Target Health is Going to Israel – Life Sciences Panel on Making it in NYC
Please let us know if you would like to attend.
As part of a highly anticipated, meeting in Israel next week, Target Health Inc. is pleased to announce that Dr. Jules T. Mitchel will participate in the panel entitled – “Making it in NYC.” On the panel will be representatives from NYC’s Life Sciences sector who will discuss case studies on academic-industry collaboration with NYC-based institutions, resources in clinical trials, funding, collaborative research opportunities and how to introduce Israeli technologies to the U.S. market.
The New York City Economic Development Corporation (NYCEDC) is the City’s primary engine for economic development charged with leveraging the City’s assets to drive growth, create jobs and improve quality of life. It is an organization dedicated to New York City and its people and uses its expertise to develop, advise, manage and invest to strengthen businesses and help neighborhoods thrive. NYCEDC also helps create affordable housing, new parks, shopping areas, community centers, cultural centers and much more.
The NYCEDC is coordinating a trip to Israel to discuss opportunities for Israeli companies and organizations to partner with NYC-based companies, organizations and Academic Medical Centers. In addition to a panel in Tel Aviv on Wednesday, April 10th, from 8:30-11am, there will be meetings at the Technion Institute of Technology in Haifa, the Hebrew University in Jerusalem and an Entreprenurial Event and CEO Roundtable in Herzilya.
The “Making it in NYC” panel will be moderated by Aaron Etra, Secretary-Treasurer, Institute for Life Sciences Collaboration and will feature:
Yuval Cohen, CEO, Morria Biopharmaceuticals
Jules Mitchel, President, Target Health Inc.
Bryan Spielman, EVP Strategy and Corporate Development, Medidata Solutions
Abram Goldfinger, Executive Director Technology Transfer, NYU School of Medicine.
RSVPs and inquiries can be sent to firstname.lastname@example.org with the subject line “Life Sciences Panel.”
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com
Fecal Transplants Being Used to Treat C. difficile Cases
Graphic: Andrea Levy
For years, hospitals have struggled to help patients overcome the life-threatening gut infection 1) ___ __, or C. diff, a stubborn bug that often won’t respond to repeated rounds of antibiotics. Now doctors are looking more and more to a treatment that has almost instant results in some of the sickest of patients. The remedy operates on the premise that antibiotics wipe out beneficial bacteria that help people combat serious infections such as C. diff. And it puts that good bacteria back into their digestive tracts so they can overcome the 2) ___. The success rate is remarkable. “Seventy-four percent of patients get better in three days,” says Dr. Lawrence Brandt, a New York gastroenterologist who’s been using the treatment since 1999. “But I’ve had patients who’ve felt better in three hours.” The only hitch: Many find the treatment repulsive. It’s called a fecal transplant. Interestingly, it’s also less expensive than the most common treatment for recurrent C. diff which is the antibiotic Vancomycin, which can cost patients about $60 a pill, or $1,200 for a 10-day course.
One reason people don’t know about fecal transplants — also called bacteriotherapy or human probiotic infusions — is that access is not always easy. Only about 15 doctors in the United States have made them an established part of their practices, says Dr. Colleen Kelly, a gastroenterologist who teaches at Brown University’s medical school and has been performing 3) ___ transplants for the past four years. There are a number of reasons why more physicians don’t provide the treatment, says Dr. Cliff McDonald, a medical epidemiologist and senior adviser for science at the U.S. Centers for Disease Control’s division of Healthcare Quality Promotion. One, he says, is that it’s so unappealing.
Transplants can be performed in a number of ways. Most often, doctors use a colonoscopy-like procedure, sedating a patient and depositing liquefied, donated stool through a tube in the rectum. But sometimes they use a nasogastric tube, that goes through the nose, down the throat and into the gut. Other times, the stool is administered as an 4) ___.
“Nobody in training teaches you how to do it,” says Dr. Kelly, who practices at the Women’s Medicine Collaborative in Providence, R.I. “My first one, I had no idea how to start.” Besides that, Kelly says, doctors can’t always get the OK from the medical institution they’re affiliated with. There’s a lot of red tape. You have to bring it in front of a Board of Directors. And all it takes is one person not feeling comfortable with this procedure. According to Dr. McDonald, the most important issue, is that no one has done a randomized, controlled trial, until now. The doctor heading the new study is Dr. Kelly, who’s working on it with Dr. Brandt, chief of gastroenterology at Montefiore Medical Center in New York, using a grant from the National Institutes of Health. When the study is finished, sometime in 2014, about 50 patients will have undergone 5) ___, half using donor feces, and the other half, the control group, using their own. It’s a double-blind study, so neither the patients nor the doctors will know who received which treatment. The real hope is that this study will provide the randomized, controlled, double-blind proof that’s needed, and show that it’s efficacious and safe. Then if doctors come up against a barrier at their hospital, they can point to the 6) ___-based science that proves how effective it is. Sites are recruiting patients for other fecal transplant studies in the United States and elsewhere. Some of those studies are looking into other uses for the procedure — to treat ulcerative colitis, for example, or inflammatory 7) ___ disease in children.
Shirley Kaiser, who’s 78, drove 12 hours to the Mayo Clinic in Minnesota for a fecal transplant. After eight years of severe C. diff-induced diarrhea, after her treatment, she felt better by the next day. Her C. diff was severe; it made her so weak she couldn’t walk half a mile down the street without having to sit on the curb to rest. She spent entire days in her bedroom which was close to the bathroom. On her worst day, she counted 37 trips to the bathroom. She tried Vancomycin — she only had to pay $30 of the $1,100 cost for a 10-day supply — but as soon as she stopped taking it, her 8) ___ were back. Her transplant at the Mayo Clinic, turned all that around. Since she’s had it, she hasn’t been sick once.
C.diff bacterium lives in the colon and produces hard-to-kill spores that cause cramps, abdominal pain and severe diarrhea in about 500,000 people in the United States a year. It can lead to 9) ___ poisoning. It can damage colons so badly they have to be removed. And it kills. Every year in the United States, an estimated 14,000 to 30,000 people die from the disease. And it’s said to contribute to 100,000 additional deaths. Because its spores are so hardy, they survive on bed sheets, countertops, hospital curtains and other surfaces where people can pick them up months or years later.
Most of us have trillions of healthy micro-organisms in our gut to fight it off. But for many people, C. diff strikes after a round of antibiotics has killed off good micro-organisms, leaving the body with little natural ammunition to fight the disease. Physicians know that getting that good bacteria back into the 10) ___ takes care of the problem. Yogurt and over-the-counter probiotics have no effect on this superbug. That leaves doctors with some medication and the fecal transplant. It’s been used in veterinary medicine for decades.
For now, the treatment isn’t regulated by the FDA but that could change in the future. It doesn’t usually cost patients much. Because insurance doesn’t typically cover the doctor’s fee to administer the treatment, many doctors don’t charge for it. However, insurance often pays for office visits, the colonoscopy-like procedure to administer it and testing of the donor for HIV, hepatitis and other diseases. But as the incidence of C. diff began increasing in recent years, more and more doctors adopted it for human use. Now with more doctors offering the treatment, there’s more documentation of how well it works. Doctors who have tracked their cases, report that about 90% of patients get better after the first transplant; 95% after a second one. And because it’s so successful, the medical community is searching for ways to make it more palatable.
Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota Medical Center, is one of the researchers trying to isolate the good bacteria that cures C. diff so that a more palatable treatment, such as an easy-to-swallow capsule, can be developed. Others are looking into the effect that the trillions of bacteria and other micro-11) ___ in our guts have on diseases such as Parkinson’s, autism and obesity. A study in mice, for example, found that lean mice that received fecal transplants from obese mice became fat. And a small study in humans indicates that they might, also, respond in the same way. It will be decades before we know exactly how all the microscopic organisms in our 12) ___ affect our health. “We could say in the 19th and 20th centuries, the biggest achievements were in conquering infectious disease,” says Khorus. But with all this sanitation and hygiene and anti-bacterial everything, he says, we may have unleashed a slew of other diseases. “This is the big question right now,” he says. “This is why everybody is so excited about this new frontier.”
ANSWERS: 1) Clostridium difficile; 2) disease; 3) fecal; 4) enema; 5) transplants; 8) evidence; 7) bowel; 8) symptoms; 9) blood; 10) colon; 11) organisms; 12) guts
Fecal bacteria at 10,000× magnification
Desperate times sometimes call for desperate measures, especially in the world of medicine. And throughout history, some of those measures have had a pretty high yuck factor.
If you lived in China at the turn of the 11th century and wanted to avoid contracting smallpox, you’d have been advised to blow small pox scabs up your nose. (While the technique had a 0.5% to 2.0% mortality rate, it was considerably less than the 20% to 30% mortality rate of the disease itself!) In 1921, maggots were introduced at Johns Hopkins University as a highly successful treatment for open wounds. (Eighty-three years later, the FDA approved maggots as a therapy for deep wound healing)
Another distasteful therapy, was the medicinal use of stool to treat illness, which dates back to 4th century China, when the physician Ge Hong described fecal solutions. Patients were given liquefied feces to drink as a treatment for severe diarrhea and food poisoning. The remedy was considered a “medical miracle that brought patients back from the brink of death,” Dr. Faming Zhang of Nanjing Medical University wrote in the American Journal of Gastroenterology. Later, in the 16th century Ming Dynasty, herbal healers prescribed fermented fecal solutions for abdominal ailments, calling the concoction “yellow soup” to make it more palatable.
Doctors in the West were more reticent, although it was known that certain mammals, such as dogs and camels, consumed excrement when they were ill, and that veterinarians sometimes used a fecal solution to treat ill horses. It wasn’t until 1958 that the first scientific paper on the use of fecal transplants in humans appeared in the United States. That year, a team of Colorado researchers reported that an unusual procedure known as fecal bacteriotherapy held promise for fighting a stubborn gastrointestinal infection caused by an unknown organism, now known to be Clostridium difficile (C. difficile). Also referred toas fecal microbiota transplantation (FMT), the procedure involves the infusion of a healthy donor’s feces into an infected patient’s gut to restore a normal balance of healthy bacteria. The first description of FMT was published in 1958 outlining the successful treatment of four patients with pseudomembranous colitis before C. difficile was the known cause. Since that time sporadic cases have appeared in the literature. Australian gastroenterologist Dr. Thomas Borody performed his first in the mid-1980s. The story, as detailed in the magazine The Scientist, began when a woman came to him with an inflamed colon that wasn’t getting better. Borody began researching alternative treatments and stumbled upon a paper published in 1958 that described four cases in which a similar condition was treated with feces from healthy donors. “So I looked at the method and kind of made up the rest of it,” Borody told the magazine. Within days, the woman’s colitis was gone. And it never came back.
At the CDC there were indications that FMT could benefit other conditions including ulcerative colitis,] autoimmune disorders, neurological conditions, obesity, metabolic syndrome and diabetes and Parkinson’s disease.
C. difficile infection (CDI) is typically caused by taking antibiotics that wipe the gut clean of its normal bacterial balance. Without normal levels of healthy bacteria, the gut becomes susceptible to C. difficile, especially in the hospital setting. Characterized by profuse diarrhea, uncontrollable vomiting, and high fever, the infection often does not respond to antibiotics. CDIs kill approximately 14,000 people annually in the United States, they are very difficult to treat, and the failure rates for antibiotic therapy are high. In addition, the treatment costs are estimated to exceed $1 billion a year. In recent years, a more deadly, antibiotic-resistant form of the bacteria has emerged. The antibiotics approved to treat the infection are expensive and, as importantly, are not effective in up to 25% of patients. Additionally, the estimated efficacy of antibiotic therapy for a first recurrence is 60%, which declines further in patients with multiple recurrences.
It appears that widespread use of fecal bacteriotherapy has been limited by a paucity of evidence-based data rather than by patient preference. Although patients find the concept unappealing, they are open to considering the procedure to treat recurrent CDI, especially when recommended by a physician. Clinical uptake of the procedure by the medical community has been most hampered by a lack of clinical data showing that the procedure is more effective than antibiotics – the current care standard.
Until now, that is. A recent study published in the New England Journal of Medicine reports that among 42 patients with multiple recurrences of CDI, the infusion of donor feces was significantly more effective for the treatment of recurrent CDI than the use of vancomycin or vancomycin with bowel lavage. Success was defined as the resolution of diarrhea associated with CDI without relapse after 10 weeks. Overall, fecal infusions resulted in a cure rate of 94% (15 of 16 patients). Among those who received vancomycin or vancomycin plus lavage, the cure rates were 31% and 23%, respectively. Because so many people in the control group experienced relapses of CDI, the trial was stopped early. Of note is that among 18 patients who relapsed and subsequently underwent transfusion, 15 were also cured (83%). Importantly, there was no significant difference in adverse events among the study groups, except for mild gastrointestinal symptoms in the transplant group on the infusion day. After 2 weeks, the patients who had undergone the transfusion developed an increased diversity of fecal bacteria similar to their donors. There is also an ongoing study at Montefiore Medical Center in New York, using a grant from the National Institutes of Health, to provide the randomized, controlled, double-blind proof that’s needed, to show whether donor fecal implants or fecal bacteriotherapy, are efficacious and safe.
Dr. Jonathan Eisen: “Not all microbes are pathogens” As Jonathan Eisen of the University of California of Davis points out, “the health of our microbiome is vital to protecting us from disease”.
Stressful Life Events May Increase Stillbirth Risk
Stillbirth is the death of a fetus at 20 or more weeks of pregnancy. According to the National Center for Health Statistics, in 2006, there was one stillbirth for every 167 births.
According to an article published online in the American Journal of Epidemiology (26 March 2013) pregnant women who experienced financial, emotional, or other personal stress in the year before their delivery had an increased chance of having a stillbirth.
The study asked more than 2,000 women a series of questions, including whether they had lost a job or had a loved one in the hospital in the year before they gave birth. Whether or not the pregnancy ended in stillbirth, most women reported having experienced at least one stressful life event in the previous year. It was found that 83% of women who had a stillbirth and 75% of women who had a live birth reported a stressful life event. Almost 1 in 5 women with stillbirths and 1 in 10 women with livebirths in this study reported recently experiencing 5 or more stressful life events. This study measured the occurrence of a list of significant life events, and did not include the woman’s assessment of how stressful the event was to her.
Women reporting a greater number of stressful events were more likely to have a stillbirth. Two stressful events increased a woman’s odds of stillbirth by about 40%. A woman experiencing five or more stressful events was nearly 2.5 times more likely to have a stillbirth than a woman who had experienced none. Women who reported three or four significant life event factors (financial, emotional, traumatic or partner-related) remained at increased risk for stillbirth after accounting for other stillbirth risk factors, such as sociodemographic characteristics and prior pregnancy history.
Non-Hispanic black women were more likely to report experiencing stressful events than were non-Hispanic white women and Hispanic women. Black women also reported a greater number of stressful events than did their white and Hispanic counterparts. According to the authors, this finding may partly explain why black women have higher rates of stillbirth than non-Hispanic white or Hispanic women.
Within 24 hours of either a live birth or a stillbirth delivery, the women in the study were asked about events grouped into four categories: emotional, financial, partner-related and traumatic. They answered yes or no to 13 scenarios, including the following:
— I moved to a new address.
— My husband or partner lost his job.
— I was in a physical fight.
— Someone very close to me died.
Some of the stressful events were more strongly associated with stillbirth than were others. For example, the risk of stillbirth was highest:
— for women who had been in a fight(which doubled the chances for stillbirth)
— if she had heard her partner say he didn’t want her to be pregnant
— if she or her partner had gone to jail in the year before the delivery
Lithium in ALS – Not All Clinical Trials Work
Lithium has neuroprotective effects in cell and animal models of amyotrophic lateral sclerosis (ALS), and a small pilot study in patients with ALS showed a significant effect of lithium on survival. As a result, a study published in The Lancet Neurology (2013;12:339-345) was performed to assess whether lithium improves survival in patients with ALS.
The lithium carbonate in amyotrophic lateral sclerosis (LiCALS) trial is a randomized, double-blind, placebo-controlled trial of oral lithium taken daily for 18 months in patients with ALS. Patients aged at least 18 years who had ALS according to the revised El Escorial criteria, had disease duration between 6 and 36 months, and were taking riluzole were recruited from ten centers in the UK. Patients were randomly assigned (1:1) to receive either lithium or matched placebo tablets. Randomization was via an online system done at the level of the individual by block randomization with randomly varying block sizes, stratified by study center and site of disease onset (limb or bulbar). All patients and assessing study personnel were blinded to treatment assignment. The primary endpoint was the rate of survival at 18 months and was analyzed by intention to treat.
Between May 26, 2009, and November 10, 2011, 243 patients were screened and 214 were randomly assigned to receive lithium (107 patients) or placebo (107 patients). Two patients discontinued treatment and one died before the target therapeutic lithium concentration could be achieved. A total of 63/107 (59%) patients in the placebo group and 54/107 (50%) patients in the lithium group were alive at 18 months. The survival functions did not differ significantly between groups. After adjusting for study center and site of onset, the relative odds of survival at 18 months (lithium vs placebo) was 0.71. In terms of safety, 56 patients in the placebo group and 61 in the lithium group had at least one serious adverse event.
According to the authors, there was no evidence of benefit of lithium on survival in patients with ALS, but nor were there safety concerns, which had been identified in previous studies with less conventional designs. This finding emphasizes the importance of pursuing adequately powered trials with clear endpoints when testing new treatments.
Treatment of HCV Infection by Targeting MicroRNA
The stability and propagation of hepatitis C virus (HCV) is dependent on a functional interaction between the HCV genome and liver-expressed microRNA-122 (miR-122). Miravirsen is a locked nucleic acid-modified DNA phosphorothioate antisense oligonucleotide that sequesters mature miR-122 in a highly stable heteroduplex, thereby inhibiting its function.
According to an article published in the New England Journal of Medicine (27 March 2013), a phase 2a study was performed at seven international sites, in order to evaluate the safety and efficacy of miravirsen in 36 patients with chronic HCV genotype 1 infection. The patients were randomly assigned to receive five weekly subcutaneous injections of miravirsen at doses of 3 mg, 5 mg, or 7 mg per kilogram of body weight or placebo over a 29-day period. They were followed until 18 weeks after randomization.
Results showed that miravirsen resulted in a dose-dependent reduction in HCV RNA levels that endured beyond the end of active therapy. In the miravirsen groups, the mean maximum reduction in HCV RNA level (log10 IU per milliliter) from baseline was 1.2 (P=0.01) for patients receiving 3 mg per kilogram, 2.9 (P=0.003) for those receiving 5 mg per kilogram, and 3.0 (P=0.002) for those receiving 7 mg per kilogram, as compared with a reduction of 0.4 in the placebo group. During 14 weeks of follow-up after treatment, HCV RNA was not detected in one patient in the 5-mg group and in four patients in the 7-mg group. No dose-limiting adverse events were observed and no escape mutations occurred in the miR-122 binding sites of the HCV genome.
According to the authors, the use of miravirsen in patients with chronic HCV genotype 1 infection showed prolonged dose-dependent reductions in HCV RNA levels without evidence of viral resistance. (this study was funded by Santaris Pharma)
TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area
FDA Approves Invokana to Treat Type 2 Diabetes – First in a New Class of Diabetes Drugs
Type 2 diabetes is the most common form of the disease, affecting about 24 million people and accounting for more than 90% of diabetes cases diagnosed in the US. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
The FDA has approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. Its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with type 2 diabetes. The trials showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting plasma glucose (blood sugar) levels.
Invokana has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylurea, pioglitazone, and insulin. Invokana should not be used to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (diabetic ketoacidosis); or in those with severe renal impairment, end stage renal disease, or in patients on dialysis.
The FDA is requiring five postmarketing studies for Invokana: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.
The most common side effects of Invokana are vaginal yeast infection (vulvovaginal candidiasis) and urinary tract infection. Because Invokana is associated with a diuretic effect, it can cause a reduction in intravascular volume leading to orthostatic or postural hypotension (a sudden fall in blood pressure when standing up). This may result in symptoms such as dizziness or fainting, and is most common in the first three months of therapy.
Invokana is manufactured for Janssen Pharmaceuticals, Inc., Titusville, N.J.
Shiitake Stuffed Mushrooms
Mushrooms are low in calories, packed with nutrients, and an excellent source of B vitamins and minerals, including selenium, copper, potassium, phosphorous, zinc and manganese. Mushrooms also contain a powerful antioxidant called L-ergothioneine.
As you may recall from last week’s Target Healthy Eating, throughout Asia, mushrooms are revered for their immune-boosting properties. They also contain more protein than most vegetables, and their meaty texture makes them a good choice for vegetarians. Shiitake, maitake, oyster and king oyster mushrooms contain the highest amount of L-ergothioneine, but crimini and portabella mushrooms are also good sources.
12 Shiitake mushrooms (buy extra for any left-over stuffing)
2 tablespoons canola oil or olive oil
4 cloves garlic, minced
1 package frozen chopped spinach
1/4 cup chopped cilantro
1 cup Tofu (soy) cream cheese (Tofutti)
1/8 cup fresh parmesan, grated
1/4 teaspoon garlic salt (optional)
1/2 teaspoon dried basil
1/8 chili powder (optional or to taste)
1/4 teaspoon fine black pepper (or grind to taste)
1/4 teaspoon kosher or sea salt (optional)
1 egg, beaten
8 tablespoons almond flour or soy flour
1/4 cup mozzarella, shredded
- Defrost the frozen spinach. Then, place it on paper towels, pick the spinach up and wring all of the excess water out of it. Use more toweling, if you need them. Just be sure to wring out, with your hands, all of the water.
- Preheat oven to 350F
- Using a paring knife, remove stems from all mushroom caps. Wipe down mushrooms with a wet cloth to remove all dirt. Do not wash or rinse mushrooms. Set aside
- On a cutting board, chop all of the mushroom stems into little pieces and set aside.
- In a medium skillet, heat the oil and sauté garlic until fragrant. Add the mushroom stems and cook with the garlic.
- Add the squeezed spinach and cook with the mushroom stem mixture, until shrunk down. Remove from heat.
- In a small bowl, mix the Tofu cream cheese and parmesan. Season to taste with garlic salt (optional), dried basil, cilantro, chili powder, black pepper and salt. Mix well.
- Beat the egg and mix it into the Tofu cream cheese-parmesan-spice mixture. Sprinkle in the almond flour and mix it in
- Add spinach mixture to the bowl with cheese mixture and stir together well
- Now, with a teaspoon, mound the mixture into each mushroom cap and sprinkle with the grated mozzarella cheese.
- On a cookie sheet (or use any container you have) spray once with canola oil and spread it around.
- Place all of the mushrooms on your sheet and place in the preheated oven for about 15 to 20 minutes, or until the mozzarella has turned golden brown.
- Watch it carefully, so as not to burn
- Cool for 5 minutes and serve warm.
These delicious stuffed mushrooms make excellent appetizers. Or, simply double the recipe and serve the mushrooms as a side dish or as your main vegetable with fish or chicken, along with your favorite tossed salad. Add some warm homemade flax-seed rolls and you’re all set for a wonderful evening at home with friends and/or hubby or significant other. Enjoy this repast with a light-bodied white wine such as Sauvignon Blanc or Pinot Grigio.
Whither the Electronic Health Record (EHR) – An Individual Doctor’s Dilemma
Mark L. Horn, MD, MPH, Chief Medical Officer, Target Health Inc.
Editor’s Note: Target Health is firmly committed to electronic systems for healthcare and is shocked with the volumes of paper records that are being displayed for our veterans returning from deployments overseas, with some of these records going back to the war in Vietnam over 40 years ago. These tons of paper records are holding up the medical treatment and disability payments of soldiers returning from active duty and looking for normalcy at home.
2009 American Recovery and Reinvestment Act (ARRA)
As part of the 2009 American Recovery and Reinvestment Act (ARRA), the Medicare and Medicaid EHR Incentive Programs provide incentive payments to eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) as they adopt, implement, upgrade or demonstrate meaningful use of certified EHR technology. EPs can receive up to $44,000 through the Medicare EHR Incentive Program and up to $63,750 through the Medicaid EHR Incentive Program.
However, if Medicare eligible professionals, or EPs, do not adopt and successfully demonstrate meaningful use of a certified electronic health record (EHR) technology by 2015, the EP’s Medicare physician fee schedule amount for covered professional services will be adjusted down by 1% each year. The adjustment schedule is as follows:
2015 – 99% of Medicare physician fee schedule covered amount
2016 – 98 % of Medicare physician fee schedule covered amount
2017 and each subsequent year – 97% of Medicare physician fee schedule covered amount
If less than 75% of EPs have become meaningful users of EHRs by 2018, the adjustment will change by 1% point each year to a maximum of 5% (95% of Medicare covered amount). However, The Recovery Act allows for hardship exception from the payment adjustment in certain instances. The exemption must be renewed each year and will not be given for more than 5 years. More information on payment adjustments and the requirements to qualify for a hardship exemption will be provided in future rulemaking between now and the 2015 effective date.
A recent personal conversation led to a period of reflection, and this entirely unexpected piece for On-Target. It reflects a dilemma that will increasingly impact all stakeholders in our health care system. That is, how best to implement emerging technologies which promise long-term benefits but may create immediate or short-term disruptions. This is a classical dilemma of managing change during adoption of a “disruptive innovation.”
The conversation concerned a medical school colleague of my age, an age at which retirement, previously happily distant enters the periphery of reality and becomes, a bit unexpectedly, part of one’s thinking. My colleague, unexpectedly and somewhat sadly, has experienced an acceleration in thinking about retirement as a consequence of the anticipated penalties for physicians who fail (or choose not) to adopt Electronic Health Records (EHRs). The benefits of these systems have been widely reported; in fact EHRs are essential for achieving and measuring critical cost and quality objectives; however, as is typical with any massive ‘scale up’ of innovative technology there are challenges, some unexpected. For a small practitioner closer to the end than the beginning of practice, the expense, interruption of work flow required for staff training, and the overall effort involved in transitioning from (currently quite satisfactory for some) paper charts to an electronic system are a potentially unacceptable burden.
Left alone, this doctor would continue practice, happily using the paper systems that have proven sufficient enough and effective (for the practice and its patients) over decades, until an ultimate retirement motivated by other factors. However, this doctor will not be left alone; the American Recovery and Reinvestment Act (ARRA) which provided financial incentives for physicians to adopt EHRs also provides penalties for those who elect not to adopt these systems; this practitioner may well retire early in part as a consequence of the ARRA mandated EHR penalties.
What should we do when we think both about the best interest of physicians as well as their patients? After all, at some point a doctor will retire, move etc. and patients will need to get their records to another healthcare provider. Is it worth considering as part of patient care to partner with a younger physician, enthusiastic about the new technologies and able to provide oversight and support to training of the staff, as well as ultimately purchase part or all of the practice when that time comes? A young doctor would have to know all about EMR and/or EHR, at some point anyway. While this may be a good solution for some, it still does not solve the problem for a physician who is content with the status-quo and simply doesn’t see a reason to change.
This story resonated with me because I have heard this lament before, at medical meetings where solo practitioners or physicians in small groups raise concerns about being compelled to adopt costly systems that they don’t want, don’t feel they need, and which even with financial incentives they do not believe represent (for them, at least) prudent investments. As a believer in the critical importance of this technology, I was initially unsympathetic to these concerns but have reconsidered upon seeing numerous reports, even among supporters of EHRs, that many available systems suffer from a lack of precisely the compatibility and user and patient friendliness (Kellerman & Jones, Health Affairs 32:1 Jan. 2013: Pages 63-68) that are the fundamental justification for their adoption.
An important question now must be asked–and answered–by the supporters of the penalties for failure to adopt EHRs – is the benefit of these systems, theoretically compelling but apparently not practically achieved by at least some current products, sufficient to justify the expense and overall burden on smaller medical practices? Is a penalty for these practices truly defensible and in the public interest? If not, and I increasing think ‘not’, this policy should be reconsidered – importantly, not the goal of global EHR adoption but the approach to getting there. If switching must rely upon penalties, that (to me at least) says there is something fundamentally amiss, since well trained and motivated professionals should just do the right thing for their patients.