Now that the Tri-agencies have drawn back the curtains to reveal some of the inner workings of their developing Mental Health Parity and Addiction Equity Act (MHPAEA) comparative analysis enforcement efforts, the question is: What’s next?

Insufficient Guidance

Group health plans and health insurance issuers have been operating on limited guidance ever since the 2021 Consolidated Appropriations Act (CAA) amendments to MHPAEA set in motion the current process of non-quantitative treatment limitation (NQTL) comparative analysis review. The Tri-agencies’ 2022 MHPAEA Annual Report provided some additional clarity regarding enforcement priorities and the most common deficiencies identified during reviews (summarized in Crowell’s 2022 MHPAEA Annual Report Client Alert). But guidance preceding the 2022 Report was limited: the statute sets forth five basic elements under 29 U.S.C. § 1185a(a)(8) and 42 U.S.C. § 300gg-26(a)(8), the Tri-agencies’ FAQs Part 45 provides some additional detail, and the DOL Self-Compliance Tool—which was released as a set of recommendations and best practices but not mandatory requirements—remains the best indication of what NQTL compliance should look like. The result of that limited guidance was predictable. The 2022 Report demonstrated that group health plans and health insurance issuers were not been able to divine government expectations for NQTL comparative analyses, and not one comparative analysis reviewed was found initially compliant.

Anticipated Rulemaking

Further clarification, in one form or another, appears to be on the way. One of the biggest next steps will be the issuance of additional guidance or agency rulemaking. The CAA MHPAEA amendment codified at 29 U.S.C. § 1185a(a)(8) and 42 U.S.C. § 300gg-26(a)(8) requires further “guidance” clarifying certain aspects of MHPAEA enforcement. The relevant statutory text, under the heading “Compliance program guidance document update process,” reads:

“Not later than 18 months after December 27, 2020, the Secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section. Such draft guidance shall include guidance to clarify the process and timeline for current and potential participants and beneficiaries (and authorized representatives and health care providers of such participants and beneficiaries) with respect to plans to file complaints of such plans or issuers being in violation of this section, including guidance, by plan type, on the relevant State, regional, or national office with which such complaints should be filed.”

If the statutory deadline is followed, this means that the clarifying guidance or rules should be finalized by June 27 of this year. With that date rapidly approaching—and no clarifying guidance or regulations proposed as of yet—time is growing short for the full rulemaking process to run its course. This could mean that any additional guidance won’t come in the form of formal regulation. It could mean that a clarifying rule will be proposed very soon. Or it could mean that clarifying guidance or regulation will miss the statutory deadline. Recent precedent suggests that last option is a real possibility; the 2022 Report itself was delivered a month late.

For their parts, the Tri-agencies have put MHPAEA on their regulatory agendas for the summer of 2022. Both the Departments of Health and Human Services and Labor have noted that an upcoming notice of proposed rulemaking is planned for July of this year to clarify plans’ and issuers’ obligations under the law.

Even if this additional guidance is delivered after the statutory deadline, it is expected to mark an important step forward for the Tri-agencies. Considering the extensive data and analyses collected from plans and issuers so far, hopefully the Tri-agencies now have a more complete understanding of how the relevant NQTLs are structured, and can provide more granular explanations of how comparative analyses can achieve compliance without first facing insufficiency notices or noncompliance determinations. Although the only additional guidance required by statute relates to explaining the means by which “potential participants and beneficiaries” may file complaints regarding plan or issuer violations of the NQTL requirements, the Tri-agencies appear to be aware that plans and issuers need greater clarity on how to comply with MHPAEA, especially the CAA amendments.

In any event, the Crowell Health Solutions team will be monitoring any developments or proposed rules closely.

What is Crowell Health Solutions?

Crowell Health Solutions is a strategic consulting firm focused on helping clients to pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, health equity, and value-based health care. Through our key services—strategic counseling, policy counseling and engagement, compliance counseling, and coalition building—we help clients bring pioneering products and services to market, structure results-driven collaborations and business arrangements, and advance policy priorities in the complex and rapidly evolving health care environment.

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Photo of Christopher Flynn Christopher Flynn

Chris Flynn is a partner in Crowell & Moring’s Washington, D.C. office and is co-chair of the firm’s Health Care Group. Chris focuses his practice on complex commercial litigation before federal and state courts, administrative agencies and arbitral forums. Chris regularly represents HMOs…

Chris Flynn is a partner in Crowell & Moring’s Washington, D.C. office and is co-chair of the firm’s Health Care Group. Chris focuses his practice on complex commercial litigation before federal and state courts, administrative agencies and arbitral forums. Chris regularly represents HMOs, PPOs, IPAs, TPAs, health benefit plans, fiscal intermediaries, managed behavioral healthcare organizations, plan sponsors and health care industry associations in various litigation, investigations, and regulatory matters. Chris’ experience includes all areas of health care, including payor/provider contract disputes, class action defense, ERISA preemption, subrogation disputes, regulatory challenges and whistleblower claims. Chris has also briefed health care matters for the Supreme Court as counsel for amicus curiae.

Photo of Jim Flood Jim Flood

Jim Flood is a partner in Crowell & Moring’s Washington, D.C. office and assists health care, energy, and financial services clients with legal, legislative, and regulatory issues. He is also chair of the firm’s Government Affairs Group.

A former federal prosecutor and counsel…

Jim Flood is a partner in Crowell & Moring’s Washington, D.C. office and assists health care, energy, and financial services clients with legal, legislative, and regulatory issues. He is also chair of the firm’s Government Affairs Group.

A former federal prosecutor and counsel to Senator Charles E. Schumer (D-NY), Jim has more than 20 years of experience assisting clients facing issues before the White House, Congress, the U.S. Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), the U.S. Department of Justice (DOJ), the U.S. Drug Enforcement Administration (DEA), the U.S. Food and Drug Administration (FDA), and other federal agencies. He also works with the firm’s Healthcare Group and healthcare fraud practice team to counsel clients on issues related to Medicare, Medicaid, Part D, long-term care, health care fraud, the False Claims Act (FCA), and the anti-kickback statute.

In the area of antitrust, he has advised and guided companies through public policy issues affecting mergers in the healthcare and technology sectors. In the energy sector, Jim has experience navigating renewable energy regulatory and policy matters, and he served as the General Counsel for the American Wind Energy Association (AWEA), the American Clean Skies Foundation (ACSF), and the Advanced Biofuels Association (ABFA).

In 2023, Jim was again named a “Top Lobbyist” by The Hill.

Prior to joining Crowell & Moring, Jim led all federal and state government relations for a Fortune 400 health care company with $6 billion annual revenue. Jim led the Government Affairs Department and oversaw the company’s advocacy before Congress, HHS, CMS, DEA, key trade groups, and engaged with the White House on regulatory issues. Previously, he assisted clients at Brownstein Hyatt Farber Schreck LLP, where he provided strategic government relations advice and counsel to Fortune 500 companies in the health care, financial services, and energy sectors. Prior to that, he served as an Assistant U.S. Attorney at DOJ, where he led federal and local criminal investigations of U.S. corporations and individuals, prosecuted federal white collar grand jury criminal investigations into health care fraud, securities fraud, mortgage fraud, and government contracts fraud. He tried approximately 80 federal or local jury or bench trials during his time at DOJ, and also led a two-year nationwide FCA investigation into the sale of defective bulletproof vests to federal law enforcement agencies.