Presented by:Mildred L. Johnson, J.D., CPC, CCEP

Case Studies by Todd Bell, M.D.Assistant Professor, Departments of Internal

Medicine & Pediatrics

OBJECTIVESIdentify 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.

General PremiseTex. Occ. Code, Chapter 157.001

Physicians may delegate medical acts under specific conditions.

Tex. Occ. Code, Chapter 157.002Physicians may delegate administration and

provision of dangerous drugsTex. 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.

Ambulatory Clinic Policy 4.11General 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.

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)

The Written Protocol - ContentLists 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)

The Written Protocol Agreed to & Signed by Physician and ANP/PA

Reviewed and Signed AnnuallyTo be scheduled by Department Administrator

Maintained on SiteResponsibility of the Department AdministratorIncludes all current and past protocols.

TMB RegistrationMust Register with Texas Medical Board

(TMB), effective 1/31/10Online 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.

Delegation – The “Drugs”Dangerous Drugs

Controlled Substances, Schedules III-VPrescription, including refills cannot exceed 90

daysPhysician must be consulted before refill which

must be documented in the medical recordPhysician must be consulted before prescribing

controlled substance to children < 2 years, which must be documented in the medical record.

Prescription RequirementsPatient’s Name and AddressDrug to be DispensedDirections to the patient for taking the drugthe 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; andThe number of refills permitted

Alternate Supervising PhysicianA physician who provides supervision during

temporary absence of delegating physicianWritten Affirmation From Alternate Physician

That he/she is familiar with written protocolThat 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

Delegation - SitesRequirements for supervision & documentation

vary depending on the practice site:

Medically Underserved Populations (MUP)

Primary Practice Site

Alternate Practice Site

Facility Based Practice

MUP LocationsDefinition of MUP – Tex. Occ. Code, Sec. 157.052,

et. seqLocated in a medically underserved area;Located in a health manpower shortage areaRural health clinicA public health clinic or a family planning clinic

under contract with Texas DHS or DOHLocated 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.

MUP – RequirementsPhysician 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-SiteDepartment Administrator to Verify

MUP – Site Visits/Chart ReviewsPhysician 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 ReviewRandom Review and Countersignature of at

least 10% of patient charts during on-site Visit

MUP – Physician SupervisionResponsible for formulation/approval of orders

or protocols

Receives daily status report on any problem or complication encountered; andAPN/PA Responsible for communicating daily

status reports, as applicable

Available by phone/e-mail for consultation, patient referral or assistance with medical emergency

MUP – Written LogCreated by APN/PA and SIGNED by Physician

at end of each site visitNames 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

conductedPatients seen or whose case histories were

reviewed with the PA/APN

CASE STUDY #1Question: 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.

Primary Practice SitePractice 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 clinicPatient’s ResidenceAnother location where the physician is

physically present with the PA/APN

Primary Site - SupervisionLimit 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 reviewsContinuous Supervision, but not constant

physician presenceMust confirm to what a reasonable prudent

physician would find consistent with sound medical judgment, varied based on APN/PA’s experience.

Primary Site – Other ItemsPatient Relationships

Must have established or will establish a physician-patient relationship with the patient

Alternate Supervising Physician is allowed on a temporary basis

CASE STUDY #2Dr. 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.

CASE STUDY #2Question: 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.

CASE STUDY #2Question: 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.

Alternate Practice SiteSite 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.

Alternate Practice - SupervisionLimitations on Number of PA/APN

SupervisedCannot supervise more than four PAs or APNs

or their full-time equivalent at primary practice site and alternate practice sites, combined

Physician Site VisitsDelegating Physician is on-site at least 10% of

hours of operation of the site each month.Department Administrator responsible for

scheduling.

Alternate Practice - SupervisionPhysician 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

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

CASE STUDY #3Question: 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.

Facility – Based LocationSites

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 agreedChair of Facility’s Credentialing CommitteeDepartment Chair of a Facility Department

Facility – BasedDelegation under:

Physician’s Order;Standing Medical Order or delegation order; orProtocol developed in accordance with policies

approved by facility’s medical staff or its committee

Delegation must occur in the FacilityCannot be for treatment/care of other physician’s

patients without the other physician’s consent.Continuous Supervision, but Physician Presence

not required.

TERMINATION OF RELATIONSHIPNotification Provided to the respective

Boards

Names of each party

License numbers of each party

Delegation to CRNALocation: Licensed Hospital or ASCDelegation: 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.

Delegation for OB ServicesDelegation 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.