TAG:
Medicare
January 3, 2023, Intelligence: Late-Breaking Lab News
At the moment, it appears that the controversial Verifying Accurate Leading-edge IVCT Development (VALID) Act will have a hard time passing in Congress. The bill, which is intended to shift regulation of laboratory-developed tests (LDTs) to the federal Food and Drug Administration…
Two Positive Messages to Focus on at Year’s End
Clinical laboratory managers and anatomic pathologists are winding down another tumultuous year for the healthcare industry. It was a year marked by unexpected twists and turns. It was also a year marked by two positive developments for labs. First, the…
Lab Allegedly Billed Medicare for Tests It Did Not Perform
Following up on a Sept. 19 intelligence briefing, an attorney told The Dark Report that a federal case alleging genetic test fraud showed hallmarks of pass-through billing. As such, it raises questions about whether reference l…
Labs Face Powerful and Unwelcome Forces
OVER THE PAST 25 YEARS, THERE HAS BEEN WIDESPREAD RECOGNITION THAT HEALTHCARE IN THE UNITED STATES is on an unsustainable path. The obvious argument was that year-over-year increases in healthcare costs would eventually overcome the ability of employers (private health plans) and the government (Medi…
1999’s ‘To Err Is Human’ Still an Opportunity for Labs
NOT ONLY DID THE 1999 PUBLICATION OF ‘TO ERR IS HUMAN” trigger a wave of national news coverage about patient harm in hospitals, it also launched this nation’s healthcare system on a multi-decade journey to boost the quality of care, reduce medical errors, and increase the transparency of both pati…
June 27, 2022 Intelligence: Late-Breaking Lab News
Efforts to revise the much-criticized methods Medicare officials use to establish prices the government pays clinical laboratories under the Protecting Access to Medicare Act (PAMA) of 2014 got a boost last week. On June 22, a bipartisan bill to accomplish that was introduced in the U.S. Senate. The …
Federal Prosecutors Describe Illegal Lab Bribes to Physicians
PATHOLOGISTS AND CLINICAL LAB MANAGERS SHOULD WELCOME every federal prosecution of a physician who accepts illegal bribes and inducements in exchange for laboratory test referrals. If physicians understood that federal prosecutors would file criminal charges against them for this behavior, fewer doct…
Labs Should Be Cautious about ‘Surprising’ EKRA Ruling
CONFUSION ABOUT WHEN IT IS LEGAL UNDER TWO FEDERAL LAWS to pay commissions to sales reps based on volume and/or revenue has existed since the passage of the federal Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Now, a district court judge in Hawaii has surprisingly ruled that payments of perc…
Florida Laboratory Owner Gets 82-Month Jail Term
CEO SUMMARY: Federal prosecutors are sending a clinical lab owner to federal prison for almost eight years. Hopefully, this is a sign that the Department of Justice (DOJ) is ready to use criminal indictments more frequently against lab owners, lab managers, and lab sales reps who vi…
Comment Period Closing on Federal Surprise Billing Rule
PATHOLOGY GROUPS AND CLINICAL LABS HAD UNTIL SEPTEMBER 7 to comment on an interim final rule that provides federal protections against surprise billing and limits out-of-network (OON) cost sharing under many of the circumstances in which surprise bills arise most frequently….
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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