Enforcement Actions Present Substantial Risks for Healthcare Providers and Other Entities
For healthcare providers, facing scrutiny from state or federal authorities presents substantial risks. Enforcement actions can lead to civil or criminal penalties—not only at the organizational level, but for individuals as well. If your business or practice is facing allegations, you need experienced counsel, and you should discuss your situation with an experienced healthcare enforcement action attorney promptly.
At Oberheiden P.C., our healthcare enforcement action lawyers are highly experienced in defending providers nationwide. Crucially, this includes not only experience as providers’ defense counsel, but as former healthcare fraud prosecutors as well. As a result of this experience, our attorneys have an intimate understanding of when, why, and how the government pursues enforcement actions against healthcare providers, and we are able to use these insights to our clients’ advantage.
Dr. Nick Oberheiden
Founder
Attorney-at-Law
John W. Sellers
Former Senior Trial Attorney
U.S. Department of Justice
Local Counsel
Joanne Fine DeLena
Former Assistant U.S. Attorney
Local Counsel
Lynette S. Byrd
Former Assistant U.S. Attorney
Partner
Amanda Marshall
Former U.S. Attorney
Local Counsel
Aaron L. Wiley
Former Federal Prosecutor
Local Counsel
Roger Bach
Former Special Agent (OIG)
Gamal Abdel-Hafiz
Former Supervisory Special Agent (FBI)
Chris Quick
Former Special Agent (FBI & IRS-CI)
Kevin M. Sheridan
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Dennis A. Wichern
Former Special Agent-in-Charge (DEA)
Common Issues in Healthcare Enforcement Actions
Healthcare enforcement actions can target an extremely broad range of alleged statutory and regulatory violations. Fundamentally, however, all enforcement actions involve allegations of healthcare fraud. Being accused of healthcare fraud can have far-reaching implications; and, even if a provider is able to resolve its enforcement action favorably, it must be cognizant of other potential legal risks as well.
These risks include the possibility of civil litigation (i.e., patient or insurance company claims), disciplinary action, and facing enhanced scrutiny from auditors and government investigators in the future. When we defend healthcare providers against enforcement actions, we take these risks into account. We formulate comprehensive defense strategies focused not only on protecting our client in the instant enforcement action, but also on protecting our client against future liability.
We take this comprehensive approach to every healthcare enforcement action we handle. This includes (but is by no means limited to) enforcement actions involving allegations of:
- Billing and coding errors when seeking reimbursement from Medicare or Medicaid
- Double-billing federal healthcare programs and private insurers or patients
- Billing for medical services, supplies, or prescription medications not provided (so-called “phantom billing”)
- Billing for medically unnecessary services (as defined by the Medicare or Medicaid billing rules), other ineligible medical services, or services rendered by an unlicensed provider
- Prescription-related violations of the Controlled Substances Act (CSA) and Drug Supply Chain Security Act (DSCSA)
- Electronic prescription violations
- Violations of the U.S. Drug Enforcement Administration’s (DEA) registration requirements
- Conducting transactions that violate the Anti-Kickback Statute (AKS), Eliminating Kickbacks in Recovery Act (“EKRA”), or Stark Law (“Physician Self-Referral Law”)
- Violations of the federal telehealth and telemedicine regulations
- Failing to adequately protect patients’ private financial or health information
Steps to Take When Facing a Healthcare Enforcement Action
When targeted in enforcement actions, healthcare providers must take swift action to protect themselves. Some of the key steps involved in successfully defending against a healthcare enforcement action include:
1. Engage Defense Counsel
Whether targeted for civil or criminal prosecution, providers need to engage an experienced healthcare enforcement action lawyer promptly upon learning of the government’s action. Working with experienced defense counsel is critical for avoiding miscues, mitigating risks, and resolving the government’s enforcement action as quickly and favorably as possible.
2. Initial Response
When the government formally initiates an enforcement action, the targeted provider only has a limited amount of time to respond. Preparing an initial response takes time, and it requires knowledge of the relevant facts as well as an in-depth understanding of the relevant law.
3. Preliminary Steps
After taking any immediate initial action that may be necessary, providers targeted in healthcare enforcement actions should work with their defense counsel to begin building their defense strategies. This starts with taking several key preliminary steps—including carefully selecting an internal defense team and identifying all sources of relevant documentation.
4. Internal Audit
With a defense team in place and a clear understanding of where the relevant data are stored, the next step is to conduct a comprehensive internal audit. The purposes of this audit are twofold: to assess the veracity of the government’s allegations and to identify the defenses that the provider has available.
5. Defense Formulation
After gathering all necessary information through an internal audit, the provider’s healthcare enforcement action attorneys will work to formulate a comprehensive and cohesive defense strategy. Depending on the circumstances at hand, this defense strategy may focus on securing a pre-trial or pre-hearing resolution, negotiating a settlement that mitigates the provider’s liability, or preparing to challenge the government’s allegations at a trial or hearing.
6. Defense Execution
With an effective defense strategy in place, it is time to execute. As the enforcement action progresses, the provider will need to work closely with its defense counsel to steer the proceedings toward a favorable resolution.
7. Settlement Negotiations (as Warranted)
If warranted, the provider’s healthcare enforcement action lawyers will work to negotiate a favorable settlement on the provider’s behalf. To be clear, settlement is not warranted in all cases. But, if it appears likely that the government’s attorneys will be able to prove the allegations at issue, then negotiating a settlement that avoids publicity and provides a certain outcome may prove to be the most advantageous approach.
Potential Defenses in Healthcare Enforcement Actions
When deciding how to approach a healthcare enforcement action, it is imperative to have a clear understanding of the defenses that the provider has available. In most cases, viable defenses during healthcare enforcement actions will fall into one of five broad categories:
- Full Compliance – If a provider can demonstrate that the government’s enforcement action is misguided, this can provide the most comprehensive and most straightforward path toward a favorable resolution. Our healthcare enforcement action attorneys have used providers’ compliance documentation to successfully avoid penalties in many cases.
- No Statutory Violation – Many federal healthcare laws, including the CSA, DSCSA, AKS, and EKRA, are extremely nuanced and detailed. If even a single element of the government’s case is lacking, then an experienced healthcare enforcement action lawyer should be able to prevent the government from proving a violation.
- Safe Harbors and Exceptions – Laws such as the AKS and Stark Law also include various safe harbors and exceptions. If one of these statutory or regulatory protections applies, it can serve as a complete defense against liability.
- Unintentional Violations – Lack of intent is not a complete defense against liability in most cases. But, when targeted criminally, providers that are able to successfully challenge the government’s evidence of intent can protect themselves against criminal fines and prison time.
- Lack of Evidence – In all healthcare enforcement actions (both civil and criminal), the burden of proof rests with the government. If the government’s evidence is lacking, this is all it takes to secure a favorable resolution with no civil or criminal liability.
FAQs: Defending Against a Healthcare Enforcement Action
What Are the Risks of Facing a Healthcare Enforcement Action?
Healthcare enforcement actions present substantial risks for providers. These risks include liability for recoupments, fines, and other financial penalties; loss of government program (i.e., Medicare or Medicaid) eligibility; and, in criminal enforcement cases, prison time. Facing healthcare enforcement actions can also trigger civil litigation and, for licensed healthcare providers, disciplinary action from their state licensing board.
What Are the Possible Outcomes of a Healthcare Enforcement Action?
The possible outcomes of healthcare enforcement actions broadly fall into three categories: (i) a finding of no liability (dismissal), (ii) settlement, or (iii) a finding of civil liability or criminal guilt. To maximize their chances of securing a dismissal, targeted healthcare providers should engage experienced defense counsel as soon as possible.
How Do You Favorably Resolve a Healthcare Enforcement Action?
Favorably resolving a healthcare enforcement action requires an informed and strategic approach. Working with their defense counsel, targeted providers should work quickly to assess their risk, formulate their defense strategy, and proactively target a favorable pre-trial or pre-hearing resolution.
When Should Providers Engage a Healthcare Enforcement Action Attorney?
Providers should engage a healthcare enforcement action attorney at the first sign that they are facing scrutiny from a governmental authority. Ideally, this will be during the beginning stages of the government’s investigation. If the government has already concluded its investigation, targeted providers need to engage defense counsel immediately.
Why Do Providers Choose Oberheiden P.C. for Healthcare Enforcement Action Defense?
Oberheiden P.C. is a healthcare defense law firm with a nationwide network of lawyers who are highly experienced. The firm also has a network of defense consultants who include former law enforcement agents with the DEA, U.S. Department of Health and Human Services (DHHS), and other authorities. We have a proven record of success in high-stakes healthcare enforcement actions, with the vast majority of our clients avoiding civil and criminal charges entirely.
Speak with a Healthcare Enforcement Action Lawyer at Oberheiden P.C.
Is a government agency targeting your healthcare business or practice? If so, we encourage you to contact us immediately to discuss your defense. To speak with a senior healthcare enforcement action lawyer at Oberheiden P.C. in confidence as soon as possible, please call 888-680-1745 or tell us how we can contact you online now.
