Buyer Beware – FBI Warns of Fraud Involving Procurement of PPE and Other COVID-19 Supplies

Posted in Fraud & Abuse & False Claims Act, Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems

Many employers are now making plans to have their employees return to the workplace. Based on recent alerts from the FBI, part of preparing to protect workers from COVID-19 at work should include protecting the company from falling prey to fraudsters. To do that, employers should put in place procedures to carefully screen vendors from whom they will purchase COVID-19 supplies needed to comply with CDC and OSHA guidance and protect their employees. Continue Reading

Accepting CARES Act Relief Funds for Health Care Providers? Tell Your Compliance Department

Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

While the CARES Act signals relief for many healthcare providers, it is important to remember that there are strings attached and reasons for providers to involve their compliance departments in the use and tracking of the CARES Act relief funds.

The CARES Act promised, through the Public Health and Social Services Emergency Fund, to provide $100 billion in relief funds to hospitals and other healthcare providers (collectively “providers”) for healthcare related expenses and lost revenue attributable to COVID-19. On April 10, 2020, the government started distributing the first $30 billion in funds to eligible providers throughout the healthcare system (the “Relief Funds”). Continue Reading

Dose of Caution Needed When Making Coronavirus Drug Claims

Posted in Government Affairs, Licensure & Regulatory, Pharmacy, Drugs, Medical Devices & Equipment

Just like the dose makes the poison, the claim makes the drug.

With a pandemic well underway, some marketers are offering products that they claim will treat or prevent COVID-19, the disease caused by the novel coronavirus. Without federal approval, however, anyone making claims about unapproved drugs risks is inviting a federal enforcement action. As a result, marketers should exercise great caution when making coronavirus-related claims about their products. Continue Reading

Prescribing in Florida During the Pandemic-What is allowed, What are the gaps, and How do we fill them?

Posted in Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment

The catchphrase of the day is “social distancing” and it is the primary means of flattening the COVID-19 pandemic (the “Pandemic”) curve by keeping contagious and healthy people apart. However, there is another kind of distancing that may play a role in fighting the Pandemic – “health care distancing.” Health care distancing is a mechanism to keep the sick patients, who are sick, but not so sick that they need hands on care, out of the health care system so they don’t infect other patients and, at least equally important, the treating health care providers. Continue Reading

DOJ/FTC Issue Warning to Healthcare Industry Regarding Anticompetitive Conduct Against Employees During the COVID-19 Crisis

Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Labor Relations & Employment Law

While this period of crisis due to the pandemic has led competitors to cooperate, the crisis does not serve as an excuse for anticompetitve conduct. The Department of Justice Antitrust Division (the “Antitrust Division”) and the Federal Trade Commission (the “FTC” and with the Antitrust Division, the “Agencies”) have issued a warning to the healthcare industry that, while combatting the COVID-19 crisis may require unprecedented cooperation among competitors, the crisis cannot excuse conduct that causes anticompetitive harm to workers, including doctors, nurses and other first responders. Continue Reading

Some Things Never Change: EMTALA in the Time of COVID-19

Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

Even in this time of crisis, nothing has changed about a hospital’s obligation to comply with the Emergency Medical Treatment and Labor Act (EMTALA). However, the Centers for Medicare and Medicaid Services (CMS) has issued guidance (available here) to, and some flexibility for, hospitals on how to provide care to the growing influx of patients during the COVID-19 pandemic.

As a refresher, a Medicare participating hospital with a dedicated emergency department (ED) is required, under EMTALA, to:

  • Provide an appropriate medical screening examination (MSE) to any individual who comes to the ED in order to determine if the individual has an emergency medical condition (EMC). The examination must be performed by a qualified medical person, acting within his/her scope of practice, as defined under hospital medical staff bylaws and state law.
  • If the individual has an EMC, necessary stabilizing treatment must be provided, within the hospital’s capability and capacity. Stabilizing treatment means that the hospital shall provide necessary medical treatment to assure, “within reasonable medical probability, that no material deterioration of the patient’s condition is likely to occur.”
  • If a hospital is unable to stabilize, an appropriate transfer should be implemented.

Continue Reading

COVID-19 Isn’t the Only Virus to Fear: Cybersecurity Attackers Target Hospitals Amidst COVID-19

Posted in Electronic Health Records & Medical Records, Hospitals & Health Systems

Among the many obstacles facing businesses as a result of the COVID-19 pandemic are new cyberattacks targeting key infrastructure and industry in the United States. With all the compounding factors making this threat even more dangerous, the spike in cyberattacks was so significant that the International Criminal Police Organization (INTERPOL) has become involved and issued a “purple notice” alert to law enforcement in its member countries. The notice was issued as part of a coordinated effort to combat the attacks, and it alerts the public to information on the modus operandi, objects, devices, and concealment methods used by criminals. Since the World Health Organization’s (WHO) declaration of COVID-19 as a pandemic on March 11, 2020, cybercriminals have targeted hospitals, COVID-19 vaccine testing facilities, healthcare workers, and even the WHO itself.

The cyberattacks primarily take the form of malware (including ransomware) phishing, (including email phishing, SMS phishing, phishing for credential theft, and phishing for malware deployment) and exploitation of possible weaknesses in technologies (including from out-of-date patches and security flaws). Employees working in new remote environments and with newly deployed technologies to facilitate working from home to prevent transmission of COVID-19 are particularly vulnerable to these threats. Continue Reading

It’s More than PPE – Infection Control in Different Facility Settings

Posted in Hospitals & Health Systems, Physicians

Facing unprecedented community spread of the 2019 Novel Coronavirus Disease (COVID-19), the Centers for Medicare and Medicaid Services (CMS) has provided additional guidance to a variety of health care providers that is designed to minimize further transmission of the disease. CMS responds to frequently asked questions related to the logistics for minimizing transmission of COVID-19 in various patient settings. Specifically, on April 8, CMS issued three separate memoranda to State Survey Agency Directors (collectively, the “Guidance”) regarding infection control and transmission prevention of COVID-19 in three different settings: (i) Hospitals, Psychiatric Hospitals and Critical Access Hospitals: (ii) Outpatient Settings; and (iii) Intermediate Care facilities for Individuals with Intellectual Disabilities and Psychiatric Residential Treatment Facilities. Continue Reading

California Telehealth Updates

Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, HIPAA, Privacy, and Data Security, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment

California has joined the growing ranks of states, as well as the federal government, in efforts to facilitate the efficient provision of healthcare services during the pandemic. Accordingly, in response to federal agency updates with respect to relaxations to existing requirements related to telehealth services, California’s Governor Gavin Newsom issued an Executive Order No. 43-20 on April 3, 2020 (the “Order”) to expand telehealth services there (available here.)

Licensure Relaxations.

Similar to other states, any out-of-state licensed medical personnel may provide services within California without a license during the stated emergency upon submission of an authorization request form. Such form must be submitted to the California Emergency Medical Services Authority by a California medical facility (e.g., hospital, doctor’s office, care site, etc.), a  telehealth agency contracted with a California medical facility, or a staffing agency (available here.) Continue Reading

DOJ Antitrust Division Approves COVID-related Competitor Collaboration Under Expedited Procedures

Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Healthcare M&A, Joint Ventures, Transactions & Health Ventures

The Department of Justice Antitrust Division (the “Antitrust Division”) has granted its approval to a plan by a group of medical supply manufacturers to collaborate in response to the COVID-19 pandemic. In a business review letter issued on April 4, the Antitrust Division stated that McKesson Corp., Cardinal Health, Owens & Minor, Medline Industries and Henry Schein Inc. could work together to speed up the manufacture and distribution of COVID-19 supplies. The business review is the Antitrust Division’s first since announcing a new procedure in March to provide expedited guidance on COVID-19 related requests. Continue Reading

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