Diabetes Spectrum
Volume 12 Number 4, 1999, Page 222
From Research to Practice / Diabetes Advocacy

Legislation for Health Care Coverage for Diabetes Self-Management Training, Equipment, and Supplies: Past, Present, and Future

Anne Daly, MS, RD, LD, CDE and Carolyn Leontos, MS, RD, CDE


  In Brief

Coverage and reimbursement for diabetes self-management training, equipment, and supplies is improving at long last. Years of efforts by the diabetes community have shaped recent progress, resulting in legislation in 36 states to improve reimbursement for people with diabetes. Legislative experiences in three states are highlighted here, along with an update on Medicare regulations.

The status of coverage of and reimbursement for diabetes self-management training, equipment, and supplies is changing rapidly, for the better, at long last. Until recently, reimbursement for anything beyond physician office visits was nonexistent or inadequate, posing major barriers to quality care. The purpose of this article is to explain the history of diabetes legislation, components of and groups covered by state legislation, strategies used to obtain this coverage, recent changes in Medicare, and how attempts to secure coverage for medical nutrition therapy could affect diabetes.

Most people with diabetes receive little or no formal diabetes education. A recent nationwide survey found that only 20% of people with diabetes see a dietitian or nutritionist each year, and only 35% of adults with diabetes have ever attended a diabetes education class, course, or other diabetes education program.1 This is inconsistent with the fact that the Standards of Medical Care for Patients With Diabetes Mellitus2 state that self-management education is a critical component of comprehensive care for people with diabetes, such that diabetes care without adequate self-management education can be regarded as substandard and unethical care.3 Without adequate coverage and reimbursement, people with diabetes have limited access to essential education services, such as instruction regarding what diabetes is, what to eat, and what the benefits, as well as the risks, are of taking care of their diabetes.

Reimbursement for equipment and supplies has been inconsistent, if available at all. While many people with diabetes require insulin, oral medications, antihypertensive agents, and lipid-lowering agents, coverage for medications has been limited. Inability to pay for insulin and other medications is directly related to life-threatening complications of diabetes.4 Reimbursement for blood glucose monitors and supplies has been the exception rather than the rule for people with type 2 diabetes who do not use insulin. Surveys of managed care organizations have documented that substandard care is the norm for people with diabetes who do not use insulin.5

Data have been published to document the cost-effectiveness of maintaining good glycemic control for type 1 and type 2 diabetes,6,7 medical nutrition therapy,8 preconception glycemic control,9 and routine screening for diabetic retinopathy10 and nephropathy,11 as well as the costs of poor glycemic control.12 Despite all the talk about the importance of preventive strategies, Medicare, Medicaid, private insurers, and managed care organizations are reluctant to provide coverage for them. Payers have often chosen "penny wise and pound foolish" mentalities, by focusing on the here-and-now costs of covering preventive services, but not on the real bottom line—the long-term cost effectiveness.

The increasing prevalence of diabetes, the demand for health services, and the rising costs of health care in the United States are pressuring the health care community to provide cost-effective medical care. Coverage decisions are increasingly being made based on both costs and health outcomes. Both the Diabetes Control and Complications Trial13 and the United Kingdom Prospective Diabetes Study14 demonstrated that a reduction in the magnitude of diabetes complications requires the use of diabetes management strategies aimed at improved glycemic control, including close, ongoing support from a health care team and advanced patient knowledge and skills. Providing this level of management to all people with diabetes will require major changes in the health care system and major changes in patient self-care practices.

History of Events
A long chain of events has stimulated recent progress and has involved many groups and individuals in the diabetes community. Table 1 describes the key events that have shaped the current status of diabetes coverage and reimbursement today.

Table 1. History of Events

1970 National Commission on Diabetes Mellitus creates the National Diabetes Advisory Board (NDAB). NDAB provides funding to Centers for Disease Control and Prevention (CDC) to establish the first state-based Diabetes Control Programs (DCPs).
1976 Congress funds National Institutes of Health (NIH) to establish a National Diabetes Data Group and Diabetes Research and Training Centers to conduct research in diagnosis and treatment of diabetes, establish training programs for students and practitioners of medicine and allied health professions, and develop model programs for translation of research to clinical care.15,16
1982 NDAB establishes steering committee to develop National Standards for Patient Education Programs.
1983 Initial development of the National Standards for Patient Education Programs takes place under the auspices of the NDAB, representing consensus among American Association of Diabetes Educators (AADE), American Diabetes Association, American Dietetic Association, CDC, Department of Defense, Department of Veterans Affairs, Diabetes Research and Training Centers, Indian Health Service, and Juvenile Diabetes Foundation (JDF).
Maine DCP completes 3-year study, documenting 32% reduction in hospitalizations and lengths of stay and cost savings of $293 per diabetes education participant. Maine Blue Cross/Blue Shield, Medicare, and Medicaid approve reimbursement for ambulatory diabetes education and follow-up programs.
1984 NDAB initiates pilot study to develop review criteria to evaluate a program's 1986 conformance with National Standards for Patient Education Programs.
Airlie House Conference on Financing Quality Health Care for Persons with Diabetes takes place. It is cosponsored by the NDAB, ADA, and CDC.
1986 AADE establishes the National Certification Board for Diabetes Educators for the sole purpose of developing and implementing certification process for certified diabetes educators (CDE). First CDE exam is administered in November 1986.
ADA establishes Recognition Program for National Standards for Diabetes Education Programs.
1987 First education program is recognized by ADA.
Wisconsin legislation passes.
1988 Second Conference on Financing Costs of Diabetes Mellitus is held (follow-up to the 1984 Airlie House Conference), sponsored by the Finance Coordinating Committee (FCC), a group composed of representatives from ADA, American Dietetic Association, AADE, and NDAB. Representatives from the American Hospital Association, Health Care Financing Administration (HCFA), and private insurance are invited to attend.
1991 Multiple surveys demonstrate inconsistent and unpredictable reimbursement of diabetes self-management training, as well as disparity of codes in use.17-20
1992 ADA develops CPT Coding Guidelines for Diabetes Patient Self-Management Training, designed to identify services provided, promote consistent claim processing, and improve reimbursement for services. Codes are submitted to American Medical Association CPT Editorial Committee in November 1992. No response is received.
1993 NDAB convenes task force to review original Standards for Patient Education. Standards are revised and widely reviewed by task force participants.
American Dietetic Association submits proposal to American Medical Association CPT Editorial Panel explaining need and requesting uniform and unique codes for medical nutrition therapy. No response is received.
New York legislation passes.
1994 Revised Standards for Patient Education are accepted and re-named the National Standards for Diabetes Self-Management Education Programs. Clinton Administration dissolves NDAB. Standards become property of the diabetes community at large.
To upgrade the role of advocacy to pursue public policy goals, ADA begins a training program designed to facilitate passage of state diabetes legislation for health care coverage.
Minnesota legislation passes.
1995 Florida legislation passes.
Rep. Elizabeth Furse (D-Oreg.) assumes leadership of Medicare expansion for diabetes supplies and education and introduces legislation.
Speaker of the House Newt Gingrich (R-Ga.) begins to regularly discuss diabetes in speeches across the nation. He uses diabetes as an example of the need to address preventive care issues.
Rep. George R. Nethercutt, Jr. (R-Wash.) and Rep. Furse form Congressional Diabetes Caucus.
1996 New Jersey, West Virginia, Maine, Oklahoma, and Rhode Island pass legislation.
1997 Leaders of AADE, ADA, and American Dietetic Association finalize and circulate model language (Figure 2) to be used by states to develop state legislation to improve diabetes coverage. This model language was based on consistent components and language intent (Table 3).
New Mexico, Arkansas, Indiana, Maryland, Vermont, Washington, Texas, Connecticut, Louisiana, Missouri, North Carolina, Nevada, New Hampshire.
1998 Federal Balanced Budget Act passes and includes a provision that expands coverage for diabetes supplies and education in Medicare programs.
Georgia, Kentucky, Colorado, Arizona, Kansas, Illinois, Mississippi, and Pennsylvania pass legislation.
1999 Virginia, South Dakota, Iowa, Nebraska, and South Carolina pass legislation.

State Legislation—What Is Covered and What Is Not
To date, 36 states have passed legislation designed to improve reimbursement for their residents with diabetes (see Figure 1 and Table 2). The content of the bills varies widely, with the total length of bills ranging from 1/2-8 pages. Bills that were passed before 1997 (Wisconsin, New York, Minnesota, Florida, New Jersey, West Virginia, Maine, Oklahoma, and Rhode Island) contained inconsistencies and in some cases provided less comprehensive coverage. Concern about this prompted leaders of the American Diabetes Association (ADA), the American Association of Diabetes Educators (AADE), and the American Dietetic Association to create and circulate model state legislation language in 1997 (see Figure 2 and Table 3). Bills passed since the model language became available in 1997 tend to be more consistent in content. However, variation in specificity still exists. In many cases, diabetes bills were added as amendments to other health-related bills.

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Figure 1. Directory of Coverage of Diabetes Self-Management Education by Health Insurance: How States Are Faring. American Association of Diabetes Educators.

In general, most bills cover people with type 1, type 2, or gestational diabetes mellitus, regardless of whether they use insulin. Coverage is provided for medically necessary equipment and supplies when prescribed by a licensed physician. This can include insulin, syringes, injection aids, blood glucose monitors, test strips, lancets, lancet devices, Food and Drug Administration-approved oral medications, and glucagon emergency kits. In some cases, foot care appliances, insulin pumps, and insulin pump equipment are mentioned in equipment lists. Medication and equipment may be limited to policies or plans that provide coverage for prescription drugs and/or durable medical equipment.

Most bills designate that coverage is for outpatient diabetes education provided at the time of diagnosis or when a physician notes a significant change in a patient's symptoms or condition. Some bills, e.g., that in Illinois, were forced to include a limit on the number of visits allowed at diagnosis or when a significant change in condition occurs. Most bills specifically mention medical nutrition therapy as a covered service, since this traditionally has been a noncovered service. Some bills allow for re-education or refresher training and home visits when medically necessary. Some states limit coverage for education to programs in compliance with the ADA Recognition Program or others deemed to have met National Standards for Diabetes Education Programs.

Education providers are generally covered when they are licensed, registered, or certified health care professionals with expertise in diabetes care. However, diabetes expertise has not been defined in a single bill enacted to date. Diabetes advocates who fought for passage of the bills noticed that legislators did not seem concerned about this aspect but had assumed this would be dealt with by writing regulations once the bills were passed. However, some state insurance departments are reluctant to write regulations until documented problems arise. Others have issued regulations to define who is a qualified provider as soon as their bill went into effect.

The types of health insurance policies affected by state legislation generally include group (and in some cases individual) policies of health insurance from insurance companies and health maintenance organizations (HMOs), not including companies that are exempt under a federal law called the Employee Retirement Income Security Act (ERISA). ERISA, which was passed by Congress in l974, provides that if a company is self-insured, it is exempt from state insurance regulation. Up to two-thirds of individuals who receive health insurance through their employers work for companies that are covered by ERISA and therefore exempt from state insurance legislation. Some ERISA plans do provide comprehensive coverage, and many provide limited coverage. Federal employees, their dependents, and Medicare recipients are also not covered by state legislation.

Medicaid coverage is governed at the state level, and, therefore, coverage varies from state to state. However, in at least some states, Medicaid coverage includes medication, equipment, and supplies when prescribed and deemed medically necessary by a referring physician.

Table 2. Impact of Diabetes Legislative Initiatives

State

Year Enacted

Residents With Diabetes*

Wisconsin 1987 318,717
New York 1993 1,135,806
Minnesota 1994 253,046
Florida 1995 1,053,428
New Jersey 1996 508,023
West Virginia 1996 143,577
Maine 1996 77,709
Oklahoma 1996 211,464
Rhode Island 1996 63,591
New Mexico 1997 102,347
Arkansas 1997 171,748
Indiana 1997 416,696
Maryland 1997 349,237
Vermont 1997 34,966
Washington 1997 284,683
Texas 1997 1,183,018
Tennessee 1997 368,233
Connecticut 1997 211,050
Louisiana 1997 312,391
Missouri 1997 345,318
North Carolina 1997 500,063
Nevada 1997 93,866
New Hampshire 1997 66,818
Georgia 1998 444,536
Kentucky 1998 263,115
Colorado 1998 187,171
Arizona 1998 229,817
Kansas 1998 146,601
Illinois 1998 761,913
Mississippi 1998 194,105
Pennsylvania 1998 875,304
Virginia 1999 407,413
South Dakota 1999 21,514
Iowa 1999 192,202
Nebraska 1999 101,592
South Carolina 1999 250,826
Total: 12,281,901**

*United States Centers for Disease Control and Prevention (diagnosed and undiagnosed)

**Approximately 33% of Americans are covered by private health insurance plans regulated by state laws. The remainder either have plans not regulated by state law (e.g., Medicare, ERISA-exempt, Federal Employees Health Benefit Plan) or have no coverage at all.

Strategies Used to Get Legislation Passed
Among the 36 states that have passed legislation, some elements of the legislative process were shared, while others emerged as a result of local politics. To illustrate the process, including similarities and differences, we have chosen to highlight the experiences in three states: Nevada, Illinois, and Virginia.

The Nevada Experience
Nevada has the distinction of being the state that passed diabetes legislation most quickly. Before the beginning of the 1997 legislative session, the Nevada Diabetes Coalition approached Sen. Ray Rawson to introduce the legislation. Three months into the 6-month session, a freshman assemblyman, Dario Herrera, decided that he wanted to sponsor the legislation. He approached ADA for statistical information on diabetes in Nevada. Many telephone calls, faxes, and e-mail messages later, he was amenable to using the model state legislation (Figure 2).

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Figure 2. Model State Legislation.

Quick negotiations took place between the two legislators. Assemblyman Herrera introduced the bill in committee on May 21, 1997. Testimony was taken on the same day. One big factor in favor of the legislation was that the Speaker of the Nevada Assembly, Joe Dini, a long-time, well-respected legislator who has diabetes, was the first individual to testify in favor of the bill. Additional positive testimony followed from members of the coalition and from individuals who have diabetes. The bill passed out of committee and was approved unanimously by the State Assembly. It was forwarded to the Senate, where it received only one dissenting vote on June 24. It was then forwarded to the governor, who signed it without question. Less than 3 months passed from the first telephone call from the assemblyman's office to the time the bill was signed into law.

There is no doubt that the Diabetes Coalition in Nevada was extremely fortunate in the circumstances that led to the quick passage of this bill. However, it also took effort and quick response on the part of volunteers and staff of both the coalition and ADA. Moreover, the effort is not over, as insurers continue to quibble over claims, and the state insurance commissioner resists writing regulations.

The Illinois Experience
In Illinois, the first step was to form a state-level coalition including leaders representing the three national organizations who developed the model language: AADE, ADA, and the American Dietetic Association. These representatives, both volunteers and staff, formed a steering committee to serve as policy/decision makers and spokespeople for their organizations and to be responsible for effective communication between the coalition and the organizations. A combination of meetings, conference calls, and mailings was used to conduct business. As the coalition's work progressed, individuals from other sources, such as industry and the organizations' Government Affairs staff, were included.

The coalition also found it effective to identify a coalition coordinator. The coordinator served as a central contact person through whom all information was channeled and who had been authorized by constituent organizations to make decisions when necessary. It was important for the coordinator to be a diabetes expert who knew the organizational structure of all three organizations; who was known, respected, and trusted by all three organizations; and who had the vision, energy, and time for the project.

The second step was to decide whether to hire a lobbyist. Once the coalition decided that it needed professional help, funds to pay for a lobbyist had to be secured. The coalition coordinator was responsible for securing funding and for advertising the position and interviewing and selecting a candidate.

The Illinois coalition decided to hire a lobbyist for many reasons. The lobbyist was present in the state capitol daily. He understood the political process and provided the coalition with political insight and strategy suggestions. The lobbyist was known for being bipartisan and was respected for his ability to get legislation passed. Previous knowledge of diabetes was not required. However, the lobbyist was given basic education about diabetes and what diabetes self-management training entails.

Once the bill had sponsors, grassroots lobbying was used to gather co-sponsors and to persuade more legislators to support the bill. A lobby day was held, during which grassroots volunteers received training on the issues and process before making legislative visits and calls. At the end of the day, grassroots members reported back to the coalition about their visits.

Meeting with the governor to gain support was also necessary and helpful. As a result of the group's meeting with Illinois Gov. James Edgar, an Executive Order was issued enabling benefits for state employees with diabetes to be expanded. The Executive Order took effect in July 1997, 18 months before the legislation became effective. Winning the governor's support early on can be a plus, since many legislators are interested in the governor's position on an issue.

Once the bill was introduced, it appeared on the agenda of the Insurance Committee of the appropriate chamber for review. At this committee hearing, testimony both for and against the bill was invited. The coalition selected spokespeople to join the bill sponsors and drafted the comments to be made. In some cases, consumers with diabetes were included among the spokespeople. Again, the coalition selected appropriate clients with diabetes to deliver the message desired. When testimony from the opposition (the insurance industry) was heard, the coalition gathered facts and data to refute the opposing positions.

Over the course of the bill's progress, numerous committee hearings and opportunities to present the case for the bill occurred. Among their arguments against the bill, representatives from the insurance industry stated that they:

  • opposed all mandates in general
  • were not in the habit of paying nonphysicians
  • already paid for all the services outlined in the bill
  • did not believe that blood glucose monitoring was necessary or cost-effective for patients who do not take insulin
  • did not want to pay for education unless it could be proven that education results in behavior change
  • did not understand the concept of medical nutrition therapy
  • did not want to pay for expensive treatments, such as foot orthotics or insulin pumps, that may not be medically necessary
  • believed that the proposed legislation would raise the costs of health insurance premiums.

Coalition members deluged legislators and Congressional staff with data supporting all arguments in favor of every aspect of the bill, as well as refuting arguments made by the opposition.

The bill passed unanimously in May 1998 in both chambers, was signed into law in July 1998 by the governor, and became effective in January 1999.

The Virginia Experience
The Virginia effort began with an informal meeting during the national ADA legislative conference in 1997. By the following month, the first official meeting was held, and monthly meetings and conference calls were used thereafter to map strategies and plans.

The coalition selected a Senate sponsor who had had type 1 diabetes for 25 years. A lobbyist was hired. Coalition leaders noted the importance of hiring a lobbyist who was prepared to be very involved in the issue on a daily basis, who understood local politics, and who knew the legislators and how to work with them.

By January 1998, two bills were introduced in both the state Senate and the House. The first bill was designed to change the state employee health plan, while the second bill was directed at private insurance policies and managed care plans. The state employee health insurance bill passed in spring 1998 and became effective July 1, 1998.

The private insurance bill was referred to a special advisory commission, which by law must examine every mandated health benefit. This commission must include 4 legislative members and 10 citizen members. The role of the commission is to render an opinion to legislators on the proposed legislation.

By early December 1998, the coalition realized that the commission was not going to meet. The bill was heard despite no action from the commission as carryover legislation by the committee to which the bill had originally been referred. The Senate committee held a hearing at which an HMO representative stated his opposition to the bill. He said that the bill was unnecessary, since HMOs already provide diabetes benefits. Several coalition members who were present at the hearing simultaneously objected. Following the objections, the coalition was granted a few minutes to respond. The spokesperson chosen to respond was the mother of a child with type 1 diabetes diagnosed at the age of 16 months. After the delivery of her passionate testimony, a favorable committee vote of 7 to 5 resulted, which put the bill back on the 1999 legislative calendar.

In January 1999, a lobby day was held with Miss America 1999 Nicole Johnson. Ms. Johnson, who has type 1 diabetes and wears an insulin pump, appeared on the Senate floor. After she was introduced, the Senate voted 40–0 in favor of the bill. The Senate version of the bill moved to the House and passed unanimously (98 with 2 abstentions), and the governor signed the bill in March 1999. The special advisory commission later gave its approval to the measure, as well.

Like most states who have passed legislation, Virginia has realized that while legislation provides a strong base, there are still many battles left to fight. Like many other states, Virginia law does not require regulations to be written to implement the law. The Virginia Diabetes Legislative Coalition's effort at present is to get these laws implemented as intended. The coalition is conducting mailings to health professionals and to people with diabetes who are ADA members and is holding seminars where diabetes educators can learn more from health care payers about how they are interpreting the law.

Table 3. Intent of Model Legislation

Component Language Intent
Who the law applies to All plans sold within the state: managed care, fee-for-service, health maintenance organizations, group, and individual market.
What the law will cover Equipment, supplies, self-management training and education, medical nutrition therapy.
Who receives the coverage Person with diabetes, any type.
How the coverage is accessed Prescribed by a health care professional with prescriptive authority under state law.
Who supervises the education Not applicable.
Who provides the education A certified, registered, or licensed health care professional with expertise in diabetes

Medicare Coverage
The Balanced Budget Act of 1997 (BBA) created legislation for expanded coverage of blood glucose monitors and test strips and coverage of diabetes outpatient self-management training services for Medicare recipients with diabetes. This legislation gave the Health Care Financing Administration (HCFA) the charge of creating regulations to establish eligibility criteria for Medicare recipients. HCFA is also responsible for determining quality standards that must be met by education programs.

The BBA provision for expanded coverage of blood glucose monitors and related accessories and supplies included Medicare recipients with diabetes who are not treated with insulin, since these devices and supplies were already covered for those who use insulin. Expanded coverage of blood glucose monitors and test strips was implemented through a program memorandum to Durable Medical Equipment Regional Carriers (DMERC) effective October 1, 1998. This coverage is relatively straightforward. However, the DMERCs are responsible for ensuring that claims are for medically necessary services. Consequently, they have developed regulations germane to this benefit. The regulation states: "To be eligible for coverage, the patient must meet the following basic criteria:

1.   The patient has diabetes (ICD-9 codes 250.00-250.93), which is being   treated by a physician; and

2.   The glucose monitor and related accessories and supplies have been  ordered by the physician who is treating the patient's diabetes; and

3.   The patient (or the patient's care giver) has successfully completed     training or is scheduled to begin training in the use of the monitor, test strips, and lancets; and

4.   The patient (or the patient's caregiver) is capable of using the test results to assure the patient's appropriate glycemic control; and

5.   The device is designed for home use."

If all of the above criteria are not met, coverage will be denied as not medically necessary. Monitors with special features, such as voice synthesizers, will be covered if criteria listed above (1–5) are met and if the patient's physician certifies that the patient has a visual impairment that warrants this type of device.

All patients, regardless of whether they use insulin, may receive with a physician's prescription 100 strips and lancets every 3 months provided that coverage criteria AC, listed below, are met. In order to receive more than 100 strips and lancets every 3 months, patients must meet criteria AF below:

A.   Coverage criteria 1–5 listed above for glucose monitors are met.

B.   The supplier of the test strips and lancets maintains in its records the     order from the treating physician.

C.   The beneficiary has nearly exhausted the supply of test strips and lancets  that have been previously dispensed.

D.   The treating physician has ordered a frequency of testing that exceeds    the utilization guidelines and has documented in the patient's medical records the need for the additional strips for that particular patient.

E.   The treating physician has seen the patient and has evaluated diabetes     control within 6 months of ordering quantities of strips and lancets that exceed the utilization guide-lines.

F.   If consecutive refills for quantities that exceed the utilization guide-lines   are dispensed, the supplier has a copy of the patient's blood glucose test    results for 1 month, which document that the patient is actually testing at a frequency that corroborates the quantity of supplies that are dispensed. The documentation must consist of a copy of a written log recorded by the patient or care giver or a print-out from the monitor's memory. At a minimum, a new 1-month log must be obtained within every 6-month period when consecutive refills for quantities of supplies that exceed the guidelines are being dispensed. (Exception: This criterion does not apply to claims that represent initial dispensing of quantities of supplies that exceed utilization guide-lines.)

The pharmacy or supplier cannot dispense automatically or dispense more than a 3-month quantity of strips and lancets at a time; they must be specifically requested by either the beneficiary or the beneficiary's care giver. If an individual who has Medicare coverage is having trouble obtaining reimbursement, the state DMERC should be called. A list of DMERCS in all of the states and territories is available online at http://www.hcfa.gov. When you have accessed the web site, click on Medicare, then click on Professional Technical Information, then click on Intermediary Carrier Directory, then click on Section IV.

Diabetes Outpatient Self-Management Training Services: Interim Regulations
Before 1998, Medicare reimbursed only hospital-based outpatient programs under Medicare Part B (inpatient benefits). In 1998, HCFA issued an interim regulation covering other outpatient diabetes management training services under Medicare Part A (outpatient benefits) effective July 1, 1998. Meanwhile, hospital-based outpatient programs continue to be reimbursed under Medicare Part B. The interim regulation is effective until whenever the final rule is published. In reality, it only minimally expanded the existing education benefit, since most programs are hospital-based.

The July 1998 interim regulation states that Medicare beneficiaries' physicians must certify the need for education and that only "certified providers" can be reimbursed for providing this education. Certified providers are further defined as those physicians, individuals, or entities that are paid under the physician fee schedule. These providers must meet the National Standards for Diabetes Self-Management Education Programs.

The interim regulation added all ADA-recognized programs to the list of those eligible for reimbursement. HCFA chose to reimburse these programs whether hospital-based or not because ADA's Education Recognition process ensures that recognized programs meet the standards. HCFA requires that a copy of a recognition certificate from ADA be attached to the initial claim for diabetes self-management training services.

Highlights of the Proposed Final Regulations
On February 11, 1999, HCFA published a Notice of Proposed Rule Making in the Federal Register titled "Medicare Programs: Expanded Coverage for Outpatient Diabetes Self-Management Training Services" and allowed a 60-day period for comments from the public. The proposed rule generated a vocal and consistent response from the diabetes community. As of this writing, the regulations are not yet final.

The proposed rule is heavily influenced by the National Standards for Diabetes Self-Management Education Programs. This is clearly a positive feature. This is only a proposed rule, and changes will likely occur, although we will not know what types of changes until the final rule is published. Under the proposal, beneficiaries would have to be referred by a physician or qualified nonphysician practitioner who is treating their diabetes. Self-referral would not be covered. Referring providers would be required to develop a comprehensive plan of care that delineates the content, number, frequency, and duration of the diabetes self-management training services. Referring providers would also have to sign any changes to the plan. All education would have to be provided in a group setting, except under limited extenuating circumstances. Medicare would cover up to 10 hours of initial training within a continuous 12-month period and 1 hour of follow-up training per year billable in 1-hour increments.

The proposed benefits would not be automatic for all Medicare beneficiaries who have diabetes. In order to qualify, beneficiaries would have to:

1. be newly diagnosed.

2. be in poor glycemic control (HbA1c >9.5 for 90 days before attending  classes).

3. have a change in treatment regimen from no medication to any diabetes  medication or from oral medication to insulin.

4.    have documented episodes of hypoglycemia or hyperglycemia occurring  in the previous year that required an emergency room visit or hospitalization.

5. have existing complications, such as neuropathy, retinopathy, or      microalbuminuria.

The HCFA proposal is also very specific about who can be reimbursed for diabetes self-management training services. Physicians, individuals, or entities who meet quality standards would get reimbursed. Examples of "entities" would be end-stage renal disease facilities, critical care hospitals, and clinics. Individuals would include physicians, clinical nurse specialists, nurse practitioners, clinical social workers, psychologists, and nurse midwives. Licensed pharmacists who are providers of durable medical supplies could qualify as an approved entity. Certified diabetes educators, registered dietitians, and registered nurses would not be directly reimbursed, even though they are currently specified by HCFA regulations as required program staff.

The proposed regulations include several ways for existing education programs to qualify for reimbursement. Programs would have to be accredited by HCFA or an organization that has applied to and been approved by HCFA to accredit programs. Under the proposed rule, ADA would have to apply to HCFA and demonstrate that its Education Recognition Program meets the National Standards for Diabetes Self-Management Education Programs to become an accrediting organization. Other national organizations representing the interest of individuals with diabetes could apply and become accrediting organizations. Any applicant would have to meet or exceed either HCFA's standards or the National Standards in order become an accrediting organization. HCFA's standards vary slightly from the National Standards. For example, while the National Standards requires a diabetes advisory committee, HCFA requires a peer review organization in lieu of an advisory committee.

HCFA maintains control over its standards. The National Standards for Diabetes Self-Management Education Programs were under revision as this article was being written. It was unclear whether HCFA would accept the revised National Standards or continue with the existing standards. The proposed regulations would not recognize any other certifications.

HCFA was analyzing comments and making changes to its proposed regulations as this article went to press.

Possible Impact of the Medicare Medical Nutrition Therapy Act
The Medicare Medical Nutrition Therapy Act of 1999, H.R. 1187, and S. 660, was introduced in the 106th Session of Congress in March 1999. If passed, this act would provide Medicare Part B coverage for medical nutrition therapy by registered dietitians and other qualified nutrition professionals. This act received the support of over half of the members of the House of Representatives and one-fourth of the Senate in the 105th Congress.

The position of the American Dietetic Association is that any Medicare legislation that advances this year should contain coverage for medical nutrition therapy for all disease entities. If medical nutrition therapy is included as a covered service by Medicare, registered dietitians and other qualified nutrition professionals would be added to the list of qualified individual providers of diabetes self-management training services. Whatever the final outcome, the challenge for all of us is to continue to advocate for high quality care and education for people with diabetes.

Summary—Challenges Now
The task at hand remains huge. While we can justifiably be proud of progress made so far, we cannot simply rest on our laurels. The task will require a proactive effort by all diabetes organizations at the national and state level, as well as by every health care professional, diabetes education program, and person with diabetes. Individuals with diabetes need to be seen front and center; otherwise, health care professionals may appear to be self-serving and motivated only by profit. In order to get people with diabetes involved, legislative training is needed.

Positioning diabetes self-management therapy as a prevention-treatment concept with improved outcomes and cost savings is crucial. We must develop and complete well-controlled studies and then present our case to HCFA and policy decision makers, e.g., legislators, regulators (Medicare and Medicaid), insurance commissioners, insurance companies, managed care organizations, and self-insured companies.

In states where legislation has passed, there is a need to monitor interpretation of the law to preserve the original intent, and when necessary, work to get appropriate regulations drafted.

All states need to work with their state Diabetes Control Program and other partners to get the word out to consumers that legislation has passed and to describe what is covered. Guidance about how consumers should deal with their insurance companies and HMOs to access the coverage and what they should do if they have trouble with their insurance carrier should be provided. Getting the word out to payers that legislation has passed and describing what is covered is another important task. All health care providers need to educate staff at insurance companies and managed care organizations about this legislation, especially when a bill initially takes effect.

For states that have not passed legislation, efforts need to be initiated or continued. Advocates from states that have passed legislation are valuable resources. Some states need to look at their bills and go back to lobby for more complete coverage.

Health care providers continue to struggle with coding issues and getting reimbursement for their practice settings. We must work toward the use of uniform codes for diabetes self-management training.21 We expect a trend toward diabetes education programs arranging contracts with managed care organizations and HMOs.

Each state must deal with the issue of who will be considered a qualified provider and what diabetes expertise will be necessary to ensure that clients get quality education to improve diabetes outcomes.


References

1Coonrod BA, Betschart J, Harris MI: Frequency and determinants of diabetes patient education among adults in the U.S. population. Diabetes Care 17:852-58, 1994.

2American Diabetes Association: Position statement: Standards of medical care for patients with diabetes mellitus. Diabetes Care 21 (Suppl 1):S23-31, 1998.

3American Diabetes Association: Report of the task force on the delivery of diabetes self-management education and medical nutrition therapy. Diabetes Spectrum 12:44-47, 1999.

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Anne Daly, MS, RD, LD, CDE, is director of nutrition and diabetes education at the Springfield Diabetes and Endocrine Center in Springfield, Ill. Carolyn Leontos, MS, RD, CDE, is a nutrition specialist at the Cooperative Extension at the University of Nevada in Las Vegas.


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