Applying for FDA premarket review of medical devices will be more expensive next year. On August 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]
FDA
FDA Hikes Premarket Application User Fees by 2.5 Percent
August 26, 2021
Applying for FDA premarket review of medical devices will be more expensive next year. On Aug. 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]
PRICE TRANSPARENCY
CMS Proposes to Ease but Not End Hospital Price Transparency
June 28, 2021
If you’re a hospital lab administrator, you’ll probably be happy to learn that the Biden administration is proposing to repeal some of the more troublesome Trump price transparency rules relating. But … [Read more...]
Lab Safety
The Three Laws of Sharps Safety
May 23, 2021
By Dan Scungio In Isaac Asimov’s writings about science, he created “the three laws,” a set of rules designed by humans that robots must follow in that fictional society. Robots cannot harm human … [Read more...]
Reimbursement
CMS Proposes to Ease, but Not End Hospital Price Transparency
May 19, 2021
If you’re a hospital lab administrator, you’ll probably be happy to learn that the Biden administration is proposing to repeal some of the more troublesome Trump price transparency rules relating. But … [Read more...]
PAMA
Labs Lose a Battle But May Win the War Over Market-Based Pricing
May 10, 2021
In its crusade to get CMS to fix its warped Protecting Access to Medicare Act of 2014 (PAMA) market-based Medicare Part B pricing scheme, the lab industry lost a battle but may still end up winning … [Read more...]
PAMA
MedPAC Explores Simplified PAMA Reporting to Cut Burdens & Restore Lab Prices
May 10, 2021
The upcoming report of the Medicare Payment Advisory Commission (MedPAC) gives the lab industry new hopes for relief from the administrative burdens of Protecting Access to Medicare Act of 2014 (PAMA) … [Read more...]
PAMA
MedPAC Explores Simplified PAMA Reporting to Cut Burdens & Restore Lab Prices
April 22, 2021
The upcoming report of the Medicare Payment Advisory Commission (MedPAC) gives the lab industry new hopes for relief from the administrative burdens of Protecting Access to Medicare Act of 2014 (PAMA) … [Read more...]
The Business of Testing
Hospital Laboratories Take a Stand Against Controversial UnitedHealthcare Outpatient Reimbursement Policy
February 21, 2021
The cold war between hospital laboratories and the nation’s third largest health insurer, UnitedHealthcare (UHC), over reimbursement of diagnostic tests is getting hotter by the day. At the center of … [Read more...]
Focus On
How the Transition from Trump to Biden Will Affect Federal Regulation and Reimbursement
February 19, 2021
“Meet the new boss. . . same as the old boss.” The Who’s “Won’t Get Fooled Again” is a rock classic; but as far as U.S. presidents and federal regulation are concerned, the “new boss” is almost … [Read more...]
