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 ...
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 ...
President Donald Trump announced that the federal government will halt payments known as cost share reduction (CSR) payments. The CSR payments amounted to approximately $7 billion this year, and served as a subsidy to enable lower-income Americans to afford health insurance coverage ...
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 ...
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 ...
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 ...
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 ...
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 ...
The Second Circuit Court of Appeals recently granted a petition for interlocutory review to decide whether a violation of the FCA’s first-to-file rule can be cured by filing an amended pleading. Both the D.C. Circuit and Fourth Circuit1 recently addressed this issue, concluding that the plain language of the first-to-file rule precludes amending around the rule ...
The Health Insurance Portability and Accountability Act (“HIPAA”) contains minimum security standards that Covered Entities and Business Associates must employ to safeguard protected health information (“PHI”). As part of HIPAA’s security standards, Business Associates are obligated to report all security incidents to the Covered Entity ...
At this year’s annual meeting of the National Association of Addiction Treatment Providers in Austin, there was a clear divide on display between the “old school” and the “new school” during a session on electronic marketing strategies. The number of residential addiction treatment providers operating in the United States has exploded since the passage of the Affordable Care Act in March 2010 ...
As Hurricane Harvey continues to cause far-reaching disruptions, it is important to understand how to effectively assert or respond to assertions of force majeure. This summary outlines the steps to take to assert force majeure, and initial considerations for those who have received several notices of force majeure from counterparties ...
Hurricane Harvey has radically impacted every industry in southeastern Texas, including healthcare providers, who continue to analyze potential next steps in ensuring operations can resume so that they can further assist those in need of healthcare services. Below are several links to resources that may be helpful for healthcare providers attempting to navigate through their options ...
Few medical issues are as significant to an employee and an employer as major back surgery. The procedure incapacitates the injured worker for months and leaves the employer short staffed while the employee recovers. Additionally, these surgeries often do not result in the expected outcome, which leads to further impairment and expense ...
Medical Cannabis approvals in the City have been the subject of intense negotiations, hearings, and appeals in the last two months. First, our law firm assisted the Apothecarium - Sunset (an additional location in the Sunset District for the medical cannabis dispensary called The Apothecarium currently near the Castro), in obtaining an approval at the Planning Commission ...
We previously reported that on March 30, 2017, Ohio Gov. John Kasich and the executive directors of Ohio’s health care licensing agencies announced new standards for prescribing opiates for acute pain ...
It has been four months since the changes to 42 CFR Part 2, the confidentiality regulations that apply to all substance abuse treatment records, became effective. Ensure your policies and forms have been updated. The finalized changes to 42 CFR Part 2 by the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), took affect March 21, 2017 ...
