In brief: Invacare receives feedback from FDA, Liberator ends year with uptick in sales

Friday, December 18, 2015

ELYRIA, Ohio – Invacare has received observations from the FDA following an inspection of its corporate headquarters and Taylor Street manufacturing facility. “The FDA’s inspection included a review of the company’s compliance with terms of the consent decree, including requirements of the first and second certifications previously reviewed and accepted in 2013,” the company stated in an 8-K Form dated Dec. 9. Invacare is planning a response to the FDA. “The company remains focused on developing a strong enterprise-wide quality culture,” it stated in the form. “It will incorporate the FDA’s observations into its ongoing quality systems improvements.” Invacare is still in the process of trying to complete a third and final audit to comply with FDA regulations. The consent decree with the FDA limits the company’s ability to manufacture and sell custom power wheelchairs and seating systems.

Liberator ends year with uptick in sales

STUART, Fla. – Liberator Medical, which is being acquired by manufacturer C.R. Bard, posted a 9.4% increase in net sales for the fiscal year ended Sept. 30, 2015. Net sales were $81.6 million in 2015 vs. $74.6 million in 2014, driven primarily by the company’s continued emphasis on direct response advertising. “In 2015, we expanded the scope and reach of our sales and marketing activities, and strengthened our customer base through our proven direct response advertising efforts,” stated Mark Libratore, president and CEO. Liberator posted a 6% decrease in net income, $7.3 billion in 2015 vs. $7.8 million in 2014. The decrease was driven primarily by lower operating income due to an increase in legal and settlement costs, and advertising and bad debt expenses. It was partially offset by increased gross profits from increased sales volumes, and a reduction in payrolls costs and other general and administrative expenses. C.R. Bard, a manufacturer of medical devices for vascular, urology and surgical specialty fields, announced in November that it has agreed to buy Liberator for $181 million in a move that strengthens its direct-to-consumer platform. Liberator also made headlines in 2015, when it was one of eight companies investigated by the Department of Justice for alleged illegal kickback arrangements with Coloplast.

FMCSA starts rulemaking process for sleep reg

WASHINGTON – The Federal Motor Carrier Safety Administration has submitted an advance notice of proposed rulemaking that would regulate testing and treatment of truck drivers with sleep apnea, reports Land Line Magazine, the business newspaper for professional truckers. The FMCSA submitted the notice to the Office of Management and Budget on Dec. 15. The FMCSA lists the proposed rulemaking as not economically significant. President Obama in 2013 signed into law a bill that prevents FMCSA from proceeding with any regulation of sleep apnea without going through a rulemaking process. The FMCSA expects the notice to be published in the Federal Register in January.

AAH set to take HME Audit Key live

WASHINGTON – The HME Audit Key goes live in January, AAHomecare has announced. The association is asking providers to register for the tool now and get ready to enter their fourth quarter 2015 audit data into the tool in the second half of January. “The HME community must be able to better demonstrate the burdensome nature of audits, in terms of volumes and overturn rates,” AAHomecare stated. “Your participation will help the industry gather the data we need to make the case for reform, and will also help us identify new trends and developments in the audit space.” To learn more, providers can watch three brief presentations created by the association and its technical support partner, Provider Consulting Solutions. Enrollment opened for the audit key in April.

Associations throw support behind ‘any willing pharmacy’ bill

ALEXANDRIA, Va. – The National Federation of Independent Business (NFIB) and National Grocers Association (NGA) have written to Congress endorsing the Ensuring Seniors Access to Local Pharmacies Act. The bills, H.R. 793 and S. 1190, would allow Medicare beneficiaries to use their pharmacy of choice, provided it is located in a medically underserved area and willing to accept the drug plan’s contract terms and conditions. “In many rural and urban communities, independent pharmacies may be the sole option for residents to conveniently fill their prescriptions,” wrote NFIB and NGA, according to a release. “These pharmacies also provide employment opportunities and greatly contribute to their local economies. Yet they are still denied the opportunity to accept ‘preferred’ pharmacy contracts.” Currently Medicare beneficiaries can only use “preferred” pharmacies hand-picked by their drug plan.

Jurisdiction B finds uptick in error rates for enterals

INDIANAPOLIS – A claim review of enteral nutrition (B4035) from July 1, 2015, to Sept. 30, 2015, showed a denial rate of 75%. In the previous quarter, the rate was 67%.Of the 148 claims that were reviewed during the third quarter, 112 were denied. Of those, 23 were denied because the documentation was not received in a timely manner. The most common reasons for denial: the refill request documentation was not received; beneficiary's medical records did not demonstrate that the item was reasonable and necessary prior to the initial order; medical necessity of pump not documented; medical necessity for special enteral formulas not shown; and no proof of delivery from the supplier.

navihealth buys Rightcare Solutions

DUBLIN, Ohio – naviHealth, a Cardinal Health company, has acquired RightCare Solutions, a healthcare technology company specializing in hospital discharge planning software and readmissions management. RightCare licenses its software to hospitals and health systems to assess patients for post-acute care needs, determine risk of readmission, and coordinate patient discharges to post-acute care providers. The company also licenses its software to post-acute care providers, allowing them to save significant time and money in managing referrals from nearby hospitals through automation. “RightCare has a proven track record of delivering technology solutions to hospitals that translate into real ROI,” said Clay Richards, CEO of naviHealth, in a release.“The combination of our post-acute decision support and clinical analytics with RightCare's integrated discharge planning capabilities will further accelerate our ability to deliver a unique value proposition to health systems.”

Mediware, Prometheus expand partnership

LENEXA, Kan. – Mediware Information Systems, a post-acute care software provider, and Prometheus Group, an outcomes-based billing services provider, have signed a collaboration agreement to offer full-service billing solutions. The deal will help Fastrack HME customers make a smooth transition to CareTend and leverage advanced technology to reduce operating costs, improve productivity and enhance patient satisfaction, the companies say. “By expanding our billing and collections service solutions, providers can now have the option to outsource their A/R and focus on their core competencies,” said Paul O’Toole, vice president and general manager of the Home Care Solutions division of Mediware, in a release.

Nonprofit launches rehab company

BUFFALO, N.Y. – People Inc., a nonprofit health and human services agency, has launched People First Mobility, to provide DME, including power wheelchairs, scooters and custom seating, to Erie, Niagara and Chautuaqua counties. The provider will operate as a for-profit affiliate, with profits to benefit the People First Foundation, according to a local news report. People Inc. has revenue of more than $145 million and provides programs and services to more than 12,000 people.

Stock sellers: ResMed, Invacare, Inogen

James Hollingshead, president of the Americas at ResMed, sold 4,500 shares of company stock on Dec. 15 in a transaction valued at $251,775. He sold the shares at an average price of $55.95. Hollingshead now owns 52,069 shares valued at $2.9 million…Michael Delaney, a member of the board of directors at Invacare, sold 1,000 shares of company stock on Dec. 10 in a transaction valued at $19,050. He sold the shares at an average price of $19.05. Delaney now owns 4,254 shares valued at $81,038…Matt Scribner, executive vice president of operations at Inogen, sold 4,102 shares of company stock on Dec. 14 in a transaction valued at $165,721. He sold the shares at an average price of $40.13.