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Shedding Light on Telemedicine & Online Prescribing: The Need to Balance Access to Health Care and Quality of Care

Published online by Cambridge University Press:  01 January 2021

Abstract

The issue of online prescribing through the use of telemedicine raises ethical concerns. In particular, several studies suggest a correlation between telemedicine and overprescribing. Meanwhile, new developments in the law also have the potential to significantly impact online prescribing using telemedicine. In the absence of concrete federal guidance and a continued delay in issuing required federal regulations, states have developed their own laws, which vary considerably, regarding the ability of physicians to engage in online prescribing through telemedicine. As legal developments open doors for physicians to prescribe through telemedicine, current evidence of overprescribing, although limited, suggests the need to carefully balance access to health care and quality of care in this context, especially when crafting innovative legislative responses.

This article attempts to explore this dynamic issue by closely evaluating the research on overprescribing involving telemedicine and the ethical issues surrounding online prescribing. It will continue by analyzing the current legal landscape for online prescribing for telemedicine at both the federal and state levels. Next, this article will examine ethics opinions offered by medical groups that touch this issue. Finally, this article will suggest several recommendations for law and policy moving forward by shedding light on the ethical issues surrounding telemedicine and online prescribing and how to strike a balance between access and quality of care.

Type
Articles
Copyright
Copyright © 2020 American Society of Law, Medicine & Ethics Boston University School of Law

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References

1 Telehealth up 53%, growing faster than any other place of care, American Medical Association (May 29, 2019), https://www.ama-assn.org/practice-management/digital/telehealth-53-growing-faster-any-other-place-care [https://perma.cc/QL6Z-5Z8Z].

2 Arun Hedge, U.S. Telemedicine Market to hit $64 billion by 2025: Global Market Insights, Inc., Global Newswire (Sept. 26, 2019), https://www.globenewswire.com/news-release/2019/09/26/1921181/0/en/U-S-Telemedicine-Market-to-hit-64-billion-by-2025-Global-Market-Insights-Inc.html [https://perma.cc/C3YW-XZZN].

3 See generally American Telemedicine Association, https://www.americantelemed.org/about-us [https://perma.cc/TL6H-SQP3].

4 About Telemedicine, American Telemedicine Association, http://legacy.americantelemed.org/about/telehealth-faqs- [https://perma.cc/BM6T-3Z3V].

5 Id.

6 Id.

7 Id.; see also What's the difference between telemedicine and telehealth?, American Academy of Family Physicians, https://www.aafp.org/media-center/kits/telemedicine-and-telehealth.html [https://perma.cc/95WU-DNHH] (“Telehealth is different from telemedicine in that it refers to a broader scope of remote health care services than telemedicine. Telemedicine refers specifically to remote clinical services, while telehealth can refer to remote non-clinical services.”); What is Telehealth?, American Academy of Pediatrics, https://www.aap.org/en-us/professional-resources/practice-transformation/telehealth/Pages/What-is-Telehealth.aspx [https://perma.cc/ZG8H-SCNW] (providing distinct definitions of “telemedicine” and “telehealth” but deferring to the ATA's position on the terms being synonymous or interchangeable).

9 Id.

10 Id.

11 Id.

12 Id.

13 Id.

14 Id.

15 Id.

16 Id.

17 National Policy: Online Prescribing, Center For Connected Health Policy, https://www.cchpca.org/telehealth-policy/online-prescribing [https://perma.cc/8L6U-KVAU].

18 Id.

19 Id.

20 Id.

21 Id.

22 Tania Elliot & Jennifer Shih, Direct to Consumer Telemedicine, 19 Current Allergy Asthma Rep. 1 (2019) (“The term direct to consumer has historically referred to pharmaceutical industry tactics to advertise directly to the patient as opposed to the healthcare provider. Today, a direct to consumer approach is the ability to make healthcare instruction free and easily accessible to any patient, anywhere, anytime. Key aspects of direct to consumer healthcare include seamless connectivity—access on demand, wherever an individual is located; mobile technology—online scheduling, no-wait check-in, online encounters, and remote monitoring; individual choice—personalizing and providing optionality; and proximity—immediate and simple access points to the healthcare system for any and all of their needs.”)

23 Id. at 2.

24 Id.

25 Id.

26 Id.

27 Id. at 3.

28 Id. at 2.

29 Id.

30 Tara Jain et al., Prescriptions on Demand The Growth of Direct-to-Consumer Telemedicine Companies, 322 JAMA 925, 925 (July 26, 2019)(“More recently, DTC drug telemedicine has become increasingly popular as a model of care delivery.”)

31 Id.

32 Eric Wicklund, CVS Health Expands Direct-to-Consumer Telehealth Service to 26 States, Xtelligent Healthcare Media (July 11, 2019), https://mhealthintelligence.com/news/cvs-health-expands-direct-to-consumer-telehealth-service-to-26-states [https://perma.cc/AY67-8UMX].

33 Eric Wicklund, Rite Aid Launches Telehealth Program With Direct-to-Consumer Kiosks, Xtelligent Healthcare Media (July 30, 2019), https://mhealthintelligence.com/news/rite-aid-launches-telehealth-programs-with-direct-to-consumer-kiosks [https://perma.cc/66UC-DPYW].

34 Eric Wicklund, Amazon Makes its Move: DTC Telehealth Service Opens for Employees, Xtelligent Healthcare Media, (Sept. 25, 2019), https://mhealthintelligence.com/news/amazon-makes-its-move-dtc-telehealth-service-opens-for-employees [https://perma.cc/7KMJ-QSME].

36 Does Telemedicine Lead to Overprescribing?, Robert J. Waters Center For Telehealth And E-Health (Oct. 10, 2018), https://ctel.org/2018/10/does-telemedicine-lead-to-overprescribing [https://ctel.org/2018/10/does-telemedicine-lead-to-overprescribing].

37 Id.

38 See, e.g., id.; Kristin N. Ray et al., Antibiotic Prescribing During Pediatric Direct-to-Consumer Telemedicine Visits, 143 Pediatrics 1 (2019).

39 Ray, K. et al. Antibiotic Prescribing During Pediatric Direct-to-Consumer Telemedicine Visits, 143 Pediatrics 1 (2019).

40 Id. at 4.

41 Id.

42 Does Telemedicine Lead to Overprescribing?, supra note 36.

43 Martinez, Kathryn A. et al., Antibiotic Prescribing for Respiratory Tract Infections and Encounter Length: An Observational Study of Telemedicine, 170 Annals of Internal Med. 275, 275 (2019)CrossRefGoogle ScholarPubMed.

44 Id. at 277.

45 Id. at 276.

46 Does Telemedicine Lead to Overprescribing?, supra note 36 (“But for the telemedicine physicians, who are getting paid by the volume of patients they treat, even a small increase in the time of each encounter can be a detriment.”).

47 Id.

48 Martinez et al., supra note 43, at 277.

49 Antibiotics Prescribed as Often During Telemedicine Appointments as During Face-to-Face Examinations, Rand Corp. (May 27, 2015), https://www.rand.org/news/press/2015/05/27/index2.html [https://perma.cc/A4LA-X4K5].

50 Id.

51 Id.

52 Uscher-Pines, Lori et al., Antibiotic Prescribing for Acute Respiratory Infections in Direct-to-Consumer Telemedicine Visits, 175 JAMA 1234, 1235 (2015)Google ScholarPubMed (“When antibiotics were prescribed, Teladoc used more broad-spectrum antibiotics. This is concerning because overuse increases costs and contributes to antibiotic resistance. Greater use of broad-spectrum antibiotics may be driven by the tendency for physicians serving DTC companies to practice conservatively, with limited diagnostic information. DTC companies can work to lower rates through targeted quality-improvement initiatives to change physician behavior (eg, timely feedback), as well as direct education to patients to influence demand.”).

53 Jay Shore, Ryan Haight Online Pharmacy Consumer Protection Act of 2008, American Psychiatric Association, https://www.psychiatry.org/psychiatrists/practice/telepsychiatry/toolkit/ryan-haight-act [https://perma.cc/TYF7-ZCTW] (“The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was created to regulate online internet prescriptions, is enforced by the DEA (Drug Enforcement Agency) and also imposes rules around the prescription of controlled substances through telepsychiatry (live interactive videoconferencing).”).

54 Ryan Haight Online Pharmacy Consumer Protection Act of 2008, Pub. L. No. 110-425, § 2(e)(1), 122 Stat. 4820, 4820 (2008) (“No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.”).

55 Id.

56 Id.

57 Id.

58 Id.

59 Ryan Haight Online Pharmacy Consumer Protection Act of 2008, supra note 54.

60 Id. (“(E) is being conducted by a practitioner who has obtained from the Attorney General a special registration under section 311(h)”.).

61 Eric Wicklund, ATA Presses DEA to Loosen Telemedicine Restrictions for Prescribing, Xtelligent Healthcare Media (Jan. 16, 2019), https://mhealthintelligence.com/news/ata-presses-dea-to-loosen-telemedicine-restrictions-for-prescribing [https://perma.cc/7DKD-PQFU].

62 Id.

63 Cong. Research Serv., RL45240, The Special Registration for Telemedicine: In Brief, (updated Dec. 7, 2018), https://fas.org/sgp/crs/misc/R45240.pdf [https://perma.cc/GY6W-DMPR] (“According to the Association of American Medical Colleges (AAMC), ‘[t]he United States is suffering from a dramatic shortage of psychiatrists and other mental health providers.’ 1 There were an estimated 111 million people living in areas that have a limited number of mental health providers, as of September 2017.2 The shortage of mental health providers is of concern to some because an estimated 50% of all Americans are diagnosed with a mental illness or disorder at some point in their lives, according to the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (HHS).”).

64 Id.

65 President Donald J. Trump is Taking Action on Drug Addiction and the Opioid Crisis, The White House (Oct. 26, 2017), https://www.whitehouse.gov/briefings-statements/president-donald-j-trump-taking-action-drug-addiction-opioid-crisis [https://perma.cc/BCQ5-EA8Z].

66 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, Pub. L. No. 115-271 (2018).

67 Id. at § 3232.

68 Id. (“Regulations Relating To A Special Registration For Telemedicine. Section 311(h)(2) of the Controlled Substances Act (21 U.S.C. 831(h)(2)) is amended to read as follows: “Not later than 1 year after the date of enactment of the SUPPORT for Patients and Communities Act, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying (A) the limited circumstances in which a special registration under this subsection may be issued; and (B) the procedure for obtaining a special registration under this subsection.”).

69 Id.

70 Letter from American Telemedicine Association to Kathy L. Federico, Acting Section Chief, Regulatory Drafting and Support Section/Diversion Control Division, Department of Justice Drug Enforcement Administration (Jan. 9, 2019), https://www.foley.com/en/insights/publications/2019/01/-/media/3b234b16498a4d4f9199dade093943fe.ashx [https://perma.cc/8BVP-MR46].

71 Id. (“1. Update the current DEA registration process to specify distinctions between traditional and telemedicine prescribing privileges. 2. Allow both sites and prescribers to register for telemedicine. 3. Allow for a public comment period within the one-year timeline for special registration activation. 4. Ensure that telemedicine special registration is not restricted to any single discipline. 5. Allow telemedicine prescribers to apply for DEA registration numbers in multiple states at once.”).

72 Eric Wicklund, CTeL Presses DEA to Set Ground Rules for Prescribing by Telehealth, Xtelligent Healthcare Media (Sept. 16, 2019), https://mhealthintelligence.com/news/ctel-presses-dea-to-set-ground-rules-for-prescribing-by-telehealth [https://perma.cc/Y9T6-CZ2Z].

73 Eric Wicklund, DEA to Launch Registration Process for Prescriptions by Telemedicine, Xtelligent Healthcare Media (Nov. 21, 2019), https://mhealthintelligence.com/news/dea-launches-registration-process-for-prescriptions-bytelemedicine?eid=CXTEL000000380109&elqCampaignId=12476&utm_source=nl&utm_medium=email&utm_campaign=newsletter&elqTrackId=ae11dbe00b534817a97c2a7c46e0613d&elq=c3780875fb3a4c28b0583933cf4167fb&elqaid=13076&elqat=1&elqCampaignId=12476 [https://perma.cc/53ZQ-VY5V]; see Special Registration to Engage in the Practice of Telemedicine, Office of Information and Regulatory Affairs, Dep't of Justice, https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=1117-AB40 [https://perma.cc/EMH7-G9FR]. At the time of the writing of this article, the proposed regulations have not been made public.

74 See Letter from Patty Murray, Elizabeth Warren & Ann McLane Kuster, U.S. Sens. & Member of Cong., to Uttam Dhillon, Acting Adm'r., U.S. Drug Enf't Admin. (Jan. 17, 2020), https://www.help.senate.gov/imo/media/doc/01172020%20DEA%20Letter%20final%20PDF.pdf [https://perma.cc/YD33-NEMN]; see also Letter from Mark R. Warner, U.S. Sen., to Uttam Dhillon, Acting Adm'r., U.S. Drug Enf't Admin. (Jan. 17, 2020), https://www.warner.senate.gov/public/_cache/files/0/d/0dfe6c6c-785b-45d6-aee2-484ed6062498/82C503BFD576541E2FFF180BC7B0A5BF.01.17.20-letter-to-dea-on-telehealth.pdf [https://perma.cc/L3YX-5YPM].

75 Center for Connected Health Policy, State Telehealth Laws & Reimbursement Policies (2019), https://www.telehealthpolicy.us/sites/default/files/2019-10/50%20State%20Telehalth%20Laws%20and%20Reibmursement%20Policies%20Report%20Fall%202019%20FINAL.pdf [https://perma.cc/XN74-Y7GK] [hereinafter State Telehealth Laws].

76 Id.

77 Id.

78 Id. at 5.

79 Id.

80 See supra text accompanying notes 4-7.

81 State Telehealth Laws, supra note 75.

82 Id.

83 Eric Wicklund, States Lead the Ways in Adapting Telehealth to Meet Mental Health Needs, Xtelligent Healthcare Media (Feb. 10, 2020), https://mhealthintelligence.com/news/states-lead-theway-in-adapting-telehealth-to-meet-mental-health-needs [https://perma.cc/22E6-NBB9].

84 State Telehealth Laws, supra note 75.

85 Id.

86 Id.

87 See Center For Connected Health Policy supra note 17.

88 State Telehealth Laws, supra note 75.

89 Id.

90 Id.

91 Charles C. Dunham IV, Will Federal Special Registration Exception Preempt More Stringent State Rules on Remote Prescribing of Controlled Substances?, Nat'l L. Rev., Mar. 21, 2020, https://www.natlawreview.com/article/will-federal-special-registration-exception-preempt-more-stringent-state-rules [https://perma.cc/KZS9-7H7E].

92 State Telehealth Laws, supra note 75.

93 Center for Connected Health Policy, State Telehealth Laws & Reimbursement Policies 9 (2019).

94 Id. (“For example, while more stringent policies typically exist restricting practitioners from prescribing controlled substances through telehealth, a few states have begun opting to explicitly allow for the prescribing of controlled substances within federal limits. Many of these laws have passed as a result of the opioid epidemic and the need to prescribe certain medications associated with medication assisted therapy (MAT). In addition to more states explicitly allowing for the prescribing of controlled substances using telehealth, some Medicaid programs are also beginning to pay for medication therapy management services when provided through telehealth including IN, MN, MI and LA.”).

95 Lois Snyder Sulmasy & Thomas A. Bledsoe, American College of Physicians Ethics Manual: Seventh Edition, Annals of Internal Med. (Jan. 15, 2019) (“Medicine, law, and social values are not static. Reexamining the ethical tenets of medicine and their application in new circumstances is a necessary exercise. The seventh edition of the American College of Physicians (ACP) Ethics Manual covers emerging issues in medical ethics and revisits older ones that are still very pertinent. It reflects on many of the ethical tensions in medicine and attempts to shed light on how existing principles extend to emerging concerns. In addition, by reiterating ethical principles that have provided guidance in resolving past ethical problems, the Manual may help physicians avert future problems. The Manual is not a substitute for the experience and integrity of individual physicians, but it may serve as a reminder of the shared duties of the medical profession.”).

96 Id.

97 Id. (“Aspects of a patient–physician relationship, such as the physician's responsibilities to the patient, remain operative even in the absence of in-person contact between the physician and patient.”).

98 Id. (“‘Issuance of a prescription or other forms of treatment, based only on an online questionnaire or phone-based consultation does not constitute an acceptable standard of care.’ Exceptions to this may include on-call situations in which the patient has an established relationship with another clinician in the practice and certain urgent public health situations, such as the diagnosis and treatment of communicable infectious diseases. An example is the Centers for Disease Control and Prevention–endorsed practice of expedited partner therapy for certain sexually transmitted infections.”).

99 Id.

100 Id.

101 Id. (“Communication through e-mail or other electronic means can supplement in-person encounters; however, it must be done under appropriate guidelines. E-mail or other electronic communications should only be used by physicians in an established patient–physician relationship and with patient consent.”)

102 Ethical Practice in Telemedicine, American Medical Association, https://www.amaassn.org/delivering-care/ethics/ethical-practice-telemedicine [https://perma.cc/35UV-8S8A].

103 Id.

104 Id. (“Recognize the limitations of the relevant technologies and take appropriate steps to overcome those limitations. Physicians must ensure that they have the information they need to make well-grounded clinical recommendations when they cannot personally conduct a physical examination, such as by having another health care professional at the patient's site conduct the exam or obtaining vital information through remote technologies.”).

105 Id. (“Be prudent in carrying out a diagnostic evaluation or prescribing medication by: 1. Establishing the patient's identity; 2. Confirming that telehealth/telemedicine services are appropriate for that patient's individual situation and medical needs; 3. Evaluating the indication, appropriateness and safety of any prescription in keeping with best practice guidelines and any formulary limitations that apply to the electronic interaction; 4. Documenting the clinical evaluation and prescription”).

106 Eric Wicklund, ACP Supports Telemedicine Standards in Latest Ethics Manual Update, XTELLIGENT HEALTHCARE MEDIA, (Jan. 16, 2019), https://mhealthintelligence.com/news/acp-supports-telemedicine-standards-in-latest-ethics-manual-update [https://perma.cc/GX6C-RE73].

107 State Telehealth Laws, supra note 75.

108 Id.

109 See Ray KN et al., Antibiotic Prescribing During Pediatric Direct-to-Consumer Telemedicine Visits, National Center for Biotechnology Information (Apr. 8, 2019), https://www.ncbi.nlm.nih.gov/pubmed/30962253 [https://perma.cc/SZ23-FFBX].

110 Id.

111 See Jain et al., supra note 30.