Avatar photo
Melissa Ward
Sr. Business Analyst - Regulatory Affairs

Welcome to the newest edition of Regulatory Roundup! Each month, I review the latest legislation affecting the telehealth industry — at both federal and state levels. Let’s dive in!

virtual care regulation

Federal

Centers for Medicare and Medicaid Services (CMS) Released Roadmap for Ending the COVID-19 Public Health Emergency (PHE). 

The PHE is set to expire on October 13, 2022; however, Secretary Xavier Becerra said he would give providers 60 days’ notice before the expiration. We are less than 60 days from the expiration period, so we can expect an extension. However, while the extensions have been 90 days, it is not guaranteed the next extension will be 90 days. 

The Consolidated Appropriations Act (CAA) of 2022 requires continued Medicare reimbursement of telehealth services with current telehealth flexibilities for 151 days following the expiration of the COVID-19 public health emergency (PHE).  

The PHE roadmap, developed by the Centers for Medicare and Medicaid Services (CMS), is a comprehensive, streamlined approach to preparing the health care system for the end of the PHE. CMS will accomplish this through three concurrent phases: 

  1. Assessing the need to continue certain blanket waivers in the current phase of the PHE. Considering the impacts on communities and potential barriers and opportunities that existing flexibilities may address.
  2. Assessing which flexibilities will be most beneficial in future PHEs, including natural and man-made disasters, locally and nationally. 
  3. Continued collaboration with the healthcare industry and federal partners to ensure the healthcare system is prepared to address future emergencies.  

For full details on CMS’ roadmap visit – Creating a Roadmap for the End of the COVID-19 Public Health Emergency

Inflation Reduction Act (IRA)  

On August 16, President Joe Biden signed the act into law, allowing Medicare to negotiate prices for certain medications. The president described the act as “one of the most significant laws in our history.” Further, “the American people won, and special interests lost.” The organization representing the world’s largest pharmaceutical companies released a statement indicating that the partisan policies will lead to fewer new treatments and do enough to address the real affordability problems.  

Highlights from the IRA: 

  • Medicare Parts B (physician fee schedule) and D (prescription coverage) gain negotiating powers to a limited number of drugs with no generic or biosimilar competition. Starting in 2026, 10 drugs will be eligible, increasing to 20 by 2029. 
  • In 2023, limits out-of-pocket spending on insulin products to $35/month. Eliminates cost-sharing for adult vaccines under Part D and Medicaid. 
  • Caps inflation that limits price increases year over year. Drugmakers will face tax penalties if their drugs outpace inflation. 
  • Extends the Affordable Care Act marketplace subsidies until 2025 — they were set to expire this year. These subsidies will prevent millions from losing coverage and prevent increasing premiums.

U.S. House Bill 8497 Medicare Mental Health In-Person Requirement

Introduced on July 26, 2022, this bill seeks to amend title XVIII of the Social Security Act to remove the in-person requirement under Medicare for mental health services provided through telehealth. Removing this arbitrary requirement would allow clinicians to practice at the top of their license by enabling them to determine the best mode of delivery for their patients.

HHS Secretary Becerra Declares Public Health Emergency

On August 4, 2022, the U.S. Department of Health and Human Services Secretary Xavier Becerra declared the spread of the monkeypox virus in the U.S. a Public Health Emergency (PHE). Declaring the PHE will accelerate the response to meet the demands of the outbreak.

virtual care regulation

By State

California Assembly Bill 1759 Board of Behavioral Sciences 

This bill has passed and is awaiting the governor’s executive signature. Once enacted, associate professional clinical counselor trainees will be included in the definition of healthcare provider for purposes of authorizing telehealth. It will also permit associate clinical social workers, associate clinical counselors, and clinical counselor trainees to provide services via telehealth.  

The board of behavioral sciences allows licensees to provide care asynchronously. 

California Senate Bill 966 Federally Qualified Health Centers (FQHC) and Rural Health Clinics (RHC)

Introduced in February, this bill was amended on August 25, 2022. While FQHCs and RHCs cannot establish a new patient relationship via synchronous audio-only telehealth, this bill would allow the department to make exceptions. One proposed exception is visits related to sensitive services such as mental or behavioral health, sexual and reproductive health, sexually transmitted infections, substance use disorder, gender-affirming care, and intimate partner violence. The other exception is when a patient requests audio-only or indicates they do not have access to video.

New Hampshire Senate Bill 390 Related to Telehealth & Telemedicine

Enacted on August 3, 2022, this bill revised the definition of telehealth and telemedicine in the context of the practitioner-patient relationship.  

  • Telemedicine and Telehealth “means the use of audio, video, or other electronic media and technologies by a health care professional in one location to a patient at a different location for the purpose of diagnosis, consultation, or treatment, including the use of synchronous or asynchronous interactions.” 
  • “Asynchronous interaction means an exchange of information between a patient and a health care professional that does not occur in real time.” 
  • “Synchronous interaction means an exchange of information between a patient and a health care professional that occurs in real time.” 
  • The definition of practitioner/physician-patient relationship was revised to remove the requirement of “face-to-face 2-way real-time interactive communication,” opening the way for practitioners to establish a relationship via asynchronous interactions.

Disclaimer:
This information, and any other information, content or other materials (collectively “Information”) we provide, does not, and is not intended to, constitute legal advice; instead, all Information is provided for general informational purposes only. The Information may not constitute the most up-to-date legal or other information.  Readers should contact their attorney to obtain advice with respect to any particular legal matter. No reader or user of any Information should act or refrain from acting on the basis of Information without first seeking legal advice from counsel in the relevant jurisdiction. Only your individual attorney can provide assurances that the Information – and your interpretation of it – is applicable or appropriate to your particular situation. Use of, or access to, the Information does not create an attorney-client relationship between the reader or user, and the author or provider of the Information.

Tags: Industry Regulatory Roundup

Related Insights.

Regulatory Roundup – July 2022

Regulatory Roundup – July 2022

Interested in the latest legislation affecting the telehealth industry? You’ve come to the right place! Let's take a look at how regulations changed in July.  Federal US House Bill 4040 — Connecting Rural Telehealth to the Future Act — Passed  Introduced on June 22,...

read more