Can a Tennessee pharmacy or home medical equipment provider fit a customer for off-the-shelf diabetic shoes?

Subject

Opinion No. 13-105, Sale of Diabetic Shoes, December 19, 2013

Plain-English summary

Sen. Ferrell Haile, a licensed pharmacist, asked three questions about who can legally sell, fit, and provide patient management services for diabetic shoes in Tennessee. The AG worked through the Tennessee Orthotics, Prosthetics, and Pedorthics Practice Act of 2005 (Tenn. Code Ann. §§ 63-3-201 to -213) and the Board's implementing rules.

Question 1: Can pharmacy staff or HME providers fit and provide patient management for off-the-shelf diabetic shoes? Yes. Tenn. Code Ann. § 63-3-208(a) and Tenn. Comp. R. & Regs. 1155-04-.20(1) say nothing in the Act limits individuals acting under the supervision of a pharmacist or licensed home medical equipment provider from "measuring, fitting or adjusting any non-custom-fabricated and fitted device, including, but not limited to, over-the-counter or off-the-shelf devices," provided:

• They don't create a cast, mold, or scan to construct a medical device, AND
• They meet one of three training criteria in § 63-3-208(a)(1)-(3): (1) documented training from a manufacturer or a licensed/certified orthotist, prosthetist, or pedorthist; (2) certification from a recognized board such as BOC, the Board of Certification for Pedorthists, NCPA, or ABC; or (3) direct supervision by a trained, certified, or registered fitter.

"Patient management services" is not defined in the statute or rules, so the AG read it to fit within the statutory framework only to the extent the services involve measuring, fitting, or adjusting (or are activities covered by Tenn. Comp. R. & Regs. 1155-04-.20(3)(a), which lets an FDA-registered orthosis manufacturer's representative examine the patient to ensure proper fit).

Question 2: Can pharmacy staff or HME providers use a "crush box" impression system, scanning system, or non-custom-fabricated-and-fitted device? No. Tenn. Comp. R. & Regs. 1155-04-.20(1) prohibits creating a cast, mold, or scan of any part of the human body for the purpose of constructing a medical device. Tenn. Code Ann. § 63-3-207(b) requires a written prescription from a licensed health care practitioner before anyone can sell or dispense a device based on an image of the customer's limb captured through a mold, cast, scanning device, digital appliance, or pressure-sensitive device. Tenn. Comp. R. & Regs. 1155-04-.21 reserves certain therapeutic-footwear actions for licensed health care practitioners.

Question 3: Is the § 63-3-208(a) training sufficient? Yes. By enacting that section the General Assembly itself determined that the listed criteria constitute appropriate training to authorize pharmacy personnel or HME providers to provide these services.

The two-tier system in practice. Tenn. Code Ann. § 63-3-208(a) covers all non-custom devices broadly. § 63-3-208(b) is more specific for "non-custom-fabricated and fitted pedorthic devices, including, but not limited to, diabetic shoes" and requires criteria (a)(2) (certification) or (a)(3) (direct supervision) but not just (a)(1) (manufacturer training). So a person fitting diabetic shoes specifically needs certification or supervision by a certified fitter; manufacturer training alone isn't enough for diabetic shoes.

Currency note

This opinion was issued in 2013. Subsequent statutory amendments, court decisions, or later AG opinions may have changed the analysis. Treat this page as historical context, not current legal advice. Verify current law before relying on any specific rule, deadline, or remedy mentioned here.

The Tennessee Orthotics, Prosthetics, and Pedorthics Practice Act of 2005 and the Board of Pharmacy's rules have been amended over time. Medicare DMEPOS quality standards governing therapeutic shoe documentation have also evolved. Confirm current statute and rule text and federal Medicare requirements before relying.

Background and statutory framework

Diabetic shoes. Therapeutic shoes covered by Medicare Part B for people with diabetes meeting specific criteria. They include "depth" shoes, custom-molded shoes, and inserts. The federal program is administered through DMEPOS suppliers with quality standards. Tennessee separately licenses orthotists, prosthetists, and pedorthists and regulates who can do measuring, fitting, and adjusting under the 2005 Act.

Tenn. Code Ann. § 63-3-207(b). "No person shall dispense or sell an over-the-counter or off-the-shelf device based upon an image of the customer's limb captured by the person through a mold, cast, scanning device, digital appliance, or pressure sensitive device, unless the customer has first presented to that person a written prescription for that device from a health care practitioner authorized by law to write such a prescription." This is the bright line.

§ 63-3-208(a). Broad savings clause for pharmacy personnel and HME providers measuring/fitting/adjusting non-custom devices, with three alternative training routes.

§ 63-3-208(b). Narrower savings clause for non-custom pedorthic devices including diabetic shoes, requiring only criteria (a)(2) or (a)(3).

§ 63-3-209(3). Savings clause for FDA-registered orthosis manufacturer employees or representatives measuring/fitting/adjusting in a health care professional's office or facility under licensed practitioner supervision.

Tenn. Comp. R. & Regs. 1155-04-.20. Implementing rules for "Pharmacists, Home Medical Equipment Providers, and Orthosis Manufacturers." Subsection (1) parallels § 63-3-208(a); subsection (2) parallels § 63-3-208(b); subsection (3) parallels § 63-3-209(3). Subsection (3)(a) lets manufacturer reps examine the patient to ensure proper fit.

Tenn. Comp. R. & Regs. 1155-04-.21. Reserves certain actions for licensed health care practitioners regarding therapeutic footwear and foot-and-ankle medical devices.

Common questions

Can a pharmacy run a diabetic-shoe fitting clinic without hiring a certified pedorthist?

The pharmacy needs at least one staff member with proper training under § 63-3-208(a)(2) or (a)(3) for diabetic shoe fittings specifically, or direct supervision arrangements with a certified fitter. Manufacturer training alone is not enough for diabetic shoes.

What if I want to use a foot scanner to recommend a shoe?

You need a written prescription from a licensed health care practitioner for the device based on that scan. The pharmacy cannot use scans, casts, or molds on its own authority.

Does Medicare require something different?

Medicare has its own DMEPOS quality standards and Therapeutic Shoes for Persons with Diabetes documentation requirements separate from Tennessee law. A pharmacy/HME billing Medicare must meet both.

What is "patient management services"?

Undefined in the statute or rules. The AG read it narrowly: only to the extent it overlaps with "measuring, fitting or adjusting" or with manufacturer-rep examination under .20(3)(a). Broader concepts of "patient management" (diabetes counseling, foot care advice) live in pharmacist or other scope-of-practice law.

What about prosthetic limbs?

The savings clauses are narrower for custom-fitted prosthetic devices, where licensed prosthetists are typically required. The 2013 opinion focused on diabetic shoes and similar non-custom devices.

Citations

Tenn. Code Ann. §§ 63-3-201 to -213 (Tennessee Orthotics, Prosthetics, and Pedorthics Practice Act of 2005), specifically §§ 63-3-201(3), 63-3-201(12), 63-3-207(b), 63-3-208, 63-3-208(a), 63-3-208(a)(1)-(3), 63-3-208(b), 63-3-209, 63-3-209(3). Tenn. Comp. R. & Regs. 1155-04-.17, 1155-04-.18, 1155-04-.20, 1155-04-.21.

Source

• Landing page: https://www.tn.gov/attorneygeneral/opinions.html
• Original PDF: https://www.tn.gov/content/dam/tn/attorneygeneral/documents/ops/2013/op13-105.pdf

Original opinion text

December 19, 2013

Opinion No. 13-105

Sale of Diabetic Shoes

QUESTIONS

1. Do the provisions of Title 63 or Title 68, Tennessee Code Annotated, or any other provisions of Tennessee law permit or authorize appropriately trained pharmacy personnel or home medical equipment providers to provide fitting and patient management services for off-the-shelf therapeutic diabetic shoes and inserts?

2. Do the provisions of Title 63 or Title 68, Tennessee Code Annotated, or any other provisions of Tennessee law permit or authorize appropriately trained pharmacy personnel or home medical equipment providers to measure, fit, or adjust any device utilizing a "crush box" impression system, scanning or non-custom fabricated and fitted devices?

3. Do the training criteria described in Tenn. Code Ann. § 63-3-208(a) constitute sufficient appropriate training to permit or authorize either pharmacy personnel or home medical equipment providers to provide such services?

OPINIONS

1. Yes. Both Tenn. Code Ann. § 63-3-208 and Tenn. Comp. R. & Regs. 1155-04-.20(1) regarding "Pharmacists, Home Medical Equipment Providers, and Orthosis Manufacturers" provide that nothing in such section or rules, respectively, shall be interpreted as limiting or restricting individuals acting under the supervision and control of a pharmacist or pharmacy licensed under Title 63, or home medical equipment provider licensed under Title 68, from measuring, fitting or adjusting any non-custom fabricated and fitted device, including but not limited to over-the-counter devices or off-the-shelf devices, so long as such individual does not create a cast, mold or scan of a part of the human body for the purpose of constructing a medical device to treat a patient's medical condition and so long as such individual meets one of the criteria for such device as is articulated in Tenn. Code Ann. § 63-3-208(a)(1)-(3), or Tenn. Comp. R. & Regs. 1155-04-.20(1)(a)-(c). "Patient management services," which is not defined in either the above statute or rule, would appear to fall within the above statutory and regulatory provisions only if such services involve the "measuring, fitting or adjusting" any non-custom fabricated and fitted device, as described above.

2. No. The above regulation prohibits such individuals from "creat[ing] a cast, mold or scan of a part of the human body for the purpose of constructing a medical device to treat a patient's medical condition." Tenn. Comp. R. & Regs. 1155-04-.20(1). Furthermore, Tenn. Comp. R. & Regs. 1155-04-.20(2) permits such individuals to measure, fit or adjust "any non-custom fabricated and fitted pedorthic devices, including but not limited to diabetic shoes," provided such individual meets the criteria of either subparagraph (1)(b) or (1)(c) and "so long as the individual does not create a cast, mold or scan of a part of the human body for the purpose of constructing a medical device to treat a patient's medical problem." (Emphasis added). Further, Tenn. Code Ann. § 63-3-207(b) prohibits any person from selling or dispensing such "crush box" impression systems without a written prescription from a health care practitioner authorized by law to write such prescription, while Tenn. Comp. R. & Regs. 1155-04-.21 requires certain actions with respect to therapeutic footwear to be performed by a licensed health care practitioner.

3. By enacting Tenn. Code Ann. § 63-3-208(a), the Legislature has deemed the training criteria described in that section to constitute sufficient appropriate training to permit or authorize pharmacy personnel or home medical equipment providers to provide such services.

ANALYSIS

Diabetic shoes, which are sometimes referred to as therapeutic shoes, include depth or custom-molded shoes along with inserts for individuals with diabetes. Tenn. Code Ann. § 63-3-208, which is contained in the "Tennessee Orthotics, Prosthetics, and Pedorthics Practice Act of 2005," Tenn. Code Ann. §§ 63-3-201 to -213, provides:

(a) Nothing in this part or in the rules adopted by the board pursuant to this part shall be interpreted to limit or restrict a health care practitioner licensed under this title from engaging in the full scope of practice of such person's profession, training or services. Nothing in this part or in the rules adopted by the board pursuant to this part shall be interpreted or permitted to limit or restrict individuals acting under the supervision and control of a pharmacist or pharmacy licensed under this title or home medical equipment provider licensed under title 68 from measuring, fitting or adjusting any non-custom-fabricated and fitted device, including, but not limited to, over-the-counter or off-the-shelf devices, so long as such individual does not create a cast, mold or scan of a part of the human body for the purpose of constructing a medical device to treat a patient's medical condition and so long as such individual meets one (1) of the following criteria for such device:

(1) Documented training from a manufacturer or training from a licensed or certified orthotist, prosthetist or pedorthist;

(2) Certification or registration as a fitter of orthotic, prosthetic or pedorthic devices from a nationally recognized board or association such as the Board for Orthotist/Prosthetist Certification (BOC), the Board of Certification for Pedorthists, the National Community Pharmacists Association (NCPA) or the American Board for Certification in Orthotics and Prosthetics (ABC); or

(3) Direct supervision by a trained and experienced, or certified or registered, fitter of orthotic, prosthetic or pedorthic devices.

(b) Nothing in this part or in the rules adopted by the board pursuant to this part shall be interpreted or permitted to limit or restrict individuals acting under the supervision and control of a pharmacist or pharmacy licensed under this title or home medical equipment provider licensed under title 68 from measuring, fitting or adjusting any non-custom-fabricated and fitted pedorthic devices, including, but not limited to, diabetic shoes, so long as such individual meets the criteria of either subdivision (a)(2) or (a)(3) and so long as the individual does not create a cast, mold or scan of a part of the human body for the purpose of constructing a medical device to treat a patient's medical problem.

Further, Tenn. Code Ann. § 63-3-209(3) also provides that nothing in the above part shall be construed to restrict the measuring, fitting or adjusting of an orthotic device by an employee or authorized representative of an orthosis manufacturer registered with the federal food and drug administration, "when such employee or representative is supervised by a licensed health care professional authorized by law to prescribe, measure or fit such device, and the measuring, fitting or adjusting of such device occurs in the office of such licensed health care professional or in a health care facility." In turn, Tenn. Comp. R. & Regs. 1155-04-.20, regarding "Pharmacists, Home Medical Equipment Providers, and Orthosis Manufacturers" provides the corresponding rule.

Tenn. Code Ann. § 63-3-207(b) provides:

No person shall dispense or sell an over-the-counter or off-the-shelf device based upon an image of the customer's limb captured by the person through a mold, cast, scanning device, digital appliance, or pressure sensitive device, unless the customer has first presented to that person a written prescription for that device from a health care practitioner authorized by law to write such a prescription.

Furthermore, Tenn. Comp. R. & Regs. 1155-04-.20(1) prohibits individuals described in such rule from "creat[ing] a cast, mold or scan of a part of the human body for the purpose of constructing a medical device to treat a patient's medical condition," while Tenn. Comp. R. & Regs. 1155-04-.20(2) permits such individuals to measure, fit or adjust "any non-custom fabricated and fitted pedorthic devices, including but not limited to diabetic shoes," provided such individual meets the criteria of either subparagraph (1)(b) or (1)(c) and "so long as the individual does not create a cast, mold or scan of a part of the human body for the purpose of constructing a medical device to treat a patient's medical problem."

By enacting Tenn. Code Ann. § 63-3-208(a)(1)-(3), the Legislature has deemed the training criteria described in that section to constitute sufficient appropriate training to permit or authorize pharmacy personnel or home medical equipment providers to provide such services.

ROBERT E. COOPER, JR.
Attorney General and Reporter

BARRY TURNER
Deputy Attorney General

SARA E. SEDGWICK
Senior Counsel

Requested by:

The Honorable Ferrell Haile, D.Ph.
State Senator
10A Legislative Plaza
Nashville, Tennessee 37243