By George Leehan, Sarah Sossong, and Nathaniel Lacktman, Esq.
Telemedicine is an exciting clinical delivery tool that offers real ways to address healthcare’s persistent problems of access, coordination, and efficiency. But with innovation comes unique legal considerations, and while some states have given significant thought to telemedicine, publishing robust laws or rules to guide adoption and promote reimbursement, Massachusetts laws and regulations have not addressed the area in depth.
And yet, despite the lack of robust regulatory standards or widespread commercial coverage of telemedicine in Massachusetts, many providers and hospital systems have taken the initiative and successfully embedded telemedicine into their patient care delivery models. The resulting dissonance between telemedicine policy and telemedicine practice is particularly evident in Massachusetts, where a number of legal hurdles continue to exist, serving to inhibit the widespread adoption of certain telemedicine options in Massachusetts despite the strong efforts of the provider community to push the technology forward. Written primarily with Massachusetts healthcare providers and legal counsel in mind, this article covers the principal legal and regulatory issues around telemedicine in Massachusetts – licensure, scope of practice, credentialing, and reimbursement.[i]
Massachusetts Telemedicine in Action
Telemedicine is a collection of evolving communication, information, and diagnostic technologies that links together hospitals, clinicians and patients to improve clinical health. Importantly, telemedicine is a modality – a means through which healthcare services are delivered – rather than a distinct medical specialty practice area.[ii] Already used by many of Massachusetts’ leading healthcare institutions, telemedicine empowers providers to offer innovative care for patients around the block and around the world. These technologies have proven themselves cost-effective, improve access and enable higher quality of care. Nationwide, telemedicine is used in over 80 health service disciplines including cardiology, neurology, pediatrics, primary care, and psychiatry. Although innovative providers continue to create and enhance ways to provide care, telemedicine applications can be roughly grouped into four domains, each of which is currently in use by Massachusetts healthcare providers:
Live Video Conferencing (Synchronous): Live, two-way interaction between a person and a provider using audio-visual telecommunications technology. Video-enabled virtual visits are accomplished using high speed connections and high definition monitors, and sometimes special assistive diagnostic tools as well. Live Video Conferencing can enable “Video-enabled Virtual Consults” between a doctor at an academic medical center “hub” to a doctor at a community hospital “spoke.” Live Video Conferencing is also being used for “Video-enabled Virtual Visits” between a doctor in his/her clinic setting and a patient in his/her home (or work, or other setting).
Store and Forward (Asynchronous): Transmission of recorded health history through an electronic communications system to a practitioner, usually a specialist, who uses the information to evaluate the case or render a service (e.g., teleradiology, telepathology).
Remote Patient Monitoring (Remote Monitoring): Personal health and medical data collection from an individual in one location via electronic communication technologies, which is transmitted to a provider in a different location for use in patient care (e.g., WIFI and BlueTooth linked scales for at-home weight checks, post-surgery heart monitors).
Mobile Health (mHealth): Health care and public health practice supported by mobile communication devices such as smart phones, tablets, and PDAs. Applications can enable a range of functionality from targeted text messages that promote healthy behavior; monitoring of vitals and secure videoconferencing for medical services to wide-scale alerts about disease outbreaks (already used with the 2014 Ebola concerns).
Using telemedicine technology, providers at Massachusetts General Hospital (MGH) and other medical centers in the Commonwealth have demonstrated that telemedicine not only decreases costs compared to traditional in-office visits, but facilitates provider and patient convenience, enhances quality of care by creating collaborative care opportunities, and significantly improves rural patient access to specialists at urban academic medical centers.
In 2012 alone, the MGH/BWH TeleStroke network provided 24/7 acute stroke neurology coverage to emergency departments across 11 counties in the Commonwealth serving over 5 million inhabitants and provided care to over 700 patients. This resulted in approximately 400 avoided transfers with an estimated savings for emergency transport costs of approximately $1.4 million and an additional $676,000 of long-term savings among tissue plasminogen activator (tPA) treated patients, totaling over $2 million saved to the healthcare system in Massachusetts.
Since March 2013, MGH’s Sumner Redstone Burn Center has provided weekly post-acute virtual visits to patients discharged to Boston Spaulding Rehabilitation Hospital (SRH), which allows patients to stay at SRH rather than being transported to MGH for follow-up outpatient appointments. Over a five month period, the TeleBurns team provided regular follow-up care to 17 thermal injury patients, which enabled 90 avoided transports between MGH and SRH with an estimated cost savings of approximately $45,000. In addition, the program has demonstrated reductions in hospital readmissions, improved adherence to rehabilitation schedules, and allowed patients to return home sooner.
Telemedicine, as a mode of care delivery in connection with health care reform, will allow Accountable Care Organizations (ACOs) to improve quality of care more effectively and efficiently while still lowering costs. Many providers believe that greater regulatory equality between in-person and telemedicine-based services will help Massachusetts develop economically viable, industry-leading approaches to medical care.
Massachusetts Telemedicine Licensing and Exceptions
Massachusetts’ physician licensing system, regulated by the Board of Registration in Medicine (Board), includes telemedicine within the definition of the practice of medicine.[iii] The Board defines telemedicine as “the provision of services to a patient by a physician from a distance by electronic communication in order to improve patient care, treatment or services.”[iv] Therefore, unless a licensure exception applies, a physician who provides telemedicine services to patients located in Massachusetts must have a license to practice medicine in Massachusetts. This is consistent with the Telemedicine Policy statement of the Massachusetts Medical Society.[v]
The Massachusetts regulation on telemedicine and physician licensure is consistent with most other states across the nation, as well as the telemedicine guidelines published by the Federation of State Medical Boards (FSMB). The rationale for this requirement is that the practice of medicine occurs where the patient is located at the time of the telemedicine encounter. Physicians who treat patients via telemedicine are practicing medicine, and Massachusetts regulations require the physician to be duly licensed in the Commonwealth.
There are efforts to ease the licensing barriers for telemedicine practice, and in September 2014, the FSMB announced its final version of the Interstate Medical Licensure Compact. Under the Compact, participating States would agree to expedite license applications for physicians seeking to practice medicine across multiple states. This is a refinement of the concept underpinning the Nurse Licensing Compact introduced several years ago and adopted by 24 states, thereby facilitating the cross-border practice of nursing in those participating Compact States. Thus far, 12 state medical boards have endorsed the Interstate Medical Licensure Compact.[vi] The Massachusetts Board has been evaluating the Compact, but has not yet pronounced its endorsement.
In the absence of full licensure, the most common alternate approaches are: 1) obtaining a special purpose telemedicine license (offered by approximately ten states), or 2) structuring an arrangement to meet the consultation exception to licensure. Massachusetts does not offer a special purpose telemedicine license, but it does have a physician licensing exception for peer-to-peer consultations. The exception states that sections two to six and section eight (of MCL Ch. 112) shall not apply “to a physician or surgeon resident in another state who is a legal practitioner therein, when in actual consultation with a legal practitioner of the commonwealth.”[vii] The statute does not define the term “actual consultation,” nor is the term defined in Massachusetts regulations. In comparison, a number of states impose more explicit restrictions on the scope and applicability of the consultation exception, including limitations on how frequently an out-of-state physician may consult with an in-state physician before the out-of-state physician must himself or herself become licensed. For Massachusetts practice, providers should keep in mind that the exception allows only consults between physician peers (not physician-to-patient) and one physician must be licensed in Massachusetts with the other physician licensed in another state.
Massachusetts Telemedicine Scope of Practice
With respect to scope of practice or specific rules regarding the use of telemedicine technologies, the Board has not implemented a well-defined set of telemedicine regulations, nor has the Board published any sub-regulatory guidance on telemedicine. Providers seeking to practice telemedicine in Massachusetts can look to other sources for guidance on practice standards, including the FSMB SMART Guidelines (published in 2014) and the specialty-specific practice guidelines published by the American Telemedicine Association.
When assessing telemedicine scope of practice, a fundamental step is the creation of a valid doctor-patient relationship, the cornerstone of all medical practice and a prerequisite to providing care in a direct-to-patient arrangement. Many states permit a physician to establish a valid doctor-patient relationship via telemedicine, and do not require the physician to conduct an in-person exam of the patient (i.e., the physician and patient physically located in the same room) in order to establish said relationship. A minority of states, however, do impose certain restrictions and/or require an in-person examination as a prerequisite to a valid doctor-patient relationship. Massachusetts has not issued any guidance on this, and the regulations are silent on telemedicine and in-person examinations, neither expressly prohibiting nor permitting them.
Beyond establishing a doctor-patient relationship, a telemedicine provider should consider the nature of services he or she will offer patients, such as consultations, diagnoses, treatment recommendations, and/or remote prescribing of medications. The provider should consider those services in light of his or her medical specialty, the patients’ needs and conditions, and acceptable standards of care in that specialty for diagnosis and treatment. The provider should determine whether or not it will utilize remote monitoring, telemedicine diagnostic peripherals, or other technology in connection with the consult. The patient’s medical records, labs, and other important information should be included with the records obtained by the telemedicine provider, depending on specialty and the nature of the telemedicine consult. Similar considerations are applicable to hospitals who want to send pathology samples to an affiliated clinical lab located in another state or country for analysis. Particular specialties or service lines — such as mental health, neurology, and radiology —demand their own specific planning and practice considerations. Informed consent should also be obtained from the patient.
One telemedicine practice that has received specific attention in Massachusetts (along with the rest of the country) is remote prescribing of medications. In Massachusetts, prescriptions must be issued for a legitimate medical purpose in the usual course of the provider’s professional practice.[viii] Board guidance states there must be a physician-patient relationship that is for the purpose of maintaining the patient’s well-being and the physician must conform to certain minimum norms and standards for the care of patients, such as taking an adequate medical history and conducting an appropriate physical and/or mental status examination and recording the results.[ix] The guidance states that issuing a prescription, by any means, including the Internet or other electronic process, that does not meet these requirements is unlawful.[x] Such “internet prescribing” or “internet pharmacy” statutes were enacted in many states in the late 1990s and early 2000s in response to the online pharmacy boom, where patients were able to purchase narcotics and other prescriptions via mail order simply by completing a brief online questionnaire. Although some states have recently revisited and revised their “internet pharmacy” policies to account for current, legitimate telemedicine remote prescribing practices, a number of states have not done so. Like Massachusetts, their internet prescribing policy is the only published guidance for telemedicine providers.
Massachusetts Telemedicine Credentialing
Hospitals and physician groups are required by law to evaluate the qualifications and competencies of their physicians. This duty is typically satisfied when a hospital conducts the medical staff credentialing process. Credentialing consists of a review of the applicant physician’s background and qualifications, including extensive document requests to obtain the information and verify the sources. Each time a physician applies for practice privileges at a new hospital, the hospital must credential that physician, which can take several months.
Recognizing a streamlined credentialing process would be particularly beneficial in telemedicine, the Centers for Medicare and Medicaid Services (CMS) enacted regulations in modifying the credentialing and privileging processes for distant site telemedicine providers.[xi] CMS and the Joint Commission (TJC) implemented a distant-site credentialing approach for telemedicine providers. Under these “credentialing by proxy” rules, if a physician is currently credentialed at Hospital A, and subsequently applies for privileges to provide services via telemedicine only at Hospital B, the credentialing file and information developed by Hospital A may be used “by proxy” by Hospital B in connection with Hospital B’s evaluation and decision whether or not to grant the physician telemedicine privileges.
Note, Hospital B still has a legal duty to perform credentialing and quality assurance because the practice of medicine is deemed to occur where the patient is located. There are additional requirements set forth in the regulations and TJC standards before a hospital may utilize credentialing by proxy. Ultimately the approach facilitates the use of telemedicine services and is a particular benefit to rural hospitals in need of telemedicine-based consults from specialists located at other hospitals.
In Massachusetts, physician credentialing is subject to oversight by the Board. Despite the benefits and efficiencies offered through the credentialing by proxy rule, the Board has not yet endorsed distant-site credentialing. This leaves only the traditional “primary source credentialing” approach available to hospitals in Massachusetts.
Because of this, Massachusetts providers continue to bear a significant administrative burden for credentialing of distant site applicants, with no quality improvement benefit. The unavailability of credentialing by proxy inhibits patient access to specialist care via telemedicine and generates higher hospital administrative costs for credentialing. Indeed, following the CMS credentialing rule changes, many states revised their regulations to expressly permit credentialing by proxy. Although the topic has been under consideration by the Board for several years, there has been no action taken to date.
The Massachusetts standards for certification of an ACO already include a standard to promote patient-centeredness by demonstrating approaches to engage patients at home through methods such as telemedicine.[xii] If the Board takes action to enable credentialing by proxy, sending its clear and definite support for distant site credentialing in Massachusetts, hospitals can further enhance their ACO development efforts.
Massachusetts Telemedicine Reimbursement
For providers with limited or no experience in securing commercial and government reimbursement for telemedicine services, arrangements other than private pay or private contracting can be a challenge. While the traditional health care delivery model was historically based on a face-to-face in-person encounter between a physician and a patient, many telemedicine delivery models can provide high quality health care, including robust face-to-face encounters, without an in-person visit or geographical restrictions. In addition to provider-to-provider service contracts and patient self-pay models, the main telemedicine reimbursement options are Medicare, Medicaid, and commercial insurance. However, as discussed below, Massachusetts law and regulation can still achieve much to promote telemedicine access in the Commonwealth.
Current Medicare coverage of telemedicine services (called telehealth by CMS) is relatively limited. With the exception of Hawaii and Alaska (which reimburse for asynchronous services), Medicare only covers a limited set of face-to-face interactive telemedicine consultation services and the patient must be located at an “originating site” in a health care professional shortage area (HPSA) or a county outside a Metropolitan Statistical Area (MSA), with the telemedicine physician located at a “distant site.”[xiii] The “originating site” must be a medical facility and cannot be the patient’s home. For 2015, CMS introduced an expansion of coverage for telehealth services, including an opportunity for telemedicine-based chronic care management, but the telemedicine industry looks forward to a greater expansion of Medicare telemedicine coverage in the future.[xiv]
With respect to Medicaid coverage of telemedicine services, approximately 47 states offer some form of Medicaid reimbursement for services provided via telemedicine.[xv] Generally, states cover only face-to-face interactive video, but a minority of states reimburse for asynchronous telemedicine and remote monitoring services. Massachusetts is in the minority of states that do not cover any telemedicine services as a Medicaid fee for service benefit, although Massachusetts does have a select number of Medicaid managed care plans that cover telemedicine services.[xvi]
Nationwide, state legislatures are enacting laws mandating that commercial health insurance companies cover telemedicine services to the same extent they cover in-person services as well as laws requiring commercial insurers to pay providers the same rate for telemedicine services as for in-person services (i.e., payment parity). Currently, approximately 22 states plus the District of Columbia have enacted telemedicine commercial insurance laws, with legislation under discussion or development in at least a dozen more states.
Massachusetts enacted a telemedicine insurance statute in 2012 that at the time appeared promising for healthcare providers and patients seeking commercial insurance coverage of telemedicine services.[xvii] The statute, “Coverage for Telemedicine Services,” states that “[c]overage for health care services under this section shall be consistent with coverage for health care services provided through in-person consultation.”[xviii] Unfortunately for providers and patients seeking greater telemedicine access, a number of commercial insurers took the position that, based on the location of the statute within Chapter 224 section 158, the statutory telemedicine language did not require them to affirmatively cover telemedicine services as a health insurance benefit. The result was that patients with Massachusetts health insurance were not able to enjoy coverage of telemedicine services under their insurance policies. Since then, healthcare providers have had difficulty negotiating with insurers to include telemedicine as a covered service. Enacting a law requiring all public and private payers in Massachusetts to cover telemedicine services – and reimburse for these services at rates equal to the rates paid for identical in-person services – would represent a significant step forward toward promotion and utilization of telemedicine services in Massachusetts.
As more policymakers, industry professionals, and patients lend their support to telemedicine, we will continue to see meaningful development and expansion of these services across the United States. While Massachusetts has made some efforts in this area, and its world-class healthcare community continues to push forward with innovative telemedicine delivery models, notable opportunities remain for Massachusetts to facilitate telemedicine growth, particularly credentialing by proxy and commercial insurance payment laws. As the telemedicine industry continues to innovate, policy leaders will eventually be compelled to catch up with the needs of patients, and providers (along with their legal counsel) will do well to monitor the trends and developments in Massachusetts.
George Leehan, MPA ([email protected]) is a candidate for Juris Doctor at Suffolk University Law School (’16) and a student member of the Boston Bar Association. He is a graduate of Suffolk University’s Master of Public Administration program. His professional experience comprises 15 years collaborating with medical management on process-improvement initiatives in ambulatory care systems, including entities such as Atrius Health/Harvard Vanguard Medical Associates and the Massachusetts General Physicians Organization.
Sarah Sossong, MPH, FACHE ([email protected]) is the co-founder and Director of TeleHealth for Massachusetts General Hospital, leading the design and implementation of new strategies utilizing telehealth technology platforms to support the organization’s transformation of health care. Sarah received her Master’s in Health Policy and Management at the University of California at Berkeley and graduated magna cum laude from Princeton University with a BA in History and Minors in Spanish Literature and Latin American Studies. Learn more at www.massgeneral.org/telehealth.
Nathaniel Lacktman, Esq. ([email protected]) is a partner with Foley & Lardner and a member of the firm’s Health Care Industry Team. One of his primary practice areas is telemedicine and he advises a range of providers – including hospitals, clinics, physician groups and start-up companies – on the emerging opportunities and regulatory issues presented by telemedicine. A graduate of the University of Southern California School of Law, his practice can be found at www.foley.com/telemedicine.
[i] Other related issues such as corporate practice of medicine, anti-kickback, self-referral, privacy/security, supervision of non-physician practitioners, and federal laws (including FDA medical device rules for mHealth) are important legal considerations for telemedicine arrangements, but for intra-Massachusetts telemedicine arrangements, those laws and rules remain the same as for Massachusetts brick and mortar arrangements.
[ii] See, e.g., “Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine”, Federation of State Medical Boards (April 2014); see also “What is Telemedicine?”, American Telemedicine Association (December 2014).
[iii] 243 C.M.R. § 2.01.
[v] Reaffirmed MMS House of Delegates, 5/21/11.
[vi] AL, DC, ME, NV, SD, TX, UT, VT, WA, WI, WV, and WY.
[vii] M.G.L. Ch. 112 § 7.
[viii] M.G.L. Ch. 94C § 19(a).
[ix] Board Policy No. 03-06, “Internet Prescribing,” (Dec 17, 2003).
[xi] 42 C.F.R. § 482.12, § 482.22(a)(3), § 485.616(c), § 485.635, § 485.641(b)(4); see also TJC Standards LD.04.03.09, MS.13.01.01.
[xii] M.G.L. Ch. 6D § 15(b)(8).
[xiii] See, 42 C.F.R. § 410.78.
[xiv] 76 Fed. Reg. 67547 (Nov 13, 2014).
[xv] L. Thomas, G. Capistrant, “State Telemedicine Gaps Analysis: Coverage & Reimbursement”, American Telemedicine Association (September 2014).
[xvii] M.G.L. Ch. 175 § 47BB.
[xviii] Id. at (d).