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New Rules on Prescription Drug Importation Are Released – Or Are They?

On August 11, 2020

By: Andrew Silverio, Esq.

On July 24, 2020, the White House issued an “Executive Order on Increasing Drug Importation to Lower Prices for American Patients” as part of a handful of executive orders aimed at drug costs (available at https://www.whitehouse.gov/presidential-actions/executive-order-increasing-drug-importation-lower-prices-american-patients/).  At first glance, the order seems to take sweeping steps to facilitate the importation of prescription drugs, but does any of it really represent a departure from existing law?  The order specifically orders the Secretary of HHS to take action in three ways:

  1. Facilitate waivers to individuals against the prohibition on importation, “provided such importation poses no additional risk to public safety,” pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA);
  2. Authorize the re-importation of insulin products upon a finding that doing so is required for emergency care; and
  3. Complete the rulemaking process started by the proposed rule (more information below) to allow importation of certain drugs from Canada.

As it relates to the first item, it’s clear that this does not represent any new law or authority.  Under section 804(j)(2) of the FDCA, “The Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices, under such conditions as the Secretary determines to be appropriate.”  This order is simply an instruction to utilize said authority, and it is not clear how or whether these waivers would differ from the existing FDA policy of enforcement discretion, which is quite broad and under which individuals are rarely prosecuted for importing prescription drugs for personal use.  The important caveat that the importation must pose “no additional risk to public safety” suggests that there may be no real change at all, as this is one of the biggest factors in the FDA’s existing policy of enforcement discretion, and the key element cited by the FDA and pharmacy stakeholders in pushing back against importation.

In regard to the second item, the specific inclusion of insulin is interesting, and perhaps represents the most significant element of this order.  The proposed rules outlined in 2019 by the FDA and HHS did not specifically include insulin (available at https://www.hhs.gov/about/news/2019/07/31/hhs-new-action-plan-foundation-safe-importation-certain-prescription-drugs.html), and the drug’s special storage and safety requirements are a barrier to its inclusion in existing avenues of importation.

While we’re on the topic of the proposed rule, the third item in the executive order is nothing more than an instruction to continue that rulemaking process.  So, is this order a dramatic step toward real federal action allowing drug importation, or just a token announcement that doesn’t really accomplish anything?  Unfortunately, it’s simply too early to tell, and we will have to wait and see what HHS does in response.  It is worth noting that when the proposed rule came out, it was met with harsh criticism from our northern neighbors, many of whom discussed potential action by the Canadian government to counter any such importation efforts in order to protect their own drug supply.  As such, action taken  by the United States in regard to Canadian drug importation won’t be the only factor in whether the practice ultimately becomes both legal and practical.

Empowering Plans: P85 - Catching up with the Courts

On July 10, 2020

In this episode of the Empowering Plans podcast, Ron and Brady briefly discuss Phia's new headquarters in Canton, MA. Then, they jump into a discussion about recent high-profile court cases that could shape our industry: from requiring hospitals to post their negotiated rates with insurers online to the Trump administration's latest action in the Supreme Court case that could spell the end of the entire Affordable Care Act.

Click here to check out the podcast!  (Make sure you subscribe to our YouTube and iTunes Channels!)

WC Recovery in a Post COVID World!

On May 6, 2020

By: Chris Aguiar, Esq.

There are so many fascinating things to debate in what can only be described as perhaps the strangest times we as a society have collectively endured. Should we open the economy at the expense of American lives? Does the data even support this notion that social distancing makes a difference? How could the models have been so far off their original projections? How did the current administration do with respect to its response? It would be disingenuous to say that these are not topics in which I am interested, but in terms of the day to day business of a subrogation professional (and in the context of this blog), I’m thinking much more in the weeds.

The immediate question a lot of our subrogation clients are asking is quite simply, what is the rule regarding workers' compensation claims with respect to this pandemic? Will medical professionals, first responders, and even essential employees be able to make claims for workers' comp? One’s gut reaction might be to say, “of course they can!” – But deeper analysis requires a bit more nuanced thinking.

The success of every injury claim, be it an auto accident, a work injury, or medical malpractice, rests on a critical element of proving negligence – causation! How does one prove that they contracted the virus as a result of working with a person infected with COVID-19, rather than when they stopped at the grocery store on the way home from their shift? With a virus that the media would lead you to believe is so potent that the mere act of stepping outside your door will leave you at significant risk, how are we to know what actually “caused” that person to contract the virus? It would be virtually impossible to tie the contracting of the virus to one single event – accordingly, the theoretical answer lies in the concept of “presumptive illness”. The practical answer, as is so often the case with legal discussion, is, well, “it depends.”

Every state has different definitions of “presumptive illness” - a presumption that one who works closely with those who are ill, such as medical personnel and first responders, contracted the illness within the scope of their employment. Furthermore, every state defines the class of employees who are eligible for the presumption differently (e.g. which “essential employees” are eligible for the presumption?). Additionally, many states are currently reviewing their laws and determining whether to make a change to specifically address the current pandemic and what employees on the front lines are able to claim. Needless to say, as with everything related to COVID-19, it is a quickly developing situation. At this time, whether a plan participant is eligible for worker’s compensation benefits depends on the type of work they do, and whether that state already provides for this presumption. If it doesn’t, states will need to add this presumption in order to allow workers to access these benefits.

Anyone who has questions can feel free to reach out to our team for more information at info@phiagroup.com.

Bouncing Through Quarantine

On May 4, 2020

By: Nick Bonds, Esq.
 

While some of the United States is tentatively beginning to reopen, much of the country remains firmly under social distancing orders. The ripple effects of keeping people cooped up with their families vary wildly, but many are reveling in the extra time spent together, and are finding numerous ways to stay sane and entertained in the face of the Covid-19 pandemic.
 

Some of this has led to fairly predictable shortages, but there are reasons for hope. Aside from the struggle of grocery stores (and even a few global online retail-giants-who-shall-not-be-named) to keep toilet paper, disinfectant wipes, and hand sanitizer in stock, the fact that our stores’ shelves have been rendered entirely barren should be seen as a testament to the resilience of our modern supply chain.
 

Nonetheless, there are a number of things you just can’t find right now. Toilet paper remains scarcer than I’d like it to. The meat case at my local store has been pretty sparse of late. You probably can’t buy a Nintendo Switch from a traditional retail outlet at MSRP to save your life right now. And, spurred by the hordes of energetic youths with no safe outlet for their boundless energy, trampolines are flying off of shelves.
 

This got me thinking… plenty of people find perfectly mundane ways of injuring themselves in the home. Sure, social distancing keeps us safe from the coronavirus, and protects us in plenty of other ways. Fewer drivers on the roads means fewer car accidents. Fewer kids playing peewee football means fewer broken collarbones. But as a former kid myself, I can tell you: we will find a way to injure ourselves, trampoline or no. And fear of the coronavirus may well make people wary of visiting an emergency room (preferably an urgent care clinic), even when truly necessary, exacerbating injuries and prolonging the healing process. This will almost certainly lead to higher claims costs for plans down the line.
 

All this to say, it is imperative that we all keep up with our personal well-being in this time of social distancing. If anything, this pandemic may help all of us maintain a greater awareness of our personal health. Companies that encourage telemedicine can help their employees build a rapport with their healthcare providers, leading to better health outcomes and ultimately saving plans money. Keeping ourselves and our families mentally and physically engaged throughout this time will keep us all healthier and saner until we can finally go to our offices again. If it takes a videoconference with your doctor (or a trampoline/black-market videogame console) to make that happen, maybe it’s worth it.

The Difference – Healthcare vs. Insurance; Never Clearer

On March 16, 2020

By: Ron E. Peck, Esq.

For those who have followed my social media posts in the past, you’ll know that one issue I can’t escape is the constant political rhetoric regarding “healthcare,” and in particular, how politicians (and the general populace) refer to “healthcare” but in fact are referencing health insurance.  When they talk about the cost of healthcare, they don’t mean how much the provider charges for the care they provide.  Instead, they are referring to the premiums, co-pays, and deductibles for which the patient will be responsible out-of-pocket.  Those aren’t the costs of healthcare; they are the costs of health insurance.  I’ve said before, and will say again, health insurance can’t stich a cut or reduce a fever.  Health insurance isn’t healthcare; it’s one way by which we pay for healthcare.

This point has never been more clearly defined than by the current COVID-19 pandemic.

Note how the national dialogue is no longer about out of pocket expenses.  Instead, the public outcry is over a lack of testing kits.  People aren’t worried about their deductible; they are worried about being infected, and what they need to do to remain in relatively good health.  See how people are focused less on how much a cure “costs” and more about when a cure will exist?  Indeed – now that we truly need “health care” and not “health insurance,” people seem to understand what healthcare is, and what it isn’t.

When the dust settles, and the costs are tallied, we will need to determine who pays what to whom.  Until that time, however, the priority for all of us is to seek, improve, and prioritize health (our own and others) and healthcare – actual, true, health care – both quality of care, access to care, and effectiveness of care.

Until then, this global crisis has taught us:

  • Issues with the cost of healthcare boils down to the cost of the actual care.
  • Issues with the efficacy of healthcare boils down to the effectiveness of the actual care.
  • Issues with access to care boils down to actual access to care.

With no vaccine available, and a pandemic impacting everyone indiscriminately – from Celebrity Tom Hanks to Taxi Driver Hank Thomas – we suddenly understand that, when push comes to shove, it doesn’t matter who is paying for your healthcare, so much as whether healthcare itself is available.   Perhaps this will help us appreciate that only health care is health care, you can’t cure anything with the card in your pocket, and ultimately healthcare is expensive because health care is expensive.  It is tragic that it took something this extreme to open eyes and help people understand that on a debate stage we can pretend “health insurance” is healthcare… but when we are sick, only health care is healthcare.

New Insight on Provider Surprise Billing

On February 17, 2020

By: Andrew Silverio, Esq.

Anyone who works in health benefits is familiar with surprise billing – the specific kind of balance billing which occurs when a patient visits an in-network physician or hospital, and receives an unexpected balance bill from an out-of-network provider that they didn’t have an opportunity to select, and in many cases, didn’t even know they had utilized.  Common culprits are anesthesiologists, assistant surgeons, and outside lab work.

We often think of this as primarily a problem for emergency claims.  This makes a great deal of sense, since when someone presents at an ER or is brought there via ambulance, they likely won’t have an opportunity to ask questions about network participation or request specific providers.  However, according to surprising data released in the Journal of the American Medical Association on February 11, 2020 entitled “Out-of-Network Bills for Privately Insured Patients Undergoing Elective Surgery With In-Network Primary Surgeons and Facilities (available at jamanetwork.com/journals/jama/fullarticle/2760735?guestAccessKey=9774a0bf-c1e7-45a4-b2a0-32f41c6fde66&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=021120), these bills don’t actually seem to be more likely to arise from emergencies or other hospital stays where patients have less of an opportunity to “shop around.” 

The study looked at 347,356 patients undergoing elective surgeries, at in-network facilities with in-network surgeons.  These are patients who had ample opportunity to select their providers, and indeed did select in-network providers for both the surgeon performing their procedure and the facility in which it would occur. Shockingly, over 20% of these encounters resulted in a surprise out of network bill (“Among 347 356 patients who had undergone elective surgery with in-network primary surgeons at in-network facilities . . . an out-of-network bill was present in 20.5% of episodes...”) The instances that involved surprise bills also corresponded to higher total charges - $48,383.00 in surprise billing situations versus $34,300.00 in non-surprise billing situations.

The most common culprits were surgical assistants, with an average surprise bill of $3,633.00, and anesthesiologists, with an average bill of $1,219.00.  In the context of previous research indicating that “20 percent of hospital admissions that originated in the emergency department . . . likely led to a surprise medical bill,” it seems that even when patients are able to do their homework and select in-network facilities and surgeons, they are just as susceptible to surprise billing. (See Garmon C, Chartock B., One In Five Inpatient Emergency Department Cases May Lead To Surprise Bills. Health Affairs, available at healthaffairs.org/doi/10.1377/hlthaff.2016.0970.)

Many states have enacted protections against balance billing and surprise billing, with Washington and Texas both recently enacting comprehensive legislation.  However, these state-based laws have limited applicability, and there are to date no meaningful federal protections for patients in these situations.  Until such protections are enacted, patients are left vulnerable to sometimes predatory billing practices, and plans are left to choose between absorbing that financial blow or leaving patients out in the cold.

A Simple Mistake with Big Consequences: Is Your HDHP Actually HSA-Qualified?

On February 5, 2020

By: Kevin Brady, Esq.

Every week, we seem some variation of the question: Will this program impact our HSA-Qualified HDHP status? The programs in question often include direct primary care, telemedicine, managed care, or some combination thereof. The answer, often to the disappointment of groups hoping to provide more value to their participants, is that these types of programs can often run afoul with the Internal Revenue Service’s strict requirements on High Deductible Health Plans (HDHP).

An HDHP must meet certain criteria to allow individuals enrolled to contribute to Health Savings Accounts (HSA). The problem arises when an HDHP no longer meets that criteria and therefore loses is qualified status.

For purposes of utilizing a HDHP with an HSA, the HDHP must comply with IRC § 223(c)(2). This section of the code provides the minimum deductible and the maximum out-of-pocket expenses required for a plan to be considered an HDHP. For example, in 2020, the minimum deductible was set at $1,400 for self-only coverage and $2,800 for family coverage. Further, a Plan considered an HDHP cannot contribute to the costs of non-preventive services until an individual’s deductible is met, and the participants cannot be enrolled in other health coverage as defined by the IRS.  (See here for more information: Pub. 969)

So, when a client asks us the inevitable question, “will this program impact our HSA-Qualified HDHP status?” We typically look to determine two things; 1. Does the program inherently require the Plan to contribute to the cost of non-preventive services pre-deductible; and 2. does the program constitute other health coverage?

While it certainly requires a full and complete understanding of the proposed program, it has been our experience that the answer to at least one of these questions is often yes.

When these types of programs are included as benefits within the Plan, it often opens the door for the Plan to pay for non-preventive services before an individual’s deductible has been satisfied. Conversely, when the program is offered outside of the Plan, it often constitutes “impermissible other coverage” which renders individuals who are enrolled in both the program and the HDHP ineligible to contribute to their HSA.

If an individual makes contributions to their HSA during a period in which they are not eligible to do so, it could result in massive tax consequences for that individual and could also cause tax consequences on employers who contribute that individual’s HSA as well.

With the current guidance in place, it is difficult for groups to implement these types of alongside or within their HDHPs. This is unfortunate because the programs can often add enormous value for participants and also result in significant savings for Plans.

Luckily, in June of 2019, an Executive Order directed the Secretary of the Treasury to issue regulations to clarify the issue as to whether these types of programs can be offered within or alongside HDHPs without jeopardizing a participant’s ability to contribute to their HSA.

Given the Executive Order, and similar legislation making its way through Congress, we are hopeful that there will be new guidance to allow the expanded use of these types of programs with HDHPs in the new future. Until then, it is best to err on the side of caution and confirm that a proposed program doesn’t conflict with the IRS rules before implementing it into your benefits offerings.

 

I Got a Fever, and the Only Prescription is More Transparency

On January 23, 2020

By: Nick Bonds, Esq. 

With the Legislature moving at a glacial pace, the Trump administration has doubled down on its policy objective to reduce health care costs through executive action and administrative rulemaking. A key part of their strategy involves a push to increase transparency in the health care industry – taking special aim at hospitals and drug manufacturers. The apparent logic being that if hospitals and drug makers have to share their actual prices, patient reaction will be strong enough to drag prices down. Experts disagree as to how effective these strategies would be in theory, but we may never have the opportunity to see their impact in practice.

High-profile initiatives to emerge from this approach have run in to a number of difficulties. The administration’s proposed rule requiring drug manufacturers to disclose their drugs’ list prices in their television ads has not been largely repulsed by the pharmaceutical industry, who have had a fair amount of success thus far blocking this rule in court. The pharmaceutical industry argued that this disclosure rule lacked authority and violated their free speech. Last summer, a federal judge in Washington, D.C. ruled that HHS exceeded its authority by compelling them to disclose their prices. HHS appealed, but this past week the U.S. Court of Appeals for the D.C. Circuit appeared unsympathetic. The appeals court agreed that HHS had not been granted the requisite authority by Congress to implement this drug pricing rule, and remained unconvinced that this pricing disclosure requirement would in fact help achieve the administration’s goal of bringing down drug costs. WE expect the administration to appeal yet again.

Announced last November, another transparency-minded federal rule requires hospital systems to disclose the price discounts they have negotiated with insurers for a wide swath of procedures. This disclosure is intended to inform patients of their prospective costs before they are incurred, empowering patients to shop around for the best prices. Here again, debate swirls as to whether this tactic would be effective. Meanwhile, hospital groups have implored the D.C. District Court to block these rules from taking effect echoing the arguments of the pharmaceutical companies before them: that the administration lacks the authority to implement its rule, and that the proposed rule violates their First Amendment rights. Time will tell if the courts come down on the administration’s side this time around.

Other Trump administration efforts have seen fewer setbacks: they have slashed regulations on short terms plans and association health plans (“AHPs”), more generic drugs have been approved, and they are plowing ahead with a notice of proposed rulemaking to allow importation of prescription drugs from Canada. Nonetheless, the number of Americans without health insurance continues to rise, as do marketplace premiums and the actual costs of care. The goal of reducing healthcare costs is an admirable one, we will see how effective the administration’s attempts will be.

Embracing the Pain, Avoiding the Suffering

On January 6, 2020

By: Ron E. Peck, Esq.

I really enjoy the quote, attributed to Haruki Murakami, that “Pain is inevitable. Suffering is optional.”  This really hits home for me for a few reasons, personal and professional, but for our purposes – let’s consider how it relates to the health benefits industry and healthcare as a whole.

Anyone paying attention to the media and political debates will no doubt make note of the constant rhetoric regarding healthcare, and more to-the-point, the “cost” of healthcare.  I’ve (here and elsewhere) discussed ad-nauseam my position that health “care” and health “insurance” are not the same.  That insurance is a means by which you pay for care, and is not care itself.  That by addressing solely the cost of insurance, and not the cost of care, you build a home on a rotten foundation.  So, you can likely imagine some of the “ad-nauseam” I feel in my stomach when I hear the candidates talking on and on about how they’ll “fix” the problem of rising healthcare costs by punishing insurance carriers and making health “insurance” affordable (including Medicare-for-All).

The issue is that, ultimately, whether I pay via cash, check or credit… and whether I pay out of my own bank account, my wife’s account, or my parent’s account… at the end of the day, a beer at Gillette Stadium still costs more than a beer from the hole-in-the-wall pub, and if I keep buying beer from (and thereby encouraging the up-charging by) the stadium, prices will increase and whomever is paying (and in whatever form they are paying) will be drained, and no longer be able to pay for much longer.  In other words, making insurance affordable (or free) without addressing the actual cost itself is simply passing the buck.

So, this brings me to the quote: “Pain is inevitable. Suffering is optional.”

Pain – the pain we feel as we are forced to deal with a costly, yet necessary, thing … healthcare.  As technologies improve, research expands, and miracles take place every day, I absolutely understand that with the joys of modern medicine, come too the pain of cost.  We must identify ways to reward the innovators, the care takers, the providers of life saving care.

Yet, we – as not only an industry, but as a nation – also assume that with this inevitable pain, so too must come the suffering.  Suffering in the form of bankruptcy for hard working Americans and their families.  Suffering in the form of unaffordable care, patients being turned away by providers, and steadily rising out of pocket expenses.

I do not believe that this suffering needs to be inevitable.  If instead we accept the inevitability of the “pain” inherent in healthcare, and the costs of providing healthcare, but instead identify innovative ways to address those costs, then we can avoid the suffering.  Our own health plan, for instance, rewards providers that identify and implement ways to provide the best care, for the least cost.  Our plan rewards participants who utilize such providers as well.  We educate our plan participants regarding how, unlike in many other aspects of life, in healthcare you do NOT “get” what you “pay for.”  That fancy labels, advertisements, and price tags do not equate to better care.  We teach our participants how to leverage not only “price transparency,” but also quality measurements to identify the “best of the best” when seeking care – providers that perform as well or better than the rest, for the lowest cost.  Rather than accept the “inevitability” of suffering, we embrace the pain – we endure the costs, the time, the resources necessary to actually care, and make ourselves educated consumers of healthcare.

The result?  Plan participants – employees that have been on the plan for five or more years – will, beginning in 2020, not make any contribution payment to our plan.  That’s right; their “premium” is zero dollars.  The cost of their enrollment is covered, 100%, by the plan sponsor.  The plan sponsor, meanwhile, can afford to do this thanks to efforts it has made, as well as efforts made by its plan participants, to keep the costs down.  Indeed, a self-funded employer like us can make a choice – either assume that the suffering is inevitable, and pass the cost onto the plan members (incurring the wrath of your own employees and politicians alike), or, see that the suffering is optional, and nip it in the bud.  We have identified ways to better deal with the inevitable pain, thereby minimizing the suffering endured by our plan participants.

It can be done, and we did it.  You can too, but the first step is accepting that some things are inevitable, and others are not.  Assigning inevitability to something that is not in fact inevitable is a form of laziness and blame shifting; and the time has come to stop that behavior, accept responsibility, do the painful work necessary to change things, and recognize that – no pain, no gain. 

Prescription Drug Pricing – On a Back Burner, but Still on the Stove

On December 18, 2019

By: Nick Bonds, Esq.

With Presidential impeachment eating up the above-the-fold coverage pretty much universally, it is important to remember that Congress has other pressing issues to attend to. While a number of Democratic candidates are worried their mandatory attendance at the Senate trial will eat up valuable campaign time on the ground in the early primary states, the rest of Congress is still trying to keep the country running.

For instance, while Democrats and Republicans have an “agreement in principle” on a stopgap appropriations deal to fund the government through the end of the fiscal year, the spending package still needs to be finalized an passed before December 20 to avoid another looming shutdown. Meanwhile, the House Ways and Means Committee is working to ratify the United States-Mexico-Canada Agreement (USMCA), the Trump Administration’s replacement for NAFTA. Both of these urgent matters of business appear to have bipartisan support, but Congress is certainly feeling the pressure as this week gets underway.

The major sticking point in the USMCA negotiations appears to be the debate around the trade deal’s prescription drug provisions. The pharmaceutical lobby has long been pushing for prescription drug protections in trade deals – remember the TPP – but this time around the White House’s primary objective appears to be lowering drug prices. A concession to strike protections for biologics from the trade agreement appears to have clinched Democratic support, who opposed the deal’s 10 years of regulatory data protection for biologics innovations. Democrats argued that the biologics protections would increase drug prices in the U.S. and delay development of cheaper biosimilar drugs.

While the USMCA appears on track for ratification, Speaker Pelosi’s prize fight of the moment is her drug pricing bill – which passed the House along party lines last Thursday. The bill, named for late Representative Elijah Cummings, aims to expand Medicare, reign in drug prices, and allow the HHS Secretary to negotiate prices of between 50 and 250 prescription drugs (including insulin). President Trump appears poised to veto the Elijah Cummings Lower Drug Costs Now Act, while the Senate is debating a more moderate proposal – the Prescription Drug Pricing Reduction Act (PDPRA). The PDPRA would add consumer protections to cap out-of-pocket (OOP) prescription drug spending, and take measures to redesign Medicare Part D and reign in drug prices.

Congress has a lot of irons in the fire this week. We shall see what they can hammer out.