Understanding Why Laboratories Are Under Scrutiny

by  Knicole C. Emanuel Esq.
Jul 26th, 2023

Laboratories are suddenly under scrutiny by the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and state Medicaid departments.

Labs get urine samples from behavioral healthcare companies, substance abuse companies, hospitals, and primary care facilities that often don’t have their own labs. Owners of labs entrust their lab executives to follow procedures on the federal and/or state level for Medicare and/or Medicaid. Well, what if they don’t? For example, one client paid a urine collector by the mile. The courier service tested Medicaid beneficiaries in North Carolina 90 times a year, when Medicaid only allows 24 tests per year.

I have about 10-15 laboratory clients at the present. Several laboratories are undergoing the most serious audits in existence. Not Recovery Audit Contractor (RAC), Medicare Administrative Contractor (MAC), or Unified Program Integrity Contractor (UPIC) audits, but audits of even greater consequence. They received CIDs, or civil investigative demands, from their state Medicaid divisions.

These requests, like RAC, MAC, or UPIC audits, feature asks for lots of documents – in fact, CIDs are legally allowed to request documents for a much longer period of time than RACs, which can only look three years back. As you may know, labs must follow CLIA or be CLIA-certified, which is the federal standard.

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This article originally published on July 26, 2023 by RACmonitor.

About Knicole C. Emanuel Esq.

For more than 20 years, Knicole has maintained a health care litigation practice, concentrating on Medicare and Medicaid litigation, health care regulatory compliance, administrative law and regulatory law. Knicole has tried over 2,000 administrative cases in over 30 states and has appeared before multiple states’ medical boards. She has successfully obtained federal injunctions in numerous states, which allowed health care providers to remain in business despite the state or federal laws allegations of health care fraud, abhorrent billings, and data mining. Across the country, Knicole frequently lectures on health care law, the impact of the Affordable Care Act and regulatory compliance for providers, including physicians, home health and hospice, dentists, chiropractors, hospitals and durable medical equipment providers. Knicole is partner at Nelson Mullins and a member of the RACmonitor editorial board and a popular panelist on Monitor Monday.