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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

Bass, Berry & Sims PLC

Is Your Compliance House In Order? Tips for Ensuring Private Equity and Portfolio Company Compliance in the Wake of the Recent...

The recent Request for Information by the Federal Trade Commission (FTC), Department of Justice (DOJ) and Department of Health and Human Services (HHS) seeking input on the effects of private equity (PE) investment in the...more

McDermott Will & Emery

2024 Chart of Additional Healthcare Regulations

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During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - May 9th - 10th, San Juan, Puerto Rico

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Holland & Knight LLP

Key Value-Based Care Developments to Watch in 2024

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The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more

Mintz

EnforceMintz — Despite Few Enforcement Actions in 2023, PE Investment in Health Care Remains a Hot Topic

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Private equity (PE) investment in the health care industry has grown significantly over the last decade. This past year was no exception. While total deal volume lagged behind 2021 record highs, PE health care deal activity...more

Akerman LLP - Health Law Rx

New Safe Harbor and General Compliance Program Guidance Provides Opportunity for Buyers to Mitigate Litigation and Fraud Risk

By maintaining a robust compliance program, healthcare companies are better able to identify potential red flags early and to prevent violations of fraud and abuse laws. A failure to maintain an effective compliance program...more

ArentFox Schiff

OIG Finalizes Rule Authorizing Civil Monetary Penalties Against Information Blocking Violators

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A final rule published on July 3, 2023, empowers the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) to impose civil monetary penalties (CMP) of up to $1 million for unlawful acts of...more

Davis Wright Tremaine LLP

Information Blocking Enforcement Is Here – Are You Ready?

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced its final rule (the Enforcement Rule) implementing the information blocking penalties created by the 21st Century Cures Act...more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more

Mintz - Health Care Viewpoints

OIG, HHS Publish Information Blocking CMP Final Rule, Enforcement Priorities

Though there has been much speculation and commentary among industry stakeholders, the Office of Inspector General (OIG) and the Office of the National Coordinator for Health Information Technology (ONC) have not yet begun...more

Sheppard Mullin Richter & Hampton LLP

HHS OIG Publishes Eagerly-Anticipated Federal Information Blocking Enforcement Final Rule

Industry stakeholders have been eagerly waiting for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Secretary of HHS to provide more clarity on federal information blocking...more

Paul Hastings LLP

Finance in Five Minutes: Healthcare Finance Checkup

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While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2023 #4

News Briefs - WHO Warns Rapid Adoption of AI in Healthcare Could Be Dangerous - The World Health Organization is warning that the "meteoric" rise of artificial intelligence tools in healthcare threatens the safety of patients...more

American Conference Institute (ACI)

[Event] 14th Annual Advanced Forum on Managed Care Disputes and Litigation - March 29th - 30th, Chicago, IL

Hosted by ACI, 14th Annual Advanced Forum on Managed Care Disputes and Litigation returns for another exciting year with curated programming that will help you make sense of these developments, and their profound impact on...more

Mintz - Health Care Viewpoints

PBMs Continue to Draw Federal Scrutiny: PBM Transparency Act of 2022

As we noted in our last PBM Regulatory Roundup, there has been a wave of state regulation focused on PBM practices in the wake of Rutledge and Webhi. However, PBMs are also facing federal reform efforts. The Pharmacy Benefit...more

Blank Rome LLP

How to Know the Government Is Investigating You or Your Company in Connection with COVID Relief Funds

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In our previous blogs, we discussed the multiple government enforcers and regulators charged with authority to oversee the application, eligibility, and use of COVID relief funds. Here, we address how to know whether you or...more

Snell & Wilmer

SBA Adopts New Process for Absolving Fraudulent Loans in Attempt to Provide Certainty to Affected Businesses

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The Paycheck Protection Program (“PPP”) was created on March 27, 2020 as part of the first COVID-19 relief package. Over the past year, Congress appropriated almost $700 billion to the PPP in an effort to provide forgivable...more

Saul Ewing LLP

2020 Health Care Predictions

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The Saul Ewing Arnstein & Lehr, LLP Health Care Practice includes attorneys that handle regulatory, compliance, transactional and litigation needs for clients across the entire health care delivery system, including: ...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Burns & Levinson LLP

Divorce and Space Crimes

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The First Crime in Space! Recent headlines from The New York Times and other prominent news agencies drew in readers stating that the first crime in space had allegedly been committed. The articles went on to discuss the...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Summer 2019

Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices - Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG - The wearable device market is emerging as a key player...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - October 2018 #2

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Many consumers are unaware that retailers use facial recognition technology in retail stores to monitor shoppers and prevent shoplifting. Consumers see cameras in retail stores and assume they are there to monitor for...more

McDermott Will & Emery

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

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Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more

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