Lawyers for Regulated Facilities - Federal Lawyer
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Lawyers for Regulated Facilities

We Represent All Types of Regulated Healthcare Facilities in Federal Compliance and Defense Matters

Lynette Byrd
Attorney Lynette S. Byrd
Regulated Facilities Team Lead
Former DOJ Attorney
envelope icon Contact Lynette

All types of healthcare facilities operating in the United States must observe a multitude of strict federal requirements and therefore face evolving regulatory challenges. While this makes managing an effective regulatory compliance program extremely challenging, federal government authorities like the Centers for Medicare and Medicaid Services (CMS) and U.S. Department of Health and Human Services (HHS) have made clear that this is not an excuse for noncompliance.

At Oberheiden P.C., we take the compliance burden off of our healthcare clients’ shoulders. Our lawyers work with regulated facilities across the U.S. to help them develop, implement, and maintain effective federal compliance programs. We represent regulated facilities during federal audits, investigations and enforcement actions as well, targeting efficient and favorable resolutions that keep our clients out of court whenever possible.

About Our Lawyers for Regulated Facilities

Our lawyers have extensive experience representing all types of regulated facilities in the healthcare industry. Many of our lawyers have prior experience overseeing federal audits and conducting federal healthcare investigations at the U.S. Department of Justice (DOJ) as well. As a result of this experience, we are extremely well-versed in the full spectrum of regulated facilities’ federal compliance obligations—and we are equally well-versed in the federal government’s approach to enforcing compliance.

Along with our federal healthcare lawyers, our team also includes consultants who have prior experience at CMS, HHS, and a variety of other federal agencies. These consultants offer a wealth of federal compliance expertise that supplement our lawyers’ knowledge and insights. By taking a team-based approach to representing regulated healthcare facilities, we ensure that each client benefits from all that our team has to offer—and, in doing so, we realize efficiencies that help to minimize the costs of our clients’ representation.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd
Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester
Brian J. Kuester

Former U.S. Attorney

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney

Local Counsel

John W. Sellers
John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara
Linda Julin McNamara

Federal Appeals Attorney

Aaron L. Wiley
Aaron L. Wiley

Former DOJ attorney

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (DOJ)

Chris Quick
Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow
Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

Our Legal Services for Regulated Healthcare Facilities

We provide comprehensive federal compliance and defense services for all types of regulated healthcare facilities. This includes (but is not limited to) helping the following types of regulated facilities manage compliance, manage federal healthcare audits, and defend themselves during federal healthcare investigations:

  • Ambulatory surgery centers (ASCs)
  • Assisted living facilities and nursing homes
  • Clinical laboratories
  • Correctional healthcare facilities
  • Dental practices
  • Doctors’ offices
  • Home health agencies
  • Hospices
  • Hospitals
  • Medical spas
  • Pain management clinics
  • Pharmaceutical and medical device facilities
  • Pharmacies
  • Toxicology laboratories
  • Urgent care facilities

Federal Healthcare Compliance

For regulated facilities, managing federal healthcare compliance is simply part of doing business. All regulated facilities must take a proactive approach to compliance, and they must thoroughly document their compliance efforts so that they are prepared to withstand federal healthcare audits and investigations when necessary. Our federal healthcare compliance services for regulated facilities include:

Compliance Needs Assessments

We conduct comprehensive reviews of our clients’ existing compliance programs and thoroughly assess their compliance needs in order to provide custom-tailored compliance recommendations. We make sure our clients address all pertinent obligations without taking additional steps that are unnecessary.

Compliance Program Development

After assessing our clients’ needs, we work closely with them to develop compliance programs that are custom-tailored to their regulated facilities’ operations. We focus on developing policies and procedures that our clients can implement efficiently and effectively so that they do not face unnecessary compliance challenges.

Compliance Program Implementation and Training

We also assist regulated facilities with compliance program implementation and training. Here, too, we take a custom-tailored approach focused on ensuring that our clients and their personnel have the knowledge, resources, and protocols they need to effectively manage their substantial compliance obligations.

Compliance Program Auditing and Enforcement

Internal auditing and enforcement are essential for effective federal healthcare compliance management. We assist our clients with managing regular internal audit programs designed to both assess and document compliance on an ongoing basis. We also assist our clients with making enforcement-related decisions when their employees commit compliance violations.

Compliance Program Updates

Lastly, we take a proactive approach to helping ensure that our clients’ federal healthcare compliance programs remain up to date. New laws and regulations, changes to existing laws and regulations, and changes to regulated facilities’ operations can all necessitate compliance program updates.

Federal Healthcare Audits

The Centers for Medicare and Medicaid Services, HHS’s Office of Inspector General (OIG), the U.S. Drug Enforcement Administration (DEA), the U.S. Food and Drug Administration (FDA), and various other federal authorities audit regulated facilities for compliance. These audits can present substantial risks, so it is essential for regulated facilities to ensure that they are thoroughly prepared.

When we work with regulated facilities on an ongoing basis, our lawyers and consultants are able to assist with ensuring that they remain prepared should they receive an audit notice in the mail. In this scenario, we have a clear understanding of the facility’s policies, procedures, and ongoing compliance efforts, and we know what documentation is available to substantiate our clients’ compliance.

When regulated facilities engage us specifically for federal healthcare audits, we work quickly to ensure that our clients are equally prepared. We focus on quickly gathering the information we need so that we know what documentation is available and what (if anything) the auditors are going to find.

In both scenarios, once the audit begins, our lawyers and consultants communicate with the auditing agency on our client’s behalf. Our lawyers and consultants also oversee the entire audit process so that we can intervene to address any overreaching, flawed assumptions or methodologies, or other issues as necessary. This type of proactive approach is essential for mitigating regulated facilities’ audit-related risk and reducing the chances of needing to file an appeal.

Federal Healthcare Investigations

We also defend regulated facilities during federal healthcare investigations. These internal investigations can flow from audits or result from complaints or other law enforcement activities. Like audits, investigations present substantial risks (including the risk of criminal prosecution in some cases), so a proactive and strategic defense is critical here as well.

With our lawyers and consultants’ experience on both sides of federal healthcare investigations, we have been able to amass a substantial track record of favorable results. In the vast majority of cases, this has meant resolving the government’s investigation without formal charges being filed. Our experience includes successfully defending regulated facilities and providers during federal healthcare investigations targeting allegations including (but not limited to):

  • Anti-Kickback and Stark Law violations
  • Medicare, Medicaid, and Tricare billing violations, False Claims Act
  • DEA compliance violations
  • FDA compliance violations
  • Insurance fraud and other financial crimes

If your regulated facility has received a target letter, subpoena, search warrant, or any other type of federal law enforcement inquiry, it is imperative that you engage experienced federal defense counsel immediately. Our team has the experience required to provide effective representation for Anti-Kickback, Stark Law, and False Claims Act defense, along with DEA and FDA compliance violations, and insurance fraud and other financial crimes, and we have lawyers and consultants who are prepared to deploy to facilities across the U.S. on an emergency basis when necessary.

FAQs: Federal Compliance Management for Regulated Healthcare Facilities

What Does it Take for Regulated Facilities to Effectively Manage Federal Healthcare Compliance?

For regulated facilities, effectively managing federal healthcare compliance is a substantial undertaking. There are numerous aspects to compliance, and regulated facilities must give due consideration to all of them. At Oberheiden P.C., our lawyers and consultants rely on extensive experience in the public and private healthcare law sectors to help our clients manage federal healthcare compliance with confidence.

What Areas of Compliance Are Most Important for Regulated Healthcare Facilities?

No one area of compliance is more important than the other. For regulated facilities, any healthcare regulatory compliance failures can create exposure to fines, administrative penalties, and even criminal prosecution in some cases. A comprehensive approach to compliance is essential, and regulated facilities must take a top-down approach to maintaining compliance in all areas of their operations.

What Are the Risks of Noncompliance for Regulated Healthcare Facilities?

The risks of noncompliance for regulated healthcare facilities range from administrative penalties (i.e., loss of registration or approval) and civil monetary penalties (CMP) to criminal fines and federal incarceration for the individuals involved. By their nature, federal healthcare audits and investigations targeting regulated facilities tend to have a lot at stake, so an effective defense is critical.

How Can Regulated Facilities Assess the Efficacy of Their Compliance Programs?

Assessing the efficacy of a regulated healthcare facility’s compliance program involves conducting a comprehensive internal compliance audit. At Oberheiden P.C., our lawyers and consultants have experience conducting and overseeing audits for facilities ranging from physician-owned practices to regional hospitals. If you have questions or concerns about your facility’s compliance program, conducting an internal compliance audit is the first step toward making informed decisions.

What Are Regulated Facilities’ Obligations When They Uncover Compliance Violations?

When regulated healthcare facilities uncover compliance violations through their internal monitoring or during an internal audit, the steps they need to take depend on the specific violation at issue. Self-reporting is required in some cases, and it may be necessary to proactively address certain violations (i.e., billing violations) in some cases as well. Generally speaking, failing to appropriately address a known compliance violation can increase a facility’s exposure in the event of a federal healthcare audit or investigation, so informed decision-making is key.


Contact the Lawyers for Regulated Facilities in Our Healthcare Practice Group

If you would like to speak with a lawyer for regulated facilities in our healthcare practice group, we invite you to get in touch. Call 888-680-1745 or contact us online to schedule a complimentary consultation today.

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