Healthcare Regulatory Compliance

We Help Healthcare Providers Effectively Manage All Aspects of Regulatory Compliance

Attorney Lynette S. Byrd
Healthcare Regulatory Compliance Team Lead
Former DOJ Attorney envelope icon

Healthcare providers in the U.S. are subject to numerous regulatory requirements. To manage their regulatory compliance obligations effectively, providers must implement comprehensive policies and procedures, and they must monitor and enforce compliance internally.

At Oberheiden P.C., we assist providers with all aspects of healthcare regulatory compliance. We provide our clients with the tools and resources they need to establish compliance, and we help them maintain compliance on an ongoing basis. We also help our clients demonstrate their compliance to CMS, the FDA, and other federal authorities when necessary. If you are looking for a full-service healthcare regulatory compliance solution, we encourage you to schedule a complimentary initial consultation to learn more.

Our Regulatory Compliance Services for Healthcare Providers

Our comprehensive regulatory compliance services for healthcare providers address all aspects of compliance and are designed to protect our clients at all stages of the compliance lifecycle. Our clients receive the documentation, insights, and support they need to meet their compliance obligations, treat their patients, and bill Medicare and other payors with confidence.

1. Establishing Regulatory Compliance

For all providers, the first step toward effective healthcare regulatory compliance management is understanding their compliance obligations. While many healthcare providers are subject to the same laws and regulations, these laws and regulations can apply differently in different circumstances. Certain aspects of providers’ practices can trigger additional regulatory requirements as well. As a result, there is truly no one-size-fits-all approach; and, to establish regulatory compliance, providers must have a clear understanding of their specific compliance needs.

To help our clients establish regulatory compliance, we begin by conducting a comprehensive assessment of their compliance program needs. Our lawyers and compliance consultants thoroughly assess all aspects of our clients’ practices—from their patient and prescription practices to their operational structure and billing procedures. Then, based on this assessment, we provide recommendations for policies and procedures that reflect each individual client’s compliance burden.

While each provider’s compliance program must be custom-tailored to its own unique risks and needs, some examples of the areas of healthcare regulatory compliance that providers will typically need to address include:

CMS compliance (including Medicare and Medicaid compliance)
Tricare and DOL compliance
Private insurance and patient billing compliance
FDA and FTC compliance (including healthcare marketing compliance)
DEA compliance
Electronic prescription management compliance
HIPAA compliance
Telemedicine and telehealth compliance
Anti-kickback compliance
Employment-related legal and regulatory compliance

Again, these are just examples. When it comes to regulatory compliance, healthcare providers can face an extraordinarily broad range of obligations—and providers must dutifully address all of their obligations to avoid unnecessary financial liability and other penalties. Additionally, as these obligations can (and frequently do) change over time, even if a provider has conducted a comprehensive regulatory compliance assessment in the past, this does not necessarily mean that its compliance program is effective today.

2. Managing and Maintaining Regulatory Compliance

Along with helping healthcare providers implement policies and procedures to establish regulatory compliance, our lawyers and consultants also help providers manage and maintain compliance on an ongoing basis. As we just mentioned, providers cannot simply assess their compliance obligations once and then let their policies and procedures sit on a shelf. Managing and maintaining regulatory compliance is a dynamic process that requires a proactive approach, and providers need to work with their compliance counsel to ensure that they are consistently doing everything that is required.

We offer several services that are designed to help healthcare providers effectively manage and maintain regulatory compliance. These services include:

Internal Regulatory Compliance Auditing – To ensure that they are implementing their regulatory compliance programs effectively, healthcare providers should conduct internal audits at least annually. We conduct these audits for our clients, ensuring that they are both comprehensive and as efficient as possible, and allowing our clients to remain focused on treating their patients.
Regulatory Compliance Investigations and Enforcement – When employees make mistakes, healthcare providers must investigate promptly. They must remedy any compliance failures, and they must also enforce appropriate discipline. This is what federal regulators expect; and, if providers do not take all of these steps effectively, they can be deemed complicit in their employees’ compliance failures.
Healthcare Regulatory Compliance Monitoring – Since the federal healthcare regulations change frequently, it is important for healthcare providers to monitor for amendments and additions that impact their compliance obligations. We conduct this monitoring for our clients, and we let them know when changes to their compliance programs are necessary.
Day–to-Day Regulatory Compliance Advice – We also provide many of our healthcare clients with regulatory compliance advice on a day-to-day basis. If you have questions about compliance, you need to get your questions answered so that you can make informed decisions. Our lawyers and consultants provide our clients with the information they need to practice confidently within the confines of the law.
Regulatory Compliance Program Updates – In addition to changes in the federal healthcare regulations, changes in providers’ operations, staff, and patient and billing practices can also necessitate compliance program updates. We help our clients understand when updates are necessary, and we assist with efficiently implementing compliance program updates through training and other means.

3. Demonstrating Compliance During Healthcare Audits and Investigations

Maintaining compliance is pointless if you can’t prove it. The purpose of healthcare regulatory compliance is to avoid scrutiny from federal authorities—and to withstand scrutiny from the authorities when necessary. Federal authorities like CMS, the DEA, and the FDA expect providers to have comprehensive compliance documentation on hand; and, if providers don’t have this documentation on hand, they can face penalties even if their processes and procedures comply with the law.

With this in mind, in many respects, maintaining documentation of compliance is just as important as maintaining compliance itself. At Oberheiden P.C., we help our clients implement the systems needed to generate and store documentation of compliance as a matter of course. By generating and storing appropriate patient records, billing records, and records of internal investigations and discipline, healthcare providers can position themselves to withstand invasive federal healthcare audits and investigations.

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)

FAQs: Understanding the Challenges (and Importance) of Healthcare Regulatory Compliance

What Does It Take for Healthcare Providers to Effectively Manage Regulatory Compliance?

Effectively managing healthcare regulatory compliance requires an informed and proactive approach. Healthcare providers must have a clear understanding of their obligations, and they must adopt policies and procedures that are designed specifically to help them meet these obligations on an ongoing basis. Healthcare providers must also conduct periodic internal audits to ensure that their compliance programs are working, and they must conduct internal investigations and enforce their employees’ compliance responsibilities when necessary.

What Are the Key Aspects of a Healthcare Regulatory Compliance Program?

There are several key aspects to healthcare regulatory compliance. For example, a typical compliance program will address issues including (but not limited to) billing compliance, patient recordkeeping compliance, data privacy compliance, prescription drug compliance, and healthcare marketing compliance. Each provider must address these issues (among others) taking into the unique aspects of its practice, and all providers must have comprehensive and custom-tailored compliance programs that reflect their specific regulatory obligations.

Do Providers Need a Law Firm for Healthcare Regulatory Compliance?

Due to the risks and challenges involved with managing compliance, all healthcare providers should engage a law firm to assist them. At Oberheiden P.C., we work with healthcare providers nationwide, and our lawyers and consultants have prior experience working for the federal government in healthcare fraud enforcement. As a result, we have an in-depth understanding of what it takes not only for healthcare providers to maintain compliance, but also to prove their compliance during federal audits and investigations.

What Are the Risks of Failing to Maintain Regulatory Compliance for Healthcare Providers?

For healthcare providers, the risks of failing to maintain regulatory compliance can be substantial. Inadvertent billing errors can lead to recoupments, prepayment review, fines, program exclusion, and other penalties, while other regulatory violations can lead to civil or criminal enforcement. Combating healthcare fraud is a top federal law enforcement priority, and agencies like CMS, the DEA, and the FDA routinely target healthcare providers for a broad range of regulatory compliance violations.

What is the First Step for Establishing Healthcare Regulatory Compliance?

The first step toward establishing regulatory compliance for healthcare providers is engaging a law firm to conduct a compliance risks and needs assessment. Based on this assessment, the firm will be able to provide custom-tailored compliance recommendations and develop policies and procedures that are designed to facilitate compliance on an ongoing basis. At Oberheiden P.C., we rely on extensive relevant experience to help our clients establish and maintain compliance so that they can avoid unnecessary risks and stay focused on patient care.

Speak with a Healthcare Regulatory Compliance Lawyer at Oberheiden P.C.

Would you like to know more about how we help healthcare providers effectively manage their regulatory compliance obligations and avoid unwanted federal scrutiny? If so, we invite you to get in touch. Please call 888-680-1745 or contact us online to schedule a complimentary initial consultation.