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, PhysiciansEven 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.
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 SystemsAmong 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, PhysiciansFacing 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 & EquipmentCalifornia 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 VenturesThe 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
Taking Triage to Trial
Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, PhysiciansThe COVID 19 epidemic is bound to overwhelm available medical resources in the United States. Healthcare institutions and practitioners will be forced to make impossible life-or-death decisions regarding the allocation of manpower and supplies. They must also be ready to defend those decisions against a backlash of grief—and lawsuits—once the crisis has passed.
A defensible triage protocol must enable reasonable decisions and must include three components:
- Clearly defined written policies and procedures
- Written documentation that the policies were followed
- Training on the materials
North Carolina Telehealth Updates
Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & EquipmentNorth Carolina has drastically expanded its telehealth services during the COVID-19 pandemic in order to give individuals increased access to remote care. The following article outlines many of the important changes implemented.
Licensure
On March 10, 2020, Governor Roy Cooper issued Executive Order No. 116 (available here) waiving the requirement that healthcare and behavioral healthcare personnel be licensed in North Carolina in order to provide healthcare services to individuals within the state. The Order broadly references “healthcare services,” presumably including the provision of telehealth services. Out-of-state healthcare professionals must submit information to the applicable licensing board (e.g., physicians must submit an Emergency Disaster License Application to the North Carolina Medical Board to obtain authorization to practice within North Carolina; (available here) out-of-state licensed advanced practice registered nurses (APRNs) must hold an unrestricted license in any Nurse Licensure Compact State, perform medical acts under the supervision of a licensed North Carolina physician, and notify the North Carolina Nursing Board in writing of the name, location, and phone number of the primary supervising physician). Continue Reading
The CARES Act Impacts to Employer-Sponsored Health and Welfare Benefit Plans
Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, HIPAA, Privacy, and Data SecurityHealth and welfare benefit plans and insurers are affected by various provisions of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed on March 27, 2020. In addition to provisions impacting tax-qualified retirement plans and executive compensation (summarized here), the CARES Act affects coverage of diagnostic testing, preventive services, telehealth services, and drug reimbursement. Here are the highlights:
Section 3201 – Coverage of Diagnostic Testing for COVID-19
FFCRA Baseline. First we should recall what the Families First Coronavirus Response Act (FFCRA), enacted March 18, 2020, already addressed. The FFCRA had already required that group health plans and health insurers offering group and individual health insurance coverage (including grandfathered health plans), provide coverage for items related to COVID-19 testing. This “testing” concept was extended to FDA-approved diagnostic products, items, and services furnished during a provider visit (whether in person or in a telehealth setting), an emergency room visit, or an urgent care visit that results in a diagnostic test. Continue Reading
Texas Telemedicine Updates
Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & EquipmentAs with other states, in response to the COVID-19 pandemic and the guidance that the federal government has issued (see here), Governor Abbott of Texas issued a disaster declaration on March 13, 2020 (the Disaster Declaration) resulting in the loosening of certain existing telemedicine and telehealth related requirements in Texas.
Licensure.
For current license holders, the Texas Medical Board (TMB) will automatically extend any medical licenses expired or set to expire between February 28, 2020 and May 31, 2020 until August 31, 2020 and waive any late fees. Continue Reading
