On April 20, 2016, the DOL, HHS and IRS issued Affordable Care Act Frequently Asked Questions, Part XXXI (ACA FAQs 31), addressing specific implementation issues under numerous provisions of the ACA and other laws. This article summarizes the information in each of the 12 questions and answers, on: preventive services, rescissions, several disclosure obligations, coverage in connection with approved clinical trials, reference-based pricing and maximum out-of-pocket limits, the Mental Health Parity and Addiction Equity Act (MHPAEA), Medication Assisted Treatment (MAT) for opioid use disorder, and the Women’s Health and Cancer Rights Act (WHCRA).
Coverage of Preventive Services: Colonoscopies (Q/A 1)
If a colonoscopy is scheduled and performed as a screening procedure pursuant to the USPSTF recommendation, a plan may NOT impose cost sharing for the bowel preparation medications prescribed for the procedure because the required preparation for a preventive screening colonoscopy is an integral part of the procedure.
Coverage of Preventive Services: Standard Exception Form regarding Method of Contraception (Q/A 2)
If a plan or issuer utilizes reasonable medical management techniques within a specified method of contraception, the plan or issuer MAY develop and utilize a standard exception form and instructions as part of its steps to ensure that it provides an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider. The Medicare Part D Coverage Determination Request Form may serve as a model for plans and issuers when developing a standard exception form.
Rescissions (Q/A 3)
An employee (teacher in this case) is employed through a 10 month contract but had coverage through the employer for a full 12 months, and the full premium was paid during the 10-month contract period. If an employee submits her resignation at the end of the 12 months, the plan may NOT retroactively terminate coverage back to the end of the 10 month period where the employee did not commit fraud or make an intentional misrepresentation of a material fact.
Out-of-Network Emergency Services (Q/A 4)
Plans subject to ERISA must disclose the documentation and data used to calculate each of the minimum payment standards, including the UCR amount, for out-of-network emergency services because they are considered to be instruments under which the plan is established or operated. See ERISA section 104(b) and 29 CFR 2520.104b-1, which generally require such information be furnished to plan participants (or their authorized representatives) within 30 days of request.
Coverage for Individuals Participating in Approved Clinical Trials: Chemotherapy, Complication and Adverse Events (Q/As 5 & 6)
A plan or issuer may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for any items or services furnished in connection with participation in an approved clinical trial.
- If a plan or issuer generally covers chemotherapy to treat cancer, the plan or issue may NOT limit coverage of chemotherapy for an individual due to the fact that it is provided in connection with the individual’s participation in an approved clinical trial.
- If a plan or issuer typically covers items and services to diagnose or treat certain complications or adverse events, the plan or issuer may NOT deny coverage of such items and services when provided to diagnose or treat complications or adverse events (e.g. side effects) in connection with an individual’s participation in an approved clinical trial.
Reference-Based Pricing and MOOP Limits (Q/A 7)
The DOL reiterated its prior guidance (FAQ XXI) on reference-based pricing and what participant expenses count toward the maximum out of pocket (MOOP) if a plan uses a reference-based pricing design (or similar network design).
- If the plan uses a reasonable method to ensure adequate access to quality providers at the reference price,
- The plan may treat those providers that accept the reference-based price as the only in-network providers and not count an individual’s out-of-pocket expenses for services rendered by other providers towards the MOOP limit.
However, a plan that merely establishes a reference price without using a reasonable method to ensure adequate access to quality providers at the reference price will not be considered to have established a network for purposes of the MOOP limitations.
Background: Public Health Service Act (PHSA) section 2707(b) requires that non-grandfathered group health plans ensure that maximum out of pocket (MOOP) amounts do not exceed the limits provided in ACA 1302(c)(1). FAQ XXI listed the factors the DOL will consider in determining whether a plan used a “reasonable method” to ensure adequate access: 1) Type of service, 2) reasonable access, 3) quality standards, 4) exceptions process, 5) Disclosure.
The FAQ also cautions that additional requirements apply for individual and small group non-grandfathered health plans that must provide coverage of the “essential health benefits” (EHB) package under section 1302(a) of the Affordable Care Act.
MHPAEA: Use Plan-Specific Data in Performing “Substantially all” and “Predominant” Tests (Q/A 8)
Background:The MHPAEA prohibits health plans and issuers from imposing more restrictive financial requirements and treatment limitation on mental health and substance use disorder (MH/SUD) benefits than the “predominant” financial requirements and treatment limitations that apply to “substantially all” medical and surgical benefits under the plan. To determine what portion of medical/surgical benefits are subject to the financial requirement or treatment limitation, the plan or issuer may use “any reasonable method” to count the total dollars it expects to pay under the plan for the plan year for the particular classification of medical/surgical benefits. (There are six classifications of benefits under the MHPAEA: inpatient in-network; inpatient out-of-network; outpatient in-network; outpatient out-of-network; emergency; and prescription drug.)
The question addressed in Q/A 8 is what is a “reasonable method” in calculating the tests for financial requirements (such as copays and coinsurance) and quantitative treatment limitations (such as limits on number of days or visits)?; Specifically, whether a plan or issuer may base the above analysis on the issuer’s entire overall book of business for the year?
The answer is No. Plans and issuers should use data at the plan level (not the “product” level or based on the overall book of business for the year, for issuers) in determining the dollar amount of all plan payments for medical/surgical benefits. This applies for self-insured plans, insured large plans and insured small group and individual market plans.
Documents Plans Must Provide that Could Help in Evaluating Plan’s Compliance with MHPAEA (Q/A 9)
The issue addressed in this Q/A 9 is how to determine whether a plan is in compliance with the MHPAEA’s non-quantitative treatment limitations (NQTLs), such as whether the same or similar pre-authorization requirements are applied to MH/SUD benefits as to medical/surgical benefits.
A provider who is acting as an ERISA plan participant’s authorized representative asks what documents would be most helpful to review in evaluating the plan’s compliance with the MHPAEA. The plan asked for a pre-authorization form after the patient’s 9th visit for treatment of depression. In response, Q/A 9 lists the following documents a plan must provide upon request:
- A Summary Plan Description (SPD) from an ERISA plan, or similar summary information that may be provided by non-ERISA plans;
- The specific plan language regarding the imposition of the NQTL (such as a preauthorization requirement);
- The specific underlying processes, strategies, evidentiary standards, and other factors and evidence considered by the plan (including factors that were relied upon and were rejected) in determining that the NQTL will apply to this particular MH/SUD benefit, and the extent to which the NQTL will apply to any medical/surgical benefits within the benefit classification at issue ;
- Information regarding the application of the NQTL to any medical/surgical benefits within the benefit classification at issue; and
- Any analyses performed by the plan as to how the NQTL complies with MHPAEA.
The FAQ gives several examples of factors and evidentiary standards the plan might provide in the above case, to document that the NQTL is not being applied to MH/SUD benefits more stringently than to medical/surgical benefits. It also refers to ACA FAQ 29 (Q/A 12), and reminds readers that just because certain information (including factors and evidentiary standards used for medical/surgical benefits) “may be characterized as proprietary or commercially valuable is not legitimate grounds for not providing the information.”
Issuer must Disclose Certain Information to Current or Potential Enrollees (Q/A 10)
Under MHPAEA, the criteria for medical necessity determinations under a group health plan or individual health insurance coverage with respect to MH/SUD benefits must be made available to any current or potential enrollee or contracting provider upon request.
MHPAEA Applies to Benefits for Medication Assisted Treatment for Opioid Use Disorder (Q/A 11)
Medication Assisted Treatment (MAT) is any treatment for opioid use disorder that includes medication that is FDA-approved for detoxification or maintenance treatment in combination with behavioral health services. Opioid use disorder is a type of substance use disorder, and MAT is a “substance use disorder benefit” as defined by MHPAEA. Thus, any financial requirements and treatment limitations on opioid use disorder benefits may not be more restrictive than the predominant financial requirements and quantitative treatment limitations that apply to substantially all medical and surgical benefits in a classification. In addition, the special rule for multi-tiered prescription drug benefits also applies to the medication component of MAT.
The Women’s Health and Cancer Rights Act (WHCRA): Specific Coverage Issue (Q/A 12)
If a group health plan or health insurance issuer offering group or individual coverage provides medical and surgical benefits with respect to a mastectomy, the plan or issuer is required to provide coverage for all stages of reconstruction of the breast on which the mastectomy was performed, in a manner determined in consultation with the attending physician and the patient. This includes coverage for nipple and areola reconstruction, including repigmentation to restore the physical appearance of the breast, as a required stage of reconstruction. Under WHCRA, plans and issuers may impose deductibles and coinsurance for these benefits only if such cost-sharing requirements are consistent with those established for other benefits under the plan or coverage.