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Parity Portal, Opioids, and Fail-First Requirements Addressed in Latest Guidance
Practical Law Legal Update w-004-1974 (Approx. 8 pages)
Parity Portal, Opioids, and Fail-First Requirements Addressed in Latest Guidance
by Practical Law Employee Benefits & Executive Compensation
| Law stated as of 31 Oct 2016 • USA (National/Federal) |
The Departments of Labor (DOL), Health and Human Services (HHS), and Treasury have issued additional FAQs addressing mental health parity compliance under the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). The FAQs also address compliance with the preventive health services requirements under the Affordable Care Act (ACA).
On October 27, 2016, the DOL, HHS, and Treasury (Departments) issued FAQ guidance addressing several health and welfare plan compliance issues, including:
- Disclosure obligations under the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and its implementing regulations (see Mental Health Parity (MHPAEA) Toolkit).
- Standards for performing parity analysis regarding financial requirements and quantitative treatment limitations.
- Prohibited practices under the MHPAEA rules regarding nonquantitative treatment limitations (NQTLs).
- Under the ACA's preventive health services requirements, coverage reflecting new recommendations for tobacco cessation intervention.
Guidance Involving Mental Health Parity
The latest FAQs address several compliance issues under the MHPAEA (see Practice Note, Mental Health Parity).
MHPAEA-Related Plan Document Requests and the "Parity Portal"
The MHPAEA and its 2013 Regulations require disclosure of certain plan processes and standards regarding mental health and substance use disorder (MH/SUD) benefits. For example, a plan's criteria for medical necessity determinations must be made available by the plan administrator (or, if applicable, the insurer offering the coverage) to current or potential plan participants, beneficiaries, or contracting providers on request (see Practice Note, Mental Health Parity: Availability of Plan Information).
One FAQ involves a participant who, after having an MH/SUD benefit denied, asked the plan for documents demonstrating whether the plan treats MH/SUD benefits differently than medical/surgical benefits. The Departments indicated that depending on the plan involved, more than one government agency, including both federal and state agencies, might be able to help obtain the requested documents.
In particular, the Departments noted that:
- A new Parity Consumer Web Portal will help connect individuals to the appropriate agency.
- The various agencies are coordinating their efforts to achieve MHPAEA compliance.
External Review of Denied Claims
The Departments also indicated that the ACA's external review procedures are available:
- For claims involving nongrandfathered group health plans that are denied for reasons involving medical judgment (see Practice Notes, External Review Under the ACA and Grandfathered Health Plans Under the ACA).
- If an individual has exhausted the plan's internal claims processes (see Practice Note, Internal Claims and Appeals Under the ACA).
Claims Data for Financial Requirements and Quantitative Treatment Limits Analyses
The FAQs address application of the MHPAEA's "substantially all" and "predominant" standards, which are generally used to assess parity between MH/SUD benefits and medical/surgical benefits. Under the FAQs, if a group health plan or insurer has enough claims data to perform the substantially all or predominant analyses of the financial requirement and treatment limit aspects of the MHPAEA regulations, then this data should be used (see Practice Note, Mental Health Parity: Parity Analysis Regarding Financial Requirements and Treatment Limitations). In general, an insurer's or third-party administrator's (TPA's) broader book of business should not be used for these analyses, because the book may include plans with benefit designs that are unlike the specific plan for which MHPAEA analysis is being performed.
However, the Departments indicated that if there is not enough reliable claims data available it may be necessary to use reasonable data from outside the plan. The following standards apply:
- Plans and insurers must use a reasonable method for the substantially all and predominant analyses (for example, using reasonable data to produce reasonable projections).
- Claims data from an insurer's or TPA's entire book of business should not be used in an unreasonable manner to calculate the amount of a particular plan's or insurer's payments under the MHPAEA.
- Appropriate and sufficient data should be used to perform the analysis, consistent with the "Actuarial Standards of Practice."
Plans May Need to Hire an Actuary
Under the FAQs, if a qualified actuary determines that a group health plan or insurer lacks sufficient data at the plan or product level for the substantially all or predominant analyses, the plan or insurer should use other claims data to make a reasonable projection to conduct actuarially-appropriate analyses. To be qualified for this purpose, the actuary must:
- Be subject to and meet the qualification standards for issuing a statement of actuarial opinion regarding US health plans.
- Have the necessary education and experience to provide the actuarial opinion.
Assuming it is "actuarially appropriate," data from other similarly-structured products or plans with similar demographics may be used for the analyses. To the extent possible, the claims data should be customized to reflect the characteristics of the plan to which the substantially all and predominant analyses are being applied.
In using a reasonable method to make these projections, plans and insurers should document the assumptions used to choose a data set and make projections. However, a plan or insurer need not perform parity analysis each plan year unless there is a change in plan benefit design, cost-sharing structure, or utilization that would affect a financial requirement or treatment limit within a classification (or subclassification).
Nonquantitative Treatment Limitations: Preauthorization Practices
One FAQ addresses a plan that requires a plan representative to examine the individual in person, to determine whether inpatient care is medically necessary, before authorizing admission to an inpatient, in-network facility for a mental health condition. The plan also requires preauthorization for all medical and surgical inpatient, in-network admissions, although in this context the preauthorization is conducted over the phone without an in-person examination.
According to the Departments, the in-person preauthorization requirement for mental health inpatient admissions is not allowed under the MHPAEA. Although some differences in preauthorization practices regarding individual conditions or treatments are acceptable based on clinically appropriate standards of care, the plan or insurer may not apply stricter nonquantitative treatment limitations (NQTLs) to all benefits for mental health conditions in a classification than those applied to all medical/surgical benefits in the same classification.
Under the impermissible arrangement described in the FAQ:
- A participant must undergo an in-person examination to receive preauthorization for any inpatient, in-network mental health benefits.
- Preauthorization can be obtained more easily and quickly over the phone for any inpatient, in-network medical/surgical benefits.
Fail-First Requirement and Lack of Programs in Geographic Area to Meet Requirement
Another FAQ involves the following scenario:
- Before authorizing coverage for inpatient treatment for a substance use disorder, a plan requires participants to enroll in an intensive outpatient program, but there are no intensive outpatient programs available in a particular individual's geographic area to treat the individual's substance use disorder.
- The plan applies similar requirements to medical/surgical benefits, but the requirement can be satisfied by programs offered in the individual's geographic area.
- Upon being informed of this situation, the plan informed the individual that there no exceptions permitted.
According to the Departments, the requirement to try an intensive outpatient program before being admitted for inpatient treatment is a NQTL known as a fail-first (or step-therapy) requirement. If a fail-first requirement for MH/SUD benefits includes a condition that an individual cannot reasonably satisfy (here, the condition to first attempt an intensive outpatient program, for which there are no programs available), and the lack of access to programs for meeting the requirement exists only regarding MH/SUD benefits, then the fail-first requirement is, in operation, being applied more stringently regarding MH/SUD benefits than medical/surgical benefits. This arrangement violates the MHPAEA regulations.
Medication Assisted Treatment for Opioid Use Disorder: Buprenorphine
In previous guidance, the Departments indicated that the MHPAEA applies to plan benefits involving Medication Assisted Treatment (MAT) for opioid use disorder (see Legal Update, Colonoscopies, Mental Health Parity, and More at Issue in Latest FAQs). An FAQ in the Departments' latest guidance addresses an Food and Drug Administration (FDA)-approved medication, called buprenorphine, for use in treating opioid disorder.
The FAQ involves a plan that:
- Requires preauthorization from the plan's utilization reviewer that buprenorphine is medically necessary to treat an individual's opioid use disorder.
- Claims its preauthorization requirement is for safety risks associated with the medication.
- Does not impose similar preauthorization requirements on prescription drugs for treating medical/surgical conditions having similar safety risks.
According to the Departments, this plan's preauthorization requirement is being applied more stringently to buprenorphine when used to treat opioid use disorder than the requirement is applied to prescription drugs with similar safety risks to treat medical/surgical conditions. As a result, the preauthorization requirement on buprenorphine violates the MHPAEA.
Additional Buprenorphine-Related Issues
A related FAQ addresses a fail-first requirement in the context of buprenorphine and opioid use disorder. In this FAQ, the Departments concluded that a plan that claimed to follow nationally-recognized treatment guidelines for setting prescription drug preauthorization requirements could not require preauthorization for buprenorphine at each refill (that is, every 30 days) for an individual with opioid use disorder. This is because:
- The 30-day standard is inconsistent with nationally-recognized treatment guidelines.
- A six- or 12-month standard would be more reasonable under national guidelines.
The Departments also addressed plan use of Pharmacy and Therapeutics (P&T) committees to determine how to cover prescription drugs.
Court-Ordered Treatments
Acknowledging that some plans exclude coverage for court-ordered treatment, the Departments concluded in an FAQ that an exclusion of court-ordered treatment for substance use disorders is not allowed under the MHPAEA if the plan does not exclude court-ordered treatment for medical/surgical conditions. In the Departments' view, the MHPAEA prohibits separate plan treatment limits that apply only to MH/SUD benefits.
However, some plans apply medical necessity criteria to all treatment requests, and may do so regarding court-ordered treatment for substance use disorders. If a plan determines that court-ordered treatment is not medically necessary and denies a benefits claim, the individual must be informed of the right to appeal and request external medical necessity review.
Preventive Services: Tobacco Cessation Interventions (Comments Requested)
An additional FAQ addresses an updated recommendation by the United States Preventive Services Task Force (USPSTF) regarding tobacco cessation interventions for non-pregnant adults, which was issued in September 2015 (see Practice Note, Preventive Health Services Under the ACA, Other Than Contraceptives: Covered Preventive Services). Specifically, USPSTF recommended with an "A" rating that clinicians:
- Ask all adults about tobacco use.
- Advise them to stop using tobacco.
- Provide both behavioral interventions and FDA-approved pharmacotherapy for cessation to adults who use tobacco.
In addition, the updated USPSTF recommendation:
- Offers greater detail regarding individual, group, and telephone behavioral interventions.
- Describes seven FDA-approved over-the-counter (OTC) and prescription medications for treating tobacco dependence that are now available, including three types of OTC nicotine replacement products (for example, nicotine gum).
The Departments plan to issue additional guidance regarding what items and services must be provided without cost-sharing under this updated recommendation. The Departments requested comments on the:
- Scope of which FDA-approved tobacco interventions must be covered.
- Use of reasonable medical management techniques in this context.
Practical Impact
As with prior MHPAEA guidance, the Departments' latest FAQs demonstrate the complexity of parity analyses and the seemingly broad set of treatments and medications that fall within the scope of MHPAEA compliance. Through its newly launched Parity Portal, the government has demonstrated its interest in ensuring that individuals have assistance from the relevant oversight agencies in pursuing MHPAEA violations – which could result in increased enforcement activity for plans and insurers. As a result, plans and insurers will want to make sure their disclosures regarding MHPAEA compliance (for example, NQTL evidentiary standards and related documents) are in place. Moreover, certain of the Departments' standards involving NQTLs and the roll of qualified actuaries could, if applicable, result in additional documentation and recordkeeping efforts for plans and insurers.