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 The real problem in men and women 65 years of age or older is that outdated Medicare reimbursement policies do not pay for these products and services and the cost is too expensive for many to bear themselves.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!

High Disability and Death Rates in Bleeds Associated with New Oral Anticoagulants

In the trailer for the movie Jaws 2 they show a swimmer in the ocean with a deep voice saying, “Just when you thought it was safe to go back into the water…” followed by the classic music associated with a shark attack and a big fin approaching the unsuspecting swimmer. I feel much the same way upon reading a Medpage Today online journal review of an article in JAMA Neurology published on December 14, 2015. Jan C. Purrucker, MD and colleagues looked at 61 consecutive patients with non-trauma related cerebral hemorrhages due to the newer oral anticoagulants Pradaxa, Xarelto and Eliquis. Overall there was a death rate of 28% at three months and “two out of 3 survivors had an unfavorable outcome.”

In October of 2015 the FDA approved the use of the antibody fragment idarucizumab (Praxbind) to reverse anticoagulation in patients bleeding from the administration of the oral anticoagulant Pradaxa. There are currently no medications to reverse the bleeding from the drugs Xarelto or Eliquis but we are promised that new products are in development. The article goes on to discuss how physicians have been forced to improvise when patients on these medications show up bleeding. They have tried fresh frozen plasma, 3-factor, 4-factor and activated prothrombin complex concentrates prothrombin complex concentrates, recombinant factor VIIa and cryoprecipitate alone or in combination with marginal success at best.

Despite there being no antidote to these blood thinners, the massive direct to consumer advertising continues on television prime time and magazines as if the products are no more dangerous than an antacid for heartburn. Coumadin or warfarin is the prototype anticoagulant working by inhibiting vitamin K dependent clotting factors. Its effects are reversible with administration of Vitamin K and clotting factors if bleeding occurs. Coumadin requires periodic blood tests (INR) to check on its efficacy and there is a long list of medications and foods that need to be avoided or adjusted while taking it. It is less convenient but safer in the sense that its effects can be reversed with medication.

The newer oral anticoagulants were championed by several studies that suggested that they were more effective in preventing embolic strokes in patients with the heart rhythm atrial fibrillation. Many experts in the field felt that those conclusions were flawed because the Coumadin group was not tightly regulated to keep their INR in a therapeutic non-clotting range thus unfairly biasing the results in favor of the newer agents.

There is no question that the newer agents are more convenient than warfarin treatment, but until there are readily available antidotes, complications seem to be more difficult to limit and control.

Does Not Testing the PSA Lead to More Advanced Prostate Cancer?

Mortality from prostate cancer has diminished by almost 40% since the introduction of the PSA test in the late 1980’s. Much of this is due to the use of the PSA blood test for screening purposes. In 2011 The US Preventive Screening Task Force strongly condemned the use of PSA screening. They felt that we were finding too many inconsequential early malignancies that would not lead to death and were being over treated. In their eyes, prostate cancer treatment with surgery and or radiation carried a high price tag with multiple long term complications and the benefit of screening was not worth the risk. Prior to the USPSTF”s 2011 recommendation against screening for prostate cancer with a PSA there were 9000 – 12,000 new cases of prostate cancer diagnosed per month. In the month following the USPSTF recommendation not to screen with PSA the number of new cases dropped by almost 1400 a month or over 12%. Over the next year the decline in prostate cancer diagnosis was 37.9 % for low-risk prostate cancer, 28.1% for intermediate risk, 23.1 5 for high risk and 1.1% for non-localized cancer. Clearly if you do not look for a disease you will not find it.

In the December issue of the Journal of Urology, Daniel Barocas, MD, of Vanderbilt University and colleagues discussed the PSA testing controversy. They too noted that the consequences of not screening for intermediate and high risk prostate cancer by performing the PSA test may lead to individuals presenting with far more advanced disease that is more difficult to treat, has more complications and ultimately leads to disease related deaths. His position was debated by two major urologists in the editorial section of the journal with no firm conclusion being reached.

In an unrelated article, the Center for Medicare Services or CMS announced that it is considering penalizing physicians who test the PSA for screening in Medicare patients beginning in 2018 as part of their paying for value and quality. They said that physicians need to present their patients with an ABN (advanced beneficiary notice) stating that Medicare will not pay for this test, before the blood is drawn or face fines and penalties.

Men in their forties and older have been put in an uncomfortable and inappropriate position by health policy leaders. The truth is we are currently unsure how and when to test for prostate cancer in men with a normal digital rectal exam (DRE). The consequences of not paying for screening will not be known or understood for easily ten to fifteen years. It is clear that early stage disease has the option to be observed for progression with minimal consequences in the short term. Not enough time has elapsed for anyone to know the long term effects of this policy change. Unfortunately, men in this age group are all guinea pigs in the public health policy laboratory while the data to reach a firm scientific conclusion is assembled. The predominant policy today is spending less and doing less. With this in mind, it is best for men to see their doctor, have an annual digital rectal exam, discuss their family history of prostate disease and reach an individual decision on PSA screening appropriate for their unique situation rather than one based on large population policy.

There is No Hope for Ending Medicare Fraud

South Florida is apparently a hotbed for criminal Medicare fraud. It is easy theft with crime rings accessing Medicare numbers of the elderly in Dade County and Broward and setting up durable medical equipment companies that bill our local Medicare subsidiary for equipment that doesn’t exist. Having said that, yesterday I received a Medicare Summary of Benefits letter for my mother at my home. She is almost 90 years old and my brother and I are her legal guardians and handle all her financial affairs while she resides in a skilled nursing facility in northern Palm Beach County, Florida. We moved her to this excellent campus in May of 2015 from a facility in Broward County and by submitting a change of address notice to the US Post Office, all her mail now comes to me. The official Medicare Benefits Summary stated that on September 11, 2015 a claim had been received for a wheelchair for my mom for $280 from a durable medical equipment company in Miami, Florida. The ordering physician was her former physician at her former Broward County skilled nursing facility. I thought it was strange that a bill would be submitted for a wheelchair four months after she was gone from that facility so I tried to reach the doctor. I was told that he was no longer at that facility. I next called my mom and asked her if she had received a new wheelchair in the last few months and she just did not remember if she had or not. I had no knowledge of it but the move from one facility to another accompanied by closing down her apartment in the assisted living section had been tumultuous and disorderly.

I then called the Medicare Fraud number listed on the piece of mail, 1-800- Medicare. The call was answered by an automated attendant who did not list “Fraud Report” as one of the choices so I pressed 5 for “other.” I was placed on hold for five minutes and a pleasant gentleman asked me why I was calling. I explained and he politely asked me to please hold on. Another five minutes elapsed before he got back on the line and apologized for the delay. He started asking me personal questions about my mother for security purposes such as her address, phone number, date of birth, Medicare number. He then asked me to hold on while he prepared a report and another seven minutes elapsed. He told me he would be transferring my call to a supervisory claims officer and I held on again.

It took five or more minutes before a woman got on the phone and repeated the same questions I had already been asked and answered. I tried to explain the purpose of the call and my relationship to my mother but she politely silenced me and told me that she had the original agent’s summary and knew the reason for the call. She asked me to hold on while she looked up the claim and another ten minutes elapsed. When she returned she told me that Medicare paid durable medical equipment claims monthly for up to twelve months and possibly this was a late claim for a 13th month. I then asked her what type of non-motorized wheelchair could possibly cost 12 X $280. I explained to her that all I was interested in was reporting a suspicious claim. She told me that without me forwarding her a copy of my Power of Attorney form she would not be able to reveal any claims history information to me. I told her I wasn’t asking for her to reveal any information but was just trying to report a suspicious Medicare claim. She responded that the claim had been denied and not paid so why was I making such a fuss in the first place. Having invested almost an hour trying to be a responsible citizen I gave up. If this is the type of system we as citizens put in place and tolerate then we deserve to be ripped off!

Two Handoffs with Different Outcomes

My 66 year old professional athletic patient had a history of a scar tissue related small bowel obstruction seven years ago related to a previous appendectomy. He now had similar symptoms with cramping, lower abdominal pain, and some nausea. Since his office was next door to his longtime friend and gastroenterologist he called over there. He was given an appointment with the junior partner since his buddy was out of town. Thirty years earlier I had referred him to that practice. The junior partner examined him, thought it was a self-limited viral illness and sent him home. The next day the two met in the Emergency Department for similar symptoms and once again the patient was sent home. The symptoms continued for 48 hours, and at the end of one of his long workdays he again saw the junior partner. This time the gastroenterologist sent him over to the hospital for a CT scan at about 6PM. Two hours later he received a phone call that the patient had a small bowel obstruction and the radiologist inquired of the GI specialist; “What should I do with him?” He was told to send him to the Emergency Department. When the physician in the ED called the GI doctor for admitting orders, he responded,” call his PCP (primary care physician) I am a consultant and I do not admit patients. “Forty five minutes later I received a call from the emergency department informing me for the first time of my patient’s problem and asking me to come in and admit the patient to the hospital. I asked him why the GI doctor was not taking ownership of the problem. I was told that the gastroenterologist said he was a specialist and did consulting not admissions. When I called the gastroenterologist directly I reached one of the covering partners who told me, “We are only gastroenterologists and we have not kept up our certification in internal medicine so we are really not qualified to admit a patient with a bowel obstruction or provide the day to day medical care.”

Another patient, 67 Hispanic and female was being treated for depression. She was under the care of a psychiatrist and in the middle of a medication adjustment. Her husband brought her to me because she was hallucinating, talking to her deceased father, acting violent and sexually inappropriate. I called her psychiatrist and then her neurologist who both answered the phone call immediately and suggested we schedule a CT scan of the brain. It showed a large brain frontal lobe tumor with much swelling around it and a hint of hemorrhage. I met with the patient and informed her of the problem and called the local university medical center to speak to the director of their brain tumor department. The university center is traditionally difficult to communicate with and receive information from. This time the young new department chair took my phone call, reviewed the clinical scans and data sent to him by fax and said, “She seems like she needs our help. If she can come down now I will have our team meet her and begin her evaluation. Later that night she clinically deteriorated. I text messaged the surgeon. He responded within minutes and said, “Send her down now; my team will meet her in the Emergency Department. “ I received daily clinical updates from this department chairman and prior to discharge he called me with a complete review, medication list, things to look for and emergency contact numbers if the patient had a problem. The professionalism, thoroughness and collegial communication was outstanding and far safer for the patient than for my local patient with a bowel obstruction. I was treated as a professional colleague asking for help with a patient rather than a generalist medical doctor expected to whatever the procedural specialist did not want to do.

I thought the gastroenterologist was both rude and dismissive of primary care physicians. I believe he abandoned his patient and created a safety issue by not calling me directly if he wanted me to assume the patient’s care. I was so upset that I brought the matter to the attention of the Chairperson of the hospital department of medicine and the associate chair of our medical executive committee. Both told me that similar things had happened to them. One told me of a nephrologist performing dialysis on a mutual patient who sent a patient unannounced to the Emergency Department because his vascular access was amiss and never called him about it but expected him to admit the patient and obtain appropriate specialty help to deal with the infection. The other doctor told of a cardiology patient who saw a cardiologist in an office that was across the street from the hospital. The patient was in dire straits with florid pulmonary edema and great distress so he sent him by ambulance to the Emergency Department. When he got there and the Emergency Department called him he said, “I don’t admit. Call his PCP for that.” He never called the patient’s PCP either to tell him he was sending this mutual patient who was critically ill to the hospital. Both medical staff officers told me that I could not hope to change a national culture which dumps on the PCPs and the patients. They told me it was not a hospital staff problem but one I needed to solve with the individual consulting groups.

Failure to communicate and take responsibility for care you have begun especially when the problem is in your area of expertise is a safety issue. It will come back to harm a patient someday. When these same gentlemen are sitting in court testifying in that medical malpractice case they will say the system is not fair rather than recognize that their inactions contributed to the problem. Hospital administrators and hospital boards using physicians they now employ and a limited number of local private physicians they can control have created a culture of poor communication between caregivers at a time when the technology exists to make communication far simpler and easy. They choose physicians for committee positions that are easy to influence. Community and public input into the policies of local hospitals and health care delivery systems has been eliminated or limited so that the driving force for policy is profits whether you are dealing with a for profit or nonprofit facility. In this setting the probability of errors occurring and patients’ being harmed because of lack of communication is greatly increased. There is institutional indifference to this problem and the safety organizations responsible for inspecting hospitals have not addressed it yet.

Cold and Flu Season Coming

As we head into fall and winter we see an increase in the number of viral respiratory illnesses in the community. Most of these are simple self-limited infections that healthy individuals can weather after a period of a few days to a week of being uncomfortable from runny noses, sinus congestion, sore throats, coughs, aches and pains and sometimes fever. There are studies out of Scandinavia conducted in extreme cold temperature environments that show that taking an extra gram of Vitamin C per day reduces the number of these infections and the severity and duration in elite athletes and Special Forces military troops. Starting extra vitamin C once you develop symptoms does little to shorten the duration or lessen the intensity of the illness. Vigorous hand washing and avoidance of sick individuals helps as well. Flu shots prevent viral influenza and should be taken by all adults unless they have a specific contraindication to influenza. A cold is not the flu or influenza. Whooping cough or pertussis vaccination with TDap should be taken by all middle aged and senior adults as well to update their pertussis immunity. We often see pictures of individuals wearing cloth surgical masks in crowded areas to prevent being exposed to a viral illness. Those cloth surgical masks keep the wearers secretions and “germs” contained from others but do nothing to prevent infectious agents others are emitting from getting through the pores of the mask and infecting them. If you wish to wear a mask that is effective in keeping infectious agents out then you need to be using an N95 respirator mask.

Once you exhibit viral upper respiratory tract symptoms care is supportive. If you are a running a fever of 101 degrees or higher taking Tylenol or a NSAID will bring the fever down. Staying hydrated with warm fluids, soups and broths helps. Resting when tired helps. Most adults do not “catch” strep throat unless they are exposed to young children usually ages 2-7 that have strep throat. Sore throats feel better with warm fluids, throat lozenges and rest.

You need to see your doctor if you have a chronic illness such as asthma , COPD, heart failure or an immunosuppressive disease which impairs your immune system and you develop a viral illness with a fever of 100.8 or higher. If your fever is 101 or greater for more than 24 hours it is the time to contact your doctor. Breathing difficulty is a red flag for the need to contact your physician immediately.

Most of these viral illnesses will make you feel miserable but will resolve on their own with rest, common sense and plenty of fluids.

Real Food for Colonoscopy Preparation

Colonoscopies save lives. It is recommended that adults start having them at age 50 to detect pre malignant colon abnormalities and early colon cancer. For the physician performing the test, the colon must be clean of digested food and stool to observe the lining cells of the colon. The presence of fecal material blocks the view of the colonic mucosa. Those of us who have taken screening colonoscopies are well aware that the preparation for the test is far worse than the actual procedure (which you are usually sedated for in some manner.) Most colonoscopy preps involve starting a laxative the afternoon before the procedure and staying on clear liquids the whole day until the procedure is complete. Some preps ask you to drink large volumes of soapy flavored liquids. Others use smaller quantities of chemicals but the end result is frequent loose and watery stools until the stool looks the same on the way out as it does on the way in. At best the preparation is a necessary but unpleasant experience.

Corey Siegel, MD MS and Dough Knuth, RD along with Joshua Korzenik, MD, of Harvard Medical School have produced real food laced with PEG-3350 as a colonoscopy prep. They are so confident of this preps efficacy that they formed a company to produce it called Colonary Concepts Inc. Foods such as pasta, pretzels with dipping sauce, smoothies and nonalcoholic Pina coladas have been mixed with laxatives to produce a colonoscopy prep. They reported on their study results at Digestive Disease Week and in MedPage Today. According to the endocscopists who performed the studies on these patients, the colon was good to excellent in preparation for viewing. The patients had no problems with the prep and said they would gladly choose the real food prep again for future colonoscopies. Based on the favorable review of this prep a larger Phase II study is now in progress. This is a step forward for a necessary but uncomfortable screening procedure.