C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT › Subpart G—Payments to Part D Plan Sponsors For Qualified Prescription Drug Coverage

42 C.F.R. § 423.322

Requirement for disclosure of information

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(a) Payment conditional upon provision of information. Payments to a Part D sponsor are conditioned upon provision of information to CMS that is necessary to carry out this subpart, or as required by law.

(b) Restrictions on use of information. (1) Officers, employees, and contractors of the Department of Health and Human Services may use the information disclosed or obtained in accordance with the provisions of this subpart for the purposes of, and to the extent necessary—

(i) In carrying out this subpart, including, but not limited to, determination of payments, and payment-related oversight and program integrity activities.

(ii) In conducting oversight, evaluation, and enforcement under Title XVIII of the Act.

(2) The United States Attorney General and the Comptroller General of the United States may use the information disclosed or obtained in accordance with the provisions of this subpart for purposes of, and to the extent necessary in, carrying out health oversight activities.

(3) The restrictions described in paragraphs (b)(1) and (2) of this section do not limit either of the following:

(i) OIG's authority to fulfill the Inspector General's responsibilities in accordance with applicable Federal law.

(ii) CMS' ability to use data regarding drug claims in accordance with section 1848(m) of the Act.

[70 FR 4525, Jan. 28, 2005, as amended at 73 FR 54251, Sept. 18, 2008; 80 FR 7963, Feb. 12, 2015]
Notes of Decisions
Cited in 2 cases (1 in the last 5 years), 2012–2025 · leading case: United States ex rel. Spay v. CVS Caremark Corp., 913 F. Supp. 2d 125 (E.D. Pa. 2012).
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United States ex rel. Spay v. CVS Caremark Corp., 913 F. Supp. 2d 125 (E.D. Pa. 2012). · cites it 3× “” Within the confines of this title, 42 C.F.R. § 423.322 discusses the “Requirement for Disclosure of Information” and states, in pertinent part, that “Payments to a Part D sponsor are conditioned upon provision of information to CMS that is necessary to carry out this subpart,…”
Humana Inc. v. Biogen, Inc., 126 F.4th 94 (1st Cir. 2025). “Citing 42 C.F.R. § 423.322 , Humana alleges that the electronic record of the claim that the pharmacy submits to the insurer is called a Prescription Drug Event ("PDE"), and that generating and submitting PDE data is a condition of payment for CMS's provision of Medicare funds…”
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