Becerra v. Braidwood Management, No. 24-316 (U.S., petition filed 9/19/24)
| Sep 19 2024 | Petition for a writ of certiorari filed. (Response due October 21, 2024) |
| PetitionProof of Service | |
| Oct 21 2024 | Amicus brief of The American Cancer Society, et al. submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Oct 21 2024 | Amicus brief of Illinois submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Oct 21 2024 | Amicus brief of 35 Health Care Access Organizations submitted. |
| Main DocumentProof of ServiceCertificate of Word Count |
| Oct 21 2024 | Amicus brief of The American Public Health Association, Public Health Deans and Scholars, The Robert Wood Johnson Foundation, and Public Health Advocates submitted. |
| Main DocumentCertificate of Word CountProof of Service |
Braidwood’s brief in support of certiorari, October 21, 2024
Conditional cross-petition, October 21, 2024, No. 24-475
| Oct 21 2024 | Petition for a writ of certiorari filed. (Response due November 29, 2024) |
| PetitionCertificate of Word CountProof of Service |
| Dec 02 2024 | Brief of respondents Xavier Becerra, Secretary of Health and Human Services, et al. in opposition filed. |
| Main DocumentProof of Service | |
| Dec 09 2024 | Reply of petitioners Braidwood Management, Inc., et al. filed. |
| Main DocumentProof of ServiceCertificate of Word Count |
| Dec 18 2024 | DISTRIBUTED for Conference of 1/10/2025. |
| Dec 18 2024 | Reply of petitioners Xavier Becerra, et al. filed. (Distributed) |
| Main DocumentProof of Service |
(ORDER LIST: 604 U.S.)
FRIDAY, JANUARY 10, 2025
CERTIORARI GRANTED
24-316 BECERRA, SEC. OF H&HS, ET AL. V. BRAIDWOOD MGMT., INC., ET AL.
The petition for a writ of certiorari is granted.
Cross-petition
| Jan 13 2025 | Petition DENIED. |
US brief, and appendix, February 18, 2025
| Feb 24 2025 | SET FOR ARGUMENT on Monday, April 21, 2025. |
| Feb 24 2025 | Amicus brief of American Hospital Association, Catholic Health Association of the United States, Federation of American Hospitals, America’s Essential Hospitals, and Association of American Medical Colleges submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of The American Cancer Society, et al. submitted. |
| Main DocumentProof of ServiceCertificate of Word Count | |
| Feb 25 2025 | Amicus brief of HIV and Hepatitis Policy Institute, et al. submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of Public Citizen et al. submitted. |
| Main DocumentCertificate of Word CountProof of Service |
| Feb 25 2025 | Amicus brief of Illinois submitted. |
| Main DocumentCertificate of Word CountProof of Service |
| Feb 25 2025 | Amicus brief of United States of Care and 47 Other Organizations submitted. |
| Main DocumentProof of ServiceCertificate of Word Count | |
| Feb 25 2025 | Amicus brief of CHLPI, CIDP, ADA, MRC, CAP, et al. submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of 35 Health Care Access Organizations submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of The American Public Health Association, Public Health Deans and Scholars, The Robert Wood Johnson Foundation, and Public Health Advocates submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of Gilead Sciences, Inc. submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of 48 Bipartisan Economic and Other Social Science Scholars submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of The Center for HIV Law and Policy and Other Leading Health Policy and Reproductive Justice Organizations submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of The Susan G. Komen Breast Cancer Foundation, Inc. submitted. |
| Main DocumentCertificate of Word CountProof of Service |
| Feb 25 2025 | Brief amici curiae of HIV and Hepatitis Policy Institute, et al. filed. |
| Main DocumentProof of ServiceCertificate of Word Count | |
| Feb 25 2025 | Brief amici curiae of Patient and Physician Professional Organizations filed. |
| Main DocumentProof of ServiceCertificate of Word Count | |
| Feb 25 2025 | Brief amici curiae of Illinois, et al. filed. |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of 48 Bipartisan Economic and Social Science Scholars not accepted for filing. (To be corrected – February 28, 2025) |
| Feb 25 2025 | Brief amici curiae of 48 Bipartisan Economic and Social Science Scholars filed. (Corrected) |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of Center for HIV Law and Policy, et al. not accepted for filing. (To be corrected – February 28, 2025) |
| Feb 25 2025 | Brief amici curiae of Center for HIV Law and Policy, et al. filed. (Corrected) |
| Main DocumentCertificate of Word CountProof of Service | |
| Feb 25 2025 | Amicus brief of 35 Health Care Access Organizations submitted. |
| Main DocumentCertificate of Word CountProof of Service | |
| Mar 03 2025 | Brief amicus curiae of American College of Gastroenterology in support of neither party filed. |
| Main DocumentCertificate of Word CountProof of Service | |
| Mar 07 2025 | Record received electronically from the United States District Court for the Northern District of Texas and available with the Clerk. |
Braidwood’s brief, March 20, 2025
| Mar 21 2025 | Amicus brief of Goldwater Institute submitted. |
| Main DocumentCertificate of Word CountProof of Service |
| Mar 26 2025 | Brief amicus curiae of Association of American Physicians and Surgeons filed. (Distributed) |
| Main DocumentCertificate of Word CountProof of Service | |
| Mar 27 2025 | Brief amicus curiae of Christian Employers Alliance filed. (Distributed) |
| Main DocumentCertificate of Word CountProof of Service | |
| Mar 27 2025 | Brief amicus curiae of Manhattan Institute filed. (Distributed) |
| Main DocumentCertificate of Word CountProof of Service | |
| Mar 27 2025 | Brief amicus curiae of Cato Institute filed. (Distributed) |
| Main DocumentCertificate of Word CountProof of Service | |
| Mar 27 2025 | Brief amicus curiae of Pacific Legal Foundation filed. (Distributed) |
| Main DocumentCertificate of Word CountProof of Service | |
| Mar 27 2025 | Brief amici curiae of Texas, et al. filed. (Distributed) |
| Main DocumentCertificate of Word CountProof of Service | |
| Mar 27 2025 | Brief amicus curiae of The Buckeye Institute filed. (Distributed) |
| Main DocumentCertificate of Word CountProof of Service |
| Apr 11 2025 | Reply of petitioners Robert F. Kennedy, Jr., Secretary of Health and Human Services, et al. filed. (Distributed) |
| Main DocumentProof of Service | |
| Apr 21 2025 | Argued. For petitioners: Hashim M. Mooppan, Principal Deputy Solicitor General, Department of Justice, Washington, D. C. For respondents: Jonathan F. Mitchell, Austin, Tex. |
Transcript of oral argument, April 21, 2025
Order, April 25, 2025
(ORDER LIST: 604 U.S.)
FRIDAY, APRIL 25, 2025
ORDER IN PENDING CASE
24-316 KENNEDY, SEC. OF H&HS, ET AL. V. BRAIDWOOD MGMT., INC., ET AL.
The parties are directed to file supplemental letter briefs
addressing the following question: Whether Congress has “by Law”
vested the Secretary of the Department of Health and Human
Services with the authority to appoint members of the United
States Preventive Services Task Force. U. S. Const. art. II,
§2, cl. 2. The briefs should address this Court’s decisions in
United States v. Hartwell, 6 Wall. 385 (1868), and United States
v. Smith, 124 U. S. 525 (1888). The briefs, not to exceed 15
pages, are to be filed simultaneously with the Clerk and served
upon opposing counsel on or before 2 p.m., Monday, May 5, 2025.
| May 02 2025 | Motion of New Civil Liberties Alliance for leave to file amicus brief submitted. |
| Main DocumentProof of Service | |
| May 05 2025 | Letter Brief of Xavier Becerra, et al. submitted. |
| Main Document | |
| May 05 2025 | Supplemental Brief of Braidwood Management, Inc., et al. submitted. |
| Main DocumentProof of Service |
==
PROCEEDINGS BELOW
Kelley v. Azar, No. 4:20-cv-283 (N.D. Tex.)
Complaint, March 29, 2020
First amended complaint, July 20, 2020
Kelley first amended complaint 7 20 20
US motion to dismiss, August 7, 2020
Opposition to US motion to dismiss, September 12, 2020
US reply supporting motion to dismiss, October 25, 2020
Plaintiffs’ supplemental authority (Leal),
Order on US motion to dismiss, February 25, 2021
Kelley order on mo dism 2 25 21
Order for status report by 3/22, February 25, 2021
Kelley order for status report
Answer to first amended complaint, March 11, 2021
Joint status report, March 22, 2021
Scheduling order, March 23, 2021
Kelley scheduling order 3 23 21
Kelley scheduling order, October 26, 2021
1) Plaintiffs’ Motion for Summary Judgment is due on or before November 15.
2) Defendants’ Combined Response & Cross Motion for Summary Judgment is due
December 29.
3) Plaintiffs’ Combined Reply & Response to Cross-Motion for Summary Judgment is
due January 28, 2022.
4) Defendants’ Reply to Cross-Motion for Summary Judgment is due February 18.
Plaintiffs’ motion for summary judgment, and memo, and appendix, November 15, 2021
Dismissal of Riddles’ claims, December 2, 2021
Parties’ agreed-on rescheduling proposal, December 20, 2021
Kelley agreed mo amend briefing schedule 12 20
Event Current Schedule Parties’ Proposal
Defendants’ Combined Response & Cross Motion for Summary Judgment
December 29, 2021 January 12, 2022
Plaintiffs’ Combined Reply & Response to Cross-Motion for Summary Judgment
January 28, 2022 February 11, 2022
Defendants’ Reply to Cross-Motion for Summary Judgment
February 18, 2022 March 4, 2022
Rescheduling order, December 21, 2021
Kelley notice of additional authority (DeOtte), December 22, 2021
Kelley pltf addl auth DeOtte 12 22
Consent motion to amend briefing schedule, January 7, 2022
Kelley consent mo amend br sched 1 7
Amended briefing schedule, January 7, 2022
Def 1/28
Pltf 2/28
Def 3/21
Illinois et al amicus, January 28, 2022
US cross-motion for summary judgment, summary judgment opposition, brief, and appendix, January 28, 2022
20 Health Experts amicus, February 4, 2022
Kelley 20 health experts amicus 2 4
Plaintiffs’ motion for extension to file reply, February 25, 2022
Extension order, February 26, 2022
[Plaintiffs’ reply, 3/14, US reply, 4/4]
Plaintiffs’ further extension request, March 13, 2022
Order for extension, March 14, 2022
Kelley reply and opposition, March 28, 2022
Unopposed US request for extension (to 5/6) to file reply, March 30, 2022
Unopposed US request for extension, and extension, May 4, 2022
US reply, May 26, 2022
Order setting motions hearing for 7/26, July 7, 2022
Kelley order for 7 26 motion hearing, 7 7
| 07/26/2022 | 85 | ELECTRONIC Minute Entry for proceedings held before Judge Reed C. O’Connor: Motion Hearing held on 7/26/2022 re 44 Motion for Summary Judgment filed by Gregory Scheideman, John Scott Kelley, Joel Miller, Kelley Orthodontics, Joel Starnes, Ashley Maxwell, Braidwood Management Inc, Zach Maxwell, 62 Motion for Summary Judgment filed by Martin J Walsh, United States of America, Xavier Becerra, Janet L Yellen. Attorney Appearances: Plaintiff – Jonathan Mitchell; Defense – Christopher Lynch, Brian Stoltz. (Court Reporter: Zoie Williams) (No exhibits) Time in Court – 1:40. (chmb) (Entered: 07/26/2022) |
US supplemental filing, August 2, 2022
Kelley US supplemental pleading 8 2 22
Kelley supplemental authority (Leal), August 3, 2022
US correction, August 5, 2022
Unopposed motion to reorganize caption, August 10, 2022
Kelley unop mo amend caption 8 10
Order on caption, August 11, 2022
Braidwood notice of additional authority (DeOtte), August 23, 2022
Kelley notice addl auth DeOtte 8 23
Opinion, September 7, 2022
gov.uscourts.txnd.330381.92.0_1
Unopposed motion for extension, September 8, 2022
Extension order, September 8, 2022
Joint status report, September 16, 2022
Scheduling order, September 28, 2022
Plaintiffs’ supplemental SJ, 10/24; Defendants’ response and cross-motion, 11/23 [?]; Plaintiffs’ opposition/reply, 12/23 [?]; Defendants’ reply, 1/10 [?]
| 09/28/2022 | 97 | SCHEDULING ORDER ON SUPPLEMENTAL BRIEFING: Deadline for plaintiffs to file their supplemental motion for summary judgment: October 24, 2022. Deadline for defendants to file combined response to plaintiffs supplemental motion for summary judgment and defendants supplemental cross-motion for summary judgment: 30 days after plaintiff files supplemental motion for summary judgment. Deadline for plaintiffs to file combined response to defendants supplemental motion for summary judgment and reply brief in support of plaintiffs supplemental motion for summary judgment: 30 days after defendants file cross-motion for summary judgment. Deadline for defendants to file reply brief in support of defendants supplemental motion for summary judgment: 21 days after plaintiffs file combined response to defendants supplemental motion for summary judgment and reply brief in support of plaintiffs supplemental motion for summary judgment. (Ordered by Judge Reed C. O’Connor on 9/28/2022) (jgg) (Entered: 09/28/2022) |
Plaintiffs’ supplemental summary judgment brief, October 24, 2022
_____
Universal-vacatur discussions cited in plaintiffs’ supplemental summary judgment brief
Data Marketing Partnership, LP v. United States Dep’t of Labor, 45 F.4th 846, 859(5th Cir. 2022)
Opinion, August 17, 2022
Franciscan Alliance, Inc. v. Becerra, 47 F.4th 368 (5th Cir. 2022)
Opinion, August 26, 2022
Nicholas Bagley, Remedial Restraint in Administrative Law, 117 Colum. L. Rev. 253 (2017)
Thomas W. Merrill, Article III, Agency Adjudication, and the Origins of the Appellate Review Model of Administrative Law, 111 Colum. L. Rev. 939 (2011)
Article III Agency Adjudication and the Origins of the Appellat
Mila Sohoni, The Power to Vacate a Rule, 88 Geo. Wash. L. Rev. 1121 (2020)
_____
Defendants’ supplemental brief, and appendix, November 23, 2022
American Cancer Society amicus, November 30, 2022
BrM American Cancer Society amicus 11 30
American Medical Association amicus, November 30, 2022
Braidwood supplemental reply brief, January 6, 2023
US supplemental reply, January 27, 2023
Opinion, March 30, 2023
Judgment, March 30, 2023
Braidwood M final judgment 3 30 23
US notice of appeal, March 31, 2023
“Notice of document replacement,” April 4, 2023
BrM notice of document replacement 4 4 23
Fifth Circuit # 23-10326
Braidwood cross-appeal, April 6, 2023
BrM notice cross appeal 4 6 23
US motion for a partial stay, April 12, 2023
BrM US partial stay mo 4 12 23
Scheduling order, April 13, 2023
BrM stay responses order 4 13 23
Response, 5 pm 4/17
Reply, 4/18
Decision date: by 4/20
Defendants’ motion for extension, April 17, 2023
BrM pltf xt mo stay response 4 17 23
Order extending time for response, April 17, 2023
Braidwood’s response opposing stay, April 18, 2023
BrM Braidwood stay response 4 18 23
US reply, April 19, 2023
Order, April 20, 2023
Wall Street Journal story cited in order
Most Major Insurers to Continue Preventive Care Services
Letter cited in Wall Street Journal story and cited in order
Health Plan and Employer Group Letter on Preventive Services – 4.19.23
US stay reply, April 21, 2023
Briefing notice, April 25, 2023
5C BrM briefing notice 4 25 23
US motion for partial stay, April 27, 2023
5C BrM US mo partial stay 4 27 23
| 04/27/2023 | 30 | MOTION for partial stay pending appeal and for an administrative stay while Court considers this motion. [30]. Document is insufficient for the following reasons: lacks certificate of conference Response/Opposition due on 05/08/2023. [23-10326] |
American Lung Ass’n amicus, April 28, 2023
5C BrM Am Lung Assn amicus 4 28 23
American Cancer Society amicus, April 28, 2023
5C BrM American Cancer Society amicus 4 28 23
American Medical Ass’n amicus, April 28, 2023
American Public Health Ass’n amicus, April 28, 2023
SEIU amicus, April 28, 2023
[Adult Vaccine Access amicus
Order requesting supplemental briefing on stay request by 5/9, May 2, 2023
gov.uscourts.txnd.330381.131.0
US supplemental brief, May 4, 2023
Braidwood opposition to stay, May 5, 2023
US reply brief supporting stay, May 12, 2023
Administrative stay order, May 15, 2023
| 05/18/2023 | 101 | EXTENSION RECEIVED for Appellants/Cross-Appellees Mr. Xavier Becerra, Secretary, U.S. Department of Health and Human Services, Ms. Julie A. Su, Acting Secretary, U.S. Department of Labor, USA and Ms. Janet Yellen, Secretary, U.S. Department of Treasury. Extension Granted to and including 06/20/2023. A/Pet’s Brief deadline updated to 06/20/2023 for Appellants/Cross-Appellees Xavier Becerra, Secretary, U.S. Department of Health and Human Services, Julie A. Su, Acting Secretary, U.S. Department of Labor, United States of America and Janet Yellen, Secretary, U.S. Department of Treasury [23-10326] (MFY) [Entered: 05/18/2023 02:32 PM] |
Parties’ proposed briefing schedule, May 19, 2023
The government’s principal brief is due on June 20. For the following reasons, the government respectfully moves that the Court establish the following briefing schedule for the remainder of briefing on these crossappeals.1 Plaintiffs’ counsel has authorized us to state that plaintiffs support this proposed schedule.
June 27, 2023 Amicus briefs in support of the government
August 7, 2023 Plaintiffs’ principal and response brief
August 14, 2023 Amicus briefs in support of plaintiffs
September 29, 2023 Government’s response and reply brief
October 6, 2023 Amicus briefs in support of the government
(limited to issues raised by plaintiffs’ crossappeal)
November 3, 2023 Plaintiffs’ reply brief
Order for 6/6 oral argument on motion for partial stay, May 19, 2023
Braidwood Management motion for leave to file supplemental brief, and supplemental brief, May 25/26, 2023
Unopposed US request to respond, May 26, 2023
Order allowing supplemental brief, May 26, 2023
Braidwood supplemental brief, May 26, 2023
Order allowing US supplemental brief, May 26, 2023
US supplemental brief, May 31, 2023
Oral argument re stay, June 6, 2023
Order, June 7, 2023
Parties’ proposed stay idea, June 9, 2023
Stipulation for stay, June 12, 2023
Stipulation to amend caption, June 12, 2023
Partial stay order, June 13, 2023
In light of the parties’ stipulation filed on June 12, 2023, the first
paragraph of item 3 in the district court judgment, is STAYED pending this
Court’s issuance of the mandate in this appeal.
3) The U.S. Preventive Services Task Force’s (PSTF) recommendations operating in
conjunction with 42 U.S.C. § 300gg-13(a)(1) violate Article II’s Appointments
Clause and are therefore unlawful. Therefore, any and all agency actions taken to
implement or enforce the preventive care coverage requirements in response to an
“A” or “B” recommendation by the PSTF on or after March 23, 2010 are
VACATED and Defendants and their officers, agents, servants, and employees are
ENJOINED from implementing or enforcing 42 U.S.C. § 300gg-13(a)(1)’s compulsory coverage requirements in response to an “A” or “B” rating from PSTF in the future.
Briefing schedule orders, June 13, 2023
Pursuant to the court’s order the parties will adhere to the
following briefing schedule:
June 20, 2023 Government’s Opening Brief
June 27, 2023 Amicus briefs in support of the government
August 7, 2023 Plaintiffs’ principal and response brief
August 14, 2023 Amicus briefs in support of plaintiffs
September 29, 2023 Government’s response and reply brief
October 6, 2023 Amicus briefs in support of the government
(limited to issues raised by plaintiffs’ cross-appeal)
November 3, 2023 Plaintiffs’ reply brief
US opening brief, and excerpts of record, June 20, 2023
HIV and Hepatitis Policy Institute amicus, June 23, 2023
American Cancer Society amicus, June 27, 2023
HIV Medicine Ass’n amicus, June 27, 2023
Blue Cross Blue Shield Ass’n amicus, June 27, 2023
United States of Care amicus, June 27, 2023
American Lung Ass’n amicus, June 27, 2023
Illinois et al amicus, June 27, 2023
AARP amicus, June 27, 2023
49 Bipartisan Scholars amicus, June 27, 2023
American Public Health Ass’n amicus, June 27, 2023
American Hospital Ass’n amicus, June 27, 2023
National Health Law Program amicus, June 27, 2023
Susan G. Komen Breast Cancer Foundation amicus, June 27, 2023
SEIU amicus, June 27, 2023
Gilead Sciences amicus, June 27, 2023
American Medical Ass’n amicus, June 27, 2023
AIDS Healthcare Foundation amicus, June 27, 2023
Braidwood Management appellee/cross-appellant brief, August 7, 2023
Buckeye Institute amicus, August 14, 2023
Texas amicus, August 14, 2023
Click to access 5c-brm-us-x-appellee-br-9-29-23.pdf
American Academy of HIV Medicine amicus, August 18, 2023
[
US cross-appellee brief, September 29, 2023
American Public Health Ass’n amicus, October 6, 2023
American Medical Ass’n amicus, October 6, 2023
National Women’s Law Center amicus, October 6, 2023
Braidwood cross-appeal reply, November 3, 2023
Tentative oral argument notice (week of 3/4), December 26, 2023
Calendaring notice for 3/4 p.m., January 23, 2024
| 03/04/2024 | 322 | ORAL ARGUMENT HEARD before Judges Willett, Wilson, Ramirez. Arguing Person Information Updated for: Daniel J. Aguilar arguing for Appellant/Cross-Appellee Secretary Becerra, U.S. Department of Health and Human Services, Appellant/Cross-Appellee Acting Secretary Su, U.S. Department of Labor, Appellant/Cross-Appellee United States of America; Arguing Person Information Updated for: Jonathan F. Mitchell arguing for Appellee/Cross-Appellant Joel Miller, Appellee/Cross-Appellant Gregory Scheideman, Appellee/Cross-Appellant Incorporated Braidwood Management, Appellee/Cross-Appellant Kelley Orthodontics, Appellee/Cross-Appellant John Scott Kelley, Appellee/Cross-Appellant Ashley Maxwell, Appellee/Cross-Appellant Zach Maxwell [23-10326] (PFT) [Entered: 03/05/2024 07:47 AM] |
Plaintiffs’ supplemental authority (Clarke), March 14, 2024
Defendants’ Clarke response, Deanda supplemental authority, March 21, 2024
Plaintiffs’ Deanda response, March 26, 2024
[]
[]
Opinion, June 21, 2024
Klein withdrawal, July 31, 2024
[Order for status report]
Joint motion for trial level stay, August 27, 2024
[stay]
Cert petition, No. 24-316 (Sept. 19, 2024)
| Sep 19 2024 | Petition for a writ of certiorari filed. (Response due October 21, 2024) |
| PetitionProof of Service |
++
HHS FAQs, April 13, 2023
Becerra Braidwood statement, April 13, 2023
Becerra Braidwood statement 4 13 23
++
REMEDIES
Loftstad v. Raimondo, No. 24-1420 (3d Cir., Sept. 25, 2024)
++
Preventive Services Task Force recommendations, with date of recommendation
| Topic | Description | Grade | Release Date of Current Recommendation |
|---|---|---|---|
| Abdominal Aortic Aneurysm: Screening: men aged 65 to 75 years who have ever smoked | The USPSTF recommends 1-time screening for abdominal aortic aneurysm (AAA) with ultrasonography in men aged 65 to 75 years who have ever smoked. | B | December 2019 * |
| Anxiety in Children and Adolescents: Screening: children and adolescents aged 8 to 18 years | The USPSTF recommends screening for anxiety in children and adolescents aged 8 to 18 years. | B | October 2022 |
| Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: Preventive Medication: pregnant persons at high risk for preeclampsia | The USPSTF recommends the use of low-dose aspirin (81 mg/day) as preventive medication after 12 weeks of gestation in persons who are at high risk for preeclampsia. See the Practice Considerations section for information on high risk and aspirin dose. | B | September 2021 * |
| Asymptomatic Bacteriuria in Adults: Screening: pregnant persons | The USPSTF recommends screening for asymptomatic bacteriuria using urine culture in pregnant persons. | B | September 2019 * |
| BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing: women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or an ancestry associated with brca1/2 gene mutation | The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with breast cancer susceptibility 1 and 2 (BRCA1/2) gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing. | B | August 2019 * |
| Breast Cancer: Medication Use to Reduce Risk: women at increased risk for breast cancer aged 35 years or older | The USPSTF recommends that clinicians offer to prescribe risk-reducing medications, such as tamoxifen, raloxifene, or aromatase inhibitors, to women who are at increased risk for breast cancer and at low risk for adverse medication effects. | B | September 2019 * |
| Breast Cancer: Screening: women aged 50 to 74 years | The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. † | B | January 2016 * |
| Breastfeeding: Primary Care Interventions: pregnant women, new mothers, and their children | The USPSTF recommends providing interventions during pregnancy and after birth to support breastfeeding. | B | October 2016 * |
| Cervical Cancer: Screening: women aged 21 to 65 years | The USPSTF recommends screening for cervical cancer every 3 years with cervical cytology alone in women aged 21 to 29 years. For women aged 30 to 65 years, the USPSTF recommends screening every 3 years with cervical cytology alone, every 5 years with high-risk human papillomavirus (hrHPV) testing alone, or every 5 years with hrHPV testing in combination with cytology (cotesting). See the Clinical Considerations section for the relative benefits and harms of alternative screening strategies for women 21 years or older. | A | August 2018 * |
| Chlamydia and Gonorrhea: Screening: sexually active women, including pregnant persons | The USPSTF recommends screening for chlamydia in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. | B | September 2021 * |
| Chlamydia and Gonorrhea: Screening: sexually active women, including pregnant persons | The USPSTF recommends screening for gonorrhea in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. | B | September 2021 * |
| Colorectal Cancer: Screening: adults aged 45 to 49 years | The USPSTF recommends screening for colorectal cancer in adults aged 45 to 49 years. See the “Practice Considerations” section and Table 1 for details about screening strategies. | B | May 2021 * |
| Colorectal Cancer: Screening: adults aged 50 to 75 years | The USPSTF recommends screening for colorectal cancer in all adults aged 50 to 75 years. See the “Practice Considerations” section and Table 1 for details about screening strategies. | A | May 2021 * |
| Depression and Suicide Risk in Children and Adolescents: Screening: adolescents aged 12 to 18 years | The USPSTF recommends screening for major depressive disorder (MDD) in adolescents aged 12 to 18 years. | B | October 2022 * |
| Falls Prevention in Community-Dwelling Older Adults: Interventions: adults 65 years or older | The USPSTF recommends exercise interventions to prevent falls in community-dwelling adults 65 years or older who are at increased risk for falls. | B | April 2018 * |
| Folic Acid for the Prevention of Neural Tube Defects: Preventive Medication: women who are planning or capable of pregnancy | The USPSTF recommends that all women who are planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 ?g) of folic acid. | A | January 2017 * |
| Gestational Diabetes: Screening: asymptomatic pregnant persons at 24 weeks of gestation or after | The USPSTF recommends screening for gestational diabetes in asymptomatic pregnant persons at 24 weeks of gestation or after. | B | August 2021 * |
| Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults With Cardiovascular Risk Factors: Behavioral Counseling Interventions: adults with cardiovascular disease risk factors | The USPSTF recommends offering or referring adults with cardiovascular disease risk factors to behavioral counseling interventions to promote a healthy diet and physical activity. | B | November 2020 * |
| Healthy Weight and Weight Gain In Pregnancy: Behavioral Counseling Interventions: pregnant persons | The USPSTF recommends that clinicians offer pregnant persons effective behavioral counseling interventions aimed at promoting healthy weight gain and preventing excess gestational weight gain in pregnancy. | B | May 2021 |
| Hepatitis B Virus Infection in Adolescents and Adults: Screening: adolescents and adults at increased risk for infection | The USPSTF recommends screening for hepatitis B virus (HBV) infection in adolescents and adults at increased risk for infection. See the Practice Considerations section for a description of adolescents and adults at increased risk for infection. | B | December 2020 * |
| Hepatitis B Virus Infection in Pregnant Women: Screening: pregnant women | The USPSTF recommends screening for hepatitis B virus (HBV) infection in pregnant women at their first prenatal visit | A | July 2019 * |
| Hepatitis C Virus Infection in Adolescents and Adults: Screening: adults aged 18 to 79 years | The USPSTF recommends screening for hepatitis C virus (HCV) infection in adults aged 18 to 79 years. | B | March 2020 * |
| Human Immunodeficiency Virus (HIV) Infection: Screening: adolescents and adults aged 15 to 65 years | The USPSTF recommends that clinicians screen for HIV infection in adolescents and adults aged 15 to 65 years. Younger adolescents and older adults who are at increased risk of infection should also be screened. See the Clinical Considerations section for more information about assessment of risk, screening intervals, and rescreening in pregnancy. | A | June 2019 * |
| Human Immunodeficiency Virus (HIV) Infection: Screening: pregnant persons | The USPSTF recommends that clinicians screen for HIV infection in all pregnant persons, including those who present in labor or at delivery whose HIV status is unknown. | A | June 2019 * |
| Hypertension in Adults: Screening: adults 18 years or older without known hypertension | The USPSTF recommends screening for hypertension in adults 18 years or older with office blood pressure measurement (OBPM). The USPSTF recommends obtaining blood pressure measurements outside of the clinical setting for diagnostic confirmation before starting treatment. | A | April 2021 * |
| Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening: women of reproductive age | The USPSTF recommends that clinicians screen for intimate partner violence (IPV) in women of reproductive age and provide or refer women who screen positive to ongoing support services. See the Clinical Considerations section for more information on effective ongoing support services for IPV and for information on IPV in men. | B | October 2018 * |
| Latent Tuberculosis Infection: Screening: asymptomatic adults at increased risk for infection | The USPSTF recommends screening for latent tuberculosis infection (LTBI) in populations at increased risk. | B | September 2016 * |
| Lung Cancer: Screening: adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years | The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery. | B | March 2021 * |
| Obesity in Children and Adolescents: Screening: children and adolescents 6 years and older | The USPSTF recommends that clinicians screen for obesity in children and adolescents 6 years and older and offer or refer them to comprehensive, intensive behavioral interventions to promote improvements in weight status. | B | June 2017 * |
| Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication: newborns | The USPSTF recommends prophylactic ocular topical medication for all newborns to prevent gonococcal ophthalmia neonatorum. | A | January 2019 * |
| Osteoporosis to Prevent Fractures: Screening: postmenopausal women younger than 65 years at increased risk of osteoporosis | The USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in postmenopausal women younger than 65 years who are at increased risk of osteoporosis, as determined by a formal clinical risk assessment tool. See the Clinical Considerations section for information on risk assessment. | B | June 2018 * |
| Osteoporosis to Prevent Fractures: Screening: women 65 years and older | The USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years and older. | B | June 2018 * |
| Perinatal Depression: Preventive Interventions: pregnant and postpartum persons | The USPSTF recommends that clinicians provide or refer pregnant and postpartum persons who are at increased risk of perinatal depression to counseling interventions. | B | February 2019 |
| Prediabetes and Type 2 Diabetes: Screening: asymptomatic adults aged 35 to 70 years who have overweight or obesity | The USPSTF recommends screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years who have overweight or obesity. Clinicians should offer or refer patients with prediabetes to effective preventive interventions. | B | August 2021 * |
| Preeclampsia: Screening: pregnant woman | The USPSTF recommends screening for preeclampsia in pregnant women with blood pressure measurements throughout pregnancy. | B | April 2017 * |
| Prevention of Dental Caries in Children Younger Than 5 Years: Screening and Interventions: children younger than 5 years | The USPSTF recommends that primary care clinicians apply fluoride varnish to the primary teeth of all infants and children starting at the age of primary tooth eruption. | B | December 2021 * |
| Prevention of Dental Caries in Children Younger Than 5 Years: Screening and Interventions: children younger than 5 years | The USPSTF recommends that primary care clinicians prescribe oral fluoride supplementation starting at age 6 months for children whose water supply is deficient in fluoride. | B | December 2021 * |
| Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis: persons at high risk of hiv acquisition | The USPSTF recommends that clinicians offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition. See the Clinical Considerations section for information about identification of persons at high risk and selection of effective antiretroviral therapy. | A | June 2019 |
| Rh(D) Incompatibility: Screening: pregnant women, during the first pregnancy-related care visit | The USPSTF strongly recommends Rh(D) blood typing and antibody testing for all pregnant women during their first visit for pregnancy-related care. | A | February 2004 * |
| Rh(D) Incompatibility: Screening: unsensitized rh(d)-negative pregnant women | The USPSTF recommends repeated Rh(D) antibody testing for all unsensitized Rh(D)-negative women at 24 to 28 weeks’ gestation, unless the biological father is known to be Rh(D)-negative. | B | February 2004 * |
| Screening for Depression in Adults: general adult population, including pregnant and postpartum women | The USPSTF recommends screening for depression in the general adult population, including pregnant and postpartum women. Screening should be implemented with adequate systems in place to ensure accurate diagnosis, effective treatment, and appropriate follow-up. | B | January 2016 * |
| Sexually Transmitted Infections: Behavioral Counseling: sexually active adolescents and adults at increased risk | The USPSTF recommends behavioral counseling for all sexually active adolescents and for adults who are at increased risk for sexually transmitted infections (STIs). See the Practice Considerations section for more information on populations at increased risk for acquiring STIs. | B | August 2020 * |
| Skin Cancer Prevention: Behavioral Counseling: young adults, adolescents, children, and parents of young children | The USPSTF recommends counseling young adults, adolescents, children, and parents of young children about minimizing exposure to ultraviolet (UV) radiation for persons aged 6 months to 24 years with fair skin types to reduce their risk of skin cancer. | B | March 2018 * |
| Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication: adults aged 40 to 75 years who have 1 or more cardiovascular risk factors and an estimated 10-year cardiovascular disease (cvd) risk of 10% or greater | The USPSTF recommends that clinicians prescribe a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more CVD risk factors (i.e. dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year risk of a cardiovascular event of 10% or greater. | B | August 2022 * |
| Syphilis Infection in Nonpregnant Adolescents and Adults: Screening: asymptomatic, nonpregnant adolescents and adults who are at increased risk for syphilis infection | The USPSTF recommends screening for syphilis infection in persons who are at increased risk for infection. | A | September 2022 * |
| Syphilis Infection in Pregnant Women: Screening: pregnant women | The USPSTF recommends early screening for syphilis infection in all pregnant women. | A | September 2018 * |
| Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions: nonpregnant adults | The USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and US Food and Drug Administration (FDA)–approved pharmacotherapy for cessation to nonpregnant adults who use tobacco. | A | January 2021 * |
| Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions: pregnant persons | The USPSTF recommends that clinicians ask all pregnant persons about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for cessation to pregnant persons who use tobacco. | A | January 2021 * |
| Tobacco Use in Children and Adolescents: Primary Care Interventions: school-aged children and adolescents who have not started to use tobacco | The USPSTF recommends that primary care clinicians provide interventions, including education or brief counseling, to prevent initiation of tobacco use among school-aged children and adolescents. | B | April 2020 * |
| Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral Counseling Interventions: adults 18 years or older, including pregnant women | The USPSTF recommends screening for unhealthy alcohol use in primary care settings in adults 18 years or older, including pregnant women, and providing persons engaged in risky or hazardous drinking with brief behavioral counseling interventions to reduce unhealthy alcohol use. | B | November 2018 * |
| Unhealthy Drug Use: Screening: adults age 18 years or older | The USPSTF recommends screening by asking questions about unhealthy drug use in adults age 18 years or older. Screening should be implemented when services for accurate diagnosis, effective treatment, and appropriate care can be offered or referred. (Screening refers to asking questions about unhealthy drug use, not testing biological specimens.) | B | June 2020 |
| Vision in Children Ages 6 Months to 5 Years: Screening: children aged 3 to 5 years | The USPSTF recommends vision screening at least once in all children aged 3 to 5 years to detect amblyopia or its risk factors. | B | September 2017 * |
| Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral Interventions: adults | The USPSTF recommends that clinicians offer or refer adults with a body mass index (BMI) of 30 or higher (calculated as weight in kilograms divided by height in meters squared) to intensive, multicomponent behavioral interventions. | B | September 2018 * |
†The Department of Health and Human Services, under the standards set out in revised Section 2713(a)(5) of the Public Health Service Act and Section 223 of the 2021 Consolidated Appropriations Act, utilizes the 2002 recommendation on breast cancer screening of the U.S. Preventive Services Task Force. To see the USPSTF 2016 recommendation on breast cancer screening, go to http://www.uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening1.
*Previous recommendation was an “A” or “B.”
MIKULSKI AMENDMENT SENATE FLOOR DEBATE
Purchaser standing cases (from plaintiffs’ supplemental brief):
Center for Auto Safety v. National Highway Traffic Safety
Administration, 793 F.2d 1322, 1332–34(D.C. Cir. 1986),
andOrangeburg, South
Carolinav.FERC, 862 F.3d 1071, 1078 (D.C. Cir. 2017));
see alsoWeissman v. Nat’l
R.R. Passenger Corp., 21 F.4th 854, 857–58 (D.C. Cir. 2021);
Consumer Federation
of America v. FCC, 348 F.3d 1009, 1012 (D.C. Cir. 2003)(“[T]he inability of con-
sumers to buy a desired product may constitute injury-in-fact ‘even if they could ame-
liorate the injury by purchasing some alternative product.’”);
Competitive Enterprise
Institutev.National Highway Traffic Safety Administration, 901 F.2d 107, 112–13
(D.C. Cir. 1990)(conferring standing on aconsumer group to challenge fuel-econ-
omy standards thatreduced the number and variety of larger vehicles available for
sale);
Community Nutrition Institute v. Block,698 F.2d1239, 1246–47 (D.C. Cir.
1983)(conferring standing on consumers to challenge regulations that “deprived”
them of “a lower priced alternative to whole milk”),rev’d on other grounds, 467 U.S.
340 (1984).
Orangeburg
Orangeburg South Carolina v Federal Energy Regulatory Commission
Weissman
Weissman v National Railroad Passenger Corporation
_____
Universal-vacatur materials cited and relied on in plaintiffs’ supplemental summary judgment brief
The religious contraception rule and the moral contraception rule
Challenges to the contraception rules: California, Indiana, Massachusetts, Pennsylvania
Other contraception cases: Texas
1303 cases
New York Covid-19 restrictions Supreme Court case
The religious contraception rule and the moral contraception rule
Religious contraception rule, 82 Fed. Reg. 47792 (October 13, 2017)
Moral contraception rule, 82 Fed. Reg. 47838 (October 13, 2017)
Title X program integrity proposed rule (with proposed redefinition of “low-income”), 83 Fed. Reg. 25502 (June 1, 2018)
Final religious contraception rule (non Federal Register version released November 7, 2018), 83 Fed. Reg. 57536 (Nov. 15, 2018)
Final moral contraception rule (non Federal Register version released November 7, 2018), 83 Fed. Reg. 57592 (Nov. 15, 2018)
Original preventive services rulemaking, 2010-11
75 Fed. Reg. 41, 726 (July 19, 2010)
76 Fed. Reg. 46,621 (August 3, 2011)
+++
Dear State Medicaid Directors letter re preventive services, February 1, 2013
42 C.F.R. sec. 440.347
§ 440.347 Essential health benefits.
(a) Alternative Benefit Plans must contain essential health benefits coverage, including benefits in each of the following ten categories, consistent with the applicable requirements set forth in 45 CFR part 156:
(1) Ambulatory patient services;
(2) Emergency services;
(3) Hospitalization;
(4) Maternity and newborn care;
(5) Mental health and substance use disorders, including behavioral health treatment;
(6) Prescription drugs;
(7) Rehabilitative and habilitative services and devices, except that such coverage shall be in accordance with § 440.347(d);
(8) Laboratory services;
(9) Preventive and wellness services and chronic disease management; and
(10) Pediatric services, including oral and vision care, in accordance with section 1905(r) of the Act.
(b) Alternative Benefit Plans must include essential health benefits in one of the state options for establishing essential health benefits described in 45 CFR 156.100, subject to supplementation under 45 CFR 156.110(b) and substitution as permitted under 45 CFR 156.115(b).
(c) States may select more than one base benchmark option for establishing essential health benefits in keeping with the flexibility for States to implement more than one Alternative Benefit Plan for targeted populations.
(d) To comply with paragraph (a) of this section, Alternative Benefit Plan coverage of habilitative services and devices will be based on the habilitative services and devices that are in the applicable base benchmark plan. If habilitative services and devices are not in the applicable base benchmark plan, the state will define habilitative services and devices required as essential health benefits using the methodology set forth in 45 CFR 156.115(a)(5).
(e) Essential health benefits cannot be based on a benefit design or implementation of a benefit design that discriminates based on an individual’s age, expected length of life, present or predicted disability, degree of medical dependency, quality of life or other health conditions.
[78 FR 42307, July 15, 2013]
45 C.F.R. 147.130
§ 147.130 Coverage of preventive health services.
(a) Services —
(1) In general. Beginning at the time described in paragraph (b) of this section and subject to §§ 147.131, 147.132, and 147.133, a group health plan, or a health insurance issuer offering group or individual health insurance coverage, must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for—
(i) Evidence-based items or services that have in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force with respect to the individual involved (except as otherwise provided in paragraph (c) of this section);
(ii) Immunizations for routine use in children, adolescents, and adults that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved (for this purpose, a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is considered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention, and a recommendation is considered to be for routine use if it is listed on the Immunization Schedules of the Centers for Disease Control and Prevention);
(iii) With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Administration;
(iv) With respect to women, such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in comprehensive guidelines supported by the Health Resources and Services Administration for purposes of section 2713(a)(4) of the Public Health Service Act, subject to §§ 147.131, 147.132, and 147.133; and
(v) Any qualifying coronavirus preventive service, which means an item, service, or immunization that is intended to prevent or mitigate coronavirus disease 2019 (COVID–19) and that is, with respect to the individual involved—
(A) An evidence-based item or service that has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force; or
(B) An immunization that has in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (regardless of whether the immunization is recommended for routine use). For purposes of this paragraph (a)(1)(v)(B), a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is considered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention.
(2) Office visits.
(i) If an item or service described in paragraph (a)(1) of this section is billed separately (or is tracked as individual encounter data separately) from an office visit, then a plan or issuer may impose cost-sharing requirements with respect to the office visit.
(ii) If an item or service described in paragraph (a)(1) of this section is not billed separately (or is not tracked as individual encounter data separately) from an office visit and the primary purpose of the office visit is the delivery of such an item or service, then a plan or issuer may not impose cost-sharing requirements with respect to the office visit.
(iii) If an item or service described in paragraph (a)(1) of this section is not billed separately (or is not tracked as individual encounter data separately) from an office visit and the primary purpose of the office visit is not the delivery of such an item or service, then a plan or issuer may impose cost-sharing requirements with respect to the office visit.
(iv) The rules of this paragraph (a)(2) are illustrated by the following examples:
Example 1.
(i) Facts. An individual covered by a group health plan visits an in-network health care provider. While visiting the provider, the individual is screened for cholesterol abnormalities, which has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force with respect to the individual. The provider bills the plan for an office visit and for the laboratory work of the cholesterol screening test.
(ii) Conclusion. In this Example 1, the plan may not impose any cost-sharing requirements with respect to the separately-billed laboratory work of the cholesterol screening test. Because the office visit is billed separately from the cholesterol screening test, the plan may impose cost-sharing requirements for the office visit.
Example 2.
(i) Facts. Same facts as Example 1. As the result of the screening, the individual is diagnosed with hyperlipidemia and is prescribed a course of treatment that is not included in the recommendations under paragraph (a)(1) of this section.
(ii) Conclusion. In this Example 2, because the treatment is not included in the recommendations under paragraph (a)(1) of this section, the plan is not prohibited from imposing cost-sharing requirements with respect to the treatment.
Example 3.
(i) Facts. An individual covered by a group health plan visits an in-network health care provider to discuss recurring abdominal pain. During the visit, the individual has a blood pressure screening, which has in effect a rating of A or B in the current recommendations of the United States Preventive Services Task Force with respect to the individual. The provider bills the plan for an office visit.
(ii) Conclusion. In this Example 3, the blood pressure screening is provided as part of an office visit for which the primary purpose was not to deliver items or services described in paragraph (a)(1) of this section. Therefore, the plan may impose a cost-sharing requirement for the office visit charge.
Example 4.
(i) Facts. A child covered by a group health plan visits an in-network pediatrician to receive an annual physical exam described as part of the comprehensive guidelines supported by the Health Resources and Services Administration. During the office visit, the child receives additional items and services that are not described in the comprehensive guidelines supported by the Health Resources and Services Administration, nor otherwise described in paragraph (a)(1) of this section. The provider bills the plan for an office visit.
(ii) Conclusion. In this Example 4, the service was not billed as a separate charge and was billed as part of an office visit. Moreover, the primary purpose for the visit was to deliver items and services described as part of the comprehensive guidelines supported by the Health Resources and Services Administration. Therefore, the plan may not impose a cost-sharing requirement for the office visit charge.
(3) Out-of-network providers.
(i) Subject to paragraphs (a)(3)(ii) and (iii) of this section, nothing in this section requires a plan or issuer that has a network of providers to provide benefits for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing cost-sharing requirements for items or services described in paragraph (a)(1) of this section that are delivered by an out-of-network provider.
(ii) If a plan or issuer does not have in its network a provider who can provide an item or service described in paragraph (a)(1) of this section, the plan or issuer must cover the item or service when performed by an out-of-network provider, and may not impose cost sharing with respect to the item or service.
(iii) A plan or issuer must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for any qualifying coronavirus preventive service described in paragraph (a)(1)(v) of this section, regardless of whether such service is delivered by an in-network or out-of-network provider. For purposes of this paragraph (a)(3)(iii), with respect to a qualifying coronavirus preventive service and a provider with whom the plan or issuer does not have a negotiated rate for such service (such as an out-of-network provider), the plan or issuer must reimburse the provider for such service in an amount that is reasonable, as determined in comparison to prevailing market rates for such service.
(4) Reasonable medical management. Nothing prevents a plan or issuer from using reasonable medical management techniques to determine the frequency, method, treatment, or setting for an item or service described in paragraph (a)(1) of this section to the extent not specified in the relevant recommendation or guideline. To the extent not specified in a recommendation or guideline, a plan or issuer may rely on the relevant clinical evidence base and established reasonable medical management techniques to determine the frequency, method, treatment, or setting for coverage of a recommended preventive health service.
(5) Services not described. Nothing in this section prohibits a plan or issuer from providing coverage for items and services in addition to those recommended by the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, or provided for by guidelines supported by the Health Resources and Services Administration, or from denying coverage for items and services that are not recommended by that task force or that advisory committee, or under those guidelines. A plan or issuer may impose cost-sharing requirements for a treatment not described in paragraph (a)(1) of this section, even if the treatment results from an item or service described in paragraph (a)(1) of this section.
(b) Timing.
(1) A plan or issuer must provide coverage pursuant to paragraph (a)(1) of this section for plan years (in the individual market, policy years) that begin on or after September 23, 2010, or, if later, for plan years (in the individual market, policy years) that begin on or after the date that is one year after the date the recommendation or guideline is issued, except as provided in paragraph (b)(3) of this section.
(2) Changes in recommendations or guidelines.
(i) A plan or issuer that is required to provide coverage for any items and services specified in any recommendation or guideline described in paragraph (a)(1) of this section on the first day of a plan year (in the individual market, policy year), or as otherwise provided in paragraph (b)(3) of this section, must provide coverage through the last day of the plan or policy year, even if the recommendation or guideline changes or is no longer described in paragraph (a)(1) of this section, during the applicable plan or policy year.
(ii) Notwithstanding paragraph (b)(2)(i) of this section, to the extent a recommendation or guideline described in paragraph (a)(1)(i) of this section that was in effect on the first day of a plan year (in the individual market, policy year), or as otherwise provided in paragraph (b)(3) of this section, is downgraded to a “D” rating, or any item or service associated with any recommendation or guideline specified in paragraph (a)(1) of this section is subject to a safety recall or is otherwise determined to pose a significant safety concern by a Federal agency authorized to regulate the item or service during a plan or policy year, there is no requirement under this section to cover these items and services through the last day of the applicable plan or policy year.
(3) Rapid coverage of preventive services for coronavirus. In the case of a qualifying coronavirus preventive service described in paragraph (a)(1)(v) of this section, a plan or issuer must provide coverage for such item, service, or immunization in accordance with this section by the date that is 15 business days after the date on which a recommendation specified in paragraph (a)(1)(v)(A) or (B) of this section is made relating to such item, service, or immunization.
(c) Recommendations not current. For purposes of paragraph (a)(1)(i) of this section, and for purposes of any other provision of law, recommendations of the United States Preventive Services Task Force regarding breast cancer screening, mammography, and prevention issued in or around November 2009 are not considered to be current.
(d) Applicability date. The provisions of this section apply for plan years (in the individual market, for policy years) beginning on or after September 23, 2010. See § 147.140 of this part for determining the application of this section to grandfathered health plans (providing that these rules regarding coverage of preventive health services do not apply to grandfathered health plans).
(e) Sunset date. The provisions of paragraphs (a)(1)(v), (a)(3)(iii), and (b)(3) of this section will not apply with respect to a qualifying coronavirus preventive service furnished on or after the expiration of the public health emergency determined on January 31, 2020, to exist nationwide as of January 27, 2020, by the Secretary of Health and Human Services pursuant to section 319 of the Public Health Service Act, as a result of COVID–19, including any subsequent renewals of that determination.
[75 FR 41759, July 19, 2010, as amended at 76 FR 46626, Aug. 3, 2011; 78 FR 39896, July 2, 2013; 80 FR 41346, July 14, 2015; 82 FR 47833, 47861, Oct. 13, 2017; 85 FR 71202, Nov. 6, 2020]
75 Fed. Reg. 41,726 (July 19, 2010)
78 Fed. Reg. 4594 (Jan. 22, 2013)
78 Fed. Reg. 42,160 (July 15, 2013)
Affordable Care Act Litigation 