Pharmacy Enforcement Remains Top Priority

Today’s Topic:  Did you know that pharmacies and pharmacists continue to be a top enforcement priority for the U.S. Department of Justice and the myriad health care fraud task forces around the country?

Recent Sentencing in Compounding Pharmacy Fraud Case

This past week, a Mississippi pharmacist was sentenced to 5 years in prison for defrauding TRICARE (the government healthcare payer for the U.S. military and veterans) and some private insurance companies of $180 million through various kickback schemes.  These schemes might sound familiar because they all take on common characteristics- essentially payments to someone in exchange for referral of prescriptions to boost the pharmacy’s numbers.  And, more often than not, these prescriptions are medically unnecessary and driven by the greed of the people involved instead of the best interests of the patients.

This particular case became known as the “Mississippi Pain Cream Scheme” and led to three individuals who pled guilty, were sentenced to jail time and lost virtually everything. This past week’s announcement involved the sentencing of David “Jason” Rutledge, a pharmacist and co-owner of several compounding pharmacies.  Two others pled guilty earlier, including a Louisiana veteran, Tommy Shoemaker, who in December was ordered to pay $1.7 million in restitution and forfeit proceeds from the sale of his luxury vehicles.  And the Florida connection- Mitchell “Chad” Barrett of Gulf Breeze, was the mastermind behind this scheme as well as a larger national scheme that resulted in more than $1.5 BILLION in fraud nationwide!  It’s no wonder the government is on the hunt.Continue reading

Compounding Pharmacies Remain at the Tip of the Enforcement Spear

Compounding pharmacies are subjected to special licensing and permitting rules because of the heightened risk of the very nature of what they do- customizing a prescription by combining, mixing or altering ingredients to create a sterile or non-sterile medication for a given patient.  Pharmacies may only compound drugs where a commercially available drug/dose/formulation is not available.  Because of the heightened risk coupled with the high cost of compounded drugs and the increased prescribing of these expensive drugs, compounding pharmacies continue to be at the tip of the enforcement spear and a target for investigations.   This and the fact that the number of compounding pharmacies is only a fraction of the number of licensed pharmacies in the U.S., contributes to the increasing visibility when the U.S. Department of Justice prosecutes violators.

Growth of Compounding

From 2006 to 2015, the U.S. experienced a sevenfold increase in the prescribing of compounded drugs.  Recently, the compounding pharmacies market was valued at more than $9 billion and is projected to grow by another $5 billion over the next 30 years.Continue reading

What to Do When The Government Comes Knocking

business meeting between healthcare professionals and goverment

business meeting between healthcare professionals and govermentBy: Karen Davila

You do everything right.  You’re careful to dot your i’s and cross your t’s.  Compliance is hard-wired because you’re in an industry that’s highly regulated and you’ve built into your operations a series of compliance checks and balances.  However, even with strong controls in place, compliance efforts sometimes fall short– and whether you’re a physician group, a pharmacy, a durable medical equipment company, a home health agency, or any other health care provider, someday you might find yourself face-to-face with law enforcement officials or regulatory enforcement authorities.  What do you do?  How do you assure the most successful outcome with minimal business disruption?

Compliance is the foundation to mitigating the risks inherent in any health care operation.  Compliance can reduce the likelihood that regulators or law enforcement suddenly appear on your doorstep.  But preparation for emergencies and uncertainties is the key to reducing the risk that non-compliance leads to lengthy business interruption.  Although you may be saying “if”, you really should be thinking and acting more like “when”.  It costs everything to be ill-prepared and it costs very little to be well-prepared.  The following preparation can prevent much of the uncertainty that arises in these cases.

POLICIES AND PROCEDURES

First and foremost, make sure you have well-developed policies and procedures for what to do in such instances.  You should review these policies and procedures with your employees regularly, focusing on the importance of compliance.  Out of fear and uncertainty, employees can do things that create unnecessary challenges.  Educating them as to what their rights and responsibilities are will mitigate those risks.  Make sure your policies and procedures include the designation of who is in charge (“person in charge”) when the government does show up.Continue reading

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

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.Continue reading

How to Protect Your Pharmacy From Risky Prescriptions

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.Continue reading