health law certificate program 2015: health law basics and ... av cle materials... · health law...

Health Law Certificate Program 2015: Health Law Basics and Our Aging Population

Agenda

Day 1 - Monday, August 10, 2015 - Health Law Basics Part I 8:30am - 9:00 am Registration and Coffee Service

9:00am - 9:15 am Welcome and Introduction Erica Wolf, Seattle University School of Law Annette Clark, Dean, Seattle University School of Law

9:15am - 10:30 am Session 1: Litigation and Legislative Update Jonathon Bashford, Lane Powell, PC Jennifer Sheffield, Lane Powell, PC

10:30 am - 10:45 am Break

10:45 am - 11:45 am Session 2: Health Care Fraud: Introduction to the False Claims Act Michelle Peterson, Michelle Peterson Law, PLLC Kayla Stahman, Assistant United States Attorney

11:45 am - 12:45 pm Lunch on your own

12:45 pm - 1:45 pm Session 3: Understanding Medical Records & Medical Terminology Karin Mitchell, Johnson, Graffe, Keay, Moniz & Wick, LLP

1:45 pm - 2:30 pm

2:30 pm - 2:45 pm

Session 4: Ethics: Identifying the Client, Multijurisdictional Practice, and Confidentiality Paul Swegle, Numera, Inc. Break

2:45 pm - 3:45 pm Session 5: Representing Providers: Fundamentals of Compliance - Stark, Anti-Kickback, & HIPAA John Peick, Peick Boyer Law Group, P.S.

3:45 pm - 4:30 pm Session 6: Infectious Diseases: The Law of Emergency Preparedness Joyce Roper, Senior Assistant Attorney General of WashingtonPlease click here for a link to the Public Health Emergency Legal Tool Kit (this is a zip file and may take some time to download)

http://www.law.seattleu.edu/Documents/cle/Health%20Law%20Toolkit.zip

Faculty Biographies Jonathon Bashford Jonathon Bashford advises and litigates on behalf of long term care providers and other clients in the health care sector. His practice focuses on regulatory compliance including licensing, Medicare and Medicaid certification and payment, fraud and abuse, certificates of need, Americans with Disabilities Act, HIPAA, guardianships and estates, public records, and administrative procedure. He is experienced in complex regulatory litigation including agency hearings, state and federal court litigation, and appeals. Prior to joining Lane Powell, Jon worked as an Assistant Attorney General advising the Washington Aging and Disability Services Administration. Jon is a graduate of Harvard Law School, where he was student body treasurer and a board member of the Harvard Legal Aid Bureau. He was named a “Washington Rising Star” by Super Lawyers in 2015. Kurt Boehl Kurt Boehl is an experienced and respected attorney who balances his current practice between Marijuana Business Law and Criminal Defense. Kurt is passionate about the practice of law. In his final year of law school, he interned with both the Public Defender’s Office and Seattle’s City Attorney. As a Rule 9 public defender and prosecutor, Kurt appeared as lead counsel in over 20 jury trials. Kurt formed his solo practice in 2005, immediately after gaining his license to practice law. He represented hundreds of clients in his first two years in Criminal Defense practice, defending individuals accused of a wide variety of crimes. Kurt quickly established a strong reputation for successfully defending individuals accused of drug possession, manufacturing and trafficking. In 2008 – 2009, Kurt was one of the pioneers in advancing Washington’s medical marijuana laws. With a focus on patient access and community safety, Kurt worked successfully with several cities and counties to develop a sustainable, regulated medical marijuana market. In 2010, Kurt was fortunate to work with Alison Holcomb to draft legislation for what became I-502 (Washington’s Marijuana legalization initiative). Since then, he has worked closely with recreational marijuana business applicants, the Washington State Liquor Control Board, and select city and county officials, with the goal of wisely implementing regulations for Washington’s adult-use marijuana market Kurt has been recognized as one of the top lawyers in Washington State. Washington Law and Politics Magazine has named Kurt a Rising Star for the past 6 years, and Seattle Met Magazine named Kurt as one of Washington State's top criminal defense attorneys. In addition, Kurt has received the preeminent AV rating from Martindale Hubbell and is ranked Superb by the AVVO attorney rating service. Scott Breneman Scott Breneman is a founding member of the Seattle law firm Breneman Grube, PLLC. He has been a trial lawyer for over 25 years, and has litigated and tried hundreds of personal injury, wrongful death and malpractice cases. He has extensive experience with insurance coverage disputes. Scott is “AV®” rated by Martindale-Hubbell, rated 10 of 10 by Avvo, and is an Eagle member of the Washington State Association of Justice (“WSAJ”). He is a contributing author to the WSAJ Nursing Home Litigation Deskbook (Multi-Entity Corporate Defendants). Scott is an Order of the Coif, cum laude graduate of the University of Wisconsin Law School, where he served as a Note & Comment Editor for the University of Wisconsin Law Review. Lisa Brodoff Professor Brodoff has engaged in both scholarly work and impact litigation/legislative advocacy while teaching at Seattle University. Her areas of expertise are in the rights of sexual minorities, people with disabilities, the elderly, and public assistance beneficiaries; and in clinical law teaching theory. She is a frequent speaker at conferences and continuing legal education programs on topics including the right to counsel in civil matters, end-of-life and disability planning, and the administrative hearing process. Professor Brodoff was instrumental in the passage of legislation in Washington State creating the Mental

Health Advance Directive, a planning document for people with mental illness. Washington's statute is now considered model legislation for states seeking to expand the rights and planning options for people with mental illness. She also created a new and innovative planning document for people with Alzheimer's Disease and other types of dementia - the Alzheimer's/Dementia Mental Health Advance Directive. Thomas J. Degan Thomas J. Degan Jr. is an attorney who has successfully litigated a wide variety of cases in federal and state courts, administrative hearings, and before arbitration panels. His wide ranging legal practice has included defending individuals accused of crimes, representing victims of negligence, and defending large corporations accused of negligence. After nearly 15 years of practice, Tom decided to limit his practice to representing victims of medical negligence and joined the law firm of Chemnick Moen Greenstreet. Tom became interested in subrogation early in his career, when he realized just how dramatically subrogation claims could change his clients’ recoveries. As a result, Tom fights to maximizing his clients’ recoveries through creative and determined efforts to reduce or eliminate subrogation claims, because he thinks subrogation is simply a legal device used by insurance carriers to obtain a windfall at the expense of their insureds. Tyler Goldberg-Hoss Tyler Goldberg-Hoss is a partner in the Seattle firm of Chemnick Moen Greenstreet, which limits its practice to representing claimants in medical malpractice cases. Tyler is also an active member of the Washington State Association for Justice, where he currently serves as Board Member and Vice-Chair of the Public Affairs Committee. He is a 2009 graduate of the University of Washington School of Law. Bruce Goto Bruce Goto is a principal with Riddell Williams and a senior member of the firm’s Corporate Transactions and Finance practice, with a special focus on intellectual property and information technology issues. He has been providing pragmatic advice for business clients for 30 years, and has built long-term relationships based on trust and shared expectations. Bruce prepares and negotiates complex contracts covering cloud computing, outsourcing, application and technology development and licensing, information technology, enterprise services, and the manufacture, distribution, and marketing of various products. He develops brand strategies and registers trademarks, and counsels his clients on cyber security issues. Bruce has worked in the United States and abroad (in Tokyo and Honolulu), and is conversant in Japanese. He supplements his vast experience as outside counsel with his prior hands-on experience as in-house counsel. He regularly speaks and publishes on emerging issues in the fields of intellectual property and information technology. Laura W. Groshong Ms. Groshong is a Licensed Independent Clinical Social Worker in Washington and has been in clinical practice for the past 38 years. She is also a Registered Lobbyist in Washington for five mental health organizations. She was on the Board of the Washington Coalition for Insurance Parity for 10 years, the organization that was instrumental in passage of mental health parity in Washington in 2005 and 2007, as well as the passage of rules implementing these laws in 2014. She is the Director of Policy and Practice for the Clinical Social Work Association nationally and through the Mental Health Liaison Group worked on passage of the Mental Health Parity and Addiction Equality Act of 2008. She has written and lectured extensively on clinical and legislative issues around the country, in addition to maintaining her clinical practice. Lori Haskell Lori S. Haskell received her J.D. from Seattle University while still employed in the news department at KOMO TV. During her 10-year career in television she was a news cinematographer and editor, as well as a writer, producer and special topics producer.

After leaving television news Ms. Haskell clerked for Chief Justice Jay Rabinowitz of the Alaska Supreme Court. Upon entering private practice she chose to concentrate on trial work. Her cases are primarily in the area of tort litigation with an emphasis on personal injury and employment law. In her practice Ms. Haskell takes a wide variety of cases to trial on behalf of plaintiffs ranging from civil rights discrimination to car accidents and insurance bad faith claims. Her offices are located in Fremont, better known as the Center of the Known Universe. Ms. Haskell speaks regularly on the subject of trial work and has authored more than 35 articles on the intricacies of courtroom practice. She won a $1.3 million verdict on behalf of her client against Metro Transit for injuries sustained in a slip and fall on a bus. It is the largest verdict for a slip and fall on public transportation in this state and exposed a dangerous condition that exists on Metro buses. Ms. Haskell recently won an appellate court decision reversing the trial court in a police misconduct case. The appellate court ruled that police officers just like any other citizen-are liable for their negligent conduct. In December 2012, Ms. Haskell was notified that a Spokane court had granted custody of her elderly mother to a virtual stranger who had filed a Petition for Guardianship. The law does not require family members to receive advance notice of such actions. During a second hearing, the court overruled the notarized Durable Power of Attorney her mother had signed to assure that Lori would be named her Attorney-In-Fact. This action made Ms. Haskell's mother a ward of the state and granted complete and total control over all decision making to a Certified Professional Guardian. Lori Haskell engaged in a 10- month legal battle to gain custody of her mother. The experience has spurred her to work on behalf of reforming Washington guardianship laws so that others do not experience a similar tragedy. Bruce F. Howell Bruce Howell is one of the pioneers in the practice of health law. From being one of the founders of the Dallas (Texas) Bar Association's Health Law Section to one of the first attorneys to be certified as a Board Certified Health Lawyer by the Texas Board of Legal Specialization in 2002, Mr. Howell has experienced a vast array of issues across the health industry spectrum. He focuses his practice on various aspects of health law, including reimbursement, fraud and abuse, managed care issues, physician practice management issues, and the Affordable Care Act of 2010. He also handles cases involving genetics, organ transplant technology, laboratory matters, clinical research and health care insurance coverage. Mr. Howell has represented companies and individuals in health care governmental investigations and counseled clients in structuring transactions to comply with health law regulatory requirements. He has also created compliance programs, and consulted on corporate governance matters and tax enforcement matters in nonprofit tax/health care work. Mr. Howell is also experienced in litigating cases related to health care insurance, ERISA issues, and health law regulatory matters as well as serving as an expert witness in some of these areas. He counsels providers and businesses in complying with the requirements of and finding financial opportunities in connection with the Affordable Care Act of 2010. Mr. Howell serves on the ABA Health Law Section as Vice Chair of the Physicians Legal Issues Conference and Vice- Chair of the Health Lawyer Editorial Board. Kristin Meier Kristin is a member of Ryan Swanson’s Litigation, Employment and Healthcare groups and has provided consultation and litigation services for her healthcare and employment clients. Along with advising clients on the numerous federal, state and local employment laws that apply to them, Kristin has been speaking and advising clients on the requirements for employers contained in the ACA since its passage in 2010. Kristin has worked with clients to determine what portions of the law affect them as well as providing specific assistance with unique employee situations which could alter the client’s status under the ACA. She has also tracked the numerous changes to the law that impact employers’ compliance with the ACA and ensures that she apprises her clients of the impact, if any, of the modifications of the regulations administering the ACA. Karin Mitchell Karin Mitchell was born and raised in Washington State. She graduated from Seattle Pacific University in 1985, with a Bachelor’s of Science in Nursing. After graduation she worked at Fred Hutchinson Cancer Research Center, initially as a Bone Marrow Transplant Nurse and then as the Adult/Pediatric Critical

Care Education Specialist. During this time, Ms. Mitchell co-chaired the Medical Standard, Practice Committee and worked in Quality Management. In 1998, Ms. Mitchell accepted a position at Amgen, Inc. Over ten years, Ms. Mitchell held a variety of positions at Amgen on both the West and East Coasts. Her last position was as a Senior Marketing Manager. Ms. Mitchell lectured nationally and internationally and published textbook chapters on a variety of topics in oncology, hematology, immunology and critical care medicine. In 1996, Ms. Mitchell had the privilege of leading the President Eisenhower Citizen Ambassador Delegation to South Africa. In 2008, Ms. Mitchell resigned from Amgen, Inc. to attend law school. Ms. Mitchell graduated from Seattle University School of Law in 2011. Currently, Ms. Mitchell is an Associate Attorney at Johnson, Graffe, Keay, Moniz & Wick, where she has worked since being hired as a Law Clerk in May 2009.Since law school Ms. Mitchell lectures on a variety of issues related to medical malpractice, HIPAA, and medical ethics. Karin is also a national board member for the “National LGBTQ Taskforce” based in D.C., volunteers with Washington NAMI to provide legal review for the various county affiliates, and mentors to law students through QLaw. Donna M. Moniz Donna Moniz is a partner at Johnson, Graffe, Keay, Moniz & Wick, LLP. Her practice with the Seattle-based firm emphasizes the defense of medical negligence claims and health care law, including medical staff issues and professional licensing. Ms. Moniz has defended medical negligence claims on behalf of urban and rural hospitals and other health care providers in western Washington, with excellent results. These include the defense of cases involving brain damaged infants.Ms. Moniz has provided consultative services on a regular basis to hospitals regarding practice issues, and she also advises on medical staff bylaws, policies and procedures, physician credentialing and risk management. She also represents health care providers who are investigated or charged by the Department of Health and its various commissions. A law school graduate of the University of Washington, Ms. Moniz has over 30 years of legal experience and is frequently invited to speak to various health care professionals. Subjects of her presentations include malpractice, peer review, risk management, licensing and AIDS. She has also been published in professional books and journals. John Peick John C. Peick is a principal in the firm of Peick|Boyer Law Group, P.S. with offices located in Bellevue, Washington. He focuses on two distinct practice areas: healthcare/business law with a focus on individual providers and small to medium clinics, and plaintiff personal injury and wrongful death. He is also a neutral for mediation and arbitration dealing with issues in either of these practice areas. He is a graduate of the University of Washington with a B.A. Political Science in 1972. He attended the University of Iowa School of Law in Iowa City, Iowa, transferred to the UW Law School in 1973, and graduated in 1975. He is a member of the Washington State Bar Association (1975), U.S. District Court, Eastern & Western District, Washington (2012 & 1975), U.S. Tax Court (1976) and Ninth Circuit Court of Appeals (1998). He is a member of the American Bar Association, American Health Lawyers Association, Washington State Association for Justice (1984-Present), American Association for Justice, and National Association of Chiropractic Attorneys. He served for many years on the Board of Governors for the Washington State Association for Justice. He has taught law courses on the community college level and at City University, and has been a frequent speaker at various healthcare provider seminars and meetings. He lives in Issaquah, Washington with his beautiful wife and daughter. Michelle Peterson After practicing for 15 years in both a large law firm and a small boutique litigation firm, Michelle opened her own firm in December 2014, Michelle Peterson Law, PLLC. Michelle continues to focus her practice in commercial litigation, white collar criminal defense and government investigations. Michelle’s experience includes representing businesses and individuals in all aspects of litigation, including white collar criminal prosecutions, qui tam matters, government investigations and commercial disputes. She also focuses her practice on compliance issues and governmental investigations relating to long-term care and senior housing, including false claims, anti-kickbacks, and Medicare and Medicaid reimbursements. Michelle has experience defending clients against False Claims Act allegations and also representing relators in pursuing these claims.

Brian Peyton Brian Peyton is the Director of Legal Services for the Health Benefit Exchange. He provides legal advice and analysis to the Exchange Board and staff and oversees the Exchange appeals process. Prior to joining the Exchange, he served as Director of the Office of Policy, Legislative and Constituent Relations (PLCR) at the Washington State Department of Health. Before taking that position, he worked as Director of Regulatory Affairs for the University of Washington Medical Center. Brian was the Assistant Director of PLCR from 1998 until 2003, and was a Health Law Judge for the Department of Health from 1993 until 1998. He has worked as an Assistant Attorney General and a lawyer in private practice. He has a bachelor of arts in political science from Columbia University and a law degree from the University of Michigan. Joyce Roper Joyce Roper is a Senior Assistant Attorney General with the state of Washington Attorney General’s Office. She serves as counsel to the State of Washington Department of Health, advising the Secretary’s Office, the Office of Emergency Preparedness and Response, Risk Management, the Prescription Monitoring Program and the Pharmacy Quality Assurance Commission. Joyce’s experience in health law and policy began in the regulatory arena with health professions and health facilities licensing. Joyce assisted in the establishment of the Department of Health in 1989 as programs from the Department of Social and Health Services and the Department of Licensing were moved into the newly created Department of Health. For a time, she served as counsel to Department of Social and Health Services working with the Medicaid program. When her client assignments were outside the arena of public health, Joyce continued to gain health policy experience by serving on the Board of Trustees for Group Health Cooperative, becoming Vice-Chair of the Cooperative, until her responsibilities at the Office of the Attorney General once again included a return to serving as counsel for the Department of Health, as well as the Health Care Authority. Eric Schmidt Commissioner Eric B. Schmidt was appointed as a court commissioner for Division II of the Court of Appeals, effective January 1, 2002. Prior to his appointment, Commissioner Schmidt was the Senior Health Law Judge for the Washington State Department of Health from 1996 to 2001. Commissioner Schmidt graduated from Seattle University School of Law (formerly University of Puget Sound School of Law) in 1985. He holds a bachelor's degree in kinesiology, a master's degree in philosophy and Ph.D. in philosophy and bioethics from the University of Washington. He's also an adjunct professor of law at Seattle University School of Law, teaching bioethics and the law and medical liability. Jennifer K. Sheffield Jennifer Sheffield focuses her practice on health care and complex commercial litigation matters. She represents health care providers and long term care providers, handling cases that involve allegations of malpractice, negligent hiring and supervision, neglect, wrongful death and personal injury. Her experience includes litigation of commercial disputes in federal and state court. Jennifer was named a “Washington Rising Star” in 2013, 2014 and 2015 by Super Lawyers magazine. Jennifer is a graduate of Seattle University School of law, where she was Editor in Chief of Seattle University Law Review. Gavin Skok Gavin Skok is Chair of Riddell Williams' Litigation Group and a member of the firm's Privacy and Data Security Group. He is a commercial litigator who represents regional and national companies in state and federal courts, with an emphasis on class action defense, data security litigation, securities fraud, and intellectual property disputes. Gavin regularly advises clients on data security and privacy issues, and defends companies in data security litigation. Gavin has taken multiple cases to trial in federal, state and local courts, and regularly volunteers pro bono time to a local public defender agency. He is also a regular speaker at CLEs and in-house client trainings regarding privacy, data security, class actions and attorney-client privilege issues. Prior to joining Riddell Williams, Gavin was a federal judicial law clerk to United States District Court Judge Robert H. Whaley (E.D. Wash.) Kayla Stahman

Kayla Stahman is an Assistant United States Attorney in Seattle who focuses her practice on health care fraud cases. Prior to serving as an AUSA, Kayla was an Associate in the Securities Regulatory and Enforcement Group at Wilmer Cutler Pickering (now Wilmer Hale) in Washington D.C. Kayla is a graduate of Stanford Law School and Emory University. Shata L. Stucky Shata L. Stucky is an attorney at Riddell Williams P.S., where she focuses her practice on commercial litigation and privacy and data security issues. She assists clients with the development of privacy policies and terms of use, advises clients on privacy statutes and regulations, helps companies respond to data breaches, and has defended major corporations in nationwide class actions alleging breach of data privacy obligations. Ms. Stucky has earned the Certified Information Privacy Professional/United States (CIPP/US) credential through the International Association of Privacy Professionals (IAPP). She received her J.D., cum laude, from the University of Minnesota Law School. Prior to joining Riddell Williams, Ms. Stucky clerked for the Honorable Harriet Lansing (ret.) of the Minnesota Court of Appeals. Paul Swegle Paul Swegle is General Counsel of Numera, Inc. and he serves as Acting General Counsel to Venuelabs, Payment Gear, and cloudRIA. He is the Chair of the Corporate Counsel Section of the WSBA and serves on the WSBA’s Securities Law Committee. Paul has worked on financings and M&A deals totaling more than $11 billion. He is a former SEC Enforcement and Corporation Finance attorney and served two appointments as Special Assistant United States Attorney. Paul currently serves on the Board of the Alliance for Pioneer Square and also Co-Chairs the annual Cystic Fibrosis StairClimb in Seattle.

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Federal Prosecution of Health Care Fraud

Kayla Stahman, AUSA

U.S. Attorney’s Office

700 Stewart Street, Suite 5200

Seattle, Washington 98101

(206) 553-4319

Views expressed in these slides and in the accompanying presentation are those of the author/speaker and do not necessarily reflect the views of the Department of Justice, the United States Attorney’s Office, or any other government agency or department.

Michelle Peterson

Michelle Peterson Law, PLLC

1420 Fifth Avenue, Suite 2200

Seattle, Washington 98101

(206) 224-7618

Sources of Cases

Offices of Inspectors General

FBI

Insurance Companies

Medicare Program Integrity Contractor

Qui Tam Relators

Altruistic Whistleblowers/Hotline Complaints

Patients

Disgruntled Employees

Ex-Spouses

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Frequently Used Criminal Statutes:

Health Care Fraud – 18 USC § 1347 (public or private health care benefits programs)

False, Fictitious, Fraudulent claims – 18 USC § 287

Conspiracy to Defraud the United States – 18 USC § 371

Theft of Public Money – 18 USC § 641

Conspiracy to Defraud the United States with Respect to False Claims – 18 USC § 286

False Statements – 18 USC § 1001

False Statements Relating to Health Care Matters – 18 USC §1035

Wire Fraud – 18 USC § 1343

Mail Fraud – 18 USC § 1341

Criminal Prosecution of Health Care Fraud

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Criminal Investigative Tools

Search Warrant: Issued upon finding of probable cause by judicial officer(s) that federal criminal violation has occurred. Fruits of search can be shared with civil side.

Grand Jury Subpoena: Production/testimony cannot be shared with civil side.

HIPAA Subpoena: DOJ administrative subpoena issued in connection with open criminal investigation. Production canbe shared with civil side. Testimony cannot be compelled.

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Civil Health Care Prosecutions

Civil Remedies:

False Claims Act, 31 USC § 3729

Treble damages and $5,500 - $11,000 civil penalties per claim

Qui Tam Action, 31 USC § 3730

Common Law Claims: Breach of Contract; Unjust Enrichment; Payment by Mistake; Fraud

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Elements of False Claims Act (“FCA”) Violation, 31 U.S.C. § 3729

Claim for payment

Falsity

Materiality

“Knowledge”

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Elements of False Claims Act (“FCA”) Violation, 31 U.S.C. § 3729

(a)(1). FCA imposes liability on any person who:

A. knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval

B. knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim

C. conspires to commit a violation of the statute

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Elements of False Claims Act (“FCA”) Violation, 31 U.S.C. § 3729 (continued)

G. knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit money or property to the Government, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government

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5


Materiality: Statement must be material to Medicare’s payment decision:

“[A statement] having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.” 31 U.S.C. § 3729(b)(4)

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(b)(1) “Knowingly” –

(A)(i) Actual knowledge that a claim for payment or record/statement used to get claim paid is false

(ii) Deliberate ignorance of the truth or falsity of a claim or record/statement

(iii) Reckless disregard of the truth or falsity of a claim or record/statement

(B) No specific intent to defraud is required

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6


(b)(2) “Claim” -- any request or demand for money or property:

(A)(i) Presented to an officer, employee or agent of the United States, or

(ii) Made to a contractor, grantee, or other recipient if the money or property is to be spent or used on the government’s behalf or to advance a government program or interest, and if the United States

(3) “Obligation” -- an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, from a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment

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Liability: Civil penalty between $5,500 and $11,000 (adjusted for inflation), plus 3 times the amount of damages sustained by the government. See 31 U.S.C. 3729(a)(1)(G)

Burden of Proof: Preponderance of the Evidence. See 31 U.S.C. § 3731(d)

Statute of Limitations: 6 years from the date of the violation or not more than 3 years after the date when facts material to the right of action are known or reasonably should have been known by the official of the United States charged with responsibility to act in the circumstances, but in no event more than 10 years after the date of the violation. See 31 U.S.C. §3731(b)

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ACA’s Changes to the FCA

Incorporate AKA: Establishes that a violation of the Anti-Kickback Statute (“AKS”) can be the basis for an FCA violation.

Knowledge and Intent: Changes intent-and-knowledge requirements under AKS. Now, a “person need not have actual knowledge or specific intent to commit a violation of this section”

Hanlester Defense: Affects Hanlester defense, interpreting AKS to require proof defendant (1) had specific knowledge of the law, and (2) had specific intent to disobey the law. Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995).

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ACA’s Changes to the FCA

Overpayments: Creates Per Se FCA Violation for Failure to Report and Return Overpayments:

ACA provides a 60-day deadline for reporting and returning overpayments.

Deadline is the later of:

(A) the date which is 60 days after the date on which the overpayment was identified; or

(B) the date any corresponding cost report is due, if applicable.

Effective for overpayments “identified” as of March 23, 2010.

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Qui Tam Actions

Typical Relators:

Disgruntled/Concerned Employees (salesmen, compliance officers, QA personnel)

Ex-Employees

Competitors

Consultants

Ex-Spouses/Significant Others of Corporate Insiders

Patients

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Qui Tam Actions

Procedural Posture:

Action filed under seal.

Statutorily-mandated 60-day investigation with extensions for good cause.

Government required to elect intervention/non-intervention.

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Qui Tam Actions

Relators:

Relator’s share = 15-25% or 25-30%.

Relator who “planned and initiated.”

Relator may object to government settlement.

3730(h): Whistleblower protection provision.

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Civil Investigative Tools

OIG Subpoena: Administrative subpoena issued by investigative agency (HHS-OIG). Documents only. Production may be shared with criminal side.

Civil Investigative Demands: Authority to issue recently delegated to United States Attorneys. Testimony and documents.

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Importance of Intervention

The Government intervenes in roughly 30% of qui tam cases filed.

Rate has stayed roughly consistent since 1986

In intervened cases, there is a “success” rate (settlement or verdict) of roughly 90%

In non-intervened cases, the “success” rate is inversed or roughly 10%

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“Public Disclosure Bar”

“Parasitic” lawsuits – i.e., lawsuits based upon criminal indictments or other information already known to the government.

Affordable Care Act recently amended the FCA, liberalizing the showing Relators must make when the information upon which the allegations in their qui tam lawsuits are based has been “publicly disclosed.”

A Relator must have either

(1) voluntarily provided the information to the government prior to the public disclosure or

(2) have knowledge that is “independent of and materially adds to” the publicly disclosed allegations.

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Administrative Remedies

Civil Monetary Penalties Law

Exclusion Proceedings

Suspension Proceedings

Corporate Integrity Agreement – typically imposed in conjunction with FCA settlement

Annual independent audit with prescribed error rate (5%)

Annual reporting requirement

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FY2013 False Claims Act Statistics and Recoveries

$3.8 billion in FCA settlement and judgments

$2.6 billion of $3.8 billion resulted from health care fraud matters (Medicare, Medicaid, Tricare, VA, Federal Employee Health Benefits Program)

Approximately $2.9 billion of FY2013 recoveries associated with qui tam actions

Whistleblowers (“Relators”) received $345 million from proceeds of recoveries

Total FCA recoveries since FCA substantially amended in 1986 = $39 billion

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USAO/DOJ Health Care Fraud Enforcement Priorities

Pharmaceutical Companies: Off-Label Promotion, Kickbacks, Pricing to Federal Customers

Labs (Genetic Testing/Urine Testing): Physician Kickbacks and Tests Never Performed

Individual Providers: Upcoding, Medical Necessity, Services Not Rendered, Kickbacks

Hospitals: Upcoding DRGs, Medical Necessity (in-patient vs. out-patient procedures, etc.), Kickbacks

Nursing Homes: Overutilization of Services, Medical Necessity/Ability-to-Benefit, Quality of Care

Physical, Occupational and/or Speech Therapy: Overutilization, Missing Prescriptions, Use of Timed Codes vs. “Per Encounter” Codes

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Frequently Seen Medicaid Issues

Home Health Care Services not rendered, medically unnecessary services, provider not

trained/qualified

Assisted Living Facilities/Group Homes Services not rendered or deficient care, worthless services,

untrained/unlicensed providers

Skilled Nursing Inadequate care, medically unnecessary services

Occupational/Physical/Speech Therapy Over-utilization, patient lacks inability to benefit

Psychological Counseling Over-utilization, patient lacks ability to benefit

Pain Management Over-utilization, upcoding

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Characteristics of a Good Case

Objective evidence of wrongdoing

Widespread/persistent wrongdoing

Actual/potential risk of patient harm

Significant monetary loss

Readily ascertainable damages

Relatively straightforward scheme

Blatant/flagrant nature of conduct

Clear and reasonable payer prohibition

If medical necessity is an issue, limited potential for battle of experts

Financial means of defendant → Individual v. Entity

Availability of claims data/medical records

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Case Studies

Oncology: Dr. Fata

Medical Devices: LifeWatch and CardioNet

Nursing Home Failure of Care: Houser Nursing Homes

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Karin J. Mitchell, RN, JDJohnson, Graffe, Keay, Moniz & Wick LLP

August 10, 2015

Gary Larson“Far Side”

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Have a basic knowledge of anatomy

Prefix – usually location or area of the body LIPO

Root – principal meaning DYS

Suffix – modifies the terms central meaning TROPHY

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Percutaneous Pancytopenia Contraceptive Endoscopy Erythrocyte Laminectomy

Gastritis Osteoporosis Hyperglycemia Hepatitis Hyperlipidemia Angioplasty

Simplifying Medical Terminology:Take apart the word

a.c. b.i.d. BMP C&S COPD CVA DM DVT ETOH ggt

H&H HTN I&D NPO OD/OS/OU ORIF PRN PERRLA PLT SOB

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Detailed color anatomy resource

Illustrated medical dictionary

Manual of diagnostic and laboratory tests

General medical references specific to specialty area

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Data belongs to the patients

The physical form the data takes belongs to the entity maintaining the medical record

Medical History

Medical Encounter/ Progress Notes

Orders & Prescriptions

Flowsheets

Laboratory and Diagnostic Test Results

Administrative Information

Medical Billing and Coding

Mental Health Records

Discharge Instructions

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Overview Initial history and physical Most recent history and physical Most recent progress note Discharge note if available

Target date range or specific provider(s)

If data heavy create tables/graphs for trending

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Create key records set Supplement as necessary

Provide key records to experts Do not include any firm created tables or graphs If limited number of records provide entire record Supplement as requested by expert

Create medical chronology

DATE BATES PROVIDER NOTES7/27/040154

37 Dr. Jones Assessment1. ARF2. Bleeding diathesis3. Acute blood loss anemia4. Hemorrhagic shock5. PEA cardiac arrest6. DIC7. S/P C-section8. Pulmonary edema

Plan1. Resp; Titrate PEEP until stable enough for diaphoresis; r/o transfusion related acute lung injury2. CV: Episodes of cardiac arrest likely secondary to volume loss and metabolic derangements3. GYN: Continued oozing from multiple sites4. Renal: Function appears intake with adequate output. Metabolic disturbances were corrected. Monitor

for intra-abdominal hypertension or compartment syndrome that may affect renal function5. HEME: Received approximately 14 units PRBC’s, 6 units FFP, 4 units Cryo, two 6 packs of platelets, 2

does of recombinant factor VIIA. Not required further blood products; INR and PTT are normalizing. Fibrinogen mildly low with significantly elevated D-Dimer

6. Endocrine: Insulin drip to permit tight glycemic control.

Smith v. Dr. JonesMedical Records Chronology of Jane Doe July 26, 2004 – August 29,2004

12

From your client - Examples All medical records for past 5 years Identify date ranges Identify outside providers – e.g. pathologist

From opposing party - Examples Stipulation Have to request mental health records separately from

medical records Request all medical records including those from outside

providers

BATES Labeling

Electronic Medical Records are not conducive to printing

Without printing they cannot be reorganized into sections

Use searchable database to identify and print key records to reorganize (e.g. OCR)

1

Identifying the Client,Protecting Confidentiality, and Managing Multijurisdictional

Practice Issues

Paul Swegle

August 10, 2015

Identifying the Client

• Company

• Affiliates

• Subsidiaries

• Other stakeholders– Officers, directors

– Owners

2


• The existence of an attorney‐client relationship “turns largely on the client’s subjective belief that it exists”– In re McGlothlen, 99 Wn.2d 515, 522, 663 P.2d 1330 (1983)

• Subjective belief does not control unless it is reasonably formed based on the circumstances, including the attorney’s words or actions– Bohn v. Cody, 119 Wn.2d 357, 363, 832 P.2d 71 (1992)


• Healthcare Organizations. Need for vigilance heighted by:– Organizational complexity/affiliate relationships

– Ever‐changing regulatory mandates

– Trends toward greater integration and transparency

• The Organizational Client and its “Constituents”. Rule 1.13(a) states the following overarching principle: A lawyer employed or retained by an organization represents the organization acting through its duly authorized constituents.

• Role Clarification. The above principle is not always well understood by others. • Rule 1.13(f) ‐ In dealing with an organization's directors, officers, employees, members,

shareholders or other constituents, a lawyer shall explain the identity of the client when the lawyer knows or reasonably should know that the organization's interests are adverse to those of the constituents with whom the lawyer is dealing.

• Dual Representation. Carries special risks, both for the lawyer and the clients. Requires strong alignment of interests, such as between a parent company and its wholly‐owned subsidiaries.

3

Identifying the Client:Potential Issues

• Conflicts of Interest ‐Where counsel has mistakenly allowed a colleague, affiliate or other third party to believe that counsel is actually their/its attorney too, the attorney may find it impossible to fulfill his or her duties to the real client under the conflicts rules because of the “pre‐existing relationship” that has developed.

• Confidentiality Issues – Violation of RPC 1.6, loss or Attorney‐Client Privilege.

Identifying the ClientHypotheticals

• Fellow employee Beth asks you, in‐house counsel, for information about her rights under a company stock plan.

• A dominant shareholder calls to ask for your opinion regarding the tax consequences of a previous restructuring transaction.

• The Chair of the Audit Committee calls to discuss a specific internal audit report with you.

4

Protecting Confidentiality

• Duty to Protect. Comment 2 to Rule 1.13 ‐ the in‐house lawyer has a duty to protect the client’s confidences – to not divulge “information relating to the representation” unless the client gives informed consent or the disclosure is “impliedly authorized to carry out the representation.”

• Case‐by‐Case. For in‐house counsel, “the representation” is not a single project or issue – it involves numerous separate and distinct projects and issues. – Use professional judgment to determine which employees are

appropriate recipients of any “information relating to the representation.”

– Carefully manage written and oral communications.– Special Investigations and other situations require specific disclosures.

• Exceptions to Prohibition against Non‐disclosure. RPC 1.6(b)

Protecting ConfidentialityHypotheticals

• Andrew, a highly regarded Project Manager, stops you in the hallway to ask how the acquisition of XYZ Hospital is going.

• Mark, the CFO, stops you in the hall to ask how a certain internal investigation not involving her is going.

• The CEO knows you have been working with the board’s compensation committee on her new employment agreement and calls you in to ask how it’s looking.

• You’re GC of a large HMO and you are invited to speak at a CLE on how your organization is responding to certain new regulatory mandates.

5

Multijurisdictional Practice

• RPC 5.5(a) ‐ A lawyer shall not practice law in a jurisdiction in violation of the regulation of the legal profession in that jurisdiction, or assist another in doing so.

– It’s a violation to violate any jurisdiction’s licensing requirements, not just WA’s.

– Any work in other jurisdictions requires a similar analysis.

Multijurisdictional Practice

• RPC 5.5(b) ‐ A lawyer who is not admitted to practice in this jurisdiction shall not:

– (1) except as authorized by these Rules or other law, establish an office or other systematic and continuous presence in this jurisdiction for the practice of law; or

– (2) hold out to the public or otherwise represent that the lawyer is admitted to practice law in this jurisdiction.

6

Temporary Practice

• RPC 5.5(c) ‐ A lawyer admitted in another United States jurisdiction, and not disbarred or suspended from practice in any jurisdiction, may provide legal services on a temporary basis in this jurisdiction that:

(1) are undertaken in association with a lawyer who is admitted to practice in this jurisdiction and who actively participates in the matter;(2) are in or reasonably related to a pending or potential proceeding before a tribunal in this or another jurisdiction, if the lawyer, or a person the lawyer is assisting, is authorized by law or order to appear in such proceeding or reasonably expects to be so authorized; (3) are in or reasonably related to a pending or potential arbitration, mediation, or other alternative dispute resolution proceeding in this or another jurisdiction, if the services arise out of or are reasonably related to the lawyer’s practice in a jurisdiction in which the lawyer is admitted to practice and are not services for which the forum requires pro hac vice admission; or(4) are not within paragraphs (c)(2) or (c)(3) and arise out of or are reasonably related to the lawyer’s practice in a jurisdiction in which the lawyer is admitted to practice.

• RPC 5.5 (d) ‐ A lawyer admitted in another United States jurisdiction, and not disbarred or suspended from practice in any jurisdiction, may provide legal services in this jurisdiction that:

(1) are provided to the lawyer’s employer or its organizational affiliates and are (i) provided on a temporary basis and (ii) not services for which the forum requires pro hac vice admission; …

Non‐Temporary Alternatives• Two non‐temporary alternatives in WA:

– APR 3(c) ‐ Admission by Motion as a fully licensed attorney for under APR 3(c) if the attorney has practiced 3 out of last 5 years.

» APR 3(c) ‐ two primary hurdles: (1) active legal experience for 3 out of the last 5 years; and (2) passing the Washington Law Component (WLC) test.

– APR 8(f) ‐ “Limited house counsel license.”

» APR 8(f) ‐ Attorneys admitted as “house counsel” under APR 8(f) are strictly limited to providing advice to their employer‐client and cannot appear in court, but still must abide by the same MCLE requirements and license fees as fully licensed members.

• Oregon – Attorney Admission Rule 16.05:– Admission of House Counsel – proof bar passage, entity‐employer affidavit, OR Bar

investigation into character and fitness, and pass Professional Responsibility Exam.

– Business cards, letterhead and directory listings must identify the attorney's employer and that admitted to practice in Oregon only as house counsel or the equivalent;

– Admission suspended if employment terminates

7

Multi‐jurisdictional Practice Hypotheticals

• Lawyer joins Washington‐based ABC HMO as in‐house counsel

• Lawyer is licensed to practice in California• Lawyer’s office will be located in Washington• XYZ Hospital is ABC’s wholly owned subsidiary, located in Oregon

• Lawyer will spend 2/3 of her work time in Washington, at ABC’s offices

• Lawyer will spend 1/3 of her work time in Oregon, at XYZ’s offices

Multi‐jurisdictional Practice Hypotheticals

• Manager asks Lawyer to draft non‐compete agreements for new ABC HMO’s employees (WA).

• Manager asks Lawyer to draft cost‐sharing agreement between ABC HMO and XYZ Hospital.

• Manager asks Lawyer to review and advise about his employment agreement, which is up for renewal.

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Excerpts from Comments

• “Other than as authorized by law or this Rule, a lawyer who is not admitted to practice generally in this jurisdiction violates paragraph (b) if the lawyer establishes an office or other systematic and continuous presence in this jurisdiction for the practice of law.” RPC 5.5 cmt. 4

• “Presence may be systematic and continuous even if the lawyer is not physically present here. Such a lawyer must not hold out to the public or otherwise represent that the lawyer is admitted to practice law in this jurisdiction.” RPC 5.5 cmt 4

• “In Washington, paragraph (d)(1) applies to lawyers who are providing the services on a temporary basis only. If an employed lawyer establishes an office or other systematic presence in this jurisdiction for the purpose of rendering legal services to the employer, the lawyer must seek general admission through APR 3 or house counsel admission under APR 8(f).” RPC 5.5 cmt. 17

Discussion

1

NAVIGATING THE HEALTHCARE MINEFIELD

Defending Providers

JOHN C. PEICK, J.D.PEICK | BOYER LAW GROUP, P.S.

BELLEVUE, WASHINGTONWWW.PEICKLAW.COM

425-462-0660

MISSTEPS CAN BE FATAL 2

2

YOU CANNOT DEPEND ON THEM FOR SALVATION

3

COMPLIANCE

WHY SHOULD I CARE?

3

LOMPOC

CAMP SHERIDAN

4

PRINCIPAL INTERFACES

PAYERS

Co-PROVIDERS

YOU PATIENTS

REGULATORS

WHY WORRY?

If you have a provider client that responds to your cautionary comments with:

My patients love me!My staff love me!

In fact, I do not know anyone that does not love me.

8

5

THEY ARE

DOOMED!

9

REALITY TIME!SOURCES OF RISK

EMPLOYEESPATIENTS

COMPETITORSCME/IME REVIEWERS

ATTORNEYSREGULATORS

PAYERSYOU

10

6

WHAT CAN HAPPEN

Professional Discipline Criminal Investigation

Insurance Company Audits Insurance Company Terminations

Civil Claims by Patients

REGULATORY COMPLIANCE

WHERE THE BIG STICK CAN SMASH THE *%*$&$ OUT OF YOUR LIFE

7

FEDERAL HEALTHCARE CRIMINAL LAWS

Healthcare Fraud under HIPAA

False Statements relating to Healthcare

Medicare Patient Protection Act

Anti-Kickback & Self-Referral (Stark I & II)

False Claims Act

Mail & Wire Fraud

Obstruction of Justice

State Healthcare Related Laws

Anti-Rebating (Ch. 19.68 RCW) Healthcare Insurance Trafficking (Ch. 48.30A

RCW ) False Insurance Claims (RCW 48.30.230) Healthcare Fraud (Ch. 48.80 RCW) Criminal Profiteering (RCW 9A.82.010) Healthcare Disciplinary Act (RCW 18.130.180) Self-Referral Prohibitions (DSHS) Medical Records Privacy (Ch. 70.02 RCW)

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8

PRIVACY, SECURITY & ACCESS

HIPAA covered entity status governs HIPAA vs. UHCIA UHCIA has parallel features but less complex HIPAA has both privacy aspects and electronic security HITECH amendments to HIPAA increase security breach

sanctions but also place direct HIPAA responsibility on Business Associates

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MINIMAL CLIENT HIPAA-HITECH COMPLIANCE

Encrypt your computers & email containing PHI Conduct a HIPAA risk assessment review Create training for staff on HIPAA Review data safeguards for your PHI Create and distribute your Notice of Privacy Practices Make sure you have promulgated and trained staff on

your other HIPAA policies & procedures Have you made provisions for reporting any breach of

HIPAA? If your clients need a compliance review, contact John

Conniff at 253-759-7767 with Compliant Solutions.

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9

Attorneys & HIPAA-HITECH

Merely handling PHI does not trigger HIPAA: So personal injury attorneys do not have to be HIPAA compliant. They represent patients not providers.

However, when you represent a healthcare provider and have access to PHI, you become a business associate of the provider. Under HIPAA-HITECH, you are directly responsible for privacy and security compliance with those records.

In addition to your engagement letter, have a business associate agreement signed by the provider.

Retain IT personnel familiar with HIPAA and NIST security standards.

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COMMON PROVIDER MISTAKES Billing for non-credentialed providers Billing for unbundled services Billing wrong codes for services Billing higher time codes without supporting

documentation Collecting discount balances from patients for covered

services (P.I., Insurance or L&I) Billing services under inappropriate provider No or little documentation of services No or little documentation of medical necessity No or little documentation of reasonableness

10

GROUP PRACTICES

MISERY LOVES COMPANYOR

THE MORE THE MERRIER

What is Group Practice

“Group Practice” is generally defined as three or more providers who deliver patient care, make joint use of equipment and personnel, and divide income by a prearranged formula.

Group Practice may be single discipline or multidisciplinary.

11

Legal Structure of Group Practices

Sole Proprietor with Associates Partners (with or without Associates) Shareholders in Professional Service Corporation (with or

without Associates) Members in Professional Limited Liability Company (with

or without Associates) Combination of Above Entities

Advantages of Group Practice

Increased Economies of Scale in Use of Equipment & Technology

Reduces Per Provider Staff Overhead Increased Marketing Capabilities & Resources Generates Stable Income Stream Enables Practice to Maximize Utilization of Associates

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12

Disadvantages of Group Practices

Requires Uniformity in Staff Procedures & Billing Individual Practice Variations Will Come Under Scrutiny

for E&O Exposure Increased Financial Accountability A General Sense of Loss of Control Requires Team Player Skills

23

MULTI-DISCIPLINARY PROFESSIONAL COMBINATIONS

GROUP IAcupuncturist, Mental Health,

Podiatrist, DC, Dental Hygienist, Opticians, Hearing Aid, Naturopathic, Midwifery, Optometry, Ocularist, Osteopathy, D.O. Assistant, Pharmacist, M.D., P.A., Nurses, Psychologist, Respiratory, LMP, Dieticians, Nutritionists

GROUP IIPhysical TherapistsOccupational

Therapists

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MultiDisciplinary Group Practice Advantages

Same economies of scale as single discipline groups. Breadth of healthcare expertise is a marketing strength

to consumers - One Stop Shopping Marketing advantage to MCO & ACOs Opportunity to deliver more comprehensive health care

solutions with better patient outcomes Same disadvantages

Traps for the Unwary Multi-disciplinary Group

Failure to incorporate as professional services corporation or PLLC

Failure to understand scope of practice limitations between professionals

Failure to delineate services provided Failure to bill separately Failure to document reasons for intercompany referrals Failure to contract and credential all professionals-

lending your NPI

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SEXUAL MISCONDUCT

A healthcare provider shall not engage, or attempt to engage, in sexual misconduct with a current patient, client, or key party, inside or outside the health care setting.

KEY PARTY'Key party' means immediate family members and others who would be reasonably expected to play a significant role in the health care decisions of the patient or client and includes, but is not limited to, the spouse, domestic partner, sibling, parent, child, guardian and person authorized to make health care decisions of the patient or client.

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DEFINITIONS

Twenty one separate offenses which constitute sexual misconduct (WAC 246-16-100(1)

Suggesting or discussing the possibility of a dating, sexual or romantic relationship after the professional relationship ends.

Terminating a professional relationship for the purpose of pursuing a relationship.

Any behavior, gestures, or expressions that may reasonably be interpreted a seductive or sexual.

TERMINATION

The healthcare provider shall not engage, or attempt to engage, in the activities listed in (1) of this section with a former patient, client or key party within two years after the provider-patient/client relationship ends.

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POST TWO YEARS?

After the two year period, a health care provider shall not engage in the (1) activities, IF

There is a significant likelihood that the patient, client or key party will seek or require additional services from the provider.

There is an imbalance of power, influence, opportunity and/or special knowledge of the professional relationship.

DEFENSE

'Legitimate health care purpose' means activities for examination, diagnosis, treatment, and personal care of patients or clients, including palliative care, as consistent with community standards of practice for the profession. The activity must be within the scope of practice of the health care provider.

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MANDATORY REPORTING

There has always been some reporting requirements, particularly courts and insurance companies.

In May 2008, the reporting requirements were broadened to require licensees to report on other licensees and to self report their own defined acts or omissions.

Failure to provide a mandatory report is unprofessionaconduct in and of itself.

Carefully read the definitions of the mandatory reporting rules because not everything or everyone has the same standard for reporting.

EMPLOYMENT CHALLENGES

Employee vs. Independent ContractorWhether the staff person is an employee or an independent contractor is determined in large part as a matter of employer control of work, finances and behaviors. What your employer designates you is not the determining factor – it is control.

Employment Security, IRS and Department of L&I all have their own classification standards.

18

CONSEQUENCES OF MISCHARACTERIZATION

Employer tax penalties and fines from IRS, ESD & DOLI

Labor & Industries imposition of liability upon employer for not insuring workers

Worker vulnerability to unfunded tax liabilities and injury

Employer liability to employee for insufficient payment of minimum wage, if any.

QUESTIONS

John C. PeickPeick|Boyer Law Group, P.S.

3633 136th Pl. SE #205Bellevue, Washington 98006

[email protected]

Visit www.peicklaw.com

1

INFECTIOUS DISEASES: THE LAW OF EMERGENCY PREPAREDNESS

Joyce A. RoperSr. Assistant Attorney GeneralAgriculture & Health DivisionState of Washington Office of the Attorney General

8/10/2015Health Law Basics, Seattle University

School of Law

1

Diseases Sampler• 2001: Anthrax• 2002: Smallpox Concerns• 2003: Monkeypox, SARS• 2003-04: Bovine Spongiform Encephalopathy

(BSE, aka “Mad Cow) – not infectious• 2009-10: Pandemic Influenza (H1N1)• Multiple years: Avian Influenza, Tuberculosis,

Influenza, West Nile Virus (not infectious)• 2012-15: Middle East Respiratory Syndrome

(MERS)• 2014-15: Ebola

8/10/2015Health Law Basics, Seattle University School

of Law

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2

Public Health’s Authorizing Source : Police Power• Jacobson v. Massachusetts, 197 U.S. 11 (1905)▫ Per state law, municipalities may mandate

smallpox vaccination “if necessary for the public health and safety”

▫ Cambridge mandated, Jacobson declined, $5 fine• U.S. Supreme Court held, at 27:▫ [A] community has the right to protect itself

against an epidemic of disease which threatens the safety of its members.


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Washington Constitution

Local Jurisdictions’ Authority Article 11, §11 Police and Sanitary Regulations:“Any county, city, town or township may make and enforce within its limits all such local police, sanitary and other regulations as are not in conflict with general laws.”


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3

Washington Constitution

State of Washington’s AuthorityJudicially recognized: “That the preservation of the public health is a proper subject for the exercise of the police power goes without saying; indeed it is the first concern of the state.”State ex rel. McBride v. Superior Court for King County, 103 Wash. 409, 419, 174 P. 973 (1918)


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Scenario

There are reports of cases of MERS in the Middle East and Korea. MERS:• Is not easily transmissible from person to

person; requires close contact, including providing unprotected health care to an infected person

• Symptoms are fever, cough, shortness of breath, some GI upset. Sometimes pneumonia.

• 36% of reported cases have resulted in death


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4

Your Role in the Scenario

• You represent a hospital in Vancouver, Washington.

• Many flights arrive from Korea, China and Japan at Portland and SeaTac.

• Do you recommend instituting any procedures in the hospital as a result of the MERS outbreak? If so, what?


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Events Unfold

• A hospital employee came to work feeling a bit ill, then feeling worse, leaves work early, taking sick leave.

• The next day, the employee stays home sick. On the third day, the employee, consults with her doctor. She has a fever, cough, difficulty breathing. Her doctor prescribes antibiotics and tells her to stay home until 24 hours after the fever breaks.


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5

More Events Unfold

• There are reports that a couple of patients on the oncology ward, where this employee worked, have developed a fever, cough, shortness of breath.

• Do you make any recommendations?• You are told that some of the hospital staff are

talking about the sick employee’s fiancée, who recently returned from a trip to visit family in South Korea.


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More Information

• The employee’s fiancé is not ill.• The employee is getting worse. Day 5, she is

diagnosed with pneumonia and admitted to the hospital. Specimens are collected. Tests are being run.

• Her fiancé arrives at the hospital to visit her and mentions that her brother in South Korea was sick, but he improved and seemed fine when she left.


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6

Events and Your Actions?

• State Lab tests for MERS-CoV –not all labs can test for MERS-CoV.

• Test results in 48 hours from receipt of specimens.

• Do you make recommendations based on the information from the employee’s fiancé?

• Some people infected with MERS-CoV are asymptomatic carriers.


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Timeline, Considerations• Day 7 – Confirmation of employee’s MERS.• Events since Day 1 (employee went home sick):▫ Day 3, two oncology patients ill. Were specimens sent to the lab? Which lab? Additional patients/employees exposed? Family

members and other visitors?▫ Day 5, employee admitted as an in-patient. Where? Special room (negative pressure)?

Shared room? Asymptomatic infected fiancé visited;

who else might have been infected by her?


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7

Government: The Cast• Local▫ Boards of Health▫ Local Health Officers (LHOs)▫ Local Emergency Management ▫ “Heads of Political Subdivisions”

• State▫ Board of Health▫ Department of Health (DOH), Secretary▫ Emergency Management Division, Military Dept.

(EMD)▫ Governor


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Government: The Cast (cont.)

• Tribal▫ Health Authorities▫ Tribal Leadership

• Federal▫ Dept. of Health and Human Services (DHHS)▫ Center for Disease Control (CDC)▫ Federal Drug Administration (FDA)▫ Department of Homeland Security (DHS),

depending on the event


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8

Local, State, Tribal, and Federal

• Work in tandem, particularly for major events.• Generally, events unfold locally, but can be

quickly escalated to partner with State, Tribal, and Federal health authorities.

• Public health at each level strives to avoid hierarchical operation.


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Overlapping Authorities

• LHOs shall “control and prevent the spread of any dangerous, contagious or infectious diseases that may occur within his or her jurisdiction” [RCW 70.05.070(3)]

• Secretary shall investigate outbreaks and epidemics that may occur and advise LHOs on measures to be taken to prevent and control the diseases [RCW 43.70.130(5)]


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9

Infectious Disease Control Measures

• Isolation and Quarantine (I&Q)▫ Isolate sick▫ Quarantine exposed▫ Monitoring (reduce travel, avoid crowds)

• Social Distancing▫ Community: closure, cancel mass gatherings (e.g.

sporting events)▫ School closures, including child care, other places

where children gather▫ Protective sequestration of vulnerable populations▫ Workplace: telecommute, liberal leave, reduced work

force


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Other Disease Control Measures

• Expanded health care and infection control▫ Alternate care sites ▫ Designation of specific health care facilities to

preserve other needed sites▫ Home care and (voluntary) isolation of ill▫ (Voluntary) quarantine of exposed▫ Mass prophylaxis


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10

Isolation and Quarantine Rules

• State Board of Health authorized to adopt I&Q rules▫ Updated WA’s rules in 2003 (SARS)▫ I&Q Rules: WAC 246-100-011 through -070▫ Rt. to counsel, hearing, conditions of I&Q

• Surveillance, Notifiable Conditions▫ WAC 246-101-001, et seq.▫ Broad range of reporting entities


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Legal Issues• Surge Capacity▫ Mutual Aid Agreements▫ Licensure/Scope of Practice▫ Liability

• Prioritization of Limited Resources (aka “rationing”)

• Crisis Standard of Care▫ Who decides?▫ Managing expectations▫ Liability


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11

Legal Issues

• Tribal Lands▫ Relationships▫ Authority▫ Entry/Invitation

• Commandeering (private citizens, equipment)• Suspension/Waiver of Laws Impeding Effective

Response and Recovery• Martial Law


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Key Partnerships


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12

Washington Military Dept., EMD

• Emergency Management Division (EMD)• Washington’s all hazards approach, RCW 38.52, • Federally, Secretary of DHHS may declare a

“public health emergency”▫ Triggers potential for Congressional funding▫ Similar to Stafford Act, but Stafford does not apply

to naturally occurring disease events


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What is an Emergency?

• “Emergency” is “an event or set of circumstances which (i) demands immediate action to preserve public health, protect life, protect public property, or to provide relied to any stricken community overtaken by such occurrences, or (ii) reaches such a dimension or degree of destructiveness as to warrant the governor declaring a state of emergency.” RCW 38.52.010(6)(a)


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13

Powers of Governor and Executive Heads of Political Subdivisions• Governor issues emergency proclamations,

RCW 43.06.200 - .270• Governor & executive heads of political

subdivisions authorized to use governmental services, equipment, supplies and facilities to response to event, RCW 38.52.110(1)

• After a proclamation, may command the service and equipment of citizens as necessary, RCW 38.52.110(2)


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Governor’s Powers

• May direct the state militia or state patrol to assist local officials in restoring order, RCW 43.06.270

• Lead and supporting state agencies depends upon the nature of the emergency per the Comprehensive Emergency Management Plan (CEMP)


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14

Comprehensive Emergency Management Plan (CEMP)• Designed to address all hazards• Identifies lead state agencies and supporting

agencies/resources in Emergency Support Functions (ESF)

• DOH Lead Agency for ESF 8: Health and Medical Services, with Appendix 3 – Mass Fatality Incident Support and Appendix 4 – Pandemic Influenza Plan

• Biological, chemical, radiological event and other mass casualty event, including natural disasters, overwhelming the local jurisdiction’s ability to respond


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Mutual Aid Agreements

• Congressionally authorized▫ Pacific Northwest Emergency Management

Arrangement (PNEMA) Washington, Alaska, British Columbia, Yukon

Territory, Oregon, Idaho Multiple public health agreements

• Interstate▫ Emergency Management Assistance Compact All 50 States RCW 38.10


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15

Mutual Aid Agreements

• Tribal to State▫ Centennial Accord

• Local to Local, RCW 38.52.091(2)• Tribal to Local• Tribal to Tribal


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Compendium of Resources

• Since 9-11, many opportunities to update and learn from each event and planning for future events.

• Partnerships strengthened and formalized in agreements.

• Too many resources to delve into during this session.

• Materials available electronically. Review Table of Contents.


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Contact Information

Joyce A. [email protected](360)664-4968


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Table of Contents Page 1

Public Health Emergency Legal Tool Kit (v.3.0)

Table of Contents Titled

Table of Contents Table of Contents.doc

Lawyers’ Roles in Preparing and

Responding to Disasters 8/15/2007

WSBA CLE Are You Prepared.pdf

Agreements, Compacts, MOUs:

Alaska Department of Health and Social

Services, Public Health Laboratory; Idaho

Department of Health and Welfare, Public

Health Laboratory; Oregon Department of

Human Services, Public Health Laboratory;

and Washington State Department of

Health Public Health Laboratory

PHLab MOU 2004_Final.pdf

B.C. & Washington Public Health

Memorandum of Understanding (based on

PNEMA & Annex B)

British Columbia And Washington Public

Health MOU. pdf

B.C. & Washington Public Health

Operational Plan for Moving Emergency

Medical Services Staff and Resources

Across the Washington and British

Columbia Border

Wa-BC-EMS_Agreement.pdf

Emergency Management Assistance

Compact Website

EMAC Informational Website

Olympic Regional Tribal-Public Health

Collaboration and Mutual Aid Agreement

OlympicRegTribePH_MAA.pdf

Pacific Northwest Emergency Management

Arrangement (PNEMA)

Pacific Northwest Emergency Management

Arrangement (congressionally

approved).pdf

Public Health Inter-Jurisdictional Mutual

Aid Agreement

PubHealthInterJurisMAAFinal Agmt.pdf

Puyallup – Tacoma Pierce County Health

Department Mutual Aid Agreement

Puyallup-TPCHD Public Health Mutual

Aid.pdf

Tribal Olympic Regional Agreement Tribal Olympic Regional Agreement

Washington & B.C. Memorandum to Share

and Protect Health Information to Assure

Prompt and Effective Identification of

Infectious Disease and Other Public Health

Threats

BC-WA-Info-Share-MOU-Oct-9.09.pdf


Washington & B.C. Memorandum to

Provide Mutual Aid through Sharing Public

Health Laboratory Services March 25,

2015

BC-WA-PH-Lab-MOU.pdf

Washington & B.C. Memorandum of

Understanding Public Health Emergencies

BC-WA-Public-Health-Collaboration-

MOU-Signed.pdf

Washington & B.C. Signed Copy of

PNEMA Annex B

WA-BC Signed Copy of PNEMA Annex B

.pdf

Washington Statewide Pharmacy-Local

Health Jurisdiction Memorandum of

Understanding

Washington statewide pharmacy mou.pdf

RCW for EMAC RCW for the Emergency Management

Assistance Compact Website

Case Law:

Citoli v. City of Seattle Citoli v. City of Seattle.pdf

City of Seattle v. Cottin City of Seattle v. Cottin.pdf

Cougar Business Owners Assoc. v.

Washington

Cougar Business Owners Assoc. v.

Washington.pdf

Eggleston v. Pierce County Eggleston v. Pierce Cy.pdf

Karr v. State Karr v. State.pdf

Kaul v. City of Chehalis Kaul v. City of Chehalis.pdf

State v. Partlow Lehman v. Partlow.pdf

Lindsey v. Tacoma-Pierce Cty. Health

Dep’t

Lindsey v. Tacoma-Pierce Co. Health

Dep’t.pdf

State v. Superior Court McBride v. Superior Ct for King Co.pdf

Menotti v. City of Seattle Menotti v. City of Seattle.pdf

Parkland Light & Water Co. v. Tacoma-

Pierce Cty. Bd. of Health

Parkland Light & Water Co. v. Tacoma-

Pierce Co Bd of Health.pdf

Property Located at 14255 53rd

Ave S. Property Located at 14255 53rd

Ave S.pdf

Snohomish Cty. Bldrs. Ass’n v. Snohomish

Health Dist.

Snohomish Co Builders’ Assoc v.

Snohomish Co Health Dis.pdf

Spokane Cty. Health Dist. V. Brockett Spokane Co Health Dist v. Brockett.pdf

State v. Superior Court Westman v. Superior Ct for King Co.pdf


King County Benchbook:

King County Benchbook – Model on Court

Administrator’s Website

Washington State Courts – Emergency

Procedures Public Health Emergency

Bench Book

Legal Authorities Overview and Memo:

Social Distancing Law Project Part 1:

Legal Assessment (ASTHO & CDC)

Social Distancing Law Project.pdf

10-23-06 Overview of 10/20/06

Memorandum on Public Health

Emergencies – Updated 9/30/08

Public Health legal authority Overview 9-

30-08 updates.pdf

10-23-06 Memorandum Describing Legal

Authorities During Public Health

Emergencies to Secretary Selecky from

Joyce Roper – Updated 9/30/08

Public Health legal authority Memo 9-30-

08 updates.pdf

Relevant Provisions of State & Federal Statutes and Rules:

Emergency Management Act, RCW 38.52 Chapter 38.52 RCW Emergency

management

Emergency Use Authorization Emergency Use Authorization – PHE.htm

EAU.pdf

Emergency Worker Program Rules,

WAC 118-04

Chapter 118-04 WAC Emergency worker

program

Communicable Diseases Rules,

WAC 246-100 excerpts

Chapter 246-100 WAC Communicable and

certain other diseases

Countermeasures Injury Compensation

Program (CICP)

CICP.pdf

Notifiable Conditions Rules,

WAC 246-101

Chapter 246-101 WAC Notifiable

conditions

State Department of Health Authority,

RCW 43.70 excerpts

DOH Authority, relevant provisions

RCW 43-70.doc

Family Educational Rights and Privacy

(FERPA), Final Rule re: Emergencies

FERPA Rule re emergencies.pdf

Governor’s Authority, RCW 43.06

excerpts

Governor’s Authority, relevant provisions

RCW 43-06.doc

Local Health Jurisdiction Authority,

RCW 70.05 excerpts

LHJ Authority, relevant provisions

RCW 70-05.doc


Pandemic and All-Hazards Preparedness

Act (PAHPA)

PAHPA.pdf

Pandemic and All-Hazards Preparedness

Reauthorization Act

PAHPRA.pdf

The Public Readiness and Preparedness

(PREP) Act

PREP Act.pdf and

PREP Act Language.mht

State Board of Health Authority,

RCW 43.20

excerpts

SBOH Authority, relevant

provisions RCW 43.20.doc

1135 Waiver 1135-waivers.pdf

1135-AuthorityWaiveReqNtlEM.pdf

1135 Waivers – PHE.htm

State &Federal Isolation and Quarantine Resources

Center for Disease Control Legal

Authorities for Isolation and Quarantine

Legal Authorities for Isolation and

Quarantine Quarantine CDC.htm

legal-authorities-isolation-quarantine.pdf

Federal Rule Requiring Notification of

Communicable Diseases to LHJ by

pilots/captains for Interstate Transport

21 cfr part 1240.pdf

Federal Quarantine Rules at U.S. Ports 42 cfr part 71.pdf

Presidential Order Authorizing Quarantines

for Specific Diseases

federal quarantinable diseases 4-1-2005

amd.pdf

State Forms & Resources Isolation and quarantine forms and

resources - WA State Dept. of Health

Website

Washington CEMP****

Washington State Comprehensive

Emergency Management Plan

Washington State Comprehensive

Emergency Management Plan [CEMP].htm

CEMP 2011.pdf

****This folder contains sub-folders. Please disregard the “-files” folder. This folder

contains items necessary for the document in the .htm folder to function.