The US Supreme Court announced in July that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely watched, given its potentially far-reaching impacts on reimbursements to most hospitals that participate in the Medicare program, not just those that participate in the 340B Program.
The US Departments of Health and Human Services, Treasury and Labor, and the Office of Personnel Management issued an Interim Final Rule with comment implementing portions of the No Surprises Act, legislation enacted in December 2020 that bars surprise billing beginning January 1, 2022. Under the law, payers and providers (including hospitals, facilities, individual practitioners and air ambulance providers) are prohibited from billing patients more than in-network cost-sharing amounts in emergency and non-emergency circumstances. This IFR establishes regulations defining the payment methodology. The regulation proposes the methodology payers must use to determine cost sharing; the information payers must share with out-of-network providers; the process for submitting and receiving consumer complaints; and the format and details of the notice and consent requirements.
McDermott Will & Emery lawyer Emily J. Cook recently spoke to Bloomberg Law about a drug alternative dispute resolution (ADR) process that’s on hold after the Biden administration removed its Trump administration appointees. This particular process concerns Department of Health and Human Services panelists that will determine the direction of a 340B drug review board.
The federal government has taken major steps to boost insurers’ coverage of mental health and substance abuse treatment in recent years, and with the confirmation of former California Attorney General Xavier Becerra to lead the U.S. Department of Health and Human Services, that trend will likely continue.
Political divisiveness on Capitol Hill, a focus on impeachment activity and financial relief for the COVID-19 pandemic—as well as delays in confirming President Joe Biden’s nominees for cabinet and subcabinet positions—so far have caused a slowdown in the new administration’s ability to make sweeping changes affecting healthcare.
In an article for Pharmacy Practice News, McDermott partner James Kim discusses key issues to watch from Congress and the White House in 2021.
The Consolidated Appropriations Act (the Act) was signed into law by the president on December 27, 2020, and includes significant health and welfare benefits provisions that affect group health plans and health insurance issuers. The Act is the most comprehensive single piece of legislation to impact group health plans since the Affordable Care Act.
On October 29, 2020, the US Departments of Health and Human Services, Labor, and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth requirements for group health plans and health insurance issuers to disclose cost-sharing information upon request to participants, as well as additional pricing information to the general public.
One day before an updated rule of the US Department of Health and Human Services regarding Section 1557 of the Patient Protection and Affordable Care Act took effect, the US District Court for the Eastern District of New York ordered a stay and issued a preliminary injunction precluding the most recent final rules from becoming operative. Entities subject to Section 1557 should — at least until decisions are issued in cases pending in US district courts — be cautious in their approach to their non-discrimination compliance obligations.
The US Supreme Court ruled June 15 in Bostock v. Clayton County, Ga. that the prohibition against sex discrimination in the workplace under Title VII of the Civil Rights Act covers sexual orientation and gender identity. Title VII applies to employers with 15 or more employees, including part-time and temporary workers.
Following the decision, benefits experts advise that employers review their benefits programs to ensure that lesbian, gay, bisexual, transgender and queer (LGBTQ) employees are treated equally. Employers can use a checklist to find and correct discriminatory language and practices, and thereby reduce the likelihood of being sued under Title VII or other statutes that provide employees with sexual-orientation and gender-identity protections.
On June 12, 2020, the Office for Civil Rights (OCR) of the US Department of Health and Human Services (HHS) finalized a rule under Section 1557 of the Patient Protection and Affordable Care Act (the 2020 Final Rule) that rescinds certain protections afforded to LGBTQ individuals and persons with limited English proficiency. At the same time, the 2020 Final Rule removes burdensome disclosure requirements that may be a welcome relief for entities covered by Section 1557. On June 15, 2020, the Supreme Court of the United States ruled that workplace discrimination based on gender identity and sexual orientation is forbidden under Title VII of the Civil Rights Act of 1964. Although Title VII is not included in the precedential civil rights laws that gave rise to Section 1557, we nevertheless anticipate that the Supreme Court’s holding will lead to legal challenges in a number of areas, including healthcare and health insurance, religious exemptions and the 2020 Final Rule from HHS OCR.
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