HHS
Subscribe to HHS's Posts

HHS Final Section 1557 Nondiscrimination Regulations: Gender-Affirming Care and the Role of Carriers Under ASO Arrangements

On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press releasefact sheetFAQs) reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex, age or disability, or any combination thereof, in a health program or activity, any part of which is receiving federal financial assistance. The rule, which has staggered effectivity dates starting on July 5, 2024, largely finalizes the policies as proposed in HHS’s August 2022 Notice of Proposed Rulemaking, including clarifying protections for gender-affirming care, as provided by group health plans, carriers and third-party administrators under administrative-services-only (ASO) arrangements.

Read more here.




read more

OCR Update on Tracking Technologies Provides Little Relief for HIPAA-Regulated Entities

On March 18, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) issued an update to its December 1, 2022, bulletin titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates.” In releasing the 2024 update, OCR stated that its purpose was to “increase clarity for regulated entities and the public.” While the update appears to narrow the scope of what OCR considers to be HIPAA-protected health information (PHI) in the context of online tracking technologies, it largely reconfirms prior guidance in the 2022 bulletin and will likely have limited practical impact for HIPAA-covered entities and business associates that have already heeded the 2022 bulletin.

Read more here.




read more

2024 Chart of Healthcare Regulations

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.

Access the chart.




read more

Hospital Settles With OCR for $4.75 Million Over HIPAA Violations

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.




read more

HHS Publishes New Rights of Conscience Final Rule

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.

Read more here.




read more

New Proposed Rules Aim to Enhance Healthcare Accessibility for People With Disabilities

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?

Read more here.




read more

The MHPAEA Proposed Rule: ‘Meaningful Benefits’ and the ‘Scope of Services’

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.

  • A plan that generally covers treatment for autism spectrum disorder (ASD), a mental health condition, and covers outpatient, out-of-network developmental evaluations for ASD but excludes all other benefits for outpatient treatment for ASD, including applied behavior analysis (ABA) therapy, when provided on an out-of-network basis. (ABA therapy is one of the primary treatments for ASD in children.) The plan generally covers the full range of outpatient treatments and treatment settings for M/S conditions and procedures when provided on an out-of-network basis. The plan in this example violates the applicable parity standards.
  • In another example, a plan generally covers diagnosis and treatment for eating disorders, a mental health condition, but specifically excludes coverage for nutrition counseling to treat eating disorders, including in the outpatient, in-network classification. Nutrition counseling is one of the primary treatments for eating disorders. The plan generally provides benefits for the primary treatments for medical conditions and surgical procedures in the outpatient, in-network classification. The exclusion of coverage for nutrition counseling for eating disorders results in the plan failing to provide meaningful benefits for the treatment of eating disorders in the outpatient, in-network classification, as determined in comparison to the benefits provided for M/S conditions in the classification. Therefore, the plan violates the proposed rules.

Notably, the newly proposed meaningful benefits requirement is separate from, [...]

Continue Reading




read more

The MHPAEA Proposed Rule: Standards of Care and Medical Necessity

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 [...]

Continue Reading




read more

HHS Proposes Updates to Disability Nondiscrimination Regulations for First Time in Nearly 50 Years

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.

Access full article.




read more

Treasury, DOL and HHS Issue Landmark Mental Health Parity Proposed Rule

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.

Read more here.




read more

STAY CONNECTED

TOPICS

ARCHIVES

Top ranked chambers 2022
US leading firm 2022