TN 4 (10-21)

DI 45001.015 Medical Review of Non-DOFA ESRD Claims

A. Medical requirements

After determining that all nonmedical factors are met, review the medical records including the Form CMS-2728-U3 End Stage Renal Disease Medical Evidence Report Medicare Entitlement And/Or Patient Registration regarding Treatment Information, Items 13 through 32. In the event that a medical record other than the CMS-2728-U3 is the primary medical evidence, it must be clear to the reviewer that the medical record does provide unequivocal evidence of ESRD. The findings must be compatible to the pertinent questions to which a CMS-2728-U3 requires answers, and include validation. Any doubts must be resolved pre-adjudicatively by consultation with an ODO disability examiner, who may provide a definite response, suggest development, or suggest referral to CMS, BERC, OEP, DMEP, Medicare Entitlement Branch, Room 349 EHR. These cases should be sent to CMS via OD, SPB, 3-M-25 Operations Building. If the evidence from other than a CMS-2728-U3 is determined to be sufficient for a decision of ESRD Medicare entitlement without referral to CMS, complete all necessary award actions and refer the case to OD post-adjudicatively. OD will at that time be certain that CMS has all the needed statistical information that would have been on a CMS-2728-U3.

To be medically eligible for Medicare (ESRD) entitlement, the individual must:

  1. 1. 

    have end-stage renal disease, and

  2. 2. 

    be undergoing regular dialysis or have received a kidney transplantation.

    NOTE: Before cases are referred to CMS (via OD), develop through the DO to resolve any discrepancies

B. CMS-2728-U3 End Stage Renal Disease Medical Evidence Report Medicare Entitlement And/Or Patient Registration

To view form CMS-2728-U3 see HI 00801.902.

Item 1-14 should be completed in all cases, but non-completion of these items does not preclude entitlement.

Items 15 a-d or 16 a-d must be completed if the claimant received a regular course of dialysis. If 15d or 16d is marked “yes” , 15e or 16e, as appropriate, must be completed pre-adjudicatively.

Item 19-25 should be completed, as appropriate, if the claimant had a kidney transplant. If early entitlement based on transplantation (HI 00801.221) is a factor, item 22 must be completed and the hospital must appear as an approved facility on the current Renal Provider List.

Item 26 must be completed. If the question in the first block in unanswered or in answered “no” and there is an entry in item 15a-c, 16a-c, or 19, develop for clarification through the district office to resolve the discrepancy between the claimant’s allegation and the information shown on the Form CMS-2728-U3. If the discrepancy is not resolved by the development response, forward the case to the Office of Disability, Division of Vocational Rehabilitation and Special Programs, Special Programs Branch, 3-M-25 Operations for possible referral to CMS, BERC, OEP, DMEP, Medicare Entitlement Branch, 349 EHR. If the signature of the physician is not shown, but a signature is shown in item 32, follow the development and, if necessary, the referral procedure shown immediately above. If no signature appears in either item 26 or item 32, redevelop for a new Form CMS-2728-U3 through the FO. (Adjudication should not be precluded because only the date signed is not completed.)

Items 27-32 must be completed if the claimant received self-care dialysis training (see DI 45001.015F., below). If items 27-31 are completed but a signature is not entered in item 32, redevelop for a signature post-adjudicatively if entitlement can be establish DI 45001.015 see DI 45001.015F.2., below).

C. Processing closed period of coverage cases

A closed period of coverage is appropriate if:

  1. 1. 

    a transplant occurred 33 months or more before adjudication, but not more than 48 months before the month the application was filed, or

  2. 2. 

    cessation of regular dialysis occurred 10 months or more before adjudication, but not more than 24 months before the month the application was filed, or

  3. 3. 

    the ESRD patient dies before adjudication and entitlement can be established.

Care should be taken when a closed period is involved in a reopening to insure the proper Amendment (pre-1978 or 1978) and policy regarding coverage are applied.

If there is an indication that a closed period of coverage should be established, be certain that the individual has not had a later transplant, or subsequently has not been put on dialysis. Either of these latter situations indicates entitlement to a continuous period, or perhaps multiple periods of Medicare coverage. Separate SSA-892-U3’s will, of course, be necessary for each of the multiple periods of coverage. These should be prepared and processed normally per DI 45001.025. If the final period of coverage is a closed period rather than an open period, prepare SSA-892-U3’s for multiple periods and control via the adjudicating unit’s holding file for imminent recall of the folder and timely processing. The initial notice should be shown on an SSA-865 and modified appropriately to notify the individual of both entitlement and the impending termination, unless evidence to the contrary is received. (Be guided as appropriate by DI 45010.001.) Also do not forward the folder to a benefit authorizer when the award is processed via the EAM facility. In that case, the folder is routed directly to a typist after processing is complete.


NOTE: See DI 45010.050 for specific instructions for folder maintenance in closed period cases.


D. Dialysis ended or was interrupted during qualifying period

If (new) evidence is received which indicates that the patient was not on dialysis throughout the qualifying period and neither a transplant nor death was involved, the claim should be denied unless dialysis has resumed. There has been instances in which dialysis ended prior to expiration of the qualifying period but (it may be learned later that) the patient resumed dialysis, received a kidney transplant, or dies from renal failure. These cases should be handled as follows:

  1. 1. 

    If the patient is certified by a physician to have ESRD and resumes dialysis in 30 or less days following the date dialysis initially ended, Medicare should be awarded based on the earlier date.

  2. 2. 

    If the patient is certified by the physician to have ESRD and resumes dialysis more than 30 days following the date dialysis initially ended, Medicare should be awarded based on the later dialysis start date.

  3. 3. 

    If the patient has been awarded coverage before it is discovered that there was a dialysis interruption which occurred during the qualifying period and more than 30 days elapsed between the two periods of treatment, an amended award should be prepared to adjust the claimant’s HI entitlement to the later date. The SMI award, however, will not be disturbed in accordance with the equitable relief provision in HI 00805.210.

  4. 4. 

    If the dialysis interruption (as applied in the situation in DI 45001.015D.3., above) was for 30 or less days, neither the HI nor SMI award will be disturbed.

  5. 5. 

    Allowed cases in which subsequent evidence established that dialysis did not last through the qualifying period (i.e., resumption of dialysis, transplant or death of the claimant within 30 days of the date dialysis ended are not involved) should be reopened and reversed to a denial. (If the subsequent evidence is received at such a long time after dialysis ended and raises a question of administrative finality, submit the case of OD per DI 45001.015E., below before any action.) Also see DI 45001.060 for equitable relief provisions.

  6. 6. 

    If the patient receives a transplant after the dialysis ends in the qualifying period or if the patient was denied previously because dialysis ended before the end of the qualifying period and it is discovered that the individual had a transplant, award the claim using the transplant date. However see DI 45001.001 C. to determine whether early transplant provisions apply to the claim.

E. Referral of medical issues

Refer all claims by SSA-559 which contain an unresolved medical issue or meets the referral criteria described above, to: OD, SPB, 3-M-25 Operations Building for possible referral to CMS. These referrals must be reviewed prior to release to OD as indicated in DI 45001.010 C. On the transmittal show “Allowed” or “Unprocessed ESRD claim”. Cite the reference above or item on the CMS-2728-U3 which raises the question or other medical issue which ODO recognized as a problem situation. After review OD will return the claim and indicate what, if any, additional medical development is needed. If the claim should be denied without any further development the reason for the denial will be furnished, which should be sufficient to determine the appropriate denial notification language.

The physician’s certification of ESRD should not be disputed unless there is clearly contradictory information in file, e.g., although the physician indicates that the patient has chronic renal failure on the CMS-2728-U3, he adds the statement that the patient’s condition is acute renal failure. If the physician certifies to the existence of ESRD and a regular course of dialysis or transplant is the mode of treatment, it is immaterial what diagnosis is shown on the CMS-2728-U3.

Also, if a partial award is in order, it should be adjudicated using the later date of entitlement prior to referral to OD for consideration of an earlier date of entitlement.

F. Processing waiver of qualifying period for self-dialysis cases

  1. 1. 

    The 3-month period to qualify for R-HI/R-SMI based on regular dialysis can be waived if the person:

    1. a. 

      begins a self-dialysis training program in a Medicare approved center,

    2. b. 

      is expected to complete (or has completed) the program,

    3. c. 

      can be expected to self-dialyze thereafter, and

    4. d. 

      maintain a regular course of dialysis throughout the 3-month period (see HI 00801.226 C. when death involved).

      When the person participates in a self-care dialysis training program before the end of the qualifying period, entitlement can begin with the first month of the qualifying period that R-HI insured status is met. Also see HI 00801.226 C. NOTE, to determine when it is acceptable for a family member to be trained in lieu of the patient.

  2. 2. 

    If the “Certification for Self-Care Dialysis Training” statement is not properly signed by a physician, develop for a properly signed form through the FO and process an award without waiver of the qualifying period.

  3. 3. 

    If the provider is not listed as certified for self-care dialysis training obtained (see DI 45001.005 C.7.), the Earnings Review Examiner will process an award without waiver of the qualifying period and refer the folder (after award adjudication), for consideration to OD for possible referral to CMS, BDMS, OSDM, DIA, ESRD Systems Branch. On the award notice, advise the claimant, “We will notify you later if your Medicare coverage can begin at an earlier date, as we did not take into account your self-dialysis treatment.”

  4. 4. 

    When an award on the basis of dialysis was previously processed with entitlement following the qualifying period, ODO will amend the prior R-HI award upon receipt of a satisfactory certification (or special direction by OD or CMS) to allow R-HI effective with the first month of the course of dialysis but not for entitlement before 10/1/78.

  5. 5. 

    If the qualifying period has been waived (claim adjudicated) based on self-dialysis training and subsequent third party information is received to the contrary, the waiver will continue if:

    1. a. 

      it (waiver) was not procured by fraud or similar fault, and

    2. b. 

      the claimant’s regular course of dialysis was not interrupted for more than 30 days during the qualifying period.Whenever this situation occurs and the criteria herein is not met, follow item DI 45001.015F.6. below.

  6. 6. 

    Any case (other than one of death or subsequent resumption of self-dialysis training) in which evidence shows that the individual terminated self-dialysis training before completing the course and before the end of the qualifying period will not be granted waiver of the qualifying period. If an award can be processed following the regular qualifying period rules of the 3rd month after the month dialysis began, process the award without waiving the qualifying period. If an award was previously processed, amend the award under the equitable relief guidelines in HI 00805.170. Waiver of the qualifying period and a closed period award are appropriate if training is ended because death occurs or at the point the illness prevented training if the illness resulted in death. If a DIB has also been filed, prepare an SSA-567 to route claim to a disability examiner upon completion of earnings reviewer action.

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DI 45001.015 - Medical Review of Non-DOFA ESRD Claims - 10/13/2021
Batch run: 10/13/2021