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...]
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...]
HHS
Hospital Price Transparency Is Here—But How Will It Be Enforced?
January 29, 2021
With just three days left in 2020, last-ditch efforts to derail HHS’ controversial new hospital transparency rules before they took effect on Jan. 1 failed when the U.S. Court of Appeals for the … [Read more...]
Fee Schedules
2021 Medicare Physician Fee Schedule Slashes Lab Reimbursements 5% but Provides Some PAMA Relief
September 4, 2020
On Aug. 3, CMS released the proposed Medicare Physician Fee Schedule (PFS) rule for 2021. Bottom line on top: The agency is slashing lab reimbursement rates. Here are the four key takeaways for labs. … [Read more...]
Medicare Reimbursement
The 4 Things Labs Need to Know about CMS’ Newly Proposed 2021 OPPS Rule
September 3, 2020
On Aug. 4, CMS posted the proposed Outpatient Prospective Payment System (OPPS) Rule for 2021. In case you don’t feel like reading all 785 pages of the Rule, here’s a high level summary of the four … [Read more...]
New Laws
January 1, 2021 Is D-Day for Hospital Pricing Transparency
September 3, 2020
It appears to be full speed ahead for hospital price transparency. The controversial effort to make hospitals divulge information about their healthcare pricing, including lab procedures, is very much … [Read more...]
OIG Watch
Agency to Review First Two Years of PAMA-Based Medicare Reimbursements for Lab Tests
June 17, 2020
As we pass the midpoint of the third year of the PAMA experiment—if that’s what it is—the OIG announced plans to review what happened in years one and two. One of the new items on the agency’s Work … [Read more...]
PAMA: The New LAB Act Buys Labs One Year of Price Reporting Relief
January 13, 2020
The lab industry has been making slow but steady progress in its quest for PAMA relief. After winning a federal court appeal preserving its right to challenge CMS’s PAMA pricing systems, the industry … [Read more...]
