In brief: AAH on Medicaid, AdaptHealth on expectations, GAO on waivers

WASHINGTON – AAHomecare’s Payer Relations Team has begun a nationwide campaign to work with state/regional association leaders to better align state Medicaid rates with higher costs. 

The association says HME providers are experiencing increasing product prices and operational costs due to the COVID-19 pandemic and supply chain issues, as well as ongoing inflation pressures. 

“Our work will include requesting that rates reflect the 6.4%+ CPI-U increases granted by CMS, as well as additional adjustments based on rising costs specifically facing HME suppliers in the state,” AAHomecare stated in a bulletin. “This effort can be undertaken in all states, not just the 30 states that currently follow Medicare rates.” 

Many states aligned their rates with Medicare’s in the wake of Congress passing the CURES Act in 2018. Some of these rates are pegged to the lowest Medicare rate found in the state, some are tied to non-competitive bidding area/non-rural rates, and some follow 50/50 blended rural rates for the state, AAHomecare says.  

Because rate adjustments will require legislation in some states, the association is working to address the issue in budget bills. In Florida, for example, the state Medicaid program has included a 5% DMEPOS increase in its budget request. 

“Other states where we have recently joined association leaders in meeting with Medicaid officials on reimbursements include Georgia, Kentucky, North Carolina, Oregon, Tennessee, and Virginia,” AAHomecare stated. “We are also looking at opportunities to introduce Medicaid rate floor legislation in several states.” 

AAHomecare has developed a letter that stakeholders can use to discuss rate adjustments with Medicaid authorities. 

Read AAHomecare’s analysis of the new Medicare fee schedule here. 

AdaptHealth expects 8% to 10% growth in 2023 

PLYMOUTH MEETING, Pa. – AdaptHealth Corp. is providing initial full year 2023 guidance of $3.21 billion to $3.29 billion in net revenue and adjusted EBITDA of $690 million to $750 million. 

The guidance reflects anticipated net impacts from scheduled changes in the reimbursement and regulatory environment, including increased revenue related to the consumer price index updates to the DMEPOS fee schedule, the extension of current rural and non-rural/non-CBA blended Medicare rates and the extension of sequester relief in 2023. 

“We are pleased with our guidance for the full year ending Dec. 31, 2023, which reflects continued improvement and stabilization of the supply of PAP devices for our sleep business and overall non-acquired net revenue growth for the company in the range of 8% to 10%,” said Steve Griggs, CEO. “Demand remains very strong across our businesses, and we are pleased with our ability to execute on that demand, addressing the needs of our patients and adding value for our partners. We continue to work on innovative technology solutions that allow us to seamlessly communicate with patients, providers and payers to take advantage of value-based care and chronic care management opportunities.” 

AdaptHealth expects net revenue to be near the midpoint of the previously-provided guidance range of $2.950 billion to $3.010 billion for full year 2022. It expects adjusted EBITDA to be near the low end of the previously provided guidance range of $620 million to $650 million. 

The company will release its fourth quarter and full year financial results on Feb. 28. 

• Read about how AdaptHealth had a record number of CPAP setups in the third quarter, but they were offset by a loss in resupply revenue and increased costs. 

 Inogen meets expectations in Q4 

GOLETA, Calif. – Inogen estimates preliminary, unaudited total revenue of $87.5 million to $88.5 million for the fourth quarter of 2022, representing year-over-year growth of 14.5% to 15.8%. 

It estimates total revenue of $376.7 million to $377.7 million for the full year, representing year-over-year growth of 5.2% to 5.5%. 

“Despite the prevailing macroeconomic pressures and headwinds resulting from our efforts to continue upgrading the operating disciplines in our DTC commercial team, preliminary fourth quarter 2022 results came in within the expectations we had shared during our third quarter earnings call,” said Nabil Shabshab, president and CEO. “We expect productivity to improve in the near-term as the tenure of our DTC team increases and we continue partnering with our B2B channel to manage economic pressures. While we continue to prioritize investments to drive medium to long-term growth, we are also diligently managing operating expenses in support of our plans for long-term profitability.” 

Inogen had previously projected total revenue of $87 million to $92 million for the fourth quarter. 

The company will issue fourth quarter and full year financial results on Feb. 23. 

Telehealth use declines nationally 

NEW YORK – Telehealth use nationally declined 3.7% in October 2022, according to FAIR Health's Monthly Telehealth Regional Tracker.  

The decline was larger in the South (6.8%), Midwest (4.9%) and West (4.1%), while there was an increase (1.7%) in the Northeast. The data represent the privately insured population, including Medicare Advantage, and exclude Medicare Fee-for-Service and Medicaid. 

In October, COVID-19 continued to fall among the top five telehealth diagnoses nationally and in most regions. Nationally and in the Midwest, COVID-19 fell from third to fifth place in the rankings. In the Northeast, it fell from second to third place, and in the South, it fell from fifth place out of the rankings. In the West, COVID-19 had already been out of the top rankings since September. 

Meanwhile, respiratory diseases and infections climbed in the rankings of the top five telehealth diagnoses. In the Northeast, it rose from third to second place from September to October, and in the West, it rose from fourth to second place. Nationally and in the Midwest and South, it remained at second place but increased in percentage share of telehealth claim lines.  

Launched in May 2020 as a free service, the Monthly Telehealth Regional Tracker uses FAIR Health data to track how telehealth is evolving from month to month. 

• To access the Monthly Telehealth Regional Tracker, click here. 

GAO to CMS: Conduct fingerprint-based background checks 

WASHINGTON – CMS needs to address risks posed by provider enrollment waivers and flexibilities that have been in place during the COVID-19 pandemic, the Government Accountability Office says in a new report. The GAO analyzed 47 waivers and flexibilities, such as waivers of about 7,300 fingerprint-based background checks for types of providers posing a high risk of fraud, waste and abuse, and found that Medicare took some steps to oversee providers but fell behind in others. In all, the GAO found that 220,000 providers enrolled under waivers and flexibilities from March 2020 through March 2022. DME providers represented a small portion of these enrollments (4%) but a large portion of revocations (83%). The GAO recommends CMS conduct fingerprint-based criminal background checks, increase the pace of revalidating provider eligibility, and evaluate opportunities for improvement in planning for future emergencies.  

DHA announces new TRICARE contracts 

WASHINGTON - The Defense Health Agency (DHA) recently announced new TRICARE contract awards taking effect in 2024, according to AAHomecare. The Eastern region will continue to be served by Humana Military; the West will transition to TriWest from current contractor Health Net Federal Services, a Centene subsidiary. TriWest previously held TRICARE contracts with the DoD for 17 years. In addition, six states are transitioning from the East to West region: Arkansas, Illinois, Louisiana, Oklahoma, Texas and Wisconsin. The DHA has targeted January 2024 for the transition. AAHomecare says it will monitor the transition, especially with regards to impacts and requirements for HME suppliers. 

• Read about how AAHomecare pushed for timely payments from TRICARE. 

PHE extended through April 11 

WASHINGTON – Health and Human Services Secretary Xavier Becerra has extended the public health emergency for an additional 90-day period through April 11, 2023. While the PHE remains in effect, the 75/25 blended rate in non-rural/non-competitive bid areas will remain in effect, along with other policies tied to the status of the PHE. Those other policies include providing flexibility to expand the use of home-based respiratory products and continuous glucose monitors; implementing waivers of face-to-face requirements for many products; and allowing the use of telehealth for items that are not included in the waiver such as PMD. 

Ottobock names new CEO, president 

AUSTIN, Texas – Ottobock and its board of directors has appointed Dr. Wilson P. Constantine as CEO and president of its North American operations. Constantine, a medical device industry veteran with more than 25 years of experience, most recently as president of the Americas Region of Smiths Medical, will report to Oliver Jakobi, Global CEO/CSO of Ottobock SE & Co. KGaA. "Wilson's experience leading North American operations and extensive expertise with medical technology will be of tremendous benefit to Ottobock as we enter the next phase of development and continue to build our presence across the U.S. and Canada," said Jakobi. "His proven track record of leading meaningful change and growth in organizations will help Ottobock as we continue to innovate to help people regain their quality of life." Constantine succeeds Marc C. Lundeberg, who left the company in August to pursue other opportunities. 

Soleo Health to distribute new Alzheimer’s treatment 

FRISCO, Texas – Soleo Health, a national provider of complex specialty pharmacy services, has been selected by Eisai Inc., a developer of pharmaceuticals, as the sole specialty pharmacy distribution partner for LEQEMBI, which was recently approved by the U.S. Food & Drug Administration for the treatment of Alzheimer’s disease. LEQEMBI is an anti-amyloid monoclonal antibody used to treat mild cognitive impairment due to Alzheimer’s and mild or early Alzheimer’s disease (collectively known as early AD). “The selection of Soleo Health as the sole specialty pharmacy distributor for LEQEMBI reflects confidence in our clinical expertise and differentiated patient care model supporting patients in the neurology space,” said Drew Walk, CEO of Soleo Health.” Our partnership with Eisai will afford the Alzheimer’s community continued hope while we assist patients and their caregivers as they navigate their healthcare journey.” Patients receiving LEQEMBI will be supported through Soleo Health’s Alzheimer’s Disease Therapeutic Care Management Center (TCMC), staffed with specially trained interdisciplinary teams comprising highly experienced physician specialists, nurse practitioners, therapy-care pharmacists, registered nurses, reimbursement specialists and patient care ambassadors. Soleo Health’s distinctive Alzheimer’s Disease TCMC is supported through the company’s specialty pharmacy locations nationwide with pharmacy licensure in all 50 states.  

Vivos closes on funding 

LITTLETON, Colo. – Vivos Therapeutics, Inc., a medical technology company focused on developing treatments for patients suffering from mild-to-moderate obstructive sleep apnea, has closed its previously announced private placement offering with a single institutional investor for $8 million in gross proceeds. After the placement agent fees and estimated offering expenses, the company expects to receive net proceeds of approximately $7.4 million, which it intends to use for general working capital and corporate purposes as it seeks to both drive revenue growth and manage expenses during 2023. The private placement consisted of an aggregate of 2 million shares of company common stock, pre-funded warrants to purchase up to an aggregate of 4,666,667 shares of company common stock and common stock purchase warrants to purchase up to an aggregate of 6,666,667 shares of company common stock at $1.20 per share for five years and six months from closing. Roth Capital Partners and A.G.P./Alliance Global Partners acted as placement agents for the offering. 

Inogen to launch new POC this year 

GOLETA, Calif. – Inogen has received 510(k) clearance from the U.S. Food and Drug Administration for its latest portable oxygen concentrator, the Rove 4. The company has already launched the Rove 6, a new and improved six-setting device, in European countries, where reimbursement is grandfathered, and it plans to launch the Rove 4, a four-setting device, in the U.S. by the back half of 2023. Inogen has also received European Medical Device Regulation certification to sell and commercialize its Inogen One G4 and the updated version of its Inogen One G5 POCs in the E.U. “We are pleased to announce the receipt of both the EU MDR certification and US FDA clearance,” said Nabil Shabshab, President and Chief Executive Officer. “This is an important next step in Inogen cementing its commitment to continue leading POC innovations to serve patients in need of oxygen therapy around the world. The Rove series will serve as our next generation POC platform with product launches being planned for 2023. We are excited about these new products and the progress in the overall innovation roadmap towards next generation offerings to serve COPD patients and beyond.” 

Medix Infusion closes on funding 

DALLAS – Medix Infusion has closed a $35 million Series B funding round led by Echo Health Ventures. Additional participants included Pittco Direct Investments II, the direct investing arm of Pittco Management, LLC, and initial investor Noro-Moseley Partners. The company will use its newly secured investment to support organic growth and acquire the infusion operations of the Center for Neurology and Spine, a national leader in the treatment of neurological disorders that serves patients across five infusion suites in Arizona. “We are thankful for the confidence in our company and its vision demonstrated by our new partners, Echo Health Ventures and Pittco, and energized by the continued trust of Noro-Moseley Partners through another round of investment,” said Medix Infusion CEO Gus de Avillez. “Together, we can unlock new strategic opportunities to reduce the overall cost of care and create greater access to convenient, compassionate infusion care in underserved communities across the country.” The Arizona acquisition expands Medix’s geographic footprint into its fifth state with additional operations in Texas, Oregon, Kansas and Missouri. The company simultaneously entered into a debt facility with Live Oak Bank to further support its growth. Medix has experienced 100% year-over-year growth since its inception in April 2020, quickly expanding its network of ambulatory clinics, while continuing to improve the standard of care for infusion patients. It now operates more than 30 locations across five states, along with its home infusion pharmacy operations, impacting the lives of more than 4,600 patients. 

EW announces award finalists 

WATERLOO, Iowa – Essentially Women has announced the three finalists for the 2023 Ruth Addison Award of Excellence. They are Carol Poole, owner of A New You Pink Boutique in Brandon, Fla; Patsy Taylor, former boutique coordinator, Magnolias Breast Health Boutique, Augusta, Ga.; and Ramona Hertzell, CFm, owner of Second to Nature Boutique in Greensboro, N.C. “The Essentially Women Ruth Addison Award of Excellence has become a significant award in the women’s health industry,” said Nikki Jensen, vice president of EW, a division of VGM & Associates. “Each year, I am impressed with the nominations that we received and the amazing accomplishments that women in this industry have achieved. Each one of this year’s finalists has made significant contributions to the development of the post-mastectomy industry. Congratulations to this year’s finalists!” A nomination committee selected the finalists based on their impact on their company, community and the women’s health industry. In addition to Jensen, the committee’s members are Matt Gruskin, COO, Board of Certification/Accreditation (BOC); Mike Isaacson, senior vice president, operations, VGM & Associates; and Jim Lawson, outreach development manager, American Board for Certification in Orthotics, Prosthetics and Pedorthics (ABC). EW will announce the winner of the award prior to the keynote session at its Focus Conference on Sunday, Feb. 5. 

Inspire Medical sees significant growth in Q4 

MINNEAPOLIS – Inspire Medical, the maker of an FDA-approved neurostimulation device to treat obstructive sleep apnea, expects revenue of $137.5 million to $137.9 million for the fourth quarter of 2022, about a 76% increase year over year. It expects revenue for the full year to be $407.5 million to $407.9 million, about a 75% increase compared to 2021. “We are very pleased with our strong preliminary revenue performance in the fourth quarter primarily driven by higher utilization at existing centers,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. "As we continue to activate new centers, we remain highly focused on consistent patient outcomes and enhanced center efficiencies which are the core of therapy adoption to meet robust demand.” Inspire activated 61 new centers in the fourth quarter, for a total of 905 centers in the U.S. implanting the devices. Additionally, the company created 16 new sales territories in the fourth quarter, for a total of 225 in the U.S. Inspire plans to report its full financial results on Feb. 7. 

COPD patients benefit from telerehabilitation, according to trial 

NEW YORK – Long-term telerehabilitation and unsupervised training at home for COPD patients are both successful in reducing hospital readmissions and can broaden the availability of pulmonary rehabilitation and maintenance strategies, according to a new study published in the American Journal of Respiratory and Critical Care Medicine. Researchers embarked on the randomized controlled trial because, despite the benefits of pulmonary rehabilitation in COPD, many patients do not access or complete rehabilitation. They set out to compare long-term rehabilitation or unsupervised treadmill training at home with standard care. In the trial, patients with COPD were assigned to three groups (telerehabilitation, unsupervised training, control) and followed for up to two years. Telerehabilitation consisted of individualized treadmill training at home supervised by a physiotherapist and self-management. Unsupervised training group consisted of treadmill exercise at home. Control consisted of standard care. Researchers found the incidence rate of hospitalizations and emergency department presentations was lower in the telerehabilitation (1.18 events per person-year, 95% CI: 0.94, 1.46) and unsupervised training groups (1.14, 95% CI: 0.92, 1.41) compared to the control group (1.88, 95% CI: 1.58, 2.21). The telerehabilitation and unsupervised training groups experienced better health status for one year.  

Vivos receives clearance for appliance to treat OSA 

LITTLETON, Colo. - Vivos Therapeutics, a medtech company focused on developing innovative treatments for patients suffering from obstructive sleep apnea, has received clearance from the U.S. Food and Drug Administration for its proprietary daytime-nighttime (DNA) appliance. With FDA clearance, the DNA appliance offers a new treatment regimen that opens the airway by expanding the palate and training the tongue to rest in the proper position, converting patients to nasal as opposed to oral breathing.  “This clearance is the culmination of years of pioneering clinical work,” said Kirk Huntsman, chairman and CEO of Vivos. “For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild-to-moderate OSA in adults. The FDA now joins other international regulatory bodies in recognizing the efficacy of our patented technology in the reduction and resolution of many of the symptoms of OSA that result from a lack of development of the jaws and oral cavity. We believe the DNA treatment can be life changing for many OSA patients, and we look forward to continued market adoption of our expanded menu of treatments for this debilitating condition.” The clinical data that Vivos submitted to the FDA as part of the clearance process for the DNA included pre- and post-treatment Apnea Hypopnea Index (AHI) scores obtained with no appliance in the mouth, demonstrating that: 28% of patients had their OSA resolved; 63% of patients improved by one AHI classification (i.e., severe to moderate, moderate to mild, or mild to no OSA); 86% of patients improved their airway size; and 97% of patients increased the width of their palate, allowing the tongue to rest in proper position and thus avoiding a potential airway obstruction. Additionally, in a study of patient satisfaction with DNA treatment, the company found 97% of patients achieved the desired outcome, while 98% of patients were highly satisfied or very satisfied and likely to recommend the treatment to a friend.