Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 244: The Future of Independent Physician Practices with Ray Waldrup of The Leaders Rheum
PODCAST: Williams Mullen's Benefits Companion - Cost, Care and Captives: A Mid-Size Employer’s Guide to Benefit Trends
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
EpiPen RICO Ruling Opens Door for Private AKS Enforcement
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
Drug Pricing Initiatives During the Trump Presidency
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
Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these...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
Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more
As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more
On November 26, 2024, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year 2026 proposed rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more
Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more
The Centers for Medicare & Medicaid Services (CMS) updated its guidance on the Inflation Reduction Act of 2022’s (P.L. 117-169) (IRA) Medicare Prescription Payment Plan (M3P) with its release of the Final Part Two Guidance on...more
Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...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
August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer: “Let’s lower drug prices for the consumer.” “Let’s give consumers more options in paying their out-of-pocket...more
While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more
The Inflation Reduction Act of 2022 (IRA), signed into law last August, seeks to overhaul the way Medicare buys and pays for prescription drugs. A regulatory undertaking of this scope is certain to generate a great deal of...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
The Centers for Medicare & Medicaid Services (CMS) published the proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the Proposed Rule) on...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more
This week in Washington: Negotiations for COVID-19 stimulus package are ongoing; House and Senate are in recess....more
GAO recently released a report analyzing the use of pharmacy benefit managers (“PBMs”) and efforts to manage drug spending and use in the Medicare Part D program. Importantly, the report found that use of PBMs reduced Part D...more
Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription...more
• The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential implementation of a recent proposed rule that would exclude from anti-kickback safe harbor...more
Coming Week’s Highlights: State of the Union scheduled for Feb. 5; House committees continue discussion on pre-existing conditions....more