Industry News, October 2024

The Centers for Medicare & Medicaid Services (CMS) implemented the Targeted Probe and Educate (TPE) process for Current Procedural Terminology (CPT®) code 77301, IMRT planning. The reviews with “edit effectiveness” were presented for providers in North Carolina, South Carolina, Virginia and West Virginia, Jurisdiction M of the Medicare Administrative Contractor (MAC) Palmetto GBA. 

Code 77301 Focus of MAC Targeted Probe and Educate Process

Of 8 targeted providers, 7 were found to be compliant and were removed from the probe; and 1 was found to be noncompliant and resulted in a second probe. Out of a total of 196 claims, 6 percent were denied, resulting in denials of $26,643.17.  

CMS identified the top reasons for 77301 denials and provided specific recommendations for each to avoid future denials:  

• Documentation not supporting medical necessity
  • Documentation did not contain any covered condition/indication, symptomology or diagnostic results that would support the service was reasonable and necessary for the treatment of the beneficiary.
  • CMS recommends submission of documentation which supports a covered indication or condition for service billed including physician or nonphysician provider (NPP) care management of the covered indication or condition; relevant medical history; relevant diagnostic results or symptoms; a legible physician or NPP signature on documentation; and use of the most appropriate ICD-10-CM codes to identify the beneficiary’s diagnosis.

• Records not submitted in a timely manner
  • Services billed were not covered because the documentation was not received in response to the Additional Documentation Request (ADR). The provider has 45 days from the date the ADR was generated to respond with medical records.
  • CMS recommends providers be aware of the ADR date and submit requested medical records as soon as the ADR is received; monitor status of claims Direct Data Entry (DDE) and begin gathering the medical records as soon as the claim goes to the location of SB6001; submit all information for each ADR and submit it at one time, including a copy of the ADR request; separate multiple ADR requests; ensure each set of medical records is individually identifiable and bound securely; and return medical records to appropriate mail address if mailing.  
• Recommended protocols not ordered or followed
  • Services billed were not covered because one or more requirements for coverage were not met.
  • CMS recommends clear physician/radiation oncologist orders for radiation treatment course, including specific anatomical target volumes, treatment technique, current dosage, type of radiation measuring and monitoring devices to be used and treatment fields;  relevant medical history documented prior to the date of service signed by the physician/radiation oncologist or appropriate NPP; clear indication of the diagnosis being treated and medical necessity of the services; supporting reports such as dosimetry, physicist, simulation, oncology and radiology; documentation of design and construction of Multi-Leaf Collimator; detailed itemized bill and supporting documentation of all billed services; treatment plan, including goals, treatment notes and specific dose constraints for the target and administration.  Above all, ensure the service was provided per the coverage guidelines for the service.
• Insufficient documentation – documentation submitted was insufficient for the services billed.
  • Services billed were partially or completely denied because the documentation submitted was insufficient.
    
  • CMS recommends submitting all documentation related to the services billed, including results for the date of service, correct beneficiary, proper authentication and legible provider signature.

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MACs Approve Coverage of AI-enabled Quantitative CT

​Coverage for automated quantification and characterization of coronary atherosclerotic plaque to assess the severity of coronary disease has been approved by a majority of the Medicare Administrative Contractors (MACs). These services are reported with CPT® codes 0623T-0626T and represent data analysis from a coronary computed tomographic angiography (CTA), which is a separate and distinct service from coronary fractional flow reserve, reported with code 75580. The 2024 CPT® Manual states, 

Automated quantification and characterization of coronary atherosclerotic plaque is a service in which coronary computed tomographic angiography (CTA) data are analyzed using computerized algorithms to assess the extent and severity of coronary artery disease. The computer-generated findings are provided in an interactive format to the physician or other qualified health care professional who performs the final review and report. The coronary CTA is performed and interpreted as a separate service and is not included in the service of automated analysis of coronary CTA.” 

There are four codes in this code set. Code 0623T is reported when all services are performed by the same physician or other qualified health care provider (QHP). The remaining codes are reported when a physician or other QHP performs only a portion of the service. 0624T is reported for the data preparation and transmission, 0625T is reported for the computerized analysis of data from the CTA, and 0626T is reported for the review and interpretation of the computerized analysis output into a written report. 

Effective November 24, 2024, four of the seven MACs, including Palmetto GBA, CGS Administrators, National Government Services (NGS) and WPS Government Health Administrators (GHA) will begin to cover these services. The chair of the Society of Cardiovascular Computed Tomography Health Policy and Practice Committee (HPPC), Ahmad Slim MD, who is also Director of Imaging at Pulse Heart Institute, contributed to the MAC local coverage determinations (LCDs) and final policies stated, “This is a positive step towards improved patient care. Increased access to AI-CPA, AI-augmented plaque assessment analysis tools, will help medical teams make more informed decisions for their patients, and have the potential to reduce unnecessary invasive procedures downstream.” 
 
Of the remaining MACs, Noridian is expected to publish their LCD in the upcoming days. Novitas Solutions and First Coast Service Options Inc. (FCSO) will continue to consider coverage for AI-CPA on a case-by-case basis. While the initial request for a new LCD was made by CleerlyHealth, there are several companies offering this imaging analysis technology that will also benefit from this coverage determination, including HeartFlow® and Elucid. 

The proposed LCD can be found at LCD ID DL39851, the MACs response to public comments can be found in Article A59930, and the final LCD (future effective) can be found at LCD L39851. Collectively, the MACs provide coverage for around 34 million Medicare beneficiaries. 

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OIG Supports More Oversight for Medicare Remote Patient Monitoring Services

According to a review by the Office of the Inspector General (OIG), there is a need for additional oversight by Medicare to ensure remote patient monitoring is being provided and billed appropriately.
Remote patient monitoring is the collection and transmission of health information, such as blood pressure, weight, pulse oximetry and respiratory flow rate from a patient (enrollee) at their home using a connected medical device that automatically transmits to their provider. The provider uses this data to treat or manage the patient’s condition or overall health status. Medicare began coverage of this service in 2018, referring to it as “remote physiologic monitoring”, and does not consider this service to fall under the definition of telehealth or its policies. Providers must establish medical necessity and obtain patient consent before initiation of remote patient monitoring services.

This service is comprised of three main components and is indicated in the CPT® codes for reporting:

1. Set up of the device and enrollee education on use of the device (code 99453);
2. Device supply of daily recordings or programmed alert transmissions for 30 days (code 99454); and
3. Treatment management by clinical staff/physician/other qualified health care professional for 20-minute increments during a calendar month (codes 99457, 99458), whereas code 99091 is reported for treatment management requiring a minimum of 30 minutes each day for 30 days.

 
Coverage of remote physiologic monitoring includes monitoring for any chronic or acute condition, and collection of any type of physiologic data using a variety of medical devices. Its use has widely expanded in the Medicare population with higher payments to Medicare providers billing for this service. Due to these specifics, an OIG review was performed to determine who is receiving remote physiologic monitoring services, for what conditions is this service being performed, how remote monitoring is being used, and identification of any “vulnerabilities that may limit the oversight of these services.” This review was based on analysis of Medicare claims and encounter data of remote physiologic monitoring from January 1, 2019, to December 31, 2022, with one or more of the remote physiologic monitoring codes (99091, 99453, 99454, 99457 and 99458).
 
According to CMS, each component of the service builds from the previous step. As such, these 3 components are intended allow providers to remotely manage their patient’s conditions.

Results concluded nearly 43 percent of Medicare patients receiving remote physiologic monitoring did not receive all 3 components of the service. In addition, results confirmed the sizable increase of remote physiologic monitoring from 2019 to 2022 which resulted in an increase in traditional Medicare payments from $9 million in 2019 to $201 million in 2022.  Payments were led by an increase in the number of enrollees and the average payment per enrollee. More than half of Medicare enrollees received remote physiologic monitoring services for hypertension. 
 
In total, these findings raised questions about the use of these services as intended and identified Medicare lacking key information for oversight. Specifically, the types of physiologic health data being collected; the disease or condition being monitored; the ordering provider; the delivering provider; and the types of devices being used. This lack of information limits CMS’ ability to ensure remote physiologic monitoring requirements are met, and its effectiveness to assess this service for future coverage changes.
 
The OIG offered recommendations to CMS, including implementing additional precautions to ensure that remote physiologic monitoring is used and billing appropriately to Medicare; requiring orders for the services with the ordering provider identification number on the claim; developing methods to identify the physiologic health data is being monitored, possibly a new HCPCS procedure code or modifier; offering provider education regarding the billing of these services; and identification and monitoring of companies that specialize in these services.  According to the OIG, CMS agreed with or would take into consideration all the recommendations. 

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Reactor Repair Expected to Interrupt Medical Isotope Supply

A letter shared by the Nuclear Medicine Europe (NMEU) Emergency Response Team (ERT) cautions the supply of Mo-99 and Tc-99m, the most commonly used medical isotopes in the world, could be cut by as much as 40 percent over the next few weeks. This comes as result of an inspection revealing a structural issue with a pipe in the high-flux reactor (HFR) in Petten, Netherlands, requiring immediate repair. The Petten HFR is one of the largest producers of radiopharmaceuticals for medical diagnosis and cancer treatment.
 
This unexpected HFR shutdown in combination with planned maintenance of other reactors is expected to cause “a significant impact on the supply of medical radioisotopes in the coming weeks,” the NMEU ERT’s update stated. This latest shortage will affect medical procedures requiring isotopes across the world, but especially in the U.S., since the states use Mo-99 and Tc-99m for more than 20 million procedures annually. The NMEU stated it would issue new communication if new information became available.
 
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) issued a statement regarding the impending shortage, recommending stakeholders communicate with their generator suppliers how this delay will impact their operations.

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MR Safety Codes

Among the new additions to the 2025 CPT® code set are codes that are specific to Radiology. A few codes of particular interest include magnetic resonance (MR) safety examination procedure codes. Prior to 2025, there was no way to report the extra work involved prior to an MR service that is required to ensure the safety of patients that have an implant or foreign body. The imaging provider can now be reimbursed for the work that is required for these patients, which includes implant or foreign body evaluation, implant positioning or immobilization, safety consultation and electronics preparation.
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The new MR safety code set consists of six codes. The first three codes in the code set, 76014 - 76016, represent services performed prior to the date of service (DOS) of the MR exam. 76014 and 76015 represent practice expense only services, which involve preparatory research/review performed by clinical staff, such as an MRI technologist and/or medical physicist. These practice expense only codes do not require physician work or a formal report, but they are utilized by a physician or other qualified healthcare professional (QHP) for the other services in this new code family. The practice expense only codes are reported based on time in increments of 15 minutes. Code 76014 is reported for the initial 15 minutes of MR safety implant and/or foreign body assessment. Code 76015 is reported for each additional 30 minutes of MR safety implant and/or foreign body assessment. There is one code prior to the DOS of the MR exam that does involve physician work. Code 76016 represents an MR safety determination made by a physician or other QHP and requires a formal written report.

MR Safety Services Performed Prior to DOS of MR Exam

Code		Description
Practice Expense - ​No Physician Work	76014	MR safety implant and/or foreign body assessment by trained clinical staff, including identification and verification of implant components from appropriate sources (e.g., surgical reports, imaging reports, medical device databases, device vendors, review of prior imaging), analyzing current MR conditional status of individual components and systems, and consulting published professional guidance with written report; initial 15 minutes
Practice Expense - ​No Physician Work	76015	. . . . .each additional 30 minutes (List separately in addition to code for primary procedure)
Physician Work	76016	MR safety determination by a physician or other qualified health care professional responsible for the safety of the MR procedure, including review of implant MR conditions for indicated MR exam, analysis of risk versus clinical benefit of performing MR exam, and determination of MR equipment, accessory equipment, and expertise required to perform examination with written report

​The remaining three codes in the new MR safety code set, 76017 - 76019, represent services that are performed on the same DOS of the MR exam. These codes are used to report safety medical physics examination customization planning and performance monitoring (76017), safety implant electronics preparation (76018), and safety implant positioning and/or immobilization (76019). Codes 76017 - 76019 represent services requiring physician work and a formal written report.

MR Safety Services Performed on the Same DOS of MR Exam​

Code		Description
Physician Work	76017	MR safety medical physics examination customization, planning and performance monitoring by medical physicist or MR safety expert, with review and analysis by physician or qualified health care professional to prioritize and select views and imaging sequences, to tailor MR acquisition specific to restrictive requirements or artifacts associated with MR conditional implants or to mitigate risk of non-conditional implants or foreign bodies with written report
Physician Work	76018	MR safety implant electronics preparation under supervision of physician or other qualified health care professional, including MR-specific programming of pulse generator and/or transmitter to verify device integrity, protection of device internal circuitry from MR electromagnetic fields, and protection of patient from risks of unintended stimulation or heating while in the MR room with written report
Physician Work	76019	MR safety implant positioning and/or immobilization under supervision of physician or qualified health care professional, including application of physical protections to secure implanted medical device from MR-induced translational or vibrational forces, magnetically induced functional changes, and/or prevention of radiofrequency burns from inadvertent tissue contact while in the MR room with written report

​The American College of Radiology (ACR) first published an ACR® Manual on MR Safety in 2002. The manual was recently updated and the 2024 edition provides a detailed example of the work that goes into ensuring patient safety prior to providing an MR service, including Chapter 12: Managing Patients and Research Subjects with Medical Implants and Devices in the MR Environment. The six new MR safety codes are a welcome addition to the 2025 CPT® code set and will provide financial recognition for these necessary services.

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Cardinal Health Acquiring Integrated Oncology

​Cardinal Health, a healthcare supply and services company, announced it has reached an agreement to acquire Integrated Oncology Network (ION), a network of over 50 community oncology centers, for slightly more than $1.1 billion. 
As part of the acquisition, ION’s practices, which include more than 100 providers along with various practice management and growth services, will become part of Navista, Cardinal’s cancer division. This integration will also grant these practices access to advanced AI analytics capabilities and the insights platform PPS Analytics, which Cardinal integrated after its recent acquisition of Specialty Networks. 
"Expanding our specialty services remains a key priority, and we are investing to enhance our offerings through Navista and the acquisition of Specialty Networks," stated Jason Hollar, CEO of Cardinal Health.

"With their successful model that provides comprehensive support to community oncology throughout the cancer care continuum and healthcare ecosystem, we believe that [ION] will significantly boost our oncology strategy and help us generate value for both providers and patients." 
The definitive agreement between the parties is subject to standard closing conditions, including regulatory approval. Cardinal expects the transaction to be beneficial to its earnings within a year following the closure. 
Founded in 2008, ION’s independent community oncology network operates across 10 states. Its member centers benefit from a range of supportive practice management services, including revenue cycle management, payer relations, physician recruitment, practice marketing, finance, accounting, human resources and information technology. 

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