In brief: ‘Critical juncture,’ Medline partnership, digital health committee

WASHINGTON – AAHomecare and VGM are partnering on a new virtual advocacy event to bolster awareness and support for Medicare legislation as Congress enters the final legislative weeks of the year.   

The DMEPOS Relief Act of 2023 (H.R. 5555 and S. 1294), would provide a 90/10 blended Medicare reimbursement rate for most home medical equipment products in competitive bidding areas for all of 2024 and extend the current 75/25 blended rate currently in effect in rural/non-CBA areas through 2024.  

The Virtual Hill Day, set for Monday, Nov. 13, will build on AAHomecare’s Washington Legislative Conference on Sept. 20.  

“We’re at a critical juncture for what Medicare rates are going to look like in 2024, as well as for numerous payers those rates influence,” said Tom Ryan, AAHomecare president and CEO. “We have the prospect of 75/25 rates in non-CBAs coming to an end on Jan. 1, and we have active legislation in both chambers for Congress to keep that relief in place, and even to add 90/10 blended relief for CBAs in the House bill.  With those kinds of stakes, we feel the urgency to make one more concerted push to get provisions from H.R. 5555 and S. 1294 into an end-of-year legislative package.” 

AAHomecare and VGM are in the process of developing a list of approximately 100 House and Senate offices to target, with a focus on members of committees of jurisdiction for health care finance issues, and reaching out to selected advocates that match with these offices. They’re also reaching out to state and regional HME association leaders to recruit advocates.   

VGM’s participation will allow the event, which will again use the Advocacy Associates platform, to be free. 

“It is imperative that the industry comes together to act on these pieces of legislation," said Michael Isaacson, senior vice president of government and regulatory relations, VGM. "VGM and AAHomecare continue to work together to ensure that our collective members’ voices are heard, and we are excited to be partners on this important event."  

Stakeholders who have previous advocacy experience, who live/work in a state with a member of the Senate Finance Committee, or a district represented by a member of the House Energy & Commerce Committee or Ways & Means Committee, and who are available for meetings on Nov. 13, should contact Gordon Barnes at gordonb@aahomecare.org for more details. 

Medline, Valley Health enter distribution agreement 

NORTHFIELD, Ill. – Medline has entered into a multi-year prime vendor distribution agreement with Valley Health System, which serves northern New Jersey and southern New York.  

After being with a previous vendor for the last five years, the system returns to Medline for all medical and surgical supplies across its full continuum of care, including its in-patient acute care hospital and lab facilities, and outpatient network of physician offices and home care services. 

"It is critical that our clinicians have the products they need when they need them to care for our patients," said Orville Carr, supply chain director at Valley Health System. "Medline's unwavering service to our system through the years has proven invaluable in being about to do that. Combined with their investments in on-hand inventory, price assurance plan and our collaboration with their supply chain optimization team, it is a partnership that will help to optimize our supply chain operations going forward." 

As part of the agreement, Valley Health System will have the ability to easily monitor key metrics such as item utilization, contract compliance, price accuracy and spend by product categories through Medline's advanced analytics platforms. The health system's network of facilities will be serviced from Medline's LEED-certified, state-of-the-art distribution center in Montgomery, N.Y.  

"We are honored to be expanding our partnership with Valley Health and continuing to support their mission," said Ron Barrett, vice president of corporate accounts at Medline. "The Medline team is committed to helping our partners deliver optimal care to the patients they serve by ensuring superior customer service, product availability and solutions support." 

AAH, ALS association send NIV letter to CMS 

WASHINGTON – AAHomecare and the ALS Association continue to press their case with CMS that Medicare Advantage plans are improperly denying claims and imposing stricter coverage criteria for non-invasive ventilators than Medicare allows. 

In an Oct. 4 letter to Kathryn Coleman, director, Medicare Drug & Health Plan Contract Admin Group for CMS, AAHomecare and the ALS Association share examples of MA plans that are “ignoring physician's orders and instead use excessive prior authorization requirements, requiring ‘fail first’ on respiratory assistance devices (RAD) for patients that need an NIV device and, in some instances, outright denying NIV to ALS patients.” 
 

The associations say the letter drives home the fact that NIVs are designed and approved by the U.S. Food and Drug Administration to treat chronic respiratory failure (CRF), while RADs are designed and approved to treat sleep apnea. The letter also cites peer-reviewed research showing that NIV use significantly reduces mortality and health care spending in Medicare patients with chronic respiratory failure. 

In June, AAHomecare and the ALS Association met with CMS and asked the agency to issue a memorandum clarifying medical policy and coverage of NIVs, as well as to take steps to expedite authorizations for people living with ALS.   

FDA creates digital health committee 

WASHINGTON – The U.S. Food and Drug Administration has launched a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The committee will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks and clinical outcomes associated with use of DHTs. “As one of our strategic priorities, our goal is to advance health equity in part through expanding access by bringing prevention, wellness and healthcare to all people where they live – at home, at work, in big cities and rural communities,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Digital health technologies are critical for achieving this transformation in care delivery. As digital health technologies advance, the FDA must capitalize on knowledge from inside and outside of the agency to help ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation.” The FDA plans to have the committee fully operational in 2024. 

MediWound, 3M to collaborate 

YAVNE, Israel – 3M Health Care will provide its two-layer compression systems, Coban 2 and Coban 2 Lite, to be used during the debridement and wound healing phases of the EscharEx Phase III study as part of a collaboration with MediWound, a biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair. "In our pursuit of excellence, one primary aim is to ensure consistency across subjects while delivering optimal care throughout the study,” said Ofer Gonen, CEO, MediWound. “3M Health Care's Coban compression systems stand out as global market leaders, and we're pleased to designate them as the standard for our Phase 3 study. Given that compression therapy is pivotal in managing venous leg ulcers (VLUs), it's imperative that we employ top-tier products. With 3M Health Care’s two-layer compression systems, we're confident we're doing just that." EscharEx is being evaluated for efficacy and safety in the debridement of chronic wounds, with the first indication being VLUs. During the debridement phase, as well as in the wound healing phase of the study, 3M’s two-layer compression systems will be used as standard of care in all study arms, until the wounds reach complete healing. 

Vivos appliance gets clinical trial 

LITTLETON, Colo. – Vivos Therapeutics, a medical technology company focused on developing treatments for patients suffering from mild-to-moderate obstructive sleep apnea and snoring in adults, announced that its flagship daytime-nighttime appliance (DNA) will be tested in a clinical trial at Stanford Medicine. “We are extremely excited to be starting this trial at Stanford Medicine, which has been in the works for some time” said R. Kirk Huntsman, chairman and CEO of Vivos. “I am confident that our technology will bear the scrutiny of a well-designed, prospective clinical trial. There is no better place to for our technology to undergo rigorous scientific testing than at a respected institution like Stanford. Our treatment is comfortable, safe and non-invasive, and we believe that at the end of this study, the conclusion will be that Vivos should become an essential part of every OSA care plan.” The protocol has been finalized and participant enrollment will begin in early 2024. Study participants with moderate to severe OSA will be randomly assigned to either treatment with Vivos’ DNA appliance or CPAP therapy, the current industry standard for OSA treatment. Sleep studies will be performed prior to and following a course of treatment using in-lab polysomnography to assess changes in the patients’ apnea-hypopnea index (AHI). 

Ascensia, Senseonics launch ad campaign 

PARSIPPANY, N.J., and GERMANTOWN, Md. – Ascensia Diabetes Care and Senseonics Holdings have launched a new U.S. advertising and marketing campaign for the Eversense E3 CGM System. The “CGM for Real Life” campaign seeks to drive awareness of the Eversense E3, a six-month, implantable sensor, as well as the everyday challenges people with diabetes face. “This campaign is designed to challenge the status quo in continuous glucose monitoring, which for too long has meant self-insertion and sensors that can either disrupt activities or fall off,” said Rudy Thoms, vice president, CGM Commercial U.S., Ascensia Diabetes Care. “We know that Eversense has the potential to be game-changing for people with diabetes, and so the opportunity to bring it to the attention of more people than ever before is really exciting.” The campaign will run on TV in five states, in addition to social and digital platforms. 

AOPA recognizes O&P graduates 

INDIANAPOLIS, Ind. – The University of Hartford’s first graduates of the Certificate in O&P Business Management were honored during a graduation ceremony Sept. 9 during the WASHINGTON – AAHomecare and VGM are partnering on a new virtual advocacy event to bolster awareness and support for Medicare legislation as Congress enters the final legislative weeks of the year.’s 2023 National Assembly in Indianapolis. “We were pleased to celebrate the accomplishments of the graduates during the 2023 National Assembly,” said Eve Lee, CAE, executive director of AOPA. “The Certificate in O&P Business Management is a unique leadership experience that provides an opportunity to learn fresh insights, new tools, and proven techniques for developing better business practices, all with the goal to help improve the individual’s place of business.” The Certificate in O&P Business Management is offered at UHart’s Barney School of Business through a partnership with AOPA. It is a comprehensive certificate program that offers a series of business and management courses to provide business owners, managers and practitioners of O&P patient care facilities, manufacturers and distributors an opportunity to explore crucial business challenges—finance, sales and marketing, business operations, reimbursement policies and management.  

NHIA seeks comments on pumps 

ALEXANDRIA, Va. – The National Home Infusion Association has released a draft practice standard that describes situations that may require the use of electronic mechanical pumps to minimize adverse reactions and promote adherence to infusion therapies administered in the home. NHIA practice standards represent a consensus of professional judgment, expert opinion and documented evidence, and are meant to provide guidance and direction to NHIA members and other audiences who affect the home infusion industry and the patients served. NHIA is requesting that public stakeholders review and provide feedback on the draft practice standard. It says comments on proposed practice standards play a key role in the standards development process. Please submit comments to standards@nhia.org.