42 C.F.R. § 421.1

Basis, applicability, and scope

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(a) Basis. This part is based on the provisions of the following sections of the Act:

Section 1124—Requirements for disclosure of certain information.

Sections 1816 and 1842—Provisions relating to the administration of Parts A and B.

Section 1893—Requirements for protecting the integrity of the Medicare program.

(b) Applicability. The provisions of this part apply to agreements with Part A (Hospital Insurance) fiscal intermediaries that received awards under sections 1816 or 1842 of the Act prior to October 1, 2005, contracts with Part B (Supplementary Medical Insurance) carriers that received awards under sections 1816 or 1842 of the Act prior to October 1, 2005, and contracts with Medicare integrity program contractors that perform program integrity functions.

(c) Scope. The scope of this part—

(1) Specifies that CMS may perform certain functions directly or by contract.

(2) Specifies criteria and standards CMS uses in evaluating the performance of fiscal intermediaries' successor entities and in assigning or reassigning a provider or providers to particular fiscal intermediaries.

(3) Provides the opportunity for a hearing for fiscal intermediaries and carriers affected by certain adverse actions.

(4) Provides adversely affected fiscal intermediaries an opportunity for judicial review of certain hearing decisions.

(5) Sets forth requirements related to contracts with Medicare integrity program contractors.

[72 FR 48886, Aug. 24, 2007]
Notes of Decisions
Cited in 20 cases, 1984–2019 · leading case: Ne. Hosp. Corp. v. Sebelius, 657 F.3d 1 (D.C. Cir. 2011).
Ne. Hosp. Corp. v. Sebelius, 657 F.3d 1 (D.C. Cir. 2011). · cites it 2× “See 42 C.F.R. §§ 421.1 , 421.3, 421.100-.128.”
In Re Medicare Reimbursement Litig., 414 F.3d 7 (D.C. Cir. 2005). “2001) — usually insurance companies that serve as the Secretary’s agents for purposes of reimbursing health care providers, 42 C.F.R. §§ 421.1 , 421.3; see generally id.”
Baystate Med. Ctr. v. Leavitt, 545 F. Supp. 2d 20 (D.D.C. 2008). “See 42 C.F.R. §§ 421.1 , 421.3, 421.100-.128.”
United States v. Garrison, 133 F.3d 831 (11th Cir. 1998). “42 C.F.R. § 421.1 . 5 .A suspension of payments can be made without notice to the healthcare provider if the fiscal intermediaiy determines that the claims for Medicare reimbursement "involve!] fraud or willful misrepresentation.”
Catholic Health Initiatives Iowa Corp. v. Sebelius, 718 F.3d 914 (D.C. Cir. 2013). “See 42 C.F.R. §§ 421.1 , 421.3, 421.100-.128.”
Ne. Hosp. Corp. v. Sebelius, 699 F. Supp. 2d 81 (D.D.C. 2010). “See 42 C.F.R. §§ 421.1 , 421.3, 421.100-.128.”
Provident Life & Accident Ins. v. United States, 740 F. Supp. 492 (E.D. Tenn. 1990). “§§ 1395h, 1395u; 42 C.F.R. §§ 421.1 et seq. Provident is neither an intermediary nor a carrier.”
Auburn Reg'l Med. Ctr. v. Sebelius, 686 F. Supp. 2d 55 (D.D.C. 2010). “See 42 C.F.R. §§ 421.1 , 421.3, 421.100-.128.”
Catholic Health Initiatives Iowa Corp. v. Sebelius, 841 F. Supp. 2d 270 (D.D.C. 2012). “See 42 C.F.R. §§ 421.1 , 421.3, 421.100-.128.”
Covenant Health Sys. v. Sebelius, 820 F. Supp. 2d 4 (D.D.C. 2011). “See 42 C.F.R. §§ 421.1 , 421.3, 421.100-.128.”
Allina Health Servs. v. Sebelius, 904 F. Supp. 2d 75 (D.D.C. 2012). “42 C.F.R. §§ 421.1 , 421.3, 421.100-.128.”
Allina Health Sys. v. Sebelius, 982 F. Supp. 2d 1 (D.D.C. 2013). “If a hospital disputes the intermediary’s calculations, it may then appeal the determination to the Provider Reimbursement Review Board (“PRRB”), an administrative tribunal appointed by the Secretary.”
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