Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
A Fond Farewell: Musings on the End of the Medicare Advantage Hospice Carve-In Demonstration
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 178: Life Sciences Industry Impact with Bob Coughlin, JLL Director and Former MassBio CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 175: Healthcare Inequity with Kim Smith, Healthcare Advocate and Founder of Health Evolve Technologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 173: Improving rural health care with Dr. Kevin Bennett, the Director of the Research Center for Transforming Health and the
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
The No Surprises Act: A Cost Saving Opportunity for Employer Plan Sponsors
La reforma del sistema de salud
Counsel That Cares - Value-Based Care as a Long-Term Investment
Video: Health Care's Past, Present, and Future - Diagnosing Health Care Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 117: Chris Severn, Co-Founder & CEO, Turquoise Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 115: Dr. Michael Havig, CEO, HealthMe
Taking the Pulse, A Health Care & Life Sciences Video Podcast | Episode 107: A legislative update with SC Speaker Murrell Smith
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
Value-based health care: the role of payors
Episode 09: Behold "AHCA"! – Demystifying Employment Law Implications of Proposed ACA Replacement
Polsinelli Podcast - Republicans Gain Control of the U.S. Senate - How That May Impact Health Reform
Polsinelli Podcast - Health Care Payment Changes: From Service to Value
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
House Energy & Commerce Health Subcommittee Holds Legislative Hearing on Improving Medicaid Access. Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services (CMCS), testified. Members...more
During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more
AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more
On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...more
A proposed program by the state of Florida to import certain prescription drugs from Canada has received the approval of the United States Food and Drug Administration (FDA): FDA news release on January 5, 2024....more
Congress Works to Meet Imminent Funding Deadlines. Speaker of the House Johnson (R-LA) and Senate Majority Leader Schumer (D-NY) announced an agreement on top-line spending levels to fund the government for the remainder of...more
On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on...more
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
CONGRESS - House Republicans Working to Elect New Speaker. On October 11, House Majority Leader Scalise won the Republican Conference’s nomination to become Speaker of the House after last week’s motion to vacate Speaker...more
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
CONGRESS - Senators Sanders and Marshall Release Bipartisan Primary Care and Health Workforce Act. Released on September 14, the legislation would reauthorize funding for a number of healthcare workforce programs that are...more
In recent years, an unprecedented level of interest in the promise of psychedelics has taken hold. In the United States, many types of psychedelics are being investigated for use in treating an array of mental health...more
On July 13, 2023, the Food and Drug Administration (“FDA”) approved the first daily contraceptive for use without a prescription. Opill® (norgestrel) tablet, .075 mg has been approved to prevent pregnancy in individuals of...more
As we previously reported, Perrigo Company’s subsidiary HRA Pharma submitted an application to the Food and Drug Administration (FDA) in the summer of 2022 to switch an existing prescription-only progestin birth control pill...more
At the May 9-10, 2023, Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee, U.S. Food and Drug Administration (FDA) advisers voted that the...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community. Join us for insightful discussion about the latest regulatory and reimbursement developments....more
On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the requirement that mifepristone...more
On January 3, 2023, the U.S. Food and Drug Administration (FDA) modified its risk evaluation and mitigation strategy (REMS) program (“Mifepristone REMS Program”) to provide a process for pharmacies to become certified to...more