Elizabeth Elson

Elizabeth Elson

Foley & Lardner LLP

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340B Program Update

The new year has already gotten off to a busy start for health care providers that participate in the 340B Drug Pricing Program (“340B Program”) and government agencies that reimburse these providers. Following on the heels...more

2/25/2016 - CMS Drug Pricing Federal Budget Medicaid Medicare Part B MedPAC Prescription Drugs Section 340B State Medicaid Programs

2016 Expected to Be Monumental Year for 340B Drug Discount Program

The 340B Program continues to be an area of focus from federal policymakers, and recent activity and publications indicate that 2016 could be a monumental year for the program. Below is a breakdown of the recent and upcoming...more

12/8/2015 - HRSA MCOs Medicare Part B OIG Orphan Drugs Section 340B

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

10/20/2015 - Abuse of Discretion Administrative Procedure Act Arbitrary and Capricious Comment Period Covered Entities Drug Pricing Final Rules HHS Hospitals HRSA Interpretive Rule Omnibus Guidance Orphan Drugs Pharmaceutical Industry PHRMA Section 340B Vacated

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

9/1/2015 - Comment Period Covered Entities Draft Guidance Drug Pricing Guidance Update Healthcare Facilities HHS Hospitals MCOs Medicaid Medicare New Guidance Patients Pharmaceutical Industry Pharmacies Physicians Prescription Drugs Recordkeeping Requirements Section 340B

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more

6/19/2015 - Affordable Care Act Civil Monetary Penalty Covered Entities Drug Distribution HRSA OIG Pharmaceutical Industry Pharmacies Prescription Drug Coverage Rulemaking Process Section 340B

HHS Withdraws Proposed 340B Drug Pricing Program "Mega Regs": Further Guidance Forthcoming

The Department of Health and Human Services (HHS) has withdrawn its greatly anticipated 340B Drug Pricing Program (340B Program) proposed regulations. The proposed regulations, nicknamed the 340B Program “Mega-Regs,” had been...more

11/19/2014 - HHS HRSA Prescription Drugs Proposed Regulation Section 340B

340B Drug Pricing Program Interpretative Rule Survives (for Now)

A federal court entered a new order, on August 27, 2014, in an ongoing dispute between the Health Resources and Services Administration (HRSA) and the Pharmaceutical Manufacturers of America (PhRMA) regarding HRSA’s issuance...more

9/3/2014 - HRSA Pharmaceutical Industry PHRMA Prescription Drugs Section 340B

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more

7/23/2014 - Covered Entities Healthcare HHS Hospitals HRSA Interpretive Opinions Pharmaceutical Industry Prescription Drugs Section 340B

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more

6/24/2014 - Affordable Care Act Healthcare HHS HRSA Prescription Drugs Section 340B

OIG Publishes Report Identifying Issues With 340B Contract Pharmacy Arrangements

On February 5, 2014, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) published a report (OIG Report) describing the results of a survey it had conducted of the use of contract...more

2/13/2014 - Healthcare HHS OIG Pharmacies Prescription Drugs Section 340B

340B Drug Pricing Program Developments in the New Year

On January 9, 2014, the Health Resources and Services Administration (HRSA) posted an update on its current and anticipated 340B drug pricing program (340B) program integrity efforts.1 The update includes a discussion of...more

1/14/2014 - Covered Entities HHS HRSA OIG Pharmaceutical Industry Prescription Drugs Section 340B

340B Drug Pricing Program Update: Hospital Recertification and Recent Audit Activity

As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more

8/20/2013 - Affordable Care Act Audits Compliance Hospitals HRSA Prescription Drugs Recertification Section 340B

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

4/19/2013 - Audits Fees GPOs HRSA Proposed Regulation Section 340B

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