Providers order unnecessary tests for a variety of reasons: pressure from patients, fears of malpractice suit, not being knowledgeable about current “best” practices as well as for potential financial advantage for them or their health system. Clinical pathways built on solid clinical guidelines have the potential to lower costs through reduced resource utilization of potentially unnecessary screenings, tests, and procedures. But clinical pathways are not effective if not implemented. Formal mandate of clinical pathways may be on the horizon, but enforcement has been historically slow in this sector of care.
The Centers for Medicare & Medicaid Services (CMS), one of the largest payers of health care, has a great deal to gain in terms of clinical and financial outcomes from widespread concordance to clinical pathways, but they have been slow to act on mobilizing this tool. Clinical pathways have the potential to lower costs through reduced resource utilization of potentially unnecessary screenings, tests, and procedures1-3—a well-known problem in oncology care.4 “Drugs don’t work in patients who don’t take them” is a famous quotation attributed to former Surgeon General C. Everett Koop.5 In the same vain, clinical pathways are not effective if not implemented (and followed consistently with regular updates and maintenance to evolve with the output of new data and guidelines for best care practices, of course). Formal mandate of clinical pathways may be on the horizon, but enforcement has been historically slow in this sector of care.
Protecting Access to Medicare Act of 2014
Despite passing a law over 5 years ago to reduce potentially unnecessary and expensive diagnostic imaging tests, CMS has yet to implement it.6 This law was, in part, fueled by MedPAC in 2011, who cited the rapid growth of magnetic resonance imaging (MRI) scans, computed tomography (CT) scans, and other imaging, and recommended requiring providers who order more tests than their peers to be forced to get authorization from Medicare before sending patients for such exams.7 The law requires that providers follow clinical guidelines before Medicare will pay for many common medical scans for beneficiaries.6 The 5% who order the most tests that are inappropriate as judged by clinical guideline criteria under the law are required after that to get prior approval from Medicare for their diagnostic imaging.
When the law was announced, physicians argued that this would be “cookbook medicine”—that the regulation would interfere with their practices. As a result, the Trump administration delayed putting the 2014 law in place until January 2020—two years later than originally planned. And even then, CMS has slated next year as a “testing” period, which means even if a provider does not check the guidelines, Medicare will still pay for the scan. CMS also said they will not decide until 2022 or 2023 when exactly physician penalties will begin.8
Clinical Pathways for Resources Management
Critics worry these delays come at a steep cost, both in clinical and financial outcomes, as Medicare is continuing to pay for millions of unnecessary exams, and patients are being subjected to radiation for no medical benefit. A Harvard study published in 2011 found “widespread overuse” of imaging tests for men on Medicare who were at low risk of getting prostate cancer.9 And a University of Washington study that reviewed 459 CT and MRI exams at a large academic medical center found 26% of the tests were inappropriate.10 If clinical pathways were more formally enforced, these variations and excesses in care could be reduced.1-3
Providers order unnecessary tests for a variety of reasons: pressure from patients, fears of malpractice suit, not being knowledgeable about current “best” practices as well as for potential financial advantage for them or their health system. While this law applies to providers treating patients who are enrolled in the traditional fee-for-service (FFS) Medicare system, as is typically the case, Medicare FFS procedures will drive similar practices for managed care organizations and become a practice for the majority of the marketplace. In this area, however, health insurers, including those that operate the private Medicare Advantage plans, have historically refused to pay for the exams unless provider receive prior authorization.
The benefits of implementing clinical pathways developed based on clinical guidelines can be found in studies that show the clinical and financial benefit from health systems using clinical guidelines. For example, the University of Virginia Health System found that unnecessary testing fell by between 5% and 11% after implementing clinical guideline recommendations.11 Further, the Virginia Mason Health System in Seattle in 2011 set up a system requiring its providers to consult imaging guidelines, denying claims for any tests that did not meet appropriate criteria, except in rare circumstances. This intervention led to a 23% drop in MRIs for lower back issues and headaches.12 In 2014, AtlantiCare, a New Jersey hospital system part of the Geisinger health system, began grading physicians on whether they consulted guidelines.
To ensure no delay in care, not all Medicare imaging tests will be subject to the requirements of the law, when enacted. Emergency patients are exempt, as well as patients admitted to hospitals. CMS has identified some of the most common conditions for which providers will be required to consult guidelines. Those include heart disease, headache, and pain in the lower back, neck, or shoulders.8
What Guidelines to Follow
Obviously, one major question on the implementation of this law is “whose guidelines should we follow?” The law requires the federal government to designate health societies or health systems to develop guidelines and companies that would sell software to embed that guidance into doctors’ electronic health record (EHR) systems. Among the leaders in that effort is the American College of Radiology, which lobbied for the 2014 law and has been issuing imaging guidelines since the 1990s. It is one of about 20 medical organizations and health systems certified by CMS to publish separate guidelines for providers.
The devil is often in the details, and this case is no exception. Deciding whose guidelines will serve as the basis for best practices, the process of following these guidelines, and the application of penalties are critical elements that will impact the outcomes of this program. The process of following guidelines is becoming less burdensome as EHRs evolve, allowing for embedding of clinical pathways that help guide providers in care decisions and prompt for justification when physicians choose an option outside of best practice recommendations. Even the penalty application is complex, as refusing payment for the study itself or penalizing the radiology provider for tests ordered by a provider outside the radiology group may seem inappropriate. As a result, these radiology groups will have the most to lose, since they will stand on the frontline for enforcing these guidelines themselves to ensure that tests are appropriate under the payers’ criteria in order to be paid for their work.
This movement of CMS toward formalized mandating of clinical pathways and their method for enforcement will pave the way for future regulations and how managed care will follow. For now, such action and guidance and action are not yet mature.
1. Neubauer MA, Hoverman JR, Kolodziej M, et al. Cost effectiveness of evidence-based treatment guidelines for the treatment of non-small-cell lung cancer in the community setting. J Oncol Pract. 2010;6(1):12-18. doi:10.1200/JOP.091058
2. Kreys ED, Koeller JM. Documenting the benefits and cost savings of a large multistate cancer pathway program from a payer’s perspective. J Oncol Pract. 2013;9(5):e241-e247. doi:10.1200/JOP.2012.000871
3. Jackman DM, Zhang Y, Dalby C, et al. Cost and survival analysis before and after implementation of Dana-Farber clinical pathways for patients with stage IV non-small-cell lung cancer. J Oncol Pract. 2017;13(4):e346-e352. doi:10.1200/JOP.2017.021741
4. Csik VP, Minetola J, Chapman AE, Flomenberg N. Sustaining the gains in cancer care from the oncology care model. Poster at: 2019 American Society for Clinical Oncology Annual Meeting; June 1, 2019; Chicago, IL. Abstract 6632.
5. Lindenfeld J, Jessup M. ‘Drugs don’t work in patients who don’t take them’ (C. Everett Koop, MD, US Surgeon General, 1985). Eur J Heart Failure. 2017;19(11):1412-1413. doi:10.1002/ejhf.838
6. Centers for Medicare & Medicaid Services (CMS). Appropriate use criteria program. Cms.gov website. https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/appropriate-use-criteria-program/index.html. Updated February 21, 2019.
Accessed August 28, 2019.
7. American College of Nuclear Medicine (ACNM). MedPAC report urges prior authorization for advanced imaging services. Snmmi.org website. http://www.snmmi.org/ACNM/Government/Content.aspx?ItemNumber=12075. Published June 16, 2011. Accessed August 28, 2019.
8. Hentel KD, Menard A, Mongan J, et al. What physicians and health organizations should know about mandated imaging appropriate use. Ann Intern Med. 2019;170(12):880-885. doi:10.7326/M19-0287
9. Choi WW, Williams SB, Gu X, Lipsitz SR, Nguyen PL, Hu JC. Overuse of imaging for staging low risk prostate cancer. J Urol. 2011;185(5):1645-1649. doi: 10.1016/j.juro.2010.12.033
10. Lehnert BE, Bree RL. Analysis of appropriateness of outpatient CT and MRI referred from primary care clinics at an academic medical center: how critical is the need for improved decision support? J Am Coll Radiol. 2010;7(3):192-197. doi:10.1016/j.jacr.2009.11.010
11. Huber TC, Krishnaraj A, Patrie J, Gaskin CM. Impact of a commercially available clinical decision support program on provider ordering habits. J Am College Radiol. 2018;15(7):951-957. doi:10.1016/j.jacr.2018.03.045
12. American College of Radiology/American Roentgen Ray Society. Clinical decision support systems help control inappropriate medical imaging, study suggests. ScienceDaily. January 4, 2011. https://www.sciencedaily.com/releases/2011/01/110104064023.htm. Accessed August 28, 2019.