Cardiac CT Scanner Receives FDA Clearance for LDCT
The system's deep-learning imaging reconstruction (DLIR) technology boosts image quality, while the rapid scan reduces the amount of contrast needed and limits radiation exposure.
Lung and bronchus cancer is the leading cause of cancer death in the United States with new cases diagnosed nearly every two minutes, according to the American Cancer Society(R). However, survival rates have increased by 26 percent to 28.4 percent nationally over the past five years. Arineta believes FDA clearance to their CT scanner expands access to the "critical, lifesaving imaging needed for this high-risk population." New Prostate Imaging Agent Available in the U.S.
On June 11, 2025, the biopharmaceutical company, Telix, announced the availability of a new prostate cancer imaging agent, Gozellix(R), within the United States. The newsletter noted despite the establishment of PSMA-PET imaging as the standard of care for staging and identifying recurrent prostate cancers, there are only a small number of the 3.4 million men living in the United States with prostate cancer that have benefited from PSMA-PET technology. Telix cites access and availability as challenges to obtaining PSMA-PET imaging.
According to Telix, Gozellix's enhanced formulation, with an extended "hot" shelf-life of up to six hours, offers a greater level of patient access and convenience through an extended transportation distance and clinical administration window. Telix estimates that up to 20% of PET cameras in the U.S. are beyond the reach of currently available PSMA-PET imaging agents due to distribution efficiency constraints. By overcoming this limitation, Gozellix can improve access for prostate cancer patients, regardless of where they live, with greater scheduling flexibility for clinicians and their patients."
Telix also launched PSMA-PET imaging agent, Illucix(R), in 2022. Other PSMA-PET imaging agents on the market include Pylarify (R) from Lantheus and Posluma(R) from Bracco. Telix has applied for a unique HCPCS code for Gozellix and is pursuing transitional pass-through status with the Centers for Medicare and Medicaid Services (CMS). If approved, reimbursement for Gozellix will be received for Medicare beneficiaries in the hospital outpatient setting for the next two to three years while CMS gathers additional data on the cost of Gozellix.
According to CMS, transitional pass-through payments for drugs and biologicals are reviewed on a quarterly basis with approved products currently being reimbursed at a rate of the average sales price (ASP), plus 6 percent, minus the portion of the APC payment amount that CMS determines is associated with the drug or biological. More information on CMS transitional pass-through payments policy can be found here. Proposed LCDs Restricting SRT and EBT for Skin Cancers
On May 15, 2025, five Medicare Administrative Contractors (MACs) collaborated to propose Local Coverage Determinations (LCDs) that could significantly restrict Medicare coverage for superficial radiation therapy (SRT) and electronic brachytherapy (eBT) in treating nonmelanoma skin cancers (NMSCs). The five MACs identified as Palmetto GBA, Noridian Healthcare Solutions, CGS Administrators, National Government Services (NGS), and Wisconsin Physicians Service (WPS) jointly hosted a Multi-Jurisdictional Contractor Advisory Committee (CAC) Meeting on October 17, 2024 to discuss the clinical evidence related to SRT and eBT for NMSC treatment.
One notable proposal is Palmetto GBA's DL40189, which aims to limit Medicare coverage for SRT and eBT across seven states, including North Carolina, South Carolina, Virginia, West Virginia, Alabama, Georgia, and Tennessee. The proposal suggests these therapies should only be covered for patients who are not surgical candidates, effectively downgrading them to second-line treatments. The proposed LCD also declines coverage for electronic brachytherapy (EBT), citing a lack of long-term data. This stance differs with current practices in which SRT and eBT are often considered viable first-line options, especially for patients prioritizing cosmetic outcomes or those with medical comorbidities that make surgery risky. The Dermatology Association of Radiation Therapy (DART) has voiced strong opposition to the proposed LCDs, arguing that they undermine patient choice and access to care. The organization emphasizes that Image-Guided Superficial Radiation Therapy (IGSRT), a more advanced form of SRT, has demonstrated improved outcomes and should not be conflated with traditional SRT. DART also criticizes the proposal for not adequately considering peer-reviewed studies supporting the efficacy of IGSRT. Conversely, the American College of Mohs Surgery (ACMS) supports the proposed restrictions, particularly concerning the use of image guidance and simulation with SRT. The organization has urged CMS to revise billing codes to prevent what it considers inappropriate combinations of services, aligning with efforts to ensure cost-effective and evidence-based care. The American Society for Radiation Oncology (ASTRO) has also urged Palmetto GBA to finalize the proposed LCD and hopes that the effort will encourage other MACs to follow suit. The American Brachytherapy Society advises against the routine use of electronic brachytherapy for NMSCs outside of clinical trials, citing insufficient long-term efficacy and safety data. However, the National Comprehensive Cancer Network (NCCN) guidelines acknowledge radiation therapy, including SRT, as a treatment option for patients who are not surgical candidates or who refuse surgery. This highlights a divergence in clinical opinions and underscores the need for individualized patient care decisions. Merck to Introduce Injectable Keytruda Formulation in the U.S. This October
Merck & Co Inc. announced its intention to introduce a subcutaneous version of its leading cancer immunotherapy, Keytruda, in the United States starting October 1, 2025. This percutaneous formulation, which offers an alternative to the traditional intravenous infusion, is still under review by the U.S. Food and Drug Administration (FDA), which is scheduled to issue a decision by September 23, 2025.
Administering Keytruda via subcutaneous injection is expected to streamline treatment by significantly cutting down administration time-from roughly 30 minutes with the current IV method to about two minutes per dose. "We anticipate initiating shipments immediately post-approval, likely within the first couple of weeks," said Joanne Monahan, senior vice president within Merck's oncology unit. We're fully stocked to fulfill market needs." Merck projects that between 30 percent and 40 percent of current Keytruda patients will transition to the new version at peak usage. According to Monahan, the most rapid adoption is likely among patients using Keytruda alone (monotherapy), in oral drug combinations, and those with early-stage malignancies. Keytruda, which is authorized for use against a wide array of cancers, remains the top-grossing prescription therapy globally, generating close to $30 billion in revenue in 2024. According to Reuters, Merck is positioning the subcutaneous formulation as a strategy to bolster its market position and extend exclusivity, especially with major Keytruda patents set to expire in 2028. The pharmaceutical giant also aims to introduce the new formulation in European markets by early 2026. DOJ Files False Claims Act Against Medicare Advantage Insurers
The U. S. Department of Justice (DOJ) recently filed a lawsuit under the False Claims Act (FCA) against health insurance companies Aetna Inc., Elevance Health (formerly Anthem), and Humana (collectively known as the "Defendant Insurers"); and large insurance broker organizations eHealth, Inc., GoHealth, Inc., and SelectQuote Inc. (collectively known as the "Defendant Brokers"). The allegations involve the defendant insurers paying hundreds of millions of dollars in illegal kickbacks to the defendant brokers in exchange for enrollments into the defendant insurers' Medicare Advantage (MA) plans, also known as Medicare Part C, from 2016 through at least 2021.
Medicare beneficiaries may elect to opt out of traditional Medicare and enroll in MA plans provided by private insurance companies which act as Medicare Advantage Organizations (MAOs). MAOs contract with the Centers for Medicare and Medicaid Services (CMS) to operate and manage multiple MA plans. CMS pays MAOs a fixed amount per beneficiary enrolled in each MA plan. Currently, there are 33,000,000 beneficiaries that receive their health care coverage through MA plans. Many Medicare beneficiaries rely on the Medicare brokers to help them choose the best MA plan for their needs offered by commercial insurance companies, such as Aetna, Elevance Health, and Humana. According to the complaint, the defendant brokers allegedly steered Medicare beneficiaries to the defendant insurers' plans that paid the most kickbacks, regardless of the MA plans' quality or suitability for the beneficiaries. This resulted in high rates of complaints to Medicare and disenrollments to the MA plans by beneficiaries. The lawsuit describes kickbacks from the defendant insurers to the defendant brokers "often disguised and referred to as marketing, co-op or sponsorship payments." These kickbacks were in addition to and separate from enrollment commissions. Allegations also included Aetna and Humana putting conditions on kickbacks by limiting the number of people with disabilities enrolled in their MA plans. This was due to the defendants' perception that Medicare beneficiaries with disabilities would be more expensive to cover and less profitable than beneficiaries eligible for Medicare due to age. This is described as "cherry picking," which is against the law. According to the DOJ, the defendant insurers entered into contracts with CMS in which they explicitly declared they would "comply with. . . Federal laws and regulations designed to prevent or ameliorate fraud, waste, and abuse, including, but not limited to, applicable provisions of Federal criminal law, the False Claims Act (31 [U.S.C.] §§3729 et. Seq.), and the anti-kickback statute (§ 1128B(b) of the Act." Each time the defendant insurers submitted beneficiary data and attestations regarding enrollments from defendant brokers, the defendant insurers falsely represented statutory, regulatory, and contractual compliance with the anti-kickback statute (AKS). Although multiple allegations have been identified in this lawsuit, there has been no determination of liability. However, in a press release by the Office of Public Affairs of the DOJ, The investigation and prosecution of this matter illustrates the government's emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the FCA. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to HHS at 800-HHS-TIPS (800-447-8477)." CMS Issues Updated Hospital Price Transparency Guidance to Support Executive Order on Healthcare Pricing
On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) released updated guidance on hospital price transparency, requiring hospitals to post the actual prices of items and services, not estimates, in their machine-readable files. This update follows an executive order issued earlier in the year aimed at boosting healthcare price transparency. The guidance is now available on the Hospital Price Transparency resources website.
To ensure inclusion of a dollar amount in the hospital machine-readable files and to make hospital prices more transparent, CMS is issuing the following guidance: As required in the CY 2024 OPPS/ASC final rule, hospitals must encode a standard charge dollar amount in the machine-readable file (MRF) if it can be calculated, including the amount negotiated for the item or service, the base rate negotiated for a service package, and a dollar amount if the standard charge is based on a percentage of a known fee schedule.
Per CMS, when charges are based on known methodologies, like case rates or per diem pricing, hospitals are required to calculate and report exact dollar values. If pricing is based on a percentage of an unavailable fee schedule, they must include an estimated allowed amount and explanatory notes. Estimated allowed amounts must reflect the average actual payments received from third-party payers over the previous 12 months based on electronic remittance data. Hospitals must clearly indicate whether a service has been used during this period and explain their methodology when estimating amounts.
This updated guidance builds on prior rules from 2020, 2022, and 2024, reinforcing CMS' commitment to holding hospitals accountable for providing accurate, consumer-friendly pricing data. CMS hopes these changes will improve the usability of pricing data for patients, employers, researchers, and other stakeholders, ultimately promoting price transparency, competition, and value in the healthcare system. Medicare Portable X-Ray Survey Deadline July 31, 2025
Every five years, under the direction of the Centers for Medicare and Medicaid Services (CMS), Medicare Administrative Contractors (MACs) conduct a cost analysis survey for the transportation components of portable X-ray services. According to MAC CGS(R) Administrators, LLC,
Medicare plays a critical role in ensuring beneficiaries receive medically necessary diagnostic services, including the transportation of portable X-ray imaging for patients unable to travel to a healthcare facility. MACs periodically perform cost analysis surveys to assess and update payment allowances for various services to ensure appropriate reimbursement rates."
The cost analysis survey for the transportation components of portable X-ray services is specific to establishing 2026 allowance rates for HCPCS codes R0070 and R0075. These codes represent the cost of delivery, which is a separate and distinct cost from the technical and professional components. Full HCPCS code descriptions can be found below.
Information collected in the cost analysis survey includes transportation related costs (fuel, maintenance, insurance), personnel costs (wages, benefits, travel expenses), equipment depreciation and maintenance, administrative overhead related to portable X-ray services, and geographic variations in operational costs. On June 16, 2025, CGS(R) Jurisdiction 15, the A/B MAC for the states of Kentucky and Ohio, published a reminder newsletter regarding their Medicare Portable X-ray Survey. A survey template from CGS(R) can be accessed here.
Providers that provide portable X-ray services and bill R0070 and R0075 are encouraged to access the individual MAC website for their jurisdiction to complete the survey, which has a deadline of July 31, 2025. By participating, providers will influence 2026 reimbursement rates for HCPCS codes R0070 and R0075, help Medicare reflect realistic costs, support continued access to care for homebound and institutionalized patients, and stay engaged with regulatory compliance and payment policy evolution.
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.
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