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american clinical lab
Palmetto’s Prostate Biopsy Policy Removed after Talks with CMS
By Robert Michel | From the Volume XX No. 3 – March 4, 2013 Issue
THERE IS SOME POSITIVE LAB INDUSTRY NEWS that has not been widely reported yet. It involves a decision to change an unwelcome Medicare policy that limited the number of prostate biopsy specimens per case that would be reimbursed. After discussions between lab industry groups and the federal …
Congress May Respond to Tough CLIA PT Penalties
By Joseph Burns | From the Volume XIX No. 11 – August 6, 2012 Issue
CEO SUMMARY: For years, severe penalties in cases where a laboratory has inadvertently erred in handling proficiency testing (PT) specimens have been a point of contention between the Centers for Medicare & Medicaid Services (CMS) and the clinical laboratory profession. Two bills prop…
New BlueCard Policies Affect Lab Test Claims
By Joseph Burns | From the Volume XIX No. 10 – July 16, 2012 Issue
CEO SUMMARY: This new policy from the Blue Cross and Blue Shield Association (BCBSA) becomes effective on October 14, 2012. No longer can a local lab provide service to a member under the BlueCard program and be paid by the local plan in the region where the service was provided….
MD Self-Referral Issues Target of Utilization Study
By Robert Michel | From the Volume XIX No. 6 – April 23, 2012 Issue
CEO SUMMARY: When it comes to the in-office ancillary service (IOAS) exception to physician self-referral, the issue of in-clinic pathology services has become a hot potato. Publication in Health Affairs of a study of urologists’ self-referral of their patients for anatomic pathology se…
ACLA Has its Say Regarding Molecular Dx Proposals
By Robert Michel | From the Volume XVIII No. 17 – December 19, 2011 Issue
CEO SUMMARY: It is not known how many public comments have been submitted to Palmetto GBA, the big Medicare carrier, in response to its published proposals to change how code stacked claims for genetic and molecular tests will be handled, effective February 27, 2012, for labs in Medicare …
Forecast: Tough Fee Cuts Are in Labs’ Future
By R. Lewis Dark | From the Volume XVIII No. 14 – October 17, 2011 Issue
EVERY CLINICAL LABORATORY AND ANATOMIC PATHOLOGY GROUP PRACTICE in the United States should prepare for some big-time financial belt-tightening during the next 36 months. That certainly is the message coming from intense budget battles unfolding in Washington, DC, this fall. Most of you reading this…
Congress Likely to Pass Deep Cuts in Lab Test Fees
By Robert Michel | From the Volume XVIII No. 14 – October 17, 2011 Issue
CEO SUMMARY: All signs point to a potentially dismal financial outcome for the clinical lab testing industry as Congress tries to trim spending by $1.2 trillion over the next 10 years. At least three proposals to significantly cut lab test reimbursement are in active debate by fe…
September 6, 2011 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XVIII No. 12 – September 6, 2011 Issue
Cleveland Heart Lab closed on a Series B financing round that totals $18.4 million. The money was provided by Excel Venture Management, Healthcare Ventures, and existing investors. Executives at Cleve- land Heart Lab said the new funds will be used t…
Congress Again Considers Co-Insurance for Lab Tests
By Robert Michel | From the Volume XXVIII No. 11 – August 15, 2011 Issue
CEO SUMMARY: Congressional cost-cutters are putting the 20% patient co-pay/coinsurance requirement for lab testing back on the table. The added complication this year is that the new Joint Select Committee on Deficit Reduction is mandated to produce its own list of cuts to the Me…
Many Questions About FDA Regulation of LDTs
By Robert Michel | From the Volume XVII No. 14 – October 4, 2010 Issue
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprie…
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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