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

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

Wilson Sonsini Goodrich & Rosati

CMS Announces Creation of Health Tech Ecosystem for Improving Access to Patient Data

During a “Make Health Tech Great Again” event on July 30, 2025 at the White House, the Centers for Medicare & Medicaid Services (CMS) announced its intent to create a digital health ecosystem, in partnership with private...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

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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

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

Woods Rogers

Employee Benefits Likely Impacted by Executive Orders

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During the first weeks of the second Trump Administration, a number of executive orders and other actions have been implemented, with some having potential implications for employee benefits. Executive Orders can, and do,...more

ArentFox Schiff

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

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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

Ropes & Gray LLP

A Flurry of Healthcare Sector Cybersecurity Regulatory Developments in 2024

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2024 was a record year for cyberattacks in the healthcare sector. According to the Breach Portal maintained by the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”), to date this year, there...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

Husch Blackwell LLP

HHS Publishes Nursing Facility ICPG

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In November 2024, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published the Industry-Specific Compliance Program Guidance for Skilled Nursing Facilities and Nursing Facilities (Nursing...more

Rivkin Radler LLP

Million Dollar Penalty Imposed on Pain Management Practice Following HIPAA Breach

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The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced on December 3 that it imposed a $1.19 million penalty on Gulf Coast Pain Consultants, a pain management practice in Florida, following...more

Holland & Knight LLP

Regulation of AI in Healthcare Utilization Management and Prior Authorization Increases

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Over the past two years, federal and state government agencies have moved to regulate the deployment of artificial intelligence (AI) in the healthcare setting, including in the utilization management (UM) and prior...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

McCarter & English, LLP

Medicare Technology Standards for Prescribing Part D Drugs

The Centers for Medicare & Medicaid Services (CMS), the Office of the National Coordinator for Health Information Technology (ONC), and thr Department of Health and Human Services (HHS) published 89 FR 51238 (the Final Rule),...more

Keating Muething & Klekamp PLL

Benefits Monthly Minute - August 2024

The August Monthly Minute highlights new IRS guidance addressing student loan matching programs, HHS’s increases to civil monetary penalties and Form 5330 paper filing updates....more

Arnall Golden Gregory LLP

HHS Finalizes Healthcare Provider Disincentives for Information Blocking

Recently, the United States Department of Health and Human Services (“HHS”), Centers for Medicare & Medicaid Services (“CMS”), and Office of the National Coordinator for Health Information Technology (“ONC”) announced the...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

Holland & Knight LLP

Holland & Knight Health Dose: April 30, 2024

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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....more

Dorsey & Whitney LLP

Significant New Healthcare Privacy and Cybersecurity Developments

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As the federal government continues to take action in response to events impacting the healthcare landscape, stakeholders must ensure that they are staying up-to-date with health information privacy and security developments...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

Mintz - Health Care Viewpoints

HHS Health Care Cybersecurity Performance Goals: Proposed Incentives, Penalties and Compliance Standards

As promised in the U.S. Department of Health and Human Services (HHS) concept paper in December 2023, the agency published voluntary health care and public health cybersecurity performance goals (HPH CPGs) in January 2024 and...more

NAVEX

Healthcare Organizations are Facing Increased Scrutiny – Here's What You Need to Know

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2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

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