Posts Tagged ‘Diagnostic Labs’
The True Costs of FDA’s Proposed LDT Rule and How Laboratories Can Prepare
“Labs need to be aware of and prepare for the coming sea-change in LDT regulation,” said Gregory A. Stein, Founder and CEO of Shadowbox. “If the FDA gets their way, innovation will come to a grinding halt and many of the most innovative labs will simply cease to exist.”
Read MoreProposed FDA Rule over Laboratory Developed Tests Puts Lab Innovation at Risk
On September 29, 2023, the FDA proposed a rule to tighten control over Laboratory Developed Tests (LDTs), supplanting the CMS as regulators. While supporters emphasize the need for safety, critics, especially in the medical community, fear the rule could stifle innovation, jeopardizing independent laboratories and escalating healthcare costs.
Read MoreThe Protecting Access to Medicare Act of 2014 (PAMA) for Laboratories: What You Need to Know
Congress passed the Protecting Access to Medicare Act (PAMA) in 2014. The purpose was to ensure millions of seniors could maintain access to critical health services, however the reality is that Congress was looking for an offset to previously mandated cuts to reimbursement for Physicians which were regularly exempted each year by Congress. PAMA “limited” cuts to laboratories at 10% in each of year one through three, and 15% in each of the following three years.
Read MoreThe True Cost of Traditional Lab-EHR Integrations
Automation and real-time data exchange are critical tools to advance quality care and reduce cost in healthcare. That said, more than 50% of diagnostic labs still operate using paper forms. The true cost of those paper forms is at least $30 per order.
Read MoreHealthTrackRx selects Shadowbox to Enhance EHR Interoperability
Shadowbox is excited to announce that HealthTrackRx has selected Shadowbox to automate Electronic Health Records (“EHR”) and Lab Information Management Systems (“LIMS”) interoperability with their clinician customers, expanding their approach beyond traditional integration options.
Read MoreWith COVID Test Funding Gone, Diagnostic Labs Consider Their Next Move
Diagnostic laboratories are now beginning to navigate a post-COVID market, absent federal funding, and heightened testing demand.
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