On August 15, 2024, CMS announced it negotiated lower prices with drug manufacturers for the ten selected Part D drugs, with the new prices becoming effective January 1, 2026. These drugs are some of the most expensive and most widely used in the Medicare program, treating conditions such as diabetes, heart failure, kidney disease, and blood cancers.
For 2023, about 8.8 million people with Part D coverage received the selected drugs, which accounted for $56.2 billion in total Medicare spending, or about 20 percent of total Part D gross spending. Overall, out-of-pocket costs for people with Part D coverage during 2023 was $18.9 billion, with $3.9 billion of the total going towards the selected drugs. According to CMS, the new prices are estimated to save $1.5 billion for beneficiaries with Part D coverage. In addition, all Medicare Part D enrollees will benefit from a $2,000 out-of-pocket cap on their prescription drug costs. CMS has provided a fact sheet which includes more information about the newly negotiated prices. As required by the Inflation Reduction Act, CMS will select up to 15 more drugs covered under Part D for negotiation for 2027 by February 1, 2025. CMS will then select up to 15 more drugs covered by Part B or Part D for 2028, and up to 20 more Part B or Part D drugs for subsequent years. ASTRO Provides Congressional RFI Regarding 21st Century Cures Act
On August 1, 2024, the American Society for Radiation Oncology (ASTRO) responded to a congressional request for information (RFI) regarding the implementation of the 21st Century Cures Act and its successor, Cures 2.0. Cures 2.0 was designed to expand on the 21st Century Cures Act by focusing on modernizing coverage and improving access to life-saving treatments. In their response, ASTRO highlighted five main concerns:
ASTRO also signed on to the Cancer Leadership Council’s response to the request, which included the promotion of gene and cell therapies, alternative funding plans, patient experience data, and payment reform.
ASTRO is the largest radiation oncology professional society, with over 10,000 members dedicated to promoting quality patient care, promoting research, and improving cancer treatment through health policy. HHS Proposes Rule to Update EHR Certifications
The Secretary of Health and Human Services (HHS) assigned responsibilities to the Office of the National Coordinator for Health Information Technology (ONC) for the implementation of certain provisions in Title IV of the 21st Century Cures Act (Cures Act). Signed into law in 2016, the Cures Act made sharing information the standard in healthcare. The specific provisions assigned to the ONC include the advancement of computer system or software intercommunication; support of access, exchange, and use of electronic health information; and identification of reasonable and necessary activities that do not constitute information blocking or interference.
Recently, the ONC issued the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule for public comment. The intention of this proposed rule is to “advance interoperability and improve information sharing among patients, providers, payers, and public health authorities” through:
Among the proposals under the HTI-2 proposed rule is the modification of existing certification criteria to support electronic image exchange functions, including the transition of care; view, download, and transmit; application access – all data requests; and standardized application programming interface (API) for patient and population services. The agency proposes by January 1, 2028, Health IT Modules must be updated using these criteria to maintain their certification. These modifications should support public health data exchange across healthcare settings for a wide range of uses. One specific area of improvement is imaging links in certified EHRs to allow viewing and downloading of diagnostic and low-quality radiology images.
Currently, radiology images are stored on platforms not included in electronic health records (EHRs). This format makes the electronic exchange of images more difficult and often results in the use of flash drives or CDs for patients and their providers to receive their images. If these modifications are finalized, the agency believes it will provide more consistent access to radiology images for providers and patients. Epic Adds Smartphone App Capability for Patient EHR Access
Electronic Health Record (EHR) vendor Epic Systems announced that patients will be able to download their medical information to smartphone apps of their choice, giving them more control over their medical information. Patient access to digital medical information already exists through application programming interfaces (API), and Epic currently allows patients to access their own medical records through its MyChart tool. "Epic’s goal had always been that regardless of vendor, every patient’s data should be able to be shared, with the patient’s permission, wherever the patient went," Epic founder and CEO Judy Faulkner wrote in her August 5, 2024 blog post.
Epic is one of the seven Qualified Health Information Networks (QHINs) that has been helping the federal government establish the Trusted Exchange Framework and Common Agreement™ (TEFCATM). This agreement defines the baseline legal and technical requirements for secure medical information sharing on a nationwide scale. Specifically, individual access services (IAC) is one of the “exchange purposes” under TEFCATM that promotes patient data sharing. The other exchange purposes include treatment, payment, healthcare operations, government benefits determination and public health. As part of this capability, digital health apps can volunteer to agree to TEFCATM for secure data sharing guidelines and provide the technology to support these transactions. In addition, apps must follow the Health Insurance Portability and Accountability Act (HIPAA) privacy rules, even if they are not legally mandated to do so. This is the next really important step for a patient to be able to access their own information through an application of their choice to be able to participate more directly in their own health care,” said Micky Tripathi, assistant secretary for technology policy and national coordinator for health information technology at HHS. Proper Usage of Modifier 76 and Application in Radiation Oncology
First Coast Service Options, Inc., the Medicare Administrative Contractor (MAC) for Florida, Puerto Rico, and the U.S. Virgin Islands has provided guidance for the use of modifier 76.
Modifier 76 is used to report a “repeat procedure or service by the same physician or qualified healthcare professional”. It should be used when the same provider performs the services and for procedure codes that cannot be billed multiple times. It is inappropriate to use modifier 76 for staged procedures, return to the operating room, unrelated procedures, repeat services due to equipment failure, and other scenarios. The modifier should not be used as an 'add-on' code; instead, these codes should be reported with a multiplier in the unit field to indicate how many times the service was performed. Modifier 76 should be used on a separate claim line with the number of repeated services, and documentation must support its use. The American Society for Radiation Oncology (ASTRO) has recommended coding guidance for use of modifier 76 with radiation oncology services. Modifier 76 is often utilized in radiation oncology to report brachytherapy simulations (codes 77280-77290). Simulations may be reported more than once when required for separate fractions of treatment. If a brachytherapy session is reported twice a day, each treatment may require a verification simulation prior to each treatment. In these cases, modifier 76 would be appended to the second verification simulation to report the repeat procedure in the same day. Keep in mind that certain payers may prefer modifier 59 (Distinct procedural service) to be appended to the second simulation code or require billing with two units instead. It is recommended to contact the payer and verify their billing requirements for this scenario. SNMMI Requests Nuclear Medicine Techs Be Recognized as Professionals
In a letter to the Standard Occupational Classification Policy Committee (SOCPC) of the Office of Management and Budget (OMB), the Society of Nuclear Medicine and Molecular Imaging Technologist Section (SNMMI-TS) is requesting nuclear medicine technologists (NMTs) be formally recognized as professionals. Under the 2018 Standard Occupational Classification System (SOC), NMTs are not categorized as professionals, but as Health Technologists and Technicians: Diagnostic Related Technologists and. This categorization does not support the skillset and responsibilities of these individuals in working with radiation for molecular imaging, radiopharmaceutical therapies, and research. As the field of nuclear medicine continues to grow, NMTs undergo rigorous education, training, and experience in both diagnostic and therapeutic nuclear medicine, with a stronger focus on patient care and radiation safety. According to the SNMMI, “the expertise and the complexity of the work of Nuclear Medicine Technologists clearly align with a professional classification.”
Among the specific items the SNMMI-TS is requesting for SOC review and consideration are:
FDA Approves First Colorectal Cancer Blood Test
In a recent press release, Guardant Health announced the Shield™ blood test has been approved by the U.S. Food and Drug Administration (FDA) as a primary screening option for colorectal cancer (CRC) in adults 45 years and older who are at average risk for the disease. This means providers can offer Shield™ “in a manner similar to all other non-invasive methods recommended in screening guidelines”. This is the first test approved by the FDA for this indication, and it meets performance requirements for Medicare coverage under National Coverage Determination (NCD) 210.3, "Colorectal Cancer Screening Tests".
The Shield™ blood test is available for eligible patients by prescription and is comprised of a simple blood draw or venipuncture. The company said it expects coverage for eligible Medicare beneficiaries and expansion for commercial insurance when guidelines include Shield™ by the American Cancer Society and the U.S. Preventative Task Force (USPSTF). “The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable,” said AmirAli Talasaz, Guardant Health co-CEO.
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