Group Purchasing Organizations

News & Analysis as of

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

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

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

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

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

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

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more

CMS Continues To Issue Guidance On Sunshine Act Reporting

Three weeks after the commencement of data collection under the Physician Payment Sunshine Act (the “Act”), the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance to assist applicable manufacturers...more

Ready or Not – Sunshine Act Data Collection Starts Today

Today pharmaceutical and medical device manufacturers and group purchasing organizations (“GPOs”) start to collect data on their financial arrangements with physicians and teaching hospitals to comply with the Physician...more

HRSA Finalizes 340B Program Orphan Drug Exclusion Rules

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

Let The Sunshine In – The Risks To Pharmaceutical And Medical Device Companies From Open Payment Transparency

Pharmaceutical and medical device manufacturers (as well as group purchasing organizations “GPOs”) have a major compliance challenge ahead — the Physician Payment Sunshine Act regulations. ...more

CMS Conducts First Call on Physician Payments Sunshine Act Implementation

In anticipation of the start of data collection under the Physician Payments Sunshine Act, the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance on data collection and reporting in an effort to...more

White Collar Watch - April 2013

In This Issue: - Third Circuit Panel Liberalizes “Protected Activity” Immunity for Employees Claiming Whistleblower Status - Doing Time: A Requirement for White Collar Crime? - Casting a Smaller Net:...more

340B Drug Pricing Program: Recent Developments

The 340B Drug Pricing Program (340B Program) continues to undergo a period of intense scrutiny and debate over how compliance with program rules is enforced. As previously reported in the May 30, 2012 edition of Foley’s Legal...more

CMS Officially Launches National Physician Payment Transparency Program Website

The Centers for Medicare & Medicaid Services (“CMS”) recently launched the National Physician Payment Transparency Program: OPEN PAYMENTS website, which provides Sunshine Act compliance resources, including Fact Sheets and...more

340B Program GPO Prohibition Compliance Extension

Hospitals subject to the 340B Drug Pricing Program (340B Program) Group Purchasing Organization (GPO) prohibition now have an additional four months, until August 7, 2013, to comply with 340B Program guidance issued February...more

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

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

CMS Publishes Physician Payment Sunshine Rules; Manufacturers and Group Purchasing Organizations Are Required to Submit Detailed...

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002...more

Physician Payment Sunshine Rule is Finalized

The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more

CMS Issues Final Rule for Implementing Sunshine Act

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

CMS Issues Final Physician Payment Sunshine Act Regulations

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more

Physician Payment Sunshine Rule Finalized; Let The Sun Shine In; Payment Reports Flow

The Centers for Medicare and Medicaid Services (CMS) recently published the final rule implementing the Physician Payment Sunshine Act (Sunshine Act) that requires most manufacturers of drugs, devices, biologics or medical...more

Healthcare Alert: Better Late than Never - The Sunshine Act Final Regulations are Finally Here!: Reports on Physician Ownership...

Reports on Physician Ownership and Investment Interests The Sunshine Act requires applicable manufacturers, as well as applicable GPOs, to report to the Secretary, in electronic form, certain information concerning...more

Healthcare Alert: Better Late than Never - The Sunshine Act Final Regulations are Finally Here!: Report Submission and Review

Report Submission and Review Pre-Submission Review is Not Required Applicable manufacturers may voluntarily provide covered recipients the opportunity to review the data prior to submission to CMS, but doing so is not...more

CMS Releases Final Rule on Physician Payment Disclosures

Public disclosure of payments from pharmaceutical, medical device, biologic, and medical supply manufacturers to physicians and hospitals will begin under a final rule on the Physician Payments Sunshine Act (Sunshine Act)...more

CMS Shines Light on Financial Relationships with Final Physician Payment Sunshine Act Rule

On February 8, 2013, the final Physician Payment Sunshine Act (“Sunshine Act”) rule, issued by the Centers for Medicare and Medicaid Services (“CMS”) will be published. The arrival of this final rule has been much anticipated...more

CMS Issues Final Rule to Implement Physician Payments Sunshine Act

On Friday, February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released the highly anticipated final rule to implement the federal Physician Payments Sunshine Act (the “Sunshine Act”). The final rule will...more

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