Coverage Watch · Explainer

Two patients, one rule

In its guidance to states, CMS describes two women with breast cancer. The state’s records confirm that one is medically frail. The other is sent to manual review. Here is what the federal rule says happens to each, step by step.

The examples

One woman is in treatment now. The other was diagnosed ten years ago.

Among its examples, CMS’s guidance uses two women with breast cancer. For each, it lists codes a state might find in 12 months of claims and gives its determination. Diana’s claims settle the question (CMS calls this Tier 1). Patricia’s do not (Tier 3), so her case goes to manual review.Note 1

Diana’s case is settled at the claims check. Patricia’s goes on to manual review.

Diana, 47CMS’s Tier 1 example

  1. 1 · DiagnosisStage IIIC breast cancer, diagnosed recently; now needs chemoradiation
  2. 2 · Claims checkTier 1: a code in her claims confirms she is medically frail
  3. 3 · NoticeDoes not happen: no request for documents
  4. 4 · 30 daysDoes not happen: no deadline
  5. 5 · OutcomeExcluded from the requirement; checked again at least every 12 months

Patricia, 54CMS’s Tier 3 example

  1. 1 · DiagnosisStage IIA breast cancer, diagnosed ten years ago; no recurrence found
  2. 2 · Claims checkTier 3: her claims cannot settle it
  3. 3 · NoticeManual review; the state may ask her for documents
  4. 4 · 30 days30 days to respond, if the state sends a notice of noncompliance
  5. 5 · OutcomeNot given in CMS’s example
  • Step happens
  • Where Diana’s case is decided
  • Does not happen
  • Not given by CMS
Sources: CMS, Implementing Medical Frailty Under Community Engagement, pages 27 and 28; 42 CFR 435.557 and 435.558. The drawings of the two women are outlines, not likenesses.
The rule

Before asking a patient for anything, the state must check its own records

Starting 1 January 2027, most adults aged 19 to 64 who have Medicaid through the Affordable Care Act expansion must show 80 hours a month of work or another qualifying activity, unless they are excluded. A state may start earlier, or later if CMS grants it a good-faith exemption, which cannot last past 31 December 2028.Note 2

People who are medically frail are excluded. For most people with cancer, that means a serious or complex medical condition, such as one that is life threatening or needs treatment that carries a risk of serious complications. A diagnosis is not enough on its own: the condition must also significantly impair the person’s ability to meet the requirement.Note 3

The state must first try to confirm frailty from information it already has, including claims from the past 12 months. Only when that falls short may it ask the person for documents or accept a statement signed under penalty of perjury. Until 1 January 2028 it may accept such a statement each time it checks; from then on, only once while the person stays enrolled.Note 4

CMS’s September 2026 guidance suggests one way to run that check: sort people into three tiers. States do not have to use it.Note 5

Tier 1
The state can confirm from diagnosis codes alone that the condition significantly impairs the person’s ability to comply.
Tier 2
The condition may qualify, but the state needs more information to judge whether it significantly impairs the person, such as heavy use of acute care, a high-risk mix of medicines, certain medical equipment or other conditions.
Tier 3
There is not enough information, or none, to decide. This should start a manual review, in which the state may ask the person for documents.

“The aim of a data-first approach is to limit the need to rely on manual verification by a clinician or caseworker to determine medical frailty.”

CMS, Implementing Medical Frailty Under Community Engagement, page 21

The same rule, one step at a time

Each step starts with what the federal rule says, then shows what happens to Diana and to Patricia. Where a step does not happen for one of them, or where CMS’s example ends, the card says so.

  1. Step 1: Diagnosis

    The ruleA diagnosis does not exclude anyone on its own. The condition must fit a frailty category, and it must significantly impair the person’s ability to meet the requirement.

    42 CFR 435.554(c)(5)(i)

    Diana, 47

    Diana was recently diagnosed with stage IIIC breast cancer in her right breast (HER2-positive, hormone receptor-negative invasive ductal carcinoma). The tumor was 4.2 cm, and four lymph nodes in her right armpit were involved. Before this, her medical history was limited.

    She had chemotherapy (paclitaxel, trastuzumab and pertuzumab), then a right modified radical mastectomy that also removed the lymph nodes in her armpit. Cancer remained after surgery, so she now needs chemoradiation, with transportation to appointments 3 to 5 days a week.

    She reports significant fatigue, lymphedema of her right arm that needs a compression garment to the chest wall, and neuropathy in her hands and feet from chemotherapy.

    CMS guidance, page 27

    Patricia, 54

    Ten years ago Patricia was diagnosed with stage IIA breast cancer in her left breast (hormone receptor-positive, HER2-negative invasive ductal carcinoma).

    She had a left lumpectomy with a sentinel lymph node biopsy, then radiation, and started anastrozole, a hormone therapy. She finished anastrozole five years ago, with no recurrence found.

    Her latest yearly mammogram showed no active disease. She sees her oncologist once a year and is up to date on cervical and colorectal cancer screening, a bone density scan, routine blood tests and her yearly primary care visit.

    CMS guidance, page 28

  2. Step 2: Claims check

    The ruleThe state must try to confirm frailty from information it already has, including claims from the past 12 months, whether paid, pended or denied. If that information is enough, it may not ask the person for documents.

    42 CFR 435.557(c)(1)(i) and (f)(1)

    Diana

    Tier 1: confirmed from her claims

    Medical claims
    • ICD-10-CM C77.3 Secondary and unspecified malignant neoplasms (metastatic cancer) of the axilla and upper limb lymph nodes. CMS marks this code as qualifying on its own.
    Pharmacy claims
    • J9267 Paclitaxel
    • J9355 Trastuzumab
    • J9307 Pertuzumab (as CMS gives it; in the HCPCS code set, pertuzumab is J9306 and J9307 is pralatrexate)

    CMS’s determination“Tier 1 medical frailty based on the ICD-10-CM code, which demonstrates a recent diagnosis of advanced breast cancer.”

    Her claims are enough. The state confirms she is medically frail without asking her for anything.

    Codes from 12 months of claims, as CMS lists them (“not exhaustive”). CMS guidance, page 27

    Patricia

    Tier 3: cannot be decided from her claims

    Medical claims
    • ICD-10-CM Z85.3 Personal history of malignant neoplasm of breast
    • ICD-10-CM Z13.820 Encounter for screening for osteoporosis
    • CPT 99213 Office visit, established patient, moderate complexity (as CMS gives it; in CPT, 99213 means a low level of medical decision making, and moderate is 99214)
    • CPT 77067 Screening mammography, bilateral
    • CPT 80061 Lipid panel
    • CPT 83036 Hemoglobin A1c
    Pharmacy claims
    • NDC 63044-401-01 Vitamin D supplement

    CMS’s determination“Medical frailty cannot be determined based on administrative data as severity is indeterminate or not likely. Manual review would be required before the beneficiary could be classified as medically frail based on breast cancer diagnosis.”

    Her claims record a history of breast cancer and routine care. They cannot settle whether she is medically frail, so her case goes to manual review.

    Codes from 12 months of claims, as CMS lists them (“not exhaustive”). CMS guidance, page 28

  3. Step 3: Notice

    The ruleIf the state cannot confirm that a person meets the requirement or is excluded, it must send a notice of noncompliance. The notice must say which months are checked, how to show compliance or an exclusion, the deadline, and how to send information, including online, by phone, by mail or in person.

    42 CFR 435.558(a) and (c); 435.907(a)

    Diana

    Does not happen for Diana

    There is no notice of noncompliance. The state confirmed her exclusion from its own information, so it may not ask her for documents.

    The rule still requires the state to tell her its decision, including that she is excluded.

    42 CFR 435.556(d) and 435.557(c)(1)(i)

    Patricia

    Manual review

    CMS says a Tier 3 case should start a manual review, in which the state may ask her for documents: for example, health records such as treatment records and progress notes, or documentation from her health care provider.

    Instead of documents, the state may accept a statement she signs under penalty of perjury. Until 1 January 2028 it may do so each time it checks. From then on it may do so only once while she stays enrolled, and at her next regular renewal it must confirm frailty from its records or from documents.

    If the state cannot confirm from its own information that she is excluded, or that she meets the requirement another way, the rule requires a notice of noncompliance that says what to send and by when. CMS’s example does not say whether she works or qualifies another way.

    CMS guidance, page 20; 42 CFR 435.557(f)(1)(i) and (ii); 435.558(a) and (c)

  4. Step 4: 30 days

    The ruleA notice of noncompliance gives 30 calendar days to respond, starting the day it is received. It counts as received 5 days after the date on it, unless the person shows it arrived later. For someone already enrolled, Medicaid continues during this time.

    42 CFR 435.558(a)(2), (a)(3) and (c)(4)

    Diana

    Does not apply to Diana

    With no notice of noncompliance, there is no 30-day deadline.

    42 CFR 435.558(a)

    Patricia

    If the state sends a notice

    • The date on the notice
    • The next 4 days
    • 5 days after that date: it counts as received, day 1 of 30
    • Day 30, the last day to respond

    She has 30 days from receiving it to show that she is medically frail, that she meets the requirement another way, or that another exclusion applies.

    42 CFR 435.558(a)(2) and (c)(4)

  5. Step 5: Outcome

    The ruleIf the person shows compliance or an exclusion in time, the requirement is met or does not apply. If not, before ending coverage the state must check every other way the person might qualify for Medicaid, and give advance written notice and the right to a fair hearing.

    42 CFR 435.558(a)(2) and (d)

    Diana

    Excluded

    Diana is excluded as medically frail, so she does not have to show 80 hours of work or other activities.

    Because her status was confirmed from the state’s information, the state must check it again at least every 12 months.

    42 CFR 435.554(b) and 435.557(f)(1)(iii)

    Patricia

    Not given by CMS

    CMS’s example ends at manual review. It does not say what she sends or what the state decides. The rule sets out what happens next:

    • If she shows that she is medically frail, that she meets the requirement another way or that another exclusion applies, the requirement is met or does not apply to her.
    • If she does not, the state must check every other way she might qualify for Medicaid. If none applies, it must give advance written notice and fair hearing rights, and end her coverage no later than the end of the month after the month the 30 days end.
    • If her coverage ends because she did not send the information, and she sends it within 90 days (longer in some states), the state must reconsider without a new application. She can also reapply at any time; the state may not restrict reapplying.

    42 CFR 435.558(d), (e) and (f); 435.916(a)(3)(iii)

What it shows

In CMS’s examples, what the state’s data show decides the path

Both women have had breast cancer. Diana’s claims include a code that, in CMS’s example, confirms frailty on its own. Patricia’s record a history of breast cancer and routine care, and CMS says severity from those data is “indeterminate or not likely.” One path ends at the claims check. The other goes to manual review, and can lead to a notice and a deadline.Note 6

CMS notes that its examples give “a fuller picture” of each person than a state needs in order to decide. The codes listed with them “are what would form the basis for determining medical frailty.”Note 7

On Patricia’s path, what the state receives matters. CMS gives examples of the documentation a state may seek: health records, documentation or certification from a provider, care management information from a managed care plan, and functional assessment information. Our frailty letter builder helps a clinician write that documentation in the rule’s own terms.Note 8

How many people with cancer would take Patricia’s path depends on the rules each state sets. Our national estimates, under peer review, suggest that between 13.6% and 49.5% of Medicaid adults with cancer would need individual review, depending on what evidence their state counts.Note 9 See the data.

For what to do when a patient gets a notice, see the toolkit for care teams and the patient guide.

Notes

Notes

  1. CMS guidance, pages 21 and 22 (the examples) and 27 and 28 (Diana and Patricia). ↑
  2. 42 CFR 435.551, 435.552(a), 435.559(a) and (b) and 435.560(c). ↑
  3. 42 CFR 435.554(c)(5)(i); CMS guidance, pages 4 and 5. ↑
  4. 42 CFR 435.557(c)(1)(i) and (f)(1). ↑
  5. CMS guidance, pages 10, 12 and 18 to 20. Page 10: “States are not required to use this example tiered medical frailty framework.” ↑
  6. CMS guidance, pages 27 and 28. ↑
  7. CMS guidance, page 22. ↑
  8. CMS guidance, page 20. ↑
  9. Cancer Policy Lab, Coverage Watch: share of Medicaid adults 19–64 with a cancer history sent to manual frailty review, by evidence rule. Preliminary estimates from the Medical Expenditure Panel Survey 2018–2024, under peer review. ↑
Sources

Sources and how to cite

How to cite: Cancer Policy Lab. Coverage Watch: Two patients, one rule. cancerpolicylab.org/coverage-watch/two-patients/. Checked .

Educational resource, not legal advice. The federal rule is an interim final rule, is being challenged in court, and each state carries it out differently. Check your state’s Medicaid agency before acting.