Antitrust & Anti-Kickback Compliance

Protecting Healthcare Businesses From Regulatory Risk and Federal Enforcement

The healthcare industry operates under intense regulatory scrutiny, from laws over the management of controlled substances to basic business regulations. Healthcare companies must also comply with antitrust laws and anti-kickback statutes. By ensuring antitrust & anti-kickback compliance, you can protect the longevity of your business.

There are several ways that healthcare businesses can violate these regulations, even unintentionally. Agreements that impact pricing, referrals, or competition can trigger federal and state investigations, civil penalties, or even criminal liability. Having experienced legal representation by your side is essential for preemptively assessing your business’s risk and correctly responding to investigations.

Adhering to Antitrust & Anti-Kickback Compliance Laws

At Boesen & Snow Law, we help businesses like yours understand and comply with complex antitrust and anti-kickback regulations. This includes pharmacies, healthcare providers, manufacturers, and other life sciences businesses.

Whether you’re structuring a referral relationship, negotiating a rebate agreement, or expanding into new markets, we can advise you. Our firm provides strategic counsel that assesses risks unique to your industry and keeps your business protected.

Our Services

Boesen & Snow Law can help your healthcare business with several aspects of compliance, risk assessment, and defense against enforcement, such as:

Anti-Kickback Statute (AKS) Compliance

The federal Anti-Kickback Statute prohibits offering, soliciting, or receiving anything of value in exchange for patient referrals. It also prohibits this exchange for the generation of federal healthcare business, along with any transaction that is reimbursable through federal healthcare. We ensure compliance and help clients:

• Structure relationships with prescribers, clinics, and other referral sources
• Review marketing and patient support programs for AKS compliance
• Draft and negotiate service agreements, rebate contracts, and consulting arrangements
• Evaluate arrangements under safe harbors and Office of Inspector General (OIG) advisory opinions

Stark Law and State Law Compliance

We also counsel clients on compliance with the federal physician self-referral law (Stark Law) and its state-level equivalents. We can:

• Identify improper financial relationships or referral patterns
• Structure compliant compensation models for medical directors and consulting physicians
• Ensure alignment between business strategy and regulatory frameworks

Antitrust Risk Assessment

Healthcare markets are highly sensitive to antitrust enforcement, particularly concerning pricing, supply agreements, and consolidation. While some collaboration between healthcare entities and providers is seen as beneficial, there are limits. We assist with:

• Reviewing and structuring group purchasing and network participation agreements
• Analyzing exclusivity, non-compete, and territorial restrictions
• Counseling on interactions with competitors, vendors, and Pharmacy Services Administrative Organizations (PSAOs)
• Advising on mergers, joint ventures, and pharmacy acquisition strategies

Internal Audits and Compliance Reviews

We conduct proactive compliance assessments to identify and address risk areas before they become investigation or enforcement issues. Our services include:

• Internal audits of business relationships and compensation models
• Policy and standard operating procedure (SOP) development for AKS and antitrust compliance
• Training for sales, marketing, and executive teams
• Responding to whistleblower concerns and compliance hotline reports

Enforcement Defense and Investigations

If your business is under investigation or facing enforcement action from a federal or state agency, we can provide experienced representation for:

• Responding to Department of Justice (DOJ), OIG, or state attorney general (AG) subpoenas and civil investigative demands
• Conducting internal investigations and compliance audits
• Negotiating settlements or corporate integrity agreements
• Litigating antitrust and AKS-related disputes when necessary

Types of Healthcare Facilities and Providers We Help at Boesen & Snow Law

We represent a wide range of healthcare entities, including:

• Independent and chain pharmacies
• Specialty and compounding pharmacies
• Pharmacy benefit managers (PBMs) and PSAOs
• Medical device manufacturers
• Physician practices and Management Services Organizations (MSOs)
• Telehealth and digital health companies
• Infusion and home health providers

It is important that your healthcare company protects its interests, and that’s where our firm comes in.

Antitrust and Anti-Kickback Laws: Why They Matter

It is crucial that you make sure your business and healthcare providers are in compliance with these laws. Violations of antitrust or anti-kickback laws can result in:

• Exclusion from federal healthcare programs
• Civil monetary penalties and treble damages
• Criminal prosecution
• Damage to your professional reputation and business continuity

Our team has substantial healthcare regulatory knowledge based on significant legal experience and working in healthcare businesses. We have experience in defending and advising clients in high-stakes enforcement matters. We offer practical, business-minded solutions tailored to your risk tolerance and operational goals.

FAQs

Q: What Is Anti-Kickback Compliance?

A: Anti-kickback laws prohibit incentivizing a healthcare provider, facility, or patient to engage in a transaction or referral that provides a party with reimbursable federal healthcare benefits. Healthcare providers, facilities, and manufacturers must comply with this law by not providing other providers, facilities, or patients with something of value in exchange for referrals or using specific prescription drugs or medical devices. It is also forbidden to pay others for business referrals.

Q: What Is the Meaning of Antitrust Compliance?

A: Antitrust compliance in healthcare is when healthcare facilities and practitioners ensure compliance with antitrust laws. These exist to prevent anticompetitive actions by businesses that harm consumers and clients. In healthcare, there are some exceptions that other businesses do not have, as healthcare facilities can often benefit each other and the public by working together.
However, there are still some antitrust requirements these parties must follow. If the actions monopolize the market, that would be a violation of antitrust laws.

Q: What Is an Example of an Anti-Kickback Violation?

A: An anti-kickback violation may include:

• A medical device manufacturer providing discounts to medical providers who referred patients to the manufacturer’s device
• A prescription drug company providing free vacations to physicians who prescribe their medication
• An outpatient clinic providing doctors with a discount for referring patients to their clinic

Often, kickback payments are disguised as legitimate fees, such as speaker fees, payments for meetings, or other inflated rates and payments.

Q: What Is the Cost of Antitrust & Anti-Kickback Compliance Support?

A: The cost of advice and support for antitrust and anti-kickback compliance will depend on the type of professional you work with, their experience in the field, and the specifics of your business and its needs. It can be useful to work with a legal professional to secure legal advice and in-depth support. While legal professionals may have higher costs, their exceptional and comprehensive support can be very beneficial. Always discuss costs with a professional upfront.

Contact Boesen & Snow Law Today

If you need guidance on antitrust or anti-kickback compliance, let us help you structure your business relationships and administrative agreements. That way, they can stand up to scrutiny.

Contact us today to schedule a complimentary consultation.