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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When a Gift Becomes a Kickback: Gifts from Florida Pharmacies to Long-Term Care Facilities

By Martin R. Dix on Posted in Pharmacy, Drugs, Medical Devices & Equipment
The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community Pharmacies. Normally the pharmacy and the long-term care (LTC) facility have a written agreement that governs the relationship between them. The pharmacy sends the … Continue Reading

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

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

By Martin R. Dix and Marcy Hahn-Saperstein on Posted in Hospitals & Health Systems, Laboratories, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment, Physicians
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

Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises

By Martin R. Dix on Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment
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

By Martin R. Dix on Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment
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

By Martin R. Dix on Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment
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.

By Martin R. Dix on Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment, Physicians
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

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

By Martin R. Dix on Posted in Pharmacy, Drugs, Medical Devices & Equipment, Physicians
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

Florida Pharmacy Collaborative Practice Agreements: Defining the Scope of Practice

By Martin R. Dix on Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment, Physicians
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

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

By Marcy Hahn-Saperstein and Martin R. Dix on Posted in Health Care Providers, Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment
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

By Martin R. Dix and Danielle C. Gordet on Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment
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

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

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

Florida Board of Pharmacy Adopts Emergency Rule Excusing Off-Site Consultant Pharmacists from Conducting Monthly Visits to Facilities During COVID-19 Pandemic

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

Managing the Healthcare Workplace During the COVID-19 Outbreak

By Karen M. Buesing and Martin R. Dix on Posted in Healthcare Law, HIPAA, Privacy, and Data Security, Hospitals & Health Systems, Labor Relations & Employment Law, Physicians
Healthcare providers have special concerns for their employees during the Coronavirus (COVID-19) global health pandemic. Because COVID-19 spreads primarily as a result of close exposure to an infected person, healthcare employees are at higher risk of infection. While OSHA has a standard to protect employees from the spread of bloodborne pathogens, it currently has no … Continue Reading

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

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

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

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

Paper Prescription Pads to go the Way of the Horse and Buggy as Prescribers Will Soon Be Required to Electronically Transmit Prescriptions – Sometimes

By Martin R. Dix on Posted in Electronic Health Records & Medical Records, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment
Governor Desantis recently signed House Bill 831, which will require certain healthcare practitioners to “electronically transmit prescriptions”. Unfortunately, the legislature left this term undefined, creating some ambiguity as to what the law requires. While the legislature likely intended this law to require “electronic prescribing,” the statute does not say that, and therefore the term “electronically … Continue Reading

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

By Martin R. Dix and Thomas A. Range on Posted in Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment
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 … Continue Reading

Florida Imposes new ID Requirements for Pharmacist Dispensing of Controlled Substances

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

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

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

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

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

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

By Martin R. Dix and Thomas A. Range on Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Healthcare Litigation
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) … Continue Reading

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

By Martin R. Dix, Martin L. Monaco, Jr. and Richard L. Spees on Posted in Affordable Care Act and Other Healthcare Reform Legislation, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment
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 … Continue Reading
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