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Centers for Medicare & Medicaid Services (CMS) Digital Health

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Manatt, Phelps & Phillips, LLP

Proposed Medicare Physician Fee Schedule Would Extend Telehealth Flexibilities and Add New Coverage

The Centers for Medicare & Medicaid Services (CMS) released its annual proposed rule updating the Medicare Physician Fee Schedule (MPFS) for calendar year (CY) 2025....more

Bass, Berry & Sims PLC

CMS Proposes to Extend Virtual Direct Supervision

Bass, Berry & Sims PLC on

On July 10, the Centers for Medicare & Medicaid Services (CMS) proposed to extend virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather than in-person...more

McDermott+

Second Annual CMS Health Equity Conference: Key Takeaways

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The Centers for Medicare & Medicaid Services (CMS) recently hosted its second annual CMS Health Equity Conference on May 29 – 30, 2024, focusing on the theme “sustaining health equity through action.” The event was a...more

McDermott+

CMS Hosts Health Equity Conference: Key Insights and Perspectives

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Last week, the Centers for Medicare & Medicaid Services (CMS) held the second annual CMS Health Equity Conference. The event drew several hundred in-person attendees, including my colleague Kayla Holgash, and thousands of...more

Alston & Bird

Health Care Week in Review: CMS Finalizes Medicaid DSH Rule and House Launches Bipartisan AI Task Force

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Holland & Knight LLP

Holland & Knight Health Dose: January 30, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Benesch

2024 Outlook: Behavioral Health Trends

Benesch on

Healthcare systems are facing significant challenges in recruiting and retaining talent within the burgeoning field of behavioral health services, primarily due to competition from telehealth providers and inconsistent...more

Alston & Bird

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott Will & Emery

Private Investors and Digital Health Attracting OIG Attention: General Compliance Program Guidance to Watch

McDermott Will & Emery on

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

McDermott+

REGS & TURKEY LEGS: The Regs We’re Thankful For

McDermott+ on

It’s Thanksgiving week, so instead of eating eggs with your regs, you should sit back, relax and reflect on the regs you are thankful for as you eat your turkey legs (or whatever you enjoy on Thanksgiving). Many of the...more

Alston & Bird

Health Care Week in Review: CMS Releases Updates on Center for Medicare and Medicaid Innovation Center (CMMI) Initiatives to...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2023 #2

News Briefs - States Investigate Nonprofit Hospitals' Lack of Charity Care - More than a dozen states have considered or passed legislation to better define charity care, to increase transparency about the benefits hospitals...more

McDermott Will & Emery

Key Takeaways | Regulatory Roadblocks and Opportunities: How to Thrive in a Shifting Healthcare Landscape

McDermott Will & Emery on

During this session, panelists offered insights into the regulatory action, rulemaking and legislation shaping the future of digital health, with a particular focus on artificial intelligence (AI), data privacy and the end of...more

Foley & Lardner LLP

2023 Telemedicine & Digital Health Trends

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Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will...more

Sheppard Mullin Richter & Hampton LLP

Private Equity and Digital Health in 2023: Policy Updates and Trends to Watch

As we approach the middle of the first quarter of 2023, private equity firms have continued to demonstrate their interest in investing in digital health. This does not come as a surprise, as most startups in the healthcare...more

Sheppard Mullin Richter & Hampton LLP

2023 Top-of-Mind Issues for Life Sciences Companies

Pharma and Life Sciences Investigations and Prosecutions: The First Two Years of the Biden Administration - With the two-year mark of the Biden presidency looming, the administration’s approach to prosecuting and...more

Foley & Lardner LLP

2023 Forecast for Digital Health Startups and Telemedicine Law

Foley & Lardner LLP on

With 2022 closed, there is growing anticipation (trepidation?) about what is in store for digital health in the new year. Will venture funding trickle or will 2023 see more liquidity in the markets? What legal and policy...more

Wilson Sonsini Goodrich & Rosati

New Reimbursement Rules Will Likely Impact Digital Health and Telemedicine

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Final Rule. CMS publishes a PFS annually so as to make changes in federal healthcare reimbursement and...more

Foley & Lardner LLP

Key Takeaways from the HLTH 2022 Conference

Foley & Lardner LLP on

With over 10,000 people in attendance, HLTH 2022 was inspiring and covered a wide range of subjects from health equity to the future of the digital health investment environment. Some sessions were laser-focused on current...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - August 5th, Philadelphia, PA

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

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Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Morgan Lewis

Digital Health Trends to Watch in 2022

Morgan Lewis on

In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

Goodwin

CMS Continues to Modernize by Expanding Reimbursement for Digital Health Services

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The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated...more

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