FDA

FDA Hikes Premarket Application User Fees by 2.5 Percent

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

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

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

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

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

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

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

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

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

“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...]


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