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FDA Chief Resigns – Why It’s A Loss for Self-Funding

By: Brady Bizarro, Esq.

When President Trump nominated Scott Gottlieb to be commissioner of the Food and Drug Administration (“FDA”) in March of 2017, critics were quick to point out his deep ties to the pharmaceutical industry. They had little hope that he would have the wherewithal to overcome perceived conflicts of interest and challenge the industry on important issues facing consumers and payers. Scott Gottlieb, however, proved to be a rarity, seemingly immune to regulatory capture. He received bipartisan praise as one of the administration’s most effective regulators. His departure in April will be a loss for the self-funded industry and for healthcare cost containment as a whole.

Dr. Gottlieb focused his efforts in three key areas: rising drug prices, the opioid epidemic, and the underage use of e-cigarettes. Under his leadership, the FDA worked to strengthen and speed up the review process for generic drugs. In 2018, first-time generic approval grew by 24%. In all, the FDA approved 971 generic drugs in 2018, an all-time high. With respect to the opioid crisis, which has killed some 85,000 people since 2017 and led to an enormous spike in treatment costs to payers, Dr. Gottlieb took a hard stance on opioid prescribing limits and approved a mobile app to help those with substance use disorder recovering through outpatient treatment. Finally, under Gottlieb, the FDA cracked down on teen vaping by announcing rules to restrict the sale of flavored e-cigarettes, supported banning menthol cigarettes, and reduced nicotine levels in cigarettes.

Soon after he announced his departure, the Trump administration named an interim replacement, Dr. Ned Sharpless, who now heads the Cancer Division of the National Institutes of Health (“NIH”). The search for a permanent replacement is still underway.


Foreign Drugs: Savings Worth Traveling For

By: Andrew Silverio, Esq.

In recent weeks, we have seen an influx of questions regarding the practice of procuring prescription drugs from abroad, particularly Mexico (Canada has historically been the most popular source).  The issue has also been popping up in the news, and a program for public employees in Utah to venture to Tijuana to pick up their prescriptions is now live.  The potential for significant savings compared to domestic pricing for (essentially) the same drugs is what is driving the popularity of this trend.  We won’t get into the legal standing of this practice – feel free to reach out if you’d like information on that topic – but we wanted to highlight a potential risk that we generally don’t see employers consider when looking at programs like this – not a legal or contractual risk, but a health risk stemming from the drugs themselves.

It is true that drugs manufactured for sale abroad can be chemically identical or sometimes even manufactured in the same facilities as their U.S. counterparts.  However, this is not always the case, and quality control can be an issue, as can more nefarious problems with counterfeit drugs. Countries designated as “Tier 1” (such as Canada) have comparable safety standards to those in the United States, but the fact remains that the FDA has no authority or ability to oversee drugs manufacturer for sale abroad (even drugs that come off the same conveyor belt as their U.S. counterparts).

Even at home, quality control issues happen.  Per a recent CNN article, “there’s no end in sight for one of the largest prescription drug recalls in recent memory.”  Numerous different blood pressure medications, from several manufacturers, have been pulled from shelves due to contamination related to “NDMA” (N-nitrosodimethylamine), a chemical which is used to make liquid rocket fuel.  This chemical, and another which has been identified called NDEA (N-Nitrosodiethylamine), interfere with DNA replication which can result in cancer, and the issue goes back years, not months.  These foreign manufacturers may be taking all the same appropriate corrective action for drugs packaged for sale elsewhere, but the FDA simply doesn’t have the ability or authority to make sure of it. 

Finally, in the event a patient visits a foreign country to retrieve their medications and ends up receiving tainted or counterfeit products and having adverse effects (whether due to a lack of FDA oversight or not), that patient will not have the benefit of any domestic laws relating to product safety or medical malpractice.  If any recourse against the manufacturer or pharmacy is available at all, they will likely need to return to the source of the drug and operate within an unfamiliar legal system.  Of course, if the patient’s health plan actively encouraged the patient to get their drugs from a less reputable foreign source rather than the pharmacy up the street, the plan itself could potentially be liable – and a much more appealing target than a foreign pharmacy.


The Opioid Crisis: How Employers & Self-Funded Health Plans Can Combat This Epidemic

By: Philip Qualo, J.D.

Each year more and more Americans overdose on prescription opioid drugs. In fact, the Centers for Disease Control and Prevention (CDC) reported that deaths attributed to opioid abuse and addiction now exceed car crashes as the leading cause of unintentional death in the United States. Opioid addiction has grown exponentially in recent years and is now officially the deadliest drug crisis in American history, more than heroin and cocaine combined.

Opioid drugs are routinely prescribed by healthcare providers for its lawful intended purpose, to treat severe pain. As access to healthcare has increasingly become available to all Americans from diverse backgrounds, this specific drug crisis is unique in that it crosses all social, economic and racial boundaries. This broad demographic substantially increases the likelihood that the opioid epidemic will eventually make its way into every employer’s workforce.

Employers sponsoring group health plans can incur significant financial and legal risks when dealing with plan participant opioid abuse, such as an increased use of emergency room services, hospitalizations, related medical costs, and even an increase in workers’ compensation claims. As a result of opioid abuse, the cost per claim continues to grow, as well as the number of painkillers per claim. For example, a 2012 study conducted by The Hopkins-Accident Research Fund Study, found that workers prescribed even one opioid had average total claim costs that were more than three times greater than claimants with similar claims but who were not prescribed any opioids. 

Employers who sponsor self-funded health coverage have a particular advantage in combatting the opioid epidemic in their own workforce as they have the flexibility to design their health plans in ways that could potentially discourage opioid abuse among plan participants. For example, allowing for low cost access to, or otherwise incentivizing participation in, popular alternatives to pain management. These alternatives provide plan participants with a variety of options to treat pain without the use of prescription drugs. The most common alternatives to pain management are acupuncture, chiropractic care and physical therapy. Such alternatives are likely far less expensive than the financial and legal risks associated with prescription opioid abuse.

Self-funded health plans also have the ability to ensure that healthcare providers in their networks are following CDC guidelines. These guidelines are intended to improve the way opioids are prescribed to ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose from these drugs. In the alternative, self-funded health plans could consider implementing a three-day limit on opioid prescriptions for initial pain treatment as the CDC has found that the probability of addiction increases on day four.  

Regardless of how employers and/or plan sponsors choose to address the opioid epidemic, it is important that employees and plan participants are educated about opioid abuse and its potential consequences.  Employees that are educated about the drug crisis and their healthcare options are more likely to make informed decisions regarding their pain.


Self-Funding Comes in Many Forms - When Describing, Take Care to do so Accurately!

By: Chris Aguiar, Esq.

I read what I thought was a decent article this week on some of the advantages of self-funding but wanted to take an opportunity to comment/elaborate.  Always great to see self-funding be touted in the public eye via highly visible media sources.  It can certainly be difficult to give a very detailed explanation of this complex risk model in a capped word count article, but something jumped out at me that I thought relevant to note.  The author describes self-funding generally as “the employer pays for its own employees’ claims, or at least to a certain amount, while larger claims would be handled by insurance companies”.  Certainly that is a model we’ve all seen, but it is indeed only one model and the exact kind of description that drives the misconception that a self-funded plan that uses a traditional stop loss model is not fully self-funded and is therefore insured.

It's important to understand that many self-funded plans do not utilize the hybrid approach this description implies.  To the casual observer this description suggests that a $1,000.00 claim is paid by the self-funded plan while a $100,000.00 claim is paid by some other health insurance arrangement entered into by the employer; that’s simply not accurate, certainly not among The Phia Group’s clientele.  Rather, for many self-funded plans the plan is at all times responsible for the medical bills and, only after the paying, seeks reimbursement from another insurance company.  That company from which the plan seeks reimbursement is not a health insurance carrier, rather, it’s a financial insurance vehicle that protects and ensures the viability of the Plan to make sure benefits continue to be available for all employees/beneficiaries of the plan.

So, just like the $1,000.00 medical bill, the employer/self-funded plan receives the $100,000.00 claim and must evaluate whether it is eligible for coverage and provide said coverage.  Only then, does it submit a reimbursement request (assuming the $100,000.00 is above the applicable deductible).  It is often the case that for some reason or another, the plan allows for coverage but the request for reimbursement is denied under the terms of the stop loss insurance policy.  Certainly, that self-funded plan would tell you that they were unable to “transfer the risk” on that particular claim.

The description above alone is almost 350 words – so we certainly can’t expect an article of about 750 words intended to cover both self-funding and Direct Primary Care, one of the more innovative approaches being utilized by employers to provide more cost effective health plans to their employees, to describe it in depth.  Notably, the author did not quote Mr. Thaxter when making that description, so it’s impossible to know exactly how it was described to him.  As practitioner in the self-funded space, it’s incumbent on us to do everything we can to educate those who are self-funded, or looking to become self-funded on the benefits, the risks, and strategic and innovative steps that can be taken to minimize the risk and maximize the reward – more cost effective medical benefits!

Catch the article here - https://thebusinessjournal.com/self-funded-insurance-options-come/?fbclid=IwAR3D-CxhWa1vrUy1lkmNMKJTt3cAuucs6v5q7zT4mkQA7ytD9oBQsyl92Pc


Not An Enemy

By: Ron E. Peck, Esq.

Let me first begin by reporting some good news.  Those who follow our organization closely recall back in July that I announced my wife’s diagnosis of Non-Hodgkin’s Lymphoma.  Six months later, I am pleased to announce that she is in complete remission.  It will be some time before she can be deemed well and truly “cured,” but this news is still something I am thrilled to share with you.  To the many (many) people who sent me well wishes, prayers, and requests for updates; thank you.  Relevant to this blog post, however, I also want to thank the providers – the people who saved my wife’s life, and ensured my three year old son still has his mother.

As I work on behalf of the self-funded health benefits industry, including employers, employees, brokers, stop-loss carriers, MGUs, TPAs, and pretty much every entity that plays a role in the formation and administration of said plans – one attitude consistently seems to pop up.  As payers, we assume the worst of the payees.  In other words, we routinely state that the rising cost of health care is the providers’ fault.  The affordability of health benefit plans (or lack thereof) is driven solely by exorbitant – and dare I say it – criminal pricing by hospitals and providers.

This desire to place all the blame on providers demonizes them, casts them in the light of an “enemy,” and eliminates any chance of coordinating with providers in an effort to peacefully resolve differences of opinion – hopefully before a patient is negatively affected – and fix the system we agree is flawed.

Many times have I been asked to assist in a situation where a provider has billed one amount for services rendered, the benefit plan pays a lesser amount it deems to be reasonable, and the patient is balance billed.  After reviewing the entirety of the situation with the provider, sometimes they agree to accept some amount situated between their original charged amount, and the amount paid.  The offer is fair, yet upon reviewing it with the plan sponsor or administrator, they refuse to pay more.  The rationale sometimes has to do with fiduciary duty (fair), sometimes relates to financial limitations and stop-loss availability (understandable), but sometimes the stated rationale is akin to: “I’m tired of those crooks milking me for all I’m worth, and I refuse to negotiate with terrorists.”

It pains me to see this happening.  I count myself lucky to live in an area where there are so many incredible providers of healthcare.  More of my friends are providers than any other profession, and without exception, they are all 100% focused on improving patients’ health, and 0% focused on charge-masters, billing schemes, and squeezing plans dry.  The issues (and there are many of them) are more a symptom of a broken system than intentional malfeasance on the part of all providers.  Most providers, like us, are people so exasperated by their day-to-day duties that they throw their hands in the air and default to an “us versus them” mentality.

If payers and payees cannot work together to identify a middle ground that works, is fair, and is viable long term for all involved, then “someone else” will do it for us… and I fear what that “solution” will look like.  Feel the burn?

This is why I am asking every person who reads this missive to step back, and remember who we are dealing with, and perhaps – on occasion – give them the benefit of the doubt.  They, like us, are caught in a broken system whose shortcomings perpetually fuel a death spiral; and they – like us – are just trying to do right (as they see it) for their employer and their industry.

Do we truly believe hospitals want to bite the hand that feeds them, or do they look at their own (albeit inefficient and poorly conceived) processes, witness how we in the payer community are trying to “shortchange” them, and they – like us – become defensive?

The bottom line is this.  We need to adopt and obey a process by which providers are adequately rewarded for their noble work, and on both sides waste is eliminated, innovation is awarded, and cost-containment isn’t a dirty word.  Lastly, we need to change our perspective and understand that we are all (payer and payee) part of the same entity – the healthcare industry – and that without one, the other will cease to thrive.


You Down with RBP? (You May Already Be!)

By: Jon Jablon, Esq.

Reference-based pricing is one of the most mysterious self-funding structures out there. At its core, it’s a simple enough idea: the plan changes what it pays for non-contracted claims. At its most basic level, it’s a way to redefine the traditional notion of U&C; generally, RBP plans base payment on some percentage of the Medicare rate. Guess what, though? If your plan defines U&C based on a database such as FairHealth (for instance), that’s a form of RBP too!

RBP isn’t a structure with a well-defined set of rules. Different plans, TPAs, and vendors do things very differently. The common denominator is that pricing for claims isn’t based on billed charges or an arbitrary percentage off billed charges, but an objective metric based on the value of services. If the plan considers rates set by a popular database to be indicative of the value of services, then that’s the reference upon which prices are based (there’s the R, the B, and the P!).

While of course there are practical differences between popular databases and Medicare, the easiest example being differences in the actual amounts generated), the major conceptual difference is that providers are generally more likely to accept rates generated by popular databases as payment in full than to accept Medicare rates as payment in full from the same payors. Even though the majority of hospitals do accept Medicare, the prevailing opinion among hospitals is that Medicare rates are essentially thrust onto them in a contract that they sign out of necessity (since many hospitals would lose a large percentage of their business if they didn’t accept Medicare). While payors may consider Medicare rates or a percentage above them to be reasonable, the majority of hospitals tend to disagree – at least at first.

When a health plan accesses the FairHealth database (again, just for example) to obtain pricing, there is often no patient advocacy needed, since many providers access the same database or consider those rates to be generally accepted – but to contrast that to Medicare-based pricing, a plan paying Medicare rates is much more likely to need some sort of advocacy since Medicare rates are not nearly as widely-accepted by providers. Patient advocacy is one of the must-haves in “traditional” RBP, which typically uses Medicare rates.

The morals of this story: (1) you may already be using RBP without realizing it! And (2) make sure your RBP program has patient advocacy, if necessary. If your chosen RBP payment methodology doesn’t need patient advocacy, then your RBP experience will probably be a bit simpler – but if you do need it, don’t skimp on it.


Communication Breakdown – More Lessons Learned from My Wife’s Battle Against Lymphoma

By: Ron Peck, Esq.

For those who did not tune into the “Empowering Plans” podcast, wherein I revealed why I’ve been absent from other recent Phia Group podcasts and webinars, please do check it out.  In that recording, I describe my wife’s diagnosis (the specific type of Non-Hodgkin’s Lymphoma she’s fighting), and early lessons learned through her diagnosis.  Key among them is the need for second (and even third opinions) to ensure the right diagnosis is ultimately achieved.  I implore plan sponsors to pay for – and advocate for – second (and third) opinions.  The funds expended on these opinions more than pay for themselves when we avoid unnecessary (and possibly dangerous) treatments for the wrong conditions.

The next lesson learned has been about and orbits around communication.  Communication is comprised of more than just what we say, but how we say it.  To effectively communicate, it’s necessary to put ourselves in the shoes of the ones with whom we’re communicating.  Empathy is the greatest Rosetta Stone.  With that in mind, my wife experienced a failure in communication not because the communicator was unclear, but rather, their focus, medium, and other elements missed the mark.

For instance, there were specific instructions she needed to follow to secure certain medications in accordance with rules set forth by the PBM.  Nothing was withheld, and the coverage is great – but only if the rules are obeyed.  The issue, however, was that the rules were communicated via US Mail (a/k/a “snail mail”).  I love my mail carrier as much as the next red blooded American, but – if we’re being empathetic – we need to accept that a cancer patient is likely falling behind on their mail, and are unlikely to rush to open a letter that doesn’t look like a bill.  To ensure the patient knows about the particulars of the program, we should notify them when the first dose is filled by notifying the pharmacist (so the message can be conveyed at the point of sale), and electronically (via phone call, text, e-mail, etc.). This is one silly little example of things we may not spot from the payer perspective, but as a patient, suddenly it’s clear.

Likewise, case management.  Again, the benefit plan attempts – in its estimation – to go above and beyond in its servicing of the patient, assigning a case manager to the patient’s case.  This person, the patient believes, is supposed to offer advice, act as a second set of eyes on proposed care, and generally look out for the patient’s best interest.  In our mind, that would include financial interests too, right?  Yet, when a conflict arose between the provider and plan representative, the case manager was quick to report to my wife – the patient – that the conflict was raging, claims would likely be denied, and she – the cancer patient – should encourage her oncologist (the person, the patient believes, that stands between her and certain death) to work with the plan.

Now, from the case manager’s perspective, they foresee the patient enduring financial hardship if the matter isn’t resolved, and they are trying to act preemptively to avoid it.  This is not a bad thing!  Yet, from the patient’s perspective, they are being dragged into matters of money – irrelevant and unimportant – compared to their own battle to survive.

Again, we need to step into the shoes of the patient and ask: “How would I feel if I received a call, threatening to deny my claims and saddle me with debt, unless I turn on my doctor and become their adversary on the plan’s behalf?”  We know this isn’t the purpose of the case manager’s efforts, but this is how the patient (and if we’re honest – even we) may interpret it during such a time of stress and grief.

Moreover, if the patient is enraged by this turn of events, they may take this “heads up” from the case manager to be a directive from the plan administrator – and suddenly the case manager is looking like a final, fiduciary decision maker.  I worry here, because we do not want this independent third party case manager to suddenly be a fiduciary, or impact the actual fiduciary, by “making decisions” on the plan’s behalf – without the plan’s authorization.

As my wife continues to battle cancer, my eyes continue to be opened as it relates to the patient perspective, and how they may interpret things we in the benefits industry often say without concern.  I look forward to continuing to share my observations with you.


Bridging the Gaps Between...Everything

By: Jon Jablon, Esq.

You may have heard about our new Phia Certification program, through which The Phia Group requires all employees to be “certified” to the company’s satisfaction. Certification is obtained by watching, reading, and listening to a series of training materials and then taking a series of tests to confirm the employee’s understanding of our industry and all aspects of The Phia Group’s operations.

One particularly noteworthy question is:

Which of the following is the most accurate?

  1. A “gap” is the amount a health plan pays for a claim between its normal specific deductible and a laser for a particular individual
  2. A “gap” is a misalignment or misinterpretation of verbiage between the plan document and any supporting document or policy
  3. A “gap” arises when the stop-loss policy contains a limitation that is not present within the plan document
  4. A “gap” arises when the employee handbook guarantees 8 weeks of vacation but the plan says it will only cover 4

As you may have surmised, the answer is option B, which is essentially an “all of the above” type of answer. This is especially noteworthy because we find that folks in our industry often think of “gaps” as occurring only between the plan document and stop-loss policy, while in practice there are lots of other gaps that can cause lots of unforeseen problems for health plans.

A perfect example – and one that we deal with quite frequently – is when there is a gap between the plan document and a network contract. This can be one the most problematic of all gaps, since it can come out of nowhere. The issue arises like this:

A plan incurs an in-network claim, billed at $50,000. The SPD provides the plan the responsibility to audit all claims, and an audit reveals that the appropriate payable rate (the plan’s U&C rate) for this claim is $30,000. Meanwhile, the network contract provides a 10% discount off billed charges for this particular claim – resulting in the plan paying $30,000 based on the SPD, but owing $45,000 as the network rate. This is a very common scenario and not one that can be solved quite so easily; even if the plan says “oh right – the network contract! We’ll pay the network rate to avoid a fight with the network,” the dilemma may not be over, since stop-loss presumably has underwritten coverage based on the assumption that the plan’s U&C rate will be paid, resulting in stop-loss possibly denying the $15,000 paid in excess of the plan’s U&C rate. Even though there’s a network contract and the plan may have no choice but to pay it, there’s always the chance that the stop-loss policy will define its payment on other terms.

Moral of the story? Gaps in coverage can arise between the plan document and any other document – including network contracts, ASAs, stop-loss policies, employee handbooks, PBM agreements, vendor agreements, and more. Check your contracts, and make sure your SPD aligns with all of them! (Email PGCReferral@phiagroup.com to learn more.)


The Complications Surrounding Intermittent FMLA Leave

By: Erin Hussey, Esq.

 

The Complications Surrounding Intermittent FMLA Leave

 

The Family Medical Leave Act (“FMLA”) is a federal law requiring certain employers (employers who employ 50 or more employees, for at least 20 workweeks in the current or preceding calendar year, in a 75 mile radius), to provide eligible employees an unpaid, job-protected leave of absence that continues the employee’s health benefits. It is offered for family and medical reasons and an eligible employee may take up to 12 workweeks of leave in a 12 month period. This timeline appears straightforward, but complications arise when employees take this leave in separate blocks of time, even an hour at a time (when it is medically necessary and for the same serious health condition). This is called intermittent FMLA leave.

 

Employers should ensure they are administering intermittent FMLA leave properly given the complications it can present:

 

1.            Recordkeeping: Complications can occur with tracking intermittent FMLA leave because an employee’s schedule could vary from week to week and the employer may have to measure FMLA in hourly increments or less. When these intermittent FMLA leaves occur, an employer must be diligent in tracking the leave to avoid liability of non-compliance with FMLA. For example, in Tillman v. Ohio Bell Tel. Co., 545 F. App'x 340 (6th Cir. 2013), an employee was out on intermittent FMLA leave and the employee did not provide information when asked by the employer for recertification of that leave. The employer subsequently terminated the employee. Since the employer kept thorough records of this, the court upheld the employee’s termination and the employer won the lawsuit.

 

2.            Communication: It is important for an employer to maintain communication with the employee who is out on intermittent FMLA leave. For example, in Walpool v. Frymaster, L.L.C., No. CV 17-0558, 2017 WL 5505396 (W.D. La. Nov. 16, 2017), the employee was terminated and he brought suit claiming interference with his intermittent FMLA leave and that his discharge was in retaliation of his right to take FMLA leave. The employer claimed that the employee did not follow normal policies and procedures for giving notice of an absence. However, the employee won the case. The bottom line here is that if the employer believes the employee has provided inadequate notice, the employer should maintain communication with the employee before taking any immediate adverse action.

 

3.            Paid v. Unpaid: In a recent Opinion Letter dated April 12, 2018, the Department of Labor’s Wage and Hour Division addressed a situation where an employee requested 15 minute breaks every hour under FMLA. This creates complications for employers because FMLA is unpaid and determining which 15 minute breaks are unpaid under FMLA, and which ones are paid, can be difficult for employers to track. This issue is discussed in the Opinion Letter.

 

The takeaway here is that employers should determine what their best practices will be for administering intermittent FMLA properly. Once the employer determines what their best practices are, the employer should implement them and administer their employees’ intermittent FMLA leaves accordingly.


Stories from the Front Lines…

By: Chris Aguiar, Esq.

I fight for the rights of my clients every single day.  Typically, though, the fight takes place while sitting in the confines of my office by way of telephone or email communication.  Recently, though, it has become increasingly more common for The Phia Group to have to actually appear in court in front of a judge or administrative board; such was the case last week.  An administrative worker’s compensation board in California who is constantly attempting to reduce its workload and eradicate the existence of worker’s compensation liens they so lovingly refer to “Zombie Liens”, or liens that have been bought/sold/assigned.  Simply, the board refuses to want to deal with those types of liens.  What a surprise to me, then, when several of my clients had their liens summarily dismissed without any due process or a hearing on the matter since, as we know, no assignment of rights occurs to the administrator or vendor in a traditional self-funded situation.  So, off to California I went on behalf of a client to explain to the board it’s fundamental misunderstanding of self-funding and how the interests of our clients have not been sold or assigned to The Phia Group or the claims administrator, rather, we are simply acting on their behalf in an effort to recoup funds that are rightly of the self-funded benefit plans and their beneficiaries.

Make no mistake, this was no easy task.  The Administrative Judge was hell bent on removing our client’s lien and though I don’t think I made any allies, I was able to effectively convince her that the lien should be reinstated because although she was confident that her reading of the law was clear, members of her own organization had ruled all over the map with regard to the law that was so abundantly clear it could not possibly be interpreted in a manner inconsistent with this judges opinion (…. Can you sense my sarcasm here?).

In the end, The Phia Group was able to get its 2nd lien in as many attempts reinstated.  We’ll keep fighting the good fight on behalf of our clients, and while I enjoy California very much, I hope to be able to win these from the comfort of our offices in Braintree from here on out.  Here’s hoping!