Medical Device Legal News with Sam Bernstein: Episode 19
Midyear Premium Increases and Cafeteria Plan Rules
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Collaborating Before The PTAB
On August 19, 2022, the US Departments of Health and Human Services (HHS), Labor and Treasury posted a final rule revising portions of the federal No Surprises Act (NSA). Generally, the rule finalizes three aspects of the...more
On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more
The Centers for Medicare & Medicaid Services’ Transparency in Coverage Final Rule took effect on July 1, following a six-month delay in implementation to allow payers to come into compliance....more
On October 29, 2020, HHS, the Department of Labor, and the Department of Treasury (the Departments) jointly issued a final rule requiring health plans to disclose price and cost-sharing information to participants,...more
Yesterday, the U.S. Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury (the Departments) issued new final regulations that will impose price transparency requirements on...more
On December 20, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a final rule on program integrity for Affordable Care Act (ACA) exchange plans. This rule implements a number of provisions from the ACA,...more
Federal executive agencies recently published two rules, one final and one proposed, aimed at publicizing the various costs associated with health care. A final rule, promulgated by the Department of Health and Human Services...more
On November 15, 2019, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the Departments), unveiled a proposed rule (scheduled to be published on November...more
On November 15, the Trump Administration released a final rule requiring hospitals to publicly disclose hospital charges, including negotiated prices with third-party payers by January 1, 2021. We outline key considerations...more
The Affordable Care Act requires that employer-sponsored group medical insurance plans provide contraceptive coverage without cost sharing. Earlier this year, the U.S. Department of Health and Human Services issued final...more
CMS just released the 2020 final rule with changes to remote patient monitoring (RPM), officially titled “Chronic Care Remote Physiologic Monitoring,” reimbursed under the Medicare program, as part of the Physician Fee...more
On January 6, 2017, two new safe harbors to the federal anti-kickback statute (the “AKS”) will become effective pursuant to a final rule published by the United States Department of Health and Human Services Office of the...more
On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et...more
On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more
In an uncertain health care environment following the presidential election, the Department of Health & Human Services Office of Inspector General (“OIG”) finalized a new rule expanding existing safe harbors to the federal...more
The Centers for Medicare and Medicaid Services (CMS) recently issued the final 2017 Benefit and Payment Parameters Rule (Final Rule) and concurrently released a final 2017 Letter to Issuers (Letter to Issuers) in the...more
Editor's Overview - It has been a little more than one year since the U.S. Supreme Court altered the legal landscape for litigating ERISA breach of fiduciary duty claims relating to the investment in employer stock...more
Final ACO Fraud Waiver Under OMB Review – The White House Office of Management and Budget (OMB) reported on September 9, 2015, that it began its review of the final rule (CMS-1439-F; RIN 0938-AR30), titled “Medicare Shared...more
Under a common strategy for controlling group health care plan costs, employers sometimes adopt arrangements under which an employee is offered cash as an incentive to waive coverage. These arrangements are colloquially...more
Through new FAQs and final regulations, the U.S. Departments of Labor (“DOL”), Health and Human Services (“HHS”) and the Treasury (the “Departments”) have further clarified various issues related to the preventive care...more