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
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more
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
Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more
On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...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
Although delayed as a result of the COVID-19 public health emergency, there are persistent and ongoing efforts to reform the Medicare Part D benefit. Since its June 2016 Report to Congress, the Medicare Payment Advisory...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
As the number of coronavirus cases across the country continue to rise, CMS has issued several coronavirus-specific memorandums to healthcare providers and laboratories. In the past two weeks, CMS has issued disease-specific...more
On March 10, 2020 the Centers for Medicare & Medicaid Services released a memo to Medicare Advantage Organizations and Part D Sponsors to inform them of their obligations and permissible flexibilities related to disasters and...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
Hospitals and Health Systems Prepare for a Value-Based Future - Editor’s Note: Hospitals and health systems are actively working to service their communities in numerous ways, including through the adoption of initiatives...more
Note: All fiscal estimates cited over a ten-year budget window refer to the Fiscal Year 2019-2028 budget window. The President's fiscal year 2019 (FY19) budget proposal for the Department of Health and Human Services (HHS)...more
Vaccination utilization among U.S. adults is low, and well below the Healthy People 2020 Targets, despite widespread availability of safe and effective vaccines and long-standing use recommendations by the Centers for Disease...more
On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...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
Lawmakers returning to Capitol Hill this week after the Thanksgiving recess face a daunting series of tax and budget deadlines that will set the stage for how Congress addresses year-end healthcare priorities. That...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
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
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
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
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
This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more
Last week, the HHS OIG released a proposed rule published in the October 3 Federal Register that would add new safe harbors to the Anti-Kickback Statute and expand the list of conduct exempt from civil monetary penalties...more
The U.S. Department of Health & Human Services, Office of Inspector General ("OIG") just released a proposed rule (“Proposed Rule”) that provides long awaited guidance on patient transportation services, relaxes the...more