In brief: Senators’ demands, F&P’s new execs, Belluscura’s green light

WASHINGTON – A group of senators has asked CMS to collect and publish more Medicare Advantage data to help lawmakers and regulators better understand the impact of these plans. 

AAHomecare provided the following analysis of the group's new letter to CMS Administrator Chiquita Brooks-Lasure: 

The senators cite “concerning trends” in Medicare Advantage and point to a 2019 HHS OIG study that “found that among requests MA plans denied, 13% of prior authorization denials and 18% of payment denials actually met Medicare coverage rules.” The letter also notes a CMS estimate that MA plans have received at least $106 billion in excess payments between 2010 and 2019, as well as a MedPAC forecast of a possible $27 billion in overpayments for 2023, according to a bulletin from AAHomecare. 

The senators seek data that includes: 

• Prior authorization requests, denials and appeals by type of service. 

• Justification of prior authorization denials. 

• Timeliness of prior authorization decisions. 

• Out-of-pocket costs and provider payment information. 

“CMS can collect and publish these data using its existing authority,” the letters states. “To strengthen the transparency of MA plans and improve care for Medicare beneficiaries, we urge CMS to take these actions. We also respectfully request that you provide us with a staff-level briefing on CMS’s plan to improve its data collection and reporting practices for MA plans by Dec. 27, 2023.” 

Marketplace sign-ups at record-breaking pace 

WASHINGTON – More than 745,000 people selected a Marketplace plan though healthcare.gov on Dec. 15, the most signups in a single day in history. As of Dec. 15, for healthcare.gov states and Dec. 9 for state-based marketplaces, preliminary data projects that more than 19 million consumers will enroll in 2024 coverage through the Affordable Care Act Marketplaces — more than 7 million more than when President Biden took office. “Millions of Americans signing up for health care coverage under the Affordable Care Act is good news,” said Secretary Xavier Becerra. “It means more Americans have the peace of mind of knowing that going to the doctor won't empty their bank account,” said HHS Sec. Xavier Becerra. “The Biden-Harris Administration will continue working to expand health care coverage and lower prescription drug costs, so taking care of your health is not a luxury.” The open enrollment period on healthcare.gov runs from Nov. 1 to Jan. 16. 

Georgia man pleads guilty to $127M fraud scheme 

NEWARK, N.J. – Nicco Romanowski, of Roswell, Ga., pleaded guilty to conspiracy to violate the federal anti-kickback statute and conspiracy to commit health care fraud. From June 2017 through May 2019, Romanowski participated in a scheme with DME companies, telemedicine companies and doctors to submit false claims to health care benefit programs, including Medicare and Tricare. In total, Romanowski and his conspirators caused the submission of false and fraudulent claims to health care benefit programs totaling more than $127 million for DME. Romanowski operated a marketing company where employees of the company called beneficiaries to pressure them to agree to accept DME, frequently consisting of back, shoulder and knee braces. Romanowski and his conspirators paid the company’s employees commissions, bonuses and incentives to encourage them to convince as many beneficiaries as possible to accept DME, regardless of medical necessity. Romanowski paid kickbacks to telemedicine companies, which in turn paid kickbacks to doctors, to obtain doctor’s orders for the DME. The doctors paid by the telemedicine companies signed the orders regardless of medical necessity, often without ever speaking to the patient. Romanowski and his business partner, Eric Karlewicz, then steered the orders to DME suppliers. The company received more than $63 million from DME suppliers. Karlewicz previously pleaded guilty to an information charging conspiracy to violate the anti-kickback statute and conspiracy to commit health care fraud. Sentencing is scheduled for May 21, 2024. 

Dexcom’s G7 now connects with Tandem’s t:slim X2 

SAN DIEGO – Dexcom’s G7 continuous glucose monitoring (CGM) system can now connect with Tandem Diabetes Care's t:slim X2 insulin pump. Dexcom in December 2022 received clearance from the U.S. Food and Drug Administration for the device, which can be used for people with all types of diabetes ages two years and older. The G7 features a simplified, redesigned app experience; 30-minute sensor warm up; 12-hour grace period to replace finished sensors; and enhanced alerts. Dexcom G7 sensors for t:slim X2 pump are now available through DME providers. Dexcom’s strategic partnership with Tandem Diabetes Care marks a significant step toward providing solutions that empower individuals with diabetes and health care providers alike, setting a new standard for integrated diabetes management, the company says. 

Read what Kevin Sayer, chairman, president and CEO of Dexcom had to say about the Dexcom G7. 

CMS publishes 2024 FFS schedule 

WASHINGTON – CMS has published the 2024 DMEPOS Fee-for-Service Fee Schedule. The fee schedule goes into effect on Jan. 1, 2024, and includes the 2.6% to 3% CPI-U adjustments announced earlier in the month. CMS is planning to revert back to fully adjusted rates in non-rural areas, effectively removing the current 75/25 blended reimbursement rates, says AAHomecare. Due to this, the rates for competitively bid items in non-rural areas will be considerably lower than the relief rates in effect today. AAHomecare and HME stakeholders continue to advocate for the extension of relief rates. Legislation to extend the 75/25 blended rate for suppliers in non-rural areas was approved by the House Energy & Commerce Committee on Dec. 6. Download the 2024 fee schedule here.  

Fisher & Paykel makes executive changes 

AUCKLAND, New Zealand – Fisher & Paykel Healthcare has named Justin Callahan vice president, sales & marketing. Callahan, currently the company’s president – North America & Europe, replaces Paul Shearer, who is retiring. “Justin has had an impressive track record over more than 25 years and during his tenure has helped deliver significant revenue and earnings growth in our North American business,” said Lewis Gradon, managing director and CEO. “He is well respected by our people, customers and members of the financial community and we believe he will continue to add significant value to our global business in his new role.” The company has also made several other executive changes: Andy Niccol named COO; Malena Ortiz, general director - Mexico operations; Desh Edirisuriya, general manager - New Zealand operations; and Raelene Leonard, general counsel and company secretary. “As our business continues to scale, ensuring we remain well-structured for future growth is essential,” said Gradon. “That rationale underpins each of the decisions we are announcing today.” All changes are effective April 1, 2024. 
   
Tandem launches diabetes management platform 

SAN DIEGO – Tandem Diabetes Care has launched Tandem Source, a diabetes management platform for insulin pump users and health care providers. Tandem Source brings together the features of Tandem’s legacy t:connect, t:connect HCP, and t:connect Portal offerings with new comprehensive data reporting in one central, scalable platform. “The launch of Tandem Source offers new, easy-to-use reports and the consolidation of several platforms and features into a single, convenient location for all our customers’ needs,” said John Sheridan, president and CEO of Tandem Diabetes Care. “Feedback from early adopters of Tandem Source in the United States has been overwhelmingly positive, and we look forward to expanding access to other countries in the coming year.” Tandem Source features a new web-based pump uploader, offering faster data transfers to the cloud with no computer software to install or update; automatic data transfers from users’ pumps using the t:connect mobile app, keeping online data current and removing the need for manual pump uploads; and three easy-to-use reports, consolidating all the information needed for providers to make impactful clinical recommendations. 

Belluscura gets green light in China 

LONDON and PLANO, Texas – Belluscura has received approval from the National Medical Products Administration to distribute the X-PLOR portable oxygen concentrator in China. China is part of the licensed territory covered by the exclusive license agreement with InnoMax Medical Device Technologies announced in August 2023. "We are delighted to have received approval in China which has taken over approximately 10 months,” said Bob Rauker, CEO. “This enables us to launch sales into China with immediate effect. With our arrangement with InnoMax in place, we are confident that we can now deliver on the significant potential for our products in this large and growing market.” With this approval secured, Belluscura has now entered into negotiations with several distributors in China.  Belluscura has now concluded three sizeable registrations within the Asian market: Hong Kong in September, Singapore in December and now China. Belluscura estimates the oxygen concentrator market size for the Asia Pacific region is expected to grow to nearly $1 billion in just six years.  

Siblings charged in Medicare fraud 

NEW YORK – Erin Foley and Ted Albin have been arrested on charges of health care fraud and conspiracy to violate the Anti-Kickback Statute, according to the U.S. Attorney for the Southern District of New York and the New York Regional Office of the U.S. Department of Health and Human Services - Office of Inspector General. From at least 2018 through 2021, the pair ran Grapevine Professional Services, Inc., a billing company that they used to bill Medicare for more than $25 million, and to collect more than $9 million, through claims based on orders for DME that were allegedly unlawfully sold and bought. Such billing included both billing directly to Medicare through Medicare Part B and billing to private insurance companies that were reimbursed through Medicare Part C. Most of these allegedly unlawful purchases of DME orders were by Grapevine customers that were registered with Medicare as DME supply companies. Additional unlawful purchases were made directly by Foley and Albin through three DME supply companies that they themselves owned and controlled. Foley of Loxahatchee, Fla., and Albin of Stuart, Fla., are each charged with conspiracy to commit health care fraud and wire fraud, which carries a maximum sentence of 20 years in prison; health care fraud, which carries a maximum sentence of 10 years in prison; wire fraud, which carries a maximum sentence of 20 years in prison; and conspiracy to violate the Anti-Kickback Statute, which carries a maximum sentence of five years in prison.