January 4, 2016
Mr. Andy Slavitt
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building, Room 445-G
200 Independence Avenue, SW
Washington DC 20201
VIA ELECTRONIC SUBMISSION:
Re: Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies
Dear Mr. Slavitt:
ASHP is pleased to submit comments on proposed revisions to requirements for discharge planning under the Medicare program (proposed rule) as published in the November 3, 2015 Federal Register.1 ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s more than 43,000 members include pharmacists, student pharmacists and pharmacy technicians. For over 70 years, ASHP has been on the forefront of efforts to improve medication use and enhance patient safety.
ASHP appreciates the opportunity to comment on the proposed rule. We believe that safe medication use is paramount to delivering quality care and improving outcomes. Therefore, we are pleased with CMS’s focus on improving medication safety in the proposed rule.
Medication-related errors are frequent and important problems in the United States with an estimated 1.5 million preventable medication-related adverse events occurring each year. Adverse drug events (ADEs) are associated with longer hospitalizations and higher hospital costs resulting in an additional $177 billion annual cost in medication-related morbidity and mortality. Further, using multiple medications increases the risk of experiencing an ADE. Patients with low health literacy are also at higher risk for adverse outcomes due to misunderstandings, and increased age associated with the Medicare population may increase the likelihood of medication errors and ADEs. Despite these challenges, studies show that pharmacist-led medication reconciliation and counseling at discharge contributes to better clinical outcomes and improved economic outcomes.
ASHP is supportive of the agency’s proposal to include medication reconciliation as a key element of discharge planning for hospital and critical access hospital (CAH) patients. However, we strongly urge CMS to revise the proposed rule to explicitly include pharmacists, the medication experts on the healthcare team, in the development of medication reconciliation standards. ASHP’s professional policy position on the role of pharmacists in medication reconciliation is:
To affirm that an effective process for medication reconciliation reduces medication errors and supports safe medication use by patients; further,
To advocate that pharmacists, because of their distinct knowledge, skills, and abilities, should take a leadership role in interdisciplinary efforts to develop, implement, monitor, and maintain effective medication reconciliation processes; further,
To encourage community-based providers, hospitals, and health systems to collaborate in organized medication reconciliation programs to promote overall continuity of patient care; further,
To declare that pharmacists have a responsibility to educate patients and caregivers on their responsibility to maintain an up-to-date and readily accessible list of medications the patient is taking and that pharmacists should assist patients and caregivers by assuring the provision of a personal medication list as part of patient counseling, education, and maintenance of an individual medical record.2
We encourage CMS to work with pharmacy and other stakeholders to develop medication reconciliation programs that will ensure successful transitions of care and enhance patients’ understanding of their medication regimens. In the proposed rule, CMS states that:
Medication reconciliation would include reconciliation of the patient’s discharge medication(s) as well as with the patient’s pre-hospitalization/visit medication(s) (both prescribed and over-the-counter); comparing the medications that were prescribed before the hospital stay/visit and any medications started during the hospital stay/visit that are to be continued after discharge, and any new medications that patients would need to take after discharge."3
We believe that these elements should be included in medication reconciliation and that healthcare professionals stress to Medicare beneficiaries that medication reconciliation is an ongoing process. Ongoing assessment of patient adherence and outcomes is a key element of the joint ASHP-American Pharmacists Association definition, which defines medication reconciliation as:
The comprehensive evaluation of a patient’s medication regimen any time there is a change in therapy in an effort to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions, as well as to observe compliance and adherence patterns. This process should include a comparison of the existing and previous medication regimens and should occur at every transition of care in which new medications are ordered, existing orders are rewritten or adjusted, or if the patient has added nonprescription medications to [his or her] self-care.4
Using the medication reconciliation process at discharge to educate patients on the importance of ongoing medication review may help patients utilize medications more safely and effectively—potentially reducing readmissions and improving patient outcomes.
ASHP shares the agency’s opinion that effective discharge planning requires active engagement of the patient by the entire healthcare team. However, absent from the proposed rule is a discussion of the role of pharmacists, the clinicians with more medication-related education and training than any other health care provider. In the Proposed Rule, CMS notes that "Inadequate patient education has led to poor outcomes, including medication errors and omissions, infection, injuries, worsening of the initial medical condition, exacerbation of a different medical condition, and re-hospitalization."5 Pharmacists, the medication experts on the healthcare team, are uniquely positioned to educate patients and reduce these adverse events. The absence of pharmacists from the proposed rule is concerning given that both CMS and the U.S. Department of Health and Human Services have recognized the value of pharmacists and their services in previously released, reports, final rules, and Medicare Conditions of Participation (CoPs). Thus, we strongly urge CMS to recommend that pharmacists be included on each patient’s healthcare team throughout the discharge planning process. This not only includes the development of the discharge plan, but also the provision of medication reconciliation and discharge counseling. While ASHP is encouraged by CMS’s discharge planning proposals, we believe that these requirements could be greatly improved if pharmacists are utilized fully and effectively.
As noted above, ASHP supports the inclusion of comprehensive medication reconciliation as part of each patient’s discharge plan from a hospital or CAH. In the Proposed Rule, CMS states its belief that hospital inpatient medication reconciliation is a "near universal practice" and does not provide an estimate of burden for existing practices. For CAHs, CMS states that:
…we believe that a nurse would review the patient’s chart and reconcile the pre-admission and discharge medications. The time required for this reconciliation would vary greatly depending upon the number of medications a patient was taking, both pre-admission and at discharge, and the number of changes or discrepancies that the nurse questioned. We estimate that this activity would require an average of 3 minutes for each patient or 0.05 hours.
While ASHP agrees with the agency that the time required for medication reconciliation will vary based on conditions and needs of each patient, we strongly disagree with CMS’s estimate of 3 minutes per patient and that medication reconciliation in CAHs will be predominantly conducted by nurses.
The literature supports time spent on medication reconciliation that reflects much more robust efforts on the part of pharmacists and physicians. For example, Meguerditchian et al, found that at two academic medical sites, medication reconciliation at discharge varied from about 10 minutes for general surgery patients, to about 45 minutes for internal medicine patients6 Another randomized controlled study found that clinical pharmacists spent about 20 minutes per day, per patient on medication reconciliation and education activities.7 Further, Kilcup et al, concluded that clinical pharmacists spent an average of 37 minutes per patient on medication reconciliation activities.8
ASHP believes that pharmacists, and pharmacy technicians under the supervision of a pharmacist, are the most qualified medication experts on the healthcare team to perform medication reconciliation. For example, a study conducted at an emergency department of a tertiary care teaching facility found that pharmacists identified almost 35 percent more home medications during the medication reconciliation process than those identified by other emergency department providers. In addition, almost 80 percent of medications documented by non-pharmacists were incomplete and were supplemented with information by the pharmacists.9 Another study found that twice as many nurse-conducted medication histories had discrepancies than those conducted by pharmacists.10 Pharmacist-led medication reconciliation improves patient care. Gillespie, et al found that pharmacist-conducted medication reconciliation reduced emergency department visits by almost 50 percent and overall hospital visits by 16 percent. Of note, medication-related admissions were reduced by an astonishing 80 percent.11
While a thorough medication reconciliation led by a pharmacist should be longer than the 3 minutes that CMS estimates in CAHs, pharmacists and pharmacists -supervised pharmacy technicians are most qualified to perform medication reconciliations and obtain medication histories with fewer errors than those performed by other healthcare providers. Pharmacist-conducted medication reconciliations have shown reductions in readmission and emergency department utilization and better patient outcomes.
ASHP appreciates this opportunity to provide comments to CMS on the importance of pharmacists in the hospital discharge planning process. Please contact me if you have any questions on ASHP’s comments on the proposed rule. I can be reached by telephone at 301-664-8806, or by e-mail at [email protected].
Federal Register Vol. 80, No. 212 pages 68126 – 68155
ASHP Policy Position 1117: Pharmacists’ Role in Medication Reconciliation.
80 Fed. Reg. 68134 (Nov. 3, 2015).
ASHP – APhA. Improving Patient Care through Better Medication Reconciliation - White Paper , March 08, 2012.
80 Fed. Reg. 68129 (Nov. 3, 2015).
Meguerditchian A, Krotneva S, Reidel K, Huang A, Tamblyn R. Medication reconciliation at admission and discharge: a time and motion study. BMC Health Services Research. 2013; 13:485
Koehler BE, Richter KM, Youngblood L, et al. Reduction of 30-day postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med. 2009;4(4):211-218.
Kilcup, M., Schultz, D., Carlson, J., & Wilson, B. (2013). Postdischarge pharmacist medication reconciliation: Impact on readmission rates and financial savings. Journal of the American Pharmacists Association J Am Pharm Assoc (2003), 53(1), 78-78.
Carter MK, Allin DM, Scott LA, Grauer D. Pharmacist-acquired medication histories in a university hospital emergency department. Am J Health-Syst Pharm. 2006; 63:2500-2503.
Kwan Y, Fernandes OA, Nagge JJ, et al. Pharmacist medication assessments in a surgical preadmission clinic. Arch Intern Med. 2007;167(10):1034-1040.
Gillespie U, Alassaad A, Henrohn D, et al. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009;169(9):894-900.
Christopher J. Topoleski
Director, Federal Legislative Affairs