Recent guidance issued on mental health parity and tobacco cessation programs

Below is an article recently published by the Employee Benefit Plan Review. Although issued under the Obama administration, the guidance on the MHPAEA is likely to remain relevant given the bipartisan support for mental health legislation enacted in 2016. The future of the ACA and, specifically, free preventive services such as tobacco cessation is difficult to predict at this time.

Reprinted with permission from Employee Benefit Plan Review - January 2017

On October 27, 2016, the Departments of Labor (DOL), Health and Human Services (HHS) and the Treasury (collectively, the Departments) issued FAQs regarding (i) additional guidance for compliance under the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), and (ii) the scope of tobacco cessation services, which must be provided without cost under the Affordable Care Act (ACA).

MHPAEA GUIDANCE

Disclosures Required of Plans and Issuers

The MHPAEA and the regulations thereunder require that group health plans and health insurance issuers impose no greater financial requirements and treatment limitations on mental health or substance use disorder benefits than the predominant requirements and limitations that apply to substantially all medical/surgical benefits under the plans or policies.

The MHPAEA requires that a plan or issuer disclose the criteria for medical necessity determinations. In the case of plans subject to ERISA, plans are required to provide participants, upon request, with information regarding the factors used to apply a nonquantitative treatment limitation with respect to both mental health and substance use disorder benefits as well as medical/surgical benefits.

In the recent guidance, the Departments request comments on the following questions with respect to the required disclosures:

• Would model forms whereby participants can request information be helpful? If so, what should the model forms request (e.g., a list of documents that a participant or the participant’s representative could request) and what types of model forms should be issued (e.g., forms for information about medical necessity criteria or forms for information relating to the determination of usual, customary, or reasonable charges)?
• Would model forms to be used by States as part of their review of issuers be helpful and what information should the model forms include?
• Are there any other steps the Department can take to improve or simplify the disclosure?
• Are there any steps to improve State examinations or Federal oversight of MHPAEA compliance?

All comments were due January 3, 2017.

Assistance in Obtaining Plan Documents and External Review

Sometimes participants have difficulty obtaining plan documents to prove a MHPAEA violation. In the recent guidance, the Departments note that there is a Parity Consumer Web Portal through which a participant can identify the appropriate Federal or State agency that can assist in obtaining plan documents or understanding information provided by a plan or issuer. The link is www.hhs.gov/mental-health-and-addiction-insurance-help. The Departments also remind participants that, in the event of a benefit denial, participants can seek an external review after exhausting internal appeals.

Financial and Quantitative Treatment Limitations

A plan or policy violates the MHPAEA if it imposes financial requirements (e.g., copayment or coinsurance) or quantitative treatment limitations (e.g., a day or visit limitation) on mental health or substance use disorder benefits that do not apply to at least 2/3 of medical/surgical benefits. Generally, a plan or policy issuer is permitted to use any reasonable method in making this determination, including a reasonable projection of future claims costs based on existing claims data for the plan. However, if there is not enough claims data, or a plan significantly changes its benefit package, or there is a significant workforce change, the use of existing claims data may not be a reasonable method.

In the recent guidance, the Departments clarify that, if a qualified actuary certifies that the plan or issuer does not have sufficient claims data, it is permissible to use data from similarly structured products or plans with similar demographics. It is important that plans and issuers document the assumptions applied in choosing a data set and making projections.

Nonquantitative Treatment Limitations

A plan or policy violates the MHPAEA if a nonquantitative treatment limitation is applied more stringently to mental health or substance use disorder benefits that it is to medical/surgical benefits. Nonquantitative treatment limitations include medical necessity standards, including requirements to obtain prior authorization. The MHPAEA regulations provide that requirements to obtain prior authorization may be required for some but not all mental health and substance use disorder benefits as well as some but not all medical/surgical benefits. However, the FAQs clarify that it is a violation of the MHPAEA to require an in-person examination prior to authorizing admission to an inpatient, in-network facility for a mental health condition if prior authorization for all medical and surgical inpatient, in-network admissions only requires authorization over the phone without an in-person examination. 

In addition, the FAQs clarify that it is not permissible to require an intensive outpatient program prior to authorizing coverage of inpatient treatment of mental health or substance use disorder benefits, even though there are similar requirements for medical/surgical benefits, if there are no such outpatient programs to treat substance use disorder in the participant’s geographic area. Such requirements are often referred to as “fail-first” requirements. The Departments indicate that, if the lack of access to fail-first programs exists only with respect to mental health or substance use disorder benefits, then the requirement, in operation, is applied more stringently to the mental health and substance use disorder benefits.

Medication Treatment for Opioid Use Disorder

Three medications are approved by the FDA for use in treatment for opioid use disorder, including buprenorphine. The FAQs clarify that requiring prior authorization for buprenorphine due to safety risks associated with the drug is not permitted under the MHPAEA if prior authorization is not required for drugs to treat medical/surgical conditions that have similar safety risks. The FAQs state that, in such case, the prior authorization requirement is being applied more stringently to drugs used for mental health and substance use benefits and, therefore, violates the MHPAEA.

The FAQs also clarify that requiring a participant to satisfy a non-pharmacological fail-first requirement, such as counseling, before it will authorize coverage for buprenorphine is not permissible if the plan does not impose a similar fail-first requirement on prescription drugs for medical surgical conditions. The FAQs state that a fail-first requirement on coverage for buprenorphine for opioid use disorder cannot be imposed unless such a fail-first requirement is comparable to, and applied no more stringently than, the fail-first requirements for medical surgical benefits.

The Departments note that, if a plan states that it follows nationally recognized treatment guidelines for setting prior authorization requirements for prescription drugs, it may not require prior authorization for buprenorphine/naloxone at each 30-day refill for opioid use disorder since it is not consistent with nationally recognized treatment guidelines. Alternatively, if a plan follows guidelines established by Pharmacy and Therapeutics committees in deciding how to cover prescription drugs, it is necessary to determine whether the relevant committee is comprised of comparable experts for mental health and substance use disorder conditions as compared to experts for medical and surgical conditions and how such experts reviewed nationally recognized treatment guidelines in setting authorization guidelines for mental health and substance use disorder conditions versus medical and surgical conditions. The FAQs note that a prior authorization for buprenorphine/naloxone that is limited to 30 days could be inconsistent with authorization practices for chronic medical and surgical conditions since authorization for prescription drugs intended to treat a medical or surgical condition is typically appropriate at six or 12 months (absent a comparable 30-day restriction for medical/surgical conditions).

Finally, the FAQs note that exclusion of a court-ordered treatment for substance use disorder is not permissible if a plan does not exclude a court-ordered treatment for medical or surgical conditions. However, such an exclusion is permissible if a plan applies a medical necessity criteria to all court-ordered treatment, provided that participants have the right to challenge a benefit denial and request an external medical necessity review.

ACA GUIDANCE

Preventive Services for Tobacco Cessation

 In the FAQs the Departments note that they have received numerous questions regarding the type of tobacco cessation programs that must be offered in order to comply with the ACA. In FAQs issued May 2, 2014, the Departments indicated that plans and issuers will be deemed to be in compliance with the requirement to cover tobacco use counseling and interventions if they comply with the 2009 recommendations issued by the United States Preventive Services Task Force (USPSTF). However, the USPSTF updated its recommendations regarding tobacco cessation on September 22, 2015. For example, the USPSTF now recommends both pharmacotherapy and behavioral interventions and further indicates that a combination of such interventions is the most effective approach. The September 22, 2015, USPSTF recommendations also list seven FDA-approved medications for treating tobacco dependence, including nicotine patches, nicotine lozenges, nicotine gum, and four prescription medications.

Regulations issued under the ACA define preventive services in accordance with USPSTF recommendation and require that updated USPSTF recommendations be covered as preventive services, without cost-sharing, effective as of the plan year that begins on or after one year from the issue date of such recommendations. Accordingly, plans and issuers have asked whether compliance with the September 22, 2015, USPSTF recommendations is required for plan years commencing on or after September 22, 2016.

In lieu of providing immediate guidance, the Departments request comments from plans and issuers on the following questions:

• Must all seven FDA approved medications be covered under a plan or insurance policy without cost sharing if prescribed by a health care provider, or can plans and issuers use reasonable medical management techniques to determine which medications will be covered without cost sharing?
• Can plans and issuers use reasonable medical management techniques to (i) limit the number of quit attempts per year or the duration of the interventions required, (ii) manage the types of medications that may be covered when used in combination, or (iii) limit the types of behavioral interventions that are covered without cost sharing?

All comments were due January 3, 2017.

Lori Welding Jones is the co-chair of the Human Resources Practice Group and co-chair of the Employee Benefits Practice Area of Thompson Coburn, LLP. She focuses her practice on Employee Benefits and Executive Compensation.