Sarah Cummings (US)

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Rumors of a significant shift in U.S. Department of Justice (DOJ) policy were confirmed last week when a privileged and confidential internal DOJ memo was leaked to the press. The memo outlines seven factors government attorneys should use for evaluating whether the government should seek dismissal of qui tam actions filed under the federal False Claims Act (FCA), possibly suggesting that such dismissal will—and should—occur more frequently than to date. Authored by Michael Granston, Director…
The Department of Justice (“DOJ”) announced yesterday that it recovered over $4.7 billion in fiscal year 2016 in civil cases involving claims of fraud against the government under the False Claims Act (“FCA”).  This is the third largest annual recovery in FCA history and one of the largest in recent years, easily surpassing last year’s recovery of $3.6 billion.  This number does not include state shares related to their Medicaid programs, which added hundreds of…
In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that  it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge.  This development comes at a critical time when many are focused on creatively addressing the risks posed by infectious diseases and viruses like Zika. …
Lexington Medical Center (“LMC”), a 428-bed hospital in South Carolina, has agreed to pay $17 million to resolve allegations that it violated the federal False Claims Act (“FCA”), 31 U.S.C. §§ 3729 et seq., and Physician Self-Referral Law (“Stark Law”), 42 U.S.C. § 1395nn, by allegedly providing improper financial incentives to 28 physicians for referrals.…
The manufacturer of a self-proclaimed “anti-hangover” beverage recently received a Warning Letter from the U.S. Food and Drug Administration (FDA), dated September 17 and posted on the FDA’s website earlier this week. The drink, called Life Support, claims to “prevent and relieve headaches, nausea, and grogginess caused by hangovers.” According to its website, the company suggests consuming one of its beverages after your last drink of the evening or first thing the next morning.…
Today, the Department of Health and Human Services (“HHS”) issued a long-awaited proposed rule implementing Section 1557 of the Affordable Care Act (“ACA”), which makes clear that the ACA’s extension of civil rights protections against sex discrimination in health programs and activities includes discrimination based on sexual orientation and gender identity. Before the ACA, civil rights laws enforced by HHS’s Office for Civil Rights (“OCR”) barred discrimination based only on race, color, national origin, disability,…
A home health provider may offer free “introductory visits” to new patients without fear of implicating the Anti-Kickback Statute or Civil Monetary Penalties law, so long as those patients have already chosen it as their home health provider, OIG said late last week. OIG concluded that these introductory visits “are a logical and reasonable first step in the care relationships that have been established.” Arrangement under review OIG stated its position in an advisory…
An eleven-judge panel unanimously reversed 23 years of precedent in the Ninth Circuit early last week, making it easier for federal False Claims Act (“FCA”) whistleblowers to survive a challenge based on the statute’s public disclosure bar. While last Tuesday’s decision undoubtedly loosens the requirements for whistleblowers in the Ninth Circuit, it does not dramatically expand the scope of the public disclosure bar in a manner inconsistent with other jurisdictions’ interpretation of the statute. Under…
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 the near future. I.  Report #1: Questionable Billing and Geographic Hotspots Point to Potential Fraud and Abuse in Medicare Part…