The State of Healthcare Enforcement
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Medicaid Cuts: Potential Challenges and Legal Implications for Long-Term Care Facilities — Assisted Living and the Law Podcast
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
UPIC Audits
AGG Talks: Home Health & Hospice Podcast - Episode 8: Hospice Special Focus Program: Pumping the Brakes
Hospice Insights Podcast - Upping the Ante: Will CMS’s Enhanced Oversight Efforts Cause Hospices to Fold?
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Hospice Insights Podcast - What a Difference No Deference Makes: Courts No Longer Bow to Administrative Agencies
Preparing for CMS Staffing Mandates — Assisted Living and the Law Podcast
Hospice Insights Podcast - Meet the New Laws, Same as the Old Laws: Overpayment Recoupment Update
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
The CMS Interoperability and Prior Authorization Rules
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Findings from Gibbins’ Annual Healthcare Bankruptcy Report
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
Senate HELP Committee advances legislation, examines healthcare affordability. The legislation would reauthorize expiring programs, including the Over-the-Counter Monograph Drug User Fee Program. Senate Appropriations...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a...more
Among the many rescissions of Biden administration Executive Orders, signed by President Trump on his administration’s first day, was a rescission of an Executive Order that encouraged Medicare to lower drug costs and makes...more
The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more
The Biden Administration’s Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers, has faced several legal challenges....more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Within the last few months, the Centers for Medicare and Medicaid Services (CMS) has issued guidance that will reduce the financial burdens of paying for prescription drug coverage for Medicare patients. The guidance outlines...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more
This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more
Almost 11 months after President Biden signed the Medicare Drug Price Negotiation Program (“Negotiation Program”) into law, the Centers for Medicare and Medicaid Services (CMS) has issued revised guidance that clearly details...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include... ...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ... ...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more
Inflation Reduction Act Implementation: On Dec. 1, 2022, the Centers for Medicare & Medicaid Services (CMS) distributed an invitation addressed to “All Drug Manufacturers” announcing that CMS “will host monthly one-hour calls...more
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more
It has been one year since President Biden signed a far-reaching, industry-spanning Executive Order on Promoting Competition in the American Economy. The Executive Order outlines a “whole-of-government” approach to...more
Biden Administration Releases FY 2023 Budget - The Biden Administration’s proposed Budget of the U.S. Government for FY 2023 (see also the accompanying fact sheet) includes proposals relevant to drug manufacturers....more
As Congress reconvenes, it faces a packed agenda in a legislative year that will be shortened by the upcoming midterm elections and remains buffeted by the persistent coronavirus pandemic. The list of healthcare priorities is...more
Drug Pricing Initiatives: The pathway to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA) is unclear, following Senator Joe Manchin’s withdrawal of his support for the measure. The BBBA is an approximately...more
It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more