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

Taking Triage to Trial

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

The 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

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North Carolina Telehealth Updates

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

North 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 Security

Health 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 & Equipment

As 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

COVID-19: Florida Executive Order on Elective Healthcare Services

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

In an effort to preserve healthcare resources (e.g., personal protective equipment), limit potential contact with infected individuals, and free up healthcare practitioners to assist with those suffering from COVID-19, elective healthcare services must cease. Specifically, on March 20, 2020, Florida Governor Ron DeSantis issued Executive Order 20-72 (available here), requiring all Florida licensed healthcare practitioners to immediately cease performing elective services in Florida.

A procedure or surgery is prohibited if delaying it does not place the patient’s immediate health at risk and does not worsen a “serious or life-threatening medical condition.” The guidance that follows, which also takes into account guidance provided by the Centers for Medicare & Medicaid Services (available here), is meant to assist you in navigating and complying with this new Executive Order. Continue Reading

Florida Telehealth Updates

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

In response to the public health emergency declared in Florida on March 1, 2020, Florida loosened existing licensure and other telehealth requirements in response to the COVID-19 pandemic, as outlined below.

However, unless specifically waived or relaxed by the Orders (as defined below), all current minimum practice requirements and standards of care for telehealth services set forth under F.S.A. §456.47 continue to apply, including, but not limited to, the duty to:

  • practice within his/her scope of practice and the prevailing standard of practice as provided for in-person healthcare services;
  • document the telehealth services provided in the patient’s medical record according to the same standards used for in-person services; and
  • maintain the confidentiality of all medical records generated.

Continue Reading

Illinois Telehealth Updates

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

Like many other states, in response to the COVID-19 pandemic and the guidance that the federal government has issued, Governor Pritzker of Illinois issued an executive order (2020-09) on March 19, 2020, amending and relaxing existing telehealth related requirements under 225 ILCS 60/49.5 regarding: (1) telemedicine services provided by licensed Illinois physicians; (2) telemedicine and telepsychiatry services provided to Illinois Medicaid beneficiaries under 89 Ill. Admin. Code §140.403; and (3) reimbursement for such telehealth services. A general summary of these updates is summarized below. Continue Reading

Florida Board of Pharmacy Adopts Emergency Rule Excusing Off-Site Consultant Pharmacists from Conducting Monthly Visits to Facilities During COVID-19 Pandemic

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

Like many states, Florida requires consultant pharmacists to conduct on-site monthly visits to the facilities to which they provide pharmacy services. The visits are required for Modified Class IIB Pharmacy Permits, Special ALF Pharmacy Permits, and Special ESRD Pharmacy Permits.  Because of the COVID-19 pandemic, consultant pharmacists—particularly those visiting assisted living facilities—were concerned about off-site consultant pharmacists going from facility to facility and possibly increasing the risk of COVID-19 transmission to pharmacists, staff, and residents in the process.

The Board of Pharmacy heard the concerns with safeguarding the health of both pharmacists and the public during the COVID-19 pandemic and, respecting the implementation of the Division of Emergency Management’s Order 20-006 prohibiting certain persons from visiting assisted living facilities, took immediate action. On March 19, 2020, the Board of Pharmacy adopted an emergency rule that relieves off-site consultant pharmacists from visiting the facilities. The rule was designed to allow some flexibility and does not prohibit the consultant pharmacist from visiting the facilities, so the facility and pharmacist may agree to pharmacist’s visit in certain circumstances. The rule does not relieve on-site consultant pharmacists of the on-site visit requirement, so if the pharmacists were told to leave the facility, such pharmacists may need to seek relief in other ways, though we would expect the regulatory authorities to be reasonable in such situations. Continue Reading

Breaking Developments for Telehealth and Teleprescribing in Georgia

Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment, Technology

Unsurprisingly, COVID-19 has created a great degree of liberalization in the telehealth requirements previously in place. What has not changed is the fact that telehealth services are governed by a number of different laws and regulations, all of which are constantly changing – now more than ever.  In addition to the multiple changes at the federal level, what follows is the first in a series of blog posts that outline certain state’s changes in their telemedicine rules in response to the pandemic.

For physicians currently providing or interested in providing telehealth and teleprescribing to Georgia patients, the past few days have seen new developments impacting telehealth and teleprescribing requirements tracking some of the federal developments. Continue Reading

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