new york Lawyers for pharmacies/dispensaries

The medical industry is probably the most over-regulated business market in the United States, and it is even more so now that the Affordable Care Act is finally in full implementation. This regulatory oversight is not just limited to the larger treatment facilities and physician practices. Oversight includes pharmacies and dispensaries as well, and the issues involving pharmacies and dispensaries could easily become criminal without strict adherence. This has contributed significantly to the decline in the number of individually owned pharmacies opting instead for affiliation with medical care corporations that can provide more establishment protections through the corporate structure. A family-owned pharmacy could be devastated by a civil suit or a criminal charge, including losing an operational license. This is why it is vital for any pharmacy or dispensary to have experienced healthcare legal professionalrepresenting the interests of their health provider clients.

Stark Law and HIPPA Compliance

The Stark Law is one of the most confusing laws governing pharmacies and dispensaries because the language refers to internal and outside referrals that often need explanation for the typical pharmacist. This law covers abuses of authority and fraudulent billing or representation concerning certain controlled substances that may also be targeted for investigation by the federal Drug Enforcement Agency as well as standard healthcare regulatory agencies. HIPPA laws are not as confusing, but they overlap severely and releasing unauthorized information regarding patients can lead to serious fines for any healthcare provider or affiliate. Any investigation regarding either statute can be very serious both civilly and criminally in extreme situations. Having the solid legal expertise of a former prosecutor who understands how cases are built and when the government actually needs a search warrant to continue investigations can be the difference in many instances.

Business Structure and Affiliates

Almost all pharmacies and dispensaries are members of a network of business affiliates who must comply with all of the specific organizational rules for operating in the healthcare industry. Licenses must be secured for all entities involved, right down the the final pharmacist dispensing the medication, and all business structure requirements must be met as well. This very often occurs with the beginning of a new pharmacy that must ensure that all associations with the opening of a new facility meet the legal standard. It is very important for a facility focused on long-term growth to have all of these considerations included from the very beginning, and having an experienced healthcare legal professional assisting with the company organization establishment before opening for business is always a necessity.

Audits

Many audits occur routinely in the healthcare industry, especially when an entity is focused on dispensing drugs that could come under close scrutiny by various government agencies. Many times unscheduled audits are the result of unusual patterns in billing or excessively high or erroneous billing codes. And, many times these issues are matters of human error that can be repaired by accurate information and a potential balancing of the payment books regarding restitution. However, many unscheduled investigations occur when an individual who has knowledge of illegal behavior relays the information to the appropriate government regulatory agency. This could also be a component of a False Claims Act violation as well when the “relator” is also attempting to share in any proceeds confiscated by the authorities. There are specific rules that allow this lawsuit to be acceptable legally regarding standing to sue, including relator testimony. This could a criminal situation as well as a civil lawsuit issue for the investigation target, and solid professional legal defense is absolutely necessary for a positive outcome.

Regardless of the organizational or investigative situation for a pharmacy or dispensary, it is always essential to know beforehand who you will call in the event of a legal problem. Healthcare law is complicated and often overly emphasized by government agencies who have seen an increased caseload in connection with the Affordable Care Act. Having a former prosecutor who has a track record of verifiable experience in the new legislation is vital to maintaining a highly reputable business is a highly scrutinized industry.

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Legal Scenario: What Would You Do?

Scenario

You own a small independent pharmacy in Brooklyn and just received a letter from the DEA stating they are investigating your dispensing patterns for oxycodone prescriptions, claiming your volume exceeds regional norms. Two days later, a state Board of Pharmacy inspector showed up unannounced demanding to audit your controlled substance logs and patient records.

Can I lose my pharmacy license or face criminal charges based on my prescription volume alone, and do I have to comply with this surprise inspection?

Attorney's Answer

High prescription volume by itself does not constitute a violation, but under 21 U.S.C. § 842 and DEA regulations in 21 CFR Part 1306, pharmacists have a corresponding responsibility to verify the legitimacy of each prescription before dispensing. New York Education Law § 6808 grants the Board of Pharmacy authority to conduct unannounced inspections of your premises and records, so refusing entry could itself trigger disciplinary action against your license. However, you have the right to have legal counsel present during any interrogation or interview, and you should not make voluntary statements to DEA investigators without an attorney advising you. An experienced pharmacy defense lawyer can help you organize your dispensing records, respond to the DEA's investigation strategically, and protect both your professional license and your freedom.

This is general information only. Contact us for advice specific to your situation.

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