What does value mean in healthcare?

[Image from Unsplash]

“Value” is a word that one hears a lot these days in the medical device industry and healthcare in general, but it’s hard to pin down what it exactly means.

Defining what it means matters because public and private healthcare payers in the U.S. and around the world are moving away from traditional fee-for-service payments. Instead, payers such as the U.S. government’s Medicare program and private insurers favor health providers delivering more efficient and effective care. The situation means that device companies need to have arguments for why their products create value, both to persuade hospitals and clinics to use their devices and to arrange reimbursement from insurers.

Some top medical device industry executives explored the meaning of value during a panel at the recent DeviceTalks Minnesota, June 26–27 in St. Paul. (The next DeviceTalks is Oct. 2 in Boston.) Here’s what they had to say:

Sheri Dodd

VP and general manager, Medtronic Care Management Services (formerly Cardiocom)

“When we talk about value in healthcare at Medtronic, we actually are trying to go very narrow. We’re trying to define in very narrow cohorts, with very specific outcomes for a very specific time period and engage and quantify those off-site to manage that population. … We believe that the more narrow you get, the more refined you get and the more specific you get, the more you will actually be able to address the optimal you can achieve, and we are able to do that. You can actually stop getting paid based on volume and getting paid on that outcome. These aren’t just words, this is what our CEO is talking about all the time, and he is dead serious about it, so we are undergoing a lot of that work. We’re identifying what products we have that truly get to this cost-over-outcome equation that we can stand behind with data, and appropriate intervention and then change the way we’re in the market.”

Get the full story on our sister site, Medical Design & Outsourcing.

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This wooden toe could be one of the oldest prosthetics in the world

[Image from University of Basel]

University of Basel Egyptologists have reexamined what they claim to be as one of the oldest prosthetic devices in human history to determine its origin.

A wooden big toe, thought to be almost 3,000 years old, was discovered in a female burial in the necropolis of Sheikh ´Abd el-Qurna near Luxor.

Using microscopy, X-ray technology and computer tomography, the team investigated the wooden toe and was able to figure out that the toe was refitted several times to be able to fit the foot of the owner, who happened to be a priest’s daughter. The researchers also categorized the materials used to make it and what methods were used.

Get the full story on our sister site, Medical Design & Outsourcing.

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BD extends Bard note exchange offering again

Becton Dickinson (NYSE:BDX) said today is once again extending its exchange offering for up to $1.1 billion in outstanding  C. R. Bard (NYSE:BCR) notes from July 3 to August 1.

The company is offering exchanges for approximately $500 million for 4.4% Bard note due 2021, $500 million for 3% notes due 2026 and $149.8 million in 6.7% notes due 2026.

BD said that so far, it has validly tendered approximately 85.6% of its 4.4% notes due 2021, 91.5% of its 6.7% notes due 2026 and 92.7% of its 3% notes due 2026, according to a press release. The company said that withdrawal rights have expired in respect to the offering.

The Franklin Lakes, N.J.-based company announced an initial extension from June 5 to July 3 last month.

For each of the notes in the offering, BD said it will offer $970 principal amount of equal BD notes as well as between $2.50 and $20 cash, with an early tender premium of $30 principal amount of equal BD notes. The company said it is also soliciting consents to adopt certain proposed amendments to each of the indentures governing Bard notes to eliminate restrictive covenants.

In May, BD announced the exchange offer alongside a registered offering of $2.25 billion in common stock at $1 per share, with an additional $2.25 billion in depository shares, each representing a 1/20th interest in its mandatory convertible preferred stock at $1 per share.

The offering round included an underwriters option to purchase up to an additional $225 million in common stock and $225 million in depository shares. Proceeds from the offering were slated to support its acquisition of Bard, which it expects to close in the fall of this year.

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Second Sight Medical wins expanded CMS coverage for Argus II

Second Sight Medical (NSDQ:EYES) said today its Argus II retinal prosthesis system won expanded reimbursement coverage from the Centers for Medicare and Medicaid Services in 11 additional states and the District of Columbia.

With the expansion, the Sylmar, Calif.-based company said it’s Argus II device is now reimbursable in 7 of the 12 Medicare Administrative Contractor jurisdictions, covering the device in a total of 28 states, 2 territories and D.C.

The Argus II induces visual perception in blind patients with retinitis pigmentosa by stimulating of the retina’s remaining cells with electrical pulses, which allows for the perception of light patterns to the brain, the company said.

Second Sight said that MAC Novitas Solutions published a local coverage determination authorizing coverage of the Argus II, when medically necessary, to beneficiaries in Arkansas, Colorado, Delaware, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, Texas and D.C.

“We are pleased that Novitas has made this important decision to facilitate coverage of the Argus II, which we believe will enable us to offer greater access to patients with Retinitis Pigmentosa and continue to fulfill our mission of providing useful vision to the blind,” prez & CEO Will McGuire said in a press release.

The company said it is continuing to work with other MACs and payers as it seeks further coverage for the device.

In March, Second Sight said it closed a previously announced rights offering, retaining approximately $20.1 million with proceeds slated to support development and improvement of its Argus II retinal prosthesis.

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Medtronic nearing resolution on Infuse suits

Medtronic (NYSE:MDT) is closing in on a resolution to the long-running legal battles over its Infuse bone-growth protein designed for back surgeries, according to an SEC filing posted last week.

The Fridley, Minn.-based company said that it is approaching agreements to settle approximately 6,000 cases against it which asserted personal injury claims due to the bone graft product in an SEC filing.

“As of June 1, 2017, the company has reached agreements to settle substantially all of these claims, resolving this litigation,” Medtronic wrote in an SEC filing.

While Medtronic did not release exact financial details of the settlements, it did report that it has set aside $300 million for “certain litigation charges” in the filing.

The company also said that it had received subpoenas or document requests from Attorney Generals in Massachusetts, California, Oregon, Illinois and Washington seeking more information regarding the Infuse device and that it had “accrued expenses in connection with these matters,” according to the filing.

“We continue to cooperate in the State AG inquiries and are hopeful an acceptable resolution can be reached,” Medtronic spokesperson Eric Epperson told the Star Tribune via email last week.

Approved in 2002 for use in spinal fusion surgery, Infuse at 1 point had annual sales of nearly $1 billion. The bone-grafting product has since been linked to abnormal bone growth, certain cancers and male reproductive problems. Medtronic has been accused of not only downplaying the product’s risks but also promoting it for off-label use.

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Abbott wins Health Canada nod for FreeStyle Libre glucose monitor

Abbott (NYSE:ABT) said today that its FreeStyle Libre glucose monitoring system won Health Canada approval for adults with diabetes.

The company’s disposable glucose monitoring device is worn on the back of the upper arm and senses glucose using a small filament that is placed under the skin. Every scan includes a real-time glucose reading, as well as an 8-hour snapshot of blood sugar data.

The reader contains up to 90 days of information, so users can study their glucose levels over time.

Abbott said it’s system eliminates the need for routine finger sticks, which diabetic patients traditionally use to monitor their glucose levels.

“The 1st word that came to mind when I learned about FreeStyle Libre was ‘freedom’,” Maria Miclea, who has Type I diabetes, said in a press release. “Freedom from the pain of routine testing and from social awkwardness.  Also, peace of mind, knowing that I can quickly and easily scan my glucose levels – whenever and wherever I want – to help better manage my diabetes.”

The company also said that its FreeStyle Libre system will be covered by 2 major Canadian insurers.

“At Abbott, our goal is to help people achieve their best health,” Badia Boudaiffa, GM of Abbott’s Canadian Diabetes Care business, said. “Bringing FreeStyle Libre to the three million people living with diabetes across Canada is a major milestone. This technology not only transforms how people have been testing their glucose levels for decades, it also may support improved overall diabetes management.”

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SteadyMed seeks FDA nod for Trevyent drug-device combo

SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy.

The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system.

Get the full story at our sister site, Drug Delivery Business News.

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