Pandemic and lockdowns have forced healthcare organizations to accelerate R&D of telemedicine solutions. On April 13th, 2021 I had a chance to interview Brian Levin, previous director of telehealth services at UHS. Brian has worked in telemedicine for 20 years and saw how the entire market has evolved from its very inception.
In the interview, here is what Brian had to say about COVID affecting work processes at UHS and his own involvement. “I was in the business development and my task was actually pretty much accomplished before COVID had really peaked up in March of last year. I was charged with standardizing all of the facilities using televideo and promoting the idea that telemedicine was the way to grow the business line.
My job was to standardize, get people, understanding what the responsibilities were and make sure that they did it. And that's what I did prior to lockdowns. I remember exactly the date March 13th. We had this big meeting where we discussed that we can't have any outpatients coming in for services.
We had to switch to video to continue operating. And all of a sudden, a department of one (me) became easily 30 people. Most of the senior management were involved in this project. After about 10 weeks, all programs, all facilities, were up and running to some degree with televideo services.”
Dealing with the legalities of credentialing, repayment, and malpractices is part of a healthcare business. Every telehealth software outsourcing regulation has been put up for a specific purpose.
So how does supplying the patients with remote video conferencing and interactions impact your business from a legal point of view? What is the most important telemedicine regulatory questions to be aware of?
Since telemedicine is a digital means of caring for patients, it naturally creates certain issues for physicians providing telehealth services. One of the most pressing legal questions around telemedicine is state licensing; if you've been licensed to practice medicine in a particular state, you're only allowed to treat patients in that state.
Telehealth and an integration with artificial intelligence (A.I.) was gradually gaining popularity prior to the coronavirus epidemic, but they were not widely used. COVID-19 has accelerated the use of machine learning algorithms in outsourcing telemedicine services, as seen since March 2020. However, the growing use of technology has not always been welcomed by the long-standing laws and regulations that regulate the entire health-care system. Telehealth usage was usually confined, owing to vague and frequently updating legislation governing doctor reimbursement and licensure, particularly across state lines.
In our interview with Brian, we have also discussed some issues regarding the current legislation and how it could affect the future of telemedicine.
The aim of telemedicine, however, is really to eliminate obstacles to access to health care. Fortunately, the exponential growth of technology has resulted in several legislative reforms to resolve issues. Below is a short rundown of the most important telemedicine regulatory issues to be aware of:
- Licensing: Telemedicine poses a host of legislative questions over clinical integrity and licensure. The aim of licensing health care practitioners is to ensure that they have a certain degree of experience and that medical services follow specific acceptance criteria, and to ensure state revenue flow from licensing. In the United States, for practicing in other states, doctors are required to register for full licenses as per the subject states. The states may also grant a special license, under certain terms and conditions, to doctors working across state lines. The laws vary in nature from region to region and may also change from time to time. Keeping in view the acceleration of telehealth usage due to the coronavirus pandemic, these regulations have reportedly obstructed both flow and access to proper healthtech. Vendors would need to be evaluated to ensure compliance with the government telemedicine policies.
- Standard of Care: Nowadays, digital telehealth solutions are treated with the same level of concern as in-person encounters. It is critical for doctors in telehealth to maintain and provide the best possible medical services, whether remotely or in person. To avoid malpractice liability, clinicians must have in-depth knowledge and understanding of the standard of care given to patients, based on the respective state laws. If the clinician and the patient are based in separate states, then the healthcare provider should work based on the regulations that have been laid down for such cases.
- HIPAA Compliance: The HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule sets national rules for HIPAA compliant telehealth platforms to protect individuals' medical records and other confidential health records, and it extends to health insurers, health care clearing-houses, and medical professionals that perform such electronic medical transactions. The HIPAA Security Rule contains the HIPAA Telemedicine Rules, which state:
- Only registered users can have access to the HIPAA compliance software and ePHI or Electronic Protected Health Information.
- To preserve the privacy of ePHI, a protected collaboration mechanism should be enforced.
- To avoid unintended or deliberate breaches, a method of tracking messages involving ePHI should be applied.
- HIPAA Business Associate Agreement (BAA): A Business Associate Agreement (BAA) is an agreement between a medical provider or a healthcare institution. It creates ePHI, which is maintained by a third party and the party that stores the data. The BAA shall provide the third party's procedures for ensuring data integrity and arrangements for routine information security auditing. A BAA includes the following:
- Identify the business associate's permitted and necessary purposes of protected medical data.
- Specify that the business associate may not use or further reveal confidential medical information except as allowed or needed by the contract or as legally required.
- Allow the business associate to use standard precautions to deter the use or disclosure of protected health records.
- Suppose a covered entity learns of a serious breach or infringement of the contract or agreement by a mutual partner. In that case, the covered entity must take appropriate measures to remedy the breach or end the violation, and if those steps fail, the contract or settlement must be terminated.
- A covered organization must disclose the issue to the Department of Health and Human Services (HHS) Office for Civil Rights if terminating the deal or arrangement is impossible.
- Physician-patient relationship: In telemedicine, the boundaries blur when deciding whether a doctor-patient partnership will occur online via a telehealth app or by email. Therefore, an arrangement, direct or implied, between the doctor and the patient must exist for a doctor-patient partnership, in the sense that the patient consciously needs the help of a doctor and the doctor knowingly acknowledges the patient.
- Potential for fraud and abuse: The Department of Justice reported on January 14, 2021, that in the previous year, it had secured over $2.2 billion in damages and convictions from fraud and False Claims Act lawsuits. In FY 2020, settlements of healthcare fraud and regulatory proceedings accounted for over 80% of False Claims Act recoveries, the greatest percentage of government-initiated lawsuits against healthcare agencies ever recorded. The potential for fraud and abuse arises due to some really harmful schemes in telemedicine:
- Unrequired schemes and Illegal Distribution: In September 2020, the U.S. Department of Justice reported that 86 individuals had been paying for unrequired telemedicine services such as medicines without prescriptions, medical devices, diagnostics, genetic testing, etc.
- Billing Issues: Due to the coronavirus pandemic, online doctor-patient appointments had witnessed an 11,000% rise, according to CMS.
- Consequently, issues regarding up-coding of timeframes and complexity levels of care provided emerged.
- Tele-prescribing: Limitations may be present for prescribing certain medicines. For instance, some prescriptions may require an in-person medical examination first. Healthcare professionals should hold knowledge regarding these rules.
- Telemedicine coverage: The following rules apply in medicare for remote patient monitoring:
- If the telehealth providers are instantly available to participate through interactive audio-video, direct monitoring may be achieved;
- If the patient is located at a qualified originating site;
- If the healthcare providers have been authorized to offer their healthcare services;
- If the Centers for Medicare and Medicaid Services (CMS) has approved the service.
