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Sleep Telemedicine Legal Tips and Traps

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telemedicine laws

Telemedicine is an emerging tool for sleep medicine practitioners to reach and engage with patients. Unfortunately, telemedicine practitioners’ use of 21st century technologies is sometimes limited by medical practice laws and regulations modeled on 20th century healthcare methods. Here are some legal dos and don’ts to consider when adopting telemedicine.

Definitions

In its broadest sense, telemedicine can be defined as the remote provision of healthcare services using electronic information and telecommunications technologies.1 The breadth of this definition runs the gamut from fax machines, telephones, and e-mails to texting, laptop videoconferencing, and social media postings.

The Federation of State Medical Boards proposes a more specific and limiting definition for use by state medical licensing boards. It defines telemedicine as the practice of medicine using electronic communications, information technology, or other means between a licensee in one location, and a patient in another location with or without an intervening healthcare provider.2 According to the definition’s authors, telemedicine is not an audio-only, telephone conversation, e-mail/instant messaging conversation, or fax. Rather, it involves the application of secure videoconferencing or store and forward technology to provide or support healthcare delivery by replicating the interaction of a traditional encounter in person between a provider and a patient.

The Federation’s definition distinguishes the transmission of electronic medical data from the physician’s role in establishing and following patient care via telecommunications. For example, medical boards and payors are comfortable with radiologists reading film from afar or sleep physicians reviewing sleep test data across the Internet. In most of these cases, the interpreting specialist has not examined or even seen the patient either in person or via electronic means. Still, it has long been acceptable for a distant physician to assess the patient’s electronic images or sleep test data in order to detect aberrations and recommend diagnoses like obstructive sleep apnea (OSA).

Payors and medical boards view distant assessments for treatment purposes more strictly. Many require practitioners to obtain a full history and physical exam of the patient, either face-to-face in person or via real-time electronic means, before allowing the distant practitioner to diagnose a disease or prescribe drugs or devices to treat the patient’s medical condition. In these states, diagnosing OSA or prescribing CPAP based solely on Internet questionnaires or Epworth scores could be considered substandard medical care.

Legal Tips and Traps

1. Be on Top of the Latest Rules. State medical boards’ medical standards for telemedicine practice can change frequently in response to new technologies. For example, Georgia updated its 2008 Telemedicine Practice rule in January 2014. In April 2014, the Federation of State Medical Boards adopted a Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine. The Model Policy serves as guidance to state medical boards for regulating the use of telemedicine technologies in the practice of medicine and educating licensees as to the appropriate standards of care in the delivery of medical services via telemedicine.2 Practitioners should check with their licensing authorities from time to time to be sure their telemedicine protocols are compliant.

2. Hold a Medical License in the State Where the Patient Receives Care. Most states and the Model Policy define the place of providing medical care as the location of the patient at the time that telemedicine is used.2 So a physician who interacts with a distant patient should hold a license to practice medicine, or otherwise be under the jurisdiction of the medical board, in the state where the patient is located at the time of performance of the medical service provided.3 With reference to the interpretation of sleep test data, the distant sleep physician should be licensed in the state where the patient received his sleep test. Almost all states define the interpretation of diagnostic tests to constitute the practice of medicine, and states have an interest in regulating medical care provided to their in-state patients regardless of the physician’s location at the time.

Sensitive to the burden of multistate licensing, the Federation has proposed a multistate agreement to streamline the process of gaining a license in multiple states.4 No state has yet adopted this arrangement. But as of June 2013, 11 state medical boards—including Oregon, Montana, and Nevada—have adopted special purpose licenses for out-of-state to practice telemedicine across state lines into their borders.5

3. Interpretation of a Sleep Test Alone Can Create a Physician-Patient Relationship. Rules vary between different jurisdictions as to what qualifies as a “physician-patient relationship” and the implications of these relationships. But like pathologists, radiologists, and other so-called “invisible specialists,” sleep physicians who do no more than read test data will likely be considered to have entered into a physician-patient relationship for malpractice purposes—even if the sleep doctor never sees or examines the patient.

4. Treat the Distant Patient Just Like an On-Site Patient. Telemedicine does not change a physician’s professional responsibilities to patients or the doctor’s legal obligations to practice under applicable law. Physicians seeking to offer telemedicine should adapt their intake procedures, billing, and back-office systems to accommodate the off-site provision of medical services. Providers should consider protocols and steps: 1) identify the distant patient and obtain insurance information, 2) inform the patient about the distant provider’s identity and credentials, 3) obtain the patient’s consent to use telemedicine, and 4) document the telemedicine encounter as part of the patient’s medical records.6

5. Is It OK to Order a Sleep Test or PAP Therapy via Telemedicine? The answer depends on the scope of the telemedicine encounter and individual state law. The Federation recommends that physicians be able to prescribe medications using telemedicine. Even then, physicians are urged to use discretion based on the appropriateness and safety considerations of prescribing medication based on audiovisual examinations in lieu of in-person patient consultations.4

Medical boards in different states have come to different conclusions. For example, Idaho prohibits prescribing medication through telemedicine, and it has used sanctions against physicians who violate this policy.7 But Alabama allows physicians to prescribe medication through telemedicine under the same standards that apply to an in-person consultation, as long as a proper physician-patient relationship has been established and the evaluation does not consist of only an online or telephone questionnaire.8

Almost all states have rules against prescribing all or certain classes of drugs absent an in-person examination or, in some cases, real-time electronic consultations. Some include prescriptive devices such as sleep tests, CPAP, or oral appliances in the same category as “drugs” and others do not. As the rules for prescribing medications and devices through telemedicine are still being developed and updated in many states, your practice should check regularly with your state medical board.

6. Fraud and Abuse Laws Still Apply. Healthcare fraud and abuse statutes like the Federal Anti-kickback Statute and the prohibition on physician self-referrals (the Stark law) continue to apply to healthcare services provided through telemedicine.9 For instance, the Stark law prohibits physicians from referring patients for certain health services where the physician or an immediate family member has a financial relationship.10 Anti-kickback and Stark are complex areas of law with a number of exceptions and safe harbors, so it is best to check with your healthcare legal counsel on these aspects of telemedicine practice.

7. Can I Get Paid for Telemedicine Consults? Reimbursement rules and requirements for telemedicine vary in each state and between different third-party payors. The good news is that a majority of states, including Georgia, Maine, and Louisiana, require private insurers to reimburse telemedicine services under certain conditions. Other states, like Idaho, Kansas, and North Carolina, have not enacted this requirement.11

Medicaid reimbursement is likewise a state-by-state issue. Georgia generally makes no distinction between telemedicine and on-site consultations for Medicaid reimbursement.12 However, Idaho Medicaid severely limits reimbursement for telemedicine consultations.13

Practitioners seeking Medicare reimbursement for telemedicine services face a laundry list of restrictive coverage conditions. First, Medicare reimburses telemedicine services only if the patient is located in a rural health professional shortage area, a county not classified as a metropolitan statistical area, or any federal telemedicine demonstration location.14 Next, the consultation must occur in an acceptable “originating site” such as the office of a physician or practitioner, a hospital, a rural health clinic, or other designated facility.15 In other words, Medicare will not cover a telemedicine consultation between a distant physician and a rural patient communicating from the patient’s own home. Finally, the practitioner may require a telemedicine “presenter,” such as a nurse or medical technician, to be present in the originating site with the patient to facilitate interaction with the patient as medically necessity.16

8. Can a Sleep Physician Bill for Telephone or E-mail Consultations? Private insurance companies might cover certain types of these communications with established patients. You should check your provider contract for coverage conditions.

Medicare does not cover evaluation and management services provided to established patients over e-mail (CPT Codes 98969 and 99444) or via telephone (CPT Codes 98966-98968 or 99441-99443). Medicare pays for face-to-face services, and telemedicine services, by definition, cannot be included in a face-to-face visit. But Medicare says these electronic conversations with established patients may be taken into account when the physician is determining which level of E&M code to assign on the patient’s next claim for a face-to-face E&M visit in certain instances.17 To qualify, the practitioner must maintain proper documentation of the phone call and include the electronic communication with the next patient visit. Note that these codes contemplate communications with established patients and for new complaints outside follow-up communication relating to the most recent visit.

Interestingly, Medicare says practitioners may bill beneficiaries directly for phone calls and Internet conferences if desired.17 Because these services are noncovered, the practitioner should issue an Advanced Beneficiary Notice   to inform the patient of his personal financial obligation for the services.

9. Can a Sleep Physician Bill the New CPT Codes for Providing Specialist Consultations Electronically? Commercial payors may cover these new codes but Medicare does not. CPT codes 99446–99449 describe interprofessional consultations via the Internet or telephone. The consultation is between the patient’s treating physician who requests the consult and the specialist who provides the consultation. However, use of these codes by sleep physicians may prove impractical because the codes contemplate urgent situations where face-to-face patient contact with the consulting specialist is not reasonably possible.

10. Use the Proper Billing Codes. For certain services, unique telemedicine and telehealth modifiers and/or other billing codes may apply. For instance, Medicare requires that only certain billing codes may be used for covered telemedicine services. In addition, a –GT or –GQ modifier must be added to the billing code depending on if the telemedicine service was a real-time communication or “store[d] and forward[ed]” for review at a later time.18 Your practice should obtain guidance on coding telemedicine services to Medicare or private payors.

11. Remember HIPAA. Because healthcare providers like sleep labs are almost certainly “covered entities” under HIPAA, these providers must use HIPAA-compliant telemedicine software and procedures when performing telemedicine services. These include ensuring secure transmission and storage of data, authentication of access, audit controls, and breach notification. You should check with your vendor to ensure your telemedicine software meets HIPAA requirements. Your practice must also follow HIPAA guidelines to safeguard data retained on-site and off-site in both paper copy and electronic form.

12. Consider New FDA Regulation of Medical Devices. If your practice uses smartphone applications for telemedicine services, you should know that the software or the cell phone used in the service may be subject to FDA regulation as a medical device.19 In 2013, the FDA released guidance describing its intention to regulate certain mobile applications for smartphones as medical devices.20

For instance, mobile phone applications may be subject to FDA regulation if they use the sensors built into the smartphone, or use additional sensors attached to the smartphone, in order to measure certain patient health information for making a medical diagnosis.21 While the FDA has authority to regulate additional types of mobile applications, such as simple tools to track and organize health information, the FDA feels these items pose “a low risk to patients” and has chosen not to regulate them.22

For more information about telemedicine legal compliance, you can consult the American Telemedicine Association, the Federation of State Medical Boards, your state’s medical board, or an attorney specializing in healthcare compliance.

Daniel B. Brown, Esq, is the managing member of The Daniel Brown Law Group, LLC, in Atlanta. Brown appreciates the assistance of Jeffrey Masor, Esq, in the preparation of this article. CONTACT sleepeditor@nullallied360.com

REFERENCES

1. What is telehealth? How is telehealth different from telemedicine?, HealthIT.gov. http://www.healthit.gov/providers-professionals/faqs/what-telehealth-how-telehealth-different-telemedicine. Accessed September 9, 2014.

2. Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine, Federation of State Medical Boards 5. 2014. http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/FSMB_Telemedicine_Policy.pdf.

3. Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine, Federation of State Medical Boards 5. 2014.  http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/FSMB_Telemedicine_Policy.pdf. See also Telemedicine Overview, Federation of State Medical Boards. June 2013. http://library.fsmb.org/pdf/grpol_telemedicine_licensure.pdf.

4. Interstate Medical Licensure Compact, Federation of State Medical Boards. 2014.  http://www.fsmb.org/Media/Default/PDF/Advocacy/Interstate%20Medical%20Licensure%20Compact%20%28FINAL%29%20September%202014.pdf.

5. Telemedicine Overview, Federation of State Medical Boards. June 2013. http://library.fsmb.org/pdf/grpol_telemedicine_licensure.pdf.

6. Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine, Federation of State Medical Boards 5. 2014: page 4. http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/FSMB_Telemedicine_Policy.pdf.

7. Example: Gregg H, Idaho Physician Caught in Telemedicine Battle Crossfire, Becker’s Hospital CIO. April 28, 2014. http://www.beckershospitalreview.com/healthcare-information-technology/idaho-physician-caught-in-telemedicine-battle-crossfire.html.

8. Alabama Board of Medical Examiners: Evaluation and Treatment of the Patient, 540-X-15-.11. 2014.

9. Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine, Federation of State Medical Boards 5. 2014: page 7. http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/FSMB_Telemedicine_Policy.pdf.

10. Comparison of the Anti-Kickback Statute and Stark Law, Office of Inspector General 1. https://oig.hhs.gov/compliance/provider-compliance-training/files/StarkandAKSChartHandout508.pdf. Accessed September 8, 2014.

11. 2014 State Telemedicine Legislation Tracking (as of 9/5/2014), American Telemedicine Association. http://www.americantelemed.org/docs/default-source/policy/state-telemedicine-policy-matrix.pdf?sfvrsn=56. Accessed September 5, 2014.

12. Georgia Medicaid Telemedicine Handbook, Georgia Department of Community Health 6. November 2012. https://www.mmis.georgia.gov/portal/Portals/0/StaticContent/Public/ALL/HANDBOOKS/georgiatelemedicine%20handbook%20v5%20final%2009-11-2012%20143638.pdf.

13. Example: Medicaid Information Release MA08-01, Idaho Department of Health & Welfare. January 1, 2008.  http://www.healthandwelfare.idaho.gov/Portals/0/Providers/Medicaid/IR%20MA08-01%20Telemedicine-signed.pdf.

14. Medicare Benefit Policy Manual, Centers for Medicare & Medicaid Services. August 29, 2014. Chapter 15 § 270.

15. Medicare Claims Processing Manual, Centers for Medicare & Medicaid Services. July 25, 2014. Chapter 12 § 190.2.

16. Medicare Claims Processing Manual, Centers for Medicare & Medicaid Services. July 25, 2014. Chapter 12 § 190.4.

17. Medicare Manual Change Request 5895 (Transmittal 1423), February 1, 2008.

18. Medicare Claims Processing Manual, Centers for Medicare & Medicaid Services. July 25, 2014. Chapter 12 § 190.6.1-2. The 2014 list of approved billing codes for telemedicine under Medicare have been released. Telehealth Services, Centers for Medicare & Medicaid Services 3. April 2014. http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/telehealthsrvcsfctsht.pdf.

19. Is The Product A Medical Device?, FDA. September 12, 2014.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm. Overview of Device Regulation, FDA. June 26, 2014. http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview.

20. Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff, FDA 7-8. September 25, 2013. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf.

21. Examples of MMAs the FDA Regulates, FDA. June 4, 2014.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368743.htm.

22. Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff, FDA 7-8. September 25, 2013: pages 4, 16-18. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf. See also Mobile Medical Applications, FDA. June 4, 2014. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm255978.htm.