The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio. While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees ...
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015) ...
Earlier this year, Decree No. 1 of the Ministry of Health (herein, the "Decree") was published on the Official Gazette. The Decree sets forth the graphic characteristics of the message for the promotion of healthy life habits that must be included in the advertisement of foodstuff products established in Article 5 of Law No. 20,606 -those that qualify as "High in" one or more critical nutrients- made through mass communication ...
How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice ...
At a time when tolerance seems to be an increasingly precious commodity, society can celebrate an awakening intolerance for sexual harassment. For all of the scandal and salacious detail dominating the media in recent months, there is the hope that victims of depravity can find empowerment and healing, if not justice, too ...
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
Ohio prescribers need to be aware of new rules for prescribing controlled substances that will take effect on December 29, 2017. First, prescribers will be required to include the first four characters of the ICD-10 diagnosis code or the full CDT procedure code on all prescriptions for opioids.[1] Similarly, beginning June 1, 2018, prescribers will need to include the ICD-10 diagnosis or CPT procedure code on prescriptions for all other controlled substances ...
Governor Jerry Brown approved California Senate Bill 798 on October 13, 2017. One provision of this bill imposes penalties for failure to file required reports under Business and Professions Code Section 805.01. Beginning January 1, 2018, individuals and entities with reporting obligations under Section 805.01 are subject to fines of up to $100,000 per violation for willful failures to file a Section 805 ...
The revised Phase 2 Requirements of Participation for long-term care facilities will go into effect November 28, 2017. While multiple provider groups have requested a delay of some of the rule's provisions to allow time for additional revisions, officials at the Centers for Medicare and Medicaid Services ("CMS") have indicated that they will not act on those requests at this time and plan to move forward with the November 28, 2017, implementation date for Phase 2 ...
On October 13, 2017, Governor Brown signed SB 798, amending Business and Professions Code Section 805, Civil Code Sections 43.7 and 43.8, and Evidence Code Section 1157 to include licensed midwives within their scope. Notably, these changes only apply to licensed midwives, those professionals who pass the North American Registry of Midwives examination and are licensed by the Medical Board of California ...
View a PDF of the November 2017 edition of the Haynes and Boone Health Law Vitals newsletter. FDA Improving Regulatory Oversight of Stem Cell Therapies and Regenerative Medicine Products Regenerative medicine is a burgeoning interdisciplinary research field aiming to offer new therapies that replace or regenerate human cells, tissues, or organs with the goal of restoring or establishing normal function ...
The Ugandan Insurance Regulatory Authority (“IRA”) has released clarification on its recently published bancassurance guidelines. Following the publication of the Insurance (Bancassurance) Regulations, 2017, the IRA published guidelines on the licensing of financial institutions as bancassurance agents ...
Employers should recognize three common mistakes in determining a valid workers’ compensation claim and in preparing to defend an invalid claim: 1. Failure to Investigate Thoroughly An initial thorough investigation of a workers’ compensation claim can be the key to determining a valid claim or a successful defense to an invalid claim at hearing. Early investigation allows for comprehensive documents-gathering and discovery ...
The purpose of this alert is to provide victims of the Napa/Sonoma fires a checklist to use when seeking recovery from their insurance companies. Property Insurance policies may provide coverage for damage to both your property and your business. Business losses can result from a variety of causes, all of which may be covered under a property policy ...
Earlier this year, Michigan’s Department of Licensing and Regulatory Affairs (LARA) announced the formation of “work groups” to provide input as LARA adopts emergency rules to govern activities under the State’s new Medical Marihuana Facilities Licensing Act (MMFLA). Organized around the MMFLA’s five license types, those work groups met last month ...
I lost my home in the 1991 Oakland Firestorm. As such, my heart goes out to the residents of Napa, Mendocino and Sonoma counties whose homes were damaged or destroyed, to the firefighters and first responders who have risked and are risking their lives, as well as to the community, which will also experience the aftermath of such devastating fires ...
The Ohio Supreme Court recently upheld a trial court decision that a health care provider’s statements of fault or admissions of liability made during the course of apologizing to a patient’s family were protected under Ohio’s apology statute, R.C. 2317.43. This decision broadens the definition of apology under Ohio law and provides greater protection to health care providers who make statements of apology. Stewart v. Vivian, Slip Opinion No. 2017-Ohio-7526 ...
Dubai is the fastest growing healthcare market within the GCC and is becoming an increasingly attractive sector for investors. In this inBrief article we explain the key drivers behind this growth and set out the options available to investors wishing to enter the Dubai healthcare market ...
As seen in Law Journal Newsletters The False Claims Act (FCA or Act) can be a real punch in the gut for businesses on the wrong side of an FCA claim. The Act, codified at 31 U.S.C. §§ 3729-3733, is designed to prevent private companies contracting with the government from knowingly submitting false or fraudulent claims for their services ...
Under RERA, the promoter of a real estate project is obliged to obtain the requisite insurance policies required to secure the development of project and insurances as may be notified by the government. The lack of transparency and uniformity in the Indian real estate market has done little to entice insurance companies from tapping into lucrative land deals and developing insurance products for the real estate sector ...
Norway has biobanks and health registers that from a world perspective are practically unique. We frequently use metaphors like "silver heirlooms" and "the new oil". The test nevertheless consists in whether the Norwegian research environments are successful in commercializing their research, and the commodities require a correct processing. The Lifandis StoryLifandis AS (former Hunt Biosciences) managed Norway's most valuable biobank and its data; the so-called HUNT collection ...
The Origin & Cause In 2010, a California jury returned a $671 million verdict in a class action alleging "violation of the rights of residents" under the California Health and Safety Code[1] arising from alleged understaffing at senior care facilities. Before the jury determined whether to award punitive damages, the Lavender, et. al. v.Skilled Healthcare Group, Inc.[2]lawsuit settled ...
The Origin & Cause In 2010, a California jury returned a $671 million verdict in a class action alleging "violation of the rights of residents" under the California Health and Safety Code[1] arising from alleged understaffing at senior care facilities. Before the jury determined whether to award punitive damages, the Lavender, et. al. v.Skilled Healthcare Group, Inc.[2]lawsuit settled ...
