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 (www.trgltd.com) 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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Reimbursement Impact of Obamaacare on New Tech

By MaryCorkins

For new technologies in healthcare, the process of addressing barriers to market adoption has remained largely unchanged over the last decade. At launch, manufacturers must be able to demonstration clinical endpoints and utility beyond the requirements of the FDA. They must also be prepared to support professional services training, the educational needs of all stakeholders, and the coverage, coding, and reimbursement needs of Providers and Insurers related to the new technology.

Beginning with implementation of the first phase of the Patient Protection and Affordable Care Act (a.k.a. Obamacare or PPACA) in September 2012, healthcare insurers began revamping their pre-service authorization processes. Today, these changes have been fully developed and incorporated into the Insurers’ reimbursement procedures. These changes have resulted in significant reduction of patient access to new technologies and reduced provider visibility in care guidelines decision-making.

Insurer Process Changes under Obamacare since September 2012:

1. Many Insurers now provide only electronic Explanations of Benefit (EOB).
2. Many Insurers now require provider “portal” (website) login to obtain status of Pre-authorization, Pre-certification, Pre-determination, and other pre-service requests.
3. Many Insurers are no longer accepting pre-service requests for coverage/benefits, similar to CMS Medicare-like processes.
4. Most Insurers do not permit nor accept pre-service provider-authored appeals, all pre-service appeals must be generated from the patient or guarantor.
5. Virtually all Insurers have reduced benefits provided in clinical trial due to a poorly written law (Obamacare) opening the door to misinterpretation and misunderstanding and overall denial of benefits.

With increased Insurer permissiveness supported under Obamacare, manufacturers of new technologies must develop incremental support processes that address the increased burden for new technologies. These increased barriers have significantly extended the timelines, intensity of resource needs, and overall costs of new tech product launch. Manufacturers need to be aware of these new reimbursement barriers to adoption and address proactively, or be a victim of them and a failed launch.

The post was first published on LinkedIn

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Physician P2P:  Patient Advocacy

By Mary Corkins

Although it is a recently recognized trend for the patient to take ownership of their own healthcare cost and utilization, physicians have increased responsibility in appropriately communicating their patients’ needs to the plan medical directors.

With the pre-service changes in Insurer processes under Obamacare, the role of the Peer-to-Peer (P2P) conference call has become a critical element in the availability of new technology or costly health services. Services are prescribed based on patient need and expectation of best opportunity for clinical benefit. During the course of seeking benefits & coverage from the patients’ Insurer, oftentimes the physician will be invited to participate in a P2P before services are approved. Historically, physicians have avoided these discussions like the proverbial plague. The common belief is that P2P is non-productive and the Insurer will deny benefits regardless.

Most practicing physicians have a very poor understanding of Insurer criteria for decision-making. They are left feeling powerless and out of their element – and therefore, disinclined to participate in P2P’s. And really, who can blame them? Physician fees have been cut substantially. They are required to maintain stronger and more robust documentation of provided care. They must maintain adequate staffing, malpractice insurance coverage, re/credentialing with Insurer networks, compliance with HIPAA regulations, relevant OIG advisories, and adherence to the Safe Harbor and Stark I & II statues. The continued overburdening of physicians with P2P’s has resulted in increased denial of services for the patient. It means fewer choices and less attractive healthcare options for all.

In our experience managing tens of thousands of cases, we’ve been able to put enough control back in the hands of the practicing physicians! Of the physicians that we support, approximately 80% now participate in the P2P’s. With educated participation in the P2P’s, our approval yield is currently running at approximately 75%.

Get to “YES” faster, and more often! Physicians…don’t be afraid! Learn from us! Here’s how you can be a better advocate for your patients.

Pursuant to the 2014 Utilization Review and Accreditation Commission (URAC), https://www.urac.org/resource-center/standards-interpretations/:

1. Health Utilization Management Standard 10 – Initial P2P

Individuals who conduct initial clinical review:

• Are appropriate health professionals; and

• Possess an active professional relevant license.

2. Health Utilization Management Standards 32 – Appeal or “upon request”

Appeals considerations are conducted by health professionals who:

• Are clinical peers;

• Hold an active, unrestricted license to practice medicine or a health profession;

• Are board-certified (if applicable) by:

• A specialty board approved by the American Board of Medical Specialties (doctors of medicine); or

• The Advisory Board of Osteopathic Specialists from the major areas of clinical services (doctors of osteopathic medicine);

• Are in the same profession and in a similar specialty as typically manages the medical condition, procedure, or treatment as mutually deemed appropriate; and

• Are neither the individual who made the original non-certification, nor the subordinate of such an individual.

3. Compelling, Persuasive Request for Benefits & Coverage:

DO

• Provide a BRIEF description of your background and specialty credentials; ask for a background statement of the credentials of the Medical Director representing the Payor

• Re-state that you are asking for “Individual Consideration” for this patient

• Provide specific detail on why THIS patient is in need of an intervention in order to address specific conditions/problems.

• Provide a detailed listing of failed conservative care treatments and medications (include dosages)

• Provide approximate number of times that you have performed this procedure

• Provide ‘general and anecdotal’ patient response experiences, if applicable

• Provide a comment that you discussed the patient’s recommended options for treatment AT THIS JUNCTURE, and that you and the patient BOTH agreed that this procedure provided the best opportunity for clinical improvement(s).

• Provide a copy of FDA approval/clearance letter along with all available publications relating to device/procedure.

DON’T

• Comment on Insurance Company formal Policies and Procedures…this is about specific ‘individual consideration’

• Make an impassioned-only plea…this should be about outcomes & evidence

• Talk about payment levels or amounts at this point…wait until they finalize a decision.

If physicians take the time to effectively participate in the P2P process in a meaningful way, their patients are the winners. And…with appropriate expectations and understanding of the Insurer responsibilities and guidelines for decision-making, the P2Ps can actually expedite care!

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