The Hidden Reasons Why Obama Care (ACA) is Failing

The true measure of how well the ACA is working should not be measured by how many uninsured people sign up for it.  The press fails to report the deep financial flaws brought about by a congress that passed the ACA for political gain.

One of the most litigated questions under the Affordable Care Act (ACA) is whether the United States government owes health insurers that offered qualified health plans (QHPs) through the ACA’s marketplaces the full amount that would be due them under the formula found in the ACA’s risk corridor statute and regulation. At least 17 cases brought by insurers are now pending in the Court of Federal Claims, one of which has been certified as a class action. An additional case is pending on appeal in the United States Court of Appeals for the Federal Circuit.

Background

The risk corridor program is, along with the risk adjustment and reinsurance programs, one of the Affordable Care Act’s three premium stabilization programs. It was designed to attract normally risk-averse insurers into offering a new product to a new population with uncertain prospects during the first three years of the health insurance marketplaces. It collects contributions from participating insurers that made profits that exceed certain “risk corridors” and makes payments to insurers whose losses fall outside those corridors. It was only in force for 2014, 2015, and 2016.

Nothing in the statutory provision creating the ACA program required it to be revenue neutral. Insurers entered the marketplaces in 2014 believing that risk corridor payments would be made if they were due under the statutory formula regardless of the level of collections. In 2014, however, nine months after health plans had submitted their rates for 2014 and three months after they had begun marketing qualified health plans (QHPs), CMS began to describe the program as budget neutral.

Regardless of HHS assurances and CBO projections, the potential magnitude of risk corridor receipts and payments and the effects on particular insurers and markets is highly uncertain.  The substantial uncertainty facing insurers participating in the exchanges in 2014 has only been partially resolved as they develop rates for 2015.  There remains a real possibility that promised risk corridor payments could significantly exceed receipts for 2014 or later.  If so, payment reductions could be problematic for some insurers, especially for smaller companies and/or new entrants.As it turns out, several insurers are now in court suing CMS for losses.  

Flash forward to 2016-2017.  The final accounting for evaluation of 2016 risk corridor adjustments does not occur until July 2017. The original final notice included budget neutrality while recent comments from HHS avoid that issue in it's forward looking plan for reimbursing insurance companies for their losses.  The scheme is a game of chairs.

Now it may all be moot, since President Trump and the GOP congress are about to repeal/amend the Affordable Care Act.

Dear Dr. Price: 5 suggestions for the new Health and Human Services secretary

Congratulations on your confirmation ! That was easy, and now comes the hard part.

If I could speak with the new head of HHS I would tell him many things, however this writer covers most of it .

Suneel Dhand writes his message to Tom Price. on KevinMD's blog.

 "As a physician myself, it’s great to know that a fellow physician will head up the agency. I’m sure you understand too, having been a practicing orthopedic surgeon, how disheartening and frustrating it is to have non-clinical “experts” making key decisions about health care.

I’m sure you’ve also seen the news about how your nomination has divided the physician community. Nevertheless, you have the full support of many of our nation’s top physician organizations, including the American Medical Association.

I am all for physicians taking leadership positions in health care, industry and — yes — politics. Your resume is hugely impressive. I’m aware of many of your viewpoints. And in the interests of being completely honest, I am not in agreement with all of them — as I’m sure is the case for a large percentage of the over 800,000 physicians in the United States.

Especially if you ever propose changes that risk any of our long-suffering patients losing access or have the result of making health care more unaffordable for them. Having said that, I am glad about your consistent wish to put the “doctor-patient relationship” first. Nobody needs to tell you what has gone on over the last decade and how the practice of medicine has changed for the worse. We need to consider the following five points to make American Health Care Great Again:

1. The cost of our health care system is just unsustainable, as we’ve known for a very long time. 2. The frontline of medicine has been decimated by excessively onerous regulations.   3. Let’s keep our independent physicians.  4. Let’s foster a health care system that favors doctors (or nurses, or indeed any other health care professionals) in positions of leadership.  5. As you’ve already said time and again, we must always remember that it’s all about the patient and their doctor. This paradigm is central to all health care systems — true patient-centered care.   

As much as we need to improve, let’s also not forget all of the great things about American health care. We have the most amazing doctors and nurses and lead the world in innovation and research. We can maintain our high standards, while still giving our patients the best possible deal at much lower costs. We can also make our system a great one to work in for our hard-working doctors. This health care ship can still be reversed — especially by the collective efforts of those physicians who all started off with the same call to service and altruistic intentions that you probably did too.

Author:  Heath Train Express took several liberties in quoting his article for the sake of brevity.  The entire article is linked below.

Dear Dr. Price: 5 suggestions for the new Health and Human Services secretary

Consumers want telehealth—what does that mean for health systems? | Healthcare IT News

Today, 50 million U.S. consumers would switch providers to one that offers telehealth, compared to 17 million in 2015.

60 percent of adults willing to have a video visit with a doctor want to see a doctor online regularly to help manage a chronic condition. The perception of what a visit to the doctor or clinic has shifted measurably during the past two or three years/ . It has become more accepted as an accepted mode of practice by physicians and patients alike.

Many clinics are struggling as to how to implement this function to their practice. 

Consumers want to see their PCPs

65 percent of consumers are interested in seeing their PCP over video

Consumers want to see the PCP they trust and know through tele-health. Twenty percent of consumers said they were willing to switch to a PCP that offered video visits. For health systems looking to retain current patients, as well as bring new patients into the system, making tele-health part of the primary care offering can produce big results.

What is driving this change?

Consumers are more likely to avoid an ER if telehealth is an option

20 percent of Americans would use a video visit for middle-of-the-night care

That’s not to say that consumers have abandoned the emergency room but they are open to alternative options of care. This consumer sentiment is driven largely by long wait times and high costs. Health systems can use telehealth to divert resources and costs away from the ER and urgent care facilities and into lower cost options like telehealth.

Southwest Medical Associates, a health system based in Las Vegas, Nevada, deploys an in-clinic marketing strategy for its telehealth service, SMA NowClinic. One marketing tactic involves the use of TV screens to post the wait times at all SMA Urgent Care locations—sometimes showing as high as 90 minutes—while another screen reads “Need to speak to someone right away” and promotes the telehealth service. To date, Southwest Medical has enrolled more than 30,000 patients in telehealth and conducted more than 20,000 telehealth visits.

Consumers want to use video visits for follow-up care

52 percent of adults willing to have a video visit to see a doctor are interested in using video visits for post-surgical or hospital stay follow-ups.

It’s estimated that between 15 percent and 25 percent of people discharged from the hospital will be readmitted within 30 days, with many of these readmissions being preventable. Consumers are open to the idea that follow-up care can be done via telehealth. Physicians that offer follow-up care via video may find that patients are more likely to adhere to recommendations since they feel more in control of their treatment.

In addition to offering urgent care services with its telehealth service NYP On Demand, New York-Presbyterian also offers follow-up visits so that patients can see their own physicians for appointments that do not require coming in to a clinic or hospital.

Consumers want to manager chronic conditions via video

60 percent of adults willing to have a video visit with a doctor are interested in seeing a doctor online to manage chronic conditions

Today, 1 in 2 U.S. adults have a chronic condition. Treating chronic conditions comes at a high costs for both consumers and health systems, making it equally beneficial to move these reoccurring visits to video. Building specialty programs for conditions such as diabetes, hypertension and congestive health failure—and making consumers aware of the programs—can drive better patient outcomes.

Marshfield Clinic, a health system based in Wisconsin, is expanding its virtual care services and envisions providing support to its diabetic population by monitoring blood sugar and offering medication counseling.

Consumer thoughts and perspectives on telehealth are becoming increasingly important to health systems, and forward-thinking health systems are using telehealth to determine the services they offer in the future. 

Numerous companies have sprung up to fill this need.

World Wide Telemedicine Directory of Providers

Consumers want telehealth—what does that mean for health systems? | Healthcare IT News

Early marijuana use associated with abnormal brain function, study reveals

The legalization becoming common due to recent referendums and state legislative actions.

A dried flower bud of the Cannabis plant. Credit: Public Domain

Does legalization make it safe? Has the Food and Drug Administration any jurisdiction over it's production or sale.

Marijuana is a mood altering molecule derived from a plant.  It has been popular as an underground treatment that reduces anxiety and creates distortions of sensory input (particularly visual). It increases appetite, and alters pain perception.  In the past regulation consisted of an outright ban on growing and usage.  During the past several years many states have legalized it's use for medicinal purposes by requiring a physician's signature.

Marijuana is the most commonly used illegal substance in the world. Previous studies have suggested that frequent marijuana users, especially those who begin at a young age, are at a higher risk for cognitive dysfunction and psychiatric illness, including depression, bipolar disorder and schizophrenia.

Dr. Osuch and her team recruited youth in four groups: those with depression who were not marijuana users; those with depression who were frequent marijuana users; frequent marijuana users without depression; and healthy individuals who were not marijuana users. In addition, participants were later divided into youth who started using marijuana before the age of 17 and those who began using it later or not at all.

Participants underwent psychiatric, cognitive and IQ testing as well as brain scanning. The study found no evidence that marijuana use improved depressive symptoms; there was no difference in psychiatric symptoms between those with depression who used marijuana and those with depression who did not use marijuana.

In addition, results showed differences in brain function among the four groups in areas of the brain that relate to reward-processing and motor control. The use of marijuana did not correct the brain function deficits of depression, and in some regions made them worse.

Of additional interest, those participants who used marijuana from a young age had highly abnormal brain function in areas related to visuo-spatial processing, memory, self-referential activity and reward processing. The study found that early marijuana use was also associated with lower IQ scores.

"These findings suggest that using marijuana does not correct the brain abnormalities or symptoms of depression and using it from an early age may have an abnormal effect not only on brain function, but also on IQ," said Dr. Osuch.

Read more at: https://medicalxpress.com/news/2016-10-early-marijuana-abnormal-brain-function.html#jCp
Early marijuana use associated with abnormal brain function, study reveals

How Trump’s immigration ban threatens health care, in 3 charts - Vox

But the chaos unleashed by the executive order also reveals a little-appreciated fact about our health care system: We're heavily reliant on foreigners. They're our doctors, nurses, and home care aides, and they often work in the remote places where American-born doctors don't want to go.

Sarah Frostenson

In many ways, the health system is already stretched too thin, with scarcely enough people spread evenly across the country to do many difficult jobs. And a letter from the American Medical Association to the Secretary of Homeland Security today spelled out how Trump's immigration policy could make this worse by "creating unintended consequences."

Indeed, it’s now clear that health care is going to suffer as a result of the immigration ban, particularly if the current restrictions are broadened to include more countries or different types of visas, as is expected.

Immigrants make up 22 percent of the health workforce and 30 percent of doctors and surgeons in the US

The health care workforce in the US is a lot more international than you might think. Health care currently has the largest proportion of foreign-born and foreign-trained workers of any industry in the country.

According to 2015 data from the Migration Policy Institute, the medical profession is particularly reliant on immigrant doctors. Of the active physicians and surgeons here, 30 percent are immigrants.

"India, China, Philippines, Korea, and Pakistan are the top five origin groups for physicians and surgeons," said Jeanne Batalova, a senior policy analyst and demographer at MPI. But Iran and Syria, two of the seven countries whose citizens are no longer allowed entry to the US, are the sixth and 10th largest contributors, respectively. "So we’re talking about substantial representation from these countries [in the doctor workforce] here." The ban on these people will likely be felt at hospitals and clinics across the nation, she added.

The contributions immigrants make to medical care start early on, in residency programs, which funnel doctors through training and into jobs. A data analysis performed by the Robert Graham Center showed that residents from the seven countries made up 5.7 percent of all international medical graduates in 2015, said Stan Kozakowski, director of medical Education for the American Academy of Family Physicians. (Some data sets look at the country of origin for doctors, others at where they obtained their medical degree — and doctors who trained outside of the US are called "international medical graduates.")

That’s not a huge number right now, Kozakowski added, but it’s sizable enough. "And if you add in the countries that have been tossed in as possible expansions of the ban — Pakistan, Saudi Arabia, Lebanon, and Egypt — that number goes up to 16.7 percent."

Sarah Frostenson

When you look at the numbers by medical specialty, foreign-trained doctors do a disproportionate amount of the work in many areas. They make up more than 50 percent of geriatric medicine doctors, almost half of nephrologists (or kidney doctors), nearly 40 percent of internal medicine doctors, and nearly a quarter of family medicine physicians, according to data from the Association of American Medical Colleges.

Compared with US-trained physicians, foreign doctors are also more likely to practice in areas where there are doctor shortages — in particular, in rural areas. (Many enter the US on visas that allowed them to stay if they work in an underserved area for three years after residency.) They’re also more likely to serve poor patients on Medicaid, the Centers for Disease Control and Prevention has found.

Sarah Frostenson

"Doctors — especially in rural areas that were the key constituency that supports Trump — tend to be foreign-born," said Nicole Smith, a chief economist at the Georgetown University Center on Education and the Workforce. "The old adage that foreigners are doing the work no Americans want to do even applies to medical doctors."

A new study in the BMJ revealed another twist: patients treated by foreign-trained doctors had better mortality outcomes than those treated by doctors who went through American medical schools. The study authors suggested for foreign docs' over-performance might be explained by the fact that they "represent some of the best physicians in their country of origin" and had to overcome intense competition and years of training to finally practice in the US.

Health care currently has the largest proportion of foreign-born and foreign-trained workers in the country of any industry

The foreigners in health care don't just practice medicine, though. The nursing profession is also overstretched and facing projected shortfalls in the coming years, and has come to count on immigrants. Some 20 percent of the health care support staff — including nursesand home aides — were immigrants as of 2015.

Besides work at the bedside, the research immigrants do in labs across the country is also under threat. One Syrian medical researcher told Vox he’s afraid that after working in America for more than three years at the Mayo Clinic, his application for permanent residency will now be rejected and he’ll have to leave. Other researchers on visas and green cards from Iran told us they fear leaving the US to visit family or go to conferences should they be barred from coming back home, and that this situation was untenable and had them thinking about alternative places to live.

So from the bench to the bedside, Trump’s approach isn’t just going to hurt the health system in the future — it's already hurting it now.

 

President Trump's immigration order: what it means and who it hurts

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How Trump’s immigration ban threatens health care, in 3 charts - Vox

Trump Signs Order to 'Ease the Burden of Obamacare'

 

Soon after he was sworn in, President Donald Trump signed a series of executive orders, including one to "ease the burden" of the Affordable Care Act (ACA), according to news reports.

The executive order on the White House website as of press time. But in a version posted on Twitter, the order first notes the President's intention to seek the "prompt repeal" of the ACA, and says that in the meantime, it was seeking to offer flexibility to states to create a more "free and open healthcare market."

This report from Medscape and as reported by Dan Diamond of Politico  grants authority to the heads of all federal agencies, including the Secretary of Health and Human Services to "waive, defer, grant exemptions from or delay the implementation of any provision or requirement of the Act that would impose a financial burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications."

"This order doesn't in and of itself do anything tangible," Larry Levitt, vice president at the Kaiser Family Foundation, told Vox. "But it directs federal agencies to start taking steps to use their administrative authority to unwind the ACA in all sorts of ways. This is a signal that the Trump administration is not waiting for Congress to start making big changes."

The executive order also directs federal agencies to grant states maximum flexibility in implementing "healthcare programs," and to encourage the development of "a free and open market in interstate commerce for the offering of healthcare services and healthcare insurance with the goal of achieving and preserving maximum options for patients and consumers."

During the campaign, President Trump said that he wanted to make it possible for insurers to sell policies across state lines.

None of these orders state anything specific about the ACA other than giving power back to the people.

Various professional associations, such as the AMA, the American Academy of Pediatrics, American Geriatrics Society (AGS), American Medical Women's Association, The American Nurses Association are weighing in on many aspects of the intended changes or repeal of the Affordable Care Act (ACA)

Trump Signs Order to 'Ease the Burden of Obamacare'

Live Video: Claire Wineland and Cystic Fibrosis

While the advances in medicine have extended the lives of so many children into adulthood new challenges arise.  The numbers of fortunate people surviving places a new challenge for mental health, family relationships, and economic survival.  Family and personal relationships are important as well as support groups.

The people surrounding a patient with cystic fibrosis suffer emotionally more than the patieint.

Watch this video for an inspirational story from Claire.  Share the message and contribute to the Cystic Fibrosis Foundation.

The Vertex pharmaceutical company in a partnership with the Cystic Fibrosis Foundation have developed a program creating a "pipeline'  of genetic treatments for C.F.  Many are in Clinical Trials, and many have already been approved.  This is a major reason for long term survival of patients with cystic fibrosis.








Live Video: Claire Wineland and Cystic Fibrosis | The Mighty

A Guide To Budget Reconciliation: The Byzantine Rules For Disassembling The Health Law | Kaiser Health News

Repeal and/or amend the ACA ?  How it will take two years (2018).  Maybe.

If you thought constructing and passing the ACA was difficult...just you wait !

After capturing the White House, Republicans put repealing the health law at the top of their to-do list. But since they can’t get around a Democratic filibuster in the Senate, they are forced to use an arcane legislative tool called budget reconciliation to disassemble parts of the law. KHN’s Julie Rovnerand Francis Ying explain the process.

But Congress can’t use reconciliation to change parts of the health law like provisions requiring insurance companies to provide certain benefits or sell coverage to people with preexisting conditions. Those don’t directly affect federal spending.

That has led insurance companies to complain that they will go broke if they still have to sell to sick people, but healthy people won’t have any incentive to get covered. In that case, they say, only sick people will buy insurance, and premiums will skyrocket.

And the new Republican Congress seems set on using the technique to take apart the health law. Whether that’s a good idea may depend on whether you favor or oppose the Affordable Care Act.

Once again the tools that the Congress can use are inadequate and obsolete, leading to a further possible stalemate which only serves to hurt all.

Perhaps another reason to 'drain the swamp' . HHS Secretary, Tom Price, will have his hands full. Hopefully his medical judgments will prevail.  He also has the power of "Executive Order' something which President Trump has used already to meet his campaign promises.

But even as Congress spins its wheels. Price can push forward by using his discretion to undo crucial elements of Obamacare. That’s largely thanks to the Obama administration, which granted its health officials authority to write and implement hundreds of rules tied the law. The Trump administration now plans to use that same license to undo as much of Obamacare as it can.

“The statute itself gave [HHS] a lot of discretion,” said Edmund Haislmaier, a senior research fellow at the Heritage Foundation, who worked on health policy for the Trump transition team. “Live by the administrative state, die by the administrative state.”

A Guide To Budget Reconciliation: The Byzantine Rules For Disassembling The Health Law | Kaiser Health News

World's smallest MRI helps tiny babies - BBC News

Infants are not small people.  One size MRI does not fit for diagnostics.  MRI scanners have been specifically designed for shoulders,  arms, knees, and other smaller structures.  Smaller scanners expose patients to less irradiation.

The MRI images are more detailed and higher resolution.

Doctors in Sheffield are pioneering the use of a compact MRI scanner for imaging the brains of premature babies.

The machine, at the Royal Hallamshire Hospital, is one of only two purpose-built neonatal MRI scanners in the world.

At present, ultrasound is normally used to scan the brains of newborns.

Prof Paul Griffiths, of the University of Sheffield, said MRI was better at showing the structures of the brain and abnormalities more clearly.

So far about 40 babies have been imaged in the MRI scanner, which was built by GE Healthcare with funding by the Wellcome Trust.

MRI scans are rarely performed on severely premature babies because the risks involved in transferring and handling a sick infant can outweigh the benefits.

It is not known how much a neonatal MRI machine would cost, should the system eventually get commercialised, but full-size scanners are typically priced at several hundred thousand pounds.

Cincinnati Children's Hospital has a 1.5 Tesla neonatal MRI scanner that was adapted from adult orthopaedic use.

World's smallest MRI helps tiny babies - BBC News

Who really wants to blow up the FDA? Not the drug industry

Health Train Express is following the issues that POTUS is addressing in regard to health care.

Following his not too surprising nomination of Tom Price for the head of HHS, he now turns his attention to another big player, the Food and Drug Administration.  While the FDA plays a major role in the safety of food products in the United States, not much is said about that during political campaigns or in decision making.  It's role in pharma, medical devices, and now mobile health applications draws headlines.

What most industry reporters usually mention is the length of time and the expense of developing new drugs, and how that contributes to increased drug costs.

President Trump has repeatedly said that the FDA needs to be overhauled. He’s talked about speeding up drug approvals and reducing regulations — he’s vetted possible FDA heads who want to put drugs to market before we know they are effective. But, outside the White House and Capitol Hill, is there anyone who agrees with this? STAT’s Damian Garde takes a look.


Trump has big plans to fix drug prices. Here’s your reality check

Eli Lilly has raised the price of insulin more than tenfold since 2001 and is now facing a class-action lawsuit and threats of a congressional investigation.

Amgen has repeatedly raised the price of Enbrel, a blockbuster anti-inflammatory treatment that has been on the market for nearly 20 years. The price of J&J’s competing Remicade rose by 63 percent between 2011 and 2016.Since 2010, Merck has raised its drug prices by more than 9 percent on average, and Novartis has increased the price of the cancer drug Gleevec from $26,400 in 2001 to more than $120,000 this year.

There have also been cases where drug prices have acutely skyrocketed, in come cases over 1,000 %.  drug for treating pinworm, an intestinal parasite was sold for $ 3.00 a dose, and now costs $ 300.00 dollars. Anthelmintics, such as mebendazole, pyrantel pamoate, and albendazole, are active against Enterobius vermicularis.

Mebendazole is now being studied as a drug to prevent cancer. (coincidence, or opportunistic ??

His pledges, which will need to be fleshed out, would likely require work from the Food and Drug Administration. Trump also said Tuesday that he would soon appoint a commissioner to lead the agency.

The industry, for its part, has rolled out an advertising campaign backed by tens of millions of dollars to burnish its public image. Industry officials described Tuesday’s meeting with Trump as a chance to get in the door with the new president after his incendiary comments. Depending on the time of the year, and politically expedient slogans pharma can change it's mantra.  

Late in 2014, the Amgen announced their original restructuring plans to reduce payroll was too modest, upping its goal on job cuts to 4,000. And the pharma giant followed up in the spring of 2015 by axing about 300 staffers after Bradway decided to shutter the Onyx campus obtained with its acquisition of Kyprolis.

Trump confronts big Pharma on Pricing

On Tuesday, though, Bradway became a job creator.

“We’ll be adding 1600 jobs at Amgen this year,” he told President Donald Trump, minutes after the president had finished a harangue about the new American jobs he expected in exchange for reduced regulations.

It may be unwise to paint the whole of pharma with the same accusations.  Politicians focus on the "outliers" to prove a point.  Readers should carefully consider the source and not take pronouncements at face value.

Follow Health Train Express daily by subscribing on the left sidebar.

Who really wants to blow up the FDA? Not the drug industry

Senate Finance Committee OKs Tom Price, MD, for HHS Chief

The Senate Finance Committee today approved the nomination of Rep. Tom Price, MD, (R-Ga), to head the Department of Health and Human Services (HHS) and serve as President Donald Trump's point person in repealing and replacing the Affordable Care Act (ACA).

 The 14 to 0 vote reflected the partisan tumult engulfing the nation's capital during Trump's first few weeks in office. All the votes came from Republican members of the committee because, for a second day in a row, the 12 Democratic members boycotted executive sessions to confirm both Dr Price and Steven Mnuchin, the president's nominee for Treasury secretary. Ranking member Sen. Ron Wyden (D-Ore) said the committee should not move forward on the nominations until it addresses "unanswered questions and misleading statements" by both men. Democrats contend that Dr Price has not come clean about alleged conflicts of interest regarding his investments in healthcare companies, which he has denied.

Dr Price's nomination now goes before the full Republican-controlled Senate for a vote. Because the Senate changed its rules when Democrats were in power to exempt cabinet-level appointments from a filibuster, Dr Price needs only a simple majority, or 51 votes, for confirmation. Republicans hold 52 seats.

Ignoring all the expected Republican/Democratic debate over ethics and politics, his confirmation will be unique in that he is the first physician in my memory to serve in this capacity.

Trump has chosen a man who understands the medical system as a practicing physician. In the past, leaders have been from other sectors of government who in many cases were assessed on performance as heads of other departments.  Few physicians are confident in non clinicians when it comes to making medical decisions.  

Just recently chair of the House Budget Committee, Dr Price has been an adamant foe of the ACA and government regulation that he considers burdensome for physicians. Trump has said that once confirmed, Dr Price will work with the White House to introduce a plan to replace the healthcare reform law, one that will provide "insurance for everybody." If confirmed, the orthopedic surgeon would then help implement the replacement plan.



Senate Finance Committee OKs Tom Price, MD, for HHS Chief

Finally, mHealth is the winner : Software as a drug? - Health Files by Rajendra Pratap Gupta

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