Saturday 5 November 2016

Changes of Information and Changes of Ownership Denial Reasons

Denials 

A.  Denial Reasons 

When issuing a denial, the contractor shall insert the appropriate regulatory basis (e.g., 42 CFR § 424.530(a)(1)) into its denial letter.  The contractor shall not use provisions from this chapter 15 as the basis for denial.  Except as described in section 15.8.4(B) below or as otherwise stated in this chapter, the contractor may issue a denial letter without prior approval from CMS’ Provider Enrollment & Oversight Group (PEOG) of the denial or the denial letter.  

If the applicant is a certified provider or certified supplier and one of the denial reasons listed below is implicated, the contractor need not submit a recommendation for denial to the state/RO.  

The contractor can simply: 

(1) deny the application, 
(2) close out the PECOS record, and 
(3) send a denial letter to the provider.  

The contractor shall copy the state and the RO on said letter.  

Denial Reason 1 (42 CFR §424.530(a)(1)) – Not in Compliance with Medicare Requirements  The provider or supplier is determined not to be in compliance with the enrollment requirements in subpart P (of Part 424) or on the enrollment application applicable to its provider or supplier type, and has not submitted a plan of corrective action as outlined in 42 CFR part 488. 

Such non-compliance includes, but is not limited to, the following situations:  

a.   The provider or supplier does not have a physical business address or mobile unit where services can be rendered.  
b.   The provider or supplier does not have a place where patient records are stored to determine the amounts due such provider or other person.  
c.   The provider or supplier is not appropriately licensed.  
d.   The provider or supplier is not authorized by the federal/state/local government to perform the services that it intends to render.  
e.   The provider or supplier does not meet CMS regulatory requirements for the specialty that it seeks to enroll as.  (See section 15.4.8 of this chapter for examples of suppliers that are not eligible to participate.)  
f.   The provider or supplier does not have a valid social security number (SSN) or employer identification number (EIN) for itself, an owner, partner, managing organization/employee, officer, director, medical director, and/or authorized or delegated official.  
g.   The applicant does not qualify as a provider of services or a supplier of medical and health services.  (For instance, the applicant is not recognized by any Federal statute as a Medicare provider or supplier (e.g., marriage counselors.))  An entity seeking Medicare payment must be able to receive reassigned benefits from physicians in accordance with the Medicare reassignment provisions in § 1842(b)(6) of the Act (42 U.S.C. 1395u(b)).  
h.   The provider or supplier does not otherwise meet general enrollment requirements.  With respect to (e) above – and, as applicable, (c) and (d) - the contractor’s denial letter shall cite the appropriate statutory and/or regulatory citation(s) containing the specific licensure/certification/authorization requirement(s) for that provider or supplier type.  For a listing of some of these statutes and regulations, refer to section 15.4 et seq. of this chapter.  

NOTE:  The contractor must identify in its denial letter the exact provision within said statute(s)/regulation(s) that the provider/supplier is not in compliance with. 

Denial Reason 2 (42 CFR §424.530(a)(2)) – Excluded/Debarred from Federal Program  The provider or supplier, or any owner, managing employee, authorized or delegated official, medical director, supervising physician, or other health care personnel of the provider or supplier who is required to be reported on the CMS-855 is—  

• Excluded from Medicare, Medicaid, or any other Federal health care program, as defined in 42 CFR §1001.2, in accordance with section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Social Security Act, or  

• Debarred, suspended, or otherwise excluded from participating in any other Federal procurement or non-procurement program or activity in accordance with section 2455 of the Federal Acquisition Streamlining Act.  

Denial Reason 3 (42 CFR §424.530(a)(3)) – Felony Conviction  The provider, supplier, or any owner or managing employee of the provider or supplier was, within the preceding 10 years, convicted (as that term is defined in 42 CFR §1001.2) of a federal or state felony offense that CMS determines to be detrimental to the best interests of the Medicare program and its beneficiaries.  Offenses include, but are not limited in scope and severity to:  

• Felony crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pretrial diversions.  

• Financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pretrial diversions.  

• Any felony that placed the Medicare program or its beneficiaries at immediate 
risk, such as a malpractice suit that results in a conviction of criminal neglect or misconduct.  

• Any felonies outlined in section 1128 of the Social Security Act.  While, as discussed in section 15.27.2(D) of this chapter, a re-enrollment bar will be established for providers and suppliers whose billing privileges are revoked, this does not preclude the contractor from denying re-enrollment to a provider or supplier that was convicted of a felony within the preceding 10-year period or that otherwise does not meet all of the criteria necessary to enroll in Medicare.  If the contractor is uncertain as to whether a particular felony falls within the purview of 42 CFR §424.530(a)(3), it should contact PEOG via the MACRevocationRequests@cms.hhs.gov  mailbox for guidance.  

Denial Reason 4 (42 CFR §424.530(a)(4)) – False or Misleading Information on Application  The provider or supplier submitted false or misleading information on the enrollment application to gain enrollment in the Medicare program.  

Denial Reason 5 (42 CFR §424.530(a)(5)) – On-Site Review/Other Reliable Evidence that Requirements Not Met  Upon on-site review or other reliable evidence, CMS determines that the provider or  supplier:  

(i)  Is not operational to furnish Medicare-covered items or services; or   
(ii)  Otherwise fails to satisfy any Medicare enrollment requirement.    

Denial Reason 6 (42 CFR §424.530(a)(6)) – Existing Overpayment at Time of Application  

(i)  The enrolling provider, supplier, or owner (as defined in § 424.502) thereof has an existing Medicare debt.  

(ii)  The enrolling provider, supplier, or owner (as defined in §424.502) thereof was previously the owner of a provider or supplier that had a Medicare debt that existed when the latter's enrollment was voluntarily terminated, involuntarily terminated, or revoked, and all of the following criteria are met:   
(A) The owner left the provider or supplier with the Medicare debt within 1 year before or after that provider or supplier's voluntary termination, involuntary termination or revocation.  

(B)  The Medicare debt has not been fully repaid.  

(C)  CMS determines that the uncollected debt poses an undue risk of fraud, waste,  or abuse.  

 In making this determination under §424.530(a)(6)(ii), CMS considers the following factors:     

(1)  The amount of the Medicare debt.   
(2)  The length and timeframe that the enrolling provider, supplier, or owner thereof was an owner of the prior entity.   
(3)  The percentage of the enrolling provider, supplier, or owner's ownership of the prior entity.   
(4)  Whether the Medicare debt is currently being appealed.   
(5)  Whether the enrolling provider, supplier, or owner thereof was an owner of the prior entity at the time the Medicare debt was incurred.  A denial of Medicare enrollment under paragraph (a)
(6) can be avoided if the enrolling provider, supplier or owner thereof does either of the following:   

(A)  Satisfies the criteria set forth in § 401.607 and agrees to a CMS-approved extended repayment schedule for the entire outstanding Medicare debt; or 

(B)  Repays the debt in full.   

Denial Reason 7 (42 CFR §424.530(a)(7)) – Medicare Payment Suspension  The current owner (as defined in §424.502), physician or non-physician practitioner has been placed under a Medicare payment suspension as defined in §405.370 through §405.372.  

Denial Reason 8 (42 CFR §424.530(a)(8)) – Home Health Agency (HHA) Capitalization  An HHA submitting an initial application for enrollment:   

• Cannot, within 30 days of a CMS or Medicare contractor request, furnish supporting documentation verifying that the HHA meets the initial reserve operating funds requirement in 42 CFR §489.28(a); or  

• Fails to satisfy the initial reserve operating funds requirement in 42 CFR § 489.28(a).  

Denial Reason 9 (42 CFR §424.530(a)(9)) – Hardship Exception Denial and Fee Not Paid  The institutional provider’s (as that term is defined in 42 CFR §424.502) hardship exception request is not granted, and the institutional provider does not submit the required application fee within 30 days of notification that the hardship exception request was not approved.  (This denial reason should only be used when the institutional provider fails to submit the application fee after its hardship request was denied.  The contractor shall use 42 CFR §424.530(a)(1) as a basis for denial when the institutional provider:  

• Does not submit a hardship exception request and fails to submit the application fee within the prescribed timeframes, or  

• Submits the fee, but it cannot be deposited into a government-owned account.)

Denial Reason 10 (42 CFR §424.530(a)(10)) – Temporary Moratorium  The provider or supplier submits an enrollment application for a practice location in a geographic area where CMS has imposed a temporary moratorium.  (This denial reason applies to initial enrollment applications and practice location additions.)  


Denial Reason 11 (42 CFR §424.530(a)(11)) – DEA Certificate/State Prescribing Authority Suspension or Revocation  

(i) A physician or eligible professional's Drug Enforcement Administration (DEA) Certificate of Registration to dispense a controlled substance is currently suspended or revoked; or   

(ii) The applicable licensing or administrative body for any State in which a physician or eligible professional practices has suspended or revoked the physician or eligible professional's ability to prescribe drugs, and such suspension or revocation is in effect on the date the physician or eligible professional submits his or her enrollment application to the Medicare contractor.    

B.  Denial Letters  

1.  Prior PEOG Approval Necessary    For cases involving §424.530(a)(4) (Denial Reason 4 above), the contractor  shall obtain approval of both the denial and the denial letter from PEOG via the MACRevocationRequests@cms.hhs.gov mailbox prior to sending the denial letter.  PEOG will notify the contractor of its determinations and instruct the contractor as to how to proceed.  

2.  Prior PEOG Approval Unnecessary    When a decision to deny is made, the contractor shall send a letter to the provider identifying the reason(s) for denial and furnishing appeal rights.  The letter shall follow the format of those shown in section 15.24 et seq. of this chapter.  Absent a CMS instruction or directive to the contrary, the letter shall be sent to the provider or supplier no later than 5 business days after the contractor concludes that the provider or supplier’s application should be denied.  

No reenrollment bar is established for denied applications. Reenrollment bars apply only to revocations.  

C.  Post-Denial Submission of Enrollment Application  

A provider or supplier that is denied enrollment in the Medicare program may not submit a new enrollment application until either of the following has occurred:  

• If the denial was not appealed, the provider or supplier’s appeal rights have lapsed, or 

• If the denial was appealed, the provider or supplier has received notification  that the determination was upheld.  

D.  30-Day Effective Date of Denial  

A denial is effective 30 calendar days after the contractor sends its denial notice to the provider.  As stated in 42 CFR §424.530(c), if the denial was due to adverse activity (e.g., exclusion, felony) of an owner, managing employee, an authorized or delegated official, medical director, supervising physician, or other health care personnel of the provider or supplier furnishing Medicare services, the denial may be reversed if the provider or supplier submits proof that it has terminated its business relationship with that individual or organization within 30 days of the denial notification.  

E.  Other Impacts of a Denial  

1.  Changes of Information and Changes of Ownership (CHOWs)  

a.   Expiration of Timeframe for Reporting Changes - If the contractor denies a change of information or CHOW submission per this section 15.8.4 and the applicable 90-day or 30-day period for reporting the change has expired, the contractor shall send an email to the MACR evocationRequests@cms.hhs.gov mailbox notifying PEOG of the denial.  

PEOG will determine whether the provider’s Medicare billing privileges should be deactivated under 42 CFR §424.540(a)(2) or revoked under 42 CFR §424.535(a)(1) or (a)(9) and will notify the contractor of its decision.  

b.  Timeframe Not Yet Expired - If the contractor denies a change of information or CHOW submission and the applicable 90-day or 30-day period for reporting the change has not yet expired, the contractor shall send the e-mail referred to in (1)(a) above after the expiration of said time period unless the provider has resubmitted the change request/CHOW.  

c.  Second Denial, Return, or Denial – If, per (1)(b), the provider resubmits the change of information or CHOW application and the contractor either denies it again, returns it per section 15.8.1 of this chapter, or rejects it per section 15.8.2 of this chapter, the contractor shall send the e-mail referred to in (1)(a) above regardless of whether the applicable timeframe has expired.  

PEOG will determine whether the provider’s Medicare billing privileges should be deactivated under 42 CFR §424.540(a)(2) or revoked under 42 CFR §424.535(a)(1) or (a)(9) and will notify the contractor of its decision.  

2.  Reactivations – If the contractor denies a reactivation application, the provider’s Medicare billing privileges shall remain deactivated. 

3.  Revalidations – If the contractor denies a revalidation application per this section 15.8.4, the contractor shall – unless an existing CMS instruction or directive dictates otherwise - revoke the provider’s Medicare billing privileges under 42 CFR §424.535(a)(1) if the applicable time period for submitting the revalidation application has expired.  

If it has not expired, the contractor shall revoke the provider’s billing privileges after the applicable time period expires unless the provider has resubmitted the revalidation application.  If the provider has resubmitted the application and the contractor (1) denies it again, (2) returns it per section 15.8.1 of this chapter, or (3) rejects it per section 15.8.2 of this chapter, the contractor shall - unless an existing CMS instruction or directive dictates otherwise – revoke the provider’s billing privileges, assuming the applicable time period has expired.  

F.  Provider Enrollment Appeals Process  For more information regarding the provider enrollment appeals process, see section 15.25 of this chapter.  


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