Navigating the Complexities of Pharmacy Law with Florida Healthcare Law Firm

In the ever-evolving landscape of healthcare, one crucial aspect that often goes under the radar is pharmacy law. As an integral component of the broader legal framework, pharmacy law plays a pivotal role in regulating and ensuring the safe and effective practice of pharmacy professionals. In the state of Florida, where healthcare regulations are stringent, understanding and adhering to pharmacy law is of paramount importance. This is where specialized legal entities like the Florida Healthcare Law Firm come into play, providing guidance and expertise to navigate the intricate nuances of pharmacy law.

What is Pharmacy Law?

Pharmacy law encompasses a set of regulations and statutes that govern the practice of pharmacy professionals, ensuring the safety and well-being of patients. It covers a wide range of aspects, including licensing requirements, prescription and dispensing regulations, record-keeping, and the prevention of drug abuse. Essentially, pharmacy law serves as a comprehensive guide that outlines the ethical and legal responsibilities of pharmacists and other healthcare professionals involved in the pharmaceutical supply chain.

Florida Board of Pharmacy Law

In the state of Florida, the Florida Board of Pharmacy is the regulatory authority responsible for overseeing and enforcing pharmacy law. This board sets the standards for pharmacy practice, issues licenses to qualified professionals, and takes disciplinary actions when necessary. Pharmacists in Florida must stay abreast of the regulations outlined by the board to ensure compliance with the law. Any deviation from these regulations can lead to severe consequences, including license suspension or revocation.

Navigating the Complexities with Florida Healthcare Law Firm

Given the intricate nature of pharmacy law, seeking legal counsel becomes imperative for pharmacy professionals and entities involved in the pharmaceutical industry. The Florida Healthcare Law Firm stands out as a beacon of expertise, specializing in healthcare-related legal matters, including pharmacy law. Their team of seasoned lawyers possesses an in-depth understanding of the ever-changing legal landscape and is well-versed in Florida-specific regulations.

The firm provides a range of services tailored to the needs of pharmacy professionals, including legal counsel on licensing and compliance, representation in disciplinary actions, and assistance in navigating the complexities of pharmacy law. With their finger on the pulse of the legal system, the Florida Healthcare Law Firm ensures that clients remain informed and empowered to make decisions that align with the legal framework.

Florida Pharmacy Law: A Multifaceted Approach

Florida’s pharmacy law is multifaceted, covering everything from prescription requirements to controlled substance dispensing. Pharmacists must comply with regulations related to prescription labeling, patient counseling, and maintaining accurate records. The Florida Healthcare Law Firm helps pharmacy professionals interpret and implement these regulations effectively, reducing the risk of legal pitfalls.

The Role of a Pharmacy Lawyer

Pharmacy lawyers play a crucial role in safeguarding the interests of pharmacists and pharmaceutical entities. These legal professionals offer proactive guidance to ensure compliance with pharmacy law, represent clients in legal proceedings, and provide strategic advice to navigate the complex regulatory landscape. With the Florida Healthcare Law Firm, pharmacy professionals have a dedicated ally to protect their interests and uphold the highest standards of practice.

In conclusion, pharmacy law is a dynamic and essential component of healthcare regulation. Navigating the intricacies of pharmacy law in Florida requires specialized knowledge and expertise. The Florida Healthcare Law Firm serves as a valuable partner, offering guidance and legal support to pharmacy professionals, ensuring compliance with the law and fostering a safe and effective pharmaceutical practice in the state. As the legal landscape continues to evolve, having a trusted legal ally becomes indispensable for those in the pharmacy profession.

What Are Compounding Pharmacies?

Making capsules in the pharmacy laboratory with a manual machine

In the realm of healthcare, individual patient needs sometimes call for medications that are not commercially available in standard dosages or forms. This is where compounding pharmacies step in. Compounding pharmacies play a crucial role in tailoring medications to meet specific patient requirements, ensuring personalized care. In this blog post, we will explore the concept of compounding pharmacies, their benefits, and the regulations governing their practices in Florida.

What are Compounding Pharmacies?

Compounding pharmacies are specialized facilities that prepare customized medications for patients based on prescriptions from healthcare providers. These pharmacies employ highly trained pharmacists and technicians who possess the knowledge and skills to combine or alter ingredients to create medications that cater to unique patient needs. Compounded medications are prepared in response to specific patient prescriptions, taking into account factors such as allergies, dosage requirements, and preferences.

Benefits of Compounded Medications:

Compounded medications offer several benefits, making them a valuable resource in the healthcare landscape. First and foremost, they enable healthcare providers to address individual patient needs that cannot be met by commercially available medications. Compounded medications can be prepared in various forms, such as creams, gels, capsules, or even flavored liquid suspensions, making them more convenient and easier to administer, especially for pediatric and elderly patients. Additionally, compounding pharmacies can combine multiple medications into a single dosage, simplifying complex medication regimens and improving adherence.

Regulations and Quality Assurance:

Compounding pharmacies in Florida are regulated by state and federal laws to ensure patient safety and medication quality. The Florida Board of Pharmacy oversees the licensing and operation of compounding pharmacies, while the U.S. Food and Drug Administration (FDA) provides regulatory oversight at the federal level. These regulations cover various aspects, including the sourcing and handling of ingredients, the training and qualifications of personnel, facility standards, and quality control measures.

Collaboration with Healthcare Providers:

Compounding pharmacies work closely with healthcare providers to ensure that medications are customized appropriately. Physicians, dentists, and veterinarians can collaborate with compounding pharmacists to determine the most suitable formulations and dosages for their patients. This collaboration allows for a tailored approach to patient care, taking into account unique medical conditions, allergies, and dosage preferences.

Compounding pharmacies play a vital role in providing customized medications that address the unique needs of individual patients. By working in collaboration with healthcare providers, these pharmacies ensure that patients receive personalized care and have access to medications that may not be available through standard commercial channels. By adhering to strict regulations and maintaining high-quality standards, compounding pharmacies in Florida continue to contribute to patient-centric healthcare, providing tailored solutions for improved treatment outcomes.

Pharmacy Fraud: Data Tells the Story

Today’s Topic:  Did you know the DOJ never tires of chasing the bad guys?

If a pharmacy is going to engage in nefarious activities, it should expect to get caught. Fraud in these cases is generally easy to prove. Simply verifying inventory, orders and dispensing records yields incredible data that when combined with comparative data from peer pharmacies can be used by law enforcement to establish that fraud has been committed.

Latest Enforcement Activity

On April 13, 2022, the U.S. Department of Justice (DOJ) announced a 78-month prison sentence imposed against a 37-year-old owner/operator of several pharmacies in New York, Aleah Mohammed (Mohammed). The sentence was as a result of guilty plea entered by Mohammed in April 2021 for charges of mail fraud, health care fraud and conspiracy to commit health care fraud. As part of her guilty plea, Mohammed agreed to forfeit $5.1 million and pay $6.5 in restitution.

During the course of her criminal conduct, Mohammed engaged in multiple schemes to defraud health care programs, including obtaining more than $6.5 million from Medicare Part D Plans and Medicaid drug plans. Over a five-year period, Mohammed submitted fraudulent claims to Medicare and Medicaid for prescription drugs that were:

  • not dispensed;
  • not prescribed as claimed;
  • not medically necessary;
  • dispensed during a time when one or more of the pharmacies she operated was no longer registered with the State of New York; and
  • often for expensive prescription drugs to treat HIV.

Adding to the mounting evidence against her, Mohammed led a lavish lifestyle and purchased luxury items such a Porsche and jewelry.

Lessons Learned

It seems that criminals never learn. They think that they are smarter than law enforcement and will never get caught. But rarely do those criminals win in the end. It is basic accounting and law enforcement knows how to do that. Law enforcement mines each pharmacy’s data and looks for outlier information as compared to peer pharmacies as well as inventory data. So what information did the DOJ have at its disposal in this case?

  1. On hand inventory. As with any payer audit, the payer (and law enforcement) can obtain information concerning inventory on hand. If the pharmacy never had the inventory, it could not sell the drug.
  2. Drug purchasing records. Again, unless a pharmacy had the drug in inventory or purchased the drug through one of its wholesalers, it is hard for the pharmacy to defend against fraud charges when it is filing a claim for drugs never in its inventory.
  3. Dispensing records. Dispensing records also reveal information essential to determining what was in inventory, what was purchased and what was dispensed.
  4. Comparative data concerning dispensing of high-cost drugs as a proportion of other drugs sold.
  5. Comparative data looking at peer pharmacies for dispensing trends.

Collectively, the data and these records make it easy for law enforcement to identify and prosecute fraudulent claims. Even so, criminals seemingly are undeterred, and schemes like this one are repeated time and again.

Closing Thoughts

Simply put, crime does not pay. It does not matter whether it is in the pharmacy industry or elsewhere, when government funds are involved, law enforcement will surely be looking for wrongdoers. This probably is not the last case of its kind this year, so expect to see more news of pharmacies/pharmacists behaving badly.

Controlled Substances Dispensing Gets Pharmacy in Trouble – AGAIN!

Yet another pharmacy owner was just convicted of unlawfully dispensing over 1.5 million doses of controlled substances, primarily oxycodone and hydrocodone. 

By: Karen Davila

In my last couple of articles, I’ve focused on the controls necessary to safely operate a pharmacy and dispense appropriate prescribed medications, including controlled substances.  And those of you who heed that kind of advice are likely to avoid the unwanted attention of law enforcement.  However, for those who continue to think they can operate with impunity, heads’ up:  the war against opioids in the U.S. is ongoing and enforcement activities are not slowing down.  Below is an article about this recent case out of Texas and some lessons we can all take away from what was reported.

In this most recent case, a federal jury in Texas convicted a Texas pharmacy owner (Carr) on March 7 of one count of conspiracy to unlawfully distribute and dispense controlled substances, four counts of unlawfully distributing and dispensing controlled substances, one count of conspiracy to launder money, and two counts of engaging in transactions in property obtained from the illicit activity.  Carr now faces up to 140 years in prison, among other consequences.Continue reading

DME Industry 2021 Year End Review & Looking Into 2022

Many DME providers have had tremendous hurdles to overcome this year, from the implementation of a new round of Medicare’s Competitive Bidding Program through continued impacts of COVID-19. Mergers and acquisitions are through the roof as a result, as are continued compliance concerns that plague the industry.

Let’s dive into some of the major DME related matters & issues that have come across my desk this year, and what to be on the lookout for in the next.

Competitive Bidding Impacts

After much uncertainty about what DME products would actually be included upon its implementation, Round 2021 of Medicare’s Competitive Bidding Program (“CBP”) kicked off at the beginning of this year.

With off-the-shelf knee and lumbar braces (HCPCS Code OR03) included in Round 2021 of the CBP – and thus ability to supply such devices to beneficiaries in competitive bid areas restricted to bid-winners – non bid-winning DME providers have been scrambling to find new revenue streams to fill the void. Unfortunately, many are doing so in a non-compliant manner.Continue reading

Telemedicine Pharmacy Fraud Trial Ends in Convictions

Telemedicine pharmacy arrangements continue to be of significant interest to fraud enforcement.  A 2018 case in which four individuals and seven companies were indicted ended in a month-long jury trial of one of the individuals, a Florida pharmacy owner.  The federal jury trial in the billion-dollar telehealth pharmacy fraud scheme resulted in conviction on 22 counts of mail fraud, conspiracy to commit health care fraud and introduction of misbranded drugs into interstate commerce.  Sentencing in the case is set for May of 2022.  Other co-conspirators entered plea agreements along the way, pleading guilty to various charges including felony conspiracy to commit health care fraud, felony misbranding, conspiracy to commit wire fraud, and fraudulent telemarketing of dietary supplements, skin creams and testosterone.  Many of these are still awaiting sentencing, also expected to be scheduled sometime in 2022.

THE SCHEME

The scheme involved several individuals, compounding pharmacies and telemarketers engaged in a conspiracy to commit health care fraud, mail fraud and introducing misbranded drugs into interstate commerce.  Peter Bolos, along with two other co-conspirators, owned and operated Synergy Pharmacy in Palm Harbor, Florida.  Working with HealthRight, a telemarketer, the co-conspirators generated prescriptions for drugs such as pain creams, scar creams, and vitamins.  Using the HealthRight telemarketing platform, they would call consumers and deceive them into providing their personal insurance information and accept the drugs. HealthRight then communicated the prescription requests to physicians who authorized the prescriptions without ever interacting with the patients, and paid those physicians for issuance of the prescriptions. Through this scheme, the co-conspirators were able to solicitate insurance coverage information from consumers across the county for prescription pain creams, fraudulently obtain prescriptions, mark up the prices of the drugs and bill private insurance carriers.Continue reading

Health Care Fraud Enforcement Continues to Rock Pharmacy Industry

pharmacy fraud

pharmacy fraudBy: Karen Davila

Yet again, the fraud enforcement arm of the DOJ strikes out against fraud in the pharmacy industry.  Two new cases shed continuing light on the ongoing fraud.

Announced last week by the DOJ, the owner/operator of five pharmacies in New York pled guilty to charges stemming from a scheme to defraud Medicare and Medicaid by billing for prescription drugs that were not dispensed, not prescribed, not medically necessary or dispensed when the pharmacy had no authority to dispense the prescription drugs.  This blatant disregard for the law was magnified when the owner/operator used the ill-gotten gains of her scheme to purchase luxury items like cars and jewelry.  Nothing screams “come and get me” like openly flaunting the money taken from the government.Continue reading

Health Care Fraud Enforcement Got You Worried?

healthcare fraud in 2020

healthcare fraud in 2020By: Karen Davila

Healthcare fraud continues to be a significant priority for the U.S. Department of Justice.  On February 24, 2021, the DOJ’s Criminal Division Fraud Section published its annual “Fraud Section Year in Review 2020.”  While the Fraud Section has three separate enforcement units, the Health Care Fraud (HCF) Unit is responsible for all enforcement activities in the health care industry.  The Unit’s focus is to protect against fraud and abuse in federal health care programs and recoup illicit gains.

During 2020, the HCF Unit operated 15 strike forces in 24 federal judicial districts throughout the U.S.  The efforts of these strike forces led to charges against 167 individuals alleging $3.77 billion in fraudulent charges for health care paid for by federal and state programs.  This should cause any health care provider to stand up and take notice.  And enforcement in the health care industry is not likely to go away soon with so many schemes ripe for the government’s picking and generating recoupment on behalf of the federal health care programs.

Here are couple of the latest schemes that have landed pharmacies, pharmacists and other health care professionals squarely in the crosshairs of federal enforcement:

Continue reading

2021 Pharmacy Enforcement Actions in Full Swing

By: Michael Silverman

The new year has brought with it no lull in pharmacy fraud crackdowns and enforcement actions, with allegations related to over one billion dollars in false claims.

Here’s a breakdown of the latest:

Mississippi Man Sentenced to 18 Years in Prison and $287,659,569 in Restitution

This individual spearheaded a scheme involving kickbacks to marketers and prescribers to defraud TRICARE and other healthcare programs by submitting claims for unnecessary compounded medications, which also involved routine waiver of patient financial responsibility. Continue reading