Addiction Clinic Compliance
Operating an addition clinic carries a number of legal risks and responsibilities. From billing the federal government to dispensing buprenorphine and other opioid medications, virtually all aspects of operating an addiction clinic involve legal implications at the federal level.
If not managed appropriately, these risks and responsibilities can lead to substantial liability. Billing violations, improper referral fees, and other compliance issues can lead to civil or criminal penalties. The False Claims Act, the Anti-Kickback Statute, the Controlled Substances Act, and various other federal statutes all apply to addiction clinics, and they all impose strict requirements and prohibitions.
Federal Compliance Counsel for Addition Clinics Nationwide
At Oberheiden, P.C., our federal healthcare lawyers are available to serve as compliance counsel to addiction clinics nationwide. Our lawyers have extensive experience advising a wide range of healthcare providers on all matters pertaining to federal compliance, from Medicare billing to Drug Enforcement Administration (DEA) registration, and from establishing medical necessity to avoiding allegations of Anti-Kickback Statute violations.
In addition to serving as compliance counsel, our lawyers also represent healthcare providers in Medicare audits and federal healthcare fraud investigations, and several of our attorneys previously served as healthcare prosecutors with the U.S. Department of Justice (DOJ). We utilize this experience to offer our clients insightful, practical, and comprehensive compliance solutions focused on the issues that matter most to federal authorities.
What are the Components of an Effective Federal Healthcare Compliance Program?
1. Written Policies, Procedures, and Standards of Conduct
From a compliance standpoint, developing a comprehensive set of written policies, procedures, and standards of conduct serves two parallel purposes: (i) it provides a foundation for the uniform and consistent implementation of compliance standards on an organization-wide basis, and (ii) it serves as a first line of defense in the event of a federal audit or investigation. An addiction clinic’s compliance documentation should touch on all aspects of the business, and it should be custom tailored to the clinic’s unique operations and the federal healthcare benefit program(s) under which it operates.
2. Compliant Third-Party Contracting
In addition to adopting internal documentation, addiction clinics must examine the terms of their agreements with other healthcare providers and third-party vendors as well. While there are a variety of considerations that merit close attention, two key issues are: (i) ensuring that compensation arrangements do not run afoul of the Anti-Kickback Statute’s prohibition on unlawful referral fees and other forms of remuneration; and, (ii) ensuring adequate liability protection through indemnification clauses, mandatory insurance clauses, and other key contract terms.
3. Proper Employee and Independent Contractor Classification
Proper classification of employees and independent contractors is an important documentation-related aspect of federal healthcare compliance as well. Individuals who are properly classified as employees must be treated accordingly, and independent contractors should be subject to agreements that provide appropriate protections for the clinic in the event of an audit or investigation.
4. Designation of a Compliance Officer (and Compliance Committee)
Designating a compliance officer (and potentially also a compliance committee) is a good way to demonstrate to federal authorities that your clinic is dedicated to proactive compliance. The compliance officer’s role should be clearly defined, and he or she should devote adequate time to compliance-oriented responsibilities.
5. Employee Education and Training
Once customized policies, procedures, and standards of conduct are in place, then they should be distributed to employees throughout the organization, and employees should receive appropriate training and education based upon their individual job responsibilities. Ongoing refresher and updated training programs should be conducted as well. For all education and training programs, employees’ successful completion should be documented appropriately.
6. Patient-Focused Care and Medical Necessity
For addiction clinics, one of the biggest risks for federal healthcare fraud investigations involves accusations of not providing patient-focused care. In many cases, this takes the form of allegations of providing “medically unnecessary” services and medications. From a federal enforcement perspective, not only is the provision of medically unnecessary services or medications potentially dangerous to the patient, but it also constitutes a direct form of program fraud and abuse.
7. Ongoing Documentation of Compliance
From employee training to medical necessity, one of the keys to avoiding liability for federal healthcare fraud is maintaining ongoing documentation. Even if you provide training, and even if you provide only medically-necessary services and medications, if you cannot prove it, you run the risk of being penalized. As a result, addiction clinics should systematically generate and collect various types of documentation, and forms for recording information should be prepared with clinics’ compliance obligations in mind.
8. Prescribed and Open Channels for Internal Reporting of Suspected Violations
As part of their compliance programs, addiction clinics should establish and internally publicize appropriate channels for employees to report suspected compliance issues. Employees should be able to report issues anonymously if desired, and it should be made clear that employees will not face adverse employment action as a result of reporting suspected violations of program billing regulations or federal law.
9. Established Disciplinary Procedures for Employees
When employees engage in unlawful or noncompliant practices, addiction clinics should be prepared to take appropriate disciplinary action. This is a complex area that involves aspects of both healthcare law and employment law compliance.
10. Internal Compliance Monitoring and Auditing
Addiction clinics’ compliance documentation should also establish policies and procedures for conducting internal monitoring and auditing. These are tasks that should be undertaken systematically on a periodic basis by appropriate personnel (including the clinic’s compliance officer), and they must be conducted in such a way as to not unnecessarily expose the clinic to potential liability.
11. Violation Response and Remedial Action
When an employee reports a suspected violation or an addiction clinic’s monitoring or auditing efforts reveal a compliance issue, the response should be immediate, and appropriate remedial measures (if any) should be undertaken as soon as possible. Response guidelines should be included in the clinic’s compliance documents, and outside counsel should be engaged as necessary.
12. Audit and Investigation Preparedness and Defense
Compliance policies and procedures should also include guidelines for the initial response in the event of an audit or federal investigation. Ultimately, dealing with auditors or investigators is a matter to be handled by outside counsel; however, appropriate clinic personnel will need to be actively involved in the process as well.
What Compliance Issues are of Particular Concern for Addiction Clinics?
Due to the unique nature of addiction clinics in comparison to other types of healthcare facilities and providers, there are a number of compliance issues that are of particular concern for clinic owners and administrators. When developing a compliance program, these issues (among others) may warrant special consideration:
- Services that are Ineligible for Program Reimbursement – The federal healthcare benefit programs generally do not reimburse for unproven treatment methods or for tests or medications that have not received Food and Drug Administration (FDA) approval. This includes aversion therapy and certain other forms of substance abuse treatment.
- DEA Registration Compliance – Addiction clinics that utilize buprenorphine and other controlled-substance medications must maintain strict compliance with the conditions of DEA registration, and registered addiction clinics are subject to regular inspections every few years.
- Billing Volume for Common Services and Medications – Medicare fraud scams often involve a high volume of repeated billings for similar services; and, as a result, this has become a red flag for federal healthcare fraud investigations. Since addiction clinics often bill Medicare and the other federal healthcare benefit programs for the same services and medications for multiple patients, this means that they often face close scrutiny from federal authorities.
- Unlawful Payments to Marketers – Payments to marketers can also be red flags for federal investigators. While there are absolutely legitimate and lawful marketing options available (and addiction clinics must market their businesses in order to be successful), percentage-based relationships and contracts with marketing groups known to unlawfully sell lists of program beneficiaries can raise potentially-serious Anti-Kickback Statute implications.
- Unlawful Payments to Medical Directors – Percentage-based relationships with medical directors and other doctors can create exposure for addiction clinics as well. Similar to contracts with marketers, while medical directorships can be completely legitimate, if structured incorrectly they can also trigger substantial fines and other penalties.
Consult with the Federal Healthcare Compliance Lawyers at Oberheiden, P.C.
If you would like to discuss your addiction clinic’s compliance needs with a member of our firm, we encourage you to contact us for a complimentary initial consultation. To arrange a time to speak with one of our highly-experienced federal healthcare lawyers in confidence, please call 888-680-1745 or inquire online today. Our firm represents addiction clinics and other healthcare providers nationwide