Have a Holly, Jolly Health Wonk Holiday from Health Wonk Review

Those Merry Wonksters ride again, tackling a lot of serious topics, posting and prancing on their way. So grab a cup of cheer, nestle all warm in your beds, and read on.

maxresdefault

First down the chimney is David Williams at Health Business Blog. Let’s see what he is pulling out of his sack…hmmmm, this look like an interesting package. Partners HealthCare is the 800-pound gorilla in the Massachusetts healthcare market and as such gets a lot of scrutiny. So, Partners is excited that a 700-pound gorilla —in the form of BI-Lahey— has arrived on the scene to take away some of the focus. That’s enabling Partners to move forward with a plan to open lucrative outpatient centers. By the way, David is quoted on the topic in the Boston Globe.

Next out of the bag is a post from Tom Lynch at Workers’ Comp Insider about the prohibitive cost of pharmaceuticals and what hangs in the balance when patients can’t pony up. Tom Lynch asks What Price Life?  He talks about a chronic disease requiring medication, which, if not taken every day, guarantees death within two weeks.  But the problem is that over the past 20 years prices for that medication have risen anywhere between 800% and 1,175%.

With prices skyrocketing, Hank Stern at InsureBlog talks about a solution to copays, deductibles and coinsurance that can make health insurance unaffordable, even when the premiums are paid. Henry Stern introduces us to The Zero Card, whereby all deductibles, co-pays and co-insurance are waived – and this is available for at least a fraction of the market. Read the blog for the details and fine print.

Twas-the-Night-Before-Christmas

More good news in health insurance. Louise Norris at Colorado Health Insurance Insider is here with a gift for people who think they earn too much to qualify for ACA subsidies. She says, ” We talk a lot around here about the subsidies provided by the ACA.  In Colorado, people with household incomes up to 138% of poverty (133% plus the built-in 5% income disregard) are eligible for Medicaid.  If your household income is between 138% and 400% of poverty, you most likely qualify for a subsidy to help cover the cost of a private plan purchased through the exchange; a family of four can earn more than $100,000 in 2019 and still be eligible for premium subsidies!”

On the other hand, you might want to look that ACA gift horse in the mouth. Andrew Sprung at XPostFactoid says that some of the protections of the ACA may be going away. In Will your state waive goodbye to ACA’s protections? Andrew looks at how ACA innovation proposals that conform to the “waiver concepts” recently issued by CMS might affect people with pre-existing conditions as well as low income and older marketplace enrollees. It also questions whether proposals conforming to the “concepts” could survive legal challenge.

Joe Paduda at Health Care Matters believes he has found the root of the healthcare problem and is recommending coal for Capitalism’s stocking. “Capitalism will not solve Healthcare because Capitalism is the problem with healthcare,” he says. And he backs up his opinion with lots of examples. “California’s dialysis mess, pharmacy pricing, and pretty much every other sub-sector of healthcare provides ample evidence of why the free market is the driver of our lousy and wildly expensive healthcare.”

fully-lit-menorah

Meanwhile, Jessica Williams, PhD MA at The Medical Care Blog sheds light on ways people are trying to control the cost of  care and improve outcomes, in this case through obesity and diabetes research. This post explores the questions: What research questions in obesity and diabetes should be prioritized? Which topics matter most to people with those conditions? Recent research from the Patient-Centered Outcomes Research Institute (PCORI), published in Medical Care’s October supplement, revealed 8 important topics for research from the perspective of researchers, clinicians, and people with diabetes and/or obesity – two of the largest drivers of healthcare expenditures.

Ah, but the 2018 holiday season does not end the 2016 political season. Roy Poses tackles a thorny issue with From Russia with Money – Harvard Medical School Accepts $200 Million from Russian Emigre with Ties to Russian Oligarchs and Putin, and Who Is Under Investigation for US Election Meddling. The details are riveting, and I encourage you to spend time looking at all the angles that Roy presents in this post at HC Renewal.

Let’s wrap up this holiday edition with a big red bow. Here’s the CareTalk Podcast, #CareTalk: Bipartisan Breakthroughs on Health Policy with hosts John Driscoll (CEO of CareCentrix) and David Williams (President, Health Business Group). In this month’s episode of #CareTalk youtube.com, David Williams (Health Business Group) and John Driscoll (CareCentrix) discuss how the outcome of the 2018 mid-term elections will impact healthcare moving forward. This is always an enjoyable presentation of serious material. During these 12 minutes, you get to see a Red Sox World Series Championship cap and hear what I thought may have been a suggestion for Alex Cora to manage the healthcare system.

Capture

 

 

 

 

 

thJ01UUBLUDash away, dash away, dash away, all!

 

 

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in health economics, health insurance, health policy, health reform, pharmaceutical marketing | Leave a comment

Inaugural Health Wonk Review Host Lisa Lines of the Medical Care Blog Reports from APHA

Reporting from the American Public Health Association in San Diego this week, Lisa Lines, PhD MPH, is a health researcher and takes her first turn at the wheel to drive Health Wonk Review this month. Here’s the link to the November 2018 HWR at The Medical Care Blog.

Thank you, Lisa, for your work and contribution to keeping the wonkery alive!

 

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in health economics, health insurance, health IT, health policy, health reform | Leave a comment

Technology is Catching Up to the Dream

By Peggy Salvatore, MBA

About 8 years ago, I started Health System Ed as an educational portal about the value of health information technology. It started with a blog called “Imagine” that described the dream of having all relevant patient information, all the time, in real time, to make good decisions about the patient in front of you based on best practices that had been determined by measuring what treatments worked in which patients.

Lately, as I write about genomics and sensored medical devices, it is clear that we are oh-so-close to the dream. In 2010, I didn’t have a clue how long it would take to achieve lift-off. Today, all the pieces are in place for people (masquerading as patients to the healthcare system) to know what is going on inside their bodies even before they manifest illness sometimes.

  • Scientists and researchers can peer inside the genetic code to see what has gone awry, and they can snip, delete and replace poor genetic codes.
  • Doctors can measure results by getting information about the patient in real time – whether it is a glucose reading to track the efficacy of your medication dosage, a heart rate monitor looking for signs of trouble, or a sensored knee brace telling your orthopedic surgeon whether you are doing your rehabilitative exercises
  • Patients can know how they are doing and adjust their behaviors
  • Payers know what works, what to pay for, and when to implement resource utilization strategies to encourage best practices

The electronic patient record systems are mostly in place now to capture information. They may need to be tweaked, upgraded, or replaced with the next generation of software, but the infrastructure is in place today. Next, we will build the analytics to turn data into usable information.

One of the most beneficial aspects of capturing patient data – everywhere, all the time – is that ultimately people will get the most effective treatment first which will drive down costs to the system and extend the healthy human life span. When we know what works in whom, it is a much shorter trip from disease to health.

It is nothing but exciting. We aren’t there yet. But we can see “there” from here.

Peggy is an author and writer who specializes in healthcare.

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in biotechnology, consumer health apps, electronic patient records, health economics, health insurance, health IT, health IT training, health policy, health reform | Leave a comment

Halloween HealthWonkReview! From Health Strategy Associates

Straight from Managed Care Matters, here’s this month’s Health Wonk Review. Enjoy. And thanks to Joe Paduda for his dedication to the cause!

Happy Halloween!

By Joe Paduda

Okay, I’m a bit early on the pumpkin-and-costume thing, but time is going by so damn fast I want to be early for once.

It’s also open enrollment time! that joyful event where we all get completely confused, baffled beyond belief, our minds all-a-boggled by all the tiny print on the screen describing in excruciatingly minute detail really important nuances in health benefit design that, if we ignore, will cause us to go bankrupt and die. Fear Not – Louise is here in her SuperWoman costume, typing madly away to bring you all you need to know about individual market enrollment – and in English too!

There’s been a lot of chatter about simplifying all this stuff, with much of it about Medicare for All. My contribution this week unpacks the argument that MFA would somehow harm Medicare. Hint – MFA is not the boogyman it’s made out to be.

Andrew Sprung’s found out that Bob Hugin, Republican candidate for the Senate seat held by Bob Menendez in NJ may well be hiding his real views on healthcare – but no one is asking. Andrew’s not afraid to ask…What’s behind the curtain, Mr Hugin?

Hank Stern over at Insureblog.net doesn’t like the HMO-only plans offered to his clients in the Buckeye State; Hank sees the evil hand of Obamacare at work, limiting his clients’ choices.

Our favorite healthcare economist, Jason Shafrin, has been looking into the costs of mental health that go beyond medical care. He’s also done a lot of research into medication adherence. And I can’t find any meme that works for this entry…darn it.

 

If you don a nursing costume, you may need to add a back brace. Nursing assistants get more back injuries than any other occupation. That’s the scary news from Tom Lynch at Workers’ Comp Insider.

The estimable David Williams is on a search to uncover a deep mystery – what happened to “Consumer Directed Health Plans”??? Join David as  he finds this to be a conundrum wrapped in an enigma; were they ever REALLY “consumer” directed?

Leaving my poor attempts at humor behind, Ranit Mishori MD MHS asks some very pointed questions about political determinants of health, determinants such as the for-profit motive and prioritizing religious beliefs over science.

Out long-term colleague Roy Poses MD FACP has been focusing on this as long as HWR has been around (15 years and counting). Roy’s learned big health care corporations, particularly pharma, biotech, device, and health insurance companies, provide significant sources of funding to dark money organizations.  It appears nearly all such money from health care organizations supports right- wing/ Republican/ pro-President Trump activities.

What happened to putting patients above all?

Thanks for reading, and thanks for writing contributors!

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in health economics, health insurance, health IT, health policy, health reform | Leave a comment

The Waning Days of Summer Health Wonk Review

eddie-kopp-263580

Over at Health Wonk Review, the hits keep coming. This month, Julie Ferguson posts her compilation of health wonkery at her home blog turf Worker’s Comp Insider. Click to go there for the fun or check it out right here.

Through vacations, heat waves, and days on the beach, our health policy wonks are still on the job. As we eke out the remaining days of summer and slouch toward the interim election, they continue their relentless focus on opining about the issues of the day. Check our August edition entries.

  • First up, Joe Paduda unpacks the generic term to uncover the varied approaches to universal coverage currently operating at far lower cost and far better outcomes than our “multi-payer” “system” in his post What exactly is single payer at Managed Care Matters.
  • Louise Norris tells us that the Trump administration has finalized rules that will make it easier for many Americans to buy short-term health insurance plans that may be less expensive – but aren’t as comprehensive as ACA-compliant plans. She explains the rules and how they’ll affect consumers in her post at healthInsurance.org Blog: ‘So long’ to limits on short-term plans.
  • At InsureBlog, Patrick Paule puts paid to the notion that Medicare4All is any great deal or panacea. he makes his case in his post On BernieCare.
  • What’s worse than needing help with gait, mobility and balance? Being told you need a walker. No wonder, when the typical walker basically screams “frail elderly,” and is difficult to use as well. At Health Business Blog, David Williams talks with neurologist Patricia Kavanagh about how she teamed up with a design and production team to a modern device that is more functional and stylish in an effort to get her patients with Parkinson’s and other movement disorders to use a walker.
  • Vincent Grippi of the CareCentrix’s Homefront Blog submits this month’s episode of #CareTalk, in which David Williams (Health Business Group) and John Driscoll (CareCentrix) discuss Trump’s fight with Pfizer over drug pricing, and more.
  • Here at Workers Comp Insider, we’ve yet to do a post on this important occupational health issue, but call it to your attention. We were horrified to see that the EPA is loosening regulations that will expose more workers to a know carcinogen:  EPA is now allowing asbestos back into manufacturing. At least one town in Russia – Asbest – is celebrating.

Next issue: September 20 – Andrew Sprung – xpostfactoid

 

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in biotechnology, electronic patient records, health economics, health insurance, health IT, health policy, health reform | Leave a comment

Health Wonk Review July 2018: Summer’s Coming Around Again

Watching the ships roll in, and we watch them roll away again…

anton-karatkevich-729993-unsplash

Seasons come and seasons go. Yes, in healthcare, too. We’ll open this week’s HOT Health Wonk Review looking at an enduring issue as Roy Poses of Health Care Renewal very nicely summarizes pharmaceutical marketing tactics and their effect on physicians and patients as it pertains to opiates. Some practices just keep coming around again.

Hope in a Bottle: Components of Purdue Pharma Stealth Marketing Campaign for Oxycontin Revealed by Legal Documents from Tennessee

The return of the good old days, sort of: a legal filing from the Tennessee Attorney General’s lawsuit against Purdue Pharma revealed multiple internal Purdue documents showing elements of the company’s stealth marketing campaign for Oxycontin.  These included: implied psychological manipulation of vulnerable physicians; perverse incentives for sales representatives; and use of third-party strategies (including creation of “astroturf” organizations) and miscellaneous deceptions.  More awareness and better understanding of such integrated, but deceptive marketing campaigns enables better resistance to them, and hence hopefully better professional decision making leading to better patient outcomes.  Previous stealth marketing campaigns have been revealed through litigation by the US government.  The Trump administration seems uninterested in pursuing corporate health care’s bad actors, but at least the baton has now been picked up by some state law enforcers.  Read more from Roy here.

While We’re Talking about Opioids…

Louise Norris of HealthInsurance.org tells us this year there has been an abundance of discussion about our national opioid abuse crisis and about strategies for addressing that challenge. But was the Affordable Care Act already helping address that crisis? Louise looks at how that ACA improved mental health coverage – including dramatically expanded access to additional treatment in some of the states hardest hit by the opioid crisis.

#CareTalk Podcast: Wry Healthcare Commentary with David Williams and John Driscoll

Podcast time, today our hosts David Williams and John Driscoll opine about the Right to Try law. “A great impulse and a dumb law,” says Carecentrix CEO John Driscoll. David Williams of Health Business Group agrees, “Right to try…who could argue with it, but it is a pretty cynical law.” It is redundant with compassionate use, and just removes the FDA to “take the smartest people out of the way,” says John. Lots of good stuff here as they look at a few other ways politics uses healthcare as a football. Watch, listen, learn right here.

High Deductible Health Plans: A Blunt Instrument that Doesn’t Work

High deductible health plans don’t work, so says Joe Paduda of Health Strategy Associates. Hear about why Joe calls high deductible plans “the bluntest of instruments” that has lots of nasty side effects and doesn’t reduce costs or improve care. Joe wonders “why the health plan industry is still selling these crappy plans.” Read more at Managed Care Matters where Joe talks about the ill effects of this health plan variant.

Much Ado About a Rounding Error? Looking at Sharing Ministries

Henry Stern of Insureblog channels Shakespeare while he questions if the faith-based ACA-compliant alternatives to ObamaPlans – now topping 1 million members – are such a good idea for people who need the assurance and reassurance of insurance or reinsurance. He’ll explain it all at this link.

Exploring Ethics: Is the Cost of Dying Worth It? Research Says Yes

Jason Shafrin at the Healthcare Economist asks if we are spending too much on end of life care and puts a new spin on the answer backed by research. He says we recognize that end of life care is expensive.  Conventional wisdom holds that we are spending too much on end of life care and we should just let people die at home in peace with hospice.  If only things were so simple.  The Healthcare Economist reviews new research that shows that end of life healthcare interventions may, in fact, by worthwhile. Paddle over to Jason’s blog at this link for a good discussion on an important topic.

Brush Up on Your Latin: Quo Vadis, Kentucky?

Tom Lynch of Workers’ Comp Insider recently attended a forum where he heard a presentation on the work requirements for Medicaid beneficiaries, a program called Kentucky HEALTH. Tom offers his perspective on the plan. It should be noted that a federal judge subsequently ruled the plan unlawful, but three other states are still developing plans for work requirements and other states are waiting in the wings. And this entire issue begs the question, where are we going, America? Is healthcare a right for all or privilege for those who can afford it? Tom kicks this football around a bit – on his private beach right here.

So now it’s time, dear Wonkers, to kick back, read the healthcare blogs and enjoy this summer day.

Photo by Anton Karatkevich on Unsplash

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in biopharmaceutical training, health economics, health insurance, health policy, health reform, healthcare marketing, pharmaceutical marketing, pharmaceutical sales | 1 Comment

Available Now! Retaining Expert Knowledge: What to Keep in an Age of Information Overload

K35621_v2I couldn’t wait to get out the word that my new book, the latest in the Working with Experts series, is available for sale today!

I’ll be doing some promotions which you will hear about later, but for now here’s the description on Amazon:
Retaining Expert Knowledge: What to keep in an age of information overload covers two major topics central to capturing and transferring expertise in organizations:

  • Methodology and best practices for interviewing subject matter experts (SMEs) to capture their knowledge
  • Identifying the SMEs to interview

The more critical problem is identifying the SMEs and the knowledge that needs to be captured.

One reason identifying the right experts is now so important is that in the next 10 years, the largest recorded exit of talented and knowledgeable workers from organizations will occur as baby boomers retire. In their wake, they leave their former employers understaffed and, even scarier, under-informed. Identifying the right SMEs is also critical because of the rapid acquisition of new knowledge. Some estimates say knowledge now doubles every two years, so it is crucial each organization identifies its journey and catalogues it individually and collectively.

This book provides managers with answers to the following questions:

  • Are we talking to the right subject matter experts?
  • What knowledge should we capture?
  • What knowledge needs to be captured immediately as opposed to eventually?
  • If we have limited resources, which experts are most important to speak with first?

Every organization has a history, a culture, and knowledge that may have lost its current relevance but not its importance. It is that broader vision of capturing knowledge, which this book addresses. It guides readers on how to preserve corporate knowledge and provides tools to assess organizational circumstances and judge the value of the resources to capture.

Retaining Expert Knowledge is a training resource, but it is also a business resource. As knowledge proliferates and organizational culture rapidly changes, now is the time to step back and determine what has been important to your organization’s success, where the organization is today, and what it will take to stay in the game tomorrow.

Your company houses knowledge, skills, attitudes, intellectual property, trade secrets, company culture, and individuals who will never be replicated exactly as they are today. Because they have demonstrated value in the past and are demonstrating value today, these treasures are worth preserving. This book shows how to preserve these valuable assets today for tomorrow’s successes.
You can buy this wherever you normally purchase your books.

Here’s a link directly to Amazon. 

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in biopharmaceutical training, consumer health apps, elearning, expert knowledge, Knowledge management, standard operating procedures, training | Leave a comment

In an Age of Over-Regulation, Are Compliance and Safety Mutually Exclusive?

neonbrand-349607-unsplash

This article is cross-posted at www.workingwithsmes.com.

 

In aviation, safety is always the primary concern. In fact, aviation’s safety record is so stellar that it is considered a model for healthcare. That is quite a testament.

However, a retired pilot friend recently bemoaned that the emphasis on FAA rules and regulations has overtaken concern about safety, and aviation is not better for the change.

“Now we’re only concerned about compliance. We have a cast of thousands as support staff. When I started flying in 1964, Part 91 federal regulations were about 30 pages. You could memorize it. Today, it is hundreds, if not thousands, of pages and nobody can possibly know everything that is in there. We are less safe today than we were 50 years ago,” he complained.

Making and keeping track of all those regulations costs aviation a lot of money. It requires a boatload of federal regulators to oversee them, and costs private carriers a bundle of money to hire people to monitor every jot and tittle of the laws. One misstep, and they can shut you down. And, he concludes, neither the passengers nor the airline employees benefit from this over-regulation.

Will Healthcare Follow Aviation Again?

Just about everyone in healthcare knows about the vaunted aviation checklist, and how it has become standard procedure in many operating rooms today. Books are written and consultants make good livings just teaching the checklist approach to safety. The checklist is a great tool. Healthcare is better for following aviation down that path.

But is healthcare going to benefit by following the FAA down the road to over-regulation? We can trip on our path toward safety by using regulations as stumbling blocks instead of using some common sense rules to pave a smooth road to improved quality and performance.

So Many Rules They Can’t Be Followed

Just yesterday, I was observing a training class that I wrote for a major pharmaceutical company that shall remain nameless, but one that we all know and love. We were training hourly line employees on procedures that affect product safety. To a person, they had one complaint: standard operating procedures were becoming downright cumbersome and made it very difficult to follow, let alone implement, them.

One veteran employee said when an incident occurs, someone writes another procedure and adds it to the book of procedures. Nothing else in the book is deleted or changed, and so it is becoming nearly impossible to follow. In fact, the employee complained that SOPs are written in response to each incident, meaning that many new SOPs only relate to one isolated incident each. The SOPs are losing their meaning and rationale. It is just a jumble of unrelated knee jerk reactions to specific incidents.

The employee concluded the company was creating more problems than it was solving by having a procedure manual that could not be followed. There are now so many rules to follow, the rules can no longer be followed, the employee complained.

Is All of Healthcare Headed Toward Unwieldy SOPs?

With the passage of the Accountable Care Act, known colloquially as ObamaCare, many believe that we are headed down a path of over-regulation. Where common sense and good medical practice once dominated the industry, healthcare practitioners (formerly called nurses and doctors) are overwhelmed with rules regarding how they practice, to which the actual art and science of medicine is taking a backseat.

At a recent visit accompanying a friend to a physician’s appointment at a hospital center, we observed that we were two of only four people sitting in a new waiting room with 25 chairs, two large receptionist desks – one that seated four and another with 12 stations – and a physician accompanied by a nurse and a receptionist carrying around a brochure rack deciding where to place it. Let me say that again. A highly skilled specialist was carrying around a brochure rack with his nurse and receptionist trying to find a place for it.

In this brand-spanking-new facility where our doctor’s office had been moved since our last visit (from a very modern, extremely functional office building now sitting vacant in the parking lot), we also observed not one – but two – printers behind the one receptionist desk and a wall of file drawers. We filled out our medical information on a clipboard, which we have done for each of his visits for the last three years to have it inserted into his manila file folder.

Sigh.

The Trend Is…

By personal experience as well as professional observation, the trend is toward more regulation, more staff to assure compliance with the rules, and an ongoing steady stream of physical and electronic paperwork to track patients.

Instead of continuing to ramp up our regulatory oversight into the stratosphere, perhaps it is time to – if I can paraphrase my retired pilot friend – throttle back and re-evaluate what we are really trying to accomplish.

 

Photo by NeONBRAND on Unsplash

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in biopharmaceutical training, clinical trials, electronic patient records, health IT training, regulatory compliance, standard operating procedures | Leave a comment

Falsification of Data: Truth or Consequences

justthefacts

by Peggy Salvatore and Terry McGinn

This article is cross-posted at www.workingwithsmes.com

 

Sometimes expert knowledge isn’t really knowledge at all. In fact, if your data sounds too good to be true, it just might be.  Sadly, for reasons of human sloth, greed or carelessness, sometimes the experts who supply your data are giving you bad information – and they know it.

In Finding Your SMEs, we discuss times when you may be dealing with conflicting expertise or when you may be asked to ignore some information and favor other information in your documentation to please a stakeholder. In those cases, you aren’t dealing in bad data. Rather, you are dealing with differences of opinion.

That’s an honest debate of the relevant facts.

Falsifying data to purposefully mislead someone is different than simple disagreement among experts.

When you are dealing with falsified data, there are no facts. There is no honest debate. There is only an intent to deceive. In regulated industries that depend on quality data to remain in legal compliance, falsified data can have many bad outcomes including products that are substandard, dangerous or deadly. Your best defense is to know your regulations and how to work with them because, remember, you can be guilty simply by omissions.

Remember Volkswagen? What About Your Drugs?

In 2015, the U.S. Environmental Protection Agency discovered that many VW cars were outfitted with software programmed to falsify data during emissions testing showing the cars met carbon dioxide emission standards. The brand suffered substantial damage and the company was exposed to up to $18 billion in fines when it was discovered the cars actually emitted up to 40 times the allowable amount. This attempt to defraud the public resulted in massive car recalls and a loss of company credibility along with profits.

Money lost. Reputation lost. Environment damaged.

In biopharmaceuticals, clinical trial data is the stuff upon which the Food and Drug Administration makes decisions about the safety and efficacy of pharmaceutical products. Does data get falsified there, too? Unfortunately, yes!

A 2001 study showed that falsification of scientific data used in FDA evaluations of experimental drugs was not uncommon, and it ranged from falsifying the identities of clinical trial subjects and their physical exam results to creating duplicate records to achieve the desired number of trial subjects.

It still happens today.

Just a few weeks ago, a Kyoto University research group headed by Nobel laureate Shinya Yamanaka was found guilty of fabricating all six main data figures in a study published in Stem Cell Reports. The study claimed it had modelled the blood-brain barrier in vitro using pluripotent stem (iPS) cells. Yamanaka, who won the 2012 Nobel Prize in physiology or medicine for discovering iPS cells, reportedly was going to donate his salary to the university as a mea culpa but the damage to his reputation will live beyond his paycheck.

Bad data can hurt – or even kill- patients and it exposes the biopharma research companies who rely on quality data to potentially billions of dollars in fines and, at the end of the day, the delay or loss of up to a billion dollars in research and development for a product that can’t be supported by strong, reliable data sets.

Is Your Data Subject to Tampering?

One of the ways to ensure that your data is valid is to have strong processes in place for data collection and auditing. Long before an FDA or compliance inspector finds a problem with your product or process, you can lock down your documentation with well-written and faithfully executed standard operating procedures.

By taking some strong action today, you can implement steps to avoid harm to your brand reputation, delayed or denied product approval, heavy fines, jail time and, of course, harm to patients.

If you would like to discuss your process for developing and implementing standard operating procedures, write to us at workingwithsmes@gmail.com and schedule a no-obligation appointment for a review of your organization’s data integrity vulnerabilities.

Terry McGinn has worked in regulated industry for many years and has experience in written procedures that will help pass scrutiny of a regulatory authority inspection.

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in biopharmaceutical training, biotechnology, clinical trials, expert knowledge, health IT training, standard operating procedures, training | Tagged , , | Leave a comment

Health Wonk Review: Ideas of March Edition

Direct from David E. Williams’ Health Business Blog, the Ideas of March. Enjoy the wonkery, and check out the video podcast CareTalk interview below with David and CareCentrix CEO John Driscoll. 

Beware the Ides of March” –Soothsayer to Julius Caesar
Fear not the Ideas of March” –Health Business Blog to the wonkosphere

If you see something say something

Your friendly neighborhood drug dealer

Count on Drug Channels to make sense of even the most convoluted pharmacy business models –and convoluted they are. This time the topic is the emerging trend of point-of-sale (POS) rebates. Did you know that many pharmacy benefit plans act like reverse insurance, with the sickest members subsidizing the healthiest? POS rebates start to right this wrong and bring forth uncomfortable questions such as: Where have the rebates been going until now?

Crocodile tears

Managed Care Matters shares its perspective that the Administration’s efforts to undermine the ACA have yielded bitter fruit on the marketplaces. Some premiums are up by 30% and meanwhile Congress is doing little or nothing.

Two years ago you couldn’t read the news without hearing about the disastrous premium increases due to “Obamacare,” but the media is silent now.

So what’s going on? Our blogger has a theory: The media is being manipulated and chasing bright, shiny objects.

Skimpy is as skimpy does

InsureBlog likes CMS’s proposal to restore the maximum policy length of short-term medical plans to 12 months from three. That’s even though some news outlets call the plans “skimpy” and some healthcare policy analysts consider such plans to be leeches on Obamacare, because they may siphon the healthiest people out of the marketplace risk pool and drive up premiums.

Location location location

When my son was a toddler, we trained him to say “location location location” when asked, ‘what are the three most important things about real estate?’ I still remember him driving a realtor crazy when one tried to pitch us on a house we didn’t like.

Now, Workers Comp Insider has decided that location is destiny in healthcare, too, declaring ‘It’s the Zip Code Stupid.’ Insider cites a recent JAMA Internal Medicine study that shows geography is “the biggest X-Factor in today’s American Hellzapoppin version of healthcare.”

Location: Wonk zone

The Hospital Leader (not to be confused with the Dear Leader) helpfully explains that “We need creative solutions” really means “the problem we are trying to solve has no answer.” Case study: Hospitals, hospice and SNFs – The big deceit.

A pending bill seeks to establish a state-based individual mandate in New Jersey. But a provision targeting employees of small businesses could inhibit Association Health Plans from selling insurance that does not comply with small group rules. Xpostfactoid explains.

Who knew? Health Care Renewal informs us that the ostensibly libertarian Washington Legal Foundation has become a front for healthcare corporate leaders –and leaders from other fields— to operate with impunity. The foundation’s campaign to abolish the Responsible Corporate Officer Doctrine failed, but the damage was done. (Hat tip to Health Care Renewal for anticipating today’s theme by including “methinks” in its cover note.)

Local talent

The Health Business Blog is now a teenager. I ran the annual round-up of favorite posts by month.

CareCentrix CEO John Driscoll and I rant and rave about Amazon and innovation in the latest monthly episode of #CareTalk.

Singing from the himmnal

Health System Ed shares results from the 2018 US HIMSS Leadership and Workforce Survey, a survey of providers and vendors.

Top themes: privacy and security, process improvement and workflow, data analytics, business intelligence to inform clinical decision-making remain top of mind. 

Well that’s it for the Ideas of March edition. Watch your back today!

By healthcare business consultant David E. Williams, president of Health Business Group.

facebooktwittergoogle_pluslinkedinmailfacebooktwittergoogle_pluslinkedinmail
Posted in biotechnology, consumer health apps, electronic patient records, health economics, health insurance, health IT, health policy, health reform, healthcare marketing | Leave a comment