TAG:
Medicaid
Coverage, Reimbursement Still Difficult for New Lab Tests
By Robert Michel | From the Volume XXIX, No. 11 – August 8, 2022 Issue
CEO SUMMARY: Bringing a new proprietary diagnostic test to market is an arduous process. It takes patience and planning to complete the journey from test development to payer reimbursement. This slow process stems from the fact that the healthcare reimbursement system is fragmented,…
Labs Should Be Cautious about ‘Surprising’ EKRA Ruling
By Robert Michel | From the Volume XXIX, No. 3 – February 22, 2022 Issue
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…
In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role
By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue
CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys question…
Comment Period Closing on Federal Surprise Billing Rule
By Robert Michel | From the Volume XXVIII, No. 12 – September 7, 2021 Issue
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….
XIFIN to Open New Office in South Carolina for Lab Billing
By Robert Michel | From the Volume XXVIII, No. 9 – July 6, 2021 Issue
SINCE FEBRUARY, THE TOTAL NUMBER OF PEOPLE VACCINATED grew steadily even as the number of tests for COVID-19 declined sharply in the United States. But overall test volume has remained steady at 130% of pre-pandemic levels, said Brian Kemp, Vice President of Revenue Cycle Operations for XIFIN,…
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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