1. Chronic Disease Reporting A1C Reporting for Diabetes Control in New York City Thomas Merrill, JD

2. Overview Legal Authority Legal Authority Why an A1C Registry Why an A1C Registry Description of the registry Description of the registry Implementation status Implementation status Privacy Privacy

3. Registries and the Control of Disease Determine incidence of a disease Determine incidence of a disease Examine trends Examine trends Assess services and groups at risk Assess services and groups at risk

4. The Police Power The sovereign right of a government to promote order, safety, health, morals and general welfare within its borders The sovereign right of a government to promote order, safety, health, morals and general welfare within its borders Reserved to the states under the Tenth Amendment to the United States Constitution Reserved to the states under the Tenth Amendment to the United States Constitution

5. NYS Constitution Article XVII, §3 “ The protection and promotion of the health of the inhabitants of the state are matters of public concern and provision therefor shall be made by the state and by such of its subdivisions and in such manner, and by such means as the legislature shall from time to time determine.” “ The protection and promotion of the health of the inhabitants of the state are matters of public concern and provision therefor shall be made by the state and by such of its subdivisions and in such manner, and by such means as the legislature shall from time to time determine.” (Adopted by Constitutional Convention of 1938 and approved by vote of the people November 8, 1938.) (Adopted by Constitutional Convention of 1938 and approved by vote of the people November 8, 1938.)

6. New York City Charter §556(c)(2) The Department’s jurisdiction includes the power to “supervise the reporting and control of communicable and chronic diseases” The Department’s jurisdiction includes the power to “supervise the reporting and control of communicable and chronic diseases”

7. Public Health Law § 580(3)(a) Recognizes the power and authority of DOHMH to regulate laboratories with regard to the control, prevention or reporting of diseases or medical conditions. Recognizes the power and authority of DOHMH to regulate laboratories with regard to the control, prevention or reporting of diseases or medical conditions.

8. Substantive Due Process Is it “a fair, reasonable and appropriate exercise of the police power of the State, or is it an unreasonable, unnecessary and arbitrary interference with the right of the individual to his personal liberty …?” Is it “a fair, reasonable and appropriate exercise of the police power of the State, or is it an unreasonable, unnecessary and arbitrary interference with the right of the individual to his personal liberty …?” Lochner v. New York, 198 U.S. 45, 56 (1905)

9. Second-guessing by Courts no Longer Permitted `“States have broad latitude in experimenting with possible solutions to problems of vital local concern.” -- Whalen v. Roe, 429 U.S. 589, 597 (1977)

10. Rational Basis Test Law cannot be arbitrary, capricious, or unreasonable Law cannot be arbitrary, capricious, or unreasonable Due process satisfied if rationally related to a legitimate government interest Due process satisfied if rationally related to a legitimate government interest

11. Why An A1C Registry? Prevalence of diabetes in NYC doubled between 1995 and 2005 Prevalence of diabetes in NYC doubled between 1995 and 2005 530,000 (9%) of NYC adults with diabetes 530,000 (9%) of NYC adults with diabetes 20% of NYC adults over 65 with diabetes 20% of NYC adults over 65 with diabetes 4 th leading cause of death in NYC 4 th leading cause of death in NYC

12. Evaluate Trends in Blood Sugar Control Plan programs in the Diabetes Prevention and Control Program, Plan programs in the Diabetes Prevention and Control Program, Measure outcomes of diabetes care, and thereby Measure outcomes of diabetes care, and thereby –Direct more efficient interventions to health care institutions, health care providers and people with diabetes.

13. New York City Health Code Article 11 – Reportable Diseases and Conditions Article 11 – Reportable Diseases and Conditions Article 13 -- Laboratories Article 13 -- Laboratories

14. Decision to Amend Article 13 Laboratories reporting through ECLARS Laboratories reporting through ECLARS Better compliance from labs than from providers Better compliance from labs than from providers

15. Deciding What to Collect -- A1C measures average blood sugar level in the blood over 3 months for people with diabetes. A1C measures average blood sugar level in the blood over 3 months for people with diabetes. A1C levels are used by providers and patients to monitor and change treatment plans for individuals with diabetes, the goal being an A1C less than 7.0% (average blood sugar of 170 mg/dL). A1C levels are used by providers and patients to monitor and change treatment plans for individuals with diabetes, the goal being an A1C less than 7.0% (average blood sugar of 170 mg/dL).

16. Importance of controlling A1C Strong evidence that with A1C <7.0%, the small blood vessel complications of diabetes can be reduced by over 25%. Strong evidence that with A1C <7.0%, the small blood vessel complications of diabetes can be reduced by over 25%. Every drop of 1% (e.g., from 9% to 8%), equals a 35% reduction in small blood vessel complications. Every drop of 1% (e.g., from 9% to 8%), equals a 35% reduction in small blood vessel complications.

17. Other Data Elements Information collected includes Information collected includes –Individual name, address, date of birth, sex –Name and address of ordering provider, ordering facility and testing facility –A1C test collection date and result –No diagnosis code Each person appears once and all tests for that individual are linked Each person appears once and all tests for that individual are linked –Providers and facilities have linkage as well but quality of linkage is based on quality of data

18. Board of Health Process Board approved a proposal for publication and public comment in September 2005 Board approved a proposal for publication and public comment in September 2005 Public comments received in Fall 2005 Public comments received in Fall 2005 Board adopted a resolution amending the Health Code in December 2005 Board adopted a resolution amending the Health Code in December 2005

19. Public Comments Feasibility of reporting DOB and addresses Feasibility of reporting DOB and addresses Questioned whether it should be voluntary Questioned whether it should be voluntary Attestations to success of VDIS Attestations to success of VDIS Medical providers supported proposal Medical providers supported proposal Privacy Privacy

20. Implementation Test results are entered in the New York City A1C Registry (NYCAR) which the Department uses to: Test results are entered in the New York City A1C Registry (NYCAR) which the Department uses to: DOHMH supports providers and their patients in improving diabetes care DOHMH supports providers and their patients in improving diabetes care DOHMH monitors blood sugar control in New York City over time DOHMH monitors blood sugar control in New York City over time

21. Types of Analyses Cross sectional view at years’ end Cross sectional view at years’ end Longitudinal follow-up of cohorts by year Longitudinal follow-up of cohorts by year Proportion of people seeking care at same facility, in same borough Proportion of people seeking care at same facility, in same borough Proportion of people who improve, worsen, and maintain over time Proportion of people who improve, worsen, and maintain over time

22. Facility Report Note: All information in this slide is fictitious Page 1 Page 2

23. Provider Report Note: All information in this slide is fictitious

24. High A1C Patient Letter Overdue letter currently being developed

25. Status of Implementation Majority of laboratories are reporting Majority of laboratories are reporting –35 of the 39 mandated, >90% of expected volume –Nearly 4 million tests among over 1.5 million people and 350,00 people with A1C over 7 Provider and patient outreach Provider and patient outreach –86 sites visited, 56 signed letters of agreement for patient letter service –~900 providers across 40 sites getting reports quarterly –2900 patients have received letters Self-management resources Self-management resources –Glucose strips kits –Parks coupons –Lifestyle intervention –Stanford program –Telephone intervention research project

26. Quality of Data Reported (March 2009) VARIABLE % MISSING Person’s address 7.6 Date of birth 1.4 Sex0.0 Provider name 16.0 Provider address 2.6 Ordering facility 0.1

27. Public Health Law §580(3) The failure to comply with a NYC reporting requirement “may be the basis for [NYSDOH’s] denial or non-renewal of a laboratory permit or a certificate of qualification”

28. Privacy Privacy was raised during public comment period Privacy was raised during public comment period The Constitution protects “individual interest in avoiding disclosure of personal matters” The Constitution protects “individual interest in avoiding disclosure of personal matters” -- Whalen v. Roe, 439 US 589, 599 (1977) Disease status may be protected Disease status may be protected --Doe v. City of New York, 15 F.3d 264 (2d Cir. 1994)

29. Health Code §13.07(c) Health Code §13.07(c) Test results and identifying information “[c]annot be disclosed to any person other than the individual who is the subject of the report or to such person's treating health care providers”

30. Freedom of Information Laws Provider reports without patient identifiable information may be public records Provider reports without patient identifiable information may be public records

31. Take Aways There is legal authority for using registries for chronic disease There is legal authority for using registries for chronic disease Rational basis test: have to be able to articulate programmatic need for the information Rational basis test: have to be able to articulate programmatic need for the information Letter outreach program requires data cleansing with facilities Letter outreach program requires data cleansing with facilities Privacy: obligated to protect personal information you receive Privacy: obligated to protect personal information you receive Provider reports may be subject to FOIL or FOIA Provider reports may be subject to FOIL or FOIA Effectiveness being evaluated Effectiveness being evaluated