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IP Law vs. Drug Prices

By: Nick Bonds, Esq.

Pharmaceutical companies and rapidly rising drug prices have been eating up a lot of the oxygen in the conversation around healthcare costs. From pharmaceutical executives and PBMs testifying before Congress to President Trump’s May 9 remarks from the Roosevelt Room calling for Democrats and Republicans to unite in a legislative effort to end surprise medical bills.

But Congress and the White House are not alone in their endeavors to tamp down prescription drug costs, HHS Secretary Alex Azar and the CMS recently promulgated a new rule requiring pharmaceutical manufacturers to include the list prices of their drugs in their television ads. This push for transparency is the latest tactic in a multi-pronged strategy deployed by the Trump Administration to lower drug prices in the United States, including moves to change the system of rebates paid to PBMs and to restructure Medicare Part B.  Outraged drug manufacturers cried foul, arguing that patients almost never pay their list prices and disclosing them in their commercials would lead to customer confusion.

Perhaps one of the most interesting components of this CMS rule is its enforcement mechanism. Instead of the CMS itself going after drug manufacturers who fail to comply, the rule allows other manufacturers to pursue damages and injunctions against them for claims of false or misleading advertising under Section 43(a) of the Lanham Act. Also known as the Trademark Act of 1946, this federal law relies on a “likelihood of confusion” standard for adjudicating trademark disputes. The Lanham Act and its remedies have been refined over the last 70 years to combat the very customer confusion pharmaceutical companies insist this new CMS rule will cause.

Whether you agree with drug manufacturers or the CMS, it’s worth noting that this is not the only situation where the government has turned to intellectual property law as a versatile tool to lower drug costs. A bi-partisan group of Senators, including Republicans Chuck Grassley and John Cornyn along with Democratic Presidential Candidate Amy Klobuchar, are working together on a package of legislation targeting drug pricing issues which they hope to have ready by summer. Cornyn’s bill takes a machete to the “patent thickets” crafted by drug manufacturers to artificially extend the monopolies on high-value “blockbuster” drugs granted them by their patents. These patent thickets make it all but impossible for cheaper generic drugs to reach the market, keeping the price of name brand drugs higher for longer. Legislators are coming to see these patent thickets as an abuse of our patent system, a system intended to spur and reward innovation.

It may be too early to say how effective intellectual property law will be in lawmakers’ fight against high drug prices, but it certainly looks like a trend to keep our eyes on. At the very least, it shows that Democrats and Republicans are willing to get creative, using every weapon in their arsenal in their fights with Big Pharma. And they’re willing to reach across the aisle to do it.


CMS Finalizes Drug Price Transparency Rule

By: Philip Qualo, J.D.

The Centers for Medicaid and Medicare Services (CMS) has finalized yet another rule demonstrating the agency’s commitment for greater transparency in the healthcare industry. On May 8, 2019, CMS finalized the “Regulation to Require Drug Pricing Transparency”, which will require prescription drug manufacturers to provide the Wholesale Acquisition Cost for their products in direct-to-consumer television advertisements. Under the final rule, drug makers will have to post the list price of a typical course of treatment for acute medications like antibiotics or for a 30-day supply of medications for chronic conditions. These consumer ads will be required to have a readable, text statement at the end to comply with the mandate.

The rule also requires the Health and Human Services (HHS) secretary to maintain a public list of drugs that violate the rule. Drugs with list prices under $35 per month will be exempt from the requirement.

CMS estimates that approximately 25 pharmaceutical companies will be affected by this rule, as they run an estimated 300 distinct pharmaceutical ads on television each quarter. Complying with the rule is expected to cost drug makers $5.2 million in its first year and $2.4 million in subsequent years.

The regulation, which was initially proposed in October 2018, has faced major opposition from drug manufacturers. On December 17, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) submitted comments in response to the then-proposed CMS rule arguing that disclosure of drug prices in television advertisements. PhRMA argued that the list price alone does not convey to patients meaningful information about how much they will actually pay for a medicine. Without providing additional context, such as a patient’s average, estimated, or typical out-of-pocket costs, disclosure of the list price in a direct-to-consumer advertisement could give patients the false impression that they are required to pay the full list price, rather than the copay or coinsurance that the patient is actually responsible for. They also argued that the new rule is unconstitutional on First Amendment grounds. Specifically, they believe that a government mandate on drug makers to disclose only the full list prices directly in their television ads would violate the First Amendment as "compelled speech."

One of the primary goals of this new regulation is to boost competition among drug manufacturers and provide them with incentives to lower their list prices. Greater drug price transparency will also provide new cost containment opportunities for employers who sponsor self-funded health plans and their respective Pharmacy Benefit Managers. The final rule will go into effect 60 days after it is published in the Federal Register.


Big Pharma Executives Testify Before Congress (Again)

By: Brady Bizarro, Esq.

On February 26th, and again in early April, top executives from major pharmaceutical companies and PBMs testified before the Senate Finance Committee. The companies represented included Pfizer, Merck, John and Johnson, CVS, Express Scrips, OptumRx, and others. Led by Chairman Grassley (R-IA) and Ranking Member Wyden (D-OR), the Committee sought to address the problems of continued price increases, free loading, and price transparency. They also portrayed PBMs portrayed as the shadowy middlemen who may be making these problems worse through their increased use of rebates.

The hearings proceeded mostly as Q&A sessions. When asked whether the CEOs consider negative public opinion when setting list prices, all said yes, meaning price isn’t just a function of administrative or research and development costs. Their answer Implies that if no one got upset, prices would go up more. One senator pointed out that if Humira (a drug used to treat arthritis and Crohn’s disease) were its own company, the drug would be among the Fortune 500 companies all by itself, larger than General Mills, Halliburton or Xerox.

The drug manufacturers claimed to support the Trump administration’s proposed rebate reform rule. That rule as proposed applies to Medicare Part D rebates only (which are still very large). Senators are also developing bills aimed at reforming the rebate system. Two CEOs told the Committee that they would lower their list prices if the rebate ban was extended to the private market.

Between these two hearings (for the manufacturers and then for the PBMs), the drugmakers and PBMs essentially blamed each other for high prescription drug prices. Popular ideas discussed were potentially tying U.S. drug prices to international prices. There was also serious support for value-based purchasing arrangements (sometimes called risk-sharing agreements) that tie drug payments to patient outcomes. That would mean that if a particular drug fails to produced a particular clinical or financial outcome, a price reduction would be triggered or a refund. Senators noted that these arrangements are complicated because of anti-kickback laws and proposed rebate reform rules, though. In the end, all parties agreed that the status quo isn’t working for patients, payers, or society.


The Final AHP Rules Take a Hard Hit (Part 2)

By: Erin M. Hussey, Esq.

In our previous blog post, The Final AHP Rules Take a Hard Hit, we discussed the court decision that vacated (1) the bona fide provisions (including the provisions about a substantial business purpose, control, and the expanded commonality of interest requirements), and (2) the working owner provisions from the Final Rule on Association Health Plans (“AHPs”). The court remanded their decision to the Department of Labor (“DOL”) to determine how this ruling would affect the rest of the Final Rule given the severability clause. The DOL has provided an initial response via Question and Answers (“Q&As”). Those DOL Q&As detail the following:

“The  Department disagrees with the District Court’s ruling and is considering all available options in consultation  with  the  Department  of  Justice  including  the  possibility  of  appealing  the  District  Court’s decision and the possibility of requesting that the District Court stay its decision pending an appeal.  At this time, we have not reached a decision on how to proceed.”

As such, without any action from the DOL, it appears the above-noted bona-fide and working owner provisions remain inoperative. However, the House and Senate have taken matters into their own hands. On April 11th, Sen. Mike Enzi (R-WY) and Lamar Alexander (R-TN) introduced a bill in order to protect the AHP Final Rule (S. 1170). The text of the bill is not available yet but will be made available here: https://www.govtrack.us/congress/bills/116/s1170. Sen. Enzi noted the following in his statement on the legislation:

“I rise to introduce the Association Health Plans Act of 2019 . . . My bill will simply codify the Labor Department's final rule to provide certainty for current enrollees and to ensure the pathway remains available for new association health plans to form.”

The following day, on April 12th, U.S. Representative Tim Walberg (MI-07), joined by Rep. Michael C. Burgess, M.D. (TX-26) and Rep. Virginia Foxx (NC-05), introduced the Association Health Plans Act of 2019 (H.R. 2294). The text of that bill is not available yet but will be made available here:  https://www.congress.gov/bill/116th-congress/house-bill/2294.

While it is unlikely these bills will get bipartisan support, this legislation will be something to keep in mind while we await the ultimate outcome of the AHP Final Rule.


Beware The “Lesser Of”

By: Jon Jablon, Esq.

We’ve seen it a thousand times: a health plan document provides that the plan will pay the lesser of certain factors, including billed charges, the applicable network rate, and the plan’s U&C rate (however it may be calculated). The old way of thinking in the industry is that this language gave the Plan Administrator a lot of leeway in determining appropriate payments – but it’s “the old way of thinking” for a reason.

Consider this scenario, with the language mentioned above: an out-of-network provider bills $20,000 for services, and the plan’s U&C rate is $13,000. The plan can simply pay the “lesser of” billed charges or U&C – netting payment of $13,000. There’s no contract, and no requirement to pay more than U&C. Easy stuff; very straightforward.

Now, consider this scenario: an in-network provider bills $20,000 for services; the plan’s U&C rate is $13,000; the network rate is $18,000. The plan’s language obligates the Plan Administrator to pay the “lesser of” those figures which is the U&C rate – but the network rate contractually obligates the payor to pay $18,000! Payment of the “lesser of” – that is, strict compliance with the plan document – results in violating the network contract, which can result in a contentious situation at best – but at worst, a lawsuit by the provider and possibly loss of network access (sometimes even on the TPA level, depending on the situation).

That’s what some might call a “double-edged sword,” where the Plan Administrator must make the choice either to violate the network contract and abide by the strict terms of the Plan Document (thus fulfilling its fiduciary duty), or to violate the Plan Document and abide by the terms of the network contract (thus fulfilling its contractual payment obligations). It’s a tough choice – but one that a Plan Administrator can avoid having to make in the first place, with the right plan language!

When the plan document obligates the Plan Administrator to pay less than the amount required by a separate contract, the Plan Administrator’s contractual and fiduciary obligations are at odds with one another. But it’s avoidable!

My advice? Make sure the Plan Document provides that the amount the Plan Administrator will pay is the contracted rate, if there is one. (And, hey – if that network rate doesn’t seem like it’s adding enough value, ditch the network. There are viable alternatives!)

As with so many stories in the self-funding universe, the moral of this one is to make sure your plan language lines up with your contracts. If you want to make the plan language tighter, or you think it can be better, or even if you just want to test its tensile strength to see what’s what, contact The Phia Group’s consulting division, at PGCReferral@phiagroup.com.


Suicidality On the Rise Amongst Missouri’s Child Medicaid Population

By: Andrew Silverio, Esq.

Last month, the Missouri Hospital Association released a study which highlighted some alarming numbers relating to the rates of suicidal thoughts and actions among children covered by Missouri’s Medicaid program (available at https://www.mhanet.com/mhaimages/policy_briefs/PolicyBrief_SuicidalityChildren_0319.pdf).  Among the studies key findings was a notable increase it suicidality amongst Medicare-covered children, along with a decrease in average length of inpatient admissions after the state made a switch from traditional fee-for-service Medicaid to a managed care structure in May 2017. The study looked at 18 months of data prior to the change, and 19 after.

Specifically, the study notes that after the transition from a fee-for-service model to managed care, the average length of stay at psychiatric hospitals for children and adolescents fell from 12.5 days to 7.3, and the 60 day suicidality rate among that same population nearly doubled (30, 60, and 90 day suicidality rates all saw jumps of between 81.7% and 93.2%).  The disparities in services authorized are troubling as well – the percentage of admissions which were denied jumped 7.9 times from 3.3% to 26.4%.

Of course, there’s disagreement on the extent to which these numbers can be attributed to the switch in payment model – the Missouri Health Plan Association, which represents the three managed care Medicaid plans in Missouri, has slammed the report according to Kaiser Health News.  The disparities make sense to Joan Alker, director of the Georgetown University Center for Children and Families, however, who says “Managed care is an effort to save money and that is done by getting rid of unnecessary care or coordinating care better, but a lot of managed care organizations cut corners.”

Whether the managed care structure is being administered poorly, unsuited for this patient population as a whole, or completely irrelevant to these alarming findings, the impact on an incredibly vulnerable patient population is too significant to ignore, and the state should consider getting to the bottom of it to be a top priority.


New DOL Opinion Letter: Employers May Not Delay FMLA Leave Designations

By: Philip Qualo, J.D.

On March 14, 2019, the U.S. Department of Labor (“DOL”) released an Opinion Letter advising that an employer may not delay designating a leave of absence, paid or unpaid, as a leave under the Family and Medical Leave Act ("FMLA”) (if the leave qualifies as an FMLA leave). In addition, this Opinion Letter details that an employer may not permit employees to extend FMLA leave beyond the 12-weeks (or 26 weeks for military caregiver leave) granted under the FMLA.

Under the FMLA, employees of covered employers are entitled to up to 12 weeks of unpaid leave with job protection benefits in the event of certain family and medical situations. The FMLA also permits eligible employees to take up to 26 weeks of leave to care for a covered service member with a serious illness or injury. It is the employer’s responsibility under the FMLA to designate leave as qualifying leave for FMLA purposes.

Prior to the release of the Opinion, many employers permitted employees to delay FMLA designation in specific situations. For example, in order to allow for a full 12-week FMLA leave for a new mother and her newborn to bond, employers would usually allow expectant mothers who needed to commence leave prior to the delivery date the ability to use accrued Personal Time Off (“PTO”) or sick pay until the delivery date. For example, the FMLA designation would begin onthe date of birth instead of the date the mother went on leave prior to delivery.  Many employers were under the impression FMLA designation was a matter of mutual agreement between an employer and employee as opposed to a matter of law.

The Opinion Letter specifically provides that employers are prohibited from delaying the designation of FMLA-qualifying leave as FMLA leave. The Opinion Letter also notes that neither the employee nor employer can decline FMLA protection for FMLA qualifying leave once the employee has communicated a need to take leave for an FMLA-qualifying reason. Thus, once the employer determines that the leave request is for a FMLA-qualifying leave, the leave is FMLA-protected and is counted towards the employee’s 12-week (or 26-week) FMLA leave entitlement. The Opinion Letter advises that once the employer determines the leave is FMLA-qualifying leave, the employer must provide notice of the determination to the employee within five business days. The employer does not have the option to delay this determination once the employer has the information to make such a determination.

The Opinion letter further noted that an employer is prohibited from designating more than 12 weeks of leave (26 weeks in the case of military caregiver leave) as FMLA leave. The DOL notes that an employer can still honor any family and medical leave program it offers outside of the FMLA requirements, even if the offered leave program provides greater leave benefits than that offered under the FMLA. However, any employer-provided leave is separate from the FMLA leave and cannot expand an employee’s FMLA-designated leave beyond 12 (or 26) weeks. If the employer wishes to be generous and extend leave for an employee after FMLA leave exhausts, it should specify in its plan document and employee handbook that any employer-provided leave will not run concurrently with FMLA and therefore once FMLA exhausts, an employer-provided leave can be offered thereafter. An employer should be careful when it comes to continuation of coverage during an employer-provided leave, and if coverage is offered during such a leave, it should be outlined in the plan document.

Employers subject to the FMLA should review their practices, policies, and employee communications regarding FMLA-leave designation and to ensure they are consistent with the guidance provided by the DOL in the Opinion Letter. Specifically, employers should be providing notice of determination within five days of making a FMLA-leave designation, and should not designate more than 12 (or 26) weeks as FMLA-qualifying leave, even if the employee requests to have more than 12 (or 26) weeks designated as FMLA leave or to have an FMLA-qualifying leave treated as non-FMLA leave. Compliance with FMLA and the Opinion Letter is especially important employers who sponsor self-funded health plans as incorrectly designating or extending FMLA for employees could run afoul of the plan document’s continuation of coverage provisions and create issues with stop-loss reimbursement.


Be Transparent – Tell Me What You Really Want!

By: Ron E. Peck, Esq.

 

At the risk of beating a dead horse, I want to address transparency – at least one more time.  I’ve noticed of late calls from both our industry, and from Capitol Hill, for transparency.  Of course, I don’t think these people really know for what they’re hollering.  Let’s expand our focus from healthcare, and wag the finger at people who failed those noble spirits who crusaded for transparency already – and suffered the consequences.

 

Exhibit A: JC Penny’s.  Recall in 2011, when JC Penny’s made what most experts have deemed a catastrophic, strategic mistake, regarding its pricing strategy.  What horrific miscalculation did the retail giant make?  It replaced “sales” (a/k/a “discount”) and “coupons” with everyday low prices.  JC Penny’s told consumers: “Hey!  We aren’t going to bamboozle you by inflating prices, and then throwing arbitrary discounts at you.  Instead, we’ll offer you fair prices without any games.”  This was one example where transparency failed miserably.

 

Exhibit B: Payless.  If you want to buy some sneakers from Payless, you’d better do it soon.  Payless ShoeSource, Inc. is closing for good.  I’ve never shopped at Payless myself, but they hold a special place in my heart by virtue of something they did in November of 2018.  Yes indeed; it was only a few months ago that they supported my theory that transparency without quality awareness is not only useless, but potentially dangerous.  Payless opened a fake luxury store, dubbed “Palessi.”  At this “boutique,” they displayed shoes (for which they normally charge $20 at their Payless stores), with price tags that ranged up to $600+ (a 1,800% markup).  Shoppers saw the higher prices and assumed that – if it costs more, it must be better. 

 

I could keep sharing stories of “transparency” gone bad, such as my everyday example (people pay more for brand name OTC medication instead of the identical store brand drug), but these two examples above are particularly heinous because they not only both feature businesses that proved people don’t actually care about transparency – but both businesses are now failing!  Or should I say, we’ve failed them?

 

I’ve said it before, and I’ll say it again – people want the most expensive option.  People don’t want to pay for the most expensive option, but they want to have the most expensive option.  Look no further than the credit crisis bankrupting so many Americans, who bought more than they could afford.  Credit cards made it so easy to dig that hole, from which people can’t emerge, because they made it “feel” like it was someone else’s money.

 

So… let’s review.  People inherently want the most expensive option, because they are convinced price is an indicator of quality.  Additionally, luxury purchases are a status symbol.  So we want the best, assume the most expensive must be the best; and we want other people to think we have the best (a/k/a most expensive) stuff as well.  The only roadblock is that I don’t have money with which to buy the best (most expensive) stuff, but, when someone gives me a “card” and that “card” grants me access to deeper pockets than my own, I can now use that “card” to buy the best (most expensive) stuff.  The fact that I have to pay for that “stuff” later (either in the form of credit card payments … or … [assuming my metaphor didn’t go over your head] insurance premiums) won’t stop me from running up an unaffordable bill.

 

Transparency did nothing to stop people from getting themselves into credit card debt.  Transparency will do nothing to curb people’s health care spending, and I actually foresee it making things worse.  Consider the proposals to have drug prices on TV advertisements.  I’m watching the Patriots beat another opponent, when a commercial for Viagra pops up; (pun intended).  The commercial ends by telling me the cost of the drug is $400.  Next, a commercial for Cialis appears, and tells me that drug costs $600.  Well – don’t I and my spouse deserve the best?  Cialis it is!

 

Unless and until reliable quality measurements are included in the transparency discussion, and that information is delivered in such a way that the consumer will understand and appreciate that price has no relationship with quality, I fear “price transparency” on its own is not only a step too short, but potentially a step backwards, in Palessi boots.

 


The Final AHP Rules Take a Hard Hit

By: Erin M. Hussey, Esq.

 

A federal court has ordered certain provisions of President Trump’s Association Health Plan (“AHP”) Final Rule to be vacated. The court has remanded the AHP Final Rule to the Department of Labor (“DOL”) for consideration on how the severability provision will affect the remaining portions of the Final Rule. The court detailed that “if a provision is found entirely invalid then ‘the provision shall be severable from [the Final Rule] and shall not affect the remainder thereof.’ 29 C.F.R. § 2510.3-5(g).”

 

The court ordered the following provisions, codified as 29 C.F.R. §§ 2510.3-5(b), (c), and (e), to be vacated:

 

(1) allowing coverage to be offered to working owners; and

(2) the bona fide provisions (including the provisions about a substantial business purpose, control, and the expanded commonality of interest requirements).

 

The court concluded that the provisions relating to working owners is not within the scope of ERISA because coverage is not being offered to an actual “employer”, and ERISA defines an employer as having at least two or more employees. In addition, Congress intended that only benefit plans that arise from employment relationships fall within ERISA’s scope, and when it comes to a working owner there is no employer-employee relationship. The court noted, “There is no indication that Congress crafted the statute with the intent of sweeping working owners without employees—who employ no one—within ERISA’s scope through the statutory definition of ‘employer.’” The court provided an example to detail the “absurdity of [the] DOL’s interpretation.” The example was of an association forming an AHP that consists of fifty-one working owners without employees. The court concluded that the “number of employees employed by fifty-one working owners without employees. . . reaches a sum of zero.”

 

Furthermore, allowing working owners to purchase coverage through and AHP would be an “end-run” around the Affordable Care Act (“ACA”). Using the example above, an association consisting of fifty-one working owners would be considered a large employer and the AHP formed could follow large group market rules. Thus, the Final Rule is avoiding ACA consumer protections within the individual market rules (i.e., essential health benefits). The court concluded the following:

 

“The Court cannot believe that Congress crafted the ACA, with its careful statutory scheme distinguishing rules that apply to individuals, small employers, and large employers, with the intent that fifty-one distinct individuals employing no others could exempt themselves from the individual market’s requirements by loosely affiliating through a so-called “bona fide association” without real employment ties.”

 

With regards to the bona fide provisions, the court details that this is not a meaningful limit on associations. The court focuses on the three overall criteria that the DOL previously utilized to determine which associations are “bona fide”: purpose, commonality of interest, and control. The court concludes that the Final Rule “departs significantly from the DOL’s prior sub-regulatory guidance in the way it measures these criteria.”  As for the “substantial business purpose” criterion, the court concludes that it “sets such a low bar that virtually no association could fail to meet it . . . [and] provides no meaningful limit on the associations that would qualify as ‘bona fide’ ERISA ‘employers.’”

 

As for the commonalty of interest criterion, codified at 29 C.F.R. § 2510.3-5(c), the Final Rule provides that an AHP will have commonality of interest if:

 

(i) The employers are in the same trade, industry, line of business or profession; or

(ii) Each employer has a principal place of business in the same region that does not exceed the boundaries of a single State or a metropolitan area (even if the metropolitan area includes more than one State).

 

The plaintiff states “object to the latter, which deems employers to be united in interest solely because of common geographical location.” The court agreed and noted that “[g]eography, similarly, is not a logical proxy for common interest, and substituting shared geography for the statutory requirement of common interest improperly expands ERISA’s scope.” As such, the court concluded that allowing geography to meet the commonality of interest test “creates no meaningful limit on these associations . . . [and] the geography test does no work to focus the Final Rule on the types of associations that Congress intended ERISA to cover.”

 

Lastly, as for the criterion of control, the court concludes that the control test is only meaningful if the “members’ interests are already aligned.” However, the AHPs operating under the Final Rule could consist of employer members with “widely disparate interests” and therefore, the “employers’ interests would not be aligned.”

 

Additionally, the bona fide provisions make it easier for small employers to purchase coverage from an AHP and avoid the small group market rules. Therefore, the court concluded that making it easier to allow small employers, as well as working owners, to purchase coverage through an AHP and avoid individual and small group market rules was an “end-run” around the ACA. The court did note however, that pre-Final Rule, in the “rare instances” an association met the DOL’s prior bona fide association criteria, the association coverage would be considered a single group health plan and the number of total employees of all employer members would be counted to determine whether small or large group market rules applied. 

 

The above-noted provisions, that the court ordered to be vacated, are integral to the Final Rule. Those provisions expand the ability for AHPs to form and allow AHPs to offer coverage to more individuals and groups. The remaining portions of the Final Rule are unlikely to survive, besides what is codified at 29 C.F.R. § 2510.3-5(c)(1)(i), where an association of employers in the same trade, industry, line of business or profession, who form an AHP, can expand across state lines. We will be following the reactions to this ruling and how the DOL responds.


ERISA Violations Due to Restrictive Claim Guidelines

By: Erin M. Hussey, Esq.

Whenever a self-funded health plan covers mental health/substance use disorder (“MH/SUD”) benefits, we review the plan to assess whether these benefits are covered in parity with medical/surgical benefits in order to ensure compliance with the Mental Health Parity and Addiction Equity Act (“MHPAEA”). A recent case, however, has added another layer to compliance when it comes to covering MH/SUD benefits. 

In Wit v. United Behavioral Health, 2019 WL 1033730 (N.D. Cal. 2019), class actions were brought against an insurer by plaintiffs who were “at all relevant times a beneficiary of an ERISA-governed health benefit plan” administered by the insurer. In the capacity of administering MH/SUD benefits, the insurer had developed “Level of Care Guidelines and Coverage Determination Guidelines (collectively, “Guidelines”) that it uses for making coverage determinations” of MH/SUD benefits. Those Guidelines were the main issue in this case as well as how they were utilized to adjudicate claims.

Interestingly enough, the plaintiffs' claims against the insurer did not include a violation of the MHPAEA. Instead, the plaintiffs asserted two ERISA claims: (1) breach of fiduciary duty and (2) arbitrary and capricious denial of benefits. The Plaintiffs argued that the insurer breached its fiduciary duty by:

“1) developing guidelines for making coverage determinations that are far more restrictive than those that are generally accepted even though Plaintiffs’ health insurance plans provide for coverage of treatment that is consistent with generally accepted standards of care, and 2) prioritizing cost savings over members’ interests.”

The plaintiffs also argued that the insurer improperly adjudicated and denied claims because of the overly restrictive Guidelines, and the use of those Guidelines was arbitrary and capricious.

The court ruled that the insurer breached their ERISA fiduciary duty and that the actions were an arbitrary and capricious denial of benefits, and concluded that the insurer’s Guidelines were overly restrictive and not in line with accepted standards of care. The court emphasized that the insurer placed “an excessive emphasis on addressing acute symptoms and stabilizing crises while ignoring the effective treatment of members’ underlying conditions.”

This case is a reminder that the claim guidelines utilized and the process of adjudicating and denying claims must be held to certain standards to ensure ERISA compliance when administering MH/SUD benefits.