Independent Clinical Laboratories in Maryland May Need to Step-up Outreach with Hospitals as New CMS Program Launches Jan. 1

Clinical laboratory leaders will want to pay close attention to a significant development in Maryland. The state’s All-Payer Medicare program—the nation’s only all-payer hospital rate regulation system—is broadening in scope to include outpatient services starting Jan. 1. The expanded program could impact independent medical laboratories, according to the Maryland Hospital Association (MHA), which told Dark Daily that those labs may see hospitals reaching out to them. The Centers for Medicare...

Facing Increasing Pressure from an Evolving Regulatory Environment, Clinical Laboratories Need to be ‘Inspection Ready’ in 2019

Experts say medical laboratories must overcome staffing challenges and develop a culture of continual inspection readiness Clinical laboratories and anatomic pathology groups will be entering 2019 facing not only financial upheaval from Medicare Part B fee cuts and narrowing payer networks, but also an increasingly rigorous and ever-evolving regulatory environment. Although the Clinical Laboratory Improvement Amendments (CLIA) requirements have not undergone major changes since debuting in...

Controversy Surrounding Memorial Sloan Kettering Cancer Center and Paige.AI Highlights Risks of Data Sharing and Monetization in Anatomic Pathology

Patient privacy, ethics of monetizing not-for-profit data, and questions surrounding industry conflicts appear after the public announcement of an arrangement to grant exclusive access to academic pathology slides and samples Clinical laboratories and anatomic pathology groups already serve as gatekeepers for a range of medical data used in patient treatments. Glass slides, paraffin-embedded tissue specimens, pathology reports, and autopsy records hold immense value to researchers. The...

Copay Accumulators Is a New Tactic in Struggle Between Payers and Pharma at Patients’ Expense

Though patients get a big discount when paying for drugs, copay accumulators prohibit discounts from applying to plan deductibles, extending time it takes for enrollees to reach full plan coverage There’s a new insurance/payer industry tactic in town and Dark Daily thinks clinical laboratories and anatomic pathology groups should know about it. It’s called a “copay accumulator” and it was designed by payers in response to pharmaceutical company copay assistance cards and discount coupons. How...

The Problems with Ancestry DNA Analyses

Diagnostic medical laboratories may sequence DNA genetic tests correctly, but there are issues with how companies analyze the information In 2017, some 12 million people paid to spit in a tube and have their genetic data analyzed, according to Technology Review. Many companies offer this type of DNA testing, and each of them works with one or more clinical laboratories to get the actual sequencing performed. For example, Ancestry.com, one of the largest direct-to-consumer genetic data testing...

Researchers Easily Reidentify Deidentified Patient Records with 95% Accuracy; Privacy Protection of Patient Test Records a Concern for Clinical Laboratories

Protecting patient privacy is of critical importance, and yet researchers reidentified data using only a few additional data points, casting doubt on the effectiveness of existing federally required data security methods and sharing protocols Clinical laboratories and anatomic pathologists know the data generated by their diagnostics and testing services constitute most of a patient’s personal health record (PHR). They also know federal law requires them to secure their patients’ protected...