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Frederick Robinson (US)

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DOJ charges 412 individuals in largest healthcare fraud takedown in US history

On Thursday, the DOJ announced charges against 412 individuals for their alleged participation in healthcare fraud schemes involving approximately $1.3 billion in false billings.  This marks the largest national healthcare fraud takedown in U.S. history—topping the DOJ’s announcement of charges against 301 individuals in June 2016. The enforcement actions spanned across 41 federal districts and … Continue reading

Bipartisan effort to provide greater transparency into federally-negotiated settlement agreements

This week, U.S. Senators Elizabeth Warren (D-MA) and James Lankford (R-OK) reintroduced a bill designed to provide the public with more information about settlement agreements between federal agencies and companies and individuals. The bill, called the Truth in Settlements Act, was first introduced in 2014. In September 2015, it was unanimously passed by the Senate … Continue reading

CMS issues new Self-Referral Disclosure Protocol (SRDP)

CMS recently finalized a new Self-Referral Disclosure Protocol (SRDP) that includes forms for healthcare providers to use to disclose actual and potential violations of the federal physician self-referral statute (the “Stark Law”). Use of the new forms is mandatory starting June 1, 2017, but CMS encourages healthcare providers to start using the new forms immediately. … Continue reading

Federal district court endorses Stark liberalization of writing requirement

On March 15, a federal district court in the Western District of Pennsylvania endorsed CMS commentary from November 2015 that dramatically liberalized the “written agreement” requirement of core Stark exceptions, thus providing some new insights as to what may be the outer limits of CMS’s new approach. When ruling on cross motions for summary judgment … Continue reading

FDA proposes revised oversight approach for lab developed tests

In November 2016, in a departure from its prior position, the US Food and Drug Administration (the “FDA”) announced that it would not develop final guidance to regulate laboratory developed tests (“LDTs”), as we covered previously on Health Law Pulse. In a discussion paper published on January 13, 2017, the FDA instead has proposed a … Continue reading

Teva Pharmaceuticals to pay nearly US$520M in record-breaking FCPA settlement

The world’s largest manufacturer of generic pharmaceuticals, Israeli-based Teva Pharmaceutical Industries Ltd. (“Teva International”), and certain of its global subsidiaries agreed to pay nearly US$520 million and enter into a Deferred Prosecution Agreement (“DPA”) to resolve allegations that the companies bribed government officials in Russia, Ukraine, and Mexico, in violation of the U.S. Foreign Corrupt … Continue reading

OIG Increases CMP Law Nominal Value Thresholds to $15 Per Item and $75 Per Year

On December 7, 2016, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a Policy Statement that increased the thresholds for gifts to Medicare and Medicaid beneficiaries to be considered “nominal” under the beneficiary inducement provisions of the civil monetary penalties law (section 1128A(a)(5) of the Social Security … Continue reading

A first look at the healthcare industry under President Trump

The “100 Day Action Plan” of President-elect Donald Trump promised to bring broad and sweeping change to the current laws governing the healthcare industry in the US Specifically, Trump’s 100 Day Action Plan called for the full repeal of the Patient Protection and Affordable Care Act (“ACA”) and its replacement with health savings accounts, cross-states … Continue reading

Ninth circuit upholds conviction for physician for re-using single use devices

Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients … Continue reading

SCOTUS endorses “implied certification” FCA claims

In a closely watched decision, the U.S. Supreme Court has unanimously endorsed a version of the “implied false certification” theory of liability under the False Claims Act (“FCA”).  In a decision that leaves almost as many questions unanswered as it resolved, the Court held that a material omission on a claim for payment may give … Continue reading

FCA civil penalties to increase substantially under proposed rule

Earlier this week, the Railroad Retirement Board (RRB) became the first federal agency to promulgate an interim final rule implementing provisions of the Bipartisan Budget Act of 2015 intended to index civil penalties assessed under certain statutes to inflation. The RRB’s proposed final rule would double civil penalties assessed under the False Claims Act (FCA). … Continue reading

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

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

CMS issues anticipated Medicare overpayments final rule; relaxes initial proposals

On February 11, 2016, CMS issued a final rule clarifying the requirement of § 1128J(d) of the Social Security Act (created by § 6402(d) of the Affordable Care Act) that health care providers must report and return overpayments within 60 days of the date when they have identified the overpayment or the date any applicable … Continue reading

CMS publishes final rule addressing the reporting and returning of self-identified overpayments; detailed post to follow

This morning the Centers for Medicare and Medicaid Services issued a final rule that addresses the obligation of health care providers and suppliers to report and return overpayments by the later of 60 days from the date an overpayment is identified or the due date of any corresponding cost report. According to the CMS Fact … Continue reading

Supreme court to consider viability of False Claims Act implied certification theory

On Friday, the US Supreme Court agreed to consider two questions involving the so-called “implied certification theory” under the federal False Claims Act (FCA).  First, the Court will consider whether the implied certification theory is ever viable for establishing FCA liability.  If it is, the Court will also consider under what circumstances FCA liability may … Continue reading

Fourth circuit agrees to review appeal of FCA sampling case

On Tuesday, the Fourth Circuit Court of Appeals agreed to hear an appeal of a False Claims Act (FCA) case that raises the question of whether statistical sampling and data extrapolation can be used to prove liability without other claim-by-claim proof. The case also presents the question of whether the government has absolute, unreviewable veto … Continue reading

DOJ announces new policy on prosecuting corporate individuals

Introduction On Wednesday September 9, 2015, the U.S. Department of Justice (“DOJ” or the “Department”) issued a memorandum entitled “Individual Accountability For Corporate Wrongdoing” (the “Memo”) outlining specific policy measures intended to empower U.S. prosecutors further in their pursuit of individuals alleged to be involved in corporate wrongdoing. The Memo is termed “guidance” by the … Continue reading

Federal judge rules House can pursue claims regarding ACA spending

On Wednesday, a federal district court in Washington, DC ruled that the House of Representatives had standing to bring claims against the Obama administration regarding healthcare spending under the Affordable Care Act. That is, the court found that the House could sue the administration for spending billions of dollars on the ACA subsidies that Congress … Continue reading
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