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by Courtney D Oland R.Ph. MBA, Director of Pharmacy, Waltz Long Term Care Pharmacy
On April 15th, 2011 the Federal Register Patient Protection and Affordable Care Act (Section 3310) was released, outlining the final rule with regards to the manner by which the Federal Government will require medications to be dispensed to Medicare D eligible residents residing in Long Term Care Facilities.
Section 3310 of the Patient Protection and Affordable Care Act will require that as of January 1, 2013 all Medicare Part D Plans create procedures and develop policies requiring the reduction of the "day supply" and "per fill" quantities of brand name prescription medications dispensed to beneficiaries residing in LTC facilities. (See http://edocket.access.gpo.gov/2011/pdf/2011-8274.pdf.)
Beginning January 1, 2013 Long Term Care Pharmacies must dispense these medications in 14-day supplies or less. (The rule was initially written as 7 days, but was expanded.) The stated CMS goal of what has become known as the "short cycle dispensing" provision is to minimize the amount of unused medications requiring disposal as well as a reduction in the financial impact of medications that are never used and thus wasted.
In CMS' own words "We continue to believe that 7-day-or-less dispensing more effectively minimizes the volume of unused drugs and the resulting financial waste paid for under the Part D program."
"Short Cycle" affects brand name drugs only. It does not include generic medications (which account for the vast majority of medications utilized in LTC). Also not included are medications that must be dispensed in the original package or those that are difficult to dispense in a short supply (bisphosphonates, for example). These would include such items as antibiotics and inhalers. CMS has encouraged manufacturers to consider producing smaller package sizes to reduce potential waste.
A second major requirement of "short cycle" is the need to quantify all waste by the Part D Plan. Specifically, CMS is requiring that all Part D contracts with pharmacies contain provisions for the return of unused meds to the pharmacy--not necessarily for redistribution--and reporting to CMS.
On the surface this may seem to be a strategy that might make some sense, however, the following issues are yet to be addressed, making it difficult for pharmacies and facilities to create a strategy for compliance:
- Potential need to reorder medications every 7-14 days (2-4 times a month) rather than once a month. This results in an increased burden on pharmacy and facility staff requiring that they handle medications twice as often (processing, packaging, delivering, receiving, documenting, returning and reporting).
- Potential need to change ordering/dispensing procedures (packaging system/delivery schedule).
- Returns and CMS waste reporting and whether they will be required if 14-day supplies are dispensed vs. 7-day supplies. This may determine which system is adopted by pharmacies and facilities.
- Inconsistency at the facility level if some medications are dispensed in 7- to 14-day supplies while others are dispensed in 30-, 60- and 90-day supplies. (CMS has attempted to address this concern in the April 15 document.)
- Timing and collection of co-pays from recipients.
- The specifics of the return/report provisions are not defined, thus the labor impact cannot be determined.
- Increased opportunity for medication errors due to multiple fills.
The bottom line is that this rule will have a significant impact on how we all do business. Long Term Care Pharmacy providers and Facility Management will need to work together very diligently to determine the best strategy for their situation. There are several models in development to determine the specific labor impact of the various options being discussed, i.e., 7 days vs. 14 days, and bingo card vs. unit dose packaging.
I encourage anyone practicing in the Long Term Care Industry to become more familiar with this rule and look for updates and changes to it as we approach the January 1, 2013 deadline for implementation.
Resources:
www.ltcpa.org/government-affairs-and-advocacy/primary-policy-issues/short-cycle-dispensing/
http://edocket.access.gpo.gov/2011/pdf/2011-8274.pdf
https://www.ascp.com/sites/default/files/short-cycle-talking-points041511.pdf
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