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Florida Long-Term Care Pharmacy Law

July 17th, 2021 by

Pharmacy law protects pharmacists, patients, the general public, and healthcare businesses in Florida through a number of different measures.

The details of these laws are updated regularly as new legislation is passed and old laws are changed.

It is important for healthcare industries in Florida to keep up with these changes, so they can protect their businesses and their patients.

How Does Pharmacy Law in Florida Protect Patients?

In some cases, patients may be prescribed a medication that does not work well with other medications they are taking.

The prescribing physician may not recognize that there could be a problematic interaction. Or, another physician prescribed the contraindicated medication and the second doctor isn’t aware.

Either way, a pharmacist in Florida is required by law to intervene if they see that a patient is trying to fill a script that could be lethal in combination with other prescribed medications.

How Does Florida Pharmacy Law Protect the Public?

Pharmacists in Florida are asked to fill fraudulent scripts every day by people seeking to divert addictive medications to the street.

Opioids like OxyContin and benzodiazepines like Xanax are among the most commonly abused prescription drugs, and pharmacists can often tell when the prescription is a fake.

Florida law gives pharmacists room to verify prescriptions before filling them in order to avoid filling fake scripts designed to put illicit drugs on the street.

Can Florida Pharmacy Law Protect Healthcare Businesses?

Absolutely. Laws are there to protect companies from lawsuits. By following them, healthcare businesses are better able to protect themselves and the people and businesses they serve.

Where Can I Find More Information?

If you would like to learn more about how pharmacy law in Florida could impact your business, contact us at the Florida Healthcare Law Firm today to set up a consultation.

Health Care Fraud Enforcement Continues to Rock Pharmacy Industry

April 30th, 2021 by

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. read more

Health Care Fraud Enforcement Got You Worried?

March 25th, 2021 by

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:

read more

2021 Pharmacy Enforcement Actions in Full Swing

February 5th, 2021 by

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. read more

Florida Healthcare Law Firm Begins the New Year with the Addition of Attorney Karen Davila, Pharmacy Law Specialist

January 1st, 2021 by

fhlf karen davilaFollowing last year’s growth expansion, Florida Healthcare Law Firm in Delray Beach, FL has hired board certified attorney (in Health Law) Karen Davila, as of January 4, 2021. Karen will play an essential role representing healthcare businesses with a specialized focus on retail pharmacy owners and operators. Karen has nearly 30 years’ experience in the health law space and is licensed in both Florida and Illinois.

Florida Healthcare Law Firm has announced that they have added Karen Davila to the team. Karen brings a wealth of healthcare business expertise working with national corporate pharmacies, large hospitals and local family-run businesses. As part of the firm’s expert pharmacy law team, Karen will advise independent pharmacies on matters such as PBM audits, regulatory compliance and transactional support. She also has experience complex provider relationships, reimbursement, fraud and abuse, DEA and FDA regulatory compliance, scope of practice of health care professionals, and quality/patient safety issues across the health care continuum. read more

How to Protect Your Pharmacy From Risky Prescriptions

December 31st, 2020 by

fhlf protect your pharmacyBy: Karen Davila

Pharmacies and their pharmacists are in a very tough spot in the current regulatory enforcement environment.  This is particularly true with dispensing controlled substances. Headlines like the below are commonplace:

DEA RAIDS PHARMACY AS PART OF LOCAL DRUG SWEEP

PHARMACY PAYS $500,000 IN PENALTIES FOR CONTROLLED SUBSTANCES ACT VIOLATIONS

MAN ARRESTED USING DOCTOR’S PRESCRIPTION PAD TO WRITE FRAUDULENT RX’S

So, how do you avoid filling a fraudulent prescription for controlled substances?  Before getting into the nitty gritty, it is important to lay the foundation of standard of care and the corresponding responsibility so pharmacies and pharmacists can evaluate what steps are most likely to mitigate these risks.

As background, federal law states that the primary responsibility for prescribing controlled substances rests with the prescriber.  However, that same law places a “corresponding responsibility” on the pharmacist to assure each prescription is written for a legitimate medical purpose pursuant to a valid patient-prescriber relationship.  21 CFR §1306.04(a).

Under Florida law:

  1. A pharmacist may not dispense a Schedule II-IV controlled substance to any patient or patient’s agent without first determining, in the exercise of her or his professional judgment, that the prescription is valid. F.S. §893.04 (2)(a).
  2. A prescriber or dispenser must consult the prescription drug monitoring system, eForce, to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance.S. §893.055

Once you have a clear understanding of a pharmacist’s liability, you can then consider ways to mitigate the inherent risks in filling controlled substance prescriptions. read more

What’s All This Talk About 340B Discount Drug Programs?

September 8th, 2020 by

340B Discount Drug ProgramBy: Jackie Bain

There has been so much in the news lately about 340B Discount Drug Programs and the fraud that accompanies them.

The 340B Discount Drug Program allows manufacturers participating in Medicaid to agree to provide outpatient drugs to certain designated clinics and hospitals at significantly reduced prices. The typical discount ranges from 30% to 50% off the drug’s list price. In turn those clinics/hospitals are able to reach more high-risk, high-need patients and provide more comprehensive services. Each designated clinic/hospital involved in the program is called a “covered entity.”

Covered entities may provide drugs purchased through the 340B Discount Drug Program to all eligible patients of that covered entity, regardless of a patient’s payer status. In order to be a “patient” of a specific covered entity, an individual (1) must have an established relationship with the covered entity such that the covered entity maintains records of the individual’s care; and (2) must receive care from a professional employed by or contracted with the covered entity such that responsibility for the care remains with the covered entity. Under the guidelines, an individual is not considered a patient of the covered entity if the individual only is dispensed a drug for the patient to take at home. read more

DME Fraud Enforcement: Telemarketing & Telemedicine

August 12th, 2019 by

By: Michael Silverman

The indictments and regulatory activities that took place on April 9th were just the tip of the iceberg when it comes to the crackdown on DME fraud, telemarketing and telemedicine operations.

In the weeks and months that have followed ‘Operation Brace Yourself’, healthcare providers (such as DME suppliers and telehealth physicians) and telemarketers allegedly involved in these activities have been subjected to a wide range of penalties from suspension of Medicare billing privileges to civil penalties and/or criminal charges. Here are some of the more serious recent DME, telemarketing and telemedicine related civil and criminal regulatory enforcement actions: read more

DME Provider Alert: Medicare Competitive Bidding is Back!

March 8th, 2019 by

Medicare Competitive BiddingBy: Michael Silverman

Not tomorrow, but relatively soon. And with a vengeance! We knew the current Competitive Bidding Program moratorium wouldn’t last forever, and that the floodgates that opened as of the first of this year would eventually be reined in.

Indeed, on March 7, 2019 the Centers for Medicare and Medicaid Services (“CMS”) announced a new round of Competitive Bidding, which will commence on January 1, 2021 and last through December 31, 2023.

The largest changes from previous rounds of Competitive Bidding that immediately stand out are: read more

Litigation Alert: Pharmacies with Prescription Refill Reminder Programs Take Note

January 14th, 2019 by

Prescription Refill Reminder ProgramsBy: Michael Silverman

Pharmacies using automated dialers for prescription refill reminders and relying on the statutory prescription refill reminder exemption to the TCPA’s prohibition on the use of automated dialing equipment as an impenetrable blanket against liability need to think again.

The case of Smith v. Rite Aid Corporation, 2018 WL 5828693 (W.D.N.Y. Nov. 7, 2018), revolves around a Rite Aid pharmacy’s use of a prescription refill reminder program to contact a patient to pick up a prescription. The pharmacy placed several calls per week intended to remind the patient to come into the store to pick up their prescription. However, an innocent bystander instead of the intended recipient of the mediation received the calls; either due to error in taking the phone number down or a due to the number being reassigned (which happens to thousands of numbers on a daily basis!). The unintended recipient of the multiple prescription refill reminder calls filed a class action lawsuit under the federal Telephone Consumer Protection Act (“TCPA”), which provides for statutory penalties of $500-$1,500, per call. read more