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

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

Genetic Testing: Be Hopeful but Wary

Genetic tests are valuable because they can provide important information to patients and their medical providers regarding diagnoses, treatment, and disease prevention. However, the rapid growth in the number of tests ordered, especially in light of the telemedicine expansion during the pandemic, has invited well-earned scrutiny to the industry.

Make no mistake: genetic testing is heavily regulated (and enforced). The Federal Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act, and Commercial Insurance Fraud Law have all been used to prosecute unscrupulous marketers, call centers, and telemedicine providers in the last few months. Kickbacks in exchange for genetic specimens are just as illegal as kickbacks for patients. Three months ago, a Florida man was sentenced to 10 years in prison for conspiracy to commit health care fraud. His actions resulted in the submission of approximately $3.3 million in fraudulent claims to Medicare for genetic testing.Continue reading

The Federal Opioid Fraud and Abuse Detection Unit: An Enforcement Initiative Lacking in Resources for Prevention and Treatment of Opioid Abuse

By: Jacqueline Bain

Earlier this month, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit, which is a pilot program of the United Stated Department of Justice. AG Sessions noted that there are three components to approach the opioid crisis that our nation faces: prevention, treatment and enforcement.

  1. Prevention. AG Sessions noted briefly that the DOJ is undertaking that component through raising awareness, through drug take-back programs, and through DEA’s 360 Strategy program, which incorporates law enforcement, diversion control and community outreach to tackle the cycle of violence and addiction in US cities. He also stated that law enforcement is a component of prevention.
  2. Treatment. AG Sessions articulated that treatment can help break the cycle of addiction and crime and help people get their lives back together.
  3. Enforcement. AG Sessions dove deep in the area of enforcement, reasoning that enforcing our laws helps keep drugs out of the hands of our citizens, decreases their availability, drives up their price, and reduces their purity and addictiveness. He added, “Enforcement will make a difference in turning the tide in this epidemic.”

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