New proposed rules by the Centers for Medicare Medicaid Services (CMS) Medicare and Medicaid Programs could have a big impact on Lyme patients. The Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care rules would establish a formal antibiotic stewardship program for hospitals The comment period for the proposed rule just recently closed. LymeDisease.org submitted comments on behalf of patients on August 7, 2016.

Lyme patients already have difficulty receiving care in hospitals. Patients are concerned that the new rules may take a bad situation and make it worse. In our published survey of roughly 2,500 Lyme patients, 40% reported seeking care from their current hospitals and 82% report having had difficulty receiving care. (Johnson 2011).

Many hospitals have already voluntarily instituted antibiotic stewardship programs in the past, but the new rules would make the oversight mandatory. The proposed new rules would require that two employees oversee the use of antibiotics in the hospitals. Members of the Infectious Diseases Society of America would likely oversee the program. The IDSA is the largest infectious disease specialty society in the world, has published extremely restrictive Lyme treatment guidelines, and often functions as a gatekeeper for hospital infectious services.

Although the proposed rules do not affect private practice by physicians in their own offices, there is concern that their scope may expand in the future.  Our comment letter  focuses on the adverse impact the proposal would have on access to care for Lyme patients.

The concern of the Lyme community with the antibiotic stewardship program is that it will cede more power and control over Lyme patients to the IDSA and increase the barriers to care for patients. Accordingly, we ask that any antibiotic stewardship program include the ILADS Lyme treatment guidelines, recognize the need for clinical judgment and individualized care, and require shared medical decision-making with patients.

The full letter is below.

Mr. Andy Slavitt
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attn: CMS-3295-P
PO Box 8010
Baltimore, MD 21244

Letter Submitted On-Line at www.regulations.gov

RE: CMS-3295-P – Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care

Dear Mr. Slavitt:

I appreciate the opportunity to submit comments on behalf of LymeDisease.org regarding the antibiotic stewardship program proposal: “Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care” which addresses antibiotic stewardship under section §482.42 & §485.640. The specific provision that we are commenting on is:

482. Infection Prevention and Control and Antibiotic Stewardship Programs (§ 482.42)

LymeDisease.org was founded in 1989 and is the largest grassroots organization representing Lyme patients in the United States. We play a major role in Lyme disease healthcare policy, conducting and publishing large scale surveys (5,000-7,000 respondents) in peer-reviewed journals. Our most recent effort, launched last November is a patient-centered big data project, MyLymeData, which has enrolled over 5,000 patients to date—putting it in the top 10% of patient-driven registries in the nation.

As CEO, I participate in the national healthcare policy dialogue, serving currently as a patient representative for PCORI and as the Co-Chair of Consumers United for Evidence-Based Healthcare, a coalition of over 40 patient groups affiliated with the Cochrane Collaboration. Until recently, I also served on the Executive and Steering Committees of PCORnet (PCORI’s big data project) and chaired its Patient Council.

Lyme disease patients bear a significant burden of illness, with a quality of life worse than that of patients with congestive heart failure—many are unable to work due to the illness. Access to care is a central concern of the Lyme community. The IOM defines “access to healthcare” as the timely use of medical care to obtain the best possible outcome, framing the issue as follows:

The most important consideration is whether people have the opportunity for a good outcome—especially in those instances in which medical care can make a difference. When those opportunities are systematically denied to groups in society, there is an access problem that needs to be addressed. (IOM 1993)

The major barrier to care for Lyme patients is the restrictive medical guidelines of the Infectious Diseases Society of America (IDSA) for Lyme disease. (Wormser 2006) These guidelines impose such strict diagnostic criteria that many patients can’t even get diagnosed.  Current blood tests for Lyme disease are insensitive and the IDSA guidelines require positive test results for diagnosis.

Even patients who do meet the rigid diagnostic standard are offered only limited treatment.   When patients fail the short term course of antibiotics offered by the IDSA guidelines, they are denied further treatment. Currently, the only effective treatment for Lyme disease is antibiotics.

In 2010, we conducted and published a survey on the access-to-care problems patients with Lyme disease face. Approximately 2,500 patients who were diagnosed and who tested positive on blood tests were included in the study. The study found:

Half of the sample reported that they had seen at least seven physicians between the onset of symptoms and receiving a diagnosis of Lyme disease, with over a third seeing 10 or more physicians before obtaining a diagnosis. Nearly half of the respondents reported that they travel over 50 miles to obtain treatment for Lyme disease… The majority of respondents (81.7%) who visited their local hospital for treatment had difficulty obtaining treatment… Furthermore, 30.5% of respondents applied for disability benefits, and 38.6% of these individuals were denied disability benefits based on failure to conform to the IDSA Lyme guidelines. (Johnson 2011)

Although there are two standards of care in Lyme disease, with another more flexible set of guidelines developed by the International Lyme and Associated Diseases Society (Cameron 2014), the IDSA guidelines are followed by many insurers (who mistakenly believe that restricting treatment lowers costs) and hospitals, where the IDSA strongly influences treatment of infectious disease. As a result, many patients pay large out-of-pocket costs for treatment and it is well known in the Lyme community that hospitals are unlikely to help and may make matters worse.

With regard to the access to care in hospitals, the study concluded:

Of those patients who sought medical services at their local hospitals, the majority reported difficulty in obtaining care. IDSA is highly influential in developing hospital protocols related to infectious diseases, and these protocols may result in denying patients antibiotic treatment [16,17,29]. Patients who cannot obtain care at their local hospitals may need to either travel to a hospital where their treating physician has practice privileges or forego such services. Some hospitals, however, deny hospital privileges to physicians who do not follow the IDSA Lyme guidelines, and this restriction places further limits on the patient’s treatment options. (Johnson 2011)

The situation has become so dire for patients that they have pursued legislation permitting treatment. Some states are passing insurance legislation to ease the burden of treatment costs for Lyme patients. Legislators are passing legislation because they know how profoundly the IDSA guideline restrictions affects patients in real life. Massachusetts recently passed insurance legislation. One of the bill’s sponsors Rep. David Linsky, put it plainly: “Virtually everyone in the Legislature has been affected by Lyme disease in some way. Either they’ve had Lyme disease, a family member had Lyme disease or a close friend or neighbor had Lyme disease.” (Goldberg 2016) 

The restrictive IDSA guidelines harm patients by denying them access to the care they need to get well.  While not all patients are cured by antibiotics, many are. Moreover, the restriction of patient care based on IDSA guidelines is particularly egregious because only 11% of Lyme patients are treated by infectious disease physicians. (Johnson 2011) The remainder are diagnosed and treated by rheumatologists, family physicians, and physicians who follow the Lyme disease guidelines of ILADS—currently the only guidelines that meet the stringent evidence assessment standards (GRADE) of the IOM and are listed on the National Guidelines Clearinghouse.

The impetus for the insurance legislation passage in Massachusetts was simply a recognition that the IDSA guidelines were crafted by researchers dwelling in academic towers who are not responsible for patient care and who are out of touch with patient reality.

Another critical issue in the Lyme community is patient-centered care. The IOM defines patient-centeredness as “the [provision of] care that is respectful of and responsive to individual patient preferences, needs, and values, ensuring that patient values guide all clinical decisions. (IOM 1993)

When we surveyed over 6,000 patients about Lyme disease guidelines in 2015, a large majority emphasized the importance of informing patients about the IDSA and ILADS guidelines as well as the risks and benefits or treatment and not treating chronic Lyme disease. (Johnson 2015)

Although the IOM’s standards on creating trustworthy guidelines, require that those affected by guidelines be included in the process, the IDSA guidelines panel has never included a patient with chronic Lyme disease. The IDSA guidelines are not patient-centered, do not reflect outcomes that patients find important, and do not provide for shared medical decision-making. In contrast, the ILADS guidelines included a patient as an author, are based on outcomes patients regard as important, and provide for shared medical decision-making.

The concern of the Lyme community with the antibiotic stewardship program is that it will cede more power and control over Lyme patients to the IDSA and increase the barriers to care for patients. Accordingly, we ask that any antibiotic stewardship program include the ILADS Lyme treatment guidelines, recognize the need for clinical judgment and individualized care, and require shared medical decision-making with patients.

The shared medical decision-making process should advise the patients that there are two standards of care in the treatment of Lyme disease. Patients should have a voice in the one-on-one interaction between provider and patient to determine the appropriate treatment approach taking into account the severity of their condition, their responsiveness to treatment, and their unique circumstances and preferences.

Very truly yours,

Lorraine Johnson

CEO LymeDisease.org

References:

Johnson, L. IDSA Survey: Outcomes Important to Lyme Patients Chartbook. (March 21, 2015) https://www.lymedisease.org//mylymedata/chartbooks/IDSA-chartbook.pdf

Institute of Medicine (US) Committee on Monitoring Access to Personal Health Care Services; Millman M, editor. Access to Health Care in America. Washington (DC): National Academies Press (US); 1993. Summary. Available from: http://www.ncbi.nlm.nih.gov/books/NBK235890/

Johnson L, Aylward A, Stricker RB. Healthcare access and burden of care for patients with Lyme disease: a large United States survey. Health Policy. 2011 Sep;102(1):64-71.

Goldberg, C. Mass. Lawmakers Override Veto On Long-Term Antibiotics For Lyme (August 1, 2016). http://www.wbur.org/commonhealth/2016/08/01/mass-long-term-lyme-disease-antibiotics

Cameron DJ, Johnson LB, Maloney EL. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease. Expert Review Anti-Infective Therapy. 2014 Sep;12(9):1103-35.

Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006 Nov 1;43(9):1089-134.