Regulations and Legislation: FDA, LDT, CPT & Other Things You Should Know!

Transcription

1 Regulations and Legislation: FDA, LDT, CPT & Other Things You Should Know! Mike Hiltunen, MBA, MT (ASCP) Executive Director GreatLakes Laboratory Network Objective To provide an update to keep you aware of some of the upcoming regulatory topics related to CPT codes and the LDT legislation from the FDA. There are a lot of acronyms used in laboratory regulations, so we will briefly go over a few of them and provide an update. 1

2 CPT - Current Procedural Terminology CPT codes are 5-digit medical codes that are maintained and trademarked by the American Medical Association (AMA). There are three categories of CPT codes I, II and III to differentiate between the descriptions, medical services and procedures used across the country. The most widely accepted medical nomenclature used to report medical procedures and services under public and private health insurance programs. CPT offers a way to streamline the process for coding medical services and is in its fourth edition. CPT - Current Procedural Terminology In addition to being the source for CPT codes and related coding, the AMA provides current, authoritative information based on the Healthcare Common Procedure Coding System (HCPCS) as well as the International Classification of Diseases, Ninth Revision, Clinical Modifications (ICD-9- CM). 2

3 Healthcare Common Procedure Coding System (HCPCS) (HCPCS) was established in 1978 to provide a standardized coding system for describing the specific items and services provided in the delivery of health care. Such coding is necessary for Medicare, Medicaid, and other health insurance programs to ensure that insurance claims are processed in an orderly and consistent manner. International Classification of Diseases, Ninth Revision, Clinical Modifications (ICD-9-CM). The International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) is based on the World Health Organization's Ninth Revision, International Classification of Diseases (ICD-9). ICD-9-CM is the official system of assigning codes to diagnoses and procedures associated with hospital utilization in the United States. 3

4 ICD-10-CM The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) is based on the World Health Organization's Tenth Revision, International Classification of Diseases (ICD-9). ICD-10 Code Set to Replace ICD-9 as of October 1, 2015 The latest compliance date for ICD-10 has been set as October 1, 2015, according to new regulation published by the Department of Health and Human Services (HHS) on August 4, This one-year delay in the implementation of ICD-10 came from language inserted into the Protecting Access to Medicare Act of 2014 (PAMA), which was signed into law on April 1, ICD-10-CM The transition to ICD-10 is occurring because ICD-9 produces limited data about patients medical conditions and hospital inpatient procedures. ICD-9 is 30 years old, has outdated terms, and is inconsistent with current medical practice. Also, the structure of ICD-9 limits the number of new codes that can be created, and many ICD-9 categories are full. 4

5 ICD-10-CM ICD-11-CM The WHO is already working on the ICD-11 codes and expects to submit them to the WHO World Health Assembly (WHA) for official endorsement by The ICD-11 will further define each disease with definitions that give key descriptions and guidance on the meaning of each category, which is an advancement of the ICD-10 that only gives the title headings. 5

6 Protecting Access to Medicare Act of 2014 (PAMA) Changes the way that the Clinical Laboratory Fee Schedule (CLFS) prices will be set. Certain labs will be required, beginning on January 1, 2016, to report private payer payment rates and volumes for each of their tests. Private payers included health plans, Medicare Advantage plans and Medicaid managed care organizations. Shall not include information with respect to a laboratory test for which payment is made on a capitated basis or other similar payment basis. This market data will be used to calculate new rates for the CLFS effective January 1, Protecting Access to Medicare Act of 2014 (PAMA) Reductions to payment rates resulting from the new methodology are limited to: 10% in % in % in % in % in % in

7 Laboratory Developed Tests (LDT) A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect analytes such as proteins, chemicals, hormones, peptides, steroids, DNA, etc. in a sample taken from the human body. Some LDTs are simple, such as a sodium test; others may be more complex, such as DNA testing to detect a genetic disease. The FDA currently has oversight of LDT's and a public discussion has been ongoing for 20 years. The FDA issued a draft guidance in 2006 with subsequent public meetings in Laboratory Developed Tests (LDT) Since the FDA has identified some problems with high-risk LDT s where medical claims have not been adequately supported with evidence, the FDA is concerned that people may initiate treatment or forego treatment if a test does not accurately diagnose the condition. Most recently the FDA notified congress on July 31,2014 of its intent to issue a draft guideline entitled Framework for Regulatory Oversight of Laboratory Developed Tests. The FDA issued a draft guidance on October 3, The FDA then held a public comment meeting at NIH, on Jan 8-9,

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16 Title Copy Laboratory Developed Tests (LDT) The FDA publishes notices in the Federal Register regarding posted draft guidelines and is currently reviewing the comments from the most recent public meeting and subsequent written comments that were accepted prior to the February 2, 2015 deadline. Watch for the final oversight framework draft guidance in the near future. 16

17 THANK YOU! 17

18 Create Your Roadmap to Success: Utilization Management Tools to Get You Started & Keep You Going Kim Futrell, MT (ASCP) Products Marketing Manager Orchard Software Corporation Objectives Understand the changing terrain of healthcare and the lab s role in the future of healthcare. Learn why proper test utilization is becoming more important as our healthcare system changes. Review how and why tests are misordered. Discuss the important role laboratorians play in better test utilization. Share ideas and tools to help laboratorians create, implement, and sustain a test utilization program. 18

19 How will these changes impact the lab? OUR CHANGING HEALTHCARE ENVIRONMENT Healthcare Reform PPACA PCMHs, ACOs Bundled payment plans MU PAMA Healthcare touches all of us. Work together to make improvements. Where can the lab make positive contributions? 19

20 Healthcare Costs at Nearly 18% of GDP Shift from Volume to Value Triple Aim Goals -Improve Patient Experience -Improve Population Health -Decrease Costs 20

21 The Lab in the New Healthcare Model Healthcare is in the midst of unprecedented change. Labs will no longer be reimbursed for each test performed. Currently in a transition between FFS and value-based environment. Better, Smarter, Healthier Source: HHS.org: U.S. Department of Health & Human Services 21

22 Wrongly Aligned Incentives FFS model Creates an incentive to order more tests and more treatment. Payment is dependent on the quantity of care, rather than the quality of care. Does not support alignment of financial incentives between providers. Lab s Evolution in Healthcare Expand your reach. Increase clinical effectiveness. Contribute to positive patient outcomes. Integrate and collaborate with other departments. 22

23 Lab s Future Role: Greater Impact on Patient Care Support of rapid, accurate diagnosis Maximum efficiency Eliminate waste One of the most effective ways to do this is by monitoring laboratory test utilization. Overriding Goal Accurate Right Test Results Right Cost Cognizant Patient Test Right Utilization Time Plan 23

24 Why Labs are Misordered TEST UTILIZATION Room for Improvement Laboratory testing is healthcare s highest volume activity billion tests/year Increasing awareness: Errors in lab test selection and interpretation can have significant consequences. 24

25 How Providers Use Lab Tests 70-80% of clinical data in the EHR comes from the lab. Data used for: Screening Diagnosis Disease monitoring Two-thirds of results contribute to a change in diagnosis, therapy, prognosis, or understanding of a disease. - Wertman, Bradley G. MD., et. al. Why Do Physicians Order Laboratory Tests? A Study of Laboratory Test Request and Use Patterns. JAMA. 1980; 243(20): Overuse, Underuse, & Misuse Nearly one-third of all lab testing is unnecessary. Approximately, the same number of tests that could potentially be useful are not ordered. Source: Beth Israel Deaconess Medical Center Labs may not be promptly reviewed or not communicated to the patient. 25

26 Costs of Lab Testing Lab portion of healthcare spending is approximately 3%. In overall costs, ordering a few more or less does not make a big difference. However, what happens to the patient downstream based on those results can be expensive (imaging, surgery, hospital stays, etc.). The Big Take Home It s not about ordering more or less tests. It s about ordering the right tests. And in this area there is much room for improvement. And the lab can help! 26

27 Why Lab Tests are Misordered That s the way it s always been done. Pressure from internet-educated patients Why Lab Tests are Misordered 2 Concern over missing something that can lead to litigation - or patient harm Physicians have been taught to leave no stone unturned. 27

28 Other Influential Factors The presentation of test order options influences order selection. Providers are moving at a fastpace. The Role of CPOE Confounded by EHR limitations Provide useful information at the time of order Pop-up (e.g., for duplicate tests) Online decision support 28

29 Providers Uncertain CLIHC survey PCPs uncertain about best test order in 14.7% of cases. Uncertain about interpretation in 8.3% of cases. What this means Approximately 23 million times/year, PCPs are uncertain about the best use of diagnostic tests. 29

30 Overutilization 750 billion spent in U.S. on unnecessary healthcare services IOM Report Costly tests are easy to order in the EHR With no indication of costs Or medical evidence to support use Overutilization 2 Most frequent instance of overuse occurs at the initial patient evaluation. Beth Israel Deaconess Medical Center Study Hospital settings often have inpatient SO: convenient but wasteful Large majority of tests being ordered have no impact on patient care Univ. of CA, SF Medical Center Study 30

31 Underutilization & Preventive Testing Increased >70% of Medicare Lab Testing $$ is are a vital spent component on only of 14% early of patients chronic disease who have that 6 or can more save chronic significant conditions. $$. Underutilization Example MC Beneficiaries with diabetes account Consider for the 32% Hgb of MC A1c spending. costs about $13 Source: Congressional Diabetes Caucus 31

32 Doctors Don t Turn to the Lab for Guidance Providers are aware of deficiencies in test utilization. Yet when searching for guidance, the last place they turn is to the lab. CLIHC Survey Results % of physicians: it is useful to ask the lab for test interpretation 35% guidance % of physicians that were actually able to ask a lab leader 6% for advice 32

33 How to Create, Implement, & Sustain TEST UTILIZATION TOOLKIT What s in Your Toolkit? Provider relationships Utilization report cards Test menu presentation Duplicate test alerts Unnecessary testing combinations 33

34 More Tools Internal variation analysis other data you already collect Test formulary Testing algorithms LIS tools Think Outside of the Black Box CLIHC Physician survey When consulting with radiology or pharmacy, they felt they were consulting with a colleague. When consulting with the laboratory, they felt they were talking to a black box. Using a test utilization plan can improve the laboratory s input into patient care. 34

35 Provide Data & Dialogue Provider collaboration is a must. Create opportunities for an ongoing dialogue. Physicians respond to data. multidimensional interventions most effective UTILIZATION MANAGEMENT TOOLS GENTLE MEDIUM STRONG Posting guidelines on requisition Computerized reminders on utilization guidelines Utilization report cards Changes to manual requisitions or CPOE Utilization report cards with peer or leadership review Privileging Send-outs formulary Requirement for high-level approval (e.g. pathologist, doctoral level consultant, genetic counselor) Rules requirement Solomon, DH, et.al. Techniques to improve physicians use of diagnostic tests: A new conceptual framework. JAMA

36 Test Menu Presentation Test order choice arrangement/presentation Multiple names/acronyms Useful information Cost Usage recommendations Make it Lean! Duplicate Testing Alerts Implement a duplicate testing alert in the EHR at the point of CPOE. Savings at Univ. of Mississippi Medical Center By monitoring 2 tests (CBC, BMP) Same tests ordered within a 4 hr period Saved $146,675 annualized 36

37 Johns Hopkins Bayview Reduces Overuse of Cardiac Tests Grant from ABIM Foundation Project reduced lab tests used to assess acute coronary syndrome Use Troponin alone and no more than three times. More than $1 million saved -LaRochelle, et.al. Journal of Internal Medicine, June 2014 Unnecessary Testing Groups Determine (with your providers) scenarios where it does not make clinical sense to order certain test combinations. Do not need a test until you know results of another Another test has greater diagnostic accuracy Testing only recommended for specific diagnoses 37

38 Unnecessary Testing Groups Internal Variation Analysis Examine your provider ordering patterns. Focus on a specific diagnosis. Compare the amount of variation to costs and patient outcomes. Share this data with providers. Find a physician champion who is willing to be involved. Use this data to develop best practice ordering guidelines. 38

39 Testing Formularies Management of a test menu 39

40 Test Formulary Success at Broward Health Source: LQC; Serrano, Leo, FACHE, DLM (ASCP). Broward Health. Combining Test Formularies, Algorithms, and CPOE to Significantly Reduce Lab Test Utilization. Testing Algorithms Provider orders the cascade, rather than each test. Based on initial results auto-reflexes to the next logical test. Develop in tandem with ordering providers. 40

41 Benefits of Testing Algorithms Eliminates the need for providers to choose from an overwhelming test menu. Ensures that only necessary tests are ordered. Getting the right test done at the right time improves patient care and reduces unnecessary spending. 41

42 Powerful LIS = Crucial Tool Track test utilization/ variation analysis Configure algorithms Provide data analytics for providers & managers 42

43 Lab Test Utilization Resources AACC Utilization.aspx ww.aacc.org/publications/cln/2014/april/pages/psf- Utilization-Management.aspx ARUP dex.jsp 43

44 Lab Test Utilization Resources 2 ASCLS 18/1_Lab%20Test%20Utilization.pdf ASCP/Cleveland Clinic Communications/Strategies-for-Appropriate-Test- Utilization.pdf CAP Lab Test Utilization Resources 3 Choosing Wisely Campaign/ Evidence-based Lab Medicine article Laboratory Medicine Best Practices 44

45 Lab Test Utilization Resources 4 Mayo cripts/2011/11-optimal-util/26.html PLUGS, Seattle Children s Hospital University of Rochester Medical Center labutilization.com/university-of-rochester-lab-formulary/ labutilization.com/ Opportunity to Make a Difference Disruption in healthcare Opportunity for laboratory leaders to refocus efforts Align goals with overriding healthcare reform goals Thrive in a value-based reimbursement model Alleviate downstream costs 45

46 New Paradigm Make the most of limited resources Utilize each member of the healthcare team s input to the top of their skill/ education level Lab professionals Seek out Opportunity 1. Get to know those in your organization who have access to financial data, particularly net revenue and cost accounting figures. 2. Integrate information you have in the laboratory with information obtained from colleagues in other departments. 46

47 Old Paradigm to New Provide Providing utilization high-quality, management, cost-effective clinical effectiveness, and results data integration - Curtis A. Hanson, MD, Mayo Clinic It Won t Be Easy 47

48 Final Words of Wisdom Because laboratory tests play such a crucial and ubiquitous role in medicine, efforts to identify opportunities for improvement in the selection of tests have the potential to contribute greatly to the care patients receive. - William Taylor, MD, BIDMC Questions? THANK YOU! 48