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Meeting Information

Date:

December 11, 2012

Time:

10 AM PST/11 AM MST/12 PM CST/1 PM EST

Call in Number

USA +1-203-418-3123

Passcode

1599520

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Attendees: Francis Kwakwa, Chair: Pamela Ball, Mark Baczkowski, Rod Campbell, Lisa Fennell, Linda Kitlinski, Johanna Krause, Leah LaRue, Anjum Malkana, Sue McGuinness, Valerie Smothers, Lorraine Spenser, Brian Wendling, John West, and Laura Zisblatt.

Agenda Items

  1.  Review minutes of last call

The minutes were accepted as submitted.

2.  Discuss data requirements, mapping, and proposal

Valerie began the discussion stating one of things that was discussed on the last call was whether we needed to add something to capture blueprint components addressed for those activities that are not fully compliant. There was strong opposition to including that.  Subsequent to the call, Dr. Kopelow reiterated the ACCME’s interest in collecting this data of their accredited providers.  Therefore collecting data on which blueprint components are addressed is a requirement. 

Francis clarified that this would apply to an activity that doesn’t address the full blueprint but just part of it.  Valerie had forwarded that note to the group. He asked if there were any questions about that note or about that being a requirement.  Pam asked if we include that field are we obligated then to make sure our sponsors, customers, always have this information included whether or not it is used by the accreditor.  Do they need to collect that?  Valerie noted the ACCME intends to collect that and they need a way to collect it, that’s why it has to be in the standard.  MedBiquitous would not make it a required element in the standard, and MedBiquitous certainly cannot require anyone to do anything. Pam asked if there would be any penalty for accreditors that choose not to use it.  Valerie asked if there was anyone from the RPC on the call to answer that.  Leah LaRue said she is new in the RPC CE sub-team and could not answer.  Francis summarized that we should include the element as optional.  Valerie will get clarity with regard to RPC expectations of accreditors. 

Linda provided some clarity regarding sections of blueprint. There is an introduction plus 6 sections. Each section has bullet points, all of which are known as elements. The ACCME want to indicate which sections of the blueprint are addressed.  Dr. Kopelow indicated elements in his email, but after further discussion, it appears  the ACCME interest is in tracking sections. 

Linda just wanted to make sure everybody was using the right terminology, FDA mentioned that to be REMS compliant; training has to include all elements of blueprints, all the sub-bullets. In addition, assessment has to include questions related to all of the sections.  This was verbally confirmed with the FDA.  Pamela’s question was if the AOA does not collect information on blueprint components addressed for activities that are not fully compliant, are there consequences of that.  Linda said the FDA has not listed that as a mandatory requirement in the REMS documents, the RPC doesn’t have any mandatory requirements.  She thinks during discussions that occurred on several occasions accreditors have raised the fact that this is the first time CE is given an opportunity that it could help in public health, and they want to report as comprehensively as possible.  The RPC would not be “counting” these activities that are not fully compliant, but rather the accreditors, expressed interest in reporting the full efforts of the CE community.  Valerie commented that with regards to what the other accreditors are doing, she can contact them to find out. 

Francis indicated that having an element to identify those activities that are not fully compliant would be helpful. Valerie did speak to ACCME who indicated it counts as one activity even if it has multiple events.  She talked to the AAFP and they had a similar response.  You can have an activity that is broken into multiple components that together address the full blueprint, or you can have one activity that doesn’t address the full blueprint.  Francis asked if data is self-reported, what constitutes a partial blueprint.  Valerie noted one thing we’ll have to do is to create implementation guidelines to make sure it is clear how to use the specification for communicating data related to REMS.  The questions you raise will have to be addressed in an implementation guideline. 

Francis asked Valerie to review the data requirements on audits and long term assessments.  Valerie received some additional comments from the AACCME when they spoke by phone yesterday.  The ACCME commented on the requirement to identify commercial supporters so that it is clear when an activity is funded by RPC or a different commercial supporter.  Valerie will clarify to make sure we are capturing their needs correctly and then fold that back into the document.  She continued with the mapping to MEMS. The first requirement addresses if this is REMS compliant training. There is no equivalent in the existing standard, so we would add a new element for compliant training that also indicates what is it compliant to. For that we would provide a URL to the REMS document.  That type of structure would accommodate any other regulations in the future. We want this model for CME supporting public health and regulations to continue.  Valerie asked what the group thought about that structure.  Francis asked if it is going to indicate whether the activity is fully compliant.  Valerie commented we could add another field called REMs related training to indicate if it is complaint or just related to; it could be two separate elements. 

Linda pointed out the FDA has coined the definition REMS compliant, it either is or isn’t REMS compliant.  She asked would it make sense to say REMS related but not addressing all blueprint elements.  Valerie offered to put that in the description.  Pam asked in the field for REMS compliant training, would we spell out the six components, so that people (accreditors) would be able to look at this document and know what the six components are and that they have been completed.  Valerie mentioned they are trying to have a simpler approach similar to attestation; one field that says this meets all of the requirements of REMS. If you check yes, all six sections of the blueprint are addressed.  Francis asked what if you indicate its REMS related?  Valerie mentioned you would indicate blueprint components addressed. ACCME also wants to collect data on blueprint components assessed.  We will be going back to the drawing board with regards to how to do that based on information collected on the call yesterday with ACCME. 

Lorraine asked if the use of the word “component” and “section” was interchangeable.  Valerie clarified component means something you point to, a section or an element. The important thing is to specify what you’re addressing. Loraine asked if we are getting that granular.  Valerie answered no, she used a generic term. We will come back to that on next call. 

Valerie continued the discussion on prescribers successfully completing activity. In the existing standard we have something called participant by category that allows the user to define categories of participants.  You could indicate the category is prescribers successfully completing and the number is 25. She proposed adding a label for the category and a name and then a URL that where the category is defined. Valerie commented that the URL in the example provides a draft definition of successfully completing.  The ACCME raised the question what does complete mean. Pam commented they did have the same question; she thinks it’s good to further clarify.  Valerie will do some more work on that and come back to the group and have something more refined. 

The next requirement is participants by profession, which is found in version 1 of the standard. There is a recommended list of professions in Healthcare LOM. Appendix two begins on page 46 of Healthcare LOM and provides several different professions, allied health professionals, dental, medical, nursing, public health and veterinary, underneath that many occupations, but it is a relatively limited list. The VA uses the US Department of Labor definitions which are enormous.  Francis asked if you could have a drop down with the professions and then other. Valerie commented that other is not recommended.  She recommended that learners pick the one that is the closest match.  Lorraine questioned what they actually want in terms of data, 50 physicians and 5 nurses, or do they want laundry list of who attended the activity.  Valerie mentioned they want the number by profession. Linda commented the rationale is they want to be able to insure REMS education is reaching health professions and specialties that are representing prescribing long acting opioids to patients.

Valerie commented that on the last call Jack recommended looking at the healthcare lom specialty list.  The list needs to be updated because it was created five years ago.  Internal Medicine has changed the subspecialty names. Several have been dropped, modified, or added.  Cardiology is broken into several different things.  Endocrinology has changed, and others have been added.  In pediatrics the Board of Pediatrics prepends the word Pediatrics and still refers to subspecialties like Pediatric Cardiology; the pediatric subspecialties have not changed as rapidly.  There are several changes to the list that would be in order based on those changes.  Valerie asked if we still think this is a reasonable approach to specialty data. 

Francis asked what level of specialty the FDA wants.  Specialty, subspecialty or what?  Linda claimed they are not trying to drill down to subspecialty level; they want to understand that sufficient numbers of primary care doctors are participating.  She commented that the list from Healthcare LOM 1.0 has sufficient granularity and you don’t need to drill down. Mark agreed. Linda had an RPC question: should the specialty of participants be optional? Would providers or clinicians balk at that? Could there be language to explain the rational?  If providers/participants understand the reason for the question to be asked, they might be more inclined to answer even if it is optional.  Valerie suggested explaining that further in the guidelines.  She asked if anybody would be uncomfortable gathering that data?  There was no vocal opposition. 

Valerie commented that another requirement was identifying Jointly accredited activities to avoid double counting. We can add a checkbox for that.  There is already a place that says who is the accreditor for that activity.  If something is jointly accredited, the flag would be helpful.  Linda asked if there is already some process in place that would address that?  Pam acknowledged having something that says jointly accredited is good.  Can’t see how it would hurt.  She added that the proposal to have the provider indicate consent to be audited was good.  

Valerie mentioned the long-term assessment requirement came from previous discussions with the ACCME.  Linda commented the FDA long-term assessment was defined as a separate activity apart from the CE activity. It would have no relevance for providers in day to day things.  They put together an RFP for providers conducting a separate assessment. Linda can clarify with the ACCME.   

Francis asked Valerie what the next steps were and Valerie shared she will verify points on data requirements especially those raised by the ACCME, and hopefully work on a specification. 

a.  Requirements: jointly accredited, audit consent, long term assessment, blueprint elements addressed

b.  Mapping and proposal: all

3.  Open discussion

Decisions

Action Items

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