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laboratory executive
Labs Learn About ACOs And Medical Homes
By Robert Michel | From the Volume XVIII No. 7 – May 23, 2011 Issue
IN JUST SEVEN MONTHS, the age of accountable care organizations (ACO) begins. On January 1, 2012, the Centers for Medicare and Medicaid Services (CMS) will commence contracting with ACOs. ACOs are one of the major reforms spelled out in the 2,700-page health reform law that President Obama si…
Key Legal, Compliance Issues for Labs Identified
By Joseph Burns | From the Volume XVIII No. 6 – May 2, 2011 Issue
CEO SUMMARY: It’s a first in the lab industry. In recent weeks, THE DARK REPORT asked the nation’s leading attorneys in clinical lab and anatomic pathology law to identify the most important legal, compliance and managed care issues for 2011 and 2012. Using a consensus method…
Time to Think About ACOs And Medical Homes
By Robert Michel | From the Volume XVII No. 4 – March 21, 2011 Issue
CEO SUMMARY: In less than nine months—on January 1, 2012—the new health reform legislation mandates that Medicare commence value-based purchasing. Medicare must also begin contracting with accountable care organizations (ACO). Experts say these two developments will initiate …
$241 Million May Settle Quest Medi-Cal Claims
By Robert Michel | From the Volume XVIII No. 2 – February 7, 2011 Issue
CEO SUMMARY: There’s movement in the negotiations between California state officials and Quest Diagnostics Incorporated over allegations that discounted lab test prices violated state law. In January, Quest disclosed that it had an “understanding” with California regulators…
Expect Changes in How Calif. Labs Set Test Prices
By Robert Michel | From the Volume XVIII No. 2 – February 7, 2011 Issue
CEO SUMMARY: What a difference two years makes. Back in April 2009, when then-Attorney General Jerry Brown joined the whistleblower lawsuit alleging that seven or more California lab companies had violated state law on pricing provider services, the popular wisdom among lab execu…
Medi-Cal Gets Tough on Low Lab Test Prices
By Robert Michel | From the Volume XVII No. 18 – December 27, 2010 Issue
CEO SUMMARY: This may be the most significant lab industry story of 2010, which has gone unreported until now. Starting in June and July, California’s Department of Health Care Services determined that between 10 and 30 labs had submitted what the agency considers to be false c…
Who Wins and Who Loses With 51501 Enforcement
By Robert Michel | From the Volume XVII No. 18 – December 27, 2010 Issue
CEO SUMMARY: Assume that California’s Department of Health Care Services (DHCS) wins all challenges to enforcement of its interpretation of 51501(a). DHCS will get a one-time cash infusion as it collects money from labs which violated the state statute. But going forward, feder…
How Could So Many Labs Violate California Law?
By Robert Michel | From the Volume XVII No. 18 – December 27, 2010 Issue
CEO SUMMARY: If a 40-year-old state law on Medi-Cal pricing was known to regulators and clinical laboratories alike, how did the legal and compliance departments of so many laboratories—staffed by some of the smartest legal minds in California and nationally—interpret the law…
Did Qui Tam Suit Trigger Medi-Cal Price Concerns?
By Robert Michel | From the Volume XVII No. 18 – December 27, 2010 Issue
CEO SUMMARY: It is easy to track backwards to understand why the California Department of Healthcare Services (DHCS) began aggressive enforcement of its interpretation of statute 51501(a) against a number of labs this summer. DHCS officials were given a full education and a roadm…
Our Top Ten Lab Stories Highlight Major Changes
By Robert Michel | From the Volume XVII No. 17 – December 6, 2010 Issue
CEO SUMMARY: What makes 2010 a watershed year for the laboratory testing industry is enactment of the 2,700-page Patient Protection and Affordable Care Act (PPACA). Even if parts of this bill are repealed, the remaining parts of the massive legislation will trigger major changes …
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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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