Volume 12 Number 4, 1999, Page 222
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
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 linethe 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
State LegislationWhat Is Covered and What Is Not
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.
Strategies Used to Get Legislation Passed
The Nevada Experience
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
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:
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 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 400 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.
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:
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 (15) 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:
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
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
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:
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 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.
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.
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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.
Copyright © 1999 American Diabetes Association
Last updated: 12/99