Meeting federal requirements

The United States has the most expensive health care system in the world, with an average per capita expenditure of $7290, accounting for approximately 16% of gross domestic product (GDP) as of 2007. The Congressional Budget Office has estimated that, without significant policy changes, health care expenditures will account for 25% of GDP in 2025, and 49% of GDP by 2082. However, despite the nation’s outsized health care spending compared with other post-industrial nations, it has been ranked last in nearly all quality indicators in numerous studies.

In an attempt to restrain health care expenditure growth and improve access and quality of care, on March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act into law. Key components of this legislation include improving access to coverage through the creation of state-based health exchanges; a requirement for all US citizens to have health care coverage; a requirement for all employers with more than 50 full-time employees to offer health care coverage; and the creation of premium and cost-sharing subsidies for individual beneficiaries and employers. In addition, the act includes numerous provisions relating to the administration of the Medicare program, including a restructuring of Medicare Advantage payments, an Independent Payment Advisory Board responsible for creating proposals to reduce per capita Medicare expenditures, support for the creation of accountable care organizations (ACOs), and support for comparative effectiveness research through the establishment of the Patient-Centered Outcomes Research Institute. These provisions, as well as the others present in the act, have the potential to radically restructure how health care is delivered, measured, and reimbursed in the United States, with many provisions already taking effect and affecting policy and practice.

The Center for Medicare and Medicaid Services (CMS) has planned and executed numerous demonstration projects and policy changes to support the movement to value-based health care, a model in which health care quality and costs are factored to determine the overall value of services delivered. Through projects to evaluate new care delivery models, such as the evaluation of the Patient-Centered Medical Home model, pay-for-reporting and pay-for-performance reimbursement policies including the CMS Physician Quality Reporting System (PQRS), and tools for public transparency and comparison such as the Compare websites for hospital, nursing home, and physician performance, the CMS is exploring new ways to provide patients with high-quality health care that is delivered for the most competitive costs. These emerging models represent both significant opportunities and threats to health care providers and organizations, given their capacity to reshape health care delivery and reimbursement.

Patient registries can serve as valuable tools in meeting these challenges and demonstrating an accurate representation of quality and efficiency. An example of this is the creation of the registry reporting option for PQRS program. This quality measure reporting system was established through a provision of the 2006 Tax Relief and Health Care Act, and has continued each year since. PQRS requires providers to satisfactorily report a minimum number of quality measures to receive an incentive payment for participation. In addition, the Medicare Improvement for Patients and Providers Act mandates that the names of providers who successfully submit to the PQRS be provided on the CMS Web site. In 2009, a total of $234 million in incentives were paid to 119,804 providers in 12,647 practices.

PQRS reporting was initially only available through the reporting of quality codes on Medicare claims. However, in 2008, the option to report PQRS measures through a qualifying patient registry became available. Registries meeting CMS qualification process standards are approved to submit quality measure data on behalf of providers, and are additionally required to provide feedback quality reports to participants. Since the introduction of the registry reporting mechanism, reporting rates have increased, and providers submitting to PQRS using the registry option were more likely to earn an incentive payment, and earn a higher incentive payment, than providers submitting using other options such as claims submission.

In 2010, the American Gastroenterological Association (AGA) Digestive Health Outcomes Registry (AGA Registry), a national digestive disease patient registry, achieved CMS approval as a PQRS-qualified registry for reporting 2009 measures. Seeking to provide a simple solution to meeting PQRS requirements, the registry incorporated the PQRS hepatitis C measures group, a collection of 8 measures of quality in hepatitis C treatment. The measures group reporting option through PQRS in 2009 required that a provider report all measures in the group for a minimum of 30 patients, of which 2 must be Medicare Fee for Service, or report the group for at least 80% of the provider’s Medicare Fee for Service population. By becoming a qualified registry, the AGA Registry was able to successfully report quality measures on behalf of 46 providers, qualifying them for a potential 2% reimbursement bonus for all 2009 Medicare Fee for Service claims. The registry continues to offer this option for 2010 reporting, because it offers providers a way to meet their quality reporting needs in a minimally burdensome manner, and additionally serves as a driver for registry participation. Programs such as PQRS will continue to serve as important mechanisms by which health care providers can demonstrate a commitment to quality through guideline-driven practice and efficient use of resources. As the federal government continues to seek ways to control rising health care expenditures, patient registries will serve as a vital channel through which detailed clinical data and nationally endorsed measures can drive policy and support providers as they seek reimbursement incentives and avoid penalties.

Additional opportunities for meeting federal requirements through patient registries exist in the standards established by CMS for ACOs. Medicare ACO standards include the creation of the Medicare Shared Savings Program, which is designed to improve care coordination and communications between providers. CMS has identified 65 process and outcome measures that will be used to assess the quality of patient care within the ACO setting, and has proposed that, in addition to claims-based submission of these measures, data collection will also be approved using a tool designed for clinical quality measure reporting, which includes quality-focused patient registries. In addition, measure #23 in the ACO measure set is a measure of patient registry use in the ACO. Using patient registries as data collection, measurement, and reporting systems can assist providers in meeting the ACO standards and participating in the Shared Savings Program.

Patient registries are well positioned to support coverage with evidence development (CED) studies, as outlined in a national coverage determination in 2006. CED studies collect data to determine the appropriateness of treatments and improve the evidence base for expansion of payor coverage. The American College of Cardiology’s ICD (implantable cardioverter-defibrillator) Registry is an example of a patient registry used for CED studies on behalf of CMS. Established in 2006, the ICD Registry collects information about implantable cardioverting defibrillators, including physician training and inpatient outcomes. The registry was initially proposed because of the determination of CMS that “the available evidence does not provide a high degree of guidance to providers to target these devices to patients who will clearly derive benefit.” Although randomized controlled trials showed clear benefit in ICDs as a primary prevention for sudden cardiac death, the differences in the median age of the Medicare population (70–75 years) and the trial populations were significant enough to warrant reconsideration of the evidence.

To address these questions, CMS proposed a national ICD registry in 2004, participation in which would be a condition for reimbursement for institutions performing implantations. After a workgroup was convened by the Heart Rhythm Society to determine registry design, the National Cardiovascular Data Registry (NCDR) was selected as the administrator of, and data repository for, the registry. Because participation in the registry was mandated for reimbursement, nearly 100% of eligible sites were enrolled within 4 months, and more than 400,000 procedures have been documented. Data from the registry were used to show that 22.5% of implants between 2006 and 2009 did not meet the American Heart Association, American College of Cardiology, European Society of Cardiology, and Heart Rhythm Society guidelines for appropriateness. The study further showed that disparities in physician training could be a probable factor in non–evidence-based implantations. The ICD Registry has since been updated to include lead data (including lead failures), pediatric ICD implantations, and additional quality measures beyond the registry’s original scope, and continues to be used to determine whether ICD implantations are indicated for Medicare beneficiaries.

Quality, efficiency, and appropriateness continue to drive federal decisions regarding coverage and reimbursement, as well as recognition of emerging care environments including ACOs and patient-centered medical homes, and registries have the potential to continue their unique role in supporting providers in this evolving landscape. Many federal health reform efforts have proactively included registry options and consideration, which is a positive sign that they will remain a viable quality measurement and reporting source as health care continues to be shaped by legislation.

Private payor collaboration

Private health care payors have embraced several of the trends set by the federal government, seeking to lower health care costs per beneficiary while determining which of their providers are delivering outcomes that meet performance thresholds. Programs such as United Healthcare’s UnitedHealth Premium program use quality measures derived from health care claims data to assess individual provider quality of care and cost efficiency, and provide benefits such as premium directory listings. Patient registries capturing the necessary quality measures for these programs can provide clinicians with the capability to meet the requirements of multiple health payor programs, rather than devote effort separately and incur unnecessary redundant resource consumption.

In another example, Aetna’s Institutes of Excellence and Institutes of Quality programs offer a designation for facilities and providers that demonstrate an ability to provide high-quality, cost-effective care. Additional requirements include that care is delivered in an accredited facility with appropriate infrastructure including an in-house data-driven quality improvement program, and reporting of the Leapfrog Hospital Survey or an equivalent patient safety and quality reporting program. Although such programs are currently offered as incentives, these programs will become the standard by which providers are measured in the coming decade, and, subsequently, by which reimbursement is determined.

The Aetna Institutes of Quality Cardiac Care Facilities program is an example of a health payor program that integrates with patient registries to measure quality of care. Facilities applying for recognition through this program are required to participate in, and report from, the American College of Cardiology’s NCDR, and the Society of Thoracic Surgeons (STS) National Database. Established in 1997, the NCDR is a national quality measurement registry with more than 2200 participating hospitals and encompassing a suite of 6 cardiovascular registries: CathPCI Registry, which measures quality in cardiac stenting procedures; CARE Registry, capturing carotid stenting and endarterectomy procedures; ACTION Registry, for acute coronary syndrome; ICD Registry, covering patients receiving implantable cardioverting defibrillators; IMPACT Registry, which includes adults and pediatrics with congenital heart conditions; and the PINNACLE Network, a registry measuring outpatient quality in cardiovascular care. The STS National Database was established in 1989 and supports quality improvement in thoracic surgery, with 3 components: adult cardiac, general thoracic, and congenital heart surgery. Applicants for the Aetna program must successfully report all measures supported by the NCDR, as well as their STS STAR rating (Quality Aggregate Rating) score. By using these registries to measure, monitor, and report quality, Aetna providers are able to meet requirements to become recognized for their commitment to improving outcomes in a cost-effective manner.

Given the quality measurement goals of patient registries, there is significant opportunity for integration with other payment incentive programs. The Bridges to Excellence (BTE) program through the Health Care Incentives Improvement Institute (HCI3) provides recognition programs that can lead to per patient incentive payments from participating health plans. The programs include recognition for conditions including asthma, cardiac care, depression, diabetes, hypertension, coronary artery disease, spine care, and chronic obstructive pulmonary disease. The National Committee for Quality Assurance (NCQA) provides quality measurement programs for recognition in the treatment of back pain, diabetes, and heart/stroke. These programs rely on clinical data to measure quality in the respective clinical domains, and compute aggregate quality scores to determine recognition status. Patient registries that already capture these data could be effectively integrated to allow registry participants to meet recognition needs across multiple recognition programs, and thereby see potential gains in reimbursement across health payors.

As existing sources of guidelines-driven quality measurement, patient registries have the capacity to meet reporting requirements for such programs using clinically derived, detailed data based on endorsed and validated measures, rather than via claims data that do not provide an accurate picture of patient care. In addition, registries can serve as a single source for capturing and reporting health payor program quality data, reducing redundancy and providing consistency of measurement across payors and care environments. Registries including the American Society for Clinical Oncology’s Quality Oncology Practice Initiative (QOPI) have already formed partnerships with 13 health payors to provide benefits to participating facilities who meet quality thresholds in oncologic care. The AGA is also currently working with numerous health payors and quality measurement and reporting organizations to design incentive programs that are driven by quality measures reported by the AGA Registry, including inflammatory bowel disease (IBD) management and colorectal cancer prevention (CRC-P) outcome measures. As health plans move toward the formation of tiered and narrow networks, pay for quality programs, and further recognition and designation programs, and the use of clinical data provided by registries to provide fair and accurate quality reporting will continue to grow.