News & Analysis as of

Medicare Part B Covered Entities

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Bowditch & Dewey

Broadened Non-Discrimination Mandates Imposed on Medical Providers – How to Comply

Bowditch & Dewey on

The Affordable Care Act, which was signed into law in 2010, contained a provision (commonly referred to as Section 1557) prohibiting discrimination on the basis of race, color, national origin, sex, age or disability in...more

McDermott Will & Schulte

This Week in 340B: August 2023 #2

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Schulte

This Week in 340B: February 2023 #2

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

BakerHostetler

HHS Proposes Rule Strengthening Section 1557 Protections Against Nondiscrimination in Health Activities

BakerHostetler on

​​​​​​​On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more

K&L Gates LLP

340B Update: Appellate Court Upholds 340B Payment Reduction as CMS Proposes Further Reductions for 2021

K&L Gates LLP on

In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B...more

Mintz - Health Care Viewpoints

CMS Takes Another Swing at 340B Reimbursement Cuts. Will It Be Strike Three?

The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019. Buried in the 819 pages of proposed changes and justifications, CMS took another swing at cutting Medicare Part B reimbursement...more

Mintz - Health Care Viewpoints

March 2019: Where Are We Now With 340B?

Long time readers of our blog may recall that five years ago, I predicted that 2014 might be a game-changing year for the 340B Drug Discount Program. 2014 saw attempts at regulatory changes, but a successful court challenge...more

K&L Gates LLP

340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs

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On November 1, 2017, the Centers for Medicare and Medicaid Services (“CMS”) issued a final rule updating the Medicare hospital Outpatient Prospective Payment System (“OPPS”) for the calendar year 2018. As part of this update,...more

Mintz - Health Care Viewpoints

CMS Finalizes Medicare Part B Reimbursement Cut for 340B – What Does it Mean?

On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the...more

Polsinelli

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

Polsinelli on

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

Mintz - Health Care Viewpoints

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more

Sullivan & Worcester

Employment and Benefits Advisory: 2017 Reminders and Developments

Sullivan & Worcester on

New Relief for Small Employer Health Reimbursement Arrangements - As mentioned in prior advisories, the Departments of Labor, Health and Human Services and Treasury have taken the position that employers cannot reimburse...more

McDermott Will & Emery

OIG Reports on, Proposes Alternatives to Medicare Part B Reimbursement for 340B Drugs

McDermott Will & Emery on

In November 2015, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report (the Report) on the subject of Medicare Part B (Part B) payments made for covered outpatient drugs...more

King & Spalding

OIG Report Examines Potential Scenarios for Restructuring 340B Program

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Restructuring the 340B Drug Discount Program and Part B payment rules could reduce Medicare drug expenditures by up to $1.1 billion, the HHS Office of Inspector General (OIG) reported last week. The 340B Program requires...more

Mintz - Health Care Viewpoints

Just in Time for the Phase II Audits: OIG Criticizes OCR’s Enforcement Efforts

As HIPAA-regulated entities anxiously await the commencement of the Phase II HIPAA audit program, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has issued a report critical of...more

K&L Gates LLP

HHS Proposes Rules for Nondiscrimination in Health Care

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On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) proposed new regulations implementing Section 1557 of the Patient Protection and Affordable Care Act (“ACA”). Section 1557 prohibits...more

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