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IRS Releases 2019 Inflation-Adjusted Amounts for HSAs and HDHPs

The IRS recently issued Revenue Procedure 2018-30, which sets the 2019 calendar year limits on (i) annual contributions that can be made to a health savings account (?Ç£HSA?Ç¥) and (ii) annual deductibles and out-of-pocket maximums under a high deductible health plan (?Ç£HDHP?Ç¥). The 2019 limits are as follows: Annual HSA contribution limits: $3,500 for self-only coverage ($50 increase from 2018); $7,000 for family coverage ($100 increase from 2018) Minimum HDHP deductibles: $1,350 for self-only coverage (no change from 2018); $2,700 for family coverage (no change from 2018) HDHP out-of-pocket maximum limits: $6,750 for self-only coverage ($100 increase from 2018); $13,500 for family coverage ($200 increase from 2018) View Rev. Proc. 2018-30.

DOL Announces Temporary Enforcement Policy in Response to Fifth Circuit Decision Invalidating New Fiduciary Rule

On May 7, 2018, the DOL issued Field Assistance Bulletin 2018-02 (?Ç£FAB 2018-02?Ç¥), in which it announced a temporary policy related to enforcement of its new fiduciary duty rule and related exemptions (collectively, the ?Ç£Fiduciary Rule?Ç¥) in advance of an expected order to be issued by the U.S. Court of Appeals for the Fifth Circuit vacating the entire Fiduciary Rule (for more information on the Fifth Circuit?ÇÖs decision to vacate the Fiduciary Rule, please see our prior blog post). Effective as of June 9, 2017, and until the DOL issues additional regulations, exemptions, or other applicable administrative guidance, the DOL will not pursue prohibited transaction claims against fiduciaries who provide investment advice so long as the fiduciary is working diligently and in good faith to comply with guidance previously issued by the DOL under the Fiduciary Rule, such as the best interest contract exemption or principal transactions exception. The DOL… Continue Reading

DOL Clarifies ESG Investing Guidance

The DOL recently released Field Assistance Bulletin (?Ç£FAB?Ç¥) No. 2018-01, which provides guidance on earlier-issued Interpretive Bulletins 2015-01 and 2016-01 (the ?Ç£IBs?Ç¥) regarding how ERISA plan fiduciaries may exercise shareholder rights and the extent to which such fiduciaries may take into account environmental, social, or corporate governance (?Ç£ESG?Ç¥) considerations when making plan investments. FAB 2018-01 includes additional observations regarding the IBs and cautionary notes for plan fiduciaries regarding (i) treatment of ESG factors as being economically relevant to a particular investment choice, (ii) following guidelines related to ESG factors in a plan?ÇÖs investment policy statement, (iii) selection of ESG-themed investment alternatives as a plan?ÇÖs ?Ç£qualified default investment alternative?Ç¥, and (iv) incurring significant plan expenses for shareholder engagement activities related to plan investments. View the FAB 2018-01.

New FAQs for the Mental Health Parity and Addiction Equity Act

The federal Departments of Labor (?Ç£DOL?Ç¥), Health and Human Services, and the Treasury have jointly issued a set of proposed frequently asked questions (?Ç£FAQs?Ç¥) which address nonquantitative treatment limitations (?Ç£NQTLs?Ç¥) and health plan disclosure issues under the Mental Health Parity and Addiction Equity Act of 2008 (?Ç£MHPAEA?Ç¥). Generally, the MHPAEA prohibits group health plans and issuers from imposing financial requirements or treatment limitations on ?Ç£mental health benefits?Ç¥ and ?Ç£substance use disorder benefits?Ç¥ (collectively, ?Ç£MH/SUD Benefits?Ç¥) that are more restrictive than the predominant financial requirements and treatment limitations that apply to substantially all medical and surgical benefits (collectively, ?Ç£Med/Surg Benefits?Ç¥). With respect to NQTLs, which include medical management, step therapy, and pre-authorization (versus ?Ç£quantitative treatment limitations?Ç¥, which are numerical, such as visit limits and day limits), a group health plan cannot impose an NQTL on MH/SUD Benefits in any classification unless, under the terms of the plan as written and in… Continue Reading

2018 HSA Contribution Limit Transition Relief

The IRS has issued guidance stating that taxpayers may use $6,900 as the maximum health savings account (?Ç£HSA?Ç¥) contribution limit for family coverage for 2018. In 2017, the IRS stated that the maximum HSA contribution for family coverage for 2018 would be $6,900. However, recent tax reform legislation changed how the contribution limit is calculated, and in March of 2018, the IRS issued a reduced limit for 2018 of $6,850. The new IRS guidance now permits taxpayers to continue to treat the 2018 limit as $6,900 and also provides guidance for taxpayers who already received a distribution of an excess contribution in 2018 based on the $6,850 limit. View the guidance in Rev. Proc. 2018-27.

Vanda v. West-Ward: This Time, Dosage Adjustment Claims are Patent Eligible Subject Matter

Vanda v. West-Ward: This Time, Dosage Adjustment Claims are Patent Eligible Subject Matter

The Federal Circuit?ÇÖs decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. The decision upheld the district court?ÇÖs decision finding of Vanda?ÇÖs personalized medical treatment claims as patent eligible under ?º 101. ?áThe case also confirms that amending an Abbreviated New Drug Application (ANDA) to address a patent issued after the original ANDA?ÇÖs filing can infringe the later-issued patent. Vanda owns a New Drug Application (NDA) for FANPAT (iloperidone), an antipsychotic drug used to treat schizophrenia. Id. at 4. Upon filing the NDA, Vanda listed U.S. Reissue Patent No. 39,198 in the Food and Drug Administration?ÇÖs Orange Book for iloperidone. Id. at 2. In 2013, West-Ward filed its ANDA seeking approval to manufacture and sell a generic version of iloperidone. Id. at 5. While West-Ward?ÇÖs ANDA was pending, the Patent Office issued U.S. Patent No. 8,586,610. Soon thereafter,… Continue Reading

May 2018