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
New CMS program, WISeR, will leverage third parties to screen prior authorization requests using technologically enhanced processes....more
On June 27, 2025, the Centers for Medicare & Medicaid Services (“CMS”), through its Innovation Center (“CMMI”), released the Request for Applications (“RFA”) for a new payment and service delivery initiative: the Wasteful and...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
As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more
Section 1557 of the Affordable Care Act (ACA) prohibits providers and health plans that receive reimbursement from the federal government from discriminating against individuals in the Covered Entities’ health programs. Such...more
Companies should consider how new AI risk standards may align to their operations and whether to comment on the draft standards to shape their development. On April 29, 2024, the White House announced that several federal...more
Federal and state agencies continue to remain active this year, particularly with regard to laws that impact healthcare technology. As part of our ongoing efforts to track health technology-related legislation and...more
Use of algorithms and artificial intelligence (AI) in prior authorization and utilization management is facing growing criticism and litigation. Notable lawsuits include alleged automatic authorization denials for tests that...more
This week, Heather and Matthew welcome Dr. Kevin Bennett of the University of South Carolina School of Medicine, who shares his insight on rural health care and how to both improve the delivery of services and create a more...more
While the Medicare statute provides access to healthcare services for our nation’s elderly and disabled populations, it also can serve to foreclose access for those populations when an item or service does not fall within one...more
As we approach the middle of the first quarter of 2023, private equity firms have continued to demonstrate their interest in investing in digital health. This does not come as a surprise, as most startups in the healthcare...more
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As...more
Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (the “Proposed...more
In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...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
The Centers for Medicare and Medicaid Services recently issued a proposed rule that would grant Medicare coverage to breakthrough medical devices immediately upon FDA approval. The rule also proposes to codify a new...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
- The proposed rule seeks to “demolish the existing bureaucratic barriers that have created a ‘valley of death’ for innovative products.” - A new Medicare Coverage of Innovative Technology (MCIT) pathway would allow...more
On July 29, 2019, CMS published a proposed rule revising the factors for determining Medicare payment rates under the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgery Center (ASC) Payment...more
In Depth - The Centers for Medicare & Medicaid Services (CMS) recently issued the Final Rule regarding managed care in Medicaid and Children’s Health Insurance Programs (CHIP) that revises and expands the federal rules...more