Category Archives: Government Affairs, Licensure & Regulatory

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

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

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

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

2020 Legislative Session –A Sampling of Health Related Bills Filed

The 2020 Legislative Session will begin its 60-day trek to completion on Tuesday, January 14, 2020. The following is a sample of bills that have been filed. We encourage you to review these bills, and contact us with specific questions about them. The listing of these bills should not be interpreted as any indication that they will pass into law. … 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

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

Florida Patient Brokering Act Amended – Does it Clarify or Create New Issues?

The Florida Legislature recently passed HB 369 (the Bill), which would tweak an important provision of the Florida Patient Brokering Act, Section 817.505 of the Florida Statutes (Patient Brokering Act).  It seeks to clarify the exception to the Patient Brokering Act which incorporated by reference the criminal provisions of the federal Anti-Kickback Statute (42 U.S.C. S1320a-7b(b)) pertaining to illegal remuneration) … Continue Reading

2019 Legislative Session – The Passage of Telehealth (HB 23)

In the closing days of this year’s legislative session, the Florida House and Senate came to agreement on statutory language that adopts the parameters for telehealth for Florida. HB 23, sponsored by Representative Clay Yarborough, establishes a statutory basis for telehealth services, provides meaningful definitions of the terms telehealth and telehealth provider, and creates Section 456.47 Florida Statutes which … Continue Reading

Florida Legislature Repeals its “Certificate of Need” Law

In a somewhat surprising move, on April 29, 2019 the Florida Legislature passed legislation (HB 21) that repeals the state’s “Certificate of Need” (CON) laws with respect to general hospitals and tertiary services. Such laws, which are in place in many states, typically prohibit a healthcare provider from expanding its services and from entering new markets absent its … Continue Reading

District Court Further Extends Review of CVS/Aetna Merger

The District of Columbia District Court has again deferred its decision regarding whether to approve the merger between CVS Health and Aetna, a $69 billion transaction that was first announced back in December 2017. Notably, while the parties closed the transaction back in November of 2018, after reaching a proposed settlement with the US Department of Justice (DOJ) Antitrust Division … Continue Reading

Proposed Florida House Legislation Advances, Requiring Reporting to the State Proposed Hospital and Group Practice Acquisitions

A bill recently introduced in the Florida legislature (HB 1243) requires Florida hospitals and group physician practices contemplating mergers or acquisitions to provide advance notice of such transactions to the Florida Attorney General’s Office. The bill has been reported favorably out of the Florida Health Market Reform Subcommittee.  Currently, while the Florida Attorney General’s Office is authorized to, and frequently … Continue Reading

Antitrust Exemption Allows Health System to Avoid All Claims for Damages in Antitrust Class Action

Atrium Health (formerly known as Carolinas Healthcare System) scored a big victory in its defense of an antitrust class action on March 4, when the Court ruled that the plaintiffs in Benitez v. The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas Health System, could not seek damages in the action. In granting the defendant’s motion for judgment on the pleadings on … Continue Reading

Multiple States Considering Possible Modification to Their “Certificate of Need” Laws

In December, the U.S. Department of Health and Human Services issued a report – “Reforming America’s Healthcare System Through Choice and Competition” – expressly calling upon the states to repeal their “Certificate of Need” (CON) laws. In the report, HHS indicated that the existence of such laws – which typically prevent healthcare providers from expanding their services/entering new … Continue Reading

CVS Completes Acquisition of Aetna

In a filing with the Securities and Exchange Commission on November 26, CVS Health Corporation announced that it has received all of the regulatory approvals necessary to complete its acquisition of Aetna and that the transaction will close on or before November 28. The announcement follows the recent approvals of the deal received from California and New York regulators. CVS … Continue Reading

DOJ Settles “Anti-Steering” Antitrust Case Against Atrium Health

The United States Department of Justice Antitrust Division announced on November 15 that it was settling its antitrust lawsuit against Atrium Health (formerly known as Carolinas Health System). The action, United States v. Atrium Health, filed in the United States District Court for the Western District of North Carolina, challenged Atrium’s use of restrictions in its contracts with commercial … Continue Reading

DOJ Approves CVS/Aetna Merger, Contingent on the Sale of Aetna’s Medicare Part D Business

The United States Department of Justice Antitrust Division announced on October 10, 2018, that it was conditionally approving the CVS/Aetna merger, a $69 billion transaction that combines the nation’s largest retail pharmacy chain and the nation’s third largest health insurer. The deal, which was announced late last year, has been under review by the Antitrust Division (and state regulators) since … Continue Reading

Drug Pricing Legislation Sent to the President for Enactment into Law

Two pieces of related legislation that would prohibit so called “gag clauses” in contracts between pharmacists and health plans and pharmacy benefit managers (PBM’s) have been passed by both the Senate and the House. The legislation prohibits any restrictions on the ability of pharmacists to alert consumers to situations where it may be less expensive for them to pay for … Continue Reading

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