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Legal Foundations of Health Care 2 Credits

BU 550.605.xx Class Day/Time & Start/End date

Semester Class Location

Instructor Full Name

Contact Information Phone Number: (###) ###-#### E-mail Address:

Office Hours Day/s Times

Required Text and Learning Materials Showalter, S. J. (2011). The Law of Healthcare Administration, 6th ed. Chicago: Health Administration Press. ISBN978-1-56793-57-6. Other articles made available through Blackboard.

Blackboard Site A Blackboard course site is set up for this course. Each student is expected to check the site throughout the semester as Blackboard will be the primary venue for outside classroom communications between the instructors and the students. Students can access the course site at https://blackboard.jhu.edu. Support for Blackboard is available at 1-866-669-6138.

Course Evaluation As a research and learning community, the Carey Business School is committed to continuous improvement. The faculty strongly encourages students to provide complete and honest feedback for this course. Please take this activity seriously because we depend on your feedback to help us improve so you and your colleagues will benefit. Information on how to complete the evaluation will be provided towards the end of the course.

Disability Services Johns Hopkins University and the Carey Business School are committed to making all academic programs, support services, and facilities accessible. To determine eligibility for accommodations, please contact the Carey Disability Services Office at time of admission and allow at least four weeks prior to the beginning of the first class meeting. Students should contact Rachel Pickett in the Disability Services office by phone at 410- 234-9243, by fax at 443-529-1552, or email: [email protected].

Important Academic Policies and Services  Honor Code  Statement of Diversity and Inclusion  Student Success Center  Inclement Weather Policy Students are strongly encouraged to consult the Johns Hopkins Carey Business School Student Handbook and Academic Catalog and the School website http://carey.jhu.edu/students/student-resources/university-and- school-policies for detailed information regarding the above items. BU 550.605.xx – Legal Foundations of Health Care – Instructor’s Name – Page 2 of 10

Course Description: This course provides students with an overview of the legal environment as it affects medicine and business. Cutting-edge cases are utilized as students explore medical mal-practice, negligence, liability (physician, product, and corporate), intellectual property, criminal aspects of health care, patient consent and rights, and health care reform. This is the foundational course in the health services management curriculum.

Note: Students cannot use credits for both 551.640 and 550.605 towards any degree or certificate requirements.

Course Overview: This course has been structured in the form of lectures, discussions, and case analysis sessions. I have a number of modes of instruction: legal case analysis, class discussion, role-play, research, and illustrative videos.

The purpose of this course is to introduce health care professionals to the legal issues they are likely to face in managing a health care organization. With the increasing intersection between health care delivery and law, health care professionals will encounter a wide range of legal and regulatory issues. It is thus important for students to be familiar with basic legal principles affecting how healthcare institutions are operated, how legal rules and doctrines are formulated, and how to interact effectively with attorneys.

Summary of topics Topic areas covered:

 Background: being a patient; quality health care; medical error;  Beyond the individual patient: scarce resources; public health law;  State regulation aimed at patient protection: licensing of health care professionals; regulation of health care facilities;  Aspects of the physician-patient relationship: contractual elements, informed consent, treatment refusal, decision making when the patient is incompetent, and confidentiality/privacy;  Patient protection and compensation through tort litigation: medical malpractice; institutional liability;  Access to care, especially in a medical emergency;  Paying for care: state regulation of private insurance and managed care; partial federal preemption; public insurance (Medicare and Medicaid);  Structuring the delivery of care: relationship of health care professionals to hospitals, hospital, and  Economic wrongdoing: fraud and abuse, self-referral.

Student Learning Objectives for This Course All Carey graduates are expected to demonstrate competence on four Learning Goals, operationalized in eight Learning Objectives. These learning goals and objectives are supported by the courses Carey offers. For a complete list of Carey learning goals and objectives, please refer to the website http://carey.jhu.edu/faculty-research/learning-at-carey/learning-assessment.

The learning objectives for this course are: 1. Gain an understanding of key legal concepts and how to think about legal issues given the law’s ambiguity; 2. Gain an understanding of contemporary medical problems and how the legal system grapples with resolving those problems; 3. Recognize the nature, operation and effect of the political, legal, regulatory, and court system as they apply to the operation of healthcare endeavors. 4. Identify and discuss key law concepts as they affect the delivery of healthcare. 5. Identify potential legal problems in the business/medical environment. 6. Evaluate factual problem situations, be able to apply legal concepts, and analyze possible responses. 7. Appraise healthcare situations so as to avoid creating inadvertent legal obligations and/or liabilities or waiving legal rights. BU 550.605.xx – Legal Foundations of Health Care – Instructor’s Name – Page 3 of 10

Testing Center The Testing Center provides testing-related services including:  Administration of make-up exams  Accommodation for special testing needs due to a documented disability through Disability Services  Referrals for tutoring Contact the center by phone at 410/516-9750 or email: [email protected] to inquire about testing needs.

Grading Criteria Individual in-class contributions1...... 5% Team Member Evaluation2 ...... 5% Cumulative Final Exam...... 45% Case Presentation and Problem Presentation3...... 5% Industry Portfolio...... 15% Industry Paper...... 25%

Important Notes about Grading Policy: The grade of A is reserved for those who demonstrate extraordinarily excellent performance. The grade of A- is awarded only for excellent performance. The grade for good performance in this course is a B+/B. The grades of D+, D, and D- are not awarded at the graduate level.

Please refer to the Carey Business School Student Handbook for grade appeal information http://carey.jhu.edu/students/student-handbook-and-academic-catalog/

A Few Words on Classroom Etiquette . . . . I expect all students to read the assigned readings and be prepared to participate in class. While there is lead team assigned to start the discussion, I expect all students to participate in case discussions. In addition, the PowerPoint slides will be available after class. As a general policy, laptops should NOT be open during class. Notes can be taken by hand and notes taken in preparation for class can be printed out in advance of class.

Contributions to Class Discussion/level of Preparation: Obviously, class attendance is a pre-requisite for class participation, therefore, students will score a 0 on the day they do not attend class. I do not distinguish excused from unexcused absences. In other words, every absence counts as an absence no matter why you are not in attendance/prepared. I assume that every time a student misses class and/or is not prepared the student has a good reason, such as a family emergency, job-related commitment, or unexpected plans.

Students are expected to have read the material before attending class in order to participate. Students are expected to take a proactive stance with respect to class contributions. While I will sometimes use cold calling, students should not expect this to be sufficient for opportunities to make substantive contributions. Also please note that a minimal grade will be assigned for attendance without active participation – seating warming is discouraged. Finally, I reserve the right to give “pop” quizzes on the assigned reading if participation or preparation appears to be waning.

I will evaluate students immediately after each class on their contribution to class discussions.

Contributions are defined as: observations that advance the discussion or change the direction of the class discussion, insightful commentaries that raise learning points, probing questions that challenge the extant discussion and yield new directions, and analyses that clarify and amplify case facts. Class contribution will be graded 0-5 according to the following criteria:

5 = able to answer or ask questions with good examples from the readings and makes several excellent points that reveals deep thought about the issue(s), and understanding of the readings and cases. Comes to class with additional examples and in effect raises the level of class understanding.

1 This includes preparation for each class session and the quality of participation 2 This includes team member evaluation of contributions on all team assignments 3 Each will be worth 2.5% BU 550.605.xx – Legal Foundations of Health Care – Instructor’s Name – Page 4 of 10

4 = raises a number of good points from the cases and readings, less inspired than a 5, but reveals a clear understanding of the material.

3 = makes one or two good points, and shows a rudimentary grasp of the readings and cases. Essentially, attempts to draw some linkage with the concepts used in the class.

2 = makes one or two points in discussion but does not attempt to apply any concepts learned from the readings or lectures, i.e., superficial common sense-type answers to questions that could have been approached with more insight.

1 = shows up for class but does not participate

0 = does not show up for class

Specific Reading Assignments I have attached an outline of the topics I hope we will study this semester. The study questions provide specific information about which parts of each assignment are the most important.

Industry Portfolio and Final Paper Different industries experience “the legal environment” differently. Issues that are of utmost importance in the medical insurance industry are much different than issues of utmost importance in the herbal supplements or aroma therapy industry. The pharmaceutical, medical devise, vaccines, and biotechnology industries are all examples of industries that help shape, and respond to, legislation and administrative rules.

This semester, you will submerse yourself in a particular industry. Your team will select one from the list, if however, you would like a research an industry not on the list, please let me know – I am always open to expanding the list of choice to study. There is also the possibility to do the complete industry assignment individually. If you are interested in this option, please see me.

Next, you will find and gather information about legal issues that are important in the industry you chose. Then, you will prioritize the issues, organize your research, and engage in preliminary writing. This writing will provide an overview of the legal and regulatory environment in your industry. Additionally, it will outline two to three significant legal issues from the perspectives of at least two different stakeholders (e.g., shareholders, employees, customers, managers, communities, and future generations). This part of the assignment is the “portfolio” component, and it is worth 15% of your course grade.

Twenty five percent of your course grade will be a final paper you turn in toward the end of the semester. The portfolio you will have worked on over the course of the semester will set the stage for you to write the final paper. The final paper will be a minimum of twelve, double-spaced pages in length. The paper will give you an opportunity to summarize what you have learned about legal issues that affect the industry you selected.

CASE PRESENTATIONS Each week a team is assigned to present a case in the form of a bench trial. Members of each team will take on the roles of defendant, plaintiff, and judge. Each side, defendant, and plaintiff will present their arguments to the class. The judge will provide the ruling along with the legal reasoning behind it. Teams need not dress in business attire. No power point slides are required. The aim of this exercise is to encourage students to engage in in-depth critical thinking and analysis from a particular point of view. When a team member is called on to answer questions, s/he will answer from the view point of his or her assigned role.

CASE THOUGHTS For each of the cases assigned for reading, you are required to post your thoughts on the ruling and legal reasoning. Your thoughts are to be no more than a few sentences explaining whether you agree or disagree with the ruling and reasoning of the case and why. Case thoughts are mandatory and account for part of your participation. BU 550.605.xx – Legal Foundations of Health Care – Instructor’s Name – Page 5 of 10

ASSIGNMENTS All students are expected to view the Carey Business School Honor Code/Code of Conduct tutorial and submit their pledge online. Students who fail to complete and submit the pledge will have a registrar’s hold on their account. Please contact the student services office via email [email protected] if you have any questions.

Students are not allowed to use any electronic devices during in-class tests. Calculators will be provided if the instructor requires them for test taking. Students must seek permission from the instructor to leave the classroom during an in-class test. Test scripts must not be removed from the classroom during the test.

* All materials followed by an asterisk are posted on Blackboard.

FOUNDATIONS OF THE LAW

August 19 Class Session 1 Introduction to the Legal Framework of Medicine  Sources and Classification of Law  Intersections of Law and Medicine  Court System - Following A Case Through the Judicial Process  How to Read a Case

Read Nuts & Bolts Law for Healthcare Professionals*

Skim Chapter 1: The Anglo-American Legal System and Chapter 2: “A Select timeline in the History of Medicine” on page 51 – while I will provide a background of the legal system, I recommend that you skim this material prior to our initial class session.

In addition, the Medical Marijuana scenario posted on Blackboard Course Documents Class Session 1.

In-class activity State’s Medical Marijuana Statutes – Legal or Not?

Portfolio Assignment One - Industry topics are due by the end of the day on Friday. Please email to [email protected]

August 26 Class Session 2 Contracts and Intentional Torts  Establishing a Standard of Care  Importance of Contract Law to the Physician-Patient Relationship  How Breach of Warranty Applies to the Healthcare Setting  Intentional Torts and Healthcare Professionals

Read and prepare Chapter 3: Contracts and Intentional Torts – with particular emphasis on the study questions addressing:  Stowers v. Wolodzo, 191 N.W. 2d 355 (1971)  Hawkins v. McGee,* 146 A.641 (1929)4  Esquivel v. Watters, 154 P.3d 1184 (2007)  Mills v. Pate, 225 S. W. 3d 277

4 All cases with an “*” are posted on Blackboard under Course Documents for that class session. BU 550.605.xx – Legal Foundations of Health Care – Instructor’s Name – Page 6 of 10

Problems for Group Discussion: “Cheryl Hanachek” and “Ethics and the Law Never Shall the Twain Meet?”

THE PROFESSIONAL-PATIENT RELATIONSHIP AND THE QUALITY OF CARE

September 2 Class Session 3 Negligence  Elements of Negligence Cause of action  Establishing “Standard of Care”  Vicarious Liability

Read and prepare Chapter 4: Negligence – with particular emphasis on the study questions addressing:  Helling v. Carey, 519 P.2d 981 (1974)  Perin v. Hayne, 210 N.W. 2d 609 (La. 1973)  Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972)*  “Standard of Care – In Sickness and in Health and in Emergencies,” N. ENGL J. MED., 6/3/10*

Product liability discussion – led by Professor Lee, Wyeth v. Levine and Mensing v. Pliva you are not required to prepare anything for this discussion.

Problems for Group Discussions: “Hospital Revolving Door” and “Informed Refusals”

September 9 Class Session 4 Liability of Healthcare Institutions  Responedeat Superior versus Independent Contractor  Doctrine of Apparent Agency  Doctrine of Corporate Liability  Erosion of the Doctrines of Independent Contractor Status, Captain-of-the- Ship and Borrowed Servant

Read and prepare Chapter 6: Liability of the Healthcare Institution with particular emphasis on the study questions addressing:  Norton v. Argonaut Insurance Co., 144 So.2d 249 (La. Ct. App. 1962)  Darling v. Charleston, 211 N.E. 2d 253 (Ill. 1965)*  Washington v. Washington Hospital Center, 579 A.2d 177 (1999)  Johnson v. Misericordia Community Hospital, 301 N.W. 2d 156 (1981)  “How to Stop Hospitals From Killing Us” – 9/21/12 -WSJ article*

Problem for Group Discussion: “The Patient’s Choice”

BU 550.605.xx – Legal Foundations of Health Care – Instructor’s Name – Page 7 of 10

Portfolio Assignment Two – Organizing and Outlining Assignment Due (Please submit through Blackboard – indicate your class meeting your name, industry and assignment – e.g. “wed-lee-medicaldevices outlining). September 16 Class Session 5 Consent for Treatment and Withholding Consent  Informed Consent – Physician’s Obligations  How informed must informed consent be  Refusal of the Patient to Consent  Consent for Minors and Incompetent Adults

Read and prepare Chapter 10: Consent for Treatment and Withholding Consent addressing the following cases:  Cobbs v. Grant, 8 Cal. 3d 229 (1972)  Bush v. Schiavo, 885 SO.2d 312 (2004)  In re Baby K*  Arato v. Avedon, 858 P.2d 598 (1993)  “ Court Backs a Terminally Ill Woman, but Doubts About Her Wishes Arise” NYT 10/5/12*

Problems for Group Discussion: “Christian Scientist in the ER,” “Disclosing Physician Risks” and “Not Quiet Persistent Vegetative State”

REPRODUCTIVE RIGHTS

September 23 Class Session 6 Issues of Reproduction and Emergency Care  IVF  Sterilization  Wrongful Birth and Wrongful Life  Need for Emergency Care Facilities  Duty to Treat, Aid and Exercise Reasonable Care

Read and prepare Chapter 14: Issues of Reproduction. Read and Prepare Chapter 9: Emergency Care. Read and prepare Health Law & Bioethics 5 Chapter 4 addressing the following cases:

 Johnson v. Calvert, 851 P.2d 776 (Cal. 1993)  Litowitz v. Litowitz,48 P.3d 261 (Wash. 2002)*  Skinner v. Oklahoma ex rel Attorney General, 316 U.S. 535 (1942)  Time Magazine Article- Bitter Pill: Why Medical Bills are Killing Us

Problem for Group Discussion: “Reproductive Rights Gone Awry”

REGULATORY AND BUSINESS ISSUES

September 30 Class Session 7 Affordable Care Act Overview

5 This text is available on Blackboard under e-reserves. BU 550.605.xx – Legal Foundations of Health Care – Instructor’s Name – Page 8 of 10

Fraud Laws and Corporate Compliance Abuse  Affordable Care Act Overview and Implications on Employers  False Claims Act  Anti- Kickback Statutes  Piercing the Corporate Veil

Read and prepare Chapter 7: Health Reform, Access to Care and Admission and Discharge 13: Fraud, Abuse and Corporate Compliance Programs. From Chapter 5: read pages 133 on “Piercing the Corporate Veil.” In addition, read and prepare Health Law & Bioethics Chapter 9 with particular emphasis on the study questions addressing:

 United States v. McClatchey, 217 F. 3d 823 (2000)  U.S. v. Greber, 760 F. 2d 68 (3rd Cir. 1985)  U.S. v. Krizek, 7 F. Supp. 2d 56 (D.D.C. 1998)

Problem for Group Discussion: “Medicare/Medicaid Fraud and Abuse,” “Reverse Referral Fees” and ACA exercise.

**Submit questions or topics that you would like to learn about by the end of class.

INDUSTRY PAPER DUE BY 6:00 P.M. - submit through assignment tab on blackboard.

The final exam will be made available after class through Blackboard

PUTTING IT ALL TOGETHER

October 7 Class Session 8 Final Exam Essay Question and What Matters to You  I reserve the first 45 minutes of class for addressing any substantive areas of the law that you would like to learn about but we did not have an opportunity to cover in class. Email all topics or questions to me by the end of class session seven.  While a portion of the final exam is take home, a 1 hour in class exam will also be administered on the last day of class.

In-class activity related to the Industry Assignment

TAKE HOME PORTION OF FINAL EXAM DUE BY 6:00 P.M. BU 550.605.xx – Legal Foundations of Health Care – Instructor’s Name – Page 9 of 10

Course Calendar* *The instructor reserves the right to alter course and session content as well as to adjust the pace to accommodate class progress.

Assignments Due After Class - To Read Date In Class Today After Class - To Do Date In-class activity-  Nuts a Bolts Law for Select Industry for  Chapter 3: Contracts and Intentional Class 1 State’s Medical Health Care Industry Torts Marijuana Professionals Assignment  Stowers v. Wolodzo, 191 N.W. 2d 355 Statues – Legal  Skim Chapter 1- (1971) or Not The Anglo-American  Hawkins v. McGee,* 146 A.641 Legal System and (1929)6 Chapter 2 - A Select timeline in the History of Medicine

Date Discussion of  Chapter 4: Negligence Class 2 assigned  Helling v. Carey, 519 P.2d 981 (1974) material  Perin v. Hayne, 210 N.W. 2d 609 (La. 1973) Group  Canterbury v. Spence, 464 F.2d 772 Discussion: (D.C. Cir. 1972)* Cheryl Hanachek  Standard of Care in Sickness and In Health and in Emergences  Esquivel v. Watters, 154 P.3d 1184 (2007)

Date Discussion of  Chapter 6: Liability of the Healthcare Class 3 assigned cases Institution and chapter  Norton v. Argonaut Insurance Co., material 144 So.2d 249 (La. Ct. App. 1962)  Darling v. Charleston, 211 N.E. 2d Group 253 (Ill. 1965)* Discussion:  Johnson v. Misericordia Community Hospital Hospital, 301 N.W. 2d 156 (1981) Revolving Door  How Hospitals Are Killing Us*

Date Discussion of Complete Industry  Chapter 10: Consent for Treatment Class 4 assigned cases Portfolio and Withholding Consent and chapter Organizing and  Cobbs v. Grant, 8 Cal. 3d 229 (1972) material Outlining  Bush v. Schiavo, 885 SO.2d 312 assignment (2004) Group  In re Baby K* Discussion: The  Court Backs Terminally Ill Woman Patient’s Choice  Washington v. Washington Hospital Center, 579 A.2d 177 (1999)

6 All cases with an “*” are posted on Blackboard under Course Documents for that class session. BU 550.605.xx – Legal Foundations of Health Care – Instructor’s Name – Page 10 of 10

Assignments Due After Class - To Read Date In Class Today After Class - To Do Date Discussion of Organizing and  Chapter 14: Issues of Reproduction. Class 5 assigned cases Outlining Assignment Health Law & Bioethics Chapter 4 and chapter due  Johnson v. Calvert, 851 P.2d 776 material (Cal. 1993)  Litowitz v. Litowitz,48 P.3d 261 Group (Wash. 2002)* Discussion:  Skinner v. Oklahoma ex rel Attorney Christian General, 316 U.S. 535 (1942) Scientist in the  Arato v. Avedon, 858 P.2d 598 ER and (1993) Disclosing Physician Risks

Date Discussion of Complete Industry  Chapter 13: Fraud, Abuse and Class 6 assigned cases Paper Corporate Compliance Program and chapter  Chapter 5: Piercing the Corporate material Veil  Health Law & Bioethics Chapter 9 Group  United States v. McClatchey, 217 F. Discussion: 3d 823 (2000) Reproductive  U.S. v. Greber, 760 F. 2d 68 (3rd Cir. Rights Gone 1985) Awry  U.S. v. Krizek 7 F. Supp. 2d 56 (D.D.C. 1998)  ACA materials*

Date Discussion of Industry Assignment Complete Final If we run out of time, we will carry our Class 7 assigned cases Paper due Exam ACA discussion over to class session 8 and chapter material

Group Discussion: Enforcement of the Fraud Abuse Laws by Private Citizens

Date Industry Final Exam due on the Class 8 Assignment designated exam day Culminating Activity

Copyright Statement

Unless explicitly allowed by the instructor, course materials, class discussions, and examinations are created for and expected to be used by class participants only. The recording and rebroadcasting of such material, by any means, is forbidden. Violations are subject to sanctions under the Honor Code.

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