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.

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.

• Folks at the Medical Care Blog look at an important public health issue, a children’s health crisis. Dr. Julie Graves – a family medicine and public health physician who previously served as a regional medical director in Texas – addresses the ongoing family separation crisis at the border: What’s Next? The Ongoing Crisis for Children Taken from Families Seeking Asylum at the US-Mexico Border. (Related, see her recent article on the topic at CNN: The surgeon general needs to step up for migrants.)
• When should services be covered by government insurance compared to private insurance? How does the public/private insurance vary around the world? Jason Shafrin, the Healthcare Economist investigates: What should be covered by government vs. private insurance?

• At Healthcare Renewal, Roy Poses says “This is starting to get tedious. ” He notes that it used to be nearly all the cases we found of ill-informed and/or mission-hostile health care management were about top leaders of big private health care organizations, eg, hospital systems, insurance companies, pharma/ biotech/ device companies, etc. But he notes that since 2016,  the locus has shifted: Ill-informed, Mission-Hostile Health Care Leadership… in the White House and the US Department of Health and Human Services. He makes his case with a roundup of cases.

• 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

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.

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

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.

By Peggy Salvatore and Terry McGinn

Each company in a regulated industry is required to follow written procedures.  The written procedure describes how steps or tasks are to be followed to achieve the desired outcome or result.  Having these steps identified permits the distant or precise way to achieve the end of your process or practice. 

Knowing the critical nature of having written procedures, your standard operating procedures and best practices need to follow a few procedures of their own so you can replicate what you do across your organization.  In other words, your standard operating procedures need to be transparent and streamlined.

One of the many purposes of the SOP or best practice process is to ensure that the process flow can meet expectations. Done well, your standard process or procedure should result in a quality product or achieve the desired result every time.

Knowledgeable and trained  personnel must have the SOP available to follow because no matter how many years’ experience they may have, even experts get stuck for a variety of factors. In fact, some experts know their jobs so well that they think they can skip or modify steps, take shortcuts, or do it from memory. This is a red flag!

The SOP should be written in a logical process flow that will allow someone looking for the cause of a failure later can pinpoint where a difficulty arose. Reviewing the SOP with someone internally or externally who is checking or auditing your procedure should allow them to identify what and where things  went wrong.

When you have a point of failure, an examination of the SOP should indicate gaps or problems that can include one or more of a host of issues including materials, equipment, environment and much more. Often, a failure can point to the source of your complications by reading the SOP against practice.

A well-written procedure or best practice document will:

1. Be written to describe the flow clearly to anyone trained on it
2. Include every essential step without including extraneous steps or materials that can and should be accessed elsewhere
3. Always be followed by everyone from the new hire to the veteran employee using the current SOP

Expect you will have changes to your SOPs on occasion. Expect you will need to review your documents periodically according to your SOP. And expect that when you have a clean, clear, streamlined SOP process that your errors should be few and easily identifiable.

To summarize, standard operating procedures and best practices need to follow procedures of their own so you can replicate what you do across your organization.  In other words, they need to be transparent. If they are the opposite of transparent – opaque – they are hard to follow and may result  in errors.

If you would like to talk to us about your SOP process, give us a call for a no-obligation preliminary review of your procedures.

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. To have a conversation about writing your standard operating procedures, write to us at workingwithsmes@gmail.com to set up an appointment.  

Photo by Drew Hays on Unsplash

By Terry McGinn and Peggy Salvatore

We’ve been getting quite a bit of interest and feedback regarding our series on standard operating procedures, so we’ll continue writing about this topic this week.

After all, inherent in the word “expert” is the idea that something is done correctly. Correct procedures and best practices need to be captured and passed on. Sometimes, though, it seems the only people who care if the SOPs are followed are the experts who wrote them.

Truth is, everyone needs to care. Accountability right down to the last man or woman is absolutely the key essential ingredient in ensuring regulatory compliance.

Train for Accountability

Employees who are tasked with executing the many small, incremental steps are responsible only for their piece of the process. Sometimes in the laser-focus on one task, people may lose sight of the bigger picture. That bigger picture – a safe product going out the door – needs to be reinforced occasionally. Training usually steps in here for both reinforcement and correction. When that fails, the regulatory authorities will notice. Companies get slapped with government warnings and fines at a higher rate than the average person may realize. But if you are in a regulated industry, you know how often you are out of compliance.

Think about dialing the failure point back to its origin. The failure point is when the SOP is not correctly written, understood and applied.

Only then does the employee fail to perform to specifications.

Only then will training have to step in for often very expensive correction.

Only that will happen when an audit reveals you are out of compliance with your SOPs, and the Corrective and Preventative Actions (CAPAs) applied at that point of failure. That doesn’t need to happen.

In a perfect world, it should look like this:

If your current plant is not operating flawlessly as above, identify your points of failure:

1. How many people are asked to retrain personnel after a deviation or equipment issue?
2. How many SOPs do you have? Are they overwhelming or conflicting?
3. Are they easy to understand and do they follow a logical, stepwise process?
4. After a deviation, is the SOP reviewed?
5. Are people observing the CAPAs?

And, the big question…

Do your employees feel responsible and accountable for performing their jobs according to the SOPs in place?

Employees feel empowered when they are able to follow well-written SOPs, and when they are acknowledged for contributing to a well-run organization. Points of failure cannot be business as usual. Organizations that accept points of failure as the status quo have a company culture that unintentionally encourages non-compliance.

Maybe that is worth repeating:

Organizations that accept points of failure as the status quo have a company culture that unintentionally encourages non-compliance.

And the road to audit hell is paved with regulatory non-compliance.

The Solution

Dial back your points of process failure to the source.

Ask yourself:

• Are my SOPs well written?
• Do my employees feel a sense of responsibility for performing to specifications?

If your answer to either of those questions is, “No” or “I don’t know”, give us a call.

We would be happy to speak with you.

Unlike some problems in the universe, the problem of poorly-written and executed SOPs can be solved. Let’s do it.

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. To have a conversation, write to us at workingwithsmes@gmail.com to set up an appointment.  

Photo by Drew Hays on Unsplash

Source: https://www.healthinsurance.org/blog/2018/02/15/health-wonk-review-for-february-15-2018/
Follow us: @EyeOnInsurance on Twitter | healthinsurance.org on Facebook

Here’s Joe:

“Blog posts!

Health Wonk Review returns to the inter-webs after a holiday hiatus. Refreshed, renewed, and revitalized, we bring you the best from the brightest!”

Thanks much for kicking off the new year, Joe!

Sophie’s Choice was an award-winning 1983 movie based on the William Styron novel about a Nazi concentration camp survivor who was forced to choose which of her two children to send to the death camps. In this most heart-wrenching scene ever filmed, the woman must choose and begs to choose “neither”.

For healthcare providers who are caught in a regulatory net by participating in government-funded programs, they were given a choice between installing an electronic health record system, attesting to meeting a list of nearly-impossible targets to get reimbursement for their multi-million dollar investments, or choosing not to participate which resulted in losing participation in said government-funded programs and incentives.

Most providers bit. They had no choice. And when it came time to collect the Meaningful Use incentive dollars, they attested to meeting at least the minimum requirements. The government bit back.

Department of Human Service auditors in the Office of Inspector General most recent review estimated that the Centers for Medicare and Medicaid Services has overpaid more than $729 million to providers whose paperwork didn’t pass muster. That’s more than a big whoops for many organizations. That can be an organizational nightmare to reconstruct and prove that your claims were accurate.  Click here to read the story.

Here’s an excerpt from the HealthcareITNews story reporting the overpayments:

All of these providers should begin – if they haven’t already – gathering the required documentation. While it varies by the program, [Erin} Whaley [partner at international law firm Troutman Sanders]  explained it will range from security risk assessments to screenshots. For other measures, providers will need a patient list of an audit log.

And documentation is required for every year attestations are made.

[Matthew] Fisher [partner at corporate law firm Mirick, O’Connell, DeMallie & Lougee] recommended that healthcare providers run an internal audit or review to ensure all documentation and information resides in one place and can be easily accessed.

Financial and Administrative Burdens

Yesterday, I met a young physician at a barbeque. Our conversation led to the typical “what do you do?” When I asked her what specialty she was most interested in, she said she was considering geriatrics or ob-gyn but that the business of medicine had become so dominant that instead she was thinking about getting her MBA and switching her focus completely. This woman spent her early career as a trauma nurse. She loves medicine and loves patient contact. She is currently doing toxicology research and interested in Alzheimer’s Disease research.  But her experience in the medical field is leading her to the conclusion that her brain and talents might better be used analyzing spreadsheets and business plans.

I used to think that healthcare was a positive driver of gross domestic product and a thriving sector of the economy. Now, I wonder if our focus on healthcare as a business isn’t costing us our focus on patients and causing us to lose some of our talented and dedicated medical professionals to regulation and bottom-dollar mentality. Loss for the patient. Loss for the doctor. Loss for society.

This is not a new thought.  But this is a problem that is becoming so acute that to save medicine, we need to reprioritize what we incent, how we incent it and whether the recordkeeping is worth the price of time, focus and energy toward the business rather than the medicine.

Health technology – like all technology – is making quantum leaps forward while we are looking backward to reconstruct Meaningful Use criteria that are quickly becoming meaningless.

In this article on the future of Precision Medicine here, architects of the future of healthcare at the Precision Medicine Summit in Boston last week said that the future of Precision Medicine is more accurately Precision Health. Precision Medicine was about the use of system data to help doctors make decisions about patients; Precision Health is about patient access to their own data to make good decisions about their own health.

This one move from focus on the system to focus on the individual calls into question the future value of the content of the electronic health record stored in your health system database as it relates to patient care. After all, we knew all along that the patient record was, at best, incomplete. It also further calls into question the value of the Meaningful Use criteria as they relate to the practice of medicine where it is today.

Perhaps CMS needs to call a timeout on the HHS auditors, call the MU money well-spent where it incented progress, sunk costs where it impeded progress, and walk away from this program that was as well-designed as it could have been nearly 10 years ago before we knew what we know now.

I’ve been hanging around the virtual water cooler in healthcare for two decades, and now the promise of technology as it affects and improves our lives is beginning to come to fruition. With that, here is a roundup and just a few developments and their significance to the future of healthcare from a medical, business and financial perspective.

Med-Tech: At the head of the futurist pack is Dr. Peter Diamandis, known for oh-so-many things including a founder of the X-PRIZE, Singularity University and the Human Longevity Institute. In his May 19 Abundance Insider, he looks  at a bionic hand developed in the UK “capable of grasping objects without the wearer’s focused thoughts.  The researchers created a convolutional neural network training the hand and its algorithm on the images of over 500 objects in various orientation and lighting conditions with four programmed grasps that you might use to pick up things.”  Go to the link to see the video. Under that entry, you can read the next story about an 18-year-old Mexican student who designed a bra that detects breast cancer.

Health Biz-Tech: The business of healthcare is all about how we pay for medical services and the structure of the business model. Our current system is focused on an insurance-based payment model. Already, insurance companies are toying with issuing insurance policies in real time based on your current medical history that involves instantaneous analysis of your condition, the company’s risk and what it will cost you to be covered by them. This could blow all the regulations out of the water. It could also call into question the current model of trying to cover everyone with insurance and could instigate a movement to have us begin to look at a different business model completely, especially in light of the kind of Med-Tech advances in the pipeline that will completely alter our outcomes and lifespan.

Health Fin-Tech: How and why certain goods and services get paid keep many an insurance agent, claims administrator and government regulator up at night., not to mention the security people who need to lock down our data to maintain patient privacy. The blockchain has the promise of changing the financial world, and healthcare payments and security will be part of this revolution. I am attending a Meetup of blockchain people in my area this Saturday and I’ll report back at some point.

They say those in a movement need to either lead, follow or get out of the way.

At some point in the history of the evolution of healthcare, government was in a position to lead. In the past few years, it has been in the unfortunate position of having to follow as technical advances outpaced the ability of government to legislate and regulate at the pace of change. Now it is time for government to get out of the way. At some point, we’ll need to regulate for safety and security reasons. But this is not that time.