C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 421—MEDICARE CONTRACTING › Subpart A—Scope, Definitions, and General Provisions

42 C.F.R. § 421.5

General provisions

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(a) Competitive bidding not required for carriers. CMS may enter into contracts with carriers, or with intermediaries to act as carriers in certain circumstances, without regard to section 3709 of the U.S. Revised Statutes or any other provision of law that requires competitive bidding.

(b) Indemnification of intermediaries and carriers. Intermediaries and carriers act on behalf of CMS in carrying out certain administrative responsibilities that the law imposes. Accordingly, their agreements and contracts contain clauses providing for indemnification with respect to actions taken on behalf of CMS and CMS is the real party of interest in any litigation involving the administration of the program.

(c) Use of intermediaries to perform carrier functions. CMS may contract with an intermediary to perform carrier functions with respect to services for which Part B payment is made to a provider.

(d) Nonrenewal of agreement or contract. Notwithstanding any of the provisions of this part, CMS has the authority not to renew an agreement or contract when its term expires.

(e) Intermediary availability in an area. For more effective and efficient administration of the program, CMS retains the right to expand or diminish the geographical area in which an intermediary is available to serve providers.

(f) Provision for automatic renewal. Agreements and contracts under this part may contain automatic renewal clauses for continuation from term to term unless either party gives notice, within timeframes specified in the agreement or contract, of its intention not to renew.

[45 FR 42179, June 23, 1980, as amended at 54 FR 4026, Jan. 27, 1989]
Notes of Decisions
Cited in 81 cases (6 in the last 5 years), 1982–2026 · leading case: Ohio State Chiropractic Ass'n v. Humana Health Plan Inc., 647 F. App'x 619 (6th Cir. 2016).
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Ohio State Chiropractic Ass'n v. Humana Health Plan Inc., 647 F. App'x 619 (6th Cir. 2016). · cites it 3× “In return, the insurers “act on behalf of CMS,” 42 C.F.R. § 421.5 (b), as “the Secretary’s agents,” Schweiker v.”
Lewis v. Clarke, 137 S. Ct. 1285 (2017). “See 42 C.F.R. § 421.5 (b) (2016) (providing that the Medicare Administrator "is the real party of interest in any litigation involving the administration of the program").”
Kailash C. Pani, M.D., & Kailash C. Pani, M.D., P.C. v. Empire Blue Cross Blue Shield, 152 F.3d 67 (2d Cir. 1998). · cites it 2× “Accordingly, their agreements and contracts contain clauses providing for indemnification with respect to actions taken on behalf of HCFA and HCFA is the real party of interest in any litigation involving the administration of the program.”
Randall D. Wolcott, Md, Pa v. Sebelius, 635 F.3d 757 (5th Cir. 2011). “See 42 C.F.R. § 421.5 . These carriers process claims, determine whether services are covered by Medicare, and determine the amount of payment for services furnished, among other duties.”
Schweiker v. McClure, 456 U.S. 188 (1982). “See 42 CFR § 421.5 (b) (1980). They review and pay Part B claims for the *191 Secretary according to a precisely specified process.”
Willie Goffney, Jr. v. Xavier Becerra, 995 F.3d 737 (9th Cir. 2021). “§§ 1395u(a), 1395kk-1(a); 42 C.F.R. § 421.5 (b). Each Medicare contractor is responsible for a particular region of the country.”
United States v. Erika, Inc., 456 U.S. 201 (1982). “” 42 CFR § 421.5 (b) (1980). 5 The court found respondent’s constitutional claims “insubstantial,” citing Califano v.”
Medicare&medicaid Gu 34,507 Richard D. Bushman v. Joseph E. Seiler, 755 F.2d 653 (8th Cir. 1985). · cites it 2× “42 C.F.R. § 421.5 (b) (1983). It is well settled that Medicare intermediaries and carriers can be governmental agents for immunity purposes.”
In Re World Trade Ctr. Disaster Site Litig., 521 F.3d 169 (2d Cir. 2008). “3d at 74 (quoting 42 C.F.R. § 421.5 (b)). However, the regulation here does not afford equivalent protection to the Port Authority, as it states: "No assistance will be provided to an applicant for damages caused by its own negligence.”
Tidewater Mem'l Hosp., Inc. v. Bowen (In Re Tidewater Mem'l Hosp., Inc.), 106 B.R. 876 (Bankr. E.D. Va. 1989). · cites it 3× “To support this position the United States refers the Court to 42 C.F.R. § 421.5 (b) (1987). The Hospital contends that the Department of Health and Human Services is a proper defendant; however, the Hospital voluntarily amended its complaint to comply with the United States’…”
Del Campo v. Kennedy, 517 F.3d 1070 (9th Cir. 2008). “See 42 C.F.R. § 421.5 (b). 15 Their contracts therefore treat suits against them as against the sovereign governmental entity itself, rather than extending sovereignty to private parties.”
Grp. Health Inc. v. Blue Cross Ass'n, 625 F. Supp. 69 (S.D.N.Y. 1985). · cites it 3× “42 C.F.R. § 421.5 (b) (1984). 4 The fiscal intermediary, Blue Cross, therefore, is wrapped in the protective mantle of the government’s sovereign immunity, barring GHI’s suit.”
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— 42 C.F.R. § 421.5(b) — 5 cases
Kailash C. Pani, M.D., & Kailash C. Pani, M.D., P.C. v. Empire Blue Cross Blue Shield, 152 F.3d 67 (2d Cir. 1998). “Accordingly, their agreements and contracts contain clauses providing for indemnification with respect to actions taken on behalf of HCFA and HCFA is the real party of interest in any litigation involving the administration of the program.”
City of Worcester v. HCA Mgmt. Co., Inc., 753 F. Supp. 31 (D. Mass. 1990).
United States v. Aguillon, 628 F. Supp. 2d 542 (D. Del. 2009).
United States ex rel. Garbe v. Kmart Corp., 968 F. Supp. 2d 978 (S.D. Ill. 2013).
United States v. Carell, 782 F. Supp. 2d 553 (M.D. Tenn. 2011).
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