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[Official Guidance]
Text of FDA Proposed Regs Allowing Importation from Canada of Certain Prescription Drugs
172 pages. "If the rule is finalized as proposed, States or certain other non-federal governmental entities would be able to submit importation program proposals to FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another State or non-federal governmental entity.... In addition, the proposed rule would require that the State or non-federal governmental entity and its co-sponsors, if any, explain why their program would be expected to result in a significant reduction in the cost of covered products to the American consumer."
Food and Drug Administration [FDA], U.S. Department of Health and Human Services [HHS]
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[Guidance Overview]
Trump Administration Takes Historic Steps to Lower U.S. Prescription Drug Prices
"The NPRM issued today is the first step in implementing a provision of federal law that would allow for the importation of certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public's health and safety while achieving a significant reduction in the cost of covered products to the American consumer. The draft guidance issued today describes procedures for a drug manufacturer to submit documentation that demonstrates that the product offered for import from any foreign country is, in fact, an FDA-approved drug product, including that it is manufactured in accordance with the FDA-approved application."
U.S. Department of Health and Human Services [HHS]
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[Guidance Overview]
California Enacts FSA Notice Requirement
"[E]mployees must be notified of any deadline to withdraw funds from the FSA before the end of the plan year. The requirement would apply to situations when FSA coverage terminates mid-year (such as a mid-year termination of employment) and the FSA imposes a shortened time period for submitting run-out claims.... The law does not include a specific effective date. Generally, if a statute enacted during a regular session does not have a specific effective date, it becomes effective on January 1 of the following year (January 1, 2020, in this case)."
Drinker Biddle
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[Guidance Overview]
Seattle Employers: Prepare for Employee Commuter Benefits
"Employers are covered under the ordinance if they employ twenty [20] or more employees worldwide, including part-time, seasonal, and temporary employees.... [An] employer must offer its employees a pre-tax election option for transit or vanpool expenses or a partially or wholly paid transit pass. Employers need to make the offer of the pre-tax benefits within 60 calendar days of an employee commencing employment.... Despite going into effect January 1, 2020, enforcement ... will begin January 1, 2021."
Dorsey & Whitney LLP
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Cadillac, Other ACA Taxes Repealed in Spending Bill
"Permanent repeal of the so-called Cadillac tax on 'high-cost' employer-sponsored health coverage will happen within days as part of a year-end government spending package slated for enactment. Other [ACA] changes in the package include repeal of the taxes on health insurers and medical devices, as well as extension of the annual employer fee for the Patient-Centered Outreach Research Institute (PCORI)."
Mercer
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DOJ Joins Fraud Suit Against CVS, Omnicare
"The lawsuit claims that Omnicare allegedly assigned a new number to the old prescription and kept on dispensing drugs for months, and sometimes years, after the prescriptions had expired. CVS acquired Omnicare in 2015, and DOJ said the retail pharmacy giant allegedly continued to allow the fraud to continue. CVS denied any wrongdoing and said it would 'vigorously defend the matter in court.' " [U.S. v. Omnicare, No. 15-4179 (S.D.N.J. complaint-in-intervention filed Dec. 17, 2019)]
HealthLeaders Media
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Another New Year Resolution: Prepare for the Pittsburgh Paid Sick Days Act
"[E]mployers with 15+ employees must provide paid sick leave, up to 40 hours per year, accrued at a rate of 1 hour of leave for every 35 hours worked. Employers with less than 15 employees must also provide paid sick leave at the same accrual rate, up to 24 hours per year.... [T]he PSDA will take effect on March 15, 2020.... [T]he City released guidelines on how the new ordinance will affect employers and employees in Pittsburgh[.]"
Jackson Lewis P.C.
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Benefits in General
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Last Minute Funding Action by Congress Sets the Stage for Major Savings and Health Changes
"[T]he effective dates of some changes are mere days away -- January 1, 2020 -- these dates having been retained from the legislation as passed by the House of Representatives in May, 2019. However, wisely included in the legislation is a delayed amendment deadline for employer-sponsored retirement plans. This will allow implementation of changes immediately, with amending for the changes generally by the end of the 2022 plan year[.]"
Ascensus
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Most Popular Items in the Previous Issue
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Article submission: Online form
BenefitsLink Health & Welfare Plans Newsletter, ISSN no. 1536-9595. Copyright 2019 BenefitsLink.com, Inc. All materials contained in this newsletter are protected by United States copyright law and may not be reproduced, distributed, transmitted, displayed, published or broadcast without the prior written permission of BenefitsLink.com, Inc., or in the case of third party materials, the owner of those materials. You may not alter or remove any trademark, copyright or other notices from copies of the content.
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