September 27, 2013

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September 27, 2013 

United State Congress

Shut down or no shut down: That is the question that everyone is trying to answer in Washington. The fiscal year for the federal government ends on September 30. Currently not one of the thirteen appropriations bills that fund federal programs has been signed into law. Therefore, on October 1, 2013, without intervention of Congress between now and then, the federal government will be without funding and will shutdown. The House has passed a continuing resolution (House Joint Resolution 59) that funds the federal government through December 15th. But, including the poison pill of defunding the Affordable Care Act will keep the Senate from voting in favor of the House passed resolution. The Senate gambit is to stretch out debate on the House bill, amend the resolution stripping it of the ACA provision and shortening the funding period to November 15th. If successful in passing a "clean" CR out of the Senate, the legislation returns to the House, possibly just in time for passage to stop the shutdown. It is anyone’s guess as to how the many factions of both the Democratic and Republican parties will position themselves over the next few days. Those positions will influence the strategies of both House and Senate leaders as they attempt to score political points at the expense of an operating government.

For interested policy geeks the New York Times has a graphic that describes the pathway(s) the House CR will follow in the Senate.

Compounding bill introduced in the House: The Compounding Clarity Act of 2013 (HR 3089) was introduced in the House of Representatives on September 12, 2013. The bill was sponsored by Representatives Griffith (R-VA), DeGette (D-CO) and Greene (D-TX). The legislation includes a definition of traditional compounding that requires that several conditions be met to meet the definition. The legislation was referred to the House Committee on Energy and Commerce. Legislation, Senate Bill 959 impacting the compounding of drugs was introduced in the Senate earlier this year.

The International Compounding Pharmacists Association (IACP) released a statement that describes the Association’s position on HR 3089.


CMMI MTM report: The Center Medicare and Medicaid Innovation (CMMI) and the Centers for Medicare and Medicaid Services (CMS) have released a report on the benefit of Part D medication therapy management programs implemented in 2010 impacted beneficiary and programmatic outcomes. The report, "Medication Therapy Management in a Chronically Ill Population: Final Report August 2013" is a mixed methods analysis of several Part D plans.

"…this study investigated how Part D MTM programs in operation in 2010 affected Medicare beneficiaries’ adherence, quality of prescribing, resource utilization, and cost of hospital and emergency room (ER) care."

"This study specifically focused on beneficiaries with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and diabetes because these individuals are at high-risk for poor health outcomes and thus could benefit greatly from improved medication management. We evaluated two types of outcomes: drug therapy and resource utilization. Drug therapy outcomes were divided into: (i) adherence, (ii) quality of prescribing (the use of evidence-based medications), and (iii) drug safety (the presence of drug-drug interactions, high-risk medication use in the elderly, and disease-contraindicated medications). Resource utilization outcomes were divided into: (i) hospitalization rates and ER visits, and (ii) drug, hospitalization and ER costs."

The major findings of this research are summarized as follows:

1. MTM programs enrolled Medicare patients with complex medical conditions and high preceding drug and health resource utilization. CMRs were completed for 11-14% of MTM enrollees in the study population and these beneficiaries had more chronic conditions and higher preceding hospital and drug costs than other MTM enrollees when in the PDP, but not MA-PD, setting.

2. MTM programs improved medication adherence and quality of prescribing for CHF, COPD and diabetes patients, particularly when CMRs were provided.

3. MTM programs initially improved the safety of drugs prescribed in new enrollees (first 6 months) but these positive effects had diminished or reversed by 1 year after enrollment.

4. MTM programs decreased hospital utilization and costs in diabetes and CHF patients receiving CMRs but not in COPD patients.

5. There was substantial variation in outcomes among Part D parent organizations. The best-performing Part D organizations were able to improve medication adherence and quality of prescribing while keeping healthcare costs (including drugs) from rising.

6. MTM programs appeared to improve enrollees’ adherence to drug therapies for targeted chronic medical conditions, but have smaller effects on patient adherence to therapies for non-targeted conditions.

7. Based on interview responses of high-performing Part D parent organizations, we identified the profile of an effective MTM program to include the following practices:

  • (i) Establishing proactive and persistent CMR recruitment efforts
  • (ii) Targeting and aggressively recruiting patients to complete a CMR based on information on medical events such as recent a hospital discharge in addition to scanning for the usual MTM eligibility criteria
  • (iii) Coordinating care by utilizing trusted community relationships including networks of community pharmacists to recruit MTM eligible candidates, and utilizing existing working relationships between MTM providers (pharmacists) and prescribers to make recommendations and discuss identified problems for patients
  • (iv) Employing intensive patient education efforts aimed at addressing adherence barriers including a comprehensive understanding of the importance of each medication prescribed
  • (v) Documenting the opportunities that were addressed with the patient for switching to generics or formulary alternatives
  • (vi) Improving drug adherence by providing a complete list of prescribed medicines
  • (vii) Addressing financial barriers to adherence such as high drug costs by potentially switching to generics or less expensive formulary alternatives
  • (viii) Documenting the quality and safety of prescribing as part of the MTM intervention record (e.g. ACEi/ARBs in CHF and diabetes, cardio-selective beta-blockers in CHF, drug-drug interactions, high-risk medications)
  • (ix) Conducting follow-up, documentation, and resolution of any identified drug safety issues
  • (x) Using efficient communication methods to convey medication recommendations to prescribers including the use of e-prescribing and electronic medical records
  • (xi) Leveraging all available data sources (EHR, registries, claims data) to determine whether gaps in medical care are present including preventive care and maintenance care related to the patient’s specific medical conditions (e.g. HbA1c and screening for kidney damage in diabetes patients).

The report includes several recommendations for additional research.

"The existence of organizations that positively influenced medical and drug cost outcomes (including preventing expected cost growth) suggests substantial Medicare benefits may be possible from further investigations on how this was accomplished."

"The research, identification, and dissemination of any identified operational or strategic factors of MTM programs that drive these improvements could improve health outcomes for the Medicare population and positively affect Medicare beneficiary costs."

"…our analysis provides pertinent information for additional investigations on successful MTM practices including factors such as the targeting of patients with specific disease conditions and effective enrollment strategies. The investigation of MTM effects and their effective components should be further investigated, specifically for other chronic condition cohorts. Additionally, improved data detailing which specific interventions were delivered by MTM programs to Medicare beneficiaries would allow for a more refined quantitative analysis of MTM program effects by intervention. Research would further benefit from data on factors traditionally unobserved, such as the impact of organization structure, specific MTM delivery mechanisms, frequency of MTM, and TMR on health outcomes."

National ADE Prevention Strategy: A federal interagency workgroup has published a draft report outlining a national strategy for preventing adverse drug events (ADE). The "National Action Plan for Adverse Drug Event Prevention," provides compelling evidence of the need for a systems approach to ADE prevention. The report focuses on three specific therapeutic areas: anticoagulants, diabetes agents and opioids. For each focus area the report provides state statement of the problem and evidence-based prevention tools. The draft report also includes a statement for future research that "can help inform efforts to identify patients at highest risk of ADEs and the most effective ADE prevention strategies."

This recommendation for additional research aligns with a recent grant awarded to AACP member Almut Winterstein (University of Florida) from the Association of Health-System Pharmacists Foundation. Dr. Winterstein is developing a patient complexity score that can help identify patients at high risk for ADEs.

New IOM workshop reports: The Institute of Medicine has published two workshop summaries regarding study methodologies that can support and sustain a learning healthcare system. The two reports are: 

VA recruiting: AACP was recently contacted by Veterans Affairs (VA) and asked to share the following information. This might be great information to share with your fourth year students!

"A new generation of Veterans now joins our Veterans of previous eras. In fact, more than 2.2 million Service men and women have been deployed to Middle Eastern combat zones. As our heroes continue to return to communities across our countryincluding your communitymany bring with them serious medical and healthcare challenges that require unique needs and requirements for care. As a result, the importance of having the Department of Veterans Affairs’ Veterans Health Administration grows and grows.

New and growing challenges require additional highly skilled nurses, physicians, pharmacists and other healthcare professionals.

The Department of Veterans Affairs (VA) must recruit and maintain a workforce of healthcare professionals to deliver the best possible care to the men and women who have served our nation."

Information about VA careers is available at:



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