Observational, database studies provide a powerful QI supplement vs. Unanswered questions, risks make CMS plan a bad idea
by Larry Holder, MD, FACP and Dawn Brezina, MD
The proposed rules by the Centers for Medicare & Medicaid Services (CMS), which will allow access to patient-protected Medicare data, will provide for greater transparency and for data that could be utilized toward comparative-effectiveness research (CER). Thus, these rules have the potential to improve the quality of healthcare and impact patient safety.
The Institute of Medicine in December 1999 issued its now-famous article “To Err is Human,” which reported that medical errors cause up to 98,000 deaths and more than 1 million injuries each year in the U.S.6 However, the evidence shows minimal impact on improving patient safety in the past 10 years.
A retrospective study of 10 North Carolina hospitals reported in the New England Journal of Medicine by Landrigan and colleagues found that harms resulting from medical care remained extremely common, with little evidence for improvement.7 It also is estimated that it takes 17 years on average for clinical research to become incorporated into the majority of clinical practices.8 Although the randomized control trial (RCT) is unquestionably the best research tool to explore simple components of clinical care (i.e. tests, drugs, and procedures), its translation into daily clinical practice remains difficult.
Improving the process of care leading to quality remains an extremely difficult proposition based on such sociological issues as resistance to change, the need for interdisciplinary teamwork, level of support staff, economic factors, information retrieval inadequacies, and, most important, the complexity of patients with multiple comorbidities that do not fit the parameters of the RCT.
Don Berwick, MD, the lead author in the landmark IOM report and currently CMS administrator, has stated “in such complex terrain, the RCT is an impoverished way to learn.”9 Factors that cause this chasm include:10
CER has received a $1.1 billion investment with the passage of the American Recovery and Reinvestment Act to provide evidence on the effectiveness, benefits, and harms of various treatment options.11 As part of this research to improve IOM’s goals to improve healthcare, better evidence is desperately needed to cross the translational gap between clinical research and the bedside.12 Observational outcome studies based on registries or databases derived primarily from clinical care can provide a powerful supplement to quality improvement.13
Thus, the ability to combine Medicare claims with other data through the Availability of Medicare Data for Performance Measurement would supply a wealth of information to potentially impact quality. As a cautionary note, safeguards such as provider review and appeal, monitoring the validity of the information, and only using the data for quality improvement are vital.
Dr. Holder is medical director of hospitalist services and chief medical information officer at Decatur (Ill.) Memorial Hospital. He is a member of Team Hospitalist.
On June 8, the Centers for Medicare & Medicaid Services (CMS) proposed a rule to allow “qualified entities” access to patient-protected Medicare data for provider performance publication. CMS allowed 60 days for public comment and a start date of Jan. 1, 2012. But this controversial rule appeared with short notice, little discussion, and abbreviated opportunity for comment.
CMS maintains this rule will result in higher quality and more cost-effective care. Considering the present volume of data published on multiple performance parameters for both hospitals and providers, it would seem prudent to have solid data for efficacy prior to implementing more required reporting and costs to the industry.1,2,3
Physicians and hospitals will have 30 days to review and verify three years of CMS claims data before it is released. The burden and cost of review will be borne by the private practices involved.1 This process will impose added administrative costs, and it is unlikely three years of data can be carefully reviewed in just 30 days. If practitioners find the review too cumbersome and expensive, which is likely, they will forgo review, putting the accuracy of the data in question.
Quality data already is published for both physicians and hospitals. Is there evidence this process will significantly increase transparency? Adding more layers of administrative work for both CMS and caregivers—higher overhead without defined benefit—seems an ill-conceived idea. From an evidence-based-practice standpoint, where is the evidence that this rule will improve “quality” and make care “cost-effective”? Have the risks (added bureaucracy, increased overhead, questionable data) and benefits (added transparency) been evaluated?
Additionally, it is unclear who will be monitoring the quality of the data published and who will provide oversight for the “entities” to ensure these data are fairly and accurately presented. Who will pay for this oversight, and what recourse will be afforded physicians and hospitals that feel they have been wronged?4,5
The “qualified entities” will pay CMS to cover their cost of providing data, raising concerns that this practice could evolve into patient-data “purchasing.” Although it is likely the selected entities will be industry leaders (or at least initially) with the capability to protect data, is this not another opportunity for misuse or corruption in the system?
Other issues not clearly addressed include the nature of the patient-protected information and who will interpret this data in a clinical context. How will these data be adjusted for patient comorbidities and case mix, or will the data be published without regard to these important confounders?1,3
Publishing clinical data for quality assurance and feedback purposes is essential for quality care. Transparency has increased consumer confidence in the healthcare system and, indeed, has increased the healthcare system’s responsiveness to quality concerns. Granting the benefits of transparency, published data must be precise, accurate, and managed with good oversight in order to ensure the process does not target providers or skew results. Another program, especially one being fast-tracked and making once-protected patient information available to unspecified entities, raises many questions. Who will be watching these agencies for a clear interpretation? Is this yet another layer of CMS bureaucracy? In an era of evidence-based medicine, where is the evidence that this program will improve the system for the better?
Dr. Brezina is a hospitalist at Durham Regional Hospital in North Carolina.
The Hospitalist newsmagazine reports on issues and trends in hospital medicine. The Hospitalist reaches more than 25,000 hospitalists, physician assistants, nurse practitioners, residents, and medical administrators interested in the practice and business of hospital medicine.