Quality, Performance Measures, and Practice Guidelines: What Technology Manufacturers Should Know

1. Quality, Performance Measures, and Practice Guidelines: What Technology Manufacturers Should Know Beth Kosiak, Ph.D. Associate Executive Director, Health Policy American Urological Association

2. Overview • Quality—the big picture • Performance measures • Guidelines • CMS and performance measures • What all of this means to device companies

3. What is Quality? • IOM: the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge • AHRQ: doing the right thing, at the right time in the right way, for the right person with the best possible results

4. What is Quality? • Striking the right balance in the provision of health services, by avoiding overuse (e.g., getting unnecessary tests, too many hysterectomies), underuse (e.g., not being screened for high blood pressure, low rates of hip replacement among Hispanics) and misuse (e.g., being prescribed drugs that have dangerous interactions, adverse events)

5. Why Focus on it? • US healthcare spending continues to rise at a rate many consider unacceptable (16% of GDP in 2004) • The United States continues to have the highest per capita health care spending among industrialized countries (OECD) • But international quality data places the U.S. in the bottom quartile of industrialized countries (OECD)

6. Why Focus on it? • Unexplained geographic variation in healthcare practices (Wennberg) • IOM 2001 Crossing the Quality Chasm—thegap between care we could have and care we actually get is a chasm • Most recent Medicare information shows that cost and quality vary independently of one another—high cost does not equal high quality • Disparities in healthcare exist across regions and racial and ethnic groups (AHRQ Congressionally-mandated annual reports on National Healthcare Disparities & National Healthcare Quality)

7. Why Focus on it? McGlynn, et. al. 2003 Doctors provide appropriate health care only about half the time Alcohol Dependence 11% Hip Fracture 23% Peptic Ulcer 33% Diabetes 45% Low back pain 69% Prenatal care 73% Breast Cancer 76% Cataracts 79%

8. Percent Of Recommended Care Received“The Quality of Health Care Delivered to Adults in the United States” NEJM, June 26, 2003

9. The Big Picture • High cost • Unexplained variation in care • Higher cost not associated with higher quality

10. What is a Performance Measure? • Some number or rating that enables you to monitor and track performance over time • Numerator/Denominator • Denominator—the entire population of interest (Medicare beneficiaries) • Numerator—those who received the care/process; those who have the outcome (got a flu shot)

11. What is a Performance Measure? Example: DVT Prophylaxis for patient undergoing major urologic surgery • Numerator=Patients who received DVT prophylaxis • Denominator=everyone who underwent applicable surgeries (complete cystectomy (51590); retropubic radical prostatectomy (55845); radical nephrectomy (50230))

12. What is the Purpose of Measurement? • Establish clear baseline • Monitor performance over time • Internal quality improvement • Accountability • Information for choice (purchasers, consumers, general public)

13. Types of Measures • Structure—capacity/ability to do certain things, provide services (number of hospital beds, nursing staff/patient ratio, Board certification, EMR system, facility accreditation, surgical volume) • Process---a certain procedure or service provided (Mammogram performed, flu shot given, patient told treatment options, foot exam performed, beta blocker given after heart attack, script written)

14. Types of Measures • Outcome: What happened? What was the result of the procedure or treatment course? Did the patient avoid hospitalization or re-hospitalization? Go into remission? Live longer than those who did not get the service? Experience fewer side effects? (mortality rate, re-hospitalization rate, patient quality of life)

15. Types of Measures • Patient experience of care—quality from the patients’ perspective (Consumer Assessments of Health Providers and Systems (CAHPS) survey) • Surveys are based on the latest science and have been thoroughly tested and include the following areas: • Health plans • Hospitals • Nursing homes • Dialysis facilities • Individual clinician survey

16. Types of Measures • Efficiency – when a given level of output (quality of care) is achieved at the lowest total cost • Cost of Care measure – ratio of actual resource use to expected resource use, given equivalent high quality of care • Comparative Effectiveness measures -Measures compare both clinical and cost effectiveness of medical procedures and services

17. What is a Guideline? • Systematically developed statements to guide practitioners and patient decisions about appropriate health care for specific circumstances. (Floyd and Lohr, 1990) • The content of a guideline is based on a systematic review of clinical evidence - the main source for evidence-based care

18. What is a Guideline? • Contains systematically developed recommendations, strategies, or other information to assist health care decision making in specific clinical circumstances. • Produced under the auspices of a relevant professional organization (e.g., medical specialty society, government agency, health care organization, or health plan). • Included a verifiable, systematic literature search and review of existing evidence published in peer-reviewed journals.

19. What is the Purpose of a Guideline? • To describe appropriate care based on the best available scientific evidence and broad consensus; • To reduce inappropriate variation in practice; • To provide a more rational basis for referral; • To provide a focus for continuing education; • To promote efficient use of resources; • To act as focus for quality control, including audit; • To highlight shortcomings of existing literature and suggest appropriate future research.

20. Guidelines and Measures • Guidelines provide the evidence base for development of a performance measure

21. How are Guidelines and Measures Different? • Guideline establishes the standard of care—what is the best care you should provide (ceiling) • Guideline provides compilation of latest science and how it affects practice--gives guidance to practitioner and to patient • Measure establishes the baseline for care—what is the care everyone should get? (floor) • Measure is for monitoring by others to show them how you do (grade). Rewards based on results

22. Background—Performance Measurement • Late 80s—purchasers move to managed care to save money in face of rising healthcare costs • Healthy, employed population—focus on preventive care • Enrolled population—allowed for consistent data collection and plan accountability

23. Background—Performance Measurement • Major employers (GTE, Digital) create HEDIS measures and NCQA • Wanted value—quality/cost

24. CMS and Performance Measurement • In 1998, HCFA mandated HEDIS and CAHPS patient survey data from all Medicare managed care plans • Provision of comparative information to support market model of health care, by fostering consumer and purchaser choice

25. CMS and Performance Measures • CMS continued development of quality measures with hospitals, nursing homes, home health, and dialysis facilities • CMS, states, and private purchasers mandated public reporting at the individual facility/hospital/plan level

26. CMS and Performance Measures • Health Plans—HEDIS and CAHPS, 1998 • Dialysis Facilities—2001 • Nursing Homes---2002 • Home Health Agencies—2003 • Hospitals—2005 • Physicians—2008??

27. From Public Reporting to Pay for Performance • Public reporting not enough to shift market—need to align provider incentives to encourage change • Shift from pay for service to payment for performance • Hundreds of pay for performance initiatives across the country • Don’t yet have much evidence that they work

28. Relevance to Medical Device Industry--Guidelines • CPT and HCPCS codes enable payment for devices (FDA approval, performed in multiple locations, clinical efficacy documented, in use by healthcare professionals) • However, level of evidence needed for code approval does not necessarily correspond to level of evidence needed for inclusion guideline • Thus, procedure may be currently be paid for and in use, but not included in guideline because peer reviewed evidence may not be sufficient to justify it

29. Relevance to Medical Device Industry--Guidelines • Payers are becoming more aggressive, looking for justification of continued payment in guidelines • Have denied payment for procedures because not in referenced in guideline • Thus, you should have active interest in getting independent research conducted on procedures that include your class of product

30. Relevance to Medical Device Industry—Performance Measures • Guidelines are the foundation of measures; therefore, measures include codes for procedures included in guidelines • CMS and other payers are beginning to focus on payment for those who achieve high scores (relative or absolute) on certain measures • Therefore, the payment focus will be on procedures included in those codes—ideally you have a device in those codes

31. Relevance to Medical Device Industry—Performance Measures • P4P is supposed to help foster value based purchasing: value=quality/cost • Interest is beginning to focus on high quality for the lowest cost • Therefore, assuming equal effectiveness of devices, the cost of your device if you have one that corresponds to a procedure included in a performance measure will be increasingly important • Comparative effectiveness measures

32. Relevance to Medical Device Industry--Gainsharing • CMS demonstration on gainsharing (DRA of 2005 Section 5007 Medicare Hospital Gainsharing Demonstration) • January 1, 2007-December 31, 2009 • This demonstration will examine the effects of gainsharing aimed at improving the quality of care in hospitals. It will determine if gainsharing is an effective means of aligning financial incentives to enhance quality and efficiency of care. •  CMS funding 6 projects that propose multiple approaches to achieving savings that occur during the in-patient stay and immediately after discharge

33. CMS—Emphasizing Evidence • Medicare Coverage Advisory Committee is now the Medicare Evidence Development and Coverage Advisory Committee—data collection as condition of coverage, even after initial marketing • MEDCAC--Unbiased deliberation of current state of the art technology and science

34. What You Can Do • Jointly fund research fund projects with reputable institutions • Let us know that you are doing this and if our doctors are involved • Understand that you’ll be needing more post market evidence

35. Questions? Comments? • Bkosiak@auanet.org • 410-689-3703 THANK YOU!!