In brief: Hangover clinics, SMRC audits, PHE extension

ALEXANDRIA, Va. – The National Home Infusion Association and several allied organizations have asked the U.S. Food and Drug Administration and state regulatory agencies to investigate unregulated, direct access infusion businesses that provide individuals with intravenous solutions absent the recommendation of a licensed prescriber.  

These businesses, they say, treat hangovers, exercise recovery and elevation sickness, which can usually be resolved with oral medications or through other means—making infusion treatment unnecessary. 

The result is the diversion of scarce resources—many of which appear on the FDA’s drug shortage list—from patients who have legitimate medical needs.  

“As organizations invested in the safe and effective administration of infused medications to patients with acute and chronic medical conditions, we are highly devoted to ensuring the availability of these products and their safe administration to patients with legitimate medical needs,” said Connie Sullivan, BSPharm, NHIA’s president and CEO. “In addition, as health care professionals, we approach patient care with the imperative to first do no harm. Unlicensed and unregulated businesses administering medically unnecessary therapies with no adherence to industry and professional standards introduces unwarranted risks. We urge state regulatory agencies and the FDA to assess the impact of these operations and establish an appropriate licensing requirement.”  

To ensure safety and address critical shortages of medical products, NHIA, American Society of Health-System Pharmacists (ASHP), National Association for Home Care and Hospice, American Society for Parenteral and Enteral Nutrition, National Infusion Center Association, and Infusion Nurses Society recommend the following: 

Investigate and assess the extent to which direct access infusion businesses are contributing to the ongoing national shortages of parenteral drugs, nutrition components and diluents/solutions. 

Require all businesses that sell direct access infusion therapies to the general public to comply with licensure and regulations applicable to the services offered. 

Investigate claims of health benefit, treatment or cure, and require businesses that sell direct access infusion therapies to disclose the lack of evidence and unique risks of administering compounded IV products that are not medically necessary. 

Establish a licensure category for businesses that sell direct access infusions.  

Owens & Minor turns 140 

RICHMOND, Va. – Owens & Minor on Jan. 18 marked 140 years in business.  

Founded by Otho O. Owens and George Gilmer Minor, II, as a pharmaceutical wholesale and retail company, the Owens & Minor Drug Company operated on Main Street in downtown Richmond, setting its sights on the untapped market share of rural and small-town pharmacists who needed supplies. Today, it is a global Fortune 500 company with 15,000 employees. 

"Today we celebrate all that Owens & Minor has accomplished over the past fourteen decades, while also taking stock in our recent achievements during the ongoing global pandemic and the evolving demands of the healthcare industry," said Edward A. Pesicka, president and CEO of Owens & Minor. "At the same time, we are always looking ahead to how we can better serve our customers amidst today’s changing landscape of the healthcare industry." 

OM first entered the medical and surgical supply business in 1966. Over the next 40 years, it grew from a regional company with revenue of $5 million to a national corporation with revenue over $1 billion, and over the same period, transitioned from a drug wholesaler to a hospital supplier and third-party logistics firm. 

In recent years, Owens & Minor has expanded its offerings and business standing through strategic acquisitions and customer growth, including its acquisition in 2017 of Byram Healthcare, a leading patient direct business that supplies medical products to at-home patients. More recently, OM entered into a definitive agreement to acquire Apria, Inc. at an equity value of $1.45 billion. 

Masimo finds no difference in accuracy 

IRVINE, Calif. – Masimo has announced the findings of an abstract that reviewed retrospective pulse oximetry data and concluded there was no clinically significant bias based on ethnicity for black and white volunteer subjects monitored with the company’s SET pulse oximetry and RD SET sensors. 

A prior paper and letter to the editor purported to find “racial bias” in pulse oximetry measurements based on comparison data obtained from black and white patients from multiple sets of health record data using unspecified pulse oximeters and controls. 

Masimo Founder and CEO Joe Kiani responded to that paper, promising additional research to test the company’s technology. 

Dr. Steven Barker, chief science officer at Masimo, and Dr. William Wilson, chief medical officer at the company, reviewed data collected between October 2015 and July 2021, including 7,183 paired samples (3,201 black and 3,982 white) collected from 75 subjects (39 black and 36 white) who were screened with the same criteria to remove potential bias based on health conditions. 

The authors analyzed the data to determine the bias (the mean difference in paired SpO2 and SaO2 samples), precision (standard deviation of the difference) and accuracy (root mean squared error, ARMS) for both groups. They found a negative bias of 0.20% for black subjects, compared to a negative bias of 0.05% for white subjects, a difference of 0.15% – not clinically significant. They found precision of 1.40% for black subjects and 1.35% for white subjects. 

By comparison, the letter to the editor reported a difference of 8.1% in a cohort of black and white hospital patients – 54 times higher. 

Masimo is conducting additional studies. 

Judge grants stay in case against DIR fees 

ALEXANDRIA, Va. – A U.S. District Court for the District of Columbia has granted a stay in a federal case that challenges the legality of pharmacy direct and indirect remuneration fees. 

“We are pleased by the court’s decision to grant our request for a stay, or a pause in the litigation, until the recently proposed rule potentially addressing retroactive pharmacy DIR fees is finalized,” the National Community Pharmacists Association and the American Pharmacists Association said in a statement. “We are currently analyzing the proposed rule to determine whether it addresses our longstanding concerns with retroactive pharmacy DIR fees, and we play to submit comments reflecting our analysis. Since our litigation also seeks to end retroactive pharmacy DIR fees, we believe, and the court agreed, that a pause in the case is appropriate pending the outcome of the rulemaking process.” 

The NCPA and APhA are joined in their case by the Coalition of State Rheumatology Organizations, Fruth Pharmacy of West Virginia, Hi-School Pharmacy of Washington, Kare Pharmacy of New Mexico and Tyson Drugs of Mississippi. They filed the case in January. 

The NCPA represents nearly 19,400 pharmacies that employ 215,000 individuals nationwide. 

NCPA to CMS: Raise dispensing fees on antiviral meds 

ALEXANDRIA, Va. – Community pharmacies are losing money dispensing new oral antiviral medicines based on the low fees paid by health insurance companies, writes the National Community Pharmacists Association in a letter to CMS Administrator Chiquita Brooks-LaSure. “NCPA asks for immediate intervention before these pharmacies are forced to stop dispensing the oral antiviral drugs because they can’t justify the cost to their business,” wrote B. Douglas Hoey, CEO of NCPA. Pharmacies are receiving anywhere from $10.50 to $1 to dispense the meds, when even $10.50 is far below their costs, according to the NCPA. There are also additional steps involved in dispensing these meds, Hoey says. “The pharmacies in the first distribution cycle estimate the additional time involved with dispensing the oral antivirals requires a dispensing fee consistent with the COVID‐19 vaccine administration fee of $40,” he wrote. “This reflects additional steps such as the non-standard ordering and receiving of the physical product, on-boarding new patients, and participating in the prescriber decision making process (working with prescribers to prioritize limited available doses, accurate data on e-prescriptions, transitioning patients from monoclonal antibodies to oral therapy).” 

Vivos sees significant increase in HST 

HIGHLANDS RANCH, Colo. – Vivos Therapeutics saw an 18-times increase in the total number of SleepImage Home Sleep Apnea Tests given across its network of trained dentists (known as Vivos Integrated Practices or VIPs) for the three months ended Dec. 31, 2021. The company also reported a 5.7-times increase in the number of VIPs administering HSTs; and a 3-times increase in the average number of HSTs being administered per VIP. “We have always believed that the pathway to getting more patients into treatment for OSA begins with an easy, inexpensive and highly accurate diagnostic process, which is precisely what the proprietary SleepImage test delivers,” said Kirk Huntsman, chairman and CEO of Vivos. “When coupled with the telemedicine model we have through our collaboration with Empower Sleep, which allows for the required medical diagnosis of OSA remotely, we believe that a historical barrier to patients obtaining a clear and medically valid sleep test report has now been eliminated.” As a result of the increase, Vivos has renegotiated its commercial agreement with SleepImage to lower costs and convert the entire diagnostic program. Under a new revenue model, Vivos will lease out the SleepImage ring recorders to Vivos trained dentists at a fixed price that includes a full month’s worth of diagnostic sleep test reports.  

LUCI enters seating market 

NASHVILLE, Tenn. – LUCI has introduced LUCI+Air, a real-time, smart air cushion pressure monitor. In addition to knowing if your cushion is properly inflated, LUCI+Air offers information about how much time the user spends sitting, and how often they are off-loading from their cushion. The patent-pending LUCI+Air works with the user’s air-filled cushion and the MyLuci app to display the data to help manage skin, create offloading targets, set reminders and track progress. LUCI+Air works with most air-filled cushions, including single-valve cushions, or multi-valve cushions that can be set with the valve open. After installing LUCI+Air, users can open the MyLuci app to access accurate, continuous data. The MyLuci app also gives the user the choice to securely share that information with specific members of their care team. 

Dynarex adds Southwest hub 

ORANGEBURG, N.Y. – Dynarex Corp., a leading durable medical equipment and disposable medical products company, has opened an industrial warehouse in Glendale, Ariz. The 250,000-square-foot facility will serve as Dynarex's Southwest regional distribution facility. "We are pleased and excited to announce the opening of this extensive hub to better serve our customers' needs," said Zalman Tanenbaum, CEO. "Our new warehouse offers three times the space of our previous facility in the region, providing increased storage capacity, greater efficiency and the potential for future expansion into additional product lines." The expansive building includes administrative office space and features 40-foot ceilings with ample clearance to accommodate a four-level racking system. The facility also houses 16 high-level bay doors that open for full van access, allowing for more efficient operation and faster dispatching.  

 Aeroflow Urology sponsors Native American sports 

ASHVILLE, N.C. – Aeroflow Urology is giving a $10,000 sponsorship to support the Tribal Adaptive organization, a non-profit whose mission is to use sports to improve the health and wellness of Native Americans with disabilities. "A core part of our mission at Aeroflow Urology is to give back and provide support for organizations that assist those with disabilities,” said Mica Phillips, director of Aeroflow Urology. “Tribal Adaptive is doing important work in creating access to adaptive sports, and we are proud to support their efforts." Half of the donation will be used to provide a basketball wheelchair for a 17-year-old girl. The other half of the donation will support the organization's basketball camps throughout the summer. Founded in 2015 by Noah Blue Elk Hotchkiss, Tribal Adaptive is the only organization in the United States that provides exclusive access to adaptive sporting equipment for Native American youth with disabilities. Tribal Adaptive's long-term goal is to create access to athletics for Native Americans with disabilities in every Native community in America.  

Better Medicare Alliance launches TV ad 

WASHINGTON - Better Medicare Alliance has launched a new television in Washington, D.C., as part of a seven-figure campaign touting the success of Medicare Advantage. The 30-second ad, titled “It’s Working,” will run on cable news and network Sunday shows in the D.C. region, alongside ads across digital and social platforms. “29.5 million seniors and individuals with disabilities will enroll in Medicare Advantage this year alone, and 9 out of 10 beneficiaries are satisfied with their coverage,” said Mary Beth Donahue, president and CEO of the Better Medicare Alliance. “We are taking action to ensure their voices are heard. With this ad campaign, we are reminding policymakers of Medicare Advantage’s bipartisan success story, and the need to prevent disruption for the growing, diverse population that counts on its coverage and care. On behalf of our 170 ally organizations and more than 600,000 grassroots advocates, we are proud to lead the charge to protect seniors’ health care choices.” 
  
Sunrise taps Jim Black to grow manual business 

FRESNO, Calif. – Sunrise Medical has appointed Jim Black, a three-time Paralympic athlete, as the business development manager for North America for its RGK brand of sport and made-to-measure manual wheelchairs. Black has more than 30 years of experience in sales, product management and marketing in complex rehab technology. “Bringing innovative solutions to the market and to the people who use our products is part of Sunrise’s and Jim’s DNA,” said Larry Jackson, president of Sunrise Medical Americas. “By helping riders get the best out of their made-to-measure mobility and continuing to develop exciting new products that exceed our customers’ expectations, Jim will be a great addition to the Sunrise Medical family.” Previously, Black served as director of business development/director of sales for Numotion, where he was responsible for the Numotion Gateway Region, creating business organically, directing and managing ATPs, and developing and executing education initiatives. Prior to joining Numotion, Black was manual product and marketing director for Permobil and before that director of sales, western regional, for TiLite Manual Wheelchairs. 

SMRC audits orthopedic footwear 

WASHINGTON – Noridian Healthcare Solutions, the Supplemental Medical Review Contractor for CMS, is conducting post-payment reviews for orthopedic footwear claims from Jan. 1, 2019, through Dec. 31, 2019. Orthopedic footwear is covered under the “leg, arm, back and neck braces, and artificial legs, arms and eyes” benefit. Coverage is provided when coverage, coding and documentation requirements are met. The reviews will include base and accessory codes. Noridian noted that this service category had an improper payment rate of 84.7% in 2019, according to the CERT Medicare Fee-For-Service Improper Payment Report. 

ATF Medical promotes sales exec 

NEWNAN, Ga. – ATF Medical has promoted Rick Wyche to executive director of sales, marketing and business development. As a member of the company’s senior leadership team, Wyche sets business development strategy and oversees the marketing and account management teams. “Rick’s compassion and curiosity led to in-depth knowledge of the industry, particularly the sophisticated power chairs that so many injured workers rely on,” said Sid Glover, CEO. “Over the years, he has worked in just about every area of the company and helped hundreds of people learn how to use their equipment, while also managing marketing responsibilities.” Wyche joined ATF Medical in 2008 as an intern and has grown professionally along with the company. Most recently, he was director of business development. 

Supreme Court splits decision on mandate 

WASHINGTON – The U.S. Supreme Court has blocked enforcement of the OSHA Emergency Temporary Standard mandating vaccines and testing by large businesses, but it has upheld enforcement of CMS’s interim final rule mandating it for certain covered health care providers. CMS’s IFR doesn’t apply to HME providers, but if they have employees working on behalf of a covered provider, they must comply with the mandate. Previously, a lower court had narrowed the scope of an injunction blocking CMS’s IFR. For additional analysis by VGM, go here. 

HHS extends PHE into April 

WASHINGTON – The U.S. Department of Health and Human Services has extended the current public health emergency for another 90 days, effective Jan. 16. There are a number of HME-related provisions that are tied to the PHE, including Medicare’s 75/25 blended reimbursement rates for non-rural, non-competitive bidding areas, and waivers of certain telehealth restrictions and other waivers and policy changes. The PHE was initially declared on Jan. 27, 2020.  

Invacare updates LiNX  

ELYRIA, Ohio – Invacare has added new features to its LiNX 3 electronics system. The system now features audible cues (it generates a beep sound to help users know what drive and seating profile they’re using); joystick shaping (ability to shape the field of the joystick engagement to match the hand movement of the end user); and grid navigation (ability to create a grid to set up quadrants in the joystick engagement field). “These new features represent yet another example of how Invacare is using advanced technology to provide industry leading solutions for our customers,” said Joost Beltman, senior vice president and general manager, North America. “Backed by our strong culture of innovation, Invacare is committed to remaining at the forefront of adopting technologies that strengthen our expansive portfolio of products and, ultimately, performance for end users.” 

Early rates set to expire 

PHOENIX – Early rates for Medtrade West are only in effect for a few more days, through Jan. 28. “Whether you opt for the conference pass, which includes access to the Expo floor, or the Expo Pass, this is an excellent time to buy,” said York Schwab, show director, Medtrade West. “The show is only four months away, and it’s not too early to make a commitment to improve your business and add inspiration, knowledge and new products to your 2022.” Under Early Rates, an Expo Pass is $50 and a Conference Pass is $199. Medtrade West takes place April 4-6 at the Phoenix Convention Center. To register, go here.