XIFIN White Paper: A Pay-for-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests
We recently came across XIFIN, Inc., a financial cloud computing company that provides revenue cycle management solutions for diagnostic companies. This August, they released a white paper arguing that while there are effective ways, such as Coverage with Evidence Development (CED), to secure coverage for drugs and medical devices in healthcare, they are not always suited to the needs of the molecular diagnostic environment. They argue that the current molecular diagnostic environment curbs innovation as companies, especially smaller venture-backed ones, often do not have the resources to keep afloat financially during the period of time spent gathering data on clinical utility. The authors propose overhauling the coverage determination process, and recommend a risk-sharing, pay-for-value model that would put the judgment of the appropriateness of a diagnostic test, along with the associated data, in the hands of physicians, patients and diagnostic provider rather than a governing body.
While there is no doubt that in our current system a clear definition of “sufficient evidence” is elusive, we know that this or any other solution requires good science. It seems to us, at QURE, that regulators should treat innovation in molecular diagnostics no different from therapeutics: there cannot be reimbursement unless clear evidence exists that the test improves clinical practice. While we do not agree with the model proposed in the XIFIN report, we do agree that the field will benefit from further discussion on how manufacturers, physicians, and payers can most rapidly and efficiently improve the evidence available for decision-making and identify the areas where more evidence is most needed. In molecular diagnostics, changes in coding have made purchasers and providers more sensitive to overall costs and, in a knock-on effect, the boardrooms of molecular diagnostic companies more aware that even innovative diagnostics need to prove clinical value and demonstrate the ROI for purchasers.
Instead of writing new rules, we recommend that reasonable and proactive clinical utility criteria be established, that they be made transparent and then the science be conducted to see if the threshold of ‘practice change’ can be achieved. The Center for Medical Technology Policy (CMTP) has been a leader here as they have called for, with the engagement of numerous stakeholders, and published methodological standards on study design for clinical utility. To improve the speed at which a diagnostic is approved for reimbursement, parsing out evidence categories for different tests and diseases may be a helpful addition to these recommendations. Patient level data, for example, might not be suitable for orphan diagnostics. Diagnostics for screening could be allowed, but only for affected sub-populations. Approval for coverage and reimbursement should also take into account factors such as time taken to develop or areas where there is a void with no alternative test. Even RCTs are feasible using models and in-silico approaches and these can match the rapid pace of development of innovations in the molecular diagnostic space.
Our CPV® vignettes are an example of a new in-silico methodology that generates clinical utility in a way that captures physician behavior relative to the test or device. Just recently, for example, we helped a multi-biomarker diagnostic assay secure CMS coverage and reimbursement by submitting clinical utility evidence from a CPV® vignettes randomized controlled study. The study showed that when the assay showed a change in disease activity (the test had been clinically validated), rheumatologists were more likely to make the correct assessments and treatment decisions. The measured change in the study was not an outcome nor a patient experience measure, rather it was the physician’s clinical decisions to treat (or not treat).
Current reimbursement schemes may indeed not always be adequate to incentivize research development clinical utility, thus we appreciate the thought provoking arguments posed by XIFIN. Although we may not necessarily agree with all points raised, we find value in dialogue on coverage and reimbursement spurred by papers like this. We anticipate the payor-led coverage and reimbursement (C&R) determination process, including CED, will continue to evolve, and that evidence-based decision-making will be at the forefront. We like the way Mark McClellan puts it: CED is a good way to develop a “learning-based health care system” and the coverage to support it. Simulations are a similar opportunity. We would add that starting early and doing good science remain at the core for securing coverage and reimbursement.
Center for Medical Technology Policy (CMTP). Effectiveness Guidance Document (EGD): Evaluation of Clinical Validity and Clinical Utility of Actionable Molecular Diagnostic Tests in Adult Oncology. May 2013
 McClellan M the 9th Annual Meeting of the Hematology/Oncology Carrier Advisory Committee Network (July 13-14, 2007, Washington, DC), Keynote address. Presented at.
Feature Article: Quality, Measurement and the Health Insurance Exchanges
2014 is quickly approaching, and with the year end healthcare will change in profound ways. Americans will have access to health insurance and plans that are more affordable than many originally believed and have a standard minimum of benefits (four, in fact) through the Health Insurance Exchanges. While the politics will play out in its own complex way, what has been lost is that healthcare quality and measurement will indelibly become part of plans and payment structures. We examine here four ways we expect we will begin to see the transformation of quality measurement and how quality will integrate with payment mechanisms:
1. New requirements will make exchanges the Trojan horse for standardizing quality metrics for healthcare plans: The Affordable Care Act (ACA) includes provisions that require health plans to have undergone and passed a rigorous, independent review of the quality of care and the level of service they provide their customers. Specifically, the Act outlines acceptable measures, such as “Healthcare Effectiveness Data and Information Set (HEDIS), patient experience ratings on a standardized Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey, as well as consumer access, utilization management, quality assurance, provider credentialing, complaints and appeals, network adequacy and access, and patient information programs.”
2. State exchanges will affect quality of care across payer groups: Even though the majority are actually run by the Federal government, State exchanges will have the capability of aggregating the purchasing power of individuals and small groups. This means that they may be an important mechanism for pushing quality and delivery system reforms into the private health insurance market. We know from our own research that in a marketplace if you can impact the private sector you will impact patient behavior (Quimbo et al, 2011). Working with providers and other stakeholders, exchanges will, in effect, be providing a much-needed catalyst to shift the conversation from access and volume to centralized quality improvement strategies across payer groups.
3. Performance-based contracting with plans will be used more widely: Exchanges—and this should be obvious—will establish a number of quality standards for participating plans beyond what is required by the ACA. Specifically, exchanges are allowed to set additional criteria for plan participation related to performance-based contracting. In such a scenario, the exchange could establish a process to encourage plans to submit bids that include key quality and delivery system improvement components. For example, they may require plans to use providers that are recognized as patient-centered medical homes (PCMH) or encourage them to use a common set of performance metrics, adopt pathways or use quality-based reimbursement incentives.
4. Practice in provider networks will begin to align: Performance-based contracting will also be an important driver for aligning provider networks. Plans will not necessarily seek to create identical contracts with providers groups but they will gravitate towards standardization across performance based reimbursement contracts through the exchange. For example, in our own work, we have found that suggested treatment pathways for chemotherapy regimens in breast cancer treatment vary enormously. With our CPV vignettes, we have measured and begun to align clinical practice across providers. Being the intermediary between providers and plans, we look at effectiveness of clinical practice at the level of physicians and the health care team. And by providing a single directive on chemotherapy regimes, payors have the potential of saving providers millions of dollars. The key to understanding plan aspirations is to keep the focus on value defined as higher quality and/or lower costs.
In a nutshell, State exchanges hold at least the same kind of purchasing power as large employers and can require the same level of healthcare quality transparency and demand the same efficient provider payment mechanisms. Thus, we are looking to an improved healthcare market in the near future in which exchanges will drive quality transformation by incentivizing transparency and advancement of value-based care.
Quimbo S, Peabody JW, Javier X, Shimkhada R, Solon O. Pushing on a String: How policy might encourage private doctors to compete with the public sector on the basis of quality. Econ Lett. 2011 Feb 1;110(2):101-103.
 The Affordable Care Act (ACA), Section 1311
In mid-September QURE Healthcare participated in the WHO Consultation on Autism Spectrum Disorder and other developmental disorders in Geneva. The Consultation brought together stakeholders from around the world to discuss how to best use the momentum behind the recent U.N. resolution on autism to increase global capacity for identifying and treating children with autism.
Photo courtesy of Andy Shih
President and Founder of QURE, Dr. John Peabody, presented on Tuesday at the Disease Control Priorities (DCP) 3 Quality Meeting on Instruments of Policy to Influence Intervention Access, Uptake and Quality. Hosted by the Center for Disease Dynamics, Economics & Policy (CDDEP), the objective of the two-day meeting was to discuss the availability and effectiveness of policy instruments to improve access, uptake and quality of interventions. Dr. Peabody’s talk served as an introduction, presenting trends in quality measurement and the link between quality, access and utilization.
Data from QURE’s six country study, which used CPV® vignettes to establish a baseline health-system level of care quality in heart disease, adult pneumonia, maternal and neonatal health, was included in the World Bank’s new publication, “Getting Better: Improving Health Systems Outcomes in Europe and Central Asia“. QURE’s results from the study, including data from Armenia, Albania, Georgia, Russia and Tajikistan, informed Chapter 3, specifically “The Quality of Treatment and Care for Key Conditions Is Often Poor”. Learn more about the full study here.
In Inc. Magazine’s 2013 Inc. 5000 List, QURE’s client, Crescendo Bioscience, was listed as the 67th fastest growing private company in the U.S. Ranked on three year growth rate, Crescendo grew 4,740 percent from 2010-12, making it the 5th fastest growing health care company on the list. Crescendo Bioscience is a molecular diagnostics company that developed Vectra®DA, a multi-biomarker blood test that assesses rheumatoid arthritis disease activity; it was recently approved for Medicare reimbursement.
QURE’s client, Crescendo Bioscience, was granted coverage and reimbursement by CMS (through Palmetto). (The official coverage decision is available here.) Crescendo’s product, Vectra DA, is a blood test for rheumatoid arthritis disease activity. The decision for reimbursement hinges upon clinical utility data. QURE conducted the randomized trial on clinical utility for Crescendo. As an experiment, QURE asked the question will this new technology change clinical practice? QURE’s CPV™ lifesciences study showed a significant improvement in disease assessment and treatment of rheumatology (published in PLoS ONE). QURE is excited that Crescendo has received C&R for Vectra DA, and looks forward to helping other lifesciences clients develop similar experimental clinical utility data.
On Tuesday, QURE’s CPV™ life sciences study, which investigated the clinical utility of a novel test for determining rheumatoid arthritis disease activity, was published in the peer-reviewed, online journal PloS ONE. The study was a randomized control trial using CPV™ vignettes to measure the quality of care before and after the introduction of the novel MBDA (Multi-Biomarker Disease Activity) test. The paper reports a 12% CPV™ score improvement in disease assessment and treatment decisions for the group who received education about the test. This publication will serve to bolster the body of evidence for the test, proving its positive impact on physician practice, a key factor in receiving CMS reimbursement. The full publication is available online here.
Today, QURE and Moffitt Cancer Center jointly announced a four-year partnership to improve the quality of cancer care. Using CPV™ vignettes, QURE will be providing Moffitt with a better understanding of clinical practice patterns and physician decision-making among their own physicians as well as with their strategic partners.
QURE will use its CPV™ measurement and feedback system to assess quality of care, of which adherence to Moffitt’s nationally acclaimed oncology clinical cancer pathways is a critical factor. QURE will implement the program first at Moffitt Cancer Center and then will expand to Moffitt’s network of oncology partners across Florida and other states.
The QURE and Moffitt partnership will enhance Moffitt’s leadership as a National Cancer Institute Comprehensive Cancer Center while aligning Moffitt and partner physicians to deliver the most effective and efficient care. QURE is pleased to contribute to Moffitt’s goal of ensuring high quality of cancer care, and looks forward to a fruitful relationship over the next four years.
ACOs (accountable care organizations) are being highlighted more and more frequently in the news: the New York Times published an article on Tuesday about the work that Advocate Health Care is pioneering at their facilities in Illinois.
Advocate has shown a 6 percent reduction in hospital admissions, as well as hospital stays down 9 percent. Through Advocate’s deal with Blue Cross Blue Shield (launched Jan 1, 2011 for a three year contract), about 380,000 patients have been assigned to the accountable care network, meaning the total cost of care for those patients has already been projected. In a shared savings model, Advocate splits half of the savings with Blue Cross if their costs come in under the projected total.
One significant part of the deal is that Advocate has to meet certain quality standards in order to qualify for the savings, including readmission and length of hospital stays. As a Blue Cross of Illinois article states, “insurance companies are under more pressure to spend money on quality medical care rather than quantity.” This shift is what makes quality measurement ever more important in a slow healthcare trend of shifting away from fee-for-service to accountable care.