Mary S. Schaefer, RN, M.Ed, ARM, JD CHS Corporate Director, Risk Management

1. Enterprise Risk Management of Allied Health Professionals’ Changing Scope of PracticeAHLA Enterprise Risk Management Task Force May 10, 2012 Mary S. Schaefer, RN, M.Ed, ARM, JD CHS Corporate Director, Risk Management

2. Allied Health Professionals’ Scope of Practice Risks • Allied health professionals who practice outside the legal scope of practice. • Lack of physician supervision in a variety of settings. • Failure of the allied health professional to consult with a supervising physician per written protocol. • Interstate practice of Advance Practice Nurses who step over state lines to practice. • Allied Health Professionals who are not credentialed or privileged to perform an invasive procedure.

3. Employed or Under Contract-Who are Allied Health Professionals? • Practitioners include Physician Assistants, Advanced Practice Nurse Practitioners, Certified Registered Nurse Anesthetists, Certified Nurse Midwives, Clinical Nurse Specialists and Social Workers, and Chiropractors.

4. Enterprise Risk Domains Impacted by Allied Health Professional Risks • Legal/Regulatory compliance: Out of scope practice lawsuits and failure to follow CMS supervision requirements. • Finance: Violation of Medicare rules leading to fines and penalties, malpractice litigation, and contract requirements. • Operations: Failure to follow clinical policies, protocols, and procedures in multiple care settings. • Human Capital: Negligent credentialing and screening, retention, morale, and dissatisfaction. • Strategy: Tension between medical staff and allied health professionals who seek independent practice resulting in loss of medical staff members, and loss of reputation.

5. CMS/Joint Commission Credentialing Requirements • Advanced Practice Registered Nurses (APRNs) and Physician Assistants (PAs) providing “medical level of care” must be credentialed and privileged through the medical staff bylaws - regardless of whether PAs and APRNS are employed by the organization. • TJC requires credentialing and privileging of any allied health professional who functions as a Licensed Independent Practitioner. “Any practitioner permitted by law and by the organization to provide care and services, without direction or supervision, within the scope of the practitioner license and consistent with individually assigned clinical responsibilities.”

6. Credentialing and Privileging Requirements • Advanced Practice Registered Nurses should request privileges only for those responsibilities involving “medical level of care” and not those responsibilities already allowed under the RN scope of practice. • Hospital bylaws need to specify whether and how PA’s and APRN’s may be granted privileges. Must be compliant to The Joint Commission standards. • Job descriptions should reference the privilege delineation.

7. Use Specialty Specific Privilege Forms for All Settings • For example, Orthopedic or Neurosurgery Physician Assistants need a specialty specific privilege form which should be considered the Authoritative Source for the services physician assistants and advanced practice RNs are permitted to provide. • The supervision by the sponsoring physician should be defined in the privilege form and how the physician will be held accountable. • Competency assessments should be done for all specialty procedures done in the outpatient and hospital setting.

8. CMS Requirements: Surgical Privileges by Assistive Personnel 42. C.F.R.482.51(a) • If the hospital uses RN First Assists, Nurse Practitioners, Surgical Physician Assistant, and Surgical Technicians, the hospital must also specify surgical privileges for each practitioner. • If surgical procedures are provided under supervision, the specific tasks or procedures and the degree of supervision (to include whether the supervising physician is physically present in the same OR, in line of sight of the practitioner being supervised) are delineated in that practitioner’s surgical privileges and included on the surgical roster.

9. Privileging Requirements for APRNs and PAs or Others Providing Medical Care • Once privileging process is completed, the allied health professional follows the same path as the privileged physician -focused and on-going professional practice evaluation. (same for renewal of privileges & reappointment).

10. Supervising Requirements Must Be Explicitly Defined and Monitored • The credentialing and Privileging Process also needs to outline Physician Supervision Requirements. The supervision by the sponsoring physician should be defined on the privilege form. • For newly privileged allied health professionals, there should be closer monitoring and supervision such as chart reviews, monitoring clinical practice patterns, specifying time period or number of cases for initial observation, simulation, proctoring, external peer review, and discussions with others involved with the care.

11. CMS Supervision Requirements for Outpatient Therapeutic Services • CMS requires hospitals to provide Direct Supervision for the delivery of all Therapeutic services. • CMS relaxed the definition of Direct Supervision of Non-Physician Providers (NPP) to eliminate strict location requirements so that a physician or non-physician practitioner can meet the direct supervision requirement for outpatient therapeutic services and not technically be on hospital property. • Does NOT require presence within any specific physical boundary (in the past the rules specifically required presence on the hospital campus or in the PBD).Requires that the practitioner be available throughout the procedure and not occupied with a procedure that is uninterruptible.

12. Who Can Supervise Outpatient Hospital Therapeutic Procedures? • The following practitioners and non-physician practitioners (Physicians, Nurse Practitioners, Clinical Nurse Specialists, Certified Nurse Midwives, Physician Assistants, Licensed Social Workers and Clinical Psychologists) may provide direct supervision for most hospital therapeutic services within the scope of their practice). Services include outpatient psychiatric services; wound debridement; clinic and emergency room services; drug infusions and blood transfusions; and radiation therapy. • Cardiac rehab and pulmonary rehab services require direct supervision by a doctor only.

13. CMS’ Preliminary Decisions on the Recommendations of the Hospital Outpatient Payment Panel on Supervision Levels for Select Services • CMS has given preliminary approval to change the supervision requirement for 27 hospital outpatient therapeutic services from direct supervision to general supervision, effective July 1 2012. • Services deal with psychotherapy; bladder catheterization; immunization administration; and smoking and tobacco cessation counseling. These preliminary decisions are open to public comment through May 19, 2012.

14. New Outpatient Category: Non-surgical and Extended Duration Services • CMS also designated sixteen services as “Non-surgical and Extended duration services” where direct supervision is required for the initiation of the service followed by minimum standard of general supervision for the duration of the service. • Includes observation, Intravenous, and subcutaneous infusion and injections.(Does not include chemotherapy or blood transfusions).

15. Supervision Requirements for Outpatient Diagnostic Services CMS-Defines three levels of Supervision in the Hospital Outpatient Setting. • General Supervision: Service is furnished under the overall direction presence is not required during the performance of the service. • Personal Supervision: Means a physician must be in attendance in the room during the performance of the procedure. • Direct Supervision: Requires the supervisory practitioner to be “immediately available” to furnish assistance and direction throughout the performance of a hospital outpatient service or procedure.

16. Supervision of Diagnostic Services • The level of supervision for hospital outpatient diagnostic services requires that diagnostic services be supervised by a physician or DO under the three levels of supervision-general, direct and personal supervision depending on the specific procedure as indicated in the Medicare Physician Fee Schedule for each service. • Critical Access Hospitals are not subject to the diagnostic supervision requirements at the present time. • A sleep study requires general physician supervision while MRIs or CT scans with contrast require the personal supervision of a physician and requires a radiologist to be physically present in the room and attend the performance of the procedure.

17. Imaging Firm Violated FCA by Failing to Comply with Medicare Physician Supervision Requirement • United States ex rel. Hobbs v. MedQuest Assocs., Inc., No. 3:06-01169 (M.D. Tenn. Aug. 23, 2011). • The U.S. District court found that the Independent Diagnostic Testing Facility, MedQuest violated the False Claims Act for failing to comply with Medicare’s direct supervision requirement at two facilities. • The court determined that claims for imaging tests with contrast were false because the physician supervising the tests were not proficient and tests were being conducted without physician supervision. The court granted the government’s motion for Summary judgment assessing False Claims Act $11.1 million in civil penalties and damages.

18. Review of Hospital Supervision Policies and Contracts • Hospitals need to review their supervision policies and verify that allied health professionals are not being used as supervising physicians for diagnostic procedures and also verify that a physician is available at the level of supervision for each service.) • The hospital should also ensure that contractual provisions require the appropriate level of supervision.

19. Scope of Practice is Determined by State Law • Nursing practice is regulated by the Nurse Practice Act. • Sixteen states and District of Columbia have liberalized and standardized their scope-of-practice regulations and allow nurse practitioners to practice and prescribe independently. • 10 States require that NPs’ be supervised by a MD • In 17 states, state nursing and medical boards have joint rule making authority over NP scope of practice • Remainder of states do require some degree of written protocols or formal physician involvement in NP practice. (source: N Eng. J Med 2011; 364:193-196 )

20. Scope of Practice • Scope of nurse practitioners’ practice determines: • Who you can see, treat, and under what circumstances you provide the care. • The limits and privileges of your licensure and certification as an advanced practice nurse. • The ability to bill for services-within scope of state license.

21. State Supervision Requirements of Advance Practice Nursing Specialties Vary • Definitions of “collaboration and supervision” vary from state to state, with some states identifying the responsibilities included in each definition. • Some states do not specify the requisite extent or form of physician oversight. • Supervision ranges from physical presence to phone accessibility, regular meetings and periodic chart reviews.

22. Barriers to Broadening the Scope of Nurse Practitioners • State-based regulatory barriers-limit nurse practitioners’ capacity to practice to the fullest extent of their education. • Medical groups (AMA, American Academy of Pediatrics and American Academy of Family Physicians support the requirement of direct supervision of Nurse Practitioners. • Argue that more intensive training means NP cannot deliver primary care services that are as high quality and safe as those of physicians.

23. Turf War Between Nurse Anesthetists and Anesthesiologists • Seventeen states have opted out of the Medicare rules and allow nurse anesthetists to work without a supervising physician. • Anesthesiologists maintain direct supervision is necessary to guarantee patient safety. • Nurse anesthetists maintain they provide increased access to patients in rural areas and there is no evidence that lack of supervision has increased patient deaths or complications.

24. Scope of Practice Risk Issues • Advanced Practice Nurses who Cross Lines to Practice • Multiple facilities that cross state borders- Subject to requirements imposed by the other state. • Need to have individual state licenses-may be subject to criminal or regulatory complaints. • Few states have adopted the Nurse Licensure Compact for Nurse practitioners. • Nurse Practitioners must hold an individual certificate or license to practice in each state where they see patients.

25. Scope of Practice Risk Issues • Practicing beyond the scope of practice • Examples: The collaborating physician sees children under the age of 13 in an allergy practice and the adult nurse practitioner provides care and prescription to the pediatric patients without pediatric expertise. • Cutting corners and a push by physician- “just this once” becomes normalization of deviation.

26. Scope of Practice Risk Issues in the Physician’s Office • MD hires an inadequately trained or unskilled nurse practitioner (NP), certified nurse midwife, or physician assistant (PA) who practices out of scope. • Absence of office policies and procedures. • Absence of written practice guidelines, including situations that require immediate communication by the allied health professional with a physician. • Failure to refer to collaborate with a physician • Physician is unavailable in person or by telephone • Incorrectly advises the NP or PA on a patient care issue • Inadequate supervision on the part of the physician.

27. Failure to Consult Collaborating Physician in an Office Practice • Case Example: A 41 y/o female complained to the family nurse practitioner (FNP) of vaginal bleeding and abdominal pain. In each of the six visits over a four month period, and despite worsening symptoms, the FNP attributed the patient’s symptoms to a variety of benign causes. The collaborating physician was never consulted but did co-sign the FNP notes. She and FNP were named as co-defendants in the malpractice suit filed by the family after the patient succumbed to endometrial cancer. • Failure to consult or refer the patient to the physician • MD liable for signing notes she never read and for having inadequate practice policies in place for the FNP. (Nurse Practitioners and Physician Assistants: Some Risk Management Concerns, Massachusetts Medical Society, 2004)

28. Mitigating Allied Health Professional Risks in the Physician Office Setting • Perform a credentialing check on all nurse practitioners and physician assistants. • Verify that competencies are current • Monitor newly hired physician assistant or nurse practitioner. • Make sure that the collaborating or supervising physician shares the same medical specialty as the NP or PA. • Define coverage agreements in writing. • Develop mutually agreed upon practice protocols. • Develop clinical guidelines that include cancer screening.

29. Mitigating Allied Health Professional Risks in the Physician Office Setting • Monitor prescriptive practice. • Review all notes before co-signing them. • Consider the supervising relationship with no more than two Nurse Practitioners or Physician Assistants at the same time. • Make sure that a collaborating or supervising physician is always available to the NP or PA. • Source: (Nurse Practitioners and Physician Assistants: Some Risk Management Concerns, Massachusetts Medical Society, 2004)

30. Avoiding AHP Ostensible Agency Claims • Ostensible agency-a form of implied agency relationship created by actions of parties. • Driven by the plaintiff’s perception that the allied health professional is working as an agent of the hospital or physician. • PA/NP identifies him/herself as doctor or fails to inform patient he/she is an AHP • Marketing materials that state “our physicians and staff”

31. Steps to Avoid Ostensible Agency Claims • Update conditions of admission, consent and treatment forms to include the same language as used for explaining physicians are independent contractors. • Require the nurse practitioner of physician assistant to wear an identification badge with credentials. • Provide scrubs, coats, and name tags, without the hospital logo. • Display signs indicating the independent contractor relationships in prominent areas.

32. Allied Health Professional Contractual Agreements • Contractor clause (not an employee of the institution or physician office practice). • The wording from statutes and regulations that govern the roles of Physician Assistants and Advanced Practice Nurses are spelled out. • Professional liability insurance coverage • Job duties. Compensation, and benefits • On-call coverage requirements

33. Allied Health Professional Contractual Agreements • Scope of practice and supervision defined by supervising physician. For example, some states limit the number of Physician Assistants a physician can supervise. • Requirement to participate in appropriate hospital committee meetings, including peer review, department meetings, drills, disaster planning. • Provision that the hospital will provide peer review and quality improvement information to various managed care and health plans. • Adherence to policies and procedures

34. Allied Health Professional Contractual Agreements • If the allied health professional is practicing at other facilities, what quality improvement information about the Allied Health Professional can and cannot be shared. • Practices that would be considered a breach of the contract • Termination Clause

35. Thank-You • Questions?