View all text of Subpart D [§ 460.40 - § 460.56]

§ 460.40 - Violations for which CMS may impose sanctions.

(a) In addition to other remedies authorized by law, CMS may impose any of the sanctions specified in §§ 460.42 and 460.46 if CMS determines that a PACE organization commits any of the following violations:

(1) Fails substantially to provide to a participant medically necessary items and services that are covered PACE services, if the failure has adversely affected (or has substantial likelihood of adversely affecting) the participant.

(2) Involuntarily disenrolls a participant in violation of § 460.164.

(3) Discriminates in enrollment or disenrollment among Medicare beneficiaries or Medicaid beneficiaries, or both, who are eligible to enroll in a PACE program, on the basis of an individual's health status or need for health care services.

(4) Engages in any practice that would reasonably be expected to have the effect of denying or discouraging enrollment, except as permitted by § 460.150, by Medicare beneficiaries or Medicaid beneficiaries whose medical condition or history indicates a need for substantial future medical services.

(5) Imposes charges on participants enrolled under Medicare or Medicaid for premiums in excess of the premiums permitted.

(6) Misrepresents or falsifies information that is furnished—

(i) To CMS or the State under this part; or

(ii) To an individual or any other entity under this part.

(7) Prohibits or otherwise restricts a covered health care professional from advising a participant who is a patient of the professional about the participant's health status, medical care, or treatment for the participant's condition or disease, regardless of whether the PACE program provides benefits for that care or treatment, if the professional is acting within his or her lawful scope of practice.

(8) Operates a physician incentive plan that does not meet the requirements of section 1876(i)(8) of the Act.

(9) Employs or contracts with any individual who is excluded from participation in Medicare or Medicaid under section 1128 or section 1128A of the Act (or with any entity that employs or contracts with that individual) for the provision of health care, utilization review, medical social work, or administrative services.

(10) Makes payment to any individual or entity that is included on the preclusion list, defined in § 422.2 of this chapter.

(b) If CMS or the State administering agency makes a determination under § 460.50 that could lead to termination of a PACE program agreement, CMS may impose any of the sanctions specified at §§ 460.42 and 460.46. If CMS or the State administering agency determines that the circumstances in § 460.50(b)(1) exist, neither CMS nor the State administrating agency has to determine that the circumstances in § 460.50(b)(2) exist prior to imposing a CMP or enrollment and/or payment suspension.

[64 FR 66279, Nov. 24, 1999, as amended at 81 FR 80561, Nov. 15, 2016; 83 FR 16756, Apr. 16, 2018; 84 FR 25672, June 3, 2019; 88 FR 22345, Apr. 12, 2023]