1. Scope of Practice for Advanced Practice Staff in the Eyes of TJC & CMS Catherine Ballard, Esq., Executive Director The Quality Management Consulting Group, Ltd. and Partner, Bricker & Eckler LLP cballard@qmcg.com/cballard@bricker.com 614.227.4848/614.227.8806 Alaska Association of Medical Staff Professionals June 16, 2016 10089777v1

2. Background APRNs: 128,000 in 2008 projected to be 244,000 in 2025. PAs: 74,476 in 2010 projected to be 127,821 in 2025. Surveys of medical school graduates indicate that roughly 2% of graduates are choosing primary care. © QMCG 2016 2

4. Background Affordable Care Act (ACA) and accompanying expansion of Medicaid in many states has led to increased demand for primary care services at traditional locations (i.e., physician office). American Academy of Family Physicians estimates U.S. will face shortage of 60,000 primary care physicians by 2020. © QMCG 2016 2

5. What is Scope of Practice? A Federation of State Medical Boards report defined scope of practice as the: – “Definition of the rules, the regulations, and the boundaries within which a fully qualified practitioner with substantial and appropriate training, knowledge, and experience may practice in a field of medicine or surgery, or other specially defined field. Such practice is also governed by requirements for continuing education and professional accountability.” © QMCG 2016 3

6. Scope of Practice Each state separately regulates the scope of practice for Advanced Practice Providers. In addition to State rules and statutes, scope of practice can be affected by credentialing and privileging decisions at hospitals and federal regulations. 4 © QMCG 2016

7. Current Scope of APP Practice Varies widely by state and specialty – In some cases, specific legal requirements for physician involvement continues to limit the services APPs can provide and sites of service where they can practice. © QMCG 2016 5

8. Current State of APP Prescriptive Authority Barriers to enhancement of prescriptive authority continue to be removed. In most states, APPs can prescribe drugs with varying degrees of physician involvement. Majority of states continue to require physician collaboration/supervision for controlled substance prescribing. Some states continue to have specific formulary limitations, although the formularies in many states are expanding. © QMCG 2016 6

9. Current State of Admitting Privileges Trend towards including admitting privileges within the scope of practice. As state laws change to allow APPs to admit, must look at whether language in the statutes is mandatory or permissive. © QMCG 2016 7

10. Advanced Practice Registered Nurses (APRN) © QMCG 2016 8

12. APRN Definition – The Joint Commission Advanced Practice Registered Nurse: Registered nurse who has gained additional knowledge/skills through successful completion of an organized program of nursing education that prepares nurses for advanced practice roles and who has been certified by the Board of Nursing to engage in the practice of advanced practice nursing. © QMCG 2016 9

13. APRN - History Modern nursing is usually pinpointed as beginning in 1873. Emergence of a strong public health movement in the 19 th century coupled with other occurrences are noted to have created a vehicle for independent and autonomous nursing practice. 1960s – National shortage of primary care physicians led to a gradual expansion of nursing practice. 1965 – The first nurse practitioner program at the University of Colorado was designed to prepare registered nurses (RNs) to manage childhood health problems. – Was viewed by some as a “siphoning off” of talented nurses into a form of medical practice. © QMCG 2016 10

14. APRN - History 1960s – 1970s – Rapidly emerging technology and advances in coronary care medicine fueled the desire for nurses to gain in-depth knowledge and expertise. 1970s – Universities began to develop graduate programs for APRNs in critical care and cardiovascular nursing. © QMCG 2016 11

15. Brief Note on Terminology Specialist in nursing – Traced to the turn of the 20 th century when it was used to designate a nurse who had completed a postgraduate course in a clinical specialty area or who had extensive expertise in a specific clinical area. Introduction of the APRN roles in the 1960s and the terms expanded role and extended role – Used to imply horizontal movement to encompass expertise from medicine and other disciplines. Advanced practice (1980s) – Reflects a vertical or hierarchical movement encompassing graduate education in nursing. Advanced Practice Nurse (post 1980s) – Increasingly used to delineate the four roles (CNP, CRNA, CNS, and CNM). Advanced Practice Registered Nurse (the last decade) – Adopted by state nursing practice acts. © QMCG 2016 12

17. APRN – Across the U.S. American Association of Nurse Practitioners (AANP) estimates there are more than 205,000 nurse practitioners practicing in the U.S. – 17,000 new APRNs completed their academic programs in 2013-2014 Of the APRNs currently working in the U.S., 80% are prepared in primary care specialties. – Have been in practice an average of 10 years. 13 © QMCG 2016

18. Current Scope of APRN Practice Categories Independent – no requirement for a written collaborative agreement, no supervision, no conditions for practice. Not Independent – a written agreement exists that specifies scope of practice and medical acts allowed with or without a general supervision requirement by a MD, DO, DDS or podiatrist; or direct supervision required in the presence of a licensed MD, DO, DDS or podiatrist with or without a written practice agreement. © QMCG 2016 14

19. By the Numbers: Current State of Independent Practice 21 states and the District of Columbia allow nurse practitioners to practice independent of a physician. – Some require APRNs to spend a set time in an arrangement with a physician before they gain independent prescribing rights. – Maryland is the most recent state to allow independent practice. 17 states require that APRNs have a reduced practice and require either a collaborative arrangement or set other limits on the scope of APRN practice. © QMCG 2016 15

20. By the Numbers: Current State of Independent Practice 12 states require “supervision” or team management with a physician, with those nurses prescribing through the physicians. Collaborative agreements, which are made official with forms signed by the APRN and the physician, can vary widely. – Kentucky, for instance, has never required physicians to review the APRNs’ prescribing patterns or meet with APRNs regularly © QMCG 2016 16

21. Marching Towards Independent Practice The Consensus Model for APRN Regulation: Licensure, Accreditation, Certification, and Education – Referred to as the “APRN Consensus Model.” Proposes uniformity to APRN related issues, such as the scope of practice and the lack of uniformity in education and state regulations. – Endorsed by 44 nursing organizations. – Proposes that APRNs will be licensed independent practitioners who are expected to practice within the standards established or recognized by a licensing body. – Full implementation target date was 2015. 17 © QMCG 2016

22. APRN – State-Based Status 18 ©Copyright 2016 Bricker & Eckler LLP

23. Why is this happening? Expansion of health insurance + aging population = – Heavy demand for primary care – A shortage of primary care physicians – Demand to lower costs – Pharmacies creating clinics as “loss leaders” 19 © QMCG 2016

25. Where do we see APRNs? Retail clinics Physician offices Embedded in employer settings Hospital settings 20 © QMCG 2016

27. Alaska APRNs – Alaska recognizes “advanced nurse practitioners” – To qualify as an APRN, a registered nurse must: Complete a one year academic course of study that prepares the nurse for an expanded role Hold a current certification of a nurse practitioner in a specialty area of nursing granted by a national certification body Have a written plan that is kept by the Alaska Board of Nursing – Written plan must: Describe APRN’s practice Identify expected category of clients List APRN’s method for routine and emergency consultations and referrals List the planned pharmacist for potential use of dispensing privileges Describe the quality assurance process that will be used to evaluate the APRN 21 © QMCG 2016

28. Alaska APRNs Alaska defines the scope of practice for APRNs as the “described in the scope of practice statements for nurse practitioners certified by national certification bodies recognized by the Board.” 22 © QMCG 2016

29. Alaska APRNs – APRNs who apply for authorization can prescribe and dispense legend drugs Alaska Board of Nursing publishes a quarterly list with the names of all APRNs who are authorized to prescribe and dispense drugs – APRNs can also prescribe and dispense schedule II-V control substances Must submit a separate application Must have 5 years of prescribing experience prior to applying – APRNs are not required to enter into an agreement with a physician to prescribe or dispense But they can only dispense a prescription within their scope of practice 23 © QMCG 2016

31. Physician Assistants 24 © QMCG 2016

32. PA Definition – The Joint Commission Physician Assistant (PA): Individual who practices medicine with supervision by licensed physicians, providing patients with services ranging from primary medicine to specialized surgical care. Scope of practice is determined by state law, the supervising physician’s delegation of responsibilities, the individual’s education and experience, and the specialty/setting in which the PA works. 25 © QMCG 2016

33. PA - History Dr. Eugene Stead, Jr. of Duke University assembled the first class of PAs in 1965. Class consisted of 4 Navy Hospital Corpsman who received medical training during their military service. Curriculum was based on fast-track training programs for doctors during WWII. 1970- Kaiser Permanente became first HMO to employ a PA. 1971- Comprehensive Manpower Training Act included $4 million for establishment of new PA educational programs. 1975-National Commission on Certification of Physician Assistants established to determine eligibility criteria and to administer national certifying exam. 1986- Medicare began covering PA services provided in hospitals, nursing homes and when assisting in surgery. 26 © QMCG 2016

34. PA - History 1987- Medicare coverage of outpatient services in rural and underserved areas. 1997- Medicare recognizes PAs as covered providers in all settings at a uniform rate of payment. 2000- Mississippi becomes the last state to recognize PA practice. 2007- Indiana becomes the last state to grant PAs prescriptive authority. 27 © QMCG 2016

35. PA – Across the US The American Academy of Physician Assistants (AAPA) reports there are more than 100,000 physician assistants working in the U.S. – More than 7,000 PA graduate from accredited programs each year. Report published in Public Health Reports predicts that physician assistant workforce will grow 72% between 2010 and 2025. 28 © QMCG 2016

36. Current Scope of PA Practice - States Scope of practice defined at either the practice level or by statute. 16 states still determine scope of practice by statute. – Certain states allow for broader scope of practice in hospitals. 28 states adapt the supervision requirements according to the circumstances of the practice. 11 states do not place a limit on the number of PAs a physician can supervise. 10 states still limit prescriptive authority to some extent. 29 © QMCG 2016

37. Alaska PAs PAs in Alaska cannot practice medicine or osteopathy independently; must practice under the supervision of a physician – Must have a documented collaborative plan on a form provided by the Medical Board Alaska PAs must graduate from a program accredited by the Accreditation Review Commission on Education for Physician Assistants and pass a certifying examination PAs must be certified by the National Commission of Physician Assistants (NCCPA) PAs must have at least one documented collaborative relationship with a physician 30 © QMCG 2016

38. Alaska PAs The PAs collaborative plan must include: – The names and specialties for the primary supervising physician and at least one alternate collaborating physician – The name, place of employment, and residence of the PA – The beginning date of employment and the physical location of the practice – The prescriptive authority being granted to the PA by the collaborating physician under the plan A copy of the collaborative plan must be kept at the place of employment and must be available for inspection by the public Any change in the collative plan automatically suspends the PA’s authority to practice – Changes from the collaborating physician to the listed alternate collaborating physician do not trigger this suspension PAs may work in a remote practice location – If the PA has less than 2 years of experience – must work 160 hours in direct patient care under the direct and immediate supervision of the collaborating physician – A PA with more than two years of experience – must submit a document detailing the PA’s previous experience and a written recommendation and approval from the collaborating physician 31 © QMCG 2016

39. Alaska PAs Collaborating physicians must periodically evaluate the medical care and clinical management of PAs. – Assessment must be done quarterly for PAs that have been in a collaborative agreement for less than 2 years – Regardless of experience - Must include at least a monthly direct, personal, and documented contact between PA and collaborating physician PAs can prescribe, order, administer, and dispense drugs (including controlled substances) with authorization from the assistant’s collaborating physician – A PA’s authority to prescribe cannot exceed that of the primary collaborating physician 32 © QMCG 2016

40. Interpretive Guidelines to CMS Hospital Conditions of Participation (CoP) CMS CoPs now provide that the governing body of the hospital has the authority, in accordance with State law, to grant medical staff membership and privileges to non-physician practitioners. 33 © QMCG 2016

42. Interpretive Guidelines to CMS Hospital Conditions of Participation (CoP) con’t. For non-physician practitioners granted privileges only, the hospital’s governing body and its medical staff must exercise oversight, just as it would for those practitioners appointed to the medical staff. 34 © QMCG 2016

43. Interpretive Guidelines to CMS Hospital Conditions of Participation (CoP) [Non-physician] Practitioners are defined by CMS as any of the following: Physician Assistant Nurse Practitioner Clinical Nurse Specialist Certified Registered Nurse Anesthetist Certified Nurse Midwife Clinical Social Worker Clinical Psychologist Anesthesiologist’s Assistant Registered Dietitian or Nutrition Professional 35 © QMCG 2016

45. Examples of types of licensed healthcare professionals who might be eligible for clinical privileges depending on State law and medical staff bylaws include, but are not limited to: Physical Therapist Occupational Therapist Speech Language Therapist 36 © QMCG 2016

46. Some States have established a scope of practice for certain licensed pharmacists who are permitted to provide patient care services that make them more like the other types of non- physician practitioners including the monitoring and assessing of patients and ordering of medications and laboratory tests. 37 © QMCG 2016

47. Surgical Privileges (Interpretive Guidelines to CMS Hospital Conditions of Participation 42 C.F.R. 482.51(a)(4) The hospital must specify surgical privileges for each practitioner that performs surgical tasks. This includes practitioners such as MD/DO, dentists, oral surgeons, podiatrists, RN first assistants, nurse practitioners, surgical physician assistants, surgical technicians, etc. 38 © QMCG 2016

48. Best Practices & Hospital’s Duty to Ensure Proper Collaboration/Supervision 39 © QMCG 2016

49. Credentialing - Definition Credentialing: Process of obtaining, verifying and assessing the qualifications of a health care practitioner to provide patient care services in or for a health care organization. Includes documented evidence, at a minimum, of current licensure, education, relevant training, experience, and other qualifications. 40 © QMCG 2016

50. Credentialing – Hospital Responsibility Hospital Responsibility: To assure that only designated healthcare providers who are qualified, and who continue to be qualified, exercise privileges at the hospital. 41 © QMCG 2016

51. Best Practices The Hospital is responsible for assuring that APRNs and PAs are qualified to exercise clinical privileges. This means that – Privileges must be appropriately drafted – There must be an ongoing professional review of activities, the same as for all other individuals with clinical privileges at the Hospital – This is easier for independent APRNs as they can be tracked the same as any other Practitioner with clinical privileges – This is not as easy for PAs, but it still needs to be done 42 © QMCG 2016

53. Hospital’s Duty to Ensure Proper Collaboration/Supervision Are you reviewing physician’s collaboration/supervision of the APP’s performance as part of the physician’s competency? More thorough review of APP may assist in better review in oversight activities. If physician is liable for the APP’s activities, the hospital may ultimately face vicarious liability “up the chain.” 43 © QMCG 2016

54. Hospital’s Duty to Ensure Proper Collaboration/Supervision OPPE/FPPE – Consider whether criteria developed to evaluate the performance of practitioners when “issues affecting the provision of safe, high quality patient care are identified” should include APP supervision – Consider whether problem with APP should trigger FPPE collaborating/supervising physician Who’s conducting quality oversight of APPs? 44 © QMCG 2016

55. Negligent Credentialing

56. Medical Staff Oversight Medical Staff governing document should describe collaboration/supervision duties and requirements and that failure to collaborate/supervise is grounds for corrective action Medical Staff governing document should explain requirements for bringing in new APPs to hospital and obligations of physician Hospitals can/should have their own rules 45 © QMCG 2016

57. Hospital’s Duty to Ensure Proper Collaboration/Supervision Strategies – APP Policy Part of Bylaws or Medical Staff governing documents Allows for specific description of the specialized nature of APPs APP Credentialing Committee As scope of practice/independence increases, makes sense to have APP-focused credentialing committee 46 © QMCG 2016

58. Hospital’s Duty to Ensure Proper Collaboration/Supervision Risks in relying on physician for credentialing – Hospitals have accreditation obligation to credential APPs – Collaborating/supervising physicians are generally not neutral/independent regarding the APPs with whom they work – Hospitals exposed to liability for APPs 47 © QMCG 2016

59. Uncooperative APPs/Physicians Potential Problems – Scope of Practice Misuse of APP services Permitting APP to act outside of scope – Unprofessional behavior 48 © QMCG 2016

61. Uncooperative APPs/Physicians Potential Problems – Negligent Credentialing Uncommon currently, but potential future issue for hospital to be liable for negligently credentialing APP Wellstar Health Sys. v. Green, 258 Ga. App. 86 (2002): – Health System held liable for negligent credentialing of nurse practitioner 49 © QMCG 2016

62. And What Are You Doing With Acupuncturists/Oriental Medicine Practitioners Chiropractors Homeopathic Practitioners Naturopathic Practitioners Optometrists Private “Rounding” Nurse Registered Nurse First Assistants Therapists (Physical/Respiratory/Massage/Etc.) 50 © QMCG 2016

64. Questions? Catherine Ballard, Esq., Executive Director The Quality Management Consulting Group, Ltd. and Partner, Bricker & Eckler LLP cballard@qmcg.com/ cballard@bricker.com 614.227.4848/614.227.8806 © QMCG 2016