Health & Welfare Plans Newsletter

December 18, 2019

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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 The draft guidance issued today describes procedures for a drug manufacturer to submit documentation that demonstrates that the product offered for import from any foreign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]

[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

[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

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

Potential Coverage and Federal Funding Losses for Massachusetts If Texas v. U.S. Ultimately Overturns the ACA

"Two main scenarios are described: [1] where the ACA is overturned in its entirety and the state is not able to reestablish the subsidized coverage programs created by the state's 2006 health reform and [2] where the ACA is overturned, but the state is able to reestablish its 2006 coverage programs."

The Blue Cross Blue Shield of Massachusetts Foundation

District Court Finds Breach of Fiduciary Duty Claim Adequately Plead Where Claimant Was Not Given Life Insurance Conversion Options

"The court rejected BDO’s arguments, including that there can never be a fiduciary duty under ERISA to provide notice of conversion or portability rights because the statute does not set forth such an obligation.... The court held that to accept these premiums after coverage had lapsed was a breach of fiduciary duty because it was tantamount to confirming coverage ... [and] cited to another case that concluded the cessation of the payment of premiums does not necessarily absolve a fiduciary of his duties." [Harris v. Life Ins. Co. of North America, No. 19-4594 (N.D. Cal. Dec. 11, 2019)]

Kantor & Kantor

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

Lawmakers Try to Find Next Opportunity to Tackle Drug Prices, Surprise Billing After Setback

"Lawmakers are turning their calendars to May as the next logical place to get through legislation to tackle surprise medical bills and drug prices.... May is being floated as a new opportunity because the spending deal, which passed the House on Tuesday and moves to the Senate, only funds community health centers until then."

FierceHealthcare

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.

Employers Must Ensure Their Leave Administrators Understand Who Is Entitled to FMLA Leave

"[T]he plaintiff requested a leave of absence to care for her 31-year-old daughter and minor grandchildren. The employer denied her leave request because her daughter was over 18 years old ... The court focused on contemporaneous documentation prepared by the employer in denying plaintiff's leave request in which there is no indication her daughter's capability for self-care was considered. " [Gibson v. New York State Office of Mental Health, No. 17-608 (N.D.N.Y. Nov. 25, 2019)]

Jackson Lewis

Benefits in General

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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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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