My Telehealth Patient Took an At-Home Test. Now What?
When a patient reports the results of an at-home, direct-to-consumer (DTC) test, can you base your treatment on those results? We discuss the risks and rewards of integrating DTC testing into your telehealth practice.
With a third of the nation under stay-at-home orders, medical practitioners wonder how to continue providing routine patient care. While telemedicine offers options for discussing symptoms and potential treatments, it doesn’t allow for lab testing or physical examinations. How can a provider determine when in-person care is necessary, especially when the likely illnesses aren’t life-threatening? For some patients and providers, a combination of telemedicine and at-home testing kits offers an imperfect solution.
The Rise of At-Home Lab Tests
Direct-to-consumer lab testing kits have exploded in popularity. And now, some companies are well-positioned to develop at-home COVID-19 tests, which they’ll sell directly to patients. Patients will order these tests on the company’s website for a fee (likely not covered by insurance), and they’ll receive the testing kit within a few days.
The kit includes sample-collection tools and return shipping materials. The tests promise a result within 48 hours, and positive tests will trigger an invitation to schedule a telemedicine consultation with a physician. Alternately, the patient might choose to share the results with a primary care provider and seek guidance about the next steps. The companies will share test results with federal and state reporting agencies.
Potential Clinical Value of At-Home COVID-19 Tests
A positive COVID-19 test result can be of invaluable clinical use. First, it keeps asymptomatic or minimally symptomatic patients away from the emergency room. Second, in light of very limited testing in hospitals, it provides valuable diagnostic information that may not have been available in the community. With a positive test result in-hand, you’re able to monitor your patient via telemedicine and manage their self-quarantine without risking exposure to others in your office or hospital.
At-Home Testing for High-Risk Patients
For practitioners who treat patients at higher risk of COVID-19 complications—those who are elderly, immunocompromised, or pregnant—DTC tests may also play an important role in confirming patients’ health status. Many physicians treat elderly patients who have recently returned from vacations including cruises. Confirming, rather than assuming that they are free of the virus can be of immense clinical use, should the patient begin showing symptoms of a common cold or virus. By validating that the patient does not have COVID-19, you can better manage the patient’s symptoms via telemedicine, potentially via home visit and more conservative measures.
Healthcare Workers and At-Home Testing
Healthcare workers on the front lines of the pandemic might also find utility in DTC COVID-19 tests, especially if their employers and municipalities have inadequate supply. To ensure your continued health and safety, you might purchase several of these tests to monitor your own COVID-19 status on a rolling basis. DTC tests could also help monitor the health of your family, especially if you carry the virus and worry that you infected spouses or children before a self-quarantine.
COVID-19 Test Validity Issues
When testing for COVID-19, it’s crucial to acknowledge the potential for false negatives— mainly due to the test’s awkward nasopharyngeal swabbing. If a symptomatic patient’s test produces a negative result, your clinical judgment, and an in-person test performed by a medical practitioner, may dictate more aggressive follow-up care.
Finally, it is imperative that healthcare practitioners verify the type of test that the patient has used. While there are legitimate testing companies planning to offer direct-to-consumer options, unscrupulous players are already hawking at-home tests to an anxious public. Confirm the testing company and laboratory with your patient, and request a copy of the actual test results.
CBP officers seized suspected counterfeit COVID-19 test kits. At-home COVID-19 test kits found online are fake. Authorized testing for COVID-19 is conducted in verified state & local public health labs across the US.— CBP (@CBP) March 14, 2020
Read more: https://t.co/U9hdERABkN pic.twitter.com/WeYKQfq3ES
Current State of DTC COVID-19 Testing
On March 23, 2020, the Food and Drug Administration released a statement, putting potential DTC COVID-19 testing companies on notice. The FDA intends to “actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus diagnostic, prevention and treatment claims.” The FDA also confirmed that, as of now, they have not authorized any at-home testing kits for COVID-19.
As a result of this guidance from the FDA, Nurx, Carbon Health, and Everlywell have officially halted their immediate plans to launch DTC testing kit services. However, a few other startups, including Scanwell Health, are attempting to obtain Emergency Use Authorization (“EUA”) from the FDA. EUA allows the FDA Commissioner to allow unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases.
Using DTC Tests for Routine Healthcare
As practices seek to steer patients out of their waiting rooms and onto telehealth platforms, at-home test kits for routine health problems also become more clinically useful. Take, for example, a female patient presenting with urinary pain; typically, her provider would ask that she come into the office for a visit and produce a urine sample. Because of the pandemic, she is asked to stay home unless her concern is emergent. How, then should practitioners handle situations where laboratory or clinical intervention is necessary to investigate an acute issue?
One answer: at-home testing kits for common ailments such as UTI, yeast infection, sexually transmitted diseases, and even strep throat. When a patient receives results, you can schedule a telemedicine visit to discuss the next steps or prescribe medications. DTC testing may also help you monitor chronic issues like vitamin D deficiencies, thyroid hormone levels, and cholesterol. If you’re concerned that an office visit could risk your patient’s health, at-home tests may be a reasonable stand-in for traditional in-office testing
Importantly, many of these testing services drive revenue by connecting the patient with one of the company’s own telehealth providers. If you recommend that a patient use one of these services, you may not hear about the results. Why? It’s likely that your patient was funneled into a DTC company-driven telemedicine visit.
Legal Risks of Relying on At-Home Testing
One question that arises most is some variation of: “My patient says their at-home UTI test is positive. Can I prescribe antibiotics right away, or do they need to come into the office?” The answer, as with most things in law, is “it depends.”
Clinical Judgement Matters
When deciding whether to act upon an at-home test result, you’ll need to weigh a few factors, including
- your clinical assessment of the patient’s medical history and substantiated belief about their likely diagnosis
- whether this is a new or chronic issue
- whether your patient is in a subgroup particularly vulnerable to COVID-19, elevating the risk of an in-office evaluation
- your confidence in the test’s reliability
You should also consider the risks of relying upon a false positive at-home test, such as prescribing medically-unnecessary antibiotics.
In general, relying upon negative home test results may pose a greater risk. For example, a patient whose at-home COVID-19 test reveals a negative result may still have the virus. In this case, a failure to insist upon an in-person visit and professionally-administered test might have disastrous consequences. The same applies for testing that is either difficult to self-administer or for which a false negative would be particularly dangerous, such as a highly-communicable sexually-transmitted infection.
DTC Testing Product Standards
As this method of testing becomes increasingly popular, practitioners should also do their homework. Learn about the common types of at-home tests available, the standards for CLIA-certified laboratories, and the companies selling these tests. Rigorous requirements apply to the marketing, sales, and manufacturing operations of DTC laboratory companies.
Unfortunately, many DTC testing companies are owned by non-medical personnel. Such leadership may not grasp the highly-regulated nature of healthcare. As such, beware of at-home testing products touted by social media “influencers” with glossy marketing campaigns. These companies may be operating with flagrant disregard for applicable federal and state laws—at least until the government shuts them down. A few years ago, the FDA warned off a company selling at-home pap smear tests without FDA approval.
The bottom line? The COVID-19 pandemic has raised the profile of mail-order, at-home testing. It’s also useful for patients who simply struggle to visit your office during business hours. Others may find an over-the-counter test more cost-effective than your office’s testing. Tread carefully in this emerging area of medicine. You can cautiously integrate reliable testing options into your practice, combining them with telemedicine consultations when they can facilitate safe and clinically-appropriate patient encounters.
The COVID-19 pandemic is a dynamic and evolving public health emergency. The laws and situation are fluid, and this article may not reflect the most current situation.
This blog is made for educational purposes and is not intended to be specific legal advice to any particular person. It does not create an attorney-client relationship between our firm and the reader and should not be used as a substitute for competent legal advice from a licensed attorney in your jurisdiction.