The line between pharma and health information technology is blurring. SAAD (Software ad a drug stands alongside . of SAAS (Software as a Service)
The progress is punctuated by the FDA which will require vetting of health software when it is linked to treatments. No such requirement has been proposed for electronic health records, but is now being required for mobile health applications and/or remote monitoring.
In the past the FDA (Food and Drug Administration) was responsible for the safety of food stuffs. It is also responsible for the safety and efficacy of pharmaceuticals, and medical devices. The vetting of pharmaceuticals is complex and very expensive. The cost of new drug development is quoted as between 450 million dollars and 900 million dollars. Pharma uses these figures to justify the cost of new proprietary formulations. The patents are valid for 16 years. When a new drug makes the 16 year mark it becomes available to other pharmaceutical companies to be sold as generic drugs, and the cost drops significantly.
If and when SAAD becomes available for diagnosis and treatment it will require FDA approval. Usually this takes at least 12 to 24 months, unless there are urgent medical considerations. I would expect a price increase for SAAS.
Therefore it is not at all a guaranteed win.
Finally, mHealth is the winner : Software as a drug? - Health Files by Rajendra Pratap Gupta | ET HealthWorld
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Monday, January 30, 2017
Thursday, January 26, 2017
Here's what primary care doctors really think about Obamacare - LA Times
Conducted in December and January and published online Wednesday in the New England Journal of Medicine, the new survey shows that nearly three-quarters of general practitioners favored making changes to the Obama administration’s signature healthcare reform measure.
But in this nationally representative sample of primary care doctors, only 15% favored the law’s repeal. Among responding physicians who voted for Donald Trump, only 38% favored the law’s repeal.
That makes the repeal of the Affordable Care Ac, also known as Obamacare, far less popular among the physicians on the front lines of medicine than it is in the American body politic. A Kaiser Family Foundation poll taken after the November 2016 election found that 26% of Americans wanted to see Obamacare repealed.
Among the survey’s most striking findings was strong support for an extension of the Affordable Care Act that is absent from any GOP proposals: Two-thirds of primary care physicians endorsed the idea that any healthcare reform should include a public insurance option resembling Medicare that would compete with private plans.
Study coauthor Dr. Craig Evan Pollack, an internal medicine specialist at Johns Hopkins University School of Medicine, said he was struck by the strength of physicians’ opposition to measures that increased complexity and shifted costs toward patients. He suggested it was a direct result of doctors’ experience in caring for patients.
“As physicians, we see people struggle with out-of-pocket costs, deciding which types of care they’re able to afford and making very challenging decisions,” said Pollack. Primary care physicians, he added, “try to advocate for their patients.”
The new survey reflects the answers of 426 physicians drawn from a master file of the American Medical Assn. and is considered a nationally representative sample. Its findings appear to mark a significant shift in physicians’ opinions about the Affordable Care Act. In the opening months of 2015, 48% of primary care physicians had a favorable opinion of the Affordable Care Act and 52% viewed it unfavorably.
Dr. David Grande, an internal medicine physician at the University of Pennsylvania’s Perelman School of Medicine, said that as the Affordable Care Act got up and running, virtually all of his colleagues have treated new patients who had previously been uninsured or who struggled to hold on to insurance.
NASA just made all the scientific research it funds available for free -
All of this research data contains medical studies and biologic studies. It also contains the development of sensors for remote monitoring of vital signs, blood glucose monitoring. It is a treasure chest of data.
NASA just announced that any published research funded by the space agency will now be available at no cost, launching a new public web portal that anybody can access.
The free online archive comes in response to a new NASA policy, which requires that any NASA-funded research articles in peer-reviewed journals be publicly accessible within one year of publication.
Right now, there are some 861 research articles in the database, and you can expect that number to keep rising as NASA-funded researchers get on board with the new policy.
As you’d expect, there’s an enormous spread of research already on offer, ranging from exercise routines to maintain health during long-duration space missions, to the prospects for life on Titan, and the risk of miscarriage for flight attendants exposed to cosmic radiation.
But not all NASA-funded research can be found in the archive. As the space agency indicates, patents and material governed by personal privacy, proprietary, or security laws are exempt from having to be included in PubSpace.
It also follows a growing general trend towards more openness in science research and academia more broadly. With frustration stemming over the commercial control wielded by the companies who own most academic publishing, some researchers are bypassing established journals altogether by uploading their work directly to the internet.
Others are illegally sharing scientific papers online in a dramatic bid to spread knowledge. At the same time, there are calls in Europe to make all published science funded by the public free.
NASA just made all the scientific research it funds available for free
Tuesday, January 24, 2017
Wills Eye Hospital Studies Glaucoma App
"There's an App for that !
The result was somewhat surprising
All of us are aware of the cross over between technology and medicine. Often these developments are fueled by young engineers who decide to become physicians, or biomedical engineers.
It doesn't seem unreasonable that the smartphone in your pocket could be used for medical applications, education, remote monitoring, reminders, and access to your personal health information.
The list of 'mobile apps' grows daily. A search on Googe for Smartphone Medical Apps yields over 800,000 results. Some of them are duplicated, however the number of search returns is quite impressive.
Someone posits the market value generously. There are several caveats.
1. Buyers are not always consistent users. Studies reveal that purchasers often are curious and evaluate the application, but do not continue to use it for it's intended purpose, for one reason or another.
2. Reality often does not meet consumer expectation.
3. Treatments based upon the mobile app are dangerous unless the device and software are vetted by the FDA. Some apps are considered medical devices and must be approved for an IDE(Investigative Device Exemption prior to commercial marketing
The following are key features from the Wills Eye Glaucoma app:
- Educational videos about glaucoma, how to use eye drops, benefits of glaucoma laser treatment, and surgery
- A tutorial on how to take a visual field examination
- An eye drop reminder feature
- An appointment reminder feature
- Storage of medical information
- Tracking of eye pressure results
Monday, January 23, 2017
Federal Judge Blocks Anthem-Cigna Merger
Aetna and Humana to defend pending transaction - The Health Section
Yahoo News:
Aetna Inc.’s $37 billion deal to buy rival insurer Humana Inc. was blocked by a federal judge, thwarting one of two large mergers that would reshape the U.S. health-care landscape. Aetna said it was considering an appeal.
The transaction would violate antitrust laws by reducing competition among insurers, U.S. District Judge John D. Bates in Washington ruled on Monday. With the deal defeated, Aetna owes Humana a $1 billion breakup fee under the terms of the merger agreement.
“We’re reviewing the opinion now and giving serious to consideration to an appeal after putting forward a compelling case,” T.J. Crawford, an Aetna spokesman, said. A Humana spokesman didn’t immediately respond to a request for comment.
The government case against the merger focused on the market for private health plans for the elderly, known as Medicare Advantage. The U.S. argued the Aetna-Humana deal would have eliminated competition between the insurers in 364 counties in 21 states and likely forced seniors to pay higher premiums for Medicare Advantage plans. It also threatened competition on the insurance exchanges set up under Obamacare, the Justice Department said.
The government case against the merger focused on the market for private health plans for the elderly, known as Medicare Advantage. The U.S. argued the Aetna-Humana deal would have eliminated competition between the insurers in 364 counties in 21 states and likely forced seniors to pay higher premiums for Medicare Advantage plans. It also threatened competition on the insurance exchanges set up under Obamacare, the Justice Department said.
Aetna countered that the Medicare market is much larger than the Justice Department claims because it includes both Medicare Advantage plans and original Medicare, providing more choice for seniors than the government portrayed. Competition on the exchanges isn’t an issue, they said, because Aetna withdrew from all 17 counties at issue in the government’s case.
The judge sided with the government’s view of the Medicare Advantage market. “In that market, which is the primary focus of this case, the merger is presumptively unlawful—a conclusion that is strongly supported by direct evidence of head-to head competition as well. The companies’ rebuttal arguments are not persuasive,” Bates wrote.
Judge John B. Bates ruled the "proffered efficiencies do not offset the anticompetitive effects of the merger." A finalized deal would "substantially lessen" competition in the Medicare Advantage market and public exchanges, the federal judge concluded.
from Bloomberg
The government case against the merger focused on the market for private health plans for the elderly, known as Medicare Advantage. The U.S. argued the Aetna-Humana deal would have eliminated competition between the insurers in 364 counties in 21 states and likely forced seniors to pay higher premiums for Medicare Advantage plans. It also threatened competition on the insurance exchanges set up under Obamacare, the Justice Department said.
Aetna countered that the Medicare market is much larger than the Justice Department claims because it includes both Medicare Advantage plans and original Medicare, providing more choice for seniors than the government portrayed. Competition on the exchanges isn’t an issue, they said, because Aetna withdrew from all 17 counties at issue in the government’s case.
from Bloomberg
The government case against the merger focused on the market for private health plans for the elderly, known as Medicare Advantage. The U.S. argued the Aetna-Humana deal would have eliminated competition between the insurers in 364 counties in 21 states and likely forced seniors to pay higher premiums for Medicare Advantage plans. It also threatened competition on the insurance exchanges set up under Obamacare, the Justice Department said.
Aetna countered that the Medicare market is much larger than the Justice Department claims because it includes both Medicare Advantage plans and original Medicare, providing more choice for seniors than the government portrayed. Competition on the exchanges isn’t an issue, they said, because Aetna withdrew from all 17 counties at issue in the government’s case.
The judge sided with the government’s view of the Medicare Advantage market. “In that market, which is the primary focus of this case, the merger is presumptively unlawful—a conclusion that is strongly supported by direct evidence of head-to head competition as well. The companies’ rebuttal arguments are not persuasive,” Bates wrote.
Commentary (author)
Medicare Advantage plans are not true Medicare (original) plans. They are contracted entities of private insurers. Medicare Advantage plans represent a growing penetration of the overall Medicare market. These advantage plans are contracted and paid by Medicare. They offer their own risk management, quality assurance, and a relatively closed provider network.
The penetration rate varies widely from state to state, county to county, and rural vs metropolitan regions. The Kaiser Foundation offers specific figures on Advantage Plan penetration.
Saturday, January 21, 2017
The Spectacular Incompetence of 3rd Party Payers adds to Provider Burnout
The details of the Affordable Care Act are lost in translation. This post details the major problems with the provider-CMS insurance bureaucracy. It is also the major reason for most physician burnout. Whether or not the Affordable Care Act is repealed this is one of the major problems for any revised system.
To paraphrase Tolstoy, all competence is alike, but every incompetence is incompetence in its own way. Every time I think I’ve seen the horizon of incompetence, I’m dealt a surprise. The sun never sets on incompetence. In healthcare, incompetence can be found in odd places, such as three recent examples encountered with third party payers.
Case 1: Downgrading Caviar to Boiled Salmon
A patient was referred for a CT angiogram run off – which is a CT scan of the arteries of the belly, pelvis, both legs and feet – a very detailed and costly study. The cardiologist suspected a pseudo-aneurysm of the femoral artery. The exam was an overkill, I felt, as the femoral arteries could be covered in a CT angiogram of the abdomen and pelvis – you don’t need to image down to the toes. I was confident that a pseudo-aneurysm in the femoral artery would not extend to the arteries of the feet – it would be a world record, if it did. I suggested we stop the exam in the middle of the thigh. “That’s fraud,” warned the chief technologist, who was also an expert in billing.
The Spectacular Incompetence of 3rd Party Payers | THCB
To paraphrase Tolstoy, all competence is alike, but every incompetence is incompetence in its own way. Every time I think I’ve seen the horizon of incompetence, I’m dealt a surprise. The sun never sets on incompetence. In healthcare, incompetence can be found in odd places, such as three recent examples encountered with third party payers.
Case 1: Downgrading Caviar to Boiled Salmon
A patient was referred for a CT angiogram run off – which is a CT scan of the arteries of the belly, pelvis, both legs and feet – a very detailed and costly study. The cardiologist suspected a pseudo-aneurysm of the femoral artery. The exam was an overkill, I felt, as the femoral arteries could be covered in a CT angiogram of the abdomen and pelvis – you don’t need to image down to the toes. I was confident that a pseudo-aneurysm in the femoral artery would not extend to the arteries of the feet – it would be a world record, if it did. I suggested we stop the exam in the middle of the thigh. “That’s fraud,” warned the chief technologist, who was also an expert in billing.
“Why is it fraud to restrict the field of view to the area of clinical relevance?” I asked.
“You can’t bill for a CT angiogram run off and only do the abdomen and pelvis. That’s fraud.”
“You can’t bill for a CT angiogram run off and only do the abdomen and pelvis. That’s fraud.”
“Why don’t we bill just for CT angiogram of the abdomen and pelvis?” I asked.
“You can’t bill just for the abdomen and pelvis, the patient has been pre-authorized for a run off.”
“You mean I can’t do less and bill for less when the patient has been pre-authorized for more and the insurer will pay more?” I asked.
Case 2: Cutting your nose to spite your face
A young man had a cardiac MRI for palpitations. During the exam I spotted a hole in the heart – a left-to-right shunt. It was an incidental finding. I thought we should get flow measurements through the aorta and pulmonary artery – it would be useful information which could help the management, because the timing of repair of shunts depends on these parameters.
A young man had a cardiac MRI for palpitations. During the exam I spotted a hole in the heart – a left-to-right shunt. It was an incidental finding. I thought we should get flow measurements through the aorta and pulmonary artery – it would be useful information which could help the management, because the timing of repair of shunts depends on these parameters.
“Can’t do flows. He hasn’t been pre-authorized for them,” said the tech.
“Just do it. Don’t bill – I’ll take the flak,” I offered.
“Can’t, we’re forbidden to do more than has been ordered,” the tech protested.
The referring cardiologist agreed and put an order for flow mapping. However, the order needed authorization from insurers. I phoned the insurer who connected me to a physician from the advanced imaging management elite squad – also known as radiology benefit managers. The chap, a most boring metronome, told me that the first line test for left-to- right shunt was an echocardiogram. I explained that the patient, a young professional with a demanding job, would have to take another day off work – we could easily nip the issue in the bud within five minutes. But the chap continued like a broken down record, “Our guidelines say echocardiogram first.”
The referring cardiologist agreed and put an order for flow mapping. However, the order needed authorization from insurers. I phoned the insurer who connected me to a physician from the advanced imaging management elite squad – also known as radiology benefit managers. The chap, a most boring metronome, told me that the first line test for left-to- right shunt was an echocardiogram. I explained that the patient, a young professional with a demanding job, would have to take another day off work – we could easily nip the issue in the bud within five minutes. But the chap continued like a broken down record, “Our guidelines say echocardiogram first.”
I slammed the phone and muttered “ducking tosser” under my breath.
The patient came back another day for an echocardiogram and another day for another cardiac MRI for flow measurements because the echocardiogram was not clear enough. Imagine – two separate days of taking time off work, driving on the interstate, and finding parking, could so easily have been avoided. Not to mention that the insurer could have saved money. To say nothing about time wasted by physician, imaging department and unnecessary increased exposure to radiation. This was a purely administrative issue, and flies in the face of several well established medical guidelines. 'primum non nocere' and eliminated any judgment factor on the part of the legaly respomsible provider.
The patient came back another day for an echocardiogram and another day for another cardiac MRI for flow measurements because the echocardiogram was not clear enough. Imagine – two separate days of taking time off work, driving on the interstate, and finding parking, could so easily have been avoided. Not to mention that the insurer could have saved money. To say nothing about time wasted by physician, imaging department and unnecessary increased exposure to radiation. This was a purely administrative issue, and flies in the face of several well established medical guidelines. 'primum non nocere' and eliminated any judgment factor on the part of the legaly respomsible provider.
Case3: Charity is fraud Provider Confusion
I spotted a mass in the kidney at the edge of the field of view, which looked like cancer, in an elderly man having a cardiac MRI.
I spotted a mass in the kidney at the edge of the field of view, which looked like cancer, in an elderly man having a cardiac MRI.
“Let’s go lower and cover the kidneys, and the bladder,” I asked the technologist.
“I can’t. That’s fraud. Covering the kidneys will make this an MRI of the abdomen, which the patient doesn’t have a script for.” The technologist said.
“Fraud! WTF,” I barked.
“It is Medicare fraud if you do more for the patient than what you’ve billed for,” explained the technologist. I was losing my marbles – but I wasn’t going to relent with this one.“Just do it – put my name down. Say I insisted. And if it’s fraud to do more than I billed for, I’ll happily go to Guantanamo Bay for fraud.”
“Fraud! WTF,” I barked.
“It is Medicare fraud if you do more for the patient than what you’ve billed for,” explained the technologist. I was losing my marbles – but I wasn’t going to relent with this one.“Just do it – put my name down. Say I insisted. And if it’s fraud to do more than I billed for, I’ll happily go to Guantanamo Bay for fraud.”
The kidneys were covered. I overcalled the finding in the kidney – the patient did not have cancer. However, the technologist was correct – it can be considered fraud to dispense billable services (such as an MRI of the abdomen) to Medicare patients without billing Medicare. This reminds me of a physician I once met, who specializes in physical medicine and rehabilitation, and runs a direct pay practice. She doesn’t accept Medicare, Medicaid or any insurance. She sees kids of undocumented migrants for free one afternoon a week, but won’t extend the same courtesy (i.e. waiving charges) to patients on Medicaid because she fears she might be fried for fraud.
Charity is fraud with Medicare and Medicaid. Allow that to sink for a moment.
I understand it is fraud if you buy a ticket from Philadelphia to New York and get off at Boston, but how is it fraud if you buy a ticket to Boston and get off at New York? Who makes these rules? Who are these people? Which parts of their brain light up on functional MRI? What do they eat for breakfast? How can a country which gave the world Edison, Wright brothers, and Kim Kardashian produce such imbeciles?
I understand it is fraud if you buy a ticket from Philadelphia to New York and get off at Boston, but how is it fraud if you buy a ticket to Boston and get off at New York? Who makes these rules? Who are these people? Which parts of their brain light up on functional MRI? What do they eat for breakfast? How can a country which gave the world Edison, Wright brothers, and Kim Kardashian produce such imbeciles?
It is hard to maintain disdain for such buffoonery for too long because such spectacular incompetence is an art, a practiced art to be precise, but art nonetheless, and art induces wonder, eventually. But even this explanation is wrong. Third party payers are not incompetent. They may seem to be, but they’re not.
The reason insurers, and Medicare, would rather pay more, than less, for an exam, that is cut off their nose to spite their face, is that they don’t trust physicians. They don’t trust physicians because fifty years of health economics has yielded a spectacular insight – physicians, like crack dealers, are guilty of supplier-induced demand. This meme is now structurally embedded in payers.
The information to discern between physicians inducing their demand and physicians curbing their demand is too costly to obtain. So third party payers have a blanket rule – you can neither upgrade nor downgrade an imaging study, and if you do you’ll be paid nothing or will be done for fraud.
Don’t get me wrong – I’m flattered that I induce my demand in healthcare (I wish I could induce my demand in other areas, too). But a costly game of chicken is being played between payers and providers. It’s a game of reverse chicken actually, where both sides avoid staring at each other, and adapt to each other’s pathologies. The costs of this game may be forgivable but the inconvenience to patients is inexcusable.
The Bottom Line
There is an ever present tension between providers, hospitals, and insurance companies.
There are good reasons for this state of mind. Have you ever examined a bill from the emergency department and/or hospital visit or surgical procedure? This 'Alice in Wonderland' example truly astounds. Hospitals routinely send statements to the plans for tens of thousands of dollars and accept payments of less than 30% of the billed amount. Is this fraud? Technically, it is not since plans and hospitals negotiate contracts to lesser amounts. However if a patient is not insured they would receive a statement saying they owed the full amount. A heart stopper for the patient. This has been an ongoing situation since I began medical practice over 40 years ago, and it has become much worse. It becomes even worse if one attempts to examine why, the details of which are buried in bureaucratic mandates and rules regarding formulas for reimbursement, including the diagnostic related group, which reimburses based upon diagnosis rather than fee for services. Another set of payment reform in being added to the mix, that of value based payments,k which correlates the quality measures the hospital uses based upon an arbitrary metric created by 'health experts and committees which may have no real world value.
Disclaimer
The vignettes have been modified from their true state to protect patient health information and to protect the author from HIPAA vigilantes and bounty hunters. However, the gist of the vignettes is correct.
The Spectacular Incompetence of 3rd Party Payers | THCB
Friday, January 20, 2017
Trump’s Nominee For Agriculture Has Key Health Role |
Although consumers may simply think of the Department of Agriculture (USDA) as responsible for overseeing the farming industry, it also plays a key role in promoting health. The department is influential in maintaining the nation’s health in four key areas:
Nutrition Assistance
Although food insecurity across the nation has declined in recent years, the USDA found 12.7 percent of all households in 2015 faced hunger. The department helps address this problem by managing the nation’s food assistance initiatives. The Supplemental Nutrition Assistance Program (SNAP) is among the best known of those efforts. SNAP, formerly called food stamps, provides a monthly stipend to eligible residents through an Electronic Benefit Transfer, or EBT, card to use at any qualifying grocer. Since its inception, SNAP has become the nation’s largest safety net for the hungry, feeding more than 44 million Americanslast year. There are additional programs through the school dietary program, the Summer Food Service Program distributes meals at public areas such as churches and playgrounds. This program helped feed 2.6 million children every day during the program’s peak month of July in 2015. Department of Health and Human Services, the department issued the 2015-2020 Dietary Guidelines for Americans
Supporting Rural Medicine
Among those efforts is the Distance Learning and Telemedicine Grants, which distributes millions of dollars to strengthen telecommunications in rural communities and increase access to resources such as teachers and doctors
Among those efforts is the Distance Learning and Telemedicine Grants, which distributes millions of dollars to strengthen telecommunications in rural communities and increase access to resources such as teachers and doctors
Health Education
Since 1969, the Expanded Food and Nutrition Education Program has worked with low-income families to develop healthy diet and exercise habits and educate them about food safety.
Preventing Foodborne Illness Nationally And In Your Home
The USDA helps protect the food supply through the Food Safety and Inspection Service. The office monitors the importation of meat, poultry and egg products by issuing safety certifications to some foods from other countries and auditing their food inspection systems.
The USDA helps protect the food supply through the Food Safety and Inspection Service. The office monitors the importation of meat, poultry and egg products by issuing safety certifications to some foods from other countries and auditing their food inspection systems.
Domestically, the same agency monitors food processing and distribution through microbiological testing. It also maintains a system that tracks and alerts potentially dangerous foods. For consumers, the office maintains a USDA Meat and Poultry Hotline to answer individual questions about food preparation.
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Amid the cacophony of confirmation hearings for Cabinet nominees, President-elect Donald Trump reportedly has settled on former Georgia Gov. Sonny Perdue to fill the final Cabinet-department vacancy: secretary of Agriculture.
Trump’s Nominee For Agriculture Has Key Health Role | California Healthline
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