Anti-Kickback Statute Medical Devices

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... more +
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 -
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Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

Update on the Provider Self-Disclosure Protocol

Since we last reported on the Provider Self-Disclosure Protocol (“Protocol”) issued by the Department of Health and Human Services, Office of the Inspector General (“OIG”), the entire Protocol has been revamped. Rather than...more

Health Law Alert: OIG Issues Special Fraud Alert on Physician-Owned Distributorships

On March 26, 2013, the Department of Health & Human Services Office of Inspector General (OIG) issued its latest in a line of “Special Fraud Alerts” that address the application of the Federal anti-kickback statute to...more

OIG Report Concludes that Physician-owned Distributors Increase Utilization

In response to the U.S. Senate Committee on Finance’s continued questioning of physician-owned distributorships (PODs), the U.S. Department Health and Human Services Office of the Inspector General issued its long-awaited...more

Let The Sunshine In – The Risks To Pharmaceutical And Medical Device Companies From Open Payment Transparency

Pharmaceutical and medical device manufacturers (as well as group purchasing organizations “GPOs”) have a major compliance challenge ahead — the Physician Payment Sunshine Act regulations. ...more

Doctors, Enforcement Risks And Compliance Programs

Doctors better get used to government regulation. The Affordable Healthcare Act contains a lengthy complement of new laws and regulations. ...more

Pharmaceutical And Medical Device Compliance: Domestic And Foreign Bribery

Pharmaceutical and medical device companies have a raw deal when it comes to domestic and foreign bribery. ...more

OIG Special Fraud Alert Labels Physician-Owned Distributorships (PODs) as “Inherently Suspect”

The U.S. Department of Health & Human Services, Office of Inspector General (the “OIG”) issued a Special Fraud Alert (“Alert”) on March 26, underscoring its heightened focus on fraud and abuse risks posed by physician-owned...more

OIG and CMS Issue Proposals to Extend Safe Harbor and Exception for EHR Donations

In the April 10 Federal Register, two agencies within the U.S. Department of Health and Human Services published proposed rules that many healthcare providers have been anxiously awaiting affecting donations of electronic...more

OIG Special Fraud Alert on Physician-Owned Distributorships

On March 26, 2013, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert entitled “Physician-Owned Entities.” The Alert is consistent with an ongoing theme of concern...more

OIG Issues Special Fraud Alert on Business Arrangements with Physician-Owned Entities

On March 26, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert (Fraud Alert) reiterating its long-standing concern that the opportunity for a referring physician to earn a profit by investing in a venture...more

OIG Issues Special Fraud Alert for Physician-Owned Entities

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued a Special Fraud Alert expressing concern that physician-owned entities "that derive revenue from selling, or arranging for the...more

Increased Government Scrutiny of Physician-Owned Device Distributorships

On March 26, 2013, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) increased its scrutiny of and pressure on physician-owned entities (particularly medical device distributorships) by...more

OIG Issues Special Fraud Alert on Physician-Owned Distributorships

On March 26, 2013, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert warning that OIG will view physician-owned distributorships (PODs) as “inherently suspect” under the Federal anti-kickback statute....more

OIG Calls PODs "Inherently Suspect"

Making its most strongly worded statement to date, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert on Physician-Owned Entities on March 26, 2013, calling...more

Physician-Owned Device Companies: OIG Issues Further Guidance

The Office of the Inspector General for the United States Department of Health and Human Services (OIG) issued a Special Fraud Alert on March 26, 2013 (the "2013 POD alert"), that identifies physician-owned distributorships...more

Hospitals and Doctors Beware: OIG Issues Special Fraud Alert on Physician-Owned Entities

Alert notes attributes and practices that produce substantial fraud and abuse risk. On March 26, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued its "Special Fraud...more

OIG Places Fraud and Abuse Spotlight on Physician-Owned Entities

Physician-owned distributorships continue to attract federal scrutiny. A new OIG Alert highlights health care transactions that make these distributorships vulnerable to enforcement activity. ...more

OIG Issues Special Fraud Alert on Physician-Owned Distributorships (PODs)

On March 26, 2013, the Office of the Inspector General (“OIG”) of the Department of Health and Human Services issued its first Special Fraud Alert in three years. The new Alert focuses on physician-owned distributorships...more

Health Law Blog: OIG Releases Special Fraud Alert for Physician Owned Implant Distributorships

Yesterday the Office of the Inspector General (OIG) released a special fraud alert addressing physician ownership in entities that derive revenue from implantable medical devices. While such arrangements are not per se...more

Trends to Watch in 2013: Physician-Owned Distributors

Physician-owned distributors (PODs) that sell medical devices have seen substantial growth over the last few years as well as increased regulatory scrutiny. We expect both trends to continue in 2013. PODs are arrangements in...more

False Claims Act Focus - December 2012

EDITOR’S NOTE - Recent reports from the Department of Justice that it collected a record $4.9 billion under the False Claims Act in fiscal year 2012 only underscore what we’ve been seeing in our practice and elsewhere...more

mHealth Stakeholders: Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more

Health Care Reform: Key Legislative Changes Impacting the Pharmaceutical, Biotechnology, and Medical Device Industries

Last week, Congress adopted comprehensive health care reform through the passage of the Patient Protection and Affordable Health Care Act (H.R. 3590) (signed into law on March 23) and the Health Care and Education...more

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