Industry News, April 2025

In accordance with Section 1833(t)(6)(B) of the Social Security Act, the Hospital Outpatient Prospective Payment System (HOPPS) requires that categories of medical devices be eligible for transitional pass-through payments for a minimum of two years and a maximum of three years. Additionally, Section 1833(t)(6)(B)(ii)(IV) of the Act mandates the creation of new device categories when novel medical technologies are not adequately represented by existing or former device categories.

Long Descriptor Update to Existing Device Pass-Through Category C1739

A device offset is a reduction in the pass-through payment that Medicare makes to hospitals for certain new medical devices under HOPPS. It’s a way for Medicare to avoid paying twice for a device – once through the regular payment for the procedure and again through the pass-through.

​As part of the “January 2025 Update of the Hospital Outpatient Prospective Payment System (OPPS),” outlined in Change Request 13933 (Transmittal 13032) dated January 3, 2025, HCPCS code C1739 was given preliminary approval during the quarterly review process for device pass-through status.

Effective January 1, 2025, the long code descriptor for HCPCS code C1739 has been updated to "Tissue marker, probe detectable by any method (implantable), with delivery system." Code C1739 has been assigned status indicator “H” as a pass-through device, and the codes it should always be billed with (e.g., CPT® 19281, 19283, 19285, 19287, and 10035) along with the device offset amounts were outlined by CMS and available in CR 13933. The corresponding device application will be reviewed and discussed further in the CY 2026 HOPPS proposed and final rules. Code C1739 is packaged in the Ambulatory Surgical Center (ASC) setting starting January 1, 2025.

---

Communication Technology-Based Services (CTBS): Challenges for Medicare Reimbursement

In the FY 2019 Medicare Physician Fee Schedule (MPFS) final rule, the Centers for Medicare and Medicaid Services (CMS) defined telehealth services as professional services equivalent to direct in-person patient services, like office visits and consultations. CMS also distinguished these “traditional telehealth services” from Communication Technology-Based Services (CTBS). Although CTBS are provided in an electronic format, these services are not considered a direct in-person equivalent, and therefore, a majority of CTBS services are not part of the Medicare list of telehealth services.

Since most CTBS codes do not fall under the classification of telehealth services, they are not subject to the Medicare telehealth extensions, including geographic and site restrictions, distant site provider limitations, mental health telehealth exceptions, and special case exceptions. This means CTBS codes may not be covered under state private payer laws (including Medicaid) that require telehealth services to be reimbursed on the same basis and at the same rate as their direct in-person patient service equivalents. Similar challenges have arisen with the new telehealth-specific code series (CPT® 98000-98016) from the American Medical Association (AMA), which CMS does not recognize and does not cover most of the codes as telehealth in the  FY 2025 MPFS final rule.  
While CTBS codes offer extended opportunities for remote care beyond those services CMS defines as telehealth, they also present reimbursement challenges. Each type of CTBS code has its own specific set of requirements that must be met, and practitioners should be aware of them:
Remote Physiologic Monitoring (RPM) – CPT® Codes 99091, 99453-99458

• Monitor and analyze a patient’s physiologic data such as blood pressure, O2 saturation, glucose levels and weight fluctuations using non-face-to-face technology.
• Medicare requirements include an established patient relationship with a practitioner; monitoring of an acute or chronic condition deemed medically necessary; only one practitioner can bill for RPM per patient in a 30-day period; patient must provide consent; and collection and transmittal device must meet the FDA’s definition of a medical device. More details can be found here.  

Remote Therapeutic Monitoring (RTM) – CPT® Codes 98975-98981

• Monitor a patient’s non-physiologic data related to therapeutic treatment, including treatment compliance and treatment response.
• Medicare requirements include monitoring deemed medically necessary; RPM and RTM cannot be reported together; and collection and transmittal device must meet the FDA’s definition of a medical device. More details can be found here.   

Virtual Check-Ins –HCPCS Code G2010 and CPT® code 98016 (formerly G2012)

• Brief remote evaluation of a patient’s communication through technology by the practitioner (G2010) or virtual check-in by the patient (CPT® 98016) to determine if an in-person office visit or other evaluation and management (E/M) service is required.
• Medicare requirements include an established patient relationship with a practitioner; patient must initiate the service and must verbally consent to the service; and communication must not be related to a medical visit within the past 7 days or lead to a visit within the next 24 hours. More details can be found here.   

E-Visits – CPT® Codes 99421-99423; HCPCS Codes G2061-G2063

• Time-based online digital patient assessment and management up to 7 days.
  • CPT® codes 99421-99423 are reported by practitioners who can independently bill E/M services (i.e. physicians and nurse practitioners).
  • HCPCS codes G2061-G2063 are reported by clinicians who cannot independently bill E/M services (i.e. physical and occupational therapists, speech-language pathologists and clinical psychologists).
• Medicare requirements include an established patient relationship with a practitioner; the patient must initiate the service and must verbally consent to the service; and the service is typically performed via online patient portal. More details can be found here.

E-Consults – CPT® Codes 99446-99449, 99451-99452; G0546-G0551

• Time-based interprofessional electronic patient consultations using telephone, internet or electronic health assessment and management services provided by a physician or other qualified healthcare professional (QHP). This service involves a physician or QHP requesting the clinical opinion of a practitioner with specialty expertise without the patient being seen.
  • CPT® codes 99446-99449, 99451 are reported by consulting physician or QHP. Code 99452 is reported by the treating/requesting physician or QHP.
  • HCPCS codes G0546-G0550 are reported by consulting physician or QHP for mental illness. Code G0551 is reported by the treating/requesting physician or QHP for mental illness.
• Medicare requirements include a verbal or written request for the consultation documented in the patient’s medical record with reason for consultation; verbal and written report to the patient’s requesting/treating physician or QHP; and these codes are not reported for a transfer of care. More details can be found here.

Chronic Care Management (CCM) – CPT® Codes 99490, 99439, 99491, 99437; 99487, 99489; HCPCS Codes G3002-G3003

• Time-based medical or psychosocial services provided to patients with 2 or more chronic conditions expected to last at least 12 months or until the patient’s death that put the patient at significant risk of death, acute exacerbation, decompensation or functional decline. These extensive services involve non-face-to-face communication between the patient and practitioner including phone calls, secure emails and online patient portal.
  • CPT® codes 99490, 99439 are reported for non-complex CCM services directed by practitioner or QHP.
  • CPT® codes 99491, 99437 are reported for non-complex CCM services performed by practitioner or QHP.
  • CPT® codes 99487, 99489 are reported for complex CCM services directed by practitioner or QHP which require moderate to high complexity medical decision-making (MDM) as defined in the E/M guidelines by the practitioner.
  • HCPCS codes G3002-G3003 are reported for chronic pain management services.
• Medicare requirements include an initiating visit for a new patient or for a patient who has not been seen by the billing practitioner within the previous year; written or verbal consent by the patient for CCM services; and a comprehensive care plan that is established, implemented, revised and monitored. More details including concurrent reporting of CCM services can be found here. 

Transitional Care Management (TCM) – CPT® Codes 99495-99496

• Services provided to a patient who is in a transition of care from an inpatient hospital setting to the patient’s “community setting” such as home, assisted living or nursing facility. These services involve both face-to-face visits by the practitioner, and non-face-to-face services either by the practitioner or under general supervision by the practitioner of auxiliary personnel.  
• Medicare requirements include an initiating visit for a new patient or  for a patient who has not been seen by the billing practitioner within the previous year; written or verbal consent by the patient for CCM services; within 2 business days of discharge from an inpatient hospital setting, there must be an initial communication between the patient/caregiver and the practitioner by direct in-person contact, telephone or email; and a moderate or high-level complexity MDM is required by the practitioner. More details can be found here.
• Unlike the other CTBS categories, TCM services can be considered both CTBS and Medicare telehealth services. Codes 99495 and 99496 are included in the Medicare list of telehealth services, so how the TCM services are provided and reported make a difference in how they are adjudicated for payment:
  • If these codes are reported as telehealth services because the initial communication was performed via telehealth with the place of service (POS) 02 or 10 and/or the 95 or 93 modifiers, the telehealth restrictions would apply.
  • If the initial communication was performed in-person or via email (outside telehealth) and the POS 02 or 10 and/or the 95 or 93 modifiers are not reported, the telehealth restrictions would not apply.  

CMS updates telehealth and CTBS codes and requirements through its annual MPFS proposed and final rule, which are typically issued in July and November, respectively. Telehealth FAQ for calendar year (CY) 2025 are available on the CMS website, which are current as of April 9, 2025. This covers the recent telehealth extensions through the Full-Year Continuing Appropriations and Extensions Act, 2025.

---

FDA Announces Recall of Embolization Devices

The U.S. Food and Drug Administration (FDA) announced the Medtronic Neurovascular Class I recall of two of its Pipeline Vantage Embolization Devices with Shield Technology (PVED), the 027 Compatible and the 021 Compatible devices, resulting from safety issues. These devices are used to treat brain aneurysms.

These safety issues are due to the higher occurrence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during and after procedures using these devices. According to the FDA recall, “Incomplete wall apposition and braid deformation, also sometimes called fish-mouthing, braid narrowing, or braid collapse, are known risks of these devices. The risks were higher in females, especially those younger than 45 years of age. The use of affected product may cause serious adverse health consequences, including thrombosis, stroke, or death.”

The Pipeline Vantage 027 device was linked to 13 injuries and four reported deaths, and it is being completely removed from the market. The Pipeline Vantage 021 device was linked to four reported injuries, but no deaths. This device is not being removed from the market; however, its instructions for use (IFU) have been updated to feature certain risks.

​For patients who have already been treated with Pipeline Vantage 027 and 021 devices, the treating physicians are advised to “determine the need for follow-up imaging or changes to medical management based on the patient’s overall health.” This includes assessing the use of antiplatelet therapy against the potential risks for braid deformation. 

---

Imaging Experts Raise Concerns About CMS Quality Measure Intended to Reduce CT Radiation Exposure

​The Centers for Medicare and Medicaid Services (CMS) clinical quality measure "Excessive Radiation Dose or Inadequate Image Quality for Diagnostic Computed Tomography (CT) in Adults" is raising concerns from medical imaging experts. This radiology quality measure, adopted in 2023 and implemented in January 2025 after endorsement from the National Quality Forum (NQF), intends to provide a standardized process “to monitor CT performance to discourage unnecessarily high radiation dose while maintaining adequate image quality.” The metrics require CT category or type of exam; size adjusted radiation dose, which is the patient’s dose length product (DLP) adjusted by patient size; and global noise, associated with the variance of the voxel values in CT images.

Following implementation, practitioners identified problems and concerns with the measure; and to that end, the American Association of Physicists in Medicine (AAPM) recently organized a panel of experts, including clinical practices, industry, academia, and professional societies, to discuss the issues. Their findings were published in the American Journal of Roentgenology, summarizing concerns arising after implementation of this measure. The panel identified “20 issues and ambiguities in the measure specifications,” including mandatory versus optional measure reporting, the ability to distinguish between inpatient and outpatient admission status, and potential IT burden and security issues.      

​The panel also provided recommendations to boost the measure’s intentions, including more access to the source data and reporting elements, and more consistency in determining patient admission status, among others. “Transparency and stakeholder engagement are essential for effective quality initiatives in medicine,” said M. Mahesh, M.S., Ph.D., president of AAPM, in a statement. “We wrote this paper to call attention to issues and ambiguities with the CMS measure, and we look forward to working with CMS to address these issues and continue the culture of quality and safety that has developed in CT imaging over the past two decades.” 

---

FDA Approves Expanded Use for Pluvicto®

On March 28, 2025, Novartis announced that the U.S. Food and Drug Administration (FDA) had approved an expanded indication for Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). This new approval applies to patients who have been treated with an androgen receptor pathway inhibitor (ARPI) and are considered appropriate to delay chemotherapy.

The decision is based on results from the Phase III PSMAfore trial, which showed that Pluvicto significantly reduced the risk of radiographic progression or death by 59 percent compared to switching to another ARPI. In an updated analysis, the treatment more than doubled median progression-free survival. 

“This earlier use of Pluvicto could shift how we treat mCRPC,” said Dr. Michael Morris, Section Head of Prostate Cancer at Memorial Sloan Kettering Cancer Center and lead U.S. investigator for the trial. “It provides a more effective option than a second ARPI, delaying disease progression in a targeted way.”

Safety data from the study showed Pluvicto® had a favorable and consistent profile. Most side effects were mild to moderate and included dry mouth, fatigue, nausea, and constipation. Importantly, it did not affect patients' ability to receive chemotherapy later.

Prostate cancer continues to be a major health challenge with over 35,000 deaths annually in the U.S. and rising. Many patients with mCRPC are not able to receive multiple lines of treatment due to the rapid progression of the disease. While hormone therapy and chemotherapy remain mainstays, their side effects often lead patients and doctors to look for alternatives.

“This expanded approval is a game-changer,” said Gina Carithers, CEO of the Prostate Cancer Foundation. “It gives patients more options earlier in treatment and more control over their care decisions.”  

---

All rights reserved. No part of this newsletter may be reproduced in any form whatsoever without written permission from the publisher. This newsletter may reflect coding information from the 2025 Physician’s Current Procedural Terminology (CPT® Manual). CPT is a registered trademark of the American Medical Association. CPT® five-digit codes, nomenclature and other data are copyright 2024 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT®. This product should not be considered a substitute for the codes, cross-references and exclusions located in the CPT® Manual.  AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein.