Case: 23-60167 Document: 129 Page: 1 Date Filed: 06/12/2023
`
`No. 23-60167
`United States Court of Appeals for the Fifth Circuit
`
`ILLUMINA, INC. AND GRAIL, INC.
`Petitioners,
`
`v.
`FEDERAL TRADE COMMISSION
`Respondent
`
`
`
`
`
`Petition for Review of an Order of the Federal Trade Commission
`
`BRIEF FOR THE NATIONAL HISPANIC MEDICAL
`ASSOCIATION ET AL. AS AMICI CURIAE
`IN SUPPORT OF PETITIONERS
`
`
`
`Veronica L. Craig
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`
`
`
`Zachary D. Tripp
` Counsel of record
`WEIL, GOTSHAL & MANGES LLP
`2001 M Street NW, Suite 600
`Washington, DC 20036
`(202) 682-7220
`zack.tripp@weil.com
`Mark I. Pinkert
`WEIL, GOTSHAL & MANGES LLP
`1395 Brickell Ave., Suite 1200
`Miami, FL 33176
`
`Counsel for Amici Curiae
`
`
`
`
`

`

`Case: 23-60167 Document: 129 Page: 2 Date Filed: 06/12/2023
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`
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`CERTIFICATE OF INTERESTED PERSONS
`The undersigned counsel of record certifies that the following listed
`persons and entities as described in the fourth sentence of Rule 28.2.1 have
`an interest in the outcome of this case. These representations are made in
`order that the judges of this Court may evaluate possible disqualification
`or recusal.
`
`1) Petitioners
`
`Illumina, Inc.
`GRAIL Incorporated, now known as GRAIL, L.L.C.
`2) Counsel for Petitioners
`
`David R. Marriott
`Christine A. Varney
`Sharonmoyee Goswami
`Michael J. Zaken
`Jesse M. Weiss
`CRAVATH, SWAINE & MOORE LLP
`
`Gregory G. Garre
`Michael G. Egge
`Marguerite M. Sullivan,
`Anna M. Rathbun,
`David L. Johnson
`Alfred C. Pfeiffer
`LATHAM & WATKINS LLP
`
`3) Respondent
`
`Federal Trade Commission
`
`i
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`Case: 23-60167 Document: 129 Page: 3 Date Filed: 06/12/2023
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`
`4) Counsel for Respondent
`
`Anisha S. Dasgupta
`Joel Marcus-Kurn
`Matthew M. Hoffman
`5) Amici Curiae
`
`The National Hispanic Medical Association (NHMA)
`Congresswoman Nanette Diaz Barragán (D-CA, 44th District)
`Congressman Steven Horsford (D-NV, 4th District)
`Congresswoman Terri Sewell (D-AL, 7th District)
`Congresswoman Barbara Lee (D-CA, 12th District)
`Congresswoman Sheila Cherfilus-McCormick (D-FL, 20th District)
`Congresswoman Lori Chavez-DeRemer (R-OR, 5th District)
`MANA, A National Latina Organization
`Center for Black Health and Equity
`SER Jobs for Progress National Inc.
`Dr. Jose Morey
`National Hispanic Council on Aging (NHCOA)
`Mobilizing Preachers and Communities (MPAC)
`
`6) Counsel for Amici Curiae:
`
`Zachary D. Tripp
`Mark I. Pinkert
`Veronica L. Craig
`WEIL, GOTSHAL & MANGES, LLP
`
`
`
`/s/ Zachary D. Tripp
`Zachary D. Tripp
`Counsel of Record for Amici Curiae
`
`
`
`
`
`
`
`ii
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`Case: 23-60167 Document: 129 Page: 4 Date Filed: 06/12/2023
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`TABLE OF CONTENTS
`Interest of Amici Curiae ................................................................................. 1
`Introduction ..................................................................................................... 3
`Argument ......................................................................................................... 6
`I. Underserved communities disproportionately bear the burdens
`of cancer, due in part to gaps in screening ......................................... 6
`A. Although cancer screening is critical for better outcomes,
`historically it has been costly and limited .................................... 6
`B. Members of underserved communities face cumulative
`barriers ........................................................................................... 11
`C. Members of underserved communities receive less frequent
`and less effective cancer screening .............................................. 17
`D. Members of underserved communities suffer from higher
`mortality rates and worse outcomes ........................................... 21
`II. The merger can improve care and significantly reduce cancer
`inequality by reducing barriers to screening ................................... 25
`A. Access to Galleri is currently limited to the economic elite ...... 26
`B. Widespread availability of the Galleri test would reduce
`inequality in cancer screening and outcomes ............................ 26
`III. The FTC erroneously discounted the efficiencies of the merger
`and missed the broader implications for healthcare equality
`and the economy.................................................................................. 30
`Conclusion ...................................................................................................... 33
`Certificate of Compliance ............................................................................. 34
`Certificate of Service ..................................................................................... 35
`
`
`
`
`
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`Case: 23-60167 Document: 129 Page: 5 Date Filed: 06/12/2023
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`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`FTC v. Butterworth Health Corp.,
`946 F. Supp. 1285 (W.D. Mich. 1996), aff’d, 121 F.3d 708
`(6th Cir. 1997) .......................................................................................... 32
`United States v. Long Island Jewish Med. Ctr.,
`983 F. Supp. 121 (E.D.N.Y. 1997) .......................................................... 32
`Other Authorities
`Adriana M. Reyes & Patricia Y. Miranda, Trends In Cancer
`Screening By Citizenship and Health Insurance, 2000-
`2010, 17 J Immigr. Minority Health 644 (2015) ................................... 20
`Am. Ass’n for Cancer Rsch., Cancer Disparities Progress Re-
`port (2022), https://cancerprogressreport.aacr.org/wp-
`content/uploads/sites/2/2022/06/AACR_CDPR_2022.pdf ............ passim
`Am. Cancer Soc’y, Cancer Facts & Figures for African Ameri-
`can/Black People (2022-2024), https://www.cancer.org/con-
`tent/dam/cancer-org/research/cancer-facts-and-statis-
`tics/cancer-facts-and-figures-for-african-americans/2022-
`2024-cff-aa.pdf .................................................................................... 12, 21
`Am. Cancer Soc’y, Cancer Prevention & Early Detection:
`Facts & Figures (2023-2024), https://www.cancer.org/con-
`tent/dam/cancer-org/research/cancer-facts-and-statis-
`tics/cancer-prevention-and-early-detection-facts-and-fig-
`ures/2023-cped-files/2023-cancer-prevention-and-early-de-
`tection.pdf. .................................................................................... 10, 11, 20
`Am. Cancer Soc’y, Costs and Ins. Coverage for Cancer Screen-
`ing (Apr. 20, 2021),
`https://www.cancer.org/cancer/screening/cancer-screening-
`costs-insurance-coverage.html .................................................................. 8
`Am. Cancer Soc’y, The Costs of Cancer (2020 ed.),
`https://www.fightcancer.org/sites/default/files/Na-
`tional%20Documents/Costs-of-Cancer-2020-10222020.pdf. ........ passim
`
`iv
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`Case: 23-60167 Document: 129 Page: 6 Date Filed: 06/12/2023
`
`
`Am. Cancer Soc’y, Cancer Facts & Figures for Hispanic/La-
`tino People (2021-2023), https://www.cancer.org/con-
`tent/dam/cancer-org/research/cancer-facts-and-statis-
`tics/cancer-facts-and-figures-for-hispanics-and-latinos/his-
`panic-latino-2021-2023-cancer-facts-and-figures.pdf. .............. 14, 15, 21
`AMN Healthcare: Survey of Physician Appointment Wait
`Times and Medicare and Medicaid Acceptance Rates
`(2022) ........................................................................................................... 8
`Bryn Nelson, How Structural Racism Can Kill Cancer Pa-
`tients, 128(2) Am. Cancer Soc’y–Cancer Cytopathology 83
`(Feb. 2020). ............................................................................................... 16
`Brandon A. Mahal et al., Prostate Cancer-Specific Mortality
`Across Gleason Scores in Black vs Nonblack Men, 320
`JAMA 2480 (2018). .................................................................................. 21
`CDC, American Indian and Alaska Native People and Cancer
`(Jan. 30, 2023) .......................................................................................... 17
`CDC, Equity in Cancer Prevention and Control (Dec. 16,
`2021), https://www.cdc.gov/cancer/health-
`equity/equity.htm ..................................................................................... 13
`CDC, How Racism Leads to Cancer Health Disparities (Dec.
`16, 2021), https://www.cdc.gov/cancer/health-
`equity/racism-health-disparities.htm .................................................... 16
`CDC, What Is Breast Cancer Screening? (Sept. 26, 2022),
`https://www.cdc.gov/cancer/breast/basic_info/screening.ht
`m .................................................................................................................. 9
`CDC, What is Health Equity? (July 1, 2022),
`https://www.cdc.gov/healthequity/whatis/index.html .................... 11, 15
`Chengyue Yang et al., Anxiety Associated with Colonoscopy
`and Flexible Sigmoidoscopy: A Systematic Review, 13(12)
`Am. J. Gastroenterology 1810-1818 (Dec. 15, 2018) ............................. 10
`Christina A. Clarke et al., Racial/Ethnic Differences in Can-
`cer Diagnosed after Metastasis: Absolute Burden and
`Deaths Potentially Avoidable through Earlier Detection, 31
`Cancer Epidemiol Biomarkers Prev. 521 (2022) .................................. 30
`
`v
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`Case: 23-60167 Document: 129 Page: 7 Date Filed: 06/12/2023
`
`
`Chyke A. Doubeni et al., Association between Improved Colo-
`rectal Screening and Racial Disparities, 386 N. Engl. J.
`Med. 796 (2022) ........................................................................................ 30
`Danielle J. O’Laughlin et al., Addressing Anxiety and Fear
`during the Female Pelvic Examination, 12 J. Prim. Care &
`Cmty. Health 1 (Feb. 1, 2021) ................................................................. 10
`Farhad Islami, Am. Cancer Soc’y, The State of Cancer Dis-
`parities in the United States,
`https://www.cancer.org/research/acs-research-
`highlights/cancer-health-disparities-research/state-of-
`cancer-disparities-in-the-united-states.html (last visited
`June 10, 2023) .......................................................................................... 17
`Health Disparities in Appalachia (Aug. 2017),
`https://www.arc.gov/wp-
`content/uploads/2020/06/Health_Disparities_in_Appalachi
`a_August_2017.pdf .................................................................................. 20
`Irene Hall et al., Breast and Cervical Cancer Screening
`Among Mississippi Delta Women, 15 J. Health Care for
`Poor & Underserved 375, 378 (2004). .................................................... 20
`Nat’l Cancer Inst., Cancer Screening Overview (PDQ)-Patient
`Version (Aug. 19, 2020), https://www.cancer.gov/about-
`cancer/screening/patient-screening-overview-pdq .................................. 9
`J.J. Guidry et al., Transportation as a Barrier to Cancer
`Treatment, 5(6) Cancer Pract. 361-66 (1997) ........................................ 13
`Jeremy M. O’Connor et al., Factors Associated With Cancer
`Disparities Among Low, Medium, and High-Income US
`Counties, 1(6) JAMA Network Open, Oct. 2018,
`https://jamanetwork.com/journals/jamanetworko-
`pen/fullarticle/2705856 ............................................................................ 23
`Katherine M. N. Lee et al., Distance and Transportation Bar-
`riers to Colorectal Cancer Screening in a Rural Commu-
`nity, 14 J. Prim. Care Cmty. Health 1 (Jan. 2023),
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9829879/. ................. 13
`
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`
`Kathleen Hall, What To Do About Pre-Colonoscopy Anxiety,
`U.S. News & World Report (Oct. 10, 2017),
`https://health.usnews.com/health-care/patient-advice/arti-
`cles/2017-10-10/what-to-do-about-pre-colonoscopy-anxiety. ................ 10
`Kelly M. Hoffman et al., Racial Bias in Pain Assessment and
`Treatment Recommendations, and False Beliefs about Bio-
`logical Differences between Blacks and Whites, 113(16)
`Proc. Nat’l Acad. Scis. 4296 (2016),
`https://www.pnas.org/doi/epdf/10.1073/pnas.1516047113. .................. 23
`Kristen Pallock et al., Structural Racism—A 60-Year-Old
`Black Woman with Breast Cancer, 380 N. Engl. J. Med.
`1489 (2019). .............................................................................................. 19
`Leslie B. Adams et al., Medical Mistrust and Colorectal Can-
`cer Screening Among African Americans: A Systematic Re-
`view, 42(5) J. Cmty. Health 1044 (Oct. 2017) ........................................ 16
`Lucy A. Peipins et al., The Lack of Paid Sick Leave as a Bar-
`rier to Cancer Screening and Medical Care-Seeking: Re-
`sults from the National Health Interview Survey, 12 BMC
`Pub. Health 520 (Jul. 2012) .................................................................... 14
`Nancy Krieger et al., Cancer Stage at Diagnosis, Historical
`Redlining, and Current Neighborhood Characteristics:
`Breast, Cervical, Lung, and Colorectal Cancers, Massachu-
`setts, 2001–2015, 189(10) Am. J. Epidemiology 1065-75
`(Mar. 27. 2020) ......................................................................................... 12
`Natalie Guerrero et al., Cervical and Breast Cancer Screen-
`ing Among Mexican Migrant Women, 2013, 13 Preventing
`Chronic Disease 160036, CDC (Aug. 11, 2016) ..................................... 15
`Paul Pinsky et al., Putting Cancer Screening in Perspective,
`Nat’l Insts. Health (Apr. 27, 2022),
`https://www.nih.gov/about-nih/what-we-do/science-health-
`public-trust/perspectives/science-health-public-trust/put-
`ting-cancer-screening-perspective ............................................................ 6
`Roni Nitecki et al., Employment Outcomes Among Cancer Pa-
`tients In the United States, 76 Cancer Epidemiology
`102059 (Feb. 2022) ..................................................................................... 7
`
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`
`Healthcare Access in Rural Communities, Rural Health Info.
`Hub (Nov. 21, 2022),
`https://www.ruralhealthinfo.org/topics/healthcare-access .................. 12
`Stella Winters et el., Breast Cancer Screening Outcomes
`among Mexican-origin Hispanic Women Participating in a
`Breast Cancer Screening Program, Prev. Med. Rep. (Sept.
`20, 2021) .................................................................................................... 19
`Thomas A. LaVeist et al., Mistrust of Health Care Organiza-
`tions Is Associated with Underutilization of Health Ser-
`vices, 44(6) Health Serv. Res. 2093-2105 (Dec. 2009) .......................... 16
`Yelena Gorina & Nazik Elgaddal, Patterns of Mammography:
`Pap Smear, and Colorectal Cancer Screening Services
`Among Women Aged 45 and Over, 157 Nat’l Health Statis-
`tics Reports 1-18 (June 9, 2021) ............................................................. 18
`
`
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`INTEREST OF AMICI CURIAE1
`Amici are non-profits, bipartisan members of Congress, and a medical
`professional, who are advocates for healthcare equality for people in un-
`derserved communities, and in particular for minority groups, underpriv-
`ileged individuals, and people with disabilities.
`The National Hispanic Medical Association (NHMA) is a non-profit
`association representing the interests of Hispanic physicians in the United
`States. The NMHA exists to improve the healthcare of Hispanic Ameri-
`cans and members of underserved communities.
`Congresswoman Nanette Diaz Barragán (D-CA, 44th District) is
`Chair of the Congressional Hispanic Caucus and serves on the House En-
`ergy and Commerce Subcommittees on Health. Congressman Steven
`Horsford (D-NV, 4th District) is Chair of the Congressional Black Caucus.
`Congresswoman Terri Sewell (D-AL, 7th District) is a member of the Con-
`gressional Black Caucus and serves on the House Ways and Means Sub-
`committee on Health. Congresswoman Barbara Lee (D-CA, 12th District)
`is the Co-Chair of the Democratic Policy and Steering Committee, and
`serves on the House Budget and Appropriations Committees. Congress-
`woman Sheila Cherfilus-McCormick (D-FL, 20th District) serves on the
`
`
`1 All parties consented to the filing of this brief. No party’s counsel authored any part
`of this brief. No one, apart from amici and their counsel, contributed money intended
`to fund the brief’s preparation or submission.
`
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`Congressional Black Caucus. Congresswoman Lori Chavez-DeRemer (R-
`OR, 5th District) serves on the Congressional Hispanic Conference.
`MANA, a National Latina Organization, represents the interests of
`Latina women, youth, and families on various issues that affect their com-
`munities, including health equity.
`The Center for Black Health and Equity is a national nonprofit or-
`ganization that facilitates public health programs and services that bene-
`fit communities and people of African descent.
`SER Jobs for Progress National, Inc. is a national nonprofit organiza-
`tion that formulates and advocates initiatives resulting in the increased
`development and utilization of America’s human resources, with emphasis
`on the needs of Hispanic Americans, in the areas of education, training,
`employment, business, and economic opportunity.
`The National Hispanic Council on Aging (NHCOA) works to improve
`the lives of Hispanic older adults, their families, and caregivers, and is
`dedicated to promoting, educating, and advocating for research, policy,
`and practice in the areas of economic security, health, and housing.
`Dr. Jose Morey is a medical professional and the CEO of Ad Astra
`Media, a minority-owned production company, which, among other things,
`works to provide information and awareness about the importance of vac-
`cinations for Black and Brown patients.
`
`2
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`Mobilizing Preachers and Communities (MPAC) is a Non-Profit Civil
`Rights and Faith Based organization, comprised of clergy and community
`united together for the purpose of impacting public policy through civic
`engagement, to ensure justice and equality for all people.
`Amici have a substantial interest in this case because reuniting Illu-
`mina and Grail has the potential to reduce racial, ethnic, and socioeco-
`nomic disparities in cancer diagnosis and treatment. Amici and their
`members have deep experience relevant to these antitrust efficiencies of
`the Illumina-Grail merger. Amici respectfully submit that this Court
`should hold unlawful and set aside the Commission’s order, which fails as
`a matter of law and will delay widespread adoption of Grail’s Galleri test—
`accelerated by the Grail-Illumina merger—that would be a game-changer
`for members of underserved communities.
`
`INTRODUCTION
`Evidence from a weeks-long FTC evidentiary hearing established
`that the Illumina-Grail merger will facilitate distribution of Grail’s Galleri
`cancer screening test by accelerating the path to FDA approval and payor
`reimbursement. By making cancer screening easier and cost-effective, the
`merger will save thousands of lives and prevent immeasurable suffering
`in the near term. Amici submit that the merger would improve rates of
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`cancer screening for underserved communities in particular, and thus has
`the potential to reduce inequality in cancer screening and care.
`For years, cancer screening has been invasive, expensive, time-con-
`suming, or limited in other ways. Typically, patients test for only one can-
`cer at a time, and only after a referral from a primary care physician. Be-
`cause of these limitations and others, the general public does not proac-
`tively and sufficiently screen for all cancers. Many diagnoses are missed
`at the point when intervention would be most effective. (§ I.A).
`Within that broader context is another problem: disparities in cancer
`outcomes based on race, geography, and socioeconomics. Health inequality
`in the United States is well-documented and cancer is no different. Studies
`show that members of underserved communities are less likely to obtain
`cancer screening, in part because the costs and burdens are amplified for
`them. And the obstacles are more than just dollar and cents—they include
`problems such as difficulty accessing insurance, employer inflexibility to
`take time off from work, long distances to healthcare facilities, language
`barriers, and implicit biases, among others. (§ I.B). Research shows that
`members of underserved communities receive less effective and less fre-
`quent screening. (§ I.C). And research in turn shows that members of such
`communities bear the burdens of cancer disproportionately. They are often
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`diagnosed at later stages and often have worse outcomes—i.e., higher mor-
`tality rates, more severe illnesses, and greater financial hardships. (§ I.D).
`Widespread adoption of the Galleri test would be a game-changer. It
`is a technological break-through that can significantly reduce the many
`costs and obstacles that hinder screening, particularly for the underprivi-
`leged. Galleri tests for up to 50 types of cancer at once, in a single blood
`draw, at a time when there is no standard screening method for most can-
`cers. The sooner the Galleri test can get to widespread adoption—and be
`covered by payors—the better. By saving lives in all communities, and by
`reducing the need for hospitalization and surgery, Galleri could also save
`billions of dollars in healthcare costs nationwide. (§ II).
`The unrefuted evidence from the agency hearing shows that reunit-
`ing Illumina and Grail will make all of that happen faster. Thus, the Com-
`mission erred when it cast aside this conclusive evidence of economic effi-
`ciency and deemed the merger unlawful. For the first time in decades, an
`ALJ found in favor of a merger after an in-house adjudication. But the
`Commission made up its mind when it first brought the case as the pros-
`ecutor, and overrode the ALJ’s extensive and well-supported findings. The
`Commission blocked the merger without solid reasoning and based on its
`unsubstantiated predictions about future market dynamics.
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`Amici submit that this case is about more than abstract theory and
`supposition. The merger would save thousands of lives, starting right now,
`and reduce longstanding inequalities in cancer care. The Commission’s
`Order is thus an obstruction to remarkable progress, with the Commission
`elevating its own vision of the market over the public welfare. This Court
`should hold that Order unlawful and set it aside. (§ III).
`
`ARGUMENT
`I. Underserved Communities Disproportionately Bear The Bur-
`dens Of Cancer, Due In Part To Gaps In Screening
`A. Although cancer screening is critical for better outcomes,
`historically it has been costly and limited
` Effective screening is a crucial first step for cancer treatment. See
`1.
`Paul Pinsky et al., Putting Cancer Screening in Perspective, Nat’l Insts.
`Health (Apr. 27, 2022).2 As the Commission recognized, “[b]etter screening
`methods . . . have the potential to extend and improve many human lives.”
`Op. 3.3 If cancer is diagnosed at an early stage, treatments are often less
`aggressive—and more likely to succeed. Op. 2. As the disease progresses
`and cancer metastasizes, treatments become more painful, more invasive,
`and less effective. Id. at 2-3.
`
`
`2 https://www.nih.gov/about-nih/what-we-do/science-health-public-trust/perspec-
`tives/science-health-public-trust/putting-cancer-screening-perspective.
`3 For record citation abbreviations, see Petitioners Br., Dkt. No. 96, at p.xiv.
`
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`Moreover, increased cancer screening would lead to savings in
`healthcare costs. Although studies differ in methodology for assessing the
`economic impacts of cancer, numerous researchers have found that cancer
`exerts a significant burden on the economy and that its costs will rise in
`the coming years. According to the American Cancer Society, “[a]pproxi-
`mately $183 billion was spent in the U.S. on cancer-related health care in
`2015, and this amount is projected to grow to $246 billion by 2030—an
`increase of 34%.” Am. Cancer Soc’y, The Costs of Cancer, at 3 (2020 ed.).4
`In addition, there are other substantial losses to society—including
`the loss of economic productivity. One recent study found that “[c]ancer
`diagnosis was associated with a 6.8% higher risk of part-year non-employ-
`ment and 4.1% higher risk of full-year non-employment.” Roni Nitecki et
`al., Employment Outcomes Among Cancer Patients In the United States,
`76 Cancer Epidemiology 102059 (Feb. 2022).
`2. Cancer screening in the United States is currently costly, burden-
`some, inefficient, and limited. No standard screening options exist for most
`cancers in asymptomatic individuals, and single-cancer screening exists
`for only breast, cervical, colon, lung, and prostate cancer. See Op. 2. More-
`
`
`4 https://www.fightcancer.org/sites/default/files/National%20Documents/Costs-of-Can-
`cer-2020-10222020.pdf.
`
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`over, screening can be time-consuming, difficult, and expensive, particu-
`larly if a patient’s insurance provider does not cover it. See Am. Cancer
`Soc’y, Costs and Ins. Coverage for Cancer Screening (Apr. 20, 2021);5 Am.
`Cancer Soc’y, Costs of Cancer, supra, at 30 (describing unexpected costs
`for preventative care and screening services).
`To begin, a patient typically needs a referral from a primary-care phy-
`sician to see a specialist to screen for cancers for which the patient may be
`at risk. See Am. Cancer Soc’y, Costs of Cancer, supra, at 9-10. That means
`waiting (often weeks) for a primary-care appointment; securing transpor-
`tation to the doctor’s office; taking time off work; and paying a co-pay. See
`AMN Healthcare: Survey of Physician Appointment Wait Times and Med-
`icare and Medicaid Acceptance Rates, at 4 (2022)6 (finding wait times for
`family physicians in metropolitan areas of 26 days on average, and up to
`45 days in some cities).
`If the physician determines that testing is appropriate, she typically
`refers the patient to a specialist. But that imposes additional costs and
`delays. Id. (showing specialist wait times increasing consistently over two
`decades in major cities); Am. Cancer Soc’y, Costs of Cancer, supra, at 9
`
`
`5 https://www.cancer.org/cancer/screening/cancer-screening-costs-insurance-cover-
`age.html.
`6 https://www.merritthawkins.com/uploadedFiles/MerrittHawkins/Con-
`tent/News_and_Insights/Articles/mha-2022-wait-time-survey.pdf
`
`8
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`(“The complexity of cancer treatment and the necessity of multiple special-
`ists are large drivers of cancer patient costs”). The patient needs to book
`yet another appointment with specialists who are often “in short supply”
`and farther away. Id. He must take time off work (again), and pay any co-
`pay or co-insurance (again). Id. And co-pays and co-insurance for special-
`ists tend to be higher and their wait times longer. Id.
`Many cancer tests are also invasive. “Typically, cancers are detected
`through a tissue biopsy or involve an invasive procedure,” such as a colon-
`oscopy, radiological tests, pap smear, or prostate exam—which are un-
`pleasant or risky in their own ways. Op. 26. Some of these methods involve
`exposure to radiation. IDF ¶ 75 (noting that whole-body PET/CT scans can
`be useful but are not recommended for early screening due in part to dan-
`ger from radiation); CDC, What Is Breast Cancer Screening? (Sept. 26,
`2022)7 (“[P]otential harms from breast cancer screening include pain dur-
`ing procedures and radiation exposure from the mammogram test itself.”).
`Others can lead to injury, such as bleeding and tearing. See Nat’l Cancer
`Inst., Cancer Screening Overview (PDQ)-Patient Version (Aug. 19, 2020)8
`(noting that “[n]ot all screening tests are helpful and most have risks”).
`
`
`7 https://www.cdc.gov/cancer/breast/basic_info/screening.htm.
`8 https://www.cancer.gov/about-cancer/screening/patient-screening-overview-pdq.
`
`9
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`
`And tests can be embarrassing or uncomfortable, thus causing hesi-
`tancy and anxiety. See Kathleen Hall, What To Do About Pre-Colonoscopy
`Anxiety, U.S. News & World Report (Oct. 10, 2017)9 (many patients fear
`colonoscopies); see also Chengyue Yang et al., Anxiety Associated with Co-
`lonoscopy and Flexible Sigmoidoscopy: A Systematic Review, 13(12) Am. J.
`Gastroenterology 1810, 1810-1818 (Dec. 15, 2018); Danielle J. O’Laughlin
`et al., Addressing Anxiety and Fear during the Female Pelvic Examination,
`12 J. Prim. Care & Cmty. Health 1 (Feb. 1, 2021) (“[a]nxiety and fear are
`common before and during the pelvic examination” used for cervical can-
`cer screening). Thus, as the Commission found, people tend to be more
`“comfortable and familiar with blood draws” than with procedures that
`have traditionally been used for cancer screening. Op. 3.
`For these and many other reasons, the American Cancer Society has
`found that the “potential” of cancer screening is “unfulfilled due to lower
`than optimal uptake and quality issues.” Am. Cancer Soc’y, Cancer Pre-
`vention & Early Detection: Facts & Figures, at 51 (2023-2024).10 Quite
`simply, screening even for a single cancer can require substantial invest-
`ment of time, money, and travel—all which can be even more difficult for
`
`
`9 https://health.usnews.com/health-care/patient-advice/articles/2017-10-10/what-to-do-
`about-pre-colonoscopy-anxiety.
`10 https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statis-
`tics/cancer-prevention-and-early-detection-facts-and-figures/2023-cped-files/2023-can-
`cer-prevention-and-early-detection.pdf.
`
`10
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`
`
`workers and parents who cannot afford the co-pays, time off from work, or
`child care. Testing can be intrusive, embarrassing, or painful. And screen-
`ing for multiple cancers multiplies those burdens, as the patient would
`need to screen for each cancer, one at a time.
`B. Members of underserved communities face cumulative
`barriers
`Members of underserved communities are more likely to face these
`and other structural barriers to screening, resulting in “racial/ethnic and
`socioeconomic status (SES) disparities in receipt of screening services.”
`Am. Cancer Soc’y, Cancer Prevention & Early Detection: Facts & Figures,
`supra, at 51. As the CDC explains, “[a]cross the country, racial and ethnic
`minority populations experience higher rates of poor health and disease in
`a range of health conditions.” CDC, Impact of Racisms on our Nation’s
`Health (April 8, 2021).11 Social determinants of healthcare outcomes in-
`clude: social context and racism, healthcare access, physical environment,
`workplace conditions, education levels, and income. See CDC, What is
`Health Equity? (July 1, 2022).12 While these factors are complex—and the
`literature on healthcare inequality is vast and developing—amici believe
`that the factors play a substantial role in creating or exacerbating gaps in
`cancer screening, treatment, and outcomes.
`
`11 https://www.cdc.gov/minorityhealth/racism-disparities/impact-of-racism.html
`12 https://www.cdc.gov/healthequity/whatis/index.html.
`
`11
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`Case: 23-60167 Document: 129 Page: 21 Date Filed: 06/12/2023
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`
`To begin, studies have found that people in underserved communities
`lack equal access to healthcare resources and facilities due to socioeco-
`nomic and geographical disadvantages. See, e.g., Am. Cancer Soc’y, Cancer
`Facts & Figures for African American/Black People, at 4 (2022-2024).13
`Fewer primary-care doctors in their neighborhoods, fewer appointments
`available, longer wait times, and more difficulty finding transit for ap-
`pointments. See Healthcare Access in Rural Communities, Rural Health
`Info. Hub (Nov. 21, 2022);14 see also Na