Frequently Asked Questions
What is the goal of the AJRR?
Our goal is to collect data on total hip and knee replacements completed in the U.S. in order to establish survivorship curves, track revisions, and improve quality of care for all patients.
How is the AJRR funded?
We receive private support from our many stakeholders (surgeons, orthopaedic societies, industry, hospitals, payers, and the public at large). For a complete list of supporters, click here. In 2014 we began collecting fees from hospitals for access to our dashboard system, now called RegistryInsights™, which has generated additional funding. In 2018, we began charging a modest setup fee for new participants that choose to not subscribe to the dashboards.
Why did the 2018 price for a subscription increase?
When AJRR began in 2010 we made a commitment that there would be no fee for inclusion in the Registry. In 2014, we introduced a basic online dashboard and reporting portal for a nominal subscription fee. In the first half of 2017, we evolved the dashboards, provided a patient-reported outcomes (PRO) platform, and included better functionality and performance for a more comprehensive Registry experience through the introduction of RegistryInsightsTM. We have never increased our prices over the last seven years.
Beginning on Jan. 1, 2018 we increased our pricing structure to continue evolving the Registry to deliver on our mission to improve orthopaedic care through the collection, analysis, and reporting of actionable data. We made the price increase modest and will charge all participants the current $750 set-up fee, regardless if subscription access is purchased. The new 2018 prices are $3,500 for a 1-year subscription per user and $10,000 for a 3-year subscription per user. A one-time $750 configuration fee will be charged for new participants.
What is the economic incentive to participate?
Other national joint replacement registries such as the Swedish Hip Arthroplasty Register have proven that monitoring survivorship reduces revision rates. A reduction in revisions translates into fewer costs for many of the stakeholders involved. In addition, the overall cost to the public is reduced. Joint registries demonstrate up to a 50% reduction in revision rates after registry initiation and identification of best practices. If the U.S. revision rates were reduced by just 2%, Medicare could realize a savings of over $65 million dollars. Additionally, the Centers for Medicare & Medicaid (CMS) and some insurance payers (BlueCross BlueShield’s Blue Distinction program) offer those who participate in registries additional incentives, helping to increase your motivation.
My institution is interested in joining the Registry, but the subscription fee is not in our budget. Can we still participate?
Yes. Beginning in 2018, AJRR participants will only need to pay a modest setup fee to submit data to the Registry. You will also receive a yearly report on the data your hospital submitted. If you would like access to the RegistryInsights™ dashboards, you will need to pay a small subscription fee; however, it’s considered minimal compared to some other quality initiatives available on the market. For more information about the AJRR fee structure, click here.
Is there a fee for sending Level II and Level III data?
How much time does it take to administer working with your Registry – will I need to hire any additional employees?
The number of full-time employees (FTEs) needed for Registry data submission varies greatly from institution to institution. Small, low-volume hospitals may perform only a few hip and knee procedures a year, requiring minimal employee time to input these procedures on our recommended monthly basis. Large institutions in major cities may perform hundreds of procedures a year, warranting a full-time employee to be dedicated exclusively to Registry submission. Electronic health record (EHR) systems and collaboration with patient-reported outcome (PRO) vendors will also impact employee workload. As your institution progresses through the enrollment process, the staff requirements will become more clear.
Do physicians know that their data will be shared with AJRR?
AJRR encourages open discussions within each hospital to include all participating surgeons. In fact, if you need marketing and communications support to help promote your institution’s involvement with the Registry, we can help you. This includes internal communications with your surgeons and externally with your patients. A sample press release announcing participation, verbiage for your website or print communications, and an AJRR Participant Logo are all available in the AJRR User Group Network (Unet) Forum.
Will other institutions be able to see my data?
No. Only the Authorized User and PROM Site Administrator at your institution will be able to view your data. However, de-identified data on the national level can be seen in the aggregate.
Data and IT
Who should I send my data to?
Data should be sent to AJRR via an SFTP or HTTPS site. DO NOT send your data files to your Registry Engagement Associate. We take data privacy and security very seriously and follow all HIPAA privacy rules and Protected Health Information (PHI) regulations.
How do I send my data to AJRR?
Our secure transfer site implements both an SFTP and a HTTPS service for institutions to submit data directly to us. Both services present AJRR extended validation certificates and automatically encrypt all data upon landing. If you do not have an SFTP client on your desktop, we suggest using the HTTPS. You may use any web browser to do so. Our Customer Support Analysts will go over the process with your IT staff.
How often should data be submitted?
We recommend a monthly submission; however, our IT staff will accommodate each institution’s submission accordingly.
Can you accept retrospective data?
Yes we can, and we would encourage it. Sending more data adds to your institution’s data set and creates a more robust Registry. Also, you can send retrospective data as far back as you’d like to go.
How do you prevent errors and ensure that all cases are entered?
We utilize software and humans to review each and every file to ensure the data is valid and accurate prior to analysis.
How can I add an additional Authorized User to my account?
Contact your AJRR Registry Engagement Associate to begin the steps to adding an additional Authorized User. They will be able to provide all the necessary steps for the process.
Why do you collect patient Social Security Numbers?
We collect patients’ Social Security Numbers in an effort to track and link multiple procedures to the same patient. Revisions and additional procedures may not be done by the same surgeon or at the same hospital, therefore, it is imperative to collect the Social Security Number so that the additional procedures can be linked to the same patient. This will also assist in tracking potentially poorly performing implants as well.
What type of training do you provide for the RegistryInsights platform?
AJRR participants recieve a User Guide that provides a step-by-step process for accessing and utilizing the RegistryInsights system. General platform training and PRO platform training webinars are also held periodically to inform Registry users on how to use the platform. And, if one-on-one training or additional demonstrations are needed, we will assist you and your team.
How can I access my data in the Registry?
Accessing your data in the Registry requires that your institution purchase a subscription. With this subscription, an Authorized User at your institution will receive a username and password that grants them access to your data stored in the Registry. If your institution has not purchased a subscription and would like to, please contact your AJRR Registry Engagement Associate.
How do you keep the data in the Registry secure?
We take data privacy and security very seriously and follow all HIPAA privacy rules and Protected Health Information (PHI) regulations. Our PHI is secured, maintained, and released in accordance with all applicable federal and state laws, rules and regulations, including the HIPAA Regulations. All our personnel who process, generate reports, or otherwise have contact with PHI must uphold the patient’s right to confidentiality. This policy refers to all information resources, whether written, verbal, or electronic, and whether individually controlled, shared, stand alone, or networked. Additionally, all of our staff have been trained in HIPAA privacy and security through the Collaborative Institutional Training Initiative (CITI).
How do you manage the integrity and quality of the data in the Registry?
Utilizing strict protocols for data migration, security, privacy, review, and implementation, we also conduct an annual audit with the hospitals who are providing the data.
Why is providing Post-Op Complications and the other elements of Level II so important?
Institutional Review Board (IRB)
Does each institution need to obtain informed consent from patients?
No. AJRR is designed for quality improvement purposes and has obtained a waiver of informed consent and authorization from a commercial IRB that provides blanket coverage for all U.S. sites.
Will each hospital’s IRB have to review this project?
Each hospital’s IRB is different. If you are already participating in another registry, the process may move quicker. Expect that your hospital’s IRB will need to at least review the AJRR protocol beforehand.
How can I make a request for a custom report?
As a researcher, how can I request to obtain a subset of the data within the Registry for research?
Which PROMs tools do you recommend?
Consistent with CMS' Comprehensive Care for Joint Replacement (CJR) initiative, AJRR recommends: VR-12, PROMIS-10 Global Health, HOOS, JR. and KOOS, JR.
What follow-up time frame do you recommend?
PROMs guidelines from groups such as the International Consortium for Health Outcome Measurement (ICHOM) have recommended pre-operative (baseline) and one-year follow-up as appropriate time points for data collection to provide meaningful data for comparing outcomes across providers. The CJR Final Rule also advises that post-operative surveys be collected between 270 and 365 days post-surgery.
Each time point will have a two-month window for data collection. AJRR's platform will allow for other time points (e.g., three-month, six-month, etc.) to be submitted and stored in AJRR's database should you wish. However, national benchmarks will only be reported for pre-operative and one-year outcomes.
Why does the choice of law and forum need to be Illinois?
We contract with institutions in all 50 states. It would be legally infeasible to agree to change to each institution’s state of choice.
Your legal agreements appear to be lengthy. Can we made edits to them?
Our legal and business agreements were developed and executed by a preeminent health care firm that specializes in medical registry development and deployment. They created many contracts for other registries and solely specialize in this area. Because of this, we’d prefer that you not make edits or changes to the existing contracts.
Why does our hospital have to sign both the AJRR Business Associate/Data Use Agreement (BA/DU) and Participation Agreement? If we sign the BA/DU Agreement, isn’t that sufficient?
No. You need to sign both agreements. The Participation Agreement outlines most of the terms and conditions of our relationship, for example: how and when data should be submitted, term and termination, fees, ownership and confidentiality of data, and other terms and conditions for participation. The BA/DU Agreement is necessary to comply with our joint responsibilities as covered entity (you) and the Business Associate (AJRR) under the security and privacy rules issues pursuant to the Health Insurance Portability and Accountability Act of 1996.
What are your notification requirements in the event of a breach of unsecured PHI?
We will report any breach of unsecured PHI no later than five calendar days after discovery, which is well before the 60-day HIPAA breach notification requirement.
Is my data submitted to your Registry discoverable? Can it be subpoenaed?
The data is potentially discoverable and can be subpoenaed. But, we believe it is unlikely that that we will receive such a subpoena or that any PHI would in fact be subject to discovery in state or federal court. Illinois law, which should apply to any state-based subpoena or discovery request, provides strong protection against discovery of AJRR data. At the federal level, the rules of evidence require the courts to weigh the value of the data in a particular case against the intrusion into patient privacy. In previous registry cases, the federal courts have declined to grant access to patient identifiable information. We would vigorously oppose any subpoena of AJRR data.
Will hospital/surgeon indemnification be offered?
Our Participation Agreement and BA/DU Agreement have mutual indemnification provisions in which cross indemnifications are granted by the parties. Our indemnification of participants is necessarily limited to reflect shared nature of our interests and the need to limit our risk to ensure the viability of the Registry.