New “Tools” for Prescription Drug Enforcement

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pill-shadows-1200049The exposure and concern surrounding the opioid epidemic is at an all time high. Notwithstanding the urgency of the issue itself, this publicity places increased pressure on the intervening parties—sub-agencies of the Department of Health and Human Services, Department of Justice (DOJ) and state Attorney’s General—to implement regimens that make a difference.  Our Georgia-based business and healthcare law firm follows developments that impact pain management physicians and medical practices.

At the Federal level, the DOJ is focused on taking steps to strategically intervene into physicians and pharmacies. Accordingly, the DOJ has expanded its enforcement to release a new tactic in the form of temporary restraining orders (TRO) against pharmacies that have violated the False Claims Act and the Controlled Substances Act. This tactic proved successful in a Tennessee District Court on January 13, 2019.

In the press release accompanying the initial use of this tactic, the DOJ explains, “The Department of Justice will use every available tool to stop individuals and entities responsible for the improper use of controlled substances.” This indicates that the DOJ has allocated abundant resources with no intent to rescind intervention until the problem is solved. The DEA supported this cause by stating the action “should serve as a warning to those in the pharmacy industry who choose to put profit over customer safety.” This TRO prohibits the pharmacies from conducting business until further action of the court to properly hear the issues that present the cause for granting the TRO.

At the state level, Georgia, like many states, is also devoting significant resources to this issue. These efforts have contributed to a decline in prescription related deaths but this is certainly not good enough to alleviate concern for the issues. Implementation of the Prescription Drug Monitoring Program (PDMP) has placed more formulaic restrictions on the prescribing practices of physicians. Many people have opposed this type of enforcement where physicians may no longer prescribe the medication that has provided benefit to their daily lives. The pushback suggests that these restrictions could lead to drastic outcomes including growth of the illegal market for opioids, supply from foreign markets, and in worst cases, suicide.

The PDMP is a mandatory program requiring all physicians regardless of prescribing practices to register. There are many physicians that still simply refuse to comply with the requirement implemented by the Georgia Attorney General’s office. Even though Georgia’s PDMP has clouded the medical news outlets since implemented, over 1,000 physicians remain unwilling to register for the program. The punishments for failure to conform are unclear at this point given the large market of unsubscribers though punishment may be the only means of enforcement sufficient to regulate the markets.

Both state and federal agencies are fighting in the right direction. Though Georgia is having some compliance concerns, a solution is on the horizon as we have already seen the positive effects of these programs. The crisis needs state and federal concerted action to continue making a difference in each life affected by these corrupt practices.

For healthcare providers, the heightened compliance focus of federal and state law enforcement agencies on the opioid crisis renders critical the importance of tight adherence to best practices with regard to all aspects of obtaining, sorting, prescribing and administering controlled substances.  If you have compliance concerns in this regard, it is imperative to consult with an experienced healthcare attorney.

Hamil Little PC

We advise and represent hospitals, medical practices, physicians and other healthcare providers. If you have questions about this post, contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com.  You may learn more about our law firm by visiting www.hamillittle.com.

 

** Disclaimer: Thoughts shared here do not constitute legal advice. Please consult with an attorney to discuss your legal issue.

 

Source: Department of Justice Press Release

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