Qualified Clinical Data Registry (QCDR) Access to Medicare Claims Data: A Key to Value-Based Care The Society of Thoracic Surgeons Courtney Yohe, Director of Government Relations

What is a QCDR? Submits quality data to CMS Collects medical/clinical data Patient + disease tracking Quality of care improvement Medicare quality reporting requirements A Qualified Clinical Data Registry is a clinical data registry that has been certified by CMS to help physicians meet their quality reporting requirements. Clinical data registries have existed for much longer than QCDRs but, until recently, the definition of a QCDR was the only reference to clinical data registries in statute. SHOW OF HANDS – WHO HAS USED A QCDR FOR QUALITY REPORTING

Sec. 105b of MACRA Requires Access to Claims Data for QCDRs “…the Secretary shall, at the request of a qualified clinical data registry…provide the data…for purposes of linking such data with clinical outcomes data and performing risk-adjusted, scientifically valid analyses and research to support quality improvement or patient safety” Section 105b of MACRA requires CMS to provide QCDRs with access to Medicare claims data in order to facilitate and quality improvement. READ TEXT I’ve highlighted a few key words here: *LINK*claims data with clinical outcomes data contained in the QCDR Use the claims data for *RESEARCH* *QUALITY IMPROVEMENT, *PATIENT SAFETY* Linking means we have continuous access to the data. Not just discrete, episodic matching. Research, quality improvement, and patient safety have very different meanings as well. While research is governed by strict protections and protocols and is expected to result in publication, quality improvement and patient safety efforts have different guidelines and processes.

What is the STS National Database? Established in 1989 Gold standard Approved QCDR since program’s inception Physicians = best position to measure clinical performance accurately The STS National Database is one such QCDR that could perform quality improvement activities if linked to Medicare claims data. It was established in 1989 as an initiative for quality improvement and patient safety among cardiothoracic surgeons. The Database has since grown exponentially, both in terms of participation and stature, and has become the gold standard for clinical registries. The Society of Thoracic Surgeons believes that physicians are in the best position to measure clinical performance accurately and objectively.

There are three parts to the STS National Database There are three parts to the STS National Database. The Adult Cardiac Surgery Database captures more than 5.8 million cardiac surgery procedure records and has more than 3,000 participating physicians. In fact, it captures data on more than 95% of the adult cardiac surgical procedures being performed in the country. The General Thoracic Surgery Database contains over 435,000 general thoracic surgery procedure records and more than 875 participating surgeons. Finally, the Congenital Heart Surgery Database captures more than 373,000 congenital heart surgery procedure records and has more than 800 participating physicians.

The Database Effect Study of Coronary Artery Bypass Graft (CABG) surgery @ Database-participating institutions Decreased: Observed mortality Incidence of postoperative stroke Risk of reoperation for bleeding Incidence of sternal wound infection Our experience with the STS National Database has proven that, that by collecting data on individual cardiothoracic surgical procedures, doing analysis, and providing timely feedback to practicing surgeons improve care quality. El Bardissi and colleagues studied 1,497,254 patients who underwent isolated primary Coronary Artery Bypass Graft (CABG) surgery at STS National Database-participating institutions from 2000 to 2009. They found that: Patients received more indicated care. The observed mortality rate over this period declined from 2.4% in 2000 to 1.9% in 2009, representing a relative risk reduction of 24.4% . The incidence of postoperative stroke decreased significantly from 1.6% to 1.2%, representing a relative risk reduction of 26.4%. There was also a 9.2% relative reduction in the risk of reoperation for bleeding and a A 32.9% relative risk reduction in the incidence of sternal wound infection despite the acuity of patients increasing during this period of examination.

Virginia Cardiac Services Quality Initiative Another example of the database effect is the results of the Virginia Cardiac Services Quality Initiative. It started as a surgical collaborative designed to use the STS National Database to combine clinical and cost data to develop evidence-based protocols. It has since expanded to include cardiology as well. The critical aspect of this initiative is the linking of database data to cost data. Not only did VCSQI open up new ways to identify efficiencies in care, it also allowed surgeons in VA to measure the financial impact of quality interventions. For example, when VCSQI members noted high rates of blood transfusions, best practice protocols were identified and reproduced in the region. Transfusion rates fell by 40%. Because VCSQI had access to other sources of claims data, they were able to prove that this intervention resulted in $49M in savings over a two-year period. VCSQI created a novel clinical/financial tool by combining the robust clinical information found in the STS National Database with financial data. Such a tool, deployed at a national level, could have an incredible effect on the healthcare system and on quality-based payment reforms. This is one of the reasons we hoped that Section 105(b) would finally help us to solve our claims data access issues.

STS APM Goals: Improve quality Improve patient outcomes Reduce cost of care A logical extension of the VCSQI experience is for STS to develop its own Alternative Payment Model. As CMS continues to implement MACRA, If we can align payment to support data collection, feedback, and implementation of best practices, then ALL STAKEHOLDERS stand to benefit. We are submitting comments for the record at an Energy and Commerce Health Subcommittee this week that will describe our experience developing an APM and how it has been stymied by our inability to access claims data. Thus far we have been unable to benchmark our models and adjust for financial risk without being able to link claims information to desired quality outcomes.

The Fine Print Challenges remain: Access to data Benchmarking Despite the statutory mandate in MACRA, we’ve had a little trouble convincing folks at CMS to implement this provision correctly. In January 2016, CMS published a proposed rule that essentially said that registries already had access to claims data through the Research Data Assistance Center (ResDAC). (SHOW OF HANDS, WHO HAS ACCESSED DATA FROM RESDAC?) Defied statutory mandate Insufficient to meet our needs ResDAC requires an applicant to submit a new application for each data request – The ResDAC application process is long and cumbersome. ResDAC applications are approved for specific research projects not QUALITY IMPROVEMENT and/or new payment models. CMS walked back the ResDAC proposal in the final rule and proposed to modify the Qualified Entity (QE) program to allow registries to access claims data in the way that certain entities obtain data that they can provide or sell to providers for quality improvement. STS explored this program in its early years and found it lacking. Regional All provider types Although improvements have been made, it still leaves some to be desired. Currently, CMS intends that QCDRs use a hybrid process to get the claims data provided for under section 105(b) of MACRA. They suggest that we enter into the QE program for more direct linkages. However, if any publications are to be derived form that information, the QCDR must apply to ResDAC to use those same data. Clearly, this is not what was intended by Sec 105(b) though we are limited in our recourse. We can either have Congress push back on CMS or we can start to build a legal case.

QUESTIONS / DISCUSSION? Courtney Yohe Director of Government Relations The Society of Thoracic Surgeons cyohe@sts.org 202-787-1222