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Julian represents healthcare providers and healthcare technology companies on a wide range of regulatory compliance, operations, transactions, litigation and business matters.

Julian’s work includes representing providers in Texas Medical Board license and federal health program cases. Clients seek his help in maximizing healthcare provider opportunities and navigating Food and Drug Administration (FDA) regulation. He also has extensive experience representing clients on matters involving healthcare technology, including emerging technologies with big data, artificial intelligence, telemedicine and telehealth.

The Centers for Medicare and Medicaid (CMS) expanded Medicare reimbursement for telehealth within the annual Physician Fee Schedule (PFS) final rule for 2021. During the pandemic Public Health Emergency (PHE), CMS has temporarily reimbursed many telehealth services. In light of the success of unprecedented telehealth utilization during the PHE, more than 60 services have been formally added to the Medicare telehealth list which will endure beyond the end of the PHE.

On October 29, 2020, HHS extended the effective date of compliance for the “Information Blocking” final rule promulgated as part of the 21st Century Cures Act (Information Blocking Rule). The Information Blocking Rule, which was set to take effect on November 2, 2020, prohibits health care providers, IT developers, and health information exchanges from unreasonably interfering with the access, exchange, or use of electronic health information (EHI). We previously discussed the practice of information blocking and the eight exceptions in our blog post Information Blocking: Ready or Not, Here it Comes!.

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.

The use of telehealth has become indispensable across the country in recent months due to the COVID-19 public health emergency (PHE) and Centers for Medicare and Medicaid Services (CMS)’s temporary expansion of payment for telehealth services. CMS reports that virtual visits for Medicare beneficiaries have jumped from approximately 14,000 per week pre-PHE to almost 1.7 million in the last week of April.

On April 23, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a new COVID-19 toolkit. While the toolkit is directed to the states, it should serve the American telehealth community as a focal point for the organization and alignment of the infinite number of state and federal regulations relevant to telehealth. So, it serves as a great organizing tool for provider’s own operational use but also as an architecture for providers to catalogue the changes they would like to suggest to the states in order to improve access to telehealth.

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.

In a March 24th letter to all of the nation’s Governors, Secretary Alex Azar of the Department of Health and Human Services (“HHS”) called upon states to take immediate action to loosen regulations that present obstacles to the delivery of effective in person and telehealth services during the COVID-19 emergency. In an effort to “carry out a whole-America response to the COVID-19 pandemic,” Secretary Azar asked governors to urgently take steps to “extend the capacity of the health care workforce.”

Stethoscope and Tablet_600x600-2On March 17, 2020, U.S. Department of Justice, Drug Enforcement Agency (DEA) released guidance clarifying that restrictions under the Ryan Haight Act (the Act) are removed in response to the COVID-19 pandemic, allowing health care practitioners to prescribe controlled substances to patients through the use of telemedicine without any “in-person medical evaluation.” The Act generally prohibits practitioners from dispensing controlled substances through the internet without an in-person evaluation, unless an applicable exception is met. One exception to the Act occurs in the event of a public health emergency, which was triggered when HHS Secretary Alex Azar declared an emergency in response to COIVD-19 effective January 31, 2020. Practitioners now have the go-ahead to prescribe controlled substances through telemedicine technology without compliance with the Act’s requirements, but only for the duration of the public health emergency due to COVID-19.