TAG:
laboratory association
Protecting Access to Medicare Act of 2014 Could Harm Independent Community Labs
In the Protecting Access to Medicare Act of 2014 (PAMA), the Center for Medicare and Medicaid Services (CMA) is directed to collect market price data and use the data to establish prices for the Medicare Part B Clinical Laborato…
Market Price Report Rules Must Address All Issues
CEO SUMMARY: Under the Protecting Access to Medicare Act, CMS must collect market price and volume data from certain labs beginning January 1, 2016. CMS will use this data to establish Part B clinical laboratory fees beginning in 2017. One lab association representing community a…
Where Are Pathologists When You Need Them?
WHAT’S WRONG WITH THIS PICTURE? National health insurer has exclusive national contract with a single billion-dollar lab company. Billion-dollar lab company creates a business division to manage how physicians order lab tests. This lab test order system requires physicians to follow the lab test o…
Public Comment Started on FDA LDT Regulations
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
PAMA’s New Rules Affect Lab Test Pricing, Coverage
CEO SUMMARY: For several reasons, the “Protecting Access to Medicare Act” (PAMA) has the potential to be the most disruptive federal legislation directed at the clinical lab industry since the enactment of CLIA 1988. Following passage of the law, some lab industry groups have taken di…
April 28, 2014 Intelligence: Late Breaking Lab News”
In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical L…
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…
Labs, Path Groups Face Major Financial Issues
CEO SUMMARY: Are clinical labs and pathology groups ready for the end of fee-for-service reimbursement? That’s just one important question that will be answered at the upcoming Executive War College on Lab and Pathology Management that will take place in New Orleans on April 29-30. The …
Tricare, DOD Not Paying for MoPath Codes, LDTs
CEO SUMMARY: It turns out that labs serving Tricare patients are going unpaid for certain LDTs, molecular, and genetic tests. The issue of nonpayment began in January 2013 when Tricare stopped paying for these tests that were billed under the new molecular CPT codes that replaced the prev…
Good Information Drives Good Decisions
RECENT DEVELOPMENTS DEMONSTRATE that a long-standing business adage remains as true today as when many of us first learned it decades ago. I am referring to the pithy piece of management wisdom often written as: “You need good information to make good decisions.” It is a trait held in common by …
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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