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42 C.F.R. §§ 422.594–422.619

9 sections in range

§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]

§422.600. Right to a hearing.

42 C.F.R. § 422.600

(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 of this chapter. For purposes of calculating the amount remaining in controversy under this section, references to coinsurance in § 405.1006(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.
Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998, as amended at 70 FR 4740, Jan. 28, 2005; 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 70 FR 4740, Jan. 28, 2005; 86 FR 6102, Jan. 19, 2021]

§422.602. Request for an ALJ hearing.

42 C.F.R. § 422.602

(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 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 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, 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, the ALJ discontinues the hearing and does not rule on the substantive issues raised in the appeal.
Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998, as amended at 70 FR 4740, Jan. 28, 2005; 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 70 FR 4740, Jan. 28, 2005; 82 FR 5125, Jan. 17, 2017]

§422.608. Medicare Appeals Council (Council) review.

42 C.F.R. § 422.608

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 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).
Notes, amendments, and revision history

Amendments

[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

[82 FR 5125, Jan. 17, 2017]

§422.612. Judicial review.

42 C.F.R. § 422.612

(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) 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) of the Act. See part 405 of this chapter for a description of the procedures to follow in requesting judicial review.
Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998; 63 FR 52614, Oct. 1, 1998, as amended at 65 FR 40331, June 29, 2000; 70 FR 4740, Jan. 28, 2005; 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; 63 FR 52614, Oct. 1, 1998, as amended at 65 FR 40331, June 29, 2000; 70 FR 4740, Jan. 28, 2005; 82 FR 5125, Jan. 17, 2017]

§422.616. Reopening and revising determinations and decisions.

42 C.F.R. § 422.616

(a)
Subject to paragraph (e) of this section and the rules at § 422.138(c), an organization or reconsidered determination made by an MA organization, a reconsidered determination made by the independent entity described in § 422.592, 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 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.
(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) and (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.
Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998; 63 FR 52614, Oct. 1, 1998, as amended at 70 FR 4740, Jan. 28, 2005; 82 FR 5125, Jan. 17, 2017; 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; 63 FR 52614, Oct. 1, 1998, as amended at 70 FR 4740, Jan. 28, 2005; 82 FR 5125, Jan. 17, 2017; 90 FR 15911, Apr. 15, 2025]

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

42 C.F.R. § 422.618

(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)).
(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, 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.
Notes, amendments, and revision history

Amendments

[63 FR 35107, June 26, 1998, as amended at 65 FR 40331, June 29, 2000; 68 FR 50858, Aug. 22, 2003; 80 FR 7962, Feb. 12, 2015; 82 FR 5125, Jan. 17, 2017; 84 FR 23882, May 23, 2019]

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 40331, June 29, 2000; 68 FR 50858, Aug. 22, 2003; 80 FR 7962, Feb. 12, 2015; 82 FR 5125, Jan. 17, 2017; 84 FR 23882, May 23, 2019]

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

42 C.F.R. § 422.619

(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)).
(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, 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.
Notes, amendments, and revision history

Amendments

[65 FR 40331, June 29, 2000, as amended at 68 FR 50859, Aug. 22, 2003; 80 FR 7962, Feb. 12, 2015; 82 FR 5125, Jan. 17, 2017; 84 FR 23882, May 23, 2019]

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, as amended at 68 FR 50859, Aug. 22, 2003; 80 FR 7962, Feb. 12, 2015; 82 FR 5125, Jan. 17, 2017; 84 FR 23882, May 23, 2019]