Master Guide to Clinical Lab Compliance 2021 Edition



Master Guide to Clinical Lab Compliance 2021: Compliance in the Age of COVID-19

For over two decades, clinical labs have been a favorite target of the DOJ, whistleblowers, CMS, the OIG, Medicare/Medicaid contractors and state prosecutors.

Now, private insurersindividual patients and even corporate shareholders have joined the legal feeding frenzy.

While the stream of qui tam lawsuits and false claims, anti-kickback and Stark prosecutions remains steady, these laws are now being ingeniously applied to molecular and genetic testing, toxicology, LDTs and other new forms of lab business.

At the same time, the new Eliminating Kickbacks in Recovery Act (EKRA) has changed the game of what we thought we knew about kickbacks by enabling federal and state governments to target the sales and marketing practices for any laboratory service paid for by a federal healthcare program or commercial health insurer.

Now, all of this is taking place against a backdrop of the COVID-19 pandemic that hits clinical labs with new regulations and new compliance challenges.

AVAILABLE NOW!  Protect Your Lab against Costly Compliance Fines and Penalties

The G2 Master Guide to Clinical Lab Compliance 2021: Compliance in the Age of COVID-19 is designed to give you the practical, plain-language help you need to understand the laws affecting labs, and take practical, proven steps to protect your lab from costly False-Claims, Anti-Kickback, Stark Law, and other legal and compliance violations.

Here is Just a Sample of the Practical, Easy-to-Use Compliance Help Your Guide Gives You:

  • False Claims Act: What is the FCA, What is a False Claim? Kickbacks as False Claims, Reverse False Claims and the 60 Day Repayment Rule, FCA Penalties, Whistleblowers and Qui Tam Lawsuits, How Qui Tam Lawsuits Work, Barriers to Qui Tam Lawsuits, Anti-Retaliation Provisions, Preventing and Responding to Qui Tam Complaints
  • FCA Enforcement against Clinical Labs: LabScam, Current Areas of Enforcement Focus, Referral Relationships, Test Ordering, Test Performance, Reporting and Billing for Tests, Sales and Marketing Legal Risk, State False Claims Acts
  • COVID-19 and Its Impact on Fraud Enforcement & Compliance: COVID-19 Stark and AKS Waivers, HHS Section 1135 Blanket Waivers and OIG Policy Statement, the 18 Blanket Waivers, the Blanket Waiver Blind Spot Reminder, Eligibility Requirements, Billing & Coding of COVID-19 Testing, the FFCRA and CARES Acts, Key Takeaways from the CMS Guidance, CMS Waivers Expand Coverage Rules for COVID-19 Testing, Billing of Specimen Fees during the PHE, COVID-19 Test Billing Compliance Red-Flags: “Add-On” Testing, COVID-19 Test Data Reporting Requirements, COVID-19 Anti-Fraud Initiatives
  • Anti-Kickback and Stark Law Liability Risk in Sales and Marketing: Anti-Kickback Statute, Stark Law, Risk Areas, Contract Personnel, Paying Practitioners for Personal Services, Lab Employees in Physician’s Offices, Specimen Processing Arrangements, Leasing Space from Physicians, Free Client Supplies and Equipment, Donating EHR Software, Provider Referral Exchanges, Non-Monetary Compensation, 10 Ways to Protect Your Lab
  • The Opioid Crackdown & Other Enforcement Trends: Impact on Clinical Labs, Stepped-Up CMS Opioid Testing Enforcement, Specimen Validity Testing and Medical Necessity, Drug Test Overpayments, EKRA and the Unintended Consequences of the Opioid Crackdown, Privatization of Lab Fraud Enforcement, Consumer Lawsuits against Labs, Securities Lawsuits against Labs, Creditor Lawsuits against Bankrupt Labs
  • Hospital Contracting with Hospital-Based Pathologists: Federal Laws Regulating Hospital/Pathologist Relationships, AKS liability risks, Part A Services Contracting and Payment Negotiations, Professional Component of Pathology Services, Medical Director Services, Clinical Conferences and Continuing Education, Committee Participation, Autopsy Services, Malpractice Liability, Current OIG Position, Determination of Fair Market Value, Penalties, 5 Pitfalls to Avoid
  • State Laws Affecting Labs: State Anti-Kickback and Stark Laws, State False Claims Acts, State Physician Self-Referral Laws, State Insurance and Waiver of Co-Pay Laws, State Fraud and Abuse Enforcement, Medicaid Program Integrity Initiatives
  • Implementing a Clinical Lab Compliance Program: 7 Elements of an Effective Compliance program, Latest OIG Compliance Guidance, Establishing Benchmarks for Measuring Compliance Effectiveness, The Compliance Review Process

And that’s Just a Sample! Your G2 Master Guide to Clinical Lab Compliance 2021 also give you a glossary of compliance terms and acronyms, OIG Compliance Program Guidance for Clinical Labs, a Practical Guide for Health Care Governing Boards on Compliance Oversight, the 5 recent HHS Special Fraud Alerts, OIG Self-Disclosure Protocol, and MUCH MORE!