The Wall Street Journal is reporting  that the Department of Labor’s new overtime regulations are not likely to be final and implemented until late 2016. As we discussed in prior posts, in June of this year the DOL proposed regulations that would significantly increase the salary basis test for most FLSA exemptions. The proposed change would make several million more employees eligible for overtime payments, which could have a significant impact on an employer’s bottom line. Many commentators and employers were anticipating the new regulations would go into effect either late this year or early 2016. According to the WSJ report, however, the DOL’s Solicitor of Labor, Patricia Smith, recently commented at a labor and employment law conference that the new regulations are not likely to be final before late 2016. According to the report, Ms. Smith noted the DOL received approximately 270,000 comments in response to the proposed regulations and that this, along with the complex nature of the changes, warranted additional time to complete the regulations.

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.

The patentability of genes is under scrutiny all over the world.

Several weeks ago, the High Court of Australia shed light upon the patentability of nucleic acids (D’Arcy v. Myriad Genetics Inc.). Similar to the situation in the U.S. for 35 U.S.C. §101, the High Court found that an isolated nucleic acid coding for a mutant BRCA1 protein was not patentable subject matter.

Attorneys, compliance officers, accountants, and other professionals who advise clients in the healthcare industry may want to consider attending a coming event next month in Chicago. Featuring Husch Blackwell attorneys Cori Turner and Bill Hopkins, the Fundamentals of Health Law will be held Nov. 15-17.

The American Health Lawyers Association’s event will offer continuing education credits.

3D printing continues to transform the medical field. Recently, doctors in Spain produced the world’s first 3D-printed rib cage and sternum, which is made entirely of titanium. The doctors surgically implanted the metal rib cage and sternum in a cancer patient. Last month, the FDA approved the first 3D-printed drug. The drug, which Aprecia Pharmaceuticals has named Spritam, is for treating patients with epilepsy. Aprecia Pharmaceuticals’ ZipDose® Technology utilizes 3D printing that overlays multiple layers of powdered medication on top of one another until the correct dosage is reached. This type of technology can lead to easier-to-take medication that is individualized in nature with precise dosages based on a patient’s needs.

Effective Sept. 1, 2015, there are significant changes to Texas Guardianship laws. For the first time, probate courts must consider alternatives to guardianship, and supports and services available to the proposed ward before a guardianship is created. Two new alternatives to appointing a guardian now exist: Designation of Guardian Before the Need Arises and Alternate Forms of Decision-Making Based on Person-Centered Planning; and Supported Decision Making Agreement. Tex. Est. Code §§ 1002.0015 & 1357.001.

The Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) issued a fraud alert on June 9, 2015, targeting physician compensation agreements that potentially violate the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b). The Anti-Kickback Statute prohibits remuneration of payment in exchange for referrals of patients receiving aid from federally funded healthcare programs (i.e. Medicare and Medicaid). The OIG alert references 12 recent settlements with individual physicians who entered into “questionable” medical directorship and office staff arrangements. The key concern in those cases centered on individual physicians entering into arrangements where the compensation did not “reflect [the] fair market value for bona fide services the physicians actually provide[d].”

On August 31, 2015, the Environmental Protection Agency (“EPA”) issued its long-awaited Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule, which is designed to prevent facilities from disposing of hazardous waste pharmaceuticals by flushing them down the toilet or drain. The proposal creates a new subpart under the Resource Conservation and Recovery Act’s (“RCRA”) hazardous waste regulations for the regulation of hazardous waste pharmaceuticals generated by “healthcare facilities” and “pharmaceutical reverse distributors.”

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.

Cancer Care Group, P.C. settled alleged violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules on September 2 with the U.S. Department of Health & Human Services Office for Civil Rights (OCR) for $750,000. Cancer Care, a radiation oncology private physician practice located in Indiana, also agreed to adopt a corrective action plan to remedy defects in its HIPAA compliance program.