Master Guide to Clinical Lab Compliance 2022 Edition

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Master Guide to Clinical Lab Compliance 2022: Navigating Stepped-Up Investigations, Audits & Enforcement Actions

Get Your Clinical Lab Ready for Stepped-Up Compliance Enforcement in 2022

More than ever before, clinical labs are a major enforcement target of the DOJ, whistleblowers, CMS, the OIG, Medicare/Medicaid contractors and state prosecutors.

And that’s just the tip of the iceberg.

In addition to the Federal and State Government compliance crackdowns, private insurers, individual patients, and even corporate shareholders have joined the legal feeding frenzy, and diagnostic labs are paying the price.

And while the stream of qui tam lawsuits, false claims, anti-kickback, and Stark prosecutions remains strong, 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.

And if that wasn’t enough, the continuing COVID-19 pandemic has hit labs with a flood of new regulations and compliance challenges.

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

The G2 Master Guide to Clinical Lab Compliance 2022: Navigating Stepped-Up Investigations, Audits & Enforcement Actions 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:

  • FCA Compliance for Clinical Labs: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
  • Navigating FCA Enforcement Policies and Programs: LabScam, Current Areas of Enforcement Focus, Referral Relationships, Test Ordering, Test Performance, Medically Necessary-Based Medicare Payment Denials, Medicare Medical Necessity Requirements, Medicare Financial Protection Requirements, 4 Ways to Protect Your Lab from Medical Necessity Claim Denials, Reporting and Billing for Tests, Medical Necessity and PGx Tests, Documenting, Billing, Sales and Marketing of PGx Tests, Sales and Marketing Legal Risk, State False Claims Acts
  • COVID-19 Testing, Reimbursement & 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, Reimbursement for COVID-19 Testing: the FFCRA and CARES Acts, CMS Guidance on Covered COVID-19 Tests, Medicare Reimbursement for COVID-19 Testing, CMS Waivers that Expand Coverage Rules for COVID-19 Testing, Billing of Specimen Fees during the PHE, COVID-19 Test Billing Compliance Red-Flags: “Add-On” Testing, Crackdown on COVID-19 Relief Abuses, COVID-19 Anti-Fraud Initiatives
  • Clinical Laboratory Sales and Marketing Compliance: Anti-Kickback Statute, Statutory and Regulatory AKS Safe Harbors, New OIG AKS Safe Harbors, 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, New Value-Based Care Relief Rules, New Stark Exceptions for Value-Based Arrangements, Impact of EKRA, 10 Ways to Protect Your Lab
  • Navigating the Opioid Crackdown & Other Enforcement Trends: Impact on Clinical Labs, Notable Billing Settlements, Improper Payment for Drug-Testing, The Emergence of Telemedicine Fraud, The CONNECT for Health Act, 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
  • Avoiding the 19 Most Deadly Anti-Kickback, Stark Law & EKRA Compliance Traps: Contract Sales Personnel, Commission Arrangements and EKRA Liability, Billing Company Contract Liability Risks, Paying Healthcare Practitioners for Services, Placing Lab Employees in Physician Offices, Risks of Phlebotomists in Physician Offices, Specimen Processing Arrangements, Registry Payments, Leasing or Renting Space from Physicians, Free Client Supplies, Free Computers, Telemedicine, and Other Equipment, Client Access to Lab Information, Donating EHR Equipment to Clients, Participating in Provider Referral Exchanges, Gifts, Meals and Other Non-Monetary Compensation, Professional Courtesy and Introductory Free Trials, Reduced Price and Discount Arrangements, Exclusive Referral Arrangements, Waiver of Co-Pays and Deductibles, Gainsharing Arrangements, EPTSD Incentives, 11 Ways to Protect Your Lab
  • Hospital Contracting with Hospital-Based Pathologists: Federal Laws Regulating Hospital/Pathologist Relationships, Payments for Clinical Pathology Services, 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 Calculation Pitfalls to Avoid, Hospital Services Purchased by Hospital-Based Pathologists
  • 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 Plan: 7 Elements of an Effective Compliance program, Latest OIG Compliance Guidance, Establishing Benchmarks, The “Deliverable” or Work Product, The Compliance Review and Update Process, How to Audit the Effectiveness of Your Compliance Plan, The 3 Indicators of Compliance Effectiveness, High-Risk Issues

And that’s Just a Sample! Your G2 Master Guide to Clinical Lab Compliance 2022 also gives 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!


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