California State Update California Clinical Laboratory Association November

California State Update California Clinical Laboratory Association November 4, 2010 Beatrice O’Keefe Chief, Laboratory Field Services California Department of Health Services

Topics l Direct to Consumer Genetic Tests −Background −Regulation −Future? l Meaningful Use −Objectives −Measurement

Brief History of Lab Regulation in CA 1923 -voluntary Certification of laboratories l 1938 -Licensing of clinical labs and personnel l 1990 -Non diagnostic health assessment l 2002 -Expansion of self ordered tests l 2004 -Consumer tests offered over internet l 2009 -Genetic tests offered over internet l

Future of Genetic Tests Washington G 2 Report June 2008 • Global molecular diagnostic industry 5. 5 Billion in 2008, 8 billion by 2010 • Lab market increase 5% per year, molecular diagnostics growth 20% per year Challenges • Laboratory validation • Regulator’s review and acceptance of validation

Regulation in California of Genetic Tests and Risk Analysis • Definition of “clinical laboratory test” very broad • Genetic risk analysis considered part of laboratory test • Requires physician order, licensure of laboratory, qualified director and review of report by licensed person

Diagnostic/Predictive Genetic Tests Generally Consists of Two Parts: • Determination of genetic profile of the patient • Determination of the risk or other parameters using a soft ware algorithm

Three Types of Labs offering Genetic Tests in CA • Genetic analysis only • Genetic analysis plus risk assessment • Risk assessment only

Multivariate Guidance FDA preamble to the final Analyte Specific Reagents (ASRs) “clinical laboratories that develop (in-house) tests are acting as manufacturers of medical devices and are subject to FDA jurisdiction under the Act” FDA has enforcement discretion over in-house developed tests

In. Vitro Diagnostic Multivariate Index Assays (IVDMIA) IVDMIAs have raised concerns: Include complex, statistically-derived, data driven algorithms that are not standard primary ingredients of in-house developed tests. IVDMIAs used in genetic risk analysis

Multivariate Guidance Concerns; • Safety and effectiveness • No independent review of data or clinical claims • Degree of scientific rigor by developers varies greatly • Some IVDMIAs used for patient testing while still in research phase

Multivariate Guidance FDA guidance draft -In Vitro Diagnostic Multivariate Index Assaysdefines a narrow niche of devices, whether commercially distributed or laboratory developed, that is subject to FDA regulation rather than enforcement discretion

Multivariate Guidance IVDMIAs: • Use clinical data from one or more IVD assays and sometimes demographic data to empirically identify an algorithm AND • Use the algorithm to calculate patient-specific results AND • The result cannot be interpreted by clinicians using prior knowledge of medicine without information from the test developer regarding its clinical performance and effectiveness

Multivariate Guidance IVDMIA Links 3 Components: 1. Analytical measurement 2. A calculation 3. A patient-specific result Physician can’t use the analytical measurement without the algorithm to get a result Likewise, physician can’t use the algorithm without the analytical assay

Multivariate Guidance Examples: • A microarray that predicts colon cancer recurrence based on an RNA expression pattern • An assay that integrates results from several immunoassays to obtain a “score” that predicts a person’s risk of developing Alzheimer’s disease • A test that integrates a patient’s age, gender, and genotype to diagnose cardiovascular disease

IVDMIA Issues Physicians request newest technology unaware of “research” vs. “clinical” testing regulations l Difficult to evaluate the validity of the test l Labs unwilling to share validation data Proprietary nature of test and algorithms Limited or no proficiency testing References cover analysis not algorithm Source of algorithm and establishment of reference interval cannot be independently verified – Tests considered investigational by insurance companies – Lab that develops algorithm claim it is not a test and not subject to CLIA or state regulations – – –

Multivariate Guidance FDA Guidance Document Input: • Public meeting held February 8, 2007 • 31 presentations • Comment period on guidance document closed March 5 comments in review until?

Recent Developments l Pathworks Genomics offers genetic test DTC through Walgreen stores l UC Berkeley offers genetic tests to incoming freshmen class l Stanford offers genetic tests to class of premed students l Expansion of labs and testing

Regulators Response l FDA requests documentation from expanded # of labs l GAO releases results of undercover investigation of 4 genetic companies l CDPH confers with UC Berkeley on genetic testing l European Society of Human Genetics Guidelines

Other Interested Parties l Bioethicists l Privacy Issues l Medical Implications l Organized Groups

Genetic Testing Concerns l Validation of the tests l Clinical Utility l Appropriateness of test l Quality Standards l Qualified personnel l Counseling available

Genetic Testing Concerns l Claims about tests should be transparent l Advertising must be unbiased l Unproven DTC tests hurt public perception l Marketing creates an inappropriate demand l Fate of biological material (electronic)?

California Requirements l Qualified Director l Authorized person orders test l Qualified Personnel l Validation of test l Twice a year verification of test results l Quality Assurance

Summary l IVDMIAs may be the first attempt by the FDA to regulate lab developed, home-brew tests l FDA regulation may ensure the validity of the tests available to clinicians l Future test development may be impacted l ? ? ? -will the FDA allow a grace period for LDTs

Information FDA IVDMIA Guidance http: //www. fda. gov/cdrh/oivd/guidance/1610. pdf FDA IVDMIA Public Forum http: //www. fda. gov/cdrh/oivd/meetings/020807 agen da. html FDA ASR Frequently Asked Questions http: //www. fda. gov/chrh/oivd/guidance/1590. pdf November 21 1997 final FDA ASR Rule http: //www. ashi-hla. org/usefullinksfiles/asrfreg. pdf

Meaningful Use & New Laboratory Reporting Requirements Beatrice O’Keefe, Chief Laboratory Field Services

Background l American Recovery and Reinvestment Act- 2009 HITECT Act −Funds and incentives for electronic health records (EHR) −Includes eligible providers (EP) and hospitals −Minimum requirements using certified EHR technology

Requirements for Federal Dollars l Funding to Eligible Providers and Eligible Hospitals (more than $17 billion nationally) – Eligible means a specified % of the patient panel is Medicare and/or Medicaid – California has approximately 10% of the nation’s labs Dept. of Health Care Services Office of Health IT: http: //www. dhcs. ca. gov/Pages/DHCSOHIT. aspx

Meaningful Use l Three requirements 1) Use certified EHR technology 2) Electronic Exchange of health information 3) Clinical quality measures reported to CMS (or state if Medicaid)

Timelines l Three Stages (years 2011 -2015) −Slow in starting-must move quicker to continue incentive payments −Medicare providers penalized after 2015

Timelines Stage 1 −Health information in coded format −Track clinical conditions −Implement clinical decision support tools −Report quality measures and Public Health info. to govt. entities

Timelines cont. l Stage 2 Heighten quality management Increase structured format for information exchange l Stage 3 Target more systemic health care improvements

Clinical Lab Results in EHRs CMS: EHR Incentive Program Objective: Incorporate clinical lab test results into certified EHR technology as structured data Measure: > 40% of all clinical lab tests results ordered whose results are either in a positive/ negative or numerical format are incorporated in certified EHR technology as structured data

Stage 1 EHR Standards and Certification Final Rule Text: (1) Receive results. Electronically receive clinical laboratory test results in a structured format and display such results in human readable format. (2) Display test report information. Electronically display all the information for a test report specified at 42 CFR 493. 1291(c)(1) through (7). (3) Incorporate results. Electronically attribute, associate, or link a laboratory test result to a laboratory order or patient record.

42 CFR 493. 1291(c)(1) through (7) (c) The test report must indicate the following: (1) For positive patient identification, either the patient’s name and identification number, or a unique patient identifier and identification number. (2) The name and address of the laboratory location where the test was performed. (3) The test report date. (4) The test performed. (5) Specimen source, when appropriate. (6) The test result and, if applicable, the units of measurement or interpretation, or both. (7) Any information regarding the condition and disposition of specimens that do not meet the laboratory’s criteria for acceptability.

Engage patients and families CMS: EHR Incentive Program Objective: Provide patients with timely electronic access to their health information (including lab results, problem list, medication lists, medication allergies) within four business days of the information being available to the Eligible Provider (EP) Measure: > 10% of all unique patients seen by EP are provided timely electronic access to their health information subject to the EP’s discretion to withhold certain information

Stage 1 EHR Standards and Certification Final Rule Text: Timely access. Enable a user to provide patients with online access to their clinical information, including, at a minimum, lab test results, problem list, medication list, and medication allergy list.

Four Public Health Objectives CMS: EHR Incentive Program l Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach. l Capability to submit electronic data to immunization registries of Immunization Information Systems and actual submission in accordance with applicable law and practice. l Capability to submit electronic data on reportable (as required by state or local law) lab results to public health agencies and actual submission in accordance with applicable law and practice. l Capability to submit electronic syndromic surveillance data to public health agencies and actual transmission according to applicable law and practice.

Electronic Data on Reportable Lab Results CMS: EHR Incentive Program Objective: Capability to submit electronic data on reportable lab results to public health agencies and actual submission in accordance with applicable law and practice. Measure: Performed at least one test of certified EHR technology's capacity to submit electronic data on reportable lab results to public health agencies and follow-up submission if the test is successful

Stage 1 EHR Standards and Certification Final Rule Text: Reportable lab results. Electronically record, modify, retrieve, and submit reportable clinical lab results in accordance with the standard (and applicable implementation specifications) specified in rule: HL 7 Version 2. 5. 1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm); and At a minimum, the version of the standard specified in rule: Logical Observation Identifiers Names and Codes (LOINC®) version 2. 27, when such codes were received within an electronic transaction from a laboratory.

Notable Differences Between Medicare & Medicaid From CMS Presentation dated July 19, 2010

e. Health Coordinating Committee l Includes representatives from all aspects of the California e. Health Landscape in CA l http: //www. ehealth. ca. gov/e. Health. Partners/tabid/124/Default. aspx

California e. Health Updates l Monthly Stakeholder Conference Calls – For schedule link to http: //www. ehealth. ca. gov/ l California e. Health Bulletins – Communicates the status of California's e. Health initiatives, including the development of a strategic plan and preparation for submitting proposals to the Federal government to support Health IT, Exchange and Telehealth programs.

Find out more… California e. Health § Sign up for listserv, bulletins, send comments and questions: ehealth@chhs. ca. gov § Website: www. ehealth. ca. gov § Twitter: http: //Twitter. com/CAe. Health § Operational and strategic plan: http: //www. ehealth. ca. gov/e. Health. Plan/tabid/72/Default. aspx

Find out more…California Partners l Cal e. Connect – the HIE Governance body http: //www. caleconnect. org l Regional Extension Centers – California Health Information Partnership and Services Organization (Cal. HIPSO) http: //www. calhipso. org/ – HITEC-LA http: //www. lacare. org/aboutlacare/hitec-la l California Telehealth Network http: //www. caltelehealth. org/

Thank you!