Category Archives: Government Affairs, Licensure & Regulatory

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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

FTC Announces Settlement of Antitrust Action Against Therapist Staffing Company Accused of Fixing Therapist Wages

In the Matter of Your Therapy Source, LLC – is the most recent example of federal antitrust enforcers’ increasing interest in curtailing anticompetitive conduct in employee markets, which was first announced when the Federal Trade Commission (FTC) and the Department of Justice (DOJ) issued guidance on the subject in late 2016. See Antitrust Guidance For Human Resource Professionals (available hereContinue Reading

How the Trump Tariffs Affect Healthcare

It’s not just pile drivers, combines, and frozen fish. Much of the news coverage has discussed how industrial and agricultural products are subject to new Trump administration tariffs on goods imported from China.  However, the list of Chinese products subject to the new tariffs also includes goods more familiar to healthcare providers: items like pacemakers, rubber medical gloves, MRI and … Continue Reading

House Commerce Committee Urges the FTC to Investigate Past PBM Mergers

The leadership of the House Energy & Commerce Committee has called upon the Federal Trade Commission to undertake a retrospective review of past mergers involving pharmacy benefit managers (PBMs). Specifically, in a July 27 letter to FTC Chairman Joseph Simons, House Commerce Committee Chairman Greg Walden (R-OR) requested that the FTC examine “(1) how these mergers have affected downstream prices … Continue Reading

States Begin to Hold Hearings on the Proposed CVS/Aetna Merger

In December of 2017, CVS Health and Aetna announced their intention to merge. The transaction, if approved by regulators, would combine the country’s second largest pharmacy benefit manager (PBM), Caremark – a CVS subsidiary – and the nation’s third largest commercial health insurer, Aetna, and has been valued at $69 billion. Since the announcement, federal and state regulators have been … Continue Reading

Will President Trump’s Supreme Court Pick Have an Influence on The Healthcare Industry?

On July 9, 2018, President Trump announced his intention to nominate D.C. Circuit Court Judge Brett Kavanaugh to replace retiring Justice Anthony Kennedy on the Supreme Court. Since the announcement, there has been considerable discussion about what Judge Kavanaugh’s views are on several “hot button” issues, including free speech, religious-rights and abortion, and how Judge Kavanaugh might influence the law … Continue Reading

FDA Ponders Health and Safety of Lab-Grown Meat

The hamburger of the future might be less Old MacDonald and more sci-fi – and it might be here sooner than you think. Several startups are working to scale up animal cell culture technology to grow meat tissue for human consumption. Proponents hail the nascent industry’s potential to reduce foodborne illnesses such as E. coli, lessen the environmental impacts of … Continue Reading

Florida Court Affirms Rejection of CON of a Hospice Operator’s Application, Despite a “Regional Monopoly”

Florida’s First District Court of Appeals has affirmed a decision by the Florida Agency for Health Care Administration (AHCA) that denied an application by Compassionate Care Hospice of the Gulf Coast (CCH) to open a hospice in Sarasota County.  (Compassionate Care Hospice of the Gulf Coast v. State of Florida, No. 1D16-5062, Fla. Dist. Court of Appeals). Notably, AHCA … Continue Reading

The 2018 SMMC Proposed Contract Awards: Where Do You Go From Here?

On April 24 the Agency for Health Care Administration (“AHCA”) released its proposed contract awards for the Statewide Medicaid Managed Care (“SMMC”) Program.  The determinations that AHCA made for this 5 year, $90 billion re-procurement were surprising to many and are likely to result in a significant reshaping of the program that currently exists.  First, however, AHCA must resolve any … Continue Reading

DEA Implements CARA, Enlisting Mid-Level Practitioners in the War on Opioid Addiction

Prior to the Comprehensive Addiction and Recovery Act of 2016 (CARA) only “physicians” could dispense and prescribe narcotic drugs for maintenance and detoxification treatment. CARA expanded who may prescribe for maintenance and detoxification treatment to “qualifying practitioners” (temporarily through October 1, 2021), a broader term than “physicians” that allows for a wider array of practitioners to prescribe. This change opened … Continue Reading

2018 Legislative Session –A Sampling of Health Related Bills Filed

The 2018 Florida Legislative Session began its 60 day trek to completion on Tuesday, January 9, 2018.  Both House and Senate will be debating various health related bills which may be of interest to healthcare providers in the State.  The following is a sample of those bills which we feel are pertinent to our clients’ practices and the patients/customers that … Continue Reading

AHCA Sees the Light on Nursing Home Generator Rule, Unplugging Challenge

After Hurricane Irma made landfall in Florida, a nursing home in South Florida lost power, and several residents of that nursing home died allegedly as the result of increased temperatures caused by the loss of air conditioning. In the immediate aftermath of this tragic accident, the Agency for Health Care Administration (AHCA) (for nursing homes) and the Department of Elder … Continue Reading

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