The Rise of Ketamine Clinics and Ketamine-Assisted Therapy

Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the utilization of pharmaceutical drugs for, among other factors, unapproved indications. An approved indication occurs when the Food and Drug Administration (FDA) formally approves a given drug for a named medical condition.

Centers for Medicare & Medicaid Services (CMS) has further expanded the list of telehealth services that Medicare Fee-For-Service will pay for during the COVID-19 public health emergency (PHE) as of October 14, 2020. CMS is adding 11 new services to the Medicare telehealth services list and will begin paying eligible practitioners who furnish these services immediately and through the end of the PHE. The new telehealth services include neurostimulator analysis and programming services, and cardiac and pulmonary rehabilitation services.

On April 13, 2020 the Federal Communications Commission (“FCC”) began accepting applications for the COVID-19 Telehealth Program (“Telehealth Program”), money which is part of the recent Coronavirus Aid, Relief, and Economic Security Act (“Cares Act”).  The Telehealth Program will provide $200 million in funding to assist eligible health care providers deliver telehealth services to patients in their homes or other mobile locations to combat novel Coronavirus 2019 (“COVID-19”).  The funding is available for eligible health care providers responding to the COVID-19 pandemic by compensating providers for their telecommunication services, information services, and devices necessary for them to provide critical telehealth services.

The Federal Communications Commission (“FCC”) has opened the COVID-19 Telehealth Program Application portal and is now accepting applications for the COVID-19 Telehealth Program (the “Telehealth Program”). Authorized by the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the Telehealth Program will provide $200 million in funding to assist eligible health care providers deliver telehealth services to patients in their homes or other mobile locations in an effort to combat the novel Coronavirus 2019 disease (“COVID-19”).  The funding is available for eligible health care providers responding to the COVID-19 pandemic by fully compensating providers for their telecommunication services, information services, and devices necessary for them to provide critical telehealth services. Notably, the Telehealth Program is not currently available to certain types of health care providers, including for-profit providers. Consequently, some providers, including local hospitals that are part of a larger for-profit health system, may find themselves ineligible for telehealth funding.

Centers for Medicare & Medicaid Services (CMS) held a Special Open Door Forum that was open to the public on April 8, 2020. CMS has been working to address the COVID-19 pandemic through 1) increasing hospital capacity, 2) rapid expansion of the healthcare workforce, 3) relaxing health care administrative requirements, and promoting the use of telehealth, which this call was focused on. The call provided an opportunity for health care providers to ask specific questions and express concerns about telehealth and Medicare reimbursement.

In response to the March 27th, Executive Order #16 (EO16) by Wisconsin Governor Evers, on March 30st HB blog,  the Wisconsin Office of the Commissioner of Insurance (OCI) issued guidance to medical malpractice insurance carriers to provide coverage for telemedicine services under the same terms for providers as if they were

The Centers for Medicare and Medicaid Services (“CMS”) confirmed that hospice physicians and nurse practitioners who serve as a patient’s attending physician (“NPs”) can use telehealth to perform medically necessary visits during the COVID-19 pandemic. To assist hospices in evaluating the feasibility of using telehealth for medically necessary visits with Medicare patients, Husch Blackwell has created a “Hospice Telehealth Flowchart.” The Flowchart addresses important operational considerations as well as the Medicare requirements related to rendering and billing for such telehealth visits.

Change is fast-paced in the world of COVID-19. On Monday, March 30th, CMS released an interim final rule along with hospice specific waivers. In this episode, your Hospice Team discusses these recent developments and their impact on telehealth, face-to-face encounters, virtual visits and Medicare appeals and audits.

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In this episode, your Hospice Team shares insights on operationalizing recent government guidance for hospices facing coronavirus obstacles. We discuss the role of virtual visits, how to use telehealth, and the practical impact of the Medicare appeal waiver. Listen to the full episode here: https://bit.ly/2JmhkMV

As the novel coronavirus outbreak continues, the federal government and commercial health insurers have taken significant steps to increase Americans’ access to treatment and testing. In the past week, the federal government and private insurers have issued a number of guidance documents expanding coverage and payment requirements in an effort to minimize the spread of the virus. As with any changes in coverage and reimbursement, healthcare providers offering telehealth services should carefully review these changes and take steps to ensure that all regulatory and coverage requirements are met prior to submitting claims for reimbursement.

I. Medicare

On March 6, 2020, the bipartisan Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 (“Coronavirus Appropriations Act”) was signed into law authorizing federal spending to combat the ongoing coronavirus outbreak in the United States. This Act, among other things, gives the United States Department of Health and Human Services’ (“HHS”) secretary the authority to temporarily waive certain Medicare requirements for telehealth services.

The Centers for Medicare and Medicaid Services (“CMS”) currently reimburses a limited set of telehealth services provided to Medicare beneficiaries subject to certain criteria under section 1834(m) of the Social Security Act. Generally, the patient receiving telehealth services must be located at one of eight “originating sites”, which include hospitals, physicians’ offices, and rural health clinics. In addition, the originating site must meet certain geographic requirements which have essentially limited the availability of telehealth to patients in rural areas. These requirements have long posed a hurdle to the expansion of telehealth despite the industry’s demand for lessened restrictions. However, with the rapid spread of the coronavirus and the possibility of facing large scale isolations and quarantines, lawmakers have signaled their willingness to expand access to telehealth to fight against this public health crisis.

Within the Coronavirus Appropriations Act is the Telehealth Services During Certain Emergency Periods Act of 2020, which sets forth the waiver authority for the secretary of HHS regarding the certain telehealth requirements. Under the Telehealth Services During Emergency Periods Act, the secretary is authorized to temporarily waive the originating site and geographic requirements for telehealth services provided to Medicare beneficiaries located in an identified “emergency area” during an “emergency period” when provided by a qualified provider. To qualify for the waiver, the provider must have treated the patient within the previous three years or be in the same practice (i.e., as determined by tax identification number) of a practitioner who has treated the patient in the past three years. The bill also lessens the telecommunications requirements by allowing Medicare beneficiaries to receive telehealth services via their smartphones (i.e., telephones that allow for real time, audio-video interaction between the provider and the beneficiary). Because the federal government has declared a nationwide public health emergency as a result of the coronavirus, the waiver will apply across the country until there is no longer a nationwide public health emergency.