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By Sonya Burtner, MA, CHC, CPC, CPC-H,
Compliance Specialist
Shands Corporate Compliance
This article, published in the March 2009 issue of Compliance Today, appears here with permission from the Health Care Compliance Association (HCCA).  For reprints, call HCCA at 888/580-8373.
6-2-3 Introduction When my parents lived in Chicago in the 1950’s, it was not uncommon for my mother to call our family doctor, about me or one of my siblings, to discuss a medical issue. The doctor would direct the sick child to cough into the phone. A prescription was then called in.   Patient care at a distance is certainly not a new practice. There are many examples in our history illustrating this concept. In 1642, Theophraste Renaudot, a French physician and philanthropist, created a patient booklet with lists of symptoms and simple body diagrams. The patients would check off the symptoms they were experiencing from the list and used the diagrams to identify the body parts that were troubling them. This innovative booklet enabled a patient to receive a diagnosis and treatment by post without a personal visit to the physician. Other doctors also engaged in such practices, such as William Cullen (1710-1790) of Edinburgh, Scotland and John Morgan (17351789) of Philadelphia, who were both equally active with postal consultations.1   In more recent years, due to the vast improvement of modern technology, care at a distance has become more sophisticated and developed into what we now know as telemedicine. This article proposes to explore current applications of telemedicine, the benefits, and some of the associated compliance and legal risks hospitals have to contend with when practicing telemedicine.   Definitions The American Telemedicine Association (ATA) defines telemedine as “the use of medical information exchanged from one site to another via electronic communications to improve patients’ health status.” Medical information can now be communicated via the internet, video conferencing equipment, and satellite technology. Telemedicine is as basic as a telephone call between two providers discussing the case of a patient or as complex as using satellite technology for robotic surgery.   The terms telehealth and telemedicine are often used interchangeably. Telemedicine is most often defined as focusing on clinical services and the curative aspect, whereas telehealth has a broader meaning and can refer to clinical and non-clinical services, such as medical education, administration, and research, in addition to clinical services.   Other terms used in the industry, are the “originating site” which is the site the patient receiving the service is located in, as opposed to the “distant site” being the site where the physician providing the service is located. Also, services where both parties are interacting at the same time with a communications link between them are called “real time” services or synchronous telemedicine. In contrast “store and forward technology” refers to the asynchronous transmission of medical information to be reviewed at a later time.   Current Applications The dramatic growth of technology and the internet has provided great benefits to healthcare. Consumers all over the world have a wealth of health information at their fingertips and can receive diagnostics and purchase pharmaceuticals. Among the many applications of telemedine, a few are described below:   Teleradiology/Telepathology One of the most common applications of telemedicine is teleradiology and telepathology. A smaller hospital, for example, with limited staffing resources may contract with a bigger hospital for the purposes of interpretation and/or consultation of tests for trauma patients after hours. Radiological patient images, such as x-rays, cat scans, and MRIs, are transmitted from the originating site to the distant site. This saves time and improves patient care by allowing hospitals to access radiology services 24/7. Teleradiology can be accomplished with an international distant site as well. In fact, outsourcing teleradiology services overseas (in countries such as India, Israel, and Australia) is becoming popular to cover the night hours along with radiologists in other US time zones, hence the term of “nighthawk” radiology services. Similarly, telepathology activities occur to provide urgent services at sites without a pathologist. Both teleradiology and telepathology are instrumental in providing consultative services with immediate access.  This can be extremely beneficial to physicians in rural areas or for a physician seeking a second opinion in emergency situations.   Telephone & Online Patient Consultations – Patients consulting their physicians over the phone or by e-mail via the internet is not a new practice, but until recently there were no CPT codes to report these services. The CPT codes for telephone services have been updated for 2008 to 99441, 99442, and 99443 and are based on the amount of time spent discussing the medical issue. And in 2008, the CPT code 99444 became available to report online services. According to the AMA Current Procedural Terminology (CPT), the services can only be reported for an established patient and only once for the same episode of care in a seven day-period. The service must include all other communications such as related phone calls, prescription and lab orders. The e-mails must be kept in permanent electronic or hardcopy storage. Even though the guidelines are strict, the assignment of these CPT codes is very encouraging for telemedicine providers as it is a start towards acknowledging these types of services for reimbursement purposes in a time where phone and internet communications have so many appeals to patients.   Just as note, the above CPT codes were the only existing “tele” codes, before July 1, 2008, as all other telemedicine activities are reported using the same CPT codes as the service conducted without telemedicine. Effective July 1, 2008, the AMA introduced new CPT Category III Codes to report remote-real time interactive video-conferenced critical care services. The codes are 0188T and 0189T. The creation of new CPT codes to accurately capture telemedicine activities will probably increase every year.   Telemarker A special portable phone used in Israel can assist in the determination of a real heart attack. The process is simple, if a patient is experiencing chest pain, a simple self-blood test (called Telemarker) is performed. The test can detect the presence of two proteins, which are biochemical precursors of a heart attack.  The device sends the information to a center through a modem and the doctor can analyze the results and determine if there is a real medical emergency. This device avoids unnecessary hospitalizations and reduces unnecessary costs.2 iPath, a telemedicine network developed at the University of Basel, allows publication and discussion of medical cases for second opinion consultations. iPath is a secure teleconsultation tool enabling virtual communities of care professionals to exchange advice about the management of clinical cases in several expertise domains. The network has been active since 2001 and is used in 15 French-speaking African countries, including Mali, Mauritania, Morocco, Tunisia, Senegal, Cameroon and the Ivory Coast.3   Telesurgery – On September 7, 2001, a team of French surgeons located in New York performed a gall bladder removal, with the Zeus Robotic System (at this time no longer on the market), on a 68 year-old woman located in Strasbourg, France, 4000 miles away. Operation “Lindbergh” took 45 minutes and was the first robotic transatlantic telesurgery. The procedure was successful with no complications and the patient was discharged two days after the operation.4      Telesurgeries (also known as remote surgeries) have not yet occurred with patients in the U.S., however robotic systems are being used for surgeries with a physician in the same room as the patient. The Food and Drug Administration (FDA) first cleared the da Vinci Robotic System in 2000 for general laparoscopic surgeries such as a gall bladder removal and for treatment of severe heartburn. Since then, use of the system has increased and expanded into several other surgical areas.  The da Vinci Robotic System allows surgeons to operate from a distance with a minimally invasive approach using small incisions. The robotic system includes a post with multiple arms which is positioned over the patient. The surgeon is seated across the room from the patient with arms inserted in a console and is manipulating the robot’s arms looking at magnified 3D images of the surgical site. Remote surgery is still considered investigational within the U.S. and “should not be performed except under IRB approval and by persons thoroughly familiar with the technology”.5    Nevertheless, the revolutionary event of Operation “Lindbergh” supports the incredible potential of telesurgery bringing new opportunities to the delivery of patient care. Telesurgery is hoped to enable surgeons, someday, to operate from remote locations to help fallen soldiers in a battlefield or even astronauts in space.   Benefits of Telemedicine The internet is dramatically changing the way consumers access health information, receive diagnostics and purchase pharmaceuticals and plays a key role in expanding the reach of telemedicine. Telemedicine appeals for a host of reasons:   Increased Access to Healthcare Telemedicine increases access to healthcare in a variety of situations; the ED physician can seek a second opinion quickly, the isolated community can access a specialist when there is none in the area, the understaffed hospital can contract radiology services after hours and support emergency services.   Cost Savings to Patients Telemedicine offers certain conveniences, such as allowing the patient to contact his /her family doctor without leaving home or to use the Telemarker test to save a trip to the emergency room. Internet communications are convenient and efficient for simple medical problems and save both time and money. The healthcare consumer nowadays is much more informed, educated, and accustomed to using electronic sources to gather and transfer information and more likely to ask for advice by e-mail or phone.   Cost Savings to Providers Providers also benefit from telemedicine. Travel time for providers can be significantly reduced as well. Many radiologists have opted to get the applicable equipment installed in their home when participating in teleradiology services saving on transportation expenses with the additional attraction of flexible working hours.6   Improved Patient Outcomes Telemedicine provides quicker delivery of care, which leads to improved continuity of care. Doctors can get a more accurate diagnosis of their patients with the quick access to a second opinion by teleconsulting with a specialist. Cutting Edge Opportunities Finally, state of the art equipment such as remotely controlled surgical robots are opening up many future opportunities for research, the military, and NASA.   Compliance and Legal Issues The telemedecine industry faces many challenges. Hospitals and other providers need to conduct due diligence before engaging in any telemedicine activities. Here are some of the issues:   Interstate Licensing Issues The essence of telemedicine is practicing medicine without borders. Technology enables the provider to render an opinion or interpret a test on a patient living down the road as easily as one living in a different state or across the world. However, when telemedicine is practiced across state lines, licensure becomes an issue. The patient’s physical location, i.e. the “originating” site, identifies the location where the health care is provided; so a provider must abide by the laws of that state. In many cases, this may mean that the provider has to get licensed in that state. This can be quite burdensome for a telemedicine provider who may have to fill out multiple licensure applications and pay multiple registration fees in order to practice. In addition, each state has its own licensure laws regulating telemedicine with varying degrees of restrictions or exemptions. In Arizona, licensure requirements do not apply if a doctor licensed in another state, engages in an episodic consultation about a patient with a doctor licensed in Arizona. Montana, on the other hand, prohibits the practice of telemedicine without a telemedicine certificate issued by the State Board of Medical Examiners.  7&8    some states have not determined how they want to address the out of state provider’s licensure issue. It is not just a physician issue, hospitals may be viewed as “aiding and abetting” the physician who is practicing telemedicine without a license in another state. A hospital must carefully review each state’s requirements with their Legal Department before engaging in any kind of telemedicine involving physicians in other states.   Several medical specialties such as the American College of Radiology (ACR) have developed guidelines for telemedicine activities to ensure the protection of the patient. On the topic of overseas contracting for teleradiology, the ACR recommends that the overseas radiologist “be licensed by the state(s) and credentialed by the U.S. hospital(s) that contracts for their services as stated in the American College of Radiology Teleradiology Technical Standards.” The interpreting physician should also be covered by medical malpractice insurance. Hospitals should conduct due diligence when entering in contractual arrangements with teleradiology companies.   Discussions are underway to try to resolve these licensure dilemmas. The 2001 Telemedicine Report to Congress outlined different alternatives to address these issues including assessing the feasibility of developing common licensure application forms.   Credentialing Issues – Another dilemma for which solutions are not clearly defined by the regulations are credentialing issues. Must a telemedicine provider be credentialed in the state the patient is located? Various credentialing organizations such as Joint Commission of Accreditation (JCAHO) have provided some standards for telemedicine, which indicate that a licensed practitioner who is responsible for the care of a patient via a telemedicine link is subject to the credentialing and privileging processes of the originating site. However, the originating site can use the credentialing information from the distant site, if the distant site is a JCAHO– accredited organization (Standard MS.13.01.01). JCAHO does not address all areas of telemedicine services. Consultative services, for example, fall outside the scope of the JCAHO telemedicine standards.9  And what about the teleradiologist who is unaffiliated with a particular hospital and practices independently? Telemedicine is still an underdeveloped medical-legal frontier.   Security and Privacy Issues Privacy, security and confidentiality issues are not unique to telemedicine. Similar to any other electronic transactions, hospitals must ensure that adequate precautions are taken when transmitting protected health information (PHI) out of the hospital networks. Since telemedicine activities can be broadcasted anywhere, the concerns are perhaps more prevalent. The America Medical Association (AMA) has developed guidelines for physicianpatient e-mail communications. Advances in technology have brought great benefits as well as drawbacks in this area.   Informed Consent Physicians practicing telemedicine must also consider informed consent requirements, which vary from state to state. In some states, the informed consent requirements do not apply if the patient is not involved directly in the telemedicine activity (such as consultative services). In addition, the physician home state may have different informed consent requirements than the state where the patient resides. The treating physician should explain to the patient not only the risks associated with the telemedicine service, but issues such as which state the telemedicine provider is licensed/credentialed in, the process for follow up care, the equipment required, and the operating staff that may be required at the originating site and at the distant site.10   Telemedecine Equipment The technology involved with a telephone or simple videoconference hookup for telemedicine services is easy to use and readily available.  However, depending on the type or equipment or technology used in the telemedicine service, the provider may be required to abide by state and federal regulations related to the use of such equipment. The Federal Food and Drug Administration (FDA) has the responsibility for regulating the safety and effectiveness of medical devices and therefore may regulate software and hardware used to practice telemedicine. Also, telemedicine providers must also consider state regulations. Some states have instituted specific rules governing the use of the internet, e-mail and similar technologies when treating patients.  Hospitals and telemedicine providers need to review FDA and state regulations in telemedicine arrangements in reference to equipment, related technologies and the use of the internet in the treatment of patients.   Reimbursement Issues The lack of reimbursement for the provision of this mode of treatment is an obstacle to the expansion of telemedicine. Congress has taken some action in the Balanced Budget Act (BBA) of 1997 where some Medicare reimbursement for telehealth services was authorized. Congress has further directed CMS to establish a payment methodology for telemedicine services in rural shortage areas if certain conditions are met.11   Medicare the Medicare Policy Benefit Manual has specific guidelines for coverage and payment for telehealth services. The list of services covered are; consultations, office visits, individual psychotherapy, pharmacologic management, psychiatric diagnostic interview examination, end stage renal disease related services, individual medical nutrition therapy, and most recently added in 2008, neurobehavioral status exam. The CPT codes used to report telehealth services are no different than regular services performed without the use of a telecommunications system (with the few exceptions already mentioned for telephone and online consultations and remote-real time interactive video-conferenced critical care services). The originating site must be located either in a rural health professional shortage area (HPSA) or in a county outside of a metropolitan statistical area (MSA). Authorized originating sites are limited to a physician’s office, a hospital, a critical access hospital, a rural health clinic, a federally qualified health center. On July 16, Congress passed H.R. 6331, expanding Medicare coverage beginning January 1, 2009, to include skilled nursing facilities, inhospital dialysis centers, and community mental health centers as telemedicine sites.   The guidelines further state: “For Medicare payment to occur, interactive audio and video telecommunications must be used, permitting real-time communication between the distant site physician or practitioner and the Medicare beneficiary. As a condition of payment, the patient must be present and participating in the telehealth visit.” The payment amount is equal to the reimbursement of the service without the use of telemedicine. There is one exception to the interactive telecommunications requirement in the case of Federal telemedicine demonstration programs such as the ones conducted in Alaska or Hawaii. In those cases, Medicare payment is permitted for “store and forward technology”.12   Telephone calls and online consultations Medicare does not pay for telephone calls or online consultations at this time. In fact, the Medicare Benefit Manual Medicare, Chapter 15 states that telephone call services are considered an integral part of the physician services and there is no separate payment. Though this article does not focus on nonfederal payors, it is worth mentioning that Aetna and CIGNA HealthCare are already paying some physicians for online patient consultations.13   Home health Federal regulations require face-to-face visits for home health, and telemedicine cannot be used as a substitute for those visits. However, a telemedicine encounter may be used as a supplement to the required face-to-face visits. Medicare Benefit Policy Manual Chapter 7 can be reviewed for further detail. Teleradiology Outsourced With respect to teleradiology outsourced to a different country, CMS prohibits payments to providers outside the United States. Hospitals with such arrangements would have to pay the overseas radiologists directly. The ACR has voiced concern about the interpretation of radiology images outside of the U.S., because of the risk that a U.S. radiologist would be signing off on the “ghost-read” radiographs without a careful review.14   Medicaid The Centers for Medicare & Medicaid Service (CMS) has not formally defined telemedicine services for the Medicaid Program, however, in some states, Medicaid reimbursement is available for certain services.   2009 OIG Work Plan It is noteworthy that some form of telemedicine auditing is included in the 2009 Work Plan. The OIG will be reviewing the appropriateness of Medicare claims for long-distance evaluation and management services: “Pursuant to the CMS “Medicare Benefits Policy Manual,” Pub. No. 100-02, ch. 15, § 30, a service may be considered a physician’s service if the physician either examines the patient in person or is able to visualize some aspect of the patient’s condition without a third person’s judgment. Although services provided by means of a telephone call between the physician and the beneficiary may be covered under Medicare, there are certain services that require a face-to-face visit. Previous OIG work identified instances of physicians billing for services that would normally require a face-to-face examination for beneficiaries who lived a significant distance from the physician. We will also examine factors that contribute to the submission of long-distance physician claims”.   Per the Medicare Benefit Policy Manual, Chapter 15, Section 270.2, “the use of a telecommunications system may substitute for a face-to-face, “hands on” encounter for consultations, office visits, individual psychotherapy, pharmacologic management, psychiatric diagnostic interview examination, end stage renal disease related services, and individual medical nutrition therapy”. However, since the CPT codes used are, in most cases, the same as non-telemedicine encounters, it is unclear how the OIG will pull the data for this review.   Conclusion Telemedicine plays a critical role in providing access to healthcare, especially in underserved areas. Providers must ensure that the risks of providing telemedicine services do not outweigh the benefits, carefully enter into agreements with the assistance of their Legal Department, and should develop telemedicine policies.   References: 1 Wikipedia, the Free Encyclopedia – http://en.wikipedia.org/wiki/ In_absentia_health_care 2 Official Site of the French/Israeli Chamber of Commerce Article by Michael Finkelstein – 9/27/2008 3 Reseau RAFT Network http://raft.hcuge.ch/ 4 Surgeons perform successful near real time telesurgery from New York on patient in France, http://www.hoise.com/vmw/01/articles/vmw/LV-VM-10-0120.html 5 Society of American Gastrointestinal Endoscopic Surgeons (SAGES) 2000 Remote Surgery Guidelines 6 Radiology Today “Remote Reading -PACS and Teleradiology Let Radiologists Work Almost Anywhere.” Dan Harvey 4/10/06 7 AMA Physician Licensure: An Update of Trends – Janice Robertson2/27/2008 8 Telemedicine and E-Health Law – Lynn D. Feisher and James C. Dechene – Chapter 1 9 JCAHO Perspectives Existing requirements for telemedicine practitioners explained – Feb 2003. 10 Telemedicine and E-Health Law – Lynn D. Feisher and James C. Dechene – Chapter 1 11 Telemedicine and E-Health Law – Lynn D. Feisher and James C. Dechene – Chapter 8 12 Medicare Benefit Manual – Chapter 15 – Section 270 – Telehealth Services 13 New, Revised CPT Codes Target Online, Telephone Services Sheri Porter – 2/29/08 14 The American College of Radiology ( ACR) Revised Statement on the Interpretation of Radiology Images Outside the United States – 5/23/06