No Surprises Act Controversy Takes Surprising Twist
Resolution process put on hold after federal court again strikes down parts of the regulation as being unfairly weighted in favor of insurers.
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LDT Reform: If Congress Won’t Do It, We Will, Says FDA
Hopes are high that something will finally be done to resolve the LDTs situation this year, however that action may not come from Congress.
CMS Clarifies Rules for IDTF Medicare Billing of Diagnostic Tests
The agency recently issued new guidance exempting indirect independent diagnostic testing facilities from some requirements.
Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.
Lab Owner Convicted for $463 Million Genetic Testing Fraud
Case is a recent example of the trend toward Medicare schemes involving telehealth, cancer genetic testing, and kickbacks.
Five Key Changes Affecting Labs in the New Spending Bill
While the federal spending bill passed at the end of 2022 will have a large impact on clinical labs, it doesn’t include LDTs reform.
Congress Delays Part B Price Cuts but Nixes Long-Term SALSA Solution
Legislation offering permanent relief from both PAMA price cuts and reporting didn’t make it into the federal spending bill passed Dec. 23.
Massive Caseload Overwhelming No Surprises Act Payment Dispute Resolution System
According to a recent CMS report, the sheer volume of out-of-network payment disputes is overwhelming the system.
New Payment Rules for Lab Specimen Collection & Travel Allowances
Here’s a look at what labs need to know about the new rules that take effect on Jan. 1 as part of the 2023 Medicare Physician Fee Schedule.
Hospital Workplace Violence Prevention to Face Greater Scrutiny
CMS has instructed state surveyors to crack down on hospitals that don’t implement adequate workplace violence protections.
CMS Recognizes 8 New CLIA-Waived Tests
Labs will be able to bill Medicare and Medicaid for these new CLIA-waived tests, starting on April 1, 2023.
FY 2022 OIG Enforcement Rebounds—but Recovery Dollars Don’t Show It
The agency’s latest report to Congress shows that while enforcement activity is returning to pre-pandemic levels, recoveries are still down.
The Year in Lab Compliance: The 6 Biggest Stories of 2022
The year was certainly an interesting one in terms of regulatory change in the medical laboratory space.
