Speaker:
Danielle Drissel – Hogan Lovells
Are you compiling with all of your reporting requirements?
About eight years ago states started to adopt their own reporting requirements above and beyond the Medicaid reporting requirements of manufacturers. This started in 2002 when Texas required those with any drug on the Texas formulary to submit their quarterly AMP directly to the state. They have two requirements total and they require that all price changes are communicated to Texas within 15 days. The state Attorney General seems to be paying more attention to this obligation under Texas Admin Code § 354.1923 and if you do not act in accordance with the code the state can kick you off their formulary.
Then came along New Mexico in 2004 which requires annual reporting for each prescription drug sold in New Mexico based on the data for the reporting period and has come out with additional guidance in November 2007. You have to report your AMP, CPPs, WAC, lowest price to PBM that takes possession in New Mexico, Direct sales lowest price to a company in New Mexico.
In 2005 Maine jumped on the state reporting bandwagon. This is a quarterly report of the AMP along with a methodology of how you did that calculation. Maine also requires a certification process similar to that done for the submission to CMS.
And the last state to require reporting is Vermont in 2008, which requires that you report directly to the providers as well. And this is for every drug of yours that is dispensed in the state of Vermont (Vt. Stat. Ann. Tit. 33 § 2010). This provision also covers reporting of prices to wholesalers who are actually located in Vermont. Vermont is similar to Maine and CMS in that they require a certification. This state also requires that any pharmaceutical marketers provide prescribers with which they deal a short form that discloses the AWP and the lowest dosage of your drug and for others within the same therapeutic class.
There are several other items that are specific to the reporting requirements for each of these states and you are encouraged to communicate with the states to ensure you fulfill those requirements (and those for disclosure of your marketing practices). When you are unsure of a provision, it is always best to disclose and explain to them why you have done what you have done. These states AG offices are activity looking at these issues and are prepared to take action on those who are not in compliance.
Danielle Drissel – Hogan Lovells
Are you compiling with all of your reporting requirements?
About eight years ago states started to adopt their own reporting requirements above and beyond the Medicaid reporting requirements of manufacturers. This started in 2002 when Texas required those with any drug on the Texas formulary to submit their quarterly AMP directly to the state. They have two requirements total and they require that all price changes are communicated to Texas within 15 days. The state Attorney General seems to be paying more attention to this obligation under Texas Admin Code § 354.1923 and if you do not act in accordance with the code the state can kick you off their formulary.
Then came along New Mexico in 2004 which requires annual reporting for each prescription drug sold in New Mexico based on the data for the reporting period and has come out with additional guidance in November 2007. You have to report your AMP, CPPs, WAC, lowest price to PBM that takes possession in New Mexico, Direct sales lowest price to a company in New Mexico.
In 2005 Maine jumped on the state reporting bandwagon. This is a quarterly report of the AMP along with a methodology of how you did that calculation. Maine also requires a certification process similar to that done for the submission to CMS.
And the last state to require reporting is Vermont in 2008, which requires that you report directly to the providers as well. And this is for every drug of yours that is dispensed in the state of Vermont (Vt. Stat. Ann. Tit. 33 § 2010). This provision also covers reporting of prices to wholesalers who are actually located in Vermont. Vermont is similar to Maine and CMS in that they require a certification. This state also requires that any pharmaceutical marketers provide prescribers with which they deal a short form that discloses the AWP and the lowest dosage of your drug and for others within the same therapeutic class.
There are several other items that are specific to the reporting requirements for each of these states and you are encouraged to communicate with the states to ensure you fulfill those requirements (and those for disclosure of your marketing practices). When you are unsure of a provision, it is always best to disclose and explain to them why you have done what you have done. These states AG offices are activity looking at these issues and are prepared to take action on those who are not in compliance.
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