Colonoscopies, Mental Health Parity, and More at Issue in Latest FAQs

Practical Law Legal Update w-001-9179 (Approx. 8 pages)

Colonoscopies, Mental Health Parity, and More at Issue in Latest FAQs

by Practical Law Employee Benefits & Executive Compensation

Preventive Health Service Requirements Under the ACA

Two FAQs address coverage issues involving the ACA's preventive health service requirements (see Practice Note, Preventive Health Services Under the ACA, Other Than Contraceptives).

Coverage of Colonoscopies

The Departments conclude in an FAQ that if a colonoscopy is scheduled and performed as a screening procedure under a United States Preventive Services Task Force (USPSTF) recommendation, a plan or insurer may not impose cost-sharing for bowel preparation medications prescribed for the procedure (see Practice Note, Preventive Health Services Under the ACA, Other Than Contraceptives: Colonoscopies and Related Services). The Departments view required preparation for a preventive screening colonoscopy, including bowel preparation medications, as an integral part of the procedure (see Legal Update Wellness, Obesity, Lactation Counseling, Mental Health, and More at Issue in Latest FAQs).

Coverage of FDA-Approved Contraceptives

Regarding the ACA's contraceptives coverage mandate, the Departments indicate in an FAQ that a plan or insurer that uses reasonable medical management for a contraception method may also use a standard exception form and instructions to provide an exceptions process that is not unduly burdensome on the individual, the individual's personal representative, or doctor (see Practice Note, Contraceptives Coverage Under the ACA: Reasonable Medical Management Permitted, Subject to Exceptions Process).

A doctor may use the exception form and instructions to prescribe a particular service or FDA-approved item based on a determination of medical necessity regarding the individual. According to the Departments, the Medicare Part D Coverage Determination Request Form may serve as a template for developing a standard exception form.

Coverage Rescissions

An FAQ includes an example of a health coverage termination that violates the ACA's prohibition of coverage rescissions (see Practice Note, Preexisting Condition Exclusions and Rescissions Under the ACA). The example involves the following facts:

A teacher was employed by a school district under a 10-month teaching contract from August 1 to May 31.
The teacher had health coverage under the district's health plan for a plan year that ran from August 1 to July 31, and full premiums were paid for this coverage period.
When the teacher resigned on July 31, the plan terminated the teacher's coverage retroactively to May 31.
The teacher did not request the coverage termination, commit fraud, or make an intentional misrepresentation of material fact.

In the Department's view, the plan's coverage termination retroactive to May 31 violates the ACA's prohibition on coverage rescissions, because:

It is a cancellation or discontinuance of coverage having a retroactive effect.
It is not attributable to a failure to timely pay premiums for coverage.
There was no fraud or intentional misrepresentation of material fact.

Coverage Involving Participation in Approved Clinical Trials

Two questions involve the ACA's protections for group health plan participants who participate in approved clinical trials (see Practice Note, Patient Protections and Clinical Trials Under the ACA). Under the ACA, a plan may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items or services furnished in connection with participation in an approved clinical trial.

Coverage of Chemotherapy Anti-Nausea Medication

The Departments conclude in an FAQ that if a plan typically covers chemotherapy for a participant who is not enrolled in a clinical trial, then it may not deny (or limit or impose additional conditions on) coverage for an item or service furnished in connection with participation in an approved clinical trial (for example, a new anti-nausea medication).

Coverage of Treatments for Complications and Side Effects

Under another FAQ, a plan that typically covers items and services to diagnose or treat complications may not deny coverage of these items and services when provided to diagnose or treat complications, including side effects, in connection with an individual's participation in an approved clinical trial.

Guidance Involving Mental Health Parity

Several questions involve compliance issues under the MHPAEA (see Practice Note, Mental Health Parity).

Financial Requirements and Quantitative Treatment Limits

An FAQ addresses application of the MHPAEA's "substantially all" and "predominant" standards, which are generally used to assess parity between mental health and substance use disorder (MH/SUD) benefits and medical/surgical benefits (see Practice Note, Mental Health Parity: Key Concepts: Types, Predominant, and Substantially All). The Departments indicate in an FAQ that a plan, in performing the "substantially all" and "predominant" tests regarding financial requirements and quantitative treatment limits, may not base its analysis on an insurer's entire overall book of business for the year. Doing so, according to the Departments, is not a reasonable method for determining the dollar amount of all plan payments under the MHPAEA.

Instead, a self-insured plan must make its projections using plan-specific data (if this data is available). Separate standards are addressed for insured plans, including those for which premiums are experience-rated.

Disclosures Requirements Under the MHPAEA

The MHPAEA and its 2013 Regulations require disclosure of certain plan processes and standards regarding 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 any current or potential plan participant, beneficiary, or contracting provider on request (see Practice Note, Mental Health Parity: Availability of Plan Information).

An FAQ relates to the disclosure requirements and involves a health provider who is acting as an authorized representative for a participant under an ERISA group health plan. The plan in this example:

Uses an eight-visit treatment standard for depression.
Has requested that the provider complete a preauthorization form (a nonquantitative treatment limitation (NQTL)) after the participant's ninth visit for depression treatment (regarding NQTLs, see Practice Note, Mental Health Parity, Treatment Limitations).

The FAQ addresses which documents the plan must provide to the provider on request. According to the Departments, this lengthy list includes:

A summary plan description (SPD) from an ERISA plan (or, for non-ERISA plans, similar summary information).
The specific plan language regarding the plan's imposition of an NQTL.
Information regarding the NQTL's application to any medical/surgical benefits within the benefit classification at issue.
The specific underlying processes, strategies, evidentiary standards, and other factors (including all evidence) considered by the plan (including factors that were relied upon and were rejected) in determining:
- that the NQTL applies to a particular MH/SUD benefit; and
- the extent to which the NQTL applies to medical/surgical benefits for the benefit classification at issue.
Any analyses performed by the plan as to how the NQTL complies with the MHPAEA.

In general, the Departments indicate that to be in compliance with the MHPAEA and ERISA disclosure requirements, the plan must furnish to the provider sufficient documentation of:

The NQTL factor, evidentiary standard, and analysis.
How the factor, evidentiary standard, and analysis is applied in the outpatient, in-network classification for medical/surgical benefits to demonstrate that the NQTL is not being applied to MH/SUD benefits more stringently than to medical/surgical benefits in the classification.

Disclosing Medical Necessity Criteria

In another FAQ involving individual market coverage, the Departments note that under the MHPAEA a plan's or coverage's criteria for medical necessity determinations for MH/SUD benefits must be made available to current or potential enrollees upon request.

Medication Assisted Treatment for Opioid Use Disorder

Also, the Departments indicated in an FAQ that the MHPAEA applies to plan benefits involving Medication Assisted Treatment (MAT) for opioid use disorder. Specifically, MAT includes treatment for opioid use disorder that includes FDA-approved medications for detoxification or maintenance treatment in combination with behavioral health services. The Departments take the position in this FAQ that:

Opioid use disorder is a kind of substance use disorder.
MAT is a "substance use disorder benefit" (as defined by the MHPAEA).

(See Practice Note, Mental Health Parity: MHPAEA Terminology.)

According to the Departments, plans that offer MAT benefits must satisfy the MHPAEA in doing so. For example, this means that:

Any financial requirements and treatment limitations may not be more restrictive than the predominant financial requirements and quantitative treatment limitations for substantially all medical and surgical benefits in a classification.
The rule for multi-tiered prescription drug benefits also applies to the medication component of MAT (see Practice Note, Mental Health Parity: Rules for Special Contexts).
The behavioral health services components of MAT should be treated as outpatient benefits and/or inpatient benefits as appropriate for MHPAEA purposes.

Breast Reconstruction and the Women's Health and Cancer Rights Act (WHCRA)

An FAQ provides that if a group health plan covers mastectomies, it must also provide coverage:

For all stages of reconstruction of the breast on which the mastectomy was performed, under the Women's Health and Cancer Rights Act (WHCRA) (see SPD Language, Women's Health and Cancer Rights Act of 1998 (WHCRA)).
In a manner determined in consultation with the attending doctor and patient.

This includes coverage for nipple and areola reconstruction, including nipple and areola repigmentation to restore the breast's physical appearance, as a required stage of reconstruction. Under WHCRA, a plan may impose deductibles and coinsurance for these benefits only if the cost-sharing is consistent with requirements for other benefits under the plan.

Practical Impact

As is often the case with the Departments' non-regulatory FAQs, this latest guidance covers a broad array of health plan compliance requirements (ACA-related and otherwise) and offers the agencies' thoughts on more nuanced issues that may not have been addressed in implementing regulations.

The Departments' discussion of MHPAEA-related disclosures, in particular, is notable for its expansive and potentially onerous listing of documents and plan information that must be provided on request to current or potential participants, beneficiaries, or contracting providers. Some plans and insurers may be surprised at the scope of information that is subject to disclosure, as discussed in FAQ #9 and its introductory material. In the Departments' view, these disclosure obligations are a product of not only the MHPAEA and its final implementing regulations, but also:

ERISA's requirement that instruments under which the plan is established and operated be furnished to participants and beneficiaries with 30 days of request, subject to penalties (29 U.S.C. 1024(b)(4)).
The DOL claims procedure regulations and related ACA changes involving internal claims and appeals and external review (see Practice Notes, Internal Claims and Appeals Under the ACA and External Review Under the ACA).

Citing their own prior FAQ guidance, the Departments also indicated that plans and insurers may not decline to provide this information on the grounds that it is proprietary or commercially valuable.

Other issues addressed in the FAQs include treatment of individual out-of-pocket expenses for plans that use a reference-based pricing structure.

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