Speakers:
Alice Valder Curran – Hogan Lovells
Rick Zimmerer – KPMG
What did the lawsuits teach us?
When the various parties submitted lawsuits based on the DRA, CMS learned that there are more entities that pay attention to GP than just the pharmaceutical manufacturers. Pharmacy groups, as well as others, showed CMS that they are not only reading the statutes, but they are making sure that CMS enforces the regulations, and enforces them as the group interpret the regulations to be.
In addition, they made it known that lawsuits were not off the table when it came to ensuring that manufacturers adhered to the regulations based on how they read the language.
So, CMS is listening. They come into the heathcare reform regulations with eyes open that people are watching and that interpretations may be far from the original intent. The consensus seems to be that this understanding of the language and how it affects those other than manufacturers will be taken into account when written guidance is released.
The take away? First, do not be surprised if the language used in guidance and regulations is no longer geared towards manufacturers specifically. Second, do not be surprised if the decisions on the guidance do not make sense for your type of pharmaceutical company as it may not be for your company as much as it is a way for CMS to avoid further lawsuits. Third, do not get comfortable with the HCR. When the Remember when DRA was implemented we were all in a frenzy to make the changes as we saw them. And just as we got to catch our breath due to feeling we had a good understanding of the regulations, along came the HCR bills. Chances are that in the attempt by CMS to make everyone happy, they will make someone (or everyone) unhappy and when that happens entities now know that lawsuits that get changes made even if the suit does not prevail. Nothing is for certain in Medicaid and GP other than it is a very fluid process and never set in stone.
Happy calculating!
Alice Valder Curran – Hogan Lovells
Rick Zimmerer – KPMG
What did the lawsuits teach us?
When the various parties submitted lawsuits based on the DRA, CMS learned that there are more entities that pay attention to GP than just the pharmaceutical manufacturers. Pharmacy groups, as well as others, showed CMS that they are not only reading the statutes, but they are making sure that CMS enforces the regulations, and enforces them as the group interpret the regulations to be.
In addition, they made it known that lawsuits were not off the table when it came to ensuring that manufacturers adhered to the regulations based on how they read the language.
So, CMS is listening. They come into the heathcare reform regulations with eyes open that people are watching and that interpretations may be far from the original intent. The consensus seems to be that this understanding of the language and how it affects those other than manufacturers will be taken into account when written guidance is released.
The take away? First, do not be surprised if the language used in guidance and regulations is no longer geared towards manufacturers specifically. Second, do not be surprised if the decisions on the guidance do not make sense for your type of pharmaceutical company as it may not be for your company as much as it is a way for CMS to avoid further lawsuits. Third, do not get comfortable with the HCR. When the Remember when DRA was implemented we were all in a frenzy to make the changes as we saw them. And just as we got to catch our breath due to feeling we had a good understanding of the regulations, along came the HCR bills. Chances are that in the attempt by CMS to make everyone happy, they will make someone (or everyone) unhappy and when that happens entities now know that lawsuits that get changes made even if the suit does not prevail. Nothing is for certain in Medicaid and GP other than it is a very fluid process and never set in stone.
Happy calculating!
1 comment:
And just as this blog gets posted I see this on Yahoo! Just like I said... "never set in stone."
http://news.yahoo.com/s/ap/20100914/ap_on_re_us/us_health_overhaul_lawsuit
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