What “Not Medically Necessary” and” Experimental/Investigational” Really Mean for Patient Access to Innovative Medical Technologies
A “not medically necessary” or “experimental/investigational (E/I)” decision can be frustrating, especially when a provider believes an innovative medical device is appropriate for the patient. A medical insurance denial may reflect documentation, payer policy, coding, or a technology-level coverage classification. This article explains what a medical necessity or E/I denial means, the common reasons behind […]
Why Denials Management for Medical Devices Is Fundamentally Different From Standard Authorization or Claim Denials
Standard denial management works because the rules are known. A physician’s office submits a claim for an established procedure, the payer checks it against existing policy, and any denial follows a predictable pattern with a predictable fix. New and emerging medical technologies don’t get that luxury. When a device launches without an established payer coverage […]
Medical Device Reimbursement Support Explained
Getting a medical device cleared or approved is only half the battle. The other half is getting it covered and paid for. Even the most innovative technology can stall in the market if providers can’t bill for it, patients can’t afford it, and payers won’t cover it. That’s where medical device reimbursement support comes in […]
Influencing Payer Medical Policy: The Levers You Can Actually Control
Why Payer Medical Policy Matters Behind almost every “approved” or “denied” is a document most patients never see: the payer’s medical policy. For anyone working in market access, reimbursement, or product development, these documents are the difference between a therapy reaching a patient and one stuck at the claims desk. As policy grows more complex […]
The MedTech Revenue Playbook: Driving Growth Before Payer Coverage Catches Up
VCs, acquirers, and bankers all ask one thing: does this company have a revenue machine, even before reimbursement catches up? When investors evaluate a VC-backed medtech company, they are not simply assessing whether reimbursement will eventually arrive. They are evaluating whether the company has already built the infrastructure to achieve revenue during the coverage gap […]
JDL Access, LLC Achieves SOC 2 Type II Certification, Validating the Security Foundation of Its Access Bridge™ Platform
Clearwater, FL May 26th, 2026 – JDL Access, LLC, a specialized provider of end-to-end patient and payer access and reimbursement support services for medical technology and biopharmaceutical companies, today announced it has successfully achieved SOC 2 Type II certification. The certification, conducted by an independent third-party auditor, validates the security, availability, and confidentiality controls underpinning […]
The Buy vs. Build Decision: Choosing the Right Patient Access Program Strategy for Your Medical Technology
The promise of an in-house patient access program is compelling: greater control, deeper provider relationships, and a direct hand in getting patients to therapy faster. But the path from vision to execution is lined with decisions that can make or break the effort. We offer some suggestions for consideration based on our experience. For medical […]
Two Systemic Barriers Blocking Access to Cutting-Edge Medical Technologies
Medical innovation outpaces medical policy with health insurance plans. That reality can be difficult to accept for companies that have poured significant investment into a new device, drug, or biologic. For health plans, FDA marketing authorization is important, but other factors are essential: long-term data, medical society guidelines, provider utilization, etc. Until those factors are […]
Prior Authorization: When the Burden Becomes the Bridge
Patient access isn’t just reimbursement mechanics — it’s the infrastructure that determines whether life-changing innovation actually reaches patients. Ironically, the burden of a prior authorization denial is the only bridge to a coverage decision that could change everything. The challenge isn’t defending administrative burden. It’s making sure the bridge doesn’t get demolished before patients have […]
Why Your Medical Device Needs a Patient Access Program
You’ve done the hard work. Your medical device has FDA clearance or approval. Clinical data supports its efficacy. Providers are interested. And yet, patients are being denied coverage and adoption is stalling. Two of the most common and misunderstood barriers in medical device market access are silent medical policy (no policy on file) and Experimental […]