves, masks (if available), and sanitizer to your delivery drivers
  • Think about how best to handle the elderly, pregnant, and other vulnerable patients, so they do not need to wait in a line
  • Review any State Board Guidance – some state are creating temporary abilities for Pharmacists to refill (without prescriber authorization), compounding of drugs in short supply, and other items that will better help your patients and community
  • Review your State regulations concerning Collaborative Practice Agreements to see if you can assist Physicians in any new capacity
  • Review any Collaborative Practice Agreements that you have in place to see if you can further support your Physician partners
  • Encourage patients to obtain cold medication (cough, nasal congestion, runny nose, pain, fever, sore throat, etc.) now, so they do not need to come back if they get infected
  • Stay up to date on current news about COVID-19
  • Offer delivery to patients that have a confirmed diagnosis, showing potential symptoms, or are part of a vulnerable population
  • Look into your States Regulations for Point of Care Testing

If COVID-19 is not currently circulating in your area, you likely will scale back on these actions. Alternatively, if you have COVID-19 spreading in your area, you may want to expand on these actions.

ONE LAST THING

As we all know, elected officials, the media, and other groups all have a part to play in the story and message of COVID-19 – Unfortunately, their message is not always clear.  Because of this, your patients (and maybe your employees) are not clear on the facts.  We recommend you check out the website NCPA created for Pharmacies with access to resources on COVID-19.

You should keep an eye out for additional information from the CDC, State Board of Pharmacy (NABP List of State Boards of Pharmacy), and Health Departments (CDC List of Health Boards).

We will update this blog or post subsequent blogs as necessary to reflect updated information.