News & Analysis as of

Department of Health and Human Services (HHS) Medicaid Health Insurance Portability and Accountability Act (HIPAA)

Polsinelli

The 340B Rebate Pilot: Voluntary for Manufacturers, Costly for 340B Covered Entities

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Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more

Cozen O'Connor

Democratic AGs Sue HHS, DHS Over Alleged Health Data Sharing

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20 Democratic AGs sued HHS and DHS for allegedly sharing personal health data with ICE. The complaint alleges that the Centers for Medicare & Medicaid Services—a division of HHS—transferred millions of individuals’ Medicaid...more

Holland & Knight LLP

Holland & Knight Health Dose: June 24, 2025

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Staff from U.S. Senate committees held meetings with the Senate parliamentarian over the weekend of June 20-22, 2025, to complete the "Byrd bath," a process by which committee staff make their case to the Senate...more

Holland & Knight LLP

Holland & Knight Health Dose: May 20, 2025

Holland & Knight LLP on

The budget reconciliation package is expected to be considered by the full U.S. House of Representatives as soon as May 22, 2025. The House Committee on Rules is scheduled to meet on May 21, 2025, at which time additional...more

Holland & Knight LLP

Holland & Knight Health Dose: April 29, 2025

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U.S. Congress returns from a two-week recess this week and has lofty goals to draft, mark up and pass a reconciliation bill by Memorial Day 2025. The U.S. House of Representatives Committee on Energy and Commerce, which was...more

Alston & Bird

Health Care Week in Review | Congress Passes Government Funding Package; HHS Nominee Confirmation Process Heats Up

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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

Foley & Lardner LLP

Key Takeaways: 7th Annual “Let’s Talk Compliance” Conference

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Editor’s Note: PYA and Foley & Lardner hosted the 7th Annual “Let’s Talk Compliance” two-day virtual conference on January 23 and 24, 2025. Panelists included Foley attorneys and PYA subject matter experts. The event was...more

Goodwin

Health Headlines: January 2025

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Welcome to the second issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. In this issue, we cover expected changes under the new Trump administration, the Food and Drug Administration’s...more

ArentFox Schiff

At Long Last, the OIG Issues Its Compliance Program Guidance for Nursing Facilities

ArentFox Schiff on

On November 20, 2024, the US Department of Health and Human Services, Office of Inspector General (OIG) issued its Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (Nursing Facility ICPG)....more

Arnall Golden Gregory LLP

OIG Updates Compliance Guidance for Nursing Facilities

In 1998, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services began issuing voluntary, compliance program guidance for various segments of the healthcare industry. Recently, the OIG has...more

BakerHostetler

What’s Hot in Healthcare: Digital Health Regulatory Update

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As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more

Proskauer - Health Care Law Brief

New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive...

On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more

McDermott+

McDermottPlus Check-Up: April 26, 2024

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A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...more

Foley & Lardner LLP

Health-Related Social Needs: Three Trends in Leveraging Community Partnerships

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Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more

McDermott+

Looking Forward: Top Policy Areas for 2024

McDermott+ on

Happy New Year! As we enter 2024, we want to lay out some of the main regulatory issues (both new and old) that McDermott+Consulting will be tracking over the next year. While these may evolve, we think they are still...more

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

Butler Snow LLP on

Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more

Vicente LLP

Buying a Ketamine Clinic: Why, How, and Risks to Understand

Vicente LLP on

This article is part of a continuing series of articles regarding transactional legal issues in the emerging psychedelic space. With ketamine being the only approved psychedelic drug for medical use, ketamine clinics offer a...more

King & Spalding

HHS Announces Continuing Telehealth Flexibilities Following the End of the COVID-19 PHE

King & Spalding on

On May 10, 2023, HHS announced that many telehealth and teleprescribing flexibilities will remain in place after the end of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. Congress extended many telehealth...more

Burr & Forman

Hot Topics in Health Care May 2023

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Proposed Protections for Patient Data Related to Reproductive Care - On April 12, 2023, the Office for Civil Rights (OCR) at the U.S. Department of Health & Human Services (HHS) proposed a new rule to strengthen HIPAA...more

Harris Beach Murtha PLLC

Lawsuits Reinforce Importance of Health Care Websites being HIPAA Compliant

After dozens of class-action lawsuits filed against health care providers across the country alleging their websites shared patient information with social media sites such as Facebook and Instagram, providers are again urged...more

Sheppard Mullin Richter & Hampton LLP

Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency

The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more

Holland & Knight LLP

Holland & Knight Health Dose: November 29, 2022

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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. This week's topics include . . ....more

Venable LLP

Return to "Normalcy" - Bracing for the End of the Public Health Emergency

Venable LLP on

In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more

Harris Beach Murtha PLLC

OIG Enforcement Summary: August 16, 2022 – August 31, 2022

The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more

King & Spalding

Compliance Considerations for Preparing to Unwind Reliance on Public Health Emergency Waivers

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When COVID-19 was declared a Public Health Emergency (PHE), the Secretary of HHS was authorized to waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program, HIPAA, and EMTALA requirements. Many...more

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