Telemedicine Considerations When Conducting Decentralized Clinical Trials

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Decentralized clinical trials (DCTs) involve some or all trial-related activities conducted at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s home. The use of telemedicine in DCTs implicates various state legal and regulatory considerations as the performance of research, or the performance of certain procedures within a clinical trial, may and often fall within and are deemed to be the “practice of medicine.”

For example, Texas defines the practice of medicine as:

[D]iagnosing, treating or offering to treat any mental or physical disease or disorder or any physical deformity or injury or performing such actions with respect to individual patients for compensation and shall include clinical medical research, the practice of clinical investigative medicine, the supervision and training of medical students or residents in a teaching facility or program approved by the Liaison Committee on Medical Education of the American Medical Association, the American Osteopathic Association or the Accreditation Council for Graduate Medical Education, and professional managerial, administrative, or supervisory activities related to the practice of medicine or the delivery of health care services.¹

Even if a state definition of the practice of medicine does not expressly include “clinical medical research,” most clinical trials involve some components that are considered to be the standard of care, which components will likely be deemed to be the practice of medicine. When the conduct of a clinical trial—or the conduct of standard of care procedures within a clinical trial—is considered the practice of medicine, DCT practitioners should be aware of the various individual state law telemedicine regulations, including licensure and practice standard requirements, as such must be complied with when conducting DCTs and engaging with clinical trial participants on a remote basis.

Essentially, practitioners participating as an investigator in a DCT and engaging in patient care and procedures—as well as practitioners providing services and care to patients as part of a DCT—will need to be licensed in the state in which the patient is located and applicable state practice standard requirements will need to be adhered to. Compliance with state telemedicine requirements is imperative, as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.

Licensure Considerations

Because the conduct of DCTs (or components of a DCT) may be considered the practice of medicine, practitioners participating in DCTs must adhere to individual state licensure requirements. To practice medicine within a state via telemedicine, generally a practitioner must be licensed in the state in which the patient is located or meet a state exception to licensure (herein the licensure requirement). Some common state exceptions to the licensure requirement that may be applicable to practitioners participating in the conduct of a DCT include a border state exception and a follow-up care exception.

The border state exception allows a physician licensed in one state to practice medicine in another state that shares a land border with the state in which the physician is licensed. Currently ten states offer a border state exception to licensure: Washington, D.C., Maryland, Michigan, New Hampshire, New York, Ohio, Pennsylvania, Texas, Virginia, and Washington.²

In most of these states, the exception requires that a physician not open an office or meet patients in-person within the state. Further, some of the applicable border state exceptions are limited in scope. For example, Washington’s border state exception is limited to practitioners licensed in Canada providing care in an area with a common border to Canada and which is surrounded on three sides by water.³ Additionally, Texas’s border state exception is not applicable to DCTs because it is limited only to practitioners ordering home health or hospice services in Texas.⁴

The follow-up care exception to the licensure requirement is another potentially applicable exception that may be utilized for practitioners participating in DCTs. Generally, this exception allows a practitioner to provide care to a patient in a state in which the physician is not licensed if an already existing practitioner-patient relationship exists.

This means that the practitioner first treated the patient in the state where the practitioner is licensed and then provides subsequent care to the patient when that patient is located in a different state where the practitioner is not licensed. Currently, 14 states offer some form of the follow-up care exception to licensure: Alaska, Arizona, Idaho, Illinois, Indiana, Kansas, New Hampshire, North Carolina, Ohio, Oregon, Texas, Virginia, Washington, and Wyoming.⁵

Several of these states require that the practitioner-patient relationship be established first in-person where the practitioner is licensed. For example, Alaska specifically states that a practitioner can provide follow-up care, if “(A) the physician and the patient have an established physician-patient relationship; and (B) the physician has previously conducted an in-person visit with the patient…”⁶

This means that a patient located in Alaska would need to physically visit a clinical trial site where the practitioner is licensed prior to further clinical trial care being provided via telemedicine to the patient located in a different state. Further, some states impose a frequency restriction to the follow-up care exception. For example, Idaho only allows temporary or short-term follow up health care services to ensure continuity of care.⁷ Other states with a frequency limitation to follow-up care exception include North Carolina, Ohio, Oregon, Washington, and Wyoming.⁸

If a practitioner participating in a DCT does not meet a state’s exception to licensure, then the practitioner must be licensed in the state where the patient located and is receiving care. In some states, licensure can be obtained in an expedited fashion. For example, 33 states offer a path to licensure through the Interstate Medical Licensure Compact.⁹

Additionally, nineteen states offer some form of telemedicine special purpose license: Arizona, Delaware, Florida, Georgia, Idaho, Kansas, Louisiana, Maine, Minnesota, Nevada, New Mexico, Oklahoma, Oregon, Tennessee, Texas, Utah, Vermont, West Virginia, and Wisconsin.¹⁰

Generally, a telemedicine special purpose license allows a practitioner not licensed in the state to obtain a telemedicine special purpose license allowing the practitioner to treat patients located in the state only via telemedicine. For example, Florida permits an out-of-state licensed health care practitioner to provide health care services to a patient located in Florida if the out-of-state health care professional registers with the applicable board or the Florida Department of Health.¹¹ However, not every state’s telemedicine special purpose license is applicable to DCTs. Of note, Maine’s telemedicine registration is only available for consulting clinicians.¹²

Practice Standard Considerations

In addition to state licensure requirements, practitioners participating as an investigator in a DCT and engaging in patient care and procedures, as well as practitioners providing services and care to patients as part of a DCT, must adhere to state practice standard requirements such as, but not limited to, minimum required modalities; telemedicine-informed consent requirements, which may be in addition to the consent requirements for the clinical trial; special telemedicine disclosure and patient identification requirements; and medical records requirements.

When providing care through telemedicine, many states specifically address what minimum modality is required to establish the practitioner-patient relationship and subsequent follow-up care. These modalities include synchronous audio/video communication, synchronous interactive audio using store and forward communication, and asynchronous store and forward communication.

The modality through which the practitioner can establish a valid practitioner-patient relationship depends on the language of the state law, as well as the specific clinical situation. For example, only two states, New Mexico and Mississippi, require that the practitioner-patient relationship be established via synchronous audio-video communication.¹³

Whereas 26 states explicitly allow the practitioner-patient relationship to be established via asynchronous store and forward communication. Six states require a minimum of interactive audio store and forward communication to establish the practitioner-patient relationship: Arkansas, Delaware, Kansas, Minnesota, Washington, D.C., and West Virginia.¹⁴

More than half of the states require the practitioner to obtain telemedicine-specific informed consent from the patient, patient ID verification, and provide special telemedicine disclosures to the patient. These requirements are in addition to the standard regulations governing human subjects research, including, but limited to FDA regulations under 21 CFR and DHHS regulations at 45 CFR Part 46.

For example, Texas statute provides that “[a] treating physician...shall ensure that the informed consent of the patient, or another appropriate individual authorized to make health care treatment decisions for the patient, is obtained before telemedicine medical services…or telehealth services are provided.”¹⁵

Further, Tennessee is an example of a state that requires both patient ID verification and special telemedicine disclosures. Specifically, Tennessee provides that a telemedicine practitioner “verify the patient’s identity and location with an appropriate level of confidence…and disclose his or her name, current and primary practice location, medical degree and recognized specialty area.”¹⁶

In sum, practitioners involved in a DCT must ensure compliance with applicable state telemedicine laws where the DCT itself constitutes the practice of medicine in a state, and/or where any component of the DCT includes a standard of care component. Compliance with state telemedicine requirements is imperative as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.

Practitioners engaged in DCTs and providing patient care procedures should ensure they are licensed in the state where the patient is located or otherwise meet a state law exception to licensure. Further, practitioners need to follow all applicable state telemedicine practice standard requirements.

References

1. 22 Tex. Admin. Code § 177.1(2).

2. D.C. Code Ann. § 3-1205.02; Md. Health Occ. Code Ann. § 14-302; Mich. Comp. Laws Ann. § 333.16171(i); N.H. Rev. Stat. Ann. § 329:21(III); N.Y. Educ. Law § 6526(2); Ohio Rev. Code Ann. § 4731.36(A); 63 Pa. Cons. Stat. Ann. § 422.34 (applying to allopathic physicians); Pa. Admin. Code § 17.4(a) (applying to allopathic physicians); 49 Pa. Admin. Code § 25.243(a) (applying to osteopathic physicians); 22 Tex. Admin. Code § 172.12(f); Tex. Occ. Code Ann. § 151.056(b)(4); 2022 Va. Acts 463, § 2, available here; Wash. Rev. Code § 18.71.030.

3. Wash. Rev. Code § 18.71.030(12).

4. 22 Tex. Admin. Code § 172.12(f); see also Tex. Occ. Code Ann. § 151.056(b)(4).

5. Alaska Stat. Ann. § 08.02.130(b); Ariz. Rev. Stat. Ann. § 36-3606(E); Idaho Code Ann. § 54-5713(1)(a), (b), (d); 225 Ill. Comp. Stat. Ann. 60/49.5(a)–(c); Ind. Code Ann. § 25-22.5-1-1.1; Kan. Admin. Regs. 100-26-1; Kan. Admin. Regs. 100-26-2 (defining “out of state practitioner”); N.H. Rev. Stat. § 310-A:1-g(IV), (VII); North Carolina MedicalBoard, Position Statement on Telemedicine, available here; Ohio Rev. Code Ann. § 4731.36(A)(4); Or. Rev. Stat. Ann. § 677.137(3)(c); Or. Admin. R. 847-025-0020(3); Or. Med. Bd., Telemedicine, available here; 22 Tex. Admin. Code § 172.12; Va. Code Ann. § 54.1-2901(A)(33); Va. Code Ann. § 54.1-2901(A)(35); Washington Medical Commission, Telemedicine Policy Number POL2021-02 (Nov. 2021), available here; Wash. Bd. Osteopathic Medicine & Surgery, Policy Statement: Telemedicine (March 2022), available here; Wyo. Admin. Code 052.0001.1 § 7(e).

6. Alaska Stat. Ann. § 08.02.130(b).

7. Idaho Code Ann. § 54-5713(1)(a), (b), (d).

8. North Carolina MedicalBoard, Position Statement on Telemedicine, available here; Ohio Rev. Code Ann. § 4731.36(A)(4); Or. Rev. Stat. Ann. § 677.137(3)(c); Washington Medical Commission, Telemedicine Policy Number POL2021-02 (Nov. 2021) (found here); Wyo. Admin. Code 052.0001.1 § 7(e).

9. Interstate Medical Licensure Compact, U.S. State Participation in the Compact, available here.

10. Ariz. Rev. Stat. Ann. § 36-3606(A); Ariz. Rev. Stat. Ann. § 36-3606(B)–(D); Del. Code Ann. tit. 24, § 6002(c)-(d); Del. Code Ann. tit. 24, § 6002(c)-(d); Fla. Stat. § 456.47(4); Ga. Code Ann § 43-34-31(a); Ga. Code Ann. § 43-34-31.1; Ga. Comp. R. & Regs. 360-2-.17; Idaho Code Ann. § 54-5714(2)-(3); Kan. Stat. Ann. § 65-28,135(a); La. Stat. Ann. § 37:1271; 46 La. Admin Code Pt XLV, § 7507; 46 La. Admin Code Pt XLV, § 7521; Code Me. R. tit. 02-373 Ch. 11, § 3(2); Minn. Stat. Ann. § 147.032, Subd. 1; Nev. Rev. Stat. Ann. § 630.261(1)(e); N.M. Stat. Ann. § 61-6-11.1; N.M. Admin. Code § 16.10.2.1; 59 Okla. Stat. Ann. § 633; ORS § 677.139; Tenn. Comp. R. & Regs. 1050-02-.17; 22 Tex. Admin. Code § 172.12; U.C.A. 1953 § 58-1-302.1; 26 Vt. Stat. Ann. ch. 56; W. Va. Code, § 30-1-26; W. Va. Code R. §§ 11-15-1 to 11-15-1; Wis. Stat. Ann. § 440.094.

11. See Fla. Stat. § 456.47(4).

12. Code Me. R. tit. 02-373 Ch. 11, § 3(2).

13. N.M. Admin. Code 16.10.8.7; 30 Miss. Admin. Code Pt. 2635, R. 5.4.

14. Ark. Code Ann. § § 17-80-402(4)(e)-(f); Del. Code Ann. tit. 24 § 6003(a); Del. Code Ann. tit. 24 § 6001(5-6) (defining “telehealth” and “telemedicine”); Kan. Stat. Ann. § 40-2,211(a)(5); Minn. Stat. Ann. § 147.033, Subd. 1–2; D.C. Mun. Regs. tit. 17, § 4618.4; W. Va. Code § 30-3-13a(c)(2) (allopathic medicine); W. Va. Code § 30-14-12d(c)(2) (osteopathic medicine).

15. Tex. Occ. Code Ann. § 111.002.

16. Tenn. Comp. R. & Regs. 0880-02-.16.