Amanda S. Marshall
Former U.S. Attorney
(Local Counsel)
Lynette Byrd
Former Assistant
U.S. Attorney
Roger Bach
Former Special
Agent
(OIG & DEA)
Joe Brown
Former U.S. Attorney
Dr. Nick Oberheiden
Attorney & Founder
Medical Research Studies and Anti-Kickback Investigations
Federal investigators view pharmaceutical research studies with a suspicious eye to make sure that such studies are not merely a façade for medical marketing tactics. Such suspicion follows the exposure of numerous kickback schemes disguised as research studies, including schemes committed by major corporations. For example, pharmaceutical stalwart Merck &...
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Mistakes to Avoid When Setting Up PGX Laboratories
New PGX laboratories often run into regulatory and compliance problems in the early stages of their development. While each lab is different, and their individual issues are unique, this entry addresses some of the most common problem areas for a new laboratory: Establishing an Effective Compliance Department. An engaged and...
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Defending Toxicology Laboratories in PGX Testing Fraud Cases
What Is PGX Testing? PGX testing is an emerging medical technology within the field of clinical laboratories that uses a patient’s DNA to predict how that patient will react to medication. Doctors can use PGX testing to tailor treatment regimens for individual patients as well as to prevent a patient...
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Government Investigations of Research Studies
Federal law enforcement agencies are increasingly scrutinizing medical research studies for violations of healthcare regulations. In particular, investigators are determined to hold physicians, pharmaceutical companies and medical researchers accountable for misuses of medical research studies as a means to violate the Anti-Kickback Statute and commit healthcare fraud. Fraud Allegations in...
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Defending Physicians against Kickback Charges in Connection with PGX Testing
Laboratory Kickback Prosecutions Since 2014, when the Department of Health and Human Services’ Office of the Inspector General released a Special Fraud Alert regarding improper payments by laboratories to referring physicians, federal investigators have increasingly focused on the relationships between laboratories and physicians. Federal investigators are particularly on the lookout...
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How to Defend PGX Laboratories Against Healthcare Fraud Charges
The Government’s Allegations Over the past few years, the United States government has placed a particular focus on detecting and prosecuting healthcare fraud among laboratories, even issuing several Special Fraud Alerts regarding common types of fraud committed by laboratories. Federal investigators are currently scrutinizing financial relationships between laboratories and referring...
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What Are the Ownership and Investment Interest Exceptions to the Stark Law?
The Stark Law, officially named the Physician Self-Referral Law (42 U.S.C. § 1395nn), forbids physicians to refer a Medicare/Medicaid patient to a “designated health services” (DHS) provider that the referring physician (or his immediate family member) has a “financial relationship” with, unless an exception applies. Similarly, the Stark Law disallows...
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What Are the Compensation Arrangement Exceptions to the Stark Law?
Under the Physician Self-Referral Law (42 U.S.C. § 1395nn), or Stark Law, physicians are barred from referring Medicare/Medicaid beneficiaries to a “designated health services” (DHS) provider in which the referring physician (or his immediate family member) has a “financial relationship.” Because maintaining the Stark Law without exceptions would make the...
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What Are the Reporting Requirements under the Sunshine Act?
The Sunshine Act requires applicable manufacturers to report payments or other transfers of value to physicians or teaching hospitals, as well as ownership and investment interests held in the company by physicians and their immediate family members. See 42 U.S.C. § 1320a-7h. Important Terminology The key to understanding the requirements...
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What Is the Personal Service Exception under Stark Law?
The Ethics in Patient Referrals Act (Stark) prohibits physicians who have financial relationships with entities from making referrals to those entities for the furnishing of designated health services (DHS) reimbursable by Medicare, subject to certain exceptions. See 42 U.S.C. § 1395nn(a)(1). To limit the wide and potentially unintended application of...
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