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DE Under 3: US DOL Inspector General’s Office Plans to Review Effectiveness of OFCCP Compliance Evaluations
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Independent Audits of Nonprofit Organizations With Douglas Cook
DE Under 3: U.S. OPM Proposed Allowing Federal Managers To Avoid Most Qualified Candidates To Pick Those Who Offer Better “Fit”
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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
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
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
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
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
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
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
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
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
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
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
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
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
Massachusetts’s Marketplace eliminates cost-sharing for addiction treatment in subsidized QHPs; Montana cuts its uninsurance rate in half; and a Kaiser report identifies the 50 most costly drugs for Medicaid....more
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
As U.S. spending on pharmaceuticals continues to rise, reaching $373.9 billion in 2014, government scrutiny of drug pricing practices has increased in response. Early last year, the U.S. Department of Health and Human...more
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
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
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
The recent investigations into two pharmaceutical companies active in the ophthalmic drugs market in Italy and France serve as a reminder of the cooperation that takes place between national competition authorities....more