Archive for category Medical Equipment
June 3rd 2015 Kaiser Health News reported the ACA seemed to cause more provider visits for management of diabetes “More Patients, Not Fewer, Turn To Health Clinics After Obamacare”. This is both good and bad.
The “good”: more attention to a patient’s condition is likely to result in better diabetic management, fewer complications, fewer hospitalizations and longer life.
The “bad”: since clinic visits can be billed to insurance, clinics make appointments and make money for each visit. The payment for visits rather than outcome is expensive and a known problem in US healthcare (fee for service). Diabetes can be managed over the phone in many, if not most cases — but there is no money for the provider in that approach. Phone care has a much higher value for the healthcare system and the patient; but, low-cost high-quality (high value) care is not getting the incentive.
The care of diabetics is further compromised by the pharmacy. A key piece of equipment for a diabetic is a glucose meter. The manufacturer almost gives away the meter so they can make huge profits by selling the disposable test sticks. The sticks are not interchangeable, not generic, sold in small lots, each lot sold with a co-pay, each lot requiring a visit to the pharmacy, and the use of gasoline to make the trip. If you don’t have much money the speed-bump turns into a mountain.
The solution: every few years mandate a generic test stick that manufacturers of glucose meters must support. “Uncouple” the meter maker form the test stick maker. And, sell the sticks in lots that last for at least 90 days, and that are sent to the patient by mail. Adjust the payment to providers so that they must contact diabetics by phone to adjust medications at least 2 times per month in order to bill for a medium or high level clinic visit. Also, each provider must obtain patient satisfaction data to prove the adequacy of service.
Addendum: Here is a link to an interesting court case about glucose meters
Corruption 101: medical device makers. It’s unbelievable that in the same week we get reports of device makers paying physicians billions of dollars to use their products while the FDA approves devices with skimpy rules and secret files.
To pay cardiologists to “research” how a pacemaker works after the device is mass produced is like giving a coupon to a housewife to “research” a new laundry detergent. Except, the laundry detergent costs $5 whereas the pacemaker costs $30,000. This is a kickback and it is unethical (because the doctor gets the money and the patient gets no benefit).
The idea the FDA can and does approve new models of pacemakers without proof they are safe is beyond comprehension. Many of the recent recalls involve defective pacemaker electrical leads — new models are OKed without materials testing or prolonged flexion testing that most engineers would expect. Even Consumer Reports lab could do a better job. A car recall is one thing, but cutting a patient open and jerking out a defective pacemaker wire from the heart is something hugely different.
Self policing of device makers has failed — we need regulations with teeth. In addition to safety regulation a limitation on device profit is badly needed.
Elisabeth Rosenthal of the New York Times published her article “Even Small Medical Advances Can Mean Big Jumps in Bills” on April 6, 2014. Type 1 diabetes is a rapidly fatal illness without insulin treatment. The discovery of insulin in the 1920’s changed the disease from fatal to treatable and with improved insulin and improved devices to deliver the drug people with the disease now can look forward to a long life.
The article by Ms. Rosenthal points up the cost of current insulin pump therapy. She lists the yearly cost of insulin treatment for one woman as $26,470 (a large part paid by the woman’s insurance).
Surely, big pharma would not take advantage patients with life threatening illness like diabetes. Surely, they would not pad the bill with unnecessary equipment or lock-in patients to their brand of insulin with a device linked to that brand. Surely, US big pharma would not disadvantage US citizens and favor drug plans in other countries. WRONG, WRONG AND WRONG AGAIN. It’s the modus operaindi of such organizations and a lack of regulation that allows it to happen.
- Ms. Rosenthal comments on the fluff added to the bill: talking pumps with multiple colors and new models every year.
- The linking of insulin pumps to only one type of insulin (made by the insulin maker).
- The withdrawal of less expensive insulin from the market.
- The 70% profit on insulin.
- The limited number of companies that now make insulin.
- The sweet deals for countries that drive hard bargains (acquisition cost for a bottle of insulin in the UK $30 but in the US $200).
It seems there is a line to be drawn. On one side is the unquestionable benefit of research and development that brings fantastic life saving benefit to many patients. On another side is a business formula for fantastic profit to a few people. Fortunately, one need not choose either extreme — it is possible to have adequate research and reasonable profit as demonstrated in other parts of the world.
So, what can and should be done?
- Break up drug companies to separate the manufacture of insulin and the manufacture of insulin pumps. The competition in the pump market should not be limited by the drug maker.
- Limit drug patents with a strict end point and encourage smaller companies to make generics that may not be an exact copy but simply be similar (bio-similar).
- Set prices for drugs and devices based on realistic economic considerations (like limiting profit to 5%).
- Allow government sponsored research to compare various types of similar therapy to allow a reasonable choice by patients and providers.
- And, allow the government to negotiate prices since the government now pays a big part of health care costs.
Jennifer Levits reported in the Wall Street Journal 12/18/13 “Doctors Eye Cancer Risk in Uterine Procedure“. She recounted the story of Dr. Amy Reed who had a hysterectomy. The uterus contained fibroids and the fibroids contained cancer. The procedure was done with an instrument, the morcelator. In kitchen terms it is a combination blender and vacuum cleaner. It is used during laproscopic surgery to chop up things (like a uterus with fibroids) and remove them through a small incision in the abdomen.
The problem is the morcelator does not remove all the tissue. A few cells escape the vacuum and they are left behind in the abdomen. If those cells contain cancer the cancer is then planted in the abdomen later to grow and likely kill the patient. Dr. Reed developed the seeding of cancer and claims other procedures would be better. Traditional surgery removes the uterus and fibroids intact with less chance of spreading any unsuspected cancer.
Here is what the package insert that comes with the morcelator says:
CAUTION: … use of the … Morcellator may lead to dissemination of malignant tissue.
So what are the statistics?
- 20% – 40% of women will develop fibroids
- 1 in 1000 cases of fibroids contain cancer
- intact removal of fibroids with malignancy failed to stop the malignancy 19% of the time
- morcelator removal of fibroids with malignancy failed to stop the malignancy 44% of the time
The big question is: should a morcelator be used if a woman has fibroids because it may double the risk of spreading an unsuspected cancer?
The simple answer is NO, because there are other surgical options. But, will women accept that answer? The laprosocopic procedure has less pain and quicker recovery, so the answer turns out not to be so simple. There are many forces at work on the decision to continue to use the morcelator. The analysis of these forces is called force-field analysis which was originally described by social scientist Kurt Lewin in the 1940’s. The following is such an analysis (the rating of force vectors is by the author of this blog):
So, what will happen? It seems at this point the morcelator will continue to be used. But, the risk remains. Law suits will continue. Perhaps a safer device will be developed. Perhaps a high risk of litigation will be perceived by gynecologists and the malpractice insurance companies as being too great. Such risk will lower the forces from doctors and perhaps tip the balance. Time will tell.
Update (8/1/14): since the original post the FDA issued a warning about morcelators. Yesterday, Johnson & Johnson, the major supplier, stopped selling morcelators. Looks like the forces to abandon the morcelator have been joined by the FDA and the manufacturer.
Update (2/27/15): yesterday the Wall Street Journal reported United Health (insurance) requires surgeons to obtain permission for procedures that might use the morcelator — “another blow” to the device. At this point any surgeon using the device must feel like they are walking a tightrope without a net.
The above graph is from the Dartmouth Atlas of Health Care and shows the Medicare expenditure per patient for medical equipment in each state. As with most Dartmouth graphs, the point is to highlight tremendous variability across the country. The rules of payment are the same across the country yet the system fails to follow the rules. Consistency means reliability, but the opposite is also true, inconsistency means unreliablilty. Medical equipment includes such things as nebulizers, wheelchairs and walkers to name a few.
Sadly, the medical equipment business is a hotbed of fraud and incompetence. There are just as many elderly people per capita in Iowa as Florida, but Florida has no grip on costs. Arizona monitors Medicare equipment spending quite well, but Texas is out to lunch.
There are so many problems it is hard to know where to start, here are a few examples:
- The rules for equipment are incomprehensible (just look at the CMS web site for proof) so States have difficulty following the rules and crooks can easily submit fraudulent claims.
- Wheelchairs are essential for quality of life for many people. But, for many elderly people who have other people push them around the much less expensive “transport chair” is sufficient.
- Compressor/nebulizer equipment for asthma and COPD is 99% boondoggle and 1% needed. Patients who have a prescription for an inhaler do not need a nebulizer — but medical suppliers pass them out anyway. Medicare should not pay for nebulized medications in the first place since the usual medications are generic. There is near-universal agreement (except for suppliers) that a meter dose inhaler (MDI) is more effective than a nebulizer. So if Medicare is bent on providing inhaled medication at least provide the cost effective MDI. Canadian doctors rarely find a need for nebulizers because the government provides MDIs.
- Walkers are a good hedge against falling. A broken hip is a lot more expensive than a walker. But, why does Medicare pay $65 for walkers that probably cost $20 to manufacture?
- The idea of letting the supplier get the prescription directly is inviting fraudulent behavior. The local supplier does not have the staff to investigate the truck-loads of rules so what do you think happens? Forms are filled out like the ones that passed the system before, the equipment is delivered (mostly) and Medicare pays.
- Set a national Medicare budget for equipment with some sort of priority if the budget is tight.
- Medicare should nationally purchase large volumes of commonly used equipment then send it to people by UPS or FedEx (like Amazon)
- Physicians should prescribe equipment by computer directly to Medicare (or a national clearing house). Medicare and insurance companies could then monitor the indications electronically before providing the equipment. Also, this would allow contract bidding for the equipment. The equipment vendor makes no decisions except how to deliver the goods.