Changing the Oncology Guidelines Market
For the past 4 years, various entities, large and small, have struggled to address the question of guidelines and pathways in oncology. Thousands of hours have been spent building software solutions to the complexity of oncology decision making. A handful of companies have created versions of oncology pathways, but not one of these have been able to incorporate the recognized national gold standard for oncology clinical guidelines—those produced and maintained by the National Comprehensive Cancer Network® (NCCN®). This collaboration embeds the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) and NCCN Drugs and Biologics Compendium™ (NCCN Compendium™) within the Proventys CDS Oncology system, an interactive web platform that arms oncologists with trusted indications of evidence and other key information needed for fully informed medical decision making.
Oncology Guidelines as Decision-Support Tools
One of the hottest topics in oncology management is variation, and how implementation of clinical care guidelines or the even-more-streamlined pathways programs might enforce greater consistency of care and more predictability in the costs of care. Payers seek reduction of variation both as an indicator of “best practices” and as confirmation that oncologists are not straying from evidence-based treatments without reasons. Increasingly, payers need assurance that physicians are not only looking at the status of each patient and his or her disease, but also that medical decisions incorporate full cognizance of the diagnostics, targeted therapies, alternative choices, and full impact of a given treatment for a specific clinical situation.
Most oncology information systems can manage specific regimens tightly, but there is limited ability to track through the medical decisionmaking process leading to the selection of a regimen in a way that mea sures and reports even simple con cordance with the national standards set forth for oncology care. Savvy payers are seeking proof of high levels of concordance with NCCN Guidelines™ and the NCCN Compendium™ as an essential mea sure of quality for oncology care.
Payer expectations for benchmarking care against NCCN Guidelines are problematic for practices, because current claims and practice management (PM) systems have limited medical decision-making processes or can’t integrate those processes with the details of the recognized standards for clinical care for tracking and reporting.
Available electronic health record (EHR) or PM systems have not had broad access to integrate the details of the clinical NCCN Guidelines into real-time, active decision-making algorithms. Some systems do allow reference to the Guidelines in a static manner. Consequently, even on cology practices with very sophisticated EHR or PM systems either start their data entry at the point where the medical treatment decision already has been made (which is too late for payer interest or needs) or have some type of shadow decision-making process that works around reference to the NCCN Guidelines.
Practices, therefore, are not able to report concordance with NCCN Guidelines or track variation from them through their existing technology systems. Most physicians state high levels of reliance and concordance with NCCN Guidelines and NCCN Compendium indications in practice, but have limited ability to track or report on the actual experience in their practice. Often available is the ability to report on concordance with other clinical decision points, which can vary and lead to inconsistency on aggregated platforms beyond the individual practice.
NCCN Guidelines versus Other Guideline Models
When there is a consistent, nationally recognized gold standard for clinical care, such as the NCCN Guidelines, it is referred to as the benchmark for quality and evidencebased decision making by physicians, patients, payers, and employers alike. All comparisons for quality treatment decisions are made against that standard.
NCCN has built that reputation by conducting rigorous reviews of new information about drugs and treatment, and through regular and timely updates to the clinical care guidelines. The Centers for Medicare & Medicaid Services (CMS) has set forth specific standards for the conduct and documentation of transparency in organizations that set forth care guidelines and compendia, and has approved NCCN as a primary source that is fully compliant with the CMS standards:
- Tracking of changes considered and made for not less than 5 years
- Listing all evidence considered
- Listing all participating individuals in review (credentials, disclosures)
- Keeping minutes and voting records
- Clear decision making, with no agenda other than care.
Patients, physicians, payers, and employers should expect the same transparency of other guidelines and pathways, but are not usually able to see those standards met. Despite the recent buzz about pathways and the proliferation of shadow guidelines before the NCCN/Proventys collaborative algorithm was available, most physicians still resist the idea that these allow for appropriate medical decision making for the individual patient and disease that sits in front of them.
Pathways narrow physician choices further than guidelines, and some are drawing increasing criticism for potential liability and challenge by patients and physicians who question the validity and evidence that lead to the narrowed options rather than those found in the nationally recognized evidence-based NCCN Guidelines. It may be more useful to take a step back and record consistency and utilization against the national evidence-based standards, which in turn will quickly lead to informationdriven narrowing of selected choices based on real-time practice and patient experience instead of negotiated narrowing of choices.
Likely Challenges to “Other” Guidelines and Pathways
Until the NCCN Guidelines were accessible electronically and in a web platform for easy use, the only expectations of electronic care guidelines were that some payer or some physician accepts them. Now that the nationally recognized gold standard of care is readily accessible and usable, challenges will be made on all fronts to other proposed guidelines or pathways.
Common questions and challenges now are being heard about other proposed guidelines or pathways from patients, payers, employers, and physicians:
- Why are these not the NCCN Guidelines?
- How can I convince my [patients, physicians, payers, employers] that these are better when they expect that NCCN Guidelines are the gold standard?
- What decisions drove the choices that are different from the NCCN Guidelines?
- Can you prove the evidence behind those decisions? • Were certain drugs and regimens selected based on costs or available rebates, and given preference over other options?
- Can you meet the CMS expectations for transparency in your activities?
- What is the update and maintenance process, and how does it compare with the NCCN committees, processes, and updates and reviews?
- How can I defend your recommendations/ decisions if they differ from the choices on the NCCN Guidelines, especially if the patient, employer, or the physician is comparing those options to what is on the NCCN Guidelines?
Common national platforms do evolve in clinical care standards, and it will be far more acceptable to physicians to adopt the detailed electronic algorithms of the NCCN Guidelines now that they are available than to go through the onerous time and effort to create or validate a different set of shadow guidelines, accept other guidelines created by any entity that is not NCCN out of concern for risk or potential bias in the decision-making process, or accept from a payer or external vendor other portals or processes that are not NCCN Guidelines and therefore not part of their normal clinical decision-making process.
True Evidence-Based Treatment, and Beyond
Payers, physicians, employers, and patients will demand only clinical care guidelines that incorporate the NCCN Guidelines, now that they are available, as the basic platform for oncology management. Use of the Proventys CDS Oncology platform (see description in Value-Based Cancer Care. Feb 2011:30) will not only allow physicians to see the NCCN Guidelines recommendations for a specific state and stage of disease, it also will allow that physician to see the levels of evidence for each choice, and potentially also the patient’s payer policy for each regimen (approved coverage, needs prior authorization, not covered), any internal practice pathways that may have been developed regarding each choice and, eventually, benchmarks showing utilization rates of each choice for other physicians across the country for patients with the same state and stage of disease.
The aggregation of this level of information in a consistent manner will spark expanded real-time, realworld, evidence-based treatment decisions and activity, thus leading to true evidence-based care management in oncology, grounded, as most believe it should be, in the medical decision making of the physician. Payers and physicians will quickly reap the benefits of universally applied evidencebased treatment, and progress to collection of treatment outcomes to support conversations about oncology disease management.
Preserving and supporting physician autonomy to (1) make individualized care decisions; (2) use the evidence they trust; (3) base treatment on the needs of the patient; and (4) be able to track and proved the quality of that decision. This harkens back to the core of the medical profession, the Hippocratic Oath…where physicians promise to treat patients to the “best of their ability and judgment”—not someone else’s best judgment.
Dawn Holcombe is President of DGH Consulting, which provides consulting and speaking services to practices, pharma, and payers in strategy development, MD/payer negotiations and relationships, and oncology management and pathways.