Amicus Curiae Brief — Robert F. Kennedy, Jr., Secretary of Health and Human Services, et al., Petitioners v. Braidwood Management, Inc., et al.

Supreme Court briefFeb 25, 2025

Ask Donna

What actually matters in this document.

Text

No. 24-316

In the Supreme Court of The United States

ROBERT F. KENNEDY, JR., SECRETARY OF HEALTH

AND HUMAN SERVICES, et al.,

Petitioners,

BRAIDWOOD MANAGEMENT, INC., et al.,

Respondents.

ON WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

BRIEF OF AMICI CURIAE HIV AND

HEPATITIS POLICY INSTITUTE, ADAP

ADVOCACY ASSOCIATION, AIDS ALABAMA,

INC., et al., IN SUPPORT OF PETITIONERS

RICHARD H. HUGHES IV

Counsel of Record

SPREEHA CHOUDHURY

WILLIAM WALTERS

DEVON MINNICK

LORRIN MELANSON

EPSTEIN, BECKER & GREEN, P.C.

1227 25th Street, N.W., Suite 700

Washington, D.C. 20037

rhhughes@ebglaw.com

(202) 861-4186

(FOR ADDITIONAL AMICI, SEE INSIDE

COVER)

LEGAL PRINTERS LLC ! Washington, DC ! 202-747-2400 ! legalprinters.com

AMERICAN ACADEMY OF HIV MEDICINE,

CARING AMBASSADORS PROGRAM, INC.,

COMMUNITY ACCESS NATIONAL NETWORK,

COMMUNITY LIVER ALLIANCE, COMMUNITY

RESEARCH INITIATIVE OF NEW ENGLAND, INC.

d/b/a COMMUNITY RESOURCE INITIATIVE, FASTTRACK CITIES INSTITUTE, FRANNIE PEABODY

CENTER, GEORGIA AIDS COALITION, GLOBAL

LIVER INSTITUTE, HEP B UNITED, HEPATITIS B

FOUNDATION, HOUSING WORKS, INC.,

INTERNATIONAL ASSOCIATION OF PROVIDERS

OF AIDS CARE, LATINO COMMISSION ON AIDS,

NATIONAL MINORITY AIDS COUNCIL,

SEXUALITY INFORMATION AND EDUCATION

COUNCIL OF THE UNITED STATES d/b/a SIECUS,

AND VIVENT HEALTH

TABLE OF CONTENTS

TABLE OF AUTHORITIES ..................................iii

STATEMENT OF INTEREST OF AMICI

CURIAE................................................................ 1

SUMMARY OF ARGUMENT ................................. 3

ARGUMENT ............................................................. 4

HIV and Hepatitis Affect Millions of

Americans of All Demographics, and

Weakening Bipartisan Efforts to End Their

Transmission Will Have Catastrophic

Consequences................................................. 4

HIV Is a Public Health Crisis that

Transcends All Demographics and

Affects Millions of Americans.. .......... 7

Bipartisan Commitments Have

Driven Advancements in HIV

Screening,

Treatment,

and

Prevention and Continued Access

Is Essential to Sustain Progress. ..... 11

USPSTF-Recommended Screening

Is Essential for Prevention, Early

Detection and Timely Treatment of

Viral Hepatitis. ................................. 17

The Viability of the ACA

Framework Is Dependent on its

Preventive

Services

Coverage

Requirement. .................................... 20

II.

Task Force Members are Inferior Officers

Whose

Recommendations

Must

Approved by Principal Officers Under the

Affordable Care Act. .................................... 23

Task Force Members are Inferior

Officers Who Develop EvidenceBased Recommendations, Not

Policy. ................................................ 26

Under Longstanding U.S. Health

Insurance Law, Multiple Agencies

Determine

Coverage

Requirements.. .................................. 29

CONCLUSION ....................................................... 36

TABLE

CONTENTS

FOR

APPENDIX ........................................................ 1A

APPENDIX ............................................................. 2A

TABLE OF AUTHORITIES

Page(s)

Cases

Edmond v. United States,

520 U.S. 651 (1997) ........................................... 26

Morrison v. Olson,

487 U.S. 654 (1988) ........................................... 24

Nat’l Fed’n of Indep. Bus. v. Sebelius,

567 U.S. 519 (2012) ........................................... 20

Statutes and Regulations

75 Fed. Reg. 41726 (July 19, 2010)................... 30-31

80 Fed. Reg. 41318 (July 14, 2015)........................ 30

26 CFR § 54.9815-2713 ............................... 30, 32-33

29 CFR § 2590.715-2713.. ........................... 30, 32-33

45 CFR § 147.130 ........................................ 30, 32-33

26 U.S.C. § 9815 ..................................................... 30

29 U.S.C. § 1185d ................................................... 30

42 U.S.C. § 299b-4(a)(6) ......................................... 36

42 U.S.C. §§ 300gg, et seq. ................................ 29-30

iii

Other Authorities

A. Blythe Ryerson, et al., Vital Signs: Newly

Reported Acute and Chronic Hepatitis Cases –

United States, 2009-2018,

69 MMWR 399 (2020) ......................................... 6

A. David Paltiel, et al., Increased HIV Transmissions

with Reduced Insurance Coverage for HIV PreExposure Prophylaxis: Potential Consequences of

Braidwood Management v. Becerra 4

(Oxford Univ. Press 2023) ................................ 22

A Timeline of HIV and AIDS: 1982,

HIV.GOV, https://tinyurl.com/4sfcxhmx (last

accessed Feb. 24, 2025) ....................................... 8

Affordable Care Act Implementation FAQs – Set 2,

CMS (Sept. 10, 2024),

https://tinyurl.com/mucs47zd ........................... 33

Affordable Care Act Implementation FAQs – Set 12,

CMS (Sept. 10, 2024),

https://tinyurl.com/y48mz7ep ........................... 33

Affordable Care Act Implementation FAQs – Set 18,

CMS (Sept. 10, 2024),

https://tinyurl.com/34b6cn3f ............................ 33

Affordable Care Act Implementation FAQs – Set 19,

CMS (Sept. 10, 2024),

https://tinyurl.com/yc6t5xba............................. 34

Affordable Care Act Implementation FAQs – Set 26,

CMS (Sept. 10, 2024),

https://tinyurl.com/3urzx3ux ............................ 34

Affordable Care Act Implementation FAQs – Set 29,

CMS (Sept. 10, 2024),

https://tinyurl.com/4yby9hbp ........................... 34

Affordable Care Act Implementation FAQs – Set 34,

CMS (Sept. 10, 2024),

https://tinyurl.com/u636bxwu .......................... 34

Affordable Care Act Implementation FAQs – Set 35,

CMS (Sept. 10, 2024),

https://tinyurl.com/ju8vksj5 ............................. 34

Affordable Care Act Implementation FAQs – Set 47,

CMS (Sept. 10, 2024),

https://tinyurl.com/5yafja7a ............................. 35

Affordable Care Act Implementation FAQs – Set 50,

CMS (Sept. 10, 2024),

https://tinyurl.com/52u7s678............................ 35

AIDS-Defining Illnesses,

MERCK MANUAL, https://tinyurl.com/5fnnmu2j

(last visited Feb. 24, 2025) ................................. 8

Brian Schilling, Hitting the Copay Sweet Spot,

THE COMMONWEALTH FUND,

https://tinyurl.com/ywuh826f (last visited Feb. 24,

2025) .................................................................. 21

CDC, A Cluster of Kaposi’s Sarcoma and

Pneumocystis carinii Pneumonia Among

Homosexual Male Residents of Los Angeles and

range [sic] Counties, California,

31 MMWR 305 (1982) ......................................... 7

CDC, Current Trends Mortality Attributable to HIV

Infection/AIDS – United States, 1981-1990,

40 MMWR 41 (1991) ........................................... 8

CDC, Reversing the Rise in STIs: Integrating

Services to Address the Syndemic of STIs, HIV,

Substance Use, and Viral Hepatitis,

(Mar. 22, 2023), https://tinyurl.com/ywkrvsjs . 13

CDC, Update: Acquired Immunodeficiency Syndrome

(AIDS) in Persons with Hemophilia,

33 MMWR 589 (1984) ......................................... 9

Charts,

CDC, https://tinyurl.com/yp25hsb4 (last visited

Feb. 24, 2025) .................................................... 16

Christian Trepo, A Brief History of Hepatitis

Milestones,

34 LIVER INT’L 29 (2014) ................................... 18

Dan Morain, ‘It Was So Unnecessary’: S.F. Nun

Succumbs After Contracting AIDS from a Blood

Transfusion,

L.A. TIMES (Feb. 14, 1985),

https://tinyurl.com/w7k32t8w ....................... 9-10

David H. Spach, Hepatitis C Coinfection,

NAT’L HIV CURRICULUM (Feb. 3, 2025),

https://tinyurl.com/3whbwm2v......................... 19

Early HIV Diagnosis and Treatment Important for

Better Long-term Health Outcomes,

HIV.GOV (Nov. 2, 2022),

https://tinyurl.com/4z2mxdvm ......................... 23

Erin E. Conners, et al., Screening and Testing for

Hepatitis B Virus Infection: CDC

Recommendations – United States, 2023,

72 MMWR 1 (2023) ........................................... 18

FAQS About Affordable Care Act and Coronavirus

Aid, Relief, and Economic Security Act

Implementation Part 59,

CMS (Apr. 13, 2023),

https://tinyurl.com/32987zrk ............................ 35

FAQS About Affordable Care Act and Women’s

Health and Cancer Rights Act Implementation

Part 68,

CMS (Oct. 21, 2024),

https://tinyurl.com/3kftp5vp ............................. 35

FDA Approves First Injectable Treatment for HIV

Pre-Exposure Prevention,

FDA (Dec. 20, 2021),

https://tinyurl.com/327k34de ........................... 15

FDA-Approved HIV Medicines,

HIVINFO.NIH.GOV (July 31, 2024),

https://tinyurl.com/3yspja69 ............................. 14

Gilead’s Twice-Yearly Lenacapavir Demonstrated

100% Efficacy and Superiority to Daily Truvada

for HIV Prevention,

GILEAD (June 20, 2024),

https://tinyurl.com/ycycb5ck ............................. 15

vii

Gregory Curfman & Kirsten Bibbins-Domingo, US

Preventive Services Task Force Challenged in

Federal Court,

329 JAMA 1743 (2023) ................................ 27-28

Guide to Clinical Preventive Services,

USPSTF (1996) ................................................. 26

Guide to Clinical Preventive Services: An Assessment

of the Effectiveness of 169 Interventions,

USPSTF (1989) ................................................. 26

Hans L. Tillmann, Antiviral Therapy and Resistance

with Hepatitis B Virus Infection,

13 WORLD J. GASTROENTEROLOGY 125 (2007) .. 18

Hepatitis B Surveillance,

CDC (Apr. 4, 2024),

https://tinyurl.com/msnj6nav ............................. 6

Hepatitis C Virus Infection in Adolescents and

Adults: Screening,

USPSTF (Mar. 2, 2020),

https://tinyurl.com/52zdsc69 ............................ 19

Hepatitis C Surveillance,

CDC (Apr. 4, 2024),

https://tinyurl.com/6rspxpy4 .............................. 6

HHS, VIRAL HEPATITIS: NATIONAL STRATEGIC PLAN 1

(2020), https://tinyurl.com/3mrtejzw.................. 6

HIV Care Continuum,

HIV.GOV (Oct. 27, 2022),

https://tinyurl.com/mr24sbz6 ........................... 12

viii

HIV Declines Among Young People and Drives

Overall Decrease in New HIV Infections,

CDC (May 23, 2023),

https://tinyurl.com/3fh55vut....................... 13-14

HIV Testing,

HIVINFO.NIH.GOV (May 24, 2024),

https://tinyurl.com/3pxdd9yw........................... 13

HIV Testing in the United States,

KAISER FAM. FOUND. (June 24, 2022),

https://tinyurl.com/bd9pfumc ........................... 13

Human Immunodeficiency Virus (HIV) Infection:

Screening, 1996,

USPSTF (Jan. 1, 1996),

https://tinyurl.com/43rb6muy...................... 12-13

Jacqueline Ortiz, Silence from the Great

Communicator: The Early Years of the AIDS

Epidemic Under the Reagan Administration,

4 SWARTHMORE UNDERGRADUATE HIST. J. 76

(2023) ................................................................... 8

Lisa A. Eaton, et al., Stigma and Conspiracy Beliefs

Related to Pre-exposure Prophylaxis (PrEP) and

Interest in Using PrEP Among Black and White

Men and Transgender Women Who Have Sex with

Men,

21 AIDS BEHAV. 1236 (2017) ............................ 10

Lorraine T. Dean, et al., Estimating the Impact of

Out-of-Pocket Cost Changes on Abandonment of

HIV Pre-Exposure Prophylaxis,

43 HEALTH AFFAIRS 36 (2024) .......................... 21

M.S. Gottlieb, et al., Pneumocystis Pneumonia – Los

Angeles,

30 MMWR 250 (1981) ......................................... 7

National HIV Prevention and Care Outcomes,

CDC (Feb. 7, 2025),

https://tinyurl.com/2cd3awp4 .......................... 13

Nicole Crepaz, et al., Examination of HIV Infection

Through Heterosexual Contact with Partners Who

Are Known to be HIV Infected in the United

States, 2010–2015,

31 AIDS 1641 (2017) ........................................ 10

Patrick Sullivan, et al., Association of State-Level

PrEP Coverage and State-Level HIV Diagnoses,

US, 2012-2021,

CONF. ON RETROVIRUSES AND OPPORTUNISTIC

INFECTIONS, https://tinyurl.com/53u55zb9 (last

accessed Feb. 24, 2025) ..................................... 16

Pre-Exposure Prophylaxis,

HIV.GOV (Feb. 7, 2025),

https://tinyurl.com/y2v499un ...................... 14-15

Preventing Perinatal Transmission of HIV,

HIV.GOV (Feb. 13, 2025),

https://tinyurl.com/yc56s975 ............................ 10

Prevention of Human Immunodeficiency Virus (HIV)

Infection: Preexposure Prophylaxis,

USPSTF (June 11, 2019),

https://tinyurl.com/4r9k78jv ............................. 16

Procedure Manual,

USPSTF (Apr. 2023),

https://tinyurl.com/2mmfc98v .......................... 25

Reducing New HIV Infections,

HIV.GOV (Jan. 31, 2025),

https://tinyurl.com/3udk2cuj ...................... 14, 17

Richard Stevenson, BASKETBALL; Magic Johnson

Ends His Career, Saying He Has AIDS Infection,

N.Y. TIMES (Nov. 8, 1991),

https://tinyurl.com/5n6jtbad ............................. 10

Rob Stein & Dan Eggen, White House Backs Off

Cancer Test Guidelines,

WASH. POST (Nov. 19, 2009),

https://tinyurl.com/3c8h8zue ....................... 26-27

Sabrina Corlette, et al., The ACA’s Effect on the

Individual Insurance Market,

39 HEALTH AFFAIRS 436 (2020) ........................ 20

Sagar Kumar, et al., Reviewing PrEP’s Effect on STI

Incidence Among Men Who Have sex with MenBalancing Increased STI Screening and Potential

Behavioral Sexual Risk Compensation,

25 AIDS BEHAV. 1810 (2021) ............................ 12

Said A. Al-Busafi & Ahmed Alwassief, Global

Perspectives on the Hepatitis B Vaccination:

Challenges, Achievements, and the Road to

Elimination by 2030,

12 VACCINES 1 (2024) ................................... 17-18

Task Force Recommendations Development Process:

A Graphic Overview,

USPSTF (May 2021),

https://www.tinyurl.com/zs3a7wfv ................... 28

The Associated Press, Jon Hinson, 53, Congressman

and Then Gay-Rights Advocate,

N.Y. TIMES (July 26, 1995),

https://tinyurl.com/4hadeex9 .............................. 9

The HIV/AIDS Epidemic in the United States: The

Basics,

KAISER FAM. FOUND. (Aug. 16, 2024),

https://tinyurl.com/556bahnt ....................... 4-5, 7

Thessaly La Force, Those We Lost to the AIDS

Epidemic,

N.Y. TIMES STYLE MAG. (Apr. 14, 2018),

https://tinyurl.com/2bm2euwp ........................... 9

U.S. Preventive Servs. Task Force, Preexposure

Prohylaxis to Prevent Acquisition of HIV,

330 JAMA 736 (2023) .................................. 15-16

U.S. Statistics,

HIV.GOV (Feb. 14, 2025),

https://tinyurl.com/y5ycs3t8 ........................ 10-11

Viral Hepatitis Basics,

CDC (July 30, 2024),

https://tinyurl.com/f7x2abrm....................... 17-18

What is an Opportunistic Infection?,

HIV.GOV (Aug. 16, 2021),

https://tinyurl.com/4m2pd9ap ............................ 7

xii

Who Was Ryan White?,

HRSA (Feb. 2022),

https://tinyurl.com/4zexpkm8............................. 9

Zihao Li, et al., Vital Signs: HIV Transmission Along

the Continuum of Care—United States, 2016,

68 MMWR 267 (2019) ....................................... 12

xiii

STATEMENT OF INTEREST OF AMICI

CURIAE

Amicus Curiae HIV and Hepatitis Policy

Institute is a non-profit advocacy organization

committed to advancing policies that support the

prevention

and

treatment

human

immunodeficiency

virus

(“HIV”),

acquired

immunodeficiency syndrome (“AIDS”), viral hepatitis

and other health conditions. The Institute actively

monitors policy developments that affect healthcare

access, ensuring that individuals and communities

affected by HIV and hepatitis are informed and

engaged in discussions about policies impacting their

well-being. Through education and advocacy, the

organization works to inform policymakers and the

media about efforts to end HIV and hepatitis in the

United States while striving to improve access to

high-quality, affordable healthcare for individuals

living with or at risk of serious or chronic conditions.

Additionally, the Institute focuses on securing

necessary funding, promoting effective programs and

shaping policies that drive meaningful progress in the

fight against HIV and viral hepatitis. 1 The 19 other

amici, listed in Appendix A, are organizations that

work globally, nationally, regionally, state-wide and

locally towards the elimination of HIV and/or viral

hepatitis by providing or advocating for HIV testing,

1 No counsel for a party authored this brief in whole or in part,

and no such counsel or party made a monetary contribution

intended to fund the preparation or submission of this brief. No

person other than amici curiae or their counsel made a monetary

contribution to this brief’s preparation or submission.

hepatitis B & C testing and/or HIV pre-exposure

prophylaxis (PrEP) and advocating on behalf of people

and communities affected by HIV and viral hepatitis.

All share an interest in the provision of HIV and

hepatitis preventive services affected by this case,

including PrEP.

As such, amicus HIV and Hepatitis Policy

Institute, together with these 19 other amici, have a

crucial interest in maintaining patient access to

clinical interventions that facilitate prevention and

early detection of HIV, viral hepatitis and other

health conditions.

SUMMARY OF ARGUMENT

The United States Preventive Services Task

Force (“Task Force”) and its recommendations have

been essential to the prevention of HIV, hepatitis and

many other infectious and chronic diseases for

millions of Americans. After the passage of the

Affordable Care Act (“ACA”), Task Force’s

recommendations became a critical first step in

ensuring effective interventions are covered by health

insurance. A wholesale invalidation of the coverage

requirement for Task Force’s recommendations would

strike a critical, unnecessary and costly blow to the

battle to end HIV, hepatitis and other infectious

diseases.

This brief details the impact of HIV and

hepatitis in the U.S., emphasizing that these are

infectious diseases spread by viruses which can and

will spread to any person unless prevented from doing

so. Removing access to evidence-based preventive

measures will have a devastating impact, not only on

those at risk for acquiring HIV and hepatitis, but also

the population at-large.

We then contend that the Fifth Circuit’s

decision relied on a fundamental misreading of the

Task Force’s enabling statute and a lack of

understanding of how the executive branch has

already carried out its oversight function over the

recommendations of the Task Force. If properly

understood, the Fifth Circuit could not have found

that the members of the Task Force were principal

officers in violation of the Appointments Clause. They

are, in fact, inferior officers whose independence is

solely limited to the evidence-based process by which

they make their recommendations. For these reasons,

we urge this Court to reverse the lower court’s

decisions

invalidating

Task

Force’s

recommendations.

ARGUMENT

HIV and Hepatitis Affect Millions of

Americans of All Demographics, and

Weakening Bipartisan Efforts to End

Their Transmission Will Have

Catastrophic Consequences.

The fight against HIV/AIDS is one of the most

significant public health battles of the modern era.

For decades, false assumptions about how the virus

spread and who was at risk impeded efforts to prevent

transmission and provide treatment. The devastating

toll of this delay is evident in the 700,000 American

lives lost and the 1.2 million people still living with

HIV. The HIV/AIDS Epidemic in the United States:

The Basics, KAISER FAM. FOUND. (Aug. 16, 2024),

https://tinyurl.com/556bahnt.

Both Republican and Democratic presidential

administrations and Congresses have prioritized HIV

prevention, treatment and research through decades

of bipartisan efforts. These collective efforts have

produced scientific advancements in screening,

treatment and prevention of this disease and

simultaneously expanded access to the same.

These advancements have fundamentally

changed the trajectory of HIV, with the evolution of

routine screening to enable early detection to the

advent of pre-exposure prophylaxis (PrEP) which

promises nearly 100% effectiveness in the prevention

of HIV and is the central object of Respondents’

complaint. Today, we are closer than ever to ending

HIV’s painful 44-year ordeal.

The Patient Protection and Affordable Care Act

(“ACA”) requires that insurers cover Task Forcerecommended preventive services without costsharing. The Task Force, which has existed since

1984, made evidence-based preventive care

recommendations before the enactment of the ACA.

Congress

incorporated

the

Task

Force’s

recommendations into the ACA to ensure essential

preventive services were covered. This requirement

assures access to HIV screening and PrEP for millions

of Americans at risk of acquiring HIV. Stripping away

this access will undermine the decades-long,

bipartisan fight against the epidemic.

Today, while HIV is at its lowest ebb in the

United States, there still are 32,000 new

transmissions and 13,000 deaths annually. Id. This is

unacceptable in our modern era. Without continued

access to the no-cost prevention assured under the

ACA and consequent new transmissions, our nation

will witness a reversal of decades of progress as HIV

resurges.

Viral hepatitis stands alongside HIV/AIDS as

one of our nation’s most critical and under-addressed

public health challenges. Historical misconceptions

about transmission routes and affected populations

have significantly impeded prevention and treatment

efforts, resulting in approximately 3.3 million

Americans living with chronic hepatitis B or C. HHS,

VIRAL HEPATITIS: NATIONAL STRATEGIC PLAN 1 (2020),

https://tinyurl.com/3mrtejzw. While implementation

of the bipartisan Viral Hepatitis National Strategic

Plan has driven meaningful progress, hepatitis B

(“HBV”) and hepatitis C (“HCV”) still claim roughly

14,500 American lives each year. Hepatitis B

Surveillance,

CDC

(Apr.

2024),

https://tinyurl.com/msnj6nav;

Hepatitis

Surveillance,

CDC

(Apr.

2024),

https://tinyurl.com/6rspxpy4.

The

scientific

community has achieved remarkable breakthroughs,

developing curative treatments for hepatitis C and a

highly effective vaccine and treatment for hepatitis B.

HHS, VIRAL HEPATITIS: NATIONAL STRATEGIC PLAN 1

(2020), https://tinyurl.com/3mrtejzw.

The ACA’s preventive services coverage

requirement has dramatically expanded access to

hepatitis screening and vaccination. Early diagnosis

through screening is crucial, given that new hepatitis

C infections have nearly tripled in the past decade. A.

Blythe Ryerson, et al., Vital Signs: Newly Reported

Acute and Chronic Hepatitis Cases – United States,

2009-2018, 69 MMWR 399 (2020). Removing these

coverage guarantees would severely compromise

efforts to eliminate viral hepatitis as a public health

threat.

HIV Is a Public Health Crisis that

Transcends All Demographics and

Affects Millions of Americans.

More than 700,000 lives have been lost to

HIV/AIDS and 1.2 million people are living with HIV

in the United States, highlighting that the fight

against the disease is one of the most significant

public health battles of the modern era. The

HIV/AIDS Epidemic in the United States: The Basics,

FAM.

FOUND.

(Aug.

16,

2024),

KAISER

https://tinyurl.com/556bahnt.

For

years,

false

assumptions about how the virus spread and who was

at risk impeded efforts to prevent transmission and

provide treatment.

First identified in 1981, HIV initially appeared

in a cluster of patients experiencing rare diseases

such as pneumocystis pneumonia and Kaposi’s

sarcoma. M.S. Gottlieb, et al., Pneumocystis

Pneumonia - Los Angeles, 30 MMWR 250, 250 (1981);

CDC, A Cluster of Kaposi's Sarcoma and

Pneumocystis carinii Pneumonia Among Homosexual

Male Residents of Los Angeles and range [sic]

Counties, California, 31 MMWR 305, 305 (1982).

These were the consequences of opportunistic

infections that were attacking the patients’ immune

systems. 2 Before it was well understood, the virus

2 Opportunistic infections are illnesses that occur more

frequently or become more severe in people with HIV due to their

weakened immune systems. What is an Opportunistic Infection?,

HIV.GOV (Aug. 16, 2021), https://https://tinyurl.com/4m2pd9ap.

spread uncontrollably. Jacqueline Ortiz, Silence from

the Great Communicator: The Early Years of the AIDS

Epidemic Under the Reagan Administration, 4

SWARTHMORE UNDERGRADUATE HIST. J. 76, 81 (2023).

Early attempts at treatment were ineffective and

death was an inevitability for its sufferers. Within the

first ten years of the epidemic, HIV/AIDS was

transmitted to one million people and claimed over

100,000 lives. CDC, Current Trends Mortality

Attributable to HIV Infection/AIDS -- United States,

1981-1990, 40 MMWR 41, 41 (1991).

In the early days of the epidemic, HIV was

unfortunately

termed

“Gay-Related

Immune

Deficiency” (“GRID”), creating a misconception that

HIV was confined to the gay community and that

sexual orientation was a root cause. A Timeline of HIV

and

AIDS:

1982,

HIV.GOV,

https://tinyurl.com/4sfcxhmx (last accessed Feb. 24,

2025). This misclassification obscured the reality that

HIV can infect anyone, regardless of sexual

orientation. This framing established a lasting

connection between people living with HIV and other

stigmatized populations, which continues to hinder

efforts to expand testing, prevention and treatment

against the virus.

As more HIV/AIDS cases surfaced—especially

among hemophiliacs, infants and women—it became

clearer that HIV was a public health crisis affecting a

See

AIDS-Defining

Illnesses,

MERCK

MANUAL,

https://tinyurl.com/5fnnmu2j (last visited Feb. 24, 2025).

broad swath of society. Indeed, the disease we would

come to term HIV/AIDS would choose casualties of all

genders, sexual orientations, ages, races, religions

and political persuasions. It has taken the lives of

authors, poets, actors, doctors, nurses, elected

officials, lawyers and judges. Thessaly La Force,

Those We Lost to the AIDS Epidemic, N.Y. TIMES

STYLE

MAG.

(Apr.

14,

2018),

https://tinyurl.com/2bm2euwp; The Associated Press,

Jon Hinson, 53, Congressman and Then Gay-Rights

Advocate,

N.Y.

TIMES

(July

26,

1995),

https://tinyurl.com/4hadeex9.

Hemophiliacs were among the hardest hit, as

many received contaminated blood through regular

transfusions before the threat was fully understood.

CDC, Update: Acquired Immunodeficiency Syndrome

(AIDS) in Persons with Hemophilia, 33 MMWR 589,

589 (1984), https://tinyurl.com/3aba6bbn. The most

prominent of these victims was Ryan White, a

teenager from Indiana who became a national symbol

for HIV/AIDS awareness. Who Was Ryan White?,

HRSA (Feb. 2022), https://tinyurl.com/4zexpkm8.

Diagnosed at age 13 in 1984, he fought against

discrimination after being barred from school. Id. His

struggle helped shift public perception and paved the

way for national policies to provide critical medical

support to people living with HIV. Id.

Other stories—from a Catholic nun who

became infected after a surgery to high-profile figures

like NBA star Magic Johnson, who publicly disclosed

his HIV diagnosis in 1991—further shattered the

myth that HIV was limited to certain communities.

Dan Morain, ‘It Was So Unnecessary’: S.F. Nun

Succumbs After Contracting AIDS from a Blood

Transfusion,

L.A. TIMES

(Feb.

14,

1985),

https://tinyurl.com/w7k32t8w; Richard Stevenson,

BASKETBALL; Magic Johnson Ends His Career,

Saying He Has AIDS Infection, N.Y. TIMES (Nov. 8,

1991), https://tinyurl.com/5n6jtbad.

The misconception that HIV transmission is

confined to certain “high-risk” activities is not only

flawed but dangerously misleading, failing to

recognize the virus’s ability to affect Americans across

all demographics. Lisa A. Eaton, et al., Stigma and

Conspiracy

Beliefs

Pre-exposure

Prophylaxis (PrEP) and Interest in Using PrEP

Among Black and White Men and Transgender

Women Who Have Sex with Men, 21 AIDS BEHAV.

1236, 1244 (2017). The Respondents’ claims

perpetuate a fundamental misunderstanding of HIV

transmission. Despite their contentions, HIV

transmission can occur in heterosexual marriages,

and it can spread from mother to child during

pregnancy, childbirth or breastfeeding. Nicole

Crepaz, et al., Examination of HIV Infection Through

Heterosexual Contact with Partners Who Are Known

to be HIV Infected in the United States, 2010–2015, 31

AIDS 1641, 1642 (2017); Preventing Perinatal

Transmission of HIV, HIV.GOV (Feb. 13, 2025),

https://tinyurl.com/yc56s975. HIV continues to affect

a broad spectrum of Americans, including young

people and heterosexual women and men who never

considered themselves as “at risk.” In 2022, young

people aged 13 to 24 made up 20% of new infections,

while heterosexual women accounted for about 15% of

new HIV diagnoses in the U.S. U.S. Statistics,

(Feb.

14,

2025),

HIV.GOV

https://tinyurl.com/y5ycs3t8. That same year,

heterosexual men accounted for 6% of new HIV

transmissions—approximately 2,100 cases. Id.

Bipartisan

Commitments

Have

Driven Advancements in HIV

Screening,

Treatment

and

Prevention and Continued Access Is

Essential to Sustain Progress.

HIV prevention and treatment have long been

bipartisan priorities in the United States, with

federal initiatives spanning multiple administrations

and Congresses. These initiatives began in the Ronald

Reagan administration and have continued and

expanded in scope.

The Ryan White CARE Act, signed by

President George H.W. Bush, established the largest

federally funded program for low-income Americans

with HIV. President Bill Clinton’s administration

continued to expand federal initiatives related to

HIV/AIDS-related research. President George W.

Bush launched PEPFAR in 2003, the largest singlenation commitment to fighting HIV globally. The

National HIV/AIDS Strategy, first developed under

President Barack Obama, continued under

subsequent administrations. In 2019, President

Donald J. Trump launched the Ending the HIV

Epidemic (“EHE”) initiative. In 2023, Congress

reenacted PEPFAR. Under President Trump’s second

term, Secretary of State Marco Rubio upheld access to

HIV care globally. Most recently, Secretary of Health

and Human Services Robert F. Kennedy Jr. pledged

continued support for HIV prevention, including

PrEP, and treatment, reinforcing the bipartisan

commitment to ending the epidemic.

Taken together, these efforts underscore a

longstanding tradition of bipartisan cooperation to

combat HIV/AIDS, ensuring that prevention, testing,

treatment and support services remain a national

priority.

In the 44 years since HIV was identified, nearmiraculous

scientific

advancements

have

dramatically reduced deaths, symptom severity and

transmission associated with HIV/AIDS. Today, HIV

screening, treatment and prevention form a

continuum of care. HIV Care Continuum, HIV.GOV

(Oct.

27,

2022),

https://tinyurl.com/mr24sbz6.

Comprehensive access to all parts of the continuum is

essential to reducing HIV transmission—screening

ensures HIV is detected as early as possible;

treatment suppresses HIV infection to reduce risk of

onward transmission; and PrEP lowers the risk of

acquiring HIV. Zihao Li, et al., Vital Signs: HIV

Transmission Along the Continuum of Care—United

States, 2016, 68 MMWR 267, 269 (2019); Sagar

Kumar, et al., Reviewing PrEP’s Effect on STI

Incidence Among Men Who Have Sex with Men—

Balancing Increased STI Screening and Potential

Behavioral Sexual Risk Compensation, 25 AIDS

BEHAV. 1810, 1810 (2021).

Recognizing the importance of early detection,

the Task Force recommended HIV screening for atrisk groups, including pregnant women, in 1996.

Human Immunodeficiency Virus (HIV) Infection:

Screening, 1996, USPSTF (Jan. 1, 1996),

https://tinyurl.com/43rb6muy. In 2013, it expanded

screening to all individuals aged 15 to 65 and those at

higher risk, ensuring health plan coverage and

broader access to testing. Screening is the only way to

confirm HIV status, and, therefore, the essential

gateway to treatment and long-term health. Without

it, individuals cannot access life-saving antiretroviral

therapy or take prophylactic medication to prevent

transmission. Among those who do get tested and

receive a positive diagnosis, 80% are connected to care

within one month. National HIV Prevention and Care

Outcomes,

CDC

(Feb.

2025),

https://tinyurl.com/2cd3awp4.

Regular testing is essential for early diagnosis,

as undiagnosed individuals are more likely to

transmit HIV. HIV Testing, HIVINFO.NIH.GOV (May

24, 2024), https://tinyurl.com/3pxdd9yw. Studies

show that those aware of their HIV-positive status

take proactive steps to prevent further transmission

of the virus. HIV Testing in the United States, KAISER

FAM.

FOUND.

(June

24,

2022),

https://tinyurl.com/bd9pfumc. Screening of sexually

transmitted infections is also mutually beneficial in

the prevention of HIV. A person with a sexually

transmitted infection is up to five times more likely to

acquire HIV and is at increased risk of transmitting

HIV to others. CDC, Reversing the Rise in STIs:

Integrating Services to Address the Syndemic of STIs,

HIV, Substance Use, and Viral Hepatitis (Mar. 22,

2023), https://tinyurl.com/ywkrvsjs.

Despite the Task Force’s recommendations and

strengthened health insurance coverage of screening,

13% of people with HIV remain undiagnosed. HIV

Declines Among Young People and Drives Overall

Decrease in New HIV Infections, CDC (May 23, 2023),

https://tinyurl.com/3fh55vut.

Should this Court remove the requirement that

health insurance cover Task Force-recommended HIV

screening, the number of undiagnosed individuals—

who will not know to seek treatment and will,

therefore, unknowingly transmit the virus—will

inevitably increase.

While there is still no cure for HIV, the path to

today’s highly effective treatments and preventive

interventions has been marked by decades of steady,

incremental progress. Id. Advancements in HIV

treatment paved the way for revolutionary methods

for preventing the infection altogether. Today, there

are more than fifty approved HIV medications and

three approved PrEP products, with several more in

the drug development pipeline. FDA-Approved HIV

Medicines, HIVINFO.NIH.GOV (July 31, 2024),

https://tinyurl.com/3yspja69;

Pre-Exposure

Prophylaxis,

HIV.GOV

(Feb.

2025),

https://tinyurl.com/y2v499un.

The realization that viral suppression could

prevent

onward

transmission

sparked

the

prophylactic use of ART for HIV-negative individuals

to preempt infection altogether. Known as PrEP, this

has become one of the most effective and widely

accepted tools for HIV prevention, making HIV more

preventable than ever before. Reducing New HIV

Infections,

HIV.GOV

(Jan.

31,

2025),

https://tinyurl.com/3udk2cuj.

Since FDA approval of the first daily oral PrEP

regimen in 2012, the range of available PrEP delivery

methods has expanded. Building on the success of the

daily oral pill, the FDA recently approved a longacting injectable option administered every eight

weeks. FDA Approves First Injectable Treatment for

HIV Pre-Exposure Prevention, FDA (Dec. 20, 2021),

https://tinyurl.com/327k34de. PrEP’s effectiveness is

deeply tied to adherence: when taken as prescribed,

PrEP is nearly guaranteed to prevent HIV, reducing

the risk of acquiring the virus by 99%. Pre-Exposure

Prophylaxis,

HIV.GOV

(Feb.

2025),

https://tinyurl.com/y2v499un.

Therefore,

eliminating the need for daily adherence, injectable

PrEP provides longer-lasting protection, reducing the

risk of missed doses and enhancing overall

effectiveness in preventing HIV transmission.

Emerging options like lenacapavir, a twice-yearly

injectable currently pending approval at the FDA,

have shown 100% effectiveness in preventing HIV,

signaling a promising future for even more durable

and accessible prevention methods—should access to

PrEP remain unfettered. Gilead’s Twice-Yearly

Lenacapavir Demonstrated 100% Efficacy and

Superiority to Daily Truvada for HIV Prevention,

GILEAD (June 20, 2024), https://tinyurl.com/ycycb5ck.

Seven years after the first FDA approval of PrEP, the

Task Force issued its highest endorsement for oral

PrEP in 2019, awarding a Grade A recommendation

for the intervention. U.S. Preventive Servs. Task

Force, Preexposure Prophylaxis to Prevent Acquisition

of HIV, 330 JAMA 736, 736 (2023). The

recommendation was for individuals at increased

risk, including men who have sex with men,

heterosexually active men and women and others

based on specific risk factors. Id. As awareness and

access expanded, PrEP usage increased significantly,

with approximately 31.4% of those recommended for

PrEP receiving a prescription in 2022—up from just

2015.

Charts,

CDC,

https://tinyurl.com/yp25hsb4 (last visited Feb. 24,

2025).

In 2023, the Task Force reaffirmed its support

for PrEP, expanding its recommendation to include

new options, specifically the injectable form.

Prevention of Human Immunodeficiency Virus (HIV)

Infection: Preexposure Prophylaxis, USPSTF (June

11, 2019), https://tinyurl.com/4r9k78jv.

PrEP not only prevents individual infections

but also helps curb the spread of HIV at a population

level. The widespread adoption of PrEP has already

had a significant impact on reducing HIV

transmission and overall incidence rates. Patrick

Sullivan, et al., Association of State-Level PrEP

Coverage and State-Level HIV Diagnoses, US, 20122021, CONF. ON RETROVIRUSES AND OPPORTUNISTIC

INFECTIONS,

https://tinyurl.com/53u55zb9

(last

accessed Feb. 24, 2025). Studies have shown that in

communities with high PrEP uptake, new HIV

diagnoses have declined substantially. Id.

With continued PrEP innovation—enhancing

adherence and further reducing HIV transmission—

alongside continued access to all forms of PrEP, this

intervention has brought the goal of ending the

epidemic within reach. According to CDC data, if 50%

of eligible individuals used PrEP, as envisioned by the

EHE initiative, HIV incidence could be reduced by

half by 2030. Reducing New HIV Infections, HIV.GOV

(Jan. 31, 2025), https://tinyurl.com/3udk2cuj.

USPSTF-Recommended Screening

Is Essential for Prevention, Early

Detection and Timely Treatment of

Viral Hepatitis.

Hepatitis B (HBV) and Hepatitis C (HCV) offer

parallel examples of how public health efforts—

including widespread screening—can successfully

control the transmission of a life-threatening

infectious disease. Hepatitis, an inflammation of the

liver, affects Americans from all walks of life. Like

HIV, hepatitis affects individuals of all ages, genders

and ethnicities, though it disproportionately impacts

those with underlying health conditions. Viral

Hepatitis

Basics,

CDC

(July

30,

2024),

https://tinyurl.com/f7x2abrm. HBV and HCV are

leading causes of liver disease, affecting millions of

Americans and often remaining asymptomatic until

life-threatening complications, such as cirrhosis, liver

failure or cancer, arise. Id.

In the 1960s and 1970s, researchers began

distinguishing different strains of hepatitis. The

discovery of HBV, and identification of an HBV

antigen, paved the way for development of a safe and

effective HBV vaccine. Id. Widespread attention to

HBV in subsequent decades culminated in significant

declines in new infections among vaccinated

populations. Said A. Al-Busafi & Ahmed Alwassief,

Global Perspectives on the Hepatitis B Vaccination:

Challenges, Achievements, and the Road to

Elimination by 2030, 12 VACCINES 1, 17 (2024).

Screening plays a crucial role in identifying

individuals with HBV, enabling early intervention

and access to treatment. Erin E. Conners, et al.,

Screening and Testing for Hepatitis B Virus Infection:

CDC Recommendations — United States, 2023, 72

MMWR 1,1 (2023). While there is no cure for HBV,

antiviral therapies can help suppress the virus,

reduce liver damage and lower the risk of

transmission. Hans L. Tillmann, Antiviral Therapy

and Resistance with Hepatitis B Virus Infection, 13

WORLD J. GASTROENTEROL 125, 126 (2007). Building

on this earlier research, HCV was discovered in 1989.

Christian Trepo, A Brief History of Hepatitis

Milestones, 34 LIVER INT’L 29, 29 (2014).

Initially, few treatment options existed, and

many individuals infected with the virus were

diagnosed only after considerable liver damage had

already occurred. Advances in screening technology

and more effective therapies in the 1990s and 2000s

made it possible to detect hepatitis sooner and

manage its progression. By the 2010s, direct-acting

antiviral treatments for HCV emerged, offering cure

rates of approximately 95 percent when administered

early, a remarkable achievement that transformed

the clinical outlook for HCV-infected patients. Viral

Hepatitis

Basics,

CDC

(July

30,

2024),

https://tinyurl.com/f7x2abrm. While a vaccine exists

for HBV, there is no vaccine to prevent HCV, making

early detection and treatment the only effective

means of preventing its devastating complications.

Despite these advancements, as of 2020,

approximately 880,000 U.S. adults are living with

chronic HBV, and an estimated 14,000 new infections

occur each year. Id. Since 2012, HCV has led to more

deaths than all other reportable infectious diseases

(except COVID-19) combined. Approximately 15-30%

of individuals living with HIV in the United States

are co-infected with HCV. David H. Spach, Hepatitis

C Coinfection, NAT’L HIV CURRICULUM (Feb. 3, 2025),

https://tinyurl.com/3whbwm2v.

The Task Force recognizes the urgency of

addressing undiagnosed HCV infections and

recommends universal, one-time screening for all

adults aged 18 to 79, regardless of risk factors.

Hepatitis C Virus Infection in Adolescents and Adults:

Screening,

USPSTF

(Mar.

2020),

https://tinyurl.com/52zdsc69. Such broad screening is

critical given that almost 40% of people with HCV are

uninformed of their serostatus, meaning that

thousands of Americans remain undiagnosed,

vulnerable to severe liver disease and unknowingly

contribute to further transmission of the virus. Id.

The indispensable role of early detection

parallels the experience with HIV, where routine

testing has been essential to achieving significant

reductions in morbidity and mortality. For both HIV

and hepatitis, widespread screening, coupled with

prompt and appropriate therapeutic interventions,

not only saves lives but also yields significant cost

savings for both the health care system and affected

individuals.

The

Viability

the

ACA

Framework Is Dependent on Its

Preventive

Services

Coverage

Requirement.

Congress passed the ACA “in order to improve

health insurance markets.” Nat’l Fed’n of Indep. Bus.

v. Sebelius, 567 U.S. 519, 521-22 (2012). The ACA’s

structure has been referred to as a “three-legged

stool”: (1) the individual mandate and minimum

essential coverage; (2) guaranteed issue; and (3)

subsidies to ensure access. Sabrina Corlette, et al.,

The ACA’s Effect on the Individual Insurance Market,

39 HEALTH AFFAIRS 436, 437 (2020). The first leg of

the stool was intended to promote good health

outcomes and reduce health care costs by ensuring

that the vast majority of Americans receive high

quality health insurance that includes first-dollar

coverage of preventive care.

The ACA intended for the Task Force to

recommend those preventive services that were so

essential to the public’s health that they should be

available without cost-sharing for Americans with

insurance coverage. For example, under this

framework, the Task Force undertook a rigorous

evaluation of HIV testing, PrEP and hepatitis

preventive services, awarding Grade A and Grade B

ratings on such services and interventions.

Subsequent health insurer coverage has allowed for

Americans to access such services and interventions

without cost-sharing.

If the Court were to whittle away the first leg

of the ACA’s stool by voiding the only mechanism the

ACA has contemplated to mandate most preventive

services be available without cost-sharing, fewer

people will have access to preventive services,

including PrEP and screenings for HIV and hepatitis.

This will undermine the ACA’s strategy to balance

risk pools by ensuring a floor of covered benefits and

a strengthened primary care ecosystem. It would

uproot the intentional design of the ACA and may

begin to destabilize the insurance market, as plans’

risk pools will be sicker, and, therefore, costlier.

Stripping the Task Force of its role will result

in dire consequences for the insurance market and

also for public health. The first-dollar coverage of

preventive services is imperative in promoting access

to PrEP and screenings for HIV and hepatitis. When

patients are forced to bear the cost of preventive

services, they are less likely to utilize such services;

in fact, research has demonstrated that a copayment

as low as $5 will lower utilization. Brian Schilling,

Hitting the Copay Sweet Spot, THE COMMONWEALTH

FUND, https://tinyurl.com/ywuh826f (last visited Feb.

24, 2025). Eliminating cost-free PrEP coverage

would also undermine decades of progress in HIV

prevention. Recent research underscores the

devastating consequences of introducing financial

barriers to essential preventive care. A 2024 study

found that even a small increase in out-of-pocket costs

from $0 to $10 doubled PrEP abandonment rates,

while costs exceeding $500 resulted in abandonment

rates of over 40%. Lorraine T. Dean, et al., Estimating

the Impact of Out-of-Pocket Cost Changes on

Abandonment of HIV Pre-Exposure Prophylaxis, 43

HEALTH AFFAIRS 36, 37 (2024). Alarmingly, HIV

diagnoses were two to three times higher among

individuals who abandoned PrEP prescriptions

compared to those who filled them. Another study

from the Yale School of Public Health, conducted in

response to the Fifth Circuit’s ruling in Braidwood,

estimates that for every 10% reduction in PrEP

coverage, the U.S. could see more than 1,100

additional HIV infections annually—a lower-bound

estimate given the limited study population. A. David

Paltiel, et al., Increased HIV Transmissions with

Reduced Insurance Coverage for HIV Pre-Exposure

Prophylaxis: Potential Consequences of Braidwood

Management v. Becerra 4 (Oxford Univ. Press 2023).

This data suggests that any rollback of mandatory

coverage will force some current PrEP users to

discontinue treatment, placing them at immediate

risk of acquiring or transmitting HIV.

Access to Task Force-recommended HIV and

hepatitis screening without cost-sharing is a critical

lifeline for all Americans. Full coverage of screening

enables individuals who might otherwise never

pursue testing to discover their serostatus early and

receive timely, effective treatment. Imposing cost

barriers would deter many from undergoing

screening, jeopardizing early detection and

undermining broader public health efforts to stop

transmission of these viruses. Rolling back these

measures would risk a resurgence of undetected

hepatitis

infections,

leading

increased

hospitalizations and costly liver transplants.

Similarly, full coverage of PrEP products

fosters continuous and widespread use of these lifesaving drugs, thereby enhancing its effectiveness and

reducing HIV transmission rates. Introducing out-of22

pocket costs for PrEP would undercut its widespread

use, affecting far more than individual health

outcomes. It would lead to a cascade of public health

challenges, such as delayed diagnoses, new infections

and the emergence of treatment-resistant strains,

that are difficult to reverse. Early HIV Diagnosis and

Treatment Important for Better Long-term Health

Outcomes,

HIV.GOV

(Nov.

2022),

https://tinyurl.com/4z2mxdvm.

Endorsing the Respondents’ misguided logic

and permitting the rollback of first-dollar PrEP

coverage would perpetuate the harmful stigma

associated with HIV and directly undermine

bipartisan public health efforts to combat these

diseases, triggering a significant backslide in our

country’s efforts to end the HIV epidemic, erasing

decades of progress and placing countless lives at

unnecessary risk.

II.

Task Force Members are Inferior

Officers Whose Recommendations

Must Be Approved by Principal

Officers Under the Affordable Care

Act.

The design of the ACA entails a two-part

process in order to execute the preventive services

coverage mandate: 1) that the independent Task

Force would use evidence-based criteria to determine

whether a preventive service met the clinical

threshold for a Grade A or Grade B rating and 2) that

federal agency officials make policy decisions

concerning insurance coverage requirements with

respect to Task Force recommendations.

This hierarchy establishes that principal

officers supervise the determination of insurance

coverage requirement. The Task Force takes no part

in the second step, rendering it no more than a

collection of inferior officers for constitutional

purposes.

Under Morrison, the court found that the

Independent Counsel Act of 1978 was constitutional,

despite the fact that the entity at issue was referred

to as “independent,” due to several factors, including

whether it has the “authority to formulate policy for

the Government or the Executive Branch.” Morrison

v. Olson, 487 U.S. 654, 671 (1988). Similarly, the Task

Force statute entrusts seasoned experts to apply their

individual expertise in making evidence-based

determinations to recommend preventive care

services, but only to formulate recommendations. Use

of the word “independent” within the statute refers to

and preserves the evidence-based scientific process,

allowing the members of the Task Force to

independently apply their expertise to formulate

recommendations.

Even if this were not true, the inquiry into

whether an officer is inferior must go beyond the

language of the statute to look at the practical nature

of how the role is carried out. Morrison, 487 U.S. at

672-73 (finding that “independent counsel” were

nevertheless inferior officers). Here, myriad

indicators show that the Task Force’s role is carried

out in a manner consistent with that of inferior

officers.

The Task Force has carried out its

responsibilities since 1984 and has long been

understood as an independent body. Procedure

Manual,

USPSTF

(Apr.

2023),

https://tinyurl.com/2mmfc98v.

However,

its

independence and freedom from political influence

does not equate a lack of political accountability for

its recommendations. Instead, only its process of

reviewing evidence and making recommendations for

clinical preventive services are cordoned off by the

enabling statute. This process and its resulting

recommendations are distinct from and only serve to

inform the policymaking function delegated to the

executive branch under health insurance law.

Similarly, freedom from “political pressure” is

not freedom from oversight or accountability. Rather,

it is further evidence that this provision is meant to

protect the integrity of the evidence-based

recommendation process. Otherwise, the output —

the recommendations themselves — might be

influenced to conform to political whims rather than

evidence.

The word “independent” also does not foreclose

oversight of the utilization of Task Force

recommendations by the Secretary of HHS, who

retains sole authority to accept any recommendation

for purposes of determining those services which

health insurers must cover.

This degree of oversight is sufficient for our

purposes, as the Appointments Clause does not

require that an inferior officer’s superior be involved

in every level of decision making, just direction and

supervision at “some level.” Edmond v. United States,

520 U.S. 651, 663 (1997). Such is the case here, where

superiors are involved not in the evidence review and

recommendation processes, but in the subsequent

policymaking utilized to effectuate the ACA’s

coverage requirement.

Task Force Members are Inferior

Officers Who Develop EvidenceBased

Recommendations,

Not

Policy.

Since 1989, the Task Force has published its

Guide to Clinical Preventive Services. Guide to

Clinical Preventive Services: An Assessment of the

Effectiveness of 169 Interventions, USPSTF (1989).

Since at least 1996, this guide has included the

explicit statement that its recommendations “are

independent of the U.S. Government. They should not

be construed as an official position of the Agency for

Healthcare Research and Quality (“AHRQ”) or the

U.S. Department of Health and Human Services.”

Guide to Clinical Preventive Services, USPSTF (1996).

The Task Force’s distance from policymaking

has been consistently demonstrated by the executive

branch, even predating the passage of the ACA. In

2009, HHS Secretary Kathleen Sebelius rejected a

Task Force recommendation that women ages 40-49

not receive mammograms, stressing that the

recommendation was issued by “an outside

independent panel of doctors and scientists who . . .

do not set federal policy and . . . don’t determine what

services are covered by the federal government.” Rob

Stein & Dan Eggen, White House Backs Off Cancer

Test Guidelines, WASH. POST (Nov. 19, 2009),

https://tinyurl.com/3c8h8zue.

Thus, its “independent charge to focus on the

science of prevention” long preceded the ACA and

remained intact following its enactment. Gregory

Curfman & Kirsten Bibbins-Domingo, US Preventive

Services Task Force Challenged in Federal Court, 329

JAMA 1743, 1743 (2023). In carrying out this charge,

the Task Force engages in a substantial and complex

undertaking. Its evidence review process prior to

issuing its recommendations is notable in its

thoroughness and consistency, entailing at least eight

distinct steps, including:

Consideration of topics

submitted

for

its

consideration

the

general public;

Development of a research

plan;

Receipt and review of

public comments on the

research plan;

Review of peer-reviewed

evidence;

Development of a draft

recommendation;

Receipt and review of

public comments on the

draft recommendation;

Finalization

the

recommendation; and

Vote

recommendation. 3

the

None of these steps involve promulgating a regulation

or mandating a course of action. This process and the

resulting recommendations are distinct from and only

serve to inform the policymaking function delegated

to the executive branch under health insurance law.

When amending the enabling statute and

adopting the ACA’s requirement to cover Task Force

recommendations, Congress was presumably aware

of these processes given the Task Force’s existence for

26 years prior to the ACA’s enactment. In doing so, it

cordoned off as independent its process of reviewing

evidence and making recommendations for clinical

preventive services.

In reinforcing this independence, Congress and

the executive branch did not push the Task Force

across the threshold into a policymaking function.

Instead, the Task Force has explicitly distanced itself

from the complexities of determining insurance

coverage requirements and is solely a body to provide

recommendations based on the most current scientific

and medical literature. Gregory Curfman & Kirsten

Bibbins-Domingo, US Preventive Services Task Force

Challenged in Federal Court, 329 JAMA 1743, 1743

(2023).

3 Task Force Recommendations Development Process: A Graphic

Overview, USPSTF (May 2021), https://tinyurl.com/zs3a7wfv.

Under Longstanding U.S. Health

Insurance Law, Multiple Agencies

Determine Coverage Requirements.

Although the ACA explicitly linked insurance

coverage to Task Force recommendations, it did not

delegate to the Task Force the role of deciding and

effectuating insurance coverage. Rather, that role is

reserved under Title XXVII of the Public Health

Service Act (PHSA) to three agencies – the United

States Departments of Health and Human Services,

Labor, and Treasury – known as “the tri-agencies.” 42

U.S.C. §§ 300gg, et seq. This has been the case since

the enactment of the Health Insurance Portability

and Accountability Act of 1996 (HIPAA), which

established Title XXVII. Thus, when Congress

enacted the ACA and its preventive services coverage

framework, it amended a preexisting health

insurance regulatory framework administered by the

tri-agencies.

This oversight function alone satisfies the

required Appointments Clause analysis as, once

recommendations are made, politically accountable

officials are free to circumscribe the recommendations

in the course of implementing the ACA’s preventive

services coverage requirement.

Stated plainly, if the Secretary of HHS

determines he does not wish to cover a Task Forcerecommended item or service, he maintains the

discretion to override the recommendations for

purposes of determining which of those must be

covered by health insurers.

In carrying out their responsibilities to

effectuate insurance coverage under 42 U.S.C. §

300gg-13, 29 U.S.C. § 1185d, and 26 U.S.C. § 9815,

the tri-agencies promulgated implementing rules. 45

CFR § 147.130; 29 CFR § 2590.715-2713; 26 CFR §

54.9815-2713. The very first subsection of these rules

delineate a policy that requires group health plans or

health insurance issuers to cover A- and B-rated Task

Force

recommendations

without

cost-sharing

requirements. 45 CFR § 147.130(a)(1)(i); 29 CFR §

2590.715-2713(a)(1)(i);

CFR

54.98152713(a)(1)(i). For the sake of expediency, the triagencies issued this policy via an interim final rule.

75 Fed. Reg. 41726 (July 19, 2010). It was

subsequently codified following notice and comment

rulemaking. 80 Fed. Reg. 41318 (July 14, 2015). The

tri-agencies also explicitly stated the timeline for

implementation of such Task Force recommendations

and did not link that timing to any additional action

undertaken by the tri-agencies. In other words, the

tri-agencies decided, using their rulemaking

authority, to make the Task Force’s Grade A and

Grade B ratings self-effectuating with respect to

mandatory first-dollar coverage, while still allowing

for the tri-agencies to review and accept the

recommendations as evidenced in the below list of

actions. 45 CFR § 147.130(b)(1); 29 CFR § 2590.7152713(b)(1); 26 CFR § 54.9815-2713(b)(1).

The tri-agencies were not thoughtlessly

deferential, reflexively outsourcing the responsibility

determining

health

insurance

coverage

requirements to the Task Force. Rather, the triagencies meticulously promulgated various rules and

guidance that demonstrate it carried out its

responsibility to effectuate the Task Force

recommendations as required by Congress. This is

evidenced by myriad actions taken by the triagencies, including the following:

1. In the preamble to the first interim final

rule, the tri-agencies delineated their approach

incorporating

the

Task

Force

recommendations into health insurance

coverage:

The preventive services

given a grade of A or B by

the Task Force have been

determined by the Task

Force to have at least fair

or good evidence that the

preventive

service

improves important health

outcomes and that benefits

outweigh harms in the

judgment

independent

panel

private sector experts in

primary

care

and

prevention; 75 Fed. Reg.

41726 (July 19, 2010).

2. The preamble further specified the timing of

a recommendation’s effectiveness, “which is

considered to be issued on the last day of the

month on which the Task Force publishes or

otherwise releases the recommendation”; 75

Fed. Reg. 41726 (July 19, 2010).

3. As codified, the rules begin by cabining

required coverage of USPSTF-recommended

services as “with respect to the individual

involved”; 45 CFR 147.130(a)(1)(i); 29 CFR §

2590.715-2713(a)(1)(i); 26 CFR § 54.98152713(a)(1)(i).

4. The rules outlined the circumstances under

which patients are entitled to coverage without

cost-sharing,

including

whether

the

recommended service is “the primary purpose”

of an office visit with a provider and whether

the provider who delivered a service was in

network with a health plan; 45 CFR

147.130(a)(2) - (3); 29 CFR § 2590.715-2713(2)

- (3); 26 CFR § 54.9815-2713(2) - (3).

5. The rules outlined the parameters under

which a health insurer must cover a USPSTFrecommended preventive service, including the

application

“reasonable

medical

management” and the date on which coverage

must begin; 45 CFR 147.130(a)(4) - (b)(1); 29

CFR § 2590.715-2713(a)(4) - (b)(1); 26 CFR §

54.9815-2713(a)(4) - (b)(1).

6. The rules explicitly provide that health

insurers are not required to cover services that

are not described within a Task Force

recommendation; 45 CFR 147.130(a)(5) - (b); 29

CFR § 2590.715-2713(a)(5) - (b); 26 CFR §

54.9815-2713(a)(5) - (b).

7. The rules specify the obligations of health

insurers when the Task Force alters a

recommendation; 45 CFR 147.130(b)(2); 29

CFR § 2590.715-2713 (b)(2); 26 CFR § 54.98152713(b)(2).

8. Its “Frequently Asked Questions” (“FAQs”),

issued for some recommendations over the

course of a 14-year period, have included the

following guidance, extensively interpreting

and guiding implementation of coverage for

Task Force recommendations, including:

I. Required coverage of Task Force

recommendations

when

recommendation “do[es] not definitively

state the scope, setting, or frequency of

the items or services to be covered.”

Affordable Care Act Implementation

FAQs – Set 2, CMS (Sept. 10, 2024),

https://tinyurl.com/mucs47zd.

II. Required coverage for aspirin

following its recommendation by the

Task Force to reduce the risk of

myocardial infarction; Affordable Care

Act Implementation FAQs – Set 12, CMS

(Sept.

10,

2024),

https://tinyurl.com/y48mz7ep.

III. Required coverage of updated Task

Force recommendations for breast

cancer screening; Affordable Care Act

Implementation FAQs – Set 18, CMS

(Sept.

10,

2024),

https://tinyurl.com/34b6cn3f.

IV. Required coverage for tobacco use

counseling and cessation interventions

as recommended by the USPSTF;

Affordable Care Act Implementation

FAQs – Set 19, CMS (Sept. 10, 2024),

https://tinyurl.com/yc6t5xba.

V. Required coverage of BRCA-related

genetic testing and counseling for

women;

Affordable

Care

Act

Implementation FAQs – Set 34, CMS

(Sept.

10,

2024),

https://tinyurl.com/u636bxwu.

VI. Required coverage of anesthesia,

specialist counseling, pathology exams

and bowel preparation in connection

with colonoscopies; Affordable Care Act

Implementation FAQs – Set 26, CMS

(Sept.

10,

2024),

https://tinyurl.com/3urzx3ux.

VII. Permissibility of excluding weight

management services for adult obesity

from coverage; Affordable Care Act

Implementation FAQs – Set 29, CMS

(Sept.

10,

2024),

https://tinyurl.com/4yby9hbp.

VIII. Interaction between HRSA’s

Women’s Preventive Services Guidelines

and Task Force recommendations;

Affordable Care Act Implementation

FAQs – Set 35, CMS (Sept. 10, 2024),

https://tinyurl.com/ju8vksj5.

IX. Coverage of ancillary services

associated with PrEP and clarification of

allowable

medical

management

techniques for PrEP; Affordable Care

Act Implementation FAQs – Set 47, CMS

(Sept.

10,

2024),

https://tinyurl.com/5yafja7a.

X. Rapid coverage of COVID-related

Task

Force

recommendations;

Affordable Care Act Implementation

FAQs – Set 50, CMS (Sept. 10, 2024),

https://tinyurl.com/52u7s678;

FAQs

About Affordable Care Act and

Coronavirus Aid, Relief, and Economic

Security Act Implementation Part 59,

CMS

(Apr.

13,

2023),

https://tinyurl.com/32987zrk.

XI. Coverage requirements considering

the lower court’s decision in this case

now pending before the Court; Id.; and

XII. Coverage requirements for PrEP

following the Task Force’s updated 2023

recommendation.

FAQs

About

Affordable Care Act and Women’s Health

and Cancer Rights Act Implementation

Part 68, CMS (Oct. 21, 2024),

https://tinyurl.com/3kftp5vp.

It is the tri-agencies rather than the Task Force

that possess the independent authority and

responsibility for determining how to implement the

Task Force’s recommendations for purposes of health

insurance coverage requirements.

CONCLUSION

HIV and hepatitis continues to impact millions

of Americans, requiring ongoing medical treatment

and burdening the American economy. Even should

this Court decline to sever the section of 42 U.S.C.

299b-4(a)(6) that the Petitioners take issue with, it

should recognize a reasonable construction of the

statute in favor of a constitutionally sound

interpretation. Furthermore, the Court should

recognize Congress’s intention on the face of the

statute to preserve political independence and

avoidance of political influence with respect to its

recommendation process, which is altogether distinct

from the subsequent policy-making role retained by

politically accountable principle.

Respectfully submitted,

Richard H. Hughes IV

Counsel of Record

Spreeha Choudhury

William Walters

Devon Minnick

Lorrin Melanson

Eᴘsᴛᴇɪɴ, Bᴇᴄᴋᴇʀ & Gʀᴇᴇɴ, P.C.

1227 25th Street, N.W.

Suite 700

Washington, D.C. 20037

(202) 861-4186

Counsel for Amici Curiae

APPENDIX

TABLE OF CONTENTS

List of Amici Curiae ...........................................2A

APPENDIX

LIST OF AMICI CURIAE

HIV AND HEPATITIS POLICY INSTITUTE

ADAP ADVOCACY ASSOCIATION

AIDS ALABAMA, INC.

AMERICAN ACADEMY OF HIV MEDICINE

CARING AMBASSADORS PROGRAM, INC.

COMMUNITY ACCESS NATIONAL NETWORK

COMMUNITY LIVER ALLIANCE

COMMUNITY RESEARCH INSTITUTE OF NEW

ENGLAND, INC. d/b/a COMMUNITY RESOURCE

INITIATIVE

FAST-TRACK CITIES INSTITUTE

FRANNIE PEABODY CENTER

GEORGIA AIDS COALITION

GLOBAL LIVER INSTITUTE

HEP B UNITED

HEPATITIS B FOUNDATION

HOUSING WORKS, INC.

INTERNATIONAL ASSOCIATION OF

PROVIDERS OF AIDS CARE

LATINO COMMISSION ON AIDS

NATIONAL MINORITY AIDS COUNCIL

SEXUALITY INFORMATION AND EDUCATION

COUNCIL OF THE UNITED STATES d/b/a

SIECUS

VIVENT HEALTH

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.