Chronic Disease ReportingChronic Disease Reporting

A1C Reporting for Diabetes A1C Reporting for Diabetes Control in New York CityControl in New York City

Thomas Merrill, JDThomas Merrill, JD

OverviewOverview

• Legal AuthorityLegal Authority

• Why an A1C RegistryWhy an A1C Registry

• Description of the registry Description of the registry

• Implementation statusImplementation status

• PrivacyPrivacy

Registries and the Control of Registries and the Control of DiseaseDisease

• Determine incidence of a diseaseDetermine incidence of a disease

• Examine trendsExamine trends

• Assess services and groups at riskAssess services and groups at risk

The Police PowerThe Police Power

• The sovereign right of a government The sovereign right of a government to promote order, safety, health, to promote order, safety, health, morals and general welfare within its morals and general welfare within its bordersborders

• Reserved to the states under the Reserved to the states under the Tenth Amendment to the United Tenth Amendment to the United States Constitution States Constitution

NYS Constitution Article NYS Constitution Article XVII, XVII, §3§3• “ “ The protection and promotion of the health The protection and promotion of the health

of the inhabitants of the state are matters of of the inhabitants of the state are matters of public concern and provision therefor shall be public concern and provision therefor shall be made by the state and by such of its made by the state and by such of its subdivisions and in such manner, and by subdivisions and in such manner, and by such means as the legislature shall from time such means as the legislature shall from time to time determine.” to time determine.”

(Adopted by Constitutional Convention of 1938 and approved by vote (Adopted by Constitutional Convention of 1938 and approved by vote of the people November 8, 1938.)of the people November 8, 1938.)

New York City Charter New York City Charter §556(c)§556(c)(2)(2)

• The Department’s jurisdiction The Department’s jurisdiction includes the power to “supervise the includes the power to “supervise the reporting and control of reporting and control of communicable and chronic diseases”communicable and chronic diseases”

Public Health Law Public Health Law § 580(3)§ 580(3)(a)(a)

• Recognizes the power and authority Recognizes the power and authority of DOHMH to regulate laboratories of DOHMH to regulate laboratories with regard to the control, prevention with regard to the control, prevention or reporting of diseases or medical or reporting of diseases or medical conditions.conditions.

Substantive Due Process Substantive Due Process

Is it “a fair, reasonable and appropriate Is it “a fair, reasonable and appropriate exercise of the police power of the exercise of the police power of the State, or is it an unreasonable, State, or is it an unreasonable, unnecessary and arbitrary interference unnecessary and arbitrary interference with the right of the individual to his with the right of the individual to his personal liberty …?” personal liberty …?”

Lochner v. New YorkLochner v. New York, 198 U.S. 45, 56 (1905), 198 U.S. 45, 56 (1905)

Second-guessing by Courts no Second-guessing by Courts no Longer PermittedLonger Permitted

`“States have broad latitude in `“States have broad latitude in experimenting with possible solutions experimenting with possible solutions to problems of vital local concern.” to problems of vital local concern.”

-- -- Whalen v. RoeWhalen v. Roe, 429 U.S. 589, 597 (1977), 429 U.S. 589, 597 (1977)

Rational Basis TestRational Basis Test

• Law cannot be arbitrary, capricious, Law cannot be arbitrary, capricious, or unreasonableor unreasonable

• Due process satisfied if rationally Due process satisfied if rationally related to a legitimate government related to a legitimate government interestinterest

Why An A1C Registry?Why An A1C Registry?

• Prevalence of diabetes in NYC Prevalence of diabetes in NYC doubled between 1995 and 2005doubled between 1995 and 2005

• 530,000 (9%) of NYC adults with 530,000 (9%) of NYC adults with diabetesdiabetes

• 20% of NYC adults over 65 with 20% of NYC adults over 65 with diabetesdiabetes

• 44thth leading cause of death in NYC leading cause of death in NYC

Evaluate Trends in Blood Sugar Evaluate Trends in Blood Sugar ControlControl

• Plan programs in the Diabetes Plan programs in the Diabetes Prevention and Control Program, Prevention and Control Program,

• Measure outcomes of diabetes care, Measure outcomes of diabetes care, and thereby and thereby – Direct more efficient interventions to Direct more efficient interventions to

health care institutions, health care health care institutions, health care providers and people with diabetes.providers and people with diabetes.

New York City Health CodeNew York City Health Code

• Article 11 – Reportable Diseases and Article 11 – Reportable Diseases and ConditionsConditions

• Article 13 -- LaboratoriesArticle 13 -- Laboratories

Decision to Amend Article Decision to Amend Article 1313

• Laboratories reporting through Laboratories reporting through ECLARSECLARS

• Better compliance from labs than Better compliance from labs than from providersfrom providers

Deciding What to Collect -- Deciding What to Collect --

• A1C measures average blood sugar level A1C measures average blood sugar level in the blood over 3 months for people in the blood over 3 months for people with diabetes.with diabetes.

• A1C levels are used by providers and A1C levels are used by providers and patients to monitor and change patients to monitor and change treatment plans for individuals with treatment plans for individuals with diabetes, the goal being an A1C less diabetes, the goal being an A1C less than 7.0% (average blood sugar of 170 than 7.0% (average blood sugar of 170 mg/dL). mg/dL).

Importance of controlling Importance of controlling A1CA1C• Strong evidence that with A1C Strong evidence that with A1C

<7.0%, the small blood vessel <7.0%, the small blood vessel complications of diabetes can be complications of diabetes can be reduced by over 25%.reduced by over 25%.

• Every drop of 1% (e.g., from 9% to Every drop of 1% (e.g., from 9% to 8%), equals a 35% reduction in small 8%), equals a 35% reduction in small blood vessel complications. blood vessel complications.

Other Data ElementsOther Data Elements

• Information collected includesInformation collected includes– Individual name, address, date of birth, sexIndividual name, address, date of birth, sex– Name and address of ordering provider, ordering Name and address of ordering provider, ordering

facility and testing facilityfacility and testing facility– A1C test collection date and resultA1C test collection date and result– No diagnosis codeNo diagnosis code

• Each person appears once and all Each person appears once and all tests for that individual are linked tests for that individual are linked – Providers and facilities have linkage as well but Providers and facilities have linkage as well but

quality of linkage is based on quality of dataquality of linkage is based on quality of data

Board of Health ProcessBoard of Health Process

• Board approved a proposal for Board approved a proposal for publication and public comment in publication and public comment in September 2005September 2005

• Public comments received in Fall Public comments received in Fall 20052005

• Board adopted a resolution Board adopted a resolution amending the Health Code in amending the Health Code in December 2005 December 2005

Public CommentsPublic Comments

• Feasibility of reporting DOB and Feasibility of reporting DOB and addressesaddresses

• Questioned whether it should be Questioned whether it should be voluntaryvoluntary

• Attestations to success of VDIS Attestations to success of VDIS

• Medical providers supported proposalMedical providers supported proposal

• PrivacyPrivacy

ImplementationImplementation

• Test results are entered in the Test results are entered in the NNew ew YYork ork CCity ity AA1C 1C RRegistry (NYCAR) egistry (NYCAR) which the Department uses to:which the Department uses to:

• DOHMH supports providers and their DOHMH supports providers and their patients in improving diabetes care patients in improving diabetes care

• DOHMH monitors blood sugar control DOHMH monitors blood sugar control in New York City over time in New York City over time

Types of AnalysesTypes of Analyses

• Cross sectional view at years’ endCross sectional view at years’ end

• Longitudinal follow-up of cohorts by Longitudinal follow-up of cohorts by yearyear

• Proportion of people seeking care at Proportion of people seeking care at same facility, in same boroughsame facility, in same borough

• Proportion of people who improve, Proportion of people who improve, worsen, and maintain over timeworsen, and maintain over time

Facility ReportFacility Report

Note: All information in this slide is fictitious

Page 1

Page 2

Provider ReportProvider Report

Note: All information in this slide is fictitious

High A1C Patient LetterHigh A1C Patient Letter

Overdue letter currently being developed

Status of ImplementationStatus of Implementation

• Majority of laboratories are reportingMajority of laboratories are reporting– 35 of the 39 mandated, 35 of the 39 mandated, >>90% of expected volume90% of expected volume– Nearly 4 million tests among over 1.5 million people Nearly 4 million tests among over 1.5 million people

and 350,00 people with A1C over 7and 350,00 people with A1C over 7

• Provider and patient outreachProvider and patient outreach– 86 sites visited, 56 signed letters of agreement for 86 sites visited, 56 signed letters of agreement for

patient letter servicepatient letter service– ~900 providers across 40 sites getting reports ~900 providers across 40 sites getting reports

quarterlyquarterly– 2900 patients have received letters2900 patients have received letters

• Self-management resourcesSelf-management resources– Glucose strips kitsGlucose strips kits– Parks couponsParks coupons– Lifestyle interventionLifestyle intervention– Stanford programStanford program– Telephone intervention research projectTelephone intervention research project

Quality of Data ReportedQuality of Data Reported(March 2009)(March 2009)

VARIABLEVARIABLE % MISSING% MISSING

Person’s addressPerson’s address 7.67.6

Date of birthDate of birth 1.41.4

SexSex 0.00.0

Provider nameProvider name 16.016.0

Provider addressProvider address 2.62.6

Ordering facilityOrdering facility 0.10.1

Public Health Law Public Health Law §580(3)§580(3)

The failure to comply with a NYC The failure to comply with a NYC reporting requirement “may be the reporting requirement “may be the basis for [NYSDOH’s] denial or non-basis for [NYSDOH’s] denial or non-renewal of a laboratory permit or a renewal of a laboratory permit or a certificate of qualification”certificate of qualification”

PrivacyPrivacy

• Privacy was raised during public comment periodPrivacy was raised during public comment period

• The Constitution protects “individual interest in The Constitution protects “individual interest in avoiding disclosure of personal matters” avoiding disclosure of personal matters”

-- Whalen v. Roe-- Whalen v. Roe, 439 US 589, 599 (1977), 439 US 589, 599 (1977)

• Disease status may be protectedDisease status may be protected

---- Doe v. City of New York, Doe v. City of New York, 15 F.3d 264 (2d Cir. 1994)15 F.3d 264 (2d Cir. 1994)

  Health Code Health Code §13.07(c)§13.07(c)

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

Freedom of Information Freedom of Information LawsLaws

• Provider reports without patient Provider reports without patient identifiable information may be identifiable information may be public recordspublic records

Take AwaysTake Aways

• There is legal authority for using registries for There is legal authority for using registries for chronic diseasechronic disease

• Rational basis test: have to be able to articulate Rational basis test: have to be able to articulate programmatic need for the informationprogrammatic need for the information

• Letter outreach program requires data cleansing Letter outreach program requires data cleansing with facilitieswith facilities

• Privacy: obligated to protect personal information Privacy: obligated to protect personal information you receiveyou receive

• Provider reports may be subject to FOIL or FOIAProvider reports may be subject to FOIL or FOIA• Effectiveness being evaluatedEffectiveness being evaluated