2014: A Healthccare Year to Remember

This year is action-packed with policies, mandates and programs to keep physicians, hospitals and healthcare consumers all busy and wondering what they need to do or how they may be affected. In this article, Dr. Jitesh Chawla explores of the key programs and legislation that will start up in 2014.

Health Information Exchanges

One on-going problem has been that different healthcare institutions have different IT systems. The fact that the average patient in the US moves through various providers over the course their healthcare treatment life cycle poses a problem for continuity of care as information about their past is often not available in real-time to their current provider. Meaningful Use requires system to be able to exchange data with each other. Standards such as HL7and CCR/CCD have been created. In fact, national networks such as NHIN and programs such Direct Project enable a national information highway. However, it is also at the state level that such data transfer needs to happen and health information exchanges (link) have been setup. Dr.Chawla has the opinion that patient privacy and HIPAA compliance will be of paramount importance as patient data is sent and received through the cloud. For more information about the topic, please go to http://www.healthit.gov/providers-professionals/health-information-exchange.

Health Insurance Exchanges

You all have probably heard in the news for the last several months how the Affordable Care Act legislation has mandated that everyone sign up for health insurance or face penalties. This effort, dubbed Obamacare, will have profound effects on the population. For one, today is the first day that people are using these exchanges and must have signed up for them by end of Dec 2013. The idea is to offer plans that anybody can afford. The government wants even healthy individuals to take insurance so as this will ensure subsidies to finance the sick. Other stipulations include penalties for businesses that don't sign up their employees. The penalties varies depending on the size of the businesses. Jitesh Chawla, MD feels that without acheiving the individual mandate and a national healthcare insurance system, these efforts will be short-lived and lead to only minor curbing of the unfair advantage of patients that insurers are taking.  For more information about the topic, please go to http://www.dummies.com/how-to/content/healthcare-reform-2014-mandated-coverage-insurance.html.

Meaningful Use Stage 2

Meaningful Use is a term referring to the recording and reporting of certain data by providers and hospitals to CMS in order to get extra money in their Medicare or Medicaid payments or avoid penalties. The program is divided into 3 stages each of which run, on average 2-3 years in length. For this second stage, new requirements such as emailing directly with patients, bringing up radiology reports with the EMR and entering data into speciality registries (ie. cancer, etc.) may be challenging and new for many people. Furthermore, extra expense and re-training is needed because EMR systems will have to be upgraded to allow the extra features needed to perform these functions. Dr. Jitesh Chawla feels that MU 2 compliance will be low and the standards may be lowered or another year will be added to allow time for better compliance. More information about the topic can be found at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Stage_2.html.



These are just some of the changes proposed to take place in 2014 that will affect provider, hospitals and patients. There are still other programs such as PQRS, MPPR, etc.that we won't have timeto discuss in this article but are important and you should know about. The best way to be ready is to understand what is expected of you through this article and links given and work with your local RECs, consultants or experienced office managers to devise a plan for compliance. Dr.Jitesh Chawla feels that though 2014 may be a year of many firsts for healthcare in the US, providers, hospitals and consumers will still be able to financially survive and make it work.

Protecting Identity in the New Digital Age

Now that HITECH has been able to increase the adoption of electronic medical records (EMRs), the focus is on interoperability. The market has been flooded with various EMR and PM (practice management) systems but how do they communicate? The challenge of interoperability is being addressed aggressively as we go into Meaningful Use Stage 2 and Health Information Exchanges. However, according Jitesh Chawla, MD the piece that might be forgotten is maintaining patient privacy in this new digital age.

As the nation progressively implements electronic healthcare records, stakeholders have uncovered an elephant in the room – how to implement patient identity and integrity solutions. Linking an individual’s electronic health records across disparate systems, many suggest, will more likely than not require a unique patient identifier. Yet from a policy perspective, implementing this identifier has been extremely difficult. Medical banking, or the convergence of banking and heath IT systems, is spawning new ideas that could impact this difficult area. New forms of efficiency in payment processing may yield a technology platform for managing digital identity by banks that could also be used for healthcare.

Click on this link to read the rest of the article.

Then please post comments and join Dr. Jitesh Chawla for an interesting discussion on this topic.

Dr. Jitesh Chawla reviews smoking cessation trials

Dr. Jitesh Chawla's clinical trial research shows that the first anti-nicotine vaccine to enter Phase 3 clinical trial, NicVax, was in it’s the last stage of testing before hitting the market. The product works by inciting the immune system to produce antibodies that bind to nicotine in the bloodstream, much as antibodies would attack an invading microorganism. Once bound, the nicotine cannot cross the blood-brain barrier to enter the brain. It is the neurotransmitters in the brain that cause chemical reactions leading to addictive behavior. The vaccine was therefore expected to diminish the pleasure of smoking and make it easier to quit. Unfortunately, the failure of the vaccine serves as major set-back to harness the immune system’s power to fight additions such as tobacco abuse.

Figure 1.
Trial paper posting by Dr. Chawla

Nevertheless, Micro-electric  current therapy shows a lot of promise. In one trial studied by Dr. Jitesh Chawla, 1,000 cigarette smokers treated between July 2006 and January 2008, 972 (97.2%) lost their craving for cigarettes within 1 to 5 minutes into a 20 minute session of CES. In those who were in the process of quitting and often at the height of their withdrawal symptoms, cravings started to diminish within 2 minutes of initiating CES and usually disappeared within 10 minutes. Several were 2 or 3 weeks into quitting and still experienced craving.

There may be many reasons for the difference between success and failure including the solidity of the product, trial design, lack of capital, tough FDA reviewers but clinical trials. Even after successful trials and FDA approval some smoking cessation products, like the Nicotrol Inhaler, are not adopted well, as the side-effects and limited efficacy with mediocre outcomes serves as a stumbling block. It is time to try something new. Micro-electrical current therapy has a different mechanism of action than any other therapeutic agent for smoking cessation, currently in the market, and is worth a shot. Next time you are searching for a new doctor make sure he or she keeps up with latest research regarding medical treatments for important common problems such as nicotine addition.

Also, keep following this blog for more exciting clinical trial news from Dr. Jitesh Chawla.

Emergency Care under Obamacare

Dr. Jitesh Chawla speaks from personal experience as a physician who as frequently worked in emergency rooms/  

   "Packed waiting rooms and we will have to see 50 patients or more in a shift," answered one emergency room physician.  This was in response to my question of how the Affordable Care Act will affect the volume of patients that a provider in the ER will see.  Many experts speculate that the expansion of Medicare under “Obamacare” will allow more people in the country to access the healthcare system.  These same experts believe that the people who receive this access will flood emergency departments around the nation in record numbers for conditions that are not emergent, causing physicians to be overworked.  In this article we will examine claims from the experts and also specific examples in the bill that pertain to our subject matter.  Hopefully we will shed some light on the subject as we move forward.

     So why the panic over the expansion of Medicaid? Many commentators cite numbers in a recent CDC report ¹ that show that recipients of Medicaid visit emergency rooms twice as much as the uninsured.  The program is being expanded for people between 19 and 65 years of age that meet the required criteria and this will allow millions of new people the opportunity be covered.  With this, many believe that these new recipients will run to the ER anytime there is a problem that could be treated by a primary care physician. The question comes down to human nature and people can speculate but no one can accurately predict the future.

      What are the commentators saying? Well there seems to be many differing opinions, most based on political leanings.  The fact remains that the Affordable Care Act has been upheld and it is a reality.  Whether you agree with the bill or not, it will affect you and your practice.  According to a paper done in 2010 by John Goodman, CEO of the National Center for Policy Analysis, the rise in emergency room volume is inevitable.  Goodman concludes that the expansion of Medicaid under “Obamacare” will insure an additional 32-34 million people. Using past projections of emergency room visits, Goodman calculates the increase of patients. "Consequently, we project that insuring between 32 million and 34 million additional people will generate between 848,000 and 901,000 additional emergency room visits every year," Goodman stated in his article.

     What does this mean for emergency room physicians? It means that in an average 12 hour shift, physicians may see 30-35 patients at a busy hospital and many consider this a busy night.  Some fear that with the projected rising number of patients, doctors will be spread too thin and the quality of care will decrease as physician fatigue increases.  As it is with many issues in the United States, a problem presents itself and businesses and society responds.  Many states have opened Osteopathic medical schools, with a desire to train new physicians to practice in rural or underserved areas.  The thought process is that if more physicians are trained with an emphasis on these areas, they will meet the demand that the increased numbers cause.  Many allopathic medical schools are now offering rural health programs.  The University of Alabama offers a rural physicians program in which a qualified student can train to practice in an area where healthcare is not usually abundant.  This can be in rural farming communities or lower income neighborhoods.  The hope is that by training the physicians to serve in these areas, more patients will seek help at these clinics than flock to the emergency room.

    It may be inevitable that emergency rooms will have an increased number of patients under the expansion of Medicaid.  All signs seem to be pointing in this direction.  However, maybe the attempts at filling the physician shortage in certain areas will funnel the patient load away from ER's around the country.  We will continue to examine how the Affordable Care Act will affect certain aspects of our healthcare system.

 Stay tuned from more health information from Jitesh Chawla, MD.
Reference:

1. http://www.cdc.gov/nchs/data/hus/hus10.pdf

Role of EMRs in Accountable Care Organizations

As the final rule on ACOs ( Accountable Care Organization) has come out, it is apparent that that the value that EMRs (electronic medical records) bring is unprecedented.  Under the Medicare Shared Savings Program, ACO participants (which may include medical practices, hospitals and payers) are graded and paid based on 4 domains of care quality: 1) patient experience;  2) care coordination and safety;  3) preventative health; 4) at-risk populations.  The program consists of a 3 year performance period in which the performance of the ACO mapped against thresholds set by CMS. To reap financial benefits from this program, providers must report on 23 of 33 quality measures spanning these 4 domains during the second year and 33 out of 33 in the third. Some of the measures, like # 20, which asks for the percentage of providers that have received Meaningful Use money are easy to satisfy if you have a Certified EMR.

ACO participants are incented to work together and efficiently because if they don’t meet the CMS thresholds they must pay money back. Data is key when trying to coordinate care and the exchange of clinical data must be done properly to meet the quality measures set by CMS.

Now it must be apparent to medical providers that if they want to join an ACO it is very important that they are comfortable using an EMR. The good news is that there are certain features of the software that allow providers to capture the necessary data for ACO quality measures easily. For example, in the Preventative Health domain there are measures such as Adult weight screening and follow-up and Tobacco Use Assessment. Both of these are Meaningful Use criteria and any certified EMR has screens and buttons to record this information. 

In another example, the domain of at-risk population contains a diabetes composite measure in which the number of diabetics who BP is less than 140/90 must be recorded. To do this, it may necessary to setup a report in which there are fields to search for a patient’s diabetic status and their blood pressure level concurrently. For instance, in Patagonia Health’s EMR, there is a section called “My Reports” where users can fully customize search criteria for certain disease conditions, procedures and demographic characteristics.

Finally, the exchange of health information between providers and entities requires ability for the system to send and receive data securely and in a format that the receiving end would be able to decipher. Exchange of clinical data is a Meaningful Use criterion and is done through CCR (care of continuity record) which generates a summary of the usually about the patient’s medication, laboratory, immunizations, provider names, vital signs, alerts. Providers simply need to press the CCR button and it generates a file. This file can then be sent in encrypted format through email currently (and through Health Information Exchanges later) to the other provider’s EMR.

EMRs have become a powerful tool that has empowered medical providers to collect the necessary data in order to provide medical care with a sense of accountability and level of quality in the form of an ACO. The Meaningful Use Program has further enabled different EMRs to have the standard features important for this data collection.

.

Micro-electric therapy for smoking cessation??

Dr. Jitesh Chawla discuss smoking cessation clinical trials-failures and successes

 

The first anti-nicotine vaccine to enter Phase 3 clinical trial, NicVax, was in it’s the last stage of testing before hitting the market. The product works by inciting the immune system to produce antibodies that bind to nicotine in the bloodstream, much as antibodies would attack an invading microorganism. Once bound, the nicotine cannot cross the blood-brain barrier to enter the brain. It is the neurotransmitters in the brain that cause chemical reactions leading to addictive behavior. The vaccine was therefore expected to diminish the pleasure of smoking and make it easier to quit. Unfortunately, the failure of the vaccine serves as major set-back to harness the immune system’s power to fight additions such as tobacco abuse.

Nevertheless, Micro-electric  current therapy shows a lot of promise. In one trial, 1,000 cigarette smokers treated between July 2006 and January 2008, 972 (97.2%) lost their craving for cigarettes within 1 to 5 minutes into a 20 minute session of CES. In those who were in the process of quitting and often at the height of their withdrawal symptoms, cravings started to diminish within 2 minutes of initiating CES and usually disappeared within 10 minutes. Several were 2 or 3 weeks into quitting and still experienced craving.

Picture of Micro-electrical current device- as proposed by Dr. Chawla for smoking cessation clincal trials

 

There may be many reasons for the difference between success and failure including the solidity of the product, trial design, lack of capital, tough FDA reviewers but clinical trials. Even after successful trials and FDA approval some smoking cessation products, like the Nicotrol Inhaler, are not adopted well, as the side-effects and limited efficacy with mediocre outcomes serves as a stumbling block. It is time to try something new. Micro-electrical current therapy has a different mechanism of action than any other therapeutic agent for smoking cessation, currently in the market, and is worth a shot.

 If you interested in gaining access to new treatments to help your long-time smoking habit, when you go look for a doctor who conducst such studies. Dr. Chawla suggests the best way to find out if something works for sure is to conduct a small controlled trial .

The Use of Electronic Medical Records for Clinical Trial Recruitment

By Jitesh Chawla, MD.

About EMRs

With the advent of  the HITECH Act and Meaningful Use, EMRs (electronic medical records) have become very popular among practicing clinicians. The technology enables medical providers to chart patient data into structured fields. This allows information to be easily retrieved for analysis and reporting. Another major advantage of the EMR is the ability to provide clinical decision support  (CDS). Rules can be set to alert or inform about patient clinical information that would affect treatment at the point of care. Rule parameters are configured on a settings screen and the rule is run on patient data captured in those structured fields. One example of CDS in action is an OB/GYN clinic that set for an alert to come up for every woman that was overdue on her PAP smear based on age, prior history of PAP abnormalities and family history of cervical cancer. EMRs and CDS can play a vital role in clinical trials.

Clinical Trial Enrollment

Clinical trials are divided into the following phases: 1) using healthy subjects to test for drug safety 2) using a larger group healthly subjects tested for drug efficacy 3) treatment and control groups involved in a randomized control trial 4) post marketing surveillance.  The enrollment requirements significantly increase in each phase (see table below).

Table 1. Typical Enrollment Estimates of Clinical Trials¹

Phase	Subjects Needed
1	20-100
2	100-300
3	300-3000

  Since clinical trials can account for at least 50% drug development costs, which may run up to 1 billion dollars per product, delay or cancellation of a trial due to inadequate or late enrollment is very costly². Once source cites a company lose from $600,000 to 8 million per each day a trial is delay³. Furthermore, with increased government regulations of the pharmaceutical industries and fierce competition, many drug companies cannot afford any major delays or a cancellation.

Challenges and Possible EMR Solutions for Trial Recruitment

Some reasons why recruitment and retention of subjects for clinical trials presents a challenge include:

1)Finding patients that meet the criteria and finding them quickly. The study design specifies very clearly who does and does not quality for trial participation. Also, requirements change based on the phase of study. These inclusion and exclusion criteria are very strict and need several levels of approval (ie. IRB, sponsor, investigator) before any exceptions  are made.

2)   Patient interest. Many patients may not elect to be part of a trial when they otherwise had there been better explanation about the drug being tested or condition being treated. Furthermore, some patients are just too scared to be part of an “experiment” and are not convinced by all the precautionary measures that trial staff explains they have taken.

The beauty of the CDS feature in the EMR is that each inclusion/exclusion criteria can be put as a separate rule. Furthermore, the patient reminders feature can cause a pop-up window to appear every time that rule is satisfied. Secondly, there is no better person than the patient’s provider to convince them that trying an experimental treatment might be the best option and that the benefits outweigh the risks. The relationship between provider and his or her patient is a unique one and cannot be replaced by any clinical trial staff member. EMRs have a patient education button that contains information about disease conditions and can be customized such that details about the clinical trial can be included.  Providers can go through the education sheet with their patients.

Conclusion

It is true that not all patients are suited for participating in clinical trials. Also, despite all the information and intelligence available at the point of care, some providers may choose not to use the EMR to help with trial recruitment. Nevertheless, the fact remains that clinical trial enrollment is a big issue and the EMR with its CDS and other features can help in this endeavor.

In the next article, I will go through an example of how a rule is set up in the CDS module of a typical EMR and give some real-life case study examples of organizations that have leveraged this technology to help them successfully recruit for their clinical trials.

References:

1) wikepedia

2) http://www.promodel.com/solutions/pharma/clinicaltrials.asp

3)  http://www.pdpipeline.org/2011/clinicaltrials/recruitretention.htm

Health insurance law changes and how could it affect your practice

Introduction
Medical insurance coverage is directly related to the amount of billing activity done by a practice. The better the coverage the more likely patients come and the more you can bill. There have been many changes to the insurance law in the last year and several regulations are set to be in effect in the years to come. Some of these are on off-shoot of the Affordable Care Act signed into law by President Obama. In this article, I will describe some of these changes and how it may affect your practice.

Examples of insurance law changes due to healthcare reform
For those who already have health insurance:
•Insurers will not be allowed to take away your coverage if you get sick-effective 2010
•Insurers will not be allowed to limit how much they will pay for medical benefits over your lifetime – effective 2010
•Policies will now have to pay for tests to detect chronic diseases (ie. cancer) at earlier stages but not require any deductibles, co-pays or co-insurances -effective 2010
•Insurers will not be allowed to limit how much they will pay for medical benefits during a year-effective 2014
For those who can’t afford insurance or have trouble finding coverage for 1 or more persons:
•Your children may be on your policy or be added to your family policy until they turn 26-effective Sept 2010
•Temporary coverage to those with pre-existing conditions till health insurance exchanges are set up (in 2014)- effective Sept 2010
•Insurers can no longer charge you excessively more because of past medical history age or sex. But, they can charge up to 50% more if you smoke –effective 2014
•The HIEs will be set-up for those who can’t get insurance through work or lost their job. -effective 2014. (Those who qualify for one and don’t sign up will be penalized)

What does this mean to you?
If you are a small practice, particularly in primary care, these changes may provide you increased financial viability as more people likely will seek medical care. Small practices often don’t get as much reimbursement as a larger practice for the level of work and need to make the make up the different by seeing more patients. Also, if you serve an area with a lot of uninsured patients, then you may be able to accept them soon, as nearly everyone will have health insurance by 2014. Oftentimes, patients may hesitate to seek medical care because of all the limitations on what is covered as dictated by their insurance policy. But, with changes such as no limits of benefits over a lifetime or year, coverage of illnesses excluded by pre-existing condition clauses, etc. more patients will be able to get their treatment paid for.

Conclusion
It is that apparent that there are major changes to insurance coverage as result of healthcare reform. However, if you ask Dr. Chawla this is a crucial trial period. This is just the beginning and there are many more changes expected to come over the years. Those having insurance and not having insurance are the 2 categories used as examples. But, the insurance law changes also affect people on Medicare exclusively, in long term care and small business owners. As patient volume increases, logically it becomes more and more important to have a very efficient, structured billing process in place.

What do you think about this topic? Do you think these changes will affect you? We would love to hear from you.

Patient Portals: What are they and how can they be important?

A Patient Portal is a software functional feature that enables patients to view or to send their own health data without the need of medical provider or staff. Screens are available where patients can see their medication list, allergy list, labs and schedule appointments. It can be described as a "window looking into their electronic patient chart" Some portals allow patients to also see their visit bill, fill out of their initial intake form, email their providers and send data from medical devices (ie. glucose, BP values, etc).

Patient portals can be part of an EMR or be used standalone or be linked to an EMR, PM system, etc. This a tool that has been important in getting patients engaged in their own care. Also, it helps organizations cut costs. For example, lab results don't need to be mailed, staff time is not wasted to help patients schedule appointments or answer simple questions about their bill.

Patient benefits include cutting down time filling paperwork on a new patient visit, more freedom in accessing certain health data (ie. labs, med list) on demand and an ability to contact their medical provider directly without having to depend on the practice staff.

One study revealed that 75% of patients wanted to email their physicians, 2/3 rds wanted to lab results online and at least were very to upload data from their home monitoring device into the EHR. These days it is easy for a practice to get a patient portal. In fact, Meaningful Use certified EMRs come with patient portals. Some have basic features only (results viewing), while others allow you to schedule appointments, refill meds and send messages.

Screenshot of a patient portal

(reference: omedix blog)

However, there are a few important points to what features to make available.

1. Consider the implication that the patient portal feature will have on practice workflow. For example, you may want to include lab results as a feature as most are normal and don't take away time from the provider to explain (as an abnormal result would do).

2. Getting reimbursed for the work it creates. For example, in some organizations providers don't get paid for responding to emails from patients or the pay may not be worth the time it takes. Therefore, you may not want to offer a secured messaging feature to your patients.

3. IT issues may take time or expense. Being software, patient portals are amenable to technical problems. You must decided if your practice or organization has the resources to deal with that. Once you introduce a new service to your patients, it's too late to back out. Especially, if people like using it and patient portals are becoming more and more popular.

If you want Jitesh Chawla's advice, set up a trial period with your patients in which you ask them all to utilize the patient portal for certain funcationalities such as booking appointments, requesting med refills.

I hope this has given you some basic information about patient portals and how they can be used.
Patient portals have a tremendous potential from improving practice efficiency to exchanging data with health information exchanges.Will patient portals stay or suffer the fate of some of the PHRs (like Google Health)? I am not sure and only time will tell. But, one thing is for sure - healthcare consumers want more charge of their health and health information. Patient portals serve as one of these tools.