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
August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more
On February 1, 2023, the US Centers for Medicare & Medicaid Services (CMS) released the Advance Notice of Methodological Changes for Calendar Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part C and D...more
On September 18, 2020, OIG issued Advisory Opinion No. 20-05 analyzing a pharmaceutical manufacturer’s proposal to offer direct cost-sharing assistance to Medicare beneficiaries prescribed certain of the manufacturer’s new...more
On September 18, 2020, the Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable Advisory Opinion, No. 20-05 (the Opinion), that a pharmaceutical manufacturer’s (Requestor) proposed...more
As the COVID-19 pandemic continues to spread across the United States, states, payors, and providers are looking for ways to expand access to telehealth services. Improving access to telehealth is an essential tool in...more
Over the past week, the Centers for Medicare & Medicaid Services (CMS) has made a number of announcements related to Medicare coverage in connection with the Coronavirus (COVID-19) outbreak. Several of those announcements...more
The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more
The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid...more
On November 16, 2017, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would revise regulations and clarify requirements for the Medicare Advantage (MA) and Medicare Prescription Drug Benefit...more
Welcome back everybody. With Congress returning from recess, we should expect an update on the progress of the Senate-version of the American Health Care Act. Despite the noise from GOP members about a timeline, one thing...more
On 3 April 2017, the Centers for Medicare & Medicaid Services (CMS) released its final Medicare Advantage (MA) and Part D Rate Announcement and Call Letter (Call Letter) for calendar year 2018. The Call Letter is part of...more
Just in time for the New Year, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued final regulations (Final Regulations) that revised two existing Anti-Kickback Statute safe...more
On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) issued a final rule to establish new safe harbors under the anti-kickback statute and civil monetary penalty (CMP) rules,...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
Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more
While CMS’s demonstration model will allow for reduced cost sharing and other benefit design elements to encourage targeted use of high-value clinical services, Medicare Advantage Organizations should be aware of certain...more
The Centers for Medicare & Medicaid Services (“CMS”) recently announced that, beginning January 1, 2017, Medicare Advantage plans in Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania and Tennessee will be permitted...more
On September 1, 2015, the Centers for Medicare & Medicaid Services (“CMS”) announced[1] the opportunity for plan sponsors to test value-based insurance design (“VBID”) in the Medicare Advantage (“MA”) market. VBID refers to...more
On September 1, 2015, CMS unveiled a new Medicare Advantage Value-Based Insurance Design (MA-VBID) model, which will allow Medicare Advantage plans to offer clinically-nuanced benefit packages aimed at improving quality of...more
CMS, through the Center for Medicare and Medicaid Innovation, announced on September 1, 2015, the introduction of the Medicare Advantage Value-Based Insurance Design (VBID) Model as part of the Health Plan Innovations...more
This Week: Upcoming Hearing: HHS Sec. Burwell Appearing Before E&C Committee on FY2016 Budget... CMS Issues 2016 Payment and Policy Updates for Medicare Health and Drug Plans... CMS Releases Improved Rating System for Nursing...more