42 C.F.R. §§ 422.578–422.596

§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]

§422.592. Reconsideration by an independent entity.

42 C.F.R. § 422.592

(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), 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) 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.

(2)

The independent entity determines the party failed to make out a valid request for a reconsideration that substantially complies with § 422.582(a) or (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 and 422.602.

(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 and files a proper and timely request under § 422.602 or the dismissal is vacated under paragraph (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. 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.

Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998, as amended at 86 FR 6102, Jan. 19, 2021]

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 86 FR 6102, Jan. 19, 2021]

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

42 C.F.R. § 422.594

(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;

(3)

Describe the procedures that a party must follow to obtain an ALJ hearing; and

(4)

Comply with any other requirements specified by CMS.

Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998, as amended at 65 FR 40330, June 29, 2000; 82 FR 5125, Jan. 17, 2017]

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; 82 FR 5125, Jan. 17, 2017]

§422.596. Effect of a reconsidered determination.

42 C.F.R. § 422.596

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, or unless the reconsidered determination is revised under § 422.616.

Notes, amendments, and revision history

Amendments

[65 FR 40331, June 29, 2000]

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 40331, June 29, 2000]