US MED: In brief: CMS exempts accessories, Advanced Diabetes buys US MED, FDA classifies Philips recall

WASHINGTON - CMS in a final rule issued July 29 says it will permanently stop applying competitive bidding pricing to accessories for complex rehab manual wheelchairs. In late June, CMS agreed to extend an 18-month pause on applying bid pricing to these accessories for an additional 90 days, until Oct. 1., to give the agency more time to review the industry's request. "We are sincerely grateful to CMS for making today's policy decision and protecting access for people with disabilities who depend on these individually configured CRT wheelchairs and seating systems," said Don Clayback, executive director of NCART, in an email bulletin. "This outcome was the result of several years of collaborative advocacy within the CRT community to ensure these damaging cuts did not go into effect." NCART thanked, specifically, Reps. John Larson, D-Conn., and Lee Zeldin, R-N.Y., and Sens. Bob Casey, D-Pa., and Rob Portman, R-Ohio, for their ongoing support. In June, Larson drafted a letter and collected signatures from 18 members of the House of Representatives, as well as Casey, asking CMS to extend the 18-month pause that was due to expire on July 1. NCART also thanked all the consumer, clinician, provider and manufacturer representatives and national organizations for pushing for a permanent change. Consumer and clinical groups that supported the effort included the ITEM Coalition, United Spinal Association, Christopher and Dana Reeve Foundation, ALS Foundation, Spina Bifida Association, Paralyzed Veterans of America, Center for Medicare Advocacy, the Clinician Task Force and others. Provider and manufacturer groups included NRRTS, U.S. Rehab, AAHomecare and RESNA. "We appreciate everyone's commitment to protecting access and look forward to working together to make continued progress for people who depend on CRT," Clayback said. Diabetes consolidation continues: Advanced Diabetes acquires US MED CARLSBAD, Calif. - Advanced Diabetes Supply has acquired US Medical Supply (US MED), a portfolio company of H.I.G. Capital that provides continuous glucose monitors and medical supplies. Founded in 1996, the Doral, Fla.-based US MED contracts with more than 500 insurance plans covering nearly 200 million lives. It was acquired by H.I.G in 2015. "H.I.G. served as a value-added partner to our leadership team and supported the transformation of the business," said Bill Monast, CEO, US MED. "We look forward to this next phase of growth as we work with ADS while continuing to serve as an integral partner to our patients, payers and suppliers." Advanced Diabetes Supply is a portfolio company of Court Square Capital Partners Inc. The two companies together will leverage their scale, strengths and capabilities to position themselves as a leader in the space. "We are proud to be bringing together two successful companies who share the mission of delivering outstanding patient care," said Mark Howard, co-founder and CEO at ADS. "We founded Advanced Diabetes Supply with the goal of setting a new standard for patient care in the diabetes DME space, and US MED shares that same mission and passion." Terms of the deal were not disclosed. The increasing use of CGMs has driven interested in the diabetes market. In 2020, AdaptHealth acquired Solara Medical Supplies and Pinnacle Medical Solutions. FDA classifies Philips recall as 'serious' AMSTERDAM - The U.S. Food and Drug Administration has classified the voluntary recall of certain Philips CPAP devices and ventilators as Class I. The FDA defines Class I as "a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." The agency posted recalls for the various affected devices, along with their classification, to its database on July 13 and July 22. Philips announced the recall on June 14 to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in the affected devices. It says the foam may degrade into particles that may enter the device's air pathway and be ingested or inhaled by the user, and it may off-gas certain chemicals. The company awaits regulatory clearances from the FDA to replace the foam with a new material. Congressmen urge Sec. Becerra to move on seat elevation WASHINGTON - Reps. Jim Langevin, D-R.I., and Don Young, R-Alaska, have asked Health and Human Services Secretary Xavier Becerra to encourage CMS to move forward with a pending request to include power seat elevation and power standing systems in the national coverage determination for mobility assistive equipment. "These systems improve the health and independent function of mobility-impaired individuals and allow them to more fully participate in mobility-related activities of daily living," the congressmen state in a letter. "For many individuals, they offer numerous medical benefits, including improved transfers and reaching, improved joint mobility and muscle tone, enhanced cardiovascular and respiratory functions, and reductions in falls, neck and spine injuries, skin breakdowns and muscle contractures. The ITEM Coalition in September 2020 submitted a request to CMS asking the agency to reconsider the NCD for mobility assistive equipment to include power seat elevation and power standing systems for Group 3 power wheelchairs. In 2005, the DME MACs said that the systems were not "primarily medical in nature" and, therefore, should not be included in the benefit. NSM builds home access team in California NASHVILLE, Tenn. - National Seating & Mobility has acquired Sacramento, Calif.-based Eagle Accessibility Solutions & Equipment. NSM has also hired accessibility expert Scott Lanswick, owner and founder of San Diego Age in Place Services, to oversee home access services in Southern California. "Expanding the availability of home accessibility services is a reflection of our commitment to provide the full spectrum of mobility solutions to individuals who rely on them for independence," said Bill Mixon, NSM CEO. "These investments will better position us to reach more Californians in need of these services." EASE, which was founded in 2003 by Steve Weaver, specializes in the service and installation of ceiling lifts, ramps and stairlifts, and has been recognized by the National Association of Remodeling Industry and by the National Association of Home Builders. Weaver will transition to the NSM team, alongside EASE employees. Lanswick has more than 25 years of mobility and home accessibility experience and has supported thousands of customers in the San Diego market. His expertise includes the sale, installation and service of home accessibility equipment. Option Care Health appoints chief medical officer BANNOCKBURN, Ill. - Option Care Health has named Dr. Seema Kumbhat to the newly created role of chief medical officer. She will oversee all clinical strategies, including clinical operations, continuous quality improvement, accreditation, clinically related sales and marketing efforts, and adherence to regulatory requirements. "As we continue to invest in our clinical differentiation and set the standard for delivering care to patients requiring infusion therapy in the alternate site setting, I am thrilled to have Dr. Kumbhat join our leadership team and help drive our clinical strategy going forward," said John Rademacher, CEO. "As a physician, she brings a wealth of knowledge to the Option Care Health team, and I'm confident she will make a positive impact in continuing efforts to elevate patient care." Prior to joining Option Care Health, Kumbhat served as senior vice president and regional medical officer for Fresenius Kabi. She has also held roles at Hospira, McKesson, GE Healthcare and Epic Systems. NCART, Clinician Task Force publish guide for standing devices EAST AMHERST, N.Y. - NCART and the Clinician Task Force have jointly published "Evidence-Based Response to Insurance Denials of Standing Devices," a guide to policy makers and health care insurance plans regarding the proper coverage and funding of standing devices for children and adults with disabilities. "Standing devices have a long history of prescription and use to provide important medical benefits and other positive outcomes," said Don Clayback, executive director of NCART. "When properly prescribed and utilized, they play an important role in reducing medical complications, clinical interventions and hospitalizations." Standing devices are frequently denied, says Cara Masselink, executive director of the Clinician Task Force. "These denials often stem from a lack of awareness of the evidence of medical benefits and of the reduced interventions that come from proper prescription and utilization." The document can be found at www.ncart.us and www.cliniciantaskforce.us. Physician sentenced in DME fraud DELRAY BEACH, Fla. - A U.S. district judge has sentenced Dr. Richard Davidson of Delray Beach, Fla., to six years in federal prison for conspiracy to commit health care fraud. Davidson was charged with establishing a conglomerate of DME companies that were placed in the names of straw owners. By concealing the true ownership of the companies, he and his conspirators gained control of multiple companies, allowing them to submit high volumes of illegal DME claims, while attempting to evade law enforcement scrutiny. In one year, Davidson and his conspirators submitted more than $20 million in illegal DME claims, resulting in more than $10 million in payments from Medicare and the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA). As part of his sentence, the court ordered Davidson to forfeit approximately $650,000 in funds traceable to the offense or as substitute assets. The court also entered a money judgment of $2.47 million and ordered $10.72 million in restitution. Davidson, who plead guilty in September 2020, also lost his medical license due to his conviction.