Category Archives: Pharmacy, Drugs, Medical Devices & Equipment

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ACTION REQUIRED TO AVOID FINES! DEADLINE APPROACHING: Florida Pharmacy Benefit Managers Must Be Licensed as a Third-Party Administrator by January 1, 2024

Pharmacy Benefit Managers (PBMs) take note! Under Florida’s new Prescription Drug Reform Act, PBMs must be licensed as an insurance administrator (also known as a third-party administrator, or TPA). Under this new law, any entity that wishes to provide PBM services after January 1, 2024, must be licensed as a TPA.… Continue Reading

Health Apps Beware: FTC Clarifies Health Breach Notification Rule with Significant Proposed Changes

Direct-to-consumer health and wellness applications are forewarned: the Federal Trade Commission (FTC) is proposing changes to the Health Breach Notification Rule (HBNR), 16 C.F.R. part 318, that, if finalized, would cement the HBNR’s applicability to a broad swath of direct-to-consumer health and wellness applications (apps) and confirm that a breach of security includes not only … Continue Reading

New Florida Law Will Impose A Third-Party Administrator Licensing Requirement for Pharmacy Benefit Managers

On May 3, 2023, the Florida governor signed a comprehensive law (SB 1550) regarding pharmacy benefit managers (PBMs). This new law imposes significant new requirements on PBMs. This article discusses only one of these new requirements: a PBM must obtain a license, called a certificate of authority, to act as an insurance administrator, which is … Continue Reading

The FTC Sends Another Warning to Digital Healthcare Platforms About Use of Tracking Pixels

The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for sharing consumer health information for advertising purposes (see our blog posts on each respective action here and here), and in a post published by the FTC … Continue Reading

FTC Cracks Down on BetterHelp’s Sharing of Health Information for Advertising 

Following its February settlement with GoodRx, the Federal Trade Commission (FTC) has fired another shot across the bow in its ongoing campaign to protect consumers’ digital health information. Earlier this month the FTC announced a consent order with BetterHelp, Inc., an online mental health counseling service, to resolve alleged violations of the Federal Trade Commission … Continue Reading

FTC’s Enforcement Action Against GoodRx Breathes New Life into Decade Old Regulation

The Federal Trade Commission (FTC) didn’t mince words. On September 2021, it called out the health app industry for failing to understand the agency’s Health Breach Notification Rule (HBNR) and for not disclosing its breaches. Apparently dissatisfied with the industry’s response, the agency enforced the HBNR against GoodRx for the first time since the rule … Continue Reading

May Resident Physicians Use Hospital DEA Registration Numbers Off-Site?

A Florida “resident physician” is someone who has completed their internship and graduated from medical school but is not yet licensed as a Florida medical doctor or osteopathic physician and who registers with the Department of Health as a resident physician. Resident physicians have to complete at least a one-year residency before they can take the … Continue Reading

Fix Your Weak Links in Your Medicaid Claims

Medicaid providers and suppliers have likely discovered this the hard way. A provider’s or supplier’s enrollment in the Medicaid program may be insufficient to assure that their provision of a covered and medically necessary good or service to a Medicaid patient will be deemed reimbursable. That is because the Medicaid program will also look at … Continue Reading

State Attorneys General Flex in a Post-Dobbs world – can complying with federal regulatory guidance constitute racketeering activity?

Are State Attorneys General expanding their reach in this Post-Dobbs world? On February 1, 2023, twenty state Attorneys General signed letters to both CVS and Walgreens warning the giant retail pharmacies against mailing medications that could potentially be used to induce abortions. These letters are most notable for the legal posture they assume. The state … Continue Reading

Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises

Chapter 2022-60, Laws of Florida (http://laws.flrules.org/2022/60), that went into effect July 1, 2022, allows registered pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.”  These pharmacy technicians will be allowed to administer all of the vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC … Continue Reading

Updated for Expanded DDC Interpretation: 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 … Continue Reading

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 … 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 … 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 … 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 … 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 … 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 … 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 … 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, … 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 … 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 … Continue Reading
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