Tag: substance abuse

Minimizing National Labor Relations Act Liability for Employers with Non-Unionized Workforces

This post continues our consideration of comments submitted in response to proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA).

Under current law, if a plan provides any mental health or substance use disorder (MH/SUD) benefits in any classification of benefits, benefits for that condition or use disorder must be provided in every classification in which medical/surgical (M/S) benefits are provided. Classifications for this purpose include inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs. The proposed regulations modify this standard by providing that a plan does not provide benefits for MH/SUD benefits in every classification in which M/S benefits are provided unless the plan provides meaningful benefits for treatment for the condition or disorder in each such classification “as determined in comparison to the benefits provided for medical/surgical conditions in the classification.”

The term “meaningful benefits” is nowhere defined. The regulators nevertheless “recognize that the proposal to require meaningful benefits [ ] is related to scope of services.” “Scope of services” for this purpose generally refers to the types of treatments and treatment settings that are covered by a group health plan or health insurance issuer. The preamble to the proposed regulation invites comments on how the meaningful benefits requirement “would interact with the approach related to scope of services adopted under the 2013 final regulations.” The preamble of the 2013 final regulations addressed an issue characterized as ‘‘scope of services’’ or ‘‘continuum of care’’ but otherwise failed to provide any substance. Two examples from the proposed regulations do, however, give us a sense of what the regulators have in mind.

  • A plan that generally covers treatment for autism spectrum disorder (ASD), a mental health condition, and covers outpatient, out-of-network developmental evaluations for ASD but excludes all other benefits for outpatient treatment for ASD, including applied behavior analysis (ABA) therapy, when provided on an out-of-network basis. (ABA therapy is one of the primary treatments for ASD in children.) The plan generally covers the full range of outpatient treatments and treatment settings for M/S conditions and procedures when provided on an out-of-network basis. The plan in this example violates the applicable parity standards.
  • In another example, a plan generally covers diagnosis and treatment for eating disorders, a mental health condition, but specifically excludes coverage for nutrition counseling to treat eating disorders, including in the outpatient, in-network classification. Nutrition counseling is one of the primary treatments for eating disorders. The plan generally provides benefits for the primary treatments for medical conditions and surgical procedures in the outpatient, in-network classification. The exclusion of coverage for nutrition counseling for eating disorders results in the plan failing to provide meaningful benefits for the treatment of eating disorders in the outpatient, in-network classification, as determined in comparison to the benefits provided for M/S conditions in the classification. Therefore, the plan violates the proposed rules.

Notably, the newly proposed meaningful benefits requirement is separate from, and in addition to, the newly prescribed nonquantitative treatment limitation (NQTL) testing standards. These latter standards include a “no more restrictive” requirement, a “design and application” requirement and an “outcomes data and network composition” requirement. A handful of comments nevertheless urge the regulators to add scope of services to its non-exhaustive list of NQTLs. As a result, a plan’s scope of services would be subject to comprehensive NQTL testing. Or, put another way, they would be fed back into the NQTL testing loop. Using the first of the examples above, this would require that ABA therapy to be first compared to the treatment limitations imposed on some M/S benefits in each classification. But what benefits, exactly? The problem is that a plan’s scope of services – what types of treatments a plan will pay for and in what settings – is a high-level plan design feature and not an NQTL.

While reasonable minds can and do differ on much of the substance of the proposed regulations, we doubt that anyone would claim that they streamline or simplify compliance. Compliance with these rules is already complicated and expensive; if the final rule looks anything like the proposed regulations, compliance will only get more complicated and more expensive. The proposed meaningful benefits requirement is intended to prevent plans, as a matter of plan design, from satisfying the parity rules by offering nominal or insubstantial MH/SUD benefits when compared to similar M/S benefits in each classification. Treating a plan’s scope of services as itself a separate NQTL does not advance this goal.

© 2024 McDermott Will & Emery
by: Alden J. Bianchi of McDermott Will & Emery 

For more news on Health Care Law, visit the NLR Health Law and Managed Care section.

HHS OIG Signs Off on Substance Use Recovery Incentive Program

On March 2, 2022, the Department of Health and Human Services (“HHS”) Office of the Inspector General (the “OIG”) issued a new advisory opinion (“AO 22-04”) related to a program through which the Requestor would provide certain individuals access to digital contingency management (“CM”) and related tools to treat substance use disorders (“Program”).  The OIG advised that it would not impose administrative sanctions under the Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalty Law (“CMPL”).

The Requestor, a digital health company, offers a Program that uses smartphone and smart debit card technology to implement CM for individuals with substance use disorders, addressing aspects of these disorders “in ways that conventional counseling and medications often cannot.” The Requestor makes this technology available to individuals who meet certain requirements through contracts with a variety of entities, such as health plans, addiction treatment providers, employee assistance programs, research institutions, and other treatment providers (“Customers”).

Individuals (‘Members”) are Customer- or self-referred, and are subject to a structured interview using the American Society of Addiction Medicine Continuum Triage tool before participation in the Program. The Requestor’s enrollment specialist, under the guidance of a licensed clinical supervisor, determines the type of services and frequency of recovery coaching using an evidence-based, automated algorithm. The Program technology establishes the schedule of expected target behavioral health events, objectively validates whether each expected event has occurred, and, if it has, promptly disburses the exact, protocol-specified incentive to the Member, using (where appropriate) a progressive reinforcement schedule.

The Program is not limited to treatments or federally reimbursable services; it also includes, among other features, support groups, medication reminders, and appointment attendance verification. For those that do include federally reimbursable services, the Requestor advised that such services may be furnished by a Customer. Incentives from the Program are provided to Members via a “smart debit card.” The card includes “abuse and anti-relapse protections (e.g., it cannot be used at bars, liquor stores, casinos, or certain other locations nor can it be used to convert credit to cash at ATMs or gas stations)”, and allows the Requestor to monitor use. Incentives are capped at $200/month and $599/year; individual incentives are typically relatively small, at $1-$3.

The Requestor receives fees from Customers on either a flat monthly basis, per eligible, active Member, or a pay-for-performance model, in which Requestor is paid upon a Member achieving certain agreed-upon targets for abstinence. The Requestor certified that the aggregate fees are consistent with fair market value and do not vary based on the volume or value of business generated under federal health care programs. Instead, fees are based on the service configurations being purchased and the intensity of behavioral targets that are planned for each Member, as well as whether a member is low- or high-risk, and in or out of treatment.

OIG concluded that two stream of remuneration potentially implicate the AKS and CMPL.  First, Customers pay Requestor a fee to provide services, some of which could incentivize a Member to receive a federally billable service. Second, some of the fees Customers pay to Requestor get passed on to Members as CM Incentives for achieving certain behavioral health goals, some of which may involve services that could be billable to Federal health care programs (e.g., a counseling session) by a particular provider or supplier, which could be a Customer. OIG noted its longstanding concerns relating to the offer of incentives intended to induce beneficiaries to obtain federally reimbursable items and services, as such incentives could present significant risks of fraud and abuse.

The OIG concluded that the Program presents a minimal risk of fraud and abuse and declined to impose sanctions, providing four justifications –

  1. The Requestor certified that the Program is based in research, and provided evidence that CM is a “highly effective, cost-efficient treatment for individuals with substance use disorders.” Therefore, the OIG decided that, taken together with the other safeguards present in the Arrangement, the incentives in the Requestor’s Program serve as “part of a protocol-driven, evidence-based treatment program rather than an inducement to seek, or a reward for having sought, a particular federally reimbursable treatment.”
  2. The incentives offered through the Program have a relatively low value and a cap, and largely are unrelated to any federally payable services, especially as the Requestor is not enrolled in and does not bill to federal health care programs for Program services. Therefore, the OIG determined that the risk of the incentives “encouraging overutilization of federally reimbursable services is low.”
  3. The Requestor’s Customer base is not limited to entities that have an incentive to induce receipt of federally reimbursable services. While the OIG acknowledged that there may be instances where an incentive may be given for receiving a federally billable service, the fees do not vary based on volume or value of any federally reimbursable services, and the Customers do not have control of the Program. Therefore, the OIG determined that the risk is low an entity would become a Customer to “generate business or reward referrals.”
  4. Although the incentives loaded onto a smart debit card function as cash equivalents, the OIG found the safeguards included in the Arrangement sufficient to mitigate fraud and abuse concerns. The Requestor, which does not bill federal health care programs or have an incentive to induce overutilization, determines what services an individual needs and what incentives are attached. Additionally, the smart debit card has “anti-relapse protections”, which can signal possible need for intervention. Therefore, the OIG concluded that the remuneration in the form the smart debit card is sufficiently low risk.

AO 22-04 reflects HHS’s continued aims to increase flexibility around substance use disorder treatments.  Just two weeks before, HHS announced two grant programs, totaling $25.6 million, to expand access to medication-assisted treatment for opioid use disorder and prevent the misuse of prescription drugs. In a press release, HHS Secretary Xavier Becerra is quoted as saying, “At HHS we are committed to addressing the overdose crisis, and one of the ways we’re doing this is by expanding access to medication-assisted treatment and other effective, evidenced-based prevention and intervention strategies.” HHS’ “National Tour to Strengthen Mental Health” is intended to “hear directly from Americans across the country about the challenges they’re facing, and engage with local leaders to strength the mental health and crisis care in our communities”, focused on three aspects: mental health, suicide, and substance use. Further flexibilities should be anticipated in these areas as the Tour continues.

Anyone seeking treatment options for substance misuse should call SAMHSA’s National Helpline at 800-662-HELP (4357) or visit findtreatment.gov. If you or anyone you know is struggling with thoughts of suicide, please call the National Suicide Prevention Lifeline at 800-273-TALK (8255), or text the Crisis Text Line (text HELLO to 741741).

Article By Christine M. Clements and Theresa E. Thompson of Sheppard, Mullin, Richter & Hampton LLP

For more health law legal news, click here to visit the National Law Review.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

Employer Concerns with Employee Substance Abuse and Drug Use: A Q&A with Caroline J. Berdzik of Goldberg Segalla

With headlines and staggering statistics extolling the impact of the opioid epidemic ripping through the United States, and marijuana (medical and recreational) legalized and decriminalized and a patchwork of state, federal and municipal laws across the country; employers dealing with employee substance abuse and drug use issues have a lot of things to consider. Caroline J. Berdzik, a partner with Goldberg Segalla and chair of the firm’s Labor and Employment and Health Care Groups,  focuses on counseling employers on human resources and employment matters, and was kind enough to share her thoughts on the thorny issues of employers navigating employee substance abuse and drug use.  Read on for more insight and ideas on  how employers should proceed when an employee demonstrates some indication of substance abuse, what the concerns are for employers, and some thoughts on how to move forward keeping in mind changing attitudes on addiction and the laws that may apply.

Can you outline some of the dangers employers face when employing an individual who is struggling with addiction?

Unfortunately, substance abuse addiction and its ramifications cannot avoid the workplace. There is an acknowledgment that this is not an issue that has social or economic boundaries, anyone from highly compensated executives to hourly employees may struggle with addiction. Addiction can take many forms including alcohol abuse, opioid dependency, or the use of other illegal or legally prescribed substances. Employers need to be concerned about legal issues when dealing with an employee who is struggling with addiction. It may be difficult to confirm that an employee has an addiction as they may try to hide it and depending on the circumstances, there may be limits of how far an employer can pry into these concerns.

Once the problem is confirmed, some consideration needs to be given as to whether the employee can continue to do their job while working through addiction. If they are unable to perform their job responsibilities, there are options or reasonable accommodations available to the employee or employer (i.e., leave of absence for treatment). Other components to consider include the availability of drug and alcohol testing permitted under the law in their specific jurisdiction; whether the employee’s conduct has violated any company policies; and if the behaviors associated with the employee’s addiction is negatively impacting the quality of their work and interactions with co-workers, supervisors, clients, and others outside the workplace.

What are some of the issues employers must consider when discussing an employee’s addiction problems with an employee? What are the concerns, especially since addiction can be difficult to identify? 

Employers need to be very careful in this regard. Generally, potential addiction is brought to an employer’s attention through observation or by reports from other employees, supervisors, clients, or even customers. If alcohol is the issue, it may be difficult to detect when someone is under the influence, particularly if the consumption is during non-working hours and if the employee is merely coming to work hungover―as opposed to being intoxicated on the job. If the suspected addiction involves drugs (e.g., whether legal or illegal), there are states that don’t allow for reasonable suspicion testing and some states that make it virtually impossible to test at all. Additionally―depending on the nature of the drug―it may also not show up in the drug test depending on when the test is done.

Many times, this is a difficult conversation to have with an employee since they will most likely deny having any issue because they don’t want to jeopardize their income or employment prospects. Employers need to be careful not to potentially run afoul of the Americans with Disabilities Act (ADA) and other state anti-discrimination laws when discussing a suspected substance abuse problem. Merely perceiving the employee as having a disability can open the employer up to legal risk. Therefore, it is critical to proceed with caution and consult internally or externally with legal counsel and human resources on how to best handle the situation.

How does the legality of the substance the employee is addicted to impact the employer’s actions?  For example, an employee addicted to legal opioid painkillers vs. an employee who is addicted to cocaine or other illegal substances?

The laws are greatly evolving in this area, particularly with respect to cannabis. More and more states have legalized medical marijuana and recreational marijuana. With respect to alcohol, it’s legal to drink alcohol as long as the individual is of age; however, alcohol abuse can cause just as many problems as an employee struggling with a substance abuse problem.

While it may seem easier to take certain actions when managing employees with addictions to other substances (e.g., opioids and cocaine), there are still considerations that come into play. For example, employers in some states cannot take actions against employees based on what activities that they do during off-duty hours.

Irrespective of the legality of the substance, the employer needs to focus on whether the employee is impaired at work or at work functions (e.g., on a business trip, attending a conference, meeting with clients, etc.). They also need to consider the impact of those behaviors on the individual, the company, and anyone else involved. Employers also need to be cognizant of the laws in their jurisdictions and the policies the company may have regarding the use of alcohol and drugs in the workplace. If someone is a current user of an illegal substance, there is typically no protection afforded to them under the ADA or similar anti-discrimination laws. However, if an employee can tie their addiction to an underlying mental health disorder, it becomes murkier. For employees who are recovering drug addicts or alcoholics, there is likely more protection afforded under anti-discrimination laws.

The key thing for employers to remember is to not make any knee-jerk decisions when evaluating these issues. Employers should take time to fully analyze the circumstances before taking any action and determine what legal obligations, if any, it may have to try to accommodate employees.

What legal requirements come into play when human resources intervene with an employee struggling with addiction?  For example, can this be a situation where the ADA applies?

The ADA is typically something that would come into play when dealing with an employee struggling with addiction. Human resources should consult with legal counsel while navigating through this type of issue. There are a myriad of laws that are intertwined that could potentially be relevant including the federal Family Medical Leave Act, as well as other state or local counterparts. In many circumstances, the employer may need to provide a reasonable accommodation to assist an employee struggling with addiction. Best practices may dictate this type of documented discussion with the impacted employee, even without a legal requirement to do so.

Attitudes toward addiction are changing with addiction increasingly being seen as a disease that should be treated without judgment–how does this shift change an employer’s reaction to employees with addiction issues?

As these issues become more prevalent, including the revelation that they impact individuals at higher level positions at companies, employers are increasingly willing to work with employees to get them the help they need. I have seen an uptick in counseling calls where employers are genuinely concerned about their employees’ well-being and want to find ways to assist them. However, I have seen situations where employers have gone above and beyond to work with a struggling employee and the employee failed to help themselves with the assistance being offered.

Rates of prescription opioid abuse are skyrocketing. How is this worrisome trend affecting employers, and are there any proactive steps employers can take?

Opioid use is a very serious problem impacting the workplace. Employers are well advised to have employee assistance programs (EAPs) in place. They should also have open-door policies to encourage employees to come to human resources to seek help for their addiction.

Many thanks to Caroline J. Berdzik of Goldberg Segalla for sharing her thoughts and insights on this complicated, yet increasingly relevant employment law issue.

Copyright ©2019 National Law Forum, LLC

More employment law issues on the National Law Review Labor & Employment page.