I'm taking advantage of my law school education to write about issues that are related to my work, but sometimes a bit afield of the strictly limited area of FDA regulation of advertising and promotion. Whenever I have something that I think might interest the readers of this blog, I'll post the piece to my Scribd.com account, a link to which is always available in the right rail under the label of "Long-form writings."
The first such piece is about the Medicare Access and CHIP Reauthorization Act (MACRA) and why MACRA, which was colloquially known as the "permanent doc fix," is going to be a huge issue in the 2020 election. In fact, some time next year, I expect the very serious flaws in this legislation to explode in the public consciousness and to become the next "crisis" in healthcare financing.
If you'd like to get ahead of the topic to prepare yourself, take a look at the linked piece. I'd be happy to continue the discussion of this topic in the comments on this post.
Showing posts with label Medicare. Show all posts
Showing posts with label Medicare. Show all posts
New OIG Guidance on PAP Programs
The Office of the Inspector General has released a supplemental bulletin alerting pharmaceutical manufacturers that third-party Patient Assistance Programs (PAPs) that are run by independent charities might be subject to prosecution under fraud and anti-kickback statutes.
Quoting from the press release on the OIG website:
http://oig.hhs.gov/newsroom/news-releases/2014/charity.asp
http://oig.hhs.gov/fraud/docs/alertsandbulletins/2014/independent-charity-bulletin.pdf
Quoting from the press release on the OIG website:
"OIG is mindful of the importance of helping financially needy beneficiaries of Federal programs receive needed medical care. Independent charities can play an important role in advancing this goal. If, however, a charity acts as a conduit for a drug manufacturer to induce the prescription of its drugs, Federal health care programs and their beneficiaries are put at risk. OIG will therefore closely scrutinize PAPs that do not appear sufficiently independent from their donors," said Inspector General Daniel R. Levinson.You can read the full release and access the bulletin from these links:
http://oig.hhs.gov/newsroom/news-releases/2014/charity.asp
http://oig.hhs.gov/fraud/docs/alertsandbulletins/2014/independent-charity-bulletin.pdf
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