FAQs For Oncology Practitioners – Part Two

This is part two of our answers to your questions about oncology practice compliance issues. In part one we answered questions about balancing the medical side of your practice with the business side and Medicare opt-out requirements. In this part we focus on telemedicine, health coaching, and informed consent questions.

What requirements must oncology practice meet to use telemedicine to consult with and treat cancer patients?

A few shared questions are:

• Do you have to be licensed in any given state to provide recommendations?
• Are there states that allow for tele-visits without the need for licensing?
• Are you allowed to provide a “second opinion” consultation without being licensed in the state? Many major hospitals are offering this service for cancer patients.

The laws on telemedicine are changing. During the pandemic, more and more people began to use telemedicine to reduce the risk of exposure to COVID. Both doctors and patients have seen that telemedicine is generally easy to use. Telemedicine works in certain areas better than others. Some treatments require hands-on treatment and not a video conference such as surgeries.

The laws vary from state to state and may also vary from medical practice to medical practice and for different types of diseases. For example, COVID consultations through telemedicine are generally fairly liberal to help reduce the risk of exposure. The telemedicine regarding other diseases may be stricter. The laws may also vary depending on the billing requirements. For example, Medicare has its own set of telemedicine requirements. Private insurers have their own telemedicine rules too.

Generally, before COVID, healthcare providers who used telemedicine services:

• Had to have an existing relationship with a patient based on an in-person evaluation.
• Had to be licensed in the same state as where the patient resided. This means that providers who provide medical advice to patients in a different state need to obtain another license in the state where the patient resides.
• Had to meet other state criteria.
• Had to comply with very specific criteria before doctors could prescribe medications online.

In addition to each state’s law, the Interstate Medical Licensure Compact (IMLC) helps expedite “licensure pathway for qualified physicians who want to practice in multiple states.”

“The IMLC affords physicians who meet the eligibility requirements the ability to practice medicine across state lines within the Compact. Rather than applying for a medical license through the state, physicians participating in the IMLC apply through the Compact for licensure in multiple states, receiving separate licenses from each respective state. Since the application for licensure is routed through the Compact, the overall process of gaining a state medical license becomes significantly streamlined. The Compact currently includes 29 states, the District of Columbia, and the Territory of Guam.”

How does Medicare regulate telemedicine?

CMS introduced an 1135 telemedicine waiver in response to COVID starting on March 6, 2020. The waiver applies to many different types of health disorders, not just COVID. Oncology services are generally included under this waiver.

“Under this new waiver, Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patient’s places of residence starting March 6, 2020.  A range of providers, such as doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers, will be able to offer telehealth to their patients. Additionally, the HHS Office of Inspector General (OIG) is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs.”

Prior to the Waiver, telemedicine services through Medicare were limited – though the services were expanding.

“In 2019, Medicare started making payment for brief communications or Virtual Check-Ins, which are short patient-initiated communications with a healthcare practitioner. Medicare Part B separately pays clinicians for E-visits, which are non-face-to-face patient-initiated communications through an online patient portal.”

During the COVID Public Health Emergency, Medicare should (some exceptions may apply) approve:

• Virtual office visits. These are essentially the initial consultations. For virtual services, the health provider must “use an interactive audio and video telecommunications system that permits real-time communication between the distant site and the patient at home.” “The practitioners that can furnish virtual visits (subject to state law) include: physicians, nurse practitioners, physician assistants, nurse midwives, certified nurse anesthetists, clinical psychologists, clinical social   workers, registered dietitians, and nutrition professionals.” Generally, an existing provider/patient relationship is required. Many additional requirements apply.
• E-visits. When an existing provider/patient relationship exists, providers and patients can discuss their concerns through e-visits so patients don’t have to go to the doctor’s office. There are many different requirements. E-visits are generally communications that aren’t face to face – such as email conversations.

A recent summary of state telehealth licensing requirements for Medicare and Medicaid can be found on the CCHP website. For example, CCHP states that in California:

“A provider must be licensed in CA, enrolled as a Medi-Cal rendering provider or non-physician medical practitioner (NMP) and affiliated with an enrolled Medi-Cal provider group. The enrolled Medi-Cal provider group for which the health care provider renders services via telehealth must meet all Medi-Cal program enrollment requirements and must be located in California or a border community.”

Please consult with our seasoned healthcare compliance lawyers for a review of the latest requirements.

What rules govern the international use and licensing of telemedicine services

Example questions include:

• Do you have to be licensed in a given country to offer tele-medicine consultations/second opinions?
• Are there countries that are stricter?

The US and foreign telemedicine requirements vary from country to country. Generally, we recommend that you speak to us about your location, your patient’s location, and any other locations that may be involved. The Telehealth Certification Institute has a summary of international telemedicine guidelines (to be used only as a starting point. You need to speak with a skilled healthcare lawyer to understand the latest requirements and the requirements that apply to your oncology practice).

The Telehealth Certification Institute states that:

“Internationally, licensing rules & medical practice laws are based on the location of the patient vs/ the location of the physician which means that “a physician licensed in the United Kingdom and providing teleconsultation services to a patient located in Chicago, Illinois, USA must hold a license issued by the Illinois state medical board (or otherwise meet a state licensure exception under Illinois law)…this licensure also applies to the ability of a physician to be able to prescribe, and have fulfilled, medicine in a certain jurisdiction.” 

In the USA, “a physician delivering medical services via telemedicine must be licensed in the state where the patient is located.”  It is critically important that local medical boards have the authority to set and uphold standards of medical care for citizens within their jurisdiction, giving the boards oversight to ensure that clinicians are “qualified, credentialed, and adhere to best practice clinical pathways.”

The “patient-location-law” is similar to other laws surrounding internet-based services, and also serves to clarify the jurisdiction/ procedure for reporting a “medical malpractice or negligence complaint against the treating physician.”

Two physicians consulting on a case are governed by “peer to peer consultation laws” which vary widely but, “the foreign physician typically must be licensed in the jurisdiction where the foreign physician is located, and the local physician must be licensed in the jurisdiction where the local physician and the patient are located.”

There are many other international and local considerations starting with the need to comply with standard of care requirements and global best practices so the patient receives the best medical care possible for his/her type of cancer.

What should oncology practitioners know about health coaching?

A few of the questions that we are asked are:

• Can a physician serve as a health coach?
• What are the legal concerns of health coaching?
• Can you practice as a health coach outside of your state?
• Are there books/literature/ video guidance you would recommend for physicians seeking to start a health coaching practice?

We’ve written on the general issues of health coaching before. Many of these issues apply to oncology medicine – though you should speak with our healthcare compliance to discuss your unique practice and concerns. There are many different issues that our lawyers will review regarding health coaching starting with understanding that any health coaching that is considered medicine including diagnosis and treatment – generally requires that the health coach have an approved state license to practice medicine or psychology. False or misleading advertising such as promising cures when there are no cures will likely violate federal or state law.  Other health coaching concerns include:

• “Making a disease claims for cosmetics or dietary supplements
• Prescribing controlled substances to a patient who lives in a state where you are not licensed as an MD
• Overreaching as an MSO (management services organization or MSO) and engaging in the corporate practice of medicine (CPM or CPOM)
• Payments for referrals of the healthcare business, either where healthcare services are reimbursable by Medicare, or otherwise (under state law).”

Doctors and healthcare coaches who are practicing medicine must comply with informed consent rules, have a proper license, and must “practice in an evidence-based way so that you are mindful of the standard of care.”

Additional health coaching concerns include telemedicine, dietary supplements, cosmetics, safe harbors, the manner of payment, online ventures, and other issues.

What type of consent/risk waiver is required to do to offer integrative advice or treatments to oncology patients?

Common questions include:

• What risk waivers would you recommend for those treatments that lack a large body of evidence?
• Consent for Integrative therapies – any language that you recommend to include that is unique to offering integrative recommendations
• Health coaching consent – what language should be used to let the “client” know you will not be their physician
• Are there particular situations where consent might not be necessary?

According to the National Institutes of Health, “Informed consent is a vital document while performing all surgical and aesthetic procedures, particularly in the current day practice. Proper documentation and counseling of patients is important in any informed consent.” Patients should have the information needed to decide what happens to their body – whether the patients are having a test done, a procedure, or surgery.

Generally, “obtaining consent is a must for anything other than a routine physical examination.”

The information disclosed should include:

• What condition the patient is suffering from
• The need for additional testing
• The nature course of the disorder and what complications may ensure
• What happens if the testing or treatments are not done
• What are the benefits and dangers of the tests and treatments
• The time and cost of the tests or treatment
• The reasonably expected outcomes
• What follow-up will be required

Patients should be made to feel comfortable asking questions to remove all doubts. The patient should not be pressured or forced to make a decision. The consent should be voluntary. Patients should have the right to revoke their consent before the test or procedure. The healthcare provider should not misrepresent any facts.

The person giving the consent must be mentally competent. This can be an issue for cancer patients, especially older cancer patients. Some patients may need to have someone with authority (such as someone with a proper power of attorney, a guardian, or a conservator) provide consent for the patient.

There are related issues such as when exceptions may apply, the proper way to document the consent, blanket consents, and informed refusals.

For example, “If a doctor is of the opinion that certain information can seriously harm a patient’s health – physical, mental or emotional – he has the privilege to withhold such information. But, the [information] should be shared with close relatives. This situation usually does not occur in cutaneous aesthetic surgical procedures.”

Our lawyers will explain when informed consent is required and prepare the written document that you need to have the patient sign – whether you’re providing health coaching, integrative oncology services, or other types of care.

Oncology healthcare providers provide valuable services to people whose lives are affected by cancer. These providers need to ensure that they understand the healthcare compliance laws so they can focus on helping people who are suffering. Skilled healthcare compliance lawyers will review all your telemedicine questions, the proper parameters for health coaching, and when and how to require written informed consents.

Oncology healthcare providers should contact Cohen Healthcare Law Group, PC to discuss how the federal, state, and local laws and regulations affect their practices. Our experienced healthcare attorneys advise all types of oncology healthcare providers from specialists and radiologists to complementary and integrative healthcare providers.