Understanding Health Care Denials as Violations of Standards of Care

1. Understanding Health Care Denials as Violations of Standards of Care Tracy Weitz, PhD, MPA Susan Berke Fogel, JD Jamie Brooks, JD

2. Today’s Presentation • Brief Review Overall Project • Goal • Team • Project Design • Examples of Denials that Violate Standards of Care • Recommendations • How to talk about health care refusals • Policy directions

3. The Standards of Care Project: Restrictions on Women’s Health Goal: To investigate and document whether and to what extent denials of health care and information conflict with professionally-developed, accepted medical standards of care, and to analyze the potential medical and health consequences on patients.

4. Project Team • National Health Law Program (NHeLP)* • Susan Berke Fogel, JD • Jamie Brooks, JD • University of California, San Francisco • Tracy Weitz, PhD, MPA • Public Interest Media Group • Susan Lamontagne • Adrienne Verrilli *Lourdes Rivera, JD, resigned from project 11/07

5. Judy Ann Bigby, MDMassachusetts Dept. of Health[Internal Medicine] Marcelle Ivonne Cedars, MDUniversity of California, San Francisco[Ob/Gyn nand Infertility] Don Downing RPhUniversity of Washington[Pharmacy] Timothy Johnson, MDUniversity of Michigan[Ob/Gyn and Maternal Fetal Medicine] E. Bimla Schwarz, MD, MSUniversity of Pittsburgh[Internal Medicine] Robyn Shapiro, JDMedical College of Wisconsin[Health Law Ethics] R. William Soller, PhDUniversity of California, San Francisco[Pharmacy] Sara Rosenbaum, JDGeorge Washington University[Health Law] Nada L. Stotland, MD, MPHRush Medical College[Psychiatry] Carol S. Weisman, PhDPennsylvania State University College of Medicine[Health Services Research] Nancy F. Woods, PhD, RN, FAANUniversity of Washington[Nursing] Sophia Yen, MDStanford Medical Center[Pediatrics] National Advisory Group

6. Overall Project Design • Technical medical report • How to talk about the issues included in the report • Dissemination of findings to the health care professional community

7. Report Components • Provide a new framework for examining health care refusals • Locate heath care refusals within the evolution of health care in the U.S. • Review the religious and ideologically based restrictions and denials of care • Evaluate the effects of denials of care for women with health conditions necessitating information and services • Make policy recommendations

8. Current Framework • Current frame for “conscience clauses” • Conflict between health care providers rights of conscience and patient’s right to exercise autonomy • Contest of moral perspectives • Fails to recognize that health care is unique • Decontexualization promotes issue as a philosophical debate without tangible results

9. Health Care is Unique • Practicing medicine, providing nursing care, or distributing drugs without a license are forbidden by law • Patients can only obtain certain care from professionals who are extended that privilege by the state • Information and services, therefore, do not take place in an open marketplace • Information and services occur in relationships created by law as inherently unequal

10. Trends in Health Care • Evidence-based practice • Patient-centeredness • Prevention • Transforming the provider-patient relationship to optimize health, broadly defined as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity

11. Standards of Care • The practices that are medically necessary and services that any practitioner under any circumstances should be expected to render • Requires that all health care professionals provide information and care consistent with the highest standards of scientific evidence, based on individual patient need, and with the goal of maximizing wellness

12. New Framework • The patient need for information or care includes a general claim to the information and/or services necessary to achieve health and well-being. • Denial of health care information and services can be examined using the lenses being employed to assess health care quality generally: evidence-based practice, patient-centeredness, and prevention. • Health care denials are understood as violations of the standard of care rather than as moral contests.

13. Sources of Restriction • Individual conscience clauses • Statutory/regulatory shields from liability • First introduced in 1970’s regarding abortion • Current broadly worded laws regarding anything “objectionable” • Politically-driven • Linking funding to promotion of particular type of care provision or information gag • Institutional • Religious, political, or financial

14. Catholic Health Facilities • Broadest religiously-based health care restrictions • Control > 16% of the hospital beds in the US • 5 largest Catholic hospitals reported nearly $30 billion in net patient revenues in 2004 • Governed by the Ethical and Religious Directives for Catholic Health Care Services (The Directives) • Promulgated by the U.S. Conference of Catholic Bishops • The Directives present “a theological basis for the Catholic health care ministry” • Prohibit services including abortion, sterilization, most forms of assisted reproductive technology, and contraceptives • Contain no exceptions for rape, incest, or health • e.g. no exception for use of condoms to prevent HIV/AIDS

15. Effects of Denials of Care • Review of published medical standards and practice guidelines from leading professional associations, aka standards of care • Compare the expected standards of care with restrictions and denial of health care and information

16. What Standards of Care are Violated? • Reproductive and Sexual Health • Pregnancy Prevention • Pregnancy Termination • Pregnancy Attainment

17. Pregnancy Prevention • In 2000, 34 million ♀ needed a method of pregnancy prevention • Many reasons to prevent pregnancy • Personal, social, economic • Medical • As a general standard of care • CDC Preconception Guidelines • ACOG Guidelines for Women’s Health • Every patient encounter include FP counseling and contraception options • Healthy People 2010 goal to reduce unintended pregnancies • As a specific standard of care for medical conditions

18. Use of Medications Contraindicated in Pregnancy • Acne Tx Accutane • Standard of Care (FDA iPLEDGE requirements) • Patient use of 2 forms of contraception • NFP, fertility awareness, and withdrawal not allowed • Physician counseling on contraception monthly • Consequences of pregnancy • Major birth defects (35%) • Increased risk miscarriage • Premature birth

19. Health Conditions Require Medical Stability Prior to Pregnancy • Diabetes • Standard of Care (ACOG and ADA) • Use of effective contraception at all times until metabolic control and actively seeking conception • Consequences of pregnancy • Miscarriage, IUFD • Fetal malformation or macrosomia • Maternal death, blindness, heart failure, kidney failure

20. Other Conditions Requiring Medical Management Prior to Pregnancy • Epilepsy • Major Depressive Disorder • Lupus • Heart Disease

21. Ex. of Denials of Contraceptive Information and Care • Individual • Provider failure to include or refusal to provide information on contraception in course of health care visit • Pharmacist refusals to fill prescriptions • Politically-driven • Abstinence-only-until-marriage counseling and care restrictions • Institutional • Lack of insurance coverage for contraception when other prescription drugs are covered • Catholic ERD-no information or services to be provided by health care providers or institutional services

22. Pregnancy Termination • In 2000, 1.3 million ♀ needed a pregnancy termination • Many reasons to terminate a pregnancy • Personal, social, economic • Medical • Standards of care • Within the care guidelines for conditions • Often obscured by language choice or as implied but not listed

23. Ectopic Pregnancy • Pregnancy develops outside the uterus • Standard of care • Treatment determined by individual clinical presentation and patient preference for intervention and future fertility (ACOG and RCOG) • Consequences of continued pregnancy • Non-viable fetus • Rupture, internal bleeding • Maternal death • Infertility

24. Ex. of Ectopic Care Denials • Individual • Physician refusal to treat ectopic due to presence of heart beat • Politically-driven • Institutional • ERDs • Analyze ectopic pregnancy treatment within context of prohibition on abortion • Can not perform “direct” abortion • Can perform some interventions under principle of “double effect” • i.e salpingectomy (removal of tube) • Policies differ by institution

25. Mid-trimester Premature Rupture of Membranes (PROM) • Standards of care • Pt preference for expectant management or induction of labor (i.e. abortion) (ACOG) • Complications of lack of care • Infection, rare maternal sepsis • Severe bleeding, aka hemorrhage • Infertility • Death

26. Ex. PROM Denials of Care • Individual • Physician refusal to perform abortion • Nurse refusal to participate in care for patient • Politically-driven • Lack of public funding for procedure • State bans on performance of abortions in publicly-funded facilities • Institutional • ERD prohibition on abortion if no double effect option (i.e. presence of infection) • Lack of skilled providers to perform D&E • Refusal to make direct transfer of care to another facility

27. Other Conditions Necessitating Access to Abortion Care • Preeclampsia / Eclampsia • Fetus incompatible with life • Anencephaly • Uncontrolled medical conditions • Diabetes • Lupus • Heart Disease

28. Policy Recommendations

29. Patient-Needs-First Systems and Policy Structures • Limit refusal allowances • To individuals • For care, not information or referral • Meet specific criteria for objection • Ensure composition and distribution of care providers to ensure access to care • Treat denials as violations of standards of care with equivalent consequences

30. Thank You!