Legal, Regulatory, and Ethical Issues in the Use of Telemedicine

Abstract

With major pressures to provide greater levels of care with fewer care providers, there are significant incentives to expand telemedicine/telehealth to achieve efficiency. Advancement in technology of telemedicine has far outpaced the political, legislative, legal, and ethical maturation yielding considerable uncertainty and confusion. The aim of this chapter is to review the state of the literature and legal atmosphere surrounding telemedicine and provide guidance, where possible, for providers of telemedicine services. Regarding the legislative environment, the practitioner will have to consult references provided for specifics of each state. Regarding licensure, there is an expected evolution toward or approximating national licensure or reciprocity but each state will reserve the right to design their own licensure requirements. Regarding the state of malpractice, the case law is immature and time will provide more guidance. The ethics of telemedicine and standards applicable to traditional face-to-face medicine will apply with some fine nuances. Finally, reimbursement for telemedicine services seems to have been evolving positively until the recent rules changed.

Appendix 13.1

In order to understand telemedicine/telehealth, the reader must speak “the language.” The following represents some important lexicon necessary to read the literature.

Asynchronous Telecommunications

Activities take place outside of real time such as “store-and-forward” data or image exchange. Examples include e-mail communications, radiographic image interpretation, and delayed image review such as skin lesions or pathology specimens.

Store-and-Forward Technology

Information, which could be graphical, images, or photographs, is transmitted electronically, and is interpreted in a delayed fashion. Typical applications of store-and-forward include radiography, dermatology, pathology, and retinal scans for ophthalmology.

Synchronous Telecommunications

It is real-time, two-way audio-video communications. Activities take place in real time such as real-time two-way audio-video communications, telephone calls, or direct conversations.

Telemedicine

The practice of medicine using electronic communications, information technology, or other means between a care provider in one location and a patient in another location with or without an intervening health-care provider.

Originating Site

Defined by the federal government as the location of an eligible Medicare beneficiary at the time the service being furnished via a telecommunications system occurs. Generally defined as “where the patient is located,” therefore defining which state medical licensure will apply and under which State Medical Board.

Distant Site

Where the clinician is located providing the telemedicine services. Could be same state where the patient is located (originating site) or other remote state.

Health Resources Services Administration (HRSA)

“Federal agency for improving access to health care by strengthening the health care workforce, building healthy communities and achieving health equity. HRSAs programs provide health care to people who are geographically isolated, economically or medically vulnerable” [52].

Health Professional Shortage Area (HPSA)

Geographic area or populations lacking sufficient health care. HPSAs designated by HRSA based on census tracts, townships, or counties. Designations are made for primary care, dental, and mental health. A geographic area will be designated as having a shortage of primary medical care professionals if the following three criteria are met:

• a. The area is a rational area for the delivery of primary medical care services.

• b. One of the following conditions prevails, having a population- to- full-time-equivalent primary care physician ratio of at least 3500:1 or the area has a population- to- full-time-equivalent primary care physician ratio of less than 3500:1 but greater than 3000:1 and unusually high needs for primary care services or insufficient capacity of existing primary care providers.

• c. Primary medical care professionals in contiguous areas are overutilized, excessively distant, or inaccessible to the population of the area under consideration.

Metropolitan Statistical Area (MSA)

A geographical region comprising a relatively high population density, at least 50,000. An MSA is neither a legally incorporated city nor a legal administrative entity such as a state or county.

Critical Access Hospital (CAH)

• Located in a state with a rural health plan with a State Flex Program for Medicare (Includes all states except CT, MD, DE, NJ, and RI)

• Located in a rural area or “treated as rural”

• Provide 24 × 7 × 365 services which may be on-site staff or on-call staff

• 25 or less beds

• Average length of stay (LOS) < 96 h

• Located more than 35 miles ground transportation from the nearest full-service hospital

Rural Health Clinic (RHC)

• Located in a nonurbanized area as defined by the US Census Bureau

• Qualify as a HRSA shortage area

• Employ either NPs or PAs

• Provide certain minimum diagnostic services and studies

• Have an established relationship with a local hospital

• Stock medications and biologicals for medical emergencies

• Not an FQHC

• Meet certain administrative requirements

Federally Qualified Health Centers (FQHC)

• The main purpose of the FQHC program is to enhance the provision of primary care services in underserved urban and rural communities

• Received a grant from the federal government Public Health Service (PHS)

• Has been a FQHC as of 1/1990 or

• Has been providing native American tribe or tribal health services as of 10/1/1991

Medically Underserved Area/Medically Underserved Population (MUA/MUP)

• HRSA-defined area as medically underserved areas/medically underserved populations are areas or populations designated by HRSA as having too few primary care providers, high infant mortality, high poverty, and/or high elderly population.

Healthcare Common Procedural Coding System (HCPCS) [57]

• The HCPCS is divided into two principle subsystems, referred to as level I and level II of the HCPCS. Level I of the HCPCS comprises CPT, maintained by the AMA. Level II of the HCPCS is a standardized coding system used primarily to identify products, supplies, and services not included in the CPT codes, such as ambulance services and durable medical equipment, prosthetics, orthotics, and supplies.