April 2012 Policy & Advocacy Briefing Analysis of CMS Consultant Pharmacist Independence Proposal

1. April 2012 Policy & Advocacy BriefingAnalysis of CMS Consultant Pharmacist Independence Proposal ASCP’s Policy & Advocacy Department ltcrule@ascp.com www.ascp.com/ltcrule

2. Summary • No requirement for January 1, 2013 • CMS believes any requirement needs to be broader in scope • LTC community expected to voluntarily improve transparency immediately • Measurable improvement on prevalence of unnecessary drugs, overutilization • CMS plans a future notice and comment rulemaking • Public comments due 60 days from Federal Register publication

3. Overview: Independence Policy • CMS believes public comments justified concerns over conflicts of interest • Does not believe CP-SNF employment represents conflict of interest • Pharmacy employment relationship = financial relationship that exerts pressure • Oct. 2011 proposal disproportionately targets consultant pharmacists • Must consider broader changes than CP independence for a future rulemaking

4. Definition of Independence • CMS did not respond directly to their definition or alternatives submitted through public comments • No indication of whether CMS would consider modifying this definition

5. Alternative Approaches to Independence • ASCP suggested separate contracts, fair market rates, pharmacy attestation to CP clinical independence, disclosure statements • CMS considered finalizing requirements which would have included: separate contracts, fair market rates, pharmacy attestation to CP clinical independence, disclosure statements

6. Alternative Approaches to Independence • CMS believes requiring independence is part of the right approach • However other factors contribute to conflicts of interest, drug overutilization, unnecessary drugs • Strongly encourages the industry to voluntarily adopt these recommendations to improve transparency

7. Measures for CP Performance • CMS suggests industry collect data • Number of interventions • Type of interventions • Outcomes • Work with PQA to develop performance measures

8. LTC Settings with Difficulty Complying with Proposed Independence • ASCP recommended a waiver option for certain settings including rural, Tribal, closed-systems, charitable, others • CMS will consider comments in a future rulemaking

9. Relationships with Pharma • Public comments did not change CMS’s belief that CP-pharma relationships should be banned, if CP is practicing • Believe that CPs receiving remuneration from pharma may be influenced • Cited exchange of scientific, educational information at event supported by pharma • Service in Ad boards, speaker bureaus

10. Timeline for Implementation • CMS not finalizing at this time • Changes as proposed would be disruptive • Will seek a targeted less disruptive approach • Expects voluntary changes from industry • In the absence of measurable improvement, CMS will use future rulemaking

11. Cost Impact • CMS acknowledges that an independence requirement would be highly disruptive to the marketplace • Would result in higher costs to the nursing homes

12. Profession Response to the Proposal • CMS did not respond specifically to the findings in ASCP’s survey • Says they were swayed by comments from current and former CPs, patient advocates • Believe that change is necessary

13. Use of Antipsychotics in NH • CMS acknowledges other factors contribute to overprescribing, overutilization • CMS must consider broader changes • Will propose those changes in a future rulemaking

14. DRR Best Practices • CMS says resident safety is at risk if CPs don’t have enough time to conduct a proper DRR • DRR not currently yielding intended outcomes, beneficiary protections • Questioning the purpose of CP DRR • CMS may consider changes to the requirement to explore alternative approaches • Expects industry to demonstrate value of CP DRR to resident quality of care

15. CMS Solicitation for Public Comments

16. Enhancing medication management and the effectiveness of medication review • What actions/steps should be taken to strengthen attending physician (and other prescribers) medication management and prescribing practices to ensure the best quality of care for the nursing home resident? • What is and should be the role of nursing home medical director in overseeing the attending physician (or other prescribers) medication management activities? • What actions, if any, should the medical director take when attending physicians (or other prescribers) fail to engage in appropriate/adequate medication management activities?

17. Enhancing medication management and the effectiveness of medication review • What actions/steps could be undertaken to establish and ensure the independence and effectiveness of a consultant pharmacist in conducting their medication reviews on behalf of nursing home residents? • What training and best practice models would assist all nursing home staff to better understand behavior signs and symptoms and respond appropriately and effectively in assisting and caring for nursing home residents?

18. Data collection and use • What data are needed to enable and support the Medicare and Medicaid programs and others in monitoring the appropriateness and adequacy of medication management activities, including the use of antipsychotics drugs? • What data are needed to enable CMS to study the effectiveness of consultant pharmacist medication reviews? • What data are needed to create public performance metrics regarding the independence of consultant pharmacists and prescribers from pharmacies and drug manufacturers/distributors? • Are data needed on the number and type of interventions recommended by consultant pharmacists and on the outcomes of those recommendations? If so, how could such data be used and by whom?

19. Increasing transparency • What information is needed to assess the independence and adequacy of physician (and other prescriber) medication management and oversight on behalf of nursing home patients? What metrics could be used to assess the adequacy and appropriateness of prescriber response to consultant pharmacist recommendations? • What metrics could be used to describe the adequacy and appropriateness of a LTC facility's medication management program? • Describe the incentives and other arrangements that create the conflict of interest in LTC that contributes to overutilization and inappropriate drug use in LTC facilities. How can the conflict of interest stemming from these incentives and arrangements be contained

20. Increasing transparency • What specific details regarding the financial (and other) What metrics could be used to describe the adequacy and appropriateness of a LTC facility's medication management program? • Describe the incentives and other arrangements that create the conflict of interest in LTC that contributes to overutilization and inappropriate drug use in LTC facilities. How can the conflict of interest stemming from these incentives and arrangements be contained

21. ltcrule@ascp.comwww.ascp.com/ltcrule703-739-1316Lynne Batshon x141Angelina Panettieri x151Arnie Clayman x178