Hospitals & Health Systems

In the 2016 Physician Fee Schedule Final Rule published on Nov. 16, 2014, the Centers for Medicare & Medicaid Services (CMS) finalized the proposed exception for timeshare arrangements that we discussed in our earlier blog post [80 Fed. Reg. 70,886, 71,300 (Nov. 16, 2015)]. As we stated in our earlier post, a timeshare or part-time “space use” arrangement typically provides a physician with the use of office space during scheduled time periods. The space usually includes furnishings with basic medical office equipment, supplies and support personnel so that the physician is able to use the space, on a turn-key basis, to see patients during scheduled times. Prior to the implementation of the new timeshare exception, these types of arrangements needed to be structured to comply with the Rental of Office Space Exception, which includes “exclusive use” requirements that many hospitals and physicians found burdensome [42 C.F.R. § 411.357(a)].

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.

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.

Proposed Stark exception could impact hospital and physicians timeshare/ part-time agreement arrangements

In July 2015, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule pertaining to payment policies under the 2016 Medicare Physician Fee Schedule (“Proposed Rule”) (80 Fed. Reg. 41,685). In addition to changes to the Medicare Physician Fee Schedule and other Medicare Part B payment policies, the Proposed Rule addresses modifications to the Stark Law and provides guidance on CMS’s interpretation of existing Stark Law exceptions.

The U.S. Court of Appeals for the District of Columbia Circuit issued an opinion June 12, 2015, lambasting the Centers for Medicare & Medicaid Services’ (“CMS”) rationale in implementing the ban on “per-click” space and equipment leases under the Stark Law. This ban, which went into effect Oct. 1, 2009, was effectively challenged by the Council for Urological Interests (“Council”), which was also behind the successful challenge against the application of the Stark Law to hospital lithotripsy services in 2002.

Among the more colorful descriptions used by the Court in describing CMS’s position were that it was “incomprehensible,” “tortured”, and “the stuff of caprice.” And on an even more scathing note, the Court described CMS’s reading of the legislative history of the Stark Law as belonging to the “cross-your-fingers-and-hope-it-goes-away school of statutory interpretation.”

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…

The DOL’s self-imposed February deadline for announcing new FLSA regulations redefining “white collar” exemptions has come and gone with without any action from the DOL. No new deadline has been announced; however, the DOL’s website suggests that it still hopes to release the new regulations soon. Stayed tuned, and we will report back when the…

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.

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.