PUBLIC HEALTH LAW PROBLEM SOLVING FOR EXPERTS

1. PUBLIC HEALTH LAW PROBLEM SOLVINGFOR EXPERTS Daniel O’Brien Maryland Office of the Attorney General November 4, 2006

2. Katrina – A recent problem

3. Public Health Law: Where Professions Intersect • “. . . The study of the legal powers and duties of the state to assure the conditions for people to be healthy and the limitations on the power of the state to constrain the legally protected interests of individuals for the protection of community health.” • Prof. L. Gostin, Public Health Law – Power, Duty, Restraint, 2000

4. CDC: The New Mission Statement • Health Impact Focus: Align CDC to maximize impact on the population's health and safety. • Customer-centricity: Market what people want and need to choose health. • Public Health Research: Create and disseminate the knowledge and innovations people need to protect their health. • Leadership: Leverage CDC’s unique expertise, partnerships and networks to improve the health system. • Global Health Impact: Extend CDC’s knowledge and tools to promote health protection around the world. • Accountability: Sustain people’s trust and confidence by making the most efficient and effective use of their investment in CDC.

5. “The Case of the Lacerated Cornea ” • Scene One: • State Health Secretary home on Tuesday night and watching local news

6. Local News BroadcastMay 14, 2001 *Cosmetic Contact lenses sold at Baltimore City beauty salons without prescription or consumer warnings *Cornea damage, conjunctivitis dangers WBAL Investigative Reporter

7. The Hue and Cry • May 15th - Governor, Attorney General and Press ask “How can this happen and what are you doing” • May 15th – Evening News - Officials not able to comment or identify any efforts to protect the public health

8. Deciding a Strategy • May 15th – Senior staff summoned and questioned • May 15th – Legal office consulted: FDA deregulation, Board of Optometry antitrust limitations • May 21st – Decision meeting scheduled

9. Private AG – consumer lawsuits Public Health Advisory (lens dangers) Formal Declaratory Ruling (Illegal to Sell) Cease and Desist Order to Known Distributors Individual case prosecution – civil or criminal Adopt new regulations Seek legislation Legal Options – Seven Means To Prohibit Illegal Lens Sales

10. Public Health Officer’s Role

11. Legal Counsel’s Role

12. Illegal Contact Lens Sales:The public health decision • Issue cease and desist orders to known distributors • Issue public health media advisory • Seek injunctive relief through courts as necessary

13. AN IMPERFECT ENDING • WBAL – TV: APRIL 11, 2002 • - New reports of continued lens sales • - On camera interview with 15 year old girl who suffers cornea damage • - Agency inspector interview detailing cease and desist orders

14. Ongoing Efforts to Reduce Cosmetic Lens Injuries • Established complaint response protocol • Prepared cease and desist orders • Adopted inspection procedures for new complaints • Prepared legal pleadings for enforcement activities

15. “The Case of the Missing Herd” Scene One • Local Television Shows Graphic Slaughtering Operation • Years of Complaints • Mercedes and Goats

16. The Business – Custom Slaughter( c) FreeFoto.com

17. Scene Two • Nuisance complaints • Defamation Case • Decaying carcases • News reports • Inspections • State/Federal jurisdictional issues

18. Legal Options • Private Litigation • State – local nuisance abatement actions • Criminal referrals • Animal cruelty • State/federal food processing violations • Environmental crimes • Injunctive actions & civil fines

19. The Agency Response Eleven Pigs Discovered on Quarantined Schisler Farm ANNAPOLIS, MD - Oct. 6, 2006 - Following up on reports received yesterday of pigs being present on Carroll Schisler, Sr.'s farm at 2546 Marston Road in New Windsor, officials from Maryland Department of Agriculture today visited the farm to determine the accuracy of the reports. Ten feral pigs and one small piglet were found on the property and another, which is believed to have been struck and killed by a car just off the farm, were collected. The 10 adult pigs were humanely euthanized and will undergo full necropsy and testing for, among other things, trichinosis and toxoplasmosis. These are diseases of human health importance which have been present in other swine on the farm and just outside the farm. The piglet, which because of its age officials deemed to be unlikely to be carrying disease, was turned over to Carroll County Animal Control. Test results from the swine should be available in 10 days' time.

20. “The Case of An Improved Vaccination Statute” Scene One • Health Commissioner sees immunization rate decline in State • Demands overhaul of the existing statute • Wants recommendations on key statutory elements

21. State Role 1: Procurement

22. Vaccine for Children ProgramSeattle Washington “Vaccines for Children was established in 1993 to remove the barriers of cost and access to attaining childhood immunizations. The program is funded by the [CDC] and the State of Washington, and supplies vaccines to providers across the state. Almost 95%of public and private immunization providers in King County are currently enrolled. All children from birth up to the 19th birthday are eligible….”

23. Cooperative Purchasing Agreements • Welcome to the Minnesota Multi-State Contracting Alliancefor Pharmacy (MMCAP) web site. • MMCAP is a voluntary group purchasing organization operated by the State of Minnesota serving government-authorized healthcare facilities. The goal of MMCAP is to provide member organizations the combined purchasing power to receive the best prices available for pharmaceuticals, hospital supplies, and related products.

24. State Role 2: Statutory Insurance Mandates – GWU Rosenbaum, et al.

25. Defining the General Scope of the Benefit Package • A health benefit plan shall also provide that the health benefits applicable to children include coverage for immunization services up to the age of thirteen. • Colorado

26. Statutory Epidemiology

27. State Role 3: Defining Providers’ “Scope of Practice” www.whitehouse.gov/ omb/budget/fy2006/hhs.html

28. All permit physician delegation of immunization practice Non-physicians granted limited statutory authority MA: full practice by “prescriptive practice nurse” Broad variation in permissible “standing orders” and delegations Overall, physicians control scope and extent of state’s immunization practice Five State Survey Finding (GA, NY, MA, OR, TX)

29. How States Regulate Immunization Practice • States define practice of medicine • Immunizations constitute practice of medicine • States regulate physician’s ability to delegate medical duties • “Standing orders” • “Delegation agreements”

30. Mandated Coverage v. Mandated Offer • Every insurer shall provide insurance which covers benefits for the comprehensive care of children • California • A plan that provides benefits for a family member shall provide an option to elect coverage for immunizations • Mississippi

31. Range of Immunizations Covered • The minimum package of child wellness services shall cover at least: all visits and costs of childhood and adolescent immunizations recommended by the Advisory Committee on Immunization Practices of the CDC • Maryland

32. Locate supplies Control supplies Manage distribution Mandate vaccination Quarantine alternative Liability and immunity Going off label Create surge capacity Scope of practice Locations Record keeping Set prices Manage price gouging Pay fair compensation Emergency Vaccination Powers

33. Other Statutory Ranges • Appropriate immunizations in keeping with prevailing medical standards • Arkansas • Coverage for preventive care services as recommended by the physician • District of Columbia • Immunizations as prescribed by the Commissioner of Health • Virginia

34. “The Case of An Improved Regional Response System” Scene One • Senior manager in health department near state border • After – action meeting following hurricane • Serious problems with securing cross border aid

35. Mutual Aid – Easier Said Than Done

36. Nine Legal Strategies

37. Objective One – Right People at Right Place at Right Time • Encourage the development of a health care workforce that is fully prepared to respond to a catastrophic event • FEMA Library

38. Legal Issues – Health Care Providers: • Staff and volunteers - fully credentialed? • By multiple hospitals • By multiple governmental entities? • Staff and volunteers – legal immunities? • Within home jurisidiction? • In “receiving state” under EMAC? • Medical staff – duty & incentives to report? • Licensing and professional standards established? • Protection/support of families? • Scope of Practice Rules – relaxed in emergencies? • Operational details – badges, transportation …..

39. Healthcare Providers: Legal Initiatives • By federal statute or regional compact: • Implement multi-facility and cross border credentialing rules • Clarify immunities and tort claim protections for healthcare staff and volunteers • Adopt broader scope of practice rules to maximize health care coverage • Assure needed support for HCP families • Prophylactics and vaccines – local stockpiles

40. Healthcare Providers:Legal Initiatives • Use tuition payback rules to encourage: • Expanded numbers of primary care practitioners • Use “start up” grants to encourage: • Relocation of practices to underserved areas • Examine medical malpractice rate setting practices to encourage: • Retention of senior practitioners

41. Objective Two: Right Facilities With Right Capacities at the Right Place? • Encourage the development of health care facilities that are properly prepared to respond to a catastrophic event • FEMA library

42. Legal Issues - Health Care Facilities • Hospital rebuilding programs – anticipate CHE? • The urban clinic expansion effort – anticipate CHE? • Demise of traditional public health clinics • Growth of for profit and FQHC alternatives • Plan for distribution of patient surge • Anticipate security needs of hospitals • Hospitals not locus of emergency treatment

43. Legal IssuesHCF Support Organizations • HCF Support Organizations Identified? • Food, fuel, medical suppliers, utilities, transportation, security • HCF and Support Organizations - Interlocking COOPs in place? • Employee / Members – trained and protected? • Disseminate electronic medical records to individuals • Encourage primary care linkages • Integrate evacuation plans with employer and school systems

44. Healthcare Facilities:Legal Initiatives • Attack imbalances – misuse of ERs • Create “medical home” for now and later • Use bond bills and financing incentives to: • Build community clinic capacity • Create “home grown” strategic stockpiles • If “special use” facilities needed: • Plan for and identify • Recognize & acknowledge “takings” obligations

45. Healthcare Facilities:Legal Initiatives • By statute or compact, assess and plan for regional needs • Bed type and design • Dispersion of resources • Utilize regulatory systems to require new HCF building to meet CHE objectives • Use financing systems to encourage HCFs to meet CHE objectives

46. Objective Three: Organizational Resiliency • Encourage organizations to develop a robust capacity to withstand a CHE and support the continuation of civil society FEMA library

47. Private Sector:Legal Initiatives • Begin dialogue on condemnation and eminent domain • What would be needed and taken? • Private Sector COOPs: • Incentives & standards to make routine • Integrate with public sector COOPs • Utilize private sector strengths: • Pre event contracts for maintaining supply chain