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McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

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Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

Holland & Knight LLP

Healthcare Law Update: October 2021

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Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

McDermott Will & Emery

GAO Recommends CMS, HRSA Improve 340B Duplicate Discount Oversight

On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more

Sheppard Mullin Richter & Hampton LLP

Is Prescription Drug Pricing The Cure For Partisanship?

In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA)...more

Hogan Lovells

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

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In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 6: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Dual Special Needs Plans - This part 6 of our 7 part series focuses on the provisions regarding dual special needs plans (“D-SNPs”) released by the Centers for Medicare and Medicaid Services (“CMS”) in the proposed rule...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 5: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Part D Plan Sponsors’ Access to Medicare Parts A and B Claims Data Extracts - As detailed in previous posts in this series, one major objective that the Centers for Medicare and Medicaid Services (“CMS”) addressed in a...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 4: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Quality Improvement Programs - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes two technical changes to 42 C.F.R. Part 422. The first change...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 3: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Medicare Advantage and Part D Preclusion List - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 2: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Requirements for MA Plans Offering Additional Telehealth Benefits - As part of the proposed rule issued November 1, 2018 by the Centers for Medicare and Medicaid Services (“CMS”) regarding updates to the Medicare Advantage...more

Sheppard Mullin Richter & Hampton LLP

Blog Series: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit,...

On October 26, 2018, the Centers for Medicare and Medicaid Services (“CMS”) released for viewing a proposed rule that includes significant changes for Medicare Advantage organizations (“MAOs”), Part D prescription drug plan...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Robinson & Cole LLP

Health Law Pulse - October 2015

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The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

BakerHostetler

340B Guidance: Eight Key Points Covered Entities Should Consider

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On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

Baker Donelson

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

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After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

Cooley LLP

Blog: HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 2015

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On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the...more

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