1. THE EPIDEMIOLOGY OF U.S. IMMUNIZATION LAW: Translating CDC Immunization Guidelines into Practice State Laws Related to the Use of Standing Orders Covering Immunization Practice For the 2006 National Immunization Conference Alexandra Stewart, J.D.; Marisa Cox, M.A.; Sara Rosenbaum, J.D. The George Washington University School of Public Health and Health Services, Department of Health Policy March 6, 2006

2. 2 Introduction, Background and Overview

3. 3 Introduction Fifth in a series of immunization law analyses sponsored by the CDC/NIP Completed Studies: State Health Insurance Coverage Laws (2003) Medicaid Coverage for non-institutionalized Adults (2003) Federal Health Employee Health Benefits (2004) Immunization Requirements for Long-Term Care Facility Staff and Residents (2004) Source: GWU/SPHHS Review of Standing Orders – Fall 2005

4. 4 Background and Overview Standing Orders Defined: A formal written protocol authorizing medical care practice by a health professional other than a physician. Source: GWU/SPHHS Review of Standing Orders – Fall 2005

5. 5 Background and Overview Immunization services constitute the legal practice of medical care: (1) assess patients and diagnose the need for immunizations, with no contra-indication; (2) prescribe an immunization; (3) administer an immunization. Steps (1) and (2) constitute core elements of medical care practice Source: GWU/SPHHS Review of Standing Orders – Fall 2005

6. 6 Background and Overview Medical care practice must be authorized under state health professions laws (e.g., nurse practice act or laws regulating physician assistant practice). Authorization can take 2 forms: 1) A medical professional can be authorized to conduct medical care under his or her own license 2) The conduct can be authorized by delegation from medical professionals to one or more classes of health professionals Source: GWU/SPHHS Review of Standing Orders – Fall 2005

7. 7 Background and Overview Widespread access to routine and emergency immunization services may be limited, without broad health professions practice acts and/or the permissible use of standing orders in a broad range of settings. To date, there has been no systematic study of the status of U.S. health and medical professions law related to the use of standing orders to extend immunization access. Source: GWU/SPHHS Review of Standing Orders – Fall 2005

8. 8 Study Purposes, Design and Methods

9. 9 Study Purposes To examine and report on the status of state laws as they relate to the use of standing orders to support immunization practice: –for both routine and emergency-related health care needs, –in both health care and community settings To create an evidence-based body of research that could be applied to the development of a model standing orders law for use by states Source: GWU/SPHHS Review of Standing Orders – Fall 2005

10. 10 Study Design and Methods Five-state pilot study in 2005, with completion of all states during 2005-2006 Initial pilot study states: GA, MA, NY, OR, TX Study states were selected in consultation with NIP staff based on geography and state approach to health professions regulation: Highly Prescriptive & Detailed versus Broad Source: GWU/SPHHS Review of Standing Orders – Fall 2005

11. 11 Study Design and Methods Review and analysis of legal documents related to 3 phases of immunization practice: assessment/diagnosis; prescribing; administration) Health professional licensure statutes and regulations State attorney generals opinions Medical and health professions licensure board rulings Source: GWU/SPHHS Review of Standing Orders – Fall 2005

12. 12 Study Design and Methods Key informant interviews: State and local health and legal officials charged with interpreting, applying, and ensuring enforcement with existing laws Community vaccinators Source: GWU/SPHHS Review of Standing Orders – Fall 2005

13. 13 Applied findings to five hypothetical immunization practice settings (four health care, one community): Long-term care facilities Acute care hospitals Adult and pediatric private practice in office-based settings Community health settings in medically underserved and clinician shortage areas Non-health community setting (e.g., grocery store) Study Design and Methods Source: GWU/SPHHS Review of Standing Orders – Fall 2005

14. 14 Study Findings

15. 15 NO PILOT STUDY STATE appears to make full use of either the licensure potential of health professionals or the potential to advance accessible immunization practice through the use of broad standing orders powers. General Findings Source: GWU/SPHHS Review of Standing Orders – Fall 2005

16. 16 States show a highly variable legal environment regarding: THE ASPECTS OF IMMUNIZATION PRACTICE (i.e., assessment/diagnosis, prescribing, and administering) in which health professionals other than physicians may engage under state law General Findings Source: GWU/SPHHS Review of Standing Orders – Fall 2005

17. 17 States show a highly variable legal environment regarding: THE CATEGORIES OF HEALTH PROFESSIONALS (other than physicians) who are authorized to engage in one or more aspects of immunization practice under their own license General Findings Source: GWU/SPHHS Review of Standing Orders – Fall 2005

18. 18 States show a highly variable legal environment regarding: THE SCOPE OF THE LAW The extent to which state law clearly permits the delegation by physicians to health professionals of all aspects of immunization practice in all settings (health care and community) General Findings Source: GWU/SPHHS Review of Standing Orders – Fall 2005

19. 19 MASSACHUSETTS The only pilot study state that explicitly permits a specific category of health professional to assess, prescribe, and administer medications under the professional’s own license. (Prescriptive Practice Nurses) 244 CMR 3.02: Responsibilities and Functions – Registered Nurse (assess) 244 CMR 4.05 Definitions (2005) (prescribe) 244 CMR 9.02 Definitions Standards of Conduct for Nurses (2005) (prescribe) 244 CMR 9.03 Standards of Conduct for Nurses (2005) (administer) Specific Finding: Immunization Practice Under Health Professions Practice Licenses Source: GWU/SPHHS Review of Standing Orders – Fall 2005

20. 20 ( The degree of variation in state health professions laws related to immunization practice under a health profession license (other than a medical license) OR NY TX GA Prescribe: Nurse practitioners Assessment: Registered nurses, advanced nurse practitioners, and physician assistants. Assessment: Registered nurses, Prescribe: Nurse practitioners, Administer: Pharmacists No authorization for any non-physician to perform any of the three elements of immunization practice. MA Source: GWU/SPHHS Review of Standing Orders – Fall 2005 Assessment: Midwives, Nurse Practitioners, Practical nurses, Registered nurses Prescribe: Prescriptive nurses Administer: Midwives, Nurse practitioners

21. 21 TEXAS The only pilot study state that explicitly permits 3 categories of non-physicians to assess, prescribe, and administer medications under standing orders. (Advanced Practice Nurses, Registered Nurses, Physician Assistants) Tex Occ. Code 157.002 (2004) General Delegation of Administration and Provision of Dangerous Drugs (administration) Opinion No. MW-318, 1981 Tex. AG Delegation of medical acts by means of standing orders (assessment, administration) Advanced Practice Nurses with Prescriptive Authority 222.4. Minimum Standards for Carrying Out or Signing Prescriptions. (prescribe) Tex Occ. Code 157.051 (2004) Definitions. (prescribe) Tex Occ. Code 301.002 (2004) Definitions. (administration) Tex Occ. Code 157.051 (2004) Definitions. (prescribe) Immunization Practice Through Delegation of Medical Practice Powers under Standing Orders Source: GWU/SPHHS Review of Standing Orders – Fall 2005

22. 22 ( Immunization Practice Through Delegation of Medical Practice OR NY TX GA Designated nurses in advanced roles may complete all three elements of immunization practice. Administer: Registered nurse supervisors, health department registered nurses, and physician assistants in limited circumstances. Prescribe: Physician assistants, nurses may transmit information Administer: Nurses MA Source: GWU/SPHHS Review of Standing Orders – Fall 2005 Designated nurses in advance roles may complete all three elements of immunization practice. Assessments, Prescribe: Physician assistants Assessment: Advanced nurse practitioners, midwives, nurse practitioners, practical nurses, registered nurses, registered nurse supervisors, vocational nurses, pharmacists, physician assistants. Administer: Advanced nurse practitioners, midwives, nurse practitioners, practical nurses, registered nurses, registered nurse supervisors, vocational nurses, pharmacists, physician assistants Prescribe: Advanced practice nurses, registered nurses, vocational nurses, physician assistants

23. 23 MASSACHUSETTS The only study state that authorizes a single category of non-physician to assess, prescribe, and administer medications when standing orders are combined with powers granted under their own license (Midwives) 244 CMR 4.26 Scope of Practice for Categories of Nurses Practicing in an Expanded Role (assess) ALM GL ch. 112 80G (2005) Nurse-Midwives Authorized to Order Certain Tests and Issue Certain Prescriptions (prescribe) 244 CMR 9.03 (2005) Standards of Conduct for Nurses (administer) Board of Registration in Nursing Advisory Rulings. Verification of Medication Orders, Ruling 9324 (issued 1993, revised 2002) Immunization Practice Through Both Practice License & Delegation of Medical Powers Under Standing Orders Source: GWU/SPHHS Review of Standing Orders – Fall 2005

24. 24 How State Laws Address the Site of Immunization Practice All 5 study states (GA, MA, NY, OR, TX) address the practice settings in which non-physicians are permitted to practice to some degree. Texas is the only state that addresses practice settings for pharmacists. Source: GWU/SPHHS Review of Standing Orders – Fall 2005

25. 25 ( Permissible Immunization Practice Sites Under State Law OR NY TX GA Institutional Care: Physician Assistants Institutional Care: Nurses, physician assistants Private Practice: Physician assistants Clinics: Physician assistants Various Community: Nurses, physician assistants Institutional Care: Physician Assistants Private Practice: Physician Assistants Clinics: Physician Assistants Various Community: Physician Assistants MA Source: GWU/SPHHS Review of Standing Orders – Fall 2005 Institutional Care: Nurses, Physician Assistants Private Practice: Nurses, Physician Assistants Clinics: Physician Assistants Various Community: Physician Assistants Institutional Care: Nurses, physician assistants, pharmacists Private Practice: Nurses, physician assistants, pharmacists Clinics: Nurses, physician assistants Various Community: Nurses, physician assistants, pharmacists

26. 26 Summary of Pilot State Findings Study states that explicitly permit nurses, physician assistants, and pharmacists to engage in immunization practice under their own license 0 Study states that explicitly authorize immunization practice under standing orders by nurses, physician assistants, and pharmacists. 0 Study states that explicitly address all settings (four health care and one community) for nurses, physician assistants, and pharmacists. 0 Source: GWU/SPHHS Review of Standing Orders – Fall 2005

27. 27 Community Vaccinator and State Public Health Representatives FACTORS that ADVANCE the use of STANDING ORDERS: Respondents support the use of standing orders. Physicians in private practice permit community vaccinators to conduct clinics in their offices. Source: GWU/SPHHS Review of Standing Orders – Fall 2005

28. 28 Community Vaccinator and State Public Health Representatives FACTORS that HINDER the use of STANDING ORDERS: Unnecessarily complex legal environment. Limited ability to reach Medicaid beneficiaries and individuals living in remote, physician-shortage areas. Source: GWU/SPHHS Review of Standing Orders – Fall 2005

29. 29 Next Steps and Recommendations

30. 30 Complete national review and assess results: Assumption: Informal delegation of powers occurs frequently, but limited formal authority, resulting in: Confusion, Selective application of prohibitions, and Potential liability exposure for both physicians and health professionals, ie: Unauthorized practice of medicine; Unlawful delegation of medical powers Next Steps Source: GWU/SPHHS Review of Standing Orders – Fall 2005

31. 31 National Study Preliminary Observations Preliminary findings from the national study: Lack of uniform legal/regulatory provisions regarding healthcare delegation related to vaccine delivery. Support the assumptions generated by the pilot study: –Confusion, –Selective application of prohibitions, –Potential liability exposure for all providers Source: GWU/SPHHS Review of Standing Orders – Fall 2005

32. 32 1.Develop a model standing orders statute that will: Permit broad delegation of immunization practice powers to nurses, physicians assistants, and pharmacists in key health care and community care settings 2.Consider whether reforms in state health professions liability laws will be required to incentivize adoption of the model statute Recommendations Source: GWU/SPHHS Review of Standing Orders – Fall 2005

33. 33 3. Analyze state laws that address the role of standing orders during emergencies 4. Review how Medicaid/Medicare reimbursement policies affect the use of standing orders and vaccine delivery in community care settings Recommendations Source: GWU/SPHHS Review of Standing Orders – Fall 2005

34. 34 Studies discussed and further information about the immunization policy project are available at: www.gwumc.edu/sphhs/healthpolicy/immunization Resources Source: GWU/SPHHS Review of Standing Orders – Fall 2005