Electronic Prescribing Standards Update
Tony Trenkle
10/7/2008

Slide: 1
Thank you Joel, I appreciate the introduction. She has told everybody to eat the brownie without coffee and you told them we are going to talk about standards and you mentioned that Tracy had two of the most boring degrees around. So, I guess the board has been has been set pretty low for, so I guess we have no where to go but up from here but….. Many years ago when I was in one of the many fields that Joel mentioned, I ran a nationwide logistics group and my boss referred to us as doing plumbing and call me the plumber and I guess I moved to different fields but once again it appears that in the plumbing business is what he is prescribing if you do not have plumbing down, the standards down, really all the incentives and all the other work we do is really not going to happen because the standards of the foundation of building blocks that makes this happen and what we got here today is I am going to talk about how we put the standards into place regulation. Tracy is going to talk about now they are in place how you deal with the part D plans and putting into place to make sure they happen and Jon can talk about the CCHIT, one of David Brailer’s acronyms that we are talk about how he get them into the systems. So, all these things need to work together. I think it is critical you can just put standards into place and just allow him to sit. You have got to make sure that they have been acted upon and when you get E-Prescribing systems in place using the standards because the power I will be prescribing really comes into place when you begin to utilize all the features of it and as you begin to put into systems where the certification comes into place that is when the providers can go out and see the systems they need you buy the software, the hardware, the other type to things I need to make it work.

Slide: 2
What is E-Prescribing? What I am really going to talk about is E-Prescribing under part D and what we did is we put a very specific definition under part D and I am not going to read this because I will run out of breath before end up. You can see, it is really the transmission of information and is the information between all the parties involved whether be the prescriber, the dispenser, the PBM, the health plan, and directly or indirectly. I think the key point about the standards is we try to make the standards work for all situations for all types of transactions that the people do with E-Prescribing with prescribing. We have standards in place. We are going to continue add to them but I think that the important thing is that this involves a lot to participants. The other thing under part D is it E-Prescribing is voluntary. It is not mandatory under part D. The plans are required to support it work required to put standards in place but the providers and the pharmacies are voluntary which I think is a critical distinction. A lot of people think it is mandatory.

Slide: 3
What is it? It does not require manual transcription. Traditional faxing is not E-Prescribing, and secured E-mail was not E-Prescribing. I think it is important as well. There are distinctions here we talking about.

Slide: 4
The benefits; we have gone over them today and I am not going to continue to go over. We can talk about them till the cows come in. There are plenty of benefits but the benefits depend on them being utilized.

Slide: 5
We really begin doing E-Prescribing several years ago and really laid the foundations in place with start of the Medicare modernization act. The part D plans went into effect on January 1, 2006 and as Tracy know that was a quite an interesting exercise within the agency. The one of the little factors involved in it and the people did not look at that time was it was the first implementation of E-Prescribing standards. On November 7, 2005 we had the final regulation for the initial E-Prescribing standards and in 2006 we implemented them. Following that, we did a series of pilots with my colleague, John White. Our at CMS collaborated on five pilots throughout the 2006 calendar year and they culminated a report to congress and it culminated beyond the report to congress into additional standards making which we will talk about in just a moment.

Slide: 6
The approach to building standards is not a one shot deal. It is also not looking at standards that are not put in use. He is looking is for mature standards with a track record similar to what you hear with the HIPPA B standards. One other thing we have been talking about is David Brailer is working closer with the Office of National Coordinator. They have the medication management use case. It involves some our E-Prescribing standards we have now have is CCHIT now and will be certify and standalone E-Prescribing systems. Over the past several years, we try to align to work we are doing at CMS with the work has been done by National Coordinator and we will also continue to work with industry to can you work with the standard development organization such as the NCPDP to “grow” other standards as needed and of course we have our advisory board, the National Center For Vital Health Statistics where all the standards come into under testimony before they become a proposed regulation.

Slide: 7
Round one of the standards 2006 as I mentioned these were just the basic eligibility standards. The basic exchange of information as you can see here are the advantages, eliminated handwriting and keystroking. It reduces the administrative cost associated with phone calls but this is a bare bones that we have put into place with a couple of HIPPA standards and it was the NCPDP script.

Slide: 8
Then we had the pilot test where we tested six additional standards of formulary and benefits, medication history, and Rx-fill, RxNorm and you can see the rest of them. So, basically we took a bare bones approach to put it into place to just get it in time for the prescription drug plan that went beyond that one need to a pilot stage and took what came out of the pilot and did additional room making and we will do more beyond this.

Slide: 9
Because what we found that it is result of pilot is only three of these are really ready for adoption, that the other three that we tested needed more work. The RxNorm, the Codified Sig and the prior authorization; we are continuing to work with AHRQ and others to move these along. So last April, we published a final roll that is effective in April 2009 which are bring in the place to three initial standards as we call them.

Slide: 10
The other thing to point at about the role we also adopted the Use of National Provider Identifier (NPI) as an individual identifier. We upgraded and retired NCPDP 5.0 and replaced with 8.1 and of course we got to the point where we also needed to coordinate this with the MIPPA legislation once that pass this summer.

Slide: 11
There are also other initiatives of the people we talking about the day. The Medicaid Transformation Grants. Somebody asked this morning to begin into the work with the states in the Medicaid area. Actually, we working very closely with the Medicaid staff and looking it how we can adopt the standards in the Medicaid area and also make sure they coordinated. Also the quality improvement organizations nice scope for work, we are adding an e-prescribing special study to look it how he prescribed in supports patient’s safety initiatives and we will hope that would be completed within the next year and go from a special study to made may be a major theme scope of work for the QIO program.

Slide: 12
Once again, we are partnering with their friends from AHRQ. We are actually retesting and further testing RxNorm and Structured and Codified Sig as result of the pilot testing we had an industry experts meet in February of 2008 and were starting a pilot within the next several months that one of the things about the initial pilots because we have we required by congress to do them within an calendar year. In the lot of cases, we do not live testing of the pilots to standards to the extent that we need it and since 2006, we made additional modifications RxNorm, Codified Sig that we wanted to test and this new pilot that the Corporation is working with us on. This also test the NCPDPT SCRIPT 10.5 which is the money is needed for us to live long term care exemption. The prior authorization I saw attorney this morning and we are talking about that and that is something that is going to take a little bit longer and once John told me it be done but I get it still has a way to go. So, we are hoping to get the next two sets of standard out after the pilot testing to get the long term care exemption lifted very shortly with the prior authorization will take probably at least to another couple of years before we get to that point and then of course it will be future standards work as we move along.

Slide: 13
People have been talking all day about friends from the drug enforcement administration and what happen with them. Actually the DEA was supposed to be here on the panel this afternoon, but because they are busy analyzing the comments they got, they decided not to come. That was their story and they are sticking to it but in all seriousness, we have been working with the DEA for several years. Attempts to work with them go back probably for 5 years now and we are going to continue to work with them. We have concerns that I have expressed in congressional testimony about advocating the technical solution as opposed to integrating the e-prescribing controlled substances in a way that is inoperable with existing e-prescribing systems. I will tell you that secretary is very interested in working with the DEA to make this work and we have work going on at staff and the leadership level with DEA and I can tell you when the final roll come out but I am hopeful that we can forge a relationship and based on the comments and I have read a number of comment that people have said and I appreciate the thoughtful and very useful comments that people provide. I think people really did a good job and showing how what the DEA is proposing is something that has some flaws and things needs to be worked on and I think the DEA appreciated this well. I think it is just a matter of cultural law enforcement idea the way they should work and we are trying to work with them in terms of patient’s safety and some of the other things that each one of this is important. Some happen over the next period of time, we can work with DEA at the department level. We can integrate the comments that people send in and hopefully have them come out with a final rule is that something work with the industry.

Slide: 14
The other big issue that comes with us is the computer generated fax exemption. This was something that was in the original e-prescribing standards that came out in 2005 and at that time, we heard from industry the people want ready to have computer generated fax exempt where we set up an exemption. They want ready to lift the exemption. We put the exemption to place in 2005 hoping that we could lift it within several years. Last year, we actually tightened the exemption to only apply the temperature transmissions problems. So, actually we are planning to lift the exemption except the cases of that. However, we heard again from number of view that there was concerns about consequences regarding refills that will cause people to go back to paper based faxing or just paper prescribing all together. So, in this year NPRM, we proposed retaining exemption for prescription refill request. We have gotten over 50 comments regarding that. Unless we have the MIPPA legislation that pass in between that time, so we are looking at all these factors together and hopefully when we come out final roll in November 2008, effective in January that will be able to address the concerns of the people have. When we originally proposed lifting this, the idea was to create a tipping effect to really reach a point where we would a tipping that would actually push e-prescribing adoption. Now with the MIPPA legislation, we have got incentive in place to do that. So, we are continuing to looking this and the roll be coming out shortly. It is in clearance within the department and the office management budget.

Slide: 15
Where we go from here? I think I have pretty well gone through this finish the initial standard with the additional standards that we did not adopt in April. Continue to work with DEA lifting long term care and generated fax exemption. Monitor the effective use standards. As I said before, it is not just putting in place. This is a now working with the partners in Tracy’s shop that really work with the plans and make sure that the standards are being used effectively and finally continuing worked with the standards development organizations and the NCVHS and additional standard requirements.