---
kind: "range"
citation: "42 C.F.R. §§ 422.592–422.626"
title: "42"
from: "422.592"
to: "422.626"
count: 14
url: "https://uscodex.org/cfr/42/422.592..422.626"
---

# §422.592. Reconsideration by an independent entity.

- (a) When the MA organization affirms, in whole or in part, its adverse organization determination, the issues that remain in dispute must be reviewed and resolved by an independent, outside entity that contracts with CMS. In accordance with [§ 422.590(i)](/cfr/42/422.590.md?p=i), the independent entity is responsible for reviewing MA organization dismissals of reconsideration requests.
- (b) The independent outside entity must conduct the review as expeditiously as the enrollee's health condition requires but must not exceed the deadlines specified in the contract.
- (c) When the independent entity conducts a reconsideration, the parties to the reconsideration are the same parties listed in [§ 422.582(d)](/cfr/42/422.582.md?p=d) who qualified during the MA organization's reconsideration, with the addition of the MA organization.
- (d) The independent entity dismisses a reconsideration request, either entirely or as to any stated issue, under any of the following circumstances:
  - (1) The person or entity requesting a reconsideration is not a proper party under [§ 422.578](/cfr/42/422.578.md).
  - (2) The independent entity determines the party failed to make out a valid request for a reconsideration that substantially complies with § [422.582(a)](/cfr/42/422.582.md?p=a) or [(b)](/cfr/42/422.582.md?p=b).
  - (3) The enrollee or the enrollee's representative files a request for a reconsideration, but the enrollee dies while the request is pending, and both of the following criteria apply:
    - (i) **The enrollee's surviving spouse or estate has no remaining financial interest in the case.**
    - (ii) No other individual or entity with a financial interest in the case wishes to pursue the reconsideration.
  - (4) The party filing the reconsideration request submits with the independent review entity a timely request for withdrawal of the request for reconsideration.
- (e) The independent entity mails or otherwise transmits a written notice of the dismissal of the reconsideration request to the parties. The notice must state the following:
  - (1) **The reason for the dismissal.**
  - (2) **That there is a right to request that the independent entity vacate the dismissal action.**
  - (3) The right to a review of the dismissal under §§ [422.600](/cfr/42/422.600.md) and [422.602](/cfr/42/422.602.md).
- (f) If good cause is established, the independent entity may vacate its dismissal of a request for reconsideration within 6 months from the date of the notice of dismissal.
- (g) The independent entity's dismissal is binding and not subject to further review unless a party meets the requirements in [§ 422.600](/cfr/42/422.600.md) and files a proper and timely request under [§ 422.602](/cfr/42/422.602.md) or the dismissal is vacated under [paragraph (f)](#f) of this section.
- (h) The party or physician acting on behalf of an enrollee who files a request for reconsideration may withdraw the request by filing a request for withdrawal with the independent entity.
- (i) If the independent entity determines that the MA organization's dismissal was in error, the independent entity vacates the dismissal and remands the case to the plan for reconsideration consistent with [§ 422.590](/cfr/42/422.590.md). The independent entity's decision regarding an MA organization's dismissal, including a decision to deny a request for review of a dismissal, is binding and not subject to further review.

# §422.594. Notice of reconsidered determination by the independent entity.

- (a) **Responsibility for the notice.** When the independent entity makes the reconsidered determination, it is responsible for mailing a notice of its reconsidered determination to the parties and for sending a copy to CMS.
- (b) **Content of the notice.** The notice must—
  - (1) State the specific reasons for the entity's decisions in understandable language;
  - (2) If the reconsidered determination is adverse (that is, does not completely reverse the MA organization's adverse organization determination), inform the parties of their right to an ALJ hearing if the amount in controversy meets the requirements of [§ 422.600](/cfr/42/422.600.md);
  - (3) Describe the procedures that a party must follow to obtain an ALJ hearing; and
  - (4) **Comply with any other requirements specified by CMS.**

# §422.596. Effect of a reconsidered determination.


A reconsidered determination is final and binding on all parties unless a party other than the MA organization files a request for a hearing under the provisions of [§ 422.602](/cfr/42/422.602.md), or unless the reconsidered determination is revised under [§ 422.616](/cfr/42/422.616.md).


# §422.600. Right to a hearing.

- (a) If the amount remaining in controversy after reconsideration meets the threshold requirement established annually by the Secretary, any party to the reconsideration (except the MA organization) who is dissatisfied with the reconsidered determination has a right to a hearing before an ALJ.
- (b) The amount remaining in controversy, which can include any combination of Part A and Part B services, is computed in accordance with [part 405](/cfr/42/part405.md) of this chapter. For purposes of calculating the amount remaining in controversy under this section, references to coinsurance in [§ 405.1006(d)](/cfr/42/405.1006.md?p=d) of this chapter should be read to include coinsurance and copayment amounts.
- (c) If the basis for the appeal is the MA organization's refusal to provide services, CMS uses the projected value of those services to compute the amount remaining in controversy.

# §422.602. Request for an ALJ hearing.

- (a) **How and where to file a request.** A party must file a written request for a hearing with the entity specified in the IRE's reconsideration notice.
- (b) **When to file a request.**
  - (1) Except when an ALJ or attorney adjudicator extends the time frame as provided in [part 405](/cfr/42/part405.md) of this chapter, a party must file a request for a hearing within 60 calendar days of receipt of the notice of a reconsidered determination. The time and place for a hearing before an ALJ will be set in accordance with [§ 405.1020](/cfr/42/405.1020.md) of this chapter.
  - (2) For purposes of this section, the date of receipt of the reconsideration is presumed to be 5 calendar days after the date of the notice of the reconsidered determination, unless there is evidence to the contrary.
- (c) **Parties to a hearing.** The parties to a hearing are the parties to the reconsideration, the MA organization, and any other person or entity whose rights with respect to the reconsideration may be affected by the hearing, as determined by the ALJ.
- (d) **Insufficient amount in controversy.**
  - (1) If a request for a hearing clearly shows that the amount in controversy is less than that required under [§ 422.600](/cfr/42/422.600.md), the ALJ dismisses the request.
  - (2) If, after a hearing is initiated, the ALJ finds that the amount in controversy is less than the amount required under [§ 422.600](/cfr/42/422.600.md), the ALJ discontinues the hearing and does not rule on the substantive issues raised in the appeal.

# §422.608. Medicare Appeals Council (Council) review.


Any party to the ALJ's or attorney adjudicator's decision or dismissal, including the MA organization, who is dissatisfied with the decision or dismissal, may request that the Council review the decision or dismissal. The regulations under [part 405](/cfr/42/part405.md) of this chapter regarding Council review apply to matters addressed by this subpart to the extent that they are appropriate, except as provided in [§ 422.562(d)(2)](/cfr/42/422.562.md?p=d-2).


# §422.612. Judicial review.

- (a) **Review of ALJ's or attorney adjudicator's decision.** Any party, including the MA organization, may request judicial review (upon notifying the other parties) of an ALJ's or attorney adjudicator's decision if—
  - (1) The Council denied the party's request for review; and
  - (2) **The amount in controversy meets the threshold requirement established annually by the Secretary.**
- (b) **Review of Council decision.** Any party, including the MA organization, may request judicial review (upon notifying the other parties) of the Council decision if it is the final decision of CMS and the amount in controversy meets the threshold established in [paragraph (a)(2)](#a-2) of this section.
- (c) **How to request judicial review.** In order to request judicial review, a party must file a civil action in a district court of the United States in accordance with [section 205(g)](/cfr/42/205.md?p=g) of the Act. See [part 405](/cfr/42/part405.md) of this chapter for a description of the procedures to follow in requesting judicial review.

# §422.616. Reopening and revising determinations and decisions.

- (a) Subject to [paragraph (e)](#e) of this section and the rules at [§ 422.138(c)](/cfr/42/422.138.md?p=c), an organization or reconsidered determination made by an MA organization, a reconsidered determination made by the independent entity described in [§ 422.592](/cfr/42/422.592.md), or the decision of an Administrative Law Judge (ALJ) or attorney adjudicator or the Council that is otherwise final and binding may be reopened and revised by the entity that made the determination or decision, under the rules in [part 405](/cfr/42/part405.md) of this chapter.
- (b) Reopening may be at the instigation of any party.
- (c) The filing of a request for reopening does not relieve the MA organization of its obligation to make payment or provide services as specified in [§ 422.618](/cfr/42/422.618.md).
- (d) Once an entity issues a revised determination or decision, any party may file an appeal.
- (e) If the MA organization approved an inpatient hospital admission under the rules at § [412.3(d)(1)](/cfr/42/412.3.md?p=d-1) and [(3)](/cfr/42/412.3.md?p=d-3) of this chapter, any additional clinical information obtained after the initial organization determination cannot be used as new and material evidence to establish good cause for reopening the determination.

# §422.618. How an MA organization must effectuate standard reconsidered determinations or decisions.

- (a) **Reversals by the MA organization—**
  - (1) **Requests for service.** If, on reconsideration of a request for service, the MA organization completely reverses its organization determination, the organization must authorize or provide the service under dispute as expeditiously as the enrollee's health condition requires, but no later than 30 calendar days after the date the MA organization receives the request for reconsideration (or no later than upon expiration of an extension described in [§ 422.590(f)](/cfr/42/422.590.md?p=f)).
  - (2) **Requests for payment.** If, on reconsideration of a request for payment, the MA organization completely reverses its organization determination, the organization must pay for the service no later than 60 calendar days after the date the MA organization receives the request for reconsideration.
  - (3) **Requests for a Part B drug.** If, on reconsideration of a request for a Part B drug, the MA organization completely reverses its organization determination, the MA organization must authorize or provide the Part B drug under dispute as expeditiously as the enrollee's health condition requires, but no later than 7 calendar days after the date the MA organization receives the request for reconsideration.
- (b) **Reversals by the independent outside entity—**
  - (1) **Requests for service.** If, on reconsideration of a request for service, the MA organization's determination is reversed in whole or in part by the independent outside entity, the MA organization must authorize the service under dispute within 72 hours from the date it receives notice reversing the determination, or provide the service under dispute as expeditiously as the enrollee's health condition requires, but no later than 14 calendar days from that date. The MA organization must inform the independent outside entity that the organization has effectuated the decision.
  - (2) **Requests for payment.** If, on reconsideration of a request for payment, the MA organization's determination is reversed in whole or in part by the independent outside entity, the MA organization must pay for the service no later than 30 calendar days from the date it receives notice reversing the organization determination. The MA organization must inform the independent outside entity that the organization has effectuated the decision.
  - (3) **Requests for a Part B drug.** If, on reconsideration of a request for a Part B drug, the MA organization's determination is reversed in whole or in part by the independent outside entity, the MA organization must authorize or provide the Part B drug under dispute within 72 hours from the date it receives notice reversing the determination. The MA organization must inform the independent outside entity that the organization has effectuated the decision.
- (c) **Reversals other than by the MA organization or the independent outside entity—**
  - (1) **General rule.** If the independent outside entity's determination is reversed in whole or in part by the ALJ or attorney adjudicator, or at a higher level of appeal, the MA organization must pay for, authorize, or provide the service under dispute as expeditiously as the enrollee's health condition requires, but no later than 60 calendar days from the date it receives notice reversing the determination. The MA organization must inform the independent outside entity that the organization has effectuated the decision or that it has appealed the decision.
  - (2) **Effectuation exception when the MA organization files an appeal with the Council.** If the MA organization requests Council review consistent with [§ 422.608](/cfr/42/422.608.md), the MA organization may await the outcome of the review before it pays for, authorizes, or provides the service under dispute. A MA organization that files an appeal with the Council must concurrently send a copy of its appeal request and any accompanying documents to the enrollee and must notify the independent outside entity that it has requested an appeal.

# §422.619. How an MA organization must effectuate expedited reconsidered determinations.

- (a) **Reversals by the MA organization—**
  - (1) **Requests for service or item.** If, on reconsideration of an expedited request for service, the MA organization completely reverses its organization determination, the MA organization must authorize or provide the service or item under dispute as expeditiously as the enrollee's health condition requires, but no later than 72 hours after the date the MA organization receives the request for reconsideration (or no later than upon expiration of an extension described in [§ 422.590(f)](/cfr/42/422.590.md?p=f)).
  - (2) **Requests for a Part B drug.** If, on reconsideration of a request for a Part B drug, the MA organization completely reverses its organization determination, the MA organization must authorize or provide the Part B drug under dispute as expeditiously as the enrollee's health condition requires, but no later than 72 hours after the date the MA organization receives the request for reconsideration.
- (b) **Reversals by the independent outside entity—**
  - (1) **Requests for service or item.** If the MA organization's determination is reversed in whole or in part by the independent outside entity, the MA organization must authorize or provide the service under dispute as expeditiously as the enrollee's health condition requires but no later than 72 hours from the date it receives notice reversing the determination. The MA organization must inform the independent outside entity that the organization has effectuated the decision.
  - (2) **Requests for a Part B drug.** If, on reconsideration of a request for a Part B drug, the MA organization's determination is reversed in whole or in part by the independent outside entity, the MA organization must authorize or provide the Part B drug under dispute as expeditiously as the enrollee's health condition requires but no later than 24 hours from the date it receives notice reversing the determination. The MA organization must inform the outside entity that the organization has effectuated the decision.
- (c) **Reversals other than by the MA organization or the independent outside entity—**
  - (1) **General rule.** If the independent outside entity's expedited determination is reversed in whole or in part by the ALJ or attorney adjudicator, or at a higher level of appeal, the MA organization must authorize or provide the service under dispute as expeditiously as the enrollee's health condition requires, but no later than 60 days from the date it receives notice reversing the determination. The MA organization must inform the independent outside entity that the organization has effectuated the decision.
  - (2) **Reversals of decisions related to Part B drugs.** If the independent outside entity's determination is reversed in whole or in part by an ALJ/attorney adjudicator or at a higher level of appeal, the MA organization must authorize or provide the Part B drug under dispute as expeditiously as the enrollee's health condition requires but no later than 24 hours from the date it receives notice reversing the determination. The MA organization must inform the outside entity that the organization has effectuated the decision.
  - (3) **Effectuation exception when the MA organization files an appeal with the Council.** If the MA organization requests Council review consistent with [§ 422.608](/cfr/42/422.608.md), the MA organization may await the outcome of the review before it authorizes or provides the service under dispute. A MA organization that files an appeal with the Council must concurrently send a copy of its appeal request and any accompanying documents to the enrollee and must notify the independent outside entity that it has requested an appeal.

# §422.620. Notifying enrollees of hospital discharge appeal rights.

- (a) **Applicability and scope.**
  - (1) For purposes of §§ 422.620 and [422.622](/cfr/42/422.622.md), the term hospital is defined as any facility providing care at the inpatient hospital level, whether that care is short term or long term, acute or non acute, paid through a prospective payment system or other reimbursement basis, limited to specialty care or providing a broader spectrum of services. This definition also includes critical access hospitals.
  - (2) For purposes of §§ 422.620 and [422.622](/cfr/42/422.622.md), a discharge is a formal release of an enrollee from an inpatient hospital.
- (b) **Advance written notice of hospital discharge rights.** For all Medicare Advantage enrollees, hospitals must deliver valid, written notice of an enrollee's rights as a hospital inpatient including discharge appeal rights. The hospital must use a standardized notice, as specified by CMS, in accordance with the following procedures:
  - (1) **Timing of notice.** The hospital must provide the notice at or near admission, but no later than 2 calendar days following the enrollee's admission to the hospital.
  - (2) **Content of the notice.** The notice of rights must include the following information:
    - (i) The enrollee's rights as a hospital inpatient, including the right to benefits for inpatient services and for post hospital services in accordance with 1866(a)(1)(M) of the Act.
    - (ii) The enrollee's right to request an immediate review, including a description of the process under [§ 422.622](/cfr/42/422.622.md) and the availability of other appeals processes if the enrollee fails to meet the deadline for an immediate review.
    - (iii) The circumstances under which an enrollee will or will not be liable for charges for continued stay in the hospital in accordance with 1866(a)(1)(M) of the Act.
    - (iv) The enrollee's right to receive additional information in accordance with section [§ 422.622(e)](/cfr/42/422.622.md?p=e).
    - (v) **Any other information required by CMS.**
  - (3) **When delivery of notice is valid.** Delivery of the written notice of rights described in this section is valid if—
    - (i) The enrollee (or the enrollee's representative) has signed and dated the notice to indicate that he or she has received the notice and can comprehend its contents, except as provided in [paragraph (b)(4)](#b-4) of this section; and
    - (ii) The notice is delivered in accordance with [paragraph (b)(1)](#b-1) of this section and contains all the elements described in [paragraph (b)(2)](#b-2) of this section.
  - (4) **If an enrollee refuses to sign the notice.** The hospital may annotate its notice to indicate the refusal, and the date of refusal is considered the date of receipt of the notice.
- (c) **Follow up notification.**
  - (1) The hospital must present a copy of the signed notice described in [paragraph (b)(2)](#b-2) of this section to the enrollee (or enrollee's representative) prior to discharge. The notice should be given as far in advance of discharge as possible, but not more than 2 calendar days before discharge.
  - (2) Follow up notification is not required if the notice required under 422.620(b) is delivered within 2 calendar days of discharge.
- (d) **Physician concurrence required.** Before discharging an enrollee from the inpatient hospital level of care, the MA organization must obtain concurrence from the physician who is responsible for the enrollee's inpatient care.

# §422.622. Requesting immediate QIO review of the decision to discharge from the inpatient hospital.

- (a) **Enrollee's right to an immediate QIO review.** An enrollee has a right to request an immediate review by the QIO when an MA organization or hospital (acting directly or through its utilization committee), with physician concurrence determines that inpatient care is no longer necessary.
- (b) **Requesting an immediate QIO review.**
  - (1) An enrollee who wishes to exercise the right to an immediate review must submit a request to the QIO that has an agreement with the hospital as specified in [§ 476.78](/cfr/42/476.78.md) of this chapter. The request must be made no later than the day of discharge and may be in writing or by telephone.
  - (2) The enrollee, or his or her representative, upon request by the QIO, must be available to discuss the case.
  - (3) The enrollee may, but is not required to, submit written evidence to be considered by a QIO in making its decision.
  - (4) An enrollee who makes a timely request for an immediate QIO review in accordance with [paragraph (b)(1)](#b-1) of this section is subject to the financial liability protections under [paragraph (f)](#f) of this section, as applicable.
  - (5) When an enrollee does not request an immediate QIO review in accordance with [paragraph (b)](#b) of this section, he or she may request expedited reconsideration by the MA organization as described in [§ 422.584](/cfr/42/422.584.md), but the financial liability rules of [paragraph (f)](#f) of this section do not apply.
- (c) **Burden of proof.** When an enrollee (or his or her representative, if applicable) requests an immediate review by a QIO, the burden of proof rests with the MA organization to demonstrate that discharge is the correct decision, either on the basis of medical necessity, or based on other Medicare coverage policies. Consistent with [paragraph (e)(2)](#e-2) of this section, the MA organization should supply any and all information that a QIO requires to sustain the organization's discharge determination.
- (d) **Procedures the QIO must follow.**
  - (1) When the QIO receives the enrollee's request for an immediate review under [paragraph (b)](#b), the QIO must notify the MA organization and the hospital that the enrollee has filed a request for an immediate review.
  - (2) The QIO determines whether the hospital delivered valid notice consistent with [§ 422.620(b)(3)](/cfr/42/422.620.md?p=b-3).
  - (3) **The QIO examines the medical and other records that pertain to the services in dispute.**
  - (4) The QIO must solicit the views of the enrollee (or his or her representative) who requested the immediate QIO review.
  - (5) The QIO must provide an opportunity for the MA organization to explain why the discharge is appropriate.
  - (6) When the enrollee requests an immediate QIO review in accordance with [paragraph (b)(1)](#b-1) of this section, the QIO must make a determination and notify the enrollee, the hospital, the MA organization, and the physician of its determination within one calendar day after it receives all requested pertinent information.
  - (7) If the QIO does not receive the information needed to sustain an MA organization's decision to discharge, it may make its determination based on the evidence at hand, or it may defer a decision until it receives the necessary information. If this delay results in extended Medicare coverage of an individual's hospital services, the MA organization may be held financially liable for these services, as determined by the QIO.
  - (8) When the QIO issues its determination, the QIO must notify the enrollee, the MA organization, the physician, and hospital of its decision by telephone, followed by a written notice that must include the following information:
    - (i) **The basis for the determination.**
    - (ii) **A detailed rationale for the determination.**
    - (iii) An explanation of the Medicare payment consequences of the determination and the date an enrollee becomes fully liable for the services.
    - (iv) Information about the enrollee's right to a reconsideration of the QIO's determination as set forth in [§ 422.626(f)](/cfr/42/422.626.md?p=f), including how to request a reconsideration and the time period for doing so.
- (e) **Responsibilities of the MA organization and hospital.**
  - (1) When the QIO notifies an MA organization that an enrollee has requested an immediate QIO review, the MA organization must, directly or by delegation, deliver a detailed notice to the enrollee as soon as possible, but no later than noon of the day after the QIO's notification. The detailed notice must include the following information:
    - (i) A detailed explanation of why services are either no longer reasonable and necessary or are no longer covered.
    - (ii) A description of any applicable Medicare coverage rule, instruction, or other Medicare policy including information about how the enrollee may obtain a copy of the Medicare policy from the MA organization.
    - (iii) Any applicable MA organization policy, contract provision, or rationale upon which the discharge determination was based.
    - (iv) Facts specific to the enrollee and relevant to the coverage determination sufficient to advise the enrollee of the applicability of the coverage rule or policy to the enrollee's case.
    - (v) **Any other information required by CMS.**
  - (2) Upon notification by the QIO of a request for an immediate review, the MA organization must supply any and all information, including a copy of the notices sent to the enrollee, as specified in § [422.620(b)](/cfr/42/422.620.md?p=b) and [(c)](/cfr/42/422.620.md?p=c) and [paragraph (e)(1)](#e-1) of this section, that the QIO needs to decide on the determination. The MA organization must supply this information as soon as possible, but no later than noon of the day after the QIO notifies the MA organization that a request for an expedited determination has been received from the enrollee. The MA organization must make the information available by phone (with a written record made of any information not transmitted initially in writing) and/or in writing, as determined by the QIO.
  - (3) In response to a request from the MA organization, the hospital must supply all information that the QIO needs to make its determination, including a copy of the notices required as specified in § [422.620(b)](/cfr/42/422.620.md?p=b) and [(c)](/cfr/42/422.620.md?p=c) and [paragraph (e)(1)](#e-1) of this section. The hospital must furnish this information as soon as possible, but no later than by close of business of the day the MA organization notifies the hospital of the request for information. At the discretion of the QIO, the hospital must make the information available by phone or in writing (with a written record of any information not transmitted initially in writing).
  - (4) Upon an enrollee's request, the MA organization must provide the enrollee a copy of, or access to, any documentation sent to the QIO by the MA organization, including written records of any information provided by telephone. The MA organization may charge the enrollee a reasonable amount to cover the costs of duplicating the documentation for the enrollee and/or delivering the documentation to the enrollee. The MA organization must accommodate such a request by no later than close of business of the first day after the day the material is requested.
- (f) **Coverage during QIO expedited review.**
  - (1) An MA organization is financially responsible for coverage of services as provided in this paragraph, regardless of whether it has delegated responsibility for authorizing coverage or discharge determinations to its providers.
  - (2) When the MA organization determines that hospital services are not, or are no longer, covered,
    - (i) If the MA organization authorized coverage of the inpatient admission directly or by delegation (or the admission constitutes emergency or urgently needed care, as described in §§ [422.2](/cfr/42/422.2.md) and [422.112(c)](/cfr/42/422.112.md?p=c)), the MA organization continues to be financially responsible for the costs of the hospital stay when an appeal is filed under paragraph (a)(1) of this section until noon of the day after the QIO notifies the enrollee of its review determination, except as provided in [paragraph (b)(5)](#b-5) of this section. If coverage of the hospital admission was never approved by the MA organization or the admission does not constitute emergency or urgently needed care as described in §§ [422.2](/cfr/42/422.2.md) and [422.112(c)](/cfr/42/422.112.md?p=c), the MA organization is liable for the hospital costs only if it is determined on appeal that the hospital stay should have been covered under the MA plan.
    - (ii) The hospital may not charge the MA organization (or the enrollee) if—
      - (A) It was the hospital (acting on behalf of the enrollee) that filed the request for immediate QIO review; and
      - (B) **The QIO upholds the non-coverage determination made by the MA organization.**
  - (3) If the QIO determines that the enrollee still requires inpatient hospital care, the hospital must provide the enrollee with a notice consistent with [§ 422.620(c)](/cfr/42/422.620.md?p=c) of this subpart when the hospital or MA organization once again determines that the enrollee no longer requires inpatient hospital care.
  - (4) If the hospital determines that inpatient hospital services are no longer necessary, the hospital may not charge the enrollee for inpatient services received before noon of the day after the QIO notifies the enrollee of its review determination.
- (g) **Effect of an expedited QIO determination.** The QIO determination is binding upon the enrollee, physician, hospital, and MA organization except in the following circumstances:
  - (1) **Right to request a reconsideration.** If the enrollee is still an inpatient in the hospital and is dissatisfied with the determination, he or she may request a reconsideration according to the procedures described in [§ 422.626(g)](/cfr/42/422.626.md?p=g).
  - (2) **Right to pursue the standard appeal process.** If the enrollee is no longer an inpatient in the hospital and is dissatisfied with this determination, the enrollee may appeal to OMHA for an ALJ hearing, the Council, or a Federal court, as provided for under this subpart.

# §422.624. Notifying enrollees of termination of provider services.

- (a) **Applicability.**
  - (1) For purposes of §§ 422.624 and [422.626](/cfr/42/422.626.md), the term provider includes home health agencies (HHAs), skilled nursing facilities (SNFs), and comprehensive outpatient rehabilitation facilities (CORFs).
  - (2) **Termination of service defined.** For purposes of this section and [§ 422.626](/cfr/42/422.626.md), a termination of service is the discharge of an enrollee from covered provider services, or discontinuation of covered provider services, when the enrollee has been authorized by the MA organization, either directly or by delegation, to receive an ongoing course of treatment from that provider. Termination includes cessation of coverage at the end of a course of treatment preauthorized in a discrete increment, regardless of whether the enrollee agrees that such services should end.
- (b) **Advance written notification of termination.** Prior to any termination of service, the provider of the service must deliver valid written notice to the enrollee of the MA organization's decision to terminate services. The provider must use a standardized notice, required by the Secretary, in accordance with the following procedures—
  - (1) **Timing of notice.** The provider must notify the enrollee of the MA organization's decision to terminate covered services no later than two days before the proposed end of the services. If the enrollee's services are expected to be fewer than two days in duration, the provider should notify the enrollee at the time of admission to the provider. If, in a non-institutional setting, the span of time between services exceeds two days, the notice should be given no later than the next to last time services are furnished.
  - (2) **Content of the notice.** The standardized termination notice must include the following information:
    - (i) **The date that coverage of services ends.**
    - (ii) **The date that the enrollee's financial liability for continued services begins.**
    - (iii) A description of the enrollee's right to a fast-track appeal under [§ 422.626](/cfr/42/422.626.md), including information about how to contact an independent review entity (IRE), an enrollee's right (but not obligation) to submit evidence showing that services should continue, and the availability of other MA appeal procedures if the enrollee fails to meet the deadline for a fast-track IRE appeal.
    - (iv) The enrollee's right to receive detailed information in accordance with § [422.626 (e)(1)](/cfr/42/422.626.md?p=e-1) and [(2)](/cfr/42/422.626.md?p=e-2).
    - (v) **Any other information required by the Secretary.**
- (c) **When delivery of notice is valid.** Delivery of the termination notice is not valid unless—
  - (1) The enrollee (or the enrollee's representative) has signed and dated the notice to indicate that he or she has received the notice and can comprehend its contents; and
  - (2) The notice is delivered in accordance with [paragraph (b)(1)](#b-1) of this section and contains all the elements described in [paragraph (b)(2)](#b-2) of this section.
- (d) **Financial liability for failure to deliver valid notice.** An MA organization is financially liable for continued services until 2 days after the enrollee receives valid notice as specified under [paragraph (c)](#c) of this section. An enrollee may waive continuation of services if he or she agrees with being discharged sooner than 2 days after receiving the notice.

# §422.626. Fast-track appeals of service terminations to independent review entities (IREs).

- (a) **Enrollee's right to a fast-track appeal of an MA organization's termination decision.** An enrollee of an MA organization has a right to a fast-track appeal of an MA organization's decision to terminate provider services.
  - (1) An enrollee who desires a fast-track appeal must submit a request for an appeal to an IRE under contract with CMS, in writing or by telephone, by noon of the first day after the day of delivery of the termination notice. If, due to an emergency, the IRE is closed and unable to accept the enrollee's request for a fast-track appeal, the enrollee must file a request by noon of the next day that the IRE is open for business.
  - (2) If an enrollee makes an untimely request to an IRE, the IRE accepts the request and makes a determination as soon as possible, but the timeframe under [paragraph (d)(5)](#d-5) of this section and the financial liability protection under [paragraph (b)](#b) of this section do not apply.
- (b) **Coverage of provider services.** Coverage of provider services continues until the date and time designated on the termination notice, unless the enrollee appeals and the IRE reverses the MA organization's decision. If the IRE's decision is delayed because the MA organization did not timely supply necessary information or records, the MA organization is liable for the costs of any additional coverage required by the delayed IRE decision. If the IRE finds that the enrollee did not receive valid notice, coverage of provider services by the MA organization continues until at least two days after valid notice has been received. Continuation of coverage is not required if the IRE determines that coverage could pose a threat to the enrollee's health or safety.
- (c) **Burden of proof.** When an enrollee appeals an MA organization's decision to terminate services to an IRE, the burden of proof rests with the MA organization to demonstrate that termination of coverage is the correct decision, either on the basis of medical necessity, or based on other Medicare coverage policies.
  - (1) To meet this burden, the MA organization must supply any and all information that an IRE requires to sustain the MA organization's termination decision, consistent with [paragraph (e)](#e) of this section.
  - (2) The enrollee may submit evidence to be considered by an IRE in making its decision.
  - (3) The MA organization or an IRE may require an enrollee to authorize release to the IRE of his or her medical records, to the extent that the records are necessary for the MA organization to demonstrate the correctness of its decision or for an IRE to determine the appeal.
- (d) **Procedures an IRE must follow.**
  - (1) On the date an IRE receives the enrollee's request for an appeal, the IRE must immediately notify the MA organization and the provider that the enrollee has filed a request for a fast-track appeal, and of the MA organization's responsibility to submit documentation consistent with [paragraph (e)(3)](#e-3) of this section.
  - (2) When an enrollee requests a fast-track appeal, the IRE must determine whether the provider delivered a valid notice of the termination decision, and whether a detailed notice has been provided, consistent with [paragraph (e)(1)](#e-1) of this section.
  - (3) The IRE must notify CMS about each case in which it determines that improper notification occurs.
  - (4) Before making its decision, the IRE must solicit the enrollee's views regarding the reason(s) for termination of services as specified in the detailed written notice provided by the MA organization, or regarding any other reason that the IRE uses as the basis of its review determination.
  - (5) An IRE must make a decision on an appeal and notify the enrollee, the MA organization, and the provider of services, by close of business of the day after it receives the information necessary to make the decision. If the IRE does not receive the information needed to sustain an MA organization's decision to terminate services, it may make a decision on the case based on the information at hand, or it may defer its decision until it receives the necessary information. If the IRE defers its decision, coverage of the services by the MA organization would continue until the decision is made, consistent with [paragraph (b)](#b) of this section, but no additional termination notice would be required.
- (e) **Responsibilities of the MA organization.**
  - (1) When an IRE notifies an MA organization that an enrollee has requested a fast-track appeal, the MA organization must send a detailed notice to the enrollee by close of business of the day of the IRE's notification. The detailed termination notice must include the following information:
    - (i) A specific and detailed explanation why services are either no longer reasonable and necessary or are no longer covered.
    - (ii) A description of any applicable Medicare coverage rule, instruction or other Medicare policy including citations, to the applicable Medicare policy rules, or the information about how the enrollee may obtain a copy of the Medicare policy from the MA organization.
    - (iii) Any applicable MA organization policy, contract provision, or rationale upon which the termination decision was based.
    - (iv) Facts specific to the enrollee and relevant to the coverage determination that are sufficient to advise the enrollee of the applicability of the coverage rule or policy to the enrollee's case.
    - (v) **Any other information required by CMS.**
  - (2) Upon an enrollee's request, the MA organization must provide the enrollee a copy of, or access to, any documentation sent to the IRE by the MA organization, including records of any information provided by telephone. The MA organization may charge the enrollee a reasonable amount to cover the costs of duplicating the information for the enrollee and/or delivering the documentation to the enrollee. The MA organization must accommodate such a request by no later than close of business of the first day after the day the material is requested.
  - (3) Upon notification by the IRE of a fast-track appeal, the MA organization must supply any and all information, including a copy of the notice sent to the enrollee, that the IRE needs to decide on the appeal. The MA organization must supply this information as soon as possible, but no later than by close of business of the day that the IRE notifies the MA organization that an appeal has been received from the enrollee. The MA organization must make the information available by phone (with a written record made of what is transmitted in this manner) and/or in writing, as determined by the IRE.
  - (4) An MA organization is financially responsible for coverage of services as provided in [paragraph (b)](#b) of this section, regardless of whether it has delegated responsibility for authorizing coverage or termination decisions to its providers.
- (f) **Responsibilities of the provider.** If an IRE reverses an MA organization's termination decision, the provider must provide the enrollee with a new notice consistent with [§ 422.624(b)](/cfr/42/422.624.md?p=b) of this subpart.
- (g) **Reconsiderations of IRE decisions.**
  - (1) If the IRE upholds an MA organization's termination decision in whole or in part, the enrollee may request, no later than 60 days after notification that the IRE has upheld the decision that the IRE reconsider its original decision.
  - (2) The IRE must issue its reconsidered determination as expeditiously as the enrollee's health condition requires but no later than within 14 days of receipt of the enrollee's request for a reconsideration.
  - (3) If the IRE reaffirms its decision, in whole or in part, the enrollee may appeal the IRE's reconsidered determination to OMHA for an ALJ hearing, the Council, or a Federal court, as provided for under this subpart.
  - (4) If on reconsideration the IRE determines that coverage of provider services should terminate on a given date, the enrollee is liable for the costs of continued services after that date unless the IRE's decision is reversed on appeal. If the IRE's decision is reversed on appeal, the MA organization must reimburse the enrollee, consistent with the appealed decision, for the costs of any covered services for which the enrollee has already paid the MA organization or provider.