Assessing the Clinical Service & Revenue Issues of the LDT Rule

By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue

BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…

Read More

---

What if Congress Chooses to Pass an LDT-Specific Law?

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed test…

Read More

---

How Private Health Insurers May Respond to FDA LDT Regulation

By Virchow | From the Volume XXXI, No. 8 – June 10, 2024 Issue

…

Read More

---

Congressional Subcommittee Hears Testimony on FDA LDT Rule

By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue

DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…

Read More

---

Examining the Worldwide Pathologist Shortage

By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue

CEO SUMMARY: Demand for pathology services is growing faster than the number of pathologists available to meet that demand. This is true for the United States and most other nations. Consequently, efforts are underway to more accurately measure the number of pathologists practicing in eac…

Read More

---

CLIA Lab Directors Must Watch Delegated Duties

By Robert Michel | From the Volume XXX, Number 17 – December 4, 2023 Issue

CEO SUMMARY: Laboratory accredito…

Read More

---

How Certain Labs Can Crack into Health Plans’ Closed Networks

By Virchow | From the Volume XXX, Number 16 – November 13, 2023 Issue

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed…

Read More

---

Proficiency Testing Ranks High as a CLIA Violation

By Robert Michel | From the Volume XXX, Number 15 – October 23, 2023 Issue

CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scr…

Read More

---

Actions Pathologists Can Take to Protect Their Income

By jpschlingman | From the Volume XXX, No. 12 – August 21, 2023 Issue

CEO SUMMARY: Pathology groups may feel their income is under attack from lower Medicare reimbursement rates and rising practice costs. But steps to protect that income can include carefully determin…

Read More

---

Competency Assessments Prove To Be a Nagging CLIA Deficiency

By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue

CEO SUMMARY: Competency assessment problems rank high among frequently cited deficiencies during CLIA inspections. Representatives from the CAP, COLA, and The Joint Commission explain what areas to…

Read More

---