The Chronic Wounds: Money-spinner!

Confined to a wheelchair with diabetes, 53-year-old Mncedisi* battled one of the most daunting complications associated with diabetes; limb amputations, which added to her other stubborn wounds.

For many years, Mncedisi fought diabetes, one of the top leading cause of natural deaths in South Africa. In that time, she lost her legs, an arm and independence.

In December Mncedisi lay on the hospital bed wracked with pain and despondent. When the Statistician General releases deaths data for 2016, Mncedisi’s death will tally under diabetes.

Conditions associated with chronic wounds are a common factor in the top underlying causes of natural deaths. The problem could spiral out of control due to the increasing number of people ailing from non-communicable diseases, yet it has not received enough prominence.

There is no firm data on the cost of managing chronic wounds in South Africa. But, the more than R250 million claimed from medical insurance providers in 2016, points to a base number.

Wound care has become a lucrative business venture for some medical device companies and easy prey for corruptible practitioners.

This new series shall examine the costs and associated burdens of improper clinical and medical practices; ‘snake-oil’ suppliers to surgeons who are too fast and reckless with their scalpels. In memory of Mncedisi, we start the series with the wounds situation in South Africa’s private sector.

Wound care is largely led by unsupervised nurses. What happens when nurses meet patients like Mncedisi with complicated, stubborn wounds? Ideally, they would ask wounds specialists or doctors for help.

Unfortunately, South Africa’s medical schools aren’t teaching enough about chronic wounds. A 2010 survey by Dr JF Coetzee concluded; “Very little if any training on chronic wounds is offered in South Africa.” Students and practitioners interviewed for the survey confessed to not having adequate knowledge on the subject, including effective wound care products.

The science and art of wound healing has advanced since the Florence Nightingale era of bandages and gauzes. Today there are innovative ‘plug-and-go’ devices, special bandages and sprays in the market.

The biggest wound care money-spinner is the VAC (vacuum-assisted closure). Invented in 1991 by Wake Forest University researchers, Louis C. Argenta and Michael J. Morykwas, the patent for VAC was assigned to the American university.

When the university’s bid to tap big medical manufacturers as buyers or licensees failed, it turned to a little-known Kinetic Concept Inc. (KCI). As the licensee, KCI obtained pre-market approval for VAC from the US Food and Drugs Administration in 1995. In 2002, KCI – now a global wound healing technology corporation - got confirmation for a general market release of the product.

uSpiked turned to journalist Ken Otterbourg for the best lay description of how VAC works.

Otterbourg wrote in Fortune Magazine; “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.”

The VAC technology helped KCI and West Forest University make their mark on the maps of medical device manufacturing and technological research, respectively.

KCI raked in hundreds of millions of dollars in VAC sales. In the 2000s, the product became a hit in battlefield hospitals of Iraq and Afghanistan. Every medical device company wanted a piece of the cake.

As the VAC technology continued to gain market traction, competing devices popped up. One early competitor was healthcare equipment and supplies company, BlueSky whose device used gauzes instead of the KCI’s foams.

Also joining the fray for the lucrative market was British healthcare giant Smith & Nephew that opted to acquire BlueSky and its gauze device.

But there was one problem; customers/doctors preferred the KCI’s foam version. Smith & Nephew started making foam-based devices thereby sparking a patent war with KCI.

Bruised financially by the legal patent claims fights, West Forest University, KCI and Smith& Nephew reached multi-million dollars settlements that ultimately opened up the market in 2014 on the expiry of West Forest assigned patent.

However, it would take more than an excellent product to capture sizable market share. Companies that intimately knew how to ‘leverage’ medical practitioners to routinely and exclusively prescribe their products to patients stood the best chance of success.

This is the state of the business of Negative Pressure Wound Therapy (NPWT) devices, and indeed the entire pharmaceutical industry – companies notoriously grease the palms of medical practitioners in kind and in cash to promote and prescribe specific pharmaceutical products.

The consequences are grave for many patients and medical insurance funds globally.

In 2015, Business Insider revealed how America drug manufacturers spent almost $20 million during the last five months of 2013 trying to convince physicians and teaching hospitals to give their freshly-patented drugs to patients, “many of them near-copies of existing drugs that treat the same conditions.”

Non-profit investigative journalism publication, ProPublica, tracked conflicts of interest in medicine in the US and produced the Dollars for Docs database.

In December 2016, ProPublica updated the database with new data made available through a new law requiring pharmaceutical and medical device companies to release details of their payments to doctors and teaching hospitals. Between 2013 and 2015, the industry spent $6.2 billion on promotional talks, research and consulting.

Three companies associated with Negative Pressure Wound Therapy devices spent $584,000 of the $6.2 billion on doctors and teaching hospitals. The three companies were Smith & Nephew, Inc. ($505,000), KCI USA ($72,561) and Medela Inc. ($6,168).

In South Africa, the approach for capturing wound care ‘clients’ has a twist.

Firstly, there’s no law requiring pharmaceutical and medical device companies to disclose ‘marketing’ spend on practitioners. Secondly, benefiting medical practitioners certainly won’t talk about such payments publicly.

The three big suppliers of NPWT devices in South Africa are Smith & Nephew, Equity Medical Technology (a business unit of Clinigen SA) and Systagenix Wound Management SA (Pty) Ltd (an Acelity Company – subsidiary of KCI).

Due to the education inadequacies found by Dr Coetzee’s survey, it made economic sense for the suppliers to pursue private nurses for new businesses. The ‘incentives’ to nurses (the primary wound carers) are well-hidden, but our team gained valuable insight from analysing various data.

Are NPWT devices overrated and overprescribed?

For answers, we turned to Cochrane, a respected database of systematic reviews in health care. The reviews on NPWT are worrying.

On the usage of NPWT for the treatment of leg ulcers, Cochrane reviewers concluded; “There is limited rigorous RCT evidence available concerning the clinical effectiveness of NPWT in treatment of leg ulcers…” 

On the treatment of partial-thickness burns, the authors concluded; “There was not enough evidence available to permit any conclusion to be drawn regarding the use of NPWT…”

Reviewers reached similar conclusions for the same device treating other kinds of wounds.

The only favourably reviewed NPWT’s usage is on foot wounds caused by diabetes mellitus. The authors concluded, “There is some evidence to suggest that negative pressure wound therapy is more effective in healing post-operative foot wounds and ulcers of the foot in people with DM compared with a moist wound dressing.” But, some caution from the reviewers: “These findings are uncertain due to the possible risk of bias in the original studies.”

Despite the reservations raised by Cochrane reviewers, it has been business as never before for contracted private nurses and suppliers of NPWT devices.

We examined a partially signed agreement that KCI’s South African subsidiary is circulating among private nurses in its marketing campaign. Working on figures contained in the agreement and data provided by a source from a leading medical scheme company, we can reveal that some nurses can earn up to R1,600 per week per wound. Top earning nurses draw as much as R60,000 a month for treating wounds using NPWT devices.

Comparative costs of wound healing systems

One of the things that appeal to nurses in these deals is that they do not have to submit any individual claims to the medical insurance companies. The device suppliers take this role and motivate health insurers to pay for the services rendered to their members by the contracted nurses.

How a typical NPWT scheme works

A private nurse would be called to assess the wound(s) on the patient. The assessment includes taking pictures of the wound and confirming that the patient has medical insurance. The next stage involves introducing the patient to NPWT and signing them up.

Then there is the issue of the signing of an ‘Informed Consent Form’. Patients in pain from chronic wounds would sign up for anything that promises relief.

At this point, the nurse would start the NPWT ‘treatment’ consuming at least a device a week. Every change of dressing or devices is logged and invoiced directly to the respective device maker.

For assessment, KCI-contracted nurses are allowed to render accounts of R185 for assessments and R430 per dressing/device. When submitting their Invoices to KCI, all the contracted nurses have to include photos showing measurements of the wounds, assessment reports, and photos of the devices “clearly showing the serial number”.

Depending on the number of dressings a week, (a decision that is at the respective private nurses’ discretion), and based on the number of wounds on the patient’s body, some nurses would make a tidy sum of money from NPWT; no wonder very few of the nurses would be keen to talk about any other options to their patients.

KCI's 2017 contracted fees for private nurse practitioners

The South African device suppliers would pay the nurses from their own pockets and then approach the medical insurance providers with their own claims.

According to data pulled together by our team, claims of up to R3,000 per wound per week are submitted to insurance providers for wound dressings done using NPWT. With an average of one dressing per week (more for serious cases), the device suppliers can claim up to R12,000 a month per wound. And with tens of thousands of wounds across the country, the monthly wounds’ claims must be enough to keep the insurance companies very busy through the year.

In 2016, more than R250 million was claimed from medical insurance providers. Smith & Nephew collected the lion’s share – some R150 million, according to estimates by industry insiders. The money is shared with the contracted private nurses.

Medical insurance companies, we are informed, aren’t taking the financial haemorrhage lying down and are considering ways of stopping the leakages. One such means is a requirement that is presently under consideration by top providers requiring a medical doctor to sign off on all assessments recommending NPWT provided by nurses. That could work, but every time a doctor examines a wound an account would be rendered to the insurance provider - a costly exercise, one would imagine. But at least unnecessary deployments of NPWT devices would be reduced.

We contacted the South African Nursing Council and the Society of the Private Nurse Practitioners of South Africa to ask about the possible inducements of their members to recommend or exclusively use a specific supplier’s devices, and how they deal with such cases. The two organisations did not respond to our repeated inquiries.

The nursing Code of Ethics requires nurses to do good, choose the “best option” of care under given circumstances and act with kindness at all times. Nurses are also expected to respect the autonomy of patients “to make their own decisions and choices in matters affecting their health.”

The fraternity would rather ignore their own code of ethics.

We have documented cases of certain private nurses pressurising patients to accept the NPWT and deliberately omitting to provide options of affordable products such as Drawtex. Patented in South Africa, Drawtex would cost patients and medical schemes about R100 per dressing.

The nursing council has left desperate patients at the mercy of unethical nurses. The oversight ball is now in the courts of patients – before signing the informed consent form, ask for more information about all other treatment options and demand answers.

The upcoming reports in this series will reveal:

• the identities of the top-earning private nurses working with predatory suppliers of NPWT devices
• the NPWT treatments that failed patients, including cases of patients who should not have been put on NPWT in the first place
• how nurses deal with clients whose medical insurance savings get depleted before their wounds are healed.

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