REGULATORY ANALYSIS 
FOR 
Proposed Rules for the Colorado
Cancer Drug Repository Program
May 2, 2006
1.	A description of the classes of persons who will be affected by the proposed rule, including the classes of persons who will bear the costs of the proposed rule, and the classes of persons who will benefit from the proposed rule.
Persons affected by the proposed cancer repository rules and those bearing the costs of proposed rules include cancer patients, their families and authorized agents, health care facilities, medical clinics, and pharmacies, and the recipients of cancer drugs and devices.  Entities storing, redistributing, and dispensing medications will have costs associated with these activities. These costs will be partially covered by a dispensing fee they are allowed to charge.   
Persons who will benefit from the proposed rules include health care facilities, medical clinics, and pharmacies, as well as the uninsured and underinsured cancer patients who will receive cancer drugs and devices at a very low cost. 
To the extent that the State of Colorado is obligated to provide cancer drugs and devices to certain of the intended recipients, the State is also likely to benefit from the proposed rules.  The cost savings the State will realize from these rules arises from the State’s ability to avoid purchase of new cancer drugs and devices through the use of redispensed cancer drugs and devices.  
2.	A description of the probable quantitative and qualitative impacts of the proposed rule, economic or otherwise, upon the affected classes of persons (to the extent possible).
Qualitative impacts include assurance that any cancer drug or device that is donated and thereafter redispensed through the program is safe.  Entities meeting requirements to participate in the program will be able to accept and redispense cancer drugs and devices.  Entities storing, redistributing, and dispensing medications will have costs associated with these activities.  
Cancer patients will have an economic benefit by having access to medications that will cost only a minimal dispensing fee.  The State of Colorado may also realize an economic benefit because the State may be able to realize cost savings from the utilization of donated and redispensed cancer drugs and devices, rather than new cancer drugs and devices.
Quantitative impacts are unknown.  Given the small number of drugs and devices that meet the requirements of the program, impact should be minimal at this time.  
3.	A discussion of the probable costs to the agency adopting the proposed rule and to any other agency in implementing and enforcing the proposed rule and any impact on state revenue.
No additional costs are anticipated for any state agency nor will it have any impact on state revenue.  These rules assume that the Department is not required to maintain an updated list of eligible and ineligible drugs and devices and is not involved in eligibility determination.
4.	A comparison of the probable costs and benefits of the proposed rule if it is adopted to the probable costs and benefits if the proposed rule is not adopted.
If the rule is adopted:  Probable costs are not fully known at this time.  Benefits include assurance that any person accepting and redistributing or redispensing cancer drugs and devices within the context of this statute and their actions will not be the basis for any kind of legal challenge.  Uninsured and underinsured patients may have access to cancer medications at a very low cost, which they may not be able to afford otherwise.   Cancer patients, families, and authorized agents will benefit by knowing that donated drugs and devices can be used by an uninsured or underinsured cancer patient.  
If the rule is not adopted:  If the rule is not adopted, the Department will not have given effect to the legislative mandate established by the Colorado Cancer Drug Repository Program.  All drugs or devices will be destroyed and none will be available to be donated to an uninsured or underinsured cancer patient.  As a result, uninsured and underinsured cancer patients will not be able to obtain donated and redispensed cancer drugs and devices at low cost.
5.	A determination of whether there are less costly methods or less intrusive methods of achieving the purpose of the proposed rule.
The proposed rules are the least intrusive and least costly method of achieving the purposes of the legislative mandate.
6.	A description of alternative methods of achieving the purpose of the proposed rule that were seriously considered by the agency and the reasons why the alternative methods were rejected in favor of proceeding with the proposed rule.
No other methods were considered as the proposed rules are consistent with the legislative mandate.  Promulgation by  emergency rule making process was the most expeditious method to provide the benefits of the new cancer drug repository program to the citizens of Colorado.  
7.	To the extent practical, a quantification of the data used in the analysis, the analysis must take into account both short-term and long-term consequences.
There is no quantifiable data to analyze at this time.  Anecdotal reports from other states with similar cancer drug repositories report that the programs are used infrequently due to the necessary restrictions.