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MCOs Pharmaceutical Industry

McDermott+

Pharmacy Benefit Manager Reform: What’s on the Horizon?

McDermott+ on

The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government. Pharmacy benefit...more

McDermott Will & Emery

HHS Takes Steps to Resolve 340B Medicaid MCO Duplicate Discount Confusion

On May 26, 2023, the Centers for Medicare and Medicaid Services (CMS) proposed an update to the Medicaid Drug Rebate Program (MDRP) rules, which includes provisions aimed at preventing 340B duplicate discounts on claims...more

Manatt, Phelps & Phillips, LLP

[Webinar] Prenatal Vaccines in Medicaid & CHIP: Current State Payment Rates and Strategies to Increase Access - June 8th, 2:00 pm...

Prenatal vaccines provide important protection for pregnant women and newborns against communicable diseases such as whooping cough and influenza. However, fewer than one out of four pregnant women receives all federally...more

Hogan Lovells

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

Hogan Lovells on

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more

American Conference Institute (ACI)

[Virtual Event] 11th Annual Advanced Forum on Managed Care Disputes and Litigation - July 22nd-23rd

ACI’s 11th Annual Advanced Forum on Managed Care Disputes and Litigation will be offered in a virtual format this year to help you make sense of these developments, and their profound impact for managed care....more

K&L Gates LLP

K&L Gates Triage: 340B Update: CMS Issues Guidance for Avoiding Duplicate Discounts in Medicaid

K&L Gates LLP on

In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to...more

Manatt, Phelps & Phillips, LLP

Manatt Health Releases 50-State Survey on 340B in State Medicaid Programs

Manatt, Phelps & Phillips, LLP, a multidisciplinary, integrated professional services firm, announced today the release of its Comprehensive 50-State Survey: State Medicaid Programs and 340B. Conducted by Manatt Health, the...more

Mintz - Health Care Viewpoints

New York (Again) Seeks to Regulate Pharmacy Benefit Managers

On January 15, 2019, Governor Cuomo released the 2019-2020 Executive Budget, which proposes substantial legislative changes that would affect pharmacy benefit managers (PBMs). Among other things, the law would require PBMs to...more

Jones Day

Certain Pharmaceutical Discounts No Longer Safe Under the "Safe Harbors"?

Jones Day on

The proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products. On February 6, 2019, the Department of Health and Human Services ("HHS") published...more

Gray Reed

Proposed Revisions To The Anti-Kickback Regulatory Discount Safe Harbor: What Does This Mean For The Drug Industry And For Your...

Gray Reed on

Continuing the Trump administration’s efforts to lower drug prices and reduce patient out-of-pocket costs, on February 6,2019, the U.S. Department of Health and Human Services Office of Inspector General (“HHS”) released a...more

Husch Blackwell LLP

HHS Targets PBMs But May Exceed Its Legal Authority In Proposed Rule Eliminating AKS Protection For Drug Rebates

Husch Blackwell LLP on

The Trump Administration’s latest effort to limit the power of pharmacy benefit managers (“PBMs”) is marred by economic uncertainty and looming legal scrutiny. The Office of Inspector General (“OIG”) within the Department of...more

Verrill

OIG Proposes Revisions to Anti-Kickback Safe Harbor Regulations Affecting Prescription Drug Rebates

Verrill on

Recently, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) in the Federal Register to amend the federal anti-kickback statute safe harbor...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

K&L Gates LLP

HHS Issues Proposed Rule to Remove Safe Harbor for Drug Rebates

K&L Gates LLP on

On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if finalized, would modify the discount safe harbor under the federal Anti-Kickback...more

Epstein Becker & Green

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

Dorsey & Whitney LLP

Drug Rebates Threatened Under Proposed Anti-kickback Rule

Dorsey & Whitney LLP on

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more

Cooley LLP

Blog: HHS Proposed Rule Would Remove Safe Harbor Protection for Certain Discounts

Cooley LLP on

On January 31, 2019, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule designed to combat rising drug costs (“Proposed Rule”). The Proposed Rule seeks to...more

Skadden, Arps, Slate, Meagher & Flom LLP

Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans

The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more

Bass, Berry & Sims PLC

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

Holland & Knight LLP

Administration Proposes Changes to the Drug Rebate Program

Holland & Knight LLP on

On Jan. 31, 2019, the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects...more

McDermott Will & Emery

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify...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

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