Accreditation of Advanced Diagnostic Imaging Suppliers

I. Background:

Section 135(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (P.L. 110-275) amended section 1834(e) of the Social Security Act (the Act).  This amendment requires suppliers of the technical component of advanced diagnostic imaging (ADI) services to be accredited by a designated accrediting organization in order to receive Medicare reimbursement.  This accreditation requirement for ADI suppliers was effective January 1, 2012.  CMS has the statutory authority to designate accrediting organizations which accredit suppliers furnishing the technical component of ADI services.  These requirements do not apply to hospitals or critical access hospitals.

Under section 1861(d) of the Act, an ADI supplier is defined as a physician or other practitioner, or facility such as an Independent Diagnostic Testing Facility that furnishes the technical component of ADI services.  “Technical component” is defined as all non-physician work performed by an ADI supplier, including administrative and non-physician personnel time and use of the ADI equipment and facility.

Section 1834(e)(1)(B) of the Act defines “advanced diagnostic imaging” procedures as diagnostic magnetic resonance imaging (MRI), computed tomography (CT), and nuclear medicine imaging procedures, such as positron emission tomography (PET).  ADI procedures do not include x-ray, ultrasound, fluoroscopy procedures or diagnostic and screening mammography.  
Note: Diagnostic and screening mammography are subject to oversight by the U.S. Food and Drug Administration.   

II. Information about the Advanced Diagnostic Imaging Accrediting Organizations

• Application for CMS-designation as an ADI accrediting organization is a voluntary process.  Application and re-application procedures are set forth at 42 CFR 414.68(c).  (A link to these regulations is available in the “Related Links” section below).

• Each designated ADI accrediting organization may establish its own individual quality standards.  At a minimum, these standards must address, but are not limited to, the following areas: staff qualifications; equipment standards and safety; safety of patients, family and staff; medical records; and patient privacy.

• While the standards among the designated ADI accrediting organizations may vary, each accrediting organization must demonstrate that its accreditation program standards meet or exceed the standards established by statute and in the Medicare regulations.

• Designated ADI accrediting organizations are private entities which charge fees for their accreditation services.

• Suppliers or other entities seeking additional information about CMS-designated ADI accrediting organizations and their accreditation programs may contact the accrediting organizations listed below.

III. Contact Information for CMS-designated ADI Accrediting Organizations:

• American College of Radiology (ACR)
1892 Preston White Drive
Reston, VA 20191-4326
Local telephone number: 703-648-8900
Toll-free telephone number: 800-770-0145
Email address: info@acr.org   
Website: http://www.acr.org/Quality-Safety/Accreditation

• Intersocietal Accreditation Commission (IAC)
6021 University Boulevard, Suite 500
Ellicott City, MD 21043
Toll-free telephone number: 800-838-2110
Email address: info@intersocietal.org
Website: http://www.intersocietal.org/

• RadSite
326 First Street, Suite 28
Annapolis, Maryland 21403
Telephone number: (443) 440-6007
Email address: info@radsitequality.com
Website: http://www.radsitequality.com/

• The Joint Commission (TJC)
TJC Corporate Office:
Ambulatory Care Accreditation Program
One Renaissance Boulevard
Oakbrook Terrace, IL 60181
Customer Service: 630-792-5800
Ambulatory Care Accreditation Representative: 630-792-5286
Fax Number: 630-792-5005
Email address: webmaster@jointcommission.org  
Website: http://www.jointcommission.org/

• TJC Washington DC Office:
601 13th Street, NW
Suite 560 South
Washington, DC 20005

IV. ADI Change of Ownership Policy

A. Transfer of the Existing Medicare Enrollment from the Current Owner to the New Owner

The Medicare enrollment of the current owner of an ADI facility may be transferred to the new owner of the ADI facility only when certain criteria are met. For example, if the change of ownership (CHOW) does not result in a change of business information for an ADI facility, (including the legal business name, provider transaction access number (PTAN), tax identification number (TIN) or national provider identification (NPI) number), the Medicare enrollment of the existing owner can be transferred to the new owner of the ADI facility.

•  Update of Ownership Information on the Existing CMS-855(b) Enrollment Application 

If the new owner is not changing the legal business information for the ADI facility, it is not necessary to submit a new CMS-855B enrollment application. However, to transfer a Medicare enrollment for an ADI facility, the new owner must update the ownership information in Section 6 of the CMS-855B enrollment application filed by the previous owner. All other information regarding the enrollment would not change.

• Re-Assignment of the NPI Number and TIN from the Current Owner to the New Owner 

The NPI and TIN assigned to the current owner of an ADI facility may be transferred to the new owner of the ADI facility only if the new owner makes no changes to the legal business information for the ADI facility (i.e. - legal business name, TIN, NPI & PTAN) and only updates the information in Section 6 of the CMS-855B enrollment application filed by the previous owner.

• Re-Assignment of the PTAN from the Current Owner to the New Owner      

The PTAN assigned to the current owner of an ADI facility can be transferred to the new owner only if the new owner makes no changes in the legal business information for the ADI facility and updates only the information in Section 6 of the CMS-855B enrollment application filed by the previous owner.

B. CHOW in Which the Legal Business Information for the ADI Facility is Being Changed

If the new owner is changing the business information for the ADI facility (i.e. - legal business name, TIN, PTAN, NPI, etc.), they are required to submit a new CMS-855B enrollment application for that ADI facility.

The NPI and TIN assigned to the current owner of an ADI facility cannot be transferred to the new owner if the new owner either voluntarily decides or is required to request a new Medicare enrollment for that ADI facility.

The PTAN cannot be transferred to the new owner of an ADI facility, if the new owner either voluntarily decides or is required to request a new Medicare enrollment for that ADI facility.

It is important to note that a Medicare Part B PTAN cannot be transferred to another Medicare enrollment once it has been deactivated. The PECOS system will not allow this to occur.

C. Effects upon the Accreditation Status of the ADI Facility When A New Owner is Not Required to Submit a New CMS-855(b) Enrollment Application

If it is not necessary for the new owner of the ADI facility to submit a new CMS-855B enrollment application, then:

• The existing accreditation of the ADI facility may remain in effect. However, the accrediting organization (AO) which accredits that ADI facility must provide written permission for transfer of the remaining term of accreditation to the new owner within three (3) months of the effective date of the CHOW (or less if the ADI supplier’s term of accreditation expires sooner).

 

• The AO is required to conduct a full accreditation survey within 9 months from the effective date of the CHOW to ensure continued compliance with the AO’s accreditation program standards under the new ownership.       

 D. When the New Owner Changes the Legal Business Information for the ADI Facility and is Required to Submit a New CMS-855(b) Enrollment Application:

 If the new owner is required to obtain new Medicare enrollment because they have changed the legal business information for the ADI facility, they must also seek new accreditation for the ADI facility. They must do so because:

• The remaining term of accreditation would not transfer to the new business entity; and,
• It is the new owner’s responsibility to apply for new accreditation immediately to avoid a lapse in Medicare reimbursement.

Both the current and new owners of the ADI facility are responsible and have an interest in notifying the AO of the CHOW within 30 calendar days of the effective day of the CHOW, because: 

• The current owner has a contractual obligation to notify the AO of their withdrawal from their accreditation contract; and, 
• Accreditation is a requirement for reimbursement of Medicare claims. Therefore, the new owner has a financial interest in continuing accreditation to avoid a lapse in Medicare reimbursement for ADI services provided.

 V. NEMA XR-29 Compliance 

The Protecting Access to Medicare Act (H.R. 4302; P.L. 113-93), also known as PAMA, enacted on April 1, 2014, amended section 1834 of the Social Security Act (the Act) by adding a new section (p). Section 1834(p) of the Social Security Act requires that, effective 01/01/2016, ADI suppliers and hospital outpatient radiology departments that furnish CT services to Medicare beneficiaries use CT equipment that meets the National Electrical Manufacturers Association (NEMA) Standard XR-29-2013, entitled “Standard Attributes on CT Equipment Related to Dose Optimization and Management (hereinafter referred to as “NEMA XR-29-2013.”

Section 1834(p)(1) to 1834(p)(5) requires ADI suppliers and hospital outpatient departments that use non-NEMA XR-29-2013 compliant CT systems to furnish “applicable” CT procedures to Medicare beneficiaries will receive a decrease in the payment they receive from Medicare in the amount of 5% for CT services provided in CY 2016 and 15% for CT services provided in 2017 and all years thereafter. Section 1834(p)(2) of the Act defines an “applicable” CT service as “a service billed using diagnostic radiological imaging codes for computed tomography (identified as of January 1, 2014, by HCPCS codes 70450-70498, 71250-71275, 72125-72133, 72191-72194, 73200-73206, 73700-73706, 74150-74178, 74261-74263, and 75571-75574 (and any succeeding codes).”

Section 1834(p)(6) of the Act requires that “The Secretary shall require that information be provided and attested to by a supplier and a hospital outpatient department that indicates whether an applicable computed tomography service was furnished that was not consistent with the CT equipment standard (described in paragraph (4)). Such information may be included on a claim and may be a modifier. Such information shall be verified, as appropriate, as part of the periodic accreditation of suppliers under section 1834(e) and hospitals under section 1865(a).”

In the calendar year 2016 Physician’s Fee Schedule Final Rule, published on 11/16/2015 (80 FR 70930), CMS finalized the requirement that ADI suppliers and hospital outpatient radiology departments that use non-NEMA XR-29-2013 compliant CT equipment to furnish CT procedures to Medicare beneficiaries must use the payment modifier “CT” on the claims they submit to Medicare for these services. The use of this payment modifier will trigger the required payment reduction.

VI. Educational Resources for ADI Accrediting Organizations and Suppliers

Medicare Learning Network (MLN) publications and products:

• The Medicare Learning Network website (A link to this website is available in the “Related Links” section below).
• MLN publication (ICN 907164) titled, “Medicare Coverage of Imaging Services.” (A link to this publication is available in the “Related Links” section below).

VII. Help for ADI Accrediting Organizations and Suppliers

ADI Accreditation E-Mailbox
To submit a question to CMS regarding the accreditation process for ADI technical component suppliers, please submit your question to the ADI Accreditation helpdesk e-mailbox at:  ADIAccreditation@cms.hhs.gov.

Medicare Enrollment Questions
Medicare enrollment operations are managed by Medicare Administrative Contractors (MAC).  The MAC(s) serving your State or jurisdiction will be able to answer your enrollment questions and process your enrollment application.

A list of Medicare Administrative Contractors (MACs) and their contact information is available on the CMS website. See the “Related Links” section below to access this information.