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
What is the cost of a knee implant in the inpatient setting? How much does Medicare pay for different types of cardiac valve procedures? How have Medicare inpatient volumes changed over time for inpatient hip and femur...more
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more
The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more
A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more
As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more
Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more
With a rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in the biopharma and medical devices sectors. In our inaugural biopharma and medical devices briefing, we highlight a...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
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
Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more
Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more
On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly anticipated take on a mechanism to expedite...more
In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more
How will the election affect life sciences in 2021 and beyond? What’s ahead for the regulatory and policy environment? In this session, our elite group of policy analysts reviewed the election results and the far-reaching...more
The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid...more
On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more
On September 1st, the Centers for Medicare & Medicaid Services (CMS) proposed a rule offering medical device manufacturers Medicare coverage upon FDA clearance or approval when their products have been designated by the U.S....more