In brief: Oxygen guidance, Inogen’s innovation, PHE guidance

WASHINGTON – The DME MACs have published an updated FAQ to provide additional guidance related to the new local coverage determination for home oxygen therapy. 

The FAQ comprises 25 questions related to continued need, the new N modifiers and more. 

AAHomecare highlighted the following questions in a bulletin: 

1. Is an initial F2F evaluation required? 
Answer: While there’s no formal requirement in the NCD or LCD, good medical practice would dictate some type of F2F or telehealth evaluation prior to ordering oxygen. 
 
6. Will a CMN or DIF dated prior to Jan. 1, 2023, still be sufficient to show continued need/use, once CMNs are eliminated? 
Answer: Yes, a CMN (initial, recert, revised) obtained prior to 1/1/23 will be good for one year from the initial, recertified, or revised date on the CMN. 
 
7. If the N3 modifier for oxygen is used, will the claim automatically deny, or will it suspend for review? 
Answer: The N-modifiers will be required in place of the KX modifier for new oxygen rental periods beginning on or after April 1, 2023. The N3 modifier will be used to identify patients with normal (i.e., ≥90%) oxygen levels who qualify based on their specific diagnosis (e.g., cluster headaches). 
 
To review all the questions and answers, go here. 

CMS published a new LCD and policy article in November. 

Inogen focuses on ‘innovation pipeline’ 

GOLETA, Calif. - Inogen reported total revenue increased 15.3% to $88.1 million in the fourth quarter of 2022 compared to the same period in 2021. 

The company reported total revenue increased 5.4% to $377.2 million for the full year 2022. 

“Despite the headwinds we faced in 2022, I am pleased with how our team successfully managed these challenges, while growing revenue and executing on our transformation,” said Nabil Shabshab, president and CEO. “We remain focused on our innovation pipeline to provide a foundation for growth along with judicious management of operating expenses to drive medium to long-term growth.” 

Inogen reported a net loss of $56.4 million for the fourth quarter (vs. 23.1 million for the same period in 2021) and a net loss of $85.4 million for the full year 2022 (vs. $5.3 million for 2021). 

The company has also announced it will provide a strategy update with Shabshab and CFO Kristin Caltrider on Monday, Feb. 27. 

CMS to provide guidance on sunsetting of PHE 

WASHINGTON – COVID-19 remains a significant priority for the Biden-Harris Administration and over the next several months, CMS will work to ensure a smooth transition. The Department of Health and Human Services announced Feb. 9 that the public health emergency will end May 11, 2023. During the PHE, CMS has used a combination of emergency authority waivers, regulations, enforcement discretion, and sub-regulatory guidance to ensure easier access to care during the PHE for health care providers and their beneficiaries. Some of the flexibilities that were created during the pandemic were recently expanded by the Consolidated Appropriation s Act, 2023. Others are no longer needed. CMS has made further updates to its CMS Emergencies Page with useful information for providers – specifically around major telehealth and individual waivers – that were initiated during the PHE. In the coming weeks, CMS will be hosting stakeholder calls and office hours to provide additional information. Please continue to visit the CMS Emergencies Page for continuous updates regarding PHE sunsetting guidance as information becomes available to the public. 

• Provider-specific fact sheets about COVID-19 Public Health Emergency (PHE) waivers and flexibilities: https://www.cms.gov/coronavirus-waivers 
• Department of Health & Human Services Fact Sheet:  https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html 

In the coming weeks, CMS will be hosting stakeholder calls and office hours to provide additional information. Please continue to visit the CMS Emergencies Page for continuous updates regarding PHE sunsetting guidance as information becomes available to the public. 

Bill introduced in Iowa addresses catheters made with DEHP 

DES MOINES, Iowa – Democratic Iowa State Representative Josh Turek has introduced the Better Caths for Iowa Act (H.F. 387) to review the use and reimbursement of certain catheters under the Medicaid program, specifically urinary catheters made with the harmful chemical DEHP.  

A four-time Paralympian who was born with spina bifida, Josh and his basketball team most recently brought home gold from the 2020 Tokyo Paralympics.  

 "Bladder cancer took the life of Dale Ericksen, my wheelchair basketball coach at Southwestern Minnesota State University," said Turek. "I introduced this bill to improve health equity for Iowans with disabilities," he adds. "I encourage state and federal representatives, nationwide, to introduce similar legislation." 

Per the bill: 

• The Iowa Medicaid program shall not reimburse claims for catheters made with DEHP until after the completion and pending the results of a historical rate of bladder cancer review that includes the Medicaid director’s recommendation regarding which catheters should be reimbursable. 
• The Medicaid director shall inform Medicaid providers and patients of the prohibition against reimbursement of catheters made with DEHP during the pendency of the review and shall make available to Medicaid providers and patients a list of alternative products that are not made with DEHP and that are reimbursable under Medicaid when provided to Medicaid recipients during the pendency of the review. 
•  A historical records review of Medicaid recipients who used catheters made with phthalate chemicals like DEHP to determine whether Iowa Medicaid recipients who use these medical devices made with phthalate chemicals have a higher incidence rate of bladder cancer than the general population. 
•  Identification of the brands of catheters with DEHP that are correlated with higher levels of bladder cancer in the Iowa Medicaid population of catheter users by comparing the diagnosis codes associated with bladder cancer against individual patient-level data that includes catheter billing at the stock keeping unit level. 
• A comparison of the average lifetime cost of care for a Medicaid recipient who uses catheters with the average lifetime cost of care for a Medicaid recipient who has bladder cancer treatment. 

The legislation is supported by the BetterCaths Health Equity Coalition, a grassroots volunteer organization of bladder cancer survivors who use catheters, disability advocates, and urological industry experts, assisted in drafting the bill's language and provided supporting clinical evidence. 

The BetterCaths legislative effort was established in honor of Karen Fernbaugh Roy, a licensed clinical social worker who was paralyzed while being robbed at gun point as a college student. She served as the 2018 Ms. Wheelchair America and has advocated for health equity and health access for people with disabilities for decades. Roy used urinary catheters made with DEHP, a known carcinogen, for more than 20 years before discovering her invasive medical supplies had a cancer warning label on them.  

Philips makes progress toward ESG goals 

AMSTERDAM – Royal Philips reached 1.81 billion lives improved with its products and services in 2022, even as it reduced operational emissions and indirect emissions across the health care value chain, part of its environmental, social and governance (ESG) ambitions.  
 
“We continue to move closer to our aim of improving 2 billion lives per year by 2025, while stepping up our sustainability efforts in our operations and value chain,” said Marnix van Ginneken, chief ESG & legal officer at Royal Philips. “The growing momentum across the health care industry and among customers to reduce our collective environmental footprint encourages us on a daily basis, as we continue to strive to reduce emissions across the end-to-end health care value chain and drive the shift to a circular economy.” 
 
Increasing social impact 

Of the 1.81 billion lives reached, 202 million were in underserved communities. Improved access to care in underserved communities in 2022 was driven by shared-value partnerships, the development of innovative digital solutions, and the roll-out of new business and financing models that are both sustainable and scalable. 
 
Other key developments include a 30% representation of women in senior leadership roles, increased focus on employee health and well-being (both physical and mental health), and continued emphasis on ensuring a safe and healthy workplace. 

Reducing operational emissions and waste 

In addition to remaining carbon-neutral in its operations (since 2020), Philips achieved 77% renewable energy usage, exceeding the 75% goal for 2025. It also reduced transport- and distribution-related CO₂ emissions by 22% through a stricter air-freight policy and optimized warehouse locations. 
 
Philips also improved the circularity of its waste stream to 91%, increasingly recycling, re-using or reducing waste. An example is the replacement of single use plastic in supplier packaging with boxes that can be used repeatedly. As a result, less than 0.1% of the remaining operational waste was land-filled, in line with our zero-waste to landfill ambition. 
 
CDP, a global NGO that assesses the CO₂ emissions performance and management of reporting companies, ranked Philips on the CDP Climate Change “A” List for the 10th time in a row, thanks to the company’s continued climate performance and transparency. 
 
Advancing toward low-carbon operations and value chain 

In 2022, Philips became the first health technology company with approval from the Science Based Targets initiative (SBTi) for its entire value-chain CO₂ emissions reduction targets, including Scope 1-3. In addition, 41% of suppliers (based on spend) have now committed to science-based targets. Philips’ goal is 50% by 2025. 

Quipt named to 2023 TSX Venture list 

CINCINNATI – Quipt Home Medical has been named to the 2023 TSX Venture 50 for the Clean Tech & Life Sciences industry. The Venture 50 highlights top-performing companies from Canada and around the world that are driving growth across their respective sectors. There are more than 1,700 companies listed on the TSX Venture Exchange. “We are truly honored to have been selected for the TSX Venture 50, which marks the second time we have received this accolade in the previous four years,” said Greg Crawford, CEO. “This inclusion is a credit to the dedication of our team members and the ongoing support of our shareholders. Over the past year, several noteworthy accomplishments have been made, including the expansion of our robust patient-centric ecosystem and the achievement of sizeable scale through accretive acquisitions and organic growth. These developments have all contributed to the company’s strong and reliable financial and operational performance. We are very enthusiastic about our growth prospects as 2023 gets underway, given our conservative balance sheet and pipeline of opportunities.” The TSX Venture 50 showcases issuers across five sectors with an equal weighting of each firm’s performance during 2022 across three key indicators: market capitalization growth, share price appreciation and trading volume. 

Philips publishes annual report 

AMSTERDAM – Philips has published its annual report, calling 2022 a “very disappointing year” and reiterating its commitment to improve in 2023. The report will be on the agenda of the Annual General Meeting of Shareholders on May 9. Also on the agenda: the 2022 Remuneration Report, which explains how remuneration has been impacted by the company’s performance in 2022. The supervisory board and current board of management have jointly concluded that it was appropriate to waive any 2022 annual incentive pay-out and any vesting of the 2020 long-term incentive grant of the members of the board of management. Philips filed the annual report with the Netherlands Authority for the Financial Markets (AFM) in European Single Electronic Format (ESEF) and on Form 20-F with the U.S. Securities and Exchange Commission. The annual report is available to shareholders and other interested parties at www.results.philips.com.  

Ascensia, SNAQ collaborate on nutrition management 

PARSIPPANY, N.J. – Ascensia Diabetes Care is partnering with SNAQ, an award-winning app-based solution that offers insights on food and nutrition for people with diabetes. Users of Ascensia’s Contour blood glucose monitoring systems can seamlessly incorporate SNAQ into their diabetes management to make data-driven decisions about food and nutrition. “This collaboration is a further in Ascensia’s mission to simplify diabetes management while providing convenient and effective solutions for people with diabetes and their health care providers,” said Frank Held, head of BGM marketing and strategy at Ascensia. “I look forward to working together with SNAQ as we collaborate to bring this valuable tool to more people.” Through the SNAQ app, users take a photo of their food and receive nutrition information and actionable insights, including easy-to-read graphs. The three-year partnership launches first in the U.S. and will extend across several phases and regions. 

Medline inks supply deal with post-acute care group 

NORTHFIELD, Ill. – Medline has entered a multi-year, prime vendor partnership with Florida-based Synthase Collaborative, a partnership of four post-acute and home-based care organizations that provide not-for-profit hospice, palliative care and other chronic Illness management community focused programs and services. Medline will exclusively provide an extensive portfolio of essential medical supplies, such as incontinence, advanced wound care, skin care products and general nursing supplies, to Synthase's member organizations, which provide care to more than 2,200 patients daily in 23 Florida counties. "To further drive patient-focused care, Synthase is committed to pursuing new opportunities among industry partners to help meet seniors' unmet needs,” said Wenona Bowen-Palombi, program director, Synthase. “A strategic relationship with Medline that looks at how our member organizations approach supply management is an essential part of making sure we have the necessary tools to improve the health of Florida residents.” The partnership focuses on monitoring product utilization to manage supply costs and drive best-in-class patient care. "We are taking a team-based approach toward creating solutions that adapt to value-based care," said Josh Paul, Florida division sales director, Medline. "Synthase was built on a collaboration model, and by having a seat at their table to recommend best practices, we hope we can be a true partner to help them balance quality and cost and ultimately drive their mission of meeting the community's needs for compassionate care." 

Homelink announces new SVP 

WATERLOO, Iowa – Homelink has announced that Kim Radcliffe has joined its senior leadership team as senior vice president of clinical and product strategy. Radcliffe brings more than 16 years of experience in the workers' compensation arena, with a background in physical therapy. During her career, she has held leadership roles in clinical program development, network development and operations. "The patients are always the focus in my work,” Radcliffe said. “I am energized to be part of HOMELINK's care coordination team that is dedicated to quality ancillary care that meets all the needs of the patients.” Homelink coordinates care for 30 million patients each year, making it a national leader in ancillary services. 

VGM opens registration for Heartland 

WATERLOO, Iowa – VGM has opened registration for its 22nd Heartland Conference scheduled for June 12-14 in Waterloo, Iowa, with special pricing until April 14. “Heartland is more than a premier educational conference,” said Jeremy Stolz, president of VGM & Associates and VGM Fulfillment. “It also provides unique opportunities to make important connections with key experts and colleagues in the industry. Heartland is truly the best place to be part of something bigger. This is an industry event you should not miss.” Registration includes education, including pre-conference sessions; an exhibit hall with products and business solutions; and meals and entertainment. This year’s education offers the opportunity to earn about 15.75 contact hours/CEUs. The conference’s keynote speaker will be Adam Markel, a Wall Street Journal best-selling author and resilience researcher and expert on becoming “change proof.” 

Motion schedules Rehab Expo series 

TORONTO – Motion has scheduled a number of dates for its Motion Rehab Expo series, kicking off with April 6 in Ottawa, Ontario. Other dates include April 18 in Barrie, Ontario; May 2 in Edmonton, Alberta; May 3 in Red Deer, Alberta; May 4 in Calgary, Alberta; June 14 in Winnipeg, Manitoba; and Sept. 26 in Kelowna, British Columbia. The expos feature a complimentary full day of education with presentations by leading health care professionals and equipment suppliers, as well as a networking event. The provider of mobility and accessibility solutions, which has been in business for more than 35 years, was formerly known as Canadian Healthcare Products. 

WellSky Foundation makes $100K donation 

OVERLAND PARK, Kan. – The WellSky Foundation has gifted $100,000 to Care Beyond the Boulevard, a nonprofit committed to providing comprehensive medical care to the homeless, uninsured or otherwise vulnerable populations of Kansas City. The organization will use the donation to enhance its medical services with a portable ultrasound machine to assist with diagnoses and a new van to transport their team, medical resources and the people they serve. “At the WellSky Foundation, our team is driven by our passion to make lasting health and wellness accessible for all,” stated Brett Fuller, executive director, WellSky Foundation. “It’s organizations like Care Beyond the Boulevard that demonstrate our mission daily by providing comprehensive medical care to people experiencing homelessness. We are thrilled to enable their continued work in the Kansas City area.” In 2022, Care Beyond the Boulevard’s volunteer staff – consisting of 15 health care providers and more than 200 community members – served 3,000 patients and completed more than 9,000 visits. WellSky Foundation has donated more than $1 million to nearly 30 organizations since its inception in 2019. To learn more about the WellSky Foundation’s mission and impact, visit WellSkyFoundation.org. 

CSI Pharmacy opens first East Coast location 

NASH, Texas – CSI Pharmacy plans to open a location in Enfield, Conn., its first on the East Coast, according to a local news outlet. The 4,000-square-foot location will allow the company to navigate complex payer and regulatory requirements more effectively in the region and to provide redundant pharmacy services, distribution and medication storage capabilities in the event of localized service disruptions. "The opening of our Connecticut pharmacy signals the next step in CSI Pharmacy’s growth strategy," co-founder and CEO James Sheets told Patch.com. "Having a presence on the East Coast gives us, not only additional capacity to expand within a highly populous region, but also additional resources to be able to respond rapidly to customers’ needs and continue providing five-star service to existing customers." CSI Pharmacy has walk-in retail, compounding, specialty pharmacies; infusion suites; and out-of-state licensed and local patient-support sites. It is licensed in all states except California and North Dakota. 

Swedish company plans to buy Diabetic Supplies 

STOCKHOLM and COLUMBUS, Ohio – ADDvise Group has signed a letter of intent with the shareholders of Diabetic Supplies to buy all shares in the company. Diabetic Supplies, which distributes, among other things, continues glucose monitors and insulin pumps, generated revenues of $70 million in 2022, with an EBITDA of $2.7 million. “Through the acquisition of Diabetic Supplies, we complement our existing range of diabetes products and strengthen our market position,” said Rikard Akhtarzand, CEO of ADDvise Group. “Diabetic Supplies’ strong brand and good relationships with insurance companies open up new growth opportunities.” The purchase price for Diabetic Supplies amounts to a total of $15.8 million, divided into an initial payment of $10.3 million, and two potential earn-outs of a maximum of $5.5 million in total. To be entitled to the earn-outs, Diabetic Supplies must reach an EBITDA of $3.1 million during the next 12 months after completion of the acquisition and an EBITDA of $3.4 million for the following 12 months. ADDvise Group is a supplier of equipment to health care and research facilities. The group consists of two business areas: Lab and Healthcare. 

CMS details process for new insulin cap  

WASHINGTON – Part B co-insurance for a month’s supply of insulin used in an insulin pump covered under the DME benefit can’t exceed $35 starting on July 1, 2023, according to an MLN facet sheet. CMS will adjust payments to suppliers and pharmacies to account for the balance of the reduced co-insurance. Suppliers will continue to get the Medicare payment amount for the insulin (average sales price plus 6%), minus any applicable co-insurance, which, again, is now capped at $35. “Don’t bill for supplies of insulin for July or subsequent months before July 2023,” the fact sheet states. “We’ll complete the system updates to make sure patients aren’t charged more than the $35 maximum allowed for the month of July. Your DME Medicare Administrative Contractor will also educate you about billing during the May – June transition period.” Two new modifiers have been added to the April 2023 HCPCS quarterly file: JK, drug one-month supply or less; and JL, drug three-month supply. Before July 2023: For “from date of service” in May or June 2023, suppliers shouldn’t bill a three-month supply on insulin; instead, they should bill a 1-month supply with the JK modifier. Starting July 2023: For “from date of service” in July and later, they should bill a three-month supply of insulin with the JL modifier or a one-month supply with the JK modifier.  

Diathrive Health partners with Mark Cuban 

SALT LAKE CITY and DALLAS – Diathrive Health, a diabetes and chronic disease management solution, and Mark Cuban Cost Plus Drug Company have announced a new collaboration that they say will give consumers lower cost medications and diabetes testing supplies and more personalized, higher quality care so that they can achieve better health outcomes. “As a practicing physician I saw first-hand the danger of patients not being able to afford medications and supplies," said Alex Oshmyansky, CEO of Mark Cuban Cost Plus Drug Company. "I founded the Mark Cuban Cost Plus Drug Company to help solve this problem and provide a way for patients to receive their treatments at an affordable price. We already offer transparent, low prices to cash-pay consumers and are excited to now be working with a company like Diathrive Health to further reduce the cost to patients, and to keep the patient record complete from both a clinical and financial perspective." Diathrive Health’s solution offers members unlimited glucose testing supplies, time with nurses who are certified diabetes care and education specialists, and use of the company’s app to manage their data and condition. The company says it saves employers up to 85% on their diabetes health benefits. Cost Plus Drugs launched an online pharmacy in January 2022 and now carries more than 1,000 prescription products delivered by mail to thousands of customers every day. It charges a standard markup on every drug it sells.