Pills bottle-92816346On 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.”
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horizon_lights178441822Proposed 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.
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clipboard with white blank paper masks stethoscope blood pressurThe 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.”
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HB initials LogoNational 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

money-closeup122486570The U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a special fraud alert on June 9, 2015, stating that physician compensation arrangements may result in significant liability. Hopefully this is not a surprise to any physician or entity that treats federal health plan beneficiaries. However, given that, historically, OIG regulatory actions largely (although not exclusively) focused on the entity from which a physician received compensation, such as hospitals, laboratories, durable medical equipment suppliers, pharmacies, etc., the June 9, 2015, fraud alert highlights the potential for physician liability in these arrangements.
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Laptop with medical diagnostic software and stethoscope

New Texas Medical Board (TMB) rules effective June 3, 2015, limit the ability to prescribe drugs based only on telephonic consults. The rules also raise questions about the viability of some call-coverage arrangements. Specifically, for a physician prescribing medication, Tex. Admin. Code tit. 22 §190.8 now requires, among other things, a “defined physician-patient relationship” that must include a physical examination performed by the provider face-to-face or in accordance with Tex. Admin. Code tit. 22 ch. 170 rules for telemedicine. Significantly, the limitations do not apply to mental health services, except in cases of behavioral emergencies.


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dollar-signiStock_000013001848_LargeThe 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

physicians155824955Changes to Texas Medical Board regulations regarding the supervision of physician assistants went into effect March 12, 2015, and will reduce both: (i) physician oversight obligations; and (ii) conflict with prescriptive delegation regulations. Specifically, requirements of Tex. Admin. Code tit. 22 §185.16 were reduced to only prohibiting a physician assistant from independently billing patients “except where provided by law.”
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patient493915589Over 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.
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