I would like to address 2 areas of the proposed rule, The first being if a medication administration should be considered a unit defined as unit per med or unit per incident. In my opinion it would be unfair to administer a civil penalty in the form of unit per med.
Today we have several different amounts that meds can be dispersed in. Some pharmacies will dispense a 3 month supply, if directed by the physician, and others may dispense on a monthly basis, such as the case with controlled substances.
I find it highly unfair to treat each manufacturer differently when it is beyond their control as to how many meds are dispensed at a time. Even if a physician writes a prescription for 3 month dispersal the patient still has the right to have the pharmacy only dispense one month at a time.
The second area is the model in which to follow for making a rule on civil penalties for non-compliant manufacturers. I have reviewed the models that have been suggested and have found that manufacturer’s should comply through the provisions of 1927(b)(3)(C)(ii) and 1927 (b)(3)(C)(ii) of the Social Security Act. Their model has been clearly defined for years which have given them ample opportunity to revise or amend a model that deals with civil penalties for entities that willingly and intentionally overcharge for a 340B medications. I find it unnecessary to reinvent the wheel when there is a direct model in place that will treat all individuals in the same manner.
Comment on FR Doc # 2010-23461
This is comment on Proposed Rule
340B Drug Pricing Program Manufacturer Civil Monetary Penalties
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