Regulations and Compliance Programs for Pharmacies Across the United States
Pharmacies are under attack. Law enforcement agencies across the country are investigating pharmacies for compliance and alleged healthcare fraud and physician kick-back schemes. Of particular scrutiny are compound pharmacies that have billed high amounts to Tricare, Medicare, and the Department of Labor health programs. In light of this climate of dangerous investigations, pharmacies and their executives are well advised to pursue a strong and effective pharmacy compliance program to obviate impressions of any wrongdoing. How that can be done is subject of this brief overview.
Dennis A. Wichern
Former Special Agent-in-Charge, DEA, Chicago Field Office
Former Chief of Investigations, Texas State Board of Pharmacy & Former Chief Drug Diversion Control Office
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The Risk of No Compliance
When investigators inspect premises or request records from pharmacies by way of OIG subpoenas, one of the first things they look for is the existence of an effective pharmacy compliance program. In a great number of cases, OIG and FBI agents in charge of pharmacy investigations find either no compliance program or, what they call “window-dressing,” that is a program merely on paper. Because in many fraud investigations the difference between civil recoupment of overcharged amounts and actual criminal charges is just a fine line, pharmacy owners are silly not to have the safety net of a compliance program in place.
Without any doubt, a realistic and professionally set up compliance program will significantly reduce the risk of criminal exposure. Compliance programs are designed to establish, monitor, and enforce proper conduct and to demonstrate to auditors and the government that no bad intent— which is needed for criminal prosecutions— ever existed among the pharmacy’s owners and decision-makers.
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5 Key Compliance Areas for Pharmacies that Bill Federal Benefit Programs
What does it take for a pharmacy to be federally-compliant? While there are numerous aspects to federal compliance, most pharmacies’ obligations can be condensed into five key areas:
1. DEA Registration Compliance
Registering with the U.S. Drug Enforcement Administration (DEA) entails a host of compliance obligations. Pharmacies must go to great lengths to ensure that their storage, labeling, and dispensing practices are fully compliant with the federal Controlled Substances Act (CSA), and they must be prepared to demonstrate their compliance in the event of a DEA inspection or investigation.
2. Prescription Drug Fraud
Pharmacies can face a broad range of prescription drug fraud allegations in DEA and other federal agency investigations. From dispensing medications pursuant to invalid prescriptions to accepting illegal compensation from prescribing physicians, pharmacies must ensure that all aspects of their business operations are structured to avoid allegations of fraud.
3. Prescription Drug Diversion
Prescription drug diversion has received blame for contributing to the nation’s opioid epidemic; and, for this reason, combatting diversion is a top federal law enforcement priority. With this in mind, pharmacies must adopt comprehensive controls, policies, and procedures to ensure that their medications end up in the hands of patients who truly need them.
4. Electronic Prescription Compliance
Electronic prescriptions are continuing to play an increasing role in pharmaceutical practice. The DEA has established comprehensive regulations governing pharmacy electronic prescription applications, and pharmacists and pharmacy owners have affirmative obligations to ensure that all electronic prescriptions they fill are valid.
5. Federal Program Billing Compliance
Like all health care providers that bill the federal government for reimbursements, pharmacies must maintain strict compliance with the applicable program billing rules and regulations. Billing and coding mistakes can have severe consequences, and pharmacies must ensure that they have adequate internal and external controls in place.
Special Areas of Concern with Regard to Pharmacy Compliance
In addition to the areas of compliance that are common among virtually all pharmacies that bill Medicare, Medicaid, Tricare, and other government health care benefit programs, certain pharmacies will face additional compliance obligations as well. For example, our pharmacy compliance attorneys have particular experience in the areas of:
1. Specialty Pharmacy Compliance
Due to the nature of their practice, specialty pharmacies face a number of unique compliance obligations. We represent specialty pharmacies with regard to federal benefit program and private pharmacy benefit manager (PBM) compliance.
2. Compound Pharmacy Compliance
Compound pharmacies face unique compliance obligations as well. We help compound pharmacies across the country bill the federal government with confidence while maintaining full compliance with the Controlled Substances Act.
3. CBD Compliance for Pharmacies
Cannabidiol (CBD), CBD formulations and variants, and synthetic cannabinoids have become mainstream, and this means that pharmacies are increasingly being asked to fill CBD-based prescriptions. While it is possible to do so legally, pharmacies must be extremely careful when it comes to CBD compliance.
Elements of a Pharmacy Compliance & Regulation Program
A healthcare compliance program must convince the government or auditor that the company and its key executives not just have a program in place, but that they are actually serious about following its self-imposed policies and standards. It is of critical importance to properly document each compliance effort and to set up mechanisms designed to demonstrate the company’s zero tolerance against unlawful behavior and operations. Each compliance program should consist of the following three features: policy, training, and enforcement.
- Written Policies and Procedures
- Compliance Officers
- Compliance Training
- Open Communication Channels
- Internal Monitoring
- Policy Enforcement
With respect to policies, the company should have waterproof documentation of its policies and standards of ethics. Such a collection may include Employment Manuals, Code of Conducts, and other corporate documents that outline the company’s expectation of its employees and affiliates.
- Company & Operating Agreement
- Employment Agreement
- Independent Contractor Agreement
- Marketing Agreement
- Review of Marketing Materials
- Code of Conduct
- Employment Manual
- Training Materials
The policies that define company’s ethical goals must be conveyed to company’s executive and staff. Regular compliance training on topics such as fraud and abuse laws, anti-kickback laws, Stark Law, or HIPAA and OSHA are mandatory elements of any serious compliance program in the healthcare industry.
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Your Pharmacy Compliance Attorneys
Oberheiden, P.C. offers effective pharmacy compliance programs to avoid or to mitigate government investigations. Our compliance attorneys bring in the experience of former government officials, former chief prosecutors for healthcare fraud from the Department of Justice, and team leaders and chief coordinators of the Medicare Fraud Strike Force. We have an impeccable track record when it comes to avoiding criminal charges in healthcare matters.
Emergency Defense Package
We understand that some clients simply do not have the time to set up long-term compliance programs. Due to pending or imminent investigations, the goal of these clients is to accomplish as many compliance efforts as possible in a short amount of time.
We serve these clients with our “Emergency Defense Package”, by which we turn around corporate and compliance paperwork and set up OIG approved compliance programs within days from our engagement. The Emergency Defense Package is a proven protocol that summarizes decades of experience in healthcare investigations and it has been featured by news stations across the country.
This information has been prepared for informational purposes only and does not constitute legal advice. This information may constitute attorney advertising in some jurisdictions. Reading of this information does not create an attorney-client relationship. Prior results do not guarantee similar future outcomes. Oberheiden, P.C. is a Texas LLP with headquarters in Dallas. Mr. Oberheiden limits his practice to federal law.
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