Over the last few decades, the healthcare industry has come to recognize that research on children is necessary to determine the safest and most effective treatments for pediatric patients. Whether your institution is part of a nationally renowned research program or participates in a few pharmaceutical research studies a year, the following two issues are critical when structuring research studies that involve pediatric patients.

Husch Blackwell attorneys are presenting at the Colorado Health Care Association and Center for Assisted Living Legal Symposium on elder abuse and financial exploitation on March 12 in Denver.

Healthcare providers are responsible for detecting, preventing and reporting elderly abuse, including financial exploitation. With the enactment of the Affordable Care Act, the reporting requirements of the Elder Justice Act are now in effect.

As with any transaction, a healthcare deal typically starts with a Letter of Intent (“LOI”) or Term Sheet to outline the base agreements on the business deal. The LOI or Term Sheet should include not only the purchase price (or range), purchase price adjustments, payment terms, closing conditions, confidentiality, exclusivity, and other common items, but also the transaction structure – for example, asset sale, stock/membership interest sale, merger, joint venture, affiliation, etc.

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.

The Department of Labor (“DOL”) published its final rule on Feb. 24, 2015, relating to the definition of “spouse” under the Family and Medical Leave Act  (“FMLA”) Regulations. Beginning March 27, 2015, when the final rule becomes effective, the definition of “spouse” for purpose of FMLA leave will include eligible employees in legal same-sex marriages. Prior to this rule change, same-sex partners were only considered spouses if their marriage was recognized in the state where they lived. Under the new rule, the focus shifts to where the marriage was “celebrated.” Accordingly, if the marriage is legal under the law of the state where the marriage was performed or “celebrated,” the same-sex marriage is legal for purposes of the FMLA regardless of state law where the employee lives.

U.S. Citizenship and Immigration Services announced it will be extending U.S. employment authorization to certain H-4 spouses of foreign nationals in H-1B status. Family members of H-1B workers are permitted to enter the United States in H-4 status as dependents of the H-1B worker, but they are not authorized to work. This change permits spouses in H-4 status to apply for an unrestricted work card provided the principal H-1B employee:

  1.  Is the beneficiary of an approved Form I-140, Immigrant Petition for Alien Worker; or
  2. Has been granted H-1B status under the American Competitiveness in the Twenty-First Century Act of 2000 (AC21), which permits H-1B employees seeking permanent residency to extend their H-1B status beyond the usual six-years.

On Friday, February 20, 2014, the Centers for Medicare & Medicaid Services (“CMS”) unveiled its adjustments to Nursing Home Compare, a website many view as the premier tool for evaluating the nation’s nursing homes. CMS hopes the changes will cause nursing homes to make quality improvements, while critics warn that that the information is still unreliable and could confuse consumers who witness a sudden downward change in a facility’s rating. Nearly a third of the nation’s nursing homes experienced lower star ratings as a result of the changes. CMS stated that 1.4 million viewers access the website annually, with 85 percent of users reporting that they found the information they sought regarding nursing homes.

In March 2014, President Obama directed the Secretary of Labor to prepare and propose new FLSA regulations. These new rules were to be announced late last year, but have been repeatedly delayed. Now it appears the new rules will be announced later this month. While the scope of the changes is unknown, it is anticipated the changes will reduce the number of employees who qualify for exempt status.

Having no need to brandish bandanas to obscure identity or firearms to force entry, it was reported Wednesday that cyber bandits, in a sophisticated and well-orchestrated robbery, recently waltzed into the IT vaults of Anthem, the second-largest U.S. health insurer, and walked off with personally identifiable information on about 80 million current and former members, a population that comprises Anthem customers, employees and its CEO, Joseph R. Swedish. The haul is reported to have included names, birthdates, social security numbers, medical identification numbers, street and email addresses and employee income data. Fortunately, there’s no indication at this point that credit-card numbers, claims information, test results or diagnostic codes were compromised as part of the crime. That said, to minimize the potential harm, Anthem has called in the FBI and is notifying affected individuals and offering free credit and identity-theft monitoring.

The Texas Health & Human Services Commission’s (HHSC) final rules regarding physician billing for services provided by an APRN or PA became effective Jan. 1, 2015, and include limitations on such billing arrangements. See 39 Tex. Reg. 9884 (Dec. 19, 2014). The adopted rule requires that a physician billing for services provided by an APRN or PA under the physician’s Medicaid billing number must make a decision regarding the patient’s care or treatment on the same date of service as the billable medical visit and documented that decision in the patient’s record. See Tex. Admin. Code Tit. 1 §354.1062. If a physician billing for such services does not make a decision regarding the patient’s care or treatment on the same date of service, the physician must note on the claim that the services were provided by a supervisee. See Tex. Admin. Code Tit. 1 §354.1001.