HHS Will Relax HIPAA Rules to Facilitate Telehealth During COVID-19 Pandemic
To facilitate the use of telehealth services during the coronavirus disease 2019 (COVID-19) pandemic, some of which may not be fully compliant with the requirements of the Health Insurance Portability and Accountability Act (HIPAA), the United States Department of Health and Human Services’ (HHS’s) Office for Civil Rights (OCR) will “exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules,” according to an HHS notification. Specifically, health care providers may use popular applications that allow for video chats, including Apple FaceTime, Facebook Messenger, Google Hangouts, Zoom, or Skype, to provide telehealth services without risk that OCR may seek to impose penalties for noncompliance with HIPAA rules related to the good faith provision of telehealth. Public facing video communication applications, such as Facebook Live, Twitch, and TikTok, should not be used in the provision of telehealth.
More information can be found in the final guidance, published in the April 7, 2020 issue of the Federal Register.
Trump Administration Warns of “Toughest Week” Yet in COVID-19 Crisis
President Donald J. Trump and other administration officials warn that this week may be the “toughest week” yet of the COVID-19 pandemic, and some experts anticipate that the outbreaks in Louisiana, Michigan, and New York may hit their peaks in the next six to seven days. As local, state, and federal government agencies work to address the crisis, most Americans support continued drastic measures to stop the spread of the virus, and are expecting the crisis to last for months, according to a recent poll sponsored by USA Today. In addition, developments over the last few days include:
- Centers for Disease Control and Prevention (CDC) released new guidelines recommending that all Americans wear a cloth face covering in public settings where social distancing is harder to achieve, including in pharmacies. The guidance specifies that medical masks, such as N-95 respirators, should be reserved for health care workers and other medical first responders.
- Food and Drug Administration (FDA) published frequently asked questions regarding the use of respirators approved under standards in other countries.
- FDA and Federal Trade Commission (FTC) issued additional warning letters to companies for selling fraudulent COVID-19 products.
- Centers for Medicare & Medicaid Services approved additional Medicaid waivers to provide states with “flexibility to address coronavirus issues.”
Daily updates on the spread of the virus, including a state-by-state breakdown of known infections and fatalities, are available from CDC. International information is available from World Health Organization (WHO).
NABP continues to collect information about how boards of pharmacy are responding to COVID-19 in the Coronavirus Updates section of the NABP website. Pharmacists are also encouraged to check their state board(s) of pharmacy websites for jurisdiction-specific information. Additional resources for pharmacists and other health care providers are available from the American Pharmacists Association’s (APhA’s) Pharmacists’ Guide to Coronavirus.
USP Provides Hand Sanitizer Toolkit for Compounders, Other Facilities
To help facilities address a shortage caused by the COVID-19 pandemic, US Pharmacopeial Convention (USP) has launched a hand sanitizer toolkit on its website. The web page provides guidelines for producing alcohol-based hand sanitizer for compounders, over-the-counter drug manufacturers, and other facilities (such as distilleries) that may produce hand sanitizer during the emergency. The toolkit collects guidance information from USP, WHO, FDA, and the National Alliance of State Pharmacy Associations.
Medical Supplies Confiscated From Price Gougers in New York, New Jersey
Federal authorities have seized and distributed hundreds of thousands of personal protective equipment (PPE) from hoarders and price gougers in New York and New Jersey. The Federal Bureau of Investigations discovered the supplies during an enforcement operation by the Department of Justice’s COVID-19 Hoarding and Price Gouging Task Force on March 30, 2020, and alerted HHS, which used its authority under the Defense Production Act to order the supplies be immediately furnished to the US. The supplies seized include nearly 200,000 N95 respirator masks, nearly 600,000 medical grade gloves, and 130,000 surgical masks, according to an HHS press release. The owner of the hoarded equipment will be paid fair market value for the supplies, and the supplies are being distributed to meet the critical need among health care workers in New York and New Jersey.
“If you are amassing critical medical equipment for the purpose of selling it at exorbitant prices, you can expect a knock at your door,” said Attorney General William P. Barr. “The Department of Justice’s COVID-19 Hoarding and Price Gouging Task Force is working tirelessly around the clock with all our law enforcement partners to ensure that bad actors cannot illicitly profit from the COVID-19 pandemic facing our nation.”
Pharmacists and Patients Should Be Wary of Fraudulent COVID-19 Products and Other Scams, APhA Warns
APhA has issued new guidance for pharmacists and patients promoting vigilance against fake medical products and other scams emerging in the midst of the COVID-19 crisis. Specifically, the guidance warns of a “new epidemic of fraudsters and scammers, preying on the vulnerability of a public hungry for treatments, tests, personal protection equipment, and more.” The guidance also provides a list of red flags to watch for that may indicate a possible scam. These include offers that seem too good to be true, are unsolicited for products in short supply, and from unknown sources.
“Health care professionals, pharmacies, and patients must be cautious about offers of cures, treatments, and tests that are too good to be true,” said APhA Senior Vice President, Pharmacy Practice and Government Affairs, Ilisa Bernstein, PharmD, JD, FAPhA, in a press release. “The marketplace is seeing an explosion of scams, false and misleading claims, counterfeit and diverted products, and other opportunistic proposals that prey on our vulnerability at this time of crisis.”
Other information in the guidance includes a list of examples of known scams, and a list of webpages that can be checked to ensure FDA approval or emergency use authorization. Health care providers and consumers are both urged to report any suspected fraudulent activity to FDA, FTC, or the Federal Communications Commission.
FDA Webinar Addresses Enforcement Policy for PPE
FDA held a free webinar for device manufacturers and industry to discuss and answer questions on the recently issued, immediately in effect guidances on enforcement policy for PPE during the COVID-19 pandemic. The guidances discussed include:
- Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
- Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency
The webinar was held on April 6, 2020. A transcript, recording, and slides from the webinar will be available through FDA’s Medical Device Webinars and Stakeholder Calls web page.