Regulatory & Compliance
24 articles
DSCSA Track-and-Trace Enforcement Reaches Full Implementation: What Facilities Should Verify
The Drug Supply Chain Security Act track-and-trace requirements have reached full implementation, and facilities need to confirm their pharmacy systems are genuinely compliant, not just nominally so.
Jun 20, 2026
Surgical Smoke Evacuation Laws Continue Expanding State by State in 2026
More states have adopted mandatory surgical smoke evacuation legislation, requiring facilities to build compliant equipment and protocol programs across their surgical footprint.
Jun 17, 2026
Complex Rehab Technology Policy Changes: What Suppliers Serving High-Acuity Mobility Patients Need to Know
Complex rehab technology, covering highly customized power mobility for patients with significant physical disabilities, continues to face distinct and evolving reimbursement policy considerations.
Jun 6, 2026
Matching Mobility Devices to Patient Needs: A Buyer's Guide to Rollators, Wheelchairs, and Scooters
Choosing the right category of mobility device involves more than just stocking a range of products — matching device type to patient functional status meaningfully affects outcomes and satisfaction.
Jun 1, 2026
DME Claims Denial Rates Remain Elevated — Here Is Where Documentation Gaps Most Often Occur
Durable medical equipment claim denials continue running higher than most other Medicare claim categories, with documentation gaps as the leading cause. Here is where suppliers most often trip up.
May 31, 2026
Specimen Transport Cold Chain Compliance: The Overlooked Link in Diagnostic Accuracy
Temperature-controlled specimen transport between collection site and testing laboratory remains an underappreciated source of diagnostic result variability when not managed consistently.
May 29, 2026
Pediatric DME Faces Distinct Supply Chain Challenges That Adult Equipment Markets Do Not
Pediatric durable medical equipment suppliers navigate a structurally more difficult supply chain than adult DME, with smaller volumes, more customization, and thinner manufacturer competition.
May 27, 2026
Power Mobility Device Medicare Documentation Requirements Continue to Tighten in 2026
Medicare documentation and prior authorization requirements for power mobility devices remain a persistent administrative burden for DME suppliers and the facilities that refer patients to them.
May 26, 2026
Home Mechanical Ventilation Growth Is Straining DME Supplier Capacity for Neuromuscular Patients
Growing home mechanical ventilation utilization, particularly among patients with progressive neuromuscular conditions, is testing DME supplier capacity for this highly specialized, high-acuity equipment category.
May 24, 2026
IV Compounding Automation Adoption Accelerates as USP Chapter Enforcement Tightens
Automated IV compounding technology adoption is accelerating as pharmacy compliance requirements under USP sterile compounding standards face tighter enforcement.
May 23, 2026
Ventilator Stockpile Modernization: What Happened to the Emergency Fleets Built During COVID
Emergency ventilator stockpiles assembled rapidly during the pandemic are now facing maintenance, obsolescence, and modernization decisions that many facilities and governments are still working through.
May 22, 2026
The Long Tail of the Philips CPAP Recall: Where Supply and Trust Stand in 2026
Years after the initial Philips respiratory device recall, its long-tail effects continue shaping sleep medicine equipment supply chains, patient trust, and supplier market share.
May 20, 2026
Portable Oxygen Supplier Accreditation Faces Tighter Medicare Audit Scrutiny in 2026
Medicare accreditation and audit requirements for portable oxygen and respiratory equipment suppliers continue to tighten, raising the compliance bar for DME providers in this category.
May 19, 2026
USP 800 Compliant Glove Selection: What Facilities Handling Hazardous Drugs Need to Verify
USP General Chapter 800 chemotherapy handling requirements demand specific glove testing standards that many facilities do not fully verify against their current glove supply.
May 6, 2026
340B Program Compliance Changes in 2026: What Covered Entities and Their Supply Partners Should Know
State and federal scrutiny of 340B drug pricing program compliance continues to intensify, with implications extending into inventory management and supply chain documentation.
May 5, 2026
CMS Conditions of Participation and Supply Chain: The Documentation Requirements Facilities Often Miss
Supply chain documentation gaps are a more common source of Conditions of Participation findings than many facilities realize. Here is where the risk tends to hide.
May 4, 2026
Right-to-Repair Laws Are Reaching Medical Equipment: What It Means for Facility Maintenance Budgets
A growing number of states are extending right-to-repair legislation to medical devices, potentially reshaping how facilities service and maintain capital equipment.
Apr 27, 2026
Medical Device Cybersecurity Is Now a Procurement Question, Not Just an IT One
FDA premarket cybersecurity requirements and growing ransomware risk have pushed device security evaluation earlier into the purchasing process. Here is what procurement teams now need to ask.
Apr 26, 2026
What Joint Commission Surveyors Are Actually Looking for in Supply Chain Documentation in 2026
Supply chain and inventory management practices are drawing more direct survey attention than in past accreditation cycles. Here is what facilities should have ready.
Apr 25, 2026
FDA Unique Device Identification Enforcement Tightens in 2026: What Distributors and Buyers Need to Know
FDA has signaled stricter enforcement of Unique Device Identification requirements across the distribution chain in 2026, with implications for how facilities document and track device purchasing.
Apr 24, 2026
UFLPA Enforcement and Medical Supply: Navigating Forced-Labor Compliance in 2026
Uyghur Forced Labor Prevention Act enforcement continues to affect medical supply imports, particularly in categories with Xinjiang-linked cotton and rubber supply chains.
Apr 23, 2026
GS1 Item-Level Tagging Is Extending Traceability Down to the Individual Implant
GS1 standards adoption is moving beyond case and unit-of-use barcoding into individual item-level tagging for implants, closing traceability gaps that have persisted for years.
Apr 20, 2026
NTAP Policy Shifts: What Changes to New Technology Add-On Payments Mean for Device Adoption
Ongoing policy debate around New Technology Add-on Payments continues to shape how hospitals evaluate the financial case for adopting newly approved high-cost devices and drugs.
Apr 17, 2026
CMS Rapid Coverage Pathways: What Faster Device Coverage Decisions Mean for Facility Purchasing
CMS has continued expanding faster coverage decision pathways for breakthrough medical devices, changing the timeline facilities face when a new technology reaches market.
Apr 16, 2026Stock Your Facility with Clinical-Grade Supplies
400,000+ FDA-cleared products. Bulk pricing for healthcare facilities nationwide.