collaborating physician kit table of contents

Collaborating Physician Kit Table of Contents

Advanced Practice Nurse (APN) Collaboration Checklist Introduction & Reference Materials

2

Credentials for the Advanced Practice Nurse 3 Credentials for the Collaborating Physician 3 Collaboration Requirements 4 Protocols 5 Medical Record Review 6 Special Prescribing Dispensing Rules 7 Advertising for Services Provided by an APN 10 Physician Assistant (PA) Collaboration Checklist Introduction & Reference Materials

13

Credentials for the Physician Assistant 14 Credentials for the Collaborating Physician 14 Collaboration Requirements 16 Protocols 15 Medical Record Review 17 Special Prescribing Dispensing Rules 18 Additional Collaboration Requirements for Physicians Who Collaborate With Temporary PA License Holders

22

Billing of Physician Assistant Services 23 Advertising for Services Provided by a PA 23 Appendix A – APN Practicing in a Registered Pain Management Clinic

26

Appendix B – APN or PA Performing Interventional Pain Management in a Medical Office

34

Appendix C – Collaborating Physician’s Checklist for Advance Practice Nurse or Physician Assistant Practicing Hormone Replacement Therapy

36

Appendix D – PA Practicing in in a Registered Pain Management Clinic

38

1 of 42

08/22/2019 www.tnmed.org

Collaborating Physician’s Checklist Advance Practice Nurse in a Medical Office or Retail Clinic

Introduction and Reference Materials These practice guidelines were developed by TMA for the convenience of its members who collaborate with, or contemplate collaborating with, APNs, either in a medical office or retail clinic. The guidelines were developed from Tennessee law and the rules promulgated by the Tennessee Board of Medical Examiners (BME) and the Tennessee Board of Nursing (BN); however, they should not be a substitute for a thorough reading of the rules by the collaborating physician and mid-level practitioner. In 2017, the General Assembly passed legislation to change the terminology used to describe the physician from “supervising” physician to “collaborating” physician. This checklist has been amended to reflect this change in terminology in the law. The rules have not yet been amended by the licensing boards and the term “supervising” is still used. TMA has made comments and suggestions about some of the rules (in italics). These comments should not be considered as official positions of either regulatory board or as legal advice. They are practical suggestions to assist the office in delivering meaningful collaboration and quality care. The full text of the applicable rules discussed herein may be found at:

• Medical Board Rules for Supervising Physicians: http://share.tn.gov/sos/rules/0880/0880-06.pdf

• Nursing Board Rules for Nurse Practitioner Prescription Writers: http://share.tn.gov/sos/rules/1000/1000-04.20150622.pdf

There are additional requirements for when a physician collaborates with an APN in certain practice settings. At the end of this kit are checklists for each setting and they are found at the end of this document.

• In a Registered Pain Management Clinic – See Nurse Practitioners Practicing in a Pain Clinic • Interventional Pain Management – See Nurse Practitioners & Physician Assistants Practicing

Interventional Pain Management • In a Hormone Replacement Therapy Clinic – See Nurse Practitioners & Physician Assistants

Practicing in a Hormone Replacement Therapy Clinic

2 of 42


http://share.tn.gov/sos/rules/0880/0880-06.pdf

http://share.tn.gov/sos/rules/0880/0880-06.pdf

http://share.tn.gov/sos/rules/1000/1000-04.20150622.pdf

Credentials for the APN A collaborating physician should have policies and procedures in place at each practice location and for each APN so that the following information is checked annually and updated as required by law: ___ Current Tennessee Registered Nurse license.

TMA Comment: The Tennessee Department of Health has an official license verification check https://apps.health.tn.gov/Licensure/. Practices can rely on this data for current licensure status.

___ Current certification as an Advanced Practice Nurse (APN). TMA Comment: Same as above. ___ Current Certificate of Fitness to Prescribe and/or Issue Legend Drugs TMA Comment: Same as above. ___ Current Drug Enforcement Administration Certificate to Prescribe Controlled Substances at each

practice location (if prescribing Controlled Drugs). ___ Documentation of CME for the current term of the APN’s Certificate of Fitness should be

submitted to the collaborating physician upon completion of the CME. ___ Notice and Formulary Form must be submitted by the APN to the Tennessee Board of Nursing.

Whenever there is a change to the information on the form, it must be updated within 30 days. ___ National Provider Identifier (NPI). Credentials for Collaborating Physician A collaborating physician should have policies and procedures in place at each practice location so that the following information is checked annually and updated as required by law: ___ Current and “unencumbered” Tennessee MD or DO license.

TMA comment: The term “unencumbered” is not defined in the rules and regulations of the Tennessee Board of Medical Examiners. It probably means the medical license is not on probation or otherwise restricted by the BME. If this might be a problem for a potential collaborating physician, the physician should contact the BME at 800-778-4123.

3 of 42


https://apps.health.tn.gov/Licensure/

http://tn.gov/health/article/nursing-applications

___ Current Drug Enforcement Administration Certificate to Prescribe Controlled Substances at each

practice location (if prescribing Controlled Drugs). TMA comment: It is TMA’s position that if the collaborating physician does not have an active DEA number, the APNs they collaborate with cannot prescribe controlled drugs because BME rules provide at 0880-06-.02(3) that the collaborating physician (or substitute collaborating physician) “shall have experience and/or expertise in the same area of medicine as the certified nurse practitioner.”

___ National Provider Identifier (NPI) (if the collaborating physician will collaborate with APNs who

will treat either TennCare or Medicare patients). Collaboration Requirements Policies in place at locations where an APN is practicing must include, at a minimum, all of the following: ___ The collaborating physician is available for consultation at all times or shall make arrangements

for a substitute collaborating physician to be available. BME rule 0880-06-.02 does not require the “continuous and constant presence” of the collaborating physician. TMA comment: Consultation may be by telephone. There is no geographic proximity rule but TMA recommends the collaborating physician be no more than 30 miles or 30 minutes from the clinic staffed by the APN in case the patient needs to be seen by the physician.

___ The collaborating physician or substitute “shall have experience and/or expertise in the same

area of medicine as the certified nurse practitioner.” Rule 0880-06-.02 (3) TMA comment: This rule would likely preclude, for example, a pediatrician from collaborating with an APN who treats adult patients and vice-versa, or a psychiatrist from collaborating with an OB APN.

___ On-site visits to each clinic by the collaborating physician are required every thirty (30) days.

TMA comment: The rules do not state how long this site visit must last or specify what must be done during the visit. Although not required by rules, TMA strongly recommends the duration of the visit be longer to clinics where the APN is relatively inexperienced because of being a recent graduate, new to the practice, or new to the area of medicine practiced at the clinic. Although not required specifically by rule, TMA ardently recommends the APN be present during the collaborating physician’s visit and that some exchange regarding patient charts and protocols takes place.

___ TMA comment: Although not required by rule, TMA recommends that a discharge sheet be given

to each patient if the clinic is not the patient’s medical home. If the patient has no medical home, the APN should encourage the patient to link to a primary care provider.

4 of 42


___ TMA comment: Although not required by rule, TMA recommends the clinic have a policy that

both the collaborating physician and APN review the BME and APN rules at least annually and document such review in case changes are made that might affect the protocols in the interim.

___ TMA comment: Although not required by rule, collaborating physicians should institute policies

to ensure they are not overextended by collaborating with more PAs/ APNs than they can reasonably handle. There is no hard and fast rule but the BME in the past has indicated collaborating with more than four (4) mid-level practitioners at a time may not be wise in some cases.

Protocols Protocol must be used and their requirements are: ___ Must be jointly developed by the collaborating physician and the APN. ___ Must be approved, signed and dated by the collaborating physician.

___ Shall outline and cover the applicable standard of care.

___ Shall be reviewed and updated every two years.

TMA comment: We suggest that each update entry contain the date it is updated and signed, so it is easy for a reviewer to ascertain when a protocol update went into effect.

___ Copies of the current protocols must be kept at the practice site.

___ Copies of the current formularies must be kept at the practice site.

___ Shall account for all protocol drugs by appropriate formulary.

___ Shall be specific to the population seen.

___ Health Related Boards investigators must be able to inspect and copy protocols and formularies upon request.

___ Policies and procedures must be in place to ensure compliance with the applicable standards of care required under the protocol requirements above.

5 of 42


___ Develop clinical guidelines in collaboration with the APN to include a method for documenting consultation and referral.

6 of 42


Medical Record Review ___ The APN’s medical records and charts must be reviewed and you must certify this is done by the

signature and date as outlined below. TMA comment: It is not specifically required in the rules but would be advisable for the collaborating physician to maintain a log of the charts reviewed of each APN. The log should indicate the patient name or number, date of service, whether review was mandatory or within the 20% rule, date reviewed and place for signature or initials of the reviewing physician. Otherwise, there is no way to document compliance for regulators with either the mandatory review rule or the 20% rule. It may be appropriate as well to document how long you spend reviewing the charts. At least one retail clinic chain has instituted a policy to periodically assess APNs’ performance based on the chart reviews. While not required by the rules, it may be a policy consideration for your practice.

___ Charts must be reviewed by the collaborating physician for all of the following patients within

ten (10) business days after the patient has seen the APN. Policies should be in place to ensure timely review of the following categories: ___ When medically indicated. ___ When requested by the patient. ___ When prescriptions written by the APN fall outside of the protocols. ___ When a controlled drug has been prescribed.

___ Establish a policy of how the collaborating physician will communicate with the APN any inappropriate treatment provided by the APN, or other comments or suggestions as medically necessary. TMA comment: Meaningful collaboration does not exist without feedback on mistakes or suggestions on further treatment from the physician. Failure to do so is a liability risk for both the APN and collaborating physician. The policy should state how communication will take place, how soon after chart review it shall take place and, if necessary, how the patient will be contacted.

For categories of patients not included above requiring a review of every chart, review shall be as follows:

___ 20% of the charts prepared by the APN every 30 days.

7 of 42


___ Document a site visit to every remote site at least once every thirty (30) days.

TMA comment: There is no amount of time specified in the rules as to how long the collaborating physician’s visit to the site should be or what the physician must do during these site visits. Also, the 20% rule is a flat rule and does not take into account how long the relationship between the physician and APN has been established. Although not required by rule, TMA recommends that in-depth chart review take place more frequently and at a higher percentage of charts that 20% for the first 12 months of the relationship, especially if the APN is a new graduate and relatively inexperienced or new to a particular area of medicine.

Special Prescribing/Dispensing Rules Board of Nursing rule 1000-04-.09 requires that the following prerequisites be completed prior to prescribing drugs, even over the Internet, to a patient. The only exceptions to the prerequisites being completed are: 1) In admission orders for a newly hospitalized patient; 2) for a patient of a physician or APN for whom the prescriber is taking cal ls or for whom the prescriber has verified the appropriateness of the medication; 3) for continuation medications on a short-term basis for a new patient prior to the patient's first appointment; or 4) for established patients who, based on sound practices, the APN, having proper authority to prescribe, believes do not require a new physical examination before issuing new prescriptions. Otherwise: ___ Perform an appropriate history and physical examination. ___ Diagnose based upon the examinations and all diagnostic and laboratory tests consistent

with good health care. ___ Formulate a therapeutic plan and discuss it, along with the basis for it and the risks and

benefits of various treatments options, a part of which might be the prescription or dispensed drug, with the patient or guardian.

___ Ensure the availability of the APN or coverage for the patient for appropriate follow-up care.

TMA comment: Many health plans have policies against clinics just having a message stating call 911 or go to the ED in case of emergency. This might require a beeper or other way to contact the treating APN immediately in case of emergency. Also, it might be a good idea to get your APN credentialed at the local hospital in case a patient seen by the APN presents to the ED after hours.

8 of 42


___ Ensure the APN complies with Board of Nursing rule 1000-04-.09(3) regarding Internet

prescribing. TMA comment: The rule addresses the situation where customers order drugs from an Internet site with no prior provider-patient relationship. It is not designed to stymie legitimate electronic prescribing by a prescriber as long as the prescribing prerequisites are complied with. Most clinics do not prescribe over the Internet.

___ Prescribing of medicines in schedules II, III and IV

1. The prescription must be specifically authorized by the formulary or expressly approved after consultation with the collaborating physician before the initial issuance of the prescription or dispensing of the medication.

2. A schedule II or III opioid listed on the formulary may only be prescribed for a maximum of a non-refillable, 30-day course of treatment unless specifically approved after consultation with the collaborating physician before the initial issuance of the prescription or dispensing the medicine.

TMA Comment: The collaborating physician should keep a record of these conversations and his/her approval or disapproval of the prescription. The nurse practitioner should note that the collaborating physician approved the prescription in the patient’s medical record.

Prescriptions issued by the APN must meet the following minimum requirements. ___ Only APN s with a certificate of fitness to prescribe may issue prescriptions for drugs. ___ Must be pre-printed pads.

TMA comment: T.C.A. § 63-7-123 is confusing and on its face inconsistent. Subsection (3)(A) states every prescription issued by an APN has to be on a preprinted pad. Subsection (3)(B), however, authorizes APNs to write handwritten prescriptions. TMA believes APNs can write legible handwritten prescriptions.

___ Tamper-resistant prescription paper must be used. The paper must meet the requirements in

BN Rule 1000-04-.10 (3). ___ Must contain the name, address and telephone number of the collaborating physician.

___ The APN must place a check mark beside or circle around the name of the primary collaborating

physician on the prescription, if the pre-printed prescription pad contains the names of more than one physician.

___ Must contain the name, address and telephone number of the APN.

___ Must contain the signature of the prescribing APN on every prescription written by the APN

(unless a standing order issued in a hospital, nursing home, or assisted living facility).

9 of 42


___ The APN shall use the APN’s own DEA number when prescribing Controlled Substances. ___ Must be legible. ___ Must contain the name and strength of the drug prescribed. ___ Must contain the quantity of the drug prescribed written in both letters and numerals (if

handwritten). ___ Must contain instructions for the proper use of the drug. ___ Must contain the date the drug is prescribed. ___ Prescriptions issued by the APN for long-term treatment of pain must meet the following

minimum requirements found in BN rule 1000-04-.08. TMA comment: In an overwhelming percentage of disciplinary cases brought against providers

of chronic pain management, the reason for the disciplinary action by the regulatory board stems from the provider’s poor documentation or the provider’s lack of training in treating this difficult type of patient. Some practices utilize a “narcotic contract” with terms including the promise that the patient only receive controlled drugs from that prescriber.

___ Only APNs with a certificate of fitness to prescribe and a current DEA certificate may issue

prescriptions for controlled drugs for pain. ___ If the APN chooses not to provide long-term pain management to a patient with intractable

pain, such APN shall offer the patient a referral to a provider of chronic pain management. ___ If the APN chooses to treat patients with intractable pain with opiates, such APN must

demonstrate a current knowledge of long-term pain management (and the collaborating physician should be engaged in the treatment of long-term chronic pain) and follow the BME’s rules:

___ Each patient’s medical record shall include a documented medical history and physical

examination by the APN providing the medication. Historical data shall include pain history, any pertinent evaluations by another provider, history of and potential for substance abuse, pertinent coexisting diseases and conditions, psychological functions and the presence of a recognized medical indication for the use of a controlled substance.

10 of 42


___ Each patient’s medical record shall contain a written treatment plan tailored

for individual needs of the patient and shall include objectives such as pain relief and/or improved physical and psychosocial function, and shall consider need for further testing, consultations, referrals, or use of other treatment modalities dependent on patient response.

___ The APN shall discuss the risks and benefits of the use of controlled substances with

the patient or patient’s guardian. ___ At each periodic interval in which the APN providing care evaluates the patient for

continuation or change of medications, the patient record shall include progress toward reaching treatment objectives, any new information about the etiology of the pain, and an update on the treatment plan.

___ Remember, BME rules require the collaborating physician review the charts of all

patients when a controlled substance is prescribed by an APN. Rules provide that non-controlled drugs are to be dispensed from the clinic in an appropriate container labeled with at least, the following:

___ Patient's name. ___ Date. ___ Complete directions for usage. ___ The name and address of the APN having proper authority to prescribe. ___ A unique number, or the name and strength of the medication. ___ Whenever dispensing takes place, appropriate medial records shall be

maintained. ___ A separate log must be maintained for controlled substances dispensing.

___ Reporting to the Controlled Substance Database for the State of Tennessee.

Controlled Substance Database. An APN may act as a practitioner extender for a physician and query the database under the direction/supervision of the physician prescriber/dispenser. The physician prescriber/dispenser must cancel the APN extender’s access to the database upon the end of the relationship. [Rule 1140-11-.02 (2)(f)]

11 of 42


Advertising for Services Provided by an APN The rules for advertisements placed by APN s may be found at BN rule 1000-01-.19. Rules for advertisements placed by physicians may be found at BME rule 0880-2-.13. Policies should be in place requiring the APN’s collaborating physician review any advertisement to be placed by the APN because the collaborating physician may be found jointly responsible for its content. TMA comment: Advertisements placed by corporate offices of retail clinics provide problems for both the collaborating physician and APN. Neither the BME nor BN has established if a licensee is responsible for such ads. Boards may not like retail clinics circumventing advertising ethics rules by placing the ads instead of the licensee, so the boards may choose to hold the licensee responsible. Physicians who act as collaborators to APNs in retail clinics should express this concern to the clinic’s corporate office and legal representatives. Legal Analysis: Part of the definition of "supervising physician" is a physician who accepts responsibility for supervising APN s, BME rule 0880-06-.01(4). The rest of the rules for APN supervision discuss clinical supervision requirements and delivery of quality healthcare. Finally, in BME rule 0880-06-.03, a physician supervising the services of an APN who practices in a manner inconsistent with the Tennessee Medical Practice Act shall be subject to disciplinary action. In reviewing the supervision rules for a physician, there is no specific mention of advertising. Similarly, BN rule 1000-01-.19(4) lists specific violations for "the context of advertisement by any licensee" that may subject an APN to discipline. The violation closest to requiring the type of practitioner to be specifically named in an ad is subsection (4)(p), stating that any corporation, partnership or individual not listing its individual licensees in an ad must provide the names when requested and display a directory of all licensees at the office in a conspicuous location. The use of the phrase "advertisement by any licensee" implies the ad must be placed by the APN (and therefore the APN is responsible). ___ A policy should be in place requiring that any APN placing an advertisement should be aware of

and comply with the Board of Nursing rules on advertising. ___ Advertisements should be reviewed by the supervising physician prior to publication. ___ Advertisements should not contain misleading language regarding the APN’s credentials such as

“board certified practitioner” or simply Dr. Jo Jones if the APN has a doctoral degree. TMA comment: We’ve actually seen these ads. Board certification is typically associated with physicians. The APN rules found at BN 1000-04 mention in several places the term "national certification" when listing the requirements for licensure. The rules do not use the term “board-certification” for APNs. Tennessee's Consumer Protection Act is found at T.C.A. Title 47, Chapter 18. Specifically, T.C.A. § 47-18-104 lists the acts/practices that are considered violations. Subsection (b)(2) lists as a violation any act/practice that will cause a "likelihood of confusion or

12 of 42


of misunderstanding as to the source, sponsorship, approval or certification of goods or services. This subdivision (b)(2) does not prohibit the private labeling of goods and services.” The argument here is that the use of the term "board-certified practitioner" is a deceptive representation of a service actually provided by an APN with a national certification when typically this phrase indicates a physician to the public at large. Thus, the clinic corporation may have some legal exposure under state consumer protection laws if misleading representations are made.

___ TMA comment: Lab coats worn by APN s should clearly designate the practitioner is an APN and not a physician. Appropriate abbreviations such as “APN” should be used in charts and in public.

___ TMA comment: Policies should be in place to make sure APNs are not addressed as “doctor” or

other misleading title by staff or patients inappropriately. When any misleading address is used, it should be immediately corrected by the APN and the patient given an explanation as to what type of practitioner is treating them.

TMA members with questions about this checklist can contact the TMA Legal Department at 800-659-1862 or [email protected].

DISCLAIMER: These materials and discussion of these issues should not be construed as legal advice or representation by the TMA. It does not constitute an attorney-client relationship

between you or any TMA employee. This unwarranted material is provided only for informational purposes. Should you require legal advice or representation,

you should contact your personal attorney.

13 of 42


mailto:[email protected]

Collaborating Physician’s Checklist Physician Assistant in a Medical Office or Retail Clinic

Introduction and Reference Materials These practice guidelines for TMA members practicing in a medical office or retail clinic were developed by TMA for the convenience of its members who collaborate with, or contemplate collaborating with, physician assistants. The guidelines were developed from Tennessee law and the rules promulgated by the Tennessee Board of Medical Examiners and the Tennessee Committee on Physician Assistants; however, they should not be a substitute for a thorough reading of the rules by the physician and mid-level practitioner. TMA has made comments (in italics) and suggestions about some of the rules. These comments should not be considered as official positions of either regulatory board or as legal advice. They are practical suggestions to assist the office in delivering meaningful collaboration and quality care. The full text of the applicable rules discussed herein can be found at: Medical Board Rules for Supervising Physicians http://share.tn.gov/sos/rules/0880/0880-02.20150426.pdf in Section .18 Physician Assistant Rules: http://share.tn.gov/sos/rules/0880/0880-03.20160621.pdf There are additional requirements for when a physician collaborates with an APN in certain practice settings. At the end of this kit are checklists for each setting and they are found at the end of this document.

• In a Registered Pain Management Clinic – See Physician Assistants Practicing in a Pain Clinic • Interventional Pain Management – See Nurse Practitioners & Physician Assistants Practicing

Interventional Pain Management • In a Hormone Replacement Therapy Clinic – See Nurse Practitioners & Physician Assistants

Practicing in a Hormone Replacement Therapy Clinic

14 of 42





Credentials for the Physician Assistant A collaborating physician should have policies and procedures in place at each practice location and for each PA so that the following information is checked annually and updated as required by law: ___ Current Tennessee Physician Assistant license.

TMA Comment: The Tennessee Department of Health has an official license verification check on-line at https://apps.health.tn.gov/Licensure/. Practices can rely on this data for current licensure status.

___ Documentation of CME for the current term of the PA’s license should be submitted to the collaborating physician upon completion of the CME.


of their practice locations (if prescribing Controlled Drugs). TMA Comment: Same as above. ___ PA Collaborating Physician Form submitted by the PA to the Committee on Physician Assistants.

This form needs to be updated within 15 days when there is a change of information. TMA Comment: Same as above. ___ National Provider Identifier (NPI) (if either TennCare or Medicare patients will be treated). Credentials for Collaborating Physician A collaborating physician should have policies and procedures in place at each practice location so that the following information is checked annually and updated as required by law: ___ Current and unencumbered Tennessee MD or DO license.

TMA comment: The term “unencumbered” is not defined in the rules and regulations of the Tennessee Board of Medical Examiners. It probably means that the medical license is not on probation or otherwise restricted by the Board. If this might be a problem for a collaborating physician, such physician should contact the Tennessee Board of Medical Examiners at 1-800-778-4123.


of their practice locations (if prescribing Controlled Drugs). TMA comment: It is TMA’s position that if the collaborating physician does not have an active DEA number, the PAs that he/she collaborates with cannot prescribe controlled drugs because state medical board rules provide at 0880-2-.18(3) that the collaborating physician (or substitute

15 of 42


https://apps.health.tn.gov/Licensure/

http://tn.gov/assets/entities/health/attachments/PA_Supervising_Physician_Application.pdf

collaborating physician) “shall have experience and/or expertise in the same area of medicine as the physician assistant.”

___ National Provider Identifier (NPI) (if the collaborating physician will collaborate with PAs who

will treat either TennCare or Medicare patients)

16 of 42


Collaboration Requirements Policies in place at locations where a PA is practicing must include, at a minimum, all of the following: ___ The collaborating physician is available for consultation at all times or shall make arrangements

for a substitute collaborating physician to be available. Rule 0880-2-.18(2) does not require the “continuous and constant presence” of the collaborating physician. TMA comment: Consultation may be by telephone or other electronic means.

___ The collaborating physician or substitute “shall have experience and/or expertise in the same

area of medicine as the physician assistant”. TMA comment: This rule would likely preclude, for example, a pediatrician from collaborating with a PA who treats adult patients and vice-versa.

Protocols Protocol must be used and their requirements are: ___ Must be jointly developed by the collaborating physician and the PA. ___ Must be approved, signed and dated by the collaborating physician.

___ Shall outline and cover the applicable standard of care.

___ Shall be reviewed and updated every two years.

TMA comment: We suggest that each update entry contain the date it is updated. We also suggest that the fact the document was reviewed be memorialized in writing by signature and date somewhere in the document so that it is easy for a reviewer to ascertain when an update went into effect.

___ Copies of the current protocols must be kept at the practice site.

___ Shall account for all protocol drugs by appropriate formulary.

___ Shall clearly indicate whether the PA is authorized by the collaborating physician to prescribe legend or controlled drugs.

___ Shall be specific to the population seen.

17 of 42


___ Health Related Boards investigators must be able to inspect and copy protocols and formularies upon request.

___ Policies and procedures in place to ensure compliance with the applicable standards of care required under the protocol requirements above.

___ Develop clinical guidelines in collaboration with the PA to include a method for documenting

consultation and referral. TMA comment: The Tennessee Academy of Physician Assistants (TAPA) has developed a

template protocol which may be tailored to the individual needs of the practice or clinic. TAPA may be reached at 615-463-0026. Use of its template does not warrant compliance with Tennessee law.

Medical Record Review Review of the PA’s medical records and charts and certify this is done by the collaborating physician’s signature and date as follows. TMA comment: It is not specifically required in the rules but it would be advisable for the collaborating physician to maintain a log of the charts reviewed of each PA. The log should indicate the patient name or number, date of service, whether review was mandatory or within the 20% rule, date reviewed and place for signature or initials of the reviewing physician. Otherwise, there is no way to document compliance for regulators with either the mandatory review rule or the 20% rule. It may be appropriate as well to document how long you spend reviewing the charts. At least one retail clinic chain has instituted a policy to periodically assess its mid-level’s performance based on the chart reviews. While not required by the rules, it may be a policy consideration by your practice.

For all of the following patients within ten (10) business days after the patient has seen the PA:

___ When medically indicated. ___ When requested by the patient. ___ When prescriptions written by the PA fall outside of the protocols. ___ When prescriptions are written by a PA with a temporary license. ___ When a controlled drug has been prescribed.

18 of 42


___ Establish a policy of how the collaborating physician will communicate with the PA any

inappropriate treatment provided by the PA, comments, or suggestions as medically necessary. TMA comment: Meaningful collaboration does not exist without feedback on mistakes or suggestions on further treatment from the physician. Failure to do so is a liability risk for both the PA and collaborating physician. The policy should state how communication will take place and how soon after chart review it shall take place and if necessary, how the patient will be contacted.

For categories of patients not included above requiring a review of every chart, review shall be as follows:

___ 20% of the charts prepared by the PA every 30 days.

___ Document a site visit to every remote site at least once every thirty (30) days.

TMA comment: There is no amount of time specified in the rules as to how long the collaborating physician’s visit to the site should be or what the physician must do during these site visits.

Special Prescribing/Dispensing Rules Board of Medical Examiners rule 0880-2-.14(7)(b) requires that the following prerequisites be completed prior to a physician prescribing drugs, even over the Internet, to a patient. The exceptions to the prerequisites being completed are only: 1) In admission orders for a newly hospitalized patient; 2) for a patient of a physician or PA to prescribe for whom the prescriber is taking cal ls or for whom the prescriber has verif ied the appropriateness of the medication; 3) for continuation medications on a short-term basis for a new patient prior to the patient's first appointment; or 4) for established patients who, based on sound practices the physician or PA believes does not require a new physical examination before issuing new prescriptions. Otherwise: ___ Perform an appropriate history and physical examination. ___ Diagnose based upon the examinations and all diagnostic and laboratory tests consistent

with good health care. ___ Formulate a therapeutic plan, and discuss it, along with the basis for it and the risks and

benefits of various treatments options, a part of which might be the prescription or dispensed drug, with the patient or guardian.

19 of 42


___ Ensure the availability of the PA or coverage for the patient for appropriate follow-up care.

TMA comment: Many health plans have policies against clinics just having a message stating call 911 or go to the ER in case of emergency. This might require a beeper or other way to contact the treating PA immediately in case of emergency. Also, it might be a good idea to get your PA credentialed at the local hospital in case a patient seen by the PA presents to the ED after hours.

___ Ensure that the PA complies with medical board rule 0880-2-.14(7)(a) regarding Internet

prescribing. TMA comment: The rule addresses the situation where customers order drugs from an Internet site with no prior provider-patient relationship. It is not designed to stymie legitimate electronic prescribing by a prescriber as long as the prescribing prerequisites are complied with. Most clinics do not prescribe over the Internet.

___ Ensure that the PA is not authorized to issue any drug whose sole purpose is to cause an

abortion. TMA comment: That is statutorily prohibited under TCA § 53-10-104.

___ Prescribing of medicines in schedules II, III and IV 1. The prescription must be specifically authorized by the formulary or expressly approved after

consultation with the collaborating physician before the initial issuance of the prescription or dispensing of the medication.

2. A schedule II or III opioid listed on the formulary may only be prescribed for a maximum of a non-refillable, 30-day course of treatment unless specifically approved after consultation with the collaborating physician before the initial issuance of the prescription or dispensing the medicine.

TMA Comment: The collaborating physician should keep a record of these conversations and his/her approval or disapproval of the prescription. The PA should note that the collaborating physician approved the prescription in the patient’s medical record.

Prescriptions issued by the PA are required to meet the following minimum requirements. ___ Only PAs with specific authority from their collaborating physician may issue prescriptions for

drugs. ___ Must be on pre-printed pads.

___ Tamper-resistant prescription paper must be used. The paper must meet the requirements in

BME Rule 0880-2-.23 (3). ___ Must contain the name, address and telephone number of the collaborating physician.

___ Must contain the name, address and telephone number of the PA.

20 of 42


___ Must contain the signature of the prescribing PA on every prescription written by the PA on the

day it is issued (unless a standing order issued in a hospital, nursing home, or assisted living facility).

___ The PA must indicate on the prescription which of the physicians is the PA’s primary collaborating physician by placing a checkmark beside or a circle around the name of such physician if the pre-printed prescription pad contains the names of more than one physician.

___ The PA shall use the PA’s own DEA number when prescribing Controlled Substances. ___ Must be legible (if handwritten). ___ Must contain the name and strength of the drug prescribed. ___ Must contain the quantity of the drug prescribed written in both letters and numerals (if

handwritten). ___ Must contain instructions for the proper use of the drug. ___ Must contain the date the drug is prescribed. Prescriptions issued by the PA for long-term treatment of pain are required to meet the following minimum requirements found in medical board rule 0880-2-.14(6). TMA comment: In an overwhelming percentage of disciplinary cases brought against providers of chronic pain management, the reason for the disciplinary action by the regulatory board stems from the provider’s poor documentation or the provider’s lack of training in treating this difficult type of patient. Some practices utilize a “narcotic contract” with terms including the promise that the patient only receives controlled drugs from that prescriber. ___ Only PAs with authorization to prescribe and a current DEA certificate may issue prescriptions

for controlled drugs for pain. ___ If the PA chooses not to provide long-term pain management to a patient with intractable pain,

such PA shall offer the patient a referral to a provider of chronic pain management. ___ If the PA chooses to treat patients with intractable pain with opiates, such PA must demonstrate

a current knowledge of long-term pain management (and the collaborating physician should be engaged in the treatment of long-term chronic pain) and follow the board’s guidelines:

21 of 42


___ Each patient’s medical record shall include a documented medical history and physical examination by the PA providing the medication. Historical data shall include pain history, any pertinent evaluations by another provider, history of and potential for substance abuse, pertinent coexisting diseases and conditions, psychological functions and the presence of a recognized medical indication for the use of a controlled substance.

___ Each patient’s medical record shall contain a written treatment plan tailored

for individual needs of the patient and shall include objectives such as pain relief and/or improved physical and psychosocial function, and shall consider need for further testing, consultations, referrals, or use of other treatment modalities dependent on patient response.

___ The PA shall discuss the risks and benefits of the use of controlled substances with

the patient or his/her guardian. ___ At each periodic interval in which the PA is providing care evaluates the patient

for continuation or change of medications, the patient record shall include progress toward reaching treatment objectives, any new information about the etiology of the pain, and an update on the treatment plan.

Rules provide that non-controlled drugs are to be dispensed in an appropriate container labeled with at least, the following:

___ Patient's name. ___ Date. ___ Complete directions for usage. ___ The name and address of the PA having authority to prescribe. ___ A unique number, or the name and strength of the medication.

___ Whenever dispensing takes place, appropriate medical records shall be maintained.

___ A separate log must be maintained for controlled substances dispensing.

___ Reporting to the Controlled Substance Database for the State of Tennessee.

22 of 42


Additional Collaboration Requirements for Physicians Who Collaborate with Temporary PA License Holders Policies in place at locations where a PA with a temporary license is practicing must include, at a minimum, the following: ___ The collaborating physician must be physically on-site where and while the PA with a temporary

license is practicing. ___ All of the charts of the PA with temporary license must be reviewed by the collaborating

physician when prescriptions are written by a PA with a temporary license. The collaborating physician must certify review of these charts by his/her signature and date.

Billing of Physician Assistant Services

TMA comment: TMA has never considered the supervision of a PA’s claims submissions to managed care plans such as TennCare MCOs within the scope of collaboration required by law. However, the State Attorney General’s Office filed a lawsuit in 2015 seeking to hold a supervising physician liable for claims submitted to TennCare MCOs by a PA.

In that case, a PA contracted with a physician to perform supervisory functions. The PA had his own practice and submitted his own bills through a third-party billing company under the PA’s own billing number. The TMA Legal Department assisted the defense counsel for the physician and provided information, legal theories to bolster the defense, policy documents and an amicus brief. TMA argued in its brief that state law does not require a PA’s supervising physician to supervise the billing aspect of the PA’s practice; just the clinical aspect of it. On September 4, 2015, the trial judge ruled with TMA and the Tennessee Academy of Physician Assistants as a matter of law that a supervising physician is not responsible for the billing and coding practice of a physician assistant that he/she supervises.

Advertising for Services Provided by a PA The advertisement rules for advertisements placed by PAs may be found at state PA Committee rule 0880-3-.20. Advertisement rules for advertisements placed by physicians may be found at rule 0880-2-.13. Policies should be in place that the PA’s collaborating physician review any advertisement to be placed by the PA because the collaborating physician may be found jointly responsible for its content. TMA comment: Advertisements placed by corporate offices of retail clinics provide problems for both the collaborating physician and PA. Neither the medical board nor PA committee has established if a licensee is responsible for such ads. Boards may not like retail clinics circumventing advertising ethics rules by placing the ads instead of the licensee so the boards may choose to hold the licensee responsible.

23 of 42


Physicians who collaborate with PAs in retail clinics should communicate with corporate and express this concern to its legal representatives. Legal Analysis. Part of the definition of "supervising physician" is a physician that accepts responsibility for supervising PAs, medical board rule 0880-06-.01(4). The rest of the rules for PA supervision discuss clinical supervision requirements and delivery of quality healthcare. Finally, in medical board rule 0880-06-.03 a physician supervising the services of a PA who practices in a manner inconsistent with the Tennessee Medical Practice Act shall be subject to disciplinary action. In reviewing the supervision rules for a physician, there is no specific mention of advertising. Similarly, PA committee rule 0880-3-.20(4) lists specific violations for "the context of advertisement by any licensee" that may subject a PA to discipline. The violation closest to requiring the type of practitioner to be specifically named in an ad is subsection (p) and it states that any corporation, partnership or individual not listing its individual licensees in an ad must provide the names when requested and display a directory of all licensees at the office in a conspicuous location. The use of the phrase "advertisement by any licensee" implies that the ad must be placed by the PA. TMA Note: The rules need to be updated to reflect the change from supervising to collaboration. Once those rules are promulgated, this section of the kit will be updated. ___ A policy should be in place such that the PA informs patients that services are being provided by

a PA. ___ A sign shall be placed in a conspicuous place within the clinic indicating that certain services may

be performed by a PA. ___ A policy should be in place such that any PA placing an advertisement should be aware of and

comply with the PA committee rules on advertising. ___ Advertisements should be reviewed by the supervising physician prior to publication. ___ Advertisements should not contain misleading language regarding the PA’s credentials such as

“board certified practitioner”. TMA comment: We’ve actually seen these ads used by nurse practitioners. Board certification is typically associated with physicians. The PA rules do not use the term “board-certification” for PAs. Tennessee's Consumer Protection Act is found at T.C.A. Title 47, Chapter 18. Specifically, T.C.A. § 47-18-104 lists the acts/practices that are considered violations. Subsection (b)(2) lists as a violation any act/practice that will cause a "likelihood of confusion or of misunderstanding as to the source, sponsorship, approval or certification of goods or services. This subdivision (b)(2) does not prohibit the private labeling of goods and services.” The argument here is that the use of the term "board-certified practitioner" is a deceptive representation of a service that is actually provided by a PA with a national certification when typically this phrase indicates a physician to the public at large. Thus, the clinic corporation may have some legal exposure under state consumer protection laws.

24 of 42


___ Lab coats worn by PAs should clearly designate that the practitioner is a PA and not a physician.

Appropriate abbreviations such as “PA” or “OPA” should be used. ___ Policies should be in place to make sure that PAs are not addressed as “doctor” or other

misleading title by staff or patients inappropriately. When any misleading address is used, it should be immediately corrected by the PA and the patient given an explanation as to what type of practitioner is treating them.

Any questions from TMA members can be addressed to the TMA legal department, 615-385-2100 or [email protected]. DISCLAIMER: This correspondence and discussion of this issue should not be construed as legal advice

or representation by the TMA. It does not constitute an attorney-client relationship between you or any TMA employee. This unwarranted material is provided only for

informational purposes. Should you require legal advice or representation, you should contact your personal attorney.

25 of 42



Appendix A Collaborating Physician’s Checklist: Advanced Practice Nurse Practicing in a

Registered Tennessee Pain Management Clinic These practice guidelines for TMA members practicing in a registered Tennessee pain management clinic were developed by TMA for the convenience of its members who collaborate with, or contemplate collaborating with, advance practice nurse with certificate of fitness to prescribe (APN) in a registered Tennessee pain management clinic setting. These guidelines were developed from Tennessee law and the rules promulgated by the Tennessee Department of health and are designed to be in addition to the guidelines in our TMA Collaborating Physician’s Checklist: Advance Practice Nurse in a Medical Office or Retail Clinic. They should not be a substitute for a thorough reading of the Department of Health’s rules promulgated by the Division of Pain Management Clinics and the pain clinic laws. TMA has made comments (in italics) and suggestions about some of the rules. These comments should not be considered as official positions of either regulatory board or as legal advice. They are practical suggestions to assist the office in delivering meaningful collaboration and quality care. The full text of the applicable rules discussed herein can be found at: • Department of Health rules for Pain Management Clinics: http://share.tn.gov/sos/rules/1200/1200-

34/1200-34-01.20120326.pdf • The TMA online Law Guide topic titled Pain Management Clinics can be found at

www.tnmed.org/lawguide Credentials and Requirements for the APN In addition to the policies and procedures in place at each practice location that are outlined in the TMA Collaborating Physician’s Checklist: Advanced Practice Nurse in a Medical Office or Retail Clinic, the following information is checked annually for all of the clinic’s APNs and updated as required by law. It must be disclosed in initial application for pain clinic registration and within 10 days of occurrence any of the following: TMA comment: These requirements also apply to anyone who owns, co-owns, operates, or provides services in a pain clinic. ___ Has ever been denied, by any jurisdiction, a license under which the person may prescribe,

dispense, administer, supply or sell a controlled substance. ___ Has ever held a license issued by any jurisdiction, under which the person may prescribe,

dispense, administer, supply or sell a controlled substance.

26 of 42


http://share.tn.gov/sos/rules/1200/1200-34/1200-34-01.20120326.pdf


http://www.tnmed.org/lawguide

___ Has ever been subject to disciplinary action by any licensing entity for conduct that was the

result of inappropriately prescribing, dispensing, administering, supplying, or selling a controlled substance.

Other requirements: ___ Proof of current DEA registration. ___ Disclose to the state any license denial, restriction, or discipline imposed on the APN. TMA comment: The reference to the term “license” is not clarified in scope. It likely means

professional license as opposed to driver’s or hunting license, for instance. ___ Each health care provider providing pain management services at a clinic, including an APN, shall

complete ten (10) hours in continuing education courses during each health care provider’s licensure renewal cycle which shall be a part of the continuing education requirements established by each of the health care provider’s respective boards. The ten (10) continuing education hours shall address at least one or more of the following topics related to pain management: (a) prescribing controlled substances; (b) drug screening or testing; (c) pharmacological and non-pharmacological pain management; (d) completing a pain management focused history and physical examination and maintaining appropriate progress notes; (e) comorbidities with pain syndromes; and (f) substance abuse and misuse including diversion, prevention of same, and risk assessment for abuse.

Credentials and Requirements for the Medical Director Each physician serving as the medical director at a clinic shall meet at least ONE (1) of the following requirements: ___ (a) Successful completion of a residency program in physical medicine and rehabilitation,

anesthesiology, addiction medicine, neurology, neurosurgery, family practice, preventive medicine, internal medicine, surgery, orthopedics or psychiatry approved by the Accreditation Council for Graduate Medical Education (ACGME) or American Osteopathic Association Bureau of Osteopathic Specialists (AOABOS); OR

___ (b) Board certification in physical medicine and rehabilitation, anesthesiology, addiction

medicine, neurology, neurosurgery, family practice, preventive medicine, internal medicine, surgery, orthopedics or psychiatry approved by the ACGME or AOABOS; OR

27 of 42


___ (c) Subspecialty certification in pain management, hospice and palliative medicine, geriatric medicine, rheumatology, hematology, medical oncology, gynecologic oncology, infectious disease, pediatric hematology-oncology, or pediatric rheumatology recognized by the ABMS or AOABOS with a certificate of added qualification from the Bureau of Osteopathic Specialists; OR

___ (d) Board certification by the American Board of Pain Medicine; OR ___ (e) Board certification by the American Board of Interventional Pain Physicians; OR ___ (f) Completion of forty (40) hours of in-person, live-participatory AMA Category I or AOABOS

Category I CME coursework in pain management completed within three (3) years prior to implementation of this rule or prior to serving as medical director for the clinic, whichever event is most recent. The required coursework is set forth in the rules at 1200-34-01-.09(1)(f)(1)-(12).

In addition to the policies and procedures in place at each practice location that are outlined in TMA’s Collaborating Physicians’ Checklist: Advanced Practice Nurse in a Medical Office or Retail Clinic, the following information is checked annually and updated as required by law: ___ Current, unencumbered, and unrestricted Tennessee MD or DO license.

TMA comment: The term “unencumbered” is not defined in the rules and regulations of the Tennessee Board of Medical Examiners. It probably means the same thing as unrestricted in that the medical license is not on probation or otherwise restricted by the Board. If this might be a problem for a collaborating physician, such physician should contact the Tennessee Board of Medical Examiners at 1-800-778-4123.

___ Cause the clinic certificate from the state to be posted in a conspicuous location so as to be

clearly visible to patients. ___ Ensure that the clinic certificate is current (it expires on the second anniversary of the date it is

issued). If not, it must be renewed according to the rules. ___ Ensure that a policy is in place so that no payment is made in cash; a clinic may only accept a

check or credit card in payment for services provided at the pain clinic except that, a pain clinic may accept cash for a co-pay, coinsurance, or deductible when the balance will be submitted to the patient’s insurance plan. See our Law Guide topics titled Pain Management Clinics and Pain Management Clinics – Guidance on Cash Prohibition for additional information on the laws for pain clinics.

___ Obtain a current DEA registration for the clinic, if required by law.

28 of 42


___ Make sure that all staff know that they must give board inspectors access to the clinic and its records, including medical records of its patients.

___ Ensure that each supervising physician for each of the health care providers working at the clinic

complies with the supervision requirements contained in Tenn. Comp. Rules and Regulations Chapter 0880-03 and Chapter 0880-06, or Rule 1050-02-.15, as applicable.

TMA comment: These are essentially the guidelines described in TMA’s Collaborating Physician Kit.

___ Ensure the establishment of protocols for the health care providers employed by or working at

the pain management clinic as provided in Tenn. Comp. Rules and Regulations Chapter 0880-03 and Chapter 0880-06 and ensure that providers comply with such protocols, as well as any other established policies and procedures.

___ Ensure that, in the event that the medical director for the clinic is unable to fulfill his or her

duties on a temporary basis because of illness, vacation, or unavailability, there is an alternate or substitute medical director meeting the same qualifications as a medical director under rule 1200-34-01-.09.

Establish quality assurance policies and procedures, which, at a minimum, include, but are not limited to: ___ Documentation of the background, training, licensure, and certifications for all pain

management clinic staff providing patient care. ___ A written drug screening policy and compliance plan for patients to include random urine drug

screening as clinically indicated, but at a minimum, upon each new admission and once every six (6) months thereafter.

___ Use of substance abuse risk assessment tools upon new patient admission and periodic review

or re-assessment. ___ Evaluating and monitoring the quality and appropriateness of patient care, the methods of

improving patient care as well as identifying and correcting deficiencies, and the opportunities to improve the clinic’s performance and quality of care.

___ Medication counts for any controlled substances prescribed by the clinic to the clinic’s patients. ___ Use of patient agreements (aka Narcotic Contracts or Drug Contracts) and periodic review of

such agreements.

29 of 42


___ Healthcare provider access to and review of patient information contained in the controlled substance monitoring database in accordance with T.C.A. §§ 53-10-301 - 53-10-309, as clinically indicated, but at a minimum upon each new admission and once every six (6) months thereafter.

___ Documentation of requests for records from other health care providers. Establish an infection control program to provide a sanitary environment for the prevention, control, and investigation of infections and communicable diseases, including, but not limited to: ___ Written infection control policies and procedures. ___ Techniques and systems for identifying, reporting, investigating and controlling infections at the

clinic. ___ Written policies and procedures relative to the use of aseptic techniques. ___ Training for clinic staff providing direct patient care relative to infection control and aseptic

techniques. ___ A log of incidents related to infectious and communicable diseases and the corrective action

taken. ___ Establish written policies and procedures for health and safety requirements at the clinic. ___ Ensure compliance with the patient safety standards established by the licensing boards for

each health care provider. TMA comment: These would be found in the rules of each licensee’s governing board. ___ Establish written policies and procedures to assure patient access to their medical records and

continuity of care should the pain management clinic close. ___ Each health care provider providing pain management services at a clinic shall complete ten (10)

hours in continuing education courses during each health care provider’s licensure renewal cycle which shall be a part of the continuing education requirements established by each of the health care provider’s respective boards. The ten (10) continuing education hours shall address at least one or more of the following topics related to pain management: (a) prescribing controlled substances; (b) drug screening or testing; (c) pharmacological and non-pharmacological pain management; (d) completing a pain management focused history and physical examination and maintaining appropriate progress notes; (e) comorbidities with pain syndromes; and (f)

30 of 42


substance abuse and misuse including diversion, prevention of same, and risk assessment for abuse.

Credentials and Requirements for the Owner of the Clinic According to TCA 63-1-309(b), a pain clinic may not be owned wholly or partly by a person who has been convicted of, pled nolo contender to, or received deferred adjudication for: ___ An offense that constitutes a felony; OR ___ An offense that constitutes a misdemeanor, the facts of which relate to the distribution of illegal

prescription drugs or a controlled substance. Notifications required to be made by the clinic owner: ___ Notify the Department within 10 days if there is a change in majority ownership of the clinic. ___ Notify the Department within 10 days if the clinic no longer has a medical director or the

director no longer meets the requirements to be medical director. ___ Notify the Department within ten (10) business days of the occurrence if any person who owns,

co-owns, operates, provides pain management services in the clinic, is an employee of the clinic, or contracts with the clinic to provide services has been denied, held a restricted certificate, or been subject to disciplinary action relative to prescribing, dispensing, administering, supplying or selling a controlled substance.

___ Notify the Department within 10 days in the event that the name of the clinic changes.

Collaboration Requirements Policies in place at pain management clinic locations where an APN is practicing must include, at a minimum, those required in medical offices and all of the following. These are in addition to those enumerated in TMA’s Collaborating Physician’s Checklist: Advanced Practice Nurse in a Medical Office or Retail Clinic. ___ If the APN (or anyone) dispenses or prescribes more than a 72-hour does of controlled

substances for the treatment of chronic or nonmalignant pain, the APN must document in the patient’s record the reason for prescribing or dispensing that quantity.

31 of 42


___ The medical director must be onsite at least 20% of the clinic’s weekly total number of operating hours.

Protocols The pain clinic laws and rules do not add any additional protocol requirements than those enumerated in TMA’s Collaborating Physician’s Checklist: Advance Practice Nurse in a Medical Office or Retail Clinic. Make sure all of those protocol requirements are met for each APN. Medical Records ___ Make sure that all staff know that they must give board inspectors access to the clinic and its

records, including medical records of its patients. The medical director shall ensure that each health care provider employed by or working at a certified pain management clinic shall maintain complete and accurate medical records of patient consultation, examination, diagnosis, and treatment, which shall include, but not be limited to the following: ___ Patient medical history. ___ Physical examination. ___ Diagnostic, therapeutic, and laboratory results. ___ Evaluations and consultations. ___ Treatment objectives. ___ Documentation of informed consent and discussion of risks and benefits of treatment. ___ Treatments and treatment options. ___ Medications prescribed (including date, type, dosage and quantity prescribed). ___ Instructions and agreements. ___ Periodic reviews. ___ Reason for prescribing or dispensing more than a seventy-two (72) hour dose of controlled

substances for the treatment of chronic nonmalignant pain;

32 of 42


___ A notation indicating whether the controlled substance monitoring database had been accessed

for a particular patient as required. TMA comment: For more information on the requirements for registration and querying the

Controlled Substance Monitoring Database, see TMA’s online Law Guide topic on “Controlled Substance Database” on www.tnmed.org .

___ Copies of records, reports, or other documentation obtained from other health care providers. ___ Results of urine drug screens to be performed as clinically indicated, but at a minimum upon

each new admission and once every six (6) months thereafter. Special Prescribing/Dispensing Rules The pain clinic law requires, in addition to the requirements set forth in TMA’s Collaborating Physician’s Checklist: Advanced Practice Nurse in a Medical Office or Retail Clinic: ___ If the APN (or anyone) dispenses or prescribes more than a 72-hour does of controlled

substances for the treatment of chronic or nonmalignant pain, the APN must document in the patient’s record the reason for prescribing or dispensing that quantity.

Any questions from TMA members can be addressed to the TMA legal department, 800-659-1862 or [email protected]. DISCLAIMER: This correspondence and discussion of this issue should not be construed as legal advice or representation by the TMA. It does not constitute an attorney-client relationship between you or any TMA employee. This unwarranted material is provided only for informational purposes. Should you require legal advice or representation, you should contact your personal attorney.

33 of 42


http://www.tnmed.org/


Appendix B: Collaborating Physician’s Checklist for Advance Practice Nurse or Physician Assistant

Performing Interventional Pain Management in a Medical Office These practice guidelines were developed by TMA for the convenience of its members who collaborate with, or contemplate collaborating with, advance practice nurses (APNs) or physician assistants (PAs) performing interventional pain management (IPM). These guidelines were developed from Tennessee law and are designed to be in addition to the guidelines in our TMA Collaborating Physician’s Checklist for APNs and PAs. They should not be a substitute for a thorough reading of Tennessee law. TMA has made comments (in italics) and suggestions about some of the rules. These comments should not be considered as official positions of either regulatory board or as legal advice. They are practical suggestions to assist the office in delivering meaningful supervision/collaboration and quality care. The full text of the applicable statutes discussed herein may be found at: • Advanced Practice Nurse Statute, new section on Collaborating Physicians for Interventional Pain:

TCA §63-7-126(f) (effective July 1, 2013).

• Physician Assistant Collaborating Physician Statute, new section on Interventional Pain: TCA §63-19-107(5) (effective July 1, 2013).

• Physician Statute on Interventional Pain Management: TCA §63-6-244 (effective July 1, 2013).

• The TMA online Law Guide topic titled Interventional Pain Management can be found at

www.tnmed.org/lawguide Credentials for Collaborating Physician ___ Current board certification through either:

The American Board of Medical Specialties (ABMS), American Osteopathic Association (AOA) or the American Board of Physician Specialties (ABPS)/American Association of Physician Specialists (AAPS) in one of the following medical specialties: • Anesthesiology • Neurological surgery • Orthopedic surgery • Physical medicine and rehabilitation • Radiology • Any other board-certified physician who has completed an ABMS subspecialty board

in pain medicine or completed an ACGME-accredited pain fellowship. TCA § 63-6-

34 of 42



244(a)(1) (effective July 1, 2013). OR

• A different ABMS, AOA or ABPS/AAPS specialty and completed a post-graduate training program in IPM approved by the BME. TCA § 63-6-244(a)(3) (effective July 1, 2013).

TMA Comment: In January 2013, the BME ruled that physicians not board certified in the five specialties or by the associations listed above would still be approved to practice IPM if they become board certified through the American Board of Interventional Pain Physicians (ABIPP) or complete an ACGME-approved pain fellowship.

Collaboration Requirements ___ Physician must “directly supervise” APNs or PAs performing IPM, which means the physician

must be in the same building as the APN at the time he/she performs any IPM procedure. TCA § 63-7-126(f) (effective July 1, 2013).

___ Physician must be actively practicing spinal injections AND have current privileges to do so at a

facility licensed by the state (i.e. hospital or ASTC). TCA § 63-7-126(f) (effective July 1, 2013). TMA Comment: The phrase “actively practicing” is not defined in the statute or in the rules and

regulations of the BME. Typically the phrase refers to having an active license in the state in which the physician practices. However, in this context it likely means performing spinal injections regularly since it also requires the physician to have current privileges.

Any questions from TMA members can be addressed to the TMA legal department, 615-385-2100 or [email protected]. DISCLAIMER: This correspondence and discussion of this issue should not be construed as legal advice or representation by the TMA. It does not constitute an attorney-client relationship between you or any TMA employee. This unwarranted material is provided only for informational purposes. Should you require legal advice or representation, you should contact your personal attorney.

35 of 42



Appendix C: Collaborating Physician’s Checklist for Advance Practice Nurse or

Physician Assistant Practicing Hormone Replacement Therapy Introduction These practice guidelines developed by TMA for the convenience of its members who collaborate with, or contemplate collaborating with, advance practice nurse with certificate of fitness to prescribe (APN) or a Physician Assistant (PA) practicing in a hormone replacement therapy (HRT) clinic. These guidelines were developed from Tennessee law and a policy titled Position Statement on Hormone Replacement Therapy issued by the Board of Medical Examiners, Board of Osteopathic Examinations, Board of Nursing and Committee on Physicians Assistants and are designed to be in addition to the guidelines in our TMA Collaborating Physician’s Checklist for APNs and PAs. They should not be a substitute for a thorough reading of the statutes and policy. Please review TMA’s Law Guide topic titled Hormone Replacement Therapy found at www.tnmed.org/lawguide to determine if your practice is considered a HRT Clinic under Tennessee law and must comply with these additional collaboration requirements as well as other practice requirements. The full text of the applicable statute discussed herein may be found at: • T.C.A. § 63-6-242 (M.D.) and T.C.A. § 63-9-119 (D.O.)

• The TMA online Law Guide topic titled Hormone Replacement Therapy can be found at

www.tnmed.org/lawguide

• The policy titled Position Statement on Hormone Replacement Therapy can be found at http://tn.gov/assets/entities/health/attachments/ME_HRT_Policy.pdf.

Practice Requirements ___ The collaborating physician must be immediately notified upon discovery of a complication.

36 of 42




http://tn.gov/assets/entities/health/attachments/ME_HRT_Policy.pdf

Medical Record Review ___ The collaborating physician must make a personal review of the historical, physical and

therapeutic data gathered by the treating provider and shall so certify the review in the patient’s chart within seven days of the patient being treated.

Any questions from TMA members can be addressed to the TMA legal department, 615-385-2100 or [email protected].

DISCLAIMER: These materials and discussion of these issues should not be construed as legal advice or representation by the TMA. It does not constitute an attorney-client relationship

between you or any TMA employee. This unwarranted material is provided only for informational purposes. Should you require legal advice or representation, you should

contact your personal attorney.

37 of 42



Appendix D Collaborating Physician’s Checklist:

Physician Assistant in a Registered Tennessee Pain Management Clinic These practice guidelines for TMA members practicing in a registered Tennessee pain management clinic were developed by TMA for the convenience of its members who collaborate with, or contemplate collaborating with, physician assistants (PAs) in a registered Tennessee pain management clinic. These guidelines were developed from Tennessee law and the rules promulgated by the Tennessee Department of health and are designed to be in addition to the guidelines in our TMA Collaborating Physician’s Checklist: Physician Assistant in a Medical Office or Retail Clinic. They should not be a substitute for a thorough reading of the Department of Health’s rules promulgated by the Division of Pain Management Clinics and the pain clinic laws. TMA has made comments (in italics) and suggestions about some of the rules. These comments should not be considered as official positions of either regulatory board or as legal advice. They are practical suggestions to assist the office in delivering meaningful collaboration and quality care. The full text of the applicable rules discussed herein can be found at: • Department of Health rules for Pain Management Clinics: http://share.tn.gov/sos/rules/1200/1200-

34/1200-34-01.20120326.pdf.

• The TMA online Law Guide topic titled Pain Management Clinics can be found at www.tnmed.org/lawguide

TMA Note: See our Law Guide topic on “Pain Management Clinics” for all requirements a clinic and medical director must meet. Credentials and Requirements for the Physician Assistant In addition to the policies and procedures in place at each practice location that are outlined in the TMA Collaborating Physician’s Checklist: Physician Assistant in a Medical Office or Retail Clinic, the following information is checked annually for all of the clinic’s PAs and updated as required by law. It must be disclosed in initial application for pain clinic registration and within 10 days of occurrence any of the following: TMA comment: These requirements also apply to anyone who owns, co-owns, operates, or provides services in a pain clinic.

38 of 42





___ Has ever been denied, by any jurisdiction, a license under which the person may prescribe, dispense, administer, supply or sell a controlled substance.

___ Has ever held a license issued by any jurisdiction, under which the person may prescribe,

dispense, administer, supply or sell a controlled substance. ___ Has ever been subject to disciplinary action by any licensing entity for conduct that was the

result of inappropriately prescribing, dispensing, administering, supplying, or selling a controlled substance.

Other requirements: ___ Proof of current DEA registration. ___ Disclose to the state any license denial, restriction, or discipline imposed on the PA. TMA comment: The reference to the term “license” is not clarified in scope. It likely means

professional license as opposed to driver’s or hunting license, for instance. ___ Each health care provider providing pain management services at a clinic, including a PA, shall

complete ten (10) hours in continuing education courses during each health care provider’s licensure renewal cycle which shall be a part of the continuing education requirements established by each of the health care provider’s respective boards. The ten (10) continuing education hours shall address at least one or more of the following topics related to pain management: (a) prescribing controlled substances; (b) drug screening or testing; (c) pharmacological and non-pharmacological pain management; (d) completing a pain management focused history and physical examination and maintaining appropriate progress notes; (e) comorbidities with pain syndromes; and (f) substance abuse and misuse including diversion, prevention of same, and risk assessment for abuse.

Collaboration Requirements Policies in place at pain management clinic locations where a PA is practicing must include, at a minimum, those required in medical offices and all of the following. These are in addition to those enumerated in TMA’s Collaborating Physician’s Checklist: Physician Assistant in a Medical Office or Retail Clinic. ___ If the PA (or anyone) dispenses or prescribes more than a 72-hour does of controlled substances

for the treatment of chronic or nonmalignant pain, the PA must document in the patient’s record the reason for prescribing or dispensing that quantity.

39 of 42


___ The medical director must be onsite at least 20% of the clinic’s weekly total number of operating hours.

Protocols The pain clinic laws and rules do not add any additional protocol requirements than those enumerated in TMA’s Collaborating Physician’s Checklist: Physician Assistant in a Medical Office or Retail Clinic. Make sure all of those protocol requirements are met for each PA. Medical Records ___ Make sure that all staff know that they must give board inspectors access to the clinic and its

records, including medical records of its patients. ___ The medical director shall ensure that each health care provider employed by or working at a

certified pain management clinic shall maintain complete and accurate medical records of patient consultation, examination, diagnosis, and treatment, which shall include, but not be limited to the following:

___ Patient medical history. ___ Physical examination. ___ Diagnostic, therapeutic, and laboratory results. ___ Evaluations and consultations. ___ Treatment objectives. ___ Documentation of informed consent and discussion of risks and benefits of treatment. ___ Treatments and treatment options. ___ Medications prescribed (including date, type, dosage and quantity prescribed). ___ Instructions and agreements. ___ Periodic reviews.

40 of 42


___ Reason for prescribing or dispensing more than a seventy-two (72) hour dose of controlled substances for the treatment of chronic nonmalignant pain;

___ A notation indicating whether the controlled substance monitoring database had been accessed

for a particular patient as required. TMA comment: For more information on the requirements for registration and querying the

Controlled Substance Monitoring Database, see TMA’s online Law Guide topic on “Controlled Substance Database” on www.tnmed.org .

___ Copies of records, reports, or other documentation obtained from other health care providers. ___ Results of urine drug screens to be performed as clinically indicated, but at a minimum upon

each new admission and once every six (6) months thereafter. Special Prescribing/Dispensing Rules The pain clinic law requires, in addition to the requirements set forth in TMA’s Collaborating Physician’s Checklist: Physician Assistant in a Medical Office or Retail Clinic: ___ If the PA (or anyone) dispenses or prescribes more than a 72-hour does of controlled substances

for the treatment of chronic or nonmalignant pain, the PA must document in the patient’s record the reason for prescribing or dispensing that quantity.

Additional Collaboration Requirements for Physicians Who Collaborate with Temporary PA License Holders Policies in place at locations where a PA with a temporary license is practicing must include, at a minimum, the following: ___ The collaborating physician must be physically on-site where and while the PA with a temporary

license is practicing. ___ All of the charts of the PA with temporary license must be reviewed by the collaborating

physician when prescriptions are written by a PA with a temporary license. The collaborating physician must certify review of these charts by his/her signature and date.

Any questions from TMA members can be addressed to the TMA legal department, 800-659-1862 or [email protected].

41 of 42


http://www.tnmed.org/


DISCLAIMER: This correspondence and discussion of this issue should not be construed as legal advice or representation by the TMA. It does not constitute an attorney-client relationship between you or any TMA employee. This unwarranted material is provided only for informational purposes. Should you require legal advice or representation, you should contact your personal attorney.

42 of 42


collaborating physician kit table of contents

Documents