Summary of 2019 Federal Bill
March 24, 2019
The bill (H.R. 220) is approximately 20 pages long and in typical bill/legal language that is difficult for many (including myself sometimes) to decipher. This easier to read summary was written to help explain what it is saying and how it affects us. Hope it helps!
Below the summary are responses to some questions and comments made by patients. I'd have shared them on the Facebook page where they were originally asked, and actually I did already, but the Lyme Army deleted my information and blocked me from posting - before they started their typical attacks on me and others.
Summary
1. So far (March 2019) there are eight sponsors for the bill. Great start!
2. Bill language states an "Office of Oversight and Coordination for Tick-Borne Diseases" will be established to "oversee", "update" and "coordinate" national and international strategies to help improve our situation.
3. The new Office of Oversight is ordered to expand, oversee, design, create and coordinate:
a. Epidemiological, clinical, biological research
b. Lyme and tick borne disease surveillance and reporting
c. Effective diagnostic tests to accurately and timely diagnose Lyme disease and other tick-borne disease, including direct detection tests
d. Treatments to cure or improve the lives of those who are infected with Lyme disease or other tick-borne disease or who suffer from a tick-induced disorder
e. Clinical trials of sufficient size and duration to support clinical recommendations (our doctors have been wanting/needing this for a long time)
f. Development and maintenance of registries of patients and doctors relating to exposure, diagnosis, and treatment of tick-borne disease, including outcomes. Registries shall protect the confidentiality and safety of patient data.
g. QUOTE- "Inclusion of individuals with chronic Lyme disease in clinical, research, and service efforts."
4. Reports are to be completed, submitted and then updated no later than every two years.
5. The reports shall include:
a. proposed budgetary requirements;
b. an assessment of all federally funded programs and activities related to surveillance, diagnosis, treatment, education, or prevention with respect to Lyme disease or other tick-borne disease (Look out IDSA/CDC- we've got your number and we are moving on in- we have a voice finally!)
c. an evaluation of progress and performance and a description of significant challenges or barriers to performance (tattle tales R-Us), including an assessment of Federal grants awarded; (Good- monitor & evaluate where the money goes and what they are doing with it!)
d. a strategy for improving diagnosis, treatment, and prevention, including increasing the impact of grants (The money already allotted will be better spent!)
e. a strategy for improving outcomes of individuals with Lyme and tick-borne diseases or "disorders", including chronic or persistent symptoms and chronic or persistent infection and coinfections
f. evaluating the value of observational studies, research, patient-centered research, or other real world evidence and the appropriate benchmarks to measure progress (No more crummy, useless studies and cutting back on money wasted from giving it to toads.)
g. improving partnerships with other agencies and global entities (world wide efforts!)
h. steps taken to implement the recommendations
6. Heads of federal agencies in consultation with the Tick-Borne Disease Working Group, shall provide for the coordination of the activities related to Lyme and tick-borne diseases and disorders, and Bartonella. (Bartonella is still said to NOT be a tick borne disease by IDSA/CDC/Hopkins and other butt-heads, so it is great to see it pointed out here in the wording... and grant funding for Bartonella which is almost non-existent will be in the new line-up.)
7. The activities to be conducted or supported consist of the following:
a. Expansion and enhancement of research for all TBD's, Bartonella and the activation and deactivation of immune system processes.
b. Clinical outcomes research to find out the effectiveness of different treatments
c. Establish patient-centered research to help shed light on promising treatment protocols for individuals suspected of harboring coinfections with more than one tick-transmitted pathogen
8. Outline key research questions, methodologies, and knowledge gaps; expand research proposals; and expand the number of research grants
9. Evaluate establishing a deidentified human database and expand current biorepositories (blood & tissue storage facilities) for Lyme and other tick-borne diseases
10. QUOTE- "PRIORITY- In carrying out this paragraph, the Secretary shall make it a priority to determine the extent of posttreatment persistence of Borrelia burgdorferi and the clinical significance of such persistence."
11. DEVELOPMENT OF NEW AND IMPROVED DIAGNOSTIC TESTS.
a. improve sensitivity of Lyme tests at all stages of disease progression
b. develop a Lyme test capable of distinguishing between past and active infections
c. improve tests for Rocky Mountain spotted fever and other tick-borne diseases
12. Design and propose or implement expediting the approval of improved diagnostic tests for Lyme and other tick-borne diseases. (To get them to the market faster.)
13. ENSURING SAFETY AND EFFICACY OF VACCINES.
a. Ensure the safety and efficacy of any new, renewed, or modified human vaccine for Lyme disease, other tick-borne disease, or a combination of such diseases
b. Require the Commissioner of Food and Drugs to submit (prior to final approval of the vaccine) a report detailing the safety of the vaccine and compare its safety profile with the human vaccine withdrawn from the market in 2002 and how those concerns have been addressed with a new vaccine. (This information has not been shared and we REALLY need it.)
14. MONITORING HUMAN CASES OF LYME & OTHER TICK-BORNE DISEASES. (New system!)
a. Establish and maintain a statistically sound, scientifically credible surveillance system to be known as the National Tick-Borne Disease Surveillance System (As we all know, the reporting system now is so wildly flawed it is sickening.)
b. blah blah blah... (more on reporting practices)
c. Evaluate the feasibility of creating a national uniform reporting system including mandatory reporting by physicians and laboratories in each State including bartonellosis transmitted by any vector
d. Shall provide for the collection and storage of other available information... such as age, race, sex, geographic location blah blah blah... progression of signs and symptoms, diagnostic and treatment history and outcomes blah blah blah
15. SHALL consult with individuals with appropriate expertise...
a. epidemiologists
b. national patient advocacy and research organizations that focus on tick-borne disease and have demonstrated experience in research, data collection, or patient access to care (This means they can't pick someone like me- who wouldn't be good in this situation due to my strong desire to punch them in the nose- and therefore, they would have to pick the best of our best.)
c. health information technology experts or other information management specialists ( an experienced staff to do the computer type work needed?)
d. clinicians with expertise in Lyme disease or other tick-borne diseases
e. research scientists
16. GRANTS.—The Secretary may award grants to, or enter into contracts or cooperative agreements with, public or private nonprofit entities to carry out activities under this paragraph. (That's new and great! OUR researchers/doctors/organizations will be able to apply for grants!)
17. COORDINATION- Make (ensure) information and analysis in the National Tick-Borne Disease Surveillance System is available to the public and other interested parties (Transparency!)
18. PRIVACY- Shall ensure that information is made available only to the extent permitted by applicable law, and in a manner that protects personal privacy.
19. EDUCATION AND PREVENTION
a. Shall increase public education related to Lyme and other tick-borne diseases and disorders to include development and publication of a consumer tick disease pamphlet, available online and by hard copy
b. It will address ticks and tick-borne diseases, signs and symptoms, tick removal instructions, reducing risk of exposure to ticks and additional community-based actions to reduce risk of exposure to ticks
c. In designing it, they shall coordinate with legally incorporated Lyme disease or other tick-borne disease organizations
20. DISSEMINATION- shall make pamphlets available in rural health centers and clinics
21. PHYSICIAN EDUCATION- carry out a physician education program that addresses the full spectrum of scientific research related to Lyme disease and other tick-borne diseases and disorders, including:
a. the role of clinical diagnosis and limitations of tests
b. guidelines- the voluntary nature of clinical practice guidelines (Important since new IDSA guidelines are due out soon.)
c. the complexities presented by coinfections relating to symptomology, diagnosis, and treatment, including prudently acting in the patient’s interest in non- or low-incidence States, blah blah blah...
22. PROCESS FOR DEVELOPING PHYSICIAN EDUCATION PROGRAM
a. conduct a public meeting to solicit input for the design of the physician education program and give the public notice of meeting at least 45 days in advance.
b. publish a proposed syllabus for the physician education program, allow for a 60-day public comment period and publish a summary of the comments
23. TICK SURVEILLANCE AND TESTING- provide a report to Congress describing the tick surveillance and pathogen testing activities of the Department and entities funded by the Department, including:
a. detailed description of the tick surveillance and tick pathogen testing and planned activities and within such description the roles of participating academic, governmental, and private institutions (Tattle Tales R-Us)
b. develop a framework and an implementation plan for a comprehensive nationwide strategy for the surveillance and testing of ticks for human pathogens and microorganisms with unknown pathogenicity, including a plan for a network of tick identification and testing laboratories
c. consult and coordinate with the American Veterinary Medical Association and the Companion Animal Parasite Council on obtaining and sharing data on the surveillance and testing of ticks and tick-borne pathogens, including geographic information from veterinary encounters
24. INVESTIGATION- investigate and promote the use of advanced new technologies, such as tools to discover all known and all previously unidentified microorganisms in a vector and allow for the possibility of rapid geographic migration of tick vectors and pathogens and unexpected findings.
25. TICK CONTROL AND PREVENTION
a. development of safer and more effective tick repellents, both natural and chemical and the use of acaricides or other chemical interventions including nonchemical environmental measures
b. genetic therapies for vectors or animal hosts to interfere with the life cycle of pathogens and development of vector or reservoir host vaccines
c. make data on tick surveillance, testing, control and prevention available to the public (good!)
26. CONFERENCES, SYMPOSIA, SEMINARS, AND OTHER PUBLIC MEETINGS
a. sponsor a state-of-the-science conference on Lyme and other tick-borne diseases
b. not later than 120 days later make available a final report on the conference
c. sponsor a symposium on the use of real-world evidence- meaning data from sources other than randomized clinical trials (our clinical experiences like LymeDisease.org does now with their My Lyme Data project)
d. sponsor a researcher workshop on solutions for clinical trial design and implementation for Lyme disease (no more slop-jar studies like the ones that were done that are useless to us and only help IDSA/insurers limit or deny treatment and coverage)
e. design a survey targeted to patients and patient advocates, physicians and health care providers, and researchers regarding recommended subjects and agendas for federally sponsored meetings including webinars and provide a published analysis for a 60 day comment period
f. provide a final analysis and a proposed schedule and agenda for incorporation into the national strategy
27. COMMON RESEARCH BIBLIOGRAPHY- assemble a bibliography that includes literature relating to possible mechanisms of persistent infectionwith Borrelia burgdorferi or other types of Borrelia. (CHRONIC Lyme)
28. Reports SHALL contain: (I'm leaving the exact wording in the "a" section below as an example, and to demonstrate the complexities of the bill language and why sometimes I just say blah blah blah.)
a. "a scientifically qualified assessment of Lyme disease and other tick-borne disease, including a summary of prevalence, geography, important exposure characteristics, disease stages and manifestations or symptoms of those stages, based on a synthesis of the broad spectrum of empirical evidence of treating physicians, as well as published peer-reviewed data, to include for each tick-borne disease a state-of-the-science diagnosis and treatment"
This is another major Tattle Tales R-us section below... good for us!
The report will contain.... b. a description of all programs and activities funded by the Department of Health and Human Services that are related to the surveillance, diagnosis, treatment, education, or prevention of Lyme disease or other tick-borne disease, and an evaluation of progress and performance based on mission and purpose, and discussion of significant challenges or barriers to performance, to include—
c. a description of the intramural and extramural research portfolios of the Centers for Disease Control and Prevention, the National Institutes of Health, and other agencies and offices of the Department of Health and Human Services which conducted or contracted for research projects related to Lyme disease or on other tick-borne disease or disorder, including information on the award amount, institution, primary investigator, principal investigative question or questions, and significant conclusions (transparancy regarding what they've been doing- a big ouch on them)
d. studies that received Federal funds and were terminated, in progress, or initiated in the fiscal year including the date of enactment of this Act and the 5 prior fiscal years (we know about the bad studies and now everyone will- ho ho ho on them)
e. information on agreements, partnerships, cooperation, coordination, and data sharing with external entities, such as State and local governments, other Federal agencies, working groups, and global entities (Look out Matthew Cartter (CT), for example, and the rest of the bunch that has this system so messed up!)
f. a description of major externally funded research, surveillance, education, or other programs and initiatives impacting the management or science of tick-borne disease
g. a description of clinical practice guidelines for any tick-borne disease published on the National Guideline Clearinghouse (ouch on IDSA and the neurology toads) blah blah blah...
29. Biennial Reports Of NIH
QUOTE- "The Secretary shall ensure that each biennial report under title III of the Public Health Service Act (42 U.S.C. 241 et seq.) or each triennial report under section 403 of such Act (42 U.S.C. 283) includes information on actions undertaken by the National Institutes of Health to carry out research with respect to Lyme disease and other tick-borne disease.
In other words- do what you are told or you will be burned!
30. DEFINITIONS
blah blah blah....
The End!