Michigan Public Health Institute September 23, 2014

Transcription

1 Michigan Public Health Institute September 23, 2014 The Doctor Is In Provider Discussion and Clinical Cases Brent N. Davidson, M.D. Service Chief, Women s Health Services Henry Ford Health System Henry Ford Medical Group

2 Objectives Be able to integrate the content of 3 evidence based family planning guidlelines in the care of women with chronic medical and mental health conditions. Have a clear understanding of when referral of patient to a specialist physician is indicated. List 5 circumstances when medications given for chronic medical or mental health conditions may interact with hormonal contraceptives.

3 Objectives List 4 provisions of the ACA that deal with quality of care and apply these sections to family planning service delivery List 3 potential national family planning quality metrics and explain how the numerator and denominator for each metric could be computed List 5 commonly asked questions by clients regarding why and how they should seek coverage through mechanisms of the ACA available in the state in which they reside List the 8 categories services available to women without cost saving for those who have non grandfathered health plans and how women can access covered services if they are withheld by their health plan

4 Case Study #1 19 year old G0 woman is seen for a periodic health screening visit (aka, a Well Woman visit) Same male partner for the past year Feeling well; no complaint of vaginal discharge, abnormal bleeding, dyspareunia Weight: 210 pounds; BMI: 32 kg/m2 Using contraceptive patch; asks about insertion of LNG IUS Questions Do you have a primary care provider? Which methods are best relative to her BMI and age? What needs to be done at her check up visit?

5 US MEC: Age and Parity Nullip Parous

6 SPR: Initiation of LNG-IUDs Timing The LNG-IUD can be inserted at any time if it is reasonably certain that the woman is not pregnant Need for Back-Up Contraception If inserted <7 days since menstrual bleeding started, no additional protection is needed If inserted >7 days since menstrual bleeding started, the woman needs to abstain from sexual intercourse or use additional protection for the next 7 days

7 Examinations and Tests Needed Before Initiation of a Cu-IUD or an LNG-IUD Bimanual exam and cervical inspection are necessary Routinely screen for CT and GC according to national screening guidelines If not screened, perform at the time of insertion Women with purulent cervicitis or current GC or CT should not undergo IUD insertion (U.S. MEC 4) If a very high individual likelihood of STD exposure generally should not have IUD insertion (U.S. MEC 3)

8 SPR: IUD Recommendations Prophylactic antibiotics at the time of IUD insertion Not recommended for Cu-IUD or LNG-IUD insertion Routine follow-up after IUD insertion No routine follow-up visit is required Advise a woman to return at any time To discuss side effects or other problems If she wants to change the method When it is time to remove or replace the IUC

9 Routine STI Screening in Women AGE CT (Both) Annually Hi risk GC (Both) Hi risk HIV Syphillis Vag trich Hepatitis C - CDC 2012 Once, then hi risk only Hi risk Hi risk Hi risk Routine annual screening of sexually active women under 26 One time screening of adults born

10 Routine Metabolic Screening in Women AGE BP <Q2 yrs BMI <Q2 yrs Q 3 yrs T2DM -ADA - USPFTF Lipids -ATP - USPFTF Hi Risk HTN [B] Q 5 yrs Hi Risk Q3y HTN [A] ATP: Adult Treatment Panel CHD: coronary heart disease CBE: Clinical breast exam CDC: Centers for Disease Control USPSTF: US Prev Services Task Force

11 Patient #1: Management QFP: discuss all methods; review reproductive life plan; additional advice regarding adolescent services MEC: IUC can be inserted today; string check visit optional SPR: assess BP, BMI; bimanual exam before IUC insertion STD: screen for chlamydia and gonorrhea HIV: one time HIV screening indicated Preconception care: deferred (until IUC removed) Cancer screening: not indicated Coding: CPT based on counseling time ICD 9: V25.1 (insert IUD) + V25.09 (other FP advice)

12 Patient #2: Headaches Ms. K is a married 22 year old G2 P0 TAB2 established client who is seen for pregnancy determination visit Her first two pregnancies were at 17 and 19 years old and occurred while using condoms She stated that she has occasional sick headaches Recently, 2 episodes were so severe that she left work She does not want to be pregnant Interested in starting OCs Visit 38 minutes; 25 minutes counseling

13 QFP: Pregnancy Testing & Counseling Pregnancy testing is a reason many clients first seek family planning services Visit should include: Discussion of reproductive life plan Medical history Pregnancy test Confirmation of result with client Counseling & referral, as appropriate

14 Tension Headache Most common headache: 59% of reproductive aged women Diagnosis Lasts for 30 minutes 7 days At least two of Bilateral location Pressing/tightening in neck, scalp; non pulsating Mild moderate intensity Not made worse by physical activity Both of No nausea/vomiting No more than 1 of photophobia, phonophobia

15 Tension Headache Improved with sleep, analgesics, relaxation Not associated with increased stroke risk No effects of menstrual cycles or exogenous hormones on frequency or severity of headaches

16 Migraine Headache Without Aura aka: common or simple migraine Attacks last 4-72 hours (untreated or unsuccessful) At least 2 of the following Unilateral or bilateral temporal pain Pulsating (throbbing) quality Moderate or severe pain intensity Aggravated by routine physical activity At least 1 of the following during the attack Nausea, vomiting Phonophobia (sound) and photophobia (light) Not attributed to another disorder

17 Migraine Headache With Aura (aka: complex or classic migraine) A. Meets criteria for migraine, and >2 attacks with B D B. B. Aura, with at least one fully reversible finding Visual flickering lights, spots, lines or loss of vision Flashing zig zag line from center of visual field to periphery Sensory: pins and needles and/or numbness Dysphasic speech disturbance

18 Migraine Headache With Aura (continued) C. At least 2 other characteristics Homonymous visual symptoms or unilateral sensory sxs At least 1 aura symptom develops over > 5 mins Each symptom lasts > 5 mins and < 60 minutes D. Headache develops during the aura or follows <60 min Aura without headache = opthalmic migraine E. Not attributed to another disorder

19 Migraine Headache: Complications Migraine with aura associated with stroke risk An increased relative risk A low absolute risk Condition Odds ratio Stroke/10,000/yr No migraine or OCs Migraine without aura 1.8 Migraine with aura Migraine + COCs Migraine with smoking 7-10 Migraine +smoking + OC 34.4 Edlow AG, Bartz D. Rev in Obstet Gynecol, 2010; 3(2): 55-65

20 Headaches and Contraception: Management Differentiate migraine from non-migraine headaches If unclear, seek neurologist consultation Menstrual headaches: extended regimen OCs or NuvaRing CHC in women with migraines without aura Use low estrogen dose product Recommend frequent follow-up visits initially If HA worsening frequency or severity, or new neurological symptoms, discontinue CHC Progestin-only methods, IUC are safe and effective

21 Patient #2: Management QFP: discuss all methods; review reproductive life plan MEC: acceptable to use OCs (US MEC-2) SPR: Check BP, otherwise no exam needed. Quick start STD: candidate for CT and GC screen HIV: one time HIV screening indicated (15-65 y.o.) Preconception care: defer until OCs discontinued Cancer screening: not indicated Coding: based on counseling time (UPT) ICD-9: V25.01 (prescription of OC) + V72.41 (PT visit, neg)

22 Patient 3: Seizure Disorder 26 year old woman is seen with a request for oral contraceptives She has had a seizure disorder since age 17; using carbamazepine (Tegretol) daily Seizures usually are well controlled, but she still experiences occasional episodes Last visit to neurologist was 4 years ago; carbamazepine prescriptions are provided by PCP Is she a good combined OC candidate?

23 Seizure Disorder Goals of contraceptive management of women with seizure disorders Seizure control with anti epileptic drugs (AEDs) Highly effective contraception, as exposure to some AEDs is associated with congenital anomalies Minimize drug interaction of AEDs and contraceptive Enzyme inducing AEDs reduce CHC efficacy by secondary metabolism of both E + P by induction of CYP450 (3A4) enzymes SHBG 7 free progestin ( less so with EE)

24 AEDs: Non Inducers of Hepatic Enzymes Generic name Ethosuximide Levetiracetam Tiagabine Valproic acid Vigabatrin Zonisamide Clonazepam Pregabalin Brand name Zarontin Keppra Gabitril Depakene, Depakote Sabril Zonegran Klonopin Lyrica

25 Enzyme Inducing Anti-Epileptic Drugs (AEDs) Drug Brand name E reduction P reduction Carbamazepine Tegretol 42% 58% Equatro Felbamate Felbatol 13% 42% Oxcarbazepine Trileptal 48% 32% Phenobarbital Generic 64-72% None Phenytoin Dilantin 49% 42% Phenytek Topiramate Topamax 15-33% None (>200 mg only) Thorneycroft I, Epliepsy and Behavior 2006;9:31

26 Other Uses of EI-AEDs Drug Brand name Common Other Uses Carbamazepine Tegretol Equetro Trigeminal neuralgia, schizophrenia, bipolar disorder Felbamate Felbatol Neuropathic pain, migraines Lamotrigine Lamictal Bipolar, PTSD Oxcarbazine Trileptal Bipolar, neuropathic pain Phenobarbital generic None Phenytoin Dilantin None Phenytek Topiramate Topamax Migraines, bipolar, obesity

27 Management of Women Using EI-AEDs Ideal contraceptives IUCs (Mirena, ParaGard) DMPA: high efficacy; improves seizure control No drug interactions with any AED Unknown if DP-104 reduces seizure activity Oral contraceptives non-evidence based Use at least 35 mcg EE + high progestin product Shorten hormone free interval to 4 days or less Avoid low progestin contraceptives OrthoEvra patch; progestin only pills Thorneycroft I, Epliepsy and Behavior 2006;9:31

28 Lamotrigine (Lamictal) Each drug increases the metabolism of the other In a lamotrigine (single drug) users started on Ocs Lamotrigine levels drop by 49% (41-64%) Seizure activity increases Side effects of lamotrigine when OC stopped If using OCs, use higher start dose of lamotrigine If using lamotrigine and initiating Ocs Double lamotrigine dose before starting Ocs If side effects in HFI, reduce lamotrigine by 25% in HFI Before stopping OCs, cut lamotrigine dose by half No effect of progestin only methods on lamotrigine

29 2010 US-MEC: Lamotrigine OC/P/R are considered US-MEC 3 because pharmacokinetic studies show levels of lamotrigine decrease significantly during COC use This recommendation applies only where lamotrigine monotherapy is taken with COCs Anticonvulsant treatment regimens that combine lamotrigine and non-enzyme inducing AEDs (such as sodium valproate) do not interact with COCs

30 2010 US Medical Eligibility Criteria Drug OC P/R POP DMPA Imp lant Cu- IUC LN- IUC Rifampin (E-I) E-I Anticonvulsants Lamotrigine Antifungal drugs Other antibiotics

31 Patient #3: Management QFP: discuss all methods; review reproductive life plan; MEC: Progestin only method preferred, but OCs acceptable SPR: Check BP, no exam necessary. Quick start OCs STD: CT and GC screening not indicated HIV: one time HIV screening unless previously screened Preconception care: Review anti-seizure medications; switch or discontinue before becoming pregnant Folate 5 mg per day for 1 month before conception and throghout first trimester

32 Patient #4: A History of Depression 32 year old G0P0woman using 20 ug EE monophasic OC for 2 years; no problems Will use OCs for another 6 months, then considering becoming pregnant with her current partner Feeling sad over the past 3 months tried St John s Wort tablets with no effect Her PCP recommended trial of fluoxetine Will OCs make her depression worse? Will fluoxetine reduce OC efficacy?

33 QFP: Preconception Health Services Preconception health services should be offered to female and male clients Priority populations are Individuals/couples trying to achieve pregnancy Clients seeking basic infertility services Clients at high risk of unintended pregnancy

34 QFP: Preconception Health Services Aim to identify and modify biomedical, behavioral, and social risks Promote health before conception, reducing pregnancy-related adverse outcomes Low birth weight Premature birth Infant mortality Improve women s and men s health even if they choose not to have children

35 QFP: Preconception Services for Women Discussion of reproductive life plan Medical history Sexual health assessment Screening and referral/treatment for Intimate partner violence Alcohol and drug use Tobacco use Immunizations Depression High blood pressure Diabetes

36 QFP: Preconception Services for Men Address men as partners in both preventing and achieving pregnancy including: Direct contributions to infant health & fertility Role in improving the health of women Improve the health of men, regardless of pregnancy intention

37 QFP: Preconception Services for Men Discussion of reproductive life plan Medical history Sexual health assessment Screening for Alcohol and drug use Tobacco use Immunizations Blood pressure Depression Height, weight, and BMI Diabetes

38 Do Hormonal Contraceptives Cause or Worsen Depression? Older studies suggested that progestins could Make pre-existing depression worse Cause depression in a small % of users More likely with progestin-only methods MEC Evidence: COC and POC use did not increase depressive symptoms in women with depression compared with baseline or with nonusers with depression No data on bipolar disorder or postpartum depression All methods are categorized as US-MEC-1

39 Risk of Unintended Pregnancy Among Young Women with Mental Health Symptoms Risk of pregnancy in women with depression 922 women years of age, followed for 1 year 24% of women had moderate/severe depression Pregnancy in 14% with depression vs 9% without Pregnancy in 15% with stress vs. 9% without If depression and stress, 2-fold increased pregnancy risk 2.3 fold increased risk if no prior pregnancy Hall KS et.al, Social Sci and Medicine 2014;62-71

40 Young Women s Consistency Of ContraceptiveUse Does Depression Or Stress Matter? Consistent contraceptive use was 10 15% lower among women with mod-severe depression and stress than those without symptoms Women with depression and stress symptoms had 47% and 69% reduced odds of contraceptive consistency each week than those without symptoms, respectively Conclusion: Women with depression and stress symptoms appear to be at increased risk for user-related contraceptive failures, especially for the most commonly used methods Hall KS, Contraception 2013; 88:

41 St John s Wort and OC Use St John s Wort widely used for depressionmany studies show induction of CYP450 (3A4) Comparable to rifampin and carbamazepine when given for >10 days (Markowitz, NEJM 2003) Studies of SJW in OC users Study Hormone level Ovulation Follicle growth Hall 2003 P, E No NA Pfrunder 2003 P 42% No No Murphy 2006 P 15% probable 38% Yes Caution patients that OC effectiveness may be reduced

42 CDC 2010: Rountine STI Screening Women AGE CT (both) Annually Hi Risk GC (both) Hi Risk HIV Syphillis Vag trich Once, then Hi Risk only Hi Risk Hi Risk Hepatitis C - CDC 2012 Hi Risk Routine annual screening of sexually active women under 26 One time screening of adults born

43 OCs and Treatment of Depression and Bipolar Disorder Depression Possible effect: St John s Wort Noeffect SSRIs (fluoxetine), SNRIs (venlafaxine) Tricyclics (imipramine, amitryptaline) Bipolar Disorder Enzyme-inducing anti-epileptic drugs (WHO-3) Carbamazepine, Oxcarbazine, Lamotrigine, Topiramate Noeffect Lithium, Aripiprazole (Abilify), Valproate

44 Patient #4: Management QFP: Provide preconception care advice aimed at both women and men MEC: All methods considered to be US MEC-1 St John s wort may reduce OC effectiveness SPR: BP check, otherwise exam unnecessary STD: targeted screening based on risk behaviors HIV: one time HIV screening indicated Cancer screening: cytology q3 or co-testing q 5 years Preconception care: as previously described

45 Routine Cancer Screening in Women AGE Cervic CA - Cytology None Q 3 yrs -Co-testing None Q 5 yrs CBE None Q 3 yrs -ACS X Mammogram -ACS -USPSTF None HI Risk [1] Annual with MG Annual Q2y [C] Q2y [B] Colorectal cancer None HI Risk [A] ACOG: Am College of Ob-Gyn ACS: American Cancer Society CBE: Clinical breast exam CDC: Centers for Disease Control USPSTF: US Prev Services Task Force

46 SPR Appendix B: When To Start Using Specific Contraceptive Methods Method When to start Back-Up Exam Cu-IUC Anytime none pelvic exam LNG-IUS Anytime If >7d* Pelvic exam Implant Anytime If >5d* none Injection Anytime If >7d* none CHC Anytime If >5d* BP POP Anytime If >5d* none

47 SPR Appendix D: Routine Follow-Up After Contraceptive Initiation IUC Implant Injectable CHC POP Return any time X X X X X Assess satisfaction at X X X X X routine visits Asses for change in health status (MEC 3,4) X X X X X Consider string check Consider assessing weight change Measure blood pressure X X X X X X X

48 SPR Appendix C: Exams And Tests Needed Before Method Initiation Examination Blood pressure Clinical Breast Examination Weight (BMI) Bianual examination, cervical inspection Glucose, Lipids Liver enzymes Thrombogenic mutations Cervical cytology (Papanicolaou smear) STD Screening with laboratory tests HIV screenign with laboratory tests Needed for OC, patch, ring None Hormonal methods IUC, cap, diaphragm None None Noe None None None

49 Filling The Gaps Pregnancy testing and counseling Achieving pregnancy Basic infertility Preconception health Preventive health screening of women and men Contraceptive counseling, incl reproductive life plan

50 Who Is the Target Audience? For primary care It depends on the For women s Providers patient health care providers Core FP Services Related PH Services Other PH Services

51 Other Preventive Health Services Interventions unrelated to core family planning Discuss and counsel Screening Healthy diet counseling Dental health Injury prevention Breast cancer preventive medication Tobacco and drug use cessation interventions Administer vaccines: DTaP booster, influenza, rubella Colorectal cancer screening DM, hyperlipidemia screening (unrelated to BCM) Skin cancer screening (high risk) Thyroid disease (high risk)

52 US MEC 2010: Diabetes OC/P/R POP DMPA Impl LNG- IUD Cu- IUD Hx gestational diabetes Nonvascular disease i. Noninsulin-dependent ii. Insulin-dependent Nephropathy/retinopathy/ neuropathy 3/ Other vascular disease or diabetes of >20 yrs duration 3/

53 Preconception Care for Diabetics Diabetes in pregnancy is associated with higher rates of Miscarriage Fetal malformations: esp cardiac and neural tube defect Pre-eclampsia, preterm labor Macrosomia, birth injury, and perinatal mortality Lower risk if optimal glycemic control, before & during pregnancy Insulin to achieve target blood glucose levels Use metformin as an adjunct or alternative Mahmud M, Mazza D: Preconception care of women with diabetes: a review of current guideline recommendations. BMC Women s Health :5

54 Preconception Care for Diabetics Counseling Folate 5 mg daily pre-conceptually until 12 weeks gestation Inform about risk of miscarriage, congenital malformation and perinatal mortality with poor metabolic control Inform re: how DM affects pregnancy and pregnancy affects DM Use effective contraception until target blood glucose is achieved Encourage smoking cessation and reduction in alcohol intake Encourage management of weight to achieve a BMI < 27 Contraindications to pregnancy HbA1C >10% Impaired renal function (increased risk of progression to dialysis) Mahmud M, Mazza D: BMC Women s Health :5

55 Promoting Prevention through the Affordable Care Act Howard. K. Koh, M.D., M.P.H., and Kathleen G. Sebelius, M.P.A. Specified preventive services must be covered with no cost-sharing (no out-of-pocket costs) Applies to private and public programs (New) Private insurance policies 2010 Medicare, Medicaid 2011 State insurance exchanges 2014 Improves coverage for preventive services in many individual and small group plans

56 Promoting Prevention through the Affordable Care Act Howard. K. Koh, M.D., M.P.H., and Kathleen G. Sebelius, M.P.A. Preventive services include all services USPSTF grade [A] or [B] recommendations AAP Bright Futures recommendations for adolescents CDC ACIP vaccination recommendations IOM recommended to HRSA additional women s prevention benefits not addressed by USPSTF intended to close the gap

57 Institute of Medicine Committee on Preventive Services for Women Closing the Gaps released July 20, member panel 8 additional preventive services recommended

58 Reproductive Health Cancer Healthy Behaviors Pregnancy related Immunizations Chronic conditions STI and HIV counseling ; all sexually active F) Breast Cancer Mammography Alcohol S&C Alcohol S&C TdaP, Td booster, MMR, varicella CV: HTN, lipids Ct, GC, Syphilis screening HIV screening (adults at HR; all sexually active F) Contraception (women w/repro capacity Genetic S&C Tobacco C&I Tobacco C&I Influenza T2DM screen Preventive medication counseling Cervix: Cytology HPV + cytology Diet counseling if CVD risk Interpersonal and DV S&C Folic acid supplement GDM screen Rh screen Anemia screen Hepatitis A, B Meningococcal HPV (women 19 26) Depression screen Osteoporosis screen Colorectal: FOBT, Colonoscopy, Sigmoid Well woman visits STI screen Bacteruria screen Pneumococcal Zoster Obesity screen; C&I if obese Lactation Supports S&C: screening and counseling C&I: counseling and interventions

59 Women's Preventive Services HHS Guideline for Insurance Coverage Well-woman visits annually including preconception and prenatal care Frequency Several visits may be needed to obtain all recommended services, depending on health status, health needs, and other risks

60 Women's Preventive Services HHS Guideline for Insurance Coverage All FDA approved contraceptive methods, sterilization procedures, and patient education & counseling for women with reproductive capacity Frequency As prescribed Limited exclusion for religious institutions (e.g., churches) from providing contraceptive coverage for insured employees DHHS accommodation extended to religion-affiliated non- profits employers and certain for-profit companies (Burwell vs. Hobby Lobby, USSC, 2014)

61 Can Plans Limit Contraceptives Covered Without Cost-Sharing? Plans must cover all of FDA-approved methods, but not all products Reasonable medical management techniques are allowed Cost-sharing for brand-name drugs Cost-sharing for out-of-network services Prescription for over-the-counter methods The Waiver Process Allows women to access medically appropriate method without cost-sharing if plan typically imposes costsharing Usually done through pharmacy pre-authorization

62 How Do You Know If You Have First Dollar Coverage for Contraceptives? Call Member Services at your health plan the number is on your health insurance card. If you feel you are not receiving benefits to which you are entitled, contact the National Women s Law Center PILL4US pill4us@nwic.org

63 Clinical Pearls Six CDC-developed evidence based guidelines are now available that cover most clinical circumstances that occur in family planning clients The QFP fill in gaps left between the guidelines and then ties all the guidelines cohesively Most family planning services will be coded based on client counseling, not on physical assessment or lab testing Most women covered by commercial health insurance, Medicaid, state FP programs, and Title X will have no out-of-pocket cost for contraceptives

64 THANK YOU