Category Archives: Pharmacy, Drugs, Medical Devices & Equipment

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TV Drug Commercials Must Disclose the Drug’s List Price if HHS Adopts Proposed Rule

We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them. The U.S. Department of Health and Human Services (HHS) announced a proposed rule that would require pharmaceutical companies that advertise their prescription drug products on television to also disclose … 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

CMS Announces Loosening of Rules Regarding Part D Formularies

In a memorandum issued by the Centers for Medicare and Medicaid Management (“CMS”) on August 29, 2018, the federal government outlined new ‘flexibility’ and tools for Part D plans to “expand choices and lower drug prices for patients.” Beginning in 2020, Part D plans will be able to utilize what is called ‘indication-based formulary design’ to change their drug formularies … 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

Florida Imposes new ID Requirements for Pharmacist Dispensing of Controlled Substances

The Florida legislature passed HB 21, which imposes a number of new requirements on prescribers and pharmacists regarding controlled substance prescribing and dispensing. Part of the law requires pharmacists to verify the identity of the person named on the prescription. These requirements do not apply in an institutional setting or to a long-term care facility, including assisted living facilities or … Continue Reading

Pharmacies Accuse Drug Maker of Anticompetitive Contracting to Restrict Biosimilar Market

Walgreens and Kroger have filed an antitrust action in the United States District Court for the Eastern District of Pennsylvania accusing Johnson & Johnson (J&J) of engaging in anticompetitive conduct designed to stymie the growth of biosimilar alternatives to J&J’s Remicade, a biologic drug used to treat certain chronic immune disorders (Walgreen Co. v. Johnson & Johnson, Case … Continue Reading

Derailing the Gravy Train – Trump Unveils Plan to Reduce Drug Prices

Throughout his presidential campaign, President Trump championed the need to allow the government to negotiate drug prices on behalf of the Medicare program. However, that third rail for pharmaceutical companies was not included as part of the President’s recently released blueprint for lowering drug prices. Instead, the plan takes aim at the entire supply chain that lies between drug manufacturers … Continue Reading

Class III Hospital Permits – Efficient Drug Management May Become a Reality

At the close of the 2018 session, the Florida Legislature passed Senate Bill (SB) 675, which if allowed to become law by the Governor, will help hospitals and their facilities that are under common control manage their patients’ drugs much more efficiently. Under prior law, the hospitals had to obtain a restricted drug distributor-health care entity permit to allow the … 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

Get your Single IRB lined up for Multi-Site Research

Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted, supported, or regulated by the federal government. While many of the Common Rule changes go into effect in 2018, the single IRB requirement has a compliance date … Continue Reading

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the exchange plans, the donut hole for Medicare Part D, states’ necessary Medicaid rebates, and certain recipients of 340B drugs.… Continue Reading

DEA Tweaks, Walks Back Changes to Renewal Process

DEA recently revised an earlier announcement that would have eliminated the grace period for renewals of controlled substance registrations. After initially declaring that prescribers and other registrants would no longer be able to renew their expired registrations during a grace period, DEA announced it would instead continue allowing that practice – for now at least. As a result, registrants who … Continue Reading

Deciphering Florida’s New Laws on ARNP and PA Controlled Substance Prescribing

During the 2016 legislative session, Florida granted authority to both advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to prescribe controlled substances, subject to approval by their supervising practitioner. This change brings these professionals’ authority in line with what most other states allow. However, this was not a complete grant of prescribing authority and, as explained below, leaves these … Continue Reading

Recent CyberSecurity Incidents Emphasize Importance of Cyberinsurance

As the threat of cyberattacks continues to pose daily threats to businesses large and small, more companies have turned to cyber insurance products to shore up protection against these disruptive threats. A spate of recent incidents has highlighted the importance of taking steps to prepare for and mitigate possible damages. As such, healthcare entities have begun exploring Cyberinsurance as a … Continue Reading

Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals

The 2016 Florida Legislature enacted substantial legislation (Ch. 2016-212, Laws of Florida) to bring Florida’s Drug and Cosmetic Act (Ch. 499, Florida Statutes) in line with the federal Drug Supply Chain and Security Act (“DSCSA”). Since the DSCSA preempts state law, the changes were necessary to avoid confusion between the state and federal exemptions to the term “wholesale … Continue Reading

Recent Legislative Developments Affecting Florida Pharmacies

Florida’s 2015 Legislative Session ushered in two new laws affecting pharmacies: One addressing pharmacist immunizations (HB 279) and the second clarifies that veterinarians are authorized to dispense compounded drugs and regulates “maximum allowable cost” pricing (HB 1049). In addition, the FDA has delayed enforcement of certain provisions of the federal Drug Quality and Security Act (DQSA) that went into effect … Continue Reading

OIG’s Rejection of Payments for Prescription Transfers Leaves Questions about Central Fill Pharmacy Arrangements.

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently refused to bless a specialty pharmacy’s request to pay a per-prescription fee to retail pharmacies for “support services” to be provided in connection with prescriptions transferred to the specialty pharmacy (OIG Advisory Opinion 14-06). The OIG found that the per prescription fee could influence the retail … Continue Reading

Guidance Helps Medical Device Companies Determine Substantial Equivalence

When is a medical device substantially equivalent to another device? Like so much else, it depends. On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance that aims to clarify that question. The document is officially directed at FDA staff, but it is equally instructive to companies seeking FDA approval for their devices.

The FDA … Continue Reading

FDA Offers Guidance for Choosing Prescription Drug Names

If you’ve seen your share of prescription drug commercials, you’ve likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations of letters, but naming a drug requires more than a marketing brainstorm session. A recent draft guidance document from the U.S. Food and Drug Administration (“FDA”) shows many considerations go … Continue Reading

FDA Issues Draft Guidance for Drug and Device Information on Social Media

The Food and Drug Administration (“FDA”) recently issued two draft guidance documents relating to the use of Twitter and other social media by drug and medical device companies. Emphasizing that companies must give a balanced presentation of their products, the Agency stated that companies must provide risk information along with any benefit information within a tweet or similar promotional message.… Continue Reading

Florida Board of Pharmacy Clarifies that Pharmacies Can’t Compound Sterile Human Drugs for “Office Use”

The Florida Board of Pharmacy rules allow pharmacies to engage in office-use compounding. Rule 64B16-27.700, FAC. This allows pharmacies to compound drugs for physicians to use in treating their patients in the office without writing a patient-specific prescription. It does not allow the physician to dispense the office-use drugs to their patients (i.e. give the patient a supply to take … Continue Reading

Florida Says Can Do To Medical Cannabis

In the waning days of the 2014 legislative session, the Florida Legislature passed the Compassionate Medical Cannabis Act of 2014.  It is a very limited medical marijuana bill with very strict restrictions and conditions on use.  The bill allows access to only low-THC (tetrahydrocannabinol) cannabis (so-called “Charlotte’s Web”) for persons with cancer or another condition that produces seizures or … Continue Reading

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