Radiation Oncology Model Delayed – Industry News, April 2022

RO Model Delayed, Again

Since its initial intended implementation date of January 1, 2021, the Radiation Oncology (RO) Model has experienced a multitude of delays. Most recently, on April 6, 2022, CMS proposed another delay to the start of the RO Model to a yet to be determined date that will be established through future rulemaking.

The long-awaited and highly controversial episodic payment model for radiation therapy treatments was initially finalized in 2020 but the implementation date was delayed several times due to the ongoing Public Health Emergency (PHE) in response to the COVID-19 pandemic. Prior to the April 6 proposed rule, The Protecting Medicare and American Farmers from Sequester Cuts Act prohibited the start of The Model until no earlier than January 1, 2023. However, the Centers for Medicare and Medicaid (CMS) now proposes a delay to the start date that would be determined via future rulemaking. As mandated with proposed rules, there is a comment period that extends through June 7, 2022.

Be heard! Submit a formal comment.

ACR Releases 20 New and Updated Criteria

The American College of Radiology (ACR) released five new topic areas in their Appropriateness Criteria ® (AC) and made updates to fifteen existing topics.

The ACR Appropriateness Criteria® are evidence-based guidelines which aim to enhance quality of care and streamline the use radiology services. The guidelines are intended to assist physicians and providers in making the most appropriate imaging and/or treatment decisions for specific clinical conditions. The guidelines also include a narrative, evidence table and literature search summary

Guidelines are developed and reviewed annually. The ACR has recently released a list of five new topic areas as well as fifteen updated guidelines, accessible below.

ACR, Advocacy Groups Ask CMS to Cover CT Colonography

Five patient advocacy groups, along with the American College of Radiology, have submitted a formal National Coverage Determination (NCD) reconsideration request to CMS to allow for coverage of CT colonography (CTC). CTC, sometimes called “virtual colonoscopy,” is widely utilized but is currently the only primary cancer screening test to be endorsed by both the U.S. Preventative Services Task Force and American Cancer Society and not be covered by Medicare or Medicaid. The ACR also sent a letter to HHS Secretary Xavier Becerra requesting that Medicare cover CTC.

Colorectal cancer occurs more frequently in communities of color and underserved communities, and CTC provides a convenient, cost-effective, and less invasive means of screening for the disease.

Among those who signed the request are the Colorectal Cancer Alliance, the Colon Cancer Coalition, and the Black Women’s Health Imperative.

“Medicare coverage for CTC has been a top priority for the ACR throughout the last decade, as the college strives for the mutual goal of screening as many patients as possible,” the ACR said in its April 9 Advocacy in Action eNewsletter. “Making another screening option available to Medicare beneficiaries will save lives.”

Public Health Emergency Extended

Xavier Becerra, Secretary of Health and Human Services (HHS) announced the renewal of the public health emergency (PHE) declared due to the Coronavirus Disease 2019 (COVID-19). The PHE was originally declared on January 31, 2020 and renewed on April 21, 2020. This new extension went into effect on April 16, 2022 and will last for 90 days, making the new expiration date July 15, 2022. The extension of the PHE allows for the flexibilities implemented by CMS to help compensate for the ever-changing healthcare environment due to the pandemic to continue.

To view the PHE Renewal, please click here.

FDA Approvals for PI3K Inhibitors in Jeopardy

The Food and Drug Administration (FDA) has announced that the future approvals of four existing PI3K inhibitors for hematologic cancers should have supporting survival data after a concerning patter of worse overall survival.

Since 2014, four phosphatidylinositol 3-kinase (PI3K) inhibitors have been approved for use in patients with certain blood cancers. However, there is “concerning” data that shows an excess of fatal adverse events (AEs) and high rates of severe and overall toxicity. After a summarization of data provided to the Oncologic Drugs Advisory Committee (ODAC), randomized control trial support was deemed necessary when considering future approvals.

The negative data presented to the ODAC came mostly from studies of patients with indolent lymphomas, which are linked to prolonged survival. This data exposed the sponsors heavy reliance of single-arm trials which were focused on assessing response rate with maximum or near-maximum doses and providing limited study of lower drug doses, leaving survival rate studies at the wayside.

While the vote was mostly supported by the ODAC, there was one absentee vote. The advisory member who chose to abstain from voting cited concerns the vote would discourage the continuation of development for an entire drug class.

“The overall survival information is early and represents a low number of events; yet, we have the same pattern observed across multiple trials,” the authors of the FDA report stated. “Further, in each trial, there was a higher rate of death due to adverse events in the PI3K inhibitor arm, suggesting the potential detriment in overall survival may be due to toxicity.” – FDA Report

SBRT to Lung Nodules Jumps When Radiologists Include ROs in Treatment Conversation

While Radiation Oncologists (ROs) have traditionally been left out of the workup and management of pulmonary nodules, new research suggests their inclusion could be advantageous.

The investigational research published in JAMA Network Open highlights the impact of radiation therapy as a treatment option for patients who present with incidental or screen-detected pulmonary nodules. While multidisciplinary review and management of these lung nodules is recommended, radiation oncologists are often left out of the discussion. However, it was found that when Massachusetts General Hospital began including radiation oncologists in their pulmonary nodule and lung cancer screening clinic in 2015, the percentage of patients receiving stereotactic body radiation therapy (SBRT) rather than surgical resection increased from 7% to almost 33%.

A corresponding editorial on the topic urges an update in guidelines regarding the multidisciplinary management of pulmonary nodules to include the involvement of radiation oncologists to benefit patients by facilitating the most appropriate treatment option.

April Coding Corner

Within this section, current topics will be the focus. In some cases, the Q&A could reflect common questions received by Revenue Cycle Coding Strategies and in other cases, represent current issues encountered by Revenue Cycle Coding Strategies professionals.

Question: We had a vendor tell us that we can charge for 2 injections for Evenity since we have to inject in both arms on the same day. Is this correct?

Advice: Per package insert you have to give 2 individual shots each month for 12 months. It is provided in 2 syringes, so therefore they are allowed two injection codes for this injection.

Question: Can I bill for a new plan for a patient with significant weight loss? This plan will have to have modified treatment volumes re drawn by the physician. The modified volumes will include a new node in the area of treatment discovered on a recent MRI.

Answer: If there is significant change to the tumor volume and/or surrounding anatomy documented by the physician with the medical necessity for a new data set and resulting new treatment plan, a new plan can be billed.

Question: Can you share with us how to document our SBRT procedures in support of the 77435 code. Is it appropriate to document a combined procedure note or should there be individual procedure notes for each SBRT treatment?

Advice: With SBRT treatments, the physician is required to compile a procedure note for every fraction of treatment. Part of the physician’s work outlined by the AMA for each fraction of treatment includes review of patient setup, imaging review, and the management of the patient after treatment delivery. The physician should be evaluating the patient after each treatment fraction and including the assessment in the required procedure note. The procedure notes serve as the supporting documentation for the management code, 77435, reportable once during the course of SBRT treatment.