State Operations Manual (Pub. 100-07), Ch. 3 § 3001
Initial Denials of Medicare Provider/Supplier Requests for
3001 - Initial Denials of Medicare Provider/Supplier Requests for
Program Participation
(Rev. 1, 05-21-04)
Denials are made only when there has been an expression, written or otherwise, of
interest in participating (or in expanding the scope of existing participation) and/or an
initial survey is performed. Because the RO makes the compliance decision for Medicare
and approves an effective date of participation, the SA should not lead the
provider/supplier to believe that the provider/supplier has been approved and can start to
furnish services to Medicare beneficiaries.
An initial denial is made when, after evaluating the evidence the adjudicating office (in
this case the RO) finds that the requirements of law and regulation are not met. The SA
forwards recommendations for initial denials to the RO within 10 working days after the
date of survey. Formal written denial notices that explain the right to appeal are issued
by the RO as soon as possible.
3001A - Authority for Adjudicating Denials
(Rev. 1, 05-21-04)
The RO adjudicates all approvals or disapprovals for Medicare participation. 42 CFR
498 addresses determination and appeal procedures. Title 42 CFR Part 488 provides the
basis for denying suppliers of services. The statutory authority is implied in §§1819,
1832, 1861, and 1881 of the Act which authorize the Secretary to establish CoPs or CfCs.
3001B - Vacated Actions Which Are Not Denials
(Rev. 1, 05-21-04)
If the SA is contacted by a potential provider and it schedules a survey, but the survey is
canceled after finding that the party is either no longer interested in participating or in
meeting program requirements, the SA notifies the RO by Form CMS-1539, indicating
the lack of interest. The RO sends a written notice to the potential provider to document
the reason why certification action was not completed. Despite the lack of interest, if the
potential provider operates a SNF, and the SA has sufficient information, the SA prepares
a §1819(a)(1) (formerly §1861(j)(1)) certification, if indicated. (See §2164.)
3001C - Vacated Actions Which Are Denials
(Rev. 1, 05-21-04)
If a potential provider or supplier is surveyed and deficiencies are cited, the SA forwards
Form CMS-1539 and related documentation to the RO, even when the request for
participation is withdrawn. The RO either notifies the provider or supplier of the failure
to meet eligibility requirements or affirms the provider’s or supplier’s request to
withdraw. The SA uses Form CMS-1539 to transmit all certification forms and pertinent
documents to the RO within 45 calendar days of the survey. A §1819(a)(1) certification
is included, if indicated.
NOTE: The RO, based on notification by the FI or carrier of their inability to verify
environment data, may issue the provider or supplier a notice of Medicare denial of
participation.
3001D - RO Processing of Denials
(Rev. 1, 05-21-04)
The RO processes the denial and sends the provider or supplier a formal notice, with a
copy to the SA, the State Medicaid Agency (SMA), and the intermediary, if applicable,
documenting the basis for the action.
The RO includes the following information in the formal notice:
• The date of the notice;
• The decision and reason for it (cite provisions of the law or regulations not met);
• The right to request participation in the future; and
• The procedures to follow for a formal reconsideration and a hearing before an
administrative law judge (ALJ).
A denial notice must be signed by the RO official delegated to adjudicate denials.