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White House Launches ‘Time Is Money’ Initiative

On August 12, 2024, the Biden administration launched a new “Time Is Money” initiative, seeking to crack down on time-consuming and burdensome business processes.

The initiative includes a requirement for federal employee health plans to provide an online opportunity to submit claims. It also features an accompanying letter to health insurance CEOs from the heads of the US Department of Health and Human Services and US Department of Labor that challenges the CEOS to offer online claim submissions, deny claims only where appropriate, and provide clear steps to appeal decisions.

Read more about the initiative and other McDermott+ healthcare-related regulatory updates here.




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IRS Announces Second Employee Retention Credit Voluntary Disclosure Program

On August 15, 2024, the Internal Revenue Service (IRS) released Announcement 2024-30, which provides a second Employee Retention Credit Voluntary Disclosure Program for employers to resolve erroneous claims. This program aims to help employers avoid civil litigation, penalties, and interest by settling their civil tax liabilities. It will run through November 22, 2024.

Read more about the new program and other IRS developments in our Weekly IRS Roundup here.




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Provider-Sponsored Health Plans and Value-Based Care Strategies

In response to evolving market demands, an increasing number of hospitals and health systems are considering creating provider-sponsored health plans (PHSPs), which are health insurance plans owned and operated by healthcare providers. McDermott’s healthcare team recently hosted a webinar exploring how PSHPs may offer hospitals a strategic pathway towards achieving sustainable, patient-centered care delivery by driving improvements in care coordination, health outcomes, and member satisfaction.

Watch the recording here.




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New IRS Revenue Procedure Affects Defined Benefit Pension Plan Sponsors

The Internal Revenue Service (IRS) recently released a new revenue procedure that outlines how sponsors of defined benefit pension plans should request approval to use plan-specific substitute mortality tables for plan years beginning on or after January 1, 2025. The IRS also issued new proposed regulations that would increase penalties for employers that erroneously claimed employment tax credit refunds under the Families First Coronavirus Response Act; the Coronavirus Aid, Relief, and Economic Security Act; and the American Rescue Plan Act of 2021.

Check out this Weekly IRS Roundup here for more information.




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Federal Court Invalidates Key Part of HHS OCR Bulletin Regarding Application of HIPAA to Online Tracking Technologies

In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled that the US Department of Health and Human Services Office for Civil Rights exceeded its authority in certain respects in sub-regulatory guidance. The guidance concerned HIPAA’s application to cookies and other online tracking technologies on HIPAA-regulated entities’ unauthenticated webpages.

Read more here.




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Pending California Law Undermines Growth of Digital Health Companies and Patient Access to Virtual Care

In California, pending Assembly Bill 3129 could severely limit the ability of digital health companies to grow and operate in the state by prohibiting arrangements between physician, psychiatric, and dental practices and any entity that furnishes business or management services to providers that accept investments from private equity groups and hedge funds. The legislation’s current definition of private equity is arguably broad enough to capture venture capital funds, angel investors, family offices and even the innovation or investment arms of academic and nonprofit medical centers. Digital health companies based in California who provide benefits services should closely monitor the potential impact of this proposed legislation on their businesses.

Read more here.




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FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance

On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance provides valuable information about what steps the FDA will expect sponsors to take to promote adequate representation across demographic characteristics in study populations.

Read more here.




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Assessing the Recent Claims Against Sellers and Other Non-Trustees in Lawsuits Relating to ESOPs

Increasingly, sellers of stock and others who customarily have not been named as defendants alongside employee stock ownership plan (ESOP) trustees are being sued in lawsuits relating to ESOPs. Chris Nemeth and Jane Kim recently presented a webinar to members of the National Center for Employee Ownership (NCEO) analyzing this trend. They discussed the types of claims recently brought against sellers, company executives, outside investors and other non-trustees in recent lawsuits relating to ESOPs, and they offered practical tips for protecting against such lawsuits.

Watch the recording here.




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The Case for the Welfare Plan Fiduciary Committee

Recent lawsuits filed against the group health plans of two large US employers underscore the importance of implementing formal welfare benefit plan governance structures that include fiduciary committees comparable to the governance structures employer sponsors of retirement plans routinely adopt. Establishing such committees can help employers reduce litigation risk and ensure compliance with Employee Retirement Income Security Act fiduciary standards.

Read more here.




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Regs, Regs and More Regs: The Biden Administration Releases Spring 2024 Unified Agenda

The Biden administration recently released its Spring 2024 Unified Agenda (a few months late), which lists all the regulations that the administration plans to issue by the end of the year and beyond.

In this update, Jeffrey Davis previews new regulations that could impact the health and welfare benefits industry related to the No Surprises Act, new standards for the exchange of health information under the Health Insurance Portability and Accountability Act, the finalization of new Mental Health Parity and Addiction Equity Act rules, and more.




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