K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more
The Federal No Surprises Act (“NSA”) was signed into law on December 27, 2020, as part of the Consolidated Appropriations Act of 2021. Since its enactment, the NSA has been supplemented on two occasions by regulations which...more
Employers should be aware that the No Surprises Act has an impact on the maximum-out-of-pocket ("MOOP") limit for annual cost-sharing under the Affordable Care Act ("ACA") and facility fee transparency. The new set of...more
On March 30, 2023, the U.S. District Court for the Northern District of Texas issued a final judgment in Braidwood Management Inc. v. Becerra, invalidating a requirement in the Patient Protection and Affordable Care Act (ACA)...more
The Consolidated Appropriations Act, 2021 (the “Act”) adopted a series of transparency requirements that apply to employer-sponsored group health plans. These transparency rules impose a series of new and complex obligations...more
Section 108, Division BB of the Consolidated Appropriations Act, 2021 requires the Departments of Labor, Health & Human Services and the Treasury (the “Departments”) to issue regulations under Section 2706(a) of the Public...more
Two chambers of commerce, the Chamber of Commerce the United States of America and the Tyler (TX) Area Chamber of Commerce, filed a lawsuit on August 10, 2021, in the US District Court for the Eastern District of Texas...more
On July 19, the US Departments of Labor, Health and Human Services, and Treasury (the Departments) issued Part 47 of their frequently asked questions (FAQs) about Affordable Care Act (ACA) implementation. There are three new...more
The protections for participants and their beneficiaries in the Patient Protection and Affordable Care Act (ACA) were expanded by the Consolidated Appropriations Act, 2021 (the “Act”). Some of the changes build on concepts in...more
On July 17, 2020, the American Hospital Association and several additional associations and individual hospitals filed their opening brief in their appeal of a decision of the district court, which, had upheld CMS’s price...more
On June 23, 2020, Judge Carl Nichols of the United States District Court for the District of Columbia issued a decision upholding CMS’s price transparency rule, which was adopted late last year. The case is cited as American...more
On February 24, 2020, the Ninth Circuit, sitting en banc, upheld the Trump administration’s regulation that prohibits grantees under Title X of the Public Health Service Act from referring patients for, or otherwise...more
The move by some employer plans to a “reference-based” pricing model has created a need for healthcare providers to develop a strategy to confront payment challenges that these plans create. A prevalent model of...more
As we previously reported, on June 13, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) issued a coordinated set of final regulations (“final rules”) permitting employers...more
On June 13, the Departments of Labor, Treasury and Health and Human Services jointly released final regulations dealing with health reimbursement accounts (“HRAs”). These regulations fulfill the Trump administration’s...more
On June 13, 2019, the Department of Health and Human Services (HHS), the Department of Labor (DOL), the Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) (collectively, the “Departments”)...more
In the last post in this series, we examined the regulatory response by certain states to the final regulations governing association health plans, which were issued by the U.S. Department of Labor (DOL) in June 2018. As we...more
Timely Topics - By Shannon B. Hartsfield - The U.S. Department of Health and Human Services (HHS) announced on Jan. 18, 2018, the creation of a new division within its Office for Civil Rights (OCR). OCR is described as...more
Editor's Overview - For over two decades, federal law has required covered health plans and insurers to ensure that certain mental health benefits are in parity with offered medical/surgical benefits. The meaning of...more
Over the past month, we provided additional details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program and Medicare Therapy Caps. In this post we will go into...more
In Central United Life Ins. Co. v. Burwell, D.C. Cir. No. 15-5310 (July 1, 2016), a D.C. Circuit panel affirmed, 3-0, a trial court injunction barring enforcement of the 2014 HHS regulation permitting individual...more
The Court of Appeals for the District of Columbia affirmed the District Court’s decision in Central United Life v. Burwell on July 1, 2016. This decision is very significant for those assessing the future strength of, and...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more
Health and welfare have been around for a long time, and they are ubiquitous. Employees have come to expect medical, dental, life, and other insurance as part of their benefits packages. Employers offer coverage in order to...more
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more