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 … Continue Reading
Category Archives: Healthcare Law
Subscribe to Healthcare Law RSS FeedTaking Triage to Trial
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 … Continue Reading
North Carolina Telehealth Updates
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 … Continue Reading
The CARES Act Impacts to Employer-Sponsored Health and Welfare Benefit Plans
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 … Continue Reading
Texas Telemedicine Updates
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 … Continue Reading
COVID-19: Florida Executive Order on Elective Healthcare Services
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 … Continue Reading
Florida Telehealth Updates
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 Reading
Illinois Telehealth Updates
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 … Continue Reading
Florida Board of Pharmacy Adopts Emergency Rule Excusing Off-Site Consultant Pharmacists from Conducting Monthly Visits to Facilities During COVID-19 Pandemic
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 … Continue Reading
Breaking Developments for Telehealth and Teleprescribing in Georgia
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 … Continue Reading
Managing the Healthcare Workplace During the COVID-19 Outbreak
Healthcare providers have special concerns for their employees during the Coronavirus (COVID-19) global health pandemic.
Because COVID-19 spreads primarily as a result of close exposure to an infected person, healthcare employees are at higher risk of infection. While OSHA has a standard to protect employees from the spread of bloodborne pathogens, it currently has no standard for the spread of … Continue Reading
FTC Brings First Hospital Merger Challenge Since 2016
The Federal Trade Commission (FTC) announced on February 27 that it has filed an administrative complaint challenging the proposed merger of Jefferson Health (Jefferson) and Albert Einstein Healthcare Network (Einstein), two Philadelphia-area hospital systems. The action is the FTC’s first hospital merger challenge since late 2016, when the agency successfully challenged the Hershey/Pinnacle Health transaction, also in Pennsylvania.
In this … Continue Reading
FTC Commissioners Call for Study on the Competitive Effects of Consummated Healthcare Transactions that Did Not Previously Receive Regulatory Review
The Federal Trade Commission announced on February 11, 2020 that it had issued Special Orders to five large technology companies, requiring them to provide information to the FTC concerning all corporate acquisitions they have completed over the last ten years that had not previously been required to be submitted for review by the FTC under the Hart-Scott-Rodino Act (HSR). The … Continue Reading
OCR Fee Limits for Third Party Directive Record Requests Struck Down
On January 28, 2020, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) issued a notice (the OCR Notice) regarding individuals’ right of access to health records in response to a January 23, 2020 court ruling in the Ciox Health, LLC v. Azar, et al., No. 18-cv-0040 (D.D.C. Jan. 23, 2020) case. OCR noted that … Continue Reading
Sutter Health Settles California Attorney General Antitrust Case With Cash and an Agreement to Make Significant Changes to its Operations
The terms of a settlement that resolved antitrust litigation between the State of California and Sutter Health, the largest health system in Northern California, have now become public, almost two months after the settlement put an end to the case. The settlement, which was inked only days before a trial in the case was set to begin, includes both the … Continue Reading
Hackers Raise the Stakes By Possibly Causing Physical Harm
Computer hacking, and the permutation of crimes that can be committed by hackers, generally does not spur images of infliction of physical harm. However, in a chilling turn of events, computer hackers have opened a new front in the damage that can be inflicted through cybercrime. In a nefarious series of developments, cyber-liabilities now arise from remote manipulation of the … Continue Reading
Is A Federal Privacy Law In The Cards for 2020?
In May of 2018, the European Union enacted the General Data Protection Rules, or GDPR, a legal framework that outlines not only how companies may collect and process personal information of EU residents, but how that data is stored and used. Since its enactment, GDPR has triggered a global push towards compliance with those standards. In the United States, there … Continue Reading
You Can’t Always Get What You Want
The Florida Fifth District Court of Appeal harmonized the interpretation of state statutory and constitutional language in the first post Amendment 7 case dealing with access to adverse medical incident reports and their use at trial. The Florida statutory prohibition against the use and admissibility of certain incident reports was postulated to conflict with the state constitutional access to adverse … Continue Reading
FTC Investigating the Competitive Effects of Certificates of Public Advantage
The Federal Trade Commission has issued orders to five health insurers and two health systems requiring them to provide information that will assist the FTC in studying the competitive effects of certificates of public advantage (COPAs) with respect to prices, quality, access and innovation in healthcare. The orders were sent on October 21 to Aetna, Anthem, Blue Cross Blue Shield … Continue Reading
Direct Patient Billing Can Create Provider Liability in Florida
To bill or not to bill, that is the question. Or, more appropriately, who to bill and when to bill, that is the question. Providers who bill patients under the circumstances described below may face liability. What is a provider to do?
A patient was injured in the course of her employment in December 2013 and applied for workers’ compensation … Continue Reading
Addressing Acute Mental Health Concerns: Parkland’s Legacy – Florida’s Red Flag Law
We are all too aware of the horrors of the Parkland shooting. In response to that awful day, the Florida Legislature enacted Florida Statute Section 790.401 in 2018, “the Marjory Stoneman Douglas High School Safety Act.” Part of this new law is the “red flag” provision which allows courts to proactively remove firearms from individuals who pose a significant danger … Continue Reading
Healthcare Providers Must Remember HIPAA Before Responding to Online Reviews
The latest HIPAA resolution agreement by the U.S. Department of Health and Human Services Office for Civil Rights (OCR) is a reminder that healthcare providers must take the high road when responding to unflattering online reviews by patients. While it is tempting to respond to a bad and perhaps untrue online review, healthcare providers need to take care to not … Continue Reading
Possible Relief for Hospitals in the Protection of PSO Information?
Last Thursday, September 5, 2019, Judge James Moody, Jr. of the United States District Court for the Middle District of Florida issued a positive ruling for hospitals dealing with patient safety organization (PSO) data. The opinion can be reviewed here. Note, while this decision is not binding on state courts, it is persuasive authority. It may be used to … Continue Reading
Long Delayed CVS/Aetna Merger Finally Gains Court Approval
Concluding one of the longest merger reviews in history, on September 4, Judge Richard Leon, District Judge for the District of Columbia, issued his final ruling in United States v. CVS Health, approving the proposed settlement of the United States’ challenge to CVS’s merger with Aetna. The ruling concludes Judge Leon’s eleven month review of the proposed settlement, during … Continue Reading
