Sarah Cummings (US)

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Rumors of sea change in DOJ policy potentially confirmed by two recent memos

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 … Continue reading

DOJ recovers $4.7 billion in 2016, third highest in FCA history

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 … Continue reading

No monetary penalties for manufacturer providing physicians with free vaccine refrigeration storage system

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 … Continue reading

Physicians’ compensation structure results in $17M Stark Law fine and CIA for hospital

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.… Continue reading

So-called hangover cure beverage now subject to FDA regulation as a “drug”

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 … Continue reading

HHS issues proposed rule implementing ACA civil rights protections

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 … Continue reading

Free introductory visits by home health provider are not a kickback, says OIG

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 … Continue reading

Ninth Circuit expands “original source” exception, joins sister circuits

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 … Continue reading

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

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

D.C. Circuit sends HHS back to the drawing board on Medicare equipment lease rule

The U.S. Department of Health and Human Services (“HHS”) will be heading back to District Court—and likely the drawing board altogether—to grapple with a recent federal court holding that the Medicare equipment lease rule is probably illegal. The final rule, issued in 2008, effectively prohibits physicians who lease medical equipment to hospitals from referring their … Continue reading

FDA limits use of antibiotics in food-producing animals

By December 2016, it will be illegal to use certain antibiotics in food-producing animals’ feed or water unless (1) the animal producer obtains authorization from a licensed veterinarian and (2) the drug is used only for prevention, control, or treatment of a specifically identified disease. The U.S. Food and Drug Administration (“FDA”) announced the new … Continue reading

Feds clarify: insurers must cover birth control and other services with no cost-sharing

Several federal agencies jointly issued new guidance on Monday clarifying the Affordable Care Act’s requirement that health plans cover FDA-approved birth control and other preventive services at no additional cost to the insured. Specifically, the guidance addresses mandatory insurance coverage of the following: 1. Birth Control Federal officials explained that insurers must cover “the full … Continue reading