Martin R. Dix

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Board Certified by The Florida Bar in Health Law, Martin Dix focuses his practice primarily on pharmacy and drug distribution law. His clients encompass nearly all aspects of the legal drug delivery system, including pharmacies, pharmacists, and pharmacy benefit managers; drug wholesalers; drug and dietary supplement manufacturers; retail medical oxygen dealers; and compressed medical gases wholesalers. He has also represented a variety of other health care providers and entities, such as physician practices, health care clinics, clinical laboratories, mental health centers, home health agencies and hospitals.

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

By Martin R. Dix on Posted in Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment, Physicians
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, … Continue Reading

The Board of Pharmacy’s 40 Hour Rule is Dead! Long live the 20 Hour Rule! Community Pharmacy Ownership Rule Change Creates new Opportunities

By Martin R. Dix and Stacey L. Callaghan on Posted in Government Affairs, Licensure & Regulatory, Healthcare Law
The Florida Board of Pharmacy (BOP) recently amended the rules regarding community pharmacy hours of operation to reduce required daily operating hours from 40 to 20 hours per week. As before, the hours have to be posted and the pharmacy must have a policy and procedure for transferring prescriptions and addressing emergency doses.… Continue Reading

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

By Martin R. Dix on Posted in Healthcare Law, Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment
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 … Continue Reading

Recent Legislative Developments Affecting Florida Pharmacies

By Martin R. Dix on Posted in Government Affairs, Licensure & Regulatory, Pharmacy, Drugs, Medical Devices & Equipment
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) … Continue Reading

New HIPAA Guide to Privacy and Security of Electronic Health Information

By Martin R. Dix on Posted in HIPAA, Privacy, and Data Security
The HHS Office of the National Coordinator for Health Information Technology (ONC) recently released Version 2.0 of its Guide to Privacy and Security of Electronic Health Information (Guide). The Guide is primarily applicable to physician groups and smaller health care providers and businesses, but it provides a good overview of HIPAA for any covered entity. … Continue Reading

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

By Martin R. Dix on Posted in Pharmacy, Drugs, Medical Devices & Equipment
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 … Continue Reading

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

By Martin R. Dix on Posted in Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment, Physicians
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 … Continue Reading

Florida Says Can Do To Medical Cannabis

By Martin R. Dix and Sheryl D. Rosen on Posted in Pharmacy, Drugs, Medical Devices & Equipment, Physicians
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 … Continue Reading

Florida Acknowledges Exemption for Intracompany Sales of Pharmaceuticals

By Sheryl D. Rosen and Martin R. Dix on Posted in Pharmacy, Drugs, Medical Devices & Equipment
A new declaratory statement from Florida regulators clarifies the restrictions on intracompany sales of pharmaceuticals.  Previously, if one pharmacy in Florida wanted to send a bottle of prescription medicine to its sister pharmacy down the street, it had to obtain a type of wholesale drug distributor permit, as well as provide pedigree papers for the … Continue Reading

HHS Makes Good on Its Promise: Releases HIPAA Guidance for Refill Reminder Programs

By Martin R. Dix on Posted in HIPAA, Privacy, and Data Security, Pharmacy, Drugs, Medical Devices & Equipment
As previously reported, HHS announced earlier this month that it would be providing clarification on the HIPAA Privacy Rule as it relates to marketing and prescription refill reminder programs.  On September 19, 2013, HHS made good on that promise when the Office for Civil Rights announced guidance on when refill reminders and other communications about … Continue Reading

HHS to Revamp Limits on Payments to Pharmacies for Refill Reminder Programs

By Martin R. Dix on Posted in HIPAA, Privacy, and Data Security, Pharmacy, Drugs, Medical Devices & Equipment
The HIPAA Privacy Regulations have long required covered entities to seek a patient authorization in order to use or disclose protected health information (“PHI”) for marketing purposes. However, the Office for Civil Rights made it clear in its Q and A on its website that pharmacies were allowed to provide refill reminders to patients without … Continue Reading

Florida Board of Pharmacy Approves the Centralized Prescription Filling Rule (Central Fill Pharmacy) for Hospital Pharmacies

By Martin R. Dix on Posted in Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment
On August 14, 2013 the Florida Board of Pharmacy voted to approve central fill pharmacy in a hospital setting. Centralized prescription filling or “central fill” is where two pharmacies separate the duties and responsibilities of dispensing a prescription. Generally, one pharmacy will receive the prescription and send it to, or share it with, another pharmacy … Continue Reading

Recent Judicial Activity on the Pharmacy Front

By Martin R. Dix on Posted in Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment
Reimbursement for the Difference Between the Brand and Generic Drug Graphic Communications Local 1B Health & Welfare Fund “A”, et al., Appellants, vs. CVS Caremark Corporation, et al.,  State of Minnesota Court Of Appeals, Case No. A12-1555 (May 6, 2013). A recent decision by the Minnesota Court of Appeals reversed the dismissal of a case … Continue Reading

Florida Board of Pharmacy Continues to Review Sterile Compounding Issues

By Martin R. Dix on Posted in Pharmacy, Drugs, Medical Devices & Equipment
In light of the horrific meningitis outbreak attributed to drugs compounded by Massachusetts’ New England Compounding Center (“NECC”) in 2012, state boards of pharmacy around the country are undertaking a comprehensive review of their regulations governing sterile compounding and the enforcement of existing and new regulations. Sterile compounding generally involves a pharmacy compounding drugs that … Continue Reading
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