42 C.F.R. §§ 422.568–422.590

§422.568. Standard timeframes and notice requirements for organization determinations.

42 C.F.R. § 422.568

(a)

Method and place for filing a request. An enrollee must ask for a standard organization determination by making a request with the MA organization or, if applicable, to the entity responsible for making the determination (as directed by the MA organization), in accordance with the following:

(1)

The request may be made orally or in writing, except as provided in paragraph (a)(2) of this section.

(2)

Requests for payment must be made in writing (unless the MA organization or entity responsible for making the determination has implemented a voluntary policy of accepting verbal payment requests).

(b)

Timeframes—

(1)

Requests for service or item. Except as provided in paragraph (b)(2) of this section, when a party has made a request for an item or service, the MA organization must notify the enrollee (and the physician or provider involved, as appropriate) of its determination as expeditiously as the enrollee's health condition requires but no later than either of the following:

(i)

For a service or item not subject to the prior authorization rules in § 422.122, 14 calendar days after receiving the request for the standard organization determination.

(ii)

Beginning on or after January 1, 2026, for a service or item subject to the prior authorization rules in § 422.122, 7 calendar days after receiving the request for the standard organization determination.

(2)

Extensions; requests for service or item—

(i)

Extension of timeframe on a request for service or item. The MA organization may extend the timeframe by up to 14 calendar days under any of the following circumstances:

(A)

The enrollee requests the extension.

(B)

The extension is justified and in the enrollee's interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization's decision to deny an item or service.

(C)

The extension is justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee's interest.

(ii)

Notice of extension.

(A)

When the MA organization extends the timeframe, it must— (1) Notify the enrollee in writing of the reasons for the delay; and

(2) Inform the enrollee of the right to file an expedited grievance if the enrollee disagrees with the MA organization's decision to grant an extension.

(B)

The MA organization must notify the enrollee of its determination as expeditiously as the enrollee's health condition requires, but no later than upon expiration of the extension.

(3)

Requests for a Part B drug. An MA organization must notify the enrollee (and the prescribing physician or other prescriber involved, as appropriate) of its determination as expeditiously as the enrollee's health condition requires, but no later than 72 hours after receipt of the request. This 72-hour period may not be extended under the provisions in paragraph (b)(2) of this section.

(c)

Timeframe for requests for payment. The MA organization must process requests for payment according to the “prompt payment” provisions set forth in § 422.520.

(d)

Written notice for MA organization denials. The MA organization must give the enrollee and the physician or provider involved, as appropriate, a written notice if—

(1)

An MA organization decides to deny a service or an item, Part B drug, or payment in whole or in part, or reduce or prematurely discontinue the level of care for a previously authorized ongoing course of treatment.

(2)

An enrollee requests an MA organization to provide an explanation of a practitioner's denial of an item, service or Part B drug, in whole or in part.

(e)

Form and content of the MA organization notice. The notice of any denial under paragraph (d) of this section must—

(1)

Use approved notice language in a readable and understandable form;

(2)

State the specific reasons for the denial;

(3)

Inform the enrollee of his or her right to a reconsideration;

(4)

(i)

For service, item, and Part B drug denials, describe both the standard and expedited reconsideration processes, including the enrollee's right to, and conditions for, obtaining an expedited reconsideration and the rest of the appeal process; and

(ii)

For payment denials, describe the standard reconsideration process and the rest of the appeal process; and

(5)

Comply with any other notice requirements specified by CMS.

(f)

Effect of failure to provide timely notice. If the MA organization fails to provide the enrollee and the physician or provider involved, as appropriate, with timely notice of an organization determination as specified in this section, this failure itself constitutes an adverse organization determination and may be appealed.

(g)

Dismissing a request. The MA organization dismisses an organization determination request, either entirely or as to any stated issue, under any of the following circumstances:

(1)

The individual or entity making the request is not permitted to request an organization determination under § 422.566(c).

(2)

The MA organization determines the party failed to make out a valid request for an organization determination that substantially complies with paragraph (a) of this section.

(3)

An enrollee or the enrollee's representative files a request for an organization determination, but the enrollee dies while the request is pending, and both of the following 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 organization determination.

(4)

A party filing the organization determination request submits a timely request for withdrawal of their request for an organization determination with the MA organization.

(h)

Notice of dismissal. The MA organization must mail or otherwise transmit a written notice of the dismissal of the organization determination request to the parties. The notice must state all of the following:

(1)

The reason for the dismissal.

(2)

The right to request that the MA organization vacate the dismissal action.

(3)

The right to request reconsideration of the dismissal.

(i)

Vacating a dismissal. If good cause is established, the MA organization may vacate its dismissal of a request for an organization determination within 6 months from the date of the notice of dismissal.

(j)

Effect of dismissal. The dismissal of a request for an organization determination is binding unless it is modified or reversed by the MA organization upon reconsideration or vacated under paragraph (i) of this section.

(k)

Withdrawing a request. A party that requests an organization determination may withdraw its request at any time before the decision is issued by filing a request with the MA organization.

Notes, amendments, and revision history

Amendments

[65 FR 40329, June 29, 2000, as amended at 70 FR 4739, Jan. 28, 2005; 70 FR 52027, Sept. 1, 2005; 75 FR 19812, Apr. 15, 2010; 75 FR 32859, June 10, 2010; 80 FR 7961, Feb. 12, 2015; 84 FR 23880, May 23, 2019; 86 FR 6101, Jan. 19, 2021; 89 FR 8976, Feb. 8, 2024; 90 FR 15910, Apr. 15, 2025]

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

Amendments

[65 FR 40329, June 29, 2000, as amended at 70 FR 4739, Jan. 28, 2005; 70 FR 52027, Sept. 1, 2005; 75 FR 19812, Apr. 15, 2010; 75 FR 32859, June 10, 2010; 80 FR 7961, Feb. 12, 2015; 84 FR 23880, May 23, 2019; 86 FR 6101, Jan. 19, 2021; 89 FR 8976, Feb. 8, 2024; 90 FR 15910, Apr. 15, 2025]

§422.570. Expediting certain organization determinations.

42 C.F.R. § 422.570

(a)

Request for expedited determination. An enrollee or a physician (regardless of whether the physician is affiliated with the MA organization) may request that an MA organization expedite an organization determination involving the issues described in § 422.566(b)(3) and (b)(4). (This does not include requests for payment of services already furnished.)

(b)

How to make a request.

(1)

To ask for an expedited determination, an enrollee or a physician must submit an oral or written request directly to the MA organization or, if applicable, to the entity responsible for making the determination, as directed by the MA organization.

(2)

A physician may provide oral or written support for a request for an expedited determination.

(c)

How the MA organization must process requests. The MA organization must establish and maintain the following procedures for processing requests for expedited determinations:

(1)

Establish an efficient and convenient means for individuals to submit oral or written requests. The MA organization must document all oral requests in writing and maintain the documentation in the case file.

(2)

Promptly decide whether to expedite a determination, based on the following requirements—

(i)

For a request made by an enrollee the MA organization must provide an expedited determination if it determines that applying the standard timeframe for making a determination could seriously jeopardize the life or health of the enrollee or the enrollee's ability to regain maximum function.

(ii)

For a request made or supported by a physician, the MA organization must provide an expedited determination if the physician indicates that applying the standard timeframe for making a determination could seriously jeopardize the life or health of the enrollee or the enrollee's ability to regain maximum function.

(d)

Actions following denial. If an MA organization denies a request for expedited determination, it must take the following actions:

(1)

Automatically transfer a request to a standard organization determination and make the determination within the applicable timeframe, established in § 422.568 for a standard determination. The timeframe begins when the MA organization receives the request for expedited determination.

(2)

Give the enrollee prompt oral notice of the denial and subsequently deliver, within 3 calendar days, a written letter that—

(i)

Explains that the MA organization will process the request using the 14-day timeframe for standard determinations;

(ii)

Informs the enrollee of the right to file an expedited grievance if he or she disagrees with the MA organization's decision not to expedite; and

(iii)

Informs the enrollee of the right to resubmit a request for an expedited determination with any physician's support; and

(iv)

Provides instructions about the grievance process and its timeframes.

(e)

Action on accepted request for expedited determination. If an MA organization grants a request for expedited determination, it must make the determination and give notice in accordance with § 422.572.

(f)

Prohibition of punitive action. An MA organization may not take or threaten to take any punitive action against a physician acting on behalf or in support of an enrollee in requesting an expedited determination.

(g)

Dismissing a request. The MA organization dismisses an expedited organization request in accordance with § 422.568.

Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998, as amended at 65 FR 40329, June 29, 2000; 70 FR 4739, Jan. 28, 2005; 84 FR 23880, May 23, 2019; 86 FR 6101, Jan. 19, 2021; 89 FR 8977, Feb. 8, 2024]

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

Amendments

[63 FR 35107, June 26, 1998, as amended at 65 FR 40329, June 29, 2000; 70 FR 4739, Jan. 28, 2005; 84 FR 23880, May 23, 2019; 86 FR 6101, Jan. 19, 2021; 89 FR 8977, Feb. 8, 2024]

§422.572. Timeframes and notice requirements for expedited organization determinations.

42 C.F.R. § 422.572

(a)

Timeframes—

(1)

Requests for service or item. Except as provided in paragraph (b) of this section, an MA organization that approves a request for expedited determination must make its determination and notify the enrollee (and the physician involved, as appropriate) of its decision, whether adverse or favorable, as expeditiously as the enrollee's health condition requires, but no later than 72 hours after receiving the request.

(2)

Requests for a Part B drug. An MA organization that approves a request for expedited determination must make its determination and notify the enrollee (and the physician or prescriber involved, as appropriate) of its decision as expeditiously as the enrollee's health condition requires, but no later than 24 hours after receiving the request. This 24-hour period may not be extended under the provisions in paragraph (b) of this section.

(b)

Extensions; requests for service or item.

(1)

When timeframe may be extended. The MA organization may extend the 72-hour deadline for expedited organization determinations for requests for services or items by up to 14 calendar days if—

(i)

The enrollee requests the extension;

(ii)

The extension is justified and in the enrollee's interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization's decision to deny an item or service; or

(iii)

The extension is justified due to extraordinary, exigent, or other nonroutine circumstances and is in the enrollee's interest.

(2)

Notice of extension. When the MA organization extends the deadline, it must notify the enrollee in writing of the reasons for the delay and inform the enrollee of the right to file an expedited grievance if he or she disagrees with the MA organization's decision to grant an extension. The MA organization must notify the enrollee of its determination as expeditiously as the enrollee's health condition requires, but no later than upon expiration of the extension.

(c)

Confirmation of oral notice. If the MA organization first notifies an enrollee of an adverse expedited determination orally, it must mail written confirmation to the enrollee within 3 calendar days of the oral notification.

(d)

How the MA organization must request information from noncontract providers. If the MA organization must receive medical information from noncontract providers, the MA organization must request the necessary information from the noncontract provider within 24 hours of the initial request for an expedited organization determination. Noncontract providers must make reasonable and diligent efforts to expeditiously gather and forward all necessary information to assist the MA organization in meeting the required timeframe. Regardless of whether the MA organization must request information from noncontract providers, the MA organization is responsible for meeting the timeframe and notice requirements of this section.

(e)

Content of the notice of expedited determination.

(1)

The notice of any expedited determination must state the specific reasons for the determination in understandable language.

(2)

If the determination is not completely favorable to the enrollee, the notice must—

(i)

Inform the enrollee of his or her right to a reconsideration;

(ii)

Describe both the standard and expedited reconsideration processes, including the enrollee's right to request, and conditions for obtaining, an expedited reconsideration, and the rest of the appeal process; and

(iii)

Comply with any other requirements specified by CMS.

(f)

Effect of failure to provide a timely notice. If the MA organization fails to provide the enrollee and the physician or prescriber involved, as appropriate, with timely notice of an expedited organization determination as specified in this section, this failure itself constitutes an adverse organization determination and may be appealed.

Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998, as amended at 65 FR 40329, June 29, 2000; 70 FR 4739, Jan. 28, 2005; 80 FR 7961, Feb. 12, 2015; 84 FR 23881, May 23, 2019; 90 FR 15911, Apr. 15, 2025]

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

Amendments

[63 FR 35107, June 26, 1998, as amended at 65 FR 40329, June 29, 2000; 70 FR 4739, Jan. 28, 2005; 80 FR 7961, Feb. 12, 2015; 84 FR 23881, May 23, 2019; 90 FR 15911, Apr. 15, 2025]

§422.574. Parties to the organization determination.

42 C.F.R. § 422.574

The parties to the organization determination are—

(a)

The enrollee (including his or her representative);

(b)

An assignee of the enrollee (that is, a physician or other provider who has furnished a service to the enrollee and formally agrees to waive any right to payment from the enrollee for that service);

(c)

The legal representative of a deceased enrollee's estate; or

(d)

Any other provider or entity (other than the MA organization) determined to have an appealable interest in the proceeding.

Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998, as amended at 75 FR 19812, Apr. 15, 2010]

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

Amendments

[63 FR 35107, June 26, 1998, as amended at 75 FR 19812, Apr. 15, 2010]

§422.576. Effect of an organization determination.

42 C.F.R. § 422.576

The organization determination is binding on all parties unless it is reconsidered under §§ 422.578 through 422.596 or is reopened and revised under § 422.616.

Notes, amendments, and revision history

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

§422.578. Right to a reconsideration.

42 C.F.R. § 422.578

Any party to an organization determination (including one that has been reopened and revised as described in § 422.616) may request that the determination be reconsidered under the procedures described in § 422.582, which address requests for a standard reconsideration. A physician who is providing treatment to an enrollee may, upon providing notice to the enrollee, request a standard reconsideration of a pre-service request for reconsideration on the enrollee's behalf as described in § 422.582. An enrollee or physician (acting on behalf of an enrollee) may request an expedited reconsideration as described in § 422.584.

Notes, amendments, and revision history

Amendments

[74 FR 1542, Jan. 12, 2009]

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

Amendments

[74 FR 1542, Jan. 12, 2009]

§422.580. Reconsideration defined.

42 C.F.R. § 422.580

A reconsideration consists of a review of an adverse organization determination, the evidence and findings upon which it was based, and any other evidence the parties submit or the MA organization or CMS obtains.

Notes, amendments, and revision history

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

§422.582. Request for a standard reconsideration.

42 C.F.R. § 422.582

(a)

Method and place for filing a request. A party to an organization determination or, upon providing notice to the enrollee, a physician who is treating an enrollee and acting on the enrollee's behalf, must ask for a reconsideration of the determination by making a written request to the MA organization that made the organization determination. The MA organization may adopt a policy for accepting oral requests.

(b)

Timeframe for filing a request. Except as provided in paragraph (c) of this section, a request for reconsideration must be filed within 60 calendar days after receipt of the written organization determination notice.

(1)

The date of receipt of the organization determination is presumed to be 5 calendar days after the date of the written organization determination, unless there is evidence to the contrary.

(2)

For purposes of meeting the 60-calendar day filing deadline, the request is considered as filed on the date it is received by the plan or delegated entity specified in the MA organization's written organization determination.

(c)

Extending the time for filing a request.

(1)

General rule. If a party or physician acting on behalf of an enrollee shows good cause, the MA organization may extend the timeframe for filing a request for reconsideration.

(2)

How to request an extension of timeframe. If the 60-day period in which to file a request for reconsideration has expired, a party to the organization determination or a physician acting on behalf of an enrollee may file a request for reconsideration with the MA organization. The request for reconsideration and to extend the timeframe must—

(i)

Be in writing; and

(ii)

State why the request for reconsideration was not filed on time.

(d)

Parties to the reconsideration. The parties to the reconsideration are the parties to the organization determination, as described in § 422.574, and any other provider or entity (other than the MA organization) whose rights with respect to the organization determination may be affected by the reconsideration, as determined by the entity that conducts the reconsideration.

(e)

Withdrawing a request. The party or physician acting on behalf of an enrollee who files a request for reconsideration may withdraw it by filing a request for withdrawal at one of the places listed in paragraph (a) of this section.

(f)

Dismissing a request. The MA organization 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.

(2)

The MA organization determines the party failed to make a valid request for a reconsideration that substantially complies with paragraph (a) of this section.

(3)

The party fails to file the reconsideration request within the proper filing time frame in accordance with paragraph (b) of this section.

(4)

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.

(5)

A party filing the reconsideration request submits a timely request for withdrawal of the request for a reconsideration with the MA organization.

(g)

Notice of dismissal. The MA organization must mail or otherwise transmit a written notice of the dismissal of the reconsideration request to the parties. The notice must state all of the following:

(1)

The reason for the dismissal.

(2)

The right to request that the MA organization vacate the dismissal action.

(3)

The right to request review of the dismissal by the independent entity.

(h)

Vacating a dismissal. If good cause is established, the MA organization may vacate its dismissal of a request for reconsideration within 6 months from the date of the notice of dismissal.

(i)

Effect of dismissal. The MA organization's dismissal is binding unless the enrollee or other party requests review by the independent entity in accordance with § 422.590(h) or the decision is vacated under paragraph (h) of this section.

Notes, amendments, and revision history

Amendments

[74 FR 1542, Jan. 12, 2009, as amended at 86 FR 6101, Jan. 19, 2021; 89 FR 30827, Apr. 23, 2024]

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

Amendments

[74 FR 1542, Jan. 12, 2009, as amended at 86 FR 6101, Jan. 19, 2021; 89 FR 30827, Apr. 23, 2024]

§422.584. Expediting certain reconsiderations.

42 C.F.R. § 422.584

(a)

Who may request an expedited reconsideration. An enrollee or a physician (regardless of whether he or she is affiliated with the MA organization) may request that an MA organization expedite a reconsideration of a determination that involves the issues described in § 422.566(b)(3) and (b)(4). (This does not include requests for payment of services already furnished.)

(b)

Procedure and timeframe for filing a request. A request for reconsideration must be filed within 60 calendar days after receipt of the written organization determination notice. (1) To ask for an expedited reconsideration, an enrollee or a physician acting on behalf of an enrollee must submit an oral or written request directly to the MA organization or, if applicable, to the entity responsible for making the reconsideration, as directed by the MA organization.

(2)

A physician may provide oral or written support for a request for an expedited reconsideration.

(3)

The date of receipt of the organization determination is presumed to be 5 calendar days after the date of the written organization determination, unless there is evidence to the contrary.

(4)

For purposes of meeting the 60-calendar day filing deadline, the request is considered as filed on the date it is received by the plan or delegated entity specified in the MA organization's written organization determination.

(c)

How the MA organization must process requests. The MA organization must establish and maintain the following procedures for processing requests for expedited reconsiderations:

(1)

Handling of requests. The MA organization must establish an efficient and convenient means for individuals to submit oral or written requests, document all oral requests in writing, and maintain the documentation in the case file.

(2)

Prompt decision. Promptly decide on whether to expedite the reconsideration or follow the timeframe for standard reconsideration based on the following requirements:

(i)

For a request made by an enrollee, the MA organization must provide an expedited reconsideration if it determines that applying the standard timeframe for reconsidering a determination could seriously jeopardize the life or health of the enrollee or the enrollee's ability to regain maximum function.

(ii)

For a request made or supported by a physician, the MA organization must provide an expedited reconsideration if the physician indicates that applying the standard timeframe for conducting a reconsideration could seriously jeopardize the life or health of the enrollee or the enrollee's ability to regain maximum function.

(d)

Actions following denial. If an MA organization denies a request for expedited reconsideration, it must take the following actions:

(1)

Automatically transfer a request to the standard timeframe and make the determination within the 30 calendar day or 7 calendar day, as applicable, timeframe established in § 422.590(a) and (c). The timeframe begins the day the MA organization receives the request for expedited reconsideration.

(2)

Give the enrollee prompt oral notice, and subsequently deliver, within 3 calendar days, a written letter that—

(i)

Explains that the MA organization will process the enrollee's request using the 30-day timeframe for standard reconsiderations;

(ii)

Informs the enrollee of the right to file a grievance if he or she disagrees with the organization's decision not to expedite;

(iii)

Informs the enrollee of the right to resubmit a request for an expedited reconsideration with any physician's support; and

(iv)

Provides instructions about the grievance process and its timeframes.

(e)

Action following acceptance of a request. If an MA organization grants a request for expedited reconsideration, it must conduct the reconsideration and give notice in accordance with § 422.590.

(f)

Prohibition of punitive action. An MA organization may not take or threaten to take any punitive action against a physician acting on behalf or in support of an enrollee in requesting an expedited reconsideration.

(g)

Dismissing a request. The MA organization dismisses an expedited reconsideration request in accordance with § 422.582(f) through (i).

Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998, as amended at 65 FR 40330, June 29, 2000; 70 FR 4739, Jan. 28, 2005; 84 FR 23881, May 23, 2019; 86 FR 6101, Jan. 19, 2021; 89 FR 30827, Apr. 23, 2024]

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

Amendments

[63 FR 35107, June 26, 1998, as amended at 65 FR 40330, June 29, 2000; 70 FR 4739, Jan. 28, 2005; 84 FR 23881, May 23, 2019; 86 FR 6101, Jan. 19, 2021; 89 FR 30827, Apr. 23, 2024]

§422.586. Opportunity to submit evidence.

42 C.F.R. § 422.586

The MA organization must provide the parties to the reconsideration with a reasonable opportunity to present evidence and allegations of fact or law, related to the issue in dispute, in person as well as in writing. In the case of an expedited reconsideration, the opportunity to present evidence is limited by the short timeframe for making a decision. Therefore, the MA organization must inform the parties of the conditions for submitting the evidence.

Notes, amendments, and revision history

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

§422.590. Timeframes and responsibility for reconsiderations.

42 C.F.R. § 422.590

(a)

Standard reconsideration: Requests for service or item.

(1)

Except as provided in paragraph (f) of this section, if the MA organization makes a reconsidered determination that is completely favorable to the enrollee, the MA organization must issue the determination (and effectuate it in accordance with § 422.618(a)) as expeditiously as the enrollee's health condition requires, but no later than 30 calendar days from the date it receives the request for a standard reconsideration.

(2)

If the MA organization makes a reconsidered determination that affirms, in whole or in part, its adverse organization determination, it must prepare a written explanation and send the case file to the independent entity contracted by CMS as expeditiously as the enrollee's health condition requires, but no later than 30 calendar days from the date it receives the request for a standard reconsideration (or no later than the expiration of an extension described in paragraph (a)(1) of this section). The organization must make reasonable and diligent efforts to assist in gathering and forwarding information to the independent entity.

(b)

Standard reconsideration: Requests for payment.

(1)

If the MA organization makes a reconsidered determination that is completely favorable to the enrollee, the MA organization must issue its reconsidered determination to the enrollee (and effectuate it in accordance with § 422.618(a)(2)) no later than 60 calendar days from the date it receives the request for a standard reconsideration.

(2)

If the MA organization affirms, in whole or in part, its adverse organization determination, it must prepare a written explanation and send the case file to the independent entity contracted by CMS no later than 60 calendar days from the date it receives the request for a standard reconsideration. The organization must make reasonable and diligent efforts to assist in gathering and forwarding information to the independent entity.

(c)

Standard reconsideration: Requests for a Part B drug.

(1)

If the MA organization makes a reconsidered determination that is completely favorable to the enrollee, the MA organization must issue the determination (and effectuate it in accordance with § 422.618(a)(3)) as expeditiously as the enrollee's health condition requires, but no later than 7 calendar days from the date it receives the request for a standard reconsideration. This 7 calendar-day period may not be extended under the provisions in paragraph (f) of this section.

(2)

If the MA organization makes a reconsidered determination that affirms, in whole or in part, its adverse organization determination, it must prepare a written explanation and send the case file to the independent entity contracted with CMS no later than 7 calendar days from the date it receives the request for a standard reconsideration. The organization must make reasonable and diligent efforts to assist in gathering and forwarding the information to the independent entity.

(d)

Effect of failure to meet timeframe for standard reconsideration. If the MA organization fails to provide the enrollee with a reconsidered determination within the timeframes specified in paragraph (a), (b), or (c) of this section, this failure constitutes an affirmation of its adverse organization determination, and the MA organization must submit the file to the independent entity in the same manner as described under paragraphs (a)(2), (b)(2), and (c)(2) of this section.

(e)

Expedited reconsideration—

(1)

Timeframe for services or items. Except as provided in paragraph (f) of this section, an MA organization that approves a request for expedited reconsideration must complete its reconsideration and give the enrollee (and the physician involved, as appropriate) notice of its decision as expeditiously as the enrollee's health condition requires but no later than 72 hours after receiving the request.

(2)

Timeframe for Part B drugs. An MA organization that approves a request for expedited reconsideration must complete its reconsideration and give the enrollee (and the physician or other prescriber involved, as appropriate) notice of its decision as expeditiously as the enrollee's health condition requires but no later than 72 hours after receiving the request. This 72-hour period may not be extended under the provisions in paragraph (f) of this section.

(3)

Confirmation of oral notice. If the MA organization first notifies an enrollee of a completely favorable expedited reconsideration orally, it must mail written confirmation to the enrollee within 3 calendar days.

(4)

How the MA organization must request information from noncontract providers. If the MA organization must receive medical information from noncontract providers, the MA organization must request the necessary information from the noncontract provider within 24 hours of the initial request for an expedited reconsideration. Noncontract providers must make reasonable and diligent efforts to expeditiously gather and forward all necessary information to assist the MA organization in meeting the required timeframe. Regardless of whether the MA organization must request information from noncontract providers, the MA organization is responsible for meeting the timeframe and notice requirements.

(5)

Affirmation of an adverse expedited organization determination. If, as a result of its reconsideration, the MA organization affirms, in whole or in part, its adverse expedited organization determination, the MA organization must submit a written explanation and the case file to the independent entity contracted by CMS as expeditiously as the enrollee's health condition requires, but not later than within 24 hours of its affirmation. The organization must make reasonable and diligent efforts to assist in gathering and forwarding information to the independent entity.

(f)

Extensions; requests for service or item.

(1)

As described in paragraphs (f)(1)(i) through (iii) of this section, the MA organization may extend the standard or expedited reconsideration deadline for services by up to 14 calendar days if—

(i)

The enrollee requests the extension; or

(ii)

The extension is justified and in the enrollee's interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization's decision to deny an item or service; or

(iii)

The extension is justified due to extraordinary, exigent or other non-routine circumstances and is in the enrollee's interest.

(2)

When the MA organization extends the deadline, it must notify the enrollee in writing of the reasons for the delay and inform the enrollee of the right to file an expedited grievance if he or she disagrees with the MA organization's decision to grant an extension. The MA organization must notify the enrollee of its determination as expeditiously as the enrollee's health condition requires, but no later than upon expiration of the extension.

(g)

Failure to meet timeframe for expedited reconsideration. If the MA organization fails to provide the enrollee with the results of its reconsideration within the timeframe described in paragraph (e)(1) or (2) of this section, as applicable, this failure constitutes an adverse reconsidered determination, and the MA organization must submit the file to the independent entity within 24 hours of expiration of the timeframe set forth in paragraph (e)(1) or (2) of this section.

(h)

Who must reconsider an adverse organization determination.

(1)

A person or persons who were not involved in making the organization determination must conduct the reconsideration.

(2)

When the issue is the MA organization's denial of coverage based on a lack of medical necessity (or any substantively equivalent term used to describe the concept of medical necessity), the reconsidered determination must be made by a physician with expertise in the field of medicine that is appropriate for the services at issue. The physician making the reconsidered determination need not, in all cases, be of the same specialty or subspecialty as the treating physician.

(i)

Requests for review of a dismissal by the independent entity. If the MA organization dismisses a request for a reconsideration in accordance with §§ 422.582(f) and 422.584(g), the enrollee or other proper party under § 422.578 has the right to request review of the dismissal by the independent entity. A request for review of a dismissal must be filed in writing with the independent entity within 60 calendar days from the date of the MA organization's dismissal notice.

Notes, amendments, and revision history

Amendments

[84 FR 23881, May 23, 2019, as amended at 86 FR 6102, Jan. 19, 2021; 88 FR 22334, Apr. 12, 2023]

Source

Source: 63 FR 35107, June 26, 1998, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

Source

Source: 63 FR 18134, Apr. 14, 1998, unless otherwise noted.

Amendments

[84 FR 23881, May 23, 2019, as amended at 86 FR 6102, Jan. 19, 2021; 88 FR 22334, Apr. 12, 2023]