HEALTHLAWYER

Welcome to Alan S. Goldberg's HEALTHLAWYERBLOG(sm)

Welcome to Alan S. Goldberg's HEALTHLAWYERBLOG(sm) for lawyers and law and other students for educational purposes only.

My CV: About Alan S. Goldberg

My web site: http://www.healthlawyer.com

My blog: http://www.healthlawyerblog.com

DISCLAIMER: This blog is for lawyers and law and other students for educational purposes only and does not create a business or professional services relationship. This blog is provided upon the understanding that this blog does not constitute the rendering of legal or other professional services. While all reasonable attempts are made to ensure the accuracy of the information appearing in this blog, there are no express or implied representations or warranties regarding the accuracy of this information. This information may not be relied upon or used as a substitute for consultation with legal, accounting, tax, or other professional advisors. New York law requires a reminder that this is attorney advertising. Prior results do not guarantee a similar outcome.

___________________________________________________________________________

Alan S. Goldberg, JD, LLM (Tax), Attorney & Counsellor-at-Law, 6845 Elm Street, Suite 205, McLean, Virginia 22101

Admitted VA NY DC FL MA

© Copyright 2009, Alan S. Goldberg. All rights reserved.

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 347

Welcome to my law students.  Our course will commence on August 20, 2009.  The coursebooks are:

Furrow, Greany, Johnson, Jost & Schwartz' Health Law: Cases, Materials & Problems, 6th (American Casebook Series®), Author: Furrow, Barry R; Greaney, Thomas L.; Johnson, Sandra H.; Jost, Timothy S; Schwartz, Robert L., Publisher: West Law School;

and

Pocket Edition of the Constitution of the United States

http://www.abanet.org/abastore/index.cfm?fm=Product.AddToCart&pid=3170033

Both books eventually should be available at the GMU bookstore.

Additional materials will be assigned from time to time, and will be listed, along with updates to the curriculum and assignments, on

http://www.healthlawyerblog.com

Your first assignment will include providing me with your biography/CV/resume, that includes your educational, work, and other relevant experiences and your expectations with respect to our Health Law course specifically and your legal education generally. 

Thank you and I look forward to welcoming you to our Health Law course.

Legal Iss Relevnt Hlthcare Adm GMU HHS 750 X01 WED 4:30 PM EDT

Here are references relating to health care privacy and security:

http://www.inova.org/patient-and-visitor-information/pdfs/privacy-policy.pdf

http://www.medicare.gov/privacypractices.asp

http://aspe.hhs.gov/admnsimp/pL104191.htm

_________________________________________________________________

Here are references to federal civil and criminal laws relating to health care.

Anti-kickback:

http://www.law.cornell.edu/uscode/42/1320a-7b.html

False Claims, Civil:

http://www.law.cornell.edu/uscode/31/usc_sec_31_00003729----000-.html

False Claims, Criminal:

http://www.law.cornell.edu/uscode/uscode18/usc_sec_18_00000287----000-.html

False Statement, Criminal: 

http://www.law.cornell.edu/uscode/18/usc_sec_18_00001001----000-.html

Legal Iss Relevnt Hlthcare Adm GMU HHS 750 X01 WED 4:30 PM EDT

Here are references for studying the Medicare/Medicaid programs.  

http://www.medicare.gov/Publications/Search/SearchCriteria.asp?version=default&browser=IE|6|WinXP&Language=English&pagelist=Home&comingFrom=13

http://www.medicare.gov/Publications/Pubs/pdf/10050.pdf

http://www.cms.hhs.gov/History/

http://www.ssa.gov/OP_Home/ssact/title18/1800.htm

http://topics.law.cornell.edu/wex/medicare

http://www.cms.hhs.gov/MedicaidGenInfo/03_TechnicalSum

Legal Iss Relevnt Hlthcare Adm GMU HHS 750 X01 WED 4:30 PM EDT

As a further assignment for our class scheduled for June 3, 2009, please:

1.  Familiarize yourself with the Thomas web site:

http://www.thomas.gov

Download a copy of Public Law 111-005 from

http://snipr.com/fexbr

OR

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ005.111.pdf

and familiarize yourself with the HITECH ACT provisions found at pages 226 et seq. (the pages are not numbered but you will be able easily to find the page if you search for "HITECH" in the .pdf document).

2.  Familiarize yourself with the Federal Register web site:

http://www.gpoaccess.gov/fr/

3.  Familiarize yourself with the Office for Civil Rights web site

http://snipr.com/iy0i7

OR

http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html

4.  Familiarize yourself with the Office of Inspector General web site

http://www.oig.hhs.gov/

_______________________________________________________________________

Please know that the term paper should, insofar as at least the first twenty pages are concerned, be "space and one-half" with typeface size 12 and margins no greater than one and one-quarter inch.

_______________________________________________________________________

Please refer to the following web site locations in preparation for our class scheduled for June 3, 2009 and prepare a proposed form of living will/health care directive and bring a copy with you to class.  Note please in your readings and preparation that generally there is a distinction between a living will, which is not necessarily legally binding, and a health care directive or proxy, which is legally binding but only in certain specifically defined circumstances.  Your assignment is intended to cause you to consider under what, if any, circumstances someone is or is not willing to permit others to make decisions relating to extraordinary care and treatment; and what occurs if, and when, an individual is unable to make or communicate decisions regarding the individual's health care.  See the following in addition to the assigned text materials relating to Virginia and elsewhere including a hot link to a site containing the Schiavo case wherein you should please peruse the materials there that appear to be of interest please :

http://www.norfolk.gov/circuit_court/pdfforms/Living-Wills-in-Virginia.pdf

http://www.vsb.org/sections/hl/add06/2005Form.pdf

http://www.va.gov/vaforms/medical/pdf/vha-10-0137-fill.pdf

http://news.findlaw.com/legalnews/lit/schiavo/

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2982

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2983

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2984

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2985

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2986

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2987

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2987.1

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2988

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2989

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2989.1

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2990

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2991

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2992

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2993

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2994

______________________________________________________________________

Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 X01, Wednesday 4:30 PM EDT beginning May 20, 2009

 

To: Students registered for Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 X01, Wednesday 4:30 PM EDT beginning May 20, 2009

[Please know that the following is a duplicate of an email I sent before, but now that additional students are registered for our course, I am resending the following email previously sent before everyone registered.  Thank you to those students who already have responded; and those who need to respond, please do so as soon as convenient and in any event before the day of our first class, please.  This is important, because I endeavor to design our curriculum based in part upon your responses, and having your responses available before our first class will expedite my preparation of your syllibus and publication of your reading and study assignments for class preparation in final form.  In the meantime, I am providing, at the end of this email, a preliminary draft of our syllibus which, please understand, is subject to revision as and when I receive all of your responses to my email set forth below.  Kindly read and study the Constitution, referenced below, in anticipation of our first class and our discussion of the Constitution and health law during our first class and thereafter during our course, as well as the other material referenced as a part of the draft curriculum for our May 20 first class.  Thank you: I look forward to welcoming and to meeting each and all of you!]

"Good day: it will be my pleasure to welcome you to our course during the Summer term.  Our class is to occur at a unique time in the evolution of health care delivery and health law in the United States, and we will be discussing some of the most current areas of concern including universal health care initiatives, health information technology including eHealth, privacy and security, regulatory enforcement and compliance programs, and quality of care initiatives, in addition to many others.

The required books for the course are:

Problems in Health Care Law, 9th Edition, by Robert D. Miller

http://www.jbpub.com/catalog/9780763745554/

and

Pocket Edition of the Constitution of the United States

http://www.abanet.org/abastore/index.cfm?section=main&fm=Product.AddToCart&pid=3170033

Both books should be available at the GMU bookstore in time for the first class, which is scheduled for Wednesday May 20 at 4:30 PM.  Regarding the duration of our course, I am still in the process of determining how many weeks we will be meeting.  Although our room is reserved for the entire Summer 2009 sessions period, we will not be meeting during that entire period; instead, I expect that we can complete the course, as before, in a period of time less in duration than the entire Summer 2009 sessions period, depending upon the time we meet each week.  And there may be a weekly class or two that I am unable to attend because of other commitments.  I will discuss all the foregoing further with you during our first class, when our calendar for the course will be provided along with our curriculum and your reading assignments (the assignments for prior terms are not necessarily the same as the assignments for our impending term).  Your grade for our course will be based upon your submission in a timely manner of a term paper reflecting your original work product of at least twenty business letter-size sheets in length (footnotes, appendices and the like are in addition to such twenty sheets) and upon your term paper verbal presentation (in person during our class) and your class attendance and quality of class discussion participation.  We will discuss the subjects appropriate for terms papers when we meet in class.  Your attendance during every class is expected and required, unless unusual and special circumstances prevent attendance during a particular class, as I may determine based upon your explanation.

In the meantime, your initial assignment, please, is to provide me via email sometime within the next ten days with your CV that includes your academic and work background; your goals overall in attending CHHS and obtaining your degree; your professional aspirations; and any specific areas of health law that you are interested in learning about in addition to our overall curriculum.  Note that I use my blog site:

http://www.healthlawyerblog.com

to provide information for my health law students.  Although the Summer term curriculum is not yet posted at that site, feel free to visit that site to see what prior curricula have been.  I modify the course content in certain respects each term in order to assure that our discussions reflect current developments, but overall we focus on your being able to respond to the following course objectives:

1. Describe legal principles for making professional and administrative decisions affecting health care service delivery.

2. Examine statues, regulations and case law relevant to health professional's licensure, including practices acts, contracts and employment law.

3. Explain state and federal legislative and regulatory activities related to quality oversight for health services.

4. Develop strategies for regulatory compliance for quality health systems, consistent with case law.

5. Develop conflict management and resolution skills to facilitate issue resolution with legal frameworks.

6. Compare fiduciary responsibility for healthcare systems.

I look forward to meeting you!"

PRELIMINARY DRAFT OF SYLLABUS, SUBJECT TO REVISION

HHS 750 - Legal Issues Relevant to Health Care Administration
Credits: 3 Prepares health professionals to understand legal principles, statutes, regulations, and case law related to managing health care organizations and health professionals’ practice. May compare legal health care issues from domestic and international perspectives.

Course objectives:

1. Describe legal principles for making professional and administrative decisions affecting health care service delivery.

2. Examine statues, regulations and case law relevant to health professional's licensure, including practices acts, contracts and employment law.

3. Explain state and federal legislative and regulatory activities related to quality oversight for health services.

4. Develop strategies for regulatory compliance for quality health systems, consistent with case law.

5. Develop conflict management and resolution skills to facilitate issue resolution with legal frameworks.

6. Compare fiduciary responsibility for healthcare systems.

____________________

SESSION X

Days, dates, and times determined by individual course instructors.

____________________

PRELIMINARY SCHEDULE SUBJECT TO CHANGE: Classes held on May 20, May 27, June 3, June 10, June 17 NO CLASS, June 24, July 1, July 8, and possibly July 15.

READING AND STUDY ASSIGNMENTS:

May 20 – Constitution of the United States including amendments, Problems in Health Care Law, 9th Edition, by Robert D. Miller, Pp. 1-28, Introduction to the American Legal System, pp. 29-74, Organization of the Health Care Delivery System

May 27 – Pp. 121-139, Individual Providers and Caregivers, Licensing and Certification, pp. 213-314, Medical Staff & Relationship of Patient and Provider

June 3 – Pp. 315-426, Decision-making Concerning Individuals, Pp.427-492, Health Care Information

June 10 – pp. 681-708, Criminal Law and Civil Penalties

June 17 - NO CLASS

June 24 – Pp. 493-527, Paying for Health Care Resources and Services

TERM PAPER DUE JUNE 30

July 1 – Presentation and Discussion of Term Papers

July 8 – Presentation and Discussion of Term Papers; FINAL CLASS – Course review (subject to change and possible final class on July 15).

Regards, Alan S. Goldberg
AGoldbe1@gmu.edu
Alan@GoldbergLawyer.com
6845 Elm St. - Ste. 205
McLean, VA 22101
http://www.healthlawyer.com
http://www.healthlawyerblog.com
(703) 915-4790
Adj. Prof. of Health Law
George Mason University
Admitted VA NY DC FL MA

Legal Iss Relevnt Hlthcare Adm GMU HHS 750 X01 WED 4:30 PM EDT start 5/20/09

To: Students registered for Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 X01, Wednesday 4:30 PM EDT beginning May 20, 2009

Good day: it will be my pleasure to welcome you to our course during the Summer term.  Our class is to occur at a unique time in the evolution of health care delivery and health law in the United States, and we will be discussing some of the most current areas of concern including universal health care initiatives, health information technology including eHealth, privacy and security, regulatory enforcement and compliance programs, and quality of care initiatives, in addition to many others.
The required books for the course are: Problems in Health Care Law, 9th Edition, by Robert D. Miller

http://www.jbpub.com/catalog/9780763745554/

and

Pocket Edition of the Constitution of the United States 

http://www.abanet.org/abastore/index.cfm?section=main&fm=Product.AddToCart&pid=3170033

Both books should be available at the GMU bookstore in time for the first class, which is scheduled for Wednesday May 20 at 4:30 PM.  Regarding the duration of our course, I am still in the process of determining how many weeks we will be meeting.  Although our room is reserved for the entire Summer 2009 sessions period, we will not be meeting during that entire period; instead, I expect that we can complete the course, as before, in a period of time less in duration than the entire Summer 2009 sessions period, depending upon the time we meet each week.  And there may be a weekly class or two that I am unable to attend because of other commitments.  I will discuss all the foregoing further with you during our first class, when our calendar for the course will be provided along with our curriculum and your reading assignments (the assignments for prior terms are not necessarily the same as the assignments for our impending term).  Your grade for our course will be based upon your submission in a timely manner of a term paper reflecting your original work product of at least twenty business letter-size sheets in length (footnotes, appendices and the like are in addition to such twenty sheets) and upon your term paper verbal presentation (in person during our class) and your class attendance and quality of class discussion participation.  We will discuss the subjects appropriate for terms papers when we meet in class.  Your attendence during every class is expected and required, unless unusual and special circumstances prevent attendance during a particular class, as I may determine based upon your explanation. 

In the meantime, your initial assignment, please, is to provide me via email sometime within the next ten days with your CV that includes your academic and work background; your goals overall in attending CHHS and obtaining your degree; your professional aspirations; and any specific areas of health law that you are interested in learning about in addition to our overall curriculum.  Note that I use my blog site:

http://www.healthlawyerblog.com

to provide information for my health law students.  Although the Summer term curriculum is not yet posted at that site, feel free to visit that site to see what prior curricula have been.  I modify the course content in certain respects each term in order to assure that our discussions reflect current developments, but overall we focus on your being able to respond to the following course objectives:

1. Describe legal principles for making professional and administrative decisions affecting health care service delivery.

2. Examine statues, regulations and case law relevant to health professional's licensure, including practices acts, contracts and employment law.

3. Explain state and federal legislative and regulatory activities related to quality oversight for health services.

4. Develop strategies for regulatory compliance for quality health systems, consistent with case law.

5. Develop conflict management and resolution skills to facilitate issue resolution with legal frameworks.

6. Compare fiduciary responsibility for healthcare systems.

I look forward to meeting you!

WYETH, PETITIONER v. DIANA LEVINE - Certification - Preemption

FROM: Alan S. Goldberg, JD, LLM (Tax), Mod'r, HIT listserv, AHLA Past Pres. & Inaug. Fellow, Alan@GoldbergLawyer.com

  6845 Elm St., Suite 205, McLean, Virginia 22101, http://www.healthlawyer.com

  Adj. Prof. of Health Law, George Mason University - Admitted VA NY DC FL MA - This email is neither legal nor tax advice and cannot be used by anyone to avoid penalties under the Internal Revenue Code of 1986, as amended; please retain a competent attorney for legal or tax advice.

Query how the PL 111-005 provisions relative to certification quoted below are to be construed in light of the decision of the USSCT referenced below (and regardless, this decision is a fascinating performance by the Justices providing much to consider, ponder, and reflect upon regarding preemption and federal-state relationships in matters of health care regulation):

    `(c) Duties of the National Coordinator-

            `(1) STANDARDS- The National Coordinator shall--

                  `(A) review and determine whether to endorse each standard, implementation specification, and certification criterion for the electronic exchange and use of health information that is recommended by the HIT Standards Committee under section 3003 for purposes of adoption under section 3004;

                  `(B) make such determinations under subparagraph (A), and report to the Secretary such determinations, not later than 45 days after the date the recommendation is received by the Coordinator; and

                  `(C) review Federal health information technology investments to ensure that Federal health information technology programs are meeting the objectives of the strategic plan published under paragraph (3).

           

            `(5) CERTIFICATION-

                  `(A) IN GENERAL- The National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, shall keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria adopted under this subtitle. Such program shall include, as appropriate, testing of the technology in accordance with section 13201(b) of the Health Information Technology for Economic and Clinical Health Act.

                  `(B) CERTIFICATION CRITERIA DESCRIBED- In this title, the term `certification criteria' means, with respect to standards and implementation specifications for health information technology, criteria to establish that the technology meets such standards and implementation specifications.

WYETH, PETITIONER v. DIANA LEVINE

quote

The Supreme Court ruled yesterday in favor of a woman who had her arm amputated after an improper injection of an anti-nausea medication and said drugmakers could not rely on federal regulation to shield them from lawsuits brought under state consumer protection laws.

The 6 to 3 vote in the court's most anticipated business decision of the term was a rejection of Bush administration policy and a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them.

http://www.washingtonpost.com/wp-dyn/content/article/2009/03/04/AR2009030401407.html

______________

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf

WYETH, PETITIONER v. DIANA LEVINE

...Our answer to that question must be guided by two cornerstones of our pre-emption jurisprudence. First, “the purpose of Congress is the ultimate touchstone in everypre-emption case.” Medtronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996) (internal quotation marks omitted); see Retail Clerks v. Schermerhorn, 375 U. S. 96, 103 (1963). Second, “[i]n all pre-emption cases, and particularly in those inwhich Congress has ‘legislated . . . in a field which the States have traditionally occupied,’ . . . we ‘start with theassumption that the historic police powers of the States were not to be superseded by the Federal Act unless thatwas the clear and manifest purpose of Congress.’” Lohr, 518 U. S., at 485 (quoting Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947)).

In order to identify the “purpose of Congress,” it is appropriate to briefly review the history of federal regulation of drugs and drug labeling. In 1906, Congress enacted itsfirst significant public health law, the Federal Food andDrugs Act, ch. 3915, 34 Stat. 768. The Act, which prohibited the manufacture or interstate shipment of adulterated or misbranded drugs, supplemented the protection for consumers already provided by state regulation and common-law liability. In the 1930’s, Congress becameincreasingly concerned about unsafe drugs and fraudulent marketing, and it enacted the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended,21 U. S. C. §301 et seq. The Act’s most substantial innovation was its provision for premarket approval of new drugs.

____

JUSTICE ALITO, with whom THE CHIEF JUSTICE and JUSTICE SCALIA join, dissenting.

This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs. That result cannot be reconciled with Geier v. American Honda Motor Co., 529 U. S. 861 (2000), or general principles of conflict pre-emption. I respectfully dissent.

I The Court frames the question presented as a “narro[w]” one—namely, whether Wyeth has a duty to provide “an adequate warning about using the IV-push method” toadminister Phenergan. Ante, at 8. But that ignores the antecedent question of who—the FDA or a jury in Vermont—has the authority and responsibility for determining the “adequacy” of Phenergan’s warnings. Moreover, it is unclear how a “stronger” warning could ....

_____________

GMU CHHS Health Law & Policy March 4, 2009 Assignment

As discussed in class last week, please prepare a living will/health care directive for class on March 4, 2009.  Note please in your readings and preparation that there generally there is a distinction between a living will that is not necessarily legally binding, and a health care directive or proxy which is legally binding but only in certain specifically defined circumstances.  Your assignment is intended to cause you to consider under what, if any, circumstances someone is or is not may or is willing to permit others to make decisions relating to extraordinary care and treatment and what occurs, and when, if one is unable to make or communicate decisions regarding one's health care.  See the following in addition to the assigned text materials relating to Virginia and elsewhere including a hot link to a site containing the Schiavo case wherein you should please peruse the materials there that appear to be of interest please :

http://www.norfolk.gov/circuit_court/pdfforms/Living-Wills-in-Virginia.pdf

http://www.vsb.org/sections/hl/add06/2005Form.pdf

http://www.va.gov/vaforms/medical/pdf/vha-10-0137-fill.pdf

http://news.findlaw.com/legalnews/lit/schiavo/

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2982

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2983

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2984

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2985

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2986

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2987

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2987.1

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2988

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2989

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2989.1

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2990

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2991

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2992

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2993

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2994

___________________________

ARRA 2009 HITECH

The following postings relate to ARRA 2009 HITECH including HIPAA Administrative Simplification subtitle and HITECH Subtitle D.

______________________________________________________________________

Good morning: the following gov't hot link seems to be a site wherein the new ARRA 09 is now available albeit still as portions of the Conference Report for HR1:

http://www.conferencereport.gpoaccess.gov/SearchCongressionalRecord.aspx?CongressionalRecordId=xN/m0fuchas=

OR

http://tinyurl.com/b7m22x

quote

Title:

      Conference Report on H.R. 1 (1 of 5)

Complete PDF:View PDF File
Complete ASCII:View ASCII File
Conference Report on H.R. 1 (2 of 5) PDF ASCII Text
Conference Report on H.R. 1 (3 of 5) PDF ASCII Text
Conference Report on H.R. 1 (4 of 5) PDF ASCII Text
Conference Report on H.R. 1 (5 of 5) PDF ASCII Text

Recall the DOJ HIPAA enforcement Memo to HHS:

http://www.usdoj.gov/olc/hipaa_final.htm

and consider how the foregoing is affected by ARRA 09/HITECH:

quote

(b) Application of Civil and Criminal Penalties- In the case of a business associate that violates any security provision specified in subsection (a), sections 1176 and 1177 of the Social Security Act (42 U.S.C. 1320d-5, 1320d-6) shall apply to the business associate with respect to such violation in the same manner such sections apply to a covered entity that violates such security provision.

AND

SEC. 13409. CLARIFICATION OF APPLICATION OF WRONGFUL DISCLOSURES CRIMINAL PENALTIES.

Section 1177(a) of the Social Security Act (42 U.S.C. 1320d-6(a)) is amended by adding at the end the following new sentence: `For purposes of the previous sentence, a person (including an employee or other individual) shall be considered to have obtained or disclosed individually identifiable health information in violation of this part if the information is maintained by a covered entity (as defined in the HIPAA privacy regulation described in section 1180(b)(3)) and the individual obtained or disclosed such information without authorization.'.

Note the following newly federally statutorily defined terms:

quote

(1) BREACH- The term `breach' means the unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security, privacy, or integrity of protected health information maintained by or on behalf of a person. Such term does not include any unintentional acquisition, access, use, or disclosure of such information by an employee or agent of the covered entity or business associate involved if such acquisition, access, use, or disclosure, respectively, was made in good faith and within the course and scope of the employment or other contractual relationship of such employee or agent, respectively, with the covered entity or business associate and if such information is not further acquired, accessed, used, or disclosed by such employee or agent.

(5) ELECTRONIC HEALTH RECORD- The term `electronic health record' means an electronic record of health-related information on an individual that is created, gathered, managed, and consulted by authorized health care clinicians and staff.

(11) PERSONAL HEALTH RECORD- The term `personal health record' means an electronic record of individually identifiable health information on an individual that can be drawn from multiple sources and that is managed, shared, and controlled by or for the individual.

(18) VENDOR OF PERSONAL HEALTH RECORDS- The term `vendor of personal health records' means an entity, other than a covered entity (as defined in paragraph (3)), that offers or maintains a personal health record.

(A) IN GENERAL- Subject to subparagraph (B), for purposes of this section, the term `unsecured protected health information' means protected health information that is not secured through the use of a technology or methodology specified by the Secretary in the guidance issued under paragraph (2).

(B) EXCEPTION IN CASE TIMELY GUIDANCE NOT ISSUED- In the case that the Secretary does not issue guidance under paragraph (2) by the date specified in such paragraph, for purposes of this section, the term `unsecured protected health information' shall mean protected health information that is not secured by a technology standard that renders protected health information unusable, unreadable, or indecipherable to unauthorized individuals and is developed or endorsed by a standards developing organization that is accredited by the American National Standards Institute.

(1) BREACH OF SECURITY- The term `breach of security' means, with respect to unsecured PHR identifiable health information of an individual in a personal health record, acquisition of such information without the authorization of the individual.

(2) PHR IDENTIFIABLE HEALTH INFORMATION- The term `PHR identifiable health information' means individually identifiable health information, as defined in section 1171(6) of the Social Security Act (42 U.S.C. 1320d(6)), and includes, with respect to an individual, information--

(A) that is provided by or on behalf of the individual; and

(B) that identifies the individual or with respect to which there is a reasonable basis to believe that the information can be used to identify the individual.

(3) UNSECURED PHR IDENTIFIABLE HEALTH INFORMATION-

(A) IN GENERAL- Subject to subparagraph (B), the term `unsecured PHR identifiable health information' means PHR identifiable health information that is not protected through the use of a technology or methodology specified by the Secretary in the guidance issued under section 13402(h)(2).

(B) EXCEPTION IN CASE TIMELY GUIDANCE NOT ISSUED- In the case that the Secretary does not issue guidance under section 13402(h)(2) by the date specified in such section, for purposes of this section, the term `unsecured PHR identifiable health information' shall mean PHR identifiable health information that is not secured by a technology standard that renders protected health information unusable, unreadable, or indecipherable to unauthorized individuals and that is developed or endorsed by a standards developing organization that is accredited by the American National Standards Institute.

AND THE FOLLOWING IMPLICATES A DEFINITION FOR HIE/HIEO/RHIO/EPG:

SEC. 13408. BUSINESS ASSOCIATE CONTRACTS REQUIRED FOR CERTAIN ENTITIES.

Each organization, with respect to a covered entity, that provides data transmission of protected health information to such entity (or its business associate) and that requires access on a routine basis to such protected health information, such as a Health Information Exchange Organization, Regional Health Information Organization, E-prescribing Gateway, or each vendor that contracts with a covered entity to allow that covered entity to offer a personal health record to patients as part of its electronic health record, is required to enter into a written contract (or other written arrangement) described in section 164.502(e)(2) of title 45, Code of Federal Regulations and a written contract (or other arrangement) described in section 164.308(b) of such title, with such entity and shall be treated as a business associate of the covered entity for purposes of the provisions of this subtitle and subparts C and E of part 164 of title 45, Code of Federal
Regulations, as such provisions are in effect as of the date of enactment of this title.

AND [psychotherapy notes]

SEC. 13421 ... The Secretary shall by rule amend such Federal regulations as required to make such regulations consistent with this subtitle. In carrying out the preceding sentence, the Secretary shall revise the definition of `psychotherapy notes' in section 164.501 of title 45, Code of Federal Regulations, to include test data that is related to direct responses, scores, items, forms, protocols, manuals, or other materials that are part of a mental health evaluation, as determined by the mental health professional providing treatment or evaluation.

Query when HHS will provide proposed/interim final/final rules  
regarding the following time-sensitive provisions and note "take  
effect" which used to be different from "enforceable" but it seems,  
subject to further review, that the following are not "standards" and  
thus won't suffer under a two year + delay period:

SEC. 13423. EFFECTIVE DATE.

Except as otherwise specifically provided, the provisions of part I  
shall take effect on the date that is 12 months after the date of the  
enactment of this title.

...

-PART I--IMPROVED PRIVACY PROVISIONS AND SECURITY PROVISIONS

SEC. 13401. APPLICATION OF SECURITY PROVISIONS AND PENALTIES TO  
BUSINESS ASSOCIATES OF COVERED ENTITIES; ANNUAL GUIDANCE ON SECURITY  
PROVISIONS.

(a) Application of Security Provisions- Sections 164.308, 164.310,  
164.312, and 164.316 of title 45, Code of Federal Regulations, shall  
apply to a business associate of a covered entity in the same manner  
that such sections apply to the covered entity. The additional  
requirements of this title that relate to security and that are made  
applicable with respect to covered entities shall also be applicable  
to such a business associate and shall be incorporated into the  
business associate agreement between the business associate and the  
covered entity....

SEC. 13404. APPLICATION OF PRIVACY PROVISIONS AND PENALTIES TO  
BUSINESS ASSOCIATES OF COVERED ENTITIES.

(a) Application of Contract Requirements- In the case of a business  
associate of a covered entity that obtains or creates protected health  
information pursuant to a written contract (or other written  
arrangement) described in section 164.502(e)(2) of title 45, Code of  
Federal Regulations, with such covered entity, the business associate  
may use and disclose such protected health information only if such  
use or disclosure, respectively, is in compliance with each applicable  
requirement of section 164.504(e) of such title. The additional  
requirements of this subtitle that relate to privacy and that are made  
applicable with respect to covered entities shall also be applicable  
to such a business associate and shall be incorporated into the  
business associate agreement between the business associate and the  
covered entity.

SYL: GMU CHHS Lgl Iss Relevnt Hlthcare Admin - 12415 - HHS 750 – 001

George Mason University Legal Issues HHS 750-001 Spring 2009 Term

Lgl Iss Relevnt Hlthcare Admin - 12415 - HHS 750 – 001

Coursebook: Problems in Health Care Law, 9th Edition, by Robert D. Miller

The following assigned readings are mandatory, and additional readings are to be assigned from time to time.  The question/answer materials at the end of chapters in the coursebook are not part of the required readings.  Assignments are subject to change, so please be sure periodically to visit

http://www.healthlawyerblog.com

so that you will have the most current assignments and information regarding our course.

February 4 – Constitution of the United States including amendments

February 11 – Pp. 1-28, Introduction to the American Legal System, pp. 29-74, Organization of the Health Care Delivery System

February 18 – Pp. 121-139, Individual Providers and Caregivers, Licensing and Certification, pp. 213-238, Medical Staff 

February 25 – Pp. 239-278, Medical Staff, pp. 279-314, Relationship of Patient and Provider

March 4 – Pp. 315-426, Decision-making Concerning Individuals

March 11 – NO CLASS SCHEDULED

March 18 – Pp. 427-492, Health Care Information

March 25 – Pp. 427-492, Health Care Information, pp. 681-708, Criminal Law and Civil Penalties

April 1 – Pp. 681-708, Criminal Law and Civil Penalties

April 8 – Pp. 493-527, Paying for Health Care Resources and Services 

April 15 – Pp. 559-586, Third-party Health Care Coverage

TERM PAPER DUE APRIL 21

April 22 – Assigned materials to be provided, Disagreements, Disputes, Litigation, Mediation, Arbitration, and Conciliation, and Corporate Compliance Programs

April 29 – FINAL CLASS – Course review

As you read the foregoing and other assigned materials and during our classroom discussions, please keep the following course objectives in mind:

1. Describe legal principles for making professional and administrative decisions affecting health care service delivery.

2. Examine statues, regulations and case law relevant to health professional's licensure, including practices acts, contracts and employment law.

3. Explain state and federal legislative and regulatory activities related to quality oversight for health services.

4. Develop strategies for regulatory compliance for quality health systems, consistent with case law.

5. Develop conflict management and resolution skills to facilitate issue resolution with legal frameworks.

6. Compare fiduciary responsibility for healthcare systems.

 _________________________________________________________________________

 

 

George Mason University Legal Issues HHS 750-001 Spring 2009 Term

To my students: welcome to --

Lgl Iss Relevnt Hlthcare Admin - 12415 - HHS 750 - 001
Associated Term: Spring 2009
Levels: Graduate, Non-Degree, Consortium
Attributes: Graduate - Advanced
Fairfax Campus
Lecture
3.000 Credits
Class 4:30 pm - 7:10 pm W Innovation Hall 207

Spring term calendar

No class during Spring Break, March 11, 2009.

Final term paper due April 21, 2009.

Last class April 29, 2009.

Please endeavor to obtain the coursebook, Problems in Health Care Law, 9th Edition, by Robert D. Miller, and bring the coursebook with you to our class scheduled for February 4, 2009. 

Your assignment for February 4, 2009 is to read the Constitution of the United States of America including the Bill of Rights and other amendments, with a particular focus on references to courts, judges, and the judiciary, and to any references to health care and life.  Please bring a copy of the Constitution with you to class for ready-reference.  Note please that helpful information also appears at the House of Representatives Educational Resources and Government Printing Office Constitution of the United States web sites regarding the Constitution and law.  Please also reflect upon our classroom discussion on January 28, 2009 regarding the several branches of our federal government, which we will discuss again in the context of bills, laws and statutes, regulations and rules, and law enforcement and decisions by the judiciary.

If you are able to obtain the coursebook before our class scheduled for February 4, 2009, please study pages 1-28 and pages 29-74 which will form the basis for our discussions during our February 4, 2009 class if the coursebooks are available to all students by that time.  Thereafter, please study pages 121-139 and pages 205-209; and hereafter, please study pages 213-277; we will be focusing on these pages in the coming weeks.  Note please that the questions that appear at the end of the Chapters in the coursebook are not part of your assignment.  The syllabus for the course will be posted soon after I receive the educational and work information from my students that I requested in my welcoming email last week.

Thank you.

GMU Health Law Additional Assignment Materials - October 2008

Please review materials referenced at the following sites/cites for our October 23, 2008 class. Be sure each URL appears on one single line, not truncated, in your browser address space. 

http://www.lawlib.state.ma.us/healthinsurance.html

http://www.boston.com/news/local/articles/2008/02/03/subsidized_care_plans_cost_to_double?mode=PF

http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/2008/08/22/the_trauma_of_high_costs?mode=PF

In addition, here are references for studying the Medicare/Medicaid programs.

http://www.medicare.gov/Publications/Search/SearchCriteria.asp?version=default&browser=IE|6|WinXP&Language=English&pagelist=Home&comingFrom=13

http://www.cms.hhs.gov/History/

http://www.ssa.gov/OP_Home/ssact/title18/1800.htm

http://topics.law.cornell.edu/wex/medicare

http://www.cms.hhs.gov/MedicaidGenInfo/03_TechnicalSummary.asp

GMU School of Law - Health Law - IRS Materials

Please download Internal Revenue Service Form 1023

and draft form 990 Schedule H

and study these materials in anticipation of our next class.   

Health Law Syllabus - George Mason University School of Law – Fall Term 2008

1.    Health Law 233; 3 credits; Hazel Hall, Room 347, Tuesday and Thursday
4:30 pm - 5:45 pm; final examination: 12/12/08,12:00 noon – 3 pm

2.    Adj. Prof. Alan S. Goldberg: electronic mail: AGoldbe1@gmu.edu; http://www.healthlawyerblog.com; http://www.healthlawyer.com; hours by appointment.

3.    Attendance: in accordance with GMUSL policy and attendance during at least 80% of classes is required.  Other than in an emergency, you should advise Adj. Prof. Goldberg in advance if you are not able to attend any class.

4.    Coursebook: Furrow, Greaney, Johnson, Jost, and Schwartz' Health Law, Cases, Materials and Problems, 6th (American Casebook Series), By Barry R. Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S. Jost, Robert L. Schwartz – hardbound, Copyright: 2008; students also receive CD-ROM materials from the American Bar Association Health Law Section regarding fraud and abuse laws, and from the American Health Lawyers Association regarding fundamentals of health law.

5.    Examination and grading: the final examination will be essay closed-book. No materials may be brought into the examination room. Grades will be based primarily on the final examination; however, a grade may increase or decrease by a half letter (+ or -) based upon class participation.

6.    For the first class, please locate and study the portion of the Virginia Code that addresses licensure and regulation of physicians and nurses.  If your goal is to be admitted to the bar in a jurisdiction other than the Commonwealth of Virginia, also locate and study the portions of the statutes in the other jurisdiction that address licensure and regulation of physicians and nurses.  In particular, focus on what constitutes the practice of medicine and the practice of nursing.  In addition, study the materials from the Massachusetts Society of Pathologists and Board of Medicine regarding tissue and the removal of “Massachusetts tissue” to New Hampshire for analysis by pathologists located in New Hampshire.  These materials will also be discussed during the second class.

7.    There will not be a Health Law class on September 30, October 9, and November 6; an effort will be made to schedule make-up class times.  There also will not be a Health Law class on October 14 (Tuesday classes replaced by Monday classes).

Assignments for study follow (subject to change):

Syllabus assignments (include  “Notes and Questions” and omit “Problems”); additional outside readings will be assigned including from the CD-ROMs given to students; the syllabus will be updated during class and electronically via  http://www.healthlawyerblog.com

1
8/21     115-158     Professional licensure      

2
8/26, 8/28    115-158, 195-230     Professional licensure, relationships with patients        

3
9/2, 9/4     849-871, 874-884, 909-1020    Physicians, hospitals, managed care      

4
9/9, 9/11    909-1020     Structure of health care enterprises      

5
9/16, 9/18   21-71, 159-194      Quality, regulatory oversight     

6
9/23, 9/25  327-351, 370-380, 390-404, 412-421     Liability of physician     

7
10/2     437-456, 462-470, 476-497, 504-516       Liability of institution or organization      

8
10/7     596-637, 638-648, 660-670, 671-677       Access to care, managed care       

9
10/16      688-703, 710-734, 748-752    Federal regulation, ERISA, COBRA       

10
10/21, 10/23     767-821, 825-827, 845-847      Medicare, Medicaid       

11
10/28, 10/30      1023-1094, supplementary materials to be provided and assigned      Fraud and abuse, Stark        

12
11/4     1023-1094, supplementary materials to be provided and assigned    Fraud and abuse, Stark      

13
11/11, 11/13     230-276, 283-325      Consent, privacy, disclosure, HIPAA Administrative Simplification subtitle       

14
11/18, 11/20    Supplementary materials to be provided and assigned      eHealth, ePrescribing, regional health information organizations         

15
11/25      1352-1378, 1381-1389, 1408-1424, 1432-1436, 1442-1446, 1450-1464, 1488-1499    Genetics, GINA, life, death       

16
12/2     1352-1378, 1381-1389, 1408-1424, 1432-1436, 1442-1446, 1450-1464, 1488-1499    Genetics, GINA, life, death       

ASG/tt
121626082008

Welcome to Health Law - First & Second Assignments

To:  My Law Students, GMU School of Law, Health Law, Fall 2008

From:  Adjunct Professor Alan S. Goldberg

Re:  Welcome, and First and Second Assignments

Good morning.  Please know that we have been advised that the coursebook is now available at the bookstore.  In addition, those who were present in class yesterday received CD-ROMs from the American Bar Health Law Section regarding antifraud and abuse law, and from the American Health Lawyers Association regarding Fundamentals of Health Law, and other miscellaneous AHLA membership materials, and a copy of the Massachusetts Society of Pathologists/Board of Registration materials relating to Massachusetts tissue in New Hampshire.  There will be some assignments relating to the CD-ROMs; but now please focus your attention on the coursebook and, for our class on August 26 please study pages 115 through 158 in the coursebook and for our class on August 28 please study pages 195 to 230 in the coursebook. After these materials, we will be studying Chapters 12 and 13, and more specific information regarding those materials will appear in the syllabus for our course which I will provide via email and at http://www.healthlawyerblog.com before our next class.  You should include the "notes" in your studies but you are not required to include the "problems" that appear periodically in the coursebook.  Please be sure to provide me with your CV via email today.  More particularly, I would welcome knowing your academic and work biographical information including your undergraduate and any graduate educational information, and your goals with respect to your current legal education.  As indicated during our class yesterday, our class will not be held on September 30 and October 9; I am unsure yet whether we can have our class on November 6 but I should be able to provide advice regarding the same next week when we meet.  You should visit http://www.healthlawyerblog.com for copies of my email updates for our course, and you may send inquiries to me at AGoldbe1@gmu.edu regarding our course.  I will be scheduling meeting times, most likely in the hour prior to our classroom meetings, from time to time, in order to confer with you regarding our course and your studies.  Kindly acknowledge receipt of this email before the end of today; thank you.

Welcome to Health Law - First Assignment

To:  My Law Students, GMU School of Law, Health Law, Fall 2008 [bcc:]

From:  Adjunct Professor Alan S. Goldberg

Re:  Welcome, and First Assignment

Good day: a warm welcome to our Health Law course.

Please note that the coursebook is identified at

http://www.law.gmu.edu/assets/files/academics/schedule/2008/fall/GOLDBERG_HealthLaw-Syllabus20080811.pdf

OR

http://tinyurl.com/6rcpxg

Furrow, Greaney, Johnson, Jost and Schwartz' Health Law, Cases, Materials and Problems, 6th (American Casebook Series)

By Barry R Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S Jost, Robert L. Schwartz
Book - hardbound
Copyright: 2008

http://west.thomson.com/productdetail/141889/40647563/productdetail.aspx

where an overview of our course appears (see also below for a copy of the overview).  The coursebook recently has been published in a new edition, and so preparation of the class assignments and related informational material is still underway.  But for our first class scheduled for August 21, 2008 at 4:30 PM in Hazel Hall 347, please study pages 115 through 158 in the coursebook. The books have been ordered and I hope they arrive in a timely manner for purchase in the bookstore.  Please tell me if you are having difficulty obtaining the coursebook.

For our first class, please also locate and study the portion of the Virginia Code that addresses licensure and regulation of physicians and nurses.  If your goal is to be admitted to the bar in a jurisdiction other than the Commonwealth of Virginia, please also locate and study the portion of the statutes of the other jurisdiction that address licensure and regulation of physicians and nurses.  In particular, focus on what constitutes the practice of medicine and the practice of nursing.

Additional information concerning our course will be provided during our first class and via email.  From time to time, there also will be postings at

http://www.healthlawyerblog.com

and there also are free materials that will be provided to you from and because of the kindness of staff personnel at professional legal associations and otherwise.

It will be my pleasure to greet you at our first class and I look forward to a successful educational experience with you as we study a critical and increasingly important and changing area of the law.

Finally, please favor me with your CV via email prior to our first class.  More particularly, I would welcome knowing your academic and work biographical information including your undergraduate and any graduate educational information, and your goals with respect to your current legal education.  Thank you.

Regards, *Alan S. Goldberg, JD, LLM (Tax)
Alan@GoldbergLawyer.com
http://www.healthlawyer.com
Attorney & Counsellor-at-Law
6845 Elm Street, Suite 205
McLean, Virginia 22101
Adjunct Professor of Health Law
George Mason University
School of Law &
College of Health & Human Services
Dept. of Health Administration & Policy
AGoldbe1@gmu.edu
---------------------------------
*Admitted VA, NY, DC, FL, MA

Health Law Syllabus

Delivering and paying for health care is a dynamic and rapidly expanding multi-national profession and business influenced by increasingly complex laws. While heavily regulated, health care provides many business and entrepreneurial opportunities in a trillions of dollars per year part of the economy. Health law provides structure and establishes limits that often are evolving and unclear. With new and exciting health care challenges and opportunities in mind, we examine the complexities and relationships of common law and federal and state statutes, rules, and administrative actions, as well as the powerful influences of politics, ethics, and other non-governmental forces that inform and influence contractual and other legal relationships. We analyze the legal foundations of the Medicare and Medicaid programs, managed care, professional licensure and discipline, health care crimes including fraud and abuse, living and dying, eHealth and privacy, hospitals and nursing homes including charitable organizations, the practice of medicine, and other significant areas of health law. Traditional areas of law, including contracts, torts, constitutional law, taxation, intellectual property, and litigation, as well as newer areas including information technology and the Internet, employment law, and life sciences, affect and are affected by developing health law principles, and specific aspects of those areas will be analyzed with respect to their particular influence upon and relevance to health care delivery and payment. The differing perspectives of and health care laws that affect providers, payers, patients, contractors, and governments are considered and analyzed. Completion of this course results in a basic knowledge and understanding of an increasingly important body of law, and provides a sound foundation for further learning.

GMU CHHS Health Law Summer 2007 Additional Materials for July 17, 2007 Class

NO CLASS JULY 10, NEXT CLASS WILL OCCUR UNTIL 9.15 PM JULY 17.

Here is additional material relating to some of the topics we discussed July 3 in class.  We will discuss this material during our class on July 17, please.  Enjoy a pleasant holiday.

http://oig.hhs.gov/fraud/docs/alertsandbulletins/121994.html

http://www.bmj.com/cgi/content/full/326/7400/1202

http://www.nytimes.com/2007/06/27/health/psychology/27doctors.html?_r=1&adxnnl=1&oref=slogin&pagewanted=print&adxnnlx=1183547270-n2bk2O3F/XU+f1hXd2Gstw

OR

http://tinyurl.com/376kkz

http://www.citizen.org/publications/release.cfm?ID=7531

http://oig.hhs.gov/fraud/docs/advisoryopinions/2006/AdvOpn06-18A.pdf

http://oig.hhs.gov/fraud/docs/advisoryopinions/1998/ao98_7.pdf

http://oig.hhs.gov/fraud/docs/advisoryopinions/2003/ao0308.pdf

GMU Health Law July 10, 2007 class assignment

Further regarding materials for

Assignment 7 for July 10 - Health Care Transactions

An outline of health care transactional and contract materials will be provided for study and discussion.

Please read the following:

1.  http://world.std.com/~goldberg/ahlaoigcorpresp.pdf 

2. http://world.std.com/~goldberg/ahlaoigjunesixteenth2004.pdf

3. http://world.std.com/~goldberg/ahlaoigjunetwentynine2007.pdf

4. http://world.std.com/~goldberg/tenetciafinal.pdf

OR

http://oig.hhs.gov/fraud/cia/agreements/TenetCIAFinal.pdf

5. http://world.std.com/~goldberg/ahlaoigjulyone2004.pdf

 

6.  http://oig.hhs.gov/fraud/cia/docs/ciafaq1.html

GMU CHHS Health Law Summer 2007 First Written Assignment Due July 1, 2007

Here is your written assignment one, due not later than 11:59 PM on July 1, 2007 via email to me please.  Your written submission should be prepared in a font size no smaller than Microsoft Word for Windows 12 or a comparable font and size; you should provide me with not less than ten 8 and 1/2 inch size pages plus footnotes or citations (in other words, footnotes and citations are not included in determining whether you meet the total size of your submission requirement); there is no upper limit so you can submit more than ten pages; and your submission should primarily be based upon your assigned readings for our course, our discussion in class, and your research and knowledge generally; and your submission is to be your work product.  If you have questions, please contact me via email and be assured that we will discuss these requirements in class as well and during our student conferences.

______________

You are being asked by the new Chief Executive Officer of Mason General Hospital System, a charitable not for profit federally tax-exempt organization, to provide a memorandum to the CEO regarding several important areas of concern.  Bear in mind that the CEO is not experienced in health care; instead, the CEO has experience in the marketing and sales of resort shared-time condominium units and the Board of the System thought that experience in the hospitality area would benefit the System in marketing the System's services.  Unfortunately, though, the CEO does not know anything about the following areas, which the CEO expects you to review and analyze not as an attorney, but instead as someone experienced in the practical aspects of health care operations and administration and with the benefit of having studied health law at George Mason University.

First of all, the CEO is concerned about the risks taken by the System, which includes a hospital, a nursing home, and several physicians and groups that are affiliated with the System and whose physicians have the benefit of medical staff privileges at the hospital, bearing in mind that the group-related physicians are not employees of the System.  There are also some physicians who are employed by the hospital and also have the benefit of medical staff privileges at the hospital.  The CEO wants to  know the nature of the risks involving patient care and peer review of physicians; how best to oversee the several operating areas of the System with respect to assuring that the physicians practice medicine in a manner consistent with the policies and chief medical office requirements for the System; and whether there are any new and different ways of avoiding or lessening the burdens of any failures professional to provide adequate health care services to regular patients and for emergency patient cases. 

Second, the CEO does not understand what medical staff privileges mean and how employment and non-employment status either is related to or not related to medical staff privileges, and the CEO does not understand what differences exist between and among the affiliated physicians and groups insofar as some being partnerships, some being professional corporations, and some being limited liability companies several physicians being sole proprietorships and not groups at all. 

Third, the CEO has been told that because the System is a charitable not for profit federally tax-exempt organization, there are special rules that are applicable to how the System operates and how much the System pays employees, including the CEO, and others who perform services at or for the System, and the CEO wants to know the nature of these concerns and how to address them.

And fourth, the CEO has been told that privacy and security concerns are a critical part of the compliance requirements for the System in a manner quite different from how hospitality businesses operate, and therefore the CEO needs to know the nature of the concerns and how best to address them.

Please provide the CEO with your memorandum -- you may choose any three of the foregoing four topics and limit your paper to those three, or you may include all four topics in your paper, depending upon your decision regarding how best to proceed and what the length of your paper is to be and any other considerations you believe relevant.  Be sure to place your name and email address on the cover sheet of the memorandum and include your name and email address in the header of each page.

GMU CHHS Health Law Summer 2007

Syllabus Continuation - GMU CHHS Health law

Assignment 5 for June 19 - Health Care Information

Read chapter 8 in the Miller text and

read The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Chapters 1 and 2 to be provided to you via email

read the materials linked at

http://aspe.hhs.gov/admnsimp/pl104191.htm

http://www.hhs.gov/ocr/privacysummary.pdf

http://www.abanet.org/health/esource/vol1no2/loitz.html

I will also be providing you via email with a HIPAA Glossary which you should peruse.

Assignment 6 for July 3 - Civil and Criminal Enforcement and Penalties

Read chapter 12 in the Miller text and from the Baumann text read Appendices A-1, B-1, C-1, D-1, E-1, E-2, E-3

and read as much of what interests you and that time permits in the Baumann text generally

and read the decision linked at

http://biotech.law.lsu.edu/cases/fca/greber.htm

and read the materials linked at

http://oig.hhs.gov/fraud/docs/alertsandbulletins/consultants.pdf

 

http://oig.hhs.gov/fraud/docs/alertsandbulletins/042303SABJointVentures.pdf

http://www.vba.org/section/health/OpenLettertoProviders2006.pdf

Assignment 7 for July 10 - Health Care Transactions

An outline of health care transactional and contract materials will be provided for study and discussion.

Assignment 8 for July 17 - Health Care Decisions and Life and Death

Read chapters 7 and 15 in the Miller text and

peruse and read as much as time permits of the materials found at

http://www6.miami.edu/ethics/schiavo/timeline.htm

and more particularly from the foregoing linked site, the required reading is the decision at

http://www6.miami.edu/ethics/schiavo/pdf_files/2D02-5394.pdf

and peruse and read as much as time permits of the material found at

http://www.abanet.org/aging/docs/StandardsforSurrogateDecisionMakingChart.pdf

and read the material found at

http://www.vsb.org/sections/hl/add06/SummaryAct-2006.pdf

Assignment 9 for July 24 - Managed Care, Medicare, and Third Party Payors

Read chapters 9 and 10 in the Miller text.

Assignment 10 for July 31 - Review of Course Specifically and Health Law Generally

GMU CHHS Health Law Summer 2007

Assignment four for our class scheduled for June 12, 2007 is as follows:

    a.    Read materials linked at

http://www.stayexempt.org/

Tax-Exempt Status
How can you keep your 501(c)(3) exempt?
Unrelated Business Income
Does your organization generate taxable income?
Employment Issues
How should you treat your workers for tax purposes?

and

Required Disclosures
To whom do you have to show your records?

    b.    Read August 2006 American Health Lawyers Association MEMBER BRIEFING Tax and Finance Practice Group regarding STA-HOME HEALTH AGENCY, et al. v. COMMISSIONER, to be provided.   The decision is linked at

http://caselaw.findlaw.com/data2/circs/5th/0260912cv0p.pdf

and the MEMBER BRIEFING will be sent to you via email.

    c.    Read Miller text Chapter pages 544-558.

    d.    Read materials linked at

http://www.stayexempt.org/_pdfs/Mod3_Summary.pdf

and

http://www.irs.gov/pub/irs-pdf/fss8.pdf

    e.    Peruse generally the form of Application for Recognition of Exemption Under Section 501(c)(3) of the Internal Revenue Code and the IRS instructions linked at

http://www.irs.gov/pub/irs-pdf/f1023.pdf

http://www.irs.gov/pub/irs-pdf/i1023.pdf

which I will review with you in class.

GMU CHHS Health Law Summer 2007

Assignment three for our class scheduled for June 5, 2007:

a. Read Chapter 4 in Miller text: Individual Providers and Caregivers

b. Read the linked materials at

http://tinyurl.com/2zm4g4

and

 

http://tinyurl.com/yvpkmv

at the Internal Revenue Service and Small Business Administration web sites regarding business structures. Please peruse whatever income tax-related information you can, but it is not necessary to study the tax law areas in particular; instead, at this time, the purpose of these linked site reviews is to provide you with basic organizational concepts in business law.

Please read the US Supreme Court decision:

LEDBETTER v. GOODYEAR TIRE & RUBBER CO., INC.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT
No. 05–1074. Argued November 27, 2006—Decided May 29, 2007

which we will discuss during our class on June 5, 2007 in addition to other assigned materials.

http://tinyurl.com/2xnbq4

I will be distributing the BNA Health Care Fraud and Abuse texts at our class today courtesy of the Health Law Section of the American Bar Association, and materials from the American Health Lawyers Association as well.

GMU CHHS Health Law Summer 2007

For  our class scheduled for 5/29/07 please review Assignment 1 and begin the study of Assignment 2.  We will review Assignment 1 during the first part of our class and we will begin Assignment 2 during the second part of our class. 

2.    Assignment 2 for 5/29/07 class

    a. Medical errors are being studied and many are endeavoring to address how best to prevent such errors.  The following article addressed psychological issues and other citations below address related issues including the "I'm sorry" initiative.  See the following please --

http://www.newyorker.com/reporting/2007/01/29/070129fa_fact_groopman?printable=true

WHAT’S THE TROUBLE? by JEROME GROOPMAN How doctors think. Issue of
2007-01-29 Posted 2007-01-22.

b. Additional information is in the following files (albeit only in bits and pieces because we don't have the text, but the pictures and brief statements are instructive nevertheless): please see --

http://www.qualityhealthcarenetwork.ca/pdfs/crosskerry.pdf

or

http://tinyurl.com/yot2qu

and

http://www.crnns.ca/documents/Pat%20Croskerry%20May%202005.pdf

OR

http://tinyurl.com/yukohk

relating to --

The Human Factor
in Patient Safety

Pat Croskerry, MD, PhD
Safety in Health Care
Dartmouth, May 2005

c. Additional background information regarding medical errors and a "I'm sorry" initiative may be found at

http://www.nap.edu/books/0309068371/html/

and at

http://iom.edu/Object.File/Master/4/117/ToErr-8pager.pdf

and

http://www.rmf.harvard.edu/

and

http://www.sorryworks.net/

d. A general resource web site for perusal and to gain an overview of what AHRQ does and is doing is at --

http://www.ahrq.gov/qual/errorsix.htm

e. Also read the following materials:

http://healthlawyer.com/SchroederNorthwest2006.pdf

http://www.healthlawyer.com/darling.html

Please be sure to print the foregoing two judicial decisions so you have this material available for ready-reference during our classroom discussion.

f. Also from the Miller text, read Chapter 11- Civil Liability.

 

GMU CHHS Health Law Summer 2007

George Mason University College of Health and Human Services Department of Health Care Administration and Policy - Summer term: Legal Issues Relevant to Healthcare Administration

PARTIAL SYLLABUS

__________________________

George Mason University
College of Health & Human Services
Department of Health Administration & Policy
Syllabus for Health Law - Summer 2007 Term

Alan S. Goldberg, Adjunct Professor

___________________________

Welcome to George Mason University College of Health and Human Services Department of Health Care Administration and Policy Legal Issues Relevant to Healthcare Administration

On May 22, 2007 at 4:30 PM the course entitled "Legal Issues Relevant to Healthcare Administration" will commence. Here is the course catalog description:

"1) Lgl Iss Relevnt Hlthcare Admin - 40462 - HSCI 750 - X01

Section X01 meets 5/21-8/3. See http://summer.gmu.edu/ SessionX.html for add/drop dates.
Associated Term: Summer 2007
Registration Dates: Mar 19, 2007 to Jun 08, 2007
Levels: Graduate, Non-Degree, Consortium
Attributes: Graduate - Advanced

Fairfax Campus
Lecture Schedule Type
3.000 Credits
View Catalog Entry

Scheduled Meeting Times Type Time Days Where Date Range Schedule Type Instructors
Class 4:30 pm - 9:45 pm T Robinson Hall A109 May 21, 2007 - Aug 01, 2007 Lecture TBA"

Our course commences at 4:30 PM on May 22, 2007.

Because I am using a new to-be-purchased text for the Summer 2007 term for Health Law HSCI 750, the entire syllabus is not available yet. The texts will include the Miller text to be purchased, and other texts that I will make available to you without charge because of the kind cooperation of the American Health Lawyers Association and the American Bar Association Health Law Section and others so inclined:

1. Problems in Health Care Law, Ninth Edition
Robert D. Miller, JD

ISBN 13: 9780763745554
ISBN 10: 0763745553
Price: (Sugg. US List) $78.95
Cover: Paperback
Pages: 899
Copyright: 2006

2. The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Editors: Kristen Rosati, Esquire, Coppersmith Gordon Schermer Owens & Nelson PLC, Marilyn Lamar, Esquire, McDermott Will & Emery LLP, © - July 2005, American Health Lawyers Association Health Information & Technology Practice Group,

3. Health Care Fraud and Abuse: Practical Perspectives, Linda A. Baumann, Editor-in-Chief, © 2002, American Bar Association Health Law Section and Bureau of National Affairs.

In addition, miscellaneous study materials including materials available via Internet access will be assigned from time to time to supplement what is referenced above. Students are expected to be able to access the Internet for assignments but a computer is not required during classroom attendance. Students are expect to have read and studied each assignment prior to the commencement of the relevant scheduled class, unless advice to the contrary is provided to me in advance of that class.

Each Tuesday class (ten are scheduled) will commence at 4:30 PM and usually will end at 8:30 PM (NOT 9:45 PM). If there are interruptions in our expected classroom schedule or if additional time is needed, I will advise you in advance of any scheduled classroom day for which we are likely to go beyond 8:30 PM but we will never go beyond 9:45 PM.

There is no scheduled class on June 26, 2007. The final class of the Summer term is scheduled for July 31, 2007.

The syllabus will from time to time be supplemented by special materials that are timely and relevant to our course and also is subject to change. Therefore students should from time to time review information concerning this course that will appear at on my blog and it would also be helpful to subscribe to the feed from my blog by using the email notification feature on my blog using a service provided by http://www.feedblitz.com

Although reference is made on my blog to a Podcast feature, please know that my podcasting feature is still under construction.

My blog is:

HEALTHLAWYERBLOG

http://healthlawyer.typepad.com/healthlawyer/

Assignment and other information, including special assignments, updates, and other information relevant to our course, will be provided via email and also will, as appropriate, be posted on my blog. Note that because the nature of health care and health law changes rapidly and every day, we will on occasion alter our scheduled study plan in order to address new and emerging issues and developments.

Additional information about our course and your assignments, and changes in either of them, will also be announced and identified during classes, which all students are expected to attend except in unusual circumstances. If your attendance is not possible for a particular class, please tell me in advance of the class. Unexplained absences are not welcomed, please.

Each student will be required to submit two research and analysis papers during the term, which shall be a student's original personal and individual work product with appropriate citations, and which may be delivered to me via email. Each paper will consist of not less than ten sheets (there is no upper limit), double spaced and printed on one side of each sheet, using font size 12 from Microsoft (R) Word for Windows or an equivalent font size. These nature of and requirements for the two assignments will be discussed during our classes. There will be no examination for this course. I will endeavor to schedule convenient student conference times during the Summer term using the CHHS module location for the conferences, in order to provide opportunities to confer regarding our course and your questions and concerns about your studies and related topics. Your final grade for our course will be based upon the grades achieved in submitting your two papers and my evaluation of your classroom participation including classroom attendance and timely reading and study of assigned materials.

1. Assignment for 5/22/07 class

Your assignment for our class on 5/22/07 is to read the following two court decisions linked on my web site and to read Chapter 1 - Introduction to the American Legal System and Chapter 5 - Medical Staff in the Miller text:

Doe v. Florida Department of Health

http://world.std.com/~goldberg/DoevFlaDeptofHealth.pdf

and

Sarka v. Regents of the University of California

http://world.std.com/~goldberg/SarkavRegentsoftheUnivofCalifornia.pdf

Health Law HSCI 750 Summer 2007

Regarding:

1) Lgl Iss Relevnt Hlthcare Admin - 40462 - HSCI 750 - X01

Section X01 meets 5/21-8/3. See http://summer.gmu.edu/ SessionX.html for add/drop dates.
Associated Term: Summer 2007
Registration Dates: Mar 19, 2007 to Jun 08, 2007
Levels: Graduate, Non-Degree, Consortium
Attributes: Graduate - Advanced

Fairfax Campus
Lecture Schedule Type
3.000 Credits
View Catalog Entry

Scheduled Meeting Times Type     Time     Days     Where     Date Range     Schedule Type     Instructors
Class     4:30 pm - 9:45 pm     T     Robinson Hall A109     May 21, 2007 - Aug 01, 2007     Lecture     TBA

which commences May 22, 2007, please see the following.

Because I am using a new text for the Summer 2007 term for Health Law HSCI 750, the syllabus is not available yet.  The text will be:

Problems in Health Care Law, Ninth Edition
Robert D. Miller, JD, JD

ISBN 13: 9780763745554
ISBN 10: 0763745553
Price: (Sugg. US List) $78.95
Cover: Paperback
Pages: 899
Copyright: 2006

along with a complementary copy of BNA's Healthcare Fraud and Abuse courtesy of the Health Law Section of the American Bar Association and there will also be complementary materials provided by the American Health Lawyer Association.

To: My Students

Good morning; as discussed last evening in class, the assignment for April 24, 2007 will be the Assignment 10 material and you could also focus on the Assignment 11 material that will be the subject of our May 1 class, please, because I will begin the Assignment 11 material toward the end of our April 24 class.  Note particularly that the entire Medicare booklet you will download is very lengthy, so it is satisfactory to peruse the highlights if the entire booklet is too lengthy to read in light of your commitments generally; the key features for your focus are what is the Medicare program, who is eligible, what are the most important benefits, and what the various elections that proposed enrollees/beneficiaries are required to consider.  See below for these two assignments from HEALTHLAWYERBLOG; I have endeavored to make the links "live" but that feature might not work for all of you, so you might have to copy and past the entire link in the address portion of your particular web browser.

Note also that as a follow-up to our discussion in class yesterday regarding FICA, FUTA, and the like, you may want to visit:

http://www.irs.gov/businesses/small/article/0,,id=98858,00.html

in order to see a good summary of what the acronyms mean; thank you.

Please let me know if you have any questions regarding your second paper assignment.  Recall please: the due date and time is before 11.59 PM on April 29, 2007 via email to me please.

Kindly also note the following from the GMU Gazette:

quote

Mason to Hold Vigil in Memory of Virginia Tech Victims

April 18, 2007

Mason will hold a vigil on Thursday, April 19, to honor the memory of slain Virginia Tech students and faculty members.

All members of the Mason community and the general public are welcome to attend. The vigil will be held at 7 p.m. on the Johnson Center North Plaza on the Fairfax Campus.

____________________________________________________

10.    Assignment 10 for 4/17/07 class

    a.    Read Pozgar text Chapters 13 and 15

    b.    Read the following materials on the Internet --

http://www.npdb-hipdb.hrsa.gov/pubs/Data_Banks_at_a_Glance.pdf

http://www.npdb-hipdb.hrsa.gov/timeline.html

http://www.npdb-hipdb.hrsa.gov/pubs/fs/Fact_Sheet-National_Practitioner_Data_Bank.pdf

http://www.npdb-hipdb.hrsa.gov/pubs/fs/Fact_Sheet-Section_1921.pdf

http://www.npdb-hipdb.hrsa.gov/pubs/NPDB_and_1921_at_a_Glance.pdf

http://www.npdb-hipdb.hrsa.gov/pubs/NPDB-HIPDB_and_Section_1921_Comparison_Chart.pdf

http://www.npdb-hipdb.hrsa.gov/pubs/NPDB_with_Section_1921_and_HIPDB_Comparison_Chart.pdf

11.    Assignment 11 for 4/24/07 class

    a.    Read the following on the Internet --

http://www.Medicare.gov/publications/pubs/pdf/10050.pdf      

http://www.medicare.gov/Publications/Pubs/pdf/11110.pdf

http://www.medicare.gov/Publications/Pubs/pdf/11136.pdf

http://www.medicare.gov/Publications/Pubs/pdf/11126.pdf

    b.    Read the following on the Internet -- go to the site linked below and read the materials further linked as indicated below --

http://www.medicareadvocacy.org/FAQ_PartD.htm

MEDICARE PART D

      What is Medicare Part D?

      Who is eligible for Medicare drug coverage?

      What is the basic benefit of Part D?

      What drugs are covered under Part D?

    c.    Read the following on the Internet --

http://www.cms.hhs.gov/MedicaidGenInfo/Downloads/MedicaidAtAGlance2005.pdf

_________________________________________________________________________

 

GMU Health Law April 17, 2007 class

As discussed in our most recent class, our time during our April 17 class will be dedicated to a review of the materials assigned relating to taxation and originally assigned for an earlier date, as follows:

quote

8.    Assignment 8 for 4/3/07 class [now to be discussed on April 17]

    a.    Read materials on the Internet regarding the following at

http://www.stayexempt.org/

Tax-Exempt Status
How can you keep your 501(c)(3) exempt?
Unrelated Business Income
Does your organization generate taxable income?
Employment Issues
How should you treat your workers for tax purposes?

and

Required Disclosures
To whom do you have to show your records?

    b.    Read August 2006 American Health Lawyers Association MEMBER BRIEFING Tax and Finance Practice Group regarding STA-HOME HEALTH AGENCY, et al. v. COMMISSIONER, to be provided.   

9.    Assignment 9 for 4/10/07 class

    a.    Read Pozgar text Chapter 20

    b.    Read materials on the Internet --

http://www.stayexempt.org/_pdfs/Mod3_Summary.pdf

and

http://www.irs.gov/pub/irs-pdf/fss8.pdf

_________

We will discuss the assignment for April 23 during our April 17 class.

If you have questions regarding your paper assignment number two, please let me know via email.  Thank you.

GMU Health Law April 10, 2007 class

Regarding our class scheduled for April 10, 2007, please know that we will discuss the following subjects from the curriculum emailed to you and set forth on HEALTHLAWYERBLOG at

http://www.healthlawyer.typepad.com/

I realize that because of the canceled class, the make up class that many could not attend, holidays, and the like, our curriculum schedule is not where it might have been, but we'll continue along and I look forward to meeting with you again tomorrow in class.
______________________________

quote

7.    Assignment 7 for 3/27/07 class

    a.    From The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Chapters 1 and 2

    b.    Regional Health Information Organization materials to be provided.   

March 20, 2007
GMU HSIC 750 Extra Readings Assignment 7

I have sent to each of you a via email a copy of The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Editors: Kristen Rosati, Esquire, Coppersmith Gordon Schermer Owens & Nelson PLC, Marilyn Lamar, Esquire, McDermott Will & Emery LLP, (c) - July 2005, American Health Lawyers Association Health Information & Technology Practice Group that includes Chapters 1 and 2 which are assigned reading for

7.    Assignment 7 for 3/27/07 class [Professor's Note: to be discussed during April 10, 2007 class]

    a.    From The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Chapters 1 and 2

    b.    Regional Health Information Organization materials to be provided.

The following materials accessible at the linked web sites referenced below are also a part of Assignment 7 please:

1.  Visit http://www.calrhio.org/ and review the materials found at that web site; your purpose is to familiarize yourself with terminology, organizational information, and information technology features, and related areas discussed at that web site.  Note particularly that at --

http://www.calrhio.org/?cridx=5

the following linked pages appear at the left side margin, and you should please review those materials to obtain an overview of what they say and mean in the context of health law issues that we will discuss in class (you need not use the Links page to go elsewhere but you can, if you wish and you have time, surf those other sites) --

Resource Center
Overview
Briefings and Hearings
Clinical Data Set
Data Standards
Governance
Governor's Executive Order
HIE Models
Links
Personal Health Records
Privacy & Security
RHIO Glossary
Summit & Forum Proceedings
Use Cases
Vendor Solutions

2.  Please go to --

http://nvrhio.gmu.edu/legal_nov9.html

and read the minutes materials linked at the left side margin.

[Professor's Note: the following Assignment 8 materials are to be discussed briefly at the end of the class scheduled for April 10 and to be discussed in depth during the class scheduled for April 17]

8.    Assignment 8 for 4/3/07 class

    a.    Read materials on the Internet regarding the following at

http://www.stayexempt.org/


Tax-Exempt Status
How can you keep your 501(c)(3) exempt?
Unrelated Business Income
Does your organization generate taxable income?
Employment Issues
How should you treat your workers for tax purposes?

and

Required Disclosures
To whom do you have to show your records?
________________________________

Further regarding written assignment two, references to and citations of materials which are a part of the curriculum in our course  (thereby evidencing both your attendance in class and your having carefully studied the assigned materials) and also to materials which are beyond that curriculum but which you believe are relevant would be enhancing; in other words, analysis should be in part based upon critical reviews of what others have said and in part based upon your views either in concurrence or in disagreement with others referenced and cited in your paper, and should also indicate that you are and were attentive both to classroom discussions and homework assignments in this course.  The substantive content should reflect both your intellectual curiosity and your ability to provide clear and convincing prose indicating a thoughtful and sophisticated process of intellectual review and analysis. In addition, enhanced attention to grammar, spelling, and overall intelligibility are always appropriate.  Recall also that the paper should be no less than ten pages, double spaced, and footnotes or supplementary materials and citations are not to be "counted" as part of the ten page minimum; in other words, at least ten pages of substantive text are required and there is no maximum number of pager.

Please let me know if additional questions arise during your preparation of your second assignment paper.  Thank you.

GMU HSIC 750 Second Written Assignment Due by 11:59 PM on April 29, 2007

Supplementing my email to each of my students today, please recall that our makeup class, scheduled by GMU, is 4.30 PM to 7.10 PM March 23 in East 134.

Regarding the second written assignment and consistent with our discussion in class --

1.  First of all, the due date and time is before 11.59 PM on April 29, 2007 via email to me please.

2. The subject will be selected after consultation with and approval by me, after my review of your proposed outline and any appropriate discussions regarding the same please, and you may propose a subject that is directly or indirectly a part of the syllabus readings and materials that are a part of our course and/or a part of our classroom discussions, please.

3.  Your written material, as with the first written assignment, should be addressed by you to the new CEO of the health system, and should include the subject matter generally; the details of how that particular subject matter operates today; and your views regarding improvements, enhancements, flaws, corrections, or satisfactory operation of the subject matter, and I expect your outline to be sent to me via email not later than 11.59 PM on March 30, please.

4. I am available to confer with the certain of my students on March 23, 2007 at the appointed times requested, and others who are unable to consult in person on march 23, 2007 but who would like to consult with me virtually regarding the second written assignment and/or other matters involving your studies in health law including job counseling, should advise me via email of your questions and concerns.

Kindly arrive promptly because of the need to avoid inconveniencing your colleagues and please go to --

Northeast Module, Room 112, in the building housing the College of Health & Human Services Department of Health Administration and Policy, 4400 University Blvd · Fairfax, Virginia 22030-4444 · 703-993-1929.

If there is any change in your schedule, kindly advise me via email as soon as possible.

Thank you.

GMU HSIC 750 Extra Readings Assignment 7

I have sent to each of you a via email a copy of The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Editors: Kristen Rosati, Esquire, Coppersmith Gordon Schermer Owens & Nelson PLC, Marilyn Lamar, Esquire, McDermott Will & Emery LLP, (c) - July 2005, American Health Lawyers Association Health Information & Technology Practice Group that includes Chapters 1 and 2 which are assigned reading for

7.    Assignment 7 for 3/27/07 class

    a.    From The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Chapters 1 and 2

    b.    Regional Health Information Organization materials to be provided. 

The following materials accessible at the linked web sites referenced below are also a part of Assignment 7 please:

1.  Visit http://www.calrhio.org/ and review the materials found at that web site; your purpose is to familiarize yourself with terminology, organizational information, and information technology features, and related areas discussed at that web site.  Note particularly that at --

http://www.calrhio.org/?cridx=5

the following linked pages appear at the left side margin, and you should please review those materials to obtain an overview of what they say and mean in the context of health law issues that we will discuss in class (you need not use the Links page to go elsewhere but you can, if you wish and you have time, surf those other sites) --

Resource Center
Overview
Briefings and Hearings
Clinical Data Set
Data Standards
Governance
Governor's Executive Order
HIE Models
Links
Personal Health Records
Privacy & Security
RHIO Glossary
Summit & Forum Proceedings
Use Cases
Vendor Solutions

2.  Please go to --

http://nvrhio.gmu.edu/legal_nov9.html

and read the minutes materials linked at the left side margin.
______________________________________________

NE Module room 112 - GMU - Health Care Law

Re:  NE Module room 112 - GMU - Health Care Law

Good afternoon; as discussed during our recent class, I propose to be available to confer with those who are available and who desire to discuss the second paper assignment and more generally your progress in our class this term and career-related matters.  More specifically, I can be available before our March 23, 2007 4.30 PM makeup class.  I would be in NE Module room 112 from approximately nine AM until shortly before our class begins.  I can endeavor to schedule times for visits of a half an hour for each visit or perhaps a bit more, depending upon how many of you are available.  Please let me know if you would like to confer and if so, what your preferred times would be on March 23.

And note that as discussed in class, your outline for your second paper assignment should be provided to me no later than March 31 and preferably sooner so I have time to comment.  And I welcome your inquiries regarding a topic relating to our studies during this term which would form the basis for your second paper assignment or some other health law-related topic that you might suggest.

GMU HSIC 750 Extra Readings

There follow the extra readings we discussed in our class on March 6, 2007.

We will discuss the following during our next class, please.

Kindly recall that we have a special makeup class scheduled for March 23, Friday, at our usual time: 4.30 PM to 7.10 PM, in East 134.

I am endeavoring to schedule times/dates to give each of you the opportunity to confer with me in person at GMU to discuss your final paper topics and anything else about our course and your career planning that you would like to discuss with me.

1.  http://www.usdoj.gov/usao/iln/osc/documents/libby_indictment_28102005.pdf

Note the following applicable laws and compare and contrast these laws to what is included in the antifraud and abuse laws we have reviewed in the Baumann text (see the end of this email please for the antikickback statute):

Title 18 Section 1001 (false statements),

§ 1001. Statements or entries generally

(a) Except as otherwise provided in this section, whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully—
(1) falsifies, conceals, or covers up by any trick, scheme, or device a material fact;
(2) makes any materially false, fictitious, or fraudulent statement or representation; or
(3) makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry;
shall be fined under this title, imprisoned not more than 5 years or, if the offense involves international or domestic terrorism (as defined in section 2331), imprisoned not more than 8 years, or both.
(b) Subsection (a) does not apply to a party to a judicial proceeding, or that party's counsel, for statements, representations, writings or documents submitted by such party or counsel to a judge or magistrate in that proceeding.
(c) With respect to any matter within the jurisdiction of the legislative branch, subsection (a) shall apply only to—
(1) administrative matters, including a claim for payment, a matter related to the procurement of property or services, personnel or employment practices, or support services, or a document required by law, rule, or regulation to be submitted to the Congress or any office or officer within the legislative branch; or
(2) any investigation or review, conducted pursuant to the authority of any committee, subcommittee, commission or office of the Congress, consistent with applicable rules of the House or Senate.

Title 18, Section 1503 (obstruction of justice),

§ 1503. Influencing or injuring officer or juror generally

(a) Whoever corruptly, or by threats or force, or by any threatening letter or communication, endeavors to influence, intimidate, or impede any grand or petit juror, or officer in or of any court of the United States, or officer who may be serving at any examination or other proceeding before any United States magistrate judge or other committing magistrate, in the discharge of his duty, or injures any such grand or petit juror in his person or property on account of any verdict or indictment assented to by him, or on account of his being or having been such juror, or injures any such officer, magistrate judge, or other committing magistrate in his person or property on account of the performance of his official duties, or corruptly or by threats or force, or by any threatening letter or communication, influences, obstructs, or impedes, or endeavors to influence, obstruct, or impede, the due administration of justice, shall be punished as provided in subsection (b). If the offense under this section occurs in connection with a trial of a criminal case, and the act in violation of this section involves the threat of physical force or physical force, the maximum term of imprisonment which may be imposed for the offense shall be the higher of that otherwise provided by law or the maximum term that could have been imposed for any offense charged in such case.
(b) The punishment for an offense under this section is—
(1) in the case of a killing, the punishment provided in sections 1111 and 1112;
(2) in the case of an attempted killing, or a case in which the offense was committed against a petit juror and in which a class A or B felony was charged, imprisonment for not more than 20 years, a fine under this title, or both; and
(3) in any other case, imprisonment for not more than 10 years, a fine under this title, or both.

and Title 18 Section 1623 (perjury),

§ 1623. False declarations before grand jury or court

(a) Whoever under oath (or in any declaration, certificate, verification, or statement under penalty of perjury as permitted under section 1746 of title 28, United States Code) in any proceeding before or ancillary to any court or grand jury of the United States knowingly makes any false material declaration or makes or uses any other information, including any book, paper, document, record, recording, or other material, knowing the same to contain any false material declaration, shall be fined under this title or imprisoned not more than five years, or both.
(b) This section is applicable whether the conduct occurred within or without the United States.
(c) An indictment or information for violation of this section alleging that, in any proceedings before or ancillary to any court or grand jury of the United States, the defendant under oath has knowingly made two or more declarations, which are inconsistent to the degree that one of them is necessarily false, need not specify which declaration is false if—
(1) each declaration was material to the point in question, and
(2) each declaration was made within the period of the statute of limitations for the offense charged under this section.
In any prosecution under this section, the falsity of a declaration set forth in the indictment or information shall be established sufficient for conviction by proof that the defendant while under oath made irreconcilably contradictory declarations material to the point in question in any proceeding before or ancillary to any court or grand jury. It shall be a defense to an indictment or information made pursuant to the first sentence of this subsection that the defendant at the time he made each declaration believed the declaration was true.
(d) Where, in the same continuous court or grand jury proceeding in which a declaration is made, the person making the declaration admits such declaration to be false, such admission shall bar prosecution under this section if, at the time the admission is made, the declaration has not substantially affected the proceeding, or it has not become manifest that such falsity has been or will be exposed.
(e) Proof beyond a reasonable doubt under this section is sufficient for conviction. It shall not be necessary that such proof be made by any particular number of witnesses or by documentary or other type of evidence.

2.  http://biotech.law.lsu.edu/cases/fca/greber.htm

--

TItle 42 Section 1320a–7b. Criminal penalties for acts involving Federal health care programs

(a) Making or causing to be made false statements or representations
Whoever—
(1) knowingly and willfully makes or causes to be made any false statement or representation of a material fact in any application for any benefit or payment under a Federal health care program (as defined in subsection (f) of this section),
(2) at any time knowingly and willfully makes or causes to be made any false statement or representation of a material fact for use in determining rights to such benefit or payment,
(3) having knowledge of the occurrence of any event affecting
(A) his initial or continued right to any such benefit or payment, or
(B) the initial or continued right to any such benefit or payment of any other individual in whose behalf he has applied for or is receiving such benefit or payment, conceals or fails to disclose such event with an intent fraudulently to secure such benefit or payment either in a greater amount or quantity than is due or when no such benefit or payment is authorized,
(4) having made application to receive any such benefit or payment for the use and benefit of another and having received it, knowingly and willfully converts such benefit or payment or any part thereof to a use other than for the use and benefit of such other person,
(5) presents or causes to be presented a claim for a physician's service for which payment may be made under a Federal health care program and knows that the individual who furnished the service was not licensed as a physician, or
(6) for a fee knowingly and willfully counsels or assists an individual to dispose of assets (including by any transfer in trust) in order for the individual to become eligible for medical assistance under a State plan under subchapter XIX of this chapter, if disposing of the assets results in the imposition of a period of ineligibility for such assistance under section 1396p (c) of this title,
shall
(i) in the case of such a statement, representation, concealment, failure, or conversion by any person in connection with the furnishing (by that person) of items or services for which payment is or may be made under the program, be guilty of a felony and upon conviction thereof fined not more than $25,000 or imprisoned for not more than five years or both, or
(ii) in the case of such a statement, representation, concealment, failure, conversion, or provision of counsel or assistance by any other person, be guilty of a misdemeanor and upon conviction thereof fined not more than $10,000 or imprisoned for not more than one year, or both. In addition, in any case where an individual who is otherwise eligible for assistance under a Federal health care program is convicted of an offense under the preceding provisions of this subsection, the administrator of such program may at its option (notwithstanding any other provision of such program) limit, restrict, or suspend the eligibility of that individual for such period (not exceeding one year) as it deems appropriate; but the imposition of a limitation, restriction, or suspension with respect to the eligibility of any individual under this sentence shall not affect the eligibility of any other person for assistance under the plan, regardless of the relationship between that individual and such other person.
(b) Illegal remunerations
(1) Whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind—
(A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or
(B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program,
shall be guilty of a felony and upon conviction thereof, shall be fined not more than $25,000 or imprisoned for not more than five years, or both.
(2) Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person—
(A) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or
(B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program,
shall be guilty of a felony and upon conviction thereof, shall be fined not more than $25,000 or imprisoned for not more than five years, or both.
(3) Paragraphs (1) and (2) shall not apply to—
(A) a discount or other reduction in price obtained by a provider of services or other entity under a Federal health care program if the reduction in price is properly disclosed and appropriately reflected in the costs claimed or charges made by the provider or entity under a Federal health care program;
(B) any amount paid by an employer to an employee (who has a bona fide employment relationship with such employer) for employment in the provision of covered items or services;
(C) any amount paid by a vendor of goods or services to a person authorized to act as a purchasing agent for a group of individuals or entities who are furnishing services reimbursed under a Federal health care program if—
(i) the person has a written contract, with each such individual or entity, which specifies the amount to be paid the person, which amount may be a fixed amount or a fixed percentage of the value of the purchases made by each such individual or entity under the contract, and
(ii) in the case of an entity that is a provider of services (as defined in section 1395x (u) of this title), the person discloses (in such form and manner as the Secretary requires) to the entity and, upon request, to the Secretary the amount received from each such vendor with respect to purchases made by or on behalf of the entity;
(D) a waiver of any coinsurance under part B of subchapter XVIII of this chapter by a Federally qualified health care center with respect to an individual who qualifies for subsidized services under a provision of the Public Health Service Act [42 U.S.C. 201 et seq.];
(E) any payment practice specified by the Secretary in regulations promulgated pursuant to section 14(a) of the Medicare and Medicaid Patient and Program Protection Act of 1987 or in regulations under section 1395w–104 (e)(6) [1] of this title;
(F) any remuneration between an organization and an individual or entity providing items or services, or a combination thereof, pursuant to a written agreement between the organization and the individual or entity if the organization is an eligible organization under section 1395mm of this title or if the written agreement, through a risk-sharing arrangement, places the individual or entity at substantial financial risk for the cost or utilization of the items or services, or a combination thereof, which the individual or entity is obligated to provide;
(G) the waiver or reduction by pharmacies (including pharmacies of the Indian Health Service, Indian tribes, tribal organizations, and urban Indian organizations) of any cost-sharing imposed under part D of subchapter XVIII of this chapter, if the conditions described in clauses (i) through (iii) of section 1320a–7a (i)(6)(A) of this title are met with respect to the waiver or reduction (except that, in the case of such a waiver or reduction on behalf of a subsidy eligible individual (as defined in section 1395w–114 (a)(3) of this title), section 1320a–7a (i)(6)(A) of this title shall be applied without regard to clauses (ii) and (iii) of that section); and
(H) any remuneration between a health center entity described under clause (i) or (ii) of section 1396d (l)(2)(B) of this title and any individual or entity providing goods, items, services, donations, loans, or a combination thereof, to such health center entity pursuant to a contract, lease, grant, loan, or other agreement, if such agreement contributes to the ability of the health center entity to maintain or increase the availability, or enhance the quality, of services provided to a medically underserved population served by the health center entity.
(c) False statements or representations with respect to condition or operation of institutions
Whoever knowingly and willfully makes or causes to be made, or induces or seeks to induce the making of, any false statement or representation of a material fact with respect to the conditions or operation of any institution, facility, or entity in order that such institution, facility, or entity may qualify (either upon initial certification or upon recertification) as a hospital, critical access hospital, skilled nursing facility, nursing facility, intermediate care facility for the mentally retarded, home health agency, or other entity (including an eligible organization under section 1395mm (b) of this title) for which certification is required under subchapter XVIII of this chapter or a State health care program (as defined in section 1320a–7 (h) of this title), or with respect to information required to be provided under section 1320a–3a of this title, shall be guilty of a felony and upon conviction thereof shall be fined not more than $25,000 or imprisoned for not more than five years, or both.
(d) Illegal patient admittance and retention practices
Whoever knowingly and willfully—
(1) charges, for any service provided to a patient under a State plan approved under subchapter XIX of this chapter, money or other consideration at a rate in excess of the rates established by the State (or, in the case of services provided to an individual enrolled with a medicaid managed care organization under subchapter XIX of this chapter under a contract under section 1396b (m) of this title or under a contractual, referral, or other arrangement under such contract, at a rate in excess of the rate permitted under such contract), or
(2) charges, solicits, accepts, or receives, in addition to any amount otherwise required to be paid under a State plan approved under subchapter XIX of this chapter, any gift, money, donation, or other consideration (other than a charitable, religious, or philanthropic contribution from an organization or from a person unrelated to the patient)—
(A) as a precondition of admitting a patient to a hospital, nursing facility, or intermediate care facility for the mentally retarded, or
(B) as a requirement for the patient's continued stay in such a facility,
when the cost of the services provided therein to the patient is paid for (in whole or in part) under the State plan,
shall be guilty of a felony and upon conviction thereof shall be fined not more than $25,000 or imprisoned for not more than five years, or both.
(e) Violation of assignment terms
Whoever accepts assignments described in section 1395u (b)(3)(B)(ii) of this title or agrees to be a participating physician or supplier under section 1395u (h)(1) of this title and knowingly, willfully, and repeatedly violates the term of such assignments or agreement, shall be guilty of a misdemeanor and upon conviction thereof shall be fined not more than $2,000 or imprisoned for not more than six months, or both.
(f) "Federal health care program" defined
For purposes of this section, the term "Federal health care program" means—
(1) any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under chapter 89 of title 5); or
(2) any State health care program, as defined in section 1320a–7 (h) of this title.

GMU HSIC 750 First Written Assignment Due by 11:59 PM on March 18, 2007

There follows GMU HSIC 750 First Written Assignment Due by 11:59 PM on March 18, 2007.

And in order to give you another perspective on the assignment, I am setting forth a Memorandum that you should assume is coming to you from the new Chief Executive Officer of the large hospital system that you work for; you are the Special Assistant for Medical Affairs, Loss Prevention, and Risk Management for the system; and the CEO needs your advice regarding an important topic.  Your advice is to be submitted to me in not less than ten pages in length, double spaced, with any footnotes or endnotes being in addition to the ten or more pages of text, using Microsoft Word font size 12 or a comparable size, please.  I can receive your submission via email at healthlawyer@gmail.com and you should tell me if you have questions regarding your assignment.  Feel free to discuss this assignment with your classmates and any others with whom you believe such a discussion would be helpful.  But the ultimate written work product submitted to me for grading must be your own. 

______________________________________________________________

To: GMU HSIC 750 Student/New Special Assistant for Medical Affairs, Loss Prevention, and Risk Management

From: New Chief Executive Officer of Hospital System

Re: Loss Prevention and Risk Management in Hospital System; Quality of Care; Competence of Physicians and other Providers

Date: February 23, 2007

Welcome to our hospital system.  As we have discussed, I need your written advice regarding how best to address continuing concern regarding quality of care and qualifications, competence, and performance of physicians, nurses, and other providers who have received or will receive medical staff privileges for hospitals in our system.  More specifically, because I have no background in the delivery of health care and instead, I come to my new position in the system from previous employment as chief operations officer of a computer technology company that provided electronic medical records technology to health care providers and payors, I need to have a clear and understanding in a written presentation to me by you of how best to manage our hospital system in light of these concerns.  Note also, please, that I specifically have asked you to advise me because I know that you have studied several areas of licensure of care givers, credentialing, prevention of medical and other errors, quality improvement, peer review, and related areas in the portion of your GMU HSIC 750 Health Law course that have transpired before today.  Accordingly, I expect you to use both the written materials you have read and your knowledge gained from classroom discussions to provide me with your advice regarding the current manner in which patients are protected or not protected by mechanisms, procedures, and laws that seem to govern how hospitals and physicians and other providers practice health care delivery, and I need to understand the nature, extent, effectiveness, and flaws regarding such mechanisms, procedures, and laws.  In addition to the foregoing, please recall that I am newly appointed to the Governor's Task Force on Health Care Quality and Improvement and Physician and other Provider Competence.  In that connection I need also to know your views regarding any proposed many or minor changes in the current manner in which patients are protected or not protected and the competence of providers is maintained or not assured.  In other words, the Governor expects me to present advice and suggestions regarding the question whether changes should be made in order better to assure that quality health care is provided or whether the current manner of protecting patients is adequate and should not be changed or should be changed but only in minor respects.  I do not expect you to do legal research in a law library.  I do expect you to use the knowledge you gain from the materials assigned to you thusfar in your Health Law course and the discussions you have had in class, and any other independent research materials that you can obtain if you so choose, in order to give me your best advice.  Regardless of the number of pages you submit (I expect at least ten, double spaced, Microsoft Word for Windows font 12 or comparable size, exclusive of footnotes and endnotes), please address each of the two parts of your submission in a proportionate manner with respect to magnitude of pages; in other words, five and five, or six and four, or four and six, are okay; but seven and three or three and seven for each of the two parts will not be okay.  Thank you for your commitment to helping our system face the challenges of providing quality health care by competent physicians and other providers.

_________________________________________________________________

Syllabus for Health Law - Spring 2007 Term

Here is the current version of the syllabus for our course -- note please that the assignments for submission are now going to be two ten page double spaced submissions in lieu of three shorter submissions, in light of the class cancellation on February 13 and the passage of time.  In addition, note the makeup class now scheduled for March 23 at our usual time in East 134. Thank you.

__________________________

George Mason University
College of Health & Human Services
Department of Health Administration & Policy
Syllabus for Health Law - Spring 2007 Term
Alan S. Goldberg, Adjunct Professor
healthlawyer@gmail.com
Copyright © 2007 Alan S. Goldberg  All Rights Reserved

Welcome to George Mason University College of Health and Human Services Department of Health Care Administration and Policy Legal Issues Relevant to Healthcare Administration

On January 23, 2007 at 4:30 PM the course entitled "Legal Issues Relevant to Healthcare Administration" will commence.  The texts for this course are:

Legal Aspects of Health Care Administration, Tenth Edition by George D. Pozgar, MBA, CHE, © 2007, Jones and Bartlett Publishers, Inc., available via the Campus Bookstore,

and the following --

The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Editors: Kristen Rosati, Esquire, Coppersmith Gordon Schermer Owens & Nelson PLC, Marilyn Lamar, Esquire, McDermott Will & Emery LLP, © - July 2005, American Health Lawyers Association Health Information & Technology Practice Group,

and

Health Care Fraud and Abuse: Practical Perspectives, Linda A. Baumann, Editor-in-Chief, © 2002, American Bar Association Health Law Section.

In addition, miscellaneous materials including materials available via Internet access will be assigned from time to time to supplement what is referenced below.  Students are expected to be able to access the Internet for assignments but a computer is not required during classroom attendance.

Each Tuesday class will commence at 4:30 PM and will end at 7:10 PM.

There is no scheduled class on February 6, 2007; the class originally scheduled for February 13, 2007 was canceled because of a snow storm; and there is no scheduled class on March 13, 2007.  The final class is scheduled for May 1, 2007.

This syllabus will from time to time be supplemented by special materials that are timely and relevant to our course and also is subject to change.  Therefore students should review information concerning this course that will appear at HEALTHLAWYERBLOG accessible at:
http://healthlawyer.typepad.com/healthlawyer/

Additional information and changes will also be announced and identified during classes, which all students are expected to attend except in unusual circumstances.  If attendance is not possible for a particular class, please alert Professor Goldberg in advance of any missed class if at all possible.

Each student will be required to submit two research and analysis papers during the term, which shall be a student’s personal and individual work product.  Each paper will consist of not less than ten sheets, double spaced and printed on one side of each sheet, using font size 12 from Microsoft (R) Word for Windows or an equivalent font size.  These two assignments will be discussed during our classes. There will be no examination for this course.  Your grade will be based, inter alia, upon your two papers and your classroom participation.

Note that I have arranged for each of you to be registered to attend HIPAA SUMMIT FOURTEEN to be held in Washington, DC. You are not obliged to attend and this is not an event attendance requirement that is a part of our course.  Nevertheless, this would be a timely and excellent opportunity for you to participate in an extraordinary gathering of distinguished individuals active in health care and information technology and in government.  Even if you can attend only parts of this event, your experience should be worthwhile.

THE FOURTEENTH NATIONAL HIPAA SUMMIT, The Leading Forum on Healthcare EDI, Privacy, Confidentiality, Data Security and HIPAA Compliance, March 26 - 31, 2007, Hyatt Regency on Capitol Hill, Washington, DC.

1.    Assignment for 1/30/07 class

    Your assignment for our class on 1/30/07 is to read Chapter 8 from the Pozgar text and to read Chapter 5 from the Health Care Fraud and Abuse text.  In addition, please download and read the following two court decisions:

Doe v. Florida Department of Health

http://world.std.com/~goldberg/DoevFlaDeptofHealth.pdf

and

Sarka v. Regents of the University of California

http://world.std.com/~goldberg/SarkavRegentsoftheUnivofCalifornia.pdf

2.    Assignment 2 Part One for 2/20/07 class

    Medical errors are being studied and many are endeavoring to address how best to prevent such errors.  The following article addressed psychological issues and other citations below address related issues including the "I'm sorry" initiative.  See the following please --

http://www.newyorker.com/printables/fact/070129fa_fact_groopman

WHAT’S THE TROUBLE? by JEROME GROOPMAN How doctors think. Issue of
2007-01-29 Posted 2007-01-22.

Additional information is in the following files (albeit only in bits and pieces because we don't have the text, but the pictures and brief statements are instructive nevertheless): please see --

http://www.qualityhealthcarenetwork.ca/pdfs/crosskerry.pdf

or

http://tinyurl.com/yot2qu

and

http://www.crnns.ca/documents/Pat%20Croskerry%20May%202005.pdf

OR

http://tinyurl.com/yukohk

relating to --

The Human Factor
in Patient Safety

Pat Croskerry, MD, PhD
Safety in Health Care
Dartmouth, May 2005

Additional background information regarding medical errors and a "I'm sorry" initiative may be found at

http://www.nap.edu/books/0309068371/html/

and at

http://iom.edu/Object.File/Master/4/117/ToErr-8pager.pdf

and

http://www.rmf.harvard.edu/

and

http://www.sorryworks.net/

and more information appears in a recent Wall Street Journal article --

"THE INFORMED PATIENT
By LAURA LANDRO   

January 24

Doctors Learn to Say 'I'm Sorry'
Patients' Stories
Of Hospital Errors
Serve to Teach Staff
January 24, 2007; Page D5
When 6-year-old Jill Hartel was hospitalized toward the end of a long battle with leukemia, her mother woke up from a fitful sleep at her daughter's bedside, horrified to find a nurse administering an intravenous dose of Benadryl, though a medication allergy was clearly marked on her medical chart...."

A general resource web site for perusal and to gain an overview of what AHRQ does and is doing is at --

http://www.ahrq.gov/qual/errorsix.htm

Assignment 2 Part Two for 2/20/07 class

Please read Chapters 5 and 7 in the Pozgar text and the following materials as a part of Assignment 2 for our class scheduled for February 20, 2007:

http://healthlawyer.com/SchroederNorthwest2006.pdf

http://www.healthlawyer.com/darling.html

Please be sure to print the foregoing so you have this material available for ready-reference during our classroom discussion.

3.    Assignment 3 for 2/27/077 class

    a.    From the Health Care Fraud & Abuse text, Chapter 8, and Appendices A-1, B-1, C-1, D-1, E-1, E-2, E-3

    b.     From the Pozgar text, Chapter 21.

Please bring the Baumann book with you to class on February 27, 2007.

4.    Assignment 4 for 3/6/07 class

    a.    From the Health Care Fraud & Abuse text, Chapter 4

    b.     From the Pozgar text, Chapter  4.

 

5.    Assignment 5 for 3/20/07 class

    a.    From the Health Care Fraud & Abuse text, Chapters 2 and 3

    b.    From the Internet,

http://oig.hhs.gov/fraud/docs/alertsandbulletins/consultants.pdf

http://oig.hhs.gov/fraud/docs/alertsandbulletins/042303SABJointVentures.pdf

6.    Assignment 6 for 3/23/07 class

    a.    From the Internet,

http://aspe.hhs.gov/admnsimp/pl104191.htm

http://www.hhs.gov/ocr/privacysummary.pdf

    b.    From the Pozgar text, Chapters 11 and 12.

7.    Assignment 7 for 3/27/07 class

    a.    From The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Chapters 1 and 2

    b.    Regional Health Information Organization materials to be provided.   

8.    Assignment 8 for 4/3/07 class

    a.    Read materials on the Internet regarding the following at

http://www.stayexempt.org/

Tax-Exempt Status
How can you keep your 501(c)(3) exempt?
Unrelated Business Income
Does your organization generate taxable income?
Employment Issues
How should you treat your workers for tax purposes?

and

Required Disclosures
To whom do you have to show your records?

    b.    Read August 2006 American Health Lawyers Association MEMBER BRIEFING Tax and Finance Practice Group regarding STA-HOME HEALTH AGENCY, et al. v. COMMISSIONER, to be provided.   

9.    Assignment 9 for 4/10/07 class

    a.    Read Pozgar text Chapter 20

    b.    Read materials on the Internet --

http://www.stayexempt.org/_pdfs/Mod3_Summary.pdf

and

http://www.irs.gov/pub/irs-pdf/fss8.pdf

10.    Assignment 10 for 4/17/07 class

    a.    Read Pozgar text Chapters 13 and 15

    b.    Read the following materials on the Internet --

http://www.npdb-hipdb.hrsa.gov/pubs/Data_Banks_at_a_Glance.pdf

http://www.npdb-hipdb.hrsa.gov/timeline.html

http://www.npdb-hipdb.hrsa.gov/pubs/fs/Fact_Sheet-National_Practitioner_Data_Bank.pdf

http://www.npdb-hipdb.hrsa.gov/pubs/fs/Fact_Sheet-Section_1921.pdf

http://www.npdb-hipdb.hrsa.gov/pubs/NPDB_and_1921_at_a_Glance.pdf

http://www.npdbhipdb.hrsa.gov/pubs/NPDBHIPDB_and_Section_1921_Comparison_Chart.pdf
http://www.npdbhipdb.hrsa.gov/pubs/NPDB_with_Section_1921_and_HIPDB_Comparison_Chart.pdf

11.    Assignment 11 for 4/24/07 class

    a.    Read the following on the Internet --

http://www.Medicare.gov/publications/pubs/pdf/10050.pdf   

http://www.medicare.gov/Publications/Pubs/pdf/11110.pdf

http://www.medicare.gov/Publications/Pubs/pdf/11136.pdf

http://www.medicare.gov/Publications/Pubs/pdf/11126.pdf

    b.    Read the following on the Internet -- go to the site linked below and read the materials further linked as indicated below --

http://www.medicareadvocacy.org/FAQ_PartD.htm

MEDICARE PART D

      What is Medicare Part D?

      Who is eligible for Medicare drug coverage?

      What is the basic benefit of Part D?

      What drugs are covered under Part D?

    c.    Read the following on the Internet --

http://www.cms.hhs.gov/MedicaidGenInfo/Downloads/MedicaidAtAGlance2005.pdf

12.    Assignment 12 for 5/1/07 class

    During our final class, we will review the entire term and we will discuss some  circumstances that care arise in the day to day delivery of and payment for health care, including new and different entities, relationships, and transactions.  A specimen contract and related materials will be provided in advance of this class.

ASG/tt

GMU HSIC Assignment 3 for 2/27/07 class

Please read the following materials as a part of Assignment 2 for our class scheduled for February 20, 2007:

http://healthlawyer.com/SchroederNorthwest2006.pdf

http://www.healthlawyer.com/darling.html

Please be sure to print the foregoing so you have this material available for ready-reference during our classroom discussion and be sure to have reviewed Assignment 2 in full for this class. Thank you.

We will discuss written paper assignment 1 during this class.
_________________________________________________________________

Please read the following as Assignment 3 for our class scheduled for February 27, 2007:

1. Baumann, Health Care Fraud & Abuse, Chapter 8, and Appendices A-1, B-1, C-1, D-1, E-1, E-2, E-3

2. Pozgar, Legal Aspects of Health Care Administration, Chapter 21

Please bring the Baumann book with you to class on February 27, 2007.

GMU HSIC 750 Assignment 2 Part Two for 2/13/07 class

Please see the following and respond via return email to me that you have received this email.  Thank you. 

Please read Chapters 5 and 7 in the Pozgar text.  Thank you.  We will discuss both parts of Assignment 2 during our next class.

Your registrations for http://www.hipaasummit.com Fourteen and the HIT SUMMIT are in the process of being confirmed and you should receive an email confirmation soon.  As and when you do, please so advise me via email; thank you.
--
Regards,  *Alan S. Goldberg, JD, LLM (Tax)
Attorney & Counsellor at Law
8300 Greensboro Dr.
McLean, VA 22102
Voice: (703) 918-4939
Fax:    (703) 842-8887
Adjunct Professor of Health Law
George Mason University
College of Health & Human Services
Dept. of Health Administration & Policy
_______________
*Admitted VA, NY, DC, FL, MA

GMU HSIC 750 Assignment 2 Part One for 2/13/07 class

Medical errors are being studied and many are endeavoring to address how best to prevent such errors.  The following article addressed psychological issues and other citations below address related issues including the "I'm sorry" initiative.  See the following please --

http://www.newyorker.com/printables/fact/070129fa_fact_groopman

"WHAT’S THE TROUBLE? by JEROME GROOPMAN How doctors think. Issue of
2007-01-29 Posted 2007-01-22

On a spring afternoon several years ago, Evan McKinley was hiking in the
woods near Halifax, Nova Scotia, when he felt a sharp pain in his chest.
McKinley (a pseudonym) was a forest ranger in his early forties, trim
and extremely fit...He decided to see a doctor....

The mistake that Croskerry made is called a “representativeness” error.
Doctors make such errors when their thinking is overly influenced by
what is typically true; they fail to consider possibilities that
contradict their mental templates of a disease, and thus attribute
symptoms to the wrong cause....

Medical education has not changed substantially since Pat Croskerry and
I were trained. Students are still expected to assimilate large amounts
of basic science and apply that knowledge as they are taught practical
aspects of patient care. And young physicians still learn largely by
observing more senior members of their field. (“See one, do one, teach
one” remains a guiding maxim at medical schools.)....

“Currently, in medical training, we fail to recognize the importance of critical thinking and critical reasoning,” Croskerry told me. “The implicit assumption in medicine is
that we know how to think. But we don’t.”"

Additional information is in the following files (albeit only in bits and pieces because we don't have the text, but the pictures and brief statements are instructive nevertheless): please see

http://www.qualityhealthcarenetwork.ca/pdfs/crosskerry.pdf

or

http://tinyurl.com/yot2qu

http://www.crnns.ca/documents/Pat%20Croskerry%20May%202005.pdf

OR

http://tinyurl.com/yukohk

relating to --
The Human Factor
in Patient Safety

Pat Croskerry
MD, PhD
Safety in Health Care
Dartmouth, May 2005.

Additional background information regarding medical errors and a "I'm sorry" initiative may be found at

http://www.nap.edu/books/0309068371/html/

and at

http://iom.edu/Object.File/Master/4/117/ToErr-8pager.pdf

and

http://www.rmf.harvard.edu/

and

http://www.sorryworks.net/

and the previous link and more information appears in a recent Wall Street Journal article --

"THE INFORMED PATIENT
By LAURA LANDRO   

January 24

Doctors Learn to Say 'I'm Sorry'
Patients' Stories
Of Hospital Errors
Serve to Teach Staff
January 24, 2007; Page D5
When 6-year-old Jill Hartel was hospitalized toward the end of a long battle with leukemia, her mother woke up from a fitful sleep at her daughter's bedside, horrified to find a nurse administering an intravenous dose of Benadryl, though a medication allergy was clearly marked on her medical chart...."

A general resource web site for perusal and to gain an overview of what AHRQ does and is doing is at --

http://www.ahrq.gov/qual/errorsix.htm

This is the first part of Assignment 2; more materials for study as a part of Assignment 2 will be posted soon.

__________________________________________________________________________

GMU HSIC 750 HIPAA SUMMIT FOURTEEN INVITATION

To:  My Students

I have arranged for each of you to be registered to attend
HIPAA SUMMIT FOURTEEN to be held in Washington, DC.
You are not obliged to attend and this is not an event attendance
requirement that is a part of our course.  Nevertheless, this would be
a timely and excellent opportunity for you to participate in an
extraordinary gathering of distinguished individuals active in health
care and information technology and in government.  Even if you can
attend only parts of this event, your experience should be worthwhile.

You will soon receive an email from me with additional information.

In the meantime, I have not received a return email from all of you
yet confirming receipt of my email of yesterday.  So, kindly favor
me with your email today and reference this posting and, I hope,
your receipt of yesterday's email.  I will, by return email, provide
additional information regarding the HIPAA SUMMIT FOURTEEN.

Thank you.
_________________

THE FOURTEENTH
NATIONAL HIPAA SUMMIT
The Leading Forum on Healthcare EDI, Privacy, Confidentiality, Data
Security and HIPAA Compliance

March 26 - 31, 2007

Hyatt Regency on Capitol Hill
Washington, DC

GMU HSIC 750 assignment 1 for 1/30/07 class and grading for this course

As announced during our class on 1/23/07, your assignment for our class on 1/30/07 is to read Chapter 8 from the Pozgar text (to be done as and when the texts are able to be obtained from the GMU bookstore) and to read Chapter 5 from the Health Care Fraud and Abuse text.  In addition, please download and read the following two court decisions:

Doe v Fla Dept of Health

and

Sarka v Regents of the Univ of California

As further announced, each student will be required to submit three research and analysis papers during the term.  Each paper will be no less than seven sheets, double spaced, using font size 12 from Microsoft (R) Word for Windows or an equivalent.  These assignments will further be discussed during our classes.  There will be no examination for this course.  Your grade will be based, inter alia, upon your papers and your classroom participation.

I am sending each student an email setting forth the foregoing.  As requested in the email, please respond indicating your receipt of my email using the special email address for me that I provided during our class.

Please contact me via email if you have any questions.

Thank you.

Welcome to George Mason University College of Health and Human Services Department of Health Care Administration and Policy Legal Issues Relevant to Healthcare Administration

On January 23, 2007 at 4:30 PM the course entitled "Legal Issues Relevant to Healthcare Administration" will commence.  The texts for this course are:

Legal Aspects of Health Care Administration, Tenth Edition by George D. Pozgar, MBA, CHE, (c) 2007, Jones and Bartlett Publishers, Inc., available via the Campus Bookstore,

and the following --

The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks, Editors: Kristen Rosati, Esquire, Coppersmith Gordon Schermer Owens & Nelson PLC, Marilyn Lamar, Esquire, McDermott Will & Emery LLP, (c) - July 2005, American Health Lawyers Association Health Information & Technology Practice Group,

and

Health Care Fraud and Abuse: Practical Perspectives, Linda A. Baumann, Editor-in-Chief, (c) 2002, American Bar Association Health Law Section.

In addition, miscellaneous materials available via Internet access will be assigned from time to time.  Student are expected to be able to access the Internet for assignments but a computer is not required during classroom attendance.

Each Tuesday class will commence at 4:30 PM and will end at 7:10 PM.

There is no scheduled class on February 6, 2007 or on March 13, 2007.  The final class is scheduled for May 1, 2007.

Additional information concerning this course will appear at HEALTHLAWYERBLOG and at www.healthlawyer.com  and will be announced during classes. 

Welcome to Suffolk University Law School eHealth Care, Privacy, & Technology

A course description is available at

http://www.law.suffolk.edu/academic/jd/course.cfm?CourseID=326

The curriculum for this distance education law school course will be posted on this HEALTHLAWYERBLOG.   Please be sure to bring your laptop to each class.

Suffolk Law School eHealth Assignment 6 for 3/8/06

Please review Chapters 1, 2, 3, and 4 of the July 2005 AHLA Member Briefing materials.

Please also study:

http://world.std.com/~goldberg/hipaaadsipreambleprivacy2000.DOC 

relating to federal privacy laws beyond HIPAA Administrative Simplification subtitle.

Suffolk Law School eHealth Assignment 5 for 2/15/06

Please review

http://oig.hhs.gov/fraud/docs/safeharborregulations/provision070197.htm

being a letter of July 1, 1997 from the Chief of the Industry Guidance Branch of the OIG regarding information technology.

Please visit the web site of the Office of the Inspector General and locate all "advisory opinions" relating to telemedicine

http://oig.hhs.gov/

including without limitation

http://world.std.com/~goldberg/ao9818.pdf

and

http://world.std.com/~goldberg/ao9914.pdf

and

http://world.std.com/~goldberg/oig02.pdf

which are located on my web site.

Please also read:

http://world.std.com/~goldberg/eprescribingoigantikick.pdf

http://world.std.com/~goldberg/eprescribingcmsstarkrule.pdf

http://healthlawyer.com/cmsvsoig.pdf

http://healthlawyer.com/oigvscms.pdf

http://world.std.com/~goldberg/mmaepre.pdf

You should refer to the July 2005 AHLA Member Briefing materials I provided to you and in particular Chapter 3, as well as relevant portions of the ABA BNA publication on Health Care Fraud and Abuse book that I provided to you, for background information regarding the foregoing materials.

Coming attractions: if time permits, read Chapters 1 and 2 of the July 2005 AHLA Member Briefing materials regarding privacy and security, and health records.

Suffolk Law School eHealth Assignment 4 for 2/8/06

Please read the materials at:

http://www.nighthawkrad.net/ 

and at

http://www.radiologytoday.net/archive/rt_051004p20.shtml

In addition, please read the decision in Orthodontic Centers of Illinois, Inc. v. Christine Michaels, D.D.S., P.C. et al., USDC ND IL ED No. 04 C 6852 decided December 13, 2005 and the 2005 Federal Legislative Proposals Involving Telemedicine/Telehealth, American Telemedicine Association (As of November 30, 2005) which I have provided to you via email.

In addition, please listen to the speech of David Brailer, MD, available at:

http://www.wamu.org/programs/kn/06/01/31.php 

quote: 

"12:06 TT: National Health IT Coordinator
There's a lot on the plate of the nation's first National Health Care
Information Technology Coordinator. Dr. David Brailer joins Kojo on Tech
Tuesday to discuss everything from digitizing medical records to preventing
fraudulent use of 'e-prescriptions' to minimizing bureaucratic electronic
red tape. 

Guests
David Brailer, MD, National Health Information Technology Coordinator, U.S.
Department of Health and Human Services

Listen to this hour
Real Player
Windows Media Player"

Coming attractions: if time permits, read the materials linked at:

http://www.cms.hhs.gov/opendoor/ERxstarkannouncemtwebpost.pdf

http://world.std.com/~goldberg/eprescribingoigantikick.pdf

http://world.std.com/~goldberg/eprescribingcmsstarkrule.pdf

http://healthlawyer.com/cmsvsoig.pdf 

http://healthlawyer.com/oigvscms.pdf

http://world.std.com/~goldberg/mmaepre.pdf

which form a part of materials that we will be reading in the next several weeks.

I will also be sending you, via email, a copy of the class action complaint filed
in connection with the following matter, which also will be part of a future reading assignment:

http://www.providence.org/Oregon/hcs/default.htm 

Written Assignment One Due February 7, 2006

Your first written assignment for submission to me is due not later than February 7, 2006.  You have been asked by your client, a physician licensed in the state which you researched as a part of Assignment 1 (the student who did not have an assigned state is now assigned the Commonwealth of Virginia), to prepare a memorandum summarizing opportunities for reimbursement of telehealth services to be provided to patients located in that state from a distant location outside of that state and vice versa.  More particularly, your client is interested in reimbursement under the Medicare program, and under the Medicaid program in force in that state, for services your client will provide in that state, either as a distant provider to a patient located in another state, or as a provider who is physically located in the same state as the provider's patients in connection with such provider's (that is, your client's) consultations with a distant provider located in another state.  Please prepare a memorandum for your client, of approximately seven pages double spaced, addressing and responding to your client's inquiry, and supplement your memorandum with a chart of available reimbursement under the Medicare Program and the relevant state Medicaid program, so that your client can more easily understand the opportunities and requirements, and the risks and constraints, and any areas of confusion and concern.  This grading  Assignment 1 must be submitted to me via email to healthlawyer@hotmail.com no later than February 7, 2006 please.  Thank you.

Suffolk Law School eHealth Assignment 3 for 2/1/06

Assignment 3 for our class on February 1, 2006 is as follows:

Read the materials hot linked at

http://www.ama-assn.org/ama/pub/category/2378.html

ftp://ftp.hrsa.gov/telehealth/licensure.pdf

http://www.americantelemed.org/news/jachopg4.pdf

http://www.oig.hhs.gov/oas/reports/region3/30400001.pdf

In addition, Also read the materials linked at the National Council of State Boards of Nursing Web site http://www.ncsbn.org/nlc/index.asp National Council of State Boards of Nursing regarding the Nurse Licensure Compact and also the Utah law materials relative to the same http://www.dopl.utah.gov/licensing/nurse_compact_info.html Utah law materials including the Nurse Licensure Compact, 58-31c Nurse Licensure Compact, 58-31c.

Also please read the following:

http://www.fsmb.org/pdf/2002_grpol_License_Portability.pdf

http://www.fsmb.org/pdf/2002_grpol_Use_of_Internet.pdf

http://www.fsmb.org/pdf/1996_grpol_Telemedicine.pdf

Please be sure to bring with you the state practice of medicine and the federal practice of medicine and health care and telemedicine and related materials required for prior assignments.

Coming attractions: if time permits, please read the materials at:

http://www.nighthawkrad.net/

and at

http://www.radiologytoday.net/archive/rt_051004p20.shtml

which will form a part of Assignment 4 for February 8, 2006.

 

Suffolk Law School eHealth Assignment 2 for 1/25/06

Assignment 2 for our class on January 25, 2006 is as follows:

Continuing our exploration of the meaning of and payment and reimbursement for the practice of medicine including telemedicine and related terms describing telemedicine, eHealth, and the like, under federal and state law, please read the following materials hot linked below.  Note please that in some instances, the federal statutory and regulatory law materials relative to Medicare program reimbursement for telemedicine have been supplemented and changed.  As a part of your assignment, please locate the changes and  any additional provisions of federal statutory and regulatory laws relating to definitions of and reimbursement for telemedicine (regardless of the descriptive terms used), and provide me via email with the hot links to the results of your research regarding changes and additions with respect to definitions of and payment and reimbursement for telemedicine.  Be sure to include HR1, also known as Medicare Modernization Act enacted in 2003, in your research.

http://world.std.com/~goldberg/bipatele.pdf

http://world.std.com/~goldberg/telemedicinemedicare.pdf

http://world.std.com/~goldberg/justelemedicinemedicare.pdf 

The following hot link is from the new Centers for Medicare & Medicaid Services web site:

http://www.cms.hhs.gov/EmplUnionPlanSponsorInfo/downloads/hr1.pdf

Please also read the material hot linked at

http://www.fsmb.org/pdf/grpol_telemedicine_licensure.pdf

for further state law information and contrast state definitions with federal definitions and descriptions and note the particular restrictions and permissions.

Please be sure to provide me with your updated information and hot links regarding federal laws and regulations before January 25, 2006 so I am able to post additional information on my HEALTHLAWYERBLOG for our ready-reference during our class.  Thank you.

Coming attractions: if time permits, you can also read the following, which will be assigned as a part of Assignment 3 for February 1, 2006:

http://www.ama-assn.org/ama/pub/category/2378.html

ftp://ftp.hrsa.gov/telehealth/licensure.pdf

http://www.americantelemed.org/news/jachopg4.pdf

http://www.oig.hhs.gov/oas/reports/region3/30400001.pdf

__________________________________________________________________________

Suffolk Law School eHealth Assignment 1 for 1/18/06

Assignment 1 for our class on January 18, 2006 is as follows:

Find and read the provisions of the statutes and regulations in your assigned jurisdictions (jurisdictions will be assigned during our class on January 11, 2006) that define and regulate the practice of medicine, the practice of nursing, the practice of pharmacy, and telemedicine including related areas of eHealth and the use of computer technology to provide health care from a distance. 

Please also read the material linked at

http://world.std.com/~goldberg/pathology.pdf

Please also read the material linked at

http://www.massmedboard.org/regs/pdf/03-06_internet_prescribing.pdf 

published by the Massachusetts Board of Registration in Medicine.

Bring copies of these materials to you for our classroom discussion.  Please also provide me with hot  URL links to your citations of statutes and rules if available, so we can share that information with others in our class.  Thank you.

__________________________________________________________________________

University of Maryland School of Law eHealth Care Second of Two Research and Analysis Assignments

For today's ePrescribing audioconference presented by CMS --

http://www.cms.hhs.gov/opendoor/ERxstarkannouncemtwebpost.pdf

the following provides background information:

http://world.std.com/~goldberg/eprescribingoigantikick.pdf

http://world.std.com/~goldberg/eprescribingcmsstarkrule.pdf

http://healthlawyer.com/cmsvsoig.pdf

http://healthlawyer.com/oigvscms.pdf

The MMA Act snip relevant to all of this is at:

http://world.std.com/~goldberg/mmaepre.pdf

The final CMS ePre standard rule is at:

http://www.cms.hhs.gov/medicarereform/pharmacy/MasterOFRVersion.pdf

and the pending bill HR 4157 relating to ePre and more is at:

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:h4157ih.txt.pdf

____________________________________________________________

quote

E-PRESCRIBING AND ELECTRONIC HEALTH RECORDS – ANTI-KICKBACK AND PHYSICIAN SELF-REFERRAL PROPOSALS OPEN DOOR FORUM November 9, 2005 2:00 PM – 4:30 PM (Eastern) The Centers for Medicare & Medicaid Services (CMS) will be hosting a Special Open Door Forum (ODF) on November 9, 2005 to discuss the CMS and HHS Office of Inspector General (OIG) proposed rules associated with certain aspects of electronic prescribing and electronic health records information technology. The CMS proposed rule: “Medicare Program; Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships; Exceptions for Certain Electronic Prescribing and Electronic Health Records Arrangements; Proposed Rule”, and the OIG proposed rule: “Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Certain Electronic Prescribing Arrangements Under the Anti-Kickback Statute” were published in the Federal Register on October 11, 2005. We have planned this Open Door Forum during the comment period for the CMS and OIG proposed regulations to have an informal dialogue with the health care industry and other interested parties. We are seeking information on the benefits, risks, costs, and savings for entities donating and utilizing electronic prescribing and electronic health records technology. The forum is in addition to, and not in lieu of, the public comment process discussed in the proposed rules. To be assured consideration, please forward written comments, as outlined in the Federal Register, by the close of the comment period. One of the primary goals of the ODF is general outreach. Because we are in the early stages of the rulemaking process and we will be considering the many forthcoming written public comments, we are not supplying any final policy information during this forum. The topics that CMS and OIG are interested in hearing about during the forum include: Covered Technology What health information technology is necessary to have a useful, interoperable electronic health records system, and which components should be included in physician self-referral exceptions and anti-kickback safe harbors? What safeguards are important to reduce the potential for fraud and abuse? Value of the Protected Technology Should there be a limit to the value of donated technology? How could this be measured and applied? Impact of the Proposed Rule on Adoption If made final, would the proposed rules improve the adoption of health information technology? What would be the overall impact, considering both the overall cost of donated technology and savings attributable to e-prescribing and electronic health records? Linking the Exceptions to Technology Standards Will linking the exceptions to technology standards facilitate the adoption of interoperable health information technology? Permissible Donors and Recipients Are there other categories of donors and recipients that should be included in final exceptions or safe harbors and, if so, under what conditions should they be included? CMS Administrator Dr. Mark McClellan will briefly discuss the overall Health Information Technology initiative in the Department of Health and Human Services, and the importance of the proposed exceptions and safe harbors in achieving an interoperable electronic health care system. CMS and OIG staff will provide a brief overview of the proposed rules. After this, there will be a panel discussion among an invited group of outside guest experts, to elucidate some of the differing perspectives and concerns about the proposed rules. CMS will then moderate an open question and comment period where ODF participants on the phone will have an opportunity to interact with CMS, OIG, and the panelists in an informal dialog. Questions regarding policy decisions expected to be included in the final rule cannot be answered directly, although participant viewpoints and ideas are encouraged. We look forward to your participation. Open Door Participation Instructions: Dial: 1-800-837-1935 & Reference Conference ID 1567530: Note: TTY Communications Relay Services are available for the Hearing Impaired. For TTY services dial 7-1-1 or 1-800-855-2880 and for Internet Relay services click here http://www.consumer.att.com/relay/which/index.html. A Relay Communications Assistant will help. ENCORE: 1-800-642-1687 “Encore” is a recording of this call that can be accessed by dialing 1-800-642-1687 and entering the Conf. ID # 1567530. The recording begins November 10th, and expires after 4 business days. For automatic emails of Open Door Forum schedule updates (Listserv registration) and to view Frequently Asked Questions please visit our website at: www.cms.hhs.gov/opendoor.