Thursday, April 21, 2016

Compromise Prospects Recede In Contraceptive Mandate High Court Litigation

Tim-ACA-slide

While briefs filed on April 12 by the petitioners and the government in Zubik v. Burwell, the Supreme Court contraceptive mandate case, suggested that there might be room for the Court to impose a compromise, reply briefs filed on April 20, indicated that the parties are still pretty far apart.

The petitioners insist that the only acceptable solution would be one in which they did not need to do anything (including self-certification) other than provide coverage to their employees excluding contraception. Insurers could in turn offer separate contraceptive coverage in which their employees would have to enroll independently as long as the petitioners were not involved.

The petitioners further insist that they have a right under the Religious Freedom Restoration Act (RFRA) to self-insure. If they choose to self-insure, the government will have to find a way of independently providing contraceptive coverage to their employees. They also object that the government would force them to abandon self-insured church plans, although the government has expressly conceded that it cannot require self-insured church plans to cover contraceptives.

The government in its brief contends that "contraceptive only" insurance coverage would be prohibited by a number of state laws and would be unworkable. Moreover, an affirmative requirement that women enroll in contraceptive coverage would impose, the government argues, a needless barrier to the seamless coverage that it contends is necessary. RFRA does not allow the petitioners to opt out of the law without notifying anyone.

The government repeats its contention that the petitioners' proposals for self-insured plans are unworkable and would frustrate the purpose of the preventive services requirement. Finally, it questions the assertion of the petitioners that their female employees are unlikely to use contraceptives, pointing out that the petitioners include Notre Dame and a major hospital system, and that women of all religions in fact use contraceptives.

The Court may in the end impose a compromise that would be acceptable to five of the justices, but perhaps to neither party. A four-to-four split, which would leave the rule in place through most of the country except the Eighth Circuit, seems also very possible.

We may well not know until June where the Court lands.

The ACA And The Mental Health Parity, And Women's Health And Cancer Rights Act

On April 20, 2016, the Departments of Health and Human Services, Treasury, and Labor released a new set of frequently asked questions (FAQs) addressing issues that have arisen under the Affordable Care Act and Mental Health Parity ,and Women's Health and Cancer Rights Act. The FAQs by and large repeat guidance offered earlier, although in a few areas they provide greater detail. They presumably address issues where there have been misunderstandings or compliance issues.

Coverage Of Preventive Services

The first topic addressed by the FAQs is coverage of preventive services required under the ACA. The FAQs repeat earlier guidance requiring non-grandfathered group health plans and health insurance coverage to cover without cost sharing prescribed medically appropriate bowel preparation medications for screening colonoscopies.

Plans and insurers must also cover without cost sharing at least one form of contraception in each of the 18 currently approved FDA contraceptive methods. Plans and insurers must make available an expeditious exceptions process when an individual's attending provider concludes that a different FDA-approved item within a specific method of contraception is medically necessary, and must defer to the determination of the attending provider. Plans and insurers may use a standard exception form, and may use the Medicare Part D Coverage Determination Request form as a model.

Rescissions

The ACA prohibits coverage rescissions (retroactive cancellations or discontinuations) if premiums are paid on a timely basis, except when an enrollee commits fraud or makes an intentional misrepresentation. The FAQs describe a situation in which a teacher employed on a 10-month contract from August 1 to May 31 has coverage from August 1 to July 31. The FAQs clarify that if the teacher resigns on July 31, stating an intention not to teach the following year, and premiums have been paid through July 31, the health plan may not terminate coverage retroactively to May 31.

Billing For Out-Of-Network Emergency Services

The ACA prohibits non-grandfathered health plans and insurers from imposing cost sharing for out-of-network emergency services for a greater amount than that imposed for in-network emergency services. Cost sharing, however, does not include balance billing, which is the difference between what an out-of-network provider charges and the allowed amount an insurer will pay plus any cost-sharing obligations.

The emergency services regulation attempts to mitigate balance billing by requiring plans and insurers to pay out-of-network emergency services providers a minimum payment of at least the greatest of 1) the median amount paid in-network providers, 2) an amount calculated using the method the plan usually uses for paying for out-of-network services, or 3) the amount Medicare would pay. If state law or the plan or an insurer's contract limits balance billing further the minimum payment requirement may not apply, but enrollees cannot then be subjected to copayment or coinsurance requirements greater than would apply for in-network services.

The FAQs clarify that the documentation and data that plans governed by The Employee Retirement Income Security Act of 1974 (ERISA) use for calculating each of the emergency services minimum payment standards are subject to disclosure, to plan participants or their authorized representatives, within 30 days of request. Additionally, non-grandfathered health plans and insurers must provide claimants—upon request and free of charge—reasonable access to and copies of all information relevant to adverse benefit determinations, including emergency services minimum payment determinations, under Department of Labor claims procedure regulations and ACA internal claims and external appeals requirements.

Clinical Trial Participation

The ACA prohibits non-grandfathered health plans and insurance coverage from denying qualified individuals the right to participate in approved clinical trials with respect to cancer or other life-threatening diseases, or denying coverage for routine patient costs for items and services furnished in connection with participation in clinical trials. A qualified individual is an enrollee who is eligible to participate in such a clinical trial and has been referred by a participating provider, or who establishes by scientific or medical information that participation is otherwise appropriate.

Routine patient costs do not include the cost of the investigational item, device, or service; items needed solely for data collection or analysis needs; and services clearly inconsistent with widely accepted and established standards of care. Health plans and insurers are not required to cover out-of-network patient care services unless out-of-network benefits are otherwise covered.

There are two questions pertaining to coverage of clinical trial routine patient costs. The first clarifies that non-grandfathered plans and insurers cannot deny or impose additional conditions on coverage of chemotherapy that would otherwise be covered to a qualified individual who is participating in a clinical trial — for example, a trial for a new anti-nausea medication. The second FAQ provides that non-grandfathered plans and insurers must cover the costs of items and services provided to diagnose or treat adverse events and complications arising from participation in clinical trials if they would otherwise cover the items and services for individuals not enrolled in a clinical trial.

Reference Pricing

The ACA imposes maximum limits on in-network cost sharing; the limits are currently $6,850 for individuals and $13,700 for other than self-only coverage. Under reference pricing, a non-grandfathered insured or self-insured large group plan pays a fixed amount for a particular procedure (such as knee replacements) which certain providers accept as payment in full.

In earlier guidance, HHS, Treasury, and Labor stated that they would consider all facts and circumstances in deciding whether a plan's reference pricing design (or similar network design)—that treats providers who accept the reference price as the only in-network providers and excludes cost sharing for other providers from counting against the in-network maximum—is using a reasonable method to ensure adequate access to quality providers.

The FAQ states clearly that a non-grandfathered plan or insurer that merely establishes a reference price (or similar network design) without using an adequate method to ensure access to quality providers at the reference price will not be considered to have established a network for purposes of the out-of-pocket limit. The excess paid by enrollees above the reference price would thus count toward the out-of-pocket limit. It may be significant that the FAQ applies this rule not just to reference prices but also to "similar network designs," whatever that means. The FAQ states that small group and individual non-grandfathered coverage is subject to additional requirements under the essential health benefit provisions, but does not specify what these additional requirements are.

Mental Health Parity And Addiction Equity Act

Four questions clarify Mental Health Parity and Addiction Equity Act (MHPAEA) requirements. The MHPAEA prohibits plans and insurers from imposing more restrictive financial requirements or treatment limitations—including nonquantitative treatment limitations (NQTLs)—than those that apply to substantially all medical and surgical benefits.

The FAQs clarify that types of financial requirements (such as copays or coinsurance) or quantitative treatment limitations (such as day or visit limits) cannot be applied to mental health and substance use disorder (MH/SUD) benefits unless they apply to at least two thirds of all medical/surgical benefits in the same classification. (It defines "substantially all," that is, to mean two-thirds.) If a type of limitation applies to at least two thirds of the medical/surgical benefits, the predominant level of requirement or limitation that may be applied to MH/SUD benefits is the one that would apply to at least half of the medical/surgical benefits subject to the a requirement or limitation, based on dollar amount of plan payments.

One FAQ clarifies that the "substantially all" and "predominant" tests cannot be applied considering an insurer's overall book of business, but must rather be determined considering the particular group health plan at issue, or, when data is not available for the single plan, considering similarly structured group health plans with similar demographics. In the small group and individual market, the tests should be applied at the plan rather than the product level if possible. When employers or insurers contract with managed behavioral health organizations to provide MH/SUD benefits, the group health plan or health insurer is responsible for providing enough information to the managed behavioral health organization to ensure its compliance with MHPAEA requirement.

Another section of the FAQs addresses disclosure requirements. The MHPAEA requires plan administrators and health insurers to disclose the criteria for MH/SUD medical necessity determinations to any current or potential participant, beneficiary, or contracting provider on request, and to disclose the reason for any denial of payment for a MH/SUD service to a participant or beneficiary. Plans subject to ERISA must disclose information within 30 days of a request. ERISA claims procedures and ACA internal and external appeals requirements that apply to non-grandfathered plans and insurers also require disclosure of information relied on for benefit determinations.

Another FAQ addresses the question of which documents a provider (acting as an individual's authorized representative) could request to establish MHPAEA compliance. These include

  • the summary plan description;
  • specific plan language applying to an NQTL;
  • the specific underlying processes, strategies, evidentiary standards, or other factors considered by a plan in determining whether an NQTL applies;
  • information regarding the application of an NQTL to medical/surgical services; and,
  • any analyses performed by the plan as to how an NQTL complies with the MHPAEA.

Plans and insurers may not withhold this information claiming that it is proprietary or commercially valuable. Plans and insurers must provide information on request to potential as well as actual enrollees or providers.

The FAQs clarify that the MHPAEA applies to medication-assisted treatment for opioid use disorder, including medication that is FDA-approved for detoxification or maintenance treatment in combination with behavioral health services. Discrimination is prohibited with respect to network tiering.

A final FAQ clarifies that the Women's Health and Cancer Rights Act requires that plans or insurers that cover mastectomies must cover all stages of breast reconstruction, including nipple and areola reconstruction and repigmentation to restore the physical appearance of the breast.



from Health Affairs BlogHealth Affairs Blog http://ift.tt/1YIZSRZ

No comments:

Post a Comment