ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests Prepared by: Science, Education and Quality Division As of: 3/16/2016
Contents 1. Introduction... 1 2. NCDR Registries Overview... 1 3. Background on ACC Relationships with States... 3 4. ACC Procedures for Sending Proposal to the State Government... 4 5. Common Goal... 5 6. State Agency Reasons for Requesting NCDR Registries Proposal... 5 i. Statute:... 5 ii. Regulations:... 5 iii. Mandate:... 6 iv. Law:... 6 v. Code:... 6 vi. Permit:... 7 7. Tips for How to Prepare for Contacting Your State Agency... 7 8. State Organization Moves to Contracting Phase... 8 9. Conclusion... 9 APPENDIX A: NCDR State Participation Map... 10 APPENDIX B: Exploration Phase Process sample proposal e-mail to ACC Chapter Governor... 11 APPENDIX C: Implementation Phase Process sample information email to ACC Chapter Governor... 12 APPENDIX D: ACC Chapter Reference List... 13 ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests i
This guide has been developed by the ACC national office with the intended goal of providing guidance to ACC state chapters on how to guide state agencies on the benefits of registry data to meet state specific requirements. The ACC recognizes that NCDR presents an ideal opportunity for state agencies to leverage the strengths of the national cardiovascular patient observational registries to meet local reporting requirements. As we field increasing inquiries from state agencies regarding our registries, we have developed several options for their consideration. In addition to the information that we have compiled to send to inquiring state agencies, we have also created a detailed outline of our processes/procedures for responding to inquiries (included in this guide for your information). We hope this guide will serve as an educational tool for chapter leaders including chapter executives to drive the state agencies on deciding on the best options to meet the local needs. Several ACC chapters have already experienced the process beginning with the initial inquiry from the state agency all the way through the implementation step. As such, we also include the contact information for those who could share their experience and insight, and help other chapters through the process. 1. NCDR Registries Overview Currently we offer hospital-based registry data reporting options to state agencies. The registries included in our current offering are as follows. ACC NCDR Hospital Based Registries National Cardiovascular Data Registry (NCDR) is the largest, most comprehensive, outcomesbased cardiovascular patient data repository in the U.S. The registries provide participating sites with quarterly, nationally benchmarked reports and access to real-time quality improvement tools. ACTION Registry GWTG The ACTION Registry is a risk-adjusted, outcomes-based quality improvement program that focuses exclusively on high-risk STEMI/NSTEMI patients. It helps hospitals apply ACC/AHA clinical guideline recommendations in their facilities and provides invaluable tools to measure care and achieve quality improvement goals. The registry is a national acute myocardial infarction (AMI) surveillance system which contributes to the scientific enquiry process of AMI care through the facilitation of local and national quality improvement efforts 1. CathPCI Registry The CathPCI Registry assesses the characteristics, treatments and outcomes of cardiac disease patients who undergo diagnostic catheterization and/or percutaneous coronary intervention (PCI) procedures. This powerful tool captures the data that measure adherence to ACC/AHA clinical 1 http://www.ncbi.nlm.nih.gov/pubmed/20736202 ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 1
practice guideline recommendations, procedure performance standards and appropriate use criteria for coronary revascularization. The CathPCI Registry Outcomes Report contains updated metrics that can be used to identify and categorize patients undergoing a PCI into one of the three Appropriate Use Criteria (AUC) categories (Appropriate, May Be Appropriate and Rarely Appropriate). This registry is also part of qualified clinical data registries (QCDRs). ICD Registry The ICD Registry TM establishes a national standard for understanding treatment patterns, clinical outcomes, device safety and the overall quality of care provided to implantable cardioverter defibrillator (ICD) patients. Medicare coverage of ICDs required hospitals to submit data to an ICD registry as a criterion of coverage. As the CMS-mandated registry for hospitals performing ICD implantation procedures, the ICD Registry plays an important role in determining the association between evidence-based treatment strategies and clinical outcomes. Eighty percent of participating hospitals value the registry beyond the CMS-mandate capturing all ICD implantations regardless of payer or indication. Medicare required hospitals to submit data to an ICD registry as a criterion of coverage. IMPACT Registry The IMPACT Registry assesses the prevalence, demographics, management and outcomes of pediatric and adult congenital heart disease (CHD) patients who undergo diagnostic catheterizations and catheter-based interventions. Its data support the development of evidencebased guidelines for CHD treatment that will improve outcomes for CHD patients of all ages. PVI Registry This registry assesses the prevalence, demographics, management and outcomes of patients undergoing lower extremity peripheral arterial catheter-based interventions and includes carotid artery stenting (CAS) and carotid endarterectomy (CEA). The PVI Registry provides data collection and equips clinicians with decision-making data whether care is provided in a hospital cath lab, interventional radiology department, or an outpatient vascular center. STS/ACC TVT Registry This registry was created through collaboration between the Society for Thoracic Surgeons (STS) and the American College of Cardiology (ACC), and monitors patient safety and realworld outcomes related to transcatheter valve replacement and repair procedures emerging treatments for valve disease patients. Employing state-of-the-art heart valve technology, transcatheter heart valve procedures provide new treatment options for patients who are not eligible for conventional heart valve replacement or repair surgery. The TVT Registry has been approved by CMS to meet the registry requirements outlined in the national coverage decisions for transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVR). AFib Ablation Registry (Launching in early 2016) This registry will assess the prevalence, demographics, acute management and outcomes of patients undergoing atrial fibrillation (AFib) ablation procedures. Its data will support the ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 2
development of evidence-based guidelines for AFib treatments that will improve outcomes for patients. LAAO Registry The LAAO Registry captures data on left atrial appendage occlusion (LAAO) procedures to assess real-world procedural outcomes, short and long-term safety, comparative effectiveness and cost effectiveness. LAAO provides a treatment option to manage stroke risk for non-valvular atrial fibrillation patients who are unable to maintain adequate anticoagulation through medication therapy. ACC NCDR Outpatient Registries We also have outpatient registries within our NCDR suite of offerings. However, we do not offer these options to the state agencies. Below is a list of our current outpatient registries with a brief description of the registries. Diabetes Collaborative Registry The Diabetes Collaborative Registry is the first global, cross-specialty clinical registry designed to track and improve the quality of diabetes and metabolic care across the primary care and specialty care continuum. The Diabetes Collaborative Registry is being offered by the American College of Cardiology (ACC) in partnership with the American Diabetes Association (ADA), the American College of Physicians (ACP), the American Association of Clinical Endocrinologists (AACE) and the Joslin Diabetes Center. The registry is sponsored by AstraZeneca (founding sponsor) and Boehringer Ingelheim Pharmaceuticals Inc. This registry is a Qualified Clinical Data Registry (QCDR) for the 2015 Physician Quality Reporting System (PQRS) Program Year. Therefore, submission to federal incentive programs, including PQRS and the EHR Incentive Program, can be accomplished through the registry. PINNACLE Registry The PINNACLE Registry is cardiology's largest outpatient quality improvement registry, capturing data on coronary artery disease, hypertension, heart failure and atrial fibrillation. PINNACLE s outpatient registry is also considered a Qualified Clinical Data Registry (QCDR) reporting option for PQRS. A QCDR is defined as a CMS-approved entity that has successfully completed a qualification process that collects medical and/or clinical data for the purpose of patient and disease tracking to foster quality improvement for patients. For full list of NCDR Registries participants, please visit: http://cvquality.acc.org/ncdr-home/participant-directory.aspx 2. Background on ACC Relationships with States The National Cardiovascular Data Registry (NCDR ) is the ACC s suite of cardiovascular data registries that help hospitals and private practices measure and improve the quality of care that ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 3
they provide. The NCDR registries are excellent tools for state agencies to incorporate into their reporting requirements. Because of recognized excellence of NCDR registries, ACC routinely receives requests from state agencies to implement the registry (-ies) in their state. ACC provides several options for the states to choose from and match with their local reporting needs. Currently we do not proactively reach out to prospective state agencies. Rather, our process is to respond to state agency inquires as we receive requests directly from agency personnel. We currently operate under a two-part response process for state agency requests. This process is further delineated below. NCDR Formal Response Process for State Agency Requests 3. ACC Procedures for Sending Proposal to the State Government As noted above, we do not proactively reach out to the state agencies. A state agency will receive the Proposal for Hospital Registry Data Reporting Options from ACC upon receipt of their inquiry. The proposal includes an overview of the ACC and the NCDR hospital registries, options for both patient level and calculated aggregate level data, information regarding sole source justifications that typically must be address for state contracting purposes, cost information, and a listing of state agencies that work with NCDR data and have agreed to serve as resources to other states. After providing the proposal to the state agency, ACC will inform the appropriate ACC state chapter governor and executive. We also inform the state agency about our ACC local chapter and encourage them to work with the state chapter prior to submitting specific request for any of ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 4
the options listed in the NCDR proposal. After the state agency selects which option(s) will meet their needs, they submit the request to ACC. The ACC NCDR leadership reviews the scientific and strategic merits of the selected option before executing a formal agreement with state agency. At this time, a second notification that mirrors the communication to the ACC NCDR leadership is sent to the appropriate ACC state chapter governor and executive. (For examples of the chapter notifications, see Appendix B and C.) 4. Common Goal Although ACC and all state chapters share a common goal to transform cardiovascular care and improve heart health, it is important to note that the agreement between ACC and the state agency does not allow the ACC Chapters to access data that is provided to the state agency. The agreement is between ACC and the state agency under appropriate state regulatory guidance. 5. State Agency Reasons for Requesting NCDR Registries Proposal Among the major reasons that could trigger a request for an NCDR Registries proposal from the state agency, are as follows: i. Statute: Definition a statute is a law established by an act of the legislature 2. A statute started as an idea, is written as a bill by either a Senator or Assembly Member 3. Depending on the author, it will be discussed in either Senate or Assembly and it will go through first reading, committee hearings, second and third reading, repeat process in the other House (Senate or Assembly), amendments (for any amendment, it has to be agreed by both Senate and Assembly) and finally, the bill needs to be approved and signed by the Governor to become a law. The Secretary of State will assign chapter number for the bill, which is also referred to as Statute. An example of a statute that has led to the adoption of NCDR registries at the state level is SB 906 in the state of California. Effective January 1, 2015, SB 906 (Chapter 368, Statutes of 2014) permits an eligible hospital to apply to participate in the Elective PCI Program. As part of the program requirements, applicants must participate in the ACC-NCDR CathPCI Registry and share the data with the California Department of Public Health and the Office of Statewide Health Planning and Development. ii. Regulations: Definition - Regulation is a way to implement the law efficiently with some flexibility. For example, in the state of New York, the State Legislature passed a bill that allows the state agency to create rules and regulations. The proposed rules and 2 http://www.lectlaw.com/def2/s071.htm 3 http://www.leginfo.ca.gov/bil2lawx.html ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 5
regulations will be reviewed by the Administrative Regulations Review Commission for compliance issues and the impact of the new rules or regulations. Citizens are allowed to provide comments during public hearing and comments period for a proposed rule or regulation and the state agency will review the comments before finalizing the rule 4. An example of regulation change that involves the adoption of NCDR registries is for the state of Pennsylvania. The Pennsylvania Department of Health waived the regulation that requires a hospital to have an open heart surgery program in order to be able to perform percutaneous coronary intervention (PCI) 5. The concern is that, the procedure could have complications that require an open heart surgery. However, the Department has considered waiving the regulations that requires hospitals with a PCI program to enroll into NCDR registry. The hospitals are required to submit data and the NCDR registry will analyze the data and submit quarterly performance reports to the hospitals. Hospitals are required to share the data with the department and the data will allow the department to compare the result against NCDR benchmark and national data. The department signed an agreement with the NCDR to receive the data from participating hospitals and to compare the result against the NCDR national benchmark data. iii. Mandate: State mandate refers to a state law that requires a political subdivision to engage in an activity or provide a service, or to increase the level of its activities or services 6. Some state constitution will require the state to reimburse local government for the mandated activities 7. Among the mandated states that require NCDR registries are West Virginia, Massachusetts, Pennsylvania and Michigan 8. Massachusetts Department of Public Health enrolled into CathPCI Registry due to their mandated program of reporting and data analysis of clinical cardiovascular data. iv. Law: A rule established by authority, society or custom. An act or statute is a type of law enacted by state governments. v. Code: A legal citation, usually referring to a state code of regulations or administrative code, which is issued by regulatory agencies, such as health professions boards, to interpret and implement a law such as the practice act. 4 http://www.dos.ny.gov/info/rulediagram.html 5 http://www.dli.state.pa.us/portal/server.pt/community/hospital/14149/access_to_advanced_cardiac_care/558516 6 http://definitions.uslegal.com/s/state-mandate/ 7 http://www.ebudget.ca.gov/2008-09-en/budgetsummary/man/12178584.html 8 http://www.cardiosource.com/ncdr/cathpcifactsheet.pdf ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 6
vi. Permit: A document, usually issued by a state government, which authorizes the recipient to engage in a regulated activity. Sometimes used as an alternative to licensure, registration, documentation or state certification. 6. Tips for How to Prepare for Contacting Your State Agency Chapter executive, chapter governor, chapter members and relevant parties, e.g., local coalitions, should schedule time to meet and review the details of the pending proposal between the state agency and the ACC If needed, take a few moments to review the registry overview information covered on pages 3 and 4 of this document. Contact the state agency that requested the proposal from ACC to determine: Who is the department s Chief Medical Officer (or equivalent) Who would be the state agency s primary point of contact (often a project officer) at the department for the ACC chapter executive to get updates, answers to questions, etc. The reason for requesting a proposal from the ACC The names of cardiovascular experts the state agency is working directly with, either as part of a voluntary expert group or in a contracted advisory capacity Review the list of your state s hospitals that are currently participating in NCDR Visit ACC s Find Your Heart a Home web page https://www.cardiosmart.org/heart-basics/find-your-heart-a-home Click on the downloadable CSV file ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 7
Contact other ACC chapter executives [Appendix D] to understand how they might have leveraged the information ACC provides as well as other tips on how they worked with their state agency. Contact internal Chapter membership to see who may already be involved in this initiative or has knowledge about the state s efforts (while this might seem redundant to the question posed to the state agency regarding experts they are working with, asking local members may bring forward differences in opinion on the state s approach, so we encourage chapters not to rely solely on the agency for information). Reach out to your state s medical society to see if similar efforts have been made by other physician organizations, including non-cardiovascular efforts, working with this state agency or other state agencies. Final step- everyone comes together to determine if any additional steps need to be taken in regard to the current activity. 7. State Agency Moves to Contracting Phase Should the inquiring state agency wish to pursue a contract with the ACC for specific services, you will receive a second email stating that we are moving to contract [see Appendix C]. Unless we hear from you regarding any concerns/objections you may have with the proposed partnership, we will move forward according to the outlined processes. ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 8
8. Conclusion We hope that this best practice guide provides ACC chapter executives and governors with more knowledge about our NCDR Registries and their potential use for state reporting requirements. We also hope that through this guide, the ACC chapter executives and governors understand roles and expectation on the ACC chapters to assist the state agencies after the initial inquiry. With the support from ACC Chapters, the process will be easier and will benefit the chapter, members and state agencies. ACC chapters are also encouraged to reach out to the chapters listed in Appendix D to learn more from them once you received a notification about the NCDR proposal request from your state. For any additional questions, please feel free to contact us: General Inquiries By E-Mail: ncdrmail@acc.org By Phone: 1-800-257-4737 Hours of Operation Monday Friday, 9am ET - 5pm ET ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 9
APPENDIX A: NCDR State Participation Map ACC chapters should be the point of reference for the members to get more information regarding the changes and proactively inform members of any updates that will affect the members current practice. Below is a map depicting which states currently hold a valid contract with the ACC ( Yes ), those state who have inquired/received a formal proposal ( Proposed ) and those states who have contacted the ACC expressing interest in our offerings but have not yet received a formal proposal ( Exploring ). The following are the states that are already enrolled in NCDR Hospital Registry Data Reporting: (*As of November 2015) Sixteen (16) states have enrolled into the NCDR Hospital Registry Data Reporting and they will be reference for other states agencies who are interested in using the system as their reporting requirement. ACC Chapters are encouraged to reach out to these 16 state chapters that already have their state agencies enrolled into NCDR Hospital Registry Data Reporting to learn about their experience with the implementation of this system. ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 0
APPENDIX B: Exploration Phase Process sample proposal e-mail to ACC Chapter Governor From: [System Generated] Sent: [System Generated] To: ACC Chapter Governor Cc: ACC Chapter Executive; ;NCDR leadership to include: NCDR CSO; NCDR MB Chair; NCDR Sr. Medical Officer for Scientific Affairs; NCDR Sr. Medical Officer for External Affairs; Internal ACC Staff to include: ACC Director, Chapter Affairs & Board of Governors; ACC Director, State Government Relations; EVP for SEQ ; Sr. Director, NCDR Scientific Reporting; Sr. Director, Registry Services; Sr. Specialist, NCDR Analytic and Reporting Services; ; Associate for specific registry product management Subject: INFORMATION ONLY: ACC Proposal for Hospital Registry Data Reporting Options provided to [State Abbreviation and Agency Abbreviation] Dear Dr. [Per To Line]: ACC is committed to ensuring that ACC Governors are informed of requests to use the NCDR national registries to support state-based initiatives specific to their ACC Chapter. I am writing today to share with you that we received an inquiry from [Name of State Agency on the proposal cover sheet] regarding options available to states considering aligning their reporting activities, either current or under consideration, with one or more of the NCDR registries. In response to this request, we provided the state agency with a copy of the attached American College of Cardiology Proposal for Hospital Registry Data Reporting Options. The proposal was sent to [insert name and title of state POC]. We also encourage state representatives to work directly with their state ACC Chapter, if they have not already done so. We have provided them with your ACC Chapter executive s e-mail address when we sent them this proposal. If ACC receives a specific request from this state agency to move forward with one or more of the options outlined in this proposal, we will keep the ACC Chapter informed. In the meantime, please let me know if you have any questions regarding the options outlined in this proposal. Regards, [ACC staff proposal POC] ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 1
APPENDIX C: Implementation Phase Process sample information email to ACC Chapter Governor From: [System Generated] Sent: [System Generated] To: ACC Chapter Governor Cc: ACC Chapter Executive; NCDR leadership to include: NCDR CSO; NCDR Sr. Medical Officer for External Affairs; Internal ACC Staff to include: ACC Director, Chapter Affairs & Board of Governors; ACC Director, State Government Relations; Sr. Director, NCDR Scientific Reporting; Sr. Director, Registry Services; Sr. Specialist, NCDR Analytic and Reporting Services; Associate for specific registry product management Subject: INFORMATION ONLY: Follow up from ACC Proposal for Hospital Registry Data Reporting Options provided to [State Abbreviation and Agency Abbreviation] Dear Drs. [Per To Line]: ACC is committed to ensuring that ACC Governors are informed of requests to use the NCDR national registries to support state-based initiatives specific to their ACC Chapter. I am writing today to share with you that we received the following request: Requesting individual and organization: [Details provided by State Agency] Registry/ies involved: [Details provided by State Agency] Background: [Details provided by State Agency] Objectives: [Details provided by State Agency] If ACC determines we can move forward with this request, a formal agreement will be put in place, which acknowledges among other conditions that the decision by hospitals to report their data is voluntary. If you have any questions or concerns about this request, please let us know. Regards, [ACC staff proposal POC] ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 2
APPENDIX D: ACC Chapter Reference List Florida, Maryland, Virginia Jennifer Ray Beckman, CAE, MBA ACC Chapter Executive- Florida, Maryland, Virginia 3445 Seminole Trail, Ste 253 Charlottesville, VA 22911 Toll-free: (877)793-8171; Fax: (888) 637-2405 Email: jlrbeckman@verizon.net Mississippi Thad F. Waites, MD, FACC MS Chapter Member Leader 1017 Richburg Rd Hattiesburg, MS 39402 (601) 408-0720 thadwaites@gmail.com Pennsylvania* PA ACC Phone: (717) 558-7750 x1595 Email: paacc@pamedsoc.org *Preferred method of contact via email ACC State Chapters Best Practice Guide Working with States on Clinical Data Requests 0