News & Analysis as of

Healthcare Group Purchasing Organizations

Wiley Rein LLP

Contracting With PBMs: Critical High-Value Issues to Consider

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Crafting a new pharmacy benefit manager (PBM) agreement may feel like an uphill battle when you do not have the time and resources to develop a highly customized contract. While it is often more beneficial to a health plan to...more

Mintz - Health Care Viewpoints

Senate HELP Committee Eyes Drug Pricing and PBM Regulation Beyond Federal Programs

On April 25, 2023, the Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders and Ranking Member Bill Cassidy introduced a package of legislation aimed at lowering prescription drug prices. The...more

Polsinelli

Orphan Drug Ruling Disrupts the 340B Program

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On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...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

Polsinelli

Summary of Key 340B Omnibus Guidance Proposals

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As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...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

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

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On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...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

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

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Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

McDermott Will & Emery

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

King & Spalding

CMS Open Payment Program Data Indicates $6.49 Billion Paid by Manufacturers, GPOs to Physicians and Hospitals in 2014

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CMS recently released data collected through the Open Payments Program in accordance with the Affordable Care Act from applicable manufacturers and group purchasing organizations (GPOs) about payments and other transfers that...more

Cooley LLP

Is CMS Feeling the Sunshine Heat?

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As we told you about here, the Centers for Medicare & Medicaid Services (CMS) has been dealing with issues related to its Open Payments database of payments and transfers of value reported by manufacturers and group...more

Mintz - Health Care Viewpoints

As Sunshine Act Reporting Deadline Looms, CMS Issues Additional Guidance

With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for...more

Latham & Watkins LLP

Applicable Manufacturers Face June 30th Deadline for Sunshine Act Reporting

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CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more

Foley & Lardner LLP

Physician and Teaching Hospital Sunshine Act Registration to Begin June 1

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Under the Physician Payments Sunshine Act, pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) are required to annually report payments or other transfers of value made to physicians and...more

Saul Ewing Arnstein & Lehr LLP

Registration and Data Submission Begin Pursuant to the Sunshine Act

The Centers for Medicare & Medicaid Services (“CMS”) recently released guidance on its website describing a two-phase process for applicable manufacturers and group purchasing organizations (“GPOs”) to register and submit...more

King & Spalding

CMS Delays Open Payments Data Submission Deadline, Announces Registration Process; Requires Manufacturers and GPOs to Report...

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On Friday, February 7, 2014, the Centers for Medicare and Medicaid Services (CMS) announced that Open Payments registration is scheduled to begin on Tuesday, February 18, 2014 for applicable manufacturers and applicable group...more

King & Spalding

CMS Announces Sunshine Act Open Payment Registration To Begin on February 18, 2014

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On Friday, February 7, 2014, CMS announced that Open Payments registration is scheduled to begin on Tuesday, February 18, 2014 for applicable manufacturers and applicable group purchasing organizations (GPOs). ...more

Mintz - Health Care Viewpoints

More Open Questions About Open Payments Under the Sunshine Act

Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the...more

McDermott Will & Emery

HRSA Finalizes 340B Program Orphan Drug Exclusion Rules

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On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more

McDermott Will & Emery

340B Drug Pricing Program Notices on Group Purchasing Organizations and Medicaid Exclusion File

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Following the recent release of new Program Notices regarding the Group Purchase Organization (GPO) prohibition and Medicaid Exclusion File, 340B participating entities should review their 340B program policies and procedures...more

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