In Notice 2016-80, the IRS published the first Required Amendments List, which lists statutory and administrative changes in plan qualification requirements that (i) are first effective in the plan year in which the list is published and (ii) may require a plan amendment. This year’s list included just one item, which related to restrictions on accelerated distributions from underfunded single-employer, collectively-bargained defined benefit plans due to an employer’s bankruptcy. The deadline for adopting any required amendments described in this year’s Required Amendments List is December 31, 2018. View Notice 2016- 80.
Federal Agencies Release Additional Frequently Asked Questions on Special Enrollment Opportunities, Preventive Services, and Qualified Small Employer HRAs
On December 20, 2016, the federal Departments of Health and Human Services, Labor, and the Treasury issued a set of three frequently asked questions (“FAQs”) addressing issues under the Affordable Care Act (the “ACA”). These FAQs confirm that: (i) an individual who loses eligibility for individual coverage purchased through the public health insurance marketplace is entitled to a HIPAA special enrollment opportunity in employer group health plan coverage, if eligible, even if other coverage in the marketplace or in the individual market remains available; (ii) for non-grandfathered group health plans subject to the ACA, the effective date for the revised Women’s Preventive Services Guidelines released on December 20, 2016, is the first plan year beginning on or after December 20, 2017 (e.g., January 1, 2018 for calendar year plans); and (iii) the Qualified Small Employer Health Reimbursement Arrangement introduced in the 21st Century Cures Act and available to small employers… Continue Reading
The U.S. Department of Labor issued final regulations revising the ERISA claims procedures that apply to employee benefit plans offering disability benefits. Generally, these final regulations extend certain procedural rules applicable to claims submitted under group health plans to disability benefit claims submitted under ERISA plans that provide disability benefits. The final regulations apply to claims for disability benefits filed on or after January 1, 2018. View the final regulations here.
On December 7, 2016, the Court of Appeals for the Federal Circuit (CAFC) vacated a decision of the Patent Trial and Appeals Board (PTAB) in In re NuVasive, Inc., No. 15-1670 (Fed. Cir. December 7, 2016), finding that judicial review of the obviousness determination could not be meaningfully achieved without sufficient articulation of a motivation to combine the prior art references. In particular, while the Court acknowledged that common sense dictated that “additional information” could potentially be obtained by a combination of the references, the case was remanded because, without articulation of a “reason why” a person having ordinary skill in the art (PHOSITA) would have been motivated to seek out the “additional information,” the PTAB’s findings amounted “nothing more than conclusory statements.” NuVasive, page 12. This decisions is not surprising, as the CAFC has previously stated that a conclusion of obviousness “cannot be sustained with mere conclusory statements.” In… Continue Reading
The 21st Century Cures Act, which recently passed in Congress and President Obama has stated he will sign, creates a new “qualified small employer health reimbursement arrangement” (“QSEHRA”) effective January 1, 2017. The QSEHRA is a new form of health reimbursement arrangement (“HRA”) that can reimburse substantiated medical care expenses, including premiums, of up to $4,950 per year (as adjusted for inflation) or up to $10,000 per year (as adjusted for inflation) if the QSEHRA reimburses family member expenses. The QSEHRA is available to an employer that (i) is not an “applicable large employer” under the Affordable Care Act (“ACA”) (which generally means having at least 50 full-time or full-time equivalent employees, determined on a controlled group basis) and (ii) does not offer a group health plan to any of its employees in the controlled group. Unlike “regular” HRAs, the QSEHRA generally is not considered a group health plan for… Continue Reading
The design patent train has been chugging along ever since the Federal Circuit overhauled the test for determining design patent infringement back in September 2008, making it easier for design patent owners to establish infringement and signaling the start of a pro-design patent era. Apple jumped on the design patent train by winning a $399 million (!) award at the expense of Samsung after Samsung’s smartphones were found to infringe Apple’s design patents relating to the front portion of Apple’s iPhone. This high-profile litigation award heightened awareness of the value of design patents, and the design patent train kept chugging. However, the design patent train appears to have hit a cow on the tracks, the cow being a unanimous 8-0 decision by the U.S. Supreme Court in Samsung Elecs. Co. v. Apple Inc., No. 15-777, (Dec. 6, 2016), overturning Apple’s $399 million award. The $399 million award by the lower… Continue Reading
The U.S. Department of Health and Human Services (“HHS”) recently issued an interim final rule (the “HHS Rule”), which sets out inflation adjustments to the civil monetary penalty (“CMP”) amounts that HHS is authorized to assess or enforce, including for violations of the HIPAA privacy and security rules. The HHS Rule was issued for compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, which was enacted on November 2, 2015 (the “2015 Act”). The 2015 Act requires federal agencies to (i) adjust the level of CMP amounts with an initial “catch up” adjustment and (ii) make subsequent annual adjustments for inflation. The HIPAA CMP amounts had not been adjusted since 2009. Under the HHS Rule, HIPAA CMP amounts are increased by 10.2% for violations of the HIPAA privacy or security rules by a covered entity or a business associate, as follows: Prior $$… Continue Reading
Don’t Worry – You Got This: the Federal Circuit Clarifies the PTAB’s Power to Review IPR decisions after Cuozzo.
The Patent Trial and Appeals Board (PTAB) has authority to review institution decisions for inter partes reviews (IPRs), according to the Federal Circuit’s October 20 decision in Medtronic v. Robert Bosch Healthcare.1 This decision comes after Medtronic petitioned for rehearing after the Supreme Court’s decision in Cuozzo Speed Technologies, LLC v. Lee.2 Background The Medtronic suit began in 2013 when Bosch alleged that Cardiocom, LLC (a subsidiary of Medtronic) infringed Pat. Nos. 7,769,605 and 7,870,249, directed to patient monitoring systems. Cardiocom then petitioned for inter partes review (IPR) of the two patents. After those petitions were denied, Medtronic filed an additional three petitions for the same two patents, listing Medtronic as the sole real party in interest. Even though Bosch argued that the petitions should be denied because Medtronic failed to name Cardiocom as a real party in interest as required under 35 U.S.C. § 312(a)(2), the PTAB instituted IPR proceedings. … Continue Reading
On December 2, the U.S. Supreme Court agreed to hear appeals in three ongoing lawsuits challenging the “church plan” status of the pension plans of Advocate Healthcare Network, Dignity Health, and St. Peter’s Healthcare System, which are religiously affiliated healthcare systems. In each of those cases, the lower courts held that the pension plans did not qualify as “church plans” because they were not established and maintained by a church or a convention or association of churches, but rather by a non-profit organization merely affiliated with a religious organization. Church plans are generally exempt from ERISA, including its fiduciary and minimum funding requirements. If the Supreme Court agrees with the lower courts’ rulings, the pension plans of the three healthcare systems, and potentially many other religiously affiliated employers, would have to comply with all of ERISA’s requirements. The Court’s order granting certiorari for the three cases is available here.