Key takeaways from CMS’ latest regulations

by Jenna Stern, Vizient Senior Regulatory Affairs and Public Policy Director
Mina Kato, Vizient Senior Advocacy Communications and Stakeholder Engagement Manager

Each year, most states “spring forward” or “fall back” in observance of daylight savings time. So, while many of us technically “fall back” around this time of year (except for you lucky ones in Hawaii and Arizona), it is imperative that we not “fall behind” on the latest regulatory news from the Centers for Medicare & Medicaid Services (CMS).

On November 2 and 4, three critical regulations from CMS were released:

A summary of the emergency regulation is available online (and it has certainly been the hot topic within states), but we wanted to share some of the big takeaways from OPPS and PFS that may be getting less airtime but are very important for providers.

Physician fee schedule: virtual health

Because we know that all eyes are on CMS and Congress as they continue to map out the future of telehealth, we wanted to highlight what steps CMS has already taken in the physician fee schedule.

Without the COVID-19 flexibilities that are currently temporarily available due to the public health emergency, access to telehealth services would be limited to certain types of “originating sites” (e.g., physician offices and hospitals) located in certain rural areas. The physician fee schedule final rule lays the groundwork to provide permanent patient access to mental health telehealth services after the pandemic ends, even when the patient is in their home in an urban area. How? The final rule’s regulations regarding telehealth for mental health services, which will be effective once the public health emergency declaration ends, address geographic restrictions (or a lack thereof) when patients receive telehealth services for the purposes of diagnosis, evaluation or treatment of a mental health disorder.

Also, the physician fee schedule final rule makes clear the patient’s home is a permissible originating site when mental health telehealth services are provided. But it is not all sunshine and rainbows—there are certain requirements that must be satisfied when such services are provided, including:

  • In-person visits: CMS will require (with limited exceptions) an in-person visit within six months prior to the first telehealth service and then, an in-person visit every 12 months as telehealth continues to be provided. However, for situations in which the risks and burdens associated with an in-person visit outweigh the benefits of a non-telehealth service, the in-person visit requirement will not apply for that given 12-month period (the basis for that decision must be documented in the patient’s medical record). Also, CMS will allow a clinician’s colleague in the same subspecialty in the same group to provide the in-person visit if the original practitioner is unavailable.
  • Audio-only services: CMS will permit audio-only mental health telehealth services only when the patient’s home is the originating site. Also, CMS will require the provider to have the ability to furnish two-way (audio/video) telehealth services and that patient-specific factors (e.g., patient capabilities, preference or bandwidth/access limitations to interactive audio-video communications) may drive the decision to provide audio-only services. In addition, providers must document in the patient’s medical record the reason for using audio-only technology and include a service-level modifier when billing for audio-only services.

The physician fee schedule also included several other virtual health policies related to COVID-19 telehealth flexibilities:

  • Category 3 Telehealth List Extension: In the CY 2021 physician fee schedule final rule, CMS created “Category 3” on the Medicare Telehealth List which specifies telehealth services Medicare will cover for a temporary amount of time. In the CY 2022 physician fee schedule final rule, the agency indicated it will keep all current services on Category 3 until the end of CY 2023. The complete Medicare Telehealth Service List is available on the CMS telehealth website.
  • Virtual Check-ins: In the CY 2021 PFS final rule, CMS temporarily adopted HCPCS Code G2552 for a virtual check-in which is a service to determine the need for an in-person visit. In the CY 2022 PFS final rule, CMS permanently establishes separate coding and payment for virtual check-ins.
  • Remote Therapeutic Monitoring: To support the monitoring of health conditions remotely, CMS finalized five new remote therapeutic monitoring codes. These codes could be used to monitor conditions such as medication response or respiratory system status, among others.

OPPS final rule

Hospital price transparency regulations require hospitals to provide clear, accessible pricing information online about the items and services they provide. Failure to post such information results in penalties. CMS is really doubling down on their support of hospital price transparency regulations, likely to drive better compliance.

Specifically, penalties will now be determined by a scaling factor based on hospital bed count. More importantly, the potential penalties for non-compliance will sky-rocket from a maximum of $109,500 to $2,0007,500 per hospital per year, as shown in the below table. CMS will determine the number of beds for hospitals using the most recently available, finalized Medicare hospital cost report.


Number of Beds

Penalty Per Day

Total Penalty Amount Based on Full Calendar Year

30 or less

$300 per hospital

$109,500 per hospital

31 - 550

$310 - $5,500 per hospital

(number of beds times $10)

$113,150 - $2,007,500 per hospital

Greater than 550

$5,500 per hospital

$2,007,500 per hospital

OPPS Final Rule, Table 76: Application of CMP Daily Amounts for Hospital Noncompliance for CMPs Assessed in CY 2022 and Subsequent Years


Additionally, to address CMS’s concerns related to the lack of hospital standard charge data, the agency explicitly requires that the information be easily accessible via automated searches and direct downloads through a link posted on a publicly available website.

In better news, CMS has reversed course on the inpatient only list, likely due to wide opposition to the prior year’s policy (Vizient included). Notably, 291 codes out of 298 removed in 2021 will be added back to the inpatient only list for CY 2022. The seven codes that will remain off the inpatient only list include total shoulder replacement, total ankle replacement, a lumbar spinal fusion and related anesthesia codes.

In conjunction with the CY 2021 policy to eliminate the inpatient only list, CMS also provided policy to drastically expand the ASC-covered procedure list (ASC CPL) which lists procedures that will be covered by Medicare if performed in an ASC. But, like the re-established inpatient only list policy, CMS has officially changed course on the future of the ASC CPL. Specifically, CMS reinstated criteria for ASC CPL list inclusion that had been reduced in 2021. CMS is removing 255 codes from the ASC CPL list and will allow external parties to nominate a surgical procedure to be added to the ASC CPL.

With that, whether you embrace sweater weather and the shift in time or not—do not “fall behind” on these key changes affecting virtual health, price transparency and sites of care. Visit the CMS fact sheet on the CY 2022 Outpatient Prospective Payment System (OPPS) final rule and the CY 2022 Physician Fee Schedule (PFS) final rule to learn even more about recent regulatory changes.

About the authors:

Jenna Stern currently serves as Vizient’s senior regulatory affairs and public policy director. In this role, she identifies and responds to legislative and regulatory developments of most interest to Vizient’s members. Medicare reimbursement and drug policy are among the topics which Jenna focuses on at Vizient. Prior to joining Vizient, Jenna was the director for health policy at the American Pharmacists Association and a senior associate with Avalere Health, a health care consulting firm in Washington, DC. In her previous roles, she specialized in regulatory affairs, strategy, policy and data analysis for life sciences, health plans and providers. Jenna has also worked at various non-profit organizations focusing on public health and patient advocacy. Her educational background includes a Bachelor of Science in Health Sciences (Hons.) from Brock University and a Juris Doctor with a concentration in health law from Case Western Reserve University. She is admitted to the Maryland bar.

Mina Kato is the senior advocacy communications and stakeholder engagement manager for Vizient. Prior to joining Vizient, Mina managed advocacy communications initiatives for the Council for Advancement and Support of Education (CASE). She also worked in advancement at American University and started her career as a scheduler on Capitol Hill. Mina received her bachelor’s degree in political science with a focus on international affairs from the University of California, Riverside, and her master’s degree in political science from American University.

Published: November 15, 2021