The healthcare reimbursement system currently operational in the US has become a cumbersome, at times nonsensical, mechanism for calculation of compensation to healthcare providers for services rendered. It’s known as “Coverage, Coding, and Payment”. It’s a process that has developed over more than 50 years and only with the implementation of the Patient Protection and Affordable Care Act (a.k.a. PPACA or Obamacare) has it even made a claim to attempt to control or reduce real costs. Prior to that the system was about establishing consistency in reporting, tracking diseases, entitlement provision, and claim adjudication.

Having worked in the business of healthcare for almost thirty years and participating in processes with the Center for Medicare & Medicaid Services (CMS) and the American Medical Association (AMA) during that time, I believe I have a good handle on how the various programs have evolved. Why is that important? Because, dear friends, reporting of healthcare services is generally based on the intention, not the actual provision. Payment for those services is largely a factor of cost and time, not effectiveness and efficiency. It matters.

Last week, TRG began a 3-Part series on building a successful field Reimbursement team. Part 1 focused on identification of key elements in the establishment of the team and structuring its leadership and management ( Part 2 will focus on Goals & Deliverables of a successful field Reimbursement team. However, when more specific discussion is needed, I have provided names of recommended service providers for follow-up.

Goals and deliverables of the team will vary according to the classification of the type of product supported:

Pharmaceutical – Group I

  • Regulatory Pathway* – CDER
  • Coverage Pathway – Formulary
  • Product Coding – Does Not Apply
  • Service Coding – Does Not Apply

Biologic – Group II

  • Regulatory Pathway – CBER
  • Coverage Pathway – Medical Policy
  • Product Coding – HCPCS
  • Service Coding – CPT

Medical Device – Group II

  • Regulatory Pathway – CDRH
  • Coverage Pathway – Medical Policy
  • Product Coding – HCPCS
  • Service Coding – CPT

*For a complete FDA Organizational Overview, please see

In the discussion of Reimbursement Goals & Deliverables (G&D), its easy to see that Biologics and Medical Device needs are comparable, while Pharma G&D do not overlap. Manufacturers would do well to remember this when they’re staffing their Reimbursement team….or at least allow for time for cross-training. For regulatory assistance with a strong understanding of the impact to reimbursement elements, we recommend Marie Marlow and her group at M Squared Associates (

For both Groups, the Reimbursement Goals can be clearly stated and understood:

  1. Coverage: Common, predictable insurance benefit for product and services related to product.
  2. Coding: Recognized, specific coding for product, professional services related to product, and technical services related to the provision of product.
  3. Payment: Level of payment to physician sufficient to support time and displaced service payment history; Level of payment to facility relative to the projected payment from Insurance Company.

It’s the deliverables part where many manufacturers lose their way. When TRG is working with a new client and helping to develop their plan, we spend a great deal of time educating the executive staff and corporate investors about the existing reimbursement processes and structures. It’s a process that needs to be respected because they need to be successfully navigated in order to achieve the Goals.

I’ve been on the receiving end of many discussions detailing the failures of the US healthcare system, why it doesn’t work, how its not incentivizing the desirable behavior, and frustration with patients’ lack of control and understanding over their own care. Generally speaking, these things are all true. Unfortunately, too many times the next part of the discussion is about how this manufacturer is going to blaze their own path to reimbursement and force understanding upon the various stakeholders that represent barriers to this manufacturer’s success.

If the product manages to hang on long enough, the new management will generally attempt new tactics. The Reimbursement processes have long memories. These decision-makers remember who has followed the rules, and which manufacturers were overly creative or intrusive in their efforts. Problematic or complicated re-starts weigh heavily on field Reimbursement teams. Do not be your own worst enemy. Hire the right person to run your Reimbursement program. Give that person the tools, resources, and latitude to execute your approved plan.

If the Reimbursement strategic and tactical plans are solid, field Reimbursement team is well developed, well run, and well…lucky, the Goals (Coverage, Coding, and Payment) may be achieved in about 5 years from launch. That’s the ideal. Anything under 10 years from launch is still deserving of a hearty handshake and a pat on the back. I’ve never seen all three Goals delivered in less than 5 years.

There are times when investors may require development of a Reimbursement Plan and projections of Reimbursement elements in advance of implementation or actual launch preparation needs. When this happens, I encourage contact with Maren Anderson, MDA consulting ( MDA is also the perfect resource for smaller organizations looking to outsource coordination of their entire reimbursement program.

In working toward your Reimbursement Goals, manufacturers need to be able to measure progress and develop tactical initiatives. The Deliverables of a successful field Reimbursement team should include:

Group I –

  1. Economic analysis supporting pricing values and structure.
  2. Formulary placement, as measured by Covered Lives
  3. Patient Access Programs to support day to day prescribing ( does a good job with these programs in the area of Pharma, specifically).

Group II –

  1. Coding assignment for product & tech services via CMS.
  2. Coding assignment for related pro services via AMA.
  3. Economic analysis supported pricing and mapping assignment.
  4. Policy with targeted 50% of top 100 plans (see Judy Dean with Payer Strategies Group, ph. 352-678-3315). Measure Plans, not Covered Lives.
  5. Support actual Sales events via variety of programs (detailed discussion with many elements, contact TRG to schedule a call,
  6. Maintain coding position(s) through various annual updates and rules. Participate in the process, when appropriate.
  7. Maintain presence within the formal reimbursement processes for awareness of competition and prospective program changes.

If you’d like to discuss the content of this series in more detail, TRG ( can walk you through these considerations and help you flesh out your processes and specific needs. We will provide considerations for budget development and staff metrics in Part 3 of 3, next week.

This post was first featured on LinkedIn

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Sponsored by The Reimbursement Group (TRG)

December 5, 2014

It’s that time of year! Many medical device manufacturers anticipating good news from the FDA in early 2015 are busy preparing budgets and trying to prepare for product launch. The Affordable Care Act (a.k.a. Obamacare) will continue to impact pre-launch and early launch adoption of new technology medical devices. We will all need to stay tuned regarding the 3% device tax burden. But none of these issues change the need for a well-run reimbursement field team!

Over this 3-part series, The Reimbursement Group (TRG) will provide thoughtful review and consideration on this topic during the month of December 2014. We’ll identify major elements and try to provide some direction in this area.

Before evaluating your reimbursementdevelopment needs, there are significant basic processes that are non-reimbursement that that should be finalized, documented, and implemented. Direct sales representatives, distributors, or a combination? Primary and Secondary markets? Production facilities, redundancies, inventories? Initial platform product or building a portfolio?

After these decisions, manufacturers need to make decisions about field activities and building out reimbursementsupport teams. Although there is a chronological order to these elements, neither reimbursement strategic or tactical plans should be an afterthought. There is variability for reimbursement support needs based on a number of factors including clinical specialty, first-to-market product initiatives, clinical evidence development/planning, and regulatory pathway. However, not all elements are unique. There are common elements that should be identified and valued:

  1. Possible displaced clinical diagnostics or therapeutics
  2. Possible adjunct clinical diagnostics or therapeutics
  3. Coding, Charting, and reporting recommendations for your device
  4. Specific detail concerning your device episode of care – resources, setting, duration, length of stay, economics, etc.
  5. Defined global care period

You will need answers to these elements in order to make appropriate, educated projections on your reimbursementneeds. In developing and supporting many successful launches, TRG ( can provide manufacturers with the metrics for establishing and scaling reimbursementfield teams.

  • How many FTEs?
  • What training or credentials are appropriate?
  • When do you begin payor policy efforts?
  • How do you measure reimbursement goals?
  • What are the deliverables from the Reimbursement department?
  • Who should they report to?
  • What should the Reimbursement budget look like?
  • Who will manage your reimbursement plans?

Do you think you have an expert already on staff who knows all the important reimbursement details? Please….tell me it’s not your Marketing Director! Stop it, you’re killin’ me! I have known and worked with several very talented marketing people….and I would not consider any of these individuals for building and managing Reimbursementfield support. There are even fewer marketing people who would want the job! The skills do not translate. CEO’s, please stop asking your marketing people to develop and execute your reimbursementplan! It’s not the same language, not the same urgency, not the same skill set, not the same relationship.

Hiring the wrong person to develop and implement your reimbursement plan is the single, biggest mistake that manufacturers make in this area.

The second biggest failure in setting up your reimbursementfield team? Set up your Reimbursement department to report up through your Sales department. These two groups must work together, effectively, and when they do it’s a thing of beauty. However, there are times when their goals are seemingly diametrically opposed. For example, sales is working to build physician demand and support product adoption. The reimbursement person is working to build Insurance coverage and policy for labeled indications. It’s short-term versus long-term focus and timelines. For this reason, there must be a separate, rational voice in neutral territory.

The final significant element for consideration in kicking off your reimbursementfield staff development is deciding what to build out internally, and what to outsource. Do you want to outsource its planning? Management? Is your product best supported via appropriately experienced internal staff? Both options have advantages, but the best selection is generally achieved after consideration of the following:

  1. Internal staff: PMA pathway, platform product, distributor model, ongoing clinical research, first-to-market technology, complicated or changing treatment algorithm, significant evidentiary development needs, paradigm shift.
  2. Outsourcing: 510(k) pathway, subsequent product launch, distributor or direct sales, mature market, coding/charting challenges, evolutionary technology, early exit strategy.

Depending on your specific needs and after thoughtful consideration of A & B, above, manufacturers should obtain the best qualified staffing that they can afford – whether outsourced, contracted, or retained. Yes, it’s still true….you get what you pay for! For those organizations seeking to retain talent, Suzanne Bohen (, Emerson Professionals, is a very well connected executive search consultant in the area of reimbursement management for the medical device industry. TRG also provides outsourced Call Center, Case Management, augmented field staffing, and other reimbursement tactical support.

If you’d like to discuss the content of this document in more detail, TRG ( can walk you through these considerations and help you flesh out your processes and needs. We’ll be developing the Goals/Deliverables of an effective Reimbursement Field Staff in Part 2 of 3, next week.

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TRGLTD Offers Tips on Flu Season 2014


It’s Flu Season!

By Mary Corkins, TRG 

Did you forget? With all the very serious focus on Ebola, terrorism, and other crisis’ you may have been distracted from the fact that it’s Flu Season! According to the CDC there are things you should know about the 2014-2015 season:

  1. In the US, Flu Season typically peaks between December and February. October is the recommended time to get your Flu vaccine!
  2. The Influenza virus is constantly changing. Small genetic changes (“antigenic drift”) produce virus’ that are closely related on the phylogenetic tree. The current Flu vaccine composition is formulated to address this year’s drift.
  3. CDC recommends a yearly vaccine for everyone 6 months and older.
  4. Starting this year, the CDC recommends use of the nasal spray vaccine for healthy children 2 through 8 years of age.

Where can you get your vaccine? That’s the easy part! Go to to locate clinics, pharmacies, and offices where the vaccines are currently available. For those with a bit of extra time on their hands, this site invites you to sign up to help “Track the Flu” in your area by completing short, weekly surveys. Lastly, this site also provides information about other vaccines (Hepatitis A & B, Pneumonia, Shingles, etc.), who needs them, and how often.

As a final reminder, please keep track of your services (specific vaccines, anatomical site, business location & dates of service) and provide this information to your Primary Care Physician (PCP) as part of your own complete health record.

This post was first published on Linkedin HERE


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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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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


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),

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:


  • 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.


  • 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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What’s a Provider Portal?


Sponsored by The Reimbursement Group

If you’re responsible for the management of a Physician Practice, or an Ambulatory Surgery Center, or a Clinic, your job just got that much harder!

Starting next week Anthem Blue Cross Blue Shield, (the single largest health insurance plan in the United States with over 35 million members), is changing the way they interact with their physician providers. Again. Here’s how.

Anthem’s new recording advises, “After September 5, 2014, Anthem will no longer provide phone status updates. All updates must be done through the Provider Portal. The letters will continue to be sent to the office.” Anthem is not alone in this change. They are joined by other Blue Cross Blue Shield plans including Highmark and Excellus. Whether directing clinicians to a clearinghouse like or to their own homegrown access point, this represents yet another change in plan processes driven by the implementation of the Patient Protection and Affordable Care Act (a.k.a. Obamacare).

At first blush this new process would seem to improve efficiencies, likely reduce processing times for prior authorizations and appeals, and perhaps even result in shared reduction of costs. But we must also consider that many offices simply do not provide internet access to their business or billing staff. There’s a cost, both direct and perceived lost productivity, inherent in this access. A large share of practitioners source their billing to an outside company, which further reduces the perceived benefits of internet access for their in-house staff. Historically, there has been no need for front-office staff to access the internet. Clearly, that’s about to change.

The Reimbursement Group (TRG) supports business functions related to new technologies in healthcare. We develop and run reimbursement hotlines. Our case managers work to obtain authorization for benefits on prescribed services. We’re very, very good at what we do. Based on our experience, we project that something in the neighborhood of 50% of private healthcare offices do not have internet access. TRG is daily bridging the gap between changes at the Plan/Payor level with capabilities at the provider or manufacturer level. Under Obamacare, that gap is ever widening. It is further exacerbated by the long time lines present in this industry in recognizing, understanding, and then adapting to process changes. For example, there was a 1 to 2 year delay in spine surgeon awareness of coverage policy changes restricting initial surgeries to single-level instrumentation. Though the policies themselves varied, there was a significant delay between the implementation of the policies to when surgeons changed their documentation and prescribing.

TRG expects a ripple effect with the Anthem change. There will be meaningful delays in scheduling non-emergent surgeries and procedures. Physicians will experience significant problems with claim denials. Patients will be left holding the proverbial bag, having to suffer for both of these shortcomings themselves.

So what is a Provider Portal? It’s the plan’s physician access point on their website. It requires login identification and passwords. Staff will need their boss’ Tax ID number and national provider identifier (NPI) for access. Physicians, the next step is yours!

This post was first seen on LinkedIn

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