Antibiotic Associated Colitis Increases Risk

At least a half dozen times per week patient’s call with symptoms of a viral upper respiratory tract infection or present to the office for a visit with symptoms and signs of a cold.  These illnesses are caused by small viral particles which do not respond to antibiotic treatment.   Your body’s defense system attacks these viral particles and over a period of hours to days defeats them.   Despite years of ongoing public health announcements and handouts by doctors and nurses and attempts at patient education you find yourself negotiating with strong willed patients who want a “Z Pack” or some other antibiotic which they do not need.  “I know my body,” they argue.  “My northern or previous physician knew to always give me an antibiotic, why won’t you?”

The answer is quite simple. They do not work to shorten the course, intensity or duration of your illness. They do in fact put you at risk of developing complications of antibiotic use. When your infection requires the use of antibiotics to restore health, it is worth taking these risks. When you do not need the medication it definitely is not. This was confirmed by an article and research presented by E Erik Dubberke, MD of Washington University School of Medicine in Saint Louis, Missouri commenting on Medicare Data about the death rate associated with antibiotic related colitis infections due to Clostridia Difficile.  Bacteria normally reside in our large intestine and promote health and digestion.  When we prescribe an antibiotic it kills off the healthy and beneficial bacteria as well as the infection related bacteria. This destruction of healthy bacteria creates an environment conducive to “opportunistic “bacteria normally suppressed by the normal flora to invade and take over your gut. The resulting fever, cramping, diarrhea with blood occurs as the intestine become inflamed with colitis. One of the common opportunistic pathogens is Clostridia Difficile.

Dr. Dubberke looked at Medicare data and compared 175,000 patients older than 65 years of age and diagnosed with Clostridia difficile infection and compared them to 1.45 million control patients. He found that those with clostridia difficile infection had a 44% increased risk of death. When comparing admissions to nursing homes for treatment there was an 89% increased risk due to antibiotic related colitis care.

Antibiotics are wonderful when appropriate. They will always carry a risk of a side effect, adverse reaction or complication which is a risk worth taking in the correct setting.  It is clearly not worth the risk when your doctor tells you that it will not work.

How Much of Yourself Can You Give to Others?

I have been practicing general internal medicine for over 35 years in the same community. I have many patients who started with me in 1979 and are now in their late eighties to early nineties.  Predictably and sadly they are failing.  Not a week goes by without one or two of them moving from general medical care to palliative care, very often with the involvement of Hospice for end of life care.   Medicare may now compensate for discussion of end of life issues but anyone practicing general internal medicine or family practice has been discussing end of life issues appropriately for years with no compensation. It just comes with the territory.

Most of us still practicing primary care thrive on being able to improve our patient’s quality of life and our major compensation can be hearing about their interactions and social engagements with family and friends.  It is an accomplishment to see you’re 90 year old with multisystem disease for years, dance at her great grandchild’s wedding.  No one who cares for patients longitudinally for years is that dispassionate that they do not give up a piece of their heart and soul each time they lose a patient or have one take a turn for the worse.   When I lose a patient, if time permits, I will attend the funeral or family grieving gathering during the mourning period.  Everyone gets a personal hand written letter. Completion of the circle of life and then moving on is part of the process.

I think physicians’ families take the brunt of this caring and I am sure mine does. As much as you want to have time and patience and sympathy and empathy for your loved ones, the work truly drains your tank and reserve. When you answer the questions of the elderly and their families over and over, often the same questions, it drains you.  Unfortunately, I believe my elderly failing mother is cheated the most by this process. Last weekend when making my weekly visit she was complaining again about the same things, asking the same questions that have repeatedly and compassionately been addressed by my brother and I. My wife interjected that I sounded angry and annoyed. I was. I told her that unfortunately all the compassion and understanding in me had been drained already today and I needed time to recharge.

I saw the widow of a patient who expired last month in his nineties. I had offered to make home visits and they were declined several times by the patient and his spouse. His last week of life he asked to receive Hospice care and they assumed his care.  I called the surviving spouse and wrote what I considered a personal letter of condolence.  His wife told me she was disappointed in me for not coming up to see him one last time. I apologized for not meeting their needs but wondered inwardly, how much can I give and still have something left for myself and my loved ones?

PCSK9 Inhibitors Not All They Are Cranked Up To Be

For months now physicians treating patients with elevated cholesterol have been looking forward to learning how to use the new monthly injectable PCSK9 inhibitor medicines that were touted to dramatically lower LDL cholesterol and cause far fewer side effects. They were designed to be used in patients with a hereditary form of elevated cholesterol traditionally very hard to control with oral statin medications and for statin intolerant patients with coronary artery disease.

The drawbacks to the new medication is its costly nature running more than $1,200 a month with many insurers, including Medicare, not yet covering it. There were additional concerns that the lowering of LDL cholesterol was so dramatic that it may cause problems in other organ systems that require cholesterol for certain functions.

The April 3rd edition of the University of Pennsylvania’s online Medical Review known as MedPage Today revealed data from Steven E Nissan, MD, of the Cleveland Clinic on the use of evolocumab (Repatha) in the phase III GAUSS -3 trial. This study looked at statin intolerant patients who had failed on two previous statin drugs or were unable to raise the statin dose from the minimal available level.  This study compared the effects of Repatha to oral Zetia (ezetimibe) at 22 and 24 weeks.  The study clearly showed that Repatha lowered LDL cholesterol levels by about 55% compared to ezetimibe at 17%.  The level of LDL cholesterol level was similar to results of the other cholesterol lowering PCSK9 inhibitor alirocumab (Praluent).

What I found most interesting is not that these expensive new injectables worked well but that 20% of the statin intolerant patients had similar muscular aches and pains and complaints with this new non statin injectable. Less than one percent of the patients on the new injectable in the study actually stopped the drug due to the muscular pains.

At this point my practice is still investigating the new injectables. Part of that investigation is determining which insurers will pay for the use of the drug and which will not.  In the past I have waited a good year for a new type of medication to be out on the US market to observe the true adverse risk profile before prescribing it. This promising injectable monoclonal antibody to reduce LDL cholesterol will be treated no differently.

Changes Coming to Medicare Soon

CMS (Center for Medicare Services) is determined to eliminate fee for service medicine. Fee for service medicine is the system where patients see a physician or “provider” for a visit or service and the “physician or provider” bills the patient or Medicare for each service provided.  CMS argues that “providers” are seeing too much volume and providing too many services thus driving up the cost of health care and the percentage of the Gross National Product that healthcare consumes.  To contain costs they have come up with the public relations mantra of the “Triple Aim.”  The triple aim includes improving the global health of the US population while improving quality and reducing overall costs.  The true emphasis is on reducing overall costs!

To reach their goals, CMS is changing the way it pays for health care and services. By 2019, less than three years from now, CMS hopes to pay one flat fee per beneficiary to large health care organizations ( think HMOs) thus fixing their costs. That large organization will then be responsible for providing total care to a local population.   Hospitals and large health care systems have been purchasing physician practices and employing the doctors in organizations known as Accountable Care Organizations (ACO’s). These health systems believe that by employing the doctors they will control their ordering and spending habits and reduce costs to the overall system. They hope to drive an aging private community physician population into early retirement or at least to stop coming to the hospitals to care for their own patients. They still want these patients to come to their hospital for care but want their employed physicians to provide the care.

If you look around the community you will notice that the major hematologic and oncology groups are now owned by Boca Raton Regional Hospital, as is the major surgical group, several cardiology groups and a host of internists and family practitioners.  The hospital has additionally partnered with its contracted emergency room physicians to open numerous walk in clinics in young population centers to capture that business. At the same time that our local regional hospital is purchasing practices and discouraging local private physicians from continuing to practice, they have introduced a residency training program in internal medicine and surgery. By the fall of 2017 we can expect 100 internal medicine physicians and up to 45 surgical physicians fresh out of medical school and beginning their training, to be serving as a cheap physician labor force for Boca Regional Hospital.  The hope is that ultimately, the Charles Schmidt College of Medicine at FAU will attract and develop a clinical faculty worthy of a university and academic medical center that will enhance medical care in our area but until then we will always wonder, as anesthesia puts us to sleep, who actually is performing our surgical procedures?   Additionally one wonders if you become ill with a serious illness, will you be permitted and covered to see the best physician at the best institution for your problem or will you be required to stay in a narrow network of local providers contracted with the local health entity?

If physicians choose not to join a large health system organization as an employee they will be required to be part of a merit based payment system.  Government administrators, employers and private insurers are certain they can define and quantitate “quality care.”  It is unclear whether there is any meaningful evidence of what “quality care” really is.   Quality care will include parameters like patient satisfaction ( if you are not given an antibiotic for your viral illness or a narcotic pain medicine for your injury appropriately based on the illness or injury will the provider be given a low patient satisfaction grade?), did you counsel an obese patient to lose weight?  Did you counsel a tobacco smoker to stop?  Did you intervene to control a patient’s blood pressure?  All the data entry will require the physician to spend time in front of the computer screen checking more boxes and less time in face-to-face patient care.  Computers will need to communicate with each other from the office to the hospital to the lab etc. but it is unclear who will pay for this? At the end of each year the doctors will be required to send all their patient care data electronically to CMS for review.

Many physicians will choose to just leave or “opt out” of the Medicare system. They will contract privately with patients and be able to order tests and studies at approved institutions but they will not be reimbursed by Medicare for their services nor will the patient be reimbursed by Medicare for the cost of those doctors’ visits and services.  In most areas of the country where the population is not overwhelmingly composed of senior citizens 65 years of age or older, doctors have stopped seeing Medicare patients for just this reason. This may become the norm rather than the exception in South Florida as well.

For the moment my concierge practice is not changing anything. We continue to participate in all the CMS quality programs such as Meaningful Use and PQRS , vaccine registry and Eforcse (a controlled substance prescribing data base) despite the cost and time involved just to leave our future options open. I remain committed to giving my patients longer quality visits and following them where possible into the hospital when they need hospital services. As patients and citizens it is urgent that you become familiar with what CMS and the Federal Government are doing with your taxes and health care options and hold them accountable to your wishes!  If you have questions about this give me a call or set up a special time to discuss this face-to face.

Medicare Will Not Pay For Bone Marrow or Umbilical Cord Blood Transplants

Treatment of blood disorders, leukemia and lymphomas today includes the use of life saving transplants of bone marrow from genetically similar donors and use of newborn childrens’ umbilical cord blood containing stem cells.  The National Marrow Donor Program (NMDP), Be the Match, is the organization which operates the national match registry and has worked for the last 30 years to find 13.6 million adult bone marrow volunteer donors and 225,000 units of fetal cord blood for use. The NDMPs relationship with similar organizations across the globe creates a pool of 24.5 million potential marrow donors and 609,000 units of cord blood.

There are people who need these vital products and cannot find a match but, fortunately, that number is declining. The real problem in men and women 65 years of age or older is that outdated Medicare reimbursement policies do not pay for these products and services and the cost is too expensive for many to bear themselves. The Centers for Medicare & Medicaid Services (CMS) has created barriers to Medicare age recipients being covered for these products resulting in financial uncertainty for the patient. The actual cost is beyond the means of most working individuals to bear.

While private insurers cover more than 70 diseases and conditions, Medicare covers less than a dozen.  The US Department of Health and Human Services calculated that almost 20,000 people in the U.S. could benefit from life-saving marrow or cord blood transplant each year but do not receive them because CMS policy does not cover them.   Where Medicare covers the conditions, the rate of reimbursement is often insufficient to cover the costs.  As Baby Boomers become eligible for Medicare the problem will intensify.

Dr Fred LeMaistre, M.D., director of the Sarah Cannon Blood Cancer Network authored an editorial and appeal to the physician community to lobby for better coverage of marrow and cord blood transplants as a life saving measure.

I for one was stunned to realize just how poor the coverage has remained for these services and find it disgraceful that Sarah Palin’s predicted death panels have now materialized in the form of accepted lifesaving technology not being covered after age 65.  If you are as surprised as I am write to your Congressional representatives and demand appropriate reimbursement for bone marrow and cord blood transplants to save lives!

Increased Dementia Risk in Senior Citizens Due to Proton Pump Inhibitors (PPIs)

Brittany Haenisch, PhD of the German Center for Neurodegenerative Diseases in Bonn, has reported in JAMA Neurology, a study from health insurance data suggesting that taking Proton Pump Inhibitors (PPIs) such as Aciphex (omeprazole), Protonix (pantoprazole), Nexium (esomeprazole), and Prevacid (lansoprazole), was associated with a markedly increased risk of developing dementia. The correlation was stronger in men than women with a slightly increased risk for those taking Nexium.

The study, conducted from 2004 through 2011, looked at 73,679 people age 75 years or older and who were free of dementia at “baseline”.  It revealed 29,510 patients (40%) developed dementia and, of these, almost 3,000 (average age of 84) were taking a PPI medication. The authors concluded that avoiding PPIs may prevent dementia.

All of these medicines are now freely sold over the counter not requiring a prescription. Their use has dramatically increased. There is belief from animal studies that PPIs cross the blood brain barrier and effect the production of amyloid and tau protein associated with dementia. In humans, B12 levels can be lowered effecting cognitive ability. None of this data shows a clear cause and effect relationship so we cannot say PPIs hasten the onset or cause dementia. Newer well designed controlled and blinded studies will be needed for this purpose.

In the interim, I will ask my patients to reduce or avoid these medications. We can treat heartburn and indigestion with products such as antacids, weight loss, eating smaller portions and staying upright after those meals, loosening your belt at the waist and avoiding those foods that reduce lower esophageal sphincter muscle pressure leading to reflux.

There will be some with conditions such as Barret’s Esophagus, which is precancerous, and recent bleeding ulcers which require the use of PPIs for eight or more weeks and then switch to Tums, Rolaids, Gaviscon or Carafate. Some patients will need the PPIs for symptom relief beyond eight weeks and they will need to make a tough decision between symptom relief and increased dementia risk while the researchers search for the answer.

How Often Do Screening Colonoscopies Result in a Complication?

Harlan Krumholz, MD is the director of the Yale Center for Outcomes Research and Evaluation (CORE). His team at Yale is being paid extraordinarily well to determine what works and what doesn’t in Medicare. Their data will theoretically allow Medicare to issue payment for services based on success rates of care without complications. His group is part of a national program promoted by the Center for Medicare Services (CMS) to spend less for more effective high quality care. This in my humble opinion is “voodoo” health care policy.

One of their areas of interest is trips to the emergency room or hospital within 7 – 14 days of a colonoscopy. They developed a formula to look at this problem and applied it to Medicare claims data in the year 2010 in NY, Nebraska, Florida and California. They found 1.6% of healthy individuals going for screening colonoscopy ended up at the hospital within seven days. They found wide variations in this rate coming from different facilities and different doctors. When the data is extrapolated to the 1.7 million Medicare beneficiaries undergoing screening colonoscopy annually it indicates there will be at least 27,000 unplanned hospital visits within seven days of the procedure.

Determining what causes complications of a screening procedure so we can determine a root cause and then prevent it is a good thing. However; the research needs to be done by independent groups not receiving funds from CMS which has a clear and strong conflict of interest!

We need to be looking at complications related to the choice of preparation, choice of colonoscopy, choice of anesthesia and whether polyps were removed and or biopsies taken. We additionally need to assess the definition of “low risk patient.”

Within the recommended age group for screening colonoscopies of 50-75 years old, very few patients are not taking prescription medications as well as supplements. The research needs to look at procedures such as CT Scan virtual colonoscopy and fecal immunochemical human occult blood testing as well for efficacy and complication rate.

There are currently DNA analysis tests of columnar epithelium colon cells sloughed during a normal bowel movement. Pre-cancerous polyps and colon cancer have distinctive DNA patterns that can be detected by looking at fecal material. There is no prep but the cost of $500 makes determining if it works and under what circumstances important. If it works then shouldn’t it be the screening test to determine who needs to have a colonoscopy? Yes, the research must be done but it must be done by agencies not affiliated with CMS with their stated goal of spending less for better service and better quality.

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