The Cost of Hysterectomy: The Affordable Care Act and Why MIS is More Relevant Than Ever PAGS Conference Dec 13, 2013 Amanda Nickles Fader, MD Associate Professor and Director, The Kelly Gynecologic Oncology Service Johns Hopkins Hospital Disclosures • Ethicon Endosurgery consultant Research Interests • Minimally invasive surgical innovations • Health care reform and impact on delivery of gynecologic and oncology care MIS Surgeons Celebrity Endorsements/Commandments “Laparotomy is a sin!” “Robotic surgery makes me feel young again!” -Ted Lee, MD; MIS fellowship director, Magee-Womens Hospital -Tommaso Falcone, MD Chairman, CCF Let’s Talk Money • Discussion on costs of anything is not sexy • But it’s practical and very relevant to our survival as surgical speciality • In an evolving health care landscape with increasing scrutiny on medical practices, are your surgical preferences supported by the literature in terms of outcomes/costs/patient satisfaction? At a cross roads… The Best of Times and the Worst of Times… • Era of surgical innovation • Rapidly rising health care costs • Gadgets and technology options in the operating room abound! • Evolving performance metrics • More surgical choices for patients • Reimbursement models changing Objectives • Discuss how the Affordable Care Act will impact our approach to gynecologic surgery • Define patient satisfaction, quality, cost and value with respect to hysterectomy surgery • Review current U.S. hysterectomy trends • Review the cost-effectiveness of various hysterectomy types and less invasive options Patient Protectection and Affordable Care Act 2013 • The most significant regulatory overhaul of the U.S. healthcare system since the passage of Medicare and Medicaid in 1965 • Goals: increasing quality/affordability of health insurance, lowering the uninsured rate, and reducing healthcare costs • Delivery Reforms – Accountable care organizations – global capitated payment to care organization with primary care, specialty care and hospital care. – Meant to reward for quality (overall outcomes AND patient satisfaction) ACA Continued • Payment Reforms – Episode based payments for hospital based surgery and other episodes of care – Value-based purchasing - payment dependent upon metric performance – Pay for performance – payment incentives for specific metric performance ACA and the Current U.S. Health Care Economy • In a health care economy with limited resources, providers and consumers of health care services need to be accountable for the end result and the cost of care • Measurement of benefits and costs is challenging What Does this Mean for the Gynecology Surgeon? Downsides – Reduced payments for hospital-acquired infections and other complications Upsides – Payment incentives for increased outcome quality – Payment incentives for high patient satisfaction scores – Move towards single payment for management – Standardization of health of disease care delivery may improve overall outcomes – Lower volume surgeons may be at risk – High volume surgeons likely to benefit Balancing Quality and Cost with Hysterectomy • Huge requirement for savings in the health system + • Limited budget available for health care + • Increased demand to be clinically excellent have led to the need to evaluate cost and effectiveness of treatments • Introduction of new technology for hysterectomy as well as the push for shorter hospital stays – New data are needed to estimate the most cost-effective method of hysterectomy Defining the Terms • • • • Quality Patient Satisfaction Cost Value Patient Satisfaction = Quality? Quality • An emerging health care policy issue • Classic clinical measures of quality are clinical outcome and avoidance of complications • Institute of Medicine: “The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” • Centers for Medicare & Medicaid Services (CMS), hospitals, and insurance providers striving to better define and measure quality of health care (QoHC) What are typical quality measures for hysterectomy? • Surgical site infection • 30-day perioperative complications • Readmissions • Survival • Guideline-adherent care Quality Measures • These metrics do not: 1). Adequately reflect the overall patient’s health care experience or 2). The impact of the intervention (ie hysterectomy on health-related quality of life, including the disease-specific outcome (ie successful relief of pain, bleeding or treatment of cancer) IOM Recommendations • Dramatically improved information technology infrastructure • Patient safety initiatives • Reform medical education: developed the concept of “the core competencies” An Early View on the Merits of MIS and Patient Satisfaction • “The cleaner and gentler the act of operation, the less pain the patient suffers, the smoother and quicker the convalescence, the more exquisite her healed wound, the happier her memory of the whole incident.” -Lord Moynihan, MD; 1917 Famed Bristish Surgeon President, Royal College of Surgeons Patient Satisfaction • Patient satisfaction a key determinant of QoHC and component of pay-for-performance metrics • CMS Hospital Inpatient Value-Based Purchasing (HIVBP) program, Medicare reimbursements linked to patient satisfaction and surveys completed by patients • 2013: CMS will make value-based incentive payments to acute care hospitals based, on results of patient satisfaction surveys completed • Critical that gynecologic surgeons better understand this vital and complex issue Patient Satisfaction Continued • Multifaceted and a challenging outcome to define • Patient expectations of care, attitudes and psychosocial factors contribute to satisfaction – Pain, depression • Surgeons focused on surgical technique and objective outcomes as measures of “patient satisfaction” • Patients place great value on the surgeon-patient interaction Why Does This Matter? • CMS uses Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey to assess patient satisfaction in Medicare patients after an inpatient hospitalization • First national, standardized, and publicly reported survey of patients’ perspectives of hospital care How Do We Define Cost in Surgery ? • Measuring cost of care is complex • Encompasses direct costs of treatment • May include indirect societal costs • What about costs to the surgeon? What Impacts Costs/Reimbursement? • Complexity of the procedure • Surgeon skill set and learning curve • Length of procedure and patient comorbidities • Utilization of PAs, cosurgeons versus residents/fellows as assistants • Turn over times and OR efficiency • Payor mix • Choice of tools/equipment • Insurance carriers and negotation of rates negotiated reimbursement rates Direct vs. Indirect Costs Direct Costs of Care • Hysterectomy type • Cost of instrumentation /technology • Anesthesia time • Pathology consult • OR time/staffing • Surgeon or consultant fees • Length of Stay • Intraop complications or unexpected consults Indirect/Downstream Costs • Time away from work or family role • Loss of productivity • Cost of caretakers • Impairment of QoL • Long-term effects of treatment/complications • Cost to the surgeon (fatigue, back/neck injury) What is Value? • Value proposition in health care • An analysis of the benefits of care relative to the direct cost and risk of providing the care What is Value? • Excellent outcomes • Low morbidity rates = HIGH VALUE! • Happy Patients • Care at low cost Value of a Surgical Procedure • Many ways to measure value of a procedure • Current process measures such as blood loss, time of operation, rate of PE/DVT, visceral injury and SSI, readmission to hospital and “take back surgery” • Some are collecting disease-specific and generic health outcome measures from which utility scores can be calculated Value Depends on Perspective: Patient • Easy access, rapid communication, a clean and efficient office, short wait times, pleasant staff • Sometime process is even more important than quality outcome because difficult for patient to evaluate differences in outcomes • Cost often not an important factor in the eyes of the patient unless a direct out-of-pocket payment Value Depends on Perspective: Hospitals • Hospitals and facilities providing care may measure outcome and costs by factors that affect their short-term, single admission interaction, including: – LOS – Health care services utilization – Complications • Most studies on hysterectomy costs only examine inpatient or short-term outcomes Value Depends on Perspective: Payor • Want to increase enrollment which means customers must be happy with both the process and outcome, cost is most critical • May focus on a timeframe that is longer that a single admission, and may include: – Readmission within 90 days, or cost of outpatient care. • So…if cost is higher there has to be benefit Hysterectomy Trends • The most common gynecologic surgical procedure performed in the United States • One of the most common performed worldwide • Accounts for over $5 billion health care dollars Percentage of U.S. Women Undergoing Hysterectomy 20% Age 40 33% 65 43% 85 U.S. Hysterectomy Rates by Year Wright JD, Obstet Gynecol, Aug 2013 Most Hysterectomies Benign • 9/10 hysterectomies are performed for noncancerous conditions • Usually not life threatening GYN problem, but may have a negative impact on quality of life • New, improved alternatives are increasingly employed and are responsible for the fall in the rate of hysterectomies performed in the last decade Benign Hysterectomy Trends 80% 60% 40% 20% 10% Hysterectomies for Malignancy • Life threatening • 70% for endometrial cancer • 20% ovarian cancer • 10% ovarian cancer • Always medically indicated to perform surgery Oncology Hysterectomy Trends 100% 80% 60% 40% 20% When Is It Reasonable to Consider Hysterectomy? • When less invasive interventions are: – Unsuccessful – Not tolerated – Unacceptable to the patient or felt by physician to be inappropriate for the treatment of the clinical condition – A gynecologic malignancy is diagnosed Evaluating the necessity of hysterectomy • 497 women who had benign hyst between 1993-1995 in So. California • Appropriateness assessed using two sets of criteria – RAND/UCLA appropriateness method – ACOG criteria sets for hysterectomies • Most common indications were fibroids (60%), pelvic relaxation (11%), pain (9%), and bleeding (8%) • 70% of the hysterectomies did not meet appropriateness criteria recommended by the expert panel and 76% by ACOG criteria hysterectomy Hysterectomy Route…Now What? • The route chosen depends upon: – The woman's clinical circumstances – The surgeon's technical expertise and training background – The surgeon's personal preference – Availability of surgical tools/technology AAGL Position Statement “It is the position of the AAGL that most hysterectomies for benign disease should be performed either vaginally or laparoscopically and that continued efforts should be taken to facilitate these approaches.” “ Surgeons without the requisite training and skills required for the safe performance of VH or LH should enlist the aid of colleagues who do or should refer patients requiring hysterectomy to such individuals for their surgical care.” SLS Society Position Statements • “Given advantages that VH and LH offer to women, their families, their employers, and the health care system in general, it seems desirable to optimize their application in women requiring hysterectomy because of benign uterine conditions” • “Abdominal hysterectomy should be reserved for the minority of women for whom a laparoscopic, robotic or vaginal approach is not appropriate” The Laparotomy Problem • Professional organizations and research institutes have issued guidelines in support of minimally invasive procedures – Vaginal and laparoscopic hysterectomy in particular, when choosing the method of hysterectomy • Despite these recommendations and evidence of superior health and economic outcomes, most hysterectomies continue to be performed via laparotomy Why? • Women's health organizations recommend avoiding laparotomy, and advise abdominal hysterectomy (AH) only when the vaginal or laparoscopic route is not possible or ruled out • We must ask ourselves why practice tends to go against this consensus • Why are so many hysterectomies still performed by laparotomy when the majority of choles and appendectomies are performed via MIS? Difficult Issue • If not trained in residency/fellowship, difficult (and costly) to adopt new practices • No incentivization for referral to the more experienced MIS surgeon Abdominal Hysterectomy • AH is not currently contraindicated • Sufficient surgical resources that demonstrate superiority for it to be relegated to the end of the list of options • Scientific evidence favors VH and laparoscopic hysterectomy (LH) – Lower complication rates, produce less postoperative pain and shorter hospital stays, improved QoL, and allow a more rapid return to normal activity Vaginal Hysterectomy and Costs Savings • Society of Pelvic Reconstructive Surgeons estimate a potential saving of US $1,184,000 for every 1000 hysterectomies performed via the vaginal route • Reduction in complications of 20% • Subsequential indirect economical benefits (e.g., hospital stay and early work incorporation).. Vaginal Hysterectomy • Offers great access to the uterus • Fulfills criteria MIS (natural orifice) • The vagina is the most cost-effective “trocar portsite” permitting uterine manipulation, pelvic dissection and easy removal of the specimen • Multiple previous C-sections, abdominopelvic surgeries or with precancerous/cancerous pathology EVALuate Trial • Two parallel randomized trials – One comparing LH with AH – The other comparing LH with VH • 1346 women had surgery, 950 followed up at one year • Higher complication rate and longer OR time in LH arm vs. AH, but better QoL at 6 weeks, faster recovery and shorter hospital stays in LH arm • No differences in VH study, longer OR times in LH arm Garry R, Brit Med J, 2004 Cost Effectiveness of LH vs AH vs. VH •LH more costly than AH hysterectomy, though additional costs are lower in comparison with AH than with VH •The LH has a small beneficial effect in terms of quality adjusted life years (QALYs) •LH not cost effective relative to VH •May be cost effectiveness compared with AH, especially if disposables used Schulfer et al, Brit Med J, 2004 Evaluate Trial: An Unrealistic trial population? • Majority of hysterectomies 12 week size or less • Mean BMI: 26 • Mean number of Ceserean sections: 0 • Mean uterine size: 6 weeks • No information on how many more AH or VH versus LH surgeries surgeons had performed Cost of Vaginal, Abdominal, Robotic and Laparoscopic • In 2009, 688 patients underwent a benign hysterectomy • 185 (26.9%) hysterectomies were abdominal, 135 (19.6%) vaginal, 352 (51.5%) laparoscopic, and 14 (2.0%) robotic. • The rate of intraoperative complication was 1.7% for abdominal, 0.8% for vaginal, 0.3% for laparoscopic, and 0 for robotic. Wright, Einnarson, JSLS 2013 Cost Study • Mean total patient costs were $43,622 for abdominal, $31,934 for vaginal, $38,312 for laparoscopic, and $49,526 for robotic hysterectomies. • Costs were significantly influenced by method of hysterectomy, operative time, and length of stay Laparoscopic Hyst Costs • Disposable vs. • FRED or anti-FOG = $40 undisposable trocars – 3-4 disposable trocars • Carter-Thomason = $100-160 Device = $150 • Uterine manipulator--$88100 • Skin glue = $30 • Multifunctional instrument (Ligasure, Harmonic) = $350-500 • Sutures = $15 • Morcellator = $150-300 x1-3 • Endostich device = $150 Grand total = >$1200 Laparoscopic Hyst: Cost Saving Measures • Consider non-disposable trocars • Consider bipolar, PK and monopolar energy • Can shave $500-600 off costs • Alternatively, some technology may help • EEA sizer or sponge stick decrease OR costs by decreasing OR time • Morcellate manually • Suture with needle drivers Robotic Hysterectomy: Costs Compared to Open Historic Cohort N=160 da Vinci Cohort N=180 p-value $6,623 $2,658 <.001 237 2,977 <.001 Without amortization 10,368 7,644 <.001 With amortization 10,368 8,370 .002 Hospital accommodations OR Costs Overall Costs* Data from: Lau S, Outcomes and Cost Comparisons After Introducing a Robotics Program for Endometrial Cancer Surgery. Obstetrics & Gynecology. 2012 April; vol 119(4):717-724. Adoption of MIS: Evidence from Brigham and Women’s Hospital Total Mean Cost 2006 2009 % Difference P Composite Cost 11,812 ±8,510 12,296 ±6,606 4.1 0.142 Abdominal Hysterectomy 13,347 ±9,855 12,678 ±7,471 -5.0 <0.147 Laparoscopic Hysterectomy 9,288 ±4,050 12,329 ±6,317 32.7 <0.001 Vaginal Hysterectomy 7,693 ±2,378 11,820 ±6,000 53.7 <0.001 Robotic Hysterectomy 16,004 ±2,397 11,004 ±4,208 -31.2 <0.001 High volume surgery matters!! Surgeons appear to be more efficient and costs go down w/ increasing cases and further along learning curve GM Jonsdottir et al. Increasing minimally invasive hysterectomy: effect on cost and complications Obstet Gynecol. 2011 May;117(5):1142-9 Robotic Conventional vs. Single Site Costs Instrument dV Single-Site Cost Estimate dV Multi-Port Cost Estimate Monopolar Hook/ Scissors $140 $320 Bipolar Maryland or PK® Dissecting Forceps $270 $270 Needle Driver $130 $220 Single-Site Port $150 --- Seals & MCS Tip Cover $72 $70 Trocars (reusable) $0 $50 Drapes $200 $200 Total $962 $1,130 Johns Hopkins Reimbursement Model Vaginal LSC Total 52 81 174 169 Mean LOS 1.2 1.4 1.3 3.5 0.01 $5900 $7600 $8700 $20,020 0.01 Total Costs $13,050 $14,700 $15,081 $33,800 0.01 Net Margin $5613 $4990 $5591 $6,091 0.05 OR Costs Robotic ABD P value 65% MIS Simple hysterectomies (uteri <14 weeks, <2-3 pelvic surgeries, Benign disease = VH or LH Difficult or malignant/radical hysterectomies (cervix CA, Stage IV endometriosis = robotic or AH Robotic Hidden Costs • Most robotic studies do not incorporate the expensive capitol and maintenance costs of the robot: • $2.5 million cost (does not include Firefly, Single Site etc) • $110,000/yearly maintenance and instrument costs Succesful Robotic Programs • Very high volume • 3-5 cases/robot day • Difficult cases mix • Oncology, endo, myomectomy, prostatectomy, cardiac surgery Critical Appraisal of the Hysterectomy CostEffectiveness Literature • No consistent methodology for measuring costs • Most studies did not look at downstream costs (readmissions, longterm patient outcomes, cost of complications) Assessing Trends in Hyst Training Preparedness of Hyst Training Residency Program Director Trainee Vaginal 38.1% 27.8% Laparoscopic 28.6% 22.2% 0% 2.8% 76.2% 58.3% Robotic Abdominal Burkett et al, Female Pelvic Med Reconstr Surg, 2011 Sep Resident Education • What direction must we take in the future? • Must improve the training of resident doctors in vaginal and laparoscopic surgery. • Vaginal anatomy often taught inadequately • The ability to perform some of the technical aspects of VH, such as opening the anterior and posterior peritoneum should be as routine as opening abdomen layers for a gynecologial surgeon And What About The Surgeon? • Frasniak et al, Am J Obstet Gynecol 2012 – 88% of gyn surgeons report back or neck pain with vaginal or laparoscopic surgery – Needs assessment or “Save the Surgeon” Program desperately needed Controversy with Surgical Trials • Very little information on skill set and experience of the surgeon participants in the trials • Where are they at in their learning curve? • Must be equally skilled in both modalities studied • (ie VH vs. AH or LH vs. RA-LH etc) • Argue that only high volume, experienced surgeons should be allowed to enroll patients The Impact on Surgical Innovation • How do we innovate in an era of high health care costs and reform? • Innovation allows for clinical progress but expensive • Surgeon learning curves with new technology • More support from industry and simulation Health Care Policy Changes • Hysterectomy policy requires a change • How much money could be saved if standard guidelines were followed? • Essential to explore all the medical tools available to treat uterine disease in order to offer our patients more conservative treatments or MIS options Hysterectomy CostEffectiveness Summary • There is no clear cut answer for every type of patient re: the perfect choice in hysterectomy – Related to patient, surgeon, hospital and disease-related factors • For MOST (likely ≥80%), open abdominal disease is NOT the right answer Hysterectomy CostEffectiveness Summary • Vaginal hysterectomy the safest route and has the best cost–effectiveness ratio, making it the first-choice option in clinical practice – 14 week size or less – Benign disease – No history of advanced endometriosis/frozen pelvis – No adnexal masses – **Refer to high volume vaginal surgeon if you are not comfortable Hysterectomy CostEffectiveness Summary • LH cost effective in the following indications compared with AH: – – – – Risk-reducing hysterectomy +/- BSO Adnexal masses Endometriosis Very large uteri • RA-LH potentially cost effective in high volume centers when used for the following indications compared w/ AH or LH – Cancer staging – Radical hysterectomy (cervix, uterine or stage IV endometriosis – Myomectomy Another Look at the ACA… • Quality • Patient Satisfaction • Costs • Value • How do we pull this all together and consider: – Patient value perceptions/goals – Hospital financial goals – Third-party payor goals – Surgeon preferences and goals GYN Program Goals • 75% or higher MIS hysterectomy rate • Develop departmental policies regarding appropriateness for VH, LH, RA-LH and AH – Similar to • Monitor patient satisfaction scores and measure short and longterm objective measures (surgical outcomes, complication rates) • Develop skill in at least one MIS option, but versatility within a practice or individual surgeon key How do we solve the problem of volume? • Not enough hysterectomies for all GYNs to be high volume surgeons (defined as n=~25/year) • Designate 1-2 individuals in a practice to perform all hysterectomies – Incentive referral to high volume surgeons • “Teach the teachers” program at Hopkins—low volume surgeons have opportunity to learn from and operate with a high volume surgeon • Separate the O from the G in residency training An Argument for Surgical Versatility • Use of technology in medicine has historically outpaced the availability of data to support rapid adoption – Market forces may influence consumers, physicians and health care organizations • Are controlled data available to justify widespread adoption of a technology? • Are claims of clinical superiority sound? • Is health care resource utilization being optimized? Conclusions • In 1996 Stovall and Summitt concluded: “well designed clinical trials examining short term outcomes, economics, and quality of life were required to determine the role of laparoscopic hysterectomy” • Still need more than ever • Need gynecology surgeons as stakeholders at the table to help define quality indicators for straightforward vs. medically/surgically complex patients The Bottom Line • Must merge good old fashioned customer service with surgical innovation and new thinking • High volume surgeons have better outcomes..but are they more likely to provide quality outcomes at lower costs? Acknowledgments
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