On Wednesday, July 20, 2016, the U.S. Department of Justice (DOJ) filed two lawsuits in the U.S. District Court for the District of Columbia, one, Cause 1:16-cv-01494, seeking to stop the proposed merger between Aetna and Humana (valued at $37 billion) and the other, Cause 1:16-cv-01493, seeking to stop the acquisition of Cigna by Anthem (valued at $54 billion).
Continue Reading U.S. DOJ sues to stop health plan mergers

The out-of-network (OON) business model faces challenges as the result of changes to health and benefit plan OON coverage, but a ruling by Judge Hoyt of the U.S. District Court for the Southern District of Texas suggests that health plans should be careful in refusing payment based on perceived OON high charges, questions about OON co-insurance collection, or provider financial arrangements.
Continue Reading Out-of-network still in business

In some courts in the United States today, a government contractor or a healthcare provider seeking reimbursement from a federal program can violate the False Claims Act even when its work is satisfactory and its invoices are correct. Under the theory of “implied certification,” a minor instance of non-compliance with one of the thousands of applicable statutes, regulations, and contract provisions can be the basis for a federal investigation, years of litigation, as well as fines, penalties, suspension and debarment, even imprisonment of company personnel.
Continue Reading How the Supreme Court will limit False Claims Act liability for implied certification

Abbott Labs recently obtained a preliminary injunction prohibiting numerous pharmacies, wholesalers, and other distributors from importing or otherwise using in the U.S. Abbott’s FreeStyle® blood glucose test strips that are intended for sale internationally. Chief Judge Amon of the Eastern District of New York found that Abbott is likely to succeed on the merits of its Lanham Act claim that consumers will likely be confused by the sale of “gray market” FreeStyle test strips in the U.S.
Continue Reading Court strips importation and sale of ‘gray market’ glucose test strips in U.S.

In an Aug. 27, 2015, decision, a majority of the Board found that the Purple Communications standard, with respect to an employer’s email system, would apply without exception to healthcare providers and, in particular, for acute care hospitals. Contrary to the cogent arguments put forth by member Johnson in his dissent, the majority found there should be no exception to the presumption set forth under Purple Communications that employees have a statutory right to use an employer’s email system for Section 7 related communications during non-working time. The majority also found that the hospital failed to show “special circumstances” to rebut this presumption, notwithstanding the fact that evidence was submitted of studies finding a correlation between employee distractions and patients’ safety and identifying computers and other electronic communication devices as sources of such distraction.
Continue Reading No Purple Communications exception applied to healthcare providers

National healthcare publication Modern Healthcare yesterday announced Husch Blackwell LLP is the seventh-largest healthcare law firm in the U.S. according to its 2015 rankings, up from No. 12 last year. Utilizing differing measurement techniques, American Health Lawyers Association also ranked healthcare practices, placing Husch Blackwell as fifth-largest in the country in its 2015 list, released

On May 7, 2015, Governor Jay Nixon signed Senate Bill 239 into law and reinstated damage caps for Missouri medical malpractice cases. While Missouri law previously limited damages in wrongful death actions, healthcare providers faced limitless verdicts in all other medical malpractice lawsuits. Not anymore.

Under the new law, plaintiffs cannot recover more than $400,000 for non-economic damages in medical malpractice actions. If the case involves claims of catastrophic personal injury or wrongful death, the cap is increased to $700,000. The term “catastrophic personal injury” is defined by statute to include cases of quadriplegia, paraplegia, loss of 2 or more limbs, brain injuries involving permanent cognitive impairment, irreversible major organ failure, or severe vision loss.
Continue Reading Missouri tort reform reformed again: medical malpractice damage caps reinstated

The U.S. Court of Appeals for the 9th Circuit affirmed a lower court’s findings Feb. 10, 2015, that the acquisition by St. Luke’s Health System (“St. Luke’s”) of Saltzer Medical Group (“Saltzer”), a physician group consisting mostly of primary care physicians, violated Section 7 of the Clayton Act. This is the first case in which the Federal Trade Commission (“FTC”) litigated through trial a challenge to a physician acquisition.
Continue Reading UPDATE: FTC victory creates challenge for physician acquisitions

Despite getting a rare Writ of Mandamus from the D.C. Circuit Court of Appeals establishing that its internal investigations were covered by the attorney-client privilege, Kellogg Brown & Root must still turn them over. As predicted in our earlier posts on Barko v. Halliburton, Judge James Gwin has ruled that KBR waived the attorney-client privilege that would otherwise have shielded KBR’s internal investigation documents from discovery. His rationale is reflected in three opinions published in November and December 2014.
Continue Reading Barko v. Halliburton: The next (and final?) chapter

Case law regarding written description is in a state of flux so it is beneficial for the patent practitioner to understand some key Federal Circuit decisions involving the written description requirement.

One might ask why a separate written description of the invention is needed in the specification when the claims are there to define the subject matter of the invention. The reason is historical.
Continue Reading The Written Description Requirement