Whether you work at a hospital or you own your own private practice, as a physician, you need to be focused on compliance. Adopting and implementing an effective federal healthcare compliance program will greatly reduce your risk of recoupments and other penalties in the event of an audit or investigation.
As a physician, treating your patients is your top priority. It is why you went to medical school, and it is the reason you accepted the moral and ethical responsibilities of medical practice. You are passionate about what you do, and you have sacrificed a lot to put yourself in a position where you are capable of helping those in need.
But, in today’s world, practicing medicine involves much more than providing quality patient care. If you bill Medicare, Medicaid, Tricare, or the U.S. Department of Labor (DOL), complying with the relevant billing regulations is a significant aspect of your practice as well. You also need to avoid non-billing-related mistakes that can trigger civil or criminal penalties for program-participating physicians. Lacking an effective compliance program is among the most-common reasons why physicians are targeted in audits and investigations, and physicians who are unable to defend themselves against allegations of non-compliance may be at risk for losing their practice.
Federal Healthcare Compliance Lawyers for Physicians Nationwide
Oberheiden, P.C. is a federal healthcare law firm with a national presence. Our attorneys work closely with physicians and other healthcare providers around the country to help them develop and implement comprehensive compliance programs under Medicare, Medicaid, Tricare, and the DOL healthcare program. We help our clients address potential concerns under the Stark Law, the Anti-Kickback Statute, the False Claims Act, and all other relevant federal statutes as well, and we provide our clients with the tools and resources they need to remain compliant on an ongoing basis.
In addition to representing healthcare providers with regard to compliance, we have extensive experience defending physicians and other providers in audits and investigation as well. Many of our attorneys also previously served as healthcare fraud prosecutors with the U.S. Department of Justice (DOJ). Our attorneys utilize the insights and knowledge gained from their direct involvement in well over 1,000 federal healthcare fraud cases to help physicians structure compliant practices and avoid mistakes that have the potential to trigger federal prosecution.
What is Physician Compliance?
As a physician, your entire body of education and training has been focused on patient care. Unfortunately, the reality is that this is just one aspect of operating a medical practice. In order to treat your patients, you must build a compliant practice, and you must ensure that your employees, your third-party billing administrators, your other vendors, and you personally remain attuned to the risks of noncompliance at all times.
So, as a physician, what does “compliance” mean to you? For physicians who bill Medicare, Medicaid, Tricare, and the DOL healthcare program, a comprehensive compliance program will typically cover the following:
1. Practice Structuring and Organization
As an independent physician, or as a member of a physician group or joint practice, compliance starts with the structuring and organization of your practice. Our attorneys can help you choose the appropriate business entity type and organizational structure, and we can prepare and file all of the documentation needed to establish your practice in a way that does not raise questions for federal authorities.
2. Billing and Coding Compliance
For program-participating physicians, billing and coding compliance is typically the most visible and most burdensome aspect of compliance. While most physicians work with third-party billing administrators, hiring a billing company to handle your Medicare, Medicaid, Tricare, or DOL coding does not alleviate you of your legal responsibilities. Not only must physicians ensure that they are providing their billing administrators with the information they need to submit lawful reimbursement requests, but they must maintain adequate oversight over their program billings as well.
3. Substantiation of Reimbursement Claims
A common issue in audits and investigations targeting physicians is lack of documentation. Even if your program billings are compliant, if you cannot prove it, you run the risk of being fined, facing recoupments, and potentially facing other penalties as well. As a result, physicians must develop standards and protocols for adequately substantiating their reimbursement claims. This include, but is by no means limited to, establishing that all tests, treatments, and medications satisfy the relevant program’s definition of “medical necessity.”
4. DEA Registration Compliance
Physicians who prescribe and dispense medications must register with the Drug Enforcement Administration (DEA). DEA registration involves its own universe of compliance requirements, and physicians must be extremely careful to avoid mistakes that could trigger allegations of Controlled Substances Act violations.
5. Marketing Compliance
As a business owner, you will likely need to market your practice in order to be successful. While it is entirely possible to market a medical practice within the confines of federal law and the ethical standards imposed by state medical licensing boards, it is also very easy to make costly mistakes. For example, one of the most-common marketing-related compliance issues for private physicians involves the payment of referral fees to marketing companies. Even if the payments you make are not specifically labeled as “referral fees,” if they run afoul of the prohibitions of the Anti-Kickback Statute, they could put your practice in jeopardy.
6. Relationships with Suppliers and Other Healthcare Providers
Relationships with suppliers and other healthcare providers will often raise Anti-Kickback Statute implications as well. From pharmaceutical companies and durable medical equipment (DME) suppliers to testing labs and referring physicians, any type of relationship that directly or indirectly involves the transfer of Medicare, Medicaid, Tricare, or DOL-reimbursed funds must be carefully structured in order to avoid compliance concerns.
7. Stark Law Compliance
While the Stark Law is similar to the Anti-Kickback Statute in that it prohibits the payment of unlawful referral fees, it has a number of important unique aspects as well. For example, unlike the Anti-Kickback Statute (which applies to all program participants), the Stark Law applies specifically to physicians and their related entities. Engaging in unlawful “self-referral” practices can trigger substantial penalties, including the potential for Medicare and Medicaid exclusion.
8. Internal Compliance Monitoring
For physicians (and for all types of healthcare providers), federal healthcare compliance needs to be an active process. Once compliance policies, standards, and procedures have been established, the practice’s compliance efforts must be monitored on an ongoing basis. This includes internal auditing of program billings, review of compliance efforts to ensure that they remain up-to-date, and providing a way for personnel to confidentially report potential compliance issues.
9. Violation Response
In the event that an issue is identified, a physician practice’s compliance documentation should specify guidelines for violation response. Depending upon the nature and severity of the issue, this may include executing a remedy internally, modifying standards and procedures to avoid similar issues in the future, and potentially reporting the issue to federal authorities. Importantly, while the practice’s violation response guidelines should serve as a resource for the initial response, physicians will typically want to discuss any apparent violations with their compliance counsel before taking responsive measures.
10. Audit and Investigation Response
Even if your practice is fully compliant, there is a good chance that it will at some point become the focus of an audit or federal investigation. If you are contacted by auditors or federal agents, you need to be extremely careful, and you need to follow an established protocol in order to avoid potentially-dangerous mistakes. While dealing with auditors or investigators is a matter that should generally be handed over to legal counsel, there are steps that physicians can (and potentially should) take promptly in order to mitigate their risk of being federally charged.
Components of a Comprehensive Physician Compliance Program
With these considerations in mind, a comprehensive physician compliance program will typically consist of a number of different components. All compliance documents should be custom-tailored to the unique aspects of a physician’s practice, and ongoing compliance efforts should reflect the particularities of the physician’s practice as well. When we develop compliance programs for physicians, some of the key types of documents we typically prepare include:
- Business organization forms and governing documents (such as a partnership agreement, shareholder agreement, or member agreement)
- Employment and independent contractor agreements
- Marketing agreements
- Billing administrator agreements
- Compliance policies and procedures
- Record retention policies and procedures
- Employee manuals and standards of conduct
- Training materials
- Monitoring, reporting, and response guidelines
- “Emergency response” documentation for audits and investigations
With an effective compliance program in place, physicians can protect themselves against the risk of civil or criminal prosecution for Medicare, Medicaid, Tricare, or DOL fraud. To discuss your practice’s compliance needs in a complimentary initial consultation, please contact us today.
Contact Oberheiden, P.C. | Physician Compliance Lawyers
If you would like to speak with one of our attorneys about your practice’s federal healthcare compliance needs, we encourage you to get in touch. To schedule a complimentary initial consultation at Oberheiden, P.C., call 888-680-1745 or request an appointment online today.