Why the Medicare System Can Not Stay Solvent

My spry 90 year old patient decided she had a urinary tract infection two weeks ago. She had difficulty urinating and the constant urge to void with no fever, no chills, no back pain, no bloody urine. She was advised to come in for an appointment the same morning but this didn’t suit her. The alternative choice was to see her urologist who made time available that same day. She decided this was not convenient either. I called her and took a history and attempted to negotiate a visit but she declined strongly. She chose to void into a sterile container she had at home, put it into the refrigerator for storage and start to take some ampicillin that had been prescribed for her last urinary tract infection weeks before. One day into the ampicillin therapy she had her full time aide drop the urine off at the office for a culture and analysis (It came back negative for an infection several days later). That night she could not void. She called the urologist and the covering doctor suggested she drink more water. She complied even after she developed nausea and vomiting which continued into the early morning hours. Her aide called 911 and EMS brought her to the emergency department.

This frail elderly woman has not been eating well for months. As her total protein drops and her activity diminishes decreasing her leg muscle tone, her lower extremity peripheral edema or swelling increases. Her veins drain less efficiently than in the past contributing to the swelling. She suffers from a chemical electrolyte regulatory abnormality with chronic low serum sodium. Vomiting electrolyte rich material and replacing it with electrolyte free water further diluted and lowered her serum sodium. Upon arrival in the Emergency Department, the ED physician noticed the swelling in her legs and reflex ordered a Congestive Heart Failure (CHF) lab panel. The government (CMS) has made such a big deal about recognizing CHF that physicians and hospitals are afraid to not recognize it and not treat it. If you don’t treat it there are financial penalties for the docs and the institutions. The CHF panel consists of expensive and sensitive heart muscle enzymes that elevate in a heart attack, a lipid profile and a BNP which elevates in CHF. The problem is that the heart enzymes and BNP elevate in a host of chronic conditions seen in the elderly unrelated to heart failure.

I was called into the hospital to evaluate and admit the patient in the middle of the night. A Foley Catheter was now inserted into her bladder and draining fluid. Steps had been taken to slowly correct her sodium abnormality. A urine culture was sent with the initial catheterized urine and the evaluation of her heart based on “indeterminate” heart enzymes was completed. She did not have a heart attack. She was not in heart failure. Her serum sodium rebounded slowly with a treatment called fluid restriction. Three days later she was voiding without the catheter, ambulating with her walker and aides assistance and ready to go home under the care of her aide and two daughters. She was scheduled to see me in 72 hours with the urologist to follow.

I called her the next day and she was doing fine. The next morning when I called she was constipated so we instituted a program which using over the counter medications corrected the problem. At 3 PM the next day she called my office and left a message that she wanted to speak to me. My nurse asked her if she was sick and she just repeated the need to talk to me. I called her when I finished with patients and she told me, “I am dying. I am very sick. I feel like I have to pee and I cannot. I have called 911 and I am on my way to the hospital.” When I tried to determine what the definition of “very sick” meant she couldn’t elaborate. She was not febrile. She had no chest discomfort or shortness of breath, she just couldn’t void. I called the ED and spoke to the head nurse and physician and reviewed her recent clinical course and findings. One hour later they called me to tell me she was in urinary retention and her bladder was overloaded. They placed a Foley Catheter in her bladder and ¾ of a liter of urine emptied relieving her discomfort and very sick feeling. The problem was that the ED physician saw her leg edema and sent off the CHF Lab Protocol again. This was a different ED physician than the week before. This time the Troponin I cardiac enzyme marker was in a higher in determinant range. “Steve,” he said, “her EKG is abnormal. I think she is evolving a myocardial infarction and needs to be readmitted.” I reminded him that we had completed this exercise last week with her long time cardiologist and her heart was fine. He told me he didn’t care. The risk medical legally was too high to send her home. The costs and hospital stay now start again.

This patient had daily 24 hour care by an experienced aide. Both her college educated adult children were with her. She had my office phone and cell phone as well as access to the very flexible urologist. She still chose to do it her way relying on EMS and Emergency Departments due to fear, anxiety and having no financial skin in the game. The urologist wondered why she didn’t just call him and he would have reinserted the catheter in his office. I wondered why she just didn’t call earlier so we could see her before my staff left for the evening. It didn’t matter if we were capitated, being paid for quality metrics or if the fee for service system was abolished. This strong willed independent complicated ancient senior citizen was determined to do it her way. The system runs on algorithms and protocols and generates information routinely that requires a common sense interpretation based on the clinical setting and issues. The risk of medical malpractice despite government funding this care plus the risk of government sanctions based on chronic disease protocols makes intelligent and compassionate care which is affordable almost impossible.

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Telemedicine and Acute Stroke Treatment

My community hospital is holding its quarterly physician staff meeting and one of the items on the agenda will be a bylaw change which will permit outside physicians, not credentialed or vetted by our hospital credentials committee, to perform video consults on patients within our hospital. Hospital administration is pushing this bylaw change, and since there has been a quiet coup which has transferred medical staff power from the community’s practicing physicians to the hospital employed and paid physicians, it is a foregone conclusion that it will easily pass.

The bylaw change is being requested because the hospital would like to continue to reap the benefits of being an ischemic stroke comprehensive treatment center and offering the health benefits to the community despite not being able to meet the criteria. If a patient presents to the emergency department within four hours of developing ischemic stroke symptoms they must be offered the administration of a “clot busting “drug Alteplase (t-pa). The patient must not have any bleeding tendencies and no evidence of active bleeding or a mass or tumor on head CT scan and must be examined by a neurologist within 45 minutes of arrival.

The problem is that most community based neurologists with outpatient office practices and hospital staff privileges cannot and will not drop everything they are doing and run to the emergency department to evaluate a new patient each time a stroke protocol patient arrives. When given an ultimatum by the hospital administration, that they must take call and be available within 45 minutes, our community neurologists en masse relinquished their hospital privileges.

The hospital countered by bringing in several research oriented academic neurologists and neurosurgeons to man the beautiful new Neuroscience Institute and provide coverage of the ED for the stroke protocol. Few if any of these physicians were able to develop and maintain a practice within the community and they have since left. The Emergency Department is staffed by employed board certified emergency physicians who are well qualified to diagnose an ischemic stroke and administer t-pa. They refuse to do so citing the liability of a poor outcome as the reason. Despite data indicating the benefits of t-pa administration in these situations, the 6 out of 100 chances of a bleed in the brain plus the 1 in 6 chance of death is enough to deter their participation.

You would think that since the hospital hires these physicians the logical choice would be to fire them and hire a group that will provide the state of the art care in a timely fashion. This has not occurred. You would think that the state legislature would grant the ED physicians sovereign immunity from medical malpractice suits if the patient meets the criteria for the ischemic stroke protocol and the patient is given appropriate informed consent for the procedure but this common sense legislation has not been developed or passed.

The hospital has chosen a different pathway. They are opting to hire neurologists from a university medical center who will provide video consults on ischemic stroke patients from an offsite location. Robots will actually examine the patient and televise the data back to the telemedicine center after an emergency department physician performs a brief initial evaluation. The neurologist off site will then provide the needed neurology consult to proceed with the injection of the clot buster.

I suspect the mechanism will work like this. A patient or family member will call EMS via 911 and be taken to the Emergency Department. A triage nurse will ask all the questions to qualify the patient for the t-pa protocol; a robot will examine the patient and transmit via TV the data to an offsite neurologist while an ER physician does an exam. A CT scan of the head and brain will be performed. If no bleed is discovered or tumor or mass that could bleed, t-pa will be administered by the pharmacy and nursing staff. Further intervention by an interventional radiologist and or neurosurgeon may then occur.

At no point in this protocol does it call for the patient’s primary care doctor or cardiologist or usual neurologist to be called. We will be called once the procedure is complete because neither the ER physician or the neurosurgeon or the interventional radiologist will want to admit the patient to neurology ICU. While our surgical ICU and Medical ICU/CCU are covered 24 hours per day by an outsourced hired intensivist group, the neuro ICU does not have that type of coverage.

I can hear it now, my phone ringing and upon picking it up I hear the voice of a clerk in the Emergency Department, “Hello Dr Reznick, Dr. Whateverhisorhername wishes to speak to you about patient Just Had A Stroke.” I get put on hold for five minutes and then in a flat nasal voice, “Hello Steve your patient came in earlier by EMS with symptoms of an acute ischemic stroke. They met the t-pa ischemic stroke criteria and were treated. Unfortunately, they had a major hemispheric bleed with mass effect and edema and are now unresponsive and intubated on a ventilator. We need you to come in and admit him and care for him.”

I will vote in protest against this bylaw. I will lobby for recruiting neurologists who are hospital based who will actually see the patient and care for them. I will lobby for a new state law to provide sovereign immunity for ED physicians treating ischemic strokes according to the internationally recognized protocol. I will lobby for our medical and surgical residents on site and in the hospital to be permitted to administer t-pa after meeting the appropriate criteria. I will not support out of the area physicians making the final call and leaving our local physicians to deal with their results.

Glucosamine and Chondroitin Sulfate Preserves Knee Cartilage in Osteoarthritis

My brother in law is a well-respected researcher and biochemist. Thirty years ago he treated his post exercise aching knees with glucosamine and chondroitin sulfate and felt better. Since then he is a fan. Although he is a firm believer in the scientific method and double blind controlled research studies, we could not find any research to support his observations.   The discussion then turned to, “it helps me and it doesn’t hurt me so why not?”

In a double blind study sponsored by the National Institute of Health known as GAIT, 1500 or more patients with osteoarthritis and a painful knee were randomized to either receive glucosamine and chondroitin sulfate, each substance individually, Celebrex or placebo for six months. The results showed neither led to reduced pain.

Several other studies were as non-conclusive. In the few studies where pain was reduced the study methods and design were criticized and the results were felt to be questionable as were the conclusions of the researchers.   There was nothing positive to say about glucosamine and chondroitin sulfate until a recent study by Martel- Pellitier, Canadian researchers published in Arthritis Care and Research those individuals who took the combination for six years or greater tended to preserve their knee cartilage better than those who did not.  While the knee cartilage was maintained there was no difference in pain or complaints of symptoms between the treated and non- treated group. They believe that by preserving knee cartilage over time there may be less necessity for that joint to be replaced eventually.

I am sure over time this will be studied as well. In the meantime glucosamine and chondroitin sulfate seems to have little toxicity and ultimately my brother in law may be on to something positive.

How Tightly Should We Control Blood Pressure in the Elderly?

A recent publication in a fine peer reviewed medical journal of the SPRINT study proved that lowering our blood pressure to the old target of 120/80 or less led to fewer heart attacks, strokes and kidney failure.  There was no question on what to do with younger people but to lower their blood pressure more aggressively to these levels. Debates arose in the medical community about the ability to lower it that much and would we be able to add enough medication and convince the patients to take it religiously or not to meet these stringent recommendations?

There was less clarity in the baby boomer elderly growing population of men and women who were healthy and over 75 years of age. The thought was that maybe we need to keep their blood pressure a bit higher because we need to continue to perfuse the brain cells of these aging patients.

A study performed in the west coast of the United States using actual brain autopsy material hinted that with aggressive lowering of the blood pressure, patients were exhibiting signs and symptoms of dementia but their ultimate brain biopsies did not support that clinical diagnosis. In fact the brain autopsies suggested that we were not getting enough oxygen and nutrient rich blood to the brain because of aggressive lowering of blood pressure.  Maintain blood pressure higher we were told using a systolic BP of 150 or lower as a target.

A recent study of blood pressure control in the elderly noted that when medications for hypertension were introduced or increased a significant percentage of treated patients experienced a fall within 15 days of the adjustment in blood pressure treatment.  This all served as an introduction to a national meeting on hypertension last week during which the results of this same SPRINT (Systolic Blood Pressure Intervention Trial) strongly came out in favor of intensive lowering of blood pressure to 120/70 to reduce heart attacks, strokes and mortality in the elderly and claimed even in the intensive treated group there were few increased risks.   On further questioning however by reclassifying  adverse events in the SPRINT trial to “ possibly or definitely related to intensive treatment, the risk of injurious falls was higher in the intensive vs conventional treatment group.”

What does this mean in the big picture to all of us?  The big picture remains confusing.  It is clear that lowering your blood pressure aggressively and intensively will reduce the number of heart attacks and strokes and kidney disease of a serious nature.  It is clear as well that any initiation or enhancing of your blood pressure regimen puts you at risk for a fall. You will need to stay especially well hydrated and change positions slowly during this immediate post change in therapy time period if you hope to avoid a fall.  Will more intensive control of your blood pressure at lower levels lead to signs and symptoms of dementia due to poor perfusion of your brain cells?  With the SPRINT study only running for three or more years it is probably too early to tell if the intensive therapy will lead to more cognitive dysfunction.

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.