AOE Compliance Connection

Welcome to the July ‘19 edition of AOE Compliance Connection, AOE’s monthly newsletter. As summer continues, AOE wants to keep you up to date on what’s happening throughout the CME enterprise! As many organizations work through reaccreditation, we have some tips & trick for that process, as well as a look at what a recent study says about the importance of CME. We have updates to share with you from the ACCME, ANCC and ACPE, as well.

AOE strives to serve you and your CME/CE team with excellence. Our website has helpful tools like compliance tips, CME/CE news and information about the AOE team – visit aoeconsulting.com to see what’s all available!

In prior newsletters, we focused on updates to the new ACCME Self-Study and Performance-in-Practice submission process and took a deeper-dive into the Self-Study Report outline and submission process.

This month, we are highlighting the Performance-in-Practice compilation and submission process. As with the narrative portions of the Self-Study, Performance-in-Practice evidence now must be submitted online via the ACCME Program and Activity Reporting System (PARS). Below we’ve highlighted some key information and best practices.

Narrative Entry: A portion of Performance-in-Practice documentation is narrative text and data entry online. Criteria 2, 3 and 5 require that narrative descriptions are entered into PARS. Additionally, Criterion 6 requires selection of the corresponding competencies and Criterion 8 requires that, if applicable, information regarding commercial support is entered into form fields. AOE recommends utilizing the ACCME Structured Abstract Word document to maintain this information. Content saved within this document can then be easily copied and pasted into PARS, if/when needed. Be sure to pay attention to word count limits!

Uploads: The remaining Criteria require that specific attachments are uploaded. For Criterion 7 SCS 2, the ACCME requires download and completion of a specific Excel spreadsheet. Be sure to pay attention to file size as the maximum file size is 3 megabytes (MB) per document.

Tips & Tricks

• Though not technically required, using labels ensures that documents look polished and professional. Each label should match the language from PARS specific to each upload.
• For a Regularly Scheduled Series (RSS), AOE recommends use of an RSS cover page that includes the session date, session title, presenter(s) and learning objectives.
• Ensure consistency in document titles and organize documents in order of their upload into PARS.
• Review each Performance-in-Practice form to ensure that the correct documents were uploaded. Within a form, you can select “Export” from the top gray menu bar. PARS will then export a PDF that includes the narrative and file names of the attachments. This is a helpful way to review each form prior to submission.
• Once you are confident that everything has been inputted correctly, complete the attestation and submission. Once submitted, the information cannot be altered unless the accredited provider contacts the ACCME to re-open the online form. The Primary Contact on record should receive a confirmation e-mail of submission. As a best practice, print the confirmation to a PDF and save for your records.

As with Self-Study Report narrative, the key to approaching compilation of Performance-in-Practice document is to have a clear plan and timeline in place. This can streamline the process and ensure that reviews, if applicable, are completed in a timely, efficient manner and that uploading to PARS occurs at least a week in advance.

Recording the outcomes data of a CME/CE activity is a valuable practice that often shines a light on the effectiveness of the activity itself but also on the importance of CME/CE in general.

Recently, published outcomes of a CME program about biosimilars revealed that only 22% of oncology healthcare providers (HCPs) knew basic information about biosimilars, but following the completion of activity, learner’s knowledge increased to 78%. The full results of this program can be read in the article “Addressing Oncologists’ Gaps in the Use of Biosimilar Products”.

This recent biosimilars study had live and online components that both featured a slide-based lecture with interactive multiple-choice questions. Of the 9,599 individuals who participated in the activities, 114 attended live regional meetings and 9,485 took the online webcourse. The outcomes measurements came from asking participants each question twice: once before the education and once after. The participants of the regional meetings were also asked to complete a follow-up survey featuring the same questions six to eight weeks after the event.

Outcomes studies like this one consistently demonstrate not only the need for continued efforts to educate healthcare providers about various topics but also demonstrate the ability of education to effectively address the current gaps that exist among HCPs.

One feature of the ACPE’s most recent provider e-update is information regarding expanded REMS CE activities and how it may impact pharmacists and CPE providers in the future.

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications that have serious safety concerns.

The FDA previously decided that a REMS is necessary for all opioid analgesics that are intended for outpatient use. The reasoning behind this is to ensure that the benefits of these drugs continue to outweigh the many risks. In general, REMS are designed to reinforce behaviors and actions surrounding medication use to support the safe use of the drug.

The Opioid Analgesic REMS, approved on September 18, 2018, is one strategy among multiple national and state efforts to reduce the risk of abuse, misuse, addiction, overdose, and deaths due to prescription opioid analgesics.

The REMS program requires that training must be made available to all health care providers (HCPs) who are involved in the management of patients with pain, including pharmacists.

In an attempt to meet this new requirement, drug companies with approved opioid analgesics will provide unrestricted grants to accredited continuing education providers (including CPE providers) for the development of education courses for HCPs based on the FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.

Pharmacists and CPE providers can expect to be impacted by the FDA’s belief that all HCPs involved in the management of patients with pain should be educated about the fundamentals of acute and chronic pain management and the risks and safe use of opioids. The goal is that when a pharmacist dispenses a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used appropriately.