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Audits Prescription Drugs

Morgan Lewis - As Prescribed

No Surprise: 340B Audits Are on the Rise!

While audits are part of doing business in the ordinary course, businesses are generally less than eager to open the books. And the same is true when it comes to the 340B Drug Pricing Program. Audits are now making the list...more

Manatt, Phelps & Phillips, LLP

340B Hospitals Sue HRSA for Authorizing Audits of 340B Records

On July 24, two hospitals that participate in the Section 340B drug discount program—Oregon Health & Science University and Maine General Medical Center—filed separate lawsuits against the Health Resources and Services...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: June 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

Bass, Berry & Sims PLC on

On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

King & Spalding

Major Shift in Best Price Proposed in Grab Bag of MDRP Reforms

King & Spalding on

The title of CMS’s May 26 proposed rule, “Misclassification of Drugs, Program Administration and Program Integrity Updates Under the MDRP,” buries the lede. Amid twenty Medicaid Drug Rebate Program-related proposals—some...more

American Conference Institute (ACI)

[Event] 17th Annual “BIG FOUR” Pharmaceutical Pricing Boot Camp - May 1st - 2nd, New York, NY

Establish firm footing in the world of government contracting with this advanced course of study in Big Four pharmaceutical purchasing. ACI’s Big Four Pharmaceutical Pricing Boot Camp will introduce and reinforce core...more

Ballard Spahr LLP

HHS OIG to Review CMS Citations

Ballard Spahr LLP on

Summary - The Department of Health and Human Services Office of Inspector General (HHS OIG) has announced its intention to comprehensively review nursing home citations issued by the Centers for Medicare and Medicaid...more

McDermott Will & Emery

This Week in 340B: February 2023

McDermott Will & Emery on

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

Holland & Knight LLP

Holland & Knight Health Dose: January 31, 2023

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.  This week's topics include:...more

Goodwin

Common Bioresearch Monitoring Violations: Updates from FY 2021 to Now

Goodwin on

The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new product development and...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Managed Care Compliance Conference - February 8th - 9th, 8:25 am - 3:45 pm CST

Can’t attend the conference in-person? The virtual Managed Care Compliance Conference, February 8–9, allows you to hear from industry professionals just like you—all from the comfort of your home or office. Geared towards...more

Health Care Compliance Association (HCCA)

[Event] 2022 Managed Care Compliance Conference - January 30th - February 1st, Phoenix, AZ

Attend our annual event for those who manage compliance at health plan providers. Explore topics and issues that are pertinent to industry professionals like you. Learn the latest practices, share strategies, and connect with...more

Proskauer - Minding Your Business

Beyond the Pandemic: Pharmaceutical Industry Compliance Considerations

Since the ongoing states of emergency were put in place in response to a health crisis, pricing in the pharmaceutical industry is under more of a microscope than usual. While the immediate focus may be on products that are...more

Snell & Wilmer

President Trump Issues Executive Order to “Buy American” with Respect to “Essential Medicines”

Snell & Wilmer on

Amidst a flurry of policymaking from the White House last week, President Trump issued the Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States on August...more

Baker Donelson

Coronavirus: HRSA Issues Guidance Outlining Flexibility to 340B Providers

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The Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) has created a COVID-19 Resources page on its website providing information for 340B drug pricing program stakeholders. In particular,...more

Robinson+Cole Data Privacy + Security Insider

OIG Audit Finds that Majority of Part D Providers Surveyed used E1 Transactions for Potentially Inappropriate Purposes

The Centers for Medicare and Medicaid Services (CMS) requested an audit by the Office of Inspector General of Medicare Part D eligibility transactions (E1) transactions....more

McDermott Will & Emery

GAO Recommends CMS, HRSA Improve 340B Duplicate Discount Oversight

On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more

Baker Donelson

A Flurry of Recent Activity Highlights Continued Interest in 340B Program Oversight

Baker Donelson on

Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2

K&L Gates LLP on

In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more

Bradley Arant Boult Cummings LLP

Attention Healthcare Companies! New Strike Force Based in Nashville Means New Scrutiny - Government Enforcement Update

It’s Time to Review Your Compliance, Data and Auditing Plans - As we near the end of 2018, healthcare providers and companies are understandably focused on 2019 and the trends ahead. In planning for next year, however,...more

Sheppard Mullin Richter & Hampton LLP

Blog Series: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit,...

On October 26, 2018, the Centers for Medicare and Medicaid Services (“CMS”) released for viewing a proposed rule that includes significant changes for Medicare Advantage organizations (“MAOs”), Part D prescription drug plan...more

Baker Donelson

HRSA Guidance Updates Suggest Tightening of 340B Covered Entity Repayment Rules

Baker Donelson on

Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more

Holland & Knight LLP

Healthcare Law Update: September 2017

Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

Dorsey & Whitney LLP

OIG Releases 2017 Work Plan

Dorsey & Whitney LLP on

Executive Summary - The United States Department of Health and Human Services Office of the Inspector General (“OIG”) published its Fiscal Year 2017 Work Plan (“2017 Plan”) on November 10, 2016. The work plan is...more

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