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.
The US Department of Health and Human Services and the US Department of Justice recently published new proposed rules that update and create various requirements under Section 504 of the Rehabilitation Act of 1973 and Title II of the Americans with Disabilities Act of 1990. What are some of the biggest changes?
This post continues our consideration of comments submitted in response to proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). Our previous MHPAEA content is available here.
Under current law, if a plan provides any mental health or substance use disorder (MH/SUD) benefits in any classification of benefits, benefits for that condition or use disorder must be provided in every classification in which medical/surgical (M/S) benefits are provided. Classifications for this purpose include inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs. The proposed regulations modify this standard by providing that a plan does not provide benefits for MH/SUD benefits in every classification in which M/S benefits are provided unless the plan provides meaningful benefits for treatment for the condition or disorder in each such classification “as determined in comparison to the benefits provided for medical/surgical conditions in the classification.”
The term “meaningful benefits” is nowhere defined. The regulators nevertheless “recognize that the proposal to require meaningful benefits [ ] is related to scope of services.” “Scope of services” for this purpose generally refers to the types of treatments and treatment settings that are covered by a group health plan or health insurance issuer. The preamble to the proposed regulation invites comments on how the meaningful benefits requirement “would interact with the approach related to scope of services adopted under the 2013 final regulations.” The preamble of the 2013 final regulations addressed an issue characterized as ‘‘scope of services’’ or ‘‘continuum of care’’ but otherwise failed to provide any substance. Two examples from the proposed regulations do, however, give us a sense of what the regulators have in mind.
Notably, the newly proposed meaningful benefits requirement is separate from, [...]
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Comments submitted in response to the proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) reflect a broad range of perspectives. Our previous MHPAEA content is available here.
A nontrivial subset of the comments single out a particular nonqualified treatment limitation (NQTL) for special treatment or scrutiny. An example of this trend is found in an October 16, 2023, comment letter submitted by the Legal Action Center. The letter asks the US Departments of Labor, Health and Human Services, and the Treasury (the Departments) to address the rule’s treatment of medical standards of care and medical necessity.
Under the 2013 final MHPAEA regulations, a plan or issuer may not impose an NQTL with respect to mental health/substance use disorder (MH/SUD) benefits in any classification unless the processes, strategies, evidentiary standards or other factors used in applying the NQTL in the classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards or other factors used in applying the limitation with respect to medical/surgical (M/S) benefits. (Classifications for this purpose include inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs.)
The proposed regulation defines “strategies” as “practices, methods, or internal metrics that a plan or issuer considers, reviews, or uses to design an NQTL.” Compliance with and deviations from generally accepted standards of care are cited as examples. Strategies for this purpose include “the development of the clinical rationale used in approving or denying benefits,” which is the central purpose of medical necessity determinations.
Medical necessity criteria are considered NQTLs because the criteria have the capacity to limit a patient’s access to or duration of MH/SUD treatment that are not based on the frequency of treatment, number of visits, days of coverage or days in a waiting period (the latter are quantitative treatment limitations). The Legal Action Center claims that plans sometimes develop their own criteria for determining medical necessity for MH/SUD treatment or use criteria developed by nonprofit clinical specialty associations or industry entities, despite the law’s admonition that plans must treat the two comparably. Concerned that under the proposed regulation plans retain significant discretion to adopt overly restrictive medical necessity criteria, the Legal Action Center asks the Departments to revise the definition of “strategies” to include a definition of “generally accepted standards of care” that is tied to criteria and guidelines from the nonprofit clinical association for the relevant specialty.
One way to determine the quality of a medical necessity definition is to look at claims data, which offer a useful test of parity compliance. Current law does not require parity of outcomes, but the proposed regulation does. The proposed rule would require that plans collect and evaluate outcomes data for the express purpose of assessing the impact of the NQTL on access to MH/SUD benefits. Material differences in outcomes are viewed as a strong indicator of noncompliance. (For the network composition NQTL, a material difference in outcomes data [...]
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Discrimination on the basis of disability has contributed to significant disparities in healthcare and child welfare. To address these disparities, the US Department of Health and Human Services (HHS) recently proposed updated regulations implementing Section 504 of the Rehabilitation Act of 1973 to prohibit discrimination on the basis of disability in programs or activities that receive HHS funds. Although most of the revisions align with expectations imposed on stakeholders through other federal laws, some proposed changes are unique to HHS programs, including regulations impacting medical treatment, value assessments, medical diagnostic equipment, digital media and child welfare programs.
The US Departments of the Treasury, Labor, and Health and Human Services (the Departments) recently issued much-anticipated proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) to better ensure that health plans allow access to mental health or substance use disorder benefits as easily as medical or surgical benefits. The proposed regulations reiterate the Departments’ focus on mental health parity and underscore the importance of compliance for health plan sponsors. They also come after many plans have been subject to audit by the Departments which focused heavily on MHPAEA compliance, leaving plan sponsors frustrated at the lack of guidance and inconsistent application of MHPAEA.
Companies are taking a fresh look at their privacy policies in the wake of Dobbs v. Jackson Women’s Health Organization. According to this Law360 article, policymakers are putting more pressure on companies to tighten their restrictions on collecting and disclosing personal health and location data.
The US Department of Health and Human Services Office for Civil Rights (OCR) recently announced a settlement with a community hospital resolving an investigation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security rules. While the settlement involved a medical provider, it offers some important lessons for other HIPAA-covered entities, including employer-sponsored group health plans.
The settlement involved impermissible data breaches by non-medical staff who, allegedly, used their login credentials to access patient medical records maintained in the hospital’s electronic medical record system without a job-related purpose. The lesson here is straightforward: all HIPAA-covered entities must “protect the privacy and security of health information.”
The HIPAA privacy and security rules are complex, and full compliance requires substantial resources that are, as a practical matter, beyond the reach of many organizations. While OCR routinely refers to these rules as “scalable,” that claim is difficult to square with our experience. Full compliance with the particulars of the rule is costly and time-consuming, and it requires no shortage of expertise. Thankfully, in practice, OCR tends to focus its investigative resources on certain features of these rules. These features include the following items which covered entities must perform to comply:
Where group health plans are concerned, fully insured plans routinely rely on their carriers for HIPAA compliance, which requires that plan sponsors get only “summary” health information at renewal. This option is not available to self-funded plans, however, even those that contract with a carrier for administrative services. Employers in this latter category should be reasonably confident of surviving an OCR audit or investigation only, at a minimum, by taking the actions listed above.
The US Department of Health and Human Services Office of the Inspector General (HHS OIG) recently unveiled a new toolkit that seeks to help analyze telehealth claims for federal healthcare program integrity risks. It is based on methodologies highlighted in OIG’s September 2022 data brief; the data brief identified billing practices by Medicare providers that OIG was concerned posed a high risk to program integrity. OIG intends for the toolkit to be used by public and private parties—including Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units and other federal healthcare agencies—to assess program integrity risks and identify providers whose billing may warrant further scrutiny.
Medicare Advantage (MA) plans are facing both regulatory and business risks following the conclusion of the COVID-19 Public Health Emergency (PHE). What are the major MA flexibilities and requirements related to the pandemic, and have they ended along with the PHE?
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