Benjamin Wallfisch (US)

Subscribe to all posts by Benjamin Wallfisch (US)

US regulators to align key health care regulations with transformation to value-based care system; CMS and OIG propose major overhaul of Stark Law and AKS regulations

On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued two sweeping proposals aimed at revising the Stark Law and Anti-Kickback Statute (AKS) regulations to adapt to and promote the US health care system’s transformation to value-based payment … Continue reading

DOJ intervenes in FCA lawsuit against Life Spine for an illegal kickback scheme

By Savannah Wiseman (US) and Benjamin Wallfisch (US) on July 29, 2019 Posted in Enforcement

This week, the Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit against Life Spine and two of its executives, filed in the U.S. District Court for the Southern District of New York. The lawsuit alleges that Life Spine violated the Anti-Kickback Statute by paying more than $7 million in consulting fees, … Continue reading

New entity added to OIG “high risk – heightened scrutiny” list

By Savannah Wiseman (US) and Benjamin Wallfisch (US) on July 26, 2019 Posted in Enforcement

The Office of Inspector General (OIG) has added a new entity, Ridgeview Rehab & Nursing Center, LLC (Ridgeview), to its list of individuals and entities designated as “high risk – heightened scrutiny.” The “high risk – heightened scrutiny” list is part of the OIG’s fraud risk indicator tool, which the OIG made public last year. … Continue reading

OIG Publishes Guidance on Grant Self-Disclosure Program

By Carol Poindexter (US), Savannah Wiseman (US) and Benjamin Wallfisch (US) on July 18, 2019 Posted in Enforcement

Recently, the Office of Inspector General (OIG) published newly-issued guidance on the HHS OIG Grant Self-Disclosure Program (“Program”), which creates a formal framework for recipients, sub-recipients, and applicants for federal grant money to disclose potential violations of federal criminal, civil, or administrative law that may impact federally-awarded grants. Similar to the OIG’s Provider Self-Disclosure Protocol, … Continue reading

CMS releases 2018 Open Payments data

By Benjamin Wallfisch (US) and Savannah Wiseman (US) on July 2, 2019 Posted in Transparency

The U.S. Centers for Medicare and Medicaid Services (CMS) released Open Payments data reflecting payments and transfers of value from drug and medical device companies to physicians and teaching hospitals in 2018, totaling approximately $9.35 billion in payments and more than 11.4 million payment records. This represents a 4.3% increase from the $8.4 billion reported … Continue reading

US DOJ charges 601 individuals in nation’s largest healthcare fraud takedown

By Benjamin Wallfisch (US) on July 10, 2018 Posted in Enforcement

Last week, the U.S. Department of Justice announced charges against 601 individuals for their alleged participation in healthcare fraud schemes. According to the announcement, the alleged fraud is estimated to have resulted in more than $2 billion in losses to federal healthcare programs. This national healthcare fraud takedown is the largest in U.S. history, surpassing … Continue reading

CMS releases 2017 Open Payments data

By Benjamin Wallfisch (US) and Frances Morgan (US) on July 10, 2018 Posted in Transparency

The US Centers for Medicare and Medicaid Services has released Open Payments data reflecting payments and transfers of value paid by drug and device manufacturers to physicians and teaching hospitals.… Continue reading

CMS solicits comments for easing Stark Law burdens

By Benjamin Wallfisch (US) on June 25, 2018 Posted in Regulatory

Last week, the U.S. Centers for Medicare & Medicaid Services (“CMS”) released a Request for Information (“RFI”) that seeks feedback from stakeholders in the healthcare industry on possible regulatory changes to the Stark Law. CMS has expressed concern that the Stark Law may have a negative effect on alternative payment models, integrated delivery models, and … Continue reading

FDA releases new guidance on off-label promotion

By Benjamin Wallfisch (US) on June 19, 2018 Posted in FDA & Food Safety

Last week, the U.S. Food and Drug Administration (“FDA”) released two guidance documents that relate to sharing of certain information about drugs and medical devices, including economic information about unapproved products and unapproved uses, as well as information not included in a product’s FDA-approved labeling. These guidance documents are part of broader blueprint published by … Continue reading

Bakery receives Warning Letter for listing “love” as an ingredient

By Benjamin Wallfisch (US) on October 4, 2017 Posted in Enforcement

The US Food & Drug Administration does not have much of a sense of humor when it comes to the mandatory ingredient list on packaged food products. Last month, FDA issued a Warning Letter to the Nashoba Brook Bakery in Concord, Massachusetts, for, among other violations, listing “love” as an ingredient in its granola and … Continue reading

Ambulance and telehealth services among 14 new inquiries announced by HHS OIG

By Benjamin Wallfisch (US) on July 19, 2017 Posted in Enforcement

On Monday, July 17, the Office of Inspector General for the U.S. Department of Health and Human Services announced 14 new inquiries into potentially fraudulent billing of Medicare and Medicaid. The OIG announcement is part of a new policy to update its investigative Work Plan every month rather than once or twice per year. The … Continue reading

FDA announces plans to create a centralized digital health unit

By Benjamin Wallfisch (US) on May 9, 2017 Posted in FDA & Food Safety

The U.S. Food and Drug Administration (“FDA”) has announced plans to create a centralized digital health unit within the Center for Devices and Radiological Health (“CDRH”), further supporting CDRH’s 2016-2017 vision to establish a more robust national evaluation system for medical devices. FDA will form the new digital health unit within CDRH’s Office of the … Continue reading

21st Century Cures Act: impact on FDA

By Benjamin Wallfisch (US) on January 30, 2017 Posted in FDA & Food Safety, News from DC

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the “Cures Act”). We detailed the Cures Act’s provisions affecting hospitals in a prior Health Law Pulse post and will focus on a more in-depth analysis of its impact on the U.S. Food and Drug Administration (the “FDA”) here. The Cures … Continue reading

CMS releases Open Payments data refresh

By Benjamin Wallfisch (US) on January 20, 2017 Posted in Transparency

This week, the Centers for Medicare and Medicaid Services (CMS) published a refresh of its Open Payments dataset, which includes new data to account for the result of disputes and other data corrections since the last refresh in June 2016. Note that this release does not yet include 2016 data, which should be published in … Continue reading

2015 CMS “Open Payments” data released

By Benjamin Wallfisch (US) on July 5, 2016 Posted in Transparency

Last week, CMS posted the 2015 Open Payments data to its website, as well as updated payment records for 2013 and 2014. Overall, manufacturers reported $7.52 billion in payments and ownership interests to 618,931 physicians and 1,116 teaching hospitals in 2015. Nearly 1,500 companies reported making payments in 2015, comprising a total 11.9 million records. … Continue reading

Ninth Circuit approves enhanced sentences for “abuse of trust” in health care fraud case

By Benjamin Wallfisch (US) on May 2, 2016 Posted in Enforcement

In a decision that could have wider ramifications for sentencing in health care fraud cases, a Ninth Circuit panel last week affirmed a lower court’s sentencing enhancement, applied because the defendants were found to have abused a “position of trust” by submitting false information in Medicare claims. The case involves owners of a California-based DME … Continue reading

Two new OIG reports signal intensified scrutiny on Medicare Part D fraud

By Benjamin Wallfisch (US) on June 25, 2015 Posted in Enforcement

On the heels of the largest nationwide health care fraud takedown in history announced last week, the federal government on Tuesday issued two new reports detailing what it believes to be extensive evidence of suspicious billing under Medicare Part D. The move signals that the prescription drug benefit program can expect significant enforcement actions in … Continue reading

Feds unveil sweeping Medicare fraud “takedown”

By Carol Poindexter (US) and Benjamin Wallfisch (US) on June 19, 2015 Posted in Enforcement

On June 18, Federal officials announced criminal enforcement actions against 243 individuals across the country. The nationwide arrests mark the largest criminal health care fraud takedown in history and came as a result of Medicare Fraud Strike Force investigations. The Attorney General, HHS Secretary, and FBI Director announced the charges, which allege various health care … Continue reading

DOJ recovered US$2.3Bn from healthcare FCA cases in FY 2014

By Benjamin Wallfisch (US) on December 9, 2014 Posted in Enforcement

In FY 2014, for the fifth consecutive year, the Department of Justice (“DOJ”) recovered more than US$2 billion from healthcare entities in False Claims Act (“FCA”) cases. The federal government collected a total of US$5.69 billion overall in FCA actions in FY 2014, and US$2.3 billion of that amount was from healthcare-related FCA actions, according … Continue reading

Third Circuit tightens up FCA original source rule

By Benjamin Wallfisch (US) on October 29, 2014 Posted in Enforcement

A decision from the Third Circuit this week makes it harder for whistleblowers to qualify as an “original source” under the False Claims Act (FCA). The Third Circuit ruled in United States et al. v. AstraZeneca Pharmaceuticals LP that whistleblowers bringing lawsuits under the FCA must have firsthand knowledge of the alleged fraud in order … Continue reading