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Restorative Reproductive Medicine During this Era of Healthcare Reform: Opportunities Emerge Paul A. Carpentier, MD, CFCMC Accountable Care Associates,

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Presentation on theme: "Restorative Reproductive Medicine During this Era of Healthcare Reform: Opportunities Emerge Paul A. Carpentier, MD, CFCMC Accountable Care Associates,"— Presentation transcript:

1 Restorative Reproductive Medicine During this Era of Healthcare Reform: Opportunities Emerge Paul A. Carpentier, MD, CFCMC Accountable Care Associates, In His Image Family Medicine, and Consultant to the National Gianna Center for Women’s Health and Fertility Former President of the American Academy of FertilityCare Professionals Gardner, Massachusetts, USA

2 Faculty Disclosure I have no financial conflicts of interest – Dr. Carpentier

3 Objectives Understand key events during the unfolding healthcare reform movement in the U.S. Examine how this could foster the adoption of Restorative Reproductive Medicine (RRM) Learn about the economic structure of ACOs Evaluate potential benefits and pitfalls in fostering restorative reproductive medicine

4 The Massachusetts Test-Kitchen ‘Romney-care’ precedes ‘Obamacare’ By six years

5 Romney-Care Governor Mitt Romney plans for reform, why? – Too expensive – Not much quality for the price – Jeopardizing other state services – Employers crushed by premiums – So many people without coverage – Emergency rooms misused

6 Romney-Care Step one – Give everyone insurance Step two – Figure the rest out later! On someone else’s watch A new legislature – Let the pressures for change mount Further understand the crisis Employers deflect more costs to the employees

7 Result Emergency rooms overrun PCPs still not utilized Still uninsured and now underinsured Hospitals fewer but somewhat stronger – Doctors and hospitals joining forces – Attorney General anxious Employers still not happy Cities cutting services or nearly bankrupt

8 Consequences to name a few Healthcare Policy Commission Established – Autonomous – Appointed by the governor (Patrick) – One task only – to restrain the rate of rise of costs Physician Assisted Suicide narrowly defeated Legislated coverage of infertility services (IVF) – But not for Medicaid population – IVF centers become financially powerful Insurance companies pass more cost to pt – They become stronger but self spending curbed

9 Meanwhile Wise husband and wife* family physicians in western Massachusetts realize that managing care with quality goals saves money and improves outcomes (greater value) They develop IT infrastructure to boil down insurers’ “Big Data” into a usable form right in the doctors’ exam room Two insurers are intrigued and launch pilot studies using their tools and care coordinators * Drs. Philip Gaziano and A. Felicitas Thurmayr, Springfield, MA

10 Amazing Results Improved awareness of the chronic conditions of the complex patients PCPs empowered to deliver better results Much higher quality – First Massachusetts increase in three decades! – The Two insurers were flabbergasted Significantly lower costs – Beyond the benchmarks!

11 Why better results? Chronic diseases were handled with chronic approaches rather than acute care Solutions were sought to better manage these chronic diseases Acute care is expensive and fails for chr. dis. Hospitals are oriented to acute care Chronic diseases are better managed by PCPs This confirms Dr. Stanford’s intuitions last year (IIRRM Presentation)

12 Small Practices are Critical Piece More responsive to their community More flexible Better continuity Every 1% increase in continuity causes 5% increase in quality This is now being recognized Most NaPro physicians are in small practices

13 What does this have to do with RRM? A Light is Ready to Dawn

14 Infertility is a chronic disease! Acute treatments do not serve chr dis well Acute treatments are expensive Pharmaceutical companies remain powerful And now IVF companies are wealthy But Commissions, attorneys general and ACOs are poised to cut cost, power and favor chronic care management for the economic wellbeing of the country

15 Episodes of Care The cost of various options of treatment for an illness can be described as an ‘episode of care’ For example: – A patient with a cough presents to the ER versus CXR, labs, prolonged stay, high utilization, no continuity – A patient with a cough presents to their PCP Well known, minimal care needed, same outcome Quality Cost Value!!!

16 Episode of Care Infertility Treated by IVF vs NaProTECHNOLOGY

17 $12K $1000 $100 0 1 2~ 5 10 15 20 Years Infertility - IVF S M Tr L Tw PB S PB E H IVF Price IVF NICU 2 Babies Infertility - NPT S D S D $12K $1000 $100 Price Paul A. Carpentier, MD, CFCMC, In His Image Family Medicine, PC, 1/26/14

18 = Doctor Evaluation = HSG = Semen analysis = Lab Tests = Ultrasound Pelvis = progesterone support = Monitoring Loss of One Fetus = 2 Premature NICU Stay > Month = Cost of Chronic Illness of Twins = Endometrial Ablation - DUB = Hysterectomy / BSO = FertilityCare Training OCCURENCES S = Single Pregnancy Tr = Triplet Pregnancy L = Loss of one fetus Tw = Twin Pregnancy M = Miscarriage PB = Premature Birth E = Endometrial Ablation H = Hysterectomy D = Normal Delivery Height of Bubble = Cost Width of Bubble = Time Ave time to preg with NPT = 6.4 mos; almost always singleton Paul A. Carpentier, MD, CFCMC, In His Image Family Medicine, PC, 1/26/14 Episode of Care - Key

19 Obamacare Occurs (ACA) National Affordable Care Act Actually a motivation and mechanism to change the macro-system Complicated by the fact that the administration planted their agenda within it – Abortion – Contraception – Protecting pharmaceutical companies

20 Obamacare Occurs (ACA) Fosters the development of Accountable Care Organizations These strive to: – Integrate care – Make physicians liable for the entire cost of their patients’ care – Manage a patient population as well as individuals – Maintain quality while restraining costs

21 The Stage is Set for an enlightened perspective toward infertility management and other gynecological disorders

22 Restorative Reproductive Medicine Gaining Traction!

23 Infertility is a Chronic Disease As are many other Gyn problems They need to be addressed as so – Quality will improve – Outcomes should improve – Costs should be less This will catch the ear of insurers, ACOs and governmental programs Lets glance at a few examples of outcomes

24 New Opportunities in Fallopian Tube Repair: Effective and Economical Alternatives to IVF Cara Buskmiller, MSII; Institute of Bioethics and Patient Care Advancement A great example from a poster session, Catholic Medical Association, 2013:

25 ASRM Changes Their Opinion! In 2012, the American Society for Reproductive Medicine (ASRM) edited their opinion on tubal surgery, prioritizing fallopian tube repair (FTR, a.k.a. tuboplasty, recanalization) over in- vitro fertilization (IVF) for young women with tubal factor infertility. This shift heralds a potential change in mainstream reproductive medicine. This presentation compares the cost and effectiveness of IVF with currently available, ethically undisputed techniques of fallopian tube repair.

26 Detailed Results HYST=hysteroscopic, LAP=laparoscopic, LEC=linear everting catheter, SS=selective salpingography

27 The highest pregnancy rate of all techniques 55% success with laparoscopic- hysteroscopic fallopian tube repair Also competitive were hysteroscopic-only repairs including falloposcopic repair 1.ASRM: The role of tubal reconstructive surgery in the era of assisted reproductive technologies. Fertil Steril 2008;90:S250-3. 2.Update of above, in Fertil Steril 2012;97:539- 45. 3.ASRM online FAQ, Question 6. 4.Health Care Blue Book ( 5.Allahbadia GN, Merchant R: Fallopian tube recanalization: lessons learnt and future challenges. Womens Health. 2010 Jul;6(4):531-48. 6.Anil G et al: Fluoroscopy-guided, transcervical, selective salpingography and fallopian tube recanalisation. J Obstet Gynaecol. 2011 Nov;31(8):746-50. 7.Tanaka, Y, Tajima, H: Falloposcopic tuboplasty as an option for tubal infertility: an alternative to in vitro fertilization. Fertil Steril. 2011 Jan;95(1):441-3. 8.Das S et al: Proximal tubal disease: the place for tubal cannulation. Reprod Biomed Online. 2007 Oct;15(4):383-8.

28 Methods (To answer your questions on the sources of the data, $) “FTR techniques were considered viable IVF alternatives which appeared in literature published since 2004 and which reported intrauterine pregnancy rates of over 20%. These were compared with 2009 CDC data on one cycle of IVF. Estimated costs were based on publicly-available data.” 3, 4 We’ll not discuss this in the interest of time

29 Infertility after Endometriosis Surgery After endometriosis surgery, this study demonstrated better pregnancy rates for spontaneous attempts versus ovarian stimulation/IUI (Summary by Dr. Kyle Beiter, personal communication) J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):101-8. doi: 10.1016/j.jmig.2013.07.009. Epub 2013 Jul 31 SETTING: Cleveland Clinic Foundation, tertiary care center Another Key Example

30 For your reference (not to be reviewed today) J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):101-8. doi: 10.1016/j.jmig.2013.07.009. Epub 2013 Jul 31. J Minim Invasive Gynecol. Determining the fertility benefit of controlled ovarian hyperstimulation with intrauterine insemination after operative laparoscopy in patients with endometriosis. Gandhi AR 1, Carvalho LF 2, Nutter B 3, Falcone T 4. Gandhi ARCarvalho LFNutter BFalcone T Author information 1 Cleveland Clinic, Cleveland, Ohio; Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio. 2 Department of Obstetrics and Gynecology, São Paulo University, São Paulo, Brazil. 3 Cleveland Clinic, Cleveland, Ohio. 4 Cleveland Clinic, Cleveland, Ohio; Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio. Electronic address: Abstract STUDY OBJECTIVE: To determine the fertility benefit of controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI) in surgically treated endometriosis. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2).

31 For your reference (not to be reviewed today) SETTING: Cleveland Clinic Foundation, tertiary care center. PATIENTS: Ninety-six women of reproductive age who underwent operative laparoscopy to treat endometriosis- related infertility (endometriosis stage I/II n = 67; stage III/IV n = 29) from 2001 to 2011 at the Cleveland Clinic Foundation. INTERVENTIONS: COH via letrozole, clomiphene, or gonadotropins, with or without IUI. MEASUREMENTS AND MAIN RESULTS: Kaplan-Meier estimations of cumulative pregnancy rates were compared by stage between COH/IUI and spontaneous cycles. Patients with stage I/II endometriosis attempted spontaneous pregnancy for 669 months and 216 COH + IUI cycles, and patients with stage III/IV endometriosis attempted spontaneous pregnancy for 379 months and 74 COH + IUI cycles. Crude pregnancy rates were 45.7% in stage I/II and 40.5% in stage III/IV. Twelve-month cumulative pregnancy rates in stage I/II were 45% for spontaneous attempts and 42% for COH + IUI, and in stage III/IV were 20% for spontaneous attempts and 10% for COH + IUI (not significant). Cumulative pregnancy rates for COH/IUI in stage I/II were significantly higher than in stage III/IV. Monthly fecundity rates were 3.81% for stage I/II spontaneous, 4.59% for COH/IUI, 3.05% for stage III/IV spontaneous, and 1.68% for COH/IUI (not significant). CONCLUSIONS: COH + IUI did not improve pregnancy rates in any stage of endometriosis. In stage III/IV we recommend postoperative in vitro fertilization. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved. KEYWORDS: ASRM staging system; Controlled ovarian hyperstimulation; Endometriosis; Intrauterine insemination; Laparoscopy PMID: 23911563 [PubMed - indexed for MEDLINE] RRM

32 Value-based Care Value Quality Cost Accountable Care Organizations make the physician ‘accountable’ for the value of the care that he or she delivers – Financially – Quality Outcomes

33 Value-based Care High Quality includes – Outcomes Compared to other approaches Patient satisfaction Ethics could be factored, based on the design – Increased focus lately on Cultural Competence – Increased focus on ethics and religious freedom – Reporting – Meeting Thresholds – Access, timeliness, meeting standards

34 Cost Effectiveness Value! NaProTECHNOLOGY vs Artificial Reproductive Technologies Produced by Pope Paul VI Institute for the Study of Human Reproduction 2004

35 Cost Effectiveness Infertility Cost per cycle (2004 data) NaProTechnology$ 322 IVF$ 9,226 Cost of prematurity (NICU stay) Severe$500,000 Cost of Twins (maternal, compared to singleton pregnancy) 2 x Cost of Triplets (maternal, compared to singleton pregnancy) 5 x

36 Success Rates Prematurity Prematurity Rate Pope Paul VI Institute 7.0% 3.6% Traditional Care12.1% Severe Prematurity Rate Pope Paul VI Institute 1.3% Traditional Care 3.9%

37 Success Rates Live Newborn Rates in Infertility ( Due to) : Endometriosis Pope Paul VI Institute 56 - 76% Johns Hopkins Surgical Approach57% IVF (one cycle) 21% Polycystic Ovarian Disease Pope Paul VI Institute 63 – 80% Johns Hopkins Surgical Approach42% IVF (one cycle) 26% Tubal Occlusion Pope Paul VI Institute 38% IVF (one cycle) 27% Recurrent Miscarriage Pope Paul VI Institute for the Study of Human Reproduction 79% Deliver Traditional ( wide ranges reported but all are) Fewer

38 Success Rates Post Partum Depression Pope Paul VI Institute 97% over 1-10 days Traditional (antidepressants and anxiolytics) slow improvement over 6-12 months Premenstrual Dysphoric Disorder (PMS) Pope Paul VI Institute95% Traditional (antidepressants)43% Hysterectomy Rate for Chronic Pelvic Pain Pope Paul VI Institute 12% Traditional Approach40%

39 Signs of Hope Gianna Center Accountable Care Associates Dr. Patrick Yeung’s Center

40 The National Gianna Center for Women’s Health and Fertility “She hopes that couples struggling with infertility who might be thinking of IVF will discover that ‘there is an alternative that is effective, less expensive and morally acceptable that will allow them to conceive through a natural act of intercourse.’” The Gianna Center accepts most major medical insurance plans including Medicaid. “New women's health center offers reproductive care, gynecology” Catholic New York — December 31, 2009 Anne Nolte, MD, CFCMC Ron Rak, CEO, St. Peters Univ Hospital Michele Giuiliano Kyle Beiter, MD, CFCMC

41 Accountable Care Associates Phil Gaziano, MD – Visionary in Healthcare reform Innovation in Info Technology – Feli Thurmeyer, MD Largest National ACO World Leading Care Management – Patient is a person! – Physician/Pt relationship is precious Highest Quality in the Nation Reducing Expenditures Tremendously

42 Accountable Care Associates Therefore, insurers are Coming to Them to develop innovative programs CMS is impressed with Savings and Quality Other Entrepreneurs are coming with related ideas and businesses Dr. Gaziano recruits Dr. Carpentier to help to foster RRM nationwide, possibly worldwide

43 Patrick Yeung, MD and other Centers of Surgical Excellence More Effective than Most Teaching Hospitals – Surgical Excellence – Attending to Outcomes Data – Near Contact Laparoscopy – National Reputation Championed and Trained by Dr. Hilgers Another early leader was Dr. Redwine Soon other centers will be trying to catch up

44 Challenges & Next Steps Surgical Training Enough FCP’s Insurance Support

45 Will we be able to meet the needs? If RRM is adopted, advocated CFCPs, CFCMCs/NPs Especially NaProSurgeons Can PPVI Institute Train More? – Funding from insurers to do more per year – New training sites elsewhere Increased funding per surgery might help

46 Who will set the standards? Factors involved: – Price, price, price – Power Health Policy Commissions Attorneys General – Political agenda – Access – Professional Organizations Institute of Med, DPH, FDA

47 Barriers to Implementation Burdensome regulations Corporate struggles Lack of religious conscience protections Public not educated on systems and costs Lack of formation Population control, feminist, gay rights lobbies Medicaid covers abortion but not infertility

48 Potential Gains Compounding pharmacies – more business Religious liberties – increased understanding Reimbursements for FCPs – improved Healthier women/families Less: breast cancer Prematurity and NICU stays hysterectomies

49 Culture of Life Gains From Respect for Restorative Approach Authentic Feminism Life is a Gift Dignity of the Embryo – Personhood at earliest stages – Increased respect – Less embryo selection Role of Husband/father appreciated again Value of Marriage

50 Discussion Insights to share Questions

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