Tag Archives: Epstein Becker & Green

Marijuana Legalization Takes Another Step Forward in 2018 Elections

In the November 2018 mid-term elections, state ballot measures for the legalization of marijuana were approved in three states – Michigan, Missouri, and Utah – and rejected in one state – North Dakota.

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Mixed Results for Employers on Marijuana – Two Federal Courts Refuse to Find State Marijuana Laws Preempted by Federal Law

Two recent federal cases illustrate why employers – even federal contractors – must be cognizant of relevant state-law pronouncements regarding the use of marijuana (i.e., cannabis) by employees. While one case found in favor of the employer, and the other in favor of the employee, these decisions have emphasized that state law protections for users of medical marijuana are not preempted by federal laws such as the Drug-Free Workplace Act (DFWA). Employers must craft a thoughtful and considered approach to marijuana in the workplace, and in most cases should not take a zero-tolerance approach to marijuana.

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OCR Requests Comments on Ways to Modify HIPAA

On December 14, 2018 the Department of Health and Human Services, Office for Civil Rights (“OCR”) formally issued a Request For Information (“RFI”) seeking public input on “ways to modify the HIPAA Rules to remove regulatory obstacles and decrease regulatory burdens in order to facilitate efficient care coordination and/or case management and to promote the transformation to value-based healthcare, while preserving the privacy and security of PHI.”  OCR is seeking comments for a series of 54 different specific questions (many with additional subparts) corresponding to the following five major topic areas:  (1) the promotion of information sharing for treatment and care coordination; (2) the promotion of parental and caregiver involvement in addressing the opioid crisis and serious mental illness; (3) additional ways to remove regulatory obstacles and burdens to facilitate care coordination and promote value-based health care; (4) an effective means to implement the accounting of disclosures requirement of the HITECH Act; and (5) Notice of Privacy Practices operational practices.

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FDA to Overhaul Medical Device Approval Process

On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance. For over forty years, most medical devices have entered the United States market through the 510(k) clearance process. The 510(k) process offers an expedited approval process available only for products that are substantially equivalent to products already on the market (known as predicate devices). The FDA is considering no longer allowing sponsors to rely on predicates older than ten years and making public information about cleared devices that relied on predicates more than ten years old. In addition, the FDA intends to finalize guidance establishing an alternative 510(k) pathway with different criteria that reflect current technological principles.

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FDA Reexamining Communication Practices with Investigational New Drug Sponsors

On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors.  The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward.  Depending on the results of this review, communication practices and requirements could be altered, which might have an effect on the IND application process. Possible modifications might occur that could assist in removing communication bottlenecks hindering approval timelines.

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IRS Extends Deadline for Furnishing 2018 Forms 1095 to Individuals and Good Faith Transition Relief

The Internal Revenue Service (“IRS”) has released Notice 2018-94, which extends the due date for furnishing the 2018 Form 1095-B and Form 1095-C to individuals from January 31, 2019 to March 4, 2019.

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Proposed Rules Loosen Restrictions on Hardship Withdrawals

Based on proposed regulations released by the U.S. Department of Treasury on November 14, 2018 (the “Proposed Regulations”), participants in 401(k) and 403(b) plans may find it easier to get hardship withdrawals as early as plan years beginning after December 31, 2018. Hardship withdrawals are permitted on account of financial hardships if the distribution is made in response to an “immediate and heavy financial need” and the distribution is necessary to satisfy that need. The Proposed Regulations incorporate various prior statutory changes, including changes imposed by the 2017 Tax Act, the Bipartisan Budget Act of 2018, and the Pension Protection Act of 2006. These changes are summarized below:

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Tenth Circuit Holds That the False Claims Act Does Not Protect Post-Employment Retaliation

On November 6, 2018, the U.S. Court of Appeals for the Tenth Circuit handed down a decision that impacts employers across all industries, including the financial services industry. In a “win” for employers, the Tenth Circuit ruled that “…the False Claims Act’s anti-retaliation provision unambiguously excludes relief for retaliatory acts which occur after the employee has left employment.” Potts v. Center for Excellence in Higher Education, Inc., No. 17-1143 (10th Cir. Nov. 6, 2018).

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Can I Bring Cannabis from Canada Home?

Cannabis has been legalized in Canada as of October 17, 2018. What does this mean for employers with employees traveling to and from Canada? Can travelers from Canada to the United States with legally purchased cannabis simply drive to a state where recreational or medical use of cannabis is legal? The bottom line: Employers should remind employees that they cannot cross into the United States with Canadian cannabis under any circumstances.

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New York’s High Court Strikes Down Governor Cuomo’s “Soft Cap” on Executive Compensation for Health Care Providers Receiving State Funds, Yet Upholds Limitations

Last month, the New York State Court of Appeals invalidated a state Department of Health (DOH) regulation that restricted certain health care providers contracting with the state from paying executives more than $199,000 annually, regardless of whether the funds came from the state or not. However, the Court upheld two other DOH regulations; one that limits providers from using public tax-payer money directly to pay executives in excess of $199,000 annually, and another that limits the amount of public funds used for administrative costs.

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