Braidwood Management Inc. v. Xavier Becerra

CourtDistrict Court, N.D. Texas
DecidedSeptember 7, 2022
Docket4:20-cv-00283
StatusUnknown

This text of Braidwood Management Inc. v. Xavier Becerra (Braidwood Management Inc. v. Xavier Becerra) is published on Counsel Stack Legal Research, covering District Court, N.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Braidwood Management Inc. v. Xavier Becerra, (N.D. Tex. 2022).

Opinion

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION BRAIDWOOD MANAGEMENT INC. et § al., § § Plaintiffs, § § v. § Civil Action No. 4:20-cv-00283-O § XAVIER BECERRA et al., § § Defendants. § MEMORANDUM OPINION & ORDER Before the Court are Plaintiffs’ Motion for Summary Judgment (ECF Nos. 44–46), filed November 15, 2021; Defendants’ Combined Response and Cross-Motion for Summary Judgment (ECF Nos. 62–65), filed January 28, 2022; Plaintiffs’ Combined Response and Reply (ECF No. 74), filed March 28, 2022; and Defendants’ Reply (ECF No. 83), filed May 26, 2022. The Court held a hearing on the motions on July 26, 2022. Having considered the motions, arguments, and applicable law, the Court ORDERS that motions are GRANTED in part and DENIED in part. I. BACKGROUND A. The Law The Patient Protection and Affordable Care Act (“ACA”) requires most private health insurance to cover certain “preventive care.” 42 U.S.C. § 300gg-13. Specifically, group health plans and health insurance issuers must “provide coverage for and shall not impose any cost sharing requirements for” four categories of preventive care. Id. The ACA empowers three agencies affiliated with the Department of Health and Human Services (“HHS”) to determine what services fall within those four categories. Id. First, the U.S. Preventive Services Task Force (“PSTF”) recommends “evidence-based items or services that have in effect a rating of ‘A’ or ‘B.’” Id. § 300gg-13(a)(1). Second, the Advisory Committee on Immunization Practices (“ACIP”) recommends certain immunizations. Id. § 300gg-13(a)(2). Third, the Health Resources and Services Administration (“HRSA”) issues “comprehensive guidelines” with respect to infants, children, and adolescents for “evidence-

informed preventive care and screenings.” Id. § 300gg-13(a)(3). And fourth, HRSA issues “comprehensive guidelines” with respect to women for “such additional preventive care and screenings” not covered under § 300gg-13(a)(1). Id. § 300gg-13(a)(4). Private health insurance must cover the services identified by the three agencies under these categories.1 Id. § 300gg-13(a). 1. PSTF PSTF is a body of volunteers “with appropriate expertise” to make healthcare recommendations. 42 U.S.C. § 299b-4(a)(1). The Director of the Agency for Healthcare Research and Quality (“AHRQ”), an agency within HHS, “convene[s]” PSTF. Id. The purpose of PSTF is to “review the scientific evidence related to the effectiveness, appropriateness, and cost- effectiveness of clinical preventive services for the purpose of developing recommendations for

the health care community, and updating previous clinical preventive recommendations.” Id. By statute, PSTF and its members “shall be independent and, to the extent practicable, not subject to political pressure.” Id. § 299b-4(a)(6). In 2019, PSTF recommended pre-exposure prophylaxis (“PrEP”) drugs to prevent HIV infection. See Defs.’ App. 385, ECF No. 65. PSTF issued an “A” recommendation for PrEP drugs for individuals who are at high risk of HIV acquisition, which meant that health insurance plans must cover PrEP drugs under 42 U.S.C. § 300gg-13(a)(1). See Pls.’ App. 12, ECF No. 46. The

1 The Court refers to § 300gg-13(a)(1) through (a)(4) collectively as the “preventive-care mandates.” regulations delayed implementation of the coverage until June 2020. See 45 C.F.R. § 147.130(b)(1). 2. ACIP The HHS Secretary created ACIP as an advisory council under 42 U.S.C. § 217a(a) to provide guidance to HHS on vaccines. See Defs.’ App. 152, ECF No. 65. ACIP reports to the

Director of the Centers for Disease Control and Prevention (“CDC”), who exercises delegated authority from the HHS Secretary. See id. (first citing 42 U.S.C. § 243; and then citing id. § 247b). A vaccine recommendation from ACIP “is considered in effect after it has been adopted by the Director of the [CDC].” 45 C.F.R. § 147.130(a)(1)(ii). Once the CDC Director adopts a vaccine recommendation, ACIP publishes the recommendation in a weekly report. See Defs.’ App. 152, ECF No. 65. ACIP recommends the HPV vaccine to prevent new HPV infections and HPV-associated diseases, including some cancers. In 2007, ACIP began recommending the HPV vaccine for females ages eleven to twelve. See CDC, Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP) (Mar. 23, 2007),

https://www.cdc.gov/mmwr/PDF/rr/rr5602.pdf. ACIP currently recommends the HPV vaccine for all children ages eleven to twelve, plus various catch-up vaccination plans for older populations. See Elissa Meites et al., Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices (Aug. 16, 2019), https:// www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6832a3-H.pdf. Health insurance plans must cover the HPV vaccine under 42 U.S.C. § 300gg-13(a)(2). 3. HRSA The HHS Secretary created HRSA to provide direction to programs and activities within HHS. See Health Resources and Services Administration; Statement of Organization, Functions, and Delegations of Authority, 47 Fed. Reg. 38,409 (Aug. 31, 1982). HRSA is directed by an Administrator who reports to the Assistant Secretary of HHS. Id. at 38,410. The HRSA Administrator, like the CDC Director, is a non-career political appointee whose employment may be terminated by the agency at any time. See 5 C.F.R. § 317.605; Defs.’ App. 42, ECF No. 65. In 2010, HRSA promulgated a series of comprehensive guidelines for infants, children,

and adolescents. The guidelines include counseling for alcohol abuse, screening and behavioral counseling for sexually transmitted infections, screening and behavior interventions for obesity, and counseling for tobacco use. See Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act, 75 Fed. Reg. 41,726, 47,740–55 (July 19, 2010). “[A] recommendation or guideline in the comprehensive guidelines supported by HRSA is considered to be issued on the date on which it is accepted by the Administrator of HRSA or, if applicable, adopted by the Secretary of HHS.” Coverage of Certain Preventive Services Under the Affordable Care Act, 80 Fed. Reg. 41,318, 41,322 (July 14, 2015).

In 2011, HRSA promulgated additional guidelines requiring nonexempt employers to cover “[a]ll Food and Drug Administration [(FDA)] approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity.” RIN 1545-BJ60, 77 Fed. Reg. 8,725, 8,725 & n.1 (Feb. 15, 2012) (citation and internal quotation marks omitted). Those guidelines became known as the contraceptive mandate. See Burwell v. Hobby Lobby Stores, Inc., 573 U.S. 682 (2014). Health insurance plans must cover the services recommended by HRSA under 42 U.S.C. § 300gg-13(a)(3) and (a)(4). B.

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Braidwood Management Inc. v. Xavier Becerra, Counsel Stack Legal Research, https://law.counselstack.com/opinion/braidwood-management-inc-v-xavier-becerra-txnd-2022.