DELEGATION OF PRESCRIPTIVE AUTHORITY

1. DELEGATION OFPRESCRIPTIVE AUTHORITY Presented by: Mildred L. Johnson, J.D., CPC, CCEP Case Studies by Todd Bell, M.D. Assistant Professor, Departments of Internal Medicine & Pediatrics

2. OBJECTIVES • Identify the requirements under Texas laws & rules for physician delegation of prescriptive authority to an Advance Practice Nurse (APN) or Physician Assistant (PA). • Define the scope of physician delegation of prescriptive authority • Develop & Maintain Written Protocols as required by Texas law.

3. General Premise • Tex. Occ. Code, Chapter 157.001 • Physicians may delegate medical acts under specific conditions. • Tex. Occ. Code, Chapter 157.002 • Physicians may delegate administration and provision of dangerous drugs • Tex. Occ. Code, Chapter 157.051 et. seq. • Physicians may delegate the carrying out or signing of certain prescription drug orders to an APN or PA.

4. Ambulatory Clinic Policy 4.11 • General Outline of Legal & Regulatory Standards for Physician Delegation of Prescriptive Authority • Applies to TTUHSC physician delegation of prescriptive authority to TTUHSC APN or PA • Identifies responsible persons for compliance with legal requirements.

5. When Does it Apply? • Physician delegates authority to a APN or PA • Pursuant to a written protocol • To carry out or sign a prescription drug order for • Dangerous drug or Controlled Substances, Sched. III-V. • Which is registered with the Texas Medical Board (TMB)

6. The Written Protocol - Content • Lists the types/categories of drugs available for prescription, limitations on number of dosage units and refills permitted & instructions to be given to the patient for follow-up; OR • Lists the types/categories of drugs that may not be prescribed. Attachment “A” (Handout)

7. The Written Protocol • Agreed to & Signed by Physician and ANP/PA • Reviewed and Signed Annually • To be scheduled by Department Administrator • Maintained on Site • Responsibility of the Department Administrator • Includes all current and past protocols.

8. TMB Registration • Must Register with Texas Medical Board (TMB), effective 1/31/10 • Online Registration Process • Hard copy supervision and delegation forms WILL NOT be accepted as of 8/1/10 subject to some exceptions • Temporary Physician/Temporary PA or Faculty Temporary License – contact the PRC at 512-305-7030 • Verify Registration through TMB Verification site; Print and File with the Written Protocol.

9. Delegation – The “Drugs” • Dangerous Drugs • Controlled Substances, Schedules III-V • Prescription, including refills cannot exceed 90 days • Physician must be consulted before refill which must be documented in the medical record • Physician must be consulted before prescribing controlled substance to children < 2 years, which must be documented in the medical record.

10. Prescription Requirements • Patient’s Name and Address • Drug to be Dispensed • Directions to the patient for taking the drug • the dosage (and intended use, if appropriate) • The Name, Address, phone number of the Physician; • The Name, Address, phone number & ID number and signature of the APN/PA completing/signing the order • The date; and • The number of refills permitted

11. Alternate Supervising Physician • A physician who provides supervision during temporary absence of delegating physician • Written Affirmation From Alternate Physician • That he/she is familiar with written protocol • That he/she is accountable for adequately supervising prescriptive delegation pursuant to the written protocol • Contains dates of supervision & signed by alternate physician • Written Affirmation maintained with written protocol

12. Delegation - Sites • Requirements for supervision & documentation vary depending on the practice site: • Medically Underserved Populations (MUP) • Primary Practice Site • Alternate Practice Site • Facility Based Practice

13. MUP Locations • Definition of MUP – Tex. Occ. Code, Sec. 157.052, et. seq • Located in a medically underserved area; • Located in a health manpower shortage area • Rural health clinic • A public health clinic or a family planning clinic under contract with Texas DHS or DOH • Located in an area determined by Texas DOH to have insufficient number of physicians or serves a disproportionate number of clients eligible to participate in federal/state/local health care programs.

14. MUP – Requirements • Physician Supervision Limitations • Cannot supervise > 3 clinics without waiver from TMB • Cannot supervise any number of clinics with combined regular business hours > 150 concurrent hours/week without waiver from TMB • Not more than 5 PAs (Silent as to number of APN). • Written Quality Assurance Plan On-Site • Department Administrator to Verify

15. MUP – Site Visits/Chart Reviews • Physician Site Visit Requirements • On-site at least once every 10 business days while APN/PA is on-site • Responsibility of Department Administrator to schedule • Physician Chart Review • Random Review and Countersignature of at least 10% of patient charts during on-site Visit

16. MUP – Physician Supervision • Responsible for formulation/approval of orders or protocols • Receives daily status report on any problem or complication encountered; and • APN/PA Responsible for communicating daily status reports, as applicable • Available by phone/e-mail for consultation, patient referral or assistance with medical emergency

17. MUP – Written Log • Created by APN/PA and SIGNED by Physician at end of each site visit • Names or ID number of patients discussed during the daily status reports (if any) • Dates/times when physician was on site; • Summary of what physician did while on-site to include: • a description of the quality assurance activities conducted • Patients seen or whose case histories were reviewed with the PA/APN

18. CASE STUDY #1 • Question: An internist supervises a PA working at a clinic that serves migrant farm workers. At the end of the day, the PA and physician sit down to discuss ways to change a patient intake form to ensure preventive medical services are offered to appropriate patients. They summarize their conclusions in writing and the physician signs the document. Does this fulfill the quality assurance requirement for this clinic? • Answer: No. Although a worthwhile endeavor, and undoubtedly helpful for quality improvement, this project does not insure the delivery of care is in compliance with the clinic’s written quality assurance plan.

19. Primary Practice Site • Practice Location where Physician spends majority of physician’s time (>50%) • A licensed hospital, long-term care facility or adult care center where the physician and PA/APN are authorized to practice • Public School District clinic • Patient’s Residence • Another location where the physician is physically present with the PA/APN

20. Primary Site - Supervision • Limit on Number of PA/APN Supervised • Cannot supervise more than four PAs or APNs or their full-time equivalent at primary practice site and alternate practice sites, combined • No required site visits or chart reviews • Continuous Supervision, but not constant physician presence • Must confirm to what a reasonable prudent physician would find consistent with sound medical judgment, varied based on APN/PA’s experience.

21. Primary Site – Other Items • Patient Relationships • Must have established or will establish a physician-patient relationship with the patient • Alternate Supervising Physician is allowed on a temporary basis

22. CASE STUDY #2 Dr. Jones and Mr. Smith, ANP work together in a pediatric practice. Mr. Smith sees a 19 month old child sent from the ER after suffering a seizure. After assessing the patient, Mr. Smith determines the patient would likely benefit from valproic acid anti‐epileptic therapy. The patient is also prescribed rectal diazepam for recurrence of prolonged seizures. He schedules the patient to return to clinic in 4 weeks to see either himself or Dr. Jones.

23. CASE STUDY #2 • Question: In this scenario, is the mid‐level provider obligated to document any consultation or involvement by the supervising physician in this patient’s chart? • Answer: Yes. Although the evaluation of seizures in children may be within the scope of practice of the ANP, he is not allowed to prescribe diazepam (a controlled substance) to a child under age 2 without consulting his supervising physician.

24. CASE STUDY #2 • Question: The board requires that mid‐level providers functioning at a primary practice site see patients who have or will have a relationship with the supervising physician. Within what time period does Dr. Jones have to see the patient personally to satisfy that requirement? • Answer: No time frame is specified by the board.

25. Alternate Practice Site • Site were services similar to those provided at physician’s primary site are provided; and • Less than 50% of physician’s time is spent at the site (i.e., not a primary practice site); and • Site is located within 75 miles of delegating physician’s residence OR primary practice site.

26. Alternate Practice - Supervision • Limitations on Number of PA/APN Supervised • Cannot supervise more than four PAs or APNs or their full-time equivalent at primary practice site and alternate practice sites, combined • Physician Site Visits • Delegating Physician is on-site at least 10% of hours of operation of the site each month. • Department Administrator responsible for scheduling.

27. Alternate Practice - Supervision • Physician Chart Reviews • Reviews at least 10% of medical charts for each APN or PA at the site • Can be from a remote location for EHR • Available by phone/e-mail for consultation, patient referral or assistance with medical emergency

28. Alternate Practice – Written Log • Created by APN/PA and SIGNED by Physician at end of each site visit • Names or ID number of patients discussed during the daily status reports (if any) • Dates/times when physician was on site; • Summary of what physician did while on-site to include: • Patients seen or whose case histories were reviewed with the PA/APN

29. CASE STUDY #3 • Question: A physician operates a busy primary care practice in one town and supervises an ANP at a clinic in nearby small town where the physician lives. The physician goes to the alternate practice site in the evening to review charts and do paperwork. In a typical week, she spends 6‐7 hours in the evening at the clinic. Has the physician met supervisory requirements? • Answer: No. Although the physician has spent 6‐7 hours per week at the clinic, she has not been at the clinic 10% of the time that the clinic was open and the ANP was seeing patients.

30. Facility – Based Location • Sites • Hospital • Not more than 1 and unlimited number of APN/PA • Long term care facility • Not more than 2 and not more than 4 APN/PA • Delegating Physician Must Hold Specific Facility Position • Medical Director (LTCF only) or Chief of Medical Staff or a physician designee who has agreed • Chair of Facility’s Credentialing Committee • Department Chair of a Facility Department

31. Facility – Based • Delegation under: • Physician’s Order; • Standing Medical Order or delegation order; or • Protocol developed in accordance with policies approved by facility’s medical staff or its committee • Delegation must occur in the Facility • Cannot be for treatment/care of other physician’s patients without the other physician’s consent. • Continuous Supervision, but Physician Presence not required.

32. TERMINATION OF RELATIONSHIP • Notification Provided to the respective Boards • Names of each party • License numbers of each party

33. Delegation to CRNA • Location: Licensed Hospital or ASC • Delegation: Ordering of drugs and devices necessary for a CRNA to administer an anesthetic or an anesthesia-related service ordered by the physician. • Pursuant to the order and in accordance with facility policies or medical staff by-laws, the CRNA may select, obtain and administer those drugs and apply the appropriate medical devices necessary to accomplish the order and maintain the patient within a sound physiological status.

34. Delegation for OB Services • Delegation to: • PA offering OB services and certified by the TMB as specializing in obstetrics; or • APN recognized by Texas BON as a nurse midwife • Delegation of act/acts of administering or providing controlled substances to the nurse midwife’s or PA’s patient during intra-partum and immediate post-partum care.