Mobile Clinic Compliance and Defense
Mobile clinics allow health care providers to provide essential services to rural patients who might not otherwise be able to get the care they need. Recent advances in technology have made the operation of mobile clinics a viable option in many communities, and access to mobile health care has significantly improved the lives of many people suffering from illnesses, diseases, disabling injuries, and drug addiction. Family medicine practitioners are now able to access patients in underserved areas as well, providing essential preventative care and treatment to adults and children who might otherwise go years without seeing a health care professional.
But, despite the virtues of mobile clinics, mobile clinic operators and physicians who practice in mobile clinics have not escaped the federal microscope. To the contrary, many federal authorities are specifically targeting mobile clinics (among other health care providers) in compliance audits and investigations. Like all health care providers, mobile clinics are subject to a host of legal and regulatory obligations, and those that fail to establish and maintain compliance can face steep consequences.
What Are Mobile Clinics?
A mobile healthcare clinic consists of a vehicle that travels to various community centers in urban and rural areas to provide a variety of healthcare services to patients. The primary benefit to mobile healthcare clinics is that they bring medical care to the patient. This not only saves patients time and money, but also increases the likelihood of patients seeking much-needed medical care.
Overall, mobile healthcare clinics have a positive impact on society because they appeal to patients who may otherwise overlook their health issues for fear of travel, or their inability to get to larger hospitals. During the ongoing pandemic, especially, increasing the availability of safe healthcare and more broadly distributing vaccines may actually help to curb the further spread of COVID-19. However, despite the valuable benefits of mobile clinics, they are the current focus of regulatory enforcement.
While some mobile healthcare clinics provide general healthcare to patients, most mobile healthcare clinics provide specialized services. A few of the most common types of mobile clinics include:
- Mobile Electromyography (E.M.G.) Clinics
- Mobile Electroencephalogram (E.E.G.) Clinics
- Mobile Electrocardiogram (EKG) Clinics
- Mobile Toxicology Clinics
- Mobile Blood Testing Clinics
- Mobile Genetic Testing Clinics
- Mobile Hospice Care Clinics
- Mobile Home Health Care Clinics
- Mobile Radiology Clinics
- Mobile Vaccine Clinics
- Mobile X-ray Clinics
Of course, there are many other types of mobile clinics, including those that provide emergency medical care and dental services. Some mobile healthcare clinics will even provide home visits for home-bound patients.
The Government’s Concern About Mobile Healthcare Clinic Fraud
Mobile healthcare clinics present several potential areas of concern for federal law enforcement agencies and prosecutors. At Oberheiden, P.C., we are prepared to effectively address any claim of healthcare fraud related to the operation of a mobile clinic. A few of the issues we most often see involve the following:
Federal Compliance and Defense Counsel for Mobile Clinics
At Oberheiden P.C., we provide full-service compliance and defense representation to mobile clinics nationwide. Many of our lawyers are former federal prosecutors responsible for enforcing the nation’s health care laws, and our compliance consultants are former high-ranking agents with the U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG), the U.S. Drug Enforcement Administration (DEA), and other federal agencies. We assist our clients with all aspects of federal health care law compliance, and we serve as defense counsel for HHS-OIG, DEA, and other federal agency audits, inspections, and investigations as well.
Our experience encompasses representing virtually all types of health care providers in all aspects of legal and regulatory compliance. We have helped thousands of providers across the country establish compliance, maintain compliance, and avoid unwanted scrutiny. We also have an extensive track record of successfully defending health care providers during federal inquiries, and the majority of our clients have been able to avoid charges entirely.
Federal Health Care Compliance for Mobile Clinics
There are numerous aspects to federal health care compliance for mobile clinics and other health care providers. At Oberheiden P.C., we offer custom-tailored compliance solutions—including solutions that are tailored specifically to the unique needs of mobile clinics. This includes needs in the areas of:
Anti-Kickback Statute, Stark Law, EKRA, and DEA Compliance
The federal Anti-Kickback Statute and Stark Law, as well as the newer Eliminating Kickbacks in Recovery Act (EKRA), prohibit mobile clinics and physicians from entering into financial relationships that result in the payment of unlawful referral fees and other forms of “remuneration.” While these statutes’ prohibitions are not absolute, they outlaw many types of financial relationships and transactions that are relatively common within the health care sector.
Anti-Kickback Statute Violations
The Anti-Kickback Statute (A.K.S.), codified in 42 U.S.C. §1320a–7b, is a federal law prohibiting a medical provider from offering, paying, soliciting, or receiving money—or anything else of value—in exchange for patient referrals, when the patient’s medical bills are paid by any federally funded program. While many cases involving alleged violations of the A.K.S. involve the payment of money for referrals, other common kickbacks include lavish meals, expensive hotel-stays or vacations, prestigious or high-paying positions. The A.K.S. is a criminal law, and can carry the possibility of incarceration and other criminal sanctions. However, those in violation may also face civil liability under the False Claims Act.
Stark Law Violations
The Stark Law, named after Democratic Congressman from California, Pete Stark, is codified in 42 U.S.C. § 1395nn. The Stark Law is similar to the Anti-Kickback Statute and the Eliminating Kickbacks in Recovery Act of 2018 in that it places a limit on physician referrals. Specifically, the Stark Law prohibits healthcare providers from referring patients to another provider if the referring provider has a financial interest in the practice they are referring a patient to. The Stark Law is unique among criminal law statutes in that it is a strict liability offense, meaning prosecutors do not need to prove that a physician intended to violate the law, making the referring physician’s intent irrelevant. Violations of the Stark Law can also result in civil liability under the False Claims Act.
The Anti-Kickback Statute and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), is the most recently passed statute regulating physician referrals. Codified in 18 U.S.C. § 220, EKRA focuses on curbing the widespread prevalence of opioid addiction in the United States. EKRA prohibits mobile laboratory clinics and mobile toxicology clinics from soliciting or receiving any form of remuneration related to patients in need of treatment for their addiction. Additionally, EKRA makes it illegal for anyone to solicit or receive remuneration for a patient referral to any of these facilities. While EKRA is similar to the A.K.S. in many ways, two primary differences are that EKRA applies to privately paid services and, generally, punishes violators more severely. EKRA is a criminal statute; however, like the A.K.S. and the Stark Law, a violation of EKRA can also be prosecuted under the False Claims Act.
Billing compliance is essential for all types of mobile clinics. This includes both billing compliance with respect to private insurance and billing compliance with respect to Medicare, Medicaid, and other government health care benefit programs. Even inadvertent billing mistakes can subject mobile clinics to steep penalties, and mobile clinics must be extremely careful to use the correct billing codes along with maintaining clear documentation of medical necessity. Common billing compliance issues facing mobile healthcare clinics include:
- Billing for medical services that were not provided;
- Incorrectly coding legitimately performed medical procedures;
- Billing multiple times for a single course of treatment;
- Billing under a physician’s name that was not present or did not treat the patient; and
- Billing one procedure under several separate billing codes to increase the amount reimbursed.
Billing compliance issues are some of the most common types of healthcare fraud. Thus, federal law enforcement agencies are on the look-out for any red flags indicating a mobile healthcare clinic is in violation of the law.
For mobile addiction treatment clinics and other mobile clinics that prescribe and administer medications, DEA compliance is a critical component of an overall compliance program. Our lawyers and consultants – who include former DEA agents – are knowledgeable about all of the various nuanced and complex aspects of compliance under the Controlled Substances Act (CSA) and pertinent DEA regulations. Common issues that can lead to D.E.A. enforcement action include:
- Forging a prescription for a patient;
- Failing to pursue non-narcotic treatment options;
- Improper storage of controlled substances; and
- Allowing unauthorized access to narcotic medication.
Mobile healthcare clinics that prescribe or dispense controlled substances must develop a strict compliance program, focusing on:
- Implementing thorough intake procedures;
- Investigating non-narcotic therapy options;
- Performing comprehensive examinations before prescribing medication; and
- Conducting periodic audits to ensure staff compliance.
Licensing and Registration Compliance
One key aspect of DEA compliance is adhering to the rules and requirements for DEA registration. We assist mobile clients with obtaining and protecting their DEA registrations, and we assist our clients with other licensing and registration matters as well. In addition to matters at the federal level, this includes providing professional license defense for physicians and other practicing providers.
Telemedicine and Telehealth Compliance
By the nature of mobile treatment services, many mobile clinics offer telemedicine and telehealth services as well. This is a heavily-regulated area of health care practice that is subject to strict oversight, and mobile clinics must be absolutely certain that their telemedicine and telehealth practices are legally compliant.
The COVID-19 pandemic has given rise to new and unprecedented compliance concerns – and fraud risks – for mobile clinics and other health care providers. At Oberheiden P.C., we have been advising clients on COVID-19 compliance since the start of the pandemic, and we are continuing to help our clients establish compliance and avoid fraud allegations on an ongoing basis.
Unnecessary Medical Testing or Procedures
The False Claims Act provides that payment is not permitted for items or services which are “not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” This pertains to any treatment payable by any federally funded program, including Medicare and Medicaid. Mobile healthcare clinics that provide medical testing or conduct outpatient procedures, such as E.M.G. clinics, EKG clinics, E.E.G. clinics, X-ray clinics, and genetic testing clinics, are frequently targeted by federal law enforcement agencies for ordering unnecessary testing. If a mobile healthcare clinic orders what is later determined to be an unnecessary test or procedure, the clinic’s operator (as well as the ordering physician) may face civil liability under the False Claims Act. Even if a physician orders a test, a mobile lab must make an independent determination that the patient’s diagnosis supports the testing. This is because the lab, rather than the ordering physician, is the party submitting the claim for reimbursement.
An Example of a Mobile Clinic Fraud Case
While mobile healthcare clinics have recently come under heightened scrutiny, regulation is nothing new for these facilities. Over recent years, there have been several high-profile cases in which federal law enforcement agencies successfully pursued civil and criminal liability against mobile healthcare clinics. Below is just one example:
Several Physicians in Mobile Doctors Group Arrested on Medicare Fraud
In 2013, federal agents searched two locations of a mobile healthcare practice, seizing $2.6 million in what the U.S. attorneys classified as fraud proceeds. The Chicago-based group was allegedly billing Medicare for procedures that the group claimed were more complex than they were in reality. The practice group allegedly billed under Medicare codes that offered the highest reimbursement, although the amount of time spent with each patient was only between 10 and 30 minutes. The doctors also faced accusations that they falsely certified their patients were home-bound. Ultimately, the case resulted in several convictions. The C.E.O. of the practice group was sentenced to 15 months in jail and ordered to pay $1.8 million in restitution.
At Oberheiden, P.C., we have a track record of success when it comes to representing clients charged with federal healthcare fraud. Below are just a few examples of recent cases we’ve handled:
- United States v. Client: An Oberheiden, P.C. client was indicted for Medicare Fraud. The government claimed the damages to be $7 million. We obtained probation for our client.
- United States v. Client: An Oberheiden, P.C. client was indicted for Medicare Fraud. The government claimed the damages to be $3 million. We obtained probation for our client.
- United States v. Client: An Oberheiden, P.C. client was indicted for Medicare Fraud. The government claimed the damages to be $1 million. We obtained probation for our client.
These represent only a few of our success stories; there are countless others. When you bring Oberheiden, P.C. onto your defense team, you can rest assured you have a knowledgeable advocate who will be at your side every step of the way.
Federal Health Care Fraud Defense for Mobile Clinics
In addition to representing mobile clinics with regard to health care law compliance, we also serve as defense counsel for mobile clinics that are facing allegations of federal health care fraud. This includes fraud allegations of all forms, from inadvertent billing mistakes to providing unnecessary prescriptions and engaging in prohibited financial transactions.
Our federal health care fraud defense lawyers represent mobile clinics in audits, inspections, and investigations conducted by all federal agencies. This includes, but is not limited to, HHS-OIG, the DEA, the Centers for Medicare and Medicaid Services (CMS), the Federal Bureau of Investigation (FBI), and the U.S. Department of Justice (DOJ). As noted above, we provide defense representation for licensing and registration matters as well, and our federal defense lawyers are licensed to practice before federal district courts across the country.
FAQs: Avoiding (or Defending Against) Federal Fraud Allegations for Mobile Clinics
Q: Do all mobile clinics need to have comprehensive health care compliance programs?
Yes, comprehensive compliance is essential for all types of health care providers, including all types of mobile clinics. Federal authorities expect health care providers to proactively address their compliance obligations, and those that do not can face substantial penalties. Once a compliance program has been established, the compliance program must be thoroughly implemented, and mobile clinics must continue to monitor their compliance efforts and reassess their compliance needs on an ongoing basis.
Q: What does a comprehensive health care compliance program entail?
In order to be sufficiently comprehensive, a compliance program must address all aspects of federal health care law compliance—including billing, anti-kickback, and DEA compliance, among other areas. Crucially, mobile clinics’ compliance programs must be custom-tailored to their specific needs, and they must thoroughly address all areas of concern.
Q: What should I do if my mobile clinic is not fully compliant with all federal health care laws and regulations?
If your mobile clinic is not currently compliant (or if you are not sure whether your mobile clinic is fully compliant), it will be important for you to engage federal health care compliance counsel promptly. Non-compliance is a serious issue; and, if your mobile clinic is targeted in a federal audit, inspection, or investigation, the consequences could be severe.
When faced with past or ongoing compliance violations, a proactive approach is generally best. However, it is also necessary to proceed carefully. While it may be necessary to voluntarily disclose known compliance failures, any voluntary disclosure needs to be made very carefully and with a clear plan for coming into full compliance.
Q: What are the risks of federal non-compliance for mobile clinics?
The risks of federal non-compliance for mobile clinics can include fines, recoupments, denial of pending claims, pre-payment review, loss of eligibility, and other financial penalties. If your mobile clinic is accused of criminal health care fraud, then federal prison time could be on the table as well. Mobile clinics need to prioritize compliance—and they need to do so before their compliance efforts are called into question by federal authorities.
Q: As a mobile clinic operator or physician, what should I do if I have been contacted by HHS-OIG, the DEA, or another federal agency?
If you own or operate a mobile clinic and you have been contacted by HHS-OIG, the DEA, or another federal agency, you will need to engage experienced federal defense counsel promptly. You do not have time to wait, as you will need to execute a proactive defense strategy in order to mitigate your risk of facing federal charges. At Oberheiden P.C., our federal health care fraud defense lawyers have deep experience in audits, inspections, and investigations involving all major federal law enforcement agencies, and we can get to work defending you and your mobile clinic right away.
Mobile Healthcare Clinics Should Focus on Compliance, then Defense
As John F. Kennedy once said, “The time to repair the roof is when the sun is shining.” At Oberheiden, P.C., we take compliance seriously. While we offer an aggressive defense to those mobile clinics that are already under investigation, we also work with mobile healthcare clinics to develop comprehensive compliance protocols to prevent them from coming under federal scrutiny in the first place. Our dedicated team of healthcare fraud defense attorneys has a long history of developing sound strategies that, when properly followed, ensure compliance.
Speak with a Senior Attorney or Consultant at Oberheiden P.C. about Mobile Clinic Compliance or Defense
Do you have questions or concerns about your mobile clinic’s compliance efforts? If so, we encourage you to contact us 24/7. To speak with a senior attorney or compliance consultant at Oberheiden P.C. in confidence, call 888-680-1745 or inquire online now.