On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) released its highly anticipated 2021 rules for the Medicare Physician Fee Schedule (PFS) and Quality Payment Program (QPP). These rules have had, and will continue to have, a massive impact on the use of digital health tools in the American healthcare system.
Permanent Solutions Needed After the Public Health Emergency Concludes
Telehealth
CMS continues to support expanded use of telehealth in addressing the COVID-19 pandemic, adding many new services to its Medicare telehealth services list for the duration of the public health emergency (PHE). However, CMS only includes live voice and video in its definition of telehealth and does not include other modalities. CMS has taken steps to permit direct supervision of a clinician by a physician via telehealth. CMS also extended support for some audio-only telehealth services and reduced some frequency limitations for telehealth visits. CMS is currently using emergency authority to permit these telehealth allowances, such as the Medicare Diabetes Prevention Program (MDPP) flexibilities, which will end when the PHE expires. However, these allowances need to remain in place as we continue to see patient care shifting to the digital realm and remaining on that trajectory even after the pandemic is over.
Some telehealth restrictions are 20 years old and counting, far overdue for an update. These outdated restrictions prevent patients from receiving care in their own home and limit use of telehealth to rural areas. The Connected Health Initiative (CHI) is leading the charge to get Congress to repeal these backward-facing restrictions that no longer serve the public interest.
On a brighter note, communication technology-based services are now permanently available to non-physician practitioners. These services include “virtual check-in” and image/video review service Healthcare Common Procedure Coding System codes created a few years ago that remain widely important.
Medicare Diabetes Prevention Program
The MDPP continues to incent in-person diabetes prevention coaching, which is a flawed approach in Medicare efforts to prevent this chronic condition. In its 2021 PFS, CMS has taken some new steps to support virtual interactions during the PHE.
Some of the PHE-limited MDPP flexibilities include waiving the requirement for in-person attendance at the first core session and obtaining weight measurements from MDPP beneficiaries. But CMS is not allowing virtual-only MDPP suppliers to furnish MDPP services even during the PHE.
CHI is supportive of the modest steps CMS has taken to support virtual modalities in MDPP, but CMS is long overdue to permanently expand the MDPP to fully support virtual providers and virtual encounters.
Clarification of Remote Physiological Monitoring Guidance
Remote physiologic monitoring (RPM) codes have been widely supported and generated a lot of excitement when they were activated a few years ago, but over time, a need for clarity on a number of areas emerged. Several years ago, CMS promised to provide more detailed guidance and has provided it in its new rules.
Notably, CMS appears to be making clear that the required 20 minutes of time necessary to bill for services of CPT codes 99457 and 99558 can include both interactive communication with the patient or caregiver as well as time furnishing care management services. CMS originally proposed that the required time only consist of “interactive communication,” which would have deteriorated the RPM use case. They appear to be making this clarification now because a previous one in the CMS fact sheet released alongside the final PFS rule does not align with the text of the rule itself. Hopefully, CMS will clarify this point when the official copy of the Final Rule is posted on December 28, 2020. If not, CHI will seek a Technical Correction.
CMS also made a few other PHE allowances for RPM permanent, such as allowing patient consent to be obtained at the time of service, allowing auxiliary personnel (including contractors) such as clinical staff to educate patients setting up RPM devices, and that RPM devices must meet the FDA definition of a medical device.
While it is important to applaud CMS for making clarifications on a number of areas, there are still some allowances that CMS did not make for 2021. For example, billing is not allowed when there are fewer than 16 days of data transmissions by a patient in a given month. Additionally, federal qualified health centers and rural health clinics still will not be able to separately bill for RPM. CMS has indicated that they are receptive to new codes and interpretations that will inch closer to realizing the potential of RPM, but business models may need to change based on this new rule.
Artificial Intelligence
CMS finalized its proposal to activate a new CPT code for “automated point-of-care” retinal imaging. This is the first time that the use of artificial intelligence is being directly supported in Medicare, setting an encouraging precedent for both Medicare and the entire healthcare system. Unfortunately, CMS has chosen not to valuate the new AI code as recommended by the Relative Value Scale (RVS) Update Committee. CHI has strongly encouraged CMS to provide digital health reimbursements that reflect an appropriate value to encourage continued AI innovation.
Final Thoughts
Overall, the proposed changes are a welcome step in the right direction as they aim to modernize an archaic set of guidelines during a public health emergency. By allowing for flexibility in their interpretation of care and increased telehealth services, CMS is making efforts to rise to the challenge of these uncertain times.