OIG Compliance Programs for Health Care Providers
Serving Physicians, Pharmaceutical Manufactures, Clinical Laboratories, Hospitals and other Types of Health Care Companies.
Contact LynetteThe U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) vigorously enforces compliance obligations in the healthcare industry. We assist physicians, labs, hospitals and other medical entities nationwide with all aspects of compliance program implementation and defense.
Healthcare providers that bill Medicare and other U.S. Department of Health and Human Services (HHS) programs are subject to oversight by the agency’s Office of Inspector General (OIG). The OIG is tasked with monitoring and enforcing compliance obligations, and it does so through a variety of means.
In addition to analyzing program billings, the OIG conducts targeted investigations—in many cases based upon information collected by Medicare and Medicaid audit contractors. If an investigation reveals evidence of billing fraud, this can trigger either civil or criminal enforcement action, and both types of cases can lead to substantial penalties.
With this in mind, health care professionals who bill Medicare and other HHS programs must make OIG compliance a priority. They need comprehensive compliance programs, and they need to be prepared to respond appropriately in the event of an OIG investigation.
How We Help Pharmaceutical Manufactures, Clinical Laboratories, Hospitals & Healthcare Providers
At Oberheiden P.C., we represent healthcare entities nationwide in all aspects of OIG compliance program implementation and defense. We help providers establish and maintain compliance, and we help them prove it when necessary. We also defend against OIG allegations of billing fraud and other offenses, and we have a substantial track record of protecting our clients against civil and criminal charges.
All of our clients work directly with our firm’s senior attorneys and consultants. These individuals offer exceptional experience in the areas of Medicare and OIG compliance. Several of our attorneys previously served as health care fraud prosecutors for the federal government, and our compliance consultants have prior experience working as federal agents and investigators focused on uncovering and combatting HHS program fraud, waste, and abuse. Meet our team.
In the area of OIG compliance, our services include:
Compliance-Led Program Development and Implementation
All healthcare professionals like laboratories, hospitals, and physicians that bill Medicare and other HHS programs need to have a comprehensive compliance program. An effective program will touch on all aspects of regulation, from entity structuring to program billing, and from patient record-keeping to audit preparation and response. Our attorneys and compliance consultants work closely with our clients to develop policies and procedures that are custom-tailored to their operations, resources, and the specific HHS programs they bill.
Unlike companies that offer “off-the-shelf” compliance programs, our services start with counseling and advice. We ensure that we have a clear understanding of our clients’ needs, and then we help our them understand what compliance measures are necessary – and what compliance measures are not. With a clear understanding of our client’s specific needs, we then craft policies and procedures designed to specifically address the risks our client faces on a day-to-day basis.
Depending on a provider’s particular needs, the following are some examples of the issues we may address when developing an OIG compliance program:
- Corporate Structuring and Compliance – General corporate compliance is essential as a firm foundation for an effective OIG compliance program. Before we address OIG’s compliance rules specifically, we make sure our client has the necessary underpinnings to adequately mitigate its liability risks at the corporate and owner levels.
- Referral Fees, Rebates, and Kickbacks – The Stark Law and Anti-Kickback Statute (AKS) prohibit various types of financial relationships and transactions within the health care sector. Enacted in 2018, the Eliminating Kickbacks Recovery Act (EKRA) imposes additional restrictions for all types of practitioners. Our lawyers and compliance consultants have extensive experience in this area, and we can help ensure that your practice’s payments and receipts do not trigger OIG scrutiny.
- Patient Record-Keeping – Patient record-keeping is essential to many different aspects of healthcare compliance, including that for OIG. Our attorneys and compliance consultants can assess the sufficiency of your office’s patient record-keeping practices, and we can recommend any necessary modifications and/or additions.
- Documentation of Medical Necessity – One area of patient record-keeping that is of particular importance when it comes to compliance is the documentation of medical necessity. If a service or item does not qualify as “medically necessary” under the applicable HHS program billing guidelines, then it is not eligible for reimbursement. Providers frequently run into issues with the OIG due to discrepancies between what they believe is medically necessary and what constitutes medical necessity for program billing purposes.
- Medicare Billing Compliance – There are numerous aspects to Medicare billing compliance, and all providers billing Medicare must have policies and procedures in place to ensure that their program billings are compliant. Billing errors (and suspected billing errors) are among the most-common causes of OIG investigations. Medical professionals who take the necessary steps to establish and maintain compliance can significantly reduce their risk of facing an OIG inquiry.
- Other HHS Program Billing Compliance – HHS oversees more than 300 health care programs, and each program is subject to its own unique set of rules and regulations. For providers that bill HHS programs other than Medicare, it is imperative to ensure compliance with all pertinent requirements.
- Telehealth, DME, Pharmacy and Other Compliance Needs – Various specific and specialty areas of health care practice implicate unique compliance obligations as well. In addition to general health care compliance and HHS program billing compliance, our attorneys and consultants assist with telehealth, durable medical equipment (DME), pharmacy, and other compliance needs.
Compliance Investigations and Health Care Fraud Defense
Even those who implement effective compliance programs can face OIG scrutiny. As a result, while maintaining a compliant program is important, documenting compliance is equally important when it comes to mitigating the risk of penalties during an OIG investigation. In addition to representing health care providers with regard to OIG compliance, we also have extensive experience on both sides of OIG investigations. We defend providers against all types of kickback, billing fraud, and other fraud-related allegations. In many of cases we are able to favorably resolve our clients’ investigations without liability and before formal charges get filed.
Your OIG Healthcare Compliance Attorney
FAQs: What Do Health Care Providers Need to Know about Compliance, Investigations, and Defense?
Q: Do all health care providers need a compliance program?
Yes, even providers that rely purely on private health insurance and patient direct billing have health care compliance obligations at the federal level. As an example, the EKRA prohibits the payment and receipt of referral fees in connection with all health care billings—not just program billings. EKRA violations can lead to civil or criminal prosecution, as can various other types of fraudulent health care practices.
Q: When is it necessary to revisit a compliance program?
Medicare and other HHS program billing rules and regulations change frequently, and new laws routinely change the landscape for health care practitioners. As a result, they need to remain up-to-date on the latest federal requirements, and having on an outdated compliance program can be just as ineffective as having no compliance program at all.
Q: How important is it to have a custom-tailored compliance program (as opposed to using an “off-the-shelf” product)?
When it comes to OIG compliance programs, customization is extremely important. In order to be effective, a compliance program must be tailored specifically to a practice’s billing and day-to-day operations. When facing an OIG investigation, demonstrating reasonable efforts to establish compliance is crucial to mitigating any potential penalties, and the OIG expects providers to have custom-tailored compliance programs in place. The OIG also offers its General Compliance Program Guidance, or GCPG, to providers for general reference on compliance programs.
Q: What are the most-common triggers for investigations?
Several different types of compliance deficiencies can trigger OIG investigations. However, billing violations are by far the most common. Medicare and other HHS program billing violations can trigger civil liability under the False Claims Act if they are unintentional; and, if the OIG has reason to believe that a provider has intentionally overbilled the federal government, then criminal prosecution is a very real possibility.
Q: What are the potential consequences of an investigation?
The potential outcomes of an OIG investigation are entirely dependent upon the circumstances involved—including the sufficiency of the provider’s compliance program. In a best-case scenario, a provider will have fully implemented its compliance program, and this will shield it from liability.
Small-scale unintentional billing violations can lead to recoupment liability, while evidence of intentional billing fraud can lead to criminal prosecution, as noted above. Potential outcomes can also fall anywhere in between, from denial of pending claims to treble (triple) damages, and from pre-payment review to program exclusion.
Put our highly experienced team on your side
Dr. Nick Oberheiden
Founder
Attorney-at-Law
Lynette S. Byrd
Former DOJ Trial Attorney
Partner
Brian J. Kuester
Former U.S. Attorney
Hon. Kevin McCarthy
55th Speaker, U.S. House of Representatives (ret.)
Government Consultant
Mike Pompeo
Of Counsel
Former U.S. Secretary of State
John W. Sellers
Former Senior DOJ Trial Attorney
Linda Julin McNamara
Federal Appeals Attorney
Nicholas B. Johnson
Former Prosecutor
Roger Bach
Former Special Agent (DOJ)
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Ray Yuen
Former Supervisory Special Agent (FBI)
Contact the Compliance Attorneys and Consultants at Oberheiden P.C.
Do you have questions about OIG compliance for a hospital, laboratory, or another type of health care provider? If so, we can arrange for you to speak with one of our senior attorneys or compliance consultants in confidence as soon as possible. To schedule a complimentary initial consultation at Oberheiden P.C., please call 888-680-1745 or contact us online today.
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OIG Compliance Programs for Health Care Providers – Oberheiden, P.C.
