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Notes

42 C.F.R. §§ 405.1210–405.1212

3 sections in range

§405.1210. Notifying eligible beneficiaries of appeal rights when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.

42 C.F.R. § 405.1210

(a)
Applicability and scope.
(1)
For purposes of this section and §§ 405.1211 and 405.1212, 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 includes critical access hospitals (CAHs).
(2)
For purposes of this section and §§ 405.1211 and 405.1212, the change in status occurs when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services (as defined in § 405.931(h)).
(3)
For purposes of this section and §§ 405.1211 and 405.1212, a beneficiary is eligible to pursue an appeal regarding a change in status when the beneficiary meets all the following:
(i)
Was formally admitted as a hospital inpatient in accordance with an order for inpatient admission by a physician or other qualified practitioner.
(ii)
Was subsequently reclassified by the hospital as an outpatient receiving observation services after the admission.
(iii)
(A)
Was not enrolled in Part B coverage at the time of the beneficiary's hospitalization; or
(B)
Stayed at the hospital for 3 or more consecutive days but was classified as an inpatient for fewer than 3 days.
(iv)
The period “3 or more consecutive days” is counted using the rules for determining coverage of SNF services under section 1861 of the Act and § 409.30 of this chapter (that is, a beneficiary must have a qualifying inpatient stay of at least 3 consecutive calendar days starting with the admission day but not counting the discharge day).
(b)
Advance written notice of appeal rights. For all eligible beneficiaries, hospitals must deliver valid, written notice of an eligible beneficiary's right to pursue an appeal regarding the decision to reclassify the beneficiary from an inpatient to an outpatient receiving observation services. The hospital must use a standardized notice specified by CMS in accordance with the following procedures:
(1)
Timing of notice. The hospital must provide the notice not later than 4 hours before release from the hospital and as soon as possible after the earliest of either of the following:
(i)
The hospital reclassifies the beneficiary from an inpatient to an outpatient receiving observation services and the beneficiary is not enrolled in Part B.
(ii)
The hospital reclassifies the beneficiary from an inpatient to an outpatient receiving observation services and the beneficiary has stayed in the hospital for 3 or more consecutive days but was an inpatient for fewer than 3 days.
(2)
Content of the notice. The notice must include the following information:
(i)
The eligible beneficiary's change in status and the appeal rights under § 405.1211 if the beneficiary wishes to pursue an appeal regarding that change.
(ii)
An explanation of the implications of the change in status, including the potential change in beneficiary hospital charges resulting from a favorable decision, and subsequent eligibility for Medicare coverage for SNF services.
(iii)
Any other information required by CMS.
(3)
When delivery of the notice is valid. Delivery of the written notice of appeal rights described in this section is valid if—
(i)
The eligible beneficiary (or the eligible beneficiary'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) of this section; and
(ii)
The notice is delivered in accordance with paragraph (b)(1) of this section and contains all the elements described in paragraph (b)(2) of this section.
(4)
If an eligible beneficiary 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.
Notes, amendments, and revision history

Amendments

[89 FR 83292, Oct. 15, 2024, as amended at 90 FR 20808, May 16, 2025]

Source

Source: 69 FR 69264, Nov. 26, 2004, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).

Amendments

[89 FR 83292, Oct. 15, 2024, as amended at 90 FR 20808, May 16, 2025]

§405.1211. Expedited determination procedures when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.

42 C.F.R. § 405.1211

(a)
Beneficiary's right to an expedited determination by the QIO. An eligible beneficiary has a right to request an expedited determination by the QIO when—
(1)
A hospital changes a beneficiary's status from an inpatient to an outpatient receiving observation services; and
(2)
The beneficiary meets other eligibility criteria as specified in § 405.1210(a)(3).
(b)
Requesting an expedited determination.
(1)
An eligible beneficiary who wishes to exercise the right to an expedited determination must submit a request to the QIO that has an agreement with the hospital as specified in § 476.78 of this chapter. The request must be made in writing or by telephone before release from the hospital.
(2)
The eligible beneficiary, or his or her representative, upon request by the QIO, must be available to discuss the case.
(3)
The eligible beneficiary may, but is not required to, submit written evidence to be considered by the QIO in making its decision.
(4)
An eligible beneficiary who makes a timely request for an expedited QIO review in accordance with paragraph (b)(1) of this section is subject to the billing protection under paragraph (e) of this section, as applicable.
(5)
An eligible beneficiary who fails to make a timely request for an expedited determination by a QIO, as described in paragraph (b)(1) of this section, may still request an untimely expedited QIO determination at any time. The QIO issues a decision in accordance with paragraph (c)(6)(ii) of this section, but the billing protection under paragraph (e) of this section does not apply.
(c)
Procedures the QIO must follow.
(1)
When the QIO receives the request for an expedited determination under paragraph (b)(1) of this section, it must immediately notify the hospital that a request for an expedited determination has been made.
(2)
The QIO determines whether the hospital delivered valid notice consistent with § 405.1210(b)(3).
(3)
The QIO examines the medical and other records that pertain to the change in status.
(4)
The QIO must solicit the views of the eligible beneficiary (or the eligible beneficiary's representative) who requested the expedited determination.
(5)
The QIO must provide an opportunity for the hospital to explain why the reclassification of the beneficiary from an inpatient to an outpatient receiving observation services is appropriate.
(6)
The following timeframes apply for the QIO's decision when an eligible beneficiary requests—
(i)
A timely expedited determination in accordance with paragraph (b)(1) of this section, the QIO must make a determination within 1 calendar day of receiving all requested pertinent information specified in paragraph (d)(1)(i) of this section; or
(ii)
An untimely request for a QIO expedited determination, the QIO must make a determination within 2 calendar days after the QIO receives all requested information specified in paragraph (d)(1)(i) of this section.
(7)
If the QIO does not receive the information specified in paragraph (d)(1)(i) of this section, it may make its determination based on the evidence at hand, or it may defer a decision until it receives the requested information.
(8)
When the QIO issues an expedited determination, the QIO must notify the eligible beneficiary, the hospital, and SNF (if applicable) 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.
(iv)
Information about the eligible beneficiary's right to an expedited reconsideration of the QIO's determination as set forth in § 405.1212, including how to request a reconsideration and the time period for doing so.
(d)
Responsibilities of hospitals.
(1)
(i)
Upon notification by the QIO of the request for an expedited determination, the hospital must supply all information that the QIO needs to make its expedited determination, including a copy of the notice as required in § 405.1210(b) of this section.
(ii)
The hospital must furnish this information as soon as possible, but no later than by noon of the calendar day after the QIO notifies the hospital of the request for an expedited determination.
(iii)
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).
(2)
(i)
At an eligible beneficiary's (or representative's) request, the hospital must furnish the beneficiary with a copy of, or access to, any documentation that it sends to the QIO, including written records of any information provided by telephone.
(ii)
The hospital may charge the beneficiary a reasonable amount to cover the costs of duplicating the documentation and, if applicable, delivering it to the beneficiary.
(iii)
The hospital must accommodate such a request by no later than close of business of the first calendar day after the material is requested.
(e)
Billing during QIO expedited review. When an eligible beneficiary requests an expedited determination in accordance with paragraphs (b)(1) through (b)(4) of this section, the hospital may not bill the beneficiary for any disputed services until the expedited determination process (and reconsideration process, if applicable) has been completed.
(f)
Effect of an expedited QIO determination. The QIO determination is binding for payment purposes upon the eligible beneficiary, hospital, and MAC, except if the eligible beneficiary is dissatisfied with the determination, he or she may request a reconsideration according to the procedures described in § 405.1212.
Notes, amendments, and revision history

Amendments

[89 FR 83292, Oct. 15, 2024]

Source

Source: 69 FR 69264, Nov. 26, 2004, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).

Amendments

[89 FR 83292, Oct. 15, 2024]

§405.1212. Expedited reconsideration procedures regarding Part A coverage when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.

42 C.F.R. § 405.1212

(a)
Beneficiary's right to an expedited reconsideration. An eligible beneficiary who is dissatisfied with a QIO's expedited determination per § 405.1211(c)(6) may request an expedited reconsideration by the QIO identified in the written notice specified in § 405.1211(c)(8)(iv).
(b)
Requesting an expedited reconsideration.
(1)
An eligible beneficiary who wishes to obtain an expedited reconsideration must submit a request for the reconsideration to the appropriate QIO, in writing or by telephone, by no later than noon of the calendar day following initial notification (whether by telephone or in writing) after receipt of the QIO's determination.
(2)
The eligible beneficiary, or his or her representative, must be available to answer questions or supply information that the QIO may request to conduct its reconsideration.
(3)
The eligible beneficiary may, but is not required to, submit evidence to be considered by the QIO in making the reconsideration.
(4)
An eligible beneficiary who makes a timely request for an expedited reconsideration in accordance with paragraph (b)(1) of this section is subject to the billing protection under paragraph (e) of this section, as applicable.
(5)
An eligible beneficiary who fails to make a timely request for an expedited reconsideration by a QIO, as described in paragraph (b)(1) of this section, may still request an expedited QIO reconsideration at any time. The QIO issues a reconsideration in accordance with paragraph (c)(3)(ii) of this section, but the billing protection under paragraph (e) of this section does not apply.
(c)
Procedures and responsibilities of the QIO.
(1)
On the day the QIO receives the request for an expedited reconsideration under paragraph (b) of this section, the QIO must immediately notify the hospital of the request for an expedited reconsideration.
(2)
The QIO must offer the eligible beneficiary and the hospital an opportunity to provide further information.
(3)
When the eligible beneficiary makes—
(i)
A timely request in accordance with paragraph (b)(1) of this section, the QIO must make a reconsideration determination within 2 calendar days of receiving all requested pertinent information; or
(ii)
An untimely request, the QIO must make a reconsideration determination within 3 calendar days of receiving all requested pertinent information.
(4)
When the QIO issues a reconsideration determination, the QIO must notify the eligible beneficiary, the hospital, and SNF, if applicable, 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.
(iv)
Information about the eligible beneficiary's right to appeal the QIO's reconsideration decision to OMHA for an ALJ hearing in accordance with subpart I of this part, including how to request an appeal and the time period for doing so.
(d)
Responsibilities of the hospital. A hospital may, but is not required to, submit evidence to be considered by a QIO in making its reconsideration decision. If a hospital fails to comply with a QIO's request for additional information beyond that furnished to the QIO for purposes of the expedited determination, the QIO makes its reconsideration decision based on the information available.
(e)
Billing during QIO reconsideration. When an eligible beneficiary requests an expedited reconsideration in accordance with the deadline specified in paragraph (b)(1) of this section, the hospital may not bill the beneficiary for any disputed services until the QIO makes its reconsideration decision.
(f)
Effect of an expedited QIO reconsideration. The QIO expedited reconsideration is binding for payment purposes only, upon the eligible beneficiary, hospital, and MAC, except if a beneficiary elects to request a hearing by an ALJ in accordance with 42 CFR part 478 subpart B if he or she is dissatisfied with the expedited reconsideration decision.
Notes, amendments, and revision history

Amendments

[89 FR 83292, Oct. 15, 2024]

Source

Source: 69 FR 69264, Nov. 26, 2004, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).

Amendments

[89 FR 83292, Oct. 15, 2024]