Department of State

Division of Publications

312 Rosa L. Parks Avenue, 8th Floor Snodgrass/TN Tower

Nashville, TN 37243

Phone: 615-741-2650

Email: publications.information@tn.gov

For Department of State Use Only

Sequence Number: 07-12-21

Rule ID(s): 9570

File Date: 7/8/2021

Effective Date: 10/6/2021

Rulemaking Hearing Rule(s) Filing Form

Rulemaking Hearing Rules are rules filed after and as a result of a rulemaking hearing (Tenn. Code Ann. § 4-5-205).

Pursuant to Tenn. Code Ann. § 4-5-229, any new fee or fee increase promulgated by state agency rule shall take effect on July 1, following the expiration of the ninety (90) day period as provided in § 4-5-207. This section shall not apply to rules that implement new fees or fee increases that are promulgated as emergency rules pursuant to § 4-5-208(a) and to subsequent rules that make permanent such emergency rules, as amended during the rulemaking process. In addition, this section shall not apply to state agencies that did not, during the preceding two (2) fiscal years, collect fees in an amount sufficient to pay the cost of operating the board, commission or entity in accordance with § 4-29-121(b).

Agency/Board/Commission:	Tennessee Department of Health
Division:
Contact Person:	Matt Gibbs
Address:	665 Mainstream Drive, Nashville, Tennessee
Zip:	37243
Phone:	(615) 741-1611
Email:	Matthew.Gibbs@tn.gov

Revision Type (check all that apply):

___ Amendment

X New

___ Repeal

Rule(s) (ALL chapters and rules contained in filing must be listed here. If needed, copy and paste additional tables to accommodate multiple chapters. Please make sure that ALL new rule and repealed rule numbers are listed in the chart below. Please enter only ONE Rule Number/Rule Title per row)

Chapter Number	Chapter Title
1200-10-04	Waiver from Electronic Prescription Mandate
Rule Number	Rule Title
1200-10-04-.01	Petition for Waiver
1200-10-04-.02	Petition for Waiver Information
1200-10-04-.03	Duration of Waiver or Renewal of a Waiver
1200-10-04-.04	Circumstances Where Electronic Prescribing is Not Available due to Temporary Technological or Electrical Failure
1200-10-04-.05	Prescriptions to be Dispensed Out-of-State

Place substance of rules and other info here. Please be sure to include a detailed explanation of the changes being made to the listed rule(s). Statutory authority must be given for each rule change. For information on formatting rules go to https://sos.tn.gov/products/division-publications/rulemaking-guidelines.

* If a roll-call vote was necessary, the vote by the Agency on these rulemaking hearing rules was as follows:

I certify that this is an accurate and complete copy of rulemaking hearing rules, lawfully promulgated and adopted by the Tennessee Department of Health on February 4, 2021, and is in compliance with the provisions of T.C.A. § 4-5-222.

I further certify the following:

Notice of Rulemaking Hearing filed with the Department of State on: 10/28/2020

Rulemaking Hearing(s) Conducted on: (add more dates). 02/04/2021

Date: June 2, 2021

Signature: /s/___________________________________

Name of Officer: Matt Gibbs

Title of Officer: Senior Associate General Counsel

Agency/Board/Commission: Tennessee Department of Health

Rule Chapter Number(s): 1200-10-04

All rulemaking hearing rules provided for herein have been examined by the Attorney General and Reporter of the State of Tennessee and are approved as to legality pursuant to the provisions of the Administrative Procedures Act, Tennessee Code Annotated, Title 4, Chapter 5.

/s/___________________________________

Herbert H. Slatery III

Attorney General and Reporter

6/24/2021

Date

Department of State Use Only

Filed with the Department of State on: 7/8/2021

Effective on: 10/6/2021

/s/___________________________________

Tre Hargett

Secretary of State

Public Hearing Comments

The Tennessee Department of Health received one written document, total, which contained three comments from the Tennessee Medical Association on January 7, 2021. There were no oral comments made during the rulemaking hearing.

Comment #1 - Rule 1200-10-04-.01(4)(3) - change "financial insatiability" to "financial instability".

Response - The Tennessee Department of Health deleted subsection 4 in its entirety from proposed Rule 1200-10-04-.01.

Comment #2 - Edit Rule 1200-10-04-.03(3)(b) to address the possible scenario whereby a prescriber intends to continue practice in this State after 7/3/21 but at a location that does not need a waiver.

Response -The Tennessee Department of Health deleted proposed Rule 1200-10-04-.03 in its entirety.

Comment #3 - The Tennessee Medical Association suggested additional language to address rural locations where there are no pharmacies within 25 miles of the patient's home that accept electronic prescriptions. The Tennessee Medical Association asserts statutory authority exists for this language in Tennessee Code Annotated section 63-1-160(d)(2).

Response - It does not appear statutory authority exists within Tennessee Code Annotated section 63-1-160 to provide a waiver based upon the location of the patient's pharmacy.

Chapter 1200-10-04

Waiver from Electronic Prescription Mandate

New Rule Chapter

Table of Contents

1200-10-04-.01 Petition for Waiver

1200-10-04-.02 Petition for Waiver Information

1200-10-04-.03 Duration of Waiver or Renewal of a Waiver

1200-10-04-.04 Circumstances Where Electronic Prescribing is Not Available due to Temporary Technological or Electrical Failure

1200-10-04-.05 Prescriptions to be Dispensed Out-of-State

Authority: T.C.A. §§ 63-1-160, 68-1-103.

Rule 1200-10-04-.01 Petition for Waiver.

(1) A health care prescriber who is unable to comply with the electronic prescription requirement for any controlled-substance prescription(s) listed in Schedule II, Ill, IV or V, as indicated in T.C.A. § 63-1-160, may petition the commissioner or the commissioner's designee of the Tennessee Department of Health, on a form provided on the Tennessee Department of Health website, found at https://tennessee.na1.echosign.com/public/esignWidget?wid=CBFCIBAA3AAABLblqZhCupjadFM1Fh2AmAc-RFIR2N2LS-yKQ5TJclx80T5K5BzcXigkPNmPxDhKRkFCbTeQ*, for a waiver from the requirement based upon economic hardship, technological limitations that are not reasonably within the control of the health care prescriber or other exceptional circumstance demonstrated by the health care prescriber. A timely petition for renewal of a previously approved waiver shall be submitted at least 60 days in advance of the expiration of the previously approved waiver.

(2) Any health care practice may petition for a waiver for any associated health care prescriber at the practice site.

(3) This chapter does not apply to prescriptions made exempt pursuant to T.C.A. § 63-1-160(d).

Authority: T.C.A. §§ 63-1-160, 68-1-103.

Rule 1200-10-04-.02 Petition for Waiver Information. A petition for waiver from the electronic prescription requirement for controlled-substance prescriptions listed in Schedule 11, 111, IV or V, as indicated in T.C.A. § 63-1-160, shall include, but not be limited to, all of the following:

(1) The name, practice address, and license number of the health care prescriber.

(2) The reason(s) the health care prescriber is seeking a waiver. Reasons include economic hardship, technological limitations that are not reasonably within the control of the health care prescriber or other exceptional circumstance demonstrated by the health care prescriber.

Authority: T.C.A. §§ 63-1-160, 68-1-103.

Rule 1200-10-04-.03 Duration of Waiver or Renewal of a Waiver. A waiver or renewal of a waiver issued by the commissioner or the commissioner's designee of the Tennessee Department of Health shall not exceed one year from the date of issuance.

Authority: T.C.A. §§ 63-1-160, 68-1-103.

Rule 1200-10-04-.04 Circumstances Where Electronic Prescribing is Not Available due to Temporary Technological or Electrical Failure. An otherwise valid oral, written, or fax prescription, issued when electronic prescribing is not available due to temporary technological or electrical failure, shall be exempt from the electronic prescription requirement so long as the prescription(s) is issued in compliance with all other federal and state laws and regulations regarding prescriptions, provided that a prescription issued pursuant to this paragraph shall indicate on the prescription that the health care prescriber is experiencing a temporary technological or electrical failure.

Authority: T.C.A. §§ 63-1-160, 68-1-103.

Rule 1200-10-04-.05 Prescriptions to be Dispensed Out-of-State. Any prescription issued to a patient which is to be dispensed outside this State shall be issued in accordance with the dispensing state's laws regarding electronic prescriptions, if any.

Authority: T.C.A. §§ 63-1-160, 68-1-103.