In brief: Cath codes, sleep predictions, wildfire support, pulse ox guidance

WASHINGTON – The Pricing, Data Analysis and Coding (PDAC) contractor for CMS seeks primary contact information from manufacturers and distributors as it prepares to roll out new HCPCS codes for hydrophilic intermittent urinary catheters on Jan. 1, 2026, AAHomecare reports. 

Manufacturers and distributors can provide their primary contact by completing this form by March 31. Over the course of the year, the PDAC will work with the primary contact to determine if their products qualify for one of the new codes. 

Manufacturers and distributors must also submit code verification review applications for changes to product details or for new product verification by Oct. 31. The PDAC will assess whether existing products meet the criteria for the new codes for the upcoming year. All applicable product information identified for a code change will be captured and updated periodically on the Hydrophilic Intermittent Urinary Catheter Crosswalk. Products listed in the crosswalk will be transitioned to the appropriate HCPCS code effective Jan. 1, 2026. 

• Related: Catheter proposal is ‘huge step forward’ 

• Related: CMS has issued a final rule that addresses suspicious billing activity within the Medicare Shared Savings Program that resulted in an increase in DMEPOS billing for certain intermittent urinary catheter supplies. 

• Related: Noridian Healthcare Solutions, as the Supplemental Medicare Review Contractor (SMRC), is conducting post-payment review of intermittent urinary catheter claims billed with dates of service from Jan. 1, 2022, through Dec. 31, 2023 

NSF previews priorities, predictions 

LAS VEGAS – The National Sleep Foundation highlighted the growing contribution of “SleepTech” in diversifying innovation that can improve sleep, during a presentation at CES 2025 in Las Vegas. 

These advances can help everyday consumers get enough of the quality sleep they need, plus realize NSF's goal to make sleep science-based products and services more accessible and convenient, the foundation says. 

"This coming year we expect to see another spike in announcements about new SleepTech  products coming to market that advance the field and can support more people's decisions to prioritize sleep for their lifestyle, wellness and health," said John Lopos, NSF CEO. "It comes from a range of start-ups, growing platforms, and iconic names among consumer brands. The sleep economy as NSF defines it will be on a path to grow beyond what others have previously predicted."  

NSF noted a steady increase in the development of new technologies and form factors targeting sleep, spanning wearable and proximal devices, environmental solutions, and clinical sleep solutions that improve the patient experience. It noted an ongoing collaboration with the Consumer Technology Association on standards for consumer sleep technology has produced five standards already, with AI standards pending. 

NSF also highlighted the significant increased focus on sleep health by major employers and co-workers who have returned to the workplace or continue to work at home or in hybrid models. In a media session at CES, the foundation released new data showing insufficient sleep has a negative impact on the work productivity of 60% of Americans. The reported effects of poor sleep on people's performance also touch everyday life, with more than 69% of Americans reporting difficult thinking clearly, and 60% having problems handling their workload and avoiding mistakes if they've had poor sleep.  

"Whether an organization employs 20 people or 200,000, focusing on sleep health and safety in their own community of colleagues can benefit performance and productivity at work and in daily living," added Joseph Dzierzewski, PhD, NSF's senior vice president of research and scientific affairs. 

FDA issues draft guidance on pulse oximeters 

WASHINGTON – The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a range of skin pigmentations. The FDA is requesting comments on “Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling and Premarket Submission Recommendations” for 60 days, until March 10. The draft guidance includes information on “What do I need to know about oxygen concentrators,” “How are my oxygen levels monitored at home,” and “What do I need to know about pulse oximeters.” It also includes instructions for how to report problems with a device. To submit comments on the draft, go here.  

California wildfires: Henry Schein makes hotline available 

MELVILLE, N.Y. - Henry Schein has opened a customer emergency support hotline in response to the wildfires in California. The company’s dental and medical professionals who may be experiencing operational, logistical or financial difficulties are encouraged to call 800-999-9729 for 24/7 support, with real-time support available from team members from 8 a.m. to 8 p.m. EST. “We are deeply saddened by the immense loss caused by the fires in California, and our hearts go out to all the affected communities,” said Stanley M. Bergman, chairman of the board and CEO. “Our hotline remains open, and we are here to assist customers, provide guidance, and stand by dental and medical professionals to navigate this difficult time together.” Henry Schein also offers an Emergency Preparedness Guide for customers that provides steps to help them minimize the impact of a natural disaster and swiftly return to operations. For more information about Henry Schein’s emergency preparedness and relief resources, click here. 

United Spinal seeks ‘positive’ change around accessible parking 

NEW YORK – United Spinal Association has published “The Complete Guide to Accessible Parking,” a new resource for people with disabilities. This guide follows the Disability Etiquette Guide and the Wheelchair Emergency Preparedness Compendium published in 2024. “United Spinal Association's Complete Guide to Accessible Parking is the result of nearly three years of hearing from and meeting with our members, examining the many problems that exist with accessible parking,” said Stephen Lieberman, senior director, Advocacy & Policy. “It is abundantly clear that policymakers, the business community, and the general public have little awareness about accessible parking, and United Spinal is committed to leading the way forward to improve accessible parking across the country. We hope that this Complete Guide to Accessible Parking provides all Americans with the tools and information they need to make positive change on this issue in their communities.” The guide enables accessibly parking users to know – and enforce – their existing rights and highlights how existing standards, which have not been updated since 2010, could be improved. The guide also offers model goals and methods of partnership with local government to contend for change. While there are nearly 10 disabled placards per 100 vehicles nationwide, only 2% of parking spaces in large lots and one in 25 spaces in smaller lots are accessible, according to United Spinal. 

Specialty pharmacy group names new president 

WAKEFIELD, Mass. – The Health System Owned Specialty Pharmacy Alliance (HOSP), a network of leading health systems and supporting businesses dedicated to advocating for superior patient care and outcomes through integrated health system specialty pharmacies, has appointed Tim Affeldt, PharmD, vice president of specialty/infusion operations for Fairview Pharmacy Services, as its new president. The alliance says Affeldt brings a wealth of experience and passion for advancing specialty pharmacy, positioning HOSP for continued growth and impact in the health care sector. “I am confident that Tim will build on our strong foundation and lead the organization to even greater achievements,” said President Emeritus Gary Kerr. “His vision and expertise will be invaluable as HOSP continues to advocate for the critical role of health system-owned specialty pharmacies in improving patient care.” A graduate of the University of Minnesota, College of Pharmacy, Affeldt joined Fairview Pharmacy Services in 2013, providing strategic leadership to various pharmacy services, including specialty and mail-order pharmacies, infusion center pharmacy and home infusion. In addition to his role at Fairview, he has served as treasurer of HOSP and contributed to numerous professional organizations, including the National Home Infusion Association and the National Association of Specialty Pharmacy. “I am thrilled to take on this role and continue the exceptional work that Gary and the HOSP team have accomplished,” Affeldt said. “Together, we will work to address the challenges facing health system-owned specialty pharmacies and seize new opportunities to enhance patient outcomes and advance our profession.”   

Inovalon tapped by NELC to streamline processes 

BOWIE, Md. - Inovalon has announced that New England Life Care, an in-home infusion therapy provider, has selected the company’s ScriptMed Infusion pharmacy management software to optimize its pharmacy home infusion operations. ScriptMed Infusion's customizable features and modules will allow NELC to achieve operational efficiencies, improve patient engagement, and support data-driven decision-making through streamlined workflows, real-time analytics, and interoperability, the company says. "We chose Inovalon's ScriptMed solution for its ability to transform the experience of our care teams across our network of hospital partners and, most importantly, for the patients we serve,” said Brian Treptow, CIO, New England Life Care. "Tailored workflows designed for home infusion and nutrition empower our teams to feel more connected, confident and capable in delivering exceptional care. Enhanced coordination and streamlined processes allow our staff to dedicate their focus to what truly matters ― achieving safe care and the best outcomes for patients in the comfort of their homes." Additionally, NELC is integrating Inovalon's real-time, on-demand access to patient-specific clinical data, known as DataStream, to enhance clinical workflows and patient care by prepopulating patient medical history data, including critical diagnosis and medication profile datasets, empowering greater operational workflow efficiencies, a better patient consumer experience and more informed care decisions, the company says. NELC is a nonprofit hospital services cooperative that partners with more than 65 nonprofit member hospitals in Massachusetts, Maine, New Hampshire and Vermont. 

McKesson launches initiative to boost pharmacy advocacy 

IRVING, Texas — McKesson has launched McKesson Amplify, a strategic initiative intended to help protect critical pharmacy services and elevate the pharmacy profession by strengthening the voice of the industry, it says. Through McKesson Amplify, the company has committed to awarding dedicated funding to eligible state pharmacy associations across all 50 states to help meet association advocacy goals. “We believe pharmacists’ voices are one of the most important in the conversation,” said Jeanine Singer, senior vice president, national and key accounts & field sales, McKesson. “But a single voice can only be heard from so far. Recognizing that advocacy and pharmacy practice transformation happens locally, we created McKesson Amplify to collectively raise the profession and turn up the volume in support of independent community pharmacy across the nation.” To determine funding awards, McKesson reviewed applications from state pharmacy associations, which detailed activation ideas and goals, including advocacy and lobbying, events, membership drives, professional development and training, and communications, technology and digital platforms. Beyond funding, McKesson Amplify will also provide resources, strategic support and other tools to help state pharmacy associations achieve their local and state advocacy goals in 2025. 

Mölnlycke Health Care invests in Siren  

GOTHENBURG, Sweden – Mölnlycke Health Care has announced an $8 million investment in Siren, which makes the Siren sock, a temperature sensing textile technology, to help reduce the risk of diabetic foot ulcers through early detection. “Our strategic investment in Siren reflects our commitment to integrating into digital ecosystems and pioneering innovative digital solutions that revolutionize health care delivery,” says Zlatko Rihter, CEO of Mölnlycke. “Helping to prevent wounds from occurring is also in line with Mölnlycke’s Wound Care mission to ‘help free patients from the burden of wounds’ and our ambition to further support health care in the post-acute segment.” Siren has also created a service ecosystem using remote patient monitoring clinical teams. The company’s system has been clinically proven to reduce the risk of ulcers by up to 68% and amputations by 83%, it says. “We’re excited to team up with Mölnlycke to tackle diabetic foot ulcers at their earliest stages,” says Ran Ma, co-founder and CEO of Siren. “By investing in preventive technologies like ours, Mölnlycke is demonstrating real vision and leadership in helping patients avoid the debilitating consequences of diabetic foot ulcers. Their investment sends a clear message that prevention matters. By catching issues before they escalate, we can help patients stay healthy and independent, reduce unnecessary procedures, and ultimately make a real difference in their lives.” 

CDRH launches ‘Idea Lab’ 

WASHINGTON - The Center for Devices and Radiological Health (CDRH) is unveiling an Idea Lab as part of the Home as a Health Care Hub initiative to help innovators, providers and patients reimagine the home as an integral part of the health care system. The Idea Lab includes a virtual reality prototype, named Lilypad, which will give users an immersive experience inside various affordable homes representative of people living with diabetes, a chronic condition that impacts millions of Americans. “We chose people living with diabetes as a test case given the prevalence and burden of disease, the importance of medical devices and lifestyle in managing the condition and preventing comorbidities, and the mobilized patient organizations and provider groups that are well-positioned to contribute to solutioning,” wrote Michelle Tarver, M.D., Ph.D., director of CDRH. “The effort was informed by insights from patients and families living with diabetes, as well as patient organizations that support their needs to better understand the barriers faced by this population and the potential for a significant transformation in how they can manage their conditions.” Lilypad will be housed in the online Idea Lab and will provide a realistic look into the challenges and barriers people face navigating their medical conditions in their daily lives. The Idea Lab will also include insights from patients, caregivers, providers and experts, tours of different types of affordable housing environments, and landscape research into design opportunities ripe for innovation. These insights and resources are intended to help the U.S. Food and Drug Administration, innovators and other interested parties better understand how current medical devices fit into people’s homes and lives.