Clinical Laboratories & Diagnostics

Attorneys at MDRXLaw – Sauchik & Giyaur, P.C. offers comprehensive guidance to laboratories and testing facilities across the entirety of their business operations. We are frequently called upon to provide comprehensive legal and regulatory advice, addressing a broad spectrum of industry challenges. Our expertise extends to ensuring compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and associated regulations, as well as navigating state licensure and accreditation requirements. Whether our clients are involved in litigation, government investigations, or transactional matters, we represent their interests with dedication. Additionally, we offer valuable insights and recommendations on reimbursement issues.

We also represent laboratories in government investigations and False Claims Act litigation. Our track record includes successful resolutions of claims pertaining to sales and marketing practices, billing and medical necessity, testing/test kit quality, and COVID-related reimbursement issues.

• Sales and referral compliance. We review sales compensation, marketing arrangements and physician or client relationships under the federal Anti-Kickback Statute, EKRA and state law.

• Contracts and commercial agreements. We draft and negotiate client service agreements, reference laboratory arrangements, vendor and collection agreements, and employment and independent contractor agreements for sales and management staff.

• Billing and payor disputes. We advise on billing practices, medical necessity documentation, payor audits, overpayment demands and recoupments, and appeals.

• Out-of-network reimbursement. We represent laboratories pursuing additional payment for out-of-network services, including disputes under the federal No Surprises Act’s independent dispute resolution process.

• Licensure and regulatory compliance. We advise on CLIA certification, state laboratory licensing, HIPAA, and FDA questions affecting diagnostic tests.

• Transactions and financing. We handle laboratory acquisitions, ownership and investor arrangements, and lending and promissory note documentation.

• Investigations and litigation. We defend laboratories in government and payor inquiries, and in commercial disputes with partners, employees and former sales representatives.

Why MDRXLaw

Our practice is focused on healthcare businesses, including pharmacies, laboratories and medical practices. We advise clients on matters in New York, New Jersey, Pennsylvania and Maryland. We keep a laboratory’s compliance, contracts and disputes with one team, so advice on one issue accounts for the others.

Frequently Asked Questions

• Do the Anti-Kickback Statute and EKRA apply to how we pay sales representatives? Often, yes. The Anti-Kickback Statute reaches business paid for by federal health care programs. EKRA covers laboratory referrals paid for by any health care benefit program, including commercial insurance. Commission-based pay is a common risk area, so compensation plans should be reviewed before they are put in place.

• What should we do if a payor audits our claims or demands repayment? Contact counsel early, preserve your records, and avoid responding informally. Deadlines for responses and appeals can be short, and what you say early on can shape the outcome.

• Can a laboratory challenge low out-of-network payments? In some cases. Federal and state processes, including independent dispute resolution under the No Surprises Act, may be available depending on the payor and the service. We can review whether your claims qualify.

• Do you only work with large laboratories? No. We advise laboratories and diagnostic companies of different sizes, including newer companies setting up their contracts and compliance program.

• What states do you cover? We advise on matters in New York, New Jersey, Pennsylvania and Maryland.