Category Archives: Pharmacy, Drugs, Medical Devices & Equipment

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New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and Cosmetic Permits

Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come. When an applicant files for a change of ownership (“CHOW”) or change of location for one of the permits authorized by the Florida Department of Business Professional Regulation, Division of Drugs, Devices, and Cosmetics (affectionately, … Continue Reading

Have Paper Prescriptions Gone the Way of the Horse and Buggy? Almost.

For most Florida prescribers whose licenses haven’t renewed since 2019, it’s time to commence electronic prescribing. In 2019, the legislature enacted legislation that required electronic prescribing. However, this requirement became effective on the earlier of the prescriber’s license renewal date or July 1, 2021. Section 456.42(3), Florida Statutes requires health care practitioners to “electronically transmit prescription(s).”  This term is not … Continue Reading

New Florida Laws Focus on Health Care

Before closing its 2021 session, the Florida Legislature passed several bills that impact health care, summarized below.

The first bill discussed below regarding civil liability became effective on March 29, 2021. The majority of the other bills became effective on July 1, 2021.… Continue Reading

Not Without Their Parents – No Pharmacy Services to Florida Minors without Parental Consent

Pharmacists and other providers should beware of a medical consent requirement buried in the new “Parents’ Bill of Rights” signed by Governor Desantis. The law will be codified at Fla. Statutes § 1014.06 and became effective on July 1, 2021. While most see it as an educational bill that allows parents to be more involved in decisions about the education … Continue Reading

New Supreme Court Ruling Affirms State Regulation of PBM Reimbursement Pricing

The U.S. Supreme Court ruled against pharmacy benefit managers (“PBMs”) last month, in a decision that marks a major win for state regulators. (See Rutledge v. Pharmaceutical Care Management Association, 2020 WL 7250098 (U.S. 2020)). On December 10, 2020, the U.S. Supreme Court held that Arkansas’s Act 900, which “effectively requires PBMs to reimburse Arkansas pharmacies at a … Continue Reading

Florida Pharmacy Collaborative Practice Agreements: Defining the Scope of Practice

While the COVID-19 pandemic made 2020 a trying year, one unintended benefit was that the Florida legislature allowed pharmacists to further expand their scope of practice to help patients with certain chronic conditions through collaborative practice agreements. Though, as discussed below, they did not make it easy.… Continue Reading

Physicians: Beware of FTC Rules for Product Endorsements

It has become increasingly common for physicians and other healthcare professionals to share medical information with the public via video platforms, blogs, and social media sites. That can be a great public service, especially during the pandemic, but when public communications include a positive review or other favorable mention of medical products or services, such statements can unwittingly come within … Continue Reading

COVID-19 and Possible Silver Bullets: Update on Vaccine Development

As the world continues to grapple with the COVID-19 pandemic that has taken the lives of over 250,000 Americans, and worldwide over 1 million people, this year, an effective vaccine has emerged as our silver bullet – a way for the nation, and the world, to fight back and, in time, begin to return to some semblance of normalcy. There … Continue Reading

DOJ Antitrust Division Grants Green Light for Pharma Companies Sharing COVID-19 Treatment Drug Production Information

The Department of Justice Antitrust Division has advised several pharmaceutical companies that they can share competitive information regarding the status of their respective efforts to develop a COVID-19 treatment without running afoul of the federal antitrust laws.  Specifically, in a letter issued on July 23, the Antitrust Division stated that it had no intention to challenge a proposal by … Continue Reading

Novartis’ Simultaneous Settlements Break Records

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an Anti-Kickback Statute lawsuit brought by a whistleblower pursuant to the False Claims Act’s (FCA) qui tam provision, Novartis, a pharmaceutical company based in East Hanover, New Jersey, has agreed to … Continue Reading

As COVID-19 Spreads, Florida Pharmacists’ Scope of Practice Expands

Florida has been contemplating ways to increase patient access to care, especially in light of the COVID-19 pandemic and the anticipated increase in cases. Recognizing the accessibility of pharmacies, Florida is now authorizing certain qualified pharmacists to perform testing, screening, and treatment of nonchronic diseases and specific treatment of certain chronic conditions.… Continue Reading

Pharmacy Testing Centers: A Prescription for Fighting COVID-19 in Florida

Pharmacists can now engage in a new role in the battle against COVID-19 – testing patients for the virus.  Recognizing the advanced health care training that pharmacists receive and the unique consumer access to community pharmacies during the Pandemic, the Florida Department of Health has designated pharmacists as medical professionals authorized to order and provide COVID-19 tests. Additionally, pharmacies, as … Continue Reading

Dose of Caution Needed When Making Coronavirus Drug Claims

Just like the dose makes the poison, the claim makes the drug.

With a pandemic well underway, some marketers are offering products that they claim will treat or prevent COVID-19, the disease caused by the novel coronavirus. Without federal approval, however, anyone making claims about unapproved drugs risks is inviting a federal enforcement action. As a result, marketers should exercise … Continue Reading

Prescribing in Florida During the Pandemic-What is allowed, What are the gaps, and How do we fill them?

The catchphrase of the day is “social distancing” and it is the primary means of flattening the COVID-19 pandemic (the “Pandemic”) curve by keeping contagious and healthy people apart. However, there is another kind of distancing that may play a role in fighting the Pandemic – “health care distancing.” Health care distancing is a mechanism to keep the sick patients, … Continue Reading

California Telehealth Updates

California 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 … 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

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

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies.  President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a mechanism to reduce prescription drug prices.

First, at the federal level, as a result of the President’s interest, in June 2018, DHHS Secretary Azar … Continue Reading

Florida Board of Pharmacy Initiates Work on International Export Pharmacy Permit Application and Rules

International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the Board’s responsibilities under House Bill 19, which went into effect on July 1, 2019. Section 465.0157, FS, establishes an “international export pharmacy” permit as part of … Continue Reading

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