Department of Health & Human Services

On January 5, 2023, the U.S. Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking entitled “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (the “Proposed Rule“). In this article we provide a brief summary of the Proposed Rule, while also examining the statutory amendments and previous rulemakings that create its foundation.

Continue Reading HHS Issues Proposed Rule to Provide Clarity on Rights of Conscience in Healthcare

Social determinants of health (“SDOH”) consider the non-clinical factors that can profoundly impact an individual’s well-being. They are extensive and often overlap, including housing instability, food insecurity, the inability to afford and obtain medications and more. Research has indicated that healthcare systems that connect patients to basic resources have observed improvements in population health metrics, fostered trust with their patient base, and experienced reduced hospitalization costs.

Continue Reading CMS Augments “In Lieu Of Services” Medicaid Guidance to Support State Medicaid Managed Care Efforts to Address Social Determinants of Health

On December 21, 2022, the Department of Health and Human Services (“HHS”) issued a proposed rule aimed at advancing health equity and mitigating health disparities while minimizing administrative burden. The HHS Notice of Benefit and Payment Parameters for 2024 (“Proposed Rule”) would streamline ACA health plan selection, simplify marketplace enrollment, and expand access to care for low-income and medically underserved consumers through revision of network adequacy and essential community provider (“ECP”) standards. These proposed changes came in the midst of a record-breaking ACA Marketplace enrollment period, highlighting the increased demand for affordable health care coverage.

Continue Reading HHS Proposes Health Insurance Market Reforms for 2024

The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the potential for fraud and abuse. In July 2022, the Department of Health and Human Services Office of Inspector General (“OIG”) issue a Special Fraud Alert alerting practitioners to exercise caution when entering into arrangements with telemedicine companies. The issuance of this report is a significant step and reinforces the government’s interest in scrutinizing telehealth arrangements. The Department of Justice (“DOJ”) and the Drug Enforcement Agency (“DEA”) have also launched several high-profile investigations that the industry is monitoring closely. Telehealth providers should carefully review and update their practices given the heightened enforcement climate.

Continue Reading Recent Developments in Telehealth Enforcement

On December 5, 2022, the Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”), released their Semiannual Report to Congress for the period beginning on April 1, 2022, and ending on September 30, 2022 (the “Semiannual Report”).[1]

Continue Reading OIG Shines a Spotlight on Nursing Homes, Opioid Misuse, and Health Equity in the FY2022 Semiannual Report

The U.S. Department of Health and Human Services (“HHS”) has announced proposed changes (the “Proposed Rule”) to 42 C.F.R. Part 2 (“Part 2”). While the Health Insurance Portability and Accountability Act (“HIPAA”) governs the privacy and security of protected health information generally, Part 2 specifically governs the medical records of federally assisted substance use treatment programs (“SUD Records”).

Continue Reading Proposal to Overhaul Privacy Law Governing Substance Use Disorder Treatment Records

During the COVID-19 pandemic, Medicare coverage expanded to include a vast arsenal of tools that help patients access medical services while keeping patients and practitioners safe. Many of these tools involve telehealth services and were made possible by the COVID-19 emergency blanket waivers, which went into effect when the U.S. Department of Health & Human Services (“HHS”) declared a Public Health Emergency (the “PHE”). Some of these tools:

Continue Reading Finding Our Way Out of the Pandemic Haze: What Telehealth Tools Are Medicare Providers Allowed to Keep, and Which Must They Leave Behind?

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part D benefit redesign, as well as myriad other updates. Overall, the healthcare provisions of the IRA reflect the Administration’s goal of expanding the accessibility of healthcare to individuals by reducing costs to beneficiaries and capping charges by drug manufacturers. Nonetheless, additional clarification in the form of regulations is anticipated, as the text of the IRA defers multiple matters to the Department of Health and Human Services (“HHS”) for implementation.

Continue Reading Healthcare Reforms Under the IRA: Expanding Access to Care

On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule[1] that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable Care Act (the “ACA”).

Continue Reading Proposed Rule Leverages Section 1557 for Healthcare Equity

On August 19, the Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable advisory opinion, AO 22-16, with respect to the provision of gift cards to Medicare Advantage (“MA”) plan enrollees who complete certain steps in an online patient education program. This opinion underscores potential flexibility for with Medicare Advantage Organizations (“MAOs”) and their vendor partners to offer incentives to patients to engage in learning and health care engagement activities that may improve health outcomes without inappropriately steering patients toward particular providers or MA plans.

Continue Reading OIG Blesses Gift Cards for Patient Engagement with Education Tool

Last month, the U.S. Department of Health and Human Services Office of Inspector (“OIG”) released a report that studied prior authorization denials and payment denials by Medicare Advantage Organizations (“MAOs”) (the “Report”). While the Report found that the “vast majority” of prior authorizations and payment requests were approved, the Report focused on the finding that MAOs “sometimes” denied prior authorization and payment requests that met Medicare coverage rules claiming that the denials delayed or denied beneficiaries’ access to medically necessary services.
Continue Reading HHS OIG Report On Prior Authorizations Under Medicare Advantage