OIG Compliance Programs for Health Care Providers
Serving Physicians, Pharmaceutical Manufactures, Clinical Laboratories, Hospitals and other Types of Health Care Companies.
The U.S. Department of Health and Human Services (DHHS) Office of Inspector General (OIG) vigorously enforces health care providers’ compliance obligations. We assist physicians, labs, hospitals and other providers nationwide with all aspects of OIG compliance program implementation and defense.
Health care providers that bill Medicare and other U.S. Department of Health and Human Services (DHHS) programs are subject to oversight by the agency’s Office of Inspector General (OIG). The OIG is tasked with monitoring and enforcing health care provider’s compliance obligations, and it does so through a variety of different means.
In addition to analyzing providers’ program billings, the OIG also conducts targeted investigations—in many cases based upon the information collected by Medicare and Medicaid audit contractors. If an OIG 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 providers that bill Medicare and other DHHS programs need to make OIG compliance a priority. Providers need to have comprehensive OIG compliance programs, and they need to be prepared to respond appropriately in the event of an OIG compliance investigation.
How We Help Pharmaceutical Manufactures, Clinical Laboratories, Hospitals & Health Care Providers
At Oberheiden P.C., we represent health care providers nationwide in all aspects of OIG compliance program implementation and defense. We help providers establish and maintain compliance, and we help them prove compliance when necessary. We also defend providers 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 compliance consultants. These individuals offer centuries of combined 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 DHHS program fraud, waste, and abuse. Meet our team.
In the area of OIG compliance, our services for health care providers include:
OIG Compliance Program Development and Implementation
All health care providers like laboratories, hospitals, and physicians that bill Medicare and other DHHS programs need to have comprehensive OIG compliance programs. An effective program will touch on all aspects of compliance, 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 and the specific DHHS programs that 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’ OIG compliance needs, and then we help our clients understanding 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 that are designed to specifically address the compliance risks our client facts 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 compliance 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 providers. 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 health care compliance, including OIG compliance. Our attorneys and compliance consultants can assess the sufficiency of your office’s patent record-keeping practices, and we can recommend any modifications and/or additions that are necessary.
- Documentation of Medical Necessity – One area of patient record-keeping that is of particular importance when it comes to OIG compliance is the documentation of medical necessity. If a service or item does not qualify as “medically necessary” under the applicable DHHS program billing guidelines, then it is not eligible for reimbursement. Providers frequently run into issues with the OIG due to discrepancies between what their doctors 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 that bill 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, and providers that take the necessary steps to establish and maintain compliance can significantly reduce their risk of facing an OIG inquiry.
- Other DHHS Program Billing Compliance – DHHS 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 DHHS 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 DHHS program billing compliance, our attorneys and consultants assist providers with telehealth, durable medical equipment (DME), pharmacy, and other compliance needs as well.
OIG Compliance Investigations and Health Care Fraud Defense
Even health care providers that implement effective compliance programs can face OIG scrutiny. As a result, while maintaining compliance 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, and in many of cases we are able to favorably resolve our clients’ investigations without liability and before formal charges get filed.
FAQs: What Do Health Care Providers Need to Know about OIG Compliance, Investigations, and Defense?
Q: Do all health care providers need an OIG compliance program?
Yes, even providers that rely purely on private health insurance and direct patient 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 for a provider to revisit its OIG compliance program?
Medicare and other DHHS program billing rules and regulations change frequently, and new laws routinely change the landscape for health care providers. As a result, providers need to remain up-to-date on the latest federal requirements, and having on an outdated compliance program can be just as effective as having no compliance program at all.
Q: How important is it to have a custom-tailored OIG 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 provider’s billing practices 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.
Q: What are the most-common triggers for OIG investigations?
Several different types of compliance deficiencies can trigger OIG investigations. However, billing violations are by far the most common. Medicare and other DHHS 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 OIG 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.
Contact the OIG 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.
OIG Compliance Programs for Health Care Providers – Oberheiden, P.C.