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.
To support people living with dementia and their unpaid caregivers, the US Centers for Medicare & Medicaid Services recently announced the Guiding an Improved Dementia Experience (GUIDE) Model, a new, voluntary and nationwide test model designed specifically for these two rapidly growing demographic groups. The model will offer care coordination and care management for individuals living with dementia and provide education, support and respite services for their caregivers.
The US Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration have further extended flexibilities that allow providers to prescribe controlled substances via telemedicine without first performing an in-person visit. The flexibilities were initially provided during the COVID-19 public health emergency. The extension runs through December 31, 2024.
The US Circuit Court of Appeals for the Fourth Circuit recently heard two cases from North Carolina and West Virginia state-run health plans that challenge lower court decisions on coverage exclusions for gender dysphoria treatments. According to this Law360 article, the cases could determine how much health plans can restrict access to gender-affirming care. McDermott Partner Sarah Raaii said employers are investigating how to preserve gender-affirming care access in places where it might no longer be accessible.
“I think a lot of the conversation is also coming back to travel benefits,” Raaii said.
Numerous states—including Louisiana, Ohio, California, Tennessee and New Jersey—have been finalizing rulemaking and legislation that create or amend professional practice standards to incorporate telehealth. Several of these states have also proposed regulations or laws related to the provision of care to youths.
The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government.
Pharmacy benefit managers (PBMs) are a key stakeholder in the drug supply chain, functioning as intermediaries between insurance providers and pharmaceutical manufacturers. PBMs administer prescription drug benefits and seek discounts for insurers as standalone plans, such as Medicare Part D plans, or as entities embedded in commercial insurance products, including Medicare Advantage, Medicaid Managed Care Organizations and employer-sponsored coverage.
PBMs are under increased scrutiny from policymakers due to the perceived opaqueness of their operations and their perceived role in increasing drug costs. As part of this scrutiny, Congress and other stakeholders are raising questions about PBMs’ impact on drug prices and out-of-pocket costs for patients. In the 118th Congress, several key committees have advanced legislation that would increase PBM transparency and reporting obligations and modify other business practices.
Federal regulators recently announced new mental health parity proposed rules that may add significant new compliance burdens for health plan sponsors, insurers and service providers. The proposed rules may also impact the operation of health plans. A Technical Release accompanied the rules that further explains and invites comment on certain provisions of the proposed rules relating to nonquantitative treatment limitation data collection requirements and network composition. Read more here.
The Biden administration recently announced a list of Medicare-covered drugs that will be subject to price negotiations. The administration said the negotiations—a reality thanks to the Inflation Reduction Act—will benefit nearly nine million seniors.
However, according to this Insider article, some drug-policy analysts seem unconvinced by the administration’s claims.
The New York State Department of Financial Services recently announced the publication of proposed regulations that would increase the state’s oversight of pharmacy benefit managers (PBMs). If enacted, the proposed regulations would create significant requirements for PBMs and would require prompt compliance by January 1, 2024. Comments on the proposed regulations are due October 16, 2023.
This post continues our investigation of proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) issued by the US Departments of Labor, Health and Human Services and the Treasury (the Departments). Our previous MHPAEA content is available here. In Part One, we examined the proposed regulations’ definitions of “medical or surgical benefits,” “mental health benefits” and “substance use disorder benefits.” The proposed regulations would, if adopted, make minor (albeit important) clarifications to these terms, which were previously defined in the 2013 final MHPAEA regulations. This post explains other terms defined in the proposed regulations that, while used in the 2013 final rules, regulators did not previously define. MHPAEA generally requires parity between a group health plan’s and health insurance issuer’s financial requirements and treatment limitations applicable to mental health or substance use disorder (MH/SUD) and medical or surgical (M/S) benefits. Treatment limitations include nonquantitative treatment limitations (NQTLs). Under the 2013 final MHPAEA regulations, a group health plan (or health insurance coverage) must not impose an NQTL with respect to MH/SUD benefits in any classification unless:
Any processes, strategies, evidentiary standards or other factors used in applying the NQTL to MH/SUB benefits in the classification are comparable to the processes, strategies, evidentiary standards or other factors used in applying the limitation with respect to M/S benefits in the same classification.
(“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 retain this rule, relabeling it as the “design and application” requirement. The 2013 final MHPAEA regulations use—but do not define—the terms, “processes,” “strategies,” “evidentiary standards” or “other factors.” Citing the need to “provide clarity to plans and issuers” and to help them properly apply the law’s rules governing NQTL requirements, the Departments now propose to define these other terms as follows:
Processes: Processes are actions, steps or procedures that a group health plan uses to apply an NQTL. This includes actions, steps or procedures established by the plan as requirements for a participant or beneficiary to access benefits, such as through actions by a participant’s or beneficiary’s authorized representative or a provider or facility. Examples include:
Procedures to submit information to authorize coverage for an item or service prior to receiving the benefit or while treatment is ongoing (including requirements for peer or expert clinical review of that information);
Provider referral requirements; and
The development and approval of a treatment plan.
Strategies: Strategies are practices, methods or internal metrics that a plan considers, reviews or uses to design an NQTL. Examples include:
The development of the clinical rationale used in approving or denying benefits;
Deviation from generally accepted standards of care;
The selection of information deemed reasonably necessary to make a medical necessity determination;
Reliance on treatment guidelines or guidelines provided by third-party organizations; and
Rationales used in selecting and adopting certain threshold amounts, [...]
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