The U.S. Department of Labor (DOL) recently announced its first settlement related to violations of the Mental Health Parity and Addiction Equity Act (MHPAEA), a case with UnitedHealthcare, and in doing so reconfirmed that ensuring mental health and substance use disorder parity is one of its highest enforcement priorities.

MHPAEA prohibits group health plans from applying financial requirements and conditions for mental health and substance use disorder benefits less favorable than those in place for medical and surgical services. Congress first enacted mental health parity in 1996 and reinforced it in 2008. Yet, concerns remain, as outlined in this 2019 Milliman report, that enrollees needing mental health and substance use disorder services too often face barriers to accessing needed care. Current concerns stem from restrictions in the way benefits are applied: the non-quantitative treatment limitations (NQTLs), such as prior authorization, step therapy, or “must fail-first” conditions, and provider credentialing requirements which may lead to inadequate network coverage for certain services.

Hence, the December 2021 Consolidated Appropriations Act (CAA) imposed new requirements on group health plans to ensure their compliance. It requires group health plans to perform and document comparative analyses of the design and application of NQTLs to ensure parity. Plan sponsors must be prepared to submit sound evidence of compliance to the secretaries of the Department of Health and Human Services, the DOL, and the Department of the Treasury within 45 days of a request.

The CAA is clear in its intent to hold federal agencies, employers, insurers, and other plan administrators responsible for closing the gap. It requires federal agencies to request detailed comparative analyses from at least 20 group health plans and/or health insurance issuers each year. The agencies are also required to issue a report to Congress each year, and make publicly available information about the comparative analyses, including the names of the group health plans selected, whether the group health plans submitted sufficient information, and whether any of the plans were found not to be in compliance with the MHPAEA. Plans unable to successfully demonstrate parity in the required timeframe are likely to receive a corrective action plan and could be subject to public shaming and financial penalties.

Unlike many of the other provisions of the CAA that affect group health plans, the MHPAEA requirements of plan sponsors under CAA section 203 went into effect on February 10, 2021. The DOL has created a self-compliance tool to support plans and insurance companies in meeting the law’s requirements. However, specific guidance on how to quantify and compare the impact of NQTLs is not yet available. These are expected by June 2022. Your plan administrator, PBM, and consulting partner will also have resources to support you on the path to ensuring and confirming mental health and substance abuse parity in your benefit offering.

Best,

Louise Y. Probst

BHC Executive Director

The Supreme Court of the United States recently declined to hear an appeal filed by the American Hospital Association (AHA) to override a lower court’s decision enabling the Centers for Medicare & Medicaid Services (CMS) to enact site-neutral payment policies, opening a huge savings opportunity for all. A simple concept - equal payment for a service regardless of where the service was performed - has been discussed for almost a decade and hotly contested in the courts over the past few years. The CMS savings estimate alone was $800,000,000 in reduced outpatient payments in 2020.

Traditionally, CMS and private health plans have been willing to pay significantly more for outpatient services performed at a hospital-owned site of care than at a physician or non-hospital owned site of care. This was done to recognize that hospital-owned facilities may be staffed or equipped for higher risk patients and may be subject to stricter regulations. In April 2021, AHA released a study which showed that Medicare patients who received care in a hospital outpatient department were more likely to be poorer and have more severe chronic conditions than Medicare patients treated in an independent physician office.

Yet, there is another side of the story. Medicare Payment Advisory Commission research, conducted in response to a request from Congress, found that paying hospital outpatient departments at a higher rate has driven provider consolidation and created havoc in the marketplace for health care services. Responding to incentives to maximize profit, hospitals have gobbled up physician practices and dramatically expanded the number of sites billing as hospital outpatient departments.

According to the Alliance for Site Neutral Payments, these misaligned payment policies have greatly diminished the number of independent physician practices nationwide and driven costs higher for patients, employers, and taxpayers.  

The savings opportunity ushered in by this Supreme Court decision comes without impacting quality or reducing coverage and brings financial benefit to employees as well. In fact, Families USA calls it an overlooked victory for consumers.

We encourage you to talk to your health plan about their transition to site-neutral payments and to stay tuned for strategies to inform and engage employees in capturing this opportunity.

Warm regards,

Louise Y. Probst

BHC Executive Director

Last month the Food and Drug Administration (FDA) approved Aduhelm, Biogen’s new intravenous treatment to slow the progression of Alzheimer’s Disease (AD), and in doing so set off a firestorm of controversy that may take years to sort out. The FDA used the accelerated approval pathway, intended for a drug that treats a serious or life-threatening illness and that provides a meaningful therapeutic advantage over existing treatments. The agency and some patient advocates argue that, despite a lack of convincing evidence that the drug works, this is reasonable given that there are no effective medicines to slow or reverse AD, and none have been approved in almost 20 years. 

Of the 11 physician researchers and clinical experts on the independent FDA advisory panel, 10 voted against approval and one voted uncertain. They claimed that the available evidence created significant doubt that the drug will slow the progression of AD and may bring potentially serious adverse effects, with their own impact on cognition, such as brain swelling, brain bleeds, headaches, confusion, dizziness, and falling. The side effects are common and potentially serious enough to require all patients taking Aduhelm be monitored with routine MRI scans. Three members of the advisory panel resigned over the FDA’s disregard for the science, failure to communicate its change in position regarding endorsement, and a concern that the approval would slow meaningful progress in combating AD.

It seems that significant research targeting amyloid over the past twenty years has failed to produce convincing evidence of causality. Biogen had abandoned Aduhelm, stopping two clinical trials before their completion due to disappointing results. Only later upon closer examination did it note that findings in one of its studies suggested a slowing of the disease for patients with early cognitive decline. As part of its approval, the FDA will require Biogen to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. It has given them 9 years to complete the research. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug. Eli Lilly and others had invested in and shelved their drugs to treat the amyloid present in AD due to disappointing results. Lilly has now announced that it will seek approval for Donanemab during 2021 under the FDA’s accelerated approval process. Other similar drugs, previously shelved, are expected to also be presented for approval.

There is an ongoing debate about the clinical relevance of amyloid in cognitive decline. While amyloid plaques and protein tangles are commonly found in patients with AD, evidence that they cause the disease’s devastating memory loss or that reducing the amyloid will yield clinical improvement has yet to be demonstrated. Some researchers fear that approval of these drugs and their potential blockbuster profits will consume resources and research dollars better directed toward other causative factors, such as blood pressure or inflammation. Follow up interviews with members of the FDA advisory panel reveal that in November 2020 the FDA told them that it would not be counting the drug’s ability to reduce amyloid as an indication that Aduhelm might be effective, but in June and without further communication to or evaluation by advisory panel members, the FDA reversed course. Esteemed neurologists, other physicians, researchers, policy experts, and journalists are speaking out about the FDA’s action. Congress has initiated hearings into the relationship between Biogen and the FDA. 

Biogen has priced the drug at $56,000 annually per patient and projected it would be used by 1 to 2 million patients per year. With related imaging and other treatment costs, the expense is expected to be $100,000 per patient. While some think this utilization estimate is overstated, most agree that the expense is out of reach for even Medicare. Depending on the numbers, the drug is projected to add between $6 to $29 billion to Medicare Part B drug spending, more than the U.S. spends each year on NASA or the Environmental Protection Agency. Many claim that dollars would be better spent on developing better evidence for other therapeutic interventions that reduce the burden of disease. 

There is more to come on the outcome of this FDA decision. The Centers for Medicare and Medicaid is considering its options with regard to coverage of these unproven medications. While employer-based plans will have less demand for treatment and immediate financial impact than Medicare, we know all too well that the cost of U.S. health care is borne by all and most directly shouldered by American workers. Self-insured employers will want to discuss coverage options with their insurance partner and watch for CMS’ decision and the outcome of further investigations of the FDA’s decision. One thing seems clear, employers may need to reconsider their use of FDA approval as a standard for the efficacy and safety of a medication. Time will tell.

For those interested in the aging brain, 60 Minutes did a six-year update of findings from a NIH-funded research study at the University of California Irvine last fall. It provides a fascinating look at the lives of several nonagenarians and potentially instructive real world insight into the presence and impact of amyloid on memory and cognition. 

Warm regards, 

Louise Y. Probst

BHC Executive Director

Recently released survey results confirm what anecdotal conversations have been hinting at for some time: business executives’ attitudes related to health care spending and the role of government in providing coverage and lowering costs have changed. The survey report, How Corporate Executives View Rising Health Care Costs and the Role of Government, taps into the thinking of more than 300 business leaders from diverse industries, each with more than 5,000 employees. The research was a collaborative effort of the Kaiser Family Foundation and the Purchaser Business Group on Health and was funded by the Gary and Mary West Health Institute.  

Significant concern for health care spending and cost growth is widespread among employers. While organizations believe that they have some ability to control costs, such as with plan and payment design, they recognize that many solutions are outside of their control. Uncertain of how much longer they will be able to shoulder the growing financial burden without government intervention, business executives did not assign one factor as the predominant driver of excessive cost or identify a “silver bullet” solution. The survey asked the executives to rate four contributing factors to high costs: fee-for-service payments, provider consolidation, drug costs, and unhealthy behaviors. Provider consolidation is an area where the government has clearly failed the American public over the past several decades. Ninety-four percent of respondents felt it was a very large, considerable, or moderate factor in driving high health care costs.  

Historically, business executives have been believed to prefer market-based solutions in order to transform health care, and they likely still do. Yet, health care industry insiders have held significant power over the regulatory and other mechanisms that enable markets to work effectively. As a result, Americans pay between two to four times more for prescription drugs than citizens of other countries and reimbursements from businesses and their workers are two to three times above those of Medicare. These recognitions may be the financial sense behind changing employer attitudes. In some way, those higher prices have been a hidden tax imposed by health systems and other suppliers on American workers, while policymakers pretended not to notice.  

The survey is important because little research has attempted to identify and quantify the attitudes of business executives on the cost of providing health benefits. Even with these results, much remains to be understood about businesses’ health policy preferences, although it cannot be ignored that a surprising 83% of respondents reported that a greater government role in providing coverage and containing costs would benefit their business. 

These results come in conjunction with the end of the Biden Administration’s first 100 days in office, turning attention to its social and health care policy agendas. Although not included in the President’s American Families Plan announced last week, it is expected that initiatives, such as those to lower the eligibility age for Medicare, expand the range of covered health services, and empower the government to negotiate prescription drug prices are in the wings. So buckle up for a fierce debate of ideas before the November 2022 mid-term election when all 435 seats in the United States House of Representatives and 34 of the 100 seats in the United States Senate will be contested.

Warm Regards,

Louise Y. Probst

BHC Executive Director

March has arrived and brings memories of the pandemic’s beginning. Only a year ago, we were implementing new safety policies, and many of us were transitioning to remote work, without knowing how long these accommodations would be needed. While it is still not clear when "normal" will return, there is some good news regarding the impact of our prevention efforts. As we reflect on the past year and the path forward to recovery, the BHC is turning its focus to opportunities to build resilience among individuals, organizations, and communities in a post-pandemic world.

A quick look at this NPR site shows the severity of each state's coronavirus outbreak, with an easy toggle to track vaccines, new cases, hospitalizations, and deaths. New infection rates vary across the country and are organized into four risk categories of  green, yellow, orange, or red based upon the number of new daily cases per 100,000 people. Categorized as yellow, Missouri is reported to have eight new cases per 100,000 people and 476 average daily cases as of March 3, indicating the need for continued social distancing and mask usage. Along with Oregon and Hawaii, Missouri is among the lowest states for new infections, although community spread has yet to be stopped. All of Missouri’s bordering states are experiencing higher rates of new infections, ranging from 13 to 30 new daily cases per 100,000. Arkansas is categorized as a red risk level, having unchecked community spread, along with ten other states. New York and New Jersey tie for the highest at 38 new daily cases per 100,000 people.

As of the date of this post, COVID-19 vaccines have reached 15% of Americans, and about 1.7 million vaccines are being administered per day. Missouri lags a bit at only 13.6% of residents having had one or more vaccine, with state leaders expecting that everyone who wants a vaccine will be able to get one by July. Dr. Fauci reports that if 75-80% of Americans accept vaccination when offered, the U.S. should reach herd immunity by the end of second quarter 2021 and be close to our previous “normal” by the end of 2021. 

The current data on new infections suggests that Missouri’s collective commitment to prevention is working. Thanks to everyone for remaining vigilant. The data also shows that the rate of spread in states can change from week to week. Staying the course is essential. So is building our reserves so as to be positioned for the next novel virus or other public health challenge. 

The BHC's Community Forum on April 29 has been designed to identify steps that we can take as individuals, businesses, and communities to build resilience in a post-pandemic world. Keynote speaker Dr. Martin Seligman (also known as the "father of positive psychology") will share the science of fostering personal and organizational resilience, as well as growth following trauma, rather than stress. The CDC’s Deputy Director for Infectious Diseases, Dr. Jay Butler, will follow with insights on lessons learned from COVID-19 and opportunities to strengthen our public health and primary care infrastructures for future infectious threats. A panel of local leaders will close the event, reflecting on a shared to-do list to support recovery in the St. Louis region, including economic stability, health care strategies, and technological innovation. Registration for this virtual conference is free for BHC members, and we hope that you will join us for an upbeat morning focused on creating a better future. 

Warm Regards,

Louise Y. Probst,

BHC Executive Director