ASHP Update: Trends, Developments and Future Implications

1. ASHP Update: Trends, Developments and Future Implications David Chen, B.S.Pharm, MBA Director, Pharmacy Practice Sections

2. Overview • Provider Recognition • Medication Safety and Compounding • Drug Shortages • New ASHP Strategic Plan • Task Force on Organizational Structure • Pharmacy Practice Model Initiative

3. Provider Recognition Provider Recognition President Lyndon Johnson signing the Medicare Act in 1965 Photo: Library of Congress

4. What is Provider Status? • Becoming a “provider” means • Pharmacists can participate in the Medicare program and bill for services that are within their state scope of practice to perform • Becoming a provider at the federal level will not expand pharmacists’ scope of practice

5. What is Provider Status? • Being listed in section 1842 or 1861 of the Social Security Act (SSA) as a supplier of “medical and other health services”, which includes: • Physicians’ services • Nurse practitioner • Physician assistant • Certified nurse midwife services • Qualified psychologist services • Clinical social worker services • Certified nurse anesthetist • Qualified speech-language pathologist • Qualified audiologist • Registered dietitian • Physical therapist

6. Provider Recognition • Essential to recognize pharmacists as patient-care providers • Pharmacists provide distinct direct patient-care: • Pharmacists improve patient medication-use outcomes when included on the patient-care teams1 • Report to the Surgeon General by the Office of the Chief Pharmacist of the U.S. Public Health Service - compelling case for using pharmacists more effectively in the care of patients2 • Services provided should be eligible for recognition and payment by: • Medicare • Medicaid • Other third-party payers (including states and private health plans) Sources: 1) Jack BW, Chetty VK, Anthony D, Greenwald JL et al. A Reengineered Hospital Discharge Program to Decrease Rehospitalization. Ann Intern Med. 2009;150:178-187. Giberson S, Yoder S, Lee MP. Improving Patient and Health System Outcomes through Advanced Pharmacy Practice. A Report to the U.S. Surgeon General. Office of the Chief Pharmacist. U.S. Public Health Service. Dec 2011.

7. Brief History • 2001—Provider Status Coalition Co-Founded by ASHP and ACCP • 2001—Senator Tim Johnson Introduces the Medicare Pharmacist Services Coverage Act, S.974 • 2001—Representative Pallone Introduces the Medicare Pharmacist Services Coverage Act of 2001, HR 2799 The Estimated Cost (in 2001 dollars) of S.974/H.R. 2799 was $13.12 billion over 10-years (average of $1.3 billion annually)

8. History • 2002—Representative Pickering Introduced Medicare Medication Therapy Management Services Coverage Act of 2002, HR 5539 • 2003—Senators Johnson and Cochran Introduced Medication Therapy Management Act of 2003, S. 1270 • 2003—Medicare Modernization Act Enacted • Part D prescription drug benefit includes Medication Therapy Management requirement (with conditions and no explicit payment)

9. History • 2006– Senator Cochran Introduces the Pharmacist Access and Recognition in Medicare (PHARM) Act of 2006, S.2563 • 2008—Representative Wilson Introduced the Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2008, H.R. 5780

10. History • 2010—Affordable Care Act • MTM Definition, Accountable Care Organizations, MTM Grant Program, Center for Medicare & Medicaid Innovation, Value-Based Purchasing Program • 2010—Representative Heinrick Introduced the Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010, H.R. 5389 • 2010-Present—Affordable Care Act Implementation • 2012—National Pharmacy Organizations Begin Discussions on Reinitiating Provider Status Campaign

11. Provider RecognitionAdvocacy Efforts • What will it require: • Massive grassroots effort • Individual pharmacy practitioners • Affiliated state societies • Educate lawmakers about the value pharmacists bring to patient care • Strong and cohesive national coalition • Pharmacy associations • Patient and consumer groups • Other health care organizations • Multi-year strategy; achieving provider status is a marathon not a sprint • ASHP’s efforts: • 2012: Legislative Day; ASHP members met with their representatives on Capitol Hill • 2013: CEOs of the national pharmacy organizations to meet to discuss working together to pool resources and collective energies • Pharmacy stakeholder principles developed.

12. It’s About Patients Achieving provider status is about giving patients consistent access to care that improves safety, quality, outcomes, and decreases costs

13. Why Do Pharmacists Want Provider Status When Fee-For-Service is Going Away? • Now and in the future traditional fee-for-service will likely be phased out and replaced with new payment systems that emphasize quality, outcomes, and shared risk/savings/bundled payments • Pharmacists are focusing on their roles on interdisciplinary teams collaborating with others throughout the continuum of care • However, section 1861 of the SSA remains the reference point for which practitioners are eligible to participate in new and emerging delivery systems and payment models (e.g., ACOs and Medical Homes) • Therefore, to efficiently participate in new and current delivery and payment systems, pharmacists need to be listed in the SSA

14. Current Provider Status Efforts • Pharmacy Stakeholder Group Renews Discussion • Recognize the pharmacist’s role in improving patient health. • Three principles: • Improve opportunities for patients to receive pharmacists’ services • Improve opportunities for health care teams to include pharmacists • Improve patients’ experiences, health system efficiencies, and control costs through pharmacist patient care services

15. Current Provider Status Efforts • January 2012—ASHP Board Approves Initial $500,000 for Provider Status Efforts • Spring 2012—Pharmacy Organizations and other Pharmacy Stakeholders Convene to Discuss Provider Status Interests • Summer 2012—Pharmacy Stakeholders Develop Provider Status Principles

16. Current Provider Status Efforts • Fall/Winter 2012—Pharmacy Stakeholders Finalize Principles and Agree that Medicare Part B Should be the Focus • Winter/Spring 2013—Pharmacy Stakeholders Work to Develop, Narrow, and Negotiate Legislative Request • Summer/Fall 2013—Various Legislative Options Developed

17. Potential Legislative Options***Not Officially Endorsed or Supported by Any Organization*** 1) Pharmacists as providers in Medicare Part B (SSA Section 1861) 2) Pharmacists’ services approved by the Secretary of the Department of Health and Human Services for cost effectiveness and improved quality and outcomes (SSA Section 1861) 3) Pharmacists as ACO professionals (SSA Section 1899)

18. Potential Cost Limiters***Not Officially Endorsed or Supported by Any Organization*** • Physician Referral • Collaborative Drug Therapy Management Agreement • Eligible Patient Population (e.g., medically underserved) • Limiting the Number of Services • Pricing services as a percent of the physician fee schedule

19. Likely Next Steps for Pharmacy Stakeholders 1) Select a legislative option (i.e., “the ask”) 2) Formalize a coalition 3) Advocate

20. Provider Status High-Level Strategy • National coalition with multiple stakeholders • Will NOT be successful with a national strategy alone • Major leadership by states • Grassroots—letter writing, calls… • Grasstops—Relationships with key lawmakers • Practice site visits—Showing how and where it’s happening • Consensus building and formation of state coalitions • Outreach to local media • Presence at political events and fundraisers • Efforts to expand state scope of practice

21. Medication Safety The Issue of Compounding

22. Medication SafetyThe Issue of Compounding WHAT IS NEEDED?14 Stronger communication and collaboration between state boards of pharmacy and the FDA Granting the FDA the resources it needs to perform serious and meaningful regulatory oversight of entities that are potentially engaged in manufacturing A defined distinction between traditional pharmacy compounding and manufacturing Source: 14) ASHP Testifies to Senate Committee about Compounding, http://www.ashp.org/menu/News/NewsCapsules/Article.aspx?id=455 , November 2012

23. States in Which Facilities Received CSPs from NECC that Was Later Recalled www.cdc.gov/hai/outbreaks/meningitis.html

24. Case Count as of September 6, 2013 www.cdc.gov/hai/outbreaks/meningitis.html

25. Medication SafetyThe Issue of Compounding • ASHP’s Efforts: • Testified before Senate and House Committees • Worked with Senators, Representatives, and Committee Staff on draft legislation to address issues around compounding • Continue to meet with policymakers and regulators • Continue to help to educate the public and serve as subject matter expert to various media outlets • New York Times • Wall Street Journal • Fox23.com • The Tennessean • Health Leaders Media • ASHP Sterile Compounding Resource Center • http://www.ashp.org/sterilecompounding

26. Main Advocacy Points/Goals • To protect patients from receiving contaminated sterile products like the ones at the New England Compounding Center • To clarify federal and state oversight responsibilities for pharmaceutical compounding activities • Intent is to ensure a regulatory framework that recognizes an evolving pharmaceutical marketplace that has arisen to meet demands for specialized products not commercially available • Give our members the assurance they need that if they outsource for compounded products, the outsourcer is preparing products in accordance with proper requirements

27. Compounding: S. 959 • Bipartisan bill developed by the Senate Health, Education, Labor and Pensions (HELP) Committee • Would create a 3rd category of registration, not a pharmacy but not a manufacturer; “compounding manufacturer” • Compounding manufacturers would be licensed and regulated by FDA, would rely on user fees for funding • Hospitals and health systems were carved out of the category and considered traditional pharmacy compounders subject to state board • ASHP supported the bill, testified before HELP • Bill was passed out of committee

28. Compounding: H.R. 3089 • H.R. 3089 by Reps Griffith (R-Va), DeGette (D-Colo), Green (D-Tx) • Bill defines traditional pharmacy compounding: • Pursuant to a Rx • Anticipatory compounding can be done based upon historical demand and a history of prescriptions generated solely with an established relationship between the pharmacist and physician • Compounding for office use without a prescription is allowed so long as the drug is administered within the physician’s office, hospital or other health care setting • However must supply valid prescription or patient names within 7 days after drug was administered; also interstate shipment cannot account for more than 5 percent of total inventory

29. Compounding: Final Bipartisan/Bicameral Agreement, H.R. 3204 • Late September, House and Senate reach bipartisan/bicameral agreement on compounding • Largely stripped down from S. 959, H.R. 3089 • Reaffirms that Section 503A of the Food, Drug and Cosmetic Act is the law of the land (originally passed in 1997) • Severs the unconstitutional provisions from the original section 503A • Creates a new section, 503B, outsourcing facility with voluntary FDA registration • Would include risk-based FDA inspections, user fees

30. Section 503A • Defines compounding to NOT include: mixing, reconstituting, other acts in accordance with labeling/manufacturer directions • Section 503A does not apply to compounding pursuant to Rx • Section 503A allows compounding from bulk if USP compliant • Section prohibits compounding if on FDA list of products removed from the market • Cannot compound “regularly or in inordinate amounts drug products that are essentially copies of commercially available drug products” • Does not mention “office use”, leaves it to the states

31. Section 503A, Cont’d. • A drug product may not be compounded if it is demonstrably difficult to compound, as determined by FDA • Allows for anticipatory compounding in “limited” quantities and must be based upon historical relationships • Section 503A limits amount of compounded drugs to be distributed out of state to no more than 5% of total prescription orders dispensed. Unless… • Memorandum of Understanding (MOU) between states and FDA is created to address inordinate amounts of compounded drugs distributed out of state • Again, if under the 5% of total drugs dispensed, no MOU is necessary. If No MOU, then cannot exceed 5% distribution out of state.

32. Section 503B, New Section • Outsourcing Facility—Definition • Engaged in compounding of sterile drugs • Has elected to register as an outsourcing facility [with the FDA] • Complies with all requirements under 503B • Is NOT required to be a licensed pharmacy • May or may not obtain prescriptions for identified individual patients

33. Section 503B, Cont’d • Section 503B defines compounding: combining, mixing, diluting, pooling, reconstitution… to create a drug. • Outsourcers must be under supervision of pharmacist • Must report adverse events • Comply with labeling requirements (notice it’s a compounded drug)

34. H.R. 3204 • Requires enhanced communication between FDA and state boards • States can report to FDA that a compounding pharmacy may be acting contrary to Section 503A • FDA notifies state boards upon receiving registration from an outsourcing facility or, • FDA determines that a pharmacy is acting contrary to Section 503A • No more confusion! • Within 36 months, GAO must report to Congress on regulatory efforts to ensure safe compounding

35. Compounding: Final Bipartisan/Bicameral Agreement, H.R. 3204 • ASHP would have liked to see the bill go farther, but nonetheless we are supportive • House passed via voice vote on September 28 • Senate passed by unanimous consent on November 18 • Signed into law (P.L. 113-54) by President Obama on Nov. 27

36. FDA Oversight of Compounding • November 27, 2013 - President Obama signed the Drug Quality and Security Act (DQSA) • December 2, 2013 – FDA Releases three Proposed Rules and three Draft Guidance Documents • Proposed Rules • List of drugs/drug categories that are demonstrably difficult to compound • List of bulk ingredients for compounding (503A) • List of bulk ingredients for compounding (503B) • Draft Guidance • Registering as an outsourcing facility • Registering products compounded • Withdrawal of 1998 and 2002 CPGs, release of new guidance for traditional compounding under 503A

37. Going Forward • Reacquaint with Section 503A, summaries on our website: • http://www.ashp.org/DocLibrary/Advocacy/HR3204-Section503A.pdf • http://www.ashp.org/DocLibrary/Advocacy/HR3204-Section503B.pdf • Hospitals may look at the voluntary registration with FDA as a criteria in selecting an outsourcer • State board activity • Testing labs are receiving attention • Could be something to look at in the future?

38. http://www.ashp.org/sterilecompounding

39. Drug Shortages: Where Are We Now and What’s Next?

40. Drug Shortages • FDA Safety and Innovation Act • GAO Study due January 2014 • FDA Task Force submitted Strategic Plan to Congress • Guidance on hospital repackaging within health system • Continued Congressional Interest • Gray Market • Economic Factors (ASP+6%)

41. National Drug Shortages New Shortages by YearJanuary 2001 to September 30, 2013 Note: Each column represents the number of new shortages identified during that year. University of Utah Drug Information Service

42. National Drug Shortages – Active Shortages by Quarter Note that these are snapshot data; the # of active shortages could change daily as we process up to 20 updates a day. Note: Each column represents the number of active shortages on the last day each quarter. Q3-13 are data through 9/30/13. University of Utah Drug Information Service

43. Active Shortages Top 5 Drug Classes University of Utah Drug Information Service

44. Common Drug Classes in Short Supply Source: University of Utah Drug Information Service

45. Reasons for Shortages – 2012 Source: University of Utah Drug Information Service

46. So Where Do We Go from Here? • Full effect of the Food and Drug Administration Safety and Innovation Act (FDASIA) legislation remains to be seen • Analyses of economic and other factors are expected • ASHP is committed to addressing this issue • Ongoing activities with summit co-conveners and other stakeholders • Ongoing collaboration with FDA staff • Upcoming member surveys

47. New Strategic Plan

48. New ASHP Strategic Plan • New integrated strategic plan released January 2013 • http://www.ashp.org/DocLibrary/AboutUs/Strategic Plan.pdf

49. New Strategic Plan • Built from New ASHP Vision ASHP’s vision is that medication use will be optimal, safe, and effective for all people all of the time. • Includes three strategic priorities • Patients and Their Care • Members and Partners • People and Performance

50. New Strategic Plan • Revised ASHP Mission The mission of pharmacists is to help people achieve optimal health outcomes. ASHP helps its members achieve this mission by advocating and supporting the professional practice of pharmacists in hospitals, health systems, ambulatory clinics, and other settings spanning the full spectrum of medication use. ASHP serves its members as their collective voice on issues related to medication use and public health.