News & Analysis as of September 23, 2024

Anti-Kickback Statute › Federal Trade Commission (FTC)

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Investigations Newsletter: Precision Lens Pays $12 Million to Resolve FCA and AKS Violations

ArentFox Schiff on 8/5/2024

Precision Lens Pays $12 Million to Resolve FCA and AKS Violations - Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more

Checking the Pulse: An Approach to Telehealth Privacy and Cybersecurity Due Diligence

Troutman Pepper on 6/10/2024

In the rapidly evolving landscape of health care, the surge in telehealth has been nothing short of revolutionary. This digital transformation, while offering unprecedented access to health care services, also introduces a...more

Key Value-Based Care Developments to Watch in 2024

Holland & Knight LLP on 3/5/2024

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

FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone

Gardner Law on 8/8/2023

When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more

Sixth Circuit Denies Rehearing in Hospital-Physician Kickback Case

Stevens & Lee on 5/23/2023

In a prior blog post, we discussed U.S. ex. rel. Shannon Martin, M.D. v. Darren Hathaway, M.D. et al, a Sixth Circuit case involving the questions (1) whether a hospital’s decision not to hire an ophthalmologist (Dr. Martin)...more

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

McDermott Will & Emery on 3/9/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

Federal Trade Commission’s Focus on Pharmacy Benefit Managers

Epstein Becker & Green on 6/23/2022

In early June, the Federal Trade Commission (FTC) exercised its authority under Section 6(b) of the Federal Trade Commission Act and launched an inquiry into prescription benefit managers (PBMs)....more

American Health Law Association 2022 Health Care Transaction Conference

Dorsey & Whitney LLP on 4/28/2022

After a 2-year hiatus, health care transactional attorneys and related industry professionals descended upon Nashville, TN April 25th - 27th for the 2022 American Health Law Association (“AHLA”) Health Care Transactions...more

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers – Part IV: Other Potential Applicable Laws

K&L Gates LLP on 10/22/2021

This final article in our four-part series examines other relevant laws digital health providers and suppliers should know. If you missed our earlier articles, you can read about HIPAA in Part I and Part II, and the FDCA and...more

AG Climate Change Suits Continue | Dunkin’ In Hot Water | CFPB And States Settle With Student Lender

Cozen O'Connor on 9/18/2020

2022 AG Elections- Challenger Takes on Texas Incumbent Attorney General- •Joe Jaworski, former Mayor of Galveston Texas, announced his intention to seek the Democratic nomination for Texas AG to challenge Republican...more

Skadden's 2020 Insights

Skadden, Arps, Slate, Meagher & Flom LLP on 1/30/2020

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

2020 Health Care Predictions

Saul Ewing LLP on 1/28/2020

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

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

Skadden, Arps, Slate, Meagher & Flom LLP on 12/2/2019

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

Executive Order on Hospital Price Transparency May Prompt Disclosure of Negotiated Prices

McDermott Will & Emery on 6/28/2019

President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...more

Cartel Snapshot - June 2019

McDermott Will & Emery on 6/14/2019

The Department of Justice (DOJ) Antitrust Division announced three new investigations and several developments in its other investigations, including new investigations in the commercial flooring industry, online auctions for...more

AGG Food & Drug Newsletter - January 2018

Arnall Golden Gregory LLP on 1/26/2018

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Healthcare Law Update: March 2017

Holland & Knight LLP on 3/27/2017

Enforcement - OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals - On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more

The AHA’s Letter to Santa Claus

Akerman LLP - Health Law Rx on 1/10/2017

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more

Healthcare Law Update: December 2016

Holland & Knight LLP on 12/29/2016

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Legal Issues Associated with Multi-Provider Alternative Payment Model

Manatt, Phelps & Phillips, LLP on 5/23/2016

Since the passage of the Affordable Care Act (ACA), both federal and state policies have promoted the adoption of alternative payment models (APMs), providing financial incentives for groups of providers to improve care...more

The “Other” Safe Harbor: OIG Warns Healthcare Providers and Vendors Against Information Blocking and Federal Anti-Kickback...

Cozen O'Connor on 10/16/2015

For those of us who work in the privacy and security space this past week has been a whirlwind with focus on the ramifications of the European Court of Justice (ECJ) decision invalidating the EU-U.S. Safe Harbor Agreement....more

Alert: Key Regulatory Considerations for Digital Health Companies

Cooley LLP on 9/11/2015

Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more

ABA Antitrust Spring Meeting Highlight: “Antitrust & Health Care: Square Peg in a Round Hole?”

McDermott Will & Emery on 5/3/2015

In this month’s American Bar Association (ABA) Section of Antitrust Law Spring Meeting, the program “Antitrust & Health Care: Square Peg in a Round Hole?” featured debate and discussion about antitrust law treatment of health...more

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Anti-Kickback Statute › Federal Trade Commission (FTC)

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