Accreditation

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.

Section 1865(a)(1) of the Social Security Act (the Act) permits providers and suppliers "accredited" by an approved national accreditation organization (AO) to be exempt from routine surveys by State survey agencies to determine compliance with Medicare conditions. Accreditation by an AO is voluntary and is not required for Medicare certification or participation in the Medicare Program. A provider’s or supplier’s ability to bill Medicare for covered services is not impacted if it chooses to discontinue accreditation from a CMS-approved AO or change AOs. Section 1865(a)(1) of the Act provides that if the Secretary finds that accreditation of a provider entity by a national accreditation body demonstrates that all applicable conditions are met or exceeded, the Secretary may deem those requirements to be met by the provider or supplier. Before permitting deemed status for an AO's accredited provider entities, the AO must submit an application for CMS review and approval.
 

See the downloads section below for more specific information.

For Initial Surveys for New Medicare Providers- please see Survey and Cert Letter 08-03.

For Accreditation and its Impact on Various Survey and Certification Scenarios – FAQs- please see Survey and Cert Letter 09-08.

FY 2015 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program (Refer to the Survey and Cert Letter 16-07).

FY 2016 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program (Refer to the Survey and Cert Letter 17-40).

I. Background: 

A. Information & Statistics About Diabetes

The Centers for Disease Control and Prevention (CDC) provides basic information about diabetes, as well as statistics about the disease.

People who live in rural areas have higher rates of diabetes than those who live in urban areas, but have more limited diabetes self-management and education support (DSMES) services.

B. Statutory Authority for Diabetes Self-Management Training (DSMT)

Section 4105(a) of the Balanced Budget Act (BBA) of 1997 (pub. L. 105-33), enacted on August 5, 1997, provides for Medicare coverage for DSMT services provided by a “certified provider.” Section 4105 of the BBA amended section 1861 of the Social Security Act (The Act) by adding a new section (q)(q).

Additionally, section 4105(c)(1) of the BBA requires the Secretary to establish outcome measurements for purposes of evaluating the improvement of the health status of Medicare beneficiaries with diabetes.

Section 1861(qq) of the Act provides the Centers for Medicare & Medicaid Services (CMS) with the statutory authority to regulate Medicare outpatient coverage of DSMT services.

• The term “diabetes outpatient self-management training services” is defined at 1861(q)(q)(1) of the Act as “educational and training services furnished …to an individual with diabetes by a certified provider… in an outpatient setting by an individual or entity who meets the quality standards…, but only if the physician who is managing the individual's diabetic condition certifies that such services are needed under a comprehensive plan of care related to the individual's diabetic condition to ensure therapy compliance or to provide the individual with necessary skills and knowledge (including skills related to the self-administration of injectable drugs) to participate in the management of the individual's condition.
• The term “certified provider” is defined at section 1861(q)(q)(2)(A) of the Act as “a physician, or other individual or entity designated by the Secretary, that, in addition to providing diabetes outpatient self-management training services, provides other items or services for which payment may be made under this title.”

Section 1861(q)(q)(2) provides that the Department of Health and Human Services Secretary may recognize a physician, individual, or entity that is recognized by an organization as meeting standards for furnishing these services as a certified DSMT provider. This statute also provides that a physician or other individual or entity shall be deemed to have met such standards if they meet applicable standards originally established by the National Diabetes Advisory Board.

Section 1861(q)(q)(2)(B) of the Act states that “a physician, or such other individual or entity, meets the quality standards… if the physician, or individual or entity, meets quality standards established by the Secretary, except that the physician or other individual or entity shall be deemed to have met such standards if the physician or other individual or entity meets applicable standards originally established by the National Diabetes Advisory Board and subsequently revised by organizations who participated in the establishment of standards by such Board, or is recognized by an organization that represents individuals (including individuals under this title) with diabetes as meeting standards for furnishing the services.”

A final rule (65 FR 83130) was published in the Federal Register on December 29, 2000, which implemented the BBA provisions addressing the coverage, payment, quality standards, and accreditation requirements for DSMT. This final rule also implemented the DSMT regulations which are codified at Title 42 of the Code of Federal Regulation (CFR) sections 410.140 to 410.146.

The CMS regulations at 42 CFR 410.144 provide the authority for the CMS to require the DSMT AOs to use one of the following types of accreditation standards: (1) the accreditation standards set forth at §410.144(a); (2) the accreditation standards issued by the National Standards for Diabetes Self-Management Education Support (NSDSMES) (§410.144(b)); or (3) other accreditation standards, so long as they have been submitted to CMS and approved as meeting or exceeding the CMS quality standards described at §410.144(a).

42 CFR § 410.145 of the CMS DSMT regulations specifies the requirements that DSMT entities (suppliers) must meet.

42 CFR § 410.146 requires that approved DSMT entities (suppliers) collect and record in an organized systematic manner, patient assessment information at least on a quarterly basis for a beneficiary who receives DSMT training.

II. Information about the Diabetes Self-Management Training Accrediting Organizations (AOs)

A. General Information 

Application for CMS-designation as a CMS-approved DSMT AO is voluntary.

Application and re-application procedures are set forth in the CMS regulations at 42 CFR 410.142.

42 CFR, §410.143(a) sets forth the ongoing responsibilities of the DSMT AOs. The requirement at §410.143(b) sets forth the oversight activities that CMS, or its agent, will perform to ensure that a CMS approved DSMT AO and the entities the organization accredits continue to meet a set of quality standards described at §410.144.

The American Diabetes Association® (ADA) and the Association of Diabetes Care & Education Specialists (ADCES) are the two national DSMT AOs approved by CMS to accredit entities that furnish DSMT services.

These DSMT AOs are approved by CMS for six-year terms.

The ADA and ADCES use the accreditation standards established by the NSDSMES. These standards have been approved by CMS as meeting or exceeding the standards set forth at 42 CFR 410.144.

The NSDSMES quality standards are reviewed and revised approximately every five years by a task force of key stakeholders and experts within the diabetes care and education community. The current version of the NSDSMES standards was released in February 2022. These standards are scheduled for review again in 2027.

B. Information About the ADA Education Recognition Program (ERP)

All entities that provide DSMES that are operating under the current NSDSMES are eligible to apply for ADA recognition of the DSMES program. 

Services planning on applying for recognition will need to submit an ERP onboarding form to be set up in the application portal. Application supporting documents (which are outlined in the online application) must be either uploaded into the application portal or emailed to the ADA ERP department as an attachment. Find all application resources including examples, templates, and Ask the ERP Experts.

The application is reviewed by an ERP team member and the applicant is notified via the application portal of the application approval for a four-year recognition period. The applicant will also be notified via the portal if the application has deficiencies and will be provided guidance of documentation reflecting specific recognition elements required for the application approval.

ADA recognized DSMES programs and their locations can be searched via zip code. The ADA performs a random audit of less than 5% of all recognized programs, a maximum of 70 required audits each year.

The entity is notified 12 working days prior to the audit and there are no unannounced visits.

The entity is provided with the Audit Preparation Toolkit to guide the DSMES quality coordinator in audit preparation and documentation required reflecting adherence to the DSMES standards.

C. Information About ADCES

ADCES is the only organization dedicated solely to the specialty of diabetes care and education. ADCES has the expertise and resources required to support DSMES programs throughout our organization and specifically within our Diabetes Education Accreditation Program (DEAP) Department. ADCES, through collaboration with other diabetes organizations, jointly revises and embraces the NSDSMES. The NSDSMES is the framework upon which accreditation is based. ADCES’ interpretive guidance is collaboratively developed with stakeholders and quality coordinators, abides by these standards and is approved by CMS.

ADCES DSMES program accreditation is intended for DSMES services provided in the non-acute care setting.

ADCES offers 1 type of DSMT Accreditation, with these features:

• Program flexibility.
• Accreditation for traditional and nontraditional programs.
• Find a variety of site types to meet your local needs: Community, Branch, State and Microsite.
• Simple fee structure.
• User-friendly web-based application.
• Any entity that provides DSMES services, regardless of eligibility to receive reimbursement, is eligible to apply.
• ADCES facilitates a random on-site audit of approximately 5% of all programs each year with a minimum of 44 audits per year and a maximum of 70 audits per year.
• Programs are randomly selected for virtual audits. If a program is selected for a virtual audit, the quality coordinator will be notified prior to the audit date by email.
• Volunteer auditor findings are reviewed in collaboration with DEAP team and program is notified within two weeks of the virtual audit if correction plan is required and a reasonable timeline is agreed upon.

III. Contact Information for CMS-designated DSMT AOs

The contact information for the DSMT AOs is listed below.

American Diabetes Association (ADA)

2451 Crystal City Drive

Suite 800

Arlington, VA 22202

Phone: 703-549-1500

Website: http://www.diabetes.org

Association of Diabetes Care & Education Specialists (ADCES)

125 S Wacker Drive

Suite 600

Chicago, IL 60606

Phone: 312-601-4846

Website: https://www.diabeteseducator.org

IV. Oversight & Validation Process for DSMT AOs' Accreditation Processes

• CMS must provide external oversight of the DSMT AOs to ensure that federal requirements are met by the DSMT entities that are accredited by those AOs.
• The DSMT oversight and validation process, implemented in 2005, was developed by CMS to evaluate the performance of CMS approved DSMT AOs.
• The oversight and validation of the DSMT AOs accreditation process assists CMS in its efforts to determine whether approved DSMT AOs are functioning in the manner required under Medicare regulations.
• CMS uses a contractor to perform the oversight and validation process and report their findings to CMS. 
• The oversight and validation process consists of implementing a survey tool and use of a scoring mechanism.

V. Where to Submit Questions Related to the DSMT Accreditation Program

Questions about the DSMT Accreditation Program may be submitted to the DSMT Accreditation email box. We monitor this email box on a frequent basis and will respond to your email as soon as possible.