Legislative 340B Category

Oct
1st

340B Mega-Guidance – Now What?

Our Top Three Concerns with the 340B Mega Guidance Over the last month, many of our clients have been asking for input on the 340B Mega-Guidance (officially titled: 340B Drug Pricing Program Omnibus Guidance). We have also been onsite conducting external 340B audits and are already assessing the impact of the Mega-Guidance if it is […]

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Aug
28th

340B Mega Guidance & Coalition Notes

The Wait is Over 340B Mega Guidance: Well played by the government. We had some news about delays and later than September, and BOOM, 340B Omnibus Guidance is published in August (love it). First, if you did not already see it or know it came out, the 340B Mega Guidance is out for comment and […]

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It appears that 2015 went off with a bang for the 340B Program. Here are some notes from 340B University, 340B Coalition Conference, the March U.S. Congress 340B Hearing, and our own experience conducting 340B audits in the field and working with covered entities. 340B Audits: We are aware of seven (7) covered entities who […]

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Feb
19th

2016 HHS Budget – 340B Impact

2016 HHS Budget The 2016 Department of Health and Human Services (HHS) budget has been submitted to President Obama. HHS invests in scientific research, health care, disease prevention, early education, social services, and children’s well-being, to support healthier families, stronger communities, economic opportunity, and a thriving America. HRSA (and the 340B Program) fall into this […]

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Orphan Drug Interpretive Rule SUMMARY: Effective July 21, 2014, Health and Human Services (HHS) has issued an “Interpretive Rule” regarding section 340B(e) of the Public Health Service Act (PHSA), “Exclusion of Orphan Drugs for Certain Covered Entities.” This new section of 340B law was added when Section 7101 of the Affordable Care Act added several […]

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Jul
24th

340B PROGRAM UPDATE-ORPHAN DRUG RULING

The US Health Resources and Services Administration (HRSA) has finally posted the final rule defining the orphan drug exclusion from the 340B program. As you may know, Section 7101 of the Affordable Care Act allowed Critical Access Hospitals, Sole Community Hospitals, and Rural Referral Centers to participate in the 340B drug pricing program. However, the […]

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Senator Grassley statement, sequester impact on OPA, GPO Exclusion clarification marches on, and HgA1C improvement is statistically significant! The above list has one thing in common . . . 340B. Some of the items are not so good, while at least one is fantastic (in my view). Before we get into the topics for this […]

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Oct
27th

340B Program and Webinar Update

340B Program Blog and Webinar Highlights We have been busy rolling out 340B contract pharmacies and additional qualifying sites within our health-system. In addition, we have ramped up our consulting efforts and have been working with clients and creating business partnerships that we feel provide significant benefits to our clients. We’ll have more information on […]

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Inpatient discounts were in some PPACA (Obamacare) drafts, so what happened to them? Disclosure: We choose not to affiliate with either republican or democrat views regarding 340B. We have seen both opposition and support from both parties. In this article we are attempting to share what we have found. Background: The 340B drug discount program […]

Jun
30th

340B Program and PPACA (Obamacare)

What does the PPACA (Obamacare) have in it that pertains to the 340B Program The Patient Protection and Affordable Care Act (PPACA), affectionately known as Obamacare, does have some implications for the 340B program. Now that the Supreme Court has officially NOT overturned part or all of the Act, I thought it would be a […]

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