The current reimbursement environment is not new technology friendly. Patients who are enrolled in clinical trials should not expect coverage & benefits to come easily. The glory days of 2013 and earlier appear to be gone. For those health technologies and services that are newly FDA approved, the pathway to benefits may be just as onerous. The Insurance Plans appear to have the leverage. After all, their obligation is to provide benefits for health services that are (1) medically necessary, (2) reasonable, and (3) standard of care.

Obamacare’s Section 2709 opened the window for Insurance Companies to restrict or even eliminate benefits in clinical trial for non-life threatening conditions (defined as life expectancy of 2 years or less). We sincerely hope that U.S. Senator Sherrod Brown (D-OH) will quickly amend this poorly written, door-opening section of the Patient Protection and Affordable Care Act (PPACA)! A Clarification Memo is sorely needed. However, in current political climate this may not be immediately forthcoming.

But what about the patient with a health need today? What about the physician who is an early-adopter of a newly available health service….embracing new less-invasive, clinically meaningful treatment options for their patients? And let’s not forget the hospitals and ambulatory surgery centers (ASC) who are at risk in the purchasing of new supply items? Will they be paid for their outlay, supporting their physician customers? Or will everyone lose? Patients, Physicians, and Hospitals? In the long run, the Insurance Plans themselves will also be losers here. If they forgo new technologies, they will be missing the economics of improved care and reduced overall cost burden.

Enter…..Case Management. This service actually evolved from Utilization Review and Disease Management efforts. It was an early attempt to develop patient treatment algorithms and to track secondary health outcomes and long term benefits. But over the decades this service, too, became a barrier to new healthcare technologies. At least, until recently.

Now Case Management supports early adopting physicians. Case Management can provide the tool for patients to pursue their healthcare choices. Today, Case Management connects Patients, Physicians, Hospitals, and Insurance Companies. It provides the service supporting current nonlife-threatening clinical trials, and early FDA approved drugs, devices & biologics. Did I mention the Peer-to-Peer (P2P) teleconferences? Case Management puts experienced nurses in the middle of all stakeholders, an ambassador of sorts, and advances the request for appropriate benefits. “Does it work?” you ask. Yes, most of the time.

Case Management ensures that the physician is prescribing pursuant to product labeling. It ensures that the physicians are documenting patient eligibility and medical necessity. These nurses can hold the patient’s hand and be their advocate as they try to navigate the incredibly complicated pathway to “reimbursement”. Finally, Case Management supports Insurance Plan needs, too. It reduces liability for new technology benefits. It’s a vetting, really, with all stakeholders on the winning end.

TRG ( was established as a Case Management organization. We have very successfully learned to navigate these waters. We have learned to connect stakeholders, trust but verify patient selection, and to work quickly and effectively. We have a 12-15% fall-out rate (events that do not meet guidelines). Our success ranges from 52% to well over 90%, varying with specific product or service…..but consistently averaging 82+% approval rating year after year.

Medical Device and Biologics Manufacturers need to take a page from the pharmaceutical industry and plug into the Case Management value proposition. In an environment that is so stacked against newly available technologies Case Management may be the best option for access to new technologies. We invite you to contact TRG (844) 874-4411 to implement your own Case Management program.

This post was first published on LinkedIn 

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