Tag Archives: Epstein Becker & Green

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for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance.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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Sales and Marketing Compliance: New Federal Anti-Kickback Law May Alter How Clinical Laboratories Compensate Sales Personnel

Clinical laboratories need to review how they compensate sales personnel following the passage of the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) (Section 8122 of the SUPPORT Act) which is effective as of October 24, 2018.  The SUPPORT Act is a combination of more than 70 bills aimed at fighting the opioid epidemic, with EKRA intended to address patient brokering in exchange for kickbacks of individuals with substance abuse disorders.  However, as written, EKRA is far more expansive.

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FDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies

Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to amend Agency regulations to allow Institutional Review Boards (“IRBs”) to waive or alter certain informed consent elements (or in some cases, waive the informed consent requirement altogether) for FDA-regulated, minimal risk clinical investigations (“Proposed Rule”).

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Hospitals Need to Be Aware of CMS Changes to PAMA

The Centers for Medicare & Medicaid Services (CMS) issued a final rule on November 1, 2018 that updates physician fee schedule (PFS) payments for calendar year (CY) 2019 and finalizes several policies. The final rule includes amendments to the regulations promulgated under Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”) intended to increase the number of clinical laboratories that qualify as an “applicable laboratory” for reporting purposes; specifically (1) removal of payments received from Medicare Advantage (MA) Plans for determining applicable laboratory status and (2) the use of the Form CMS-1450 14x Type of Bill (TOB) to define an applicable laboratory.

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