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Hogan Lovells

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

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The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

Davis Wright Tremaine LLP

21st Century Cures Act Information Blocking Rule Finally Has Teeth With Respect to Providers

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...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 Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

Alston & Bird

Health Care Week in Review: CMS Releases IPPS Proposed Rule; Congress Holds Hearings on Chronic Care and Telehealth

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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

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #3

This Week in Washington: House Energy and Commerce Committee Subcommittee on Health holds hearing on a range of legislation concerning public health programs, patient wellbeing and caregiver support; HHS and FTC request...more

Mintz

EnforceMintz — COVID-19 Fraud Enforcement Unlikely to Slow Down in 2024

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The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more

Health Care Compliance Association (HCCA)

Hospital Settles CMP Case Over Free APPs; 'Bona Fide' Use Shouldn't Inspire Fear, Lawyer Says

In a case that may hit a raw compliance nerve, Ascension Macomb Oakland Hospital in Michigan has agreed to pay $100,000 in a settlement with the HHS Office of Inspector General (OIG) over free services provided to certain...more

Harris Beach PLLC

OIG December Enforcement Summary

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The following is a summary of selected 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...more

Quarles & Brady LLP

Indianapolis Health System to Pay $345 Million to Settle Stark Law Allegations

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Community Health Network, Inc. (“Community Health”) is a non-profit healthcare system with more than 200 hundred affiliated sites throughout central Indiana. As such, Community Health is one of the larger Midwest...more

Alston & Bird

Health Care Week in Review: House E&C Subcommittee on Health Held a Hearing on Healthcare and AI; CMS Extended the Application...

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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

Harris Beach PLLC

HHS Office of Inspector General October 2023 Enforcement Activity

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The following is a summary of selected 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...more

Alston & Bird

Health Care Week in Review: CMS Releases Three Major Medicare Final Rules

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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

Health Care Compliance Association (HCCA)

DOJ: Stanford FCA Case Involved Failures to Disclose Foreign Support From Seven Countries

Report on Research Compliance 20, no. 11 (November, 2023) It wasn't just China. China is among the countries whose support for Stanford University investigators wasn’t reported to five federal research funding agencies,...more

Harris Beach PLLC

HHS Office of Inspector General September 2023 Enforcement Activity

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The following is a summary of selected 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...more

Jones Day

Vital Signs Digital Health Law Update | Summer 2023

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more

Harris Beach PLLC

HHS Office of Inspector General August 2023 Enforcement Activity

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The following is a summary of selected 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...more

Alston & Bird

Health Care Week in Review: PAHPA Reauthorization Bills Receive House and Senate Markups

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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

Epstein Becker & Green

The 2023 DOJ Health Care Fraud Enforcement (f/k/a “Takedown”): Big Dollars or Clever Packaging?

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On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a...more

The Volkov Law Group

Telehealth: A New Opportunity for Fraudsters

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Whenever new technologies emerge or new pots of government funds for assistance are available, you can count on one thing (as the sun rises and sets) – fraudsters will figure out a way to steal money from innocent persons and...more

Manatt, Phelps & Phillips, LLP

Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 - June 2023

This bill would require 1) the Center for Medicare and Medicaid Innovation to test payment and delivery models regarding the adoption and use of telehealth tools for screening, monitoring, and managing health complications...more

Jones Day

Vital Signs Digital Health Law Update | Spring 2023

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Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more

Manatt, Phelps & Phillips, LLP

Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 -February 2023

As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access...more

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