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.
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 Texas Medical Board (TMB) Telemedicine Committee met on Thursday, August 27, 2015. During the meeting they discussed potential changes to the on-call services telemedicine rule (174.11). At the end of the meeting, they instructed board staff to draft proposed revisions to the rule to allow for changes to the rule.
Although the direction to staff was verbal, they focused on several items: expanding the scope of on-call physician specialties a physician can choose from for their on-call services; a diminishing of the current requirement that the on-call physician provide reciprocal services to the original physician; and there also appeared to be consensus that the rule should include a provision which requires the original physician to have responsibility for the on-call care.
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.”
