“WE THE PEOPLE” Advocating for Health-System Pharmacy

1. “WE THE PEOPLE”Advocating for Health-System Pharmacy South Carolina Society of Health-System Pharmacists March 10, 2008 Kevin Colgan, President-elect ASHP

2. Dedication • 50th Anniversary of the South Carolina Society of Health-System Pharmacists & my good friend, Robert Spires, their President • 125th Anniversary of the University of Wisconsin College of Pharmacy • William Zellmer, ASHP Deputy Executive Vice President • Brian Colgan, Legislative Assistant, United States Representative Judy Biggert (R-IL)

3. Agenda • What’s Advocacy? • Key Advocacy Issues Facing Pharmacy • Advocating for Health-System Pharmacy • Healthcare Platforms of the Presidential Candidates

4. Constitution of the United States “We the People of the United States, in Order to form a more perfect Union, establish Justice, insure domestic Tranquility, provide for the common defense, promotegeneralWelfare, and secure the Blessings of Liberty to ourselves and our Prosperity, do ordain and establish this Constitution of the United States.”

5. Advocacy • Active participation in the government • Voting • Calling, writing, or visiting to share your views with those elected and governmental regulatory agencies • The basic quality of an advocate is the wish to be one – requires courage, order & logic, voice • Democracy needs citizens to participate – you have tremendous power to change the way government acts

6. Advocacy Role of the Nonprofit Professional Pharmacy Organization • Promote the interest of Pharmacy • Shape the social contract we have with the citizens of our county, state, and country • Engage in public discussions about governmental policies • Join members together to nurture values and provide programs and services that strengthens public health within their communities

7. Imperatives for Advocacy • Patients are still being harmed from medication use in hospitals and health systems • Pharmacists are not universally recognized for the value they bring to health care • Imagine what a strong and effective policy effort would accomplish • Imagine how it would enhance our ability to fulfill SCSHP & ASHP’s mission

8. Key Advocacy Issues Facing Pharmacy • Medicaid NDC Reporting • Technician Education and Training • Provider Status • Advanced Practice Licensure • Follow-on Biologicals - Biosimilars • FDA Agency Funding • PGY2 Residency Funding • Federal Loan Forgiveness

9. Medicaid NDC Reporting • Deficit Reduction Act • requires state Medicaid programs to collect 11-digit NDC numbers on all “physician administered” drugs • CMS defined “physician administered” to include hospital outpatients • Creates tremendous burden on hospitals • Implementation complex and difficult • CMS cost estimate per claim is $0.09 • Survey of hospitals showed an estimated cost of $10.90 vs. $0.09

10. Medicaid NDC Reporting Three Approaches  Legislative, Regulatory, Judicial • Lobby for a delay • 17 state Medicaid programs have received a delay • Ask Congress to define “physician administered” • Risky - may not receive the answer you want • Congressional Budget Office would have to score a change and the estimated savings would need to come from somewhere else • Randy Kuiper, ASHP member from Montana met with Senate Finance Committee Chair’s staff (Senator Max Baucus D-Mont) • Litigation – file a suit over the definition • ASHP is involved with SNHPA (Safety Net Hospitals for Pharmaceutical Access)

11. Technician Education and Training • March 30, 2007 20/20 Report – Auburn University Study of Drug Store Chains in Four States • Technicians misleading patients in signing their rights away to patient counseling • Patient counseling only offered on 27 of every 100 prescriptions • Only 8 of 25 Coumadin users were provided warnings of OTC’s • 22% error rate, but no wrong medications dispensed • Too many, too few pills • Missing label instructions, child-proof caps

12. Technician Education and Training USA Today Series – Week of February 11, 2008 • “Inside a Pharmacy Where a Fatal Error Occurred” • 46 year old roofing contractor with chronic neuropathic pain • In 2001, died of a methadone overdose  label with incorrect dosing instructions • Busy Pharmacy – 380 Rx’s dispensed that day – mixed accounts on whether the volume was too much for the pharmacist to handle • Technician who made the error was a part-timer who had failed the PTCB Certification Exam

13. Technician Education and Training USA Today Series – Week of February 11, 2008 • “Rx for errors: Drug error killed their little girl ” • Rainbow Babies and Children’s Hospital: 2 year old girl named Emily treated for a curable abdominal tumor • Received last of 4 chemotherapy treatments mixed in 23.4% saline mixed by a pharmacy technician – pharmacist did not catch the mistake • Technician spent time on internet planning her wedding in the lull before the error • Legislation for mandatory technician education and training has drawn resistance from pharmacy lobbyists in Ohio • Emily’s bill submitted in the US House by Rep. LaTourette

14. Technician Education and Training ASHP Policy Statement 0412 Uniform State Laws and Regulations Regarding Pharmacy Technicians • Completion of a nationally accredited standardized program of education and training as a prerequisite to technician certification • Interim measure – one year experience vs. education program • 112 accredited programs – only 4 in health-systems • Mandatory PTCB Certification • Included in regulations of 30 state boards of pharmacy • ¾ Americans assume tech’s are required by law to be trained & certified • Registration by state boards of pharmacy

15. Provider Status • 43 states, the Department of Veterans Affairs, and the Indian Health Service all recognize the value of collaborative medication management • Senators Tim Johnson (D-SD) and Thad Cochran (R-MS) introduced the Medication Therapy Act of 2003 – supported by the Pharmacist Provider Coalition • Medicare Modernization Act of 2003 required PDP’s to offer MTM services

16. Provider Status • February, 2005 – Application made for Pharmacist MTM codes to be added to CPT codes • January, 2008 – New codes effective (99605, 99606, 99607) • ASHP supports pharmacists as providers under Medicare Part B • ASHP also supports payment for pharmacist services as part of MTM under Medicare Part D

17. How did Nurse Practitioners obtain Provider Status? The Facts • Over 300 accredited post graduate training programs – most are 2 year MS programs • Five specialty certification exams • Medicare reimburses NP’s at 85% of MD’s rate and 100% on incident-to billing – private insurance varies • Most states allow collaborative Rx authority & some allow independent practice Am J Health-Syst Pharm. 2003;60:2301-07

18. How did Nurse Practitioners obtain Provider Status? • 20 years of incremental legislative & policy victories • Research indicating that NP primary care decisions and outcomes were equivalent to MD’s N Engl J Med. 1994;330:211-4 JAMA. 2000;283:59-68 • Laying the Foundation • 14 RN’s completed RWJ Health Policy Fellowship and worked on health care issues in congressional offices • Grass roots activism – seminars teaching NP’s to communicate with legislators • Coalitions of NP organizations  American College of Nurse Practitioners (1973  1993) Am J Health-Syst Pharm. 2003;60:2301-07

19. How did Nurse Practitioners obtain Provider Status? • Rallying the troops (1993 – 1997) • testimonials, case studies, demonstration projects, & intense communication with Congress • In 1997, 18 Senators & 58 Representatives cosponsored the NP legislation that became part of the Balanced Budget Act of 1997 Am J Health-Syst Pharm. 2003;60:2301-07

20. Optometrist Licensure: Authorization to Prescribe Medications • Board of Examiners includes medications in examination of Treatment & Management of Ocular Disease • Medication exam can be administered separately • State boards of optometry vary in the level of scope of practice they allow for optometrists • Variation is primarily around the use of medications for Dx and Tx purposes • Being an optometrist is not consistent within a state or between states ≈ 1 – 3 levels of practice

21. Optometrist Licensure: Authorization to Prescribe Medications • Oklahoma – 1 license • All must be licensed to use topical and nontopical pharmaceutical agents • Maryland – 2 licenses • Diagnostic Pharmaceutical Agent Certification • Therapeutic Pharmaceutical Agent Certification • New Mexico – 3 licenses • Diagnostic Certification • Topical Certification • Oral Certification

22. Provider Status & Advanced Practice Licensure: Lessons for Pharmacy • Best to have uniformity with little state-to-state variation in scope of practice/licensure • Collect and present research that provides evidence of value • Establish standards in education and credentialing • Use professional organizations  many voices supporting common cause – Pharmacist Provider Coalition • Have a passionate, persistent commitment to the cause - advocate

23. Follow-on Biologicals - Biosimilars • Bills being introduced to provide a framework to approve abbreviated applications for follow-on biological products deemed “comparable” • No meaningful clinical differences in products • Same mechanism of action • Same route of administration • Same dosage form and strength • Biosimilar regulation has already been enacted in Europe and Australia • Issues  market exclusivity (none to 14 years)& safety (Risk Evaluation and Mitigation Strategy)

24. FDA Funding • Montgomery County, MD > larger budget than the FDA • 2007 FDA Science Board Report Outlined deficiencies within the FDA • IT upgrade needed • More trained scientists needed • PDUFA (Prescription Drug User Fee Act) reauthorized in September, 2007 • REMS & Postmarketing Surveillance were key elements of bill • $80M in new user fees + $50M from Appropriations Committee in President’s budget • ASHP is a member of the Alliance for a Stronger FDA

25. PGY2 Residency Funding • CMS discontinued funding in 2004, but left door open in future • ASHP is seeking a legislative fix • Current budget situation is tough with deficit • $7M funding request • Issue is important for hospitals and academia to recruit staff and faculty

26. Where are we now?

27. Federal Loan Forgiveness • National Health Service Corps Loan Repayment Program for those willing to work in underserved communities & rural areas • Includes MD’s, NP’s, PA’s, Nurse-midwife, Dentists, & Dental Hygienists • Requires two years of full time service (40 hrs/week) • ASHP is advocating for inclusion of Pharmacists • Submitted language to the House of Representatives • Senate Committee Report supports inclusion of Pharmacists

28. Advocating for Health-System Pharmacy • ASHP board is not happy with the pace of change • We have the capacity to be bolder in fostering needed changes What do members want? They want ASHP and their state society of health-system pharmacy to advocate effectively on their behalf for changes that are important to them.

29. Five Parts to New Advocacy Program • Build capacity for advocacy • Advocacy teams • Expand practice standards • Research • Communications

30. 1. Build capacity • Reimbursement specialist • Health policy analyst • Quality improvement • Grassroots / PAC coordinator • Survey research • (Practice standards facilitator)

31. 2. Advocacy teams • Payment, clinical services  David Chen • State requirements for pharmacy technicians  Doug Scheckelhoff • Funding residency training Brian Meyer

32. 3. Expand practice standards Policy Development • Practice Standards • Policy Positions Policy Implementation (Advocacy) • Practitioners • Pharmacy Stakeholders • External Stakeholders

33. External stakeholders • Groups outside of ASHP who need to be persuaded to take action or make a change that members want • Quality-improvement organizations (NQF, PQA, AHQA) • Federal regulatory agencies (CMS, FDA, HRSA) • States (Dept of Health, Medicaid, National Alliance of State Regulators) • Health care organizations (AHA, TJC) • Congress (Key Health Committees)

34. Key Health Committees - Senate • Health, Education, Labor & Pensions Committee • Health Care Jurisdiction: Aging, Biomedical R&D, Public Health • Ted Kennedy (MA) Chair, Michael Enzi (WY), The Ranking Member • Members: Barack Obama (IL), Hillary Rodham Clinton (NY) • Finance Committee • Health Care Jurisdiction: Health Programs under the Social Security Act and health programs financed by specific tax or trust fund • Max Baucus (MT) Chair, Chuck Grassley (IA), The Ranking Member • Subcommittee on Health Care  John Rockefeller, IV (WV) Chair, Orrin Hatch (UT), The Ranking Member; Members: Debbie Stabenow (MI)

35. Key Health Committees - House • Energy and Commerce Committee • Health Care Jurisdiction: Health Care for Senior Citizens & Children, Protect the Safety of Food and Drugs • John Dingell (MI), Chair & Diana DeGette (CO), Vice Chair • Members: Bart Stupak (MI), Charlie Melancon (LA), Mike Rogers (MI) • Ways and Means Committee • Health Care Jurisdiction: National Social Security Programs • Charles Rangel (NY), Chair; Members: Sander Levin (MI), Jim McCrery (LA), Dave Camp (MI) • Subcommittee on Health – Pete Stark (CA), Chair; Member: Dave Camp (MI)

36. 4. Research • Evidence of value in pharmacists providing clinical services • Closing gaps identified by frontline advocates • Partnership with ASHP Foundation • Fund research projects that allow ASHP to advance its advocacy agenda

37. 5. Communications • Web site for all advocacy activity • NewsLink for advocacy efforts • InterSections • Board member, officer, staff speeches and reports • “Health Policy Alerts”

38. Communicating with Congress • Officials • Senate: Lindsey Graham (R-SC), James DeMint (R-SC) • House: Henry Brown Jr. (R-01), Joe Wilson (R-02), Gresham Barrett (R-03), Bob Inglis (R-04), John Spratt (D-05), James Clyburn (D-06) • Offices (District/Capital) & Office Structure • Chief of Staff • Scheduler • Legislative Director • Legislative Assistant • Congressional Schedule • Political Action Committee

39. Meetings with Congress • Pre-arrange meeting ( 7-14 days) & identify topic • Arrive early • Practice 5 minute message “My name is__________. I take care of _______ patients at __________hospital in your district. I am hear to talk with you about ___________. I would ask you to support ___________ for the following reasons ________. Arguments against include ________” • Leave information behind in a file with your card attached • Ask for a response and preferred follow-up, when appropriate • Ask him/her to visit when in the district • Write a thank you note

40. Writing Congress • Form letters, blitz faxes, postcard campaigns don’t work! • Success is in getting to the right person, at the right time, and in the right way  “grass tops” • Tips • Use www.congress.org to determine what member cares about – put message in that context • Communicate by letter or Web Form • Include address – be specific in what you ask • Link to practice standards, talking papers, etc. • Offer to be a resource

41. Healthcare Platforms October 11, 2007 Stated Goal Provide access to affordable healthcare for all by paying only for quality healthcare, having insurance choices that are diverse and responsive to individual needs, and encourage personal responsibility Sources: Kaiser Family Foundation & www.johnmccain.com

42. Healthcare Platforms May 29, 2007 Stated Goal Affordable and high-quality universal coverage through a mix of private and expanded public insurance Sources: Kaiser Family Foundation & www.barackobama.com

43. Healthcare Platforms May 24, 2007 for cost August 23, 2007 for quality September 17, 2007 for coverage Stated Goal Affordable and high-quality universal coverage through a mix of private and public insurance Sources: Kaiser Family Foundation & www.hillaryclinton.com

44. Healthcare Platforms October 11, 2007 Overall Approach • Tax credit to increase incentive for insurance coverage • Remove favorable tax treatment for employer-sponsored plans • Insurance competition – transparency for outcomes, quality, & price • Contain costs through payment changes to providers • Care coordination • Non-payment for preventable medical errors or mismanagement • Innovative delivery systems, such as clinics in retail outlets – flexibility in permitting appropriate roles for nurse practitioners, RN’s, and MD’s • Cheaper generic versions of drugs & biologicals – safety protocols to permit re-importation • Tort reform to eliminate frivolous lawsuits & excessive damage awards

45. Healthcare Platforms May 29, 2007 Overall Approach • Required coverage for children – coverage thru parents plan up to age 25 • Expanded eligibility for Medicaid • Employers must provide plan or contribute %age of payroll to nat’l plan • Income-related subsidies for private plan, new public plan, & federal subsidies for catastrophic health care costs • National Health Insurance Exchange - create rules & standards for plans • Comparative effectiveness reviews/research – drugs, devices, procedures • Hospitals & plans required to report quality data for disparity populations • Direct negotiation of prices with drug companies for Gov’t programs • Allow drug reimportation if drugs safe & prices lower

46. Healthcare Platforms May 24, 2007 for cost August 23, 2007 for quality September 17, 2007 for coverage Overall Approach • Every American required to have coverage • Large employers must provide plan or contribute • Income-related tax subsidies available to make coverage affordable • Private and public plan options to individual through a new Health Choices Menu operated by the Federal Employee Health Benefits Program • Insurance reform – guarantee issue, auto renewal, rate protection, minimum stop-loss ratios • Chronic care management programs, such as “medical homes” • Allow Medicare to negotiate drug prices, create pathway for biogenerics, more generic competition, oversight for PhRMA/provider relationships

47. Final Thought “You can’t expect Government to do what’s right for pharmacy, unless you advocate for what’s right for pharmacy!”