By Philip Qualo, J.D.
In general, employers should review and revise their employee handbooks at least annually to account for changes in local, state, and federal laws and workplace safety requirements. As employers begin to focus on reviewing their employee handbooks in preparation for a… hopefully better… 2021, many are pondering how to update their handbooks to adequately respond to the challenges presented by the COVID-19 pandemic and continuing racial tensions sparked by the murder of George Floyd. Although employers have generally been quick to adopt and enforce policies addressing COVID-19-and diversity related issues, the rapidly changing guidance and dramatic shift in cultural perspectives has also necessitated swift revisions as best practices and requirements continue to change from day to day. In finalizing our own employee handbook for the upcoming year, we can share two important tips employers may want consider in reviewing and updating their employee handbooks in these challenging times.
Tip #1: Limit the Handbook to Static COVID-19 Language Where Possible
As updating an employee handbook multiple times within a fiscal year can be an administratively burdensome task, a best practice is to ensure all policies included or updated in the handbook are relevant, or static, for the duration of the applicable fiscal year. This has been simple in most years, however, in response to the COVID-19 pandemic, the federal government passed a series of comprehensive laws with rapidly approaching expiration dates aimed at protecting American workers by regulating group health plans and providing for new leave paid entitlements, such as the Families First Coronavirus Response Act (FFCRA). In addition to FFCRA, state and local guidance and laws continue to be updated at an unpredictable frequency that often necessitates a quick and temporary change to employment policies changes in order to comply work safety work requirements.
In order to avoid the challenge of updating and re-releasing multiple times throughout these unprecedented times, it may be helpful to limit specific references to COVID-19. We chose to use terms such as “Public Health Emergency” or “Pandemic” where possible. If COVID-19 has taught us anything, it is that life is unpredictable. Now that we have collectively experienced and continue to endure this pandemic, including language in an employee handbook referencing an employer’s responsibility to contain a public health emergency or pandemic could apply to other critical situations that pose a threat to future safety.
For policies with an approaching expiration date, or that are likely to change frequently based on changing guidance, it may be helpful to generally refer to them in the employee handbook and detail them in a referenced platform or notice that can be updated with ease. For example, we use an intranet platform to house our most up to date COVID-19 policies which allows for quick enhancements and immediate notification to employees. Although any platform accessible to all employees would be appropriate, an employer should take the additional step of distributing, announcing, or where applicable, requiring sign-off for each and every change to document compliance with notification requirements.
Tip #2: Closely Review and Update Anti-Harassment, Nondiscrimination and Sexual Harassment Policies
In the “Black Lives Matter” and “MeToo” era, organizations are taking the extra step of ensuring all policies and employment practices reflect their organizations commitment to diversity inclusion. As such, we encourage employers pay special attention to their anti-harassment, non-discrimination, and sexual harassment policies to ensure proper reporting, investigation, and anti-retaliation protocols are documented and in place. These policies send a message to employees about expected behavior. In the event of a claim against the organization, they also help to demonstrate that the organization takes its obligations seriously. Social media policies are similarly becoming a focus of concern for many employers in this day and age, when a single unwise employee post or public statement can subject the organization to a litany of negative publicity to their places. As demonstrated by the increasingly popular wave of “Karen” videos that have gone viral in recent months, employers may want to consider establishing or updating their policies to clearly reflect the handling of employees involved in large scale publicity due to inflammatory behavior or comments that could shed a negative light on the employer.
We hope these tips are helpful and provide some insight on how to enhance your employee handbook in challenging times.
By: Ron E. Peck, Esq.
COVID-19 and the current pandemic has caused even more attention to be paid to health care and health insurance. Yet, despite health care being a topic of discussion “in general,” during this Presidential election, I am surprised by how “little” airtime the specific issue of “Medicare-for-All” is receiving, compared to (for instance) the Democratic primaries. Yet, I wonder if that is due (in part) to a false belief that, by nominating Joe Biden (as compared to, for instance, Elizabeth Warren) the people of this nation have rejected the idea of Medicare-for-All, and can move on to the issue of saving or eliminating the ACA.
Yet, some eagle-eyed viewers will note Vice President Biden’s oft referenced “Medicare-for-All-Who-Want-It” and “Public Option” rhetoric. Make no mistake; if such a plan proceeds, it will amount to – eventually – a Medicare-for-All scenario.
Looking at individual States that have already proposed public options for its citizens, the backbone of such programs is a payment methodology, with that methodology centering on payment of a “percent of Medicare.” In other words, these public options will pay using a Reference Based Pricing (“RBP”) approach. Unlike private plans that dare such an approach, however, these public option plans will protect their participants from balance billing, using law and regulation. In other words, a private plan using an RBP methodology will see its members balance billed, and no legal protections exist to combat it. The public option plan, however, will pay the same (or lesser) percent of Medicare, and protect its members with the power of the law.
This will, obviously, result in the public option costing less than private options; (absent other cost drivers). If things do indeed go this way, more people will migrate from their private plans to the public option. Only the sickest members (fearful that coverage under the public option will be inadequate) will remain on the private plans, making those private plans too costly to sustain. This is called adverse selection, and it would – presumably – be the last straw that breaks the private industry’s back.
Yet, this long, drawn out road to an eventual “singer payer” scenario is not guaranteed. Only if our industry strives to beat the public option at its own game – specifically, “price” – will it lose. Yet, in so many other markets, private industry competes – and beats – government programs despite being more costly. In many scenarios, sending a parcel via the USPS is less costly than, for instance, via DHL, UPS or FedEx… yet… many choose to pay more for the private carrier’s service. Why? Likewise, taking public transit is often less expensive than driving (and parking) your own vehicle, catching a ride share, or other private means of transportation. Yet, we don’t all take the train. Public schools are readily available for most, at little to no cost, but some choose to pay tuition and send their children to private schools.
Note that I am not here to opine on these decisions or suggest why people make the choices they make. What I will say, however, is that – presumably – the people who pay more for the private option do so because, right or wrong, they perceive they are receiving more for their money. They believe they are receiving added quality, features, or benefits that make the added cost worthwhile. Further, the service provider has advertised the difference in quality – true or simply perceived – so much so that the consumer readily chooses the more costly, private option.
Members of the current health benefits industry are so accustomed to competing with each other over price. Yes, each entity offers things that differentiate their services from those offered by the competition, but the consensus is that these services are similar enough that price is the big difference maker. If they maintain this attitude, they will not be able to compete with a public option.
Enter “premium” services; enter “luxury.” In so many other industries, service providers exist – and thrive – despite prices that exceed those offered by the competition. Ask these entities whether their prices are higher than the competition, however, and they only consider vendors offering similar levels of luxury (for similar prices) as the “competition.”
It may be the case that, if and when private health benefits cannot compete with a public option on price, they will need to re-invent the industry, and instead view themselves as purveyors of “luxury” benefits. Offer services people want to buy.
Value is not synonymous with inexpensive. Value means getting more for your money. This industry’s future may, therefore, depend upon providing value – something or some things the public option does not offer – resulting in an admittedly higher price still representing value.
COVID-19 has impacted just about every aspect of our lives, and self-funded health plans have not been spared. Along with being mindful of employees' health during the pandemic, employers and HR managers must also be mindful of the state of their self-funded health plans.
More than half of the non-elderly population in the United States receives health care coverage through an employer-based plan. The majority of this group are covered by either fully or partially self-funded health care plans. As such, the health care plans of many Americans could be impacted by COVID-19.
Despite so many Americans having self-funded health plans, many are unfamiliar with the term. So what exactly are self-funded health plans? A self-funded health plan, also referred to as a self-insured plan, is a health an welfare plan through which the employer takes on the full financial risk associated with providing health care benefits to employees. Usually, self-insured employers establish a special trust fund to cover incurred claims.
Self-funded and fully insured health plans operate similarly. Money is collected and covers medical expenses for the insured population. Where self-funded plans differ from fully insured health care plans is that self-funded plans do not pass the responsibility for the financial risk onto a third party, which fully insured plans do; in a self-funded plan, claims are usually paid with a mixture of the plan sponsor's (i.e. the employer’s) assets and employee contributions.
Fully insured plans are what most people think of when they think of health insurance; it is a more traditional model, and self-funded healthcare has changed that model for the better.
How has COVID-19 impact on health care spread to the self-funded industry? What has been the financial impact of COVID-19 on the self-funded industry? Currently, benefits professionals are working hard to ensure stability for organizations during this chaotic time, and to figure out the answers to these difficult questions.
Employers with self-funded health plans are also working hard to ensure that their employees and employees' dependents can access COVID-19 testing, treatment, and medical assistance while the entire country copes with this pandemic. A self-funded health plan insures many people generally over a long period of time, which is why protecting the plan's financial viability and assessing the possible financial effects of COVID-19 is essential for employers and HR managers.
Projecting the possible financial impact of COVID-19 on a self-funded health plan is no simple task, as numerous variables should factor into projections, such as the number of infected plan members, the duration of shelter-in-place orders, employee furloughs, and many more factors. Despite these challenges, employers are still working diligently to address challenges related to COVID-19 and health care, such as adjusting eligibility standards, expanding benefits, and waiving cost-sharing for treatment related to COVID-19 performed by in-network providers.
Many employers are also relaxing open enrollment restrictions and offering more flexibility to individuals who want to join a company's benefits plan outside the traditional open enrollment period. Due to job losses, many individuals and their dependents are finding themselves without coverage, so many are scrambling to find other insurance coverage wherever possible.
Many employers are unsure about how COVID-19 will impact group health care plans. While expenses for the treatment and testing of COVID-19 are rising, utilization is down for elective and preventive services. Even employee benefits experts are still unsure of how the pandemic will continue to impact health plans, with some experts predicting an increase in employer health care costs and others predicting a decrease.
Employers who have self-funded group health care plans need to be particularly mindful of this wide range in predictions and take steps to ensure the financial viability and stability of health plans during the COVID-19 crisis. Since every plan is different, employers and HR managers will need to consider their own employee populations when trying to predict future costs and utilization, as well as their own business needs.
If your company has adjusted coverages to account for services related to COVID-19, you need to amend plan documents to reflect these adjustments. Coverage requirements have been expanded for all health plans as a result of the Coronavirus Aid, Relief and Economic Security Act and the Families First Coronavirus Response Act. Many major insurance carriers in the U.S. have chosen to go beyond requirements set by the new legislation, such as by waiving cost-sharing for COVID-19 related hospitalizations.
Though there may be a drop in health care costs in the short-term, most experts agree that this will not be the case forever. After the pandemic, there could even be an unusually sharp increase in health care costs as a result of individuals delaying care during the pandemic, and resuming care immediately afterwards.
Shelter-in-place orders could also lead to a spike in behavioral health claims due to issues with anxiety, stress, and depression. Many Americans are dealing with the loss of loved ones and loss of employment, along with loneliness as a result of unprecedented isolation. Changes in supply and demand could also contribute to an increase in health care costs. As such, you should continue accruing funds in anticipation of a need for these funds in the future.
Consider whether you want to add telemedicine to your self-funded health plan. Though historically telemedicine has seen a low level of usage, the appeal of telehealth services has spiked during the COVID-19 pandemic. Through telemedicine, which often now includes video conferences, individuals can access medical services without leaving their homes.
Even post-pandemic, telemedicine is likely to remain a popular option for Americans who want to receive medical services from the convenience of their own homes.
Now is the time to reevaluate how the characteristics of your company's insured population could negatively affect a self-funded health plan. Are the employees frontline restaurant workers, retail workers, health care professionals, or other employees who frequently come into contact with the public and may be at a higher risk of becoming infected with COVID-19? Factors like that can greatly alter a self-funded plan’s viability.
Has your company reduced staff? Furloughing or laying off employees could increase the volatility of claims. Volatility increases as the number of insured employees decreases. These changes in risk level could negatively affect your health plan and should be addressed.
The Phia Group, LLC has been working to ensure that health benefits remain affordable for employers and employees. We tailor our various cost-containment services to our clients' specific needs. If you are ready to regain control of your operations, including switching from “traditional” insurance to a self-funded health plan, we can help you minimize costs while maximizing benefits.
We provide consulting services to address a wide range of compliance concerns, business disputes, and claim-specific dilemmas. Learn more about our independent consultation and self-funded health plan evaluation or contact us today.
By: Nick Bonds, Esq.
I doubt I am alone in feeling that 2020 has already crammed in roughly a decade’s worth of health crises, and we still have months to go. From murder hornets to the ever-present threat of the coronavirus, from wildfires turning the West Coast skies orange to so many hurricanes we are running out of names; our collective physical, mental, and emotional health has been through the ringer this year. Not to mention the tumbling dominoes of economic impacts wrought by all of the above, which by itself can have a substantial impact on our health.
The cost of prescription drugs, already high even before 2020 built up a head of steam, continues to be a source of financial pain for American households. Nearly 30% of Americans have reported not taking their prescription medicine as directed due to its cost. This is one of the most glaring examples of individuals’ medical decisions being driven not by medical judgment, but by financial circumstance.
At the beginning of the year, prescription drug prices ranked top among the “pocketbook” issues most primary voters were focused on. Though the debate around Medicare for all became a clear fault line among the Democratic presidential nominee hopefuls, virtually all the candidates threw their support behind a plan to give Medicare authority to negotiate drug prices with manufacturers. They also tended to favor plans to facilitate importation of cheaper medications from overseas and reigning in drug makers’ penchant for manipulating the patent system to artificially delay development and marketing of low-cost generic drugs.
Since clinching the Democratic nomination, Vice President Biden’s stance on drug pricing reform has come into sharper focus. The Biden-Sanders “unity task force” published a detailed list of policy recommendations, including a plan for “bringing down drug prices and taking on the pharmaceutical industry.” The primary prongs of which include empowering Medicare to negotiate drug prices, pushing to keep drug price increases in line with inflation, capping prescription costs for seniors, and cracking down on anti-competitive practices among drug manufacturers.
Not to be outdone, President Trump recently announced a “hail Mary” effort on drug prices, signing his “Executive Order on Lowering Drug Prices by Putting America First” on September 13. Ostensibly, this order is designed to bring down domestic prices for prescription drugs by tying what Medicare pays for prescription drugs to the “most-favored-nation price” of those same drugs abroad. Specifically, capping Medicare’s rate to the lowest price for a pharmaceutical product that drug maker sells in a member country of the Organization for Economic Cooperation and Development (OECD).
It seems unlikely that this plan could be effectively implemented before the upcoming election, but it does show that the President still sees prescription drug prices as a viable campaign issue, even after campaigning on it in 2016 and hitting mostly dead ends in his efforts to address the issue in his first term. Recent polling shows that drug pricing remains one of the few healthcare issues where the President outstripped his Democratic challenger, and the President’s most-favored-nations policy appears to resonate among his base.
Whomever lands behind the Resolute desk in 2021, we can be sure that drug pricing reform will be high on their agenda. In the meantime, everyone stay safe, stay healthy, and be ready to vote on November 3.
By: Andrew Silverio, Esq.
Recently, the Department of Health and Human Services released updated guidance outlining some permissible uses of Protected Health Information (PHI) under HIPAA in regard to recovered COVID-19 patients (available at www.hhs.gov/sites/default/files/guidance-on-hipaa-and-contacting-former-covid-19-patients-about-plasma-donation.pdf). This guidance, which applies to health care providers, health plans, and their business associates, is an expansion of previous guidance which applied only to health care providers.
In essence, the guidance provides that these entities can use PHI to identify and contact individuals who have recovered from COVID-19 in order to inform them about how to donate their plasma, which will contain antibodies to SARS-CoV-2 which are useful in potentially treating COVID-19 patients. This activity has been classified as falling within the category of “health care operations,” and thus PHI can be used for this purpose without an individual’s authorization.
HHS outlines that these activities constitute “health care operations” in that “facilitating the supply of donated plasma would be expected to improve the covered health care provider’s or health plan’s ability to conduct case management for patients or beneficiaries that have or may become infected with COVID-19.” In regard to a health plan (as opposed to a particular provider who may use collected plasma itself to treat other patients), this justification’s connection to the “health care operations” of the specific covered entity seems tenuous. It is difficult to see how, for a health plan as opposed to a provider, an interest in increasing the availability of antibody-containing plasma generally actually furthers the “health care operations” goals of the particular plan. However, the public interest rationale here is crystal clear.
The guidance does come with an important caveat – the use of PHI for this purpose is only permitted to the extent that the outreach does not constitute marketing, which HHS outlines as “a communication about a product or service that encourages the recipient of the communication to purchase or use the product or service.” This should not be an issue for plans, but providers likely have to walk a fine line when they provide the services in question.
By: Kevin Brady, Esq.
In April of this year, following the passage of the Families First Coronavirus Response Act (FFCRA), the State of New York sued the Department of Labor (DOL), claiming that several provisions of the FFCRA exceeded the DOL’s authority under the statute.
On August 3rd, the United States District Court of the Southern District of New York issued an opinion, siding with the State of New York and invalidating several provisions of the FFCRA. Specifically, the court invalidated the following regulations:
Under the FFCRA regulations, individuals are not eligible for Emergency Family Medical Leave or Emergency Paid Leave if their employer does not actually have work for the individual to do. The court concluded that the DOL failed to properly explain this additional requirement, and invalidated the regulation.
Under the FFCRA regulations, employees are required to have approval from their employer in order to take leave under the FFCRA intermittently. The court opined that this was not permissible and vacated the regulation.
Employees are required to provide documentation regarding the reason for leave and the requested duration of leave, prior to taking leave under the FFCRA. The court reasoned that this regulation is inconsistent with the statute and struck the regulation down.
Under the regulations, employers are permitted to exclude health care providers from the leave entitlements granted under the FFCRA. The DOL’s definition of the term “health care provider” is broad and can be interpreted to include individuals who are only tangentially related to actually providing health care. The court reasoned that the exclusion of leave entitlement for health care providers is intended to apply only to those individuals who are capable of providing healthcare services.
While the court’s ruling may ultimately have a significant impact nationwide, it appears that (at least for the time being) the application of the ruling will be confined to employers in the state of New York, as the court did not specifically address whether the ruling would apply nationally. At this point, the ball is in the DOL’s court. If the DOL’s complies with the ruling, we are likely to see significant changes to the FFCRA regulations and guidance. These changes are important and may drastically increase the rights of employees looking to take leave. In the alternative, the DOL may appeal the ruling, in which case the impact may be in limbo for some time. In the meantime, employers should review their current policies and their administration of FFCRA, as well as keep their eye out for the DOL’s next steps to ensure compliance with the FFCRA leave provisions.
By: Jon Jablon, Esq.
We hear a lot of chatter in the self-funded industry about “plan mirroring.” The idea is that a stop-loss carrier will adopt the same language as what is in the SPD, in effect “mirroring” the language, and that gets rid of what we at Phia like to call “hard gaps,” where the plan and carrier are working off different language, leading to situations where the plan must pay claims but the carrier may deny them. The point of mirroring the SPD’s language is so the plan never needs to worry about those kinds of gaps.
But there are other kinds of gaps, too. Gaps tend to arise when different entities are interpreting the same language, as well (we call those “soft gaps”) – and it is crucial to keep in mind that a policy that mirrors the plan’s terms is not the same as the carrier adopting the plan’s interpretation of those terms.
Let’s talk about an example. We have mentioned this particular situation numerous times; it’s not because we’re too lazy to think of new examples, but because it keeps on happening! The SPD excludes any benefits paid for services performed by a family member. A plan member has a great uncle who is a surgeon, and elects to have him perform the surgery partially because of the great price he has offered, and partially because he knows and trusts him. As far as the plan member is concerned, this is a win-win. The claim is sent to the health plan, and the Plan Administrator uses its discretion to determine that “family member” does not include someone as attenuated as a great uncle (since the Plan Administrator interprets that term “family member” to refer to the immediate family), so the plan pays the claim, and expects that the carrier will agree, since the policy “mirrors” the plan.
Well, you can guess what happens next.
The claim goes to the stop-loss carrier, and the carrier denies the claim because its interpretation of “family member” is broader than the Plan Administrator’s interpretation, indeed including great uncle within the class of “family members.” The carrier denies the claim. The plan is both confused and angry, and thus begins a protracted fight between the plan/TPA/broker and the stop-loss carrier, caused by the carrier’s overly-salesy and idealistic explanation to the plan, TPA, and broker what mirroring actually entails.
In short, plan mirroring entails using the same language, but it does not necessarily entail thinking the same things. The carrier adopted the same exclusion that the plan uses, but the carrier cannot control how the plan interprets that exclusion, nor can the plan be underwritten based on what interpretations of the plan language the Plan Administrator could conceivably make in the future. The carrier, after all, is not a psychic – and because of that, it is the carrier’s responsibility to make absolutely sure the health plan understands what “mirroring” really entails, and what it doesn’t entail. The concept of plan mirroring in a stop-loss policy is not quite as straightforward and magical as it seems. It is certainly useful to minimize the gaps in the language used, but it’s not a panacea.
This applies just as clearly, if not more so, in the level-funded arena, where level-funded plans expect to have their expenses capped based on a guarantee that the carrier will cover all their claims above the aggregate deductible. When there is a difference in interpretation that leads to a denial, the plan is left holding the bill, and often has no idea why – especially when level-funded plans are marketed essentially as programs that mimic fully-insured policies. The important difference is that in a fully-insured policy, the plan sponsor pays its monthly premium and there is no possibility of being on the hook for claims – whereas in a level-funded program, the plan sponsor can lose its expected reimbursement if the stop-loss carrier doesn’t agree with the Plan Administrator’s discretionary decision.
Plan mirroring provisions are sometimes marketed to make a stop-loss policy airtight for the plan, but don’t be fooled by the hype: there is always still the potential for a gap somewhere along the way. Make sure you read and understand your contracts and policies before you sign, and if possible, have them reviewed by an expert!
As the worldwide coronavirus crisis continues to grind on, impacting virtually every aspect of our lives, we have necessarily become familiar with the many pieces of legislation passed by Congress in its attempts to soften the blow to our country’s economic and healthcare systems. This has engendered a whole new can of alphabet soup: CARES, FFCRA, EFMLEA, EPSLA, PPP. Enacted late spring/early summer, these legislations have become staple pieces of the daily conversation in the arena of health benefits for employees. They’ve nearly begun to blend in with the furniture.
But as we are all keenly aware – these pieces of legislation were not designed to be permanent. Many of these temporary rules are set to expire by the end of 2020, with a number of the key components like the payroll protection program, already lapsing, many of us are looking back to Capitol Hill and wondering if and when more economic aid will be coming.
Democrats in the House of Representatives put together a follow-up aid package in May. Clocking in at roughly $3 trillion ($8 billion more, give or take, than its predecessor), the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act would echo much of the relief provided in the CARES Act. Direct stimulus checks to individuals, enhanced unemployment benefits, and in some ways would go even further by expanding the PPP and employee tax credits, expanding eviction protections, providing hazard pay to for essential workers, and allocating billions to assist schools and universities reopen safely.
Though the HEROES Act passed quickly in the House, the Republican-controlled Senate was reluctant to take up the legislation. Balking at the $3 trillion price tag, and perhaps holding out hope that the coronavirus would indeed recede in the warmer summer months and render further economic aid unnecessary, the Senate has finally put together its own approach to a new round of economic stimulus: the Health, Economic Assistance, Liability Protection and Schools (HEALS) Act. Unveiled on July 27, the HEALS Act clocks in at a (relatively) svelte $1 trillion – putting a fairly clear number on just how far apart the two sides are in reaching a compromise.
The HEALS Act includes many of the provisions that proved so popular in the CARES Act: direct “economic impact” payments to individuals with money for dependents as well, enhanced (though significantly reduced) unemployment benefits, and expansions to the PPP and employee tax credit. The HEALS Act dodges some of the assistance provided under the HEROES Act: it is silent regarding eviction protections, provides less support for higher education institutions, and makes its aid to K-12 schools dependent upon their reopening. To Senate Republicans’ credit, the HEALS Act does address a number of things not touched on by either the FFCRA or the HEROES Acts. Namely, the HEALS Act provides $16 billion for coronavirus testing, introduces a potential “return to work” bonus for unemployed workers who secure new employment, and it contemplates a 5-year liability shield.
This last component, encapsulated within the SAFE TO WORK Act (a component of the HEALS Act), is likely of the greatest interest to employers. The bill is designed to shield businesses, schools, nonprofits, government agencies, and other organizations from coronavirus-related lawsuits, so long as they take “reasonable” efforts to follow public health guidelines and manage to avoid grossly negligent or intentional acts of misconduct.
Congress has yet to reach a deal on the next aid package, but there are many components on the table that could do a lot to help Americans through the next leg of this crisis, employees and employers alike. We’ll keep a weather eye on the legislation as it develops.
By: Bryan M. Dunton
Earlier this year, the coronavirus swept through the country and became such a major concern that employers shut down their physical offices and moved their operations remote. Not long after, states began mandating shutdowns and shelter-in-place orders. The overarching theme focused on how to keep everyone safe.
Now, months later, states and employers have begun to relax those restrictions by reopening, albeit in phases. With that, employees have slowly been allowed to return to work in traditional office settings. Given that employers have an interest in the wellbeing of their employees, and would likely face significant business consequences in the event of an outbreak at their place of business, some employers have implemented mandatory return-to-work testing for those employees who come back to the physical office space. On the national level, we have seen this approach implemented in major sports leagues such as the NFL, NBA, and MLB. The idea is essentially to test everyone who enters the building, regardless of whether they are displaying symptoms or have had known exposure.
The expansion and implementation of mandatory return-to-work testing has led to an interesting issue for plan administrators; who bears the cost of covering these tests?
While the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) require health plans to cover the cost of testing for COVID-19, with no cost-share to the participants, during this declared emergency, many plans are asking if they must pay the cost of the employer-mandated return-to-work testing. Seeing as testing costs vary wildly from $20-$850 (or more) per test, and an overall estimated nationwide cost of $6-25 billion annually, we can certainly see why health plans are concerned.
Section 6001 of the FFCRA, as amended by section 3201 of the CARES Act stipulates that in vitro diagnostic testing for COVID-19 must be covered, with no cost-share to participants. Further, this mandate applies to most group health plans, including self-funded plans. The Centers for Disease Control (CDC) recommends testing for the following five populations of people:
Most of these categories deal with either asymptomatic individual or someone who may have been exposed to the virus. The Department of Labor (DOL) issued additional guidance in late June 2020 to clarify that the FFCRA and CARES Act mandate to cover the cost of COVID-19 testing only applies when the testing is medically appropriate. It further clarifies that testing “not primarily intended for individualized diagnoses or treatment of COVID-19” is not within the scope of section 6001.
So here we are. What should a plan do if an employer mandates return-to-work testing for its employees?
You might be surprised by this, but the answer is: it depends. Return-to-work testing is not typically ordered by an attending physician who deems the test medically appropriate for the patient. Rather, it is ordered by the employer, most likely for purpose of public health surveillance to help diagnose individuals in the workplace. This approach can ensure prompt and proper treatment to prevent creating a hot spot and spreading the virus. Some group health plans have opted to cover the return-to-work testing as a precautionary measure to help mitigate the costs of having to treat a larger pool of participants that may become infected with COVID-19.
Plans and employers should also consider any respective state mandates and obligations which may create additional circumstances where testing would be covered. As a final consideration, some mandates could also create a situation where an employer must cover certain testing even if it is not something where the cost can be passed on to the health plan.
Most self-funded group health plans are following the spirit of the law, and we recognize this is a difficult area to navigate as guidelines and mandates are evolving frequently while we all learn more about the virus. Here at the Phia Group, we welcome the opportunity to consult and help self-funded plans contain their costs and ensure the safety and well-being of their participants.
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:
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.