In brief: Philips settlement, Compass Health network, NHIA fellows 

SAN DIEGO – Philips Respironics has paid almost $2.5 million to resolve allegations that it violated the False Claims Act by giving kickbacks to sleep laboratories, the U.S. Attorney’s Office for the Southern District of California has announced. 

The settlement resolves allegations that, from 2016 through 2021, Philips Respironics provided sleep labs with free masks used to treat and diagnose sleep-related respiratory disorders to induce physicians at the labs to write referrals or prescriptions for Respironics-brand masks that suppliers would then fill and bill to federal health care programs. 

“When kickbacks are used as bribes, patients suffer,” said U.S. Attorney Tara McGrath. “Companies like Phillips Respironics will be held accountable if they undermine our trust in the medical system and shift medical advice from a patient’s best interest to lining their own pockets.” 

The claims resolved by the settlement are allegations only, and there has been no determination of liability, according to the DOJ. 

The Anti-Kickback Statute prohibits paying money or giving goods to induce referrals for medical services or items covered by a federal health care program, such as Medicare, Medicaid or TRICARE. Claims submitted to these programs in violation of the Anti-Kickback Statute give rise to liability under the False Claims Act. 

This settlement was the result of a coordinated effort by the U.S. Attorney’s Office for the Southern District of California; the Defense Criminal Investigative Service; the Department of Health and Human Services, Office of Inspector General and Office of Counsel to the Inspector General; the Defense Health Agency Office of General Counsel; the Civil Division of the DOJ; and the National Association of Medicaid Fraud Control Units. 

• In 2022, Philips Respironics agreed to pay $1.28 million to settle allegations that, between December 2015 and December 2016, it helped a DME supplier procure a 12-month, interest-free loan that was fully guaranteed by the company. Under the arrangement, Respironics bore the full financial risk of non-collection on the loan in the event the DME supplier defaulted on the loan.   
• Also in 2022, the company agreed to pay more than $24 million to resolves allegations that it caused DME suppliers to submit claims for ventilators, oxygen concentrators, CPAP and BiPAP machines, and other respiratory related medical equipment that were false because it provided illegal inducements to the suppliers. Respironics allegedly gave suppliers prescribing data free of charge that could assist in their marketing efforts to physicians. 
• In 2016, the company agreed to pay $34.8 million to resolve allegations that it waved the per-patient per-month fee for its medSage automated resupply services for DME providers that bought the company’s masks. 

Philips posts FAQ on silicone foam 

AMSTERDAM – Philips posted a new FAQ to its website on Dec. 22 that explains the use of silicone sound abatement foam in its DreamStation 2 and other sleep and respiratory devices that were remediated as part of its June 2021 recall. “We have received a number of questions about the silicone sound abatement foam used in repaired and new replacement devices, as well as widely in the industry,” the company states. “We believe it is important that patients, care providers and business customers have access to accurate information and, most importantly, that they know that the foam is safe.” In November 2021, the U.S. Food and Drug Administration asked Philips Respironics to further test the silicone foam for volatile organic compounds (VOCs). This testing was completed in accordance with the relevant industry standard and showed that any VOCs emitted by devices with silicone foam were significantly below the applicable toxicological thresholds. This included formaldehyde, which was also significantly below the applicable FDA and World Health Organization (WHO) thresholds. The final reports of that testing were submitted to FDA in August 2022, and Philips Respironics has received no comments on that testing from FDA to date. In the FAQ, Philips addressed questions like, “The silicone sound abatement foam used by Philips Respironics in the replacement devices has been shown in some tests to emit chemicals, including formaldehyde. Can you explain this?” and “Were any changes made to the silicone foam as a result of testing?” 

Compass Health adds Quality Biomedical to network 

MIDDLEBURG HEIGHTS, Ohio – Compass Health Brands has expanded its authorized service center network with the addition of Quality Biomedical. Through this new agreement, the Boulder, Colo.-based Quality Biomedical will support Compass Health customers with in-warranty and out-of-warranty repairs for stationary and portable oxygen concentrators, CPAP and BiPAP devices, ventilators and other equipment. “Partnering with Quality Biomedical dovetails perfectly with Compass Health’s focus on growing our respiratory product offering by simplifying warranty repairs and reducing concentrator down time,” said Jim Westfall, director of product management for Compass Health. “Quality Biomedical comes highly recommended by several of our key customers. With their user-friendly web portal, national footprint and their focus on our customer’s patient, QB is a great fit with our core values and overall business.” Founded in 2004, Quality Biomedical has grown to a nationwide footprint of eight locations in Boulder; Allentown, Pa.; Cartersville, Ga.; Dallas; Fresno, Calif.; Fort Wayne, Ind.; Maryland Heights, Mo; and Pinellas Park, Fla. The company runs 26 trucks serving 45 states with free pickup and delivery. 

AAH is selling Stand Up tickets 

WASHINGTON – AAHomecare is now selling tickets for its annual Stand Up for Homecare fundraiser at Medtrade. The fundraiser, which will take place on March 27 from 5:30 p.m. to 7 p.m. at d.e.c. on dragon st. in Dallas, allows the industry to support patient advocacy groups that represent people who depend on HME products and services. These groups, including the ITEM Coalition and United Spinal Association, have been important allies on the industry’s policy priorities. AAHomecare also uses proceeds from the fundraiser to strengthen its advocacy capabilities. The association has made tickets are available here or as an add-on to a Medtrade registration. People can contact Sue Mairena at suem@aahomecare.org for multi-ticket packages and sponsorship opportunities. Current sponsors for the event are Brown & Fortunato and Rhythm Healthcare. 

OHD partners with manufacturers for ‘better results’ 

DUNEDIN, Fla. – One Health Direct, a marketer and patient engagement solution provider for DME, has announced it is partnering with manufacturers like Mobility Braces to help them design and provide products. OHD helped Mobility Braces develop a series of PDAC-approved orthotic bracing products, including back, wrist, ankle and knee braces, that address the unique needs of elderly patients. “Most DMEs provide the same brace for a young athletic patient as they would a geriatric patient, regardless of their specific preferences and needs," said Alois Rubenbauer, founder and CEO. "While a one-size-fits-all approach might fulfill the same medical needs of compression, stability and support, it doesn't prioritize the patient. OHD's focus is to achieve better results for our partners' unique DME patient populations." OHD says Mobility Braces are designed with several features that are tailored to the elderly population, including bigger pull points and thumb loops to account for less dexterity, and larger hook-n-loop landing areas to provide a more customized and secure fit.  Additionally, it says most Mobility Braces are available in a gamut of sizes, from XS to 4XL, allowing OHD's customer service team to fit them accurately over the phone. 

NHIA names fellows 

ALEXANDRIA, Va. - The National Home Infusion Association has announced the 2024 Fellow Program cohort: Thomas Brown, Maria Giannakos, Daniel Kyes, Katie Laskin and Christina Ritchey. The NHIA awards Fellow status to members who have successfully demonstrated a commitment to the field for at least seven years, have a record of sustained involvement and leadership within the association, and have been actively involved in educating practitioners and others. “Congratulations to this year’s fellows,” said NHIA’s President and CEO Connie Sullivan, BSPharm. “Now in its fourth year, this program recognizes the most highly accomplished professionals in home infusion today. This year’s honorees are exemplary of skilled and thoughtful leaders who are committed to the patients and organizations they serve, as well as the industry overall through their support of NHIA.” Fellows hold varied positions within the home and alternate site infusion industry, including pharmacists, nurses, technicians, and non-clinical sales and administration professionals. The program is administered and funded by the National Home Infusion Foundation, thanks to a generous contribution from Integrated Medical Systems, the 2024 sponsor of the NHIA Fellow Program.