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The defendants in the case had argued that simply being on notice of a potential overpayment was not enough to trigger the 60-day repayment rule, which was a provision in the 2010 Affordable Care Act.

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On January 13, 2017, the Centers for Medicare and Medicaid Services sent a Memorandum to State survey agency directors encouraging long-term care providers to "consider cybersecurity when developing or reviewing their emergency preparedness plans."

The meaningful use (MU) regulations provide incentive monies for hospitals and physicians that establish electronic health records systems (EHRs) and satisfy other criteria, such as providing new forms of ‘patient engagement’ like technologically-enabled patient-provider communications.

In fact, the affidavit of the person who claimed the most familiarity with that process, did not claim to have witnessed the submission to the government of any actual false claims.

On May 5, 2008, the FDA published for public comment a draft drug safety five-year plan entitled "Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan."

In a press conference earlier this year, Dr. Janet Woodcock, head of the U.S. FDA pharmaceutical division, stated that the FDA has been working on "establish[ing] consistent quality standards for all drugs, whether brand name or generic" over the past 10 years.

The Drug Supply Chain Security Act was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs..."

In response to the U.S. Supreme Court's holding in Pliva v. Mensing that federal laws and regulations preempted state failure-to-warn claims, the U.S. FDA in 2013 proposed to allow generic drug manufacturers to update their warning labels unilaterally.

Federal and state antitrust enforcers are keenly focused on potential anticompetitive conduct in the healthcare space.

The impact of changing payment models on private equity investments in health care was the topic explored at a February 10 event co-hosted in New York by Duane Morris and Parthenon-EY.

On Thursday September 14, 2023, the FTC issued a policy statement warning brand drug companies that improper listing of patents in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations...

Generative artificial intelligence remains a hot topic in legal and healthcare circles, but the conversation has shifted from the initial wonder of "What can it do?" to the present cautiousness of "What should it not do?"

The Federal False Claims Act (and many similar state false claims acts) allow an individual—called a "relator"—to file a lawsuit on behalf of the United States Government.

I recently reported that Multiplan and certain insurers in its network were accused of being a "cartel" that has agreed to underprice out-of-network reimbursement paid to providers...

On January 17, 2013 the federal Department of Health & Human Services ("HHS") announced a final omnibus rule that details amendments to the privacy, security, data breach and enforcement rules under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA").

Today, more than 86 percent of U.S. prescriptions are being dispensed as generic medicines.