Regulatory Roundup—July 2021

Federal

Here are the most significant updates at the federal level.

COVID-19 Public Health Emergency (PHE)

The Secretary of Health and Human Services, Xavier Becerra, has authorized an extension effective July 20, 2021. The extension allows the continued use of the 1135 waivers authorizing telehealth flexibilities.

CY 2022 Medicare Physician Fee Schedule Proposed Rule Released

Reimbursement

• CMS reimburses for telehealth services that are on the Category 1 or Category 2 list. During the public health emergency (PHE), CMS created Category 3 for temporary reimbursement of COVID-19 eligible services.
• CMS has decided not to add any Category 3 services to Category 1 or 2; however, CMS is proposing to extend the expiration deadline of Category 3 services from the end of the year the PHE ends to December 31, 2023. The extension is to allow CMS time to collect data to determine the long-term necessity of the codes.

Mental Health

• Remove geographic location restriction.
• Require an in-person mental health service within six months before the initial telehealth service and once every six months after that.

21st Century CURES Act 2.0 Draft Released

Details around CURES Act 2.0 draft were released in late June and include proposed provisions to medical research, COVID-19 public health research, clinical trials, and therapy development.

The 21st Century CURES Act 2.0 also addresses telehealth coverage policies and proposes to:

• Permanently eliminate Medicare’s geographic and originating site requirements
• Expand the category of providers and types of services eligible for payment

By State

There’s been a great deal of favorable activity happening at the state level. Here’s an overview of pending or enacted legislation in states this past month.

New Jersey (pending Governor’s signature)

New Jersey Senate Bill 2559

• Requires coverage and reimbursement parity for telehealth services with one caveat. Physical health telephone-only services “shall be at least 50 percent of the reimbursement rate for the service when provided in-person.”
• Allows for asynchronous care if the physician or non-physician practitioner feels appropriate after reviewing the medical history.
• Removes location restrictions on the originating and distant location sites.
• Prohibits restrictions on the type of technology utilized.
• The patient must be informed that a physician may not perform the services for clinics that utilize licensed physician extenders (physician’s assistants or nurse practitioners). If the patient requests the visit be with a physician, it must be scheduled as such.

I should note that this bill passed both the House and the Senate with a unanimous vote. However, industry experts are reporting that the Governor will likely veto the bill with considerations, which would allow him to revise the bill and send it back for a vote. The speculation is that he has budgetary concerns. This bill contains critical legislation for patients and providers in New Jersey are encouraged to contact the Governor’s office to voice support for the enactment of this bill.

Illinois

Illinois Senate Bill 332 – Network Adequacy and Transparency Act

• Requires network plans to inform patients if their providers offer telehealth and what modalities (if any) are covered.

New York

NY 29868 2021 – Adopted Emergency Rule, State Reimbursement for Telehealth Services

• Passage of the bill allows continuing use of medically appropriate telehealth services during the federally declared public emergency and requires reimbursement parity for telephone and other audio-only technologies.

Maine

ME S 50 – Telehealth Regulations

• Updated the definition of telehealth to include synchronous, asynchronous, store-and-forward, and telemonitoring.
  • “Asynchronous encounters” is defined as “the interaction or consultation between an enrollee and the enrollee’s provider or between providers regarding the enrollee through a system with the ability to store digital information, including, but not limited to, still images, video, audio, and text files, and other relevant data in one location and subsequently transmit such information for interpretation at a remote site by health professionals without requiring the simultaneous presence of the patient or the health professionals.”
  • “Store and forward transfer” is defined as: “transmission of an individual’s records through a secure electronic system to a person licensed under this chapter.”
• Updated parity language to be more comprehensive

Minnesota 

MN H 33a Minnesota Telehealth Act

• “Originating site” is defined as the site where the patient is located when services are delivered.
• Includes “store-and-forward technology” in the definition of telehealth.
  • “Store-and-forward” is defined as: “the asynchronous electronic transfer or transmission of a patient’s medical information or data from an originating site to a distant site for the purposes of diagnostic and therapeutic assistance in the care of a patient.”
• Allows use of audio-only communication until July 1, 2023
• Requires insurance coverage for audio-only communication if a scheduled appointment and the visit meet the standard of care – unscheduled, routine “telephone conversations” are not covered.
• Requires insurance coverage and reimbursement parity on the same basis as in-person care.

Rhode Island 

RI H 6032: Telehealth Coverage Act (Relating to Insurance)

• Provides reimbursement parity delivered by in-network primary care providers, registered dietitian nutritionists, and behavioral health providers.
• Forbids imposition of deductible, copayment, co-insurance, prior authorization, and medical review requirements above what is required of in-person visits.
• An insurer shall not impose technology requirements that are more stringent than state and federal laws.
• Adds “online adaptive interview” to the definition of telemedicine