Carla McSpadden
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Consultant pharmacists are busy preparing to implement the Centers for Medicare & Medicaid Services' newly revised survey
guidance for Pharmacy Services and Unnecessary Medications (F-Tags 329, 425, 428 and 431) in Appendix PP of the State Operations
Manual (SOM). CMS released the revised guidelines on Sept. 15, with the changes scheduled to become effective on Dec. 18.
They represent the first substantive changes in these sections in nearly seven years.
The regulations and new guidance to surveyors apply only to skilled-nursing facilities and nursing homes that meet the requirements
for each as set forth in the Social Security Act. The new guidelines do not apply to intermediate care facilities, assisted-living
facilities, or hospitals. The regulations have not changed. Instead it is the interpretive guidelines, investigative protocol,
and severity guidance that have been updated, while some of the survey tags have been combined and reorganized, specifically
those pertaining to pharmacy services and medication use in nursing facilities.
The new survey tags include Tag F329, covering unnecessary medications; Tag F425, covering pharmaceutical services; Tag F428,
covering medication regimen review; and Tag F431, addressing storage, labeling, and controlled medications.
The effects of these new pharmacy-related survey guidelines on consultant and dispensing pharmacists were discussed at length
at Senior Care Pharmacy '06, the American Society of Consultant Pharmacists' annual meeting and exhibition held last month
in Phoenix. In the general session "Changes in the State Operations Manual—Effects on Your Practice," presenters described these changes
in detail and explained the challenges that await pharmacists and facilities as they prepare for implementation.
"The expectation is that consultant pharmacists will be providing these services and that the care process will focus on looking
at the patient and medical regimen more holistically," said Carla Saxton McSpadden, R.Ph., CGP, assistant director of policy
and advocacy for ASCP. "It will increase the responsibility of the facility, prescribers, consultant pharmacists, and the
dispensing pharmacy in regard to medication management."
Other key messages stressed at the general session regarding implementation of the new survey guidelines included the increased
role of the consultant pharmacist as overall coordinator/evaluator of pharmaceutical services in the nursing home environment
as well as the significant changes regarding tapering/gradual dose reduction where the emphasis is now on how the medication
is being used rather than in which class it is categorized.
Joseph Gruber
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"The good news is that the SOM revisions outline a care process for medication therapy that places the consultant pharmacist
in an increasingly important position on the multidisciplinary care team," ASCP president Joseph Gruber, R.Ph., FASCP, CGP,
told the audience during his inaugural address. "The new regulations not only continue to hold the team accountable for 'irregularities,'
but also now place in our hands the responsibility for effica-cy, outcomes, and progress toward the goal of medication therapy."
Consultant pharmacists were also warned to be aware that there is an increased likelihood that they may be interviewed by
the surveyor during a survey, especially if problems are identified with the Medication Regimen Review (MMR) in their facility.
One of the key focus areas of the new survey guidelines is the MMR process for short-stay residents that may require reviews
more often than monthly.
Loriann DeMartini
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"The changes to the survey process are substantial," Loriann DeMartini, Pharm.D., chief pharmaceutical consultant, California
Department of Health Services, told the audience, stressing that the survey process now directs surveyors to dialogue with
physicians and pharmacists. "CMS' objective is to promote consistent and competent care. These new guidelines solidify the
role of the consultant pharmacist in regards to medication care."
ASCP has numerous resources on its Web site at http://www.ascp.com/som to help consultant pharmacists prepare their facilities for the implementation of the new SOM survey guidelines.
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