school of policy, planning, and developmentweb-app.usc.edu/soc/syllabus/20102/51403.doc · web...

PPD 605: FRONTLINE ISSUES IN HEALTH ADMINISTRATION AND POLICYFederal Health Care Regulation

Summer 2010

University of Southern California School of Policy, Planning, and Development

Friday and Saturday June 18th and 19th USC State Capital Center Friday and Saturday July 16th and 17th 1800 I Street, Sacramento

9:00 a.m. to 5 p.m. Class Hours

Instructor: Warren Barnes Office: State Capital Center (by appointment)Telephone: 916-508-6428 (cell) e-mail: [email protected] Office hours: By appointment, as well as after each class day and between sessionsCourse Materials: May be ordered at any bookstore or available on-line.

Course Description

Virtually every professional position engaged in the delivery, organization, or coverage of health care requires considerable knowledge of newly developing federal regulatory procedures and requirements, as well as skill to navigate them successfully and cost-effectively. This course develops your employability and leadership capability by increasing your knowledge of rapidly evolving federal regulation of health care and by enabling you to develop the skills necessary to navigate major regulatory changes.

This course will enable you to gain cutting-edge knowledge of the recently enacted Patient Protection and Affordable Care Act as amended and the effects of its changes in multiple areas of pre-existing federal health law and regulations. Comprehensive health insurance and delivery reforms, both immediate and delayed, raise challenging issues of interpretation and implementation and will dramatically change the pre-existing reimbursement and regulatory environment of the healthcare industry. These changes will significantly impact all stakeholders.

The recently enacted health reform legislation is an initial, major effort to address the three most pressing issues with our health care system: improving quality, increasing access, and controlling costs. An enormous amount of regulatory work lies ahead for the various agencies of the federal government, especially the Department of Health and Human Services, and the states. As regulations to interpret and implement the legislative reforms are proposed, stakeholders will have an opportunity to comment. This course provides knowledge of the regulatory process, pre-existing federal regulation, and health reform legislation sufficient to enable you to participate in the process of interpreting and implementing health reforms – as an individual or on behalf of your employer.

Regulation is the crucible where the public sector and the for-profit and nonprofit sectors often collide. This course builds your knowledge and skill to assess a rapidly evolving federal regulatory program and to design an ongoing, cost-effective compliance strategy.

Warren Barnes, J.D. of 12 USC School of Policy Planning and Development Summer 2010

mailto:[email protected]


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This course offers a perspective that enables participants in the regulatory dance to move beyond collision and confrontation to achieve an increasing degree of collaboration to solve problems common to the regulator and regulatee and to conserve their respective resources. This is consistent with the recognition of the School of Policy, Planning, and Development that the combined strengths of the public sector and the for-profit and nonprofit sectors are necessary to achieve effective dialogue, solutions to problems, and the successful pursuit of opportunities.

As we meet and discuss the readings and have in-class presentations, you will develop an increasing understanding of federal regulation. This experiential learning models the similar experience of professionals who regulate and who are regulated. For most, this learning comes only after a considerable amount of costly trial and error. Please complete all readings for each module prior to the start of class times. In the intensive class seminar format the assigned readings are the foundation for class discussion and activities. If you have questions on the readings, we will be able to discuss these in class. The readings deliberately reflect a wide variety of perspectives and degrees of actual knowledge and experience.

Your prior preparation will increase your contributions to class discussions, as well as provide a way to compare your insights to those of your classmates.

Additional handouts and materials, as well as guest lecturers, may be provided during the class. As with any graduate class, in response to questions, discussion, and breaking developments, the schedule may be modified.

Learning Objectives

1. Gain an in-depth, working knowledge of the comprehensive health insurance and delivery system reforms enacted in the Patient Protection and Affordable Care Act as amended.

2. Learn how to navigate the federal regulatory process and the current institutional framework.

3. Gain an understanding of the process of federal regulation, of leverage points, and policy development.

4. Develop an in-depth, working knowledge of at least one federal agency and at least one regulatory scheme that is significant from a policy, business, and legal perspective.

5. Gain basic skills necessary for success with health care regulation, moving as appropriate from conflict and confrontation to compromise and collaboration.

Course Requirements

1. Initial Information – By June 1st please email the following to the instructor: bullet points briefly describing your own specific learning objectives for the course and your career goals, and attach a resume. Please distribute a one-page summary resume to the class on Day 1, so the instructor and your classmates can help you fulfill your specific learning objectives.



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2. Quality Class Discussion – Cogent, insightful, succinct, and active class participation based on careful preparation and relevant professional experience should focus on the assigned readings, legal reasoning, health policy, and the impact of federal health regulation on the administration, delivery, and financing of care. Please share your practical knowledge and experience with federal health regulation and the complexities you have confronted.

3. Initial Paper – The Initial Paper (3 pages exclusive of title page, endnotes and bibliography; Word document [doc, not docx], 12-point Times New Roman, double spaced, justified right and left margins) is a focused exploration (in formal academic format) of one specific area of substantive federal health law. The paper should briefly discuss the changes, if any, that will (or may) occur under of the Patient Protection and Affordable Care Act as amended. For example, (a) highlight the changes, (b) compare and contrast “before” and “after,” (c) describe the stakeholder pressures and policy considerations that resulted in the change, (d) stakeholder pressures expected to result from the change, and (e) from a health policy perspective, the likely impact and ramifications of the change. The topic of the initial paper cannot be identical to the topic of the final paper, but they can be related. The Initial Paper is due at the beginning of Day 1.

4. Group Project -- Groups of at least three persons each will prepare a presentation about a federal regulatory agency that is responsible for an important aspect of health care regulation, its leadership, organization, culture, overall regulatory program, current initiatives, challenges, and contact information. The presentations are to use PowerPoint and to include an informative handout sufficient to enable classmates to interact effectively with the regulatory agency. Each group project presentation should be from 50 to 60 minutes including discussion. They are due on Day 3. 5. Final Paper – The Final Paper (10 pages exclusive of title page, endnotes and bibliography; Word document [doc, not docx], 12-point Times New Roman, double spaced, justified right and left margins) is an in-depth, legal and critical study (in formal academic format) of a federal regulatory program as modified by the Patient Protection and Affordable Care Act as amended, together with compliance recommendations. Discuss the requirements and prohibitions of the regulatory scheme as applied to one or more typical regulatee(s), the legal, health policy, and practical issues it presents, and how they have been or likely will be resolved and, from a health policy perspective, why. The paper should demonstrate an in-depth knowledge of the particular federal health regulatory program selected. If draft regulations have been proposed by the agency responsible for the selected regulatory program prior to Module 2, you may be able to comment on the proposed regulations as part of your final paper. The written paper is to be submitted as an attachment to email no later than Monday, July 26, 2010. Each final paper is to be presented in detail orally and with PowerPoint for 30 minutes, exclusive of discussion, on Day 3 or 4.

All students are required to have e-mail capability.

Performance Evaluation

Class Participation: 10% -- Due: throughout the courseInitial Paper: 15% -- Due: Day 1Group Project: 20% -- Due: Day 3



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Presentation of Group Project: 10% -- Due: Day 3Presentation of Final Paper (including leading discussion): 20% -- Due: Day 3 or 4Final Paper (in-depth study of a federal regulatory program): 25% -- Due: July 26

Policy Regarding Disability Services and Programs

Any student requesting academic accommodations based on a disability is required to register with Disability Services and Programs (DSP) each semester. A letter of verification for approved accommodations can be obtained from DSP. Please be sure the letter is delivered to me as early in the semester as possible. DSP is located in STU 301 and is open 8:30 a.m. – 5:00 p.m., Monday through Friday. The phone number for DSP is (213) 740-0776.

Required Readings

1. Field, Robert J. (2006). Health Care Regulation in America: Complexity, Confrontation, and Compromise. Oxford University Press. Order from any bookstore. Your reading should focus on major concepts and the organization of federal regulation (and consider its relation to state regulation).

2. Funk, William F. and Richard H. Seamon, Administrative Law; Examples and Explanations. 3rd Ed.2009. Wolters Kluwer, Publishers. Order from any bookstore. Your reading should focus on major concepts and processes of significant value for the healthcare industry especially during an era of health reform, not detail. Skip --- do not read – (often extensive) “Examples” and “Explanations.”

3. Patient Protection and Affordable Care Act as amended Title I. Quality, Affordable Health Care for All Americans Title II. Role of Public ProgramsTitle III. Improving the Quality and Efficiency of Health CareTitle IV. Prevention of Chronic Disease and Improving Public HealthTitle V. Health Care Integrity Title VII. Improving Access WorkforceTitle VI. Transparency and Program to Innovative Medical TherapiesTitle VIII. CLASS ActTitle IX. Revenue ProvisionsTitle X Strengthening Quality, Affordable Health Care for All Americans

4. Readings downloaded.5. Materials that will be distributed during or before class.

Required readings should be read primarily for major concepts, not detail. Three “readings” of each item are recommended: first, to get acquainted (for a book, including the preface, approximately 15 minutes); second, thoroughly for the author’s thesis and concepts; and third, as time allows, to critique the concepts, the evidence for them, and their usability. (See Mortimer J. Adler [1972]. How to Read a Book.)



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Optional Readings in Law, Background, Quality, and Strategic Leadership

Selected optional readings may be referred to from time to time in class. None is required for this course, although you may find them to be of value for background and reference.

6. Furrow, Barry R., Thomas L. Greaney, Sandra H. Johnson, Timothy S. Jost, and Robert L. Schwartz. Health Law: Cases, Materials and Problems. West Publishing (6th Ed. 2008) ISBN 978-0-314-18474-07. T.R. Reid (2009). The Healing of America: A Global Quest for Better, Cheaper, Fairer

Health Care. 8. Halvorson, George C. (2009). Health Care Will Not Reform Itself; A User’s Guide to

Refocusing and reforming American Health Care.9. Berry, Leonard L. and Kent D. Seltman (2008). Management Lessons from Mayo Clinic;

Inside One of the World’s Most Admired Service Organizations.10. Klaidman, Stephen (2007). Coronary; A True Story of Medicine Gone Awry. 11. Kidder, Tracy (2003) Mountains Beyond Mountains: The Quest of Dr. Paul Farmer, a Man

Who Would Cure the World.12. Berwick, Donald M. (2003). Escape Fire: Designs for the Future of Health Care.13. Walshe, Kieran (2003). Regulating HealthCare: A Prescription for Improvement? Available online.14. George, Bill (2007) True North: Discover your Authentic Leadership. 15. Collins, James (2005). Good to Great and the Social Sectors: A Monograph to Accompany

Good to Great . 16. Goleman, Daniel, Richard Boyatzis and Annie McKee (2002). Primal Leadership: Realizing

the Power of Emotional Intelligence. 17. Kotter, John P. (1996). Leading Change.18. Fisher, Roger, William Ury, and Bruce Patton (1981) Getting to Yes. 2nd Ed.

Faculty Biography

Warren Barnes is an attorney who most recently handled major health law and policy issues at the Department of Managed Health Care (DMHC). At various times he served as Supervising Counsel and Assistant Chief Counsel for the Office of Health Plan Oversight, Assistant Deputy Director and Chief of the Office of Legal Services, and Assistant Deputy Director for Planning, Policy and Training in the Director’s Office. He also represented the Secretary of the Business, Transportation and Housing Agency on the Managed Risk Medical Insurance Board (MRMIB).

He has over three decades of experience in health care law and administrative law. At the Department of Corporations he drafted portions of the Knox-Keene Health Care Service Plan (HCSP) Act and was one of two attorneys who drafted the initial regulations implementing the Act. He provided legal and policy guidance for the HCSP regulatory program, and supervised the legal, medical survey, and complaint processing staff. His innovations include contracting with over 50 part-time physicians and later U.C. Davis Medical School for approximately 300 physicians for the Warren Barnes, J.D. of 12 USC School of Policy Planning and Development Summer 2010


Summer 2010

independent medical review of consumer complaints, and with the Office of Administrative Hearings for 10 administrative law judges for the legal review of consumer complaints. He arranged for integrated training for regulatory staff at Stanford University Center for Health Policy and increased the regulatory attorney staff from six to 26.

While providing leadership in health law and policy at the Department of Corporations he represented the State of California in the Medical Necessity Decision Makers Workshop (“Decreasing Variation in Medical Necessity Decision Making”) sponsored by Stanford University Center for Health Policy and Integrated Healthcare Association with funding from the California HealthCare Foundation. He also represented the Department of Corporations as an ex officio member of the State Bar Insurance Law Committee.

He is currently the Pastor of Grace Presbyterian Church in Sacramento and Regulatory Consultant to the Right Care Initiative, a public-private-academic collaborative focused on improving quality of care for CVD and diabetes and eliminating preventable hospital acquired infections. He has served as President of the Legal Aid Society of Sacramento, a member of the national General Assembly Council and Board of Directors of the Presbyterian Church (USA), organizer and first chairperson of the AIDS Interfaith Network of Sacramento, and consultant to nonprofit organizations including La Familia Counseling Center in Sacramento.

Prior to his legal career, he was the Executive Director of the Washington Neighborhood Center, a member agency of the United Way in Sacramento. There he exercised overall executive leadership, established a bold, new vision and five-year action plan, engineered a new balance of power on the board of directors, and doubled the budget.

He has a B.A. in philosophy with honors from Seattle Pacific University, an M. Div. with honors from San Francisco Theological Seminary, and a J.D., Dean’s Honors List, McGeorge School of Law, University of the Pacific.

Class Schedule: Topics and Assigned ReadingPlease complete all readings prior to the start of class

Module 1Day 1 – Session 1 (Morning)

Due: Resume to Share and Initial Papers 1. Self-Introductions; Small Group Discussion and Report out of Expectations and Overview of Syllabus

2. Overview of the Major Impacts of the Patient Protection and Affordable Care Act (H.R. 3590) as amended by the Health Care and Education Reconciliation Act of 2010 (H.R. 4872): Access, Quality, Cost Containment

___________ (March 2010). “From hope to change; Barack Obama has made history. But he can still make mistakes,” The Economist.www.economist.com/world/united-states/displaystory.cfm?story_id=15769712


http://www.economist.com/world/united-states/displaystory.cfm?story_id=15769712


Summer 2010

____________ (March 2010). “American health-care reform: Pass the bill: Hugely expensive and full of flaws though it is, Barack Obama’s health-care plan is still worth having – just,” The Economist. www.economist.com/opinion/displaystory.cfm?story_id=15720396

____________ (March 2010). “Health Reform Implementation Timeline,” Kaiser Family Foundation.www.kff.org/healthreform/8060.cfm

Atul Gawande (April 2010). “Now What?” The New Yorker. www.newyorker.com/talk/comment/2010/04/05/100405taco_talk_gawande?printable=true

Atul Gawande (June 2009). “The Cost Conundrum.” The New Yorker.www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawande

Atul Gawande (January 2009) Getting There from Here: “How Should Obama Reform Health Care?” The New Yorker. w ww.newyorker.com/reporting/2009/01/26/090126fa_fact_gawande?currentPage=1

3. Brief Overview of Health Regulatory Structure of the Federal Government

Field, Robert J. (2006). Health Care Regulation in America: Complexity, Confrontation, and Compromise. Tables on the following pages: pp. 253-255 (Major Federal Health Care Regulatory Agencies and Organizations); 12 (DHHS) and within DHHS: 156 and 231 (HRSA), 226 (NIH), and 228 (AHRQ); for others see pp. 136 (FDA), 153 (CDC), 160 (EPA), 163 (OSHA), 215 and 229 (NSF).

4. Federal Regulation of Health Care Professionals, Hospitals and other Institutions

Field, Robert J. (2006). Health Care Regulation in America: Complexity, Confrontation, and Compromise. Preface, and the following pages of Chapters 1-3 and 9: pp. 3-18, 30-34, 39-40, 46-48, 53-73, 235-249.

The History, Policies, and Structures that Shape Health Care Regulation Regulation of Physicians and other Health Care Professionals Regulation of Hospitals and other Health Care Institutions New Regulatory Horizons and Old Policy Conflicts

18. Health Care Delivery System Reforms: Quality, Cost-Efficiency, Prevention, and Provider Workforce: Health Care Professionals, Hospitals and other Institutions

Topics may include, for example, accountable care organizations, Center for Medicare and Medicaid Innovation, bundled payments for episodes of care (including hospitalization) for Medicaid, increase in Medicaid reimbursement rates for primary care physicians, quality of care provisions such as to improve health care delivery and focus on patient health outcomes and population health, support for comparative effectiveness research, ban on new physician-owned hospitals in Medicare, reimbursement reductions for certain hospital acquired infections.


http://www.newyorker.com/reporting/2009/01/26/090126fa_fact_gawande?currentPage=1

http://www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawande

http://www.newyorker.com/talk/comment/2010/04/05/100405taco_talk_gawande?printable=true

http://www.kff.org/healthreform/8060.cfm

http://www.economist.com/opinion/displaystory.cfm?story_id=15720396


Summer 2010

Current materials and links will be provided during or before class.

Lunch

Session 2 (Afternoon)

6. Federal Regulation and Financing of Health Care

Field, Robert J. (2006). Health Care Regulation in America: Complexity, Confrontation, and Compromise. Chapter 4: Regulation and Administration of Health Care Finance, pp. 74, 78-79, 84-113.

7. Payment Reforms in Health Care Finance Systems: Public Programs

Topics may include, for example, Medicare and Medicaid payment changes including bundled payments for episodes of care (including hospitalization) for Medicaid, fraud and abuse, Anti-Kickback statute, Qui Tam changes.


8. Rules of the Regulatory Road Applicable to Federal Regulators, Part I: Administrative Law, Separation of Powers, Adjudication

Funk, William F. and Richard H. Seamon, Administrative Law; Examples and Explanations. 3rd Ed. 2009. The following pages of Chapters 1-3, excluding “Examples” and “Explanations:” 1-6, 11-16, 19, 25-34, 43, 51-52, 65-68, 74, 86-98, 103-108.

Introduction to Administrative Law How Agencies Fit into our System of Separated Powers Adjudication

Formation of groups for group projects.

Day 2 — Session 3 (Morning)

Opening: Brief Review

1. Federal Regulation of Health Care Business Relationships

Field, Robert J. (2006). Health Care Regulation in America: Complexity, Confrontation, and Compromise. Chapter 7: Regulation of Health Care Business Relationships, pp. 173-204.

2. Reforms in Program Integrity, Fraud and Abuse, Regulatory Issues, and Business Relationships



Summer 2010

Topics may include, for example, Medicare, Medicaid, fraud and abuse, changes to the Stark Physician Self-Referral Law, tax credits for small employers, temporary reinsurance for employers covering to retirees over age 55 and not Medicare eligible, tax law changes applicable to charitable hospitals, new insurance exchanges for individuals and small businesses, ban on physician-owned hospitals (in Medicare), demonstration projects to states for alternatives to current medial malpractice litigation, grants for small employers for wellness programs, employers may offer financial incentives to employees for participation in wellness programs.


Lunch


3. Rules of the Regulatory Road Applicable to Federal Regulators, Part II: Due Process and Rulemaking

Funk, William F. and Richard H. Seamon (2009). Administrative Law; Examples and Explanations.The following pages of Chapters 4 and 5, excluding “Examples” and “Explanations:” pp. 109-118, 126-127, 134-139, 141-151, 154-157, 159-162, 164-168, 172- 174-175 (all), 177-179, 183-192, 196-199, 202-204, 207-211. Prior to reading the assigned pages of Chapter 5, review the chart entitled “Reg Map:” www.reginfo.gov/ublic/reginfo/Regmap/regmap.pdf, and explanations of the chart at: www.reginfo.gov/public/reginfo/Regmap/index.jsp.

Due Process Rulemaking

4. Discussion of Complexities and Challenges of Federal Rulemaking in Health Care


Module 2Day 3 — Session 5 (Morning)


1. Limited Pre-Existing Federal Regulation of Health Plans and Health Insurance

Materials and links will be provided during or immediately before class.

2. Payment and Related Reforms in Health Care Finance Systems: Health Plans and Health Insurance Warren Barnes, J.D. of 12 USC School of Policy Planning and Development Summer 2010

http://www.reginfo.gov/public/reginfo/Regmap/index.jsp

http://www.reginfo.gov/ublic/reginfo/Regmap/regmap.pdf


Summer 2010

Topics may include, for example, various insurance market reforms, temporary national high-risk pool for individuals with pre-existing conditions, individual and employer mandates to purchase health insurance, insurance exchanges for individuals and small business, mandatory medical-loss ratio for health insurers with rebate as penalty, health insurers to justify rate increases, new requirements and prohibitions applicable to health plans and health insurers, rate regulation, bonuses for high-quality Medicare Advantage plans and rebate reductions for Medicare Advantage plans, voluntary insurance program for community living assistance services and supports (CLASS), CO-OP program to stimulate development of non-profit health insurance entities, an essential benefits package.

Current materials and links will be provided during or immediately before class.

Lunch


3. Rules of the Regulatory Road Applicable to Federal Regulators, Part III: Judicial Review

Funk, William F. and Richard H. Seamon (2009). Administrative Law; Examples and Explanations. The following pages of Chapters 6 and 7, excluding “Examples” and “Explanations: pp. 213-215, 217, 219, 232-233, 246-247, 261-262, 269-271, 279-288, 299-300, 302-304, 312-314, 323-324.

The Availability of Judicial Review The Scope of Judicial Review

3. Federal Regulation of Public Health Field, Robert J. (2006). Health Care Regulation in America: Complexity, Confrontation, and Compromise. Skim the following pages of Chapter 6: Regulation of Public Health, pp. 146-164, 168-172.

4. Presentation of Group Projects

5. Presentations of Final Papers

Note: Final Papers will be presented on Day 3 or 4. Every effort will be made to accommodate your preference.

Day 4 — Session 7 (Morning)


1. Rules of the Regulatory Road Applicable to Federal Regulators, Part IV: Information Management Warren Barnes, J.D. of 12 USC School of Policy Planning and Development Summer 2010


Summer 2010

Funk, William F. and Richard H. Seamon, Administrative Law; Examples and Explanations. Skim the following pages of Chapters 8 and 9, excluding “Examples and Explanations:” pp. 337-364, 365-422.

Government Acquisition of Private Information Public Access to Government Information


Note: Final Papers not presented on Day 3 will be presented this morning or this afternoon.

Lunch


3. Federal Regulation of Drugs, Health Care Products and Research

Field, Robert J. (2006). Health Care Regulation in America: Complexity, Confrontation, and Compromise. Skim Chapters 5 and 8: pp. 114-140, 205-234.

Regulation of Drugs and Health Care Products Regulation and Funding of Research


Note: Final Papers not presented on Day 3 or this morning will be presented this afternoon.

5. The Regulatory Dance: Focus on the Merits with Emotional Intelligence (All are Optional Reading.)

Berwick, Donald M. (2002). Escape Fire; Lessons for the Future of Health Care. (Available online www.commonwealthfund.org/usr_doc/berwick_escapefire_563.pdf.

Collins, James (2005). Good to Great and the Social Sectors: A Monograph to Accompany Good to Great.

George, Bill (2007) True North: Discover your Authentic Leadership.

Goleman, Daniel, Richard Boyatzis and Annie McKee (2002). Primal Leadership: Realizing the Power of Emotional Intelligence.

Hackman, J. Richard (May 2009). “Why Teams Don’t Work,” Harvard Business Review, pp. 98-105. www.commonwealthfund.org/usr_doc/berwick_escapefire_563.pdf.

Kotter, John P. (January 2007) “Leading Change: Why Change Efforts Fail,” Harvard Business Review. www.//hbr.org/2007/01/leading-change/ar/1.

6. Putting it All TogetherWarren Barnes, J.D. of 12 USC School of Policy Planning and Development Summer 2010

http://www.//hbr.org/2007/01/leading-change/ar/1

http://www.commonwealthfund.org/usr_doc/berwick_escapefire_563.pdf

http://www.commonwealthfund.org/usr_doc/berwick_escapefire_563.pdf


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7. Summing Up and Reflections


school of policy, planning, and developmentweb-app.usc.edu/soc/syllabus/20102/51403.doc · web...

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