TAG:

lab risk & compliance

VALID and SALSA Acts Still Pending in Congress

CEO SUMMARY: Both the pending VALID Act and SALSA Act continue to push ahead as 2022 comes to an end. Meanwhile, a new bill centered on the Physician Fee Schedule may protect pathologist payments. These three different proposals share something in common:…

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Ex-Theranos CEO Elizabeth Holmes Awaits Ruling on New Trial Request

Keeping with the unexpected and odd circumstances sur­rounding Theranos, a federal judge heard arguments on Oct. 17 about whether convicted company founder Elizabeth Holmes’ should get a new trial. That hearing stemmed from the gov­ernment’s star witness in Holmes’ 2021 tr…

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Labs Must Audit Their Cybersecurity Measures

CEO SUMMARY: While clinical laboratory managers and pathologists are aware of the risks of a data breach, they often assume that related protection measures are working as needed. That is a mistake. With the cost of healthcare data breaches on the rise, it is vitally important for l…

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Attorney Advises Labs to Track Genetic Test LCDs

CEO SUMMARY: Skyrocketing numbers of genetic test referrals and telehealth claims since 2016 are getting the full attention of both federal prosecutors and auditors from Medicare and private health insurers. The DOJ has filed criminal cases against a growing number of telehealth pro…

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On Appeal, ACLA Gains PAMA Victory in Court

CEO SUMMARY: Last month, a U.S. Court of Appeals issued a ruling that criticized how the Department of Health and Human Services originally implemented the Protecting Access to Medicare Act of 2014 (PAMA). This ruling was a win for the American Clinical Laboratory Association in its…

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PAMA Cuts Might Be Reduced to Zero for 2023

CEO SUMMARY: Congress may soon vote on a new bill that permanently reduces the amount of price cuts to Medicare Part B lab test prices, as specified under the Protecting Access to Medicare Act of 2014 (PAMA). The Saving Access to Laboratory Services Act (SALSA) eliminates a 15% paym…

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New OIG Advisory Opinion Dubious of ‘Fair Market’

CEO SUMMARY: There is a new advisory opinion from the Office of the Inspector General (OIG). It reviewed a proposal in which a clinical lab network would pay fair market value to hospitals for specimen collection based on volume of patients tested. The OIG said this arrangement woul…

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OIG: 25% of Medicare Inpatients ‘Harmed in Hospitals’ Pre-COVID

CEO SUMMARY: This year’s report to Congress on patient harm in hospitals—prepared by the Office of the Inspector General (OIG)—determined that one in four Medicare beneficiaries suffered harm while an inpatient in a hospital. The report garnered little attention outside the he…

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Passage of FDA Regulation of LDTs Inches Closer in the Senate

CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …

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Labs Can Expect COVID-19 Test Audits, Investigations

  CEO SUMMARY: Billions of federal …

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