In brief: HHS’s fraud pilot, Dingell’s CRT letter, Medtrade’s registration

WASHINGTON – The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice’s Civil Division have launched a six-month Healthcare False Claims Act Self-Disclosure Pilot Program for health care companies that voluntarily disclose potential civil violations of the federal False Claims Act.

Companies that meet the pilot’s requirements can resolve disclosed conduct through a coordinated civil release from liability under the federal False Claims Act and certain HHS administrative authorities.

“Every dollar stolen from our health care programs is a dollar taken from taxpayers and patients,” said HHS Secretary Robert F. Kennedy, Jr. “I thank President Trump for making the fight against fraud, waste and abuse a priority. HHS and DOJ are giving companies a clear path to come forward, repay what they owe, and correct misconduct – while aggressively pursuing those who defraud the American people.”

To participate, companies must:

• Disclose all relevant details about the potential violations
• Provide documents showing the full nature and operation of the conduct
• Describe the remedial steps they have taken
• Make a repayment calculated under the protocol, which applies a multiplier of 1.25 to 1.6. (The multiplier will vary based on factors such as the timeliness of the disclosure, the duration and scope of the misconduct, senior leadership involvement, the financial benefit to the company, and whether the company has successor liability for the misconduct but promptly remediated.)

In exchange, companies will receive:

• A release from DOJ for the disclosed potential False Claims Act violations
• The HHS Office of Inspector General (OIG) will not impose an exclusion or require a Corporate Integrity Agreement as part of the resolution
• CMS will not revoke the provider’s or supplier’s enrollment and billing privileges, and neither CMS nor OIG will impose civil monetary penalties.

“Transparency, accountability, and compliance are critical to safeguarding the integrity of federal health care programs,” said HHS Inspector General T. March Bell. “This pilot program provides companies with a clear pathway to self-disclose potential misconduct and resolve issues without a Corporate Integrity Agreement. By encouraging organizations to come forward, address compliance concerns, and undertake meaningful remediation, the program promotes proactive accountability that helps protects taxpayer dollars and beneficiaries.”

Companies may submit disclosures electronically to FCA-SDPP@usdoj.gov through April 22, 2027. Late or incomplete submissions will not be reviewed.

Related reading:

• CMS adds 11 medical supply companies to Preclusion List.
• CMS suspends more than 100 DME suppliers in fraud crackdown.

Lawmakers call on Medicare to cover preventative maintenance for CRT

WASHINGTON – U.S. Reps. Debbie Dingell, D-Mich., Brian Fitzpatrick, R-Pa., and colleagues have called on the Centers for Medicare & Medicaid Services (CMS) to cover preventative maintenance for complex rehab technology (CRT).

The lawmakers, in a letter to CMS Administrator Dr. Mehmet Oz, also ask the agency to drop a prescription renewal requirement for repairs of this equipment.

“Each year, tens of thousands of Medicare beneficiaries depend on CRT systems and equipment to maintain their mobility and independence,” they state. “Removing the prescription renewal barrier and providing coverage for preventative maintenance are targeted, achievable steps that would meaningfully improve care for this vulnerable population. We encourage CMS to prioritize both reforms and welcome the opportunity to discuss them further.”

Read the full letter here.

Current Medicare rules require that a component part must have already failed or malfunctioned before Medicare will cover any servicing – meaning that routine, scheduled maintenance designed to prevent failure is categorically excluded from reimbursement, the lawmakers point out.

“This framework is counterproductive in two respects,” they write. “First, it drives avoidable equipment failures: Problems that could be identified and corrected through routine maintenance instead go unaddressed until they become acute. Second, it undermines beneficiaries’ ability to plan.”

Current Medicare rules also require having a valid prescription on file dated within the prior 12 months for repairs.

“For beneficiaries who depend on power wheelchairs and similar equipment, this requirement, they say, creates an unnecessary and potentially harmful administrative obstacle,” they write.

The lawmakers believe CMS has the regulatory authority to allow for coverage of preventative maintenance and to waive or modify the requirement for prescription renewal.

Related reading:

• New York updates CRT maintenance, repair policies.
• ITEM Coalition presses policymakers to address repair issues.

ATA Action urges FDA to build risk-based framework for AI-enabled medical devices

WASHINGTON – ATA Action, the advocacy-focused affiliate of the American Telemedicine Association (ATA), has submitted comments in response to the U.S. Food and Drug Administration's discussion paper on AI-enabled medical devices, saying manufacturers should remain responsible for the safety and performances of the devices they sell.

The organization says the FDA should avoid shifting monitoring duties to the small, rural and safety-net practices that lack the staff to take them on and should instead give clinicians simple ways to report problems.

“AI has enormous potential to expand access to high-quality virtual care, but only if the regulatory framework is clear, proportionate and built to last,” said Joe Nye, head of federal government relations for ATA Action. “FDA’s discussion paper is a strong start. We look forward to working with the agency to turn it into guidance that protects patients, gives developers and clinicians predictability, and gets safe, effective tools to the people who need them, especially in rural and underserved communities.”

ATA Action's comments draw from the ATA's Policy Principles on Artificial Intelligence.

The organization also recommends:

• Provide clear disclosure that is reasonable and proportionate. FDA labeling should explain in plain language what a device does, who it is for and its known limitations; make clear the user is interacting with AI; and offer a clear path to a human clinician or emergency service, as appropriate.
• Regulate by function and risk, not by technology. Oversight should rest on what a tool does and risk, not on the fact that it uses generative AI. The FDA’s two-axis framework for AI systems that serve multiple clinical functions within a single interaction supports unified, harmonized, and risk-based regulation, with federal leadership to promote national consistency and without general prohibitions or broad pre-authorization schemes.
• Create a voluntary federal-state clinical AI sandbox. As states adopt differing approaches to clinical AI, ATA Action proposed a voluntary federal-state AI sandbox, built on the TEMPO pilot and developed with the Department of Health & Human Services (HHS) and participating states, and work alongside FDA’s existing authorization pathways. It would generate real-world evidence and phased clinician oversight, while FDA exercises conditional, time-limited enforcement discretion. This would give real-world evidence and direct insight into how these tools perform once deployed, and can inform a durable, nationally consistent framework.
• Scale validation to risk. ATA Action supports pairing benchmark testing with clinical confirmation scaled to risk, agrees that a prospective clinical study should not be required in every case, and strongly supports FDA’s openness to accepting more uncertainty at authorization when paired with strong post market monitoring and flexible predetermined change control plans.
• Evaluate performance across patient subgroups. Manufacturers should test devices with people who reflect intended users.
• Weigh the real-world alternative. In evaluating risk, FDA should consider the care a patient would realistically receive without an AI-supported service. In many rural communities and areas with clinician shortages, that alternative is a long wait or no care at all. ATA Action also encourages FDA to keep coordinating with the Centers for Medicare & Medicaid (CMS) to ensure safe and effective devices reach patients who need them.
• Rely on existing privacy and security rules. FDA should rely on established privacy and cybersecurity requirements rather than create new ones specific to generative AI and should protect the proprietary and confidential information developers share with the agency.

Read the ATA's full comment letter here.

Medtrade opens registration for first event in Fort Worth

FORT WORTH, Texas – Medtrade registration is now open. The event, scheduled for March 23-25, 2027, for the first time in Fort Worth, Texas, will feature an education program with 70 sessions across seven tracks. “With a bold new look and a new destination, we're gearing up for three days packed with fresh ideas, industry connections, and opportunities to move your business forward,” show organizers say. “Whether you're looking to stay ahead of industry changes, discover the latest HME products, or connect with the people shaping the future of care, Medtrade is where it all comes together.” Medtrade expects to draw more than 2,500 home medical equipment (HME) professionals and more than 300 exhibitors, including 15% more new exhibitors. As in years past, the event will feature a MedConnect Mixer, an AAHomecare Update and a Medtrade Happy Hour. Registration rates will be at their lowest through Nov. 20: $65 for an expo pass and $235 for a full conference pass.

• Related reading: Crowds grow at Medtrade as industry seeks greater clarity.

Senseonics initiates first-in-human study of CGM with no-body component

GERMANTOWN, Md. – Senseonics has initiated its first-in-human clinical study evaluating Freedom, an investigational next-generation continuous glucose monitor (CGM) system designed to communicate directly with a mobile device without the need for an external on-body transmitter. The company says the Freedom is an evolution of the same fundamental sensing technology as the Eversense 365 system, with the addition of an integrated battery and embedded Bluetooth communication capability. "Now being tested in humans for the first time, the Freedom CGM represents our vison to eliminate the requirement for an on-body component, effectively making continuous glucose monitoring invisible,” said Tim Goodnow, PhD, president and CEO of Senseonics. “We believe this represents an extremely attractive proposition for millions of people with diabetes and we are proudly leading the race to get there. At Senseonics, we are not interested in incremental innovation. Our mission is to transform lives in the diabetes community and push the boundaries of sensing technology to improve health and wellbeing. Eversense 365 redefined what a CGM could be by becoming the world's first and only one-year system and we are just getting started." Senseonics says the study’s purpose is to demonstrate safety and generate insights to inform a planned pivotal study that the company expects to initiate in 2027, with a targeted potential commercial launch in 2028. The company says it follows encouraging results from preclinical studies completed during the second quarter of 2026 evaluating multiple Bluetooth Low Energy (BLE) antenna designs and implantation locations to optimize communication performance and guide configuration selection. Across approximately seven weeks of testing and more than 18,500 communication data points, it says the preferred design demonstrated 100% communication success within target distance. As a result, it says, the study identified a preferred antenna configuration and implantation approach for human evaluation.

• Related reading: Senseonics launches Eversense 365 in Sweden, with other countries to follow.

Abilities Expo preps for first event of 2027

LONG BEACH, Calif. – Abilities Expo returns to the Long Beach Convention Center Jan. 14-16, 2027, building on last year’s event there, which drew more than 13,000 visitors. This year, the show will feature three, instead of two, exhibit halls with more than 200 exhibitors. “Abilities Expo filled two halls in its first year with us, and we’re proud to welcome it back with a third,” said Robert Smit, general manager of the Long Beach Convention & Entertainment Center. “Thousands of people come downtown for this free event, and that impact shows up in our hotels and restaurants along Pine Avenue. Just as important, it gives our team practical experience welcoming guests with disabilities. As we prepare this campus to host Paralympic events – including Para climbing, shooting, swimming, and sitting volleyball – for the LA28 Games in August 2028, shows like Abilities Expo help us keep improving how we serve every visitor.” Long Beach is the first stop of the 2027 Abilities Expo series, which continues to the New York metro area, Chicago, Houston, Phoenix and Orlando, Fla. The Abilities International Accessibility Conference will run alongside the expo Jan. 14-15 at the Long Beach Convention Center. After launching in Long Beach in March 2026, the conference returns for professionals who assess, prescribe, supply and support complex rehab and assistive technology, including physical and occupational therapists, ATPs, speech-language pathologists, rehab case managers, equipment suppliers and students entering the field. The 2027 theme is “Access, Applied,” with a focus on hands-on learning, with close to 10 hours of continuing education (0.975 IACET, CPTA and AOTA CEUs) across three tracks: Assessment & Provision, Clinical Skills Workshop and Adapted Living. Register for the Abilities Expo here. Register for the Abilities International Accessibility Conference here.

• Related reading: Abilities Expo will host two, rather than three, Abilities International Accessibility Conferences in 2027, focusing on events in Los Angeles on Jan. 14-15 and the New York metro area on April 29-30.

Medline hosts Truck Rodeo, awards $15K in prize money

NORTHFIELD, Ill. – Medline’s private fleet of truck drivers, MedTrans, recently completed its fourth annual National Truck Rodeo to celebrate their commitment to safety and technical abilities. The company’s fleet of more than 2,100 MedTrans drivers plays an important role in its ability to provide next-day delivery to 95% of its U.S. customers, the company says. “Medline’s team of drivers are the backbone of serving our customers, serving as a friendly face and committed supplier,” said Jeff Brennan, vice president of transportation for Medline. “Our drivers deliver critical medical supplies to customers no matter the day, weather or other challenges they may face.” Earlier this year, Medline set the stage by hosting regional rodeos for its drivers and their families at Medline facilities across the nation. These regional events follow more local events held earlier in the year at the company’s 45 U.S. distribution centers. The first-prize winner this year in each of three categories at the regional levels received an award for $1,500 and had the opportunity to compete at the MedTrans National Truck Rodeo. There, the regional winners competed for a share of $15,000 in prize money. Go here for a list of winners in the following categories: National Class A Truck, National Class B Truck and National Parcel Truck.

Diabetes Foundation, ShopRite partner on supply assistance program

MAHWAH, N.J. – The Diabetes Foundation and Wakefern Food Corp., the supermarket cooperative behind the ShopRite brand, have announced a statewide initiative designed to help New Jersey residents facing financial barriers access the supplies they need to monitor their blood glucose and manage diabetes. The initiative combines the Diabetes Foundation's no-cost supply assistance with access to affordable replacement testing supplies at ShopRite pharmacies across the state. "Diabetes management begins with access to the right tools, and ongoing blood sugar monitoring is an essential part of understanding and managing diabetes effectively," said Ginine Cilenti, executive director of the Diabetes Foundation. "We are proud to work with Wakefern and ShopRite Pharmacy to make diabetes supplies more accessible and affordable for the participants we serve." Through the Diabetes Foundation's Supply Assistance program, eligible New Jersey residents receive a blood glucose meter, test strips, a lancing device and lancets delivered directly to their homes at no cost. Each starter supply kit provides enough test strips for 100 blood glucose checks, helping individuals who are uninsured, underinsured or experiencing financial hardship continue monitoring their glucose when the cost of supplies might otherwise prevent them from doing so. The Diabetes Foundation's collaboration with Wakefern and ShopRite Pharmacy creates low-cost replacement options when the starter kit supplies run out. Participants who get a starter kit from the Diabetes Foundation can purchase replacement supplies such as test strips, blood glucose meters, lancing devices and lancets at a reduced cost at participating ShopRite pharmacies, providing participants with a more affordable way to continue blood glucose monitoring beyond the initial assistance period. "We are proud to work with the Diabetes Foundation on this important program, which helps eligible New Jersey residents obtain critical diabetes monitoring supplies at a reduced cost through ShopRite Pharmacies,” said Aaron Sapp, vice president of pharmacy and wellness for Wakefern Food Corp. “Together, we are working to remove barriers to ensure that individuals and families have access to the tools they need to monitor their health with confidence.”