PUBLIC HEALTH LAW PROBLEM SOLVING

FOR EXPERTS

Daniel O’BrienDaniel O’Brien

Maryland Office of the Attorney General Maryland Office of the Attorney General

November 4, 2006November 4, 2006

Katrina – A recent problem

Public Health Law: Where Professions Intersect ““. . . The study of the legal powers and duties of . . . The study of the legal powers and duties of

the state to assure the conditions for people to be the state to assure the conditions for people to be healthy and the limitations on the power of the healthy and the limitations on the power of the state to constrain the legally protected interests of state to constrain the legally protected interests of individuals for the protection of community individuals for the protection of community health.”health.”

Prof. L. Gostin, Public Health Law – Power, Prof. L. Gostin, Public Health Law – Power, Duty, Restraint, 2000Duty, Restraint, 2000

CDC: The New Mission Statement

Health Impact Focus: Health Impact Focus: Align CDC to maximize impact on Align CDC to maximize impact on the population's health and safety.the population's health and safety.

Customer-centricity: Customer-centricity: Market what people want and need Market what people want and need to choose health. to choose health.

Public Health Research: Public Health Research: Create and disseminate the Create and disseminate the knowledge and innovations people need to protect their knowledge and innovations people need to protect their health. health.

Leadership: Leadership: Leverage CDC’s unique expertise, Leverage CDC’s unique expertise, partnerships and networks to improve the health system. partnerships and networks to improve the health system.

Global Health Impact: Global Health Impact: Extend CDC’s knowledge and Extend CDC’s knowledge and tools to promote health protection around the world. tools to promote health protection around the world.

Accountability: Accountability: Sustain people’s trust and confidence by Sustain people’s trust and confidence by making the most efficient and effective use of their making the most efficient and effective use of their investment in CDC. investment in CDC.

“The Case of the Lacerated Cornea ”

Scene One: Scene One: State Health Secretary State Health Secretary

home on Tuesday home on Tuesday night and watching night and watching local newslocal news

Local News BroadcastMay 14, 2001

*Cosmetic Contact lenses sold at *Cosmetic Contact lenses sold at Baltimore City beauty salons without Baltimore City beauty salons without

prescription or consumer warningsprescription or consumer warnings

*Cornea damage, conjunctivitis *Cornea damage, conjunctivitis dangersdangers

WBAL Investigative ReporterWBAL Investigative Reporter

The Hue and Cry

May 15May 15th th - Governor, Attorney General and - Governor, Attorney General and Press ask “How can this happen and what Press ask “How can this happen and what are you doing”are you doing”

May 15May 15th th – Evening News - Officials not – Evening News - Officials not able to comment or identify any efforts to able to comment or identify any efforts to protect the public healthprotect the public health

Deciding a Strategy

May 15May 15thth – Senior staff summoned and – Senior staff summoned and questionedquestioned

May 15May 15thth – Legal office consulted: FDA – Legal office consulted: FDA deregulation, Board of Optometry antitrust deregulation, Board of Optometry antitrust limitationslimitations

May 21May 21stst – Decision meeting scheduled – Decision meeting scheduled

Legal Options – Seven Means To Prohibit Illegal Lens Sales Private AG – consumer Private AG – consumer

lawsuitslawsuits Public Health Advisory Public Health Advisory

(lens dangers)(lens dangers) Formal Declaratory Formal Declaratory

Ruling (Illegal to Sell)Ruling (Illegal to Sell) Cease and Desist Order to Cease and Desist Order to

Known DistributorsKnown Distributors Individual case Individual case

prosecution – civil or prosecution – civil or criminalcriminal

Adopt new regulationsAdopt new regulations Seek legislationSeek legislation

Public Health Officer’s Role1. Notify 1. Notify counsel and counsel and agency agency personnelpersonnel

4. Consult with 4. Consult with stakeholders stakeholders and affected and affected partiesparties

7. Implement 7. Implement public health public health decisiondecision

2. Gather 2. Gather regulatory regulatory backgroundbackground

5. Decide on 5. Decide on regulatory regulatory approachapproach

8. Assess 8. Assess impactimpact

3. Consider 3. Consider impact on other impact on other initiativesinitiatives

6. Prepare 6. Prepare media strategymedia strategy

9. Determine 9. Determine long term long term regulatory regulatory needsneeds

Legal Counsel’s Role

1. Establish 1. Establish strong attorney/ strong attorney/ client relationclient relation

4. Seek expert 4. Seek expert legal consultslegal consults

7. Implement 7. Implement decisiondecision

2. Broad 2. Broad monitoring legal monitoring legal developmentsdevelopments

5. Advise on 5. Advise on range of optionsrange of options

8. Monitor 8. Monitor compliance with compliance with court rulingcourt ruling

3. Know early 3. Know early warning sourceswarning sources

6. Prep case: 6. Prep case: pleadings and pleadings and witnesseswitnesses

9. Advise on 9. Advise on future regulatory future regulatory optionsoptions

Illegal Contact Lens Sales:The public health decision

Issue cease and desist orders to known Issue cease and desist orders to known distributorsdistributors

Issue public health media advisoryIssue public health media advisory Seek injunctive relief through courts as Seek injunctive relief through courts as

necessarynecessary

AN IMPERFECT ENDING WBAL – TV: APRIL 11, 2002WBAL – TV: APRIL 11, 2002 - New reports of continued lens sales- New reports of continued lens sales - On camera interview with 15 year old girl - On camera interview with 15 year old girl

who suffers cornea damagewho suffers cornea damage - Agency inspector interview detailing - Agency inspector interview detailing

cease cease and desist ordersand desist orders

Ongoing Efforts to Reduce Cosmetic Lens Injuries Established complaint response protocolEstablished complaint response protocol Prepared cease and desist ordersPrepared cease and desist orders Adopted inspection procedures for new Adopted inspection procedures for new

complaintscomplaints Prepared legal pleadings for enforcement Prepared legal pleadings for enforcement

activitiesactivities

“The Case of the Missing Herd” Scene One

Local Television Local Television

Shows Graphic Shows Graphic Slaughtering Slaughtering OperationOperation

Years of ComplaintsYears of Complaints Mercedes and GoatsMercedes and Goats

The Business – Custom Slaughter( c) FreeFoto.com

Scene Two

Nuisance complaintsNuisance complaints Defamation CaseDefamation Case Decaying carcasesDecaying carcases News reportsNews reports InspectionsInspections State/Federal State/Federal

jurisdictional issues jurisdictional issues

Legal Options

Private LitigationPrivate Litigation State – local nuisance abatement actionsState – local nuisance abatement actions Criminal referralsCriminal referrals

Animal crueltyAnimal cruelty State/federal food processing violationsState/federal food processing violations

Environmental crimes Environmental crimes Injunctive actions & civil fines Injunctive actions & civil fines

The Agency Response Eleven Pigs Discovered on Quarantined Schisler FarmEleven Pigs Discovered on Quarantined Schisler Farm ANNAPOLIS, MD - Oct. 6, 2006 - Following up on reports received ANNAPOLIS, MD - Oct. 6, 2006 - Following up on reports received

yesterday of pigs being present on Carroll Schisler, Sr.'s farm at 2546 yesterday of pigs being present on Carroll Schisler, Sr.'s farm at 2546 Marston Road in New Windsor, officials from Maryland Department of Marston Road in New Windsor, officials from Maryland Department of Agriculture today visited the farm to determine the accuracy of the Agriculture today visited the farm to determine the accuracy of the reports. Ten feral pigs and one small piglet were found on the property 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 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 just off the farm, were collected. The 10 adult pigs were humanely euthanized and will undergo full necropsy and testing for, among other euthanized and will undergo full necropsy and testing for, among other things, trichinosis and toxoplasmosis. These are diseases of human things, trichinosis and toxoplasmosis. These are diseases of human health importance which have been present in other swine on the farm 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 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 deemed to be unlikely to be carrying disease, was turned over to Carroll County Animal Control. Test results from the swine should be Carroll County Animal Control. Test results from the swine should be available in 10 days' time.available in 10 days' time.

“The Case of An Improved Vaccination Statute” Scene One Health Commissioner Health Commissioner

sees immunization rate sees immunization rate decline in Statedecline in State

Demands overhaul of Demands overhaul of the existing statutethe existing statute

Wants Wants recommendations on recommendations on key statutory elementskey statutory elements

State Role 1: Procurement

Vaccine for Children ProgramSeattle Washington““Vaccines for Children was established in 1993 Vaccines for Children was established in 1993

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

Cooperative Purchasing Agreements

Welcome to the Minnesota Multi-State Welcome to the Minnesota Multi-State Contracting AllianceContracting Alliancefor Pharmacy (MMCAP) web site. for Pharmacy (MMCAP) web site.

MMCAP is a voluntary group purchasing MMCAP is a voluntary group purchasing organization operated by the State of Minnesota organization operated by the State of Minnesota serving government-authorized healthcare facilities. serving government-authorized healthcare facilities. The goal of MMCAP is to provide member The goal of MMCAP is to provide member organizations the combined purchasing power to organizations the combined purchasing power to receive the best prices available for receive the best prices available for pharmaceuticals, hospital supplies, and related pharmaceuticals, hospital supplies, and related products.products.

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

Defining the General Scope of the Benefit Package A health benefit plan shall also provide that A health benefit plan shall also provide that

the health benefits applicable to children the health benefits applicable to children include coverage for immunization services include coverage for immunization services up to the age of thirteen.up to the age of thirteen. ColoradoColorado

Statutory Epidemiology

Any statutory mandate?Any statutory mandate? 33 yes – 18 no33 yes – 18 no

Mandated coverage v. Mandated coverage v. offer?offer?

32 coverage – 2 offer32 coverage – 2 offer

Patient classes covered?Patient classes covered? Children 33 – adults 2Children 33 – adults 2

Specific benefit Specific benefit mandated?mandated?

ACIP 6 – AAP 6 – ACIP 6 – AAP 6 – Appropriate / RegsAppropriate / Regs

Level of patient cost Level of patient cost sharing?sharing?

21 no deductible21 no deductible

13 no co payments13 no co payments

In network coverage only?In network coverage only? No state addressesNo state addresses

State Role 3: Defining Providers’ “Scope of Practice”

www.whitehouse.gov/ omb/budget/fy2006/hhs.html

Five State Survey Finding (GA, NY, MA, OR, TX) All permit physician All permit physician

delegation of delegation of immunization practiceimmunization practice

Non-physicians Non-physicians granted limited granted limited statutory authoritystatutory authority MA: full practice MA: full practice

by “prescriptive by “prescriptive practice nurse”practice nurse”

Broad variation in Broad variation in permissible “standing permissible “standing orders” and orders” and delegationsdelegations

Overall, physicians Overall, physicians control scope and control scope and extent of state’s extent of state’s immunization practiceimmunization practice

How States Regulate Immunization Practice States define practice of medicineStates define practice of medicine Immunizations constitute practice of Immunizations constitute practice of

medicinemedicine States regulate physician’s ability to States regulate physician’s ability to

delegate medical duties delegate medical duties ““Standing orders”Standing orders” ““Delegation agreements”Delegation agreements”

Mandated Coverage v. Mandated Offer Every insurer shall provide insurance which Every insurer shall provide insurance which

covers benefits for the comprehensive care covers benefits for the comprehensive care of children of children CaliforniaCalifornia

A plan that provides benefits for a family A plan that provides benefits for a family member shall provide an option to elect member shall provide an option to elect coverage for immunizations coverage for immunizations MississippiMississippi

Range of Immunizations Covered

The minimum package of child wellness The minimum package of child wellness services shall cover at least: all visits and services shall cover at least: all visits and costs of childhood and adolescent costs of childhood and adolescent immunizations recommended by the immunizations recommended by the Advisory Committee on Immunization Advisory Committee on Immunization Practices of the CDCPractices of the CDC MarylandMaryland

Emergency Vaccination Powers

Locate suppliesLocate supplies Control suppliesControl supplies Manage distributionManage distribution Mandate vaccination Mandate vaccination

Quarantine Quarantine alternativealternative

Liability and immunityLiability and immunity Going off labelGoing off label

Create surge capacityCreate surge capacity Scope of practiceScope of practice LocationsLocations Record keepingRecord keeping

Set pricesSet prices Manage price Manage price

gouginggouging Pay fair compensationPay fair compensation

Other Statutory Ranges

Appropriate immunizations in keeping with Appropriate immunizations in keeping with prevailing medical standardsprevailing medical standards ArkansasArkansas

Coverage for preventive care services as Coverage for preventive care services as recommended by the physicianrecommended by the physician District of ColumbiaDistrict of Columbia

Immunizations as prescribed by the Immunizations as prescribed by the Commissioner of HealthCommissioner of Health VirginiaVirginia

“The Case of An Improved Regional Response System” Scene One Senior manager in Senior manager in

health department near health department near state borderstate border

After – action meeting After – action meeting following hurricanefollowing hurricane

Serious problems with Serious problems with securing cross border securing cross border aidaid

Mutual Aid – Easier Said Than Done

Nine Legal Strategies

Health Care Health Care ProviderProvider

Health Care Health Care FacilityFacility

Private Private Sector Sector

Pre CHEPre CHE

During During CHECHE

Post CHEPost CHE

Objective One – Right People at Right Place at Right Time Encourage the Encourage the

development of a development of a health care workforce health care workforce that is fully prepared that is fully prepared to respond to a to respond to a catastrophic event catastrophic event

– FEMA FEMA LibraryLibrary

Legal Issues – Health Care Providers: Staff and volunteers - fully credentialed?Staff and volunteers - fully credentialed?

By multiple hospitalsBy multiple hospitals By multiple governmental entities?By multiple governmental entities?

Staff and volunteers – legal immunities?Staff and volunteers – legal immunities? Within home jurisidiction?Within home jurisidiction? In “receiving state” under EMAC?In “receiving state” under EMAC?

Medical staff – duty & incentives to report?Medical staff – duty & incentives to report? Licensing and professional standards established?Licensing and professional standards established? Protection/support of families?Protection/support of families?

Scope of Practice Rules – relaxed in emergencies?Scope of Practice Rules – relaxed in emergencies? Operational details – badges, transportation …..Operational details – badges, transportation …..

Healthcare Providers: Legal Initiatives By federal statute or regional compact:By federal statute or regional compact:

Implement multi-facility and cross border Implement multi-facility and cross border credentialing rulescredentialing rules

Clarify immunities and tort claim protections for Clarify immunities and tort claim protections for healthcare staff and volunteershealthcare staff and volunteers

Adopt broader scope of practice rules to maximize Adopt broader scope of practice rules to maximize health care coveragehealth care coverage

Assure needed support for HCP familiesAssure needed support for HCP families Prophylactics and vaccines – local stockpiles Prophylactics and vaccines – local stockpiles

Healthcare Providers:Legal Initiatives Use tuition payback rules to encourage:Use tuition payback rules to encourage:

Expanded numbers of primary care Expanded numbers of primary care practitionerspractitioners

Use “start up” grants to encourage:Use “start up” grants to encourage: Relocation of practices to underserved areasRelocation of practices to underserved areas

Examine medical malpractice rate setting practices Examine medical malpractice rate setting practices to encourage:to encourage: Retention of senior practitionersRetention of senior practitioners

Objective Two: Right Facilities With Right Capacities at the Right Place?

Encourage the Encourage the development of health development of health care facilities that are care facilities that are properly prepared to properly prepared to respond to a respond to a catastrophic event catastrophic event

• FEMA libraryFEMA library

Legal Issues - Health Care Facilities

Hospital rebuilding programs – anticipate CHE?Hospital rebuilding programs – anticipate CHE? The urban clinic expansion effort – anticipate The urban clinic expansion effort – anticipate

CHE?CHE? Demise of traditional public health clinics Demise of traditional public health clinics Growth of for profit and FQHC alternativesGrowth of for profit and FQHC alternatives

Plan for distribution of patient surgePlan for distribution of patient surge Anticipate security needs of hospitalsAnticipate security needs of hospitals

Hospitals not locus of emergency treatment Hospitals not locus of emergency treatment

Legal IssuesHCF Support Organizations HCF Support Organizations Identified?HCF Support Organizations Identified?

Food, fuel, medical suppliers, utilities, Food, fuel, medical suppliers, utilities, transportation, securitytransportation, security

HCF and Support Organizations - Interlocking HCF and Support Organizations - Interlocking COOPs in place?COOPs in place?

Employee / Members – trained and protected?Employee / Members – trained and protected? Disseminate electronic medical records to Disseminate electronic medical records to

individuals individuals Encourage primary care linkages Encourage primary care linkages Integrate evacuation plans with employer and Integrate evacuation plans with employer and

school systemsschool systems

Healthcare Facilities:Legal Initiatives Attack imbalances – misuse of ERsAttack imbalances – misuse of ERs

Create “medical home” for now and laterCreate “medical home” for now and later Use bond bills and financing incentives to:Use bond bills and financing incentives to:

Build community clinic capacityBuild community clinic capacity Create “home grown” strategic stockpilesCreate “home grown” strategic stockpiles

If “special use” facilities needed:If “special use” facilities needed: Plan for and identifyPlan for and identify Recognize & acknowledge “takings” Recognize & acknowledge “takings”

obligationsobligations

Healthcare Facilities:Legal Initiatives By statute or compact, assess and plan for By statute or compact, assess and plan for

regional needsregional needs Bed type and designBed type and design Dispersion of resourcesDispersion of resources

Utilize regulatory systems to require new Utilize regulatory systems to require new HCF building to meet CHE objectivesHCF building to meet CHE objectives

Use financing systems to encourage HCFs Use financing systems to encourage HCFs to meet CHE objectivesto meet CHE objectives

Objective Three: Organizational Resiliency Encourage Encourage

organizations to organizations to develop a robust develop a robust capacity to withstand a capacity to withstand a CHE and support the CHE and support the continuation of civil continuation of civil societysociety

FEMA libraryFEMA library

Private Sector:Legal Initiatives Begin dialogue on condemnation and eminent Begin dialogue on condemnation and eminent

domaindomain What would be needed and taken?What would be needed and taken?

Private Sector COOPs:Private Sector COOPs: Incentives & standards to make routineIncentives & standards to make routine Integrate with public sector COOPsIntegrate with public sector COOPs

Utilize private sector strengths:Utilize private sector strengths: Pre event contracts for maintaining supply Pre event contracts for maintaining supply

chainchain