Stage 2 Final Rules: Implications for Providers

Dr Jitesh Chawla feels that for the longest time, the fate of health IT was on trial.

Finally, on August 23rd, CMS released Meaningful Use Final Rules for Stage 2 of the EHR Incentive Program. For those of you that are knowledgeable about Meaningful Use and saw the proposed Stage 2 Rules there are major changes that were made based on feedback from the medical community.

Nevertheless, since the final version is now out, it is important for medical providers and hospitals to understand what is expected of them and how the criteria differ from Stage 1. This article is a quick overview of the additions and changes in Stage 2 Rules and will present some tips to how clinicians can be ready. We will not cover hospital requirements here.

 Stage 2 Requirements

Stage 2 represents “Advanced Care Processes” according to the Meaningful Use stages plan as explained by ONC. A central theme is “connectivity” where different EMRs or EHRs can exchange data with each other. Also, the first stage allowed providers to get a certified EHR and  learn how to use it to collect some meaningful data. Now the goal is to have them use more advanced functions of the EHR and collect some of the same data for a larger pool of patients.

Some of these measures are new and others represent higher thresholds from Stage 1 (latter marked by *). Examples of few of these measures are highlighted below.

·         At least 5% of patients must access have access to their online health information

·         Providers must engage in secure messaging with at least 5 % of their patients

To be sensitive to practices in rural areas CMS is granting exclusion to providers without access to broadband internet. Both measures will require internet connectivity to communicate to patients regardless of whether the EHR is web-based or not.

·         Summary of care record for more than 50% of transitions of care and referrals*

·         Transmit summary of care for more than 10% of transitions and referrals to provider even if

       they  have vendor or organizational affiliation*. However, the 2 providers that conduct the

        exchange must be using EHRs from different vendors

·         Eligible providers must select and  report on 9 out of 64 total clinical quality measures (CQMs)

·         Tobacco screening for patients 13 or older is required for 80% or more of patients

In addition, all providers must select Clinical Quality Measures (CQMs) from at least 3 of the 6 key health care policy domains from the Department of Health and Human Services’ National Quality Strategy:

 •Population and Public Health

 •Efficient Use of Healthcare Resources

 •Clinical Processes/Effectiveness

 •Patient and Family Engagement

 •Patient Safety

 •Care Coordination

  

Compared to Stage 1, EPs (eligible providers) must satisfy 20 measures 17 core and 3 / 6 for menu. Reporting will be allowed such so that batches of EPs in the same group can attest together in 1 file. For a full report of Stage 2 measures and requirements visit the CMS website.

Getting Ready

1.The patient portal is likely the medium by which patients will access online information and use email (secure messaging) to communicate with their providers. Make sure to check with your vendor if the patient portal is set-up to support all these features. PP is included as part of all certified EMRs.

Dr. Jitesh Chawla posts a trial version of a patient portal screen

 

(reference: cliniclogo)

2.Ensure policies, procedures and workflow allows collection of data in at least 3 of the 6 domains part of the National Quality Strategy. There should be a logical approach to choosing the 3. Health departments may include Population/Public Health, behavioral health practices include care coordination and practices recognized for Patient Centered Medical Home may include Clinical Processes and Effectiveness. In all 3 examples, the CQM topic represents an area that practice or clinic may focused on as part of their daily operations and so the data is being collected anyways.

3.Adopt the practice of motivational interviewing as patient engagement is bigger theme in this stage of meaningful use. Motivational Interviewing has been becoming a more widely tool in health care, as it has been used in other industries or years.

4.Keep track of the Health Information Exchanges (HIEs) in your area and make sure your HER connects with them. The good part is that Stage 1, required you to test the CCD/CCR function a which is medium by which patient information is summarized and can be submitted in exchange through a standardized format.

Concluding thoughts

The step-wise government push towards the adoption and use of EHRs is not to advocate the use of technology, help vendors with EHR sales or to create some hurdles to jump though just to get free money. But, providers and practices that streamline their work processes, capture the right patient data consistently, strive for increased quality and safety will find that EHRs are actually enablers for those goals and achieving Meaningful Use, though time consuming, is just a little more than a formality.

This certainly feels like a painful trial period for many providers, but Dr. Jitesh Chawla would encourage practices to stay persistent.

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

What medical providers need to know about switch to ICD-10

Jitesh Chawla, MD. would be the first one to say this is a major "trial period" for fellow medical colleagues due to the ever increasing requirements from the governement.

Most providers of small practices don’t have the time or resource to fully understand how ICD-10 will impact them. In this article, I will explore this very important topic and provide suggestions for providers of how to prepare for ICD-10 compliance.

The intention behind ICD-10 is to provide a tool that would provide a more detailed, accurate code to match the actual diagnosis. As disease diagnosis has become more specific, ICD-9 codes appear to be obsolete and often don't describe the condition accurately.

The law states for all organizations covered under the 5010 electronic transactions version instead of the older 4010/4010A versions. If you are not familiar with this terminology, please check with your billing manger or practice management software vendor.

ICD-10 is divided into 2 areas: clinical modification (CM) and inpatient procedure coding system (PCS). Inpatient procedure codes are not affected. Outpatient codes are still represented under the current system. ICD-10 is more specific on anatomical location, specificity of diagnosis, etc. To put this into perspective, take for example, if a patient was had a furuncle (boil) on the face and went to the dermatologist. The same patient then returned a few weeks later and had a carbuncle. In ICD-9, the same code would be used which is 680.0. In ICD-10 (specificity of the condition) would be recorded. The furuncle would be L02.92 and carbuncle would be L02.93. Furthermore, ICD-10 would enable you to record which encounter (initial versus subsequent).

The basic structure of the ICD-10 code is:

Characters 1-3: the category, 4-6: cause of problem, body part affected, severity of illness, 7: Place for extension of the code

Some EMR systems have a connection with live database and so a switch to ICD-10 will not affect the users when picking a diagnosis for their note. However, with EMRs that don’t have this link to the live database, the issue is how to migrate the codes into the system. A strategy would be to use transition tables which provide the ICD-10 equivalent to the ICD-9 code since there is no way to convert the codes. ICD 10 Code Translator . Just plug in the ICD-9 code and it will convert it to the equivalent ICD-10 code. This provides enough relevant background for most people about ICD-10 and the issues surrounding it. Please be sure to examine the table below that compares ICD-9 and ICD-10 codes. For providers, health care staff