Medicaid Program; Covered Outpatient Drugs (CMS-2345-IFC2)
2012-04-09 2012-04-09 2012-04-02 2012-03-14 2012-04-05
CMS-2012-0012-0112 CMS-2012-0012-0117 CMS-2012-0012-0028 CMS-2012-0012-0007 CMS-2012-0012-0059
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/CMS-2012-0012-0112 https://api.regulations.gov/v4/comments/CMS-2012-0012-0117 https://api.regulations.gov/v4/comments/CMS-2012-0012-0028 https://api.regulations.gov/v4/comments/CMS-2012-0012-0007 https://api.regulations.gov/v4/comments/CMS-2012-0012-0059
Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous
I think that Medicaid needs to evaluate reimbursement for outpatient drugs related to mental health.  With the way the economy has been recently, many people losing their jobs, enrolling in Medicaid, and possibly becoming depressed (or any other mental defect), people may be using other types of drugs for these conditions. Charles Cole Memorial Hospital is a critical access hospital located in north central Pennsylvania. We have a cancer center at our facility which serves a very remote/rural population. The exclusion of orphan drugs for critical access hospitals is a hardship for an organization such as ours due to our cancer program. Critical access hospitals should not have been excluded from orphan drugs at all. In addition, a drugs orphan status is misinterpreted as having orphan status beyond the indication for its original reason for gaining orphan status. For example, a drug may have received orphan status 20 years ago for its original indication and today that same drug may have 5 additional indications not associated with the original but the drug continues to maintain orphan status for all indications. The exclusion of in-patient drugs for our organization is also a hardship. In our last fiscal year, we had 1.1 million dollars in charity care. The ability for us to purchase our in-patient drugs at 340B pricing would help in offsetting these losses which are substantial for an organization our size. Your consideration for clarifying the issues related to orphan drugs as well as allowing in-patient drugs to be purchased under the 340B program would insure that we will be able to continue valuable services to our uninsured and underinsured population in our region.Thank you While I understand that CMS calculates and posts all product URAs on a quarterly basis, I also understand that it remains the responsibility of the manufacturer to do that calculation themselves.  Within the line extension (LE) alternative URA calculation, it will be important for a company with a LE to obtain the URA information for the initial product.  I see many challenges with this action.  First being, will the LE company have extra time to do their calculation as it is entirely possible that the initial product calculation details are not complete and entered into the DDR system before the 30th day.  Second is how willing will one company be in supplying reimbursement detail to a competitor?  What is to stop the LE company from using that detail to alter their contract management strategies with state programs in order to better compete (or shut down the competition) with the initial brand product?  By forcing companies to share this information, you run the risk of obliterating a companys marketing strategy, and quite possibly that product within the state and federal programs.  Third, where does the responsibility lie for the accuracy of these numbers? If the initial product numbers are incorrect, and the LE company uses those numbers as submitted to them (not knowing they were incorrect), will the LE company be out of compliance because they made their calculations and decisions off of a number that was not correct?  And what about restatements?  If the initial product is restated, does the LE company also have to restate and reconcile their rebates, PHS pricing, etc.  The myriad of challenges with this provision is a potential snowball.  The language in the proposed rule seems to raise doubt about how many manufacturers are doing their quarterly calculation.  Does CMS expect all manufactures to calculate their quarterly AMP by adding all sales for the quarter and dividing that result by the total number of units in that quarter ((M1$+M2$+M3$)/(M1Units+M2Units+M3Units))?  Or do they intend to have the calculation being the three monthly AMPs divided by 3 ((M1AMP+M2AMP+M3AMP)/3)?  And if it is the divided by 3 calculation, does CMS recognize that the AMPs will be artificially inflated by that formula? I do not support this proposed change.