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
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more
On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more
THIS WEEK’S DOSE - - House Passes Reconciliation Package. The package now moves to the Senate, where substantive changes, including in healthcare, will likely be made. - HHS Secretary Kennedy, FDA Commissioner Makary...more
On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2028 of the Drug Price Negotiation Program (DPNP) established by the Inflation Reduction...more
On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more
On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more
When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators....more
A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more
In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued multiple pieces of guidance related to Medicare Advantage plans and Medicare Part D prescription drug coverage, including the Final CY 2026 Part D...more
The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen. The US pharmaceutical industry...more
Several April releases seem to signal some basis for optimism for stakeholders in Medicare Advantage and Part D, though with sufficient undertones to recommend caution....more
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more
Key points include access to medicines in medicare is reduced as the IRA is implemented; fewer drugs are covered on Medicare Part D formularies in 2025 relative to 2024; medicines for serious conditions with high unmet needs...more
The Centers for Medicare & Medicaid Services (CMS) released on April 4, 2025, the final rule for contract year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more
This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...more
The Latham drug pricing and market access team invites you to read this digest of recent developments on healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more