The new Final Rule to dispense all brand name drugs to Medicare Part D enrollees in long-term care facilities by the Centers for Medicare & Medicaid Services will impact pharmacists and patients.
In April 2011, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule to dispense all brand name drugs to Medicare Part D enrollees in long-term care (LTC) facilities in 14-day-or-less increments starting January 2013. The rule also requires Part D plans to collect data directly from LTC pharmacies on the dispensing methodology and amount of unused Part D drugs for each dispensing event. While short-cycle dispensing is not required for generics, CMS encourages LTC pharmacies to apply the rule on a voluntary basis. The goal of the shorter fill cycles is to reduce the likelihood of waste for the Medicare Part D program resulting from unused drugs.
To ease the burden of compliance, CMS agreed to limit short-cycle dispensing to solid oral dosage forms only, excluding liquids. Antibiotics and drugs in original packaging will be exempt; however, controlled substances will not be exempt. CMS is also allowing the LTC pharmacies to select their dispensing methodology, provided that it is “uniform” throughout their LTC pharmacy facilities. Additionally, CMS waived the reporting requirement for pharmacies that agree to apply 7-day-or-less dispensing (not the required 14-day-or-less) for both brand and generic drugs. Lastly, CMS removed the requirement that unused drugs be physically returned to the pharmacy.
With much debate still pending about whether the expected Medicare Part D program savings from the short-cycle dispensing regimen will be counteracted by the additional dispensing fees incurred from increased scripts, one thing remains clear—major changes will be needed in LTC pharmacy operations to comply with this rule. Changes to dispensing methodology are just the beginning. Increased fills for the same number of patients, new tracking standards for unused medications, and new reporting requirements to Part D plans will also be necessary to support compliance with the rule.
This approach also comes with a potential of higher risks for the patient, as additional opportunities for error may result from increased workload at LTC pharmacy organizations. As a result, operational changes and system enhancements will need to be managed efficiently and cost-effectively to ensure compliance and monitor patient risk.
Operational changes will be required to manage additional expenses when complying with the short-fill rule. Consolidation of orders that are going to the same facilities will help with this initiative. From a logistical standpoint, LTC pharmacies will need to manage additional shipping, transportation, and delivery expenses associated with increased scripts. Automated refill programs should be re-evaluated to ensure that the order truly needs to go to the patient. While supporting the goal of reducing waste for Medicare Part D programs, changes to automated refills could have an impact on revenue and overall business for the affected LTC pharmacy. As a result, operational changes focused on decreasing expenses through reduced additional packaging and labor will be crucial for financial stability.
System enhancements may also be needed to support changes to order processing and order handling as a result of the short-fill rule. Increased adoption of automation technology can help support a reduction of order processing and handling activities by combining multiple patient prescriptions into a single order. Additionally, systems should be configured to support the new unused drug reporting requirements to Medicare Part D plans at the drug level.
ADDITIONAL RISKS TO PATIENTS
Additional risks to patients may be present when implementing operational changes and system enhancements to comply with the short-fill rule. LTC pharmacies will want to prevent negative patient outcomes from such changes within their operations as well as downstream within their facilities.
Improvements to patient adherence as well as reduced medication errors may be realized through multi-dose strip packaging. Early analysis of multi-dose strip packaging has shown successful reductions in the preparation and administration of medications. As a result of packaging changes, patient risk can be reduced at the pharmacy as well as at LTC facilities by reducing medication errors and allowing nurses more time to provide care to residents.
Every operational and system solution to the short-fill rule will have its advantages and challenges. In most cases, it may require investments in technologies or other solutions. In other cases, it may require collaboration and coordination across multiple stakeholders. While one solution may not be right for everyone, the key will be education and staying ahead of the January 2013 mandate. SPT
About the Authors
Jim Maguire is the chief executive officer of BioMed Intelligence, Inc, a firm specializing in health care information technology support solutions. With more than 20 years of experience, Mr. Maguire was formerly the chief information officer of a top pharmacy benefit manager and also led information technology operations at a top specialty pharmacy. He can be reached at (347)847-3570; jmaguire@biomed-intelligence. com; www.biomed-intelligence.com.
Quintin Jessee, RPh, BSPharm, is a senior consultant at D2Pharma. He can be reached at firstname.lastname@example.org.