“Routine” Is Not Enough: Insurance Coverage for Experimental Cancer Screening Methods

Blog Post | 112 KY. L. J. ONLINE | October 24, 2023

“Routine” Is Not Enough: Insurance Coverage for Experimental Cancer Screening Methods

By: Meghan Goins, Staff Editor, Vol. 112

609,820 Americans are expected to die from cancer in 2023.[1] About 14% of those incidences of cancer are detected through “a recommended screening test.”[2] According to one expert, “’the vast majority of cancer types don’t have screening tests available.’”[3] It has been estimated that having too few patients enroll causes about one-fifth “of cancer clinical trials [to] fail.”[4]  Congress has previously attempted to address these problems.[5] The CLINICAL TREATMENT Act, enacted in 2019, requires states “to cover and reimburse routine costs of care for treating a Medicaid enrollee who is participating in a qualifying clinical trial.”[6] Even when people choose to participate in clinical trials, the ambiguous language of the CLINICAL TREATMENT Act can lead to additional costs for participants.[7] Due to that ambiguity, as well as disparities in insurance policies[8] and limited diversity among participants in clinical trials,[9] further legislation is needed to expand requirements for the insurance coverage of participation in clinical trials for cancer screenings to ensure that testing methods for cancer are as effective and widely available as possible.

New methods of diagnosing and treating cancer must be tested in clinical trials before being made available for use by doctors.[10] With regard to the costs of clinical trials, there are “patient care costs” and “research costs.”[11] The CLINICAL TREATMENT Act’s definition of “[r]outine costs of care” means that “any item or service provided to prevent, diagnose, monitor, or treat complications resulting from participation in the qualifying clinical trial, such as the cost of physician visits or laboratory tests” must be covered by Medicaid.[12] Notably, “routine patient costs” do not include “an item or service that is the investigational item or service that is the subject of the qualifying clinical trial.”[13] In practice, the meaning of the phrase “routine care” is unclear, and that lack of clarity can lead to additional costs for patients.[14] Even patients who have “private insurance are” left with additional costs.[15] Factors, such as travel costs[16], preventing enrollment in trials other than insurance exist for potential clinical trial participants.[17] While insurance coverage alone may not eliminate all of those factors, further expanding insurance coverage of clinical trials could lead to greater participation by combatting one of the existing barriers to potential participants.[18]

With sufficient participation, clinical trials for cancer screening tests can lead to life-saving innovations, which themselves create a need for new legislation.[19] Multi-cancer early detection (MCED) tests are capable of detecting multiple types of cancer from a single screening method, such as a blood test.[20] Two federal bills have been introduced just this year, seeking to expand Medicare to cover MCED tests.[21] The Nancy Gardner Sew Act and the Medicare Multi-Cancer Early Detection Screening Coverage Act, if passed, “would require the Centers for Medicare & Medicaid (CMS) to cover multi-cancer tests for Medicare beneficiaries.”[22] These Acts advocate for Medicare coverage for cancer screening methods that have already made it through the requisite phases of clinical trials, rather than coverage for clinical trials themselves.[23] The tests that these Acts protect demonstrate the importance of greater insurance coverage for clinical trials. Future legislation should strive to expand insurance coverage for clinical trial participation and eliminate ambiguities in existing laws.

[1] Cancer Stat. Facts: Common Cancer Sites, Nat’l Cancer Inst., https://seer.cancer.gov/statfacts/html/common.html (last visited Oct. 23, 2023).

[2] Jacqueline Howard, Only 14% of diagnosed cancers in the US are detected by screening, report says, CNN, (Dec. 14, 2022, 6:39 PM) https://www.cnn.com/2022/12/14/health/cancers-detected-by-screening-report/index.html.

[3] Id.

[4] Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer, Am. Cancer Soc’y Cancer Action Network, (Apr. 11, 2018) https://www.fightcancer.org/policy-resources/barriers-patient-enrollment-therapeutic-clinical-trials-cancer.

[5] See Implementation of CLINICAL TREATMENT Act Advances, Increasing Access to Cancer Clinical Trials, ASCO, (July 5, 2023), https://old-prod.asco.org/news-initiatives/policy-news-analysis/implementation-clinical-treatment-act-advances-increasing#:~:text=The%20law%2C%20which%20went%20into,than%2042%20million%20Medicaid%20patients.

[6] Id.

[7] Calculating the Costs of Clinical Trials, ASH Clinical News, (Dec. 2019) https://ashpublications.org/ashclinicalnews/news/4807/Calculating-the-Costs-of-Clinical-Trials.

[8] Suzanne Leigh, In Childhood Cancer, Private Insurance Means Better Survival, Univ. of Cal. San Francisco News, (Dec. 16, 2019) https://www.ucsf.edu/news/2019/12/416061/childhood-cancer-private-insurance-means-better-survival.

[9] Karen M. Winkfield, Jonathan K. Phillips, Steven Joffe, Michael T. Halpern, Dana S. Wollins, & Beverly Moy, Addressing Financial Barriers to Patient Participation in Clinical Trials: ASCO Policy Statement, 36 J. Clinical Oncology 33, 3331 (2019).

[10] See Clinical Trials, World Health Org., https://www.who.int/health-topics/clinical-trials#tab=tab_1 (last visited Oct. 23, 2023).

[11] Health Insurance Coverage of Clinical Trials, Cancer.Net (Mar. 2022), https://www.cancer.net/research-and-advocacy/clinical-trials/health-insurance-coverage-clinical-trials.

[12] 42 U.S.C. § 1396d(gg)(1)(A)(i); Implementation of CLINICAL TREATMENT Act Advances, Increasing Access to Cancer Clinical Trials, supra note 4..

[13] 42 U.S.C. § 1396d(gg)(1)(B)(i)(I) (2023).

[14] Calculating the Costs of Clinical Trials, supra note 6.

[15] Id.

[16] Id.

[17] Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer, supra note 5.

[18] Id.

[19] See Multi-cancer Early Detection (MCED) Tests, Am. Cancer Soc’y, https://www.cancer.org/cancer/screening/multi-cancer-early-detection-tests.html (last accessed Oct. 23, 2023).

[20] See e.g., id.

[21] What is the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act and the Medicare Multi-Cancer Early Detection Screening Coverage Act?, Prevent Cancer Found., https://www.preventcancer.org/multi-cancer-early-detection/coverage-and-legislation/ (last accessed Oct. 23, 2023).

[22] Roxane Nelson, New Bill Would Allow Medicare Coverage for Multi-Cancer Tests, Medscape, (Jun. 26, 2023) https://www.medscape.com/viewarticle/993686.

[23] Id.