News & Analysis as of

Audits Prescription Drugs Hospitals

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

Baker Donelson

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

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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

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

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

McCarter & English, LLP

340B Drug Discounts: Potential HRSA Policy Shift May Limit Eligibility for Preferred Pricing

The 340B drug pricing program requires drug makers to offer covered outpatient drugs to safety net hospitals and certain other designated healthcare providers at discounted prices. A potential shift in how the governing...more

Holland & Knight LLP

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

Holland & Knight LLP on

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

King & Spalding

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

King & Spalding on

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

Robinson & Cole LLP

Connecticut Enacts Health Care Legislation in June Special Session

Robinson & Cole LLP on

On June 29 and 30, 2015, the Connecticut General Assembly conducted a special legislative session following the close of the 2015 regular session. Among other things, the General Assembly passed a bill to implement the state...more

King & Spalding

Health Headlines: Also in the News - May 2014

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OIG Reports Jurisdiction H Contractors Made $3.3 Million in Overpayments for Outpatient Drugs – According to a recent OIG report, the Medicare Contractors for Jurisdiction H overpaid providers approximately $3.3...more

Dentons

HIPAA Impaired Providers and the ER - What Happens When Your Employee Becomes Your Patient?

Dentons on

I was speaking this week at IAHIMA’s Annual Conference on the issues relating to HIPAA audits and recent updates from OCR and ONC. As part of my program we typically solicit questions prior to the presentation, most of which...more

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

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