Frequently Asked Questions
Our intent is have all your questions answered on our website; however, we acknowledge that you may have additional questions. If these answers still don’t answer your questions, please feel free to contact us directly.
What is the goal of the AJRR?
Our goal is to collect data on 90% of all 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. We plan on reaching this goal in 2019.
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 the Demand Reporting & Electronic Dashboard System which has generated some additional funding.
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 demonstrates 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 hospital is interested in joining the Registry, but the subscription fee is not in our budget. Can we still participate?
Yes. Submitting data to the AJRR is free. You will also receive a yearly report on the data your hospital submitted. If you would like access to the Demand Reporting & Electronic Dashboard System, you will need to pay a small subscription fee; however, it’s considered minimal compared to some other quality initiatives available in 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?
No hospital participating in the AJRR has had to hire additional staff to maintain regular data submission to the Registry. Once the initial report is created for the first data submission, the same report can be used each month to pull data for submission from your EMR system. This will not require much time and does not warrant the hiring of staff to specifically submit the report. One of our users recently stated that she spends between two to four hours of her time a month on the Registry.
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.
Will other institutions be able to see my hospital’s data?
No. Only the Authorized User at your hospital will be able to view your data.
What relationship does AJRR have with CJRR?
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 Program Coordinator. 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 Data Submission 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 hospital’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 Program Coordinator 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 before we access the Demand Reporting & Electronic Dashboard System?
Upon purchase of a subscription, we will provide the Authorized User with a link to a video that will serve as training for using the system. Authorized Users can access the video at any time and may view it as many times as they would like. They will also receive a User Guide that provides a step-by-step process for accessing and utilizing the system. 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 hospital purchase a subscription. With this subscription, an Authorized User at your hospital will receive a username and password that grants them access to your data stored in the Registry. If your hospital has not purchased a subscription, and would like to, please contact your Program Coordinator.
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.
Institutional Review Board (IRB)
Does each site 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 hospital’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.
What is Meaningful Use?
The Centers for Medicare & Medicaid Services (CMS) has an Electronic Health Record (EHR) Incentive Program that offers providers’ payment in return for showing that they are using their EHR in a way that can positively affect patients. In order to receive these incentives, providers must meet all of the objectives that CMS has established. There are three stages of the program, each with different guidelines. From 2015 to 2017, eligible professionals should follow the Modified Stage 2 objectives. For detailed information on the Modified Stage 2 objectives, please visit cms.gov and search “2016 Program Requirements.”
To determine if you or your institution meet CMS’ program requirements or to define your eligibility requirements, please verify directly with CMS. There you can also find the parameters for Eligible Professionals and Eligible Hospitals, checklists, and all the other information you’ll need.
In the Fall of 2015, CMS finalized the 2016 Program Requirements. For details, you can visit CMS site here.
How can AJRR help towards Meaningful Use?
There are ten Meaningful Use objectives in Stage 2. The American Joint Replacement Registry can help satisfy the public health reporting objective. One of the easiest and most cost-efficient ways to meet the objective is to submit data to a specialized registry. AJRR’s hip and knee replacement Registry is perfect for orthopaedic surgeons that are unable to or would rather not engage with immunization registries or syndromic surveillance reporting. However, two of these three measures must be met in order to satisfy this objective.
What is required to participate in AJRR for Meaningful Use?
Submission of all Level I data elements is required. If you or your private practice group cannot submit these basic elements, then you cannot be considered an AJRR participant, and AJRR will not be able to help you meet Meaningful Use requirements.
Additionally, CMS will require you to prove “active engagement” with the data that you provide. You can view CMS' definition here. Your AJRR Program Coordinator can go over the details on how you can get access to the AJRR Demand Reporting & Electronic Dashboard System where you can compare, analyze, and evaluate your data against national benchmarks so you can use the knowledge for performance improvement.
What are the required Data Elements I need to submit for MU?
If you are submitting these Level data I elements you can meet the Meaningful Use requirements:
Patient-related Data: Name (last, first), DOB, SSN, diagnosis (ICD 9/10), gender, race/ethnicity; address; hospital-related data: name, hospital name and NPI; surgeon-related data: surgeon name and NPI; procedure-related data: type (ICD 9/10, CPT), date of surgery, laterality, implants (catalog number and lot number or UDI device identifier and production identifier).
Are there key dates I need to be aware of?
Attestations for the 2015 program year will be accepted for all Medicare Eligible Hospitals, Eligible Professionals, and Critical Access Hospitals from January 4, 2016 through February 29, 2016. [NOTE: On 2/11/2016 CMS Extended the attestation deadline date until March 11, 2016.]
All Medicaid Eligible Hospitals, Eligible Professionals and Critical Access Hospitals should refer to their State Medicaid offices for information on attestation timeframes for the 2016 program year.
More information can be found here.
How do I attest to meeting Meaningful Use requirements?
What can AJRR provide if I'm audited?
CMS’ program is based on your attestation of compliance with the program. In the event that you are audited, AJRR can provide you with the following items:
· Letter indicating your participation
· Documentation of your file submission dates
Does AJRR count as a “Specialized Registry?” Can you prove it?
CMS has defined that in order to count as a specialized registry, a receiving entity needs to declare that they are ready to accept data as a specialized registry and be using the data to improve population health outcomes. The receiving entity must be able to receive electronic data generated from CEHRT; manual data entry into a web portal would not qualify for submission to a specialized registry. The electronic file can be sent to the receiving entity through any appropriately secure mechanism including, but not limited to, a secure upload function on a web portal, sFTP, or Direct. The receiving entity must also be able to support documentation related to the submitting provider's Active Engagement status. The receiving entity should have a registration of intent process, a process to take the provider through test and validation and a process to move into production. The receiving entity should be able to provide appropriate documentation for the sending provider or their current status in Active Engagement.
Consistent with existing policy, an action to meet one program requirement may not count toward meeting another objective or requirement. Therefore, the sending provider cannot meet the measure using a submission of data already being sent to meet other EHR Incentive Program requirements, such as using a QCDR to submit eCQMs to CMS to meet quality reporting requirements.
By all definitions and accounts, AJRR is considered a Specialized Registry.
Official Sponsorship by the American Association of Hip and Knee Surgeons (AAHKS). Announcement can be viewed here.
Bylaws (Adopted by the American Association of Orthopaedic Surgeons Board of Directors on March 8, 2010):
PURPOSES AND LIMITATIONS
The specific purposes of the Registry are set forth in its Articles of Incorporation. The Registry is a not-for-profit organization organized to engage in charitable, educational and scientific activities within the meaning of section 501(c)(3) of the Internal Revenue Code. The Registry’s specific activities shall include fostering a national center for data collection and research on total hip and knee replacement with far-reaching benefits to society, including reduced morbidity and mortality, improved patient safety, improved quality of care and medical decision-making, reduced medical spending through, among other things, reduction in the number of revision surgeries, and advances in orthopaedic science and bioengineering.
No part of the net earnings of the Registry shall inure to the benefit of any individual and no substantial part of the activities of the Registry shall be used in the carrying on of propaganda or otherwise attempting to influence legislation. The Registry shall not participate in, or intervene in (including the publishing or distributing of statements) any political campaign on behalf of or in opposition to any candidate for public office.
Mission & Vision: (Adopted by the AJRR Board of Directors)
AJRR’s mission focuses on improving care for patients who receive hip and knee replacements. By collecting and reporting data, the AJRR provides actionable information to guide physicians and patient decision making to improve care. It empowers health care organizations to enhance the patient experience and benchmark performance; orthopaedic surgeons to reduce complications and revision rates; device manufacturers to strengthen post-market surveillance; and health plans to effectively manage costs.
AJRR seeks to become the National Registry for total joint replacement, beginning with capturing 90% of all hip and knee replacements, and to leverage this comprehensive data to enhance orthopaedic quality of care, improve patient outcomes and safety, reduce costs, and advance orthopaedic science and bioengineering. (link to on site)
Designated as a Qualified Clinical Data Registry (QCDR) by CMS in 2014, 2015, and application pending for 2016.
The Joint Commission endorsement, March 2015
The Joint Commission is pleased to continue to work with the American Joint Replacement Registry (AJRR) to support its multiple goals, especially the aim to establish a locus of information that can be used for quality improvement and to increase patient safety related to total hip and knee replacement surgery. The Joint Commission has served on AJRR's Public Advisory Board for a number of years and has appreciated the opportunity to be part of AJRR's efforts to increase the relevancy of the registry to patients and to providers. AJRR has exhibited a very thoughtful approach to ensuring that it builds a credible data collection infrastructure and to ensuring the usability of the registry to those focused on reducing morbidity and mortality.
Membership and affiliations with international registry groups, including the Physician clinical Registry Coalition, the International Society of Arthrolplasty Registers (ISAR), and the Food and Drug Administration’s International Consortium of Orthopaedic Registers (ICOR).
What if I have additional Meaningful Use questions?
The CMS website is a wealth of information. You can find general information on the details and specifics of Meaningful Use by visiting here.
If you have questions as it relates to joining the AJRR, you can contact us and we’ll be happy to answer your questions.
What steps do eligible hospitals need to take to meet the specialized registry objective? Is it different from EPs?
For more information visit the CMS website to review the full list of frequently asked questions.
In Meaningful Use Specialized Registry Reporting, CMS requires participation in two registries. Can AJRR point me in the direction of another orthopaedic registry that reports on different measures?
AJRR, in conjunction with CECity, has developed the Orthopaedic Resource Center for reporting to CMS’ Physician Quality Reporting System (PQRS). This platform has measures that can qualify for Meaningful Use’s Specialized Registry Reporting.
To get started, first determine which EHR system you are using. If you are using one of these, contact your EHR provider directly and they can help you get started.
NOTE: This solution may work for other orthopaedic specialties besides hip and knee replacements.