TAG:
acla
Coming Next Year for Labs: PAMA, FDA, LDTs, and More
CEO SUMMARY: As 2016 approaches, nearly every lab organization is watching and waiting to learn how federal regulators at CMS and the FDA will move forward with plans to implement PAMA market reporting and regulation of laboratory-developed tests, respectively. Most knowledgeable observer…
Letter to Florida Doctor Offers to Waive Lab Test Fees
CEO SUMMARY: Florida’s highly-competitive market for lab testing services is again seeing some lab companies use “Waiver of Charges to Managed Care Patients” agreements with physicians in situations where the lab is an out-of-network provider. This means the lab will do free testing…
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…
CMS Releases Draft of PAMA Market Price Rule
CEO SUMMARY: CMS’ proposed rule details how it will collect private market data, then use that data to establish prices for the Medicare Part B Clinical Laboratory Fee Schedule beginning in 2017. The proposed rule will limit data reporting to les…
Labs Have Questions for CMS on Proposed Rule
CEO SUMMARY: On September 25, CMS took a long overdue step to issue a proposed rule on how medical laboratories are to report private market prices for lab tests to the Medicare program during 2016. The proposed rule provides insights as to how CMS envisions pricing new tests and advanced…
Are Clinical Labs and MACs Ready to Implement ICD-10?
ARE CLINICAL LABORATORIES and pathology groups prepared for ICD-10? Or, perhaps a better question to ask is this: Are Medicare administrative contractors prepared to switch to ICD-10 on October 1? A recent survey of clinical laboratories and pathology groups by McKesson Corporation showed th…
New MoPath Lab Coalition Takes its Case to Congress
CEO SUMMARY: Prices recently established for molecular diagnostic tests are so low that they put patient access in jeopardy, declared a new lab industry coalition in a statement delivered to members of Congress. Called the Coalition to Strengthen the Future of Molecular Diagnosti…
Beware Ides of March! Lawmakers Are in Session
CEO SUMMARY: Few pathologists and lab administrators know that, when the Protecting Access to Medicare Act of 2014 (PAMA) became law last April 1, language in the bill was scored to reduce Part B clinical laboratory test fees by $2.5 billion over 10 years. Congress used those lab…
Is PAML to Be Sold? ‘No Comment!’ Say Execs
CEO SUMMARY: It is one of the 10 largest lab companies in the United States. Thus, if Pathology Associates Medical Laboratories in Spokane, Washington, were to be sold, it would trigger a major shift in the competitive market for lab testing service…
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…
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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