Thursday, February 16, 2017

FDA Recommendations on Food Safety for People with Cancer

Food safety is important for everyone – but it’s especially important for those with cancer. That’s why the U.S. Department of Agriculture’s Food Safety and Inspection Service and the U.S. Department of Health and Human Services’ Food and Drug Administration have prepared a booklet of recommendations. It is designed to provide practical guidance on how to reduce your risk of foodborne illness. In addition to this guide, we encourage you to check with your physician or health care provider to identify foods and other products that you should avoid. Click the link below to view the booklet PDF.1

http://www.fda.gov/downloads/Food/FoodborneIllnessContaminants/UCM312761.pdf

"Anorexia, cachexia and tumors are common causes of malnutrition in cancer patients.
  • Anorexia (the loss of appetite or desire to eat) is a common symptom in people with cancer. Anorexia may occur early in the disease or later, when the tumor grows and spreads. Some patients may have anorexia when they are diagnosed with cancer. Almost all patients who have widespread cancer will develop anorexia. Anorexia is the most common cause of malnutrition in cancer patients.
  • Cachexia is a wasting syndrome that causes weakness and a loss of weight, fat and muscle. Anorexia and cachexia often occur together. Cachexia can occur in people who are eating enough, but who cannot absorb the nutrients. Cachexia is not related to the tumor size, type, or extent. Cancer cachexia is not the same as starvation. A healthy person's body can adjust to starvation by slowing down its use of nutrients, but in cancer patients, the body does not make this adjustment.
  • Tumors may produce chemicals that change the way the body uses certain nutrients. The body's use of protein, carbohydrates, and fat may be affected, especially by tumors of the stomach or intestines. A patient may appear to be eating enough, but the body may not be able to absorb all the nutrients from the food. Diets higher in protein and calories can help correct this and prevent the onset of cachexia. It is important to monitor nutrition early, as cachexia is difficult to completely reverse."2
References:
1.  U.S. Department of Health and Human Services. US Food and Drug Administration. Food Safety for People with Cancer. http://www.fda.gov/Food/FoodborneIllnessContaminants/PeopleAtRisk/ucm312565.htm. Accessed Feb 16, 2017.
 
2.  Mount Sinai Medical Center. Nutrition in Cancer Care. https://www.msccc.com/cancer-resources/nutrition-in-cancer-care. Accessed Feb 16, 2017.

Friday, January 20, 2017

The engineer who fixed his own heart

 
Image courtesy of © Dave Imms 
 
When Tal Golesworthy was told he was at risk of his aorta bursting, he wasn’t impressed with the surgery on offer – so he came up with his own idea. By Geoff Watts.

Lunchtime at a small medical engineering company in Tewkesbury. The entertainment thoughtfully laid on to garnish our sandwiches is a colourful video: a neat bit of cardiovascular surgery featuring someone’s heart and blood vessels.

Someone? Well, not quite anyone. The exposed and beating heart at which we’re gazing belongs to one of my dining companions. Tal Golesworthy, 60, is balding, quick-talking and often outspoken. He’s also – a clue here – tall, with unusually long fingers.

Getting on for 15 years ago Golesworthy learned that unless he was prepared to undergo major surgery on one of the vessels carrying blood away from his heart, he faced an increasing risk of premature death. He didn’t relish the prospect of an operation; but even more upsetting was the knowledge of what this particular procedure would involve.

Golesworthy is neither a doctor nor any kind of medical researcher. He’s an engineer. But with characteristic self-belief he reckoned he could devise a simpler and safer way of fixing his problem. And he did. He then persuaded a surgeon to take him seriously, became the guinea pig for the first operation, and now runs a company set up to manufacture implants like the one buried in his own chest. It’s been there for a decade, and it’s keeping him alive.

Golesworthy’s experience is notable for his persistence and single-minded determination. But there’s more to it than that. It raises questions about innovation in surgery, the acceptance of new procedures and the research required to test them. And it flags up the likelihood that other patients with other diseases are harbouring similarly ingenious or radical ideas.

 Tal Golesworthy has Marfan syndrome. The man memorialised by this name, Antoine Bernard-Jean Marfan, was a Paris paediatrician. In an 1896 case presentation he described a five-year-old girl with unusually long limbs, fingers and toes. It was not Marfan himself who named the condition, but one of his successors. Paradoxically, it is not even certain that the girl really was suffering from what now constitutes Marfan syndrome – but the name stuck.

The disorder is genetic in origin, either by inheritance or by spontaneous mutation. Besides their long, slender bones – and so their unusual height – people with the syndrome may have loose and flexible joints and various eye problems. The ultimate cause of all this is an error in the genes responsible for a protein called fibrillin, an essential component of the elastic fibres found in, among other tissues, the blood vessels. And this accounts for one of the biggest threats that Marfan syndrome presents to Tal Golesworthy and his fellow sufferers. The abnormality leaves one of their major vessels weakened and less able to cope with the strain imposed upon it by the pressure of the blood within.

One of the body’s biggest arteries, the aorta, receives blood straight from the left ventricle of the heart. The blood arrives not in a steady stream but in pulses. The aorta acts as a kind of hydraulic shock absorber, successively expanding and contracting as the pressure within it rises and falls. Any weakness in the wall of the aorta can allow the development of a balloon-like bulge, an aneurysm. For whatever reason, the weakest point of the aorta in people with Marfan syndrome is its root, the section adjacent to the valves guarding the exit from the left ventricle. If an aneurysm ruptures, the consequent internal bleeding is potentially fatal.

Golesworthy was five or six when he learned that he had Marfan syndrome. His father also had it. “He was 6 foot 8 inches and had very poor visual acuity,” Golesworthy recalls. But doctors then seem to have been less aware of the hazards of the condition. Golesworthy himself had no idea of its implications for his aorta until he was in his 30s. By then the blood vessel was already enlarged – and it was then he was told of the need for surgery.

Introduced in 1968 and reliant on a heart–lung machine temporarily to maintain the flow of blood around the body, the standard operation involves the removal of the first and weakest section of the aorta along with the adjacent heart valves. The surgeon then replaces the aorta with a length of stiff tubing made of the polyester Dacron, and the natural valves with mechanical ones.

The drawback is that mechanical valves are apt to generate blood clots. Lifelong anticoagulant drug treatment minimises this risk of an embolism, but creates hazards of its own. Users are at increased risk in any illness or injury that causes bleeding. “You’re constantly walking a tightrope between an embolism and a bleed,” Golesworthy explains.

To say he was unenthusiastic would be an understatement. “I wasn’t desperately keen on the idea of surgery,” he confides, “but what really distressed me was the thought of life on anticoagulant drugs.”

Although he didn’t know it at the time, surgeons had devised a version of the operation in which the patient’s own valves are left in place, so avoiding the need for anticoagulants. Problem solved? It seems not. Although this operation is also effective, it has a higher long-term failure rate. So here’s the choice: a good success rate at the price of lifelong anticoagulants; or avoid anticoagulants but face a greater chance of having to go through the whole procedure again.

Golesworthy doesn’t know why he wasn’t offered the alternative operation, but suspects it had more to do with the subjective preferences of individual surgeons than with hard data. Either way, he’d already begun to wonder if there might be a third way: one better than either of the two on offer.

Golesworthy saw the aortic weakness with the eyes not of a doctor but of an engineer. Why replace failing pipework, he asked himself, when it would be simpler to shore up what’s already there? “I said to myself, hang on, we can scan the aorta, we can use CAD [computer-aided design], we can produce a totally bespoke support. We can do this.”

If there were such a thing as an engineering gene, you could be confident that Golesworthy had inherited it. His father was an aeronautical engineer. “As soon as I could walk I’d pick up a screwdriver and start taking things apart. I had the back off the telly when I was about six.”

Personalised external aortic root support
Image courtesy of © Dave Imms

Golesworthy achieved his chartered engineering status the hard way. He began by studying materials science but didn’t like the course, dropped out, joined the Coal Research Establishment and discovered part-time education. “I couldn’t get engaged with university,” he says. He worked on a variety of topics from process chemistry to air pollution control; he became familiar with all sorts of instruments and technologies, including the use of textiles in fabric filters.

Golesworthy’s inspiration for his surgical invention grew out of a basic plumbing remedy for a leaking pipe: wrap something round it. This simple ploy had already occurred to surgeons, but they’d used stiff materials; when in place these tend to move out of position or cut into side vessels branching off the aorta.

Golesworthy had no idea that surgeons had already tried and abandoned the wrapping idea. In any case the engineer in him rejected it, too. “You look at the shape [of the aorta] and know you’ve got to apply a uniform force over the entire thing. How can you get that by wrapping it?” Instead, he envisaged something more sophisticated: an external, made-to-measure covering, a sleeve that would prevent the aorta’s dangerous ballooning. In due course the procedure acquired a fancy name: PEARS, standing for ‘personalised external aortic root support’.

His proposal was to use a CT scanner to plot the three-dimensional shape of the aortic root. With the right computer software, rapid-prototyping technology (3D printing) could then be used to make a life-sized model of the vessel. This would serve as a former on which to make an individualised textile sleeve of the shape and size to fit around the aorta and prevent its further expansion. And not a stiff sleeve, but a soft, pliable, knitted, porous mesh. In opting for this, Golesworthy was able to call on the knowledge he’d acquired through using textiles as filters during his coal industry days.

But there was still a hurdle: how do you launch a medical innovation if you’re an engineer with no professional involvement in healthcare? Golesworthy decided to make his pitch during one of the Marfan Association’s annual information meetings for patients about 15 years ago. One of the speakers was Tom Treasure. Now attached to the Clinical Operational Research Unit at University College London, a group that seeks practical solutions to problems in clinical medicine, Treasure was then a practising cardiothoracic surgeon.

Treasure recalls how Golesworthy approached him at the end of his lecture.

“Now then, Professor, about all this cutting out,” he said. “You ought to get up to date and use a bit of CAD modelling.” Treasure had no idea what Golesworthy was talking about. “Tal was using engineering jargon. ‘We can do RP,’ Tal told me. I hadn’t a clue then what rapid prototyping was.” But Treasure was intrigued. In subsequent conversations he began to understand and thought it had the makings of a good idea. “I’ll give this man the best hearing I can,” he decided.

He did, and the idea started to acquire momentum. “All credit to Tom,” says Golesworthy. “He opened the doors to the medical world, and away we went.”

Treasure was not in a position to perform the pioneering operation himself, so the next task was to find a surgeon who could do it. As he was well aware, many surgeons would simply have rubbished the proposed new technique. In fact many did, and even now some remain to be convinced. Treasure approached John Pepper, a professor of cardiothoracic surgery in the National Heart and Lung Institute at Imperial College London: someone else Treasure describes as “prepared to buck the trend”. Pepper’s response was positive.

I arrange to meet Pepper at the Royal Brompton Hospital. He turns out to be a solidly built man, jovial and friendly, but with the decisive manner you might expect of one of the UK’s leading heart surgeons. Coming himself from an engineering family, he clearly admires the profession that, by entering medicine, he chose not to follow. “We live in different worlds. Engineers are interested in everything down to a ten-thousandth [of an inch]. In biology we’re nowhere near that kind of precision.” It’s not surprising that he too had been quick to see the virtues of creating a model of the patent’s aorta and fashioning a made-to-measure support. “It needed an engineer to tell us poor doctors how to do things,” he says.

There was still the problem of money. Having failed to attract support from one of the big heart charities, Golesworthy was beginning to feel under pressure. He was still reluctant to undergo conventional surgery, but his aorta was in escalating need of repair. In the end he raised the money by starting a company called Exstent Ltd to look for investors. He had only one customer in mind at this point – himself.

Because he lacked the necessary CAD skills, he also sought the help of engineers at Imperial College London. “When you’re as motivated as I was, you make things happen. If you’ve got to blag your way in, you blag your way in… My aorta was dilating and I had to get on with it.”

Image courtesy of © Dave Imms 

Tal Golesworthy is not, of course, the first person with an illness to have devised a new and better way of coping. Some patient associations have cottoned on to this and do their best to spread the word. What we’ve lacked is a central repository for all such ideas. No longer.

Patient Innovation is a website set up by a group at the Católica Lisbon School of Business and Economics. It allows patients who’ve developed their own solutions for their illnesses to share what they’ve learned or invented. The project leader is Pedro Oliveira. His original interest was in user innovation generally: the part that people who use products and services can play in developing new strategies and procedures.

“What we found in our research was that patients often developed amazing devices and strategies,” says Oliveira. “But we also found that this information often doesn’t diffuse. Their main aim is to fix their own problems, not to help others.” Even if the thought of spreading the word does cross their minds, they don’t usually know how to go about it.

Oliveira and his colleagues launched Patient Innovation in February 2014, and he tells me they have received over 1,200 independent submissions. A medical team screen them all; about half have been judged worth putting on the website.

Golesworthy was among the invited speakers at Patient Innovation’s inaugural meeting, and has since been selected for one of its annual awards. Another has gone to Louis Plante, a 26-year-old Canadian with cystic fibrosis. His idea was for a hand-held acoustic device to aid airway drainage.

The lungs of people with cystic fibrosis tend to produce a large amount of thick mucus, and various methods have been devised for moving or dislodging it to allow it to be coughed up. While sitting close to the large speakers at a rock concert Plante began coughing. He wondered if it might have been induced by mucus dislodged as a consequence of low-frequency vibrations in his chest. An electronics technician by trade, he devised a machine for simulating this effect. It worked. He used his own knowledge to ease his own problem – and then commercialised it.

Other awards have been given for a sensor that sends signals to a mobile phone when an ostomy bag is full, for a walking stick for blind people that can separately detect objects at head, waist and foot level, and for foldable wheels to make wheelchairs more easily portable. How many other such ingenious ideas might there be, similarly ripe for dissemination?

By 2004, Golesworthy had convinced investors to part with enough money, and the remaining wrinkles in the manufacturing process had been ironed out. It was time to go into the operating theatre.

“I always said I’d be the first patient,” Golesworthy recalls. “Then I was persuaded that I should stand there in the theatre with the surgeon, John Pepper, in case there were any hiccups. But the guy we had lined up dropped out at the last minute.” So Golesworthy had his way; he was after all to be the guinea pig.

Although pleased to be patient number one, Golesworthy did not enjoy his ten-day wait for the operation. “I was absolutely beside myself. I couldn’t concentrate, I couldn’t work, I couldn’t eat, I was totally agitated. It was awful.” What he found unnerving was the prospect of surgery per se; in the sleeve itself he had total confidence. Fully justified, as things turned out.

When I asked Golesworthy if I could pay a visit to the company’s premises in Tewkesbury where the implants are made, he pointed out that there was virtually nothing to see. He was right. It’s even less exciting than our lunchtime sandwiches. All I can do is peer through the glass panels of the clean room where the implants are made – by Golesworthy himself.

Each is cut from a sheet of polyethylene terephthalate, a thermoplastic polymer resin chemically similar to Dacron but woven into a soft textile. About the size of a large sausage, though slightly longer and fatter, the shape is created by wrapping the textile round its customised former, and completed with a seam up one side – which the surgeon unpicks in the theatre and resews once the sleeve is in place round the aorta. It takes Golesworthy about a day to make a couple of them, and it’s quite fiddly. Although the device is protected by patent, he remains coy about the detail of making them. There is, perhaps, an element of craft skill in the process.

The sleeve – it goes by the trade name ExoVasc – arrives in the operating theatre wrapped on its former. When it is in place around the aorta the surgeon secures it by sewing up its single axial seam. Quicker, simpler, safer – and with no need to interrupt normal blood flow.

Thinking back to that first operation, Pepper says he was 95 per cent confident that the procedure would succeed. “Of course,” he says, “I’d discussed it with the patient.” He then laughs, reflecting on the absurdity of discussing the pros and cons of the implant with the man who’d invented it.

Up until this point Golesworthy had been focused on fixing his own problem. “Once I’d sorted myself out,” he says, “I thought, now I can help others.” Had Golesworthy’s implant failed, the company he’d set up would have been left mired in debt. Even success has been hard work: “It’s becoming a viable business. But from 2004 to about 2014 we were doing risible numbers of patients and struggling to survive… If I had my time again I doubt I’d do it,” he admits.

Thus far the results of PEARS have been impressive. The procedure is quicker than either variant of the conventional surgery and requires no interruption of the patient’s own blood circulation.
Of the two variants of the conventional operation, the one involving removal of the natural heart valves is more durable – but the combined risk of a bleed or thromboembolism created by the lifelong need for anticoagulant drugs comes out at an annual 0.7 per cent. That doesn’t sound too bad – until you realise that a patient who lives for 40 years after the operation faces a more worrisome overall risk of around one in four. The valve-sparing variant does not require anticoagulant drugs, but is less durable. The annual reoperation rate appears to be 1.3 per cent, so if the patient lives for 40 years the overall risk would be more than two in five.

An early study showed that the textile sleeve does indeed halt the progressive and dangerous expansion of the aortic root. A 2013 analysis of the first 34 patients, with periods since surgery of between 3 and 103 months, revealed no problems with the vessel. One patient died, but this was unrelated to the procedure itself.

Contrary to earlier fears, the sleeve stays exactly where it’s placed. Moreover, the findings of an autopsy carried out on one patient five years after surgery revealed that it seems to become incorporated within the wall of the vessel, which is consequently more robust. The pathologist compared the appearance of the section of the aorta within the sleeve with an adjacent region lying outside it, says Pepper. “The part inside looked normal… Maybe by taking some of the strain off the aorta we were allowing healing to take place.” For the present, though, this tantalising prospect is still speculative.

Model Heart
Image courtesy of © Dave Imms 

The process by which surgeons in Britain develop new procedures and decide to adopt them is less clear-cut than that for dealing with new drugs. But the state of near anarchy that once prevailed has given way to regulation by hospital ethics committees, and to a set of guidelines and protocols issued by the Royal College of Surgeons. A company wishing to evaluate a new device by clinical trial must also seek formal approval from the Medicines and Healthcare Products Regulatory Agency (MHRA). Exstent did this early in the history of the PEARS project. For routine use inside the NHS, a device or procedure then has to pass scrutiny by the National Institute for Health and Care Excellence (NICE). Its guidance on PEARS, issued in 2011, was cautiously welcoming – subject, naturally, to the accumulation of further evidence.

As Pepper and Treasure are both aware, the ideal proof of the value of PEARS would be a randomised controlled trial (RCT). These are always difficult in surgery; individual surgeons may differ in the skill with which they perform the same operation, for example. “Tom Treasure and I have discussed this in detail and consulted people at two randomised trial centres,” says Pepper. “We feel it [an RCT] is not feasible.” For reasons that include the relative rarity of Marfan syndrome and the difficulty of finding equally skilled surgeons for all three procedures, this ‘gold standard’ is unlikely to be met. All that Treasure and Pepper can do is encourage surgeons to follow-up their patients and report what they find. “We did patient number 76 yesterday,” Pepper tells me. “My plan is that when we get 100 patients we’ll go back through them all very carefully and report.”
In spite of the evidence of benefit already to hand, gaining acceptance for PEARS has not been easy. Why? Some surgeons are still rejecting it without really listening, according to Pepper. “They don’t recognise the advantages of computer-aided design and rapid prototyping. They think it’s just another old wrap that didn’t work then and probably won’t work now.”

Prompted in part by this initially negative response, Treasure has looked back to other surgical innovations. His broad conclusion is that surgeons will take on a new idea when there is no existing remedy for a problem. But when there is already a solution to hand – a procedure that may have taken years to devise and many more to perfect – they are less than receptive to the claims of an alternative approach that will mean revising or even abandoning a hard-won skill. If the alternative appears simpler and easier, says Treasure, they’re even more sceptical. But as far as PEARS is concerned, he thinks the tide of opinion is turning.

Surprisingly, for a man dependent on winning the support of surgeons, Golesworthy is less than flattering about many of them. “Arrogant, closed-minded, blinkered by their monopoly of knowledge,” he says. He wouldn’t, of course, be the first person to suggest that surgeons often display a powerful ego. And before dismissing Golesworthy’s complaints, it’s worth noting that Treasure, while speaking in more measured terms, endorses some of them. “We’ve been to meeting after meeting, and people say the same untruths. They haven’t read the papers, they often don’t listen to what you say.”

Pepper too is well aware of Golesworthy’s occasionally disparaging comments about surgeons, but seems to find them more amusing than annoying. And not only because he and Treasure are specifically excluded, but also because he feels that Golesworthy doesn’t fully accept the world we live in: a world that breeds extreme caution. “We are absolutely obsessed by safety, and that’s like motherhood and apple pie. You can’t be against it,” he says, growing progressively more animated by his own argument. “We are fantastically risk averse, and yet the public wants to see new treatments.” Risk aversion among his fellow professionals, he insists, has been fuelled by the publication of individual surgeons’ personal results – with a consequent erosion of willingness to take on difficult cases in which the likelihood of failure is inevitably higher.

Paradoxically – and boastfully but possibly also accurately – Golesworthy reckons that his personal presentation of the procedure is one factor that can change surgeons’ minds about PEARS. He speaks with the conviction born of being what he is: part of the literally living proof of PEARS. “He has a passion for it,” adds Pepper. “And to make anything work you have to have a passion.”

The relatively high cost of the sleeve makes the initial operation more expensive. But through shorter operating times and, in the longer term, the elimination of routine drug treatment and associated medical checks, and a reduced likelihood of repeat operations, PEARS should save money.

The patient numbers are creeping up. Last year 17 underwent the procedure; this year it will be over 20. It will be a while yet before the implant repays all the investment, but Golesworthy is optimistic. “It’s starting to rock and roll,” he says cheerfully. “We’ve got new surgeons and new centres. We’ve just done four patients in New Zealand, and they’re really pleased. We’ve got centres in the Czech Republic, a couple in Poland are about to start, and we’re getting two more in the UK.”

About the long-term future of PEARS, Pepper is confident. “We’ve proved the concept,” he says. He doesn’t envisage it totally displacing the other two operations. Patients whose Marfan syndrome has not been inherited may be less well-informed and, correspondingly, less likely to seek help until their condition is more advanced. Trying to sleeve a grossly enlarged and therefore fragile aorta might trigger the very calamity that PEARS is intended to prevent. But below a critical size Pepper can envisage it becoming the treatment of choice: “If the patient comes to you early in the disease, and the aorta is enlarged, but not massively enlarged, PEARS is a good procedure.”

Future Marfan patients wondering to whom they owe thanks for the modest fabric sleeve that’s keeping them alive will surely be intrigued to discover its origins. Whatever gratitude they may feel, they owe it not only to their surgeons, but to a bloody-minded and persistent engineer: a fellow sufferer who thought he knew better than his doctors how to fix his problem – and was right.

This article first appeared on www.mosaicscience.com under a creative commons license and can be found https://mosaicscience.com/story/engineer-who-fixed-his-own-heart.

Monday, November 28, 2016

Fall Managed Care Forum 2016

On November 10-11, 2016 NAMCP Medical Directors Institute, AAMCN, and AAIHDS proudly presented the Fall Managed Care Forum in Las Vegas, NV. The forum brought together Medical Directors and Nurses from around the country to learn in the same environment. Attendees were welcome to participate in live sessions in the Business Track, Health Management Track and/or the Oncology Track to earn continuing education hours. The forum provided breakfast, lunch, breaks, and plenty of reception time for building one's career network and speaking with industry exhibitors.


New Certified Managed Care Nurses (CMCNs). Below are individuals receiving the certification from AAMCN's President, Jacquelyn Smith, RN, BSN, MA, CMCN.





 Managed Care Nurse Leader of the Year:

Clare Jarrard, RN, PhD, CMCN (center)

The award was presented to Clare by Sue Ellen Scott, RN (left) and Jane Goodeve, MSN (right).

The AAMCN Leadership Council developed the award to recognize AAMCN members who have made outstanding contributions as a leader in managed care nursing, their communities and patient advocacy. The award is given out once a year at the Fall Managed Care Forum.
Nurses Only Reception


Friday, November 4, 2016

What Is an "Average" Caseload?

Pat Stricker, RN, MEd, Senior Vice President
TCS Healthcare Technologies
 

How many times have we all heard (or asked) "What is the ‘average’ caseload?" Sounds like a simple question, doesn't it However, case management programs have struggled for years trying to determine realistic, standard caseloads. People are looking for "a number" that defines the average caseload, but in reality, there is no "magic" number.  

Determining standard case loads is a challenge due to a complexity of factors across diverse CM settings. In addition, rapid changes in the medical management field have added to those complexities, e.g. the integration of utilization management (UM) and disease management (DM) into case management (CM) functions, and the increase in complex, condition management strategies. Some care management applications promote standardized workflows and acuity levels that can help determine caseloads and acuity levels for a given population. However these applications usually lack evidence-based algorithms to determine distinct, accurate, and realistic caseloads. 

Literature reviews and other research findings on this topic cite caseloads that are focused on specific clinical or program areas, which make it difficult to generalize. In fall 2008, the Case Management Society of America (CMSA) and the National Association of Social Workers (NASW) published the Caseload Concept Paper to try to fill-in long standing gaps in this area. Their research found "average caseloads" ranging from two to 365!  

 
This graph from the Health Intelligence Network shows the average monthly caseloads reported in the 2012 Healthcare Benchmarks: Healthcare Case Management.

More recently an online nursing chat site identified caseloads ranging from 28 to 350!  

How can these ranges be so different?  The disparity is due to a variety of factors that affect the "average" caseload.  The CMSA/NASW Concept Paper provides a Caseload Matrix that defines the variables that tend to impact caseloads:
  • Business environment, model, and setting 
  • Type and location of CM program, i.e. short or long term, inpatient or outpatient, provider/hospital/payor-based 
  • CM services offered and noncase-related duties assigned to the case manager
  • Simplicity/complexity of the program, i.e. on-site, telephonic, Medicaid/Medicare, 
  • Role, expertise, and training of the case manager
  • Organizational resources/extended staff available to assist the case manager
  • Patient population, i.e. severity/acuity of the patient, complexity of the case, dual-eligibles
  • Regulatory influences
  • Paper-based vs. computerized processes/documentation
The addition of integrated care management interventions, complex condition management programs, and provider-based accountable care organizations have also added to the dynamic nature of determining what the "right" caseload is in any given situation. 

As a result of the above study, CMSA developed a free Case Load Capacity Calculator that provides rules and weights based on industry research and expertise. It can be used to calculate comparative caseload capacities across teams of case managers specific to the domain and setting in which they practice. It gathers information about the variables noted above and allows organizations to customize the tool to accommodate for differences in care delivery. CMSA has given us a great start by providing the concept paper and calculator, but we all need to work together to help define average caseloads for various types of programs. I encourage all of you to try the tool. Inputting your data will help you see how the various factors affect your caseload, as well as help contribute to the overall empirical data that is needed to determine the appropriate "average" caseload.

CMSA also continues to sponsor other initiatives to determine the "average" caseload. For the past six years, CMSA has co-sponsored the Health Information Technology (HIT) survey with TCS Healthcare Technologies (TCS), and the American Board of Quality Assurance and Utilization Review Physicians, Inc. (ABQAURP). A core objective of the bi-annual survey was to identify how HIT applications impact the case management industry. Schooner Strategies (dba Schooner Healthcare Services), which conducted the surveys, has published a series of Trend Reports analyzing the results. Trend Report #7: Caseloads, focuses on care manager caseloads and time allocation.  

The survey asked respondents to estimate how many cases they handle per week, and describe how their time is allocated between various tasks, such as direct and indirect patient communication and administrative tasks. The report includes several figures and tables that analyze:
  • Average number of cases handled each week 
  • Breakdown of caseload statistics by various provider settings
  • Care managers’ time allocation broken down by different activities 
  • Relationship between time allocation, caseload levels, and activity types
The survey questions looked at weekly caseloads, as opposed to the total number of cases that might be assigned to a care manager, to generalize the data across various settings. 26.5% of the respondents said they had 25-49 cases, 19.5% had 10-24 cases, 15% had 50-74 cases per week and 11.5% reported having over 100 cases per week. 16% indicated they did not have a routine caseload (i.e., management and administrative staff).   

Case managers working in provider settings (behavioral health facilities, home care, hospital or health systems, medical group/clinic settings, retail clinics, skilled nursing or long-term care facilities) consistently reported having an average caseload of 25-49 cases. In addition, 62% of the case managers working in a home care setting reported having less than 50 cases per week, with 22% of that group supporting one to nine cases per week. Case managers in research centers or academic medical settings (29% of the respondents) were the outliers. They only reported having one to nine cases each week.  

The survey also asked respondents to indicate how much time they spend with patients and how much was devoted to performing other duties on a weekly basis:
  • Face-to-face patient contacts (meeting directly with patients in a provider setting, home visits, community settings, or clinic venues)
  • Non face-to-face patient contacts (telephonic, electronic, and/or hardcopy correspondence)
  • Administrative support (paperwork, staff meetings, trainings)
  • Other activities
Caseload levels were also compared with activities to determine the relationships with average time allocations. The highest face-to-face contacts were found in programs where case managers have between 120 and 174 weekly cases.  These are usually in provider settings with short-term cases that require more immediate and defined tasks, such as in hospital or clinic settings, rather than in long-term, complex, telephonic case management programs.   

The survey analysis supports the premise that variations in the delivery and settings for care management have a direct impact on the size of caseloads. A full copy of Trend Report #7: Caseloads and all other Trend Reports can be found here.   
Will we ever be able to determine the average caseload? It seems unlikely that we will be able to define a specific number for an average caseload, but that doesn’t mean we should stop trying. We should continue to define caseloads for our specific programs, based on all the variables. More importantly, we need to share that data with one another so we come closer to finding that "illusive number."     

To contact Pat Stricker, email her at pstricker@tcshealthcare.comor reach her at (530) 886-1700 ext. 215.  

This article was originally published in the March 2014 edition of CMSA Today. www.CMSA.org

Monday, September 19, 2016

MACRA Impact on Medicare Patients and Clinical Professionals: What You Really Need to Know


Written by Bonnie Zickgraf, RN, BSN, CPHQ
Coauthor: Aaron Turner-Phifer 


There is sweeping new federal regulation that will impact the future role of managed care nurses and physicians in the most challenging of ways. This new law is referred to as “MACRA.”

MACRA will overwhelmingly affect pre-authorizations, clinical coding review, claim reimbursements, policy development, performance measures and coordination of care, defining new roles for Medicare providers and managed care professionals in the United States.

You don’t serve the Medicare population in your current managed care position? Not to worry.

Because of the over-arching theme of increased financial risk and variable incentive payments addressing performance in the value of care, the U.S. potentially stands to lose hundreds if not thousands of providers serving Medicare patients, which can also mold and impact the commercial health care markets.

Hoping to retire someday and sign up for Medicare? Here is some helpful information you should know as a patient and as a managed care professional. Let’s look at the history, the regulation and the impact it may have on your own physician, the provider space at large, and you as a managed care professional.

This isn’t your Granddaddy’s Medicare system anymore, so I’ve enlisted input from my colleague at URAC, Aaron Turner-Phifer, Director, Government Relations and Policy, for some basic information about MACRA first:

MACRA Basics
In a rare show of bipartisanship, Congress overwhelmingly passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) which replaced the much maligned sustainable growth rate (SGR). MACRA represents the latest policy meant to facilitate the transformation of America’s delivery system toward value-based care and away from fee-for-service.
To facilitate this shift MACRA creates the Quality Payment Program which is comprised of two different programs: the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APM).
Physicians and clinicians participating in the MIPS program will receive a bonus or penalty in their overall reimbursement based on a composite score compared to others in the MIPS program. The better a physician or clinician does, the higher the bonus. The inverse is also true, the worse a physician or clinician performs compared to the field, the higher the penalty.  Beginning in 2019, the first year payment adjustments begin, the maximum payment adjustment for physicians and clinicians is four percent. This escalates to nine percent by the year 2023.
Image provided by the American College of Rheumatology
As an alternative to MIPS, physicians and clinicians can participate in the APM (Alternative Payment Model) program which excludes them from the requirements of MIPS. Physicians or clinicians in the APM program get an annual five percent lump sum bonus simply for participating beginning in 2019. APMs are defined as those that meet criteria for linking payments to quality measures, use of EHRs, and nominal risk. CMS has identified the following programs that meet this definition:
-       Track 2 and 3 Medicare Shared Savings Program ACOs
-       Next Generation ACOs, Comprehensive Primary Care Plus (CPC+), and
-       some Comprehensive ESRD Care organizations (ESCOs).
CMS released the draft rules to implement the Quality Payment Program enacted by passage of MACRA on April 27, 2016. The final rules are expected sometime in the fall but physicians and clinicians impacted by the program are encouraged to begin planning now in order to meet a potential implementation date of January 1, 2017. --- Aaron Turner-Phifer

So, as you can see, Medicare reimbursements left for physicians (that will still be accepting Medicare reimbursements after January 2017) can ultimately go up or down in 2019 as a high as 9% under one payment strategy (MIPS) or, under the APM strategy, require possible restructuring into Patient Centered Medical Homes or to join an Accountable Care Organization that may require greater financial risk by the physician or choose to participate in bundled payment models. 


Physicians will need to carefully consider all options and decide which program to participate in (or not to participate in) or whether to treat Medicare patients at all. So how will this affect you as a managed care nurse going forward?

CMS calculates the change due to MACRA will impact three-quarters of a million physicians, hospitals and other providers, especially the smaller independent practitioners. One very good article about impact to the providers can be found here: https://www.healthcatalyst.com/physicians-must-prep-for-the-financial-impact-of-macra (retrieved August 22, 2016)

Interestingly enough, what is most profoundly lacking in the resources today is the impact to nurses. In November 2015, the American Nurses Association (ANA) along with eight other nationally recognized nursing associations, submitted changes and voiced concerns to CMS about the proposed rule change, including the lack of recognition of the Advanced Practice Registered Nurse (APRN) and the roles they can most adeptly provide in light of the MACRA rule changes. This letter can be found here: http://www.nursingworld.org/DocumentVault/ANA-Comments/APRN-Comment-MACRA-RFI.PDF

For those of you working in an office or in the field as a health UM nurse or as a case manager, access to care will become paramount. Finding a suitable (or any) Medicare provider may become a bigger challenge. New patient resources will need to be gathered to address patient needs including access to timely care, transportation, transitions of care between acute, subacute and home settings and discharge planning, to coordinate the care with Medicare providers.

Underutilization will need to be identified and critically analyzed by networks and by nurses for hidden root causes such as lack of affordability to the Medicare patient, or lack of available providers or delays in care coordination. Providers under MIPs payment strategy are exempt if seeing less than 100 Medicare patients and therefore may limit the number of Medicare patients seen in a geographical area. Awareness of patient responses to questions posed to the Medicare population may benefit the wise nurse in terms of becoming a stronger patient advocate. 

Nurses can also share MACRA and newly identified network resources with other nurses, physicians and other providers toward stronger patient advocacy and quality outcomes.
Education and awareness will become key attributes in managed care, no matter which way the regulations flow with MACRA or with others to come. Be prepared for future commercial and self-insured plans to follow suit. Reimbursements for quality care will come at a price to the patient and ultimately, to us all in the form of better quality care—when you can get it. I think our veterans know this system very well. Health care can only bear quality outcomes when and if the care is provided.

Note: The opinions in this blog entry are the personal opinions of the writer(s) and not necessarily reflective of AAMCN or URAC.

 
Image provided by the American College of Rheumatology

Thursday, August 25, 2016

Managed Care Nurse Leader of the Year (MCNLOY) Award


Every year, the American Association of Managed Care Nurses (AAMCN) awards an outstanding member of their association who demonstrates great leadership skills and has made an impact on managed care nursing. The award is presented at the annual Fall Managed Care Forum. This year, the forum takes place in Las Vegas, NV and is being held at the Delano-Mandalay Bay Resort on November 10-11, 2016.  


Last year's MCNLOY award, Stefany H. Almaden, PhD, RN, MSN, CCM, CPUM, CMCN.


AAMCN members who are nominated must demonstrate trust, individual consideration, intellectual stimulation, courage, dependability, flexibility, integrity, judgment, and respect for others.

Nominations are currently being accepted until October 1, 2016. Members of AAMCN may nominate themselves or another member. Winners will receive an award trophy and one year of free membership with AAMCN. Contact April at asnyder@aamcn.org for a copy of the nomination criteria and an application link.





Thursday, August 11, 2016

Patrick Soon-Shiong to present keynote at Fall Managed Care Forum 2016


http://www.namcp.org/conferences/fmcf/16/index.htm
 

Patrick Soon-Shiong, a South African surgeon, medical researcher, businessman, philanthropist, and professor at University of California at Los Angeles, is currently chairman of the Chan Soon-Shiong Family Foundation and chairman and CEO of the Chan Soon-Shiong Institute for Advanced Health, National LambdaRail, the Healthcare Transformation Institute and NantWorks, LLC. Soon-Shiong has been selected as a keynote speaker for the annual Fall Managed Care Forum which is being held at the Delano/Mandalay Bay Resort in Las Vegas, Nevada on November 10-11, 2016. His presentation is entitled GPS Cancer and Cancer Moonshot 2020: The Era of Clinical Proteomics Has Launched to Provide Better Outcomes at Lower Cost. The conference will highlight the latest trends and practices in managed care. Nurses, medical directors, physicians, and other healthcare executives will be in attendance. The forum is sponsored by the American Association of Managed Care Nurses (AAMCN), NAMCP Medical Directors Institute, and the American Association of Integrated Healthcare Delivery Systems (AAIHDS).

Soon-Shiong founded NantHealth in 2007 to provide fiber-optic, cloud-based data infrastructure to share healthcare information. Soon-Shiong went on to found NantWorks in September 2011, which mission was "to converge ultra-low power semiconductor technology, supercomputing, high performance, secure advanced networks and augmented intelligence to transform how we work, play, and live." In October, 2012, Soon-Shiong announced that NantHealth’s supercomputer-based system and network were able to analyze the genetic data from a tumor sample in 47 seconds and transfer the data in 18 seconds. The goal of developing this infrastructure and digital technologies was to share genomic information among sequencing centers, medical research hubs and hospitals, and to advance cancer research and big science endeavors such as The Cancer Genome Atlas

In January 2013, he founded another biotech company, NantOmics, to develop cancer drugs based on protein kinase inhibitors. NantOmics and its sister company, NantHealth, were subsidiaries of NantWorks. Soon-Shiong stated that NantWorks’ vision for the future of cancer treatment was a convergence of multiple technologies that included diagnostics, supercomputing, network modeling of sharing data on tumor genes and personalized concoction of cancer drugs in combination for multi-targeted attacks. The goal was to manage cancer and achieve a sustained disease-free state.

In 2010, with Arizona State University and the University of Arizona, Soon-Shiong founded the Healthcare Transformation Institute (HTI), which he dubs a "do-tank". HTI's mission is to promote a paradigm shift in health care in the United States by better integrating the three now separate domains of medical science, health delivery, and healthcare finance.

Soon-Shiong heads the CSS Institute for Advanced Health, founded in 2011 with a mission to provide high-speed computing capabilities for human genotyping to target specific cancer treatments, as well as technologies for the better management of chronic disease. Through the CSS Institute, Soon-Shiong is working to create a national health information network for the secure sharing of biomedical information. He is supporting the development of various wireless technologies for the better management of chronic disease.

Soon-Shiong is on several boards. These include the Board of Directors of the Mendez National Institute of Transplantation, and the board of directors for the Technology Council for the Center for Cancer Nanotechnology Excellence at Northwestern University. He leads other organizations concurrently. He is Chairman of the National Coalition for Health Integration, and is the Executive Director of the UCLA Wireless Health Institute.

Soon-Shiong and his wife, Michele B. Chan, fund several health-related projects through the Chan Soon-Shiong Family Foundation. In 2007 they pledged US $1billion to support healthcare transformation and a national health information highway. The Foundation has given a total of $135 million to the Saint John's Health Center in Santa Monica, California. It gave a guarantee of $100 million that enabled the replacement of closed Martin Luther King Jr./Drew Medical Center with the new Martin Luther King, Jr. Community Hospital in Willowbrook. Its Summer 2015 opening restored healthcare access to the largely underserved residents of South Los Angeles. In 2010, Soon-Shiong and Chan were asked to and did join Bill Gates and Warren Buffett in taking The Giving Pledge, by which some of the wealthiest Americans have pledged to give the majority of their wealth to charitable causes. They will donate half their wealth. In 2011 Soon-Shiong and Chan endowed a new Chair at the USC Viterbi School of Engineering, to support research at intersection of engineering and medicine, specifically computer science, mobile vision, and robotics.

About AAMCN
The American Association of Managed Care Nurses (AAMCN) was established in 1994 in response to an identified need to educate nurses about managed healthcare. The AAMCN is a non-profit membership association of Registered Nurses, Nurse Practitioners and Licensed Practical Nurses including top level administrators, managers, directors and consultants associated with a variety of managed healthcare organizations. The American Association of Managed Care Nurses is accredited by the American Nurses Credentialing Center’s Commission on Accreditation to provide continuing nursing education credits.

About NAMCP Medical Directors Institute
NAMCP was founded in 1991 to serve the educational interests and needs of medical directors and physicians working in all forms of managed healthcare. NAMCP’s mission is to improve patient outcomes by providing educational material, evidence-based tools and resources to medical directors from purchasers, plans and provider systems. NAMCP aggressively works with medical directors to identify and strategically position our industry to respond to the various opportunities and challenges on the horizon. We support initiatives empowering medical directors with information they need to make healthcare decisions and promote healthcare quality. NAMCP is accredited by the Accreditation Council for Continuing Education to provide AMA PRA Catergory 1 creditsTM to physicians.


About AAIHDS
Established in 1993, the American Association of Integrated Healthcare Delivery Systems (AAIHDS) is a non-profit organization dedicated to the educational advancement of provider-based managed care professionals responsible for accountable and integrated healthcare delivery. Members include payer and provider-based managed care executives i.e., VPs of Managed Care, CEOs and Board members of ACOs, IPAs, and PHOs, and other executives involved in integrated healthcare delivery systems and networks.


Reference:
Wikipedia, the Free Encyclopedia. Patrick Soon-Shiong. https://en.wikipedia.org/wiki/Patrick_Soon-Shiong. Accessed August 11, 2016.