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e-CFR data is current as of August 5, 2020

Title 42Chapter IVSubchapter EPart 460 → Subpart D


Title 42: Public Health
PART 460—PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)


Subpart D—Sanctions, Enforcement Actions, and Termination


Contents
§460.40   Violations for which CMS may impose sanctions.
§460.42   Suspension of enrollment or payment by CMS.
§460.46   Civil money penalties.
§460.48   Additional actions by CMS or the State.
§460.50   Termination of PACE program agreement.
§460.52   Transitional care during termination.
§460.54   Termination procedures.

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§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 that could lead to termination of a PACE program agreement under §460.50, CMS may impose any of the sanctions specified at §§460.42 and 460.46.

[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]

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§460.42   Suspension of enrollment or payment by CMS.

(a) Enrollment. If a PACE organization commits one or more violations specified in §460.40, CMS may suspend enrollment of Medicare beneficiaries after the date CMS notifies the organization of the violation.

(b) Payment. If a PACE organization commits one or more violations specified in §460.40, for individuals enrolled after the date CMS notifies the PACE organization of the violation, CMS may take the following actions:

(1) Suspend Medicare payment to the PACE organization.

(2) Deny payment to the State for medical assistance for services furnished under the PACE program agreement.

(c) Term of suspension. A suspension or denial of payment remains in effect until CMS is satisfied that the following conditions are met:

(1) The PACE organization has corrected the cause of the violation.

(2) The violation is not likely to recur.

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§460.46   Civil money penalties.

(a) CMS may impose civil money penalties up to the maximum amounts specified in paragraphs (a)(1) through (4) of this section. These amounts will be adjusted in accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114-74) and updated amounts specified in 45 CFR part 102.

(1) For each violation regarding enrollment or disenrollment specified in §460.40(a)(3) or (4), $100,000 plus $15,000 for each individual not enrolled as a result of the PACE organization's discrimination in enrollment or disenrollment or practice that would deny or discourage enrollment.

(2) For each violation regarding excessive premiums specified in §460.40(a)(5), $25,000 plus double the excess amount above the permitted premium charged a participant by the PACE organization. (The excess amount charged is deducted from the penalty and returned to the participant).

(3) For each misrepresentation or falsification of information, specified in §460.40(a)(6)(i), $100,000.

(4) For any other violation specified in §460.40, $25,000.

(b) The provisions of section 1128A of the Act (other than subsections (a) and (b)) apply to a civil money penalty under this section in the same manner as they apply to a civil money penalty or proceeding under section 1128A(a).

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25672, June 3, 2019]

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§460.48   Additional actions by CMS or the State.

After consultation with the State administering agency, if CMS determines that the PACE organization is not in substantial compliance with requirements in this part, CMS or the State administering agency may take one or more of the following actions:

(a) Condition the continuation of the PACE program agreement upon timely execution of a corrective action plan.

(b) Withhold some or all payments under the PACE program agreement until the organization corrects the deficiency.

(c) Terminate the PACE program agreement.

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§460.50   Termination of PACE program agreement.

(a) Termination of agreement by CMS or State. CMS or a State administering agency may terminate at any time a PACE program agreement for cause, including, but not limited to the circumstances in paragraphs (b) or (c) of this section.

(b) Termination due to uncorrected deficiencies. CMS or the State administering agency may terminate a PACE program agreement if CMS or the State administering agency determines that both of the following circumstances exist:

(1) Either—

(i) There are significant deficiencies in the quality of care furnished to participants; or

(ii) The PACE organization failed to comply substantially with conditions for a PACE program or PACE organization under this part, or with terms of its PACE program agreement, including making payment to an individual or entity that is included on the preclusion list, defined in §422.2 of this chapter.

(2) Within 30 days of the date of the receipt of written notice of a determination made under paragraph (b)(1) of this section, the PACE organization failed to develop and successfully initiate a plan to correct the deficiencies, or failed to continue implementation of the plan of correction.

(c) Termination due to health and safety risk. CMS or a State administering agency may terminate a PACE program agreement if CMS or the State administering agency determines that the PACE organization cannot ensure the health and safety of its participants. This determination may result from the identification of deficiencies that CMS or the State administering agency determines cannot be corrected.

(d) Termination of agreement by PACE organization. A PACE organization may terminate an agreement after timely notice to CMS, the State administering agency, and participants, as follows:

(1) To CMS and the State administering agency, 90 days before termination.

(2) To participants, 60 days before termination.

[64 FR 66279, Nov. 24, 1999, as amended at 81 FR 80561, Nov. 15, 2016; 83 FR 16756, Apr. 16, 2018]

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§460.52   Transitional care during termination.

(a) The PACE organization must develop a detailed written plan for phase-down in the event of termination, which describes how the organization plans to take the following actions:

(1) Inform participants, the community, CMS and the State administering agency in writing about termination and transition procedures.

(2) Assist participants to obtain reinstatement of conventional Medicare and Medicaid benefits.

(3) Transition participants' care to other providers.

(4) Terminate marketing and enrollment activities.

(b) An entity whose PACE program agreement is in the process of being terminated must provide assistance to each participant in obtaining necessary transitional care through appropriate referrals and making the participant's medical records available to new providers.

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§460.54   Termination procedures.

(a) Except as provided in paragraph (b) of this section, if CMS terminates an agreement with a PACE organization, it furnishes the PACE organization with the following:

(1) A reasonable opportunity to develop and implement a corrective action plan to correct the deficiencies that were the basis of CMS's determination that cause exists for termination.

(2) Reasonable notice and opportunity for hearing (including the right to appeal an initial determination) before terminating the agreement.

(b) CMS may terminate an agreement without invoking the procedures described in paragraph (a) of this section if CMS determines that a delay in termination, resulting from compliance with these procedures before termination, would pose an imminent and serious risk to the health of participants enrolled with the organization.

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