G2 Compliance Perspectives: Clinical Laboratories Now Outside Electronic Health Records Safe Harbor and Stark Exceptions

Stakeholders in the clinical laboratory industry have frequently expressed concern about potentially suspect donations of electronic health records software, information technology, and training … [Read more...]

Compliance Perspectives: Laboratory Phlebotomists in Physician Offices? States Increasingly Saying ‘No’

A common practice among clinical laboratories is to place laboratory employees, such as phlebotomists, in physicians’ offices for the purpose of collecting lab samples. This practice has been allowed, … [Read more...]

Compliance Perspectives: Drugs-of-Abuse Testing: Noridian DL34754 Raises Critical Compliance, Legal Issues for Clinical Labs

Testing for drugs of abuse in clinical practice is a balancing act for the laboratory and health care practitioner. Testing too few or too many drugs or testing too frequently or not frequently enough … [Read more...]

Compliance Perspectives: Direct Patient Access to Laboratory Test Reports: 10 Things a Lab Should Know About the Final Rule

On Feb. 6, 2014, the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights finalized the Patients’ Access to Test Reports final … [Read more...]

Compliance Perspectives: Keeping Legal Advice In-House: Protecting the Attorney-Client Privilege

Given that laboratories operate in a heavily regulated environment, the advice of legal counsel is integral to ensuring compliance with the many laws and regulations that govern the laboratory … [Read more...]

G2 Compliance Perspectives: Implications for Clinical Laboratories In the OIG’s Proposal to Expand CMP Authority

There are potentially significant implications for the clinical laboratory industry in a proposed rule published in the Federal Register on May 12 that amends and expands the authority of the Office … [Read more...]

G2 Compliance Perspectives: OIG Warns of Anti-Kickback Statute Violations In Laboratory Payments to Referring Physicians

The Health and Human Services Office of Inspector General (OIG) on June 25 issued a special fraud alert titled “Laboratory Payments to Referring Physicians,” which should cause any laboratory that … [Read more...]

Compliance Perspectives: Compliance Warning: Watch Out for 2015 Laboratory Drug CPT® Code Changes

The American Medical Association (AMA) and the Centers for Medicare and Medicaid Services (CMS) have posted the preliminary new, revised, and deleted CPT® codes for 2015. The Drug Testing and the … [Read more...]

Compliance Perspectives: Medicare Medical Necessity Requirements Continue to Vex Clinical Laboratories

For more than a quarter century, clinical laboratories have struggled with the Medicare program over application of medical necessity requirements to laboratory services. The issue is complicated … [Read more...]

Compliance Perspectives: Defending the Medical Necessity of Anatomic, Clinical Pathology Services

"Thou shalt bill only medically necessary services.” Even though the term medical necessity appears in nearly every coverage policy issued by payers and insurers, its precise meaning remains elusive. … [Read more...]