During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies.
This chart displays health-related regulations that may be issued this year, organized by federal agency and date of potential release.
The Congressional Review Act (CRA) empowers Congress to act to invalidate regulations issued by federal agencies. These regulations include final rules, interim final rules and guidance documents. The CRA is most practically used by a new Congress to invalidate regulations issued by a previous administration and received within 60 legislative days of the previous Congress’ adjournment.
Should Republicans gain control of both chambers of Congress and the presidency, the 119th Congress could use the CRA to nullify certain Biden administration regulations. With federal elections looming later this year, this article reviews the CRA and how it might impact the current administration’s regulatory agenda.
A recently decided US Court of Appeals for the Ninth Circuit case, Ryan S. v. UnitedHealth Group, Inc., offers some useful insights on the enforcement by private litigants of the Mental Health Parity and Addiction Equity Act (MHPAEA). Like other similar cases, the case invites questions about the impact of potential changes under the proposed regulations issued under MHPAEA last year. Despite that the issues at this stage are procedural, the case nevertheless offers some useful insights, which this post explores.
Our previous MHPAEA content is available here.
According to the complaint, the group health plan under which Ryan S. was covered was administered by UnitedHealthcare. The plan covered outpatient, out-of-network mental health and substance use disorder (MH/SUD) benefits at 70% of covered charges and at 100% once the out-of-pocket maximum was met.
Ryan S. completed two different outpatient, out-of-network substance use disorder programs, coverage for which was denied on multiple occasion and for disparate reasons. As the complaint explains, the denials resulted from UnitedHealthcare’s use of an algorithm that assessed patients’ progress and referred cases for additional review. This additional layer of review was not applied to outpatient, out-of-network medical/surgical (M/S) claims. Ryan S. alleges that UnitedHealthcare applied a more stringent review process to benefits claims for outpatient, out-of-network MH/SUD treatment than to otherwise comparable M/S treatment. The complaint states this disparity in applicable review standards violates:
The Disposition of the Plaintiffs’ Claims
The district court had dismissed all the claims. The Ninth Circuit reversed on MHPAEA and ERISA fiduciary claims but let stand the district court’s dismissal of the claim related to plan terms.
MHPAEA requires that any limitations on “mental health or substance use disorder benefits” in an ERISA plan be “no more restrictive than the predominant treatment limitations applied to substantially all [covered] medical and surgical benefits.” Thus, said the court, to succeed, a plaintiff must show an ERISA plan that offers both M/S and MH/SUD benefits imposed a more restrictive limitation on MH/SUD treatment than limitations on treatment for M/S issues. The court then identified three situations in which such a violation might occur:
In the court’s view, the complaint raises internal process claims. As such, violations cannot be discerned with reference to the plan document. The court therefore saw no reason to disturb the district court’s dismissal of the claim relating to plan terms.
With respect to the MHPAEA and ERISA fiduciary claims, [...]
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The US Department of Health and Human Services Office for Civil Rights (OCR) recently reached a $4.75 million settlement with a New York City hospital for alleged violations of the Health Insurance Portability and Accountability Act (HIPAA).
According to OCR, in 2013, a former hospital employee sold the electronically protected medical records of 12,517 patients to an identity theft group, and the NYC hospital did not detect or report the breach to OCR until 2015. OCR’s investigation found several potential HIPAA violations, and in addition to the settlement, the hospital agreed to conduct a thorough security risk assessment, revise HIPAA policies, provide additional training to staff, begin recording and tracking all electronic health record (EHR) activity to monitor who is accessing patient information, and create a risk management plan. OCR will also monitor the hospital for two years for compliance with HIPAA.
New state privacy laws regulating health data impose significant obligations and heightened litigation and regulatory risks. During this webinar, Elliot Golding and Sam Siegfried discussed how these laws apply, what they require, and practical tips to implement and operationalize compliance.
On January 11, 2024, the US Department of Health and Human Services (HHS) published its new final rule governing federal healthcare conscience protection statutes. The 2024 final rule, which went into effect March 11, 2024, repeals the majority of the prior final rule from 2019 that was found to be unlawful by three federal courts and reverts to the 2011 framework created by the Obama administration to address rights of conscience.
In May 2023, the Texas Legislature passed Senate Bill No. 14 (SB 14), which prohibits physicians and other licensed medical professionals from providing gender-affirming medical care to minors. The bill faced numerous legal challenges but ultimately went into effect on September 1, 2023. The case challenging the bill remains pending before the Texas Supreme Court.
Amidst the legal challenges, the Texas Office of the Attorney General has used its investigative and enforcement powers under the Texas Deceptive Trade Practices Act to initiate investigations of a hospital and telehealth clinic based outside of Texas in connection with their provision of gender-affirming care to minors.
On January 31, 2024, the US Centers for Medicare & Medicaid Services (CMS) released the Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and D Payment Policies. CMS also released a press release and fact sheet. The advance notice is released on an annual basis and includes proposed updates to the capitation and risk adjustment methodologies used to calculate payments to MA plans, as well as other payment policies that impact Part D. The final CY 2025 rate announcement will be published no later than April 1, 2024.
The advance notice discusses several updates the Inflation Reduction Act of 2022 (IRA) made for 2025, including:
As a result of the IRA, CMS proposes updates to the Part D risk adjustment model to reflect the Part D benefit design.
CMS is annually required to update the parameters for the defined standard Part D drug benefit. This is meant to ensure that the actuarial value of the drug benefit tracks changes in Part D expenses. For non-low-income subsidy beneficiaries, the advance notice outlines the benefit parameters for defined standard benefits in 2025 as follows:
In an apparent attempt to shield physician practices from perceived abuses of close association with physician practice management (PPM) companies, a pending Oregon law could undermine a broad range of structures and transactions between physicians and laypersons, including loans, real estate leases, practice sales, national virtual care platforms, investor sponsored practice roll-ups and payor-provider joint ventures.
Oregon House Bill 4130 prohibits several relationships and control structures which would materially constrain the typical PPM structure utilized by hospitals, private equity sponsors, virtual care providers, managed care companies and others to create a more integrated approach to care delivery, to take advantage of efficiencies and, in many instances, simply to operate.
On January 9, 2024, the Centers for Medicare and Medicaid Services (CMS) approved the New York State (NY) 1115 Medicaid waiver “Medicaid Redesign Team” (MRT). The MRT is a long-standing waiver in NY that has continuously evolved to improve the administration, structure and financing of the NY Medicaid program; enhance Medicaid beneficiaries’ access to services; and improve health outcomes across the state. The recently approved waiver represents the next step in Medicaid redesign in NY and builds on the previous Delivery System Reform Incentive Payment (DSRIP) program.
This article reviews the major initiatives included in the MRT, components of the MRT that were excluded from the approval, implications for stakeholders and more.
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