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 January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...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
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 March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay...more
On November 19, 2021, OIG issued Advisory Opinion No. 21-17 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain Medicare cost-sharing obligations in the context of a...more
The chart below compares key provisions of the Affordable Care Act (ACA), the American Health Care Act (AHCA) and the Better Care Reconciliation Act (BCRA). This chart is current as of July 13, 2017, and as of that date,...more
On Thursday, May 12, 2016, a federal district court judge ruled against the Obama administration, finding that no appropriations have been made to fund payments under Section 1402 of the Affordable Care Act to reimburse...more
On May 12, 2016, the U.S. District Court in Washington, D.C. ruled in favor of House Republicans, concluding that the government wrongly spent billions reimbursing insurance companies for providing discounted health coverage...more
Federal Judge Rosemary Collyer’s May 12, 2016 ruling in House of Representatives v. Burwell, found that the Obama administration (the “Administration”) has been improperly funding an Obamacare subsidy program. House of...more
You may have heard that a federal District Court ruled that the ACA was unconstitutional today. Do not start making any changes. This decision will not directly impact most employers and their health plans. We are sending...more
On May 12, 2016, the United States District Court for the District of Columbia issued an opinion in U.S. House of Representatives v. Burwell et al., No. 14-1967 (D.D.C. May 12, 2016), enjoining the federal government’s use of...more
On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 (“Act”) into law significantly impacting how Medicare pays certain off-campus hospital departments. Specifically, Section 603 of the Act provides...more
On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more
Changing reimbursement models and a shift to consumerism were two of the hot topics discussed at Akerman LLP's recent Healthcare Briefing event titled "Financial and Corporate Implications of the Affordable Care Act: A Look...more