Updated on November 8 2011
Set forth below is the tentative schedule of distinguished guest speakers and topics relating to health care legislative, regulatory, and judicial process, subject to change, please. Study materials and assignments will be provide in advance of each class.
September 19, 2011 - Robert L. Roth - Medicare Program Determinations and Appeals
http://health-law.com/attorneys/ro-robert-l-roth/
http://web.me.com/asgoldberg1/filechute/Auburn-ARMC%20v.%20Sebelius%20-%20D.C.%20Cir.%20-%2006242100%20Opinion.zip
September 26, 2011 - Louis Alterescu, Office of General Counsel, U. S. Department of Health & Human Services, and Adam H. Greene - HIPAA Administrative Simplification and HITECH Act
http://www.dwt.com/People/AdamHGreene
http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html
http://www.hhs.gov/ocr/privacy/hipaa/administrative/index.html
http://www.hhs.gov/ocr/privacy/hipaa/administrative/statute/index.html
http://www.medicare.gov/privacypractices.asp
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.html
http://www.va.gov/vhapublications/viewpublication.asp?pub_id=1089
http://www.sibley.org/general_info/medical_information_privacy_notice.aspx
October 3, 2011 - Deven McGraw - Privacy and Public Advocacy, William Braithwaite, MD, PhD - The HIPAA Law & Lore: Dr. HIPAA Speaks
http://www.cdt.org/personnel/deven-mcgraw
http://www.hitsp.org/Braithwaite.aspx
http://www.cdt.org/files/pdfs/20090126Consent.pdf
http://caselaw.findlaw.com/us-3rd-circuit/1187927.html
October 10, 2011 - Neal Neuberger - Health Care and Public Advocacy
http://www.e-healthpolicy.org/staff.asp
http://www.e-healthpolicy.org/index.asp
http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__home/1204
October 17, 2011 - Kevin G. McAananey - Antifraud and Abuse, Anti-Kickback, Stark Law, False Claims
http://www.mcananeylaw.com/
http://oig.hhs.gov/compliance/physician-education/index.asp
http://web.me.com/asgoldberg1/filechute/oig-antifraudbook-roadmap_web_version.zip
Please study the attached AHLA material which AHLA generously has made available to us. We will discuss this material during our class on October 17/
http://sn.im/sm3qq-drp
Please also see below for a hot link to a copy of the so-called Stark Law.
http://sn.im/sm41e-aod
OR
http://www.ssa.gov/OP_Home/ssact/title18/1877.htm
and to the so-called health care civil monetary penalties false claims and antikickback statutes
http://www.ssa.gov/OP_Home/ssact/title11/1128A.htm
http://www.ssa.gov/OP_Home/ssact/title11/1128B.htm
October 24, 2011 - Thomas C. Goldstein - Health Care and Advocacy Before U. S. Supreme Court
http://www.ghrfirm.com/attorney-profiles/thomas-goldstein
http://www.supremecourt.gov/opinions/10pdf/10-779.pdf
Please also study the materials at the back of the Eskridge, Frickey and Garrett's Legislation and Statutory Interpretation course regarding the U.S. Supreme Court and statutory construction.
October 31, 2011 - John J. Castellani - PhRMA and Advocacy
http://www.phrma.org/john-castellani-biography
http://www.phrma.org/research/publications
http://www.phrma.org/about/principles-and-guidelines
Michael K. Loucks - Prosecution, and Defense of Health Care Crimes
http://www.skadden.com/index.cfm?contentID=45&bioID=9864
http://www.hhs.gov/news/press/2009pres/09/20090902a.html
http://articles.latimes.com/2009/sep/03/business/fi-pfizer3
http://www.nytimes.com/2011/06/05/business/05switch.html?_r=1
http://www.justice.gov/opa/pr/2010/December/10-civ-1464.htm
http://www.pharmalot.com/2011/06/former-prosecutor-doj-keeps-pharma-in-the-dark/
http://www.ft.com/intl/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html#axzz1a6sn1Fz4
November 7, 2011 - Richard M. "Rick" Campanelli, JD, Director of Government Relations, Health and Human Services, Washington Operations, Lockheed Martin Corporation, Former Director, Office for Civil Rights and Counselor to the Secretary of the U. S. Department of Health and Human Services
http://www.lockheedmartin.com/news/press_releases/2011/1-13-Campanelli-Health-IT-Cert-Commission.html
http://www.linkedin.com/pub/richard-campanelli/a/279/546
November 14, 2011 - Susan C. Winckler, RPh, Esq., President and CEO, Food and Drug Law Institute, former Chief of the Staff for the U.S. Food and Drug Administration (FDA) within HHS, Managing Director, Medical Products Practice, at Leavitt Partners founded by former U.S. Health and Human Services (HHS) Secretary and EPA Administrator Michael O. Leavitt
http://www.fdli.org/about/
TERM PAPERS
To: My Health Law Students
Re: Final Paper and Presentations Assignment
1. For our classes scheduled for November 21 and 28, we will be discussing your final papers and negotiating strategies relating to whether or not Congress should mandate that every patient in the United States of America that receives health care and treatment must have an electronic health record provided and paid for by the caregiver.
2. Assume that a bill mandating the use of electronic health records is introduced in the House and in the Senate, having been prepared for the President to file as a proposed amendment to the PPACA/ACA legislation, and that the bill provides that such requirement would be an unfunded federal mandate and would preempt and supervene any contrary state laws.
3. You either will be among those on the legal counsel staff of the White House asked to prepare an advocacy paper in behalf of enactment of the bill, or among those who are retained by a group of health care professional and business associations and who are asked to prepare an advocacy paper adverse to the bill, in either instance setting forth in detail the reasons under law and policy for the position you are advocating.
4. As you would if you actually were so retained as legal counsel, you will have available to you whatever legal and other resources you can locate and use, in order to provide zealous advocacy for and in behalf of your client, and you will be expected, inter alia, to address privacy and security concerns including data breaches, anti-fraud and abuse issues implicated by massive data base availability of care and payment information, reimbursement and cost implications, medical errors and standards of care including comparative effectiveness and quality care, and other relevant considerations, but constitutionality under the federal constitution need not be discussed because we will assume that the constitutionality of PPACA/ACA is upheld by the US Supreme Court.
5. Fortunately, you enjoy the benefits also of being a law student in our class and so the remarks, views, and information provided during hour class discussions including from our guest speakers, also may be cited.
6. The paper must be at least ten standard 8-1/2 by 11 inches sheets, no more than 12 point typeface, double spaced, with normal margins, and you are free to provide more than ten sheets.
7. Use The Blue Book® citations style, please, and your citations and any graphics and charts, etc., are extra: that is, the minimum number of sheets is exclusive of footnotes etc., please.
8. Your paper must be received by me not later than the end of November 20, 2011 (the day before our class), via email to Alan@GoldbergLawyer.com please.
Kindly feel free to express a preference regarding which side you would like to be on; but understand that I cannot necessarily respond to everyone's preference.
We will be discussing all the foregoing in class.
Thank you.
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November 21, 2011 - Presentation of Papers and Advocacy
November 28, 2011 - Presentation of Papers and Advocacy
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Updated on September 13, 2011
I provided via email a link to the rather large zip file with Bob Roth's recently received materials, including the USDC decision that was overturned by the Circuit Court in DC. As discussed yesterday, please familiarize yourself with these materials in order to enhance our discussion with Bob on September 19, 2011.
While lots of materials are being provided and you are not expected to master all of them, nevertheless, do try to get a sense of what went on and what was going on in the factual circumstances generally and consider how legislation and regulations seemingly failed to provide a clear path for the appellants to anticipate the position the government would take, and consider further why the government believes the appellants should not have succeeded (what would those who voted in favor or the Medicare program have wanted to occur and was the situation due to legislative or regulatory failure or simply a money issue plain and simple).
And for the classes during which we'll be discussing HIPAA/HITECH Act, please begin studying and familiarizing yourself with the original HIPAA statute (Original HIPAA) and also with the HITECH Act (HIPAA JOLT) that followed several years of what some said was watered down HIPAA (HIPAA Lite) before enforcement under the HIPAA JOLT was increased.
See:
http://www.hhs.gov/ocr/privacy/hipaa/administrative/statute/index.html
and
http://www.hhs.gov/ocr/privacy/hipaa/administrative/index.html
and in general, peruse the information located at the HHS OCR (Office for Civil Rights) web site so you will have an overview of what HIPAA/HITECH Act is all about; and additional information will be provided to you later.
See if you can locate the actual HITECH Act provisions within a larger legislative enactment and extract a copy for your use. If you have difficulty, let me know, please.
As you study these materials, consider why HIPAA was thought to be necessary; whether HIPAA has achieved the purposes intended; how an unfunded federal mandate can profoundly add to the costs of those affected; whether the benefits are worthwhile for those thought to be protected; whether HIPAA/HITECH Act makes the delivery of health care more difficult and whether, when considering Original HIPAA language, the privacy rule reflects what the legislation likely was intended to accomplish; and if, perhaps, another way of protecting health care privacy would be better overall including possibly by leaving the protections to the states to address instead of having the federal government deeply involved in privacy protection. Our discussion will mostly involve privacy, but security also is an important part of HIPAA and we'll discuss security briefly as well.
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Updated on August 29, 2011
...
I am giving you the following linked materials to add to our curriculum. These materials relate to our discussions today preliminarily about coming attractions including on September 12 regarding the health reform materials previously cited and linked for you and on September 19th with our guest Robert Roth:
http://health-law.com/attorneys/ro-robert-l-roth/
with whom we'll discuss the Medicare program legislative and regulatory materials including those available at:
http://web.me.com/asgoldberg1/filechute/rothahlaheadstailstales.pdf.zip
(we'll be studying judicial decisions Bob references in Bob's article linked above)
http://web.me.com/asgoldberg1/filechute/medicarepl89-97-1965%20-ssamends1965.pdf.zip
(the original Medicare law that includes "reasonable and necessary")
http://web.me.com/asgoldberg1/filechute/Auburn-ARMC%20v.%20Sebelius%20-%20D.C.%20Cir.%20-%2006242100%20Opinion.zip
(a current opinion in a matter Bob is shepherding)
http://www.ll.georgetown.edu/federal/judicial/dc/opinions/00opinions/00-5109a.html
(one of the decisions also relevant to our discussions).
More information regarding all the foregoing will be provided when we meet this afternoon.
Please advise me if you have difficulty opening any of the linked materials. Thank you.
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Updated on August 23, 2011:
Here are links to the online references I referred to in class yesterday and which should be useful to you during our studies. In particular, be sure to download the How Laws Are Made .pdf file for later reference and assignments.
http://www.ll.georgetown.edu/guides/legislative_history.cfm
http://thomas.loc.gov/home/lawsmade.toc.html
http://www.gpo.gov/fdsys/pkg/CDOC-110hdoc49/pdf/CDOC-110hdoc49.pdf
Please also be sure regularly to access your incoming email, both for assignments and for any messages regarding class cancellations because of bad weather or other unexpected circumstances.
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Updated on August 23, 2011:
Welcome to AU/WCL Fall 2011 Semester > HlthLaw:Legisla&Reg Process (719-001).
First of all, please know that I am delighted to have the opportunity to collaborate with you in furtherance of enhancing knowledge and insight regarding the critically important issues implicated by the legislative and regulatory process involving health care. We all are patients, and as law students, lawyers, and patients, we need to know more about how health law evolves and health care is delivered and paid for, because just about every part of law and of life affects and is affected by or involves health care.
Second, this is a particularly auspicious time to be studying health law and how the law develops and is changed by the legislative and regulatory, and the judicial, processes: the Medicare program, the Health Insurance Portability and Accountability Act of 1996 (my beloved HIPAA) and the HITECH Act, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the federal anti-kickback, false claims, and Stark laws, and most recently, the Affordable Care Act (PPACA and HCERA), are some examples of how profoundly important and consequential federal political and legislative initiatives are and how they affect health, business, the economy, and happiness.
In anticipation of our first classroom discussion and even before the new syllabus is ready for you (I am still in the process of creating the new syllabus because, inter alia, of changes in the law and enhancement of the orientation of our course for the coming the fall term), please study the materials to be found at:
http://web.me.com/asgoldberg1/filechute/asgwcl-href-as1-125409082011.zipThe file is about 6 megabytes in size and if you have difficulty in downloading or opening the files, please let me know and I can send them to you directly. You will find, for our beginning discussions, copies of PPACA and HCERA and a consolidated file (not to be relied upon as a definitive integrated reference because I don't know if it's completely accurate, but helpful nevertheless for having a better perspective), and two circuit court decisions regarding health reform constitutionality challenges, and some US Senate summary materials as well. Please endeavor to understand the broad aspects of the health reform law and the coverage and timing implications, as you study these materials, and in particular be ready to discuss the Thomas More circuit court decision specifically and the 11th Circuit decision decided August 12, 2011 cited below and the overall health reform initiatives generally. It also will help to review the federal Constitution and amendments, please.
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Please include the decision of the 11th circuit court of appeals of August 12, 2011, linked below, in your studies for our first class and our course.
Note please that I maintain a web site called:
http://www.healthlawyerblog.comwhere you will find references to the course text materials and other information for my health law students generally and for you specifically.
And note, please, that I ask that you provide me, as soon as possible, with a CV / biography that includes your academic and work and career information, as well as your experience thus far in studying health law and in working in any areas of endeavor involving health law. Feel free also to share with me your goals that are health law-related and your specific goals in participating in our course: our course is all for and about you, and so your thoughts and ideas always are welcomed.
When we meet, we also will discuss the syllabus, the periodic written submissions for our course (there is no final examination for this course), our honored guests (hopefully my distinguished colleagues and friends who I invited to visit us will be able to keep to our scheduled days), and any questions you may have about our course specifically and health law generally.
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The required texts for the course are as follows and please bring them to our first class:
1. Eskridge, Frickey and Garrett's Legislation and Statutory Interpretation, 2d (Concepts and Insights Series)By William N. Eskridge, Jr., Philip P. Frickey, Elizabeth GarrettBook - softbound Copyright: 2006 ISBN-13: 9781599410784
2. Furrow, Greaney, Johnson, Jost and Schwartz' Health Care Reform: Supplementary Materials (2011) By Barry R Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S Jost, Robert L. Schwartz Book - softbound Copyright: 2011, West Group ISBN-13: 9780314277503
3. Pocket Edition of the Constitution of the United States, Publication Date: 1998 American Bar Association Division for Public Education ISBN-13: 9781891743009
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