A. Information And Statistics About Diabetes
Diabetes mellitus is a disease of metabolism presenting as a complex group of syndromes that have in common elevated blood glucose levels. It occurs because the insulin produced by the beta cells of the pancreas is either absent, insufficient, or not used properly by target tissues. As a result, the body is unable to metabolize macronutrients in food in the normal way. Since the body cannot convert glucose into energy, high levels of glucose remain in the blood and spill into the urine, eventually resulting in micro-vascular complications (for example, kidney disease and eye disease) and macro-vascular complications (for example, stroke and ischemic heart disease).
There are two major types of diabetes that affect the Medicare population, Type 1 diabetes, previously called insulin dependent diabetes mellitus, and Type 2 diabetes, previously called non-insulin dependent diabetes mellitus.
The goals in the management of diabetes are to achieve normal metabolic control and reduce the risk of micro and macro-vascular complications. Numerous epidemiologic and interventional studies point to the necessity of maintaining good glycemic control to reduce the risk of the complications of diabetes.
Despite this knowledge, diabetes remains the leading cause of blindness, lower extremity amputations, and kidney disease requiring dialysis. Diabetes and its complications are primary or secondary factors in an estimated 9 percent of hospitalizations (Aubert, RE, et al., Diabetes-related hospitalizations and hospital utilization. In: Diabetes in America. 2nd ed. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Disease, NIH, Pub. No. 95–1468–1995: 553–570).
Overall, beneficiaries with diabetes are hospitalized 1.5 times more often than beneficiaries without diabetes. Ten percent of these hospitalizations are a direct result of uncontrolled diabetes, and more than half of these admissions occur in beneficiaries 65 and older (National Hospital Discharge Survey, U.S. National Center for Health Statistics, U.S. Department of Health and Human Services, 1990). In expanding the Medicare program to include outpatient diabetes self-management training services, the Congress intended to empower Medicare beneficiaries with diabetes to better manage and control their conditions. The Conference Report indicates that the conferees believed that ‘‘this provision will provide significant Medicare savings over time due to reduced hospitalizations and complications arising from diabetes.’’ (H.R. Conf. Rep. No. 105–217, at 701 (1997)).
According to the National Health and Nutrition Examination Survey (NHANES):
- As many as 18.7 percent of Americans over age 65 are at risk for developing diabetes.
- In 2010, about 215,000 people younger than 20 years had diabetes (type 1 or type 2) in the United States.
- From 2005–2008, based on fasting glucose or hemoglobin A1c levels, 35% of U.S. adults aged 20 years or older had pre-diabetes (50% of adults aged 65 years or older). Applying this percentage to the entire U.S. population in 2010 yields an estimated 79 million American adults aged 20 years or older with pre-diabetes.
(Diabetes Fact Sheet, The Centers for Disease Control & Prevention https://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf)
According to the Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC):
- An estimated 30.3 million people of all ages—or 9.4% of the U.S. population—had diabetes in 2015.
- This total included 30.2 million adults aged 18 years or older (12.2% of all U.S. adults), of which 7.2 million (23.8%) were not aware of or did not report having diabetes.
- The percentage of adults with diabetes increased with age, reaching a high of 25.2% among those aged 65 years or older.
- Compared to non-Hispanic whites, the age-adjusted prevalence of diagnosed and undiagnosed diabetes was higher among Asians, non-Hispanic blacks, and Hispanics during 2011–2014. (National diabetes Statistic Report, 2017; https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
- Diabetes is the seventh leading cause of death in the United States, and more than 187,000 persons died from the disease and its related complications in 1995.
- The American Diabetes Association estimates that $98.2 billion was spent in 1997 on diabetes care ($44.1 billion in costs directly attributable to diabetes and $54.1 billion for indirect medical costs, such as work loss, disability, and premature death.).
- Among Americans aged 65 and older, 4 million persons (9.3 percent of this group) are estimated to have diabetes.
B. Statutory Authority for Diabetic Self-Management Training (DSMT)
Section 4105(a) of the Balanced Budget Act of 1997 (BBA) (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).
Section 1861(qq) of the Social Security Act (the Act) provides 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 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.''
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.
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).
The American Diabetes Association (ADA) and the American Association of Diabetic Educators (AADE) 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. Section 410.143(a) sets forth the ongoing responsibilities of the DSMT AOs. The requirement at section 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.
Section 410.145 of the regulations specifies requirements that DSMT entities must meet. Section 410.146 requires that approved entity must 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 Diabetic Self-Management Training Accrediting Organizations
A. General Information
- Application for CMS-designation as a CMS-approved DSMT accrediting organization is voluntary. Application and re-application procedures are set forth in the CMS regulations at 42 CFR 410.142.
- The ADA and AADE use the accreditation standards established by the National Standards for Diabetes Self-Management Education Support (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. A revised version of the NSDSMES standards was released in September 2017. These standards are scheduled for review again in 2022.
B. Information About The ADA Education Recognition Program (ERP)
- All entities that provide diabetes self-management education and support (DSMES) that are operating under the current National Standards for DSMES are eligible to apply for ADA Recognition of the DSMES Program.
- The online new DSMES program application requires an individual to contact the ADA ERP department 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 faxed, emailed or sent via postal mail to the ADA ERP department prior to the application being placed in the application review queue. The supporting document submission options and instructions are listed within the online application.
- The application is reviewed by an ERP team member and the applicant is notified via the application portal of the application approval for a 4-year recognition period. The applicant will also be notified via the portal if the application is not approved and 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 at: https://professional.diabetes.org/erp_list_zip.
- The ADA performs a random site visit audit of less than 5 percent of all recognized programs each year.
- The entity is notified 10 working days prior to the onsite audit and there are no unannounced site visits. The entity is provided with the Audit Preparation Toolkit to guide the DSMES quality coordinator in audit preparation and documentation required reflecting adherence the DSMES standards. The Audit Preparation Toolkit can be viewed at: https://professional.diabetes.org/sites/professional.diabetes.org/files/media/erp-audit-toolkit-9-2016.pdf.
- There are 1,614 DSMES programs currently recognized by the ADA as well as an additional 2,119 sites associated with these 1,614 programs. ADA considers these as 3,733 active DSMES program locations. (Statistics from November 2017).
C. Information About the AADE
- The AADE has a one-level accreditation program. Applications are accepted by any Diabetes Self-Management Training (DSMT) entity who meet the National Standards for Diabetes Self-Management Education and Support (NSDSMES).
- The AADE’s website for completing an application is www.diabeteseducator.org/practice/diabetes-education-accreditation-program-(deap)/applying-for-accreditation
- The process for programs seeking AADE accreditation will consist of an in-depth and comprehensive review that determines the extent to which all quality standards are being implemented.
- Once the program is approved, the accreditation period is valid for four years.
- A (map) list of recognized DSMT programs can be found on the website at https://www.diabeteseducator.org/patients/find-a-diabetes-educator
- The AADE performs a random on-site audit of approximately 5 percent of all programs each year with a minimum of 44 audits per year and a maximum of 70 audits per year.
- There are 830 DSMT programs currently accredited by the AADE as well as an additional 2066 sites associated with these 830 programs. (Statistics from December 2017)
- Programs are randomly selected for site visits. If a program is selected for a site visit, the program coordinator will be notified ten working days prior to the audit date by email.
- A compliance decision is made by AADE staff within two weeks of the site visit.
III. Contact Information for CMS-designated DSMT Accrediting Organizations
There are two accrediting organizations approved by CMS to accredit DSMT entities. The contact information for these DSMT AO is listed below.
American Diabetes Association (ADA)
2451 Crystal City Drive
Arlington, VA 22202
American Association of Diabetic Educators (AADE)
200 W. Madison
Chicago, IL 60606
IV. Oversight and Validation Process for DSMT Accrediting Organizations 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 the 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 at DSMTAccreditation@cms.hhs.gov.
We monitor this email box on a frequent basis and will respond to your email as soon as possible.