TAG:
anti kickback statute
Barristers Offer Insights Into OIG Opinion 04-17
CEO SUMMARY: This is an intelligence briefing which tries to “read between the lines” and: 1) provide useful information about the OIG’s “undeclared” views on physician self-referral issues, particularly as they relate to anatomic pathology condominiums; and, 2) how specialist p…
Bi-Annual Look at Trends Reshaping Clinical Labs
CEO SUMMARY: Among other things, we declare the end to the heyday of the independent commercial lab company which offers a broad test menu to all types of office-based physicians. In its place springs forth the specialty or niche testing laboratory. Small and focused on a specific number …
Analysis of OIG’s Opinion Shows Compliance Shift
CEO SUMMARY: Attorney Richard Cooper believes the latest Advisory Opinion by the Office of the Inspector General (OIG) is consistent with its earlier anti-kickback law pronouncements about situations where a physician is in a position to profit from the patients he/she refers. Cooper also…
OIG Releases Opinion On AP Lab Condominiums
CEO SUMMARY: In responding to a request for an advisory opinion, the Office of the Inspector General (OIG) issued an advisory opinion which declares that anatomic pathology (AP) lab condominiums “could potentially generate prohibited remuneration under the anti-kickback statute.” It a…
Change Beneath Surface Marks 2004 Lab Stories
CEO SUMMARY: Presented here are THE DARK REPORT’S “Ten Biggest Lab Stories of 2004.” These are the events we consider most important to the lab industry during the year. However, in contrast to past years, 2004 lacked the types of blockbuster events which radically change and reshap…
Lawyer Argues: UroCor Charges Are a Concern
CEO SUMMARY: Criminal charges in the case against three ex-UroCor executives will likely alter existing compliance practices that affect how a lab offers price discounts to physicians and the way a lab uses “waiver of charges” in situations where it is an out-of-network provider. Atto…
“Waiver of Charges”: What Makes It Work
CEO SUMMARY: Little-used in the 1990s, when laboratory test ordering and billing practices were under intense scrutiny by federal regulators, the strategy of “free testing” is popping up in more regions around the country. To comply with compliance guidelines, labs using this strategy g…
Client Bill Pricing Policy Rises To Medicare Level
CEO SUMMARY: Within the laboratory industry, there has been a decade-long debate over whether offering discount prices in client bill states could violate some Medicare regulations. UroCor, Inc. decided that an OIG opinion issued in December to a pathology company signaled a potential cha…
Florida Medicare Carrier Raises Kickback Issues
CEO SUMMARY: When Florida’s Medicare carrier published a notice which defined certain pathology practices to be possible violations of anti-kickback laws, it created uncertainty for labs. DIANON took immediate steps to insure compliance while seeking clarification from regulators on thi…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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