TAG:
clinical diagnostic laboratory
Letter from Congress to CMS Asks for Delay in PAMA Reporting
CLINICAL LABORATORY ASSOCIATIONS are using a letter-writing campaign to members of Congress as a last-minute Hail Mary attempt to head off the controversial lab price market reporting rule that CMS intends to implement after January 1. Both Democrats and Republicans in the U.S. House of Representati…
New ADLT Payment Rate May Force Lab to Close
CEO SUMMARY: Four Medicare Administrative Contractors currently pay $2,821 for CareDx’s AlloMap test. But under the proposal that CMS issued last month to overhaul the clinical lab fee schedule, CareDx would get only $644. Such a steep price cut would put the lab out of business because…
Labs React with Criticism to Proposed ADLT Rule
CEO SUMMARY: Some in the lab industry had high hopes that passage of the Protecting Access to Medicare Act (PAMA) last year would favorably resolve a number of important issues. However, those hopes were dashed following the September 25 release by CMS of a proposed rule setting out how i…
New Pricing Formula for Advanced Diagnostic Tests
CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diagnostic tests (ADTs) and directs CMS to assign a temporary HCPCS code and use list prices to pay labs for such tests …
New Federal Law Changes How CMS Sets Lab Prices
CEO SUMMARY: CMS wanted more power to cut the prices it pays for clinical lab testing. A significant part of the lab industry wanted more transparency and consistency in how CMS established coverage guidelines and prices for new lab tests. Congress appears to have attempted to craft a law…
Congress’ New SGR Law Has Mixed News for Labs
CEO SUMMARY: Once again, the lab industry faces a mixed bag following passage of a new law by Congress last week. Besides the one-year fix for the SGR, H.R. 4302 also has language that may defer adjustments to Medicare Part B lab test fees until 2017 and creates a new procedure for Medica…
ACLA, CAP Comment on Final 2014 Medicare Rules
CEO SUMMARY: On November 27, as the nation prepared for the Thanksgiving holiday, the federal Centers for Medicare & Medicaid Services (CMS) announced the long-awaited final rules for 2014. Early analysis of the 1,300 pages of rules CMS released indicates that the agency moderated one…
Attorneys for CAP Say CMS Fee Proposals Illegal
CEO SUMMARY: In its comments about a proposal to change the way CMS pays for clinical laboratory and pathology services, the College of American Pathologists (CAP) said that CMS is using faulty assumptions. CAP further commented that the CMS proposal to cap physician fee schedule payments…
OIG Tells CMS It Could Save $910 Million on Lab Test Costs
IT IS ONE MORE POWERFUL SIGN of the changing times. Last week, the Office of the Inspector (OIG) publicly released a study it had done of the prices paid for lab testing and how the Medicare program could use this information to reduce the cost of Part B clinical laboratory testing. It was The W…
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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