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Insights from People and Organization Agencies issue new FAQs on the ACA, Mental Health Parity and Women’s Health and Cancer Rights Act April 28, 2016 In brief The Departments of Labor, Treasury and Health and Human Services (the ‘Agencies’) issued a new set of FAQs (Part 31) addressing provisions of the Affordable Care Act (ACA) , Mental Health Parity and Addition Equity Act (MHPAEA) and Women’s Health and Cancer Rights Act (WHCRA). Although the FAQs expand a number of coverage requirements, similar to other guidance, the Agencies do not provide an effective date for their interpretations. In detail Affordable Care Act guidance Preventive Services Under the ACA, nongrandfathered group health plans and health insurance issuers must cover certain preventive services without cost sharing, including colonoscopies. In the FAQs, the Agencies explain that in addition to covering the colonoscopy, any bowel preparation medications also must be covered without cost sharing, subject to reasonable medical management. Observation As with other preventive services, some charges may be medical and some may be for prescription drugs. Plan sponsors will need to coordinate with their medical and prescription drug vendors. Contraceptive coverage also is among the preventive services that must be covered without cost sharing. In previous FAQs, the Agencies clarified that a plan or issuer must cover at least one contraception form in each of the methods (currently 18) the Food and Drug Administration identified. Although a plan or insurer may use reasonable medical management techniques within a specified contraceptive method to control costs, there must be an exception process to cover methods without cost sharing that are recommended by the health care provider (and deference must be given to the health care provider’s recommendation). These FAQs explain that a plan or issuer may develop a standard exception form that an attending provider may use, and the Medicare Part D Coverage Determination Request Form may serve as a model for this form. Rescissions Under the ACA, a plan or issuer may not rescind (retroactively terminate) coverage unless the person commits fraud, makes an intentional misrepresentation of a material fact or does not pay premiums. The FAQs lay out a scenario common to the educational community. A school district employed the individual for a 10 month teaching contract from August 1 through May 31, but health care coverage was for the plan year from August 1 through July 31. www.pwc.com Insights When the person resigned on July 31, the district retroactively terminated the health care coverage effective as of May 31 (her last day of active employment). The Agencies state that this was an impermissible rescission. internal claims and appeals and external review requirements under the ACA, which apply to nongrandfathered group health plans and issuers, would require disclosing how these amounts are calculated. Observation Clinical Trial Coverage Generally, plans should not retroactively terminate health care coverage unless there is proof of fraud or material misrepresentation or non-payment of premiums, or in the limited circumstance described in a prior FAQ that allows rescission for administrative reasons. Although a nongrandfathered plan or issuer is not required to cover an investigational item that is part of a clinical trial, the ACA requires plans and issuers to cover routine patient costs associated with the clinical trial, which are costs that are covered under the plan for individuals not in a clinical trial. To date, the Agencies have not issued any guidance on this provision, and plans and issuers were expected to use a good faith, reasonable interpretation of the law to implement this provision. In these FAQs, the Agencies state that if a plan typically covers routine patient costs or items or services to diagnose or treat complications or adverse events (such as side effects), the plan or issuer cannot deny coverage for any of these items only because it is provided in connection with participation in a clinical trial. The Agencies pointed out that the ACA does not require a plan or issuer to provide coverage for outof-network routine patient costs associated with a clinical trial, unless otherwise covered under the plan. Out-of-network emergency services The ACA provides that nongrandfathered plans and issuers cannot impose cost sharing on out-ofnetwork emergency services greater than the cost sharing for in-network benefits. However, this provision does not prohibit balance billing (where a provider charges a patient for the difference between what the plan or insurer pays and the total cost). Because balance billing could leave patients with significant out-of-pocket costs, the regulations require plans to pay a reasonable amount before the patient is responsible for a balance billed amount. Plans are required to pay at least the greatest of three amounts specified in the regulations. The FAQs provide that plans are required to disclose how the minimum payment amount is calculated, including the method the plan uses to determine payments for out-ofnetwork services (such as the usual, customary, and reasonable (UCR) amount). Plans covered by the Employee Retirement Income Security Act (ERISA) would be required to disclose how the above amounts are calculated within 30 days of a participant’s request for such information. In addition, both the ERISA claims procedures and the 2 Observation Because there has not been any guidance on covering routine patient cost associated with a clinical trial, plans and issuers should review coverage to make sure they are in compliance with this new guidance. Limitations on Cost-Sharing The ACA imposes cost sharing limitations on non-grandfathered plans and issuers. For example, the maximum out-of-pocket (MOOP) limits for 2016 are $6,850 (self-only) and $13,700 (other than self-only coverage). If a plan includes a network of providers, a plan may, but is not required to, count an individual’s outof-pocket spending for out-of-network items and services toward the MOOP. In previous guidance, the Agencies discussed how reference based pricing (paying a fixed amount for a specific procedure) works with the MOOP limits. In that guidance, the Agencies were concerned about pricing structures that only treat providers who accept the reference pricing as innetwork providers and treat all others as out-of-network, so the participant’s out-of-pocket expenses for services from these providers do not count toward the MOOP limit. The previous guidance requires plans and issuers to ensure that there is adequate access to providers at the reference-based price. In these new FAQs, the Agencies state that a plan or issuer that does not ensure that there is adequate access to providers who accept the referencebased price must count the person’s out-of-pocket expenses for providers who do not accept the reference-based price toward the MOOP limit. MHPAEA guidance The MHPAEA requires that the financial requirements and treatment limitations imposed on mental health and substance use disorder (MH/SUD) benefits cannot be more restrictive than the predominant financial and treatment limitations that apply to substantially all medical and surgical benefits. The MHPAEA regulations provide a detailed, numeric formula for determining the ‘predominant’ limitations for medical and surgical benefits. The regulations allow any reasonable method to be used to make this determination. The FAQs clarify that basing this determination on an issuer’s entire book of business in a state or region is not a reasonable method. To the extent specific group health plan data pwc Insights is available, each self-insured group health plan must use that data. In the insured market, if premiums are determined on an experience rated basis, the issuer should have the information to make that MHPAEA determination. If that information is not available, data from other similarly structured group health plans should be used. In previous guidance, the Agencies addressed the MHPAEA disclosure requirements, such as the criteria for medical necessity determinations. In these FAQs, the Agencies list a number of documents that would be helpful to a provider who is acting as a plan participant’s ERISA authorized representative to request regarding the plan’s compliance with MHPAEA with respect to a pre-authorization request for a patient’s visits for depression. The Agencies list the following documents: 1. A Summary Plan Description (SPD) from an ERISA plan, or similar summary information that may be provided by non-ERISA plans; 2. The specific plan language regarding the imposition of the nonquantitative treatment limitations (NQTL) (such as a preauthorization requirement); 3. The specific underlying processes, strategies, evidentiary standards, and other factors (including, but not limited to, all 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; 4. Information regarding the application of the NQTL to any medical/surgical benefits within the benefit classification at issue; 5. The specific underlying processes, strategies, evidentiary standards, 3 and other factors (including, but not limited to, all evidence) considered by the plan (including factors that were relied upon and were rejected) in determining the extent to which the NQTL will apply to any medical/surgical benefits within the benefit classification at issue; and 6. Any analyses performed by the plan as to how the NQTL complies with MHPAEA. Observation restrictive financial or treatment limitations on MAT than the predominant financial or quantitative limits for medical, surgical and pharmacy benefits. Note that the multi-tiered prescription drug benefit rules apply to the prescription portion, and the behavioral health component should be treated as either in- or out-patient benefits, as appropriate. In addition, depending on the MHPAEA analysis, MAT may have to be offered both inand out-of-network. After the release of this FAQ, plans may receive more document requests from providers who are acting on behalf of patients where either the benefits have been denied or the plan is requesting additional information. Plans should review their plan documents, SPDs and other information to make sure that all are up to date not only with respect to MHPAEA benefits, but with all ERISA requirements. For entities subject to ERISA, failure to provide the above documents within 30 days of the date of request could subject the plan administrator to a possible $110 per day penalty. WHCRA guidance In the FAQs the Agencies also stated that medical necessity criteria for coverage of a mental health condition from an issuer or group health plan must be made available to any current or potential enrollee or contracting provider upon request. The Takeaway The FAQs clarified that the MHPAEA applies to Medication Assisted Treatment (MAT), which is any treatment for opioid use disorder that includes medication that is FDAapproved for detoxification or maintenance treatment in combination with behavioral health services. Under the WHCRA, if a plan provides coverage for mastectomies, it also must provide coverage for breast reconstruction surgery, in a manner determined in consultation with the attending physician and the patient. The FAQs clarify that this includes coverage for nipple and areola reconstruction, including nipple and areola repigmentation to restore the physical appearance. Under WHCRA, plans and issuers may impose deductibles and coinsurance on these benefits if this cost-sharing is consistent with other cost sharing under the plan. These FAQs add significantly to the health coverage and related disclosure requirements under various laws. Plan sponsors and issuers should review their plans and documentation to make sure that the coverage requirements are met, documentation is up to date and disclosure procedures will comply with these new rules. PwC can help plan sponsors and issuers come up with an action plan to ensure compliance. Observation This interpretation means that plans and issuers may not place more pwc Insights Let’s talk For more information, please contact our authors: Amy Bergner, Washington, DC (202) 312-7598 [email protected] Anne Waidmann, Washington, DC (202) 414-1858 [email protected] Chantel Sheaks, Washington, DC (202) 375-3138 [email protected] or your regional People and Organization professional: US Practice Leader Scott Olsen, New York (646) 471-0651 [email protected] Charlie Yovino, Atlanta (678) 419-1330 [email protected] Craig O'Donnell, Boston (617) 530-5400 [email protected] Jack Abraham, Chicago (312) 298-2164 [email protected] Brandon Yerre, Dallas (214) 999-1406 [email protected] Todd Hoffman, Houston (713) 356-8440 [email protected] Carrie Duarte, Los Angeles (213) 356-6396 [email protected] Ed Donovan, New York Metro (646) 471-8855 [email protected] Bruce Clouser, Philadelphia (267) 330-3194 [email protected] Jim Dell, San Francisco (415) 498-6090 [email protected] Scott Pollak, San Jose (408) 817-7446 [email protected] Nik Shah, Washington Metro (703) 918-1208 [email protected] Stay current and connected. 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