Price Comparison of NPWT Pump Systems by CMS

EXECUTIVE SUMMARY
OBJECTIVES
(1) To compare the prices that suppliers paid for new negative pressure wound therapy pump models to Medicare’s purchase price for the pumps.
(2) To describe how suppliers acquired these new pumps.
(3) To describe the extent to which suppliers reported providing
required services to Medicare beneficiaries who rented these pumps.
BACKGROUND
Negative pressure wound therapy pumps (the pumps) are portable or
stationary devices used for the treatment of ulcers or wounds that have
not responded to traditional wound treatment methods. Medicare pays
for the pumps under Part B coverage of durable medical equipment,
prosthetics, orthotics, and supplies (DMEPOS) as a capped rental item.
Between 2001 and 2007, Medicare payments for these pumps increased
583 percent, from $24 million to $164 million.
When Medicare first started covering pumps in 2001, it covered only one model, which was both manufactured and supplied by Kinetic Concepts,
Inc. (KCI). Medicare reimbursed KCI for this pump based on the
purchase price as identified by KCI. Beginning in 2005, Medicare
expanded its coverage to include several new pump models that are
manufactured by other companies. Medicare reimburses suppliers for
these new pumps based on the purchase price of the KCI pump.
This study compares the prices that suppliers paid for new pump
models to Medicare’s purchase price. Although the new pump models
currently account for a small percentage of the pump market, their
market share may grow rapidly if there is a large difference between the
amount that suppliers pay for these pumps and the amount that they
are reimbursed by Medicare. Wide profit margins may also make
pumps vulnerable to fraud, waste, and abuse.
FINDINGS
Suppliers paid an average of $3,604 for the new pump models,
compared to Medicare’s purchase price of $17,165.
Suppliers
purchased 171 of the 223 new pump models that were provided to
beneficiaries in the first half of 2007. Suppliers paid an average of$3,604 for these pumps. Medicare reimbursed suppliers for these pumps based on a purchase price of$17,165, which is more than four times the average price paid by
suppliers. On a monthly basis, Medicare reimbursed suppliers $1,716 for these pumps for the first 3 months. At this rate, suppliers recouped the average cost of a new pump model in about 2 months. Further, beneficiaries’ coinsurance
payments for pumps cover a substantial portion of the average cost of anew pump model. After just 4 months of rental, a beneficiary’scoinsurance of $1,286 covers over one-third (36 percent) of the average cost of a new pump model.
Suppliers acquired one-quarter of the new pump models byleasing, renting, or exchanging them. Suppliers acquired nearly
one-quarter (52 of 223) of the new pump models provided to
beneficiaries in the first half of 2007 through methods other than
purchasing them. They acquired these pumps through lease-to-own
agreements, daily rentals, hourly rentals, or exchanges of old pumps for
new ones. Suppliers reported not always communicating with beneficiaries’
clinicians, as required; however, they appeared to meet other
standards. Suppliers are required to communicate with the
beneficiary’s treating clinician toassess wound healing progress and to determine whether the beneficiary continues to qualify for Medicare
coverage of the pump. In addition, suppliers must meet certain
standards that include providing delivery and instruction on equipment
usage (either from the supplier or another qualified party), maintaining
and repairing the equipment as needed, and responding to beneficiaries’
questions and complaints about the equipment. Suppliers reported not
having contact with clinicians for almost one-quarter of thebeneficiaries. Suppliers reported delivering the pumps and educating
almost all of the beneficiaries, as well as providing maintenance and
repairs when needed.
RECOMMENDATIONS
Based on the findings in this report, we recommend that CMS:
Reduce Medicare’s reimbursement amount for pumps.
CMS should:
consider two methods to reduce its reimbursement amount for pumps.
CMS should:
Use its inherent reasonableness authority to reduce the reimbursement
amount for pumps. CMS should consider using its inherent
reasonableness authority to reducethe amount that it reimburses
suppliers for pumps.
•Include pumps in the second round of the the Competitive Bidding
Acquisition Program. CMS should include pumps in the second round
of the Competitive Bidding Acquisition Program. This could better
align Medicare’s reimbursement amount for pumps with the amount
that suppliers pay for the new pump models.
In addition,
CMS should: Monitor the growth of the new pump market.
CMS should continue to monitor the growth of the new pump market by tracking trends in market share among different suppliers.
Educate suppliers of new pump models on the importance of
communication with beneficiaries’ treating clinicians.
CMS should:educate suppliers of new pump models that the continued need for a
pump can be determined only through clinician input and that it isinappropriate for suppliers to submit claims for continued pump use
without this input. Follow up on the pump claims that may be inappropriate.
CMS should follow up on the claims in which suppliers: (1) reported having no
contact with the beneficiaries’ treating clinicians, (2) could not be
located, or (3) did not submit any documentation. To help CMS address this recommendation, we will forward information about these claims in
a separate memorandum.
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL
RESPONSE
CMS concurred with four of our recommendations and will consider the
remaining recommendation. It noted that it has worked on a number of
regulatory and administrative initiatives related to the prescription
Equinox Medical is just launched their smallest and lightest negative pressure wound therapy pump system in the wound care market. Halo Mini is a great alternative for any K C I wound pump when trying to win any hospital and nursing home accounts for DME and HME companies in the US.
negative Pressure wound therapy pumphalo mini faceplate
 The Halo Mini negative pressure pump system is priced for less than $3,000. Affordable and cost effective K C I wound pump alternative in the wound care market.

Dr. Kolodenker specializes in limb preservation of diabetic feet and charcot surgical reconstruction. This is a real-time video of a NPWT Pump black foam dressing change on a diabetic foot ulcer.

 

This video shows how Dr. Kolodenker specializes in limb preservation of diabetic feet and charcot surgical reconstruction. He demonstrate how to use negative pressure wound therapy pump and how to replace the black foam wound dressing.

Equinox Medical manufactures several negative pressure wound therapy and black foam dressing kits for the wound care market in the USA.

halo mini wound vacuum npwt pump system

FDA Approved Wound Dressing Kits

UNI NPWT Foam Dressing

UNI Negative Pressure Wound Therapy Foam Dressing Kit

Negative pressure wound therapy is an effective modality in advance wound care. NPWT requires less dressing changes and it’s a less painful treatment. NPWT can be used in multiple setting from acute care, long term acute care, skilled nursing to home-care. NPWT can bring positive clinical results and provide a better quality of life.

The UNI Foam Dressing Kit is design to universally work with any NPWT pump system. Our dressing can easily adapt and fit with any negative pressure wound therapy pump system.

Our foam dressings are made out of high quality reticulated polyurethane/polyethylene foam with an open pore structure (400-600 microns).  The use of our hydrophobic, hydrophilic and silver foam dressings were designed with flexible contours for deep or irregularly shaped wounds.  UNI foam dressing kits promote cellular activity and formation of granulation tissues in wounds.

The UNI foam dressings helps draw wound edges together, remove wound fluids and infectious materials. Our foam technology works actively and can easily adapt to any NPWT pump systems.

Download our Foam Dressing Brochure

UNI Black Foam Dressing(Hydrophobic)

  • Hydrophobic
  • Open-pore, reticulated
  • High tensile strength eliminates fraying and reduces contamination and infection

UNI Black foam dressing kitnew black foam dressing

 UNI White Foam Dressing(Hydrophillic)

  • Hydrophilic
  • High density
  • Ideal for tunneling and undermining wounds
  • Flexible wet or dry, minimizing damage to wound bed

white foam dressing

Indication for Use:

The UNI NPWT Foam Dressing is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through removal of excess exudate, infectious material and tissue debris.

UNI Silver Dressings

  • Silverlon antimicrobial contact layer, non-adherent  to the wound bed
  • Available for 3 days use with NPWT application
  • Accelerate wound healing and helps eliminate infection.
  • FDA K023612

Silver dressing, NPWT silver dressing, silverlon

Download Silverlon NPWT Dressing Brochure

Fed war on health care spending abuse needs to include Medicare Advantage

The Obama administration went to great lengths last week to inform us that it recovered $3.3 billion in fraudulent payments to Medicare health care providers in fiscal year 2014. Officials even went so far as to give an advance copy of their report to The Wall Street Journal, which, like the Center for Public Integrity, has been investigating Medicare fraud and abuse.

In a story that appeared in the Journal before the official release of the report, WSJ reporter Stephanie Armour wrote that the recovery “was part of an effort by the Obama administration to improve enforcement and prevent abusive billing practices.” That effort is run jointly by the Department of Health and Human Services the Justice Department.

From flickr.com/photos/68751915@N05/6629088361/: Health

 

HHS secretary Sylvia Burwell was quoted in the story as saying that “we’ve cracked down on tens of thousands of health care providers suspected of Medicare fraud,” an effort she said is helping to extend the life of the Medicare Trust Fund.

That’s good news, of course. Taxpayers benefit when doctors and other health care providers get caught trying to rip off the government.

But when it comes taking on big and well-connected insurance companies that have been ripping off the Medicare program for years, the administration has been far less aggressive in catching, much less punishing, the abusers.

As the Center for Public Integrity reported last week, officials in the Obama administration were advised as long ago as 2009 that a formula the government uses to pay private insurers that participate in the Medicare Advantage program “triggered widespread billing errors and overcharges” that waste billions of tax dollars every year.

There was no press release issued by the administration about that 2009 report; in fact, the administration buried it. The report probably never would have surfaced at all had the Center for Public Integrity not filed a Freedom of Information request seeking records going back several years regarding payments to Medicare Advantage plans.

The Medicare Advantage program is a privately run alternative to standard Medicare. Close to a third of Medicare-eligible Americans are now enrolled in insurance company-operated Medicare Advantage plans. People enrolled in these plans typically pay less out of pocket for their care–which explains their appeal–but also typically have a smaller network of providers to choose from.

As Center reporter Fred Schulte explained in his March 13 story, the federal government pays these private health plans a set monthly fee for each patient based on a formula known as a risk score. Risk scores were put in place by the government to measure the state of Medicare Advantage enrollees’ health. “Sicker patients merit higher rates than those in good health,” Schulte wrote.

Schulte’s investigation into risk score payments last year uncovered evidence that the government has been overpaying private insurers for years. That’s because the risk scores can be manipulated by insurers to make it appear that enrollees are sicker than they actually are. Just last week, the Government Accountability Office estimated that “improper payments” to Medicare Advantage plans totaled more than $12 billion in 2014 alone.

When Schulte came across the unpublished 2009 report, he asked CMS why it was never made public.

The explanation he got was preposterous. According to a CMS spokesperson, the agency wanted to publish the report but was told it was too long, that to be considered for publication on a government-run research site, it would have to be “substantially shortened.” This despite the fact that some of the reports that have been published on that site are even longer than the one on risk score manipulation.

The story gets even more incredible. The CMS spokesperson said that “given competing workload demands we were not able to revise and resubmit the article.”

I don’t doubt that the folks at CMS were especially busy in 2009. That’s the year debate began on what would eventually become Obamacare.

Equinox Medical is the fastest growing negative pressure wound therapy (NPWT) pump and black foam dressing company in the USA. FDA approved wound dressings are mandatory to use in nursing home and hospitals.

Next Generation Accountable Care Organization: A New Model From CMS

Next Generation Accountable Care Organization: A New Model From CMS

The new model will build on the experience gleaned from the existing Pioneer and Medicare Shared Savings Program models. These models permit ACOs to retain a percentage of the Medicare savings generated through their coordinated care efforts. While the existing ACO models remain available, the Next Generation initiative is based on two central features that will differentiate it from its predecessors:

  • The Next Generation model will allow an ACO to reap greater financial rewards, in exchange for assuming a larger share of financial risk, than under the Shared Savings or Pioneer models.
  • Participating ACOs will be able to offer beneficiaries significant “benefit enhancements” designed to encourage more active engagement between the ACOs and the patients they serve.

In order to support the heightened risk and reward potential, the new ACOs will feature different financial terms than are available under the previous models. Next Generation ACOs will be able to choose between the following payments models:

  • Traditional Fee-for-Service (“FFS”): Next Generation ACO providers can be paid through normal FFS channels at standard reimbursement levels, as in the standard ACO model.
  • FFS Plus a Monthly Infrastructure Payment: In addition to receiving normal FFS reimbursements, Next Generation ACOs can receive a per-beneficiary per-month (“PBPM”) payment allowing the ACO to invest in infrastructure to support its coordinated care activities. These payments will be no higher than $6 PBPM and will be recouped by CMS during reconciliation, irrespective of savings or losses realized by the ACO. In order to qualify for this payment model, an ACO will be required to maintain a financial guarantee large enough to ensure the repayment to CMS.
  • Population-Based Payments (“PBP”): This payment model provides monthly payments to ACOs to support ongoing activities and allows greater flexibility in the types of arrangements the ACO can enter into with providers. ACOs and providers will agree on a percentage reduction to FFS payments that otherwise would be made. CMS will then pay the ACO the amount by which the full FFS rates have been reduced pursuant, essentially funding ACO capital in real time through reduced FFS payments.
  • Full Capitation: Under the capitation model, CMS will estimate the total annual expenditures for the ACO’s beneficiaries and will pay that amount to the ACO in monthly installments. The ACO then assumes the responsibility for paying its providers for the services they have provided to the ACO’s beneficiaries at rates negotiated between the ACO and its providers. CMS will continue to pay normal FFS claims provided by providers and suppliers with whom the ACO does not have a capitation agreement.

The financial benchmark used to evaluate an ACO’s success in reducing health care expenditures will change as well. The Next Generation model will use a more predictable, stable benchmark that is set prospectively by CMS at the start of each performance year, rather than at the end of each year, as with the Pioneer and Shared Savings Program models. The benchmark will also be amended to reflect the concerns of ACOs under the previous models. Under those models, an ACO’s success was measured in relation to its increased efficiency compared with its past performance. ACOs have expressed concerns that this measurement system penalized ACOs that had already achieved high levels of efficiency, as it is difficult to generate significant increases in cost savings year after year. Responding to these concerns, CMS will alter the Next Generation benchmark calculation by taking into account not only an ACO’s historical performance, but also its regional and national efficiency compared to peers. This may allow historically efficient ACOs to continue to hit critical benchmarks despite decreased relative improvement over time. While the benchmark calculation methodology has been set for the first three Performance Years of the Next Generation ACO, CMS has specifically reserved the right to alter the Participation Agreement in Performance Years 4 and 5 to respond to experience acquired in the early stages of the Next Generation model’s existence.

In addition to these new financial features, the Next Generation model includes several “benefit enhancements” intended to mitigate the higher risk inherent in the Next Generation system by encouraging beneficiaries to seek higher rates of care from the ACO with which they are aligned. These “benefit enhancements” include:

  • Co-Pay Waivers: A Next Generation ACO will be permitted to reduce or even eliminate co-pays for “high-value” services, such as preventative care, in exchange for a beneficiary’s voluntary alignment with a Next Generation ACO. The reduction of such co-pays is intended to encourage more preventative care visits, which, in turn, could contribute to the reduction of health care expenditures over time.
  • Beneficiary Coordinated Care Reward: Under the Next Generation model, beneficiaries retain their freedom of provider choice, allowing them to seek care outside of the ACO network. However, beneficiaries who obtain a high rate of care from providers in the ACO with which they are aligned will become eligible for cash rewards from CMS, thereby incentivizing more active engagement by beneficiaries. These rewards are expected to equal around $50 and will be paid semi-annually.
  • Increased Coverage for Skilled Nursing Facility Care: A qualified Next Generation ACO will be exempt from the three-day inpatient stay requirement for admissions to skilled nursing facilities.
  • Telehealth Expansion: CMS will reimburse telehealth services for aligned Next Generation ACO beneficiaries regardless of where they live. This contrasts with standard payment rules, under which reimbursement for telehealth services generally is available only for beneficiaries who live in rural areas.
  • Post-Discharge Home Visits: Next Generation ACOs will also be able to offer, with “incident to” reimbursement, in-home services to beneficiaries after their discharge from an inpatient facility. Such visits will be limited to no more than one in the first ten days after discharge and one more in the twenty days thereafter.

In addition to benefitting Next Generation-aligned patients, the expansion of telehealth, SNF, and post-discharge visit coverage also provides an incentive for providers to affiliate with a Next Generation ACO in order to take advantage of these new reimbursement opportunities.

In another important shift from the previous Pioneer and Shared Savings Program models, Next Generation ACOs will be required to operate under risk-based contracts with commercial payors, in addition to governmental payors. By instituting this requirement, CMS appears to be attempting to stimulate similar cost-reduction models in the private health care insurance sector as well. This requirement, however, may be an impediment to forming a Next Generation ACO in areas where such risk-based provider contracts are less prevalent.

Due to the specifics of the new model, particularly the heightened risk ACOs will be required to assume, the Next Generation ACO will likely be most attractive to large provider organizations that have experience in delivering advanced coordinated care to specific populations. Provider groups must have a beneficiary population of over 10,000 to be eligible to qualify as a Next Generation ACO. The Shared Savings and Pioneer models require only 5,000 beneficiaries to qualify.

CMS has stated that it expects 15 to 20 providers to participate in the Next Generation model. CMS will accept applications in two rounds, on June 1, 2015 and June 1, 2016. In order to be eligible to submit an application in the first round, interested organizations must submit a Letter of Intent by May 1, 2015. Applicant organizations that are accepted into the program are expected to commence operations on January 1, 2016.

Blue Ocean Medical Products is the fastest growing FDA 510 (k) pre-market, 510 (k) submission, and fda approval consultant and pre-market medical device manufacturer in the US.

 

Pensar Medical doesn’t have the FDA approval for their foam dressing

Before purchasing or doing any business about Pensar Medical aka Accuro Medical. I suggest asking the following questions. After several searches from the FDA database. Pensar Medical is not showing any 510 (k) number for their wound dressings.

Things to ask Pensar Medical Reps before doing business with them.

1. Is a FDA K# similar to a FDA device facility number?
2.  Pensar is only allowed to export based on the their facility number registration. Why are they importing in the US.
3.  Is the Stingray pad approved by the FDA? Is there an actual 510K?
4.  How do we know, it’s safe to use the Pensar when the FDA has not even approve the Wound Pro Hydrophobic Foam Dressing kit?
5. Ask Pensar for the FDA 510K for their foam and if Pensar will provide anyone their facility registration#?  If you read closely, it’s states only for export only.
READ the fine print. The facility FDA register# is not the K# from the FDA.
Wound Pro NPWT Pump FDA recall

Smart Bandage’ To Detect Bedsores Before They Become Visible On Skin

Smart Bandage’ To Detect Bedsores Before They Become Visible On Skin

Smart Bandage
UC Berkeley engineers are developing a new “smart bandage” that uses electrical currents to detect early tissue damage from bedsores before they become visible. 

Actor Christopher Reeve died of an infection resulting from a pressure ulcer, commonly known as a bedsore, following years of paralysis. While bedsores do not commonly cause death, they affect an estimated 2.5 million Americans each year and often become difficult to treat. Now, engineers at UC Berkeley are developing a new “smart bandage” that uses electrical currents to detect early tissue damage from bedsores before they become visible — and while recovery is still possible.

“We are beginning a small clinical trial at UCSF,” Dr. Michel Maharbiz, associate professor of electrical engineering and computer sciences at UC Berkeley, told Medical Daily. If all goes well, then, smart bandages may soon be available for use.

Bedsores, which are injuries to the skin and underlying tissue, develop most often on skin that covers bony areas of the body, such as the hips and tailbone. People at risk for these pressure ulcers are those who are confined to a bed or, like Reeve, people with medical conditions requiring use of a wheelchair. The increasing prevalence of diabetes and obesity has increased the risk for bedsores, which can develop quickly and cause considerable pain and expense.

The odds of a hospital patient dying are nearly three times higher when they have pressure ulcers, according to some research.

“By the time you see signs of a bedsore on the surface of the skin, it’s usually too late,” Dr. Michael Harrison, a professor of surgery at UCSF and a co-author of the new study, said in a press statement.

Beneath the Surface

“My group had been considering ideas for monitoring the state of wounds (and maybe eventually affect wound healing) using technology for a few years,” Maharbiz told Medical Daily.

As leader of the research project, he envisioned a bandage that could detect bedsores as they are forming below the surface of the skin. To accomplish this, the research team thought about the electrical changes that occur whenever a healthy cell begins to die. Normally, a cell’s membrane is relatively impermeable and acts essentially like an insulator to the cell’s conductive contents. However, as a cell starts to die, the integrity of its walls also begin to break down, allowing electrical signals to leak out as they would from a broken resistor.

Based on this model, the researchers began the creation of a smart bandage by printing an array of electrodes onto a thin, flexible film. They found that a small current discharged between the electrodes would create a spatial map of any underlying tissue based upon electricity flows at different frequencies. (This technique involved impedance spectroscopy.)

To test their new bandage, the researchers needed a test subject, so they gently squeezed the bare skin of rats between two magnets as a way to mimic a pressure wound. After removing the magnets, resumption of normal blood flow caused inflammation and damage that accelerated cell death in the rats. Next, the researchers attached the non-invasive “smart bandage” to the skin of the injured rats. With consistency, the bandage was able to detect varying degrees of tissue damage, invisible to the human eye, across multiple animals and tracked the progress of the wounds.

For more information, watch the UC Berkeley video below:

Source: Swisher SL, Lin MC, Liao A, et al. Impedance sensing device enables early detection of pressure ulcers in vivo. Nature Communications. 2015.

Negative pressure wound therapy is a great alternative accelerated wound healing for diabetic ulcers, bed sores, venous ulcers, and post-op wounds.

TCC-EZ Casting System dramatically increases healing process of diabetic foot ulcers

Diabetics once facing the prospect of amputation to their lower limbs due to the effects of foot ulcers are now back on their feet thanks to a new technology.

Foot ulcers are common for diabetics as they often suffer from reduced sensation on the skin. Even a slightly high blood sugar level can, over time, damage some nerves – a diabetes-related issue called peripheral neuropathy.

If sensation is lost in parts of the foot, it can be difficult to know if the foot has suffered any damage. This also means it is difficult to protect small wounds by not walking on them – and the wounds can rapidly deteriorate and develop into ulcers. Foot ulcers are prone to infection and can quickly become severe and in some cases lead to amputation.

This was the case for William Hutchinson, 57, from Havant, a Type Two diabetic who has suffered from recurrent foot ulcers on both feet for a number of years and was on the verge of having to have a toe on his left foot amputated.

Mr Hutchinson said:

I have very little feeling in my feet, so any cut or nick I get on my feet can quickly turn in to an ulcer.

I attended clinics for months due to an ulcer which I had on my big toe. I was wearing an air cast walker to try and heal the ulcer, which I’d had for 13 months in total – but this caused an ulcer to develop on my other foot because I was unbalanced. I had the second ulcer for four months.

When Mr Hutchinson was referred to Solent NHS Trust’s specialist Podiatry Team at St James Hospital in Portsmouth, they suggested a very new approach – and the results were quickly evident.

Mr Hutchinson continued:

My podiatrist suggested I try a new type of total contact cast – and that I try it on both feet. I believe I was the first person in the UK to have been treated with the cast on both feet – and it worked brilliantly. I was absolutely amazed. After 12 weeks, I’ve virtually healed.

The technology is called the TCC-EZ – and is a Total Contact Casting system. Total Contact Casting is considered the gold standard of care for off-loading diabetic foot ulcers.

The TCC-EZ, from Dermasciences Europe, is a one-piece, roll-on, woven cast that can be applied in just ten minutes by the podiatrist. It works by promoting healing of the wound by minimising pressure and friction, as the TCC-EZ redistributes the weight away from the wounds, meaning it can heal even while the patient is walking.

Mr Hutchinson attended a specialist podiatry clinic at St James’ Hospital, part of Solent NHS Trust. Portsmouth Clinical Commissioning Group (CCG), which works with Solent NHS Trust as a partner organisation, has one of the highest amputation rates in the country at 4.3 per 1,000 adults with diabetes – with the neighbouring Fareham and Gosport CCG highest at 5.1 per 1,000, compared to the national average of 2.6 per 1,000.

The podiatry clinic, led by Podiatrist Advanced Practitioner Emily Sambrook, was trialling the new technology and asked Mr Hutchinson if he would like to take part – and the results were dramatic.

Emily Sambrook, Podiatrist Advanced Practitioner at Solent NHS Trust, said:

As a clinician, I’m always a little sceptical about new technologies – but the TCC-EZ is the best new technology I’ve experienced. Patients who have been seen for many months with little improvement are now healing, in some cases, within eight weeks, which is absolutely fantastic.

The TCC-EZ is an easy one-stop system– and means I don’t have to refer patients to have a plaster cast technician, at which point I might lose the patient in the system. This means I can progress a programme of care which allows the patient to follow the right routine and heal more quickly.

The system also significantly reduces the chance of amputation. We can use the TCC-EZ to dramatically increase the healing process of foot ulcers by reducing planter pressures – which typically takes many months – and results in less risk of infection. Less risk of infection ultimately means less risk of amputation.

Our patients often suffer from depression as they can’t do what they normally do and can’t see an end-goal. They will often ask how long the healing process will take. Using a traditional method, it’s very difficult to allocate a timeframe – but now I can provide an end-point based on evidence. The patients we’ve been dealing with have been amazed how quickly they are healing – and that has had a dramatic effect on their quality of life.

In just 12 weeks Mr Hutchinson went from having ulcers on both feet, with one wound at a depth of 10mm – to almost fully healed and will soon be back on his feet and out walking his dog.

Mr Hutchings continued:

I’m looking forward to getting out walking again – which is my big love. I’m pretty close to getting to that point now, which is just amazing.

“I’ve now got the correct footwear, which has been specially made, so I can get back to being outdoors – and fingers crossed, everything should be ok now.

Equinox Medical, LLC. The best leading wound care company in the united states. The company manufactures negative pressure wound therapy pumps and black foam dressing kits for diabetic ulcers, venous ulcers, and post-op wounds.

Should I buy the Pensar Medical foam dressing even if it does not have FDA approval

buyers beawareMany of the DME and HME companies in the US are familiar with the Accuro Medical Wound Pro pump. This pump was designed for gauzed dressing only. But lately, the new owner or new company Pensar have been promoting their wound pro pump with black foam dressing. The wound pro pump was off the FDA class II recall list. But their new black foam dressing kits does not have FDA approval or a FDA 510 (k) number. Anyone DME and HME companies using these kits in the wound care market are taking a major safety risk and liability.  If your company or nursing facility have been approached by Pensar Medical. Please make sure to ask the following questions.

CAN YOU PROVIDE US YOUR FDA 510 (K) NUMBER FOR STING RAY AND BLACK FOAM DRESSING KITS?

FDA recall FDA Recall

THE BLOODY PATENT BATTLE OVER A WOUND HEALING PUMP

The bloody patent battle over a healing machine


How a simple device for closing wounds made fortunes for its inventors, for its marketers, and for Wake Forest University – until rivals claimed it was too simple.


A negative-pressure wound-therapy device made by Kinetic Concepts Inc.

FORTUNE — A patent royalty is a beautiful thing. It is so much sweeter than found money because it is more than just good luck. It means that one party is paying another to use an invention. And before the lawyers got to arguing over claim constructions and prior art, before the government regulators and hospitals screamed enough was enough, and before the Russians came to Texas to explain Soviet-era library policies, there were few things more beautiful or lucrative in the world of patent royalties than the VAC.

It’s pronounced “vack” and stands for vacuum-assisted closure. Here’s what it is: You cut a piece of foam to size and place it in a wound as a barrier and protector. Then you cover the wound and seal it up. One end of a tube goes through the seal and the other goes into a small pump. The pump produces negative pressure, creating an even vacuum through the foam, and the wound is pulled together and heals. If it sounds simple, it’s because it is simple.

For much of the past 20 years this device was controlled by a San Antonio company called Kinetic Concepts Inc. The VAC transformed KCI from a second-tier medical manufacturer into a global juggernaut.

For Wake Forest University, which licensed the VAC patents to KCI, the device has meant about $500 million in royalties. Based almost entirely on the VAC deal, the university was ranked fifth by the Association of University Technology Managers in its most recent survey of licensing income, trailing only Columbia, New York University, Northwestern, and the University of California system. In recent years the KCI payments have propped up the bottom line of the university’s medical center, and the VAC money has paid for research, recruiting, and construction that probably wouldn’t have happened otherwise.

As you might imagine, all that success gave KCI and Wake Forest a powerful incentive to build a fence, to protect the patents at all cost. And it gave everybody else an equally powerful incentive to find a way through the fence.

MORE: Bad to the bone – a medical horror story

This is the story of what happens when there are billions of dollars wrapped up in a prosaic piece of technology that at its core is closer to your kid’s science-fair entry than the Human Genome Project, one that despite all the commercial success and some 4 million or so patients still has its share of doubters in the medical community. It’s a story about luck and timing and the squeezing of the health care dollar. It is about betrayal and wrangling over patents. And mostly it is about invention, the tenuous and uncertain act of breathing life into an idea that may or may not have been yours all along.

Dr. Louis Argenta says he invented the VAC, and he has the patents to prove it. He’s a plastic surgeon at Wake Forest Baptist Medical Center in Winston-Salem, N.C., but is quick to point out that he isn’t that kind of plastic surgeon. He deals with messy and nasty injuries that often can’t or won’t heal on their own. One night in the late 1980s, he was lying in bed and unable to sleep. He was reading The Gulag Archipelago and was worried about a patient who was slowly dying from an infected wound that couldn’t be closed with surgery because the stitches would make things worse. “And, just suddenly,” he would say later, “the concept of just using a giant vacuum — we had played with vacuums in the laboratory a little bit, but this was the concept of using a giant vacuum to pull this whole thing together.” He sketched a rough drawing in the margins of his book, and his wife told him to go back to sleep.



The next morning he talked to his lab manager, Michael Morykwas, a biomedical engineer, and they began working on a prototype. They tried it with success on pigs. But before they could put a device on a patient, they needed the approval of the hospital’s ethics committee, which hemmed and hawed but eventually consented. The primitive VAC, Argenta would say, saved his patient’s life.

For the next few years Argenta and Morykwas tinkered with their invention. In 1991 the university applied for a patent on their behalf and began shopping the device around. Wake Forest agreed to pay them half of any royalties, which to date has meant about $120 million apiece. But back then, getting rich seemed like a pipe dream. The leading medical journal for plastic surgery rejected a paper on their research, and there was little interest from the health care industry’s biggest players. A licensing deal was struck in 1993 with KCI, which had a business renting and selling medical beds with air chambers. It already had products that used pumps. This would be one more. The first VAC hit the market in 1995, two years before the patents were granted and any research was published.

Negative pressure is suction, and suction has long been used to drain wounds and draw infections to the surface. What’s different in wound therapy is that the pressure is maintained. Before the VAC came on the scene, the prevailing belief was that long periods of suction would damage the healthy skin that surrounds a wound.

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By 1999, KCI had built a $50-million-a-year VAC business through word of mouth, a go-go sales force, and top-notch customer service. That’s nothing to sneeze at, but it was only the beginning. In late 2000, Medicare began reimbursing for the use of the VAC, and suddenly a therapy on the fringes came with its own revenue stream as doctors used the devices to treat diabetic ulcers and pressure sores. With the government’s seal of approval, VAC revenue climbed to nearly $500 million by the end of 2003, on the way to becoming a billion-dollar product line.

That brought the money. Respect came in the field hospitals for U.S. troops in Iraq and Afghanistan.

In clinical language, the immense destruction caused by an improvised explosive device, or IED, is referred to as a high-energy soft-tissue injury. These can be devastating wounds, prone to infection and hard to close. Slight variations in healing can mean the difference in whether or where a limb is amputated. Dr. Chris Coppola operated on these wounds during two trips to Iraq. The dust and sand swirled everywhere, forcing the surgeons to use shipping containers as ORs. The VAC became such a critical part of their treatment that the medical staff pushed the military brass to give the device quick clearance for use during the airlift of wounded soldiers from the field to hospitals in Germany.

“We got our Ph.D. in the VAC over there,” Coppola says, and there is little enthusiasm in his voice when he remembers this education. Now a pediatric surgeon in Danville, Pa., Coppola has written two memoirs of his time in Iraq, and he was one of the authors of a widely circulated medical journal article on the use of the VAC for treating traumatic injuries. “Little by little we gain knowledge,” he says, “and it’s a quite sad reality that we learn more about surgery and trauma during the years of war than we do in the time between wars.”

It is not surprising that a low-tech product with such a fantastic combination of margin and mission would attract attention from competitors. Medical devices are particularly vulnerable to being copied because, unlike pharmaceuticals, the patents tend to build on previous discoveries and they don’t rely on a unique molecule. And over time, as a company fights to hold on to its patents, it is forced to draw an ever sharper line between what’s covered by the patent and what isn’t.

The first chink in KCI’s armor came in 2006, when a small company named BlueSky won the right to sell a competing product that used gauze instead of foam dressings. Other companies rushed into the market, including the British health care giant Smith & Nephew, which snatched up BlueSky and began planning a larger challenge.

Most doctors preferred foam dressings over gauze. The foam version was tested and proven, backed by years of KCI’s research. So as Smith & Nephew and others sought to break KCI’s lock, it became clear that they would need to offer foam dressings, and to do that they would have to show that the device of Lou Argenta and Mike Morykwas didn’t really deserve patent protection, that the two men may have thought they invented the VAC but had really done no such thing.

At the heart of much of patent litigation is the concept of prior art: whether earlier research or invention makes a patent invalid. It can be tricky terrain because researchers — particularly in that distant era before the web brought everything to our desktop — aren’t always aware of everything in their discipline.

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If you are a patent attorney hunting for undiscovered prior art on wound care, the place to search is Russia, which had both a tradition of innovation in this area and its own war in Afghanistan in the 1980s to push surgical advancements. That’s how, in 2008, Smith & Nephew found the research of Nail Bagaoutdinov, who had been a surgeon in Kazan, a provincial capital some 500 miles east of Moscow. In 1985 he began using negative pressure — including foam dressings — to treat infected wounds. A year later he wrote a brief paper on the results. This was the prior art that Smith & Nephew had been looking for. In late 2008 the company began selling foam-based therapy in the U.S., eager for a court fight.


Dr. Nail Bagaoutdinov began using negative pressure to treat wounds at a hospital in Kazan, Russia, in 1985.

KCI obliged, and the battle moved to a federal courtroom in San Antonio. KCI tried to exclude Bagaoutdinov’s work, arguing that the decay and disarray of the Soviet Union’s library system meant that the research fell into an abyss known as “gray literature” and didn’t qualify as prior art. Smith & Nephew countered with its own experts, including a top deputy of the Russian Federation’s Department of Libraries, flown into Houston to be deposed.

KCI lost the argument, and Bagaoutdinov’s work was allowed at trial. He testified about his research and how he had tried to get a patent, or what in the Soviet Union was called an inventor’s certificate. But he said his request was rejected because his invention too closely resembled the Bier Cup — a glass cup attached to a tiny hand pump — which has been around since the 1890s.

In March 2010 the jury rejected Smith & Nephew’s arguments and said that KCI’s patents were still valid, at least in the U.S. But eight months later the verdict was set aside. The patents, wrote Judge Royal Furgeson, were invalid based on the concept of obviousness, meaning that a person with skill in this area could have taken the existing research and arrived at the VAC. “The Bagaoutdinov references, while they may not have been easily accessible to the inventors, disclose almost all the claims asserted,” his ruling said.

KCI and Wake Forest filed a notice of appeal, and they started figuring out how to maintain market share in a new environment, one where there was no monopoly and customers knew it.

Smith & Nephew, a company with annual sales of $4.2 billion, has been a global player in bandages and wound care for years, but Thomas Dugan, the president of its North American wound-care business, said the company struggled to find traction in the negative-pressure market. “We didn’t have foam dressings. We just had gauze,” Dugan says. “We were in there, putting our feet in the water, learning a lot, getting beat up a little bit, and then as we progressed, we obviously extended our presence as we got into the foam market. And that’s what really started to open up the opportunity.”

That opportunity, the competition in pricing and products, brought growth in KCI’s VAC business to a halt. Since 2008 it has been stuck at about $1.4 billion in annual revenue. At trial, Dr. Jim Leininger, the company’s founder, grimly recited the list of customers who had already abandoned the VAC for less expensive systems. There were hospitals in Laredo, Texas, and Memphis and Nashville, and nursing homes in Texas and beyond. Each of these switches underscored the scramble among both health care providers and suppliers to protect their bottom lines.

One of the most bitter fights has taken place at San Antonio’s University Hospital, which occupies a sprawling campus just a few miles from the KCI Tower. University Hospital gets a third of its revenue from the taxpayers of Bexar County, and it is pushing hard and with considerable success to transform itself from the area’s public hospital to an institution that attracts more affluent — i.e., better insured — patients.

University was an early adopter of the VAC, but the relationship soured as costs increased. In 2009 the hospital spent $2.2 million on VAC expenses — a third more than in the previous year — at a time when it was feeling a squeeze from all directions. Moreover, it was getting little sympathy or relief from KCI.

“We were spending a lot of money, and it was becoming very expensive for the health system, these wound VACs, and we were getting direction from the C-suite that we needed to find a way to minimize the bleeding, if you will,” says Francine Crockett, the hospital’s vice president of supply-chain management.

Her team brought in another vendor, a company called Innovative Therapies Inc., which had been started in 2006 by former KCI employees. It uses a competing patent developed in Sweden in the 1970s that had languished until KCI made negative pressure a commercial success.



KCI has sued Innovative Therapies, alleging patent infringement and the violation of confidentiality and noncompete agreements. The litigation is still pending.

“This is bullyism,” says Richard Vogel, Innovative Therapies’ president. “It’s a patent that should never have been issued, because it’s anticipated by all sorts of prior art, but you have a right to that patent, and you are going to declaim loudly to the world that these are your patents, you own this space, and you are going to bully anybody and everybody into submission. And what’s more, you actually do it. You will spend tens of millions of dollars beating up on small companies and on large companies. You’ll sue customers. You’ll sue doctors. Well, after a while, people just throw up their hands and say, ‘We don’t want to have to deal with this.’ And to a large extent, that’s what happened.”

Beginning in 2010, the surgical-supply cabinets at University started carrying both KCI and ITI pumps and materials, and the upstart quickly gained a third of the business while officials evaluated the products. The hospital recently gave ITI single-vendor status for most of its operations.

Health care spending doesn’t exist in isolation, and one treatment can often prevent a more expensive expenditure at a later date. But it’s not often that providers get credits from payers for avoiding a future expense. Doctors like negative pressure because they can discharge patients sooner and don’t have to change bandages as frequently. But as Medicare’s negative-pressure payments grew from $24 million to $164 million per year between 2001 and 2007, the agency wasn’t looking only at the length of stay. It just saw an exploding line item with a huge markup. Pumps were being reimbursed at an average annual price of $17,000, about four times what suppliers paid for the equipment.

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In 2009, Medicare cut negative-pressure reimbursements by 9.5%. Now it’s rolling out competitive bidding in the industry, having companies vie for the right to sell pumps in some of the nation’s largest markets.

As part of that process, the government tried to answer some key questions. First, were foam dressings better than gauze? And second, was there any difference between the devices? KCI had claimed there were differences on both counts, with the hope of getting its own billing code — and reimbursement rate. A report commissioned for the Department of Health and Human Services said there were no differences.

But the wound healers may have bigger problems. The government’s report also contained this finding: “None of the high-quality reviews concluded that negative-pressure wound therapy provided additional benefit when compared to other interventional treatments.”

Dr. William Lineaweaver is a Mississippi plastic surgeon who specializes in burn reconstruction and is the editor of the Annals of Plastic Surgery, which 15 years ago published the first research paper on the VAC, in a sense paving the way for all that was to happen by reporting that the device promoted healing.


Expansion of the Comprehensive Cancer Center at Wake Forest’s Baptist Medical Center. The school has collected nearly $500 million in royalties on VAC patents.

Lineaweaver wasn’t the editor then, but he dismisses negative pressure as overused and unvalidated, a patient-management tool that is less about healing wounds than about cutting surgical costs. “It took advantage of the fact that reconstructive surgery has more and more to offer but is being reimbursed less and less,” Lineaweaver says.

There is plenty of evidence that negative pressure works by increasing blood flow and encouraging the formation of healthy tissue. But the research studies tend to be anecdotal, unlike the randomized trials that might be required of a drugmaker to gain FDA approval. The industry has told the government that it needs to look beyond clinical data and pay more attention to expert opinions and compelling observational studies.

In August the U.S. Court of Appeals for the Federal Circuit reversed Judge Furgeson’s invalidation ruling and sent the case back to San Antonio. The patents are still valid, for now. But KCI was by then no longer a party to that action. Instead of joining with Wake Forest in protecting the patents, as it first said it would do, the company reversed course and said the ruling from Texas — along with similar rulings in Europe — had freed it from the licensing agreement because there were no valid patents to license. Its last royalty payments, of $86 million, were in 2010. The patents expire in 2014. Wake Forest and KCI have gone to court, each accusing the other of acting in bad faith.

KCI said the university was dragging its feet on arbitration and wanted an exorbitant payout of more than $200 million for what courts here and in Europe had ruled were invalid patents. Wake Forest said KCI had abandoned its partner at a time of need, had been shorting it on payments for two years, and had timed its legal action to squeeze inside a deadline of having to pay a semiannual royalty payment of more than $40 million.

Wake Forest officials declined to be interviewed but released a short statement saying the university was pleased with the appellate court’s ruling and intended to enforce its patents against those using them without compensating the university. (Update: On Nov. 1, Smith & Nephew said it had reached a settlement with Wake Forest. The full terms weren’t disclosed, although the company’s third-quarter results and discussion with analysts suggest the agreement cut into profit by around $8 million and wouldn’t have a significant long-term impact on its wound-care business.)

John Bibb, the general counsel for KCI, says, “I wouldn’t say the relationship deteriorated so much as the strength of the patent portfolio, frankly, deteriorated. If you think about it from the context of the commercializing company, it’s hard to pay royalties for patents that have been invalidated everywhere they’ve been asserted.”

KCI was bought in 2011 for $6.3 billion by a private equity firm, Apax Partners, along with two Canadian pension funds, an arrangement that gives it the ability to retool and reinvest out of the glare of Wall Street. Shortly after the deal closed, Apax moved in a new management team, replacing KCI’s chief executive and the head of its global VAC business. Joe Woody, the new chief executive, spent six years at Smith & Nephew and was one of the architects of the company’s assault on KCI’s dominance. He says that despite that history, he’s gotten a warm reception as he repositions KCI to move past the days of product exclusivity. That means cutting costs, being sensitive to price, and keeping the focus on innovation and customer service as the company tries to grow here and abroad, where diabetes and related circulation problems are surging.

“The competitive environment is much like any other medical device company would face now that we have patents that are invalidated and we are in a different market position,” Woody says.

With all that’s happened, including shifts in a legal position that had been at the core of KCI’s corporate culture, I asked Woody and Bibb whether the Wake Forest patents should have ever been granted by the U.S. Patent Office. The line went quiet, and after an awkward period of silence, a spokesman said it was a speculative question and time to move on.

Not that long ago, an MIT student came out with a prototype for a hand-powered negative-pressure pump that she said could sell for $3 and be a boon in the developing world, where most people can’t afford the Cadillac-priced products of Western health care. Perhaps unsurprisingly, amid the praise for her resourcefulness was ridicule that she had done little more than cobble together a device from products found at a hardware store.

That’s the argument used against the VAC, and it both misses and is exactly the point. Maybe the VAC was there all along, just waiting to be found. But somebody had to find it and — more to the point — claim ownership. The patents gave the idea value, and the value helped create a market, and the market created fortunes. KCI’s founder, Jim Leininger, is a billionaire. Lou Argenta and Mike Morykwas have split about $250 million in royalties, and Wake Forest’s portion has helped build its campus and its reputation. And then there is one more inventor, a Kansas doctor named David Zamierowski, who received more than $200 million from KCI. His patents on the use of negative pressure predated the VAC and were licensed in part as a precaution, just to be safe — a fence around the fence.

Nail Bagaoutdinov never got inside that fence. He just helped tear it down. For his time, Smith & Nephew paid him $350 an hour, far less than the million-dollar bonus he originally sought.

He left Russia in 1995 and emigrated to the U.S., where he learned English so he could continue to practice medicine. Like many doctors born overseas, he now works in rural America, rotating through emergency rooms in eastern Kentucky. When we talked, he had just come off a night shift and apologized for being tired.

There was no bitterness in his voice about what might have been, and he said he was surprised when his work became the central piece of evidence in patent trials around the world.

“Negative pressure, it’s not complicated,” he said.

Bagaoutdinov doesn’t claim to be the inventor of the VAC. To this day he has never used one. His device was a much cruder affair. He said he thought he had come up with something new, but there was no way to know for sure. At the time, he was just a surgeon at Kazan City Hospital No. 8 and was unable to take his idea to the next step.