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White House announces new mental health parity regulations

By Jeff Levin-Scherz, MD, MBA | August 22, 2023

Our population health leader weighs in on mental health regulations, AI and prior authorizations, Medicare drug negotiations, exercise and hearth disease, and OTC birth control.
Health and Benefits

The Mental Health Parity and Addiction Equity Act (MHPAEA), passed 15 years ago, requires employers that provide benefits for mental health or addiction care must ensure that their plan limitations don’t exceed those on medical or surgical care plans. Yet data indicate that there are still barriers to care.

For example, parents of children who need psychiatric care have an especially hard time. Severely ill children and adolescents sometimes spend days or even weeks in hospital emergency departments awaiting an inpatient psychiatric bed. Many therapists are out-of-network, and out-of-pocket costs can make mental health care unattainable. Most with mental health issues never obtain care, and those with substance use disorder are even more likely not to obtain care.

New mental health regulations

On July 25, 2023, the Biden administration announced draft regulations aiming to increase access to mental health and substance use care. The regulations would require the following:

  • Employers must demonstrate requirements for coverage are no more stringent for mental health and substance abuse treatment than for medical surgical benefits.
  • Employers must demonstrate parity in utilization of mental health/substance abuse treatment compared to medical/surgical treatment.
  • Out-of-network payments must be calculated similarly for medical and mental health providers.
  • Applied behavioral analysis therapy coverage will be required for any plan that covers autism spectrum disorder; eating disorder treatment must be covered for any plan that covers nutritional counseling for medical diagnoses.
  • Employer health plans will continue to be required to demonstrate that mental health and addiction services and networks are adequate and are not subjected to discriminatory levels of prior authorization.

Congress added state and local governmental plans to MHPAEA in 2020, and these draft regulations would codify these changes. These regulations, once finalized, will go into effect no earlier than January 1, 2025.

The federal government’s recent annual report on MHPAEA enforcement actions shows that dozens of plans violated parity rules, including non-allowed policy limits, differential cost sharing and differential utilization management programs.

Implications for employers

  • Requirements to comply with MHPAEA are the responsibility of the plan sponsor, not the insurance carrier.
  • Employers should have an outside party complete a comparative analysis to be sure they comply with MHPAEA, including a review of utilization data to evaluate parity.
  • Mental health access can improve dramatically with virtual care. There are now virtual/home substance use disorder care offerings, too.
  • Many companies have expanded their employee assistance programs to supplement in-network care and provide support for the neurodiverse community. These services are not considered in Department of Labor parity evaluations.

AI can help streamline prior authorizations

A recent editorial in the New England Journal of Medicine sums up prior authorization well: “Prior authorization is one of the most enduring, infuriating and effective tools in the United States for managing healthcare spending.”

Medical providers hate prior authorization because it wastes patients’ and providers’ time, sometimes delays medically necessary care and comes between patients and their providers. But prior authorization for nonemergency services is a bulwark against medically unnecessary care that could hurt patients and drive up costs. Without prior authorization we’d face higher medical inflation, making health insurance less affordable and further raising out-of-pocket costs. Prior authorization and post-service claim reviews discourage low value care.

Prior authorization should be standardized so the same information is required for all payers. Determinations should be rapid, and appeals should be fair and expeditious. This type of data analysis seems a great fit for artificial intelligence (AI), especially when considering:

  • The volume of medical claims is enormous.
  • An insurance plan can use information from demographics and diagnoses from past medical and pharmacy claims to determine whether a prior authorization should be granted quickly or if it needs further review.
  • Plans could identify providers whose requests are rarely rejected and avoid requiring approvals from them altogether.
  • Clinical reviewers can limit their review to the small portion of prior authorizations that are far more likely to be justifiably rejected.

AI prior authorization denials should be reviewed

There is controversy around using AI in prior authorization that may impact members of employer-sponsored health plans and illustrate the importance of a qualified clinician’s role in the review process of denials.

Consider, for example, AI-calculated lengths of stays. StatNews reported that Medicare Advantage plans used AI to determine the likely length of stay for skilled nursing care and issued denials based on these projections. Clearly terminations of benefits for frail, elderly people in skilled nursing facilities need to be reviewed by a clinician. There has also been controversy about use of AI use in prior authorizations in commercial health plans.

There is plenty of room to use AI to identify which prior authorizations should sail through and which patients are likely to need enough skilled care that their ongoing stay in a facility need not be reviewed. But the role of human clinicians remains critical when services are being denied.

Implications for employers

  • Employers should expect their carriers to use AI tools to streamline prior authorization. This will give a competitive advantage to large national carriers that have the resources to invest in AI and the large databases on which to train their models.
    • For example, pharmacy benefit managers (PBMs) are currently reviewing how to leverage AI to analyze authorization request attributes with historical member, prescriber and physician assistant detail trends and predict the likelihood of physician assistant approval.
  • Employers can check with their carriers to be sure that denials are reviewed by clinicians before being finalized and members are fully informed and offered appropriate appeals rights.
  • Employers can also ask for reporting on denials, appeals and rates of overturning initial decisions. (Note: I would be cautious to request reporting on use of AI since I think it will be used quite widely.)
  • Carriers can increase their educational efforts around low value or out-of-network services so members are not surprised when inappropriate laboratory tests are not covered by their insurance.

Medicare drug negotiations start in September

The Inflation Reduction Act requires that the Centers for Medicare and Medicaid Services (CMS) negotiate prices for Medicare and Medicaid for certain high-cost single-source drugs and biologics. The negotiations take place between this fall and next spring, and the first negotiated prices for Part D (outpatient) drugs will go into effect in 2026. CMS is required to identify an additional 15 Part D drugs in 2027, 15 Part B (inpatient) and Part D drugs in 2028, and 20 Part B and Part D drugs in 2029. There are severe tax penalties for pharmaceutical companies with targeted drugs that cannot reach a negotiated price with CMS.

This is big news. The initial Medicare Part D legislation prohibited CMS from negotiating prices. CMS is the largest purchaser of drugs and therefore likely to be able to substantially lower acquisition cost. CMS already implements prices for inpatient and outpatient services and has historically been able to keep unit cost increases lower than those in commercial insurance.

The pharmaceutical industry is pushing back hard. Various pharmaceutical companies are suing CMS in different jurisdictions, and the Chamber of Commerce has asked for an injunction against this portion of the Inflation Reduction Act. Reuters reports that some pharmaceutical companies are reformulating their blockbuster infusions to allow self-injection to increase the period before these drugs are subject to negotiation.

Implications for employers

  • It’s hard to predict the impact of the Medicare negotiation on the prices employer-sponsored health plans pay for drugs.
    • There is concern that negotiations could encourage pharmaceutical companies to increase launch prices to avoid future inflation penalties, although this could be offset with higher rebates.
    • Others point out that for medical services, lower government reimbursements have led to lower costs in commercial health plans.
  • Lowering U.S. drug prices will likely mean less capital available to the pharmaceutical industry, which could mean less innovation in the future. The Congressional Budget Office estimated about 13 fewer new drugs (1%) over the next 30 years.
  • We’ll learn more as court cases proceed and CMS unveils the targeted drugs and begins negotiations this fall, if litigation doesn’t put this on hold.

Daily or weekend exercise can prevent heart disease

Current guidelines suggest adults should exercise moderately 150 minutes a week and do muscle strengthening exercises twice a week. This study demonstrates that it doesn’t appear to matter how we distribute that exercise through the week.

Researchers tracked the cardiovascular outcomes of almost 90,000 middle-aged adults in the U.K. over a period of 6.3 years after they did a week of accelerometer measurement to determine their exercise patterns. Those who met the recommended exercise requirements with more than 50% of calories expended during two of the seven days were categorized as weekend warriors, and those who exercised over three or more days were categorized as regular exercisers. About a third of the population did not exercise regularly at all.

The researchers found that exercising mattered a lot – those who exercised were as much as a third less likely to have cardiovascular events. It didn’t matter whether they were weekend warriors or distributed their exercise over the entire week.

The researchers note that the week of accelerometer use might not have accurately represented exercise over the six-year period, and those who had more illness at the baseline might have been more likely to be inactive.

Implications for employers

  • Encourage employees to exercise regularly. Exercise not only protects against cardiovascular disease and lowers weight, it makes people feel happier.
  • Health benefits of exercise are likely gained regardless of how that exercise is distributed through the week.
  • Employers can encourage exercise by offering onsite facilities, subsidies for gym memberships or lifestyle spending accounts, and providing bike racks and places to change for those who exercise adjacent to the workday.

Over-the-counter birth control and employer-sponsored health plans

The Food and Drug Administration (FDA) approved OPill in mid-July, and the birth control drug is expected to be available without prescription in pharmacies early in 2024. There will be no age limitation. This is a progesterone-only pill, which means it’s slightly less effective than combination estrogen-progesterone pills but does not pose special risks for smokers and is not associated with excess risk of blood clots. OPill is dramatically more effective than condoms, although less effective than long-acting contraception such as intrauterine devices (IUDs).

Birth control pills are available without a prescription in over 100 countries, and physician groups including the American Academy of Family Physicians, the American College of Obstetrics and Gynecology, and the American Academy of Pediatrics have advocated for over-the-counter (OTC) availability.

The Affordable Care Act (ACA) requires that employer-sponsored health plans cover at least one of each type of prescribed birth control (oral contraceptives, progesterone implants or injections, or IUDs) with no cost sharing, which has dramatically decreased out-of-pocket costs for women using birth control. ACA regulations do not currently require employer-sponsored plans to cover OTC oral contraceptives, although it is possible that the Biden administration will declare new regulatory language that would require such coverage.

The manufacturer has not yet released the proposed price for OPill.

Implications for employers

  • OTC availability for this contraceptive pill could increase women’s ability to control their fertility and time pregnancies.
  • PBMs have not yet announced how they will approach the potential for coverage of OPill. PBMs already offer some OTC contraception products at zero cost, including emergency contraceptives such as Plan B, spermicides, and male and female condoms, although they may require physician prescriptions for coverage.
  • Most OTC medications, even those that previously required prescriptions, are not covered by employer-sponsored health insurance. However, most are relatively inexpensive (such as ibuprofen for muscle aches or omeprazole for heartburn).
  • Adding a prescription requirement for coverage of OTC medications adds administrative complexity and increases medical costs and inconvenience if this leads to extra office visits.
  • Be on the lookout for information about pricing and potential regulations regarding coverage.

Population Health Leader, Health and Benefits, North America

Jeff is an internal medicine physician and has led WTW’s clinical response to COVID-19 and other health-related topics. He has served in leadership roles in provider organizations and a health plan and is an Assistant Professor at Harvard Chan School of Public Health.

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