Monday 14 November 2016

Form CMS-855 Reactivation / Movement of Providers and Suppliers into the High Level / On-site Inspections and Site Verifications / DMEPOS Supplier Accreditation / Compliance Standards for Pharmacy Accreditation

Reactivations 

A. Form CMS-855 Reactivations  

1.  Limited  Form CMS-855 reactivation applications submitted by providers and suppliers in the “limited” level of categorical screening shall be processed in accordance with existing instructions. 

2.  Moderate  Form CMS-855 reactivation applications submitted by providers and suppliers in the “moderate” level of categorical screening – including existing home health agencies and suppliers of durable medical equipment, prosthetics, orthotics and suppliers (DMEPOS) – shall be processed in accordance with the screening procedures for this category.  A site visit will therefore be necessary prior to the contractor’s final decision regarding the application.  

3.  High  Form CMS-855 reactivation applications submitted by providers and suppliers in the “high” level of categorical screening shall be processed in accordance with the screening procedures for this category.  A site visit will therefore be necessary prior to the contractor’s final decision regarding the application.  

B. Reactivation Certification Packages (RCPs)  

For RCPs (as described in sections 15.27.1.2.1 and 15.27.1.2.2 of this chapter), a site visit is required if the provider is in the moderate or high screening category.  A site visit is not required if the provider is in the limited screening category. 

Movement of Providers and Suppliers into the High Level 

Under §424.518(c)(3), CMS may adjust a particular provider or supplier’s screening level from “limited” or “moderate” to “high” if any of the following occur:  

1.   CMS imposes a payment suspension on a provider or supplier at any time within the last 10 years;  

2.   The provider or supplier:  

a. Has been excluded from Medicare by the Office of Inspector General; or  

b. Had its billing privileges revoked by a Medicare contractor within the previous 10 years and is attempting to establish additional Medicare billing privileges by:  

• Enrolling as a new provider or supplier; or 
• Obtaining billing privileges for a new practice location 

c. Has been terminated or is otherwise precluded from billing Medicaid  

d. Has been excluded from any Federal health care program  

e. Has been subject to any final adverse action (as defined in §424.502) within the previous 10 years. 

3. CMS lifts a temporary moratorium for a particular provider or supplier type, and a provider or supplier that was prevented from enrolling based on the moratorium applies for enrollment as a Medicare provider or supplier at any time within 6 months from the date the moratorium was lifted. 

CMS makes available to the contractor on a bi-monthly basis a list of current and former Medicare providers and suppliers within the contractor’s jurisdiction that meet any of the criteria in subsection (1) or (2) above.  Upon receipt of an initial or revalidation application from a provider or supplier that otherwise falls within the limited or moderate screening category (and after the appropriate fee has been paid, etc.), the contractor shall determine whether the provider or supplier is on the bimonthly “high” screening list.  

If the provider or supplier is not on said list, the contractor shall process the application in accordance with existing instructions.  If the provider or supplier is on the list, the contractor shall process the application using the procedures in the “high” screening category unless the provider is on the list solely because he/she/it was revoked for failing to timely respond to a revalidation request. 

If such is the case, the contractor shall contact its CMS Provider Enrollment & Oversight Group Business Function Lead for guidance as to how the situation should be handled.  With respect to subsection (3) above, if the contractor receives an initial or new location application from a provider or supplier: 

(a) that is of a provider or supplier type that was subject to a moratorium and 

(b) within 6 months after the applicable moratorium was lifted, the contractor shall process the application using the procedures in the “high” screening category.  

Temporary Moratoria 

Under §424.570(a), CMS may impose a moratorium on the enrollment of new Medicare providers and suppliers of a particular type or the establishment of new practice locations of a particular type in a particular geographic area.  The announcement of a moratorium will be made via the Federal Register, though the contractor will be separately notified of the moratorium.  The contractor shall abide by all CMS directives and instructions issued pursuant to the imposition or lifting of a particular moratorium.  

Tracking 

In April 2011, PEOG will send to each contractor an Excel spreadsheet that the contractor shall complete and submit to its PEOG liaison via e-mail no later than the 15th day of each month. 

The first report will be due on May 15, 2011.  The spreadsheet will contain data elements such as, but not limited to:  

• Number of enrolled providers and suppliers in each risk category, broken down by provider/supplier sub-type (e.g., hospital, HHA) 

• Amount of fees collected (i.e., fees that were cleared), broken down by provider and supplier type.

On-site Inspections and Site Verifications 

The contractor shall not conduct site verifications to determine if a provider or supplier (including physicians and non-physician practitioners) is operational unless CMS: 

(1) has already issued formal guidance to do so, or 
(2) issues instructions directing the contractor to conduct a pre-enrollment or post-enrollment site verification.  

Site Verifications 

(Unless otherwise stated in this chapter or in another CMS directive, this section 15.20.1 only applies to site visits/verifications that are not performed pursuant to sections 15.19.2.1 through 15.19.2.4 of this chapter.)  

A.   Background  

1.   Operational Status  

When conducting a site verification to determine whether a practice location is operational, the contractor shall make every effort to limit its site verification to an external review of the practice location.  If the contractor cannot determine whether the practice location is operational based on an external review of the location, the contractor shall conduct an unobtrusive site verification by limiting its encounter with provider or supplier personnel or medical patients.  

2.    Determining 

Whether the Provider or Supplier Meets Regulatory Requirements for Its Provider or Supplier Type   When conducting a site verification to determine whether a provider or supplier continues to meet the regulatory provisions for its provider or supplier type, the contractor shall conduct its site verification in a manner which limits the disruption for the provider or supplier.  

B.  Timing  

Site verifications should be done Monday through Friday (excluding holidays) during their posted business hours.  If there are no hours posted, the site verification should occur between 9 a.m. and 5 p.m.  If, during the first attempt, there are obvious signs that facility is no longer operational no second attempt is required. 

If, on the first attempt the facility is closed but there are no obvious indications the facility is non-operational, a second attempt on a different day during posted hours of operation should be made.  

C.  Documentation  

When conducting site verifications to determine whether a practice location is operational, the contractor shall:  

• Document the date and time of the attempted visit and include the name of the individual attempting the visit;  

• As appropriate, photograph the provider or supplier’s business for inclusion in the provider or supplier’s file on an as needed basis. 

All photographs should be date/time stamped;  

• Fully document all observations made at the facility (e.g., the facility was vacant and free of all furniture, a notice of eviction or similar documentation was posted at the facility, the space is now occupied by another company); and   

• Write a report of its findings regarding each site verification.  

D.  Signed Declaration  

The contractor shall also include a signed declaration stating the facts and verifying the completion of the site verification.  (A sample declaration is below and may be revised as necessary.)   As a reminder, this declaration is only necessary for MAC-performed site visits.  

DMEPOS Supplier Accreditation 

A.   General Requirement  

DMEPOS suppliers must be accredited prior to submitting an application to the National Supplier Clearinghouse (NSC).  The NSC shall not approve any DMEPOS supplier's enrollment application if the enrollment package does not contain an approved accreditation upon receipt or in response to a developmental request.  The NSC may reject an enrollment application if the DMEPOS supplier fails to provide supporting documentation that demonstrates that the supplier has an approved accreditation.  

The NSC shall revoke an enrolled DMEPOS supplier’s billing privileges if the DMEPOS supplier fails to: (1) obtain and submit supporting documentation that the DMEPOS supplier has been accredited, or (2) maintain its required accreditation.  

B.   Exemptions  

Individual medical practitioners, inclusive of group practices of same, do not require accreditation as a condition of enrollment.The practitioner types are those specifically stated in Sections 1848(K)(3)(B) and 1842(b)(18)(C) of the Social Security Act.  

In addition, the practitioner categories of physicians, orthotists, prosthetists, optometrists, opticians, audiologists, occupational therapists, physical therapists and suppliers who provide drugs and pharmaceuticals (only) do not require accreditation as a condition of enrollment.  

Although suppliers that provide only drugs and pharmaceuticals are exempt from the accreditation requirement, suppliers that provide equipment to administer drugs or pharmaceuticals must be accredited.  

C.   Special Situations  

1. Changes of Ownership  

a. A change of ownership application for an existing supplier location submitted by a new owner company with a new tax identification number (TIN) shall be rejected (consistent with 42 CFR § 424.525) if the new owner does not have an accreditation that covers all of its locations.  

If the old owner has such an accreditation, the new owner can be enrolled as of the date of sale if the accreditor determines that the accreditation should remain in effect as of the date of sale.  (This, however, is only applicable when the new owner also meets all other enrollment criteria found at 42 CFR §424.57).  If the new owner submits an application without evidence that the accreditation is still in effect for the new owner, the application should be rejected. 

b. Some ownership changes do not result in a complete change of ownership, since the business entity remains the same with no change in TIN.  However, in cases where more than 5 percent of the ownership has changed, the following principles apply: 

• If the change in ownership has not been reported to the NSC within the required 30-day period, the NSC shall proceed with revocation action.  

• If the change has been received within the required 30-day period and the supplier has been accredited, the NSC shall immediately notify the accreditor of the ownership change and request that the latter advise the NSC if the accreditation should still remain in effect.  

c. A non-exempt DMEPOS supplier requesting reactivation after a deactivation (regardless of the deactivation reason) is required to be accredited.  

A revoked DMEPOS supplier that has submitted an acceptable corrective action plan can be reinstated without accreditation unless the accreditation was already required prior to revocation.  

Compliance Standards for Pharmacy Accreditation 

The National Supplier Clearinghouse (NSC) shall not require that a pharmacy be accredited as a condition of enrollment before January 1, 2011.  The NSC-Medicare Administrative Contractor (MAC) shall determine which enrolled suppliers are pharmacies that are not accredited and who will be enrolled for 5 calendar years prior to January 1 of the next calendar year.  

The NSC-MAC shall then send a notice of revocation by January 10, 2011, to all enrolled pharmacies that are not accredited and who will not be enrolled for 5 calendar years as of January 1, 2011.  

The NSC-MAC shall prepare a letter which enables all individually enrolled practice locations of pharmacies who have been enrolled for 5 calendar years prior to January 1, 2011, to attest that they are exempt from the requirement to be accredited because their total durable medical equipment, prosthetics orthotics and supplies (DMEPOS) billings subject to accreditation are less than 5 percent of their total pharmacy sales, as determined based upon the total pharmacy sales of the pharmacy for the previous 3 calendar or fiscal years.  

The letter shall cite that the attestation requires the signature of the authorized or delegated official of the entity.  The authorized and delegated officials are defined in Section 15, of the Medicare Enrollment Application (CMS-855S), and as described in the internet enrollment application version of the Provider Enrollment, Chain and Ownership System (PECOS). 

Before mailing the letters, the NSC-MAC shall obtain NSC project officer approval of the letter.  The mailing shall be in the form of an endorsement letter with an enclosed stamped self addressed envelope.  The mailing should be performed between October 1, 2010 and October 31, 2010.  

For pharmacies with more than one practice location, the letters shall cite the need for each individually enrolled practice location to attest that they are exempt from the accreditation requirements. 

New locations of enrolled chain pharmacies shall not be considered to have been enrolled for 5 calendar years.  Pharmacies that have had a change of ownership in the prior 5 years which resulted in a change in their legal business entity, including a change in their tax identification number (TIN), shall not qualify for an attestation accreditation exemption and therefore shall not be sent the attestation letter.  

The NSC-MAC shall review the attestations received from pharmacies.  Pharmacies that properly signed the attestation letter shall be given an accreditation status of exempt.  The NSC shall make attempts to assist and follow-up with pharmacy suppliers that have not submitted or properly completed their attestations.   

The NSC-MAC shall send a notice of revocation by January 10, 2011, to all enrolled pharmacies who were sent an attestation letter and have not properly completed it as of the date of the notice of revocation.  The notice of revocation shall cite that the revocation is for a lack of required accreditation.  Between April 1, 2011 and April 30, 2011, the NSC-MAC shall compile a sample listing of at least 10 percent of the pharmacies that have submitted an NSC accepted attestation exempting them from accreditation.  

The NSC-MAC shall develop a letter to be sent to pharmacies that will be audited to determine if their accreditation exemption attestations are correct.  The letter shall request submission of evidence substantiating that the validity of the pharmacy supplier’s attestation.  At a minimum, requested materials for this evidence shall include a certification by an accountant on behalf of the pharmacy or the submission of tax returns filed by the pharmacy during the relevant periods.  

The NSC-MAC shall obtain NSC project officer approval of the letter.  Within 45 days after project officer approval of the letter the NSC-MAC shall mail a copy of the letter to the random sample of pharmacies which claimed exemption through an attestation.  The NSC-MAC shall determine the acceptability of the replies received in response to the audit verification random sample mailing.  The NSC shall use DMEPOS billing data for only products and services requiring accreditation to assist in the determination.  

The NSC shall make attempts to assist and follow-up with pharmacy suppliers that have not submitted or properly completed their audit verifications.  The NSC-MAC shall consult with the NSC project officer in cases where they are uncertain as to the acceptability of the supplier’s response to the audit request.  By June 30, 2011, the NSC-MAC shall send a notice of revocation to all enrolled pharmacies that were sent an audit verification letter who did not submit satisfactory evidence that they were in compliance with the requirements to obtain an accreditation exemption.  

The notice of revocation shall cite that the revocation is for a lack of required accreditation.  The NSC-MAC shall follow the procedures shown above concerning issuance of attestation letters and audit survey letters for all succeeding years after they have been performed for the first time.  

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