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
Most healthcare providers understand that routinely waiving patient cost-sharing obligations creates compliance issues under the Anti-Kickback Statute, the Civil Monetary Penalties Law, and third-party payor agreements which...more
Every year, the New Jersey legislature passes statutes that impact healthcare beyond rate increases under the Medicaid program. Last year was no different, and the discussion below highlights some of those statutes, such as...more
The Centers for Medicare & Medicaid Services (CMS) has announced new measures to enhance access to behavioral health services for Medicare beneficiaries and improve hospital price transparency as part of the final rule for...more
On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more
5 Questions is a periodic feature produced by Cornerstone Research, which asks our professionals, senior advisors, or affiliated experts to answer five questions. We interview Professor Erin Trish, of the Schaeffer Center...more
Summary - The Departments of Labor, Health and Human Services, and the Treasury have issued guidance that coordinates application of the No Surprise Billing rules under the Consolidated Appropriations Act, 2021, with the...more
On March 30, Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas issued a decision in Braidwood Management Inc. v. Becerra (“Braidwood”), invalidating the Affordable Care Act’s (“ACA’s”) mandate...more
Where did the time go? Just a brief 1,199 days after it began, the COVID-19 Public Health Emergency (PHE) is coming to an end. The PHE formally ends on May 11, 2023, short of any unexpected developments. And that means the...more
On March 30, 2023, the District Court for the Northern District of Texas issued an opinion and order in Braidwood Mgmt. Inc. v. Becerra that vacates the implementation and enforcement of certain preventive service provisions...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between September 21 and October 20, 2022. We review several criminal and civil enforcement actions related to Anti-Kickback Statute...more
The New York State Legislature recently concluded its 2022 legislative session, with the Assembly adjourning in the morning hours of Saturday, June 4, following the State Senate, which adjourned early on Friday, June 3....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
A few short weeks ago we told you in a blog post that, with only four days’ notice, the Departments of Labor, Treasury, and HHS (the Departments) required that, starting January 15, 2022, group health plans cover FDA-approved...more
On Monday, the government issued frequently asked questions (FAQs) requiring employer group health plans (Plans) and health insurance issuers to cover certain over-the-counter (OTC) COVID-19 tests at no cost to the...more
Effective January 15, 2022, health plans are required to cover the cost of over-the-counter (“OTC”) COVID-19 test kits obtained without a health care provider’s prescription or clinical assessment. This new requirement was...more
Congress kicks off this week with three weeks to go before the March 23 omnibus spending deadline. At this point it’s still not entirely clear what will be tacked on to this spending package, but immigration, market...more
Massachusetts employers with 6 or more employees will soon be required to prepare and file a new health care reporting form referred to as the “healthcare coverage form.” While reminiscent of the now repealed “Health...more
In this episode of Triage, Amanda Makki and Corbin Santo of the K&L Gates Public Policy and Law practice group discuss several fundamental issues that are currently at the center of the health care debate in Washington, DC....more
The National Governors Association and National Association of Insurance Commissioners weigh in on ACA repeal and replace; CBO releases new Medicaid and Marketplace enrollment estimates; and Massachusetts proposes reinstating...more
The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more
On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule that will have a widespread impact on health care service providers, medical transport providers,...more
On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...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
Holland & Knight issued an alert in May 2016 regarding litigation by the U.S. House of Representatives against the Obama Administration and the decision of the U.S. District Court for the District of Columbia enjoining any...more
Hospitals now have additional time before they must meet federal requirements to provide written notice to Medicare patients who are receiving observation services. Congress passed the Notice of Observation Treatment and...more