HIPPA Compliance and SSE Patient Reports

At Superstition Springs Endodontics, we have been discussing the secure, electronic reports that we send back to our referring offices.  As you can imagine, when working with different offices with different email services, each computer with different mail settings, security settings on different networks, doctors and team members reading reports on handheld as well as desktop computers and last but not least, human error, there is likely to be some complications along the way.  Our recent upgrade to TDO endodontic software was significant technology investment was meant to improve our HIPAA compliance.

What is HIPAA?  Title II of the 1996 Health Insurance Portability and Accountability Act (HIPAA) has broad implications in health care - which includes dentistry.  This law created multiple rules & regulations for various purposes.  These regulations include a privacy rule, security rule, breach notification rule and an enforcement rule with civil authority to levy monetary penalties for HIPAA violations.

The Privacy Rule: You are likely most familiar with this rule.  This rule gives patients certain rights over their personal health information which includes dental records and billing records.  This rule gives patients the right to ask for a change in their records, ask health care provider not to disclose their health information to others, or accommodate the patients requests regarding how they communicated with the patient.

The Security Rule: This rule puts the burden on the dental practice to have a written risk assessment and develop practice safeguards to protect the confidentiality, integrity and availability of electronic patient information.  These safeguards are categorized as 1. Administrative 2. Technical 3. Physical  This is a tall order in that these safeguards must make sure that patient data is not corrupted or changed without authorization, and that only authorized people have access to patient data while at the same time making it available for authorized persons to access the information whenever needed. "The HIPAA Security Rule also requires ongoing maintenance of safeguards, periodic risk assessments, workforce training, and documentation."

Breach Notification Rule: The new law enforced the adoption of EHRs for Medicare and Medicaid providers which had a greater impact on our physcians colleagues.  The Health Information Technology for Economic and Clinical Health (HITECH) Act also created the Breach Notification Rule which requires dental practices to provide notification of breaches of unsecured patient information to the patients, the federal government and in some cases the media.

Enforcement Rule:  The enforcement rule has authorized enhanced civil monetary penalties for non-criminal violations of HIPAA rules since February 18, 2009.  While there is not a big history of dentists being fined for non-compliance issues, Dr. Joseph Beck was the first dentist to be fined $12,000 for non-compliance with HIPAA rules by the office of the Indiana attorney general.  The Health and Human Services Office of Civil Rights (OCR) also has the ability to audit dental practices and issue fines/penalties.Omnibus Final Rule:  On January, 17, 2013 the HHS published the HIPAA Privacy and Security Omnibus Rule which created a compliance deadline of September 23, 2013.  The Omnibus Final rule reinforces the HIPAA rules and regulations and:

• extends the privacy and security rules to the dental practice's business associates and their contractors (any contractor who has access to patient information)

• establishes new limitations on use of patient data for marketing and fundraising purposes

• prohibits sale of patient's personal health information without authorization

• expands patients' rights to request and receive electronic copies of personal health information

• broadens patients' ability to restrict disclosure of personal health information to health insurance plans

Does HIPAA apply to your practice? Yes! HIPAA rules apply to your practice if you are a "covered entity" under the law.  You are considered a "covered entity" if you or a third party clearinghouse that you hire transmit electronic claims to a dental plan.What doest that mean for my practice?  If you are a "covered entity" then you need to take steps to comply with the HIPAA law which includes:

• Appointing a practice HIPAA privacy official

• Appointing a practice HIPAA security official

• Familiarizing yourself with the law

• Creating a HIPAA compliance team

• Performing a risk assessment

• Deciding on your practice policies and procedures

• Training your workforce

• Update business associate agreements to comply with privacy and security rules

• Maintain

You can order the ADA HIPAA compliance workbook to help walk you through the process of becoming fully HIPAA compliant at: click here


How does SSE secure patient communication work?  Our current software gives every referring doctor a username and password - allowing them to access all their patients reports, radiographs and relevant clinical data by logging into a secure server.  When a consult or treatment has been completed in our office, you will receive an email to view that specific report or log into the server to access any patient report/data.  However, every step of security also comes with the cost of added steps and login. Here are some of the trouble spots people have reporting using our secure communication tool:

1. Clicking on the wrong hyperlink:  One hyperlink will take you to your specific patient's report and another hyperlink will take you to the server where you can access all of your referred patient's data.

1. Offices with multiple doctors: Each doctor has their own login credentials to access the reports of the patient's they referred.  Team members logging in on the doctor's behalf need to login with the correct doctor to access their patient reports.   If you have multiple doctors, make sure you are logging in the with doctor's credentials who referred the patient to SSE.

1. Email settings:  Your email client (outlook, gmail etc.) may have a setting to string together emails from one source making it harder to find each individual report.  Go to your preferences/settings to make changes in your email software application.

We are committed to making sure your patient's information is protected and that it is available to you when and where you need it. If you are having any problems accessing your reports, please contact us so we can make sure our electronic communications are working seamlessly.

Sources:https://www.ada.org/en/member-center/member-benefits/practice-resources/dental-informatics/electronic-health-records/health-system-reform-resources/hipaa-privacy-security

https://www.hipaajournal.com/dental-offices-hipaa-compliance/

The Good, The Bad & The Ugly - now available for CE Credits on DentalTown

In case you missed this Inner Space Seminar presented at Superstition Springs Endodontics, it is now available on DentalTown.

1.5 Hrs of CE credit available. Click Here

What's the Deal With GentleWave?

We have been asked by many dentists regarding our thoughts on a new irrigating technology called GentleWave by Sonendo Inc.  After meeting with the GentleWave representatives, an in-office demonstration, performing the procedure on extracted teeth, discussing with colleagues using the product and critically reviewing the clinical research  on this technology, we are prepared to answer the question so many of you have asked, "What's the deal with GentleWave?"

"Thrill of the Fill" accomplished using the EndoActivator

At SSE, we have been early adopters of many new, and lasting technologies in endodontics such as microscopes and CBCT.  Our process in adapting a new technology, like GentleWave, is to carefully evaluate the technology, including the claims made by the manufacturers and a critical evaluation of whether the published evidence supports those claims.

 It is also important to evaluate the financial side of any large investment to make sure that it is a fiscally sound decision that makes sense for our patients  and our practice.  Failure to do so leaves a practice in a position where a financial commitment to a technology then determines how the technology is applied to the patient's care.

In the #1 bestselling book, Good to Great by Jim Collins, he makes a point about  our "cultural obsession with technology and technological-driven change". Nowhere can you find a group of professionals more obsessed with technology than in dentistry!

EndoActivator

However, in Collins extensive study of what made good companies become lasting, great companies, he noted that the great companies "maintained a balanced perspective on technology, while most companies become reactionary, lurching and running about like Chicken Little..."  Collins finds that technology alone is never a primary cause of either greatness or decline.

If you are following the information that the GentleWave manufacturer is delivering to offices throughout the greater Phoenix area it is obvious they are making a sizable marketing investment. With a clever marketing approach, they have included in the purchase price of the system, a marketing budget to promote the system and the practice who has invested in it.  You have likely received several invitations to CE events promoting the technology.  There are several phrases being used by the sales-force to excite dentists about GentleWave such as "the thrill of the fill", "this is the new standard of care",  "anatomy like never before seen" and "becoming part of the club". There appears  be an effort by the manufacturers and early adopters to create an impression that the evidence is in and this technique is proven to be superior to conventional irrigation methods.  If you are not adopting the technology now, you will be left behind...

A short summary of our decision regarding the GentleWave procedure as to why we have decided not invest in the technology yet because it will cost patients more, increase treatment time, and decrease our productivity without clinical evidence of improved outcomes was posted on the blog several months ago. We will continue to watch the technology, its improvement and evaluate  the evidence published over time.

The following sections provide more detail into our evaluation regarding the claims made by GentleWave.

What Does the Research Say About GentleWave?

The initial clinical study which made claims of 97% success rates, improved cleaning of canals, isthmuses &  lateral canals & improved cleaning had some major design flaws and biases. Design bias, attrition bias, selection & sampling bias and sponsorship bias were all evident in this study, including a failure to include proper positive and negative controls.

The second clinical study improved upon many of major design flaws & biases of the first study, yet again failed to include positive and negative controls.

Failure to include controls in the clinical studies is concerning to us.  This failure in study design, is hard to comprehend, unless a direct comparison with conventional techniques was not desired or conventional techniques were equally effective.  We have also asked why there has not yet been a double blind, randomized, controlled study performed?

EndoActivator

Why have the universities and residency programs not published about the Gentlewave technique? After discussing this with several people involved at that level, the  reason appears to be that if a university accepts any financial support from the company, including providing the unit, the company insists on controlling the publication of any research results.

So while we can understand the company's desire to protect its significant investment in the development of it's technology, their scientific research appears designed as a marketing tool to support manufacturer claims.  A properly designed study, (randomized, double blinded study with proper controls) will go a long way to overcome sponsorship bias that up to now has been evident in the research.  In fact we have not been able to find one study where the authors are not directly tied to and supported by Sonendo.  We will continue to watch  for this evidence and keep you updated.

3 Dimensional Cleaning, Shaping & Filling 

EndoActivator

One of the biggest claims made regarding the GentleWave technique is "improved removal of organic matter" and creating a "higher standard of clean". Evidence provided for this claim are usually images of more complex anatomy picked up when the tooth is obturated. The advocates call this "the thrill of the fill".

However, the idea of cleaning and filling lateral canals and isthmuses is not unique to GentleWave.  In our practice we have used both ultrasonic and sonic activation of irrigating solutions which has provided 3D cleaning and shaping of complex canal anatomy.

EndoActivator

I have included several radiographic that demonstrate the "Thrill of the Fill" routinely seen at SSE using sonic activation of irrigating solutions. After our hands on demonstration with the GentleWave, I began putting aside radiographs after using sonic activation and found that the fill results were equally impressive.

 In the end, we need to be honest with ourselves. How many teeth are really returning to our office as failures because we didn't clean the tooth well enough?  From our experience - very few.  When patients return to our office with a non-healing root canal procedure, typically it is because the tooth is fractured, not because it wasn't clean. We would love to add the Gentlewave technology to our office but first we need to see a tangible benefit to our patients. That day may come, but for now we would like to see more evidence than "because the company says it's better", before we invest in this technology.

Don't Just Assume A Root Is Fractured When You See Lateral Bone Loss

Sometimes we are quick to assume a tooth is fractured when we see lateral bone loss.  But that radiographic finding alone isn't enough to make that determination.  If you cannot visualize a fractured, and the tooth is diagnosed as a necrotic pulp, it doesn't matter how big the lucency is, it can and should be given the opportunity to heal.  Proper diagnosis to determine vitality is the most important test for the prognosis of this tooth.  In this case, with definite necrotic pulps on #26 and #27 and no periodontal defects, endodontic therapy is recommended.

Necrotic pulp with sinus tract on the buccal of #26.

CBCT shows the apical and lateral bone loss on #26 and #27.  The lateral bone loss on #27 is also suggestive of a possible root fracture, but since the tooth is necrotic, radiographic appearance alone is not enough evidence to diagnose this with a root fracture.  CBCT also shows a 2 canaled root form on #26.

There was concern of a possible root fracture, but none could be see internally with microscope.  CaOH medicated dressing was placed after initial debridement and NaOCl irrigation.

After 3 months in CaOH, we opened and examined again and could find no fractures.  Another application of CaOH medicated dressing was placed.

After 6 months of CaOH therapy we saw significant bone healing. The canals were obturated and case completed.

Sometimes we are quick to assume a tooth is fractured when we see lateral bone loss.  But that alone isn't always enough to make that determination.  Even with CBCT available, I tell my patients the only way to be 100% of a vertical root fracture is to see it.

Finding the Right People for Your Practice

In Jim Collins' bestselling book, Good to Great, he discussed the importance of getting the right people on your team.  He describes your team as a bus and if you get the right people on your bus, it doesn't matter where you take your bus, you will be successful.  The follow concepts are a summary of Collins's concepts of finding the right poeple from Chapter 3, p. 41-63.

In “Great” businesses, people are not your most important asset. The right people are.   Great businesses make a priority on finding the right people.

CONCEPT:  If you have the right people on the bus, the problem of how to motivate and manage people largely goes away.  With the right people, you can take the bus anywhere it needs to go. 

CONCEPT: If you have the right people on the bus, they will do everything within their power to build a great company, not because of what they will “get” for it, but because they cannot imagine settling for anything less.  The purpose of a compensation system is not to get the right behaviors from the wrong people, but to get the right people on the bus and keep them there.

CONCEPT: In finding the “right” people, greater weight is placed on character attributes than on specific educational background, practical skills, specialized knowledge or work experience.

CONCEPT:  Great companies have rigorous – not ruthless – cultures. A rigorous culture means consistently applying exacting standards at all times and at all levels – especially in upper management.  The only way to deliver to the people who are achieving is to not burden them with the people who are not achieving. 

·     To let people languish in uncertainty for months/years, stealing precious time in their lives that they could use to move on to something else, when knowing that they are not going to make it – that is ruthless

·     To deal with it right up front and let people get on with their lives – that is rigorous

CONCEPT: Practical disciplines for being rigorous – not ruthless

1.    When in doubt, don’t hire – keep looking.  The ultimate throttle on growth is not markets, technology, competition or products. It is the ability to get and keep enough of the right people.

2.    When you know you need to make a people change, ACT.  The right people don’t need to be managed.  Guided – Yes, Taught – Yes, Lead – Yes, - but not tightly managed.

a.    Great leaders don’t rush to judgment. They invest substantial effort in making sure they have someone in the right seat before concluding  they have the wrong person on the bus.  Instead of firing honest and able people who are not performing well, it is important to try to move them once or even two or three times to other positions where they might blossom.

3.    Put your best people on your biggest opportunities, not your biggest problems. Managing problems can only make you good whereas building your opportunities is the only way to become great.

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CONCEPT:  Right People + Great Company = Great Life.  Balance in work and life is possible when you have the right people on the bus.  Finding the right people is key in finding that balance and having a great life.  If we are not spending the vast majority of our time with people that we love and respect – how will we ever have a great life? Great life is made up of people who love what they do and love who they do it with.

Single-Visit vs. Multiple-Visit Endodontic Treatment: A Review

There are differing opinions regarding single-visit vs. multiple-visit endodontics.  Some clinicians feel strongly that teeth with apical periodontitis (necrotic or retreatment) need the extra step of CaOH therapy to be successful while others are comfortable with these cases being done in a single visit.  What does the research say regarding this?  Here's a summary of the more recent research:

Please note that the systematic reviews, in an effort to summarize the existing research and find the best evidence, exclude review papers, case studies, review studies and studies that are determined to be "low evidence" and focus on randomized clinical trials or quasi-randomized clinical trials.  However, like most of our dental research, there is a serious lack of studies that can be considered "high-level" evidence, large enough sample size, good research design and proper identification of study bias.  This is a problem found throughout our scientific research and requires the reader to evaluate the quality of research on a study by study basis.

Single versus Multiple Visits for Endodontic Treatment of Permanent Teeth (A Cochrane Review) by Manfredi et. al. 2016, included in their review, 25 randomized controlled trials, of which only 3 studies were found to be a low risk of bias, 8 unclear bias levels and 14 high bias levels.  They found no evidence of a difference between single visit or multiple visit treatment in terms of radiological failure, immediate post operative pain, swelling or flare-up incidence, sinus tract formation or complications.  There was moderate evidence that patients undergoing single step treatment were more likely to use painkillers over those undergoing multiple visit treatment.

A Systematic Review of Nonsurgical Single-Visit Versus Multiple-Visit Endodontic Treatment by Wong et. al 2014 which reviewed a total of 47 papers of clinical trials on the subject.  Meta-analysis showed that post-operative complications of both groups were similar.  Neither group could guarantee the absence of post-operative pain.  Neither single-visit or multiple-visit treatment had superior results in terms of healing or success rates.

Single-Visit or Multiple-Visit Root Canal Treatment: Systematic Review, Meta-Analysis and Trial Sequential Analysis by Schwendicke et. al. 2017 included 29 trials (4341 patients), of which all but 6 showed high risk of bias. Based on 10 trials, risks of complications was not significant. Based on 20 studies, risk of pain was not significant. Based on 8 studies, risk of flare-up was higher in single-visit treatment.  Conclusion was insignificant evidence to rule out whether important differences between these strategies exist.

Outcome of Single- vs. Multiple-Visit Endodontic Therapy of Non-Vital Teeth: A Meta-Analysis by Almeida et. al. 2017 is a review of 17 randomized clinical trials of non-vital teeth.  They found no difference between single or multiple visit treatment in regard to peri-apical repair or microbiological control.  They did find that single-visit treatment results in 21% less post-operative pain.

Single-Visit More Effective Than Multiple-Visit Root Canal Treatment? by Hargreaves 2006 is a review that includes 3 randomized controlled trials including 146 cases. In this review, included NSRCT of teeth with necrosis or signs of periapical bone loss - excluding pretreatment and surgical tx. It was concluded that single-visit root canal treatment was slightly more effective than multiple-visit treatment with a 6.3% higher healing rate. However this difference was not statistically significant (P = 0.3809).

Single Versus Multi-visit Endodontic Treatment of Teeth with Apical Periodontitis: An In Vivo Study with 1-Year Evaluation by Gill et. al 2016, found no significant differences in healing between teeth treated in single visit, multi-visit without dressing and multi-visit with CaOH dressing.

Treatment Outcomes of Single-Visit Versus Multiple-Visit Non-Surgical Endodontic Therapy: A Randomized Clinical Trial by Wong et. al. 2015, was a university study performed by general dentists, on 220 patients followed for at least 18 months. They reported no significant difference in success rate or prevalence of post-operative pain between the single visit or multiple visit treatments.

In my opinion, the evidence does not support that multi-step initial endodontic treatment, even of necrotic teeth, has any significant improvement in outcomes over single step treatment.  In my experience, patients usually prefer to have their endodontic treatment in single-step treatment as well.

BIAS ALERT:  In an effort to identify my own biases, I would share that I perform the majority of my endodontic procedures in a single-step.  I do use CaOH occasionally on retreatment cases that are not healing as expected or when I run out of time to complete treatment in a single step.

GentleWave by Sonendo: A Third Look

We recently had an in-office demo of the GentleWave procedure by Sonendo, Inc. (Laguna Hills, CA).  We had a great team from Sonendo who came to our office and gave a us a presentation and demonstration, including the opportunity to perform the procedure on an extracted tooth.  We spent almost 3 hours together learning about GentleWave.

The presentation was very informative and clearly explained the unique approach of the GentleWave system.  This included a history of its development with some amazing visual imaging of the technology and how the multi-sonic energy and fluid dynamics are used to clean the canal system.  We also had Dr. Mehrzad Khakpour, a GentleWave co-founder, on a conference call to answer any questions.

There is no doubt that the GentleWave system by Sonendo is a novel and unique approach to the endodontic challenge of cleaning root canal systems.  There are a several things I find very interesting about the GentleWave approach which I really like.

1. The multi-sonic energy and fluid dynamic approach to enhance irrigation and cleaning is very interesting.
2. The minimalization of canal shaping with files continues to move us in a conservative direction to preserve maximum tooth structure.
3. The concept of a negative pressure and evacuation of the irrigants and debris through the treatment instrument is a great idea.
4. The de-gassed irrigants ability to penetrate the complexities of the canal system.
5. The removal of smear layer using multi-sonic and fluid dynamics.
6. For those who do 2-step treatment, this may be a way for them to feel more comfortable with single step treatment - which patients prefer.
7. Sonendo insists that they are focused on continuing the clinical research.
8. Sonendo does have a volume discount for treatment instruments, which gives the endodontist a slight economic advantage over a general practicioner.
9. The technology is really cool. Who doesn't like new technology?

 Here are some of the questions or concerns that I have about the GentleWave procedure:

1. We have current ways to create sonic or ultrasonic activation in the canal system.  These work very well and are much faster and less expensive the GentleWave.
2. With the GentleWave procedure, you still have to locate all the canals, including calcified canals, get patency and open them up to a minimal size.  This is the most difficult and time consuming part of the endodontic procedure.  GentleWave does not solve those problems.  No time saved there.
3. Cost of the treatment instrument, materials to create the platform, additional volume of irrigants and sealers double or triple the material overhead costs of the treatment.
4. Using the GentleWave procedure will add time to the procedure. It has been estimated by one clinician currently using it that it takes 30% more time per case (20 min for this practitioner).  This would decrease the number of patients that could be treated each day.
5. The claims being made regarding improved success rates and decreased post-op sensitivity are anecdotal.
6. Hidden costs of ownership make this technology much more expensive than it appears.  A business model that requires up to 73% of the cost of the initial investment in disposable, single use treatment instruments per year (in order to get the discounted rate) ends up being a much bigger investment.
7. Will insurance companies really allow contracted clinicians to charge additional "non-covered" fees to the root canal procedure?

Being among the earliest adopters of microscopes and CBCT in Arizona, we have been through the process of evaluating new technologies and their impact on the clinical practice of endodontics.  When it comes to incorporating a new technology into practice, it should be able to:

1. Make you better - improve outcomes
2. Make you faster - more efficient
3. Make you more profitable

The GentleWave procedure will not make you faster or more profitable and there is not enough evidence to determine if it would make you better by improving outcomes significantly for patients.

This technology is fascinating. However, for such a large expense, it would be foolish to incorporate any technology into a practice that can so profoundly affect the overhead and productivity of the practice without doing an adequate cost benefit analysis, measuring the opportunity cost and evaluating the return on investment.