Tag Archives: Final Rule

August 21 Effective Date for New EPA Standards for Management of Hazardous Waste Pharmaceuticals

We recently outlined key provisions of the Environmental Protection Agency’s (EPA’s) Final Rule modifying the standards governing industry management of hazardous waste pharmaceuticals, which become effective August 21, 2019. Client Alert

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DOL Announces “Listening Sessions” As It Mulls Changing White Collar Exemption Regulations

Changes to the white collar exemptions under the Fair Labor Standards Act (“FLSA”) are coming slowly.  Very, very slowly.  Back in May 2016, under the Obama Administration, the Department of Labor issued a Final Rule updating the regulations for the FLSA’s minimum wage and overtime executive, administrative, and professional exemptions.  That rule would, among other things, have increased the minimum salary required for most employees within these exemptions from $455 a week ($23,660 a year) to $913 a week ($47,476 a year).  In November 2016, a federal judge in Texas enjoined that regulation just nine days before it was to go into effect.

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Interview – Artificial Intelligence in the Workplace

This extended interview from Employment Law This Week will be of interest to many of our readers. Attorney and co-editor of this blog, Michelle Capezza explains how recent legal developments have prepared employers for their future workforce, which will include artificial intelligence technologies working alongside human employees. She also looks at the strategies employers should start to consider as artificial intelligence is incorporated into the workplace.

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DOL Rescinds 2016 Persuader Rule – Returns to Long Standing Definition of “Advice”

One of the more controversial actions of the United States Department of Labor during the Obama Administration was its 2016 issuance of a Final Rule that was intended to radically rewrite the rules concerning the “Advice Exemption” to Labor Management Reporting and Disclosure Act of 1959 (“LMRDA”).  The 2016 Final Rule was hotly contested because it would have required employers and their labor law counsel to report concerning advice the lawyers provided even when the lawyers did not directly communicate with their client’s employees. For almost 50 years such attorney-client communications and dealings were exempt from reporting so long as the attorneys did not speak or otherwise communicate directly with their clients’ employees.

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VA Leads in Changing the Telehealth Landscape

Effective June 11, 2018, all Department of Veterans Affairs (“VA”) health care providers will be able to offer the same level of care to all beneficiaries regardless of the beneficiary’s or the health care provider’s location. In its recently released final rule, the VA stated that in December 2016 Congress mandated that the agency provide veterans with a self-scheduling, online appointment system, and that the agency meet the demands for the provision of health care services to veterans, regardless of whether such care was provided in-person or using telehealth technologies. As a general rule, most telehealth practitioners are required to comply with various and state-specific licensing, registration, and certification requirements in order to render health care services via telehealth. Failure to do so can potentially jeopardize a practitioner’s professional credentials and could expose them to penalties including fines and imprisonment for the unauthorized practice of medicine or other health care services. These state-specific requirements create certain challenges for telehealth practitioners seeking to practice across state lines.

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CMS Final Rule Will Reduce Medicare Part B Drug Payments by Nearly 30% for 340B Hospitals

On November 1, 2017, the Centers for Medicare & Medicaid Service (“CMS”) released the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) final rule (“Final Rule”), finalizing a Medicare payment reduction from Average Sales Price (“ASP”) + 6% to ASP – 22.5%, for 340B discounted drugs in the hospital outpatient setting, as was proposed in the OPPS proposed rule earlier this year. This payment reduction is effective January 1, 2018, and would primarily impact disproportionate share hospitals, rural referral centers, and non-rural sole community hospitals.

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DOL Delays Fiduciary Rule

Advisers and financial institutions that provide fiduciary investment advice have an additional 60 days before having to comply with the final regulations defining who is a fiduciary under the Employee Retirement Income Security Act of 1974, as amended (the “Fiduciary Rule”).  On April 4, 2017, the Department of Labor (“DOL”) issued a final rule (the “Final Rule”), which delays the applicability date of the Fiduciary Rule until June 9, 2017 and also extends for 60 days the applicability dates of the Best Interest Contract Exemption (the “BIC Exemption”) and the Class Exemption for Principal Transactions in Certain Assets Between Investment Advice Fiduciaries and Employee Benefit Plans and IRA (the “Principal Transaction Exemption” and collectively, the “Exemptions”).  Advisers and financial institutions relying on the Exemptions as of June 9 need only comply with the impartial conduct standards (as explained below), as the remaining conditions of the Exemptions will not become effective until January 1, 2018, if not withdrawn or revised.  The 60-day delay was proposed by the DOL on March 2, 2017, in response to a directive from President Trump to review the Fiduciary Rule (the “President’s Memorandum”), as explained in this article.

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What’s Really in The NLRB’s New Amendments to Its Rules And Regulations and What Do These Changes Mean For Employers?

 

On February 23, 2017 the National Labor Relations Board (“Board” or “NLRB”) made public a proposed Final Rule to revise its Rules and Regulations “ (the “Rules”)  to reflect modern technology, such as E-Filing, and eliminate references to telegraphs, carbon copies, and the requirements for hard copy submissions and multiple copies, and to eliminate legalistic terms” from the Rules.

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OSHA’s New Electronic Recordkeeping Rule: New Burdens for the Hospitality Industry

On May 12, 2016, the Occupational Safety and Health Administration (“OSHA”) published its long-awaited electronic recordkeeping rule (“final rule”). The final rule creates numerous new recordkeeping obligations and additional administrative burdens for hospitality and other employers. Many employers will now be required to submit injury and illness information to OSHA electronically. OSHA will then attempt to remove identifying information from the records and publish them on a searchable database on its website. The final rule also includes several new anti-retaliation provisions that provide new protections for employees reporting work-related injuries and illnesses.

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FDA Rule Providing Generic Manufacturers with the Ability to Unilaterally Update Safety Labels May be Abandoned

On May 19th, the FDA again postponed publication of the Final Rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” to April 2017 (the “Final Rule”).  On May 19th, the House of Representatives Committee on Appropriations approved the 2017 Agriculture Appropriations bill, which includes provisions within Section 747 expressly defunding any efforts by the FDA to enact the rule. The Notice of Proposed Rule-Making (“NPRM”) was originally published in November 2013 to provide generic drug and biologics manufacturers with the ability to update safety information on their labels independently of the brand manufacturer.

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