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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.

CV: About Alan S. Goldberg

Web site: http://www.healthlawyer.com

Blog: http://www.healthlawyerblog.com

Social networks:

http://twitter.com/GoldbergLawyer

http://www.linkedin.com/in/GoldbergLawyer

http://www.facebook.com/GoldbergLawyer

http://legalonramp.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. Virginia law requires a reminder that case results depend upon a variety of factors unique to each case; and case results do not guarantee or predict a similar result in any future case undertaken. Mr. Goldberg is not a Florida Bar board certified attorney in health law and is not certified as a specialist by any state bar or legal certifying organization. There is no procedure in Virginia for approving such certifying organizations.

___________________________________________________________________________

Alan S. Goldberg, Attorney & Counsellor-at-Law, 6845 Elm Street, Suite 205, McLean, Virginia 22101

Admitted PA VA NY DC FL MA

October 17, 2009 | Permalink

May 22, 2012

GMU School of Law Summer 2012 Health Law Seminar

Health Law Seminar - George Mason University School of Law - Summer 2012

Tentative Outline of Subject -- Subject to Change and US Supreme Court

The practice of medicine and nursing, state vs. federal oversight of professional licensure and quality including interstate matters, credentialing and accreditation, and the various and different participants including providers, suppliers, ancillaries, consultants, investors, governments, and patients and families, who participate in the US health care systems.

Payment and reimbursement, including first and third party, Medicare/Medicaid, VA and other special government single payor models, health plans, insurance including ERISA, disputes including alleged overpayments and adjustments, co-payments and supplementation, covered and non-covered services, and certified provider applications and oversight.

Patients and who and what they are and to whom, rights and obligations of providers and patients and families including minors, right to medical care, obligation to treat and disengagement from provider/patient relationship, responsibility and liability for care or for not caring, negligence and malpractice, and risk management and loss prevention, and corporate liability and payor liability versus provider liability.

Enforcement and adjudication, including state oversight and federal oversight, anti-kickback, Stark, false claims, and differences between civil and criminal matters and various liability implications including regarding intent, motive, knowledge, recklessness, preponderance versus beyond a reasonable doubt, and strict liability.

The structure of hospital and medical staff and other relationships including governance, responsibility, remuneration, investment, contracting including employment versus independent contractor, tax implications involving not for profit organizations and private inurement and community service, real estate tax exemptions, and peer review and discipline.

Living, dying, and death, including rights and entitlements, health care decision making, end of life, health care proxies and living wills.

Health information texhnology including HIPAA, HITECH Act, ARRA, GINA, life sciences, and FDA devices, mHealth, genetics/genomics, and telemedicine, and personalized medicine and research in academia and pharma and other funding and disclosures.

_____________________________________________________________________________________

Our course is a final paper and not an examination course. Grading for our course is determined as follows: 75% based upon the paper evaluation, and 25% based upon class attendance and participation in our discussions including due and proper preparation for each class. The final paper must be at least twelve sheets, 8-1/2 by 11, double space, exclusive of footnotes or endnotes, on an approved topic in health law. Suggested topics and outlines are due no later than June 8, 2012, and final paper submissions are due no later than June 28, 2012. There will be no class on June 26 (American Health Lawyers annual meeting) or on July 10 (Wednesday classes schedule). The final class is on July 5.

_____________________________________________________________________________________

Specific course book assignments will be provide after all the CV/resumes are received and reviewed, likely within several days. Absences (other than emergencies) should be the subject of an advance email please. Too many absences could jeopardize class credit. The usual law school honor code requirements apply regarding work product.

Questions about our course including term paper topics and outlines are welcomed.

_____________________________________________________________________________________

Our course likely will be subject to interruption as and when the U.S. Supreme Court decision regarding national health reform is published, sometime in June, which will be among the most momentous decisions both under federal constitutional law and health care law. When the decision(s) are published, the course content will include analysis of the decision(s) after careful study by each student.

ASG/tt

135522052012

May 22, 2012 | Permalink

November 24, 2011

AU Wash. College of Law Privacy & HIT (LAW-719-002) Spring 2012

Posted March 19, 2012

In anticipation of our classroom discussion this afternoon, please know that I will be discussing the following materials for your study during the coming week and thereafter, as we begin our analysis of mobile health and confidentiality and security and regulatory issues, please. You need not have studied the following before this afternoon's class; instead, I just wanted you to have a preview of the exciting and timely area of health law that we soon will be considering. And I hope the past couple of weeks were useful in providing time for you to work on your term papers; I intentionally did not give you anything more by way of a new assignment (recall we're going to talk about HIPAA enforcement/HITECH enforcement/data breach this afternoon) for today.

Let me know, please, if you have difficulty in accessing any of the materials linked below. Your primary goal is to familiarize yourself, in the coming week, with the area of mHealth. I realize that the magnitude of materials linked below will not allow for in-depth study; instead, your purpose is to immerse yourself generally is this area of law, so that when we engage in our discussions, you are familiar, generally, with as many of the words/terms/concepts etc. as reasonably will be possible.

Additional links are being sent to you via email, please.

http://ag.ca.gov/cms_attachments/press/pdfs/n2630_signed_agreement.pdf?

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm255978.htm

http://now.dartmouth.edu/2011/09/cybersecurity-health-care-and-mobile-devices/

http://www.med.yale.edu/library/services/computing/pdahardware.html

http://sharps.org/wp-content/uploads/KOTZ-SPIMACS.pdf

http://mobihealthnews.com/16456/more-on-oncs-consumer-privacy-in-mobile-health-study/

https://www.federalregister.gov/articles/2012/02/22/2012-4033/agency-information-collection-request-30-day-public-comment-request

http://www.informationweek.com/news/healthcare/mobile-wireless/232400467?printer_friendly=this-page

http://www.hhs.gov/open/initiatives/mhealth/index.html

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm243283.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments /ucm089543.htm

http://www.healthcarefinancenews.com/news/medical-devices-get-parallel-review-pilot-fda-and-cms

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm

http://www.washingtonpost.com/business/capitalbusiness/fda-moves-to-regulate-mobile-health-applications/2011/07/18/gIQApwLdNI_print.html

http://www.nejm.org/doi/pdf/10.1056/NEJMhle1113918

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf

Posted January 26, 2012

To: My Privacy & HIT Students

During our January 23, 2012 class (with some of you being absent) we began a discussion of the just-decided and important Jones decision in which the US Supreme Court addresses many of the concerns that we will be addressing during our classroom discussions. Please study the Jones decision in anticipation of our discussion during our next class:

http://www.supremecourt.gov/opinions/11pdf/10-1259.pdf

In addition, we assigned specific decisions to specific students who were in attendance, for our discussion during our next class. Those who were not in attendance yesterday should please become familiar generally with all of the decisions assigned previously and with the Brandeis article cited in our syllabus, in addition to the Jones decision cited above.

More of your effort should please be dedicated to the Jones decision and to the Brandeis article and to the Sorrell decision.

Because of the fortuitous availability of the Jones decision, the written assignment for our next class, due by 11:59 PM on the evening before our class day, is changed. More specifically, those who were in attendance yesterday in class received new assignments relating specifically to a particular decision or the Brandeis article; those who were not in attendance yesterday in class should please change the written assignment to briefly to summarizing (points of interest are okay, narrative not mandatory) just the Jones decision and the Brandeis article in lieu of all the other decisions.

Further regarding our studies, here are some links that I hope will take you to some web sites that contain helpful information regarding privacy issues. We will talk more about this during our next class; all you need do is peruse each site for at least a few moments (of course you are free to linger) in order to have some beginning familiarity with each site; nothing has to be written as an assignment because the purpose of your visits to these cites simply is to provide you with helpful resources for your papers and for your general knowledge.

You might have to copy and paste each link in your browser address ribbon to avoid truncation difficulties or the absence of direct URL connectivity via each link below.

http://www.privacyrights.org/fs/fs8-med.htm

http://www.npr.org/series/ 114250076/the-end-of-privacy

http://www.cdt.org/issue/health-privacy

http://epic.org/privacy/

https://www.eff.org/issues/privacy

http://business.ftc.gov/privacy-and-security

http://www.facebook.com/about/privacy/

http://www.google.com/intl/en/privacy/

http://www.microsoft.com/en-us/healthvault/MicrosoftsPHRDataPracticesforHealthVault.aspx

Finally, regarding the term paper, please provide me with proposed topic(s) as soon as possible and preferably within the next couple of weeks. You also may accompany your topic(s) with a brief outline and preliminary list of resources for study and analysis; or you can elect to provide an outline/resources after your topic is approved. And the final paper due date will be 3 PM on April 9, 2012, please, via eMail to me.

Kindly advise me if you have any questions or concerns regarding all the foregoing. Thank you.

Posted January 17, 2012

To: My AU WCL Privacy & Health Information Technology Students

Please feel free to inquire regarding any questions you might have about what is posted below, so that I can address any questions regarding our initial several week period of classes. As indicated during our first class and particularly because some of my students for this course have a health background while others do not, and because each of my students has taken some health and other law courses but not others, and because some of my students have been employed or are employed now in health-related areas, it usually takes several weeks and two or three classes before we can determine how best to design our course in order to mazimize the opportunities to learn for everyone in the class, regardless of experience or employment. This process also will enable us to be more specific regarding how much of the list of relevant materials referenced below can be anticipated to be part of our curriculum and discussions. And as discussed in class, because of the substantial number of new developments that occur in privacy and health information technology, some substitutions of new developments for those previously referenced below likely will occur so that your educational experience can include learning about the most important new developments.

I look forward to being with you again on January 23, please.

Regards, Alan@GoldbergLawyer.com

Posted January 16, 2012

AU Wash. College of Law Privacy & HIT (LAW-719-002) Spring 2012

To: My AU WCL Privacy & Health Information Technology Students

Coming Attractions

Please know that we will be studying, inter alia, the following in the weeks after our second class and I will provide further information during our next class. But for now, feel free to begin to peruse the following and let me know if you have any difficulty accessing any of these materials please. We likely will not be able to address all of the following materials because of time limitations and because sometimes our classroom discussions take more time than might be anticipated. In addition, current events might cause us to change our focus from time to time as new developments occur.

Genetic information and life.

1.    http://web.me.com/asgoldberg1/filechute/genepatents-USamicusbrief.pdf

2.    http://web.me.com/asgoldberg1/filechute/genepatents-AMPvUSPTO-Opinion.pdf

3.    http://graphics8.nytimes.com/packages/pdf/national/20100329_patent_opinion.pdf

Health care from a distance and information used.

4. http://web.me.com/asgoldberg1/filechute/mass%20board%20tissue%20nh%20ma%20pathology%20opinion.zip

Business method patents and health information.

5. http://www.supremecourt.gov/opinions/09pdf/08-964.pdf

6. http://www.law.berkeley.edu/files/inrebilski.pdf

Patientable process and health information.

7. http://www.bloomberglaw.com/public/document/Prometheus_Labs_Inc_v_Mayo_Collaborative_Servs_628_F3d_1347_97_US

Electronic contracts, eSignatures, and health information.

8. http://www.ftc.gov/os/2001/06/esign7.htm

9. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_cong_public_laws&docid=f:publ229.106.pdf

eSign law, UETA, health information.

10.   http://www.bankersonline.com/ebanking/ueta.html

11.    http://www.law.cornell.edu/uscode/18/usc_sup_01_18_10_I_20_119.html

12.    http://www.ncsl.org/default.aspx?tabid=13484

Health care fraud and abuse, and health information.

13. http://oig.hhs.gov/fraud/advisoryopinions.asp

[Advisory Opinions relating to HIT]

Advisory Opinion No. 99-14
Advisory Opinion No. 99-18
Advisory Opinion No. 10-04
Advisory Opinion No. 08-08
Advisory Opinion No. 08-12
Advisory Opinion No. 02-12
Advisory Opinion No. 08-19
Advisory Opinion No. 09-16
Advisory Opinion No. 04-04
Advisory Opinion No. 02-14
Advisory Opinion No. 08-01

Telemedicine and health care from a distance and health information.

14. http://www.americantelemed.org/files/public/abouttelemedicine/What_Is_Telemedicine.pdf

15. http://www.americantelemed.org/files/public/abouttelemedicine/Terminology.pdf

16; http://www.americantelemed.org/files/public/policy/Medicare_Payment_Of_Services.pdf

17. http://americantelemed.i4adev.com/files/public/abouttelemedicine/JCP_2_2_2003.pdf

18. http://www.americantelemed.org/files/public/policy/Licensure_Portability.pdf

19. http://www.americantelemed.org/i4a/pages/index.cfm?pageID=3311

20. http://www.hrsa.gov/telehealth/pubs/licensure.htm

21. https://www.cms.gov/Telemedicine/

22. http://www.cms.gov/officeoflegislation/downloads/NewRulestoEnsureAccesstoTelemedicineServices.pdf

23. http://dhmh.maryland.gov/mhqcc/pdf/2010/Sep10/Attachment_D_University_of_Maryland_School_of_Law_Telemedicine_White_Paper.pdf

24. http://web.me.com/asgoldberg1/filechute/prometh-010remand.pdf

Tissues and ownership.

25. http://web.me.com/asgoldberg1/filechute/washutissuecir-2007.pdf

26. http://www.connected-health.org/media/71068/telemed%20reimbursement%20policy.pdf

27. http://edocket.access.gpo.gov/2010/pdf/2010-12647.pdf

28. http://www.americantelemed.org/files/public/standards/Telepresenting_Draft_PublicComment.pdf

Electronic prescriptions.

29. http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.pdf

Health information technology and privacy and security: associations and standards.

30. http://www.ansi.org/internet_resources/overview/overview.aspx?menuid=12#national

31. http://www.consortiuminfo.org/links/linkscats.php?ID=48

32.    http://www.nist.gov/index.html

33.    http://www.ahima.org/

34.    http://www.wedi.org/

35.    http://www.cio-chime.org/

36.    http://www.himss.org/ASP/index.asp

37.    http://www.hl7.org/

38.    http://www.iso.org/iso/home.html

39. http://www.ansi.org/

40. https://www.amia.org/

Health Insurance Portability and Accountability Act of 1996 (HIPAA).

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

42.    http://web.me.com/asgoldberg1/filechute/HITECH%20Pages%20from%20PLAW-111publ5.pdf

43.    http://www.hhs.gov/ocr/privacy/hipaa/administrative/combined/index.html

44.    http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/adminsimpregtext.pdf

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

46. http://web.me.com/asgoldberg1/filechute/electsighipaa1998.pdf

47. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/securityrulepdf.pdf

Health information security.

48. http://csrc.nist.gov/publications/drafts/800-144/Draft-SP-800-144_cloud-computing.pdf

49. http://csrc.nist.gov/publications/drafts/800-145/Draft-SP-800-145_cloud-definition.pdf

50. http://csrc.nist.gov/publications/drafts/800-70-rev2/Draft-SP800-70r2.pdf

51. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/nist80066.pdf

52. http://web.me.com/asgoldberg1/filechute/washutissuecir-2007.pdf

53. http://web.me.com/asgoldberg1/filechute/prometh-010remand.pdf

133616012012

Term Paper and Grading

Your grade for our course will be determined by my evaluation of your term paper, your compliance with occasional memoranda submission requirements, and your class attendance and participation. There is no final examination for our course.

The term paper will be required to be at least ten sheets in length (8-1/2 by 11 paper size, 12 point typeface, double spacced) but can exceed that number of sheets if you so choose, and footnotes/citations are in addition to the minimum length requirement. We will discuss topics and other aspects of your term paper during our next class, including the due date and paper presentations and discussions.

Occasional memoranda submissions are referenced below and addendance and participation will be discussed during our next class.

Posted January 11, 2012

To: My HIT/Privacy Law Students

Good day. Here is the description of our course, for your ready-reference. How much of the course content referenced below we will be able to include in our class discussions will depend upon our progress and new developments.

Health care is a heavily regulated profession and industry, but some believe that federal and state regulation has not successfully provided adequate protection for health information. An important part of the regulatory process includes issues implicated by privacy and confidentiality, security, and data breach concerns, particularly when sensitive individually identifiable health information is created, stored, used, and disclosed, and subjected to data mining. Health care delivery and payment, and associated biomedical research and innovations have emerged as a growing part of health care with much more information being created, and radical changes in the way the ever growing amount of health information is used and in the minds of some, sometimes abused, despite applicable laws, is a growing concern. Included in areas of substantive concern are the Administrative Simplification Subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009, the Genetic Information Nondiscrimination Act of 2008 (GINA), the Patient Safety and Quality Improvement Act of 2005 (PSQIA), and the Patient Protection and Affordable Care Act (referred to as PPACA or the Affordable Care Act or the health reform law), and certain state laws, as well as the European Data Protection Directive and relevant laws of foreign nations. The emerging area of life sciences law and related federal Food and Drug Administration regulatory and information use and disclosure concerns,including software as a medical device and mobile health, sometimes referred to as mHealth, involve many fascinating issues that are publicized heavily in the media and implicate complex legal issues relating to genetics and genomics, and privacy and security. Privacy and confidentiality, security, health information technology, electronic medical and health care records, using information in research including stem cell research and ownership of information, data mining and marketing, telemedicine and eHealth, and other relevant topics relating to health care generally and the life sciences specifically, will be considered.

For your first study assignment in anticipation of our class scheduled for January 23, 2012, please visit the statutory laws and regulatory promulgations for the state jurisdiction to which you are admitted as an attorney-at-law or if you are admitted to several, select your favorite; if you are not yet admitted to the bar, please use the law of the state that you most likely will want to be admitted to; and if you have lived abroad, you may select the law of the nation abroad (France, Spain, et al...) you prefer to select. Your assignment is to determine what law(s) and regulation(s) define the practice of medicine and health care under the applicable laws of the state (or DC) or the nation selected.

In addition, your assignment is to visit the United States Code, and to determine where in the statutory law of the United States of America there are definitions of the practice of medicine, and health care (if there are too many, select what you believe to be the most important, in your judgment). Please also visit the Constitution of the United States of America as amended for your analysis regarding your search for the relevant words and concepts.

Sometimes the words used might be different: that is, instead of the practice of medicine, you might see the practice of medicine and surgery; and instead of health care, you might see healthcare or health; do the best you can, however, to focus on the the overall purpose of your analysis, which is to determine how the laws you are researching define the concepts of each of the practice of medicine, and health care, regardless of the particular words used.

Please do the same type of analysis for the word privacy and the word confidentiality, and if possible limit your analysis to practice of medicine, and to health care, contexts; but if that is not possible, feel free to go beyond those particular contexts.

Your written assignment, due by 11:59 PM on the evening before our next class, via email to me is to summarize the results of your research referenced above, please, with appropriate citations (Blue Book or other generally accepted standard will be acceptable). Feel free to limit your written submission to what would be three to five sheets of 8-1/2 by 11 inch paper but feel free to provide more information if you prefer. Submit either or both of .doc/WinWord and .pdf files, please, attached to your email.

In addition, please begin your study of the article and the judicial decisions identified below (I have provided links that I have found to be active but feel free to study these materials using other linked web sites or Lexis or Westlaw if that is more convenient for you).

We will begin discussing the materials referenced below toward the end of our second class and therefore please study as much of the following materials as you can if you want to prepare further ahead of our detailed discussion. Our discussion will continue during our third class. Your written assignment for the third class, due by 1:59 PM on the evening before that class, will be briefly to summarize (narrative not required, outline format will be satisfactory) the salient points implicated by the following assigned readings, please. Again, three to five sheets would be acceptable but more including narratives would be accepted as well.

ASSIGNED READINGS:

1. “The Right to Privacy” - Warren and Brandeis - Harvard Law Review. - Vol. IV December 15, 1890 No. 5

available at:

http://groups.csail.mit.edu/mac/classes/6.805/articles/ privacy/Privacy_brand_warr2.html

2. ROE v. WADE, 410 U.S. 113 (1973)

available at

http://caselaw.lp.findlaw.com/cgi-bin/getcase.pl?court=us& vol=410&invol=113

3. OLMSTEAD v. U.S., 277 U.S. 438 (1928)

available at:

http://caselaw.lp.findlaw.com/cgi-bin/getcase.pl?court=us& vol=277&invol=438#478

4. WILLIAM H. SORRELL, AS ATTORNEY GENERAL OF THE STATE OF VERMONT et al. v. IMS HEALTH INC. et al. including Petition for Writ of Certiorari

available at:

http://sblog.s3.amazonaws.com/wp-content/uploads/2010/12/Pet .10-779.pdf

available at:

http://www.supremecourt.gov/opinions/10pdf/10-779.pdf

5. KATZ V. UNITED STATES, 389 U. S. 347 (1967)

available at: http://supreme.justia.com/us/389/347/case.html

6. UNITED STATES of America, Appellee v. Lawrence MAYNARD, Appellant [United States v. Jones before US Supreme Court]

available at:

http://www.bloomberglaw.com/public/document/United_States_v_Maynard_615_F3d_544_DC_Cir_2010_Court_Opinion

Kindly advise if any of the links provided above are inoperative. I soon will post this email at my web site

http://www.healthlawyerblog.com

where it might be easier simply to click through to the linked web site pages (sometimes email links become truncated or otherwise don't function).

Before our third class and after I complete my review of your CVs, a full term syllabus will be published, subject to change as further developments occur in our areas of focus.

Finally, a separate email will follow soon regarding the term paper and relevant details, including topics, length and style, and more.

Please feel free to inquire of me via email if you have questions about any of the foregoing or anything else regarding our course.

Thank you and welcome to our course.

Alan S. Goldberg

http://www.healthlawyerblog.com

ASG/tt 120111012012

To: My AU WCL Privacy & HIT LLM Law Students

Good day. It will be my pleasure to be your teacher for for the Spring 2012 LLM term for Privacy & Health Information Technology (LAW-719-002) -- Meets: 04:00 PM - 05:50 PM (M). Welcome to our course, and I look forward to greeting you on January 9, 2012.

The syllabus for our course is being prepared and updated and soon will be posted here.

November 24, 2011 | Permalink

August 09, 2011

AU/WCL Fall 2011 Semester > HlthLaw:Legisla&Reg Process (719-001)

Updated on November 8 2011

Set forth below is the tentative schedule of distinguished guest speakers and topics relating to health care legislative, regulatory, and judicial process, subject to change, please. Study materials and assignments will be provide in advance of each class.

September 19, 2011 - Robert L. Roth - Medicare Program Determinations and Appeals

http://health-law.com/attorneys/ro-robert-l-roth/

http://web.me.com/asgoldberg1/filechute/Auburn-ARMC%20v.%20Sebelius%20-%20D.C.%20Cir.%20-%2006242100%20Opinion.zip

September 26, 2011 - Louis Alterescu, Office of General Counsel, U. S. Department of Health & Human Services, and Adam H. Greene - HIPAA Administrative Simplification and HITECH Act

http://www.dwt.com/People/AdamHGreene

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

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

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

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

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

http://www.va.gov/vhapublications/viewpublication.asp?pub_id=1089

http://www.sibley.org/general_info/medical_information_privacy_notice.aspx

October 3, 2011 - Deven McGraw - Privacy and Public Advocacy, William Braithwaite, MD, PhD - The HIPAA Law & Lore: Dr. HIPAA Speaks

http://www.cdt.org/personnel/deven-mcgraw

http://www.hitsp.org/Braithwaite.aspx

http://www.cdt.org/files/pdfs/20090126Consent.pdf

http://caselaw.findlaw.com/us-3rd-circuit/1187927.html

http://www.cdt.org/comments/cdt-markle-comments-requesting-revised-harm-standard

http://www.cdt.org/comments/cdt-comments-hhs-accounting-disclosures-nprm

http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/brguidance.html

October 10, 2011 - Neal Neuberger - Health Care and Public Advocacy

http://www.e-healthpolicy.org/staff.asp

http://www.e-healthpolicy.org/index.asp

http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__home/1204

October 17, 2011 - Kevin G. McAananey - Antifraud and Abuse, Anti-Kickback, Stark Law, False Claims

http://www.mcananeylaw.com/

http://oig.hhs.gov/compliance/physician-education/index.asp

http://web.me.com/asgoldberg1/filechute/oig-antifraudbook-roadmap_web_version.zip

Please study the attached AHLA material which AHLA generously has made available to us. We will discuss this material during our class on October 17/

http://sn.im/sm3qq-drp

Please also see below for a hot link to a copy of the so-called Stark Law.

http://sn.im/sm41e-aod

OR

http://www.ssa.gov/OP_Home/ssact/title18/1877.htm

and to the so-called health care civil monetary penalties false claims and antikickback statutes

http://www.ssa.gov/OP_Home/ssact/title11/1128A.htm

http://www.ssa.gov/OP_Home/ssact/title11/1128B.htm

October 24, 2011 - Thomas C. Goldstein - Health Care and Advocacy Before U. S. Supreme Court

http://www.ghrfirm.com/attorney-profiles/thomas-goldstein

http://www.supremecourt.gov/opinions/10pdf/10-779.pdf

Please also study the materials at the back of the Eskridge, Frickey and Garrett's Legislation and Statutory Interpretation course regarding the U.S. Supreme Court and statutory construction.

October 31, 2011 - John J. Castellani - PhRMA and Advocacy

http://www.phrma.org/john-castellani-biography

http://www.phrma.org/research/publications

http://www.phrma.org/about/principles-and-guidelines

Michael K. Loucks - Prosecution, and Defense of Health Care Crimes

http://www.skadden.com/index.cfm?contentID=45&bioID=9864

http://www.hhs.gov/news/press/2009pres/09/20090902a.html

http://articles.latimes.com/2009/sep/03/business/fi-pfizer3

http://www.nytimes.com/2011/06/05/business/05switch.html?_r=1

http://www.justice.gov/opa/pr/2010/December/10-civ-1464.htm

http://www.pharmalot.com/2011/06/former-prosecutor-doj-keeps-pharma-in-the-dark/

http://www.ft.com/intl/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html#axzz1a6sn1Fz4

November 7, 2011 - Richard M. "Rick" Campanelli, JD, Director of Government Relations, Health and Human Services, Washington Operations, Lockheed Martin Corporation, Former Director, Office for Civil Rights and Counselor to the Secretary of the U. S. Department of Health and Human Services

http://www.lockheedmartin.com/news/press_releases/2011/1-13-Campanelli-Health-IT-Cert-Commission.html

http://www.linkedin.com/pub/richard-campanelli/a/279/546

November 14, 2011 - Susan C. Winckler, RPh, Esq., President and CEO, Food and Drug Law Institute, former Chief of the Staff for the U.S. Food and Drug Administration (FDA) within HHS, Managing Director, Medical Products Practice, at Leavitt Partners founded by former U.S. Health and Human Services (HHS) Secretary and EPA Administrator Michael O. Leavitt

http://www.fdli.org/about/

TERM PAPERS

To: My Health Law Students

Re: Final Paper and Presentations Assignment

1. For our classes scheduled for November 21 and 28, we will be discussing your final papers and negotiating strategies relating to whether or not Congress should mandate that every patient in the United States of America that receives health care and treatment must have an electronic health record provided and paid for by the caregiver.

2. Assume that a bill mandating the use of electronic health records is introduced in the House and in the Senate, having been prepared for the President to file as a proposed amendment to the PPACA/ACA legislation, and that the bill provides that such requirement would be an unfunded federal mandate and would preempt and supervene any contrary state laws.

3. You either will be among those on the legal counsel staff of the White House asked to prepare an advocacy paper in behalf of enactment of the bill, or among those who are retained by a group of health care professional and business associations and who are asked to prepare an advocacy paper adverse to the bill, in either instance setting forth in detail the reasons under law and policy for the position you are advocating.

4. As you would if you actually were so retained as legal counsel, you will have available to you whatever legal and other resources you can locate and use, in order to provide zealous advocacy for and in behalf of your client, and you will be expected, inter alia, to address privacy and security concerns including data breaches, anti-fraud and abuse issues implicated by massive data base availability of care and payment information, reimbursement and cost implications, medical errors and standards of care including comparative effectiveness and quality care, and other relevant considerations, but constitutionality under the federal constitution need not be discussed because we will assume that the constitutionality of PPACA/ACA is upheld by the US Supreme Court.

5. Fortunately, you enjoy the benefits also of being a law student in our class and so the remarks, views, and information provided during hour class discussions including from our guest speakers, also may be cited.

6. The paper must be at least ten standard 8-1/2 by 11 inches sheets, no more than 12 point typeface, double spaced, with normal margins, and you are free to provide more than ten sheets.

7. Use The Blue Book® citations style, please, and your citations and any graphics and charts, etc., are extra: that is, the minimum number of sheets is exclusive of footnotes etc., please.

8. Your paper must be received by me not later than the end of November 20, 2011 (the day before our class), via email to Alan@GoldbergLawyer.com please.

Kindly feel free to express a preference regarding which side you would like to be on; but understand that I cannot necessarily respond to everyone's preference.

We will be discussing all the foregoing in class.

Thank you.

==========

November 21, 2011 - Presentation of Papers and Advocacy

November 28, 2011 - Presentation of Papers and Advocacy

-----------------------------------------------------

Updated on September 13, 2011

I provided via email a link to the rather large zip file with Bob Roth's recently received materials, including the USDC decision that was overturned by the Circuit Court in DC. As discussed yesterday, please familiarize yourself with these materials in order to enhance our discussion with Bob on September 19, 2011.

While lots of materials are being provided and you are not expected to master all of them, nevertheless, do try to get a sense of what went on and what was going on in the factual circumstances generally and consider how legislation and regulations seemingly failed to provide a clear path for the appellants to anticipate the position the government would take, and consider further why the government believes the appellants should not have succeeded (what would those who voted in favor or the Medicare program have wanted to occur and was the situation due to legislative or regulatory failure or simply a money issue plain and simple).

And for the classes during which we'll be discussing HIPAA/HITECH Act, please begin studying and familiarizing yourself with the original HIPAA statute (Original HIPAA) and also with the HITECH Act (HIPAA JOLT) that followed several years of what some said was watered down HIPAA (HIPAA Lite) before enforcement under the HIPAA JOLT was increased.

See:

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

and

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

and in general, peruse the information located at the HHS OCR (Office for Civil Rights) web site so you will have an overview of what HIPAA/HITECH Act is all about; and additional information will be provided to you later.

See if you can locate the actual HITECH Act provisions within a larger legislative enactment and extract a copy for your use. If you have difficulty, let me know, please.

As you study these materials, consider why HIPAA was thought to be necessary; whether HIPAA has achieved the purposes intended; how an unfunded federal mandate can profoundly add to the costs of those affected; whether the benefits are worthwhile for those thought to be protected; whether HIPAA/HITECH Act makes the delivery of health care more difficult and whether, when considering Original HIPAA language, the privacy rule reflects what the legislation likely was intended to accomplish; and if, perhaps, another way of protecting health care privacy would be better overall including possibly by leaving the protections to the states to address instead of having the federal government deeply involved in privacy protection. Our discussion will mostly involve privacy, but security also is an important part of HIPAA and we'll discuss security briefly as well.

-----------------------------------------------------

Updated on August 29, 2011

...

I am giving you the following linked materials to add to our curriculum. These materials relate to our discussions today preliminarily about coming attractions including on September 12 regarding the health reform materials previously cited and linked for you and on September 19th with our guest Robert Roth:

http://health-law.com/attorneys/ro-robert-l-roth/

with whom we'll discuss the Medicare program legislative and regulatory materials including those available at:

http://web.me.com/asgoldberg1/filechute/rothahlaheadstailstales.pdf.zip

(we'll be studying judicial decisions Bob references in Bob's article linked above)

http://web.me.com/asgoldberg1/filechute/medicarepl89-97-1965%20-ssamends1965.pdf.zip

(the original Medicare law that includes "reasonable and necessary")

http://web.me.com/asgoldberg1/filechute/Auburn-ARMC%20v.%20Sebelius%20-%20D.C.%20Cir.%20-%2006242100%20Opinion.zip

(a current opinion in a matter Bob is shepherding)

http://www.ll.georgetown.edu/federal/judicial/dc/opinions/00opinions/00-5109a.html

(one of the decisions also relevant to our discussions).

More information regarding all the foregoing will be provided when we meet this afternoon.
Please advise me if you have difficulty opening any of the linked materials. Thank you.

---------------------------------------------------------

Updated on August 23, 2011:

Here are links to the online references I referred to in class yesterday and which should be useful to you during our studies. In particular, be sure to download the How Laws Are Made .pdf file for later reference and assignments.

http://www.ll.georgetown.edu/guides/legislative_history.cfm

http://thomas.loc.gov/home/lawsmade.toc.html

http://www.gpo.gov/fdsys/pkg/CDOC-110hdoc49/pdf/CDOC-110hdoc49.pdf

Please also be sure regularly to access your incoming email, both for assignments and for any messages regarding class cancellations because of bad weather or other unexpected circumstances.

----------------------------------------

Updated on August 23, 2011:

Welcome to AU/WCL Fall 2011 Semester > HlthLaw:Legisla&Reg Process (719-001).

First of all, please know that I am delighted to have the opportunity to collaborate with you in furtherance of enhancing knowledge and insight regarding the critically important issues implicated by the legislative and regulatory process involving health care. We all are patients, and as law students, lawyers, and patients, we need to know more about how health law evolves and health care is delivered and paid for, because just about every part of law and of life affects and is affected by or involves health care.

Second, this is a particularly auspicious time to be studying health law and how the law develops and is changed by the legislative and regulatory, and the judicial, processes: the Medicare program, the Health Insurance Portability and Accountability Act of 1996 (my beloved HIPAA) and the HITECH Act, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the federal anti-kickback, false claims, and Stark laws, and most recently, the Affordable Care Act (PPACA and HCERA), are some examples of how profoundly important and consequential federal political and legislative initiatives are and how they affect health, business, the economy, and happiness.

In anticipation of our first classroom discussion and even before the new syllabus is ready for you (I am still in the process of creating the new syllabus because, inter alia, of changes in the law and enhancement of the orientation of our course for the coming the fall term), please study the materials to be found at:

http://web.me.com/asgoldberg1/filechute/asgwcl-href-as1-125409082011.zip

The file is about 6 megabytes in size and if you have difficulty in downloading or opening the files, please let me know and I can send them to you directly. You will find, for our beginning discussions, copies of PPACA and HCERA and a consolidated file (not to be relied upon as a definitive integrated reference because I don't know if it's completely accurate, but helpful nevertheless for having a better perspective), and two circuit court decisions regarding health reform constitutionality challenges, and some US Senate summary materials as well. Please endeavor to understand the broad aspects of the health reform law and the coverage and timing implications, as you study these materials, and in particular be ready to discuss the Thomas More circuit court decision specifically and the 11th Circuit decision decided August 12, 2011 cited below and the overall health reform initiatives generally. It also will help to review the federal Constitution and amendments, please.

-----------------------------------

Please include the decision of the 11th circuit court of appeals of August 12, 2011, linked below, in your studies for our first class and our course.

http://web.me.com/asgoldberg1/filechute/11thhcreformnomandate.zip

Note please that I maintain a web site called:

http://www.healthlawyerblog.com

where you will find references to the course text materials and other information for my health law students generally and for you specifically.

And note, please, that I ask that you provide me, as soon as possible, with a CV / biography that includes your academic and work and career information, as well as your experience thus far in studying health law and in working in any areas of endeavor involving health law. Feel free also to share with me your goals that are health law-related and your specific goals in participating in our course: our course is all for and about you, and so your thoughts and ideas always are welcomed.

When we meet, we also will discuss the syllabus, the periodic written submissions for our course (there is no final examination for this course), our honored guests (hopefully my distinguished colleagues and friends who I invited to visit us will be able to keep to our scheduled days), and any questions you may have about our course specifically and health law generally.

------------------------------------

The required texts for the course are as follows and please bring them to our first class:

1. Eskridge, Frickey and Garrett's Legislation and Statutory Interpretation, 2d (Concepts and Insights Series)By William N. Eskridge, Jr., Philip P. Frickey, Elizabeth GarrettBook - softbound Copyright: 2006 ISBN-13: 9781599410784

2. Furrow, Greaney, Johnson, Jost and Schwartz' Health Care Reform: Supplementary Materials (2011) By Barry R Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S Jost, Robert L. Schwartz Book - softbound Copyright: 2011, West Group ISBN-13: 9780314277503

3. Pocket Edition of the Constitution of the United States, Publication Date: 1998 American Bar Association Division for Public Education ISBN-13: 9781891743009

---------------------------------------

August 09, 2011 | Permalink

July 08, 2011

HEALTH GMU School of Law Fall 2011 Law 427 LAW SEMINAR

Updated October 25, 2011

Preliminary syllabus and course information:

Grades will be based upon attendance and class participation 20%, interim paper submissions 20%, and final paper submission and presentation 60%. There is no final examination for our course.

This syllabus will be enhanced from time to time during the Fall term with references to other materials available on the web and via email, as appropriate, including materials and information newly published during the term.

1. AUG 30 - Provide CV, introduction to our course

2. SEP 6 - Health care quality and the law including health care reform, Furrow et al. supplement pgs. 1-27, PPACA statutes

3. 13 - Health care reform including PPACA/ACA, Furrow et al. supplement pgs. 116-120, Fundamentals pgs. 81-148, original Medicare statute and amendments

4. 20 - Medicare including health care reform and PPACA, Furrow et al. supplement pgs. 165-188, Fundamentals pgs. 81-148, original Medicare statute and amendments

5. 27 - Physicians, ancillary providers, hospitals, nursing homes, hospice, home health, Furrow et al. supplement pgs. 28-61, Fundamentals pgs. 377-400, pgs. 361-376, pgs. 401-448

6. OCT 4 - Health information technology, HIPAA, HITECH Act, GINA, telemedicine, eHealth, mHealth, federal and state statutes

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

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

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

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

http://www.va.gov/vhapublications/viewpublication.asp?pub_id=1089

http://www.sibley.org/general_info/medical_information_privacy_notice.aspx

7. 11 - NO CLASS TUESDAY IS MONDAY

8. 18 - Life, death, research, genetics, consent to treatment, Furrow et al. supplement pgs 246 - 285, Fundamentals pgs. 59 - 73, 487 - 512

http://www.vsb.org/site/public/healthcare-decisions-day

http://www.vsb.org/site/public/healthcare-decisions-day/#links

and study generally the Ms. Terry Schiavo materials cited on the following linked web page:

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

and see the Virginia State Code page at:

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2981

and use the "next" feature at right side top of the pages to study generally the Virginia Health Care Decisions Act.

WASH COL LAW-719-001 Fall 2011 Health Law Legisla & Reg Process

Welcome to my students for WASH COL LAW-719-001 Fall 2011 Health Law Legisla & Reg Process.

The required texts are:

1. Eskridge, Frickey and Garrett's Legislation and Statutory Interpretation, 2d (Concepts and Insights Series)
By William N. Eskridge, Jr., Philip P. Frickey, Elizabeth Garrett
Book - softbound Copyright: 2006 ISBN-13: 9781599410784

3. Pocket Edition of the Constitution of the United States, Publication Date: 1998 American Bar Association Division for Public Education ISBN-13: 9781891743009

Additional printed materials will be available from the law school, and other materials will be made available via citation of web page locations.

The bookstore should have sufficient copies of these texts available before the first class, but please note that the 2011 Supplementary Materials are not published yet and there might be some delay in availability. Be sure to note the 2011 publication date; don't buy the 2010 publication date Supplementary Materials.

The syllabus for our course will be available only after I receive CVs of my health law students and after we meet at our first class. This enables me to design our course, as much as reasonably is possible, to complement the experience and interests, and goals, of my health law students, because our course is all about you. It will be my pleasure to meet you at our first class.

July 08, 2011 | Permalink

Legal Iss Relevnt Hlthcare Adm - Fall 2011 - GMU HAP 750

Updated October 8, 2011

Syllabus

Legal Iss Relevnt Hlthcare Adm - GMU HAP 750 - Fall 2011

Class time - Thursday, 4:30 PM to 7:15 PM

No class September 29, 2011

No Class November 24, 2011

To my Fall 2011 term health law students:

Welcome to health law. Please know that the course text materials to be purchased for the Fall 2011 term are listed below. Additional course materials and information regarding our course may from time to time be posted on HEALTHLAWYERBLOG for ready-reference http://www.healthlawyerblog.com.

The texts for our course are:

Pocket Edition of the Constitution of the United States;

Furrow, Greaney, Johnson, Jost and Schwartz' Health Care Reform: Supplementary Materials (2011), Second Edition By Barry R Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S Jost, Robert L. Schwartz Book - softbound copyright 2011; and

Furrow, Greaney, Johnson, Jost and Schwartz' Health Law, Cases, Materials and Problems, Abridged 6^th Edition By Barry R Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S Jost, Robert L. Schwartz Book - softbound copyright: 2008.

Our course objectives include the following concepts and understandings:

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.

The syllabus for our course is set forth below, subject to change, and with additional readings to be assigned from time to time as appropriate.

September 1, 2011 - Welcome, orientation, introductory discussion of health law

September 8, 2011 - U. S. Constitution and Bill of Rights, text pages 1-56, supplement pages 1-27

September 15, 2011 - Text pages 57-90

September 22, 2011 - Text pages 122-167

http://www.nytimes.com/2011/09/22/us/university-of-chicago-gets-42-million-gift-for-bucksbaum-institute.html?_r=1

http://www.usatoday.com/money/perfi/basics/story/2011-09-13/cosmetic-surgery-investigation/50395494/1

http://www.usatoday.com/news/opinion/letters/story/2011-09-21/cosmetic-surgery/50500756/1?loc=interstitialskip

http://www.ahrq.gov/news/press/pr2011/questionspr.htm

September 29, 2011 - (no class)

October 6, 2011 - Text pages 536-576, supplement pages 212-225

October 13, 2011 - Text pages 90-120 - HIPAA and beyond

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

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

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

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

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

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

http://www.va.gov/vhapublications/viewpublication.asp?pub_id=1089

http://www.sibley.org/general_info/medical_information_privacy_notice.aspx

http://www.inova.org/upload/docs/Patients%20&%20Visitors/privacy-policy.pdf

October 20, 2011 - Medicare and beyond

Text pages 369-395, Supplement pages 165-188, 202-211

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

October 27, 2011 - Text pages 369-395, Supplement pages 165-188, 202-211

November 3, 2011 - Text pages 707-750

Life, death, research, genetics, consent to treatment, Furrow et al. supplement pgs 246 - 285

http://www.vsb.org/site/public/healthcare-decisions-day

http://www.vsb.org/site/public/healthcare-decisions-day/#links

and study generally the Ms. Terry Schiavo materials cited on the following linked web page:

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

and see the Virginia State Code page at:

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2981

and use the "next" feature at right side top of the pages to study generally the Virginia Health Care Decisions Act.

June 24, 2011

Legal Iss Relevnt Hlthcare Adm - GMU HAP 750 - Summer 2011

To: My GMU HAP 750 Health Law Students

Here is the assignment for June 30, 2011 that includes, this time, a more than the one page or more usual weekly submission and reading materials. Please study the linked materials referenced on each of the web pages cited below, in addition to the weekly text assignment, and prepare a preliminary version of an advance health care directive for yourself. It is not expected that you will sign the document for this assignment. Instead, the purpose of preparing the document is to be able to provide a copy to me and to discuss your analysis of the document during our next class.

http://www.vsb.org/site/public/healthcare-decisions-day

http://www.vsb.org/site/public/healthcare-decisions-day/#links

and study generally the Ms. Terry Schiavo materials cited on the following linked web page:

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

and see the Virginia State Code page at:

http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2981

and use the "next" feature at right side top of the pages to study generally the Virginia Health Care Decisions Act.

June 24, 2011 | Permalink

June 17, 2011

Legal Iss Relevnt Hlthcare Adm - GMU HAP 750 - Summer 2011

To: My GMU HAP 750 Health Law Students

Here is the assignment for June 23, 2011 that includes the one page or more usual weekly submission and reading materials:

Compare/contrast the following two HIPAA notices of privacy practices please:

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

http://www.inova.org/upload/docs/Patients%20&%20Visitors/privacy-policy.pdf

Further information for background purposes may be found at:

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

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

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

June 17, 2011 | Permalink

May 27, 2011

Legal Iss Relevnt Hlthcare Adm - GMU HAP 750 - Summer 2011

To: My GMU HAP 750 Health Law Students

===============================

Please see the material quoted below and also the material contained
in the linked file, in connection with your written assignment for the
next class and for discussion during our next class. Thank you.

Quoted from Commonwealth of Virginia Legal References:

§§ 54.1-2900. Definitions.

"Practice of medicine or osteopathic medicine" means the prevention,
diagnosis and treatment of human physical or mental ailments,
conditions, diseases, pain or infirmities by any means or method.

§ 54.1-2903. What constitutes practice.
Any person shall be regarded as practicing the healing arts who
actually engages in such practice as defined in this chapter, or who
opens an office for such purpose, or who advertises or announces to
the public in any manner a readiness to practice or who uses in
connection with his name the words or letters "Doctor," "Dr.," "M.D.,"
"D.O.," "D.P.M.," "D.C.," "Healer," or any other title, word, letter
or designation intending to designate or imply that he is a
practitioner of the healing arts or that he is able to heal, cure or
relieve those suffering from any injury, deformity or disease. No
person regulated under this chapter shall use the title "Doctor" or
the abbreviation "Dr." in writing or in advertising in connection with
his practice unless he simultaneously uses a clarifying title,
initials, abbreviation or designation or language that identifies the
type of practice for which he is licensed.
Signing a birth or death certificate, or signing any statement
certifying that the person so signing has rendered professional
service to the sick or injured, or signing or issuing a prescription
for drugs or other remedial agents, shall be prima facie evidence that
the person signing or issuing such writing is practicing the healing
arts within the meaning of this chapter except where persons other
than physicians are required to sign birth certificates.

Rev. 03/10

INSTRUCTIONS FOR COMPLETING AN APPLICATION TO PRACTICE MEDICINE IN VIRGINIA
FOR GRADUATES OF AMERICAN MEDICAL SCHOOLS ( US/CANADA)
(This form has been designed for you to use as a checklist for
processing your application)

The applicant is responsible for forwarding all of the required forms
to the appropriate institutions, states and other agencies.

Application and Fee – The four (4) page application along with the
required fee of $302.00 must be submitted together. Please make all
checks and/or money orders made payable to the Treasurer of Virginia.
Applications received without fees and fees received without
applications will be returned the same day of receipt. The
application and fee may not be faxed.

Examination Scores –

If you took the FLEX examination or all three steps of the USMLE
examination, contact the Federation of State Medical Boards at
(817)868-4000 or www.fsmb.org for fee information and to have your
scores submitted to the Board. Scores may not be faxed and must come
directly from the Federation. If using the FCVS Credentialing
Service, your scores will be included.

If you took the National Board examination or a combination of the
USMLE examination, please contact the National Board of Medical
Examiners at (215)590-9500 or www.nbme.org for fee information and to
have your scores submitted to the Board. Scores may not be faxed and
must come directly from the National Board.

If you took the LMCC examination, please contact that agency to have
your scores submitted to the Board. This document may not be faxed.

If you took a state examination, please contact that examining board
to have your scores submitted to the board. Please note: If you took
a state examination after 1969, you must be American board certified
in a specialty to be eligible for licensure. If applicable, please
submit a copy of your specialty certificate. Scores may not be faxed,
however the specialty certificate may be.

Proof of Professional Education (Form L) – This form must be
completed by your professional school. This form may be faxed to your
medical school, but the completed form may not be faxed to the Board.
If using the FCVS Credentialing Service, proof of your education will
be included.

Transcripts – Transcripts must be official, with the school seal.
Transcripts will be accepted if they come directly from the school to
the Board or if sent to the Board by the applicant in a sealed
envelope. This document may not be faxed. If using the FCVS
Credentialing Service, medical school transcripts will be included.

Claims History Sheet (Form A) - Claims History Sheet - If you have
had malpractice cases brought against you (pending or closed), please
complete form A with details of each case. If this does not apply to
you, please disregard. This form may be faxed.

Employment Activity Questionnaire (Form B) – List activities on the
chronological page of the application, (Page 4) to include all
activities since graduation from your professional school. Forward
Form B (Activity Questionnaire) to those places of practice/employment
listed for the past five (5) years or since graduation, whichever
applies. If engaged in private practice, without hospital
affiliations, have another physician submit a letter attesting to your
practice. CV’S ARE NOT ACCEPTABLE. IF SUBMITTED IN LIEU OF PAGE 4,
YOUR APPLICATION MAY BE RETURNED FOR COMPLETION. This form may be
faxed. (Page 4 may be copied for additional activities and attached
to application.)

Jurisdiction Clearance (Form C) – Forward this form to those
jurisdictions in which you have been issued a full license,
certification or registration. This form may be copied as necessary.
Please contact the applicable jurisdictions to inquire about
processing fees. This form may be faxed directly from the
jurisdiction

AMA Physician Profile – Visit the AMA website at
http://www.ama-assn.org/amaprofiles/ to order a profile. This document
may be faxed.

Disciplinary Inquiry (Form E) – Contact the Federation of State
Medical Boards at (817)868-4083 to request a Disciplinary Inquiry or
go to www.fsmb.org to complete the online form. This documentation may
be faxed. If you are using the FCVS Credentialing Service and have
taken the FLEX or USMLE, the disciplinary inquiry will be provided.
Also, if you have taken the FLEX or USMLE, the score report will
include a disciplinary inquiry.

Postgraduate training - If your required postgraduate training was
completed over five years ago, and will not be verified on a form B,
please supply a copy/copies of certificates. This documentation may
be faxed.

Military Service – If you have been discharged from the United States
Military Service within the past ten (10) years, submit a copy of
your discharge papers. This document may be faxed.

Please note:

*Your application shouldl be reviewed within a week or two of receipt.
You will be notified by mail or email. Please allow at least 3 weeks
for processing before contacting the Board office for a status report.

*Please be aware that consistent with Virginia law and the mission of
the Department of Health Professions, addresses on file with the Board
of Medicine are made available to the public. This has been the
policy and the practice of the Commonwealth for many years. However,
with the application of new technology, which makes this information
more accessible, there has been growing concern of those licensees who
supply their residence address for mailing purposes. This notice is
to reiterate that the Board of Medicine maintains only one address for
each licensee and will allow the address of record to be a Post Office
Box or practice location.

*Applications not completed within 6 months may be purged without
notice from the board. Application fees will remain valid for up to
one year after receipt.

*Applications are not submitted for review until all supporting
documents appear to be received. Additional information may be
requested upon review.

*Application Fees are non-refundable.

*A formal letter will be sent to you after approval of licensure. Do
not begin practice until you have been notified of approval.
Submission of an application does not guarantee a license. A review
of your application could result in the finding that you may not be
eligible pursuant to Virginia laws and regulations.

*Certain forms may be faxed to 804-527-4426.

*Contact the Licensing Specialist at 804-367-4471

Rev. 11/07 MEDICINE & SURGERY

Application for a License to
Practice Medicine & Surgery

I hereby make application for a license to practice
Medicine and Surgery in the Commonwealth of
Virginia and submit the following statements:

Last

First
Street Address

City/State
Date of Birth

_______/_______/_______

Place of Birth Social Security/VA Control #
Professional School Name & Location

Professional School Graduation Date

_______/_______/_______

Please accompany with this application a check or money order made
payable to the Treasurer of Virginia in the required amount. If the
money does not accompany the application, the application will be
returned. Please submit address changes in writing immediately.

*In accordance with §54.1-1116 in the Code of Virginia, you are
required to submit your Social Security number/Control number (issued
by the Virginia Department of Motor Vehicles.). This number will be
used by the Department of Health Professions for identification
purposes only and will not be disclosed for any other purposes except
as mandated by law. Federal and State law requires that this number be
shared with other state agencies for child support enforcement
activities. Failure to disclose this number will result in the denial
of a license to practice in the Commonwealth of Virginia.

APPLICANTS DO NOT USE SPACES BELOW THIS LINE – FOR OFFICE USE ONLY

APPROVED BY: ______________________________________________________________________________
Applicant # Check # Class #

0101 Fee

$302.00

1. List in chronological order all professional practices since
graduation, including internships, residencies, hospital affiliations
and absences from work. Also list all periods of non-professional
activity or employment for more than three months. PLEASE ACCOUNT FOR
ALL TIME. If engaged in private practice, list all hospital
affiliations. If none, please explain. A completed Form B must be
received for all places listed for the last five years.

From To Name &
Location Position Held

____________ ___________
______________________________________________________
__________________________________

______________________________________________________

______________________________________________________

____________ ___________ ___________...

2. Please provide a telephone number where you can be reached during
the day. This information is not mandatory and if provided will not
be used for any purpose other than as a contact if the licensing
specialist has questions about your application.
Home #: Work #:
Email Address:

These questions must be answered in order for your application to be
considered complete. If any of the following questions (#6-15) is
answered yes, please provide supporting documentation. Letters must
be submitted by your attorney regarding malpractice suits (or you may
complete and submit Form A yourself.)

3. I hereby certify that I studied medicine and received the degree of
_______________________________________ on __________________

(degree) (date)

from _____________________________________________________________________.
Name of School

4. Do you intend to engage in the active practice of medicine in the
Commonwealth of Virginia? Yes No

5. List all jurisdictions in which you have been issued a license to
practice medicine/osteopathy. Include the number and date issued of
all active, inactive or expired licenses.
Jurisdiction Number Issued Active/Inactive/Expired

6.Which of the following have you taken: National Boards
Examination; USMLE Step 1; USMLE Step 2; USMLE Step 3; Flex

Please list the locality and the number of attempts taken for all
those selected above.__________________________________________________
__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

7. Have you ever been denied a license or the privilege of taking a
licensure/competency examination by any licensing authority? Yes
No

If yes, please explain:
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

8. Have you ever been convicted of a violation of/or pled Nolo
Contendere to any federal, state or local statute,
Yes No
regulation or ordinance, or entered into any plea bargaining
relating to a felony or misdemeanor? (Excluding
traffic violations, except convictions for driving under the influence.)

9. Have you ever been denied privileges or voluntarily surrendered
your clinical privileges while under investigation,
Yes No
been censured or warned, or requested to withdraw from the staff of
any medical school, residency or fellowship
training, hospital, nursing home, or other health care facility, or
health care provider?

10.Have you ever had any of the following disciplinary actions taken
against your license to practice medicine,
Yes No
DEA permit, state controlled substances registration, Medicaid, or
any such actions pending?
(a) suspension/revocation (b) probation (c) reprimand/cease and
desist (d) had your practice monitored
(e) limitation placed on scheduled drugs?

11. Have you ever had any membership in a state or local professional
society revoked, suspended, or sanctioned? Yes
No

12. Have you voluntarily withdrawn from any professional society
while under investigation? Yes No

13. Have you had any malpractice suits brought against you in the
last ten (10) years? If so, how many? _____
Yes No

14. Have you been physically or emotionally dependent upon the use of
alcohol/drugs or treated by, consulted with, Yes
No
or been under the care of a professional for any substance
abuse within the last two years? If so, please provide
a letter from the treating professional.

15. Do you have a physical disease, mental disorder, or any
condition, which could affect your performance of professional
Yes No
duties? If so, provide a letter from your treating professional
to include diagnosis, treatment, prognosis and fitness to
practice.

(THIS SECTION MUST BE NOTARIZED)

I, ______________________________________________________, being
first duly sworn, depose and say that I am the person referred to in
the foregoing
application and supporting documents.
I hereby authorize all hospitals, institutions, or organizations, my
references, personal physicians, employers (past and present),
business and professional
associates (past and present), and all governmental agencies and
instrumentalities(local, state, federal, or foreign) to release to the
Virginia Board of Medicine any
information, files or records requested by the Board in connection
with the processing of individuals and groups listed above, any
information , which is material
to me and my application.
I have carefully read the questions in the foregoing application and
have answered them completely, without reservations of any kind, and I
declare under
penalty of perjury that my answers and all statements made by me
herein are true and correct. Should I furnish any false information in
this application, I hereby
agree that such act shall constitute cause for the denial,
suspension, or revocation of my license to practice medicine and
surgery in the Commonwealth of
Virginia.
I have carefully read the laws and regulations related to the
practice of my profession which are available on www.dhp.virginia.gov
, and I fully understand that
Funds submitted as part of the application process shall not be refunded.

__________________________________________________________
Signature of Applicant

City/County of _________________________________________________
State of _______________________________________________

Subscribed and sworn to before me this ________________________ day
of ______________________________________ 20_____________.

My Commission expires _______________________________.

_________________________________________________
Signature of Notary Public
NOTARY SEAL

===============

As used in this chapter, unless the context requires a different meaning:
"Board" means the Board of Nursing.
"Certified nurse aide" means a person who meets the qualifications
specified in this article and who is currently certified by the Board.
"Clinical nurse specialist" means a person who is registered by the
Board in addition to holding a license under the provisions of this
chapter to practice professional nursing as defined in this section.
Such a person shall be recognized as being able to provide advanced
services according to the specialized training received from a program
approved by the Board, but shall not be entitled to perform any act
that is not within the scope of practice of professional nursing.
"Certified massage therapist" means a person who meets the
qualifications specified in this chapter and who is currently
certified by the Board.
"Massage therapy" means the treatment of soft tissues for therapeutic
purposes by the application of massage and bodywork techniques based
on the manipulation or application of pressure to the muscular
structure or soft tissues of the human body. The terms "massage
therapy" and "therapeutic massage" do not include the diagnosis or
treatment of illness or disease or any service or procedure for which
a license to practice medicine, nursing, chiropractic therapy,
physical therapy, occupational therapy, acupuncture, or podiatry is
required by law.
"Practical nurse" or "licensed practical nurse" means a person who is
licensed or holds a multistate licensure privilege under the
provisions of this chapter to practice practical nursing as defined in
this section. Such a licensee shall be empowered to provide nursing
services without compensation. The abbreviation "L.P.N." shall stand
for such terms.
"Practical nursing" or "licensed practical nursing" means the
performance for compensation of selected nursing acts in the care of
individuals or groups who are ill, injured, or experiencing changes in
normal health processes; in the maintenance of health; in the
prevention of illness or disease; or, subject to such regulations as
the Board may promulgate, in the teaching of those who are or will be
nurse aides. Practical nursing or licensed practical nursing requires
knowledge, judgment and skill in nursing procedures gained through
prescribed education. Practical nursing or licensed practical nursing
is performed under the direction or supervision of a licensed medical
practitioner, a professional nurse, registered nurse or registered
professional nurse or other licensed health professional authorized by
regulations of the Board.
"Practice of a nurse aide" or "nurse aide practice" means the
performance of services requiring the education, training, and skills
specified in this chapter for certification as a nurse aide. Such
services are performed under the supervision of a dentist, physician,
podiatrist, professional nurse, licensed practical nurse, or other
licensed health care professional acting within the scope of the
requirements of his profession.
"Professional nurse," "registered nurse" or "registered professional
nurse" means a person who is licensed or holds a multistate licensure
privilege under the provisions of this chapter to practice
professional nursing as defined in this section. Such a licensee shall
be empowered to provide professional services without compensation, to
promote health and to teach health to individuals and groups. The
abbreviation "R.N." shall stand for such terms.
"Professional nursing," "registered nursing" or "registered
professional nursing" means the performance for compensation of any
nursing acts in the observation, care and counsel of individuals or
groups who are ill, injured or experiencing changes in normal health
processes or the maintenance of health; in the prevention of illness
or disease; in the supervision and teaching of those who are or will
be involved in nursing care; in the delegation of selected nursing
tasks and procedures to appropriately trained unlicensed persons as
determined by the Board; or in the administration of medications and
treatments as prescribed by any person authorized by law to prescribe
such medications and treatment. Professional nursing, registered
nursing and registered professional nursing require specialized
education, judgment, and skill based upon knowledge and application of
principles from the biological, physical, social, behavioral and
nursing sciences.

===============

MEDICARE ENROLLMENT APPLICATION

PHYSICIANS AND
NON-PHYSICIAN PRACTITIONERS
CMS-855I

DOWNLOAD PLEASE:

https://www.cms.gov/cmsforms/downloads/cms855i.pdf

May 27, 2011 | Permalink

May 26, 2011

Legal Iss Relevnt Hlthcare Adm - GMU HAP 750 - Summer 2011

George Mason University College of Health & Human Services

Legal Iss Relevnt Hlthcare Adm - GMU HAP 750 - Summer 2011

Office Hours: by appointment

Class Time and Location - Thursday, 4:30 PM to 8:00 PM at Robinson 105A

Course begins May 26, 2011 and ends no later than July 28, 2011

_____________________________________________________________

To my summer 2011 term health law students:

Welcome to health law. Please know that the course materials to be purchased for the summer 2011 term are listed below (and hopefully sufficient quantities will be available at the campus bookstore); and additional course materials and information regarding our course may from time to time be posted on HEALTHLAWYERBLOG for ready-reference http://www.healthlawyerblog.com.

The textbooks for our course are:

Pocket Edition of the Constitution of the United States Product Code: 3170033

Publication Date: 1998 ISBN: 978-1-88147-321-3 Sponsoring Entities: Division for Public Education Topics: Constitutional Law, Courts, Public Education Pricing: $1.50

Legal Aspects of Health Care Administration, Eleventh Edition

Jones & Bartlett Learning, Publisher

Author: George D. Pozgar, MBA, CHE

Course books are required to be available in class, unless otherwise advised by faculty.

The syllabus for our course, updated to reflect the many new developments in health law, is set forth below in preliminary form. I prepare my final syllabus only after I receive CVs of my health law students and after we meet at our first class. This enables me to redesign our course, as much as reasonably is possible, to complement the experience and interests, and goals, of my health law students, because our course is all about you. So be sure to read my email updates regarding any revisions and additional materials for study and class preparation and discussion. It will be my pleasure to meet you at our first class.

______________________________________________________________________________

GMU Honor Code Expectations

Students must adhere to the GMU honor code at all times

http://catalog.gmu.edu/content.php?catoid=15&navoid=1039#Honor

Accommodation for Individuals with Disabilities

George Mason University Catalog, 2010-2011.

http://catalog.gmu.edu/content.php?catoid=15&navoid=1045&returnto=search#Conduct

Cell Phone/PDA/iPAD/Laptop Devices

The sound features of electronic voice and messaging communication devices must be turned off while in class. Laptops, iPads and other such devices are permitted to be used in class, but no voice recording devices are permitted to be used in class.

Expectations: students are responsible for assigned reading in advance of relevant class, and are expected to arrive on time for each class and to stay for the duration of each class, and actively to contribute to classroom discussions. Absences must be approved by faculty in advance, and emergency unexpected absences must be explained and also so approved. There will be a fifteen minute break period during each class. Depending upon classroom discussions and progress, the first part of each class likely will end at 6 PM; the second part of each class will begin at 6:15 PM and likely will end at or about 8:00 PM (but occasionally a class might go beyond 8:00 PM).

Students are responsible for being alert to weather interruptions/class cancellations advisories and other communications from GMU and from faculty via email. It is each student's responsibility to maintain an available GMU email address without messages being returned because email is too full.

Percentage of total evaluation toward final grade

There is no final examination for this course

Final term paper including presentation in class, 80%
Class participation (discussion/activities), 10%
Submission of periodic writing assignments, 10%

The final term paper must be based upon a topic and an outline of issues and proposed resources approved in advance by faculty. Topics will be discussed during classes and proposals should be sent via electronic mail to faculty as soon as possible, and must be approved not later than June 13, 2011. Final term papers are due in .doc (NOT .docx) and (if possible) .pdf formats; using 8-1/2 x 11 and Times New Roman 12 point type face; one inch margins; lines: space and one-half; with endnotes (NOT footnotes) citing sources; not less than twently sheets of text excluding endnotes, and student's name and topic on every sheet, preferably in the headers. Papers must be sent to faculty via email not later than July 1, 2011. Individual presentations of term papers will begin on July 7, 2011.

Tentative Syllabus Subject to Change

May 26 - Welcome; introductions; attendance, term papers, and other administrative matters; discussion of health law generally and introduction to course book; discussion and analysis: United States Constitution including amendments, government structure, legislation, execution, judicial oversight, federal versus state laws; preparation: provide CV and study Constitution and Amendments.

June 2 - Legal system in the United States, health professional licensure and regulation, medical staff structure and activities, nursing, ancillary providers; preparation: pages 1-28, pages 177-212, pages 215-242, pages 245-274.

June 9 - Corporate structure of health care providers and entities, contracts, employment, independent contractor, responsibilities of fiduciaries and others; preparation: pages 143-172, pages 85-104, pages 495-503, pages 505-511.

June 16 - Health care liability, crimes, reporting, compliance, patients' rights and responsibilities; professional ethics; preparation: pages 61-82, pages 323-333, pages 335-350.

June 23 - Information management, health information technology, HIPAA, HITECH Act, privacy and security, electronic medical records, data breach and data mining; preparation: pages 277-297, additional materials to be assigned.

June 30 - Life and death, patient consent, health care directives, living wills, Medicare, health reform; preparation: pages 301-319, additional materials to be assigned.

July 7 - Course review; final term papers presentations.

July 14 - Final term papers presentations.

July 21 - Final term papers presentations.

July 28 - Final term paper presentations.

104127052011

May 26, 2011 | Permalink

March 03, 2011

Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 - Spring 2011

Please see below for an updated readings list for the course textbook:

1. Study the materials at pages 1-30; 32-40; 47-56; 57-76; 76-90; 154-178; and 178-220.

2. Study the materials at pages 239-264; 369-395; 395-409; 417-429; and 437-448.

3. t Final term papers are due via email to me to arrive not later than 11:59 PM EDT on April 13, 2011. Be sure to put your name in the "Subject" line of the email along with the title of your term paper.

March 03, 2011 | Permalink

March 01, 2011

AMU Wash. College of Law Privacy & HIT (LAW-719-002) for March 14, 2011

Please know that we will NOT meet at the law school on March 7, 2011 because of Spring Break and our next class is on March 14, 2011.

Your study assignment includes items 8 through and including 12 from our curriculum listing, repeated for ready reference below, involving the eSign law, UETA, and related areas of law involving electronic signatures and electronic contracting.

In addition, please commence your study of the several professional and other associations listed in items 30 through and including 40, and familiarize yourself with their missions, policies, membership, and initaitives as referenced at the web sites so listed.

And thereafter, we will commence our study of the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, for which items 41 through and including 51 provide resources.

There is no special assignment for March 14, 2011, so please focus on your term paper outline and beginning the preparation of your term paper.

Study references copied from our curriculum list and relevant to the foregoing are set forth below:

8.    http://www.ftc.gov/os/2001/06/esign7.htm

9.     http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_cong_public_laws&docid=f:publ229.106.pdf

10.   http://www.bankersonline.com/ebanking/ueta.html

11.    http://www.law.cornell.edu/uscode/18/usc_sup_01_18_10_I_20_119.html

12.    http://www.ncsl.org/default.aspx?tabid=13484

30. http://www.ansi.org/internet_resources/overview/overview.aspx?menuid=12#national

31. http://www.consortiuminfo.org/links/linkscats.php?ID=48

39. http://www.ansi.org/

40. https://www.amia.org/

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

42.    http://web.me.com/asgoldberg1/filechute/HITECH%20Pages%20from%20PLAW-111publ5.pdf

43.    http://www.hhs.gov/ocr/privacy/hipaa/administrative/combined/index.html

44.    http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/adminsimpregtext.pdf

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

46. http://web.me.com/asgoldberg1/filechute/electsighipaa1998.pdf

47. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/securityrulepdf.pdf

48. http://csrc.nist.gov/publications/drafts/800-144/Draft-SP-800-144_cloud-computing.pdf

49. http://csrc.nist.gov/publications/drafts/800-145/Draft-SP-800-145_cloud-definition.pdf

50. http://csrc.nist.gov/publications/drafts/800-70-rev2/Draft-SP800-70r2.pdf

51. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/nist80066.pdf

March 01, 2011 | Permalink

February 28, 2011

AU Wash. College of Law Privacy & Health Information Tech. (LAW-719-002)

Please know that we will NOT meet at the law school in person this evening, February 28, 1011, Monday.

Instead, we will meet via telephone conference call. Information regarding telephoning into the conference call will be sent to you via email. Thank you.

February 28, 2011 | Permalink

February 15, 2011

Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 - Spring 2011

Your beginning assignments for study and class preparation and

discussion are as follows (the page numbers refer to portions of the

primary health law text book which you should bring to class each week):

1. Study the materials at pages 1-30; 32-40; 47-56; 57-76; 76-90;

154-178; and 178-220.

2. On February 17, 2011 we likely will be focusing on your readings through page 56.

3. You should study the courts decisions and the text commentaries,

but you are not responsible for studying the "problems" contained in

the text.

4. Please provide me with your suggested question sheet for a

physician who would treat someone you care about very much and who

suffers from a serious illness: what questions would you ask and what

information would you want to know, before such care and treatment

begin?

5. Your question sheet should be sent via email to me to arrive not later

than 11:59 PM the evening before our next class, please.

6. Give thought to your term paper topic including an outline and

proposed beginning bibliography of resources, which you should share

with me at soon as possible, so I can address any concerns I might

have regarding your proposed paper topic and outline and resources,

and ultimately approve them.

7. If you have questions regarding topics, feel free to inquire via email.

February 15, 2011 | Permalink

February 13, 2011

AU WCL Privacy & Health Information Technology Assignment Coming Attractions

14. http://www.americantelemed.org/files/public/abouttelemedicine/What_Is_Telemedicine.pdf

15. http://www.americantelemed.org/files/public/abouttelemedicine/Terminology.pdf

16; http://www.americantelemed.org/files/public/policy/Medicare_Payment_Of_Services.pdf

17. http://americantelemed.i4adev.com/files/public/abouttelemedicine/JCP_2_2_2003.pdf

18. http://www.americantelemed.org/files/public/policy/Licensure_Portability.pdf

19. http://www.americantelemed.org/i4a/pages/index.cfm?pageID=3311

20. http://www.hrsa.gov/telehealth/pubs/licensure.htm

21. https://www.cms.gov/Telemedicine/

22. http://www.cms.gov/officeoflegislation/downloads/NewRulestoEnsureAccesstoTelemedicineServices.pdf

23. http://dhmh.maryland.gov/mhqcc/pdf/2010/Sep10/Attachment_D_University_of_Maryland_School_of_Law_Telemedicine_White_Paper.pdf

24. http://www.hrsa.gov/telehealth/pubs/reimbursement.htm

25. http://www.sopami.hpg.ig.com.br/CCM44.pdf

26. http://www.connected-health.org/media/71068/telemed%20reimbursement%20policy.pdf

27. http://edocket.access.gpo.gov/2010/pdf/2010-12647.pdf

28. http://www.americantelemed.org/files/public/standards/Telepresenting_Draft_PublicComment.pdf

29. http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.pdf

30. http://www.ansi.org/internet_resources/overview/overview.aspx?menuid=12#national

31. http://www.consortiuminfo.org/links/linkscats.php?ID=48

39.    http://www.ansi.org/

40.    https://www.amia.org/

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

42.    http://web.me.com/asgoldberg1/filechute/HITECH%20Pages%20from%20PLAW-111publ5.pdf

43.    http://www.hhs.gov/ocr/privacy/hipaa/administrative/combined/index.html

44.    http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/adminsimpregtext.pdf

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

46. http://web.me.com/asgoldberg1/filechute/electsighipaa1998.pdf

47. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/securityrulepdf.pdf

48. http://csrc.nist.gov/publications/drafts/800-144/Draft-SP-800-144_cloud-computing.pdf

49. http://csrc.nist.gov/publications/drafts/800-145/Draft-SP-800-145_cloud-definition.pdf

50. http://csrc.nist.gov/publications/drafts/800-70-rev2/Draft-SP800-70r2.pdf

51. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/nist80066.pdf

52. http://web.me.com/asgoldberg1/filechute/washutissuecir-2007.pdf

53. http://web.me.com/asgoldberg1/filechute/prometh-010remand.pdf

54. http://www.supremecourt.gov/opinions/10pdf/09-152.pdf

55. http://www.supremecourt.gov/opinions/10pdf/09-1279.pdf

56. http://www.supremecourt.gov/oral_arguments/argument_transcripts/09-1279.pdf

074802032011

February 13, 2011 | Permalink

February 03, 2011

Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 - Spring 2011

To my CHHS Spring 2011 term health law students:

Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 - Spring 2011

Faculty:

Alan S. Goldberg, JD, LLM (Tax)

Attorney & Counsellor-at-Law

6845 Elm Street - Suite 205

McLean, Virginia 22101-3822

Alan@GoldbergLawyer.com

http://www.healthlawyerblog.com

Office Hours: by appointment

Class Time and Location - Thursday, 4:30 PM to 7:15 PM at Art/Design Bldg 2003

No class March 17, 2011; regularly scheduled final class was May 5, 2011; but now May 10 will be the scheduled make-up day for the January 27, 2011 class.

Welcome to health law. Please know that the course materials to be purchased for the Spring 2011 term are listed below (and hopefully sufficient quantities will be available at the campus bookstore); and additional course materials and information regarding our course may from time to time be posted on HEALTHLAWYERBLOG for ready-reference http://www.healthlawyerblog.com.

The textbooks for our course are:

Pocket Edition of the Constitution of the United States Product Code: 3170033

Publication Date: 1998 ISBN: 978-1-88147-321-3 Sponsoring Entities: Division for Public Education Topics: Constitutional Law, Courts, Public Education Pricing: $1.50

Furrow, Greaney, Johnson, Jost and Schwartz' Health Care Reform: Supplementary Materials (2010) By Barry R Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S Jost, Robert L. Schwartz Book - softbound Copyright: 2010 ISBN-13: 9780314266873 : $28.00:

Furrow, Greaney, Johnson, Jost and Schwartz' Health Law, Cases,

Materials and Problems, Abridged 6^th Edition By Barry R Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S Jost, Robert L. Schwartz Book - softbound Copyright: 2008 ISBN-13: 9780314196026 List Price: $131.00

The syllabus for our course, updated to reflect the many new developments in health law, will be available soon. I prepare my final syllabus only after I receive CVs of my health law students and after we meet at our first class. This enables me to redesign our course, as much as reasonably is possible, to complement the experience and interests, and goals, of my health law students, because our course is all about you. It will be my pleasure to meet you at our first class.

GMU Honor Code Expectations

Students must adhere to the GMU honor code at all times

“To promote a stronger sense of mutual responsibility, respect, trust, and fairness among all members of the George Mason University community and with the desire for greater academic and personal achievement, we, the student members of the university community, have set forth this honor code: Student members of the George Mason University community pledge not to cheat, plagiarize, steal, or lie in matters related to academic work.” George Mason University Catalog, 2010-2011. http://catalog.gmu.edu/content.php?catoid=15&navoid=1039#Honor

Accommodation for Individuals with Disabilities

http://catalog.gmu.edu/content.php?catoid=15&navoid=1045&returnto=search#Conduct

Cell Phone/PDA/IPAD/Laptop Devices

The sound features of electronic voice and messaging communication devices must be turned off while in class. Laptops, IPADs and other devices are permitted to be used in class.

Percentage or total points toward final grade

Final term paper including presentation in class 80%

Class participation (discussion/activities) 10%

Submission of periodic writing assignments 10%

100%

February 03, 2011 | Permalink

January 31, 2011

AU Wash. College of Law Privacy & Health Information Tech. (LAW-719-002) Feb. 14, 2011 class

For our February 14, 2011 class, please study the the Genetic
Information Nondiscrimination Act of 2008 and background information
regarding the statute referenced at the hot linked pages below:

1.    http://www.genome.gov/24519851

2.    http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ233.110

3.    http://www.gpo.gov/fdsys/pkg/BILLS-110hr493enr/pdf/BILLS-110hr493enr.pdf

4.    http://www.genome.gov/Pages/PolicyEthics/GeneticDiscrimination/GINAInfoDoc.pdf

5.    https://rarediseases.info.nih.gov/GARD/GINA/

6.    http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/genetic/

7.    http://www.genome.gov/10002077

8.    http://www.hhs.gov/news/press/2009pres/10/20091001b.html

9.    http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/genetic/ginanprm.pdf

and familiarize yourself with the general background and health law
context for and implications of the enactment of the statute with
emphasis on privacy and security. More particularly, please determine
which parts of the statute relate specifically to health information
technology and to electronically stored information, and to health
care privacy and security as well, and study the rule-making
compliance implications including the proposed rule published by the
Office for Civil Rights.

Special assignment: please review the foregoing hot linked web sites
and in particular GINA 2008 and the NPRM from OCR. Based upon all the
foregoing, please prepare a chart and an analysis of how GINA 2008
affects and protects (and/or does not affect and protect, depending
upon your views and analysis) health information privacy and security
including what the NPRM proposes, which may include a narrative
summary. Be prepared, please, to discuss how you would propose
further to enhance privacy and security relating to genomic and
genetic information and what you may perceive as challenges created by
GINA 2008 with respect to potential research implications and
limitations and complexities in compliance and enforcement, in the
context of privacy and security issues implicated.

Special assignment to be submitted prior to 11:59 PM on February 13, 2011 in
WinWord .doc and/or Adobe .pdf formats.

Please know that as usual and depending upon how our classroom
discussions proceed, our discussion of GINA 2008 might not occur
entirely on the expected February 14 date. But nevertheless, the
special assignment is due as noted above, please.

January 31, 2011 | Permalink

January 24, 2011

AU Wash. College of Law Privacy & Health Information Tech. (LAW-719-002)

To: My AU WCL students. For our January 31, 2011 class, special assignment: please review the several previously assigned judicial decisions and the certiorari petition relating to pharmaceutical data mining and privacy which was a part of the assignment, and please study the statutes of the several states involved in the disputes. Based upon the foregoing, please prepare a chart and an analysis of each position as reflected in the decisions (including plaintiffs, defendants, and judicial majority and dissents), which may include a narrative summary, of the opposing parties for and against the data mining statutes in the several states that are the subject of these decisions. Be prepared, please, to discuss how you would propose to resolve the disagreement among the circuits if you were the tenth justice appointed to the United States Supreme Court.

Special assignment to be submitted via eMail to Alan@GoldbergLawyer.com prior to 11:59 PM on January 30, 2011 in WinWord .doc and/or Adobe .pdf formats.

________________________________________________________________________

In anticipation of and to prepare for our February 7, 2011 class during which we will consider some FDA implications for eHealth including software, please study:

1. http://www.fda.gov/downloads/.../Guidances/ucm126955.pd

2.http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm073778.htm

3. http://medical.cms.itri.org.tw/pdf/u23.pdf

4.http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077812.htm

5.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?id=22436

6.http://www.fda.gov/downloads/ForIndustry/SmallBusinessAssistance/SmallBusinessGuidetoFDA/UCM081030.pdf

7. http://www.fda.gov/AboutFDA/WhatWeDo/default.htm

8.http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm

9. http://web.me.com/asgoldberg1/filechute/shurenfdaemrtestimonyemrrisks2010.pdf

10. http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm

For our February 7, 2011 class, special assignment: please review the FDA materials referenced above and prepare a chart and an analysis of if, how, and to what extent the FDA regulates medical software as a device or otherwise, which may include a narrative summary, and determine whether, and if so, how, the new FDA Plan of Act for Section 510(k) and Science affects the foregoing, please. And be sure to determine what Section 510(k) provides and consider what the changes could implicate with respect to privacy and health information technology.

Special assignment to be submitted prior to 11:59 PM on February 6, 2011 in WinWord .doc and/or Adobe .pdf formats.

______________________________________________________________________________________

January 24, 2011 | Permalink

January 11, 2011

AU Wash. College of Law Privacy & Health Information Tech. (LAW-719-002)

To: My AU WCL LLM Law Students

Your assignment for study for our January 24, 2011 class appears below. No class is scheduled for January 17, 2011.

___________________________________________________________

1. http://caselaw.findlaw.com/summary/opinion/us-2nd circuit/2010/11/23/252944.html

IMS HEALTH INC LLC v. SORRELL

IMS HEALTH INC., Verispan, LLC, et al., Plaintiffs-Appellants, v. William H. SORRELL, as Attorney General of the State of Vermont et al., Defendants-Appellees. Docket Nos. 09-1913-cv(L), 09-2056-cv(CON).

2. http://www.ca1.uscourts.gov/cgi-bin/getopn.pl?OPINION=08-1248P.01A

United States Court of Appeals For the First Circuit No. 08-1248

IMS HEALTH INCORPORATED, VERISPAN, LLC, and SOURCE HEALTHCARE ANALYTICS, INC., a subsidiary of WOLTERS KLUWER HEALTH, INC.,

Plaintiffs, Appellees,

JANET T. MILLS, as Attorney General for the State of Maine, Defendant, Appellant.

ON APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MAINE [Hon. John A. Woodcock, Jr., U.S. District Judge]

3. http://epic.org/privacy/imshealth/dist_ct_op.pdf

United States Court of Appeals For the First Circuit No. 07-1945 IMS HEALTH INC. AND VERISPAN, LLC, Plaintiffs, Appellees, v. KELLY A. AYOTTE, NEW HAMPSHIRE ATTORNEY GENERAL, Defendant, Appellant.

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE [Hon. Paul J. Barbadoro, U.S. District Judge]

4. http://openjurist.org/print/566777 428 F3d 167 Citizens for Health v. O Leavitt US

CITIZENS FOR HEALTH, et al. Appellants v.*Michael O. LEAVITT, Secretary U.S. Department of Health and Human Services. No. 04-2550. United States Court of Appeals, Third Circuit.

5. http://supreme.justia.com/us/429/589/case.html

WHALEN V. ROE, 429 U. S. 589 (1977)

---------------------------------

Please consider the MMA, MIPPA, and ARRA electronic prescribing and electronic health records and meaningful use incentives and requirements provisions, relative to health information creation, storage, access, use, and communications including pharmaceutical prescription information and any specific privacy and security protections affecting the foregoing. See the following background information.

Special assignment to be submitted via eMail to Alan@GoldbergLawyer.com prior to 11:59 PM on January 23, 2011 in WinWord .doc and Adobe .pdf formats.

Prepare a list and brief descriptions of the relevant federal statutes and regulations promulgated thereunder to-date. You may use a narrative or chart configuration for this assignment.

6. https://www.cms.gov/EPrescribing/01_Overview.asp#TopOfPage

7. https://www.cms.gov/EHRIncentivePrograms/

8. https://www.cms.gov/ERXIncentive/

9. http://healthit.hhs.gov/portal/server.pt?open=512&objID=1153&mode=2

10. http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__privacy_and_security/1147

January 11, 2011 | Permalink

December 29, 2010

AU Wash. College of Law Privacy & Health Information Tech. (LAW-719-002)

To: My AU WCL LLM Law Students

Good day. It will be my pleasure to be your teacher for for the Spring 2011 LLM term for Privacy & Health Information Technology (LAW-719-002) -- Meets: 06:00 PM - 07:50 PM (M) - Enrolled: 14 / Limit: 14. Welcome to our course, and I look forward to greeting you on January 10.

Please know that because my unanticipated appointment for this course occurred recently, the syllabus for our course still is in the process of being prepared.

In the meantime, for our first class on January 10, 2011, kindly study the following (for convenience I am provided hot links below that were accessible today although these materials likely are available more generally elsewhere):

1. “The Right to Privacy” - Warren and Brandeis - Harvard Law Review. - Vol. IV December 15, 1890 No. 5

available at http://groups.csail.mit.edu/mac/classes/6.805/articles/privacy/Privacy_brand_warr2.html

2. ROE v. WADE, 410 U.S. 113 (1973)

available at http://caselaw.lp.findlaw.com/cgi-bin/getcase.pl?court=us&vol=410&invol=113

3. GRISWOLD v. CONNECTICUT, 381 U.S. 479 (1965)

available at http://caselaw.lp.findlaw.com/cgi-bin/getcase.pl?navby=volpage&court=us&vol=381&page=484#484

4. OLMSTEAD v. U.S., 277 U.S. 438 (1928)

available at: http://caselaw.lp.findlaw.com/cgi-bin/getcase.pl?court=us&vol=277&invol=438#478

5. WILLIAM H. SORRELL, AS ATTORNEY GENERAL OF THE STATE OF VERMONT et al. v. IMS HEALTH INC. et al. (Petition for writ of certiorari filed) (2010)

available at http://sblog.s3.amazonaws.com/wp-content/uploads/2010/12/Pet.10-779.pdf

6. CITIZENS FOR HEALTH et al. v. Michael O. LEAVITT et al.,

United States Court of Appeals, Third Circuit, 428 F.3d 167 (2005), government's brief

available at http://www.aapsonline.org/judicial/cvt-govreply.pdf

December 29, 2010 | Permalink

October 30, 2010

Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 - Spring 2011

To my CHHS Spring 2011 term health law students: welcome to health law. Please know that the course materials to be purchased for the Spring 2011 term are listed below (and hopefully sufficient quantities will be available at the campus bookstore); and additional course materials may from time to time be posted on HEALTHLAWYERBLOG for ready-reference:

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

Pocket Edition of the Constitution of the United States

Product Code: 3170033

Publication Date: 1998

ISBN: 978-1-88147-321-3

Sponsoring Entities: Division for Public Education

Topics: Constitutional Law, Courts, Public Education

Pricing: $1.50 (Regular)

AND

http://west.thomson.com/productdetail/174675/41054549/productdetail.aspx?promcode=600582C43556&promtype=internal

and

http://west.thomson.com/productdetail/147942/40765887/productdetail.aspx?promcode=608075E60588&promtype=external

Furrow, Greaney, Johnson, Jost and Schwartz' Health Care Reform:

Supplementary

Materials (2010)

By

Barry R Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S Jost, Robert L. Schwartz

Book - softbound Copyright: 2010

ISBN-13: 9780314266873 : $28.00:

AND

Furrow, Greaney, Johnson, Jost and Schwartz' Health Law, Cases,

Materials and Problems, Abridged 6th

By Barry R Furrow, Thomas L. Greaney, Sandra H. Johnson, Timothy S

Jost, Robert L. Schwartz

Book - softbound Copyright: 2008 ISBN-13: 9780314196026

List Price: $131.00

The syllabus for our course, updated to reflect the many new develops in health law, will be available soon. In the meantime, kindly favor me with any questions regarding our course. It will be my pleasure to meet you at our first class. Thank you.

October 30, 2010 | Permalink

GMU Health Law Fall 2010

Please study the materials hot linked below, in anticipation of our discussion later this term regarding life and death and genomics/genetics and life sciences:

http://web.me.com/asgoldberg1/filechute/genepatents-USamicusbrief.pdf

http://web.me.com/asgoldberg1/filechute/genepatents-AMPvUSPTO-Opinion.pdf

OR

http://graphics8.nytimes.com/packages/pdf/business/genepatents-USamicusbrief.pdf

http://www.aclu.org/files/assets/2010-3-29-AMPvUSPTO-Opinion.pdf

-------------------------

A timely newspaper article regarding the foregoing materials appears at:

http://www.nytimes.com/2010/10/30/business/30drug.html?ref=todayspaper&pagewanted=print

and other information is available at:

http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2174

http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2186

--------------------------

Please see the eNews available at the following hot linked web page and in particular, for our next class, the article on page 5:

http://vba.org/associations/11069/files/health2010.pdf

Amendment to § 54.1-2413(E) of the Code of
Virginia: HB 143 (2010)
Hon. Stephen D. Rosenthal, page 5

-----------------------------

Please study the following AHLA material which AHLA generously has
made available to us and the other hot linked materials.

http://www.healthlawyers.org/Resources/PI/Policy/Documents/Stark White Paper.pdf

OR

http://sn.im/sm3qq-drp

Please also see below for a hot link to a copy of the so-called Stark
Law

http://sn.im/sm41e-aod

OR

http://www.ssa.gov/OP_Home/ssact/title18/1877.htm

and please also study the so-called health care civil monetary
penalties false claims and antikickback statutes

http://www.ssa.gov/OP_Home/ssact/title11/1128A.htm

http://www.ssa.gov/OP_Home/ssact/title11/1128B.htm

------------------

Please see below for some additional study materials, in anticipation of our discussion of HIPAA Administrative Simplification. Please be sure to have this material readily available either on your laptop or in dead tree media format for our impending classes.

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

Medicare program Notice of Privacy Practices for the Original Medicare Plan

http://www.inova.org/upload/docs/Patients%20&%20Visitors/privacy-policy.pdf

INOVA NOTICE OF PRIVACY PRACTICES

http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.pdf

Background - OCR publication regarding NOTICE OF PRIVACY PRACTICES FOR PROTECTED
HEALTH INFORMATION [45 CFR 164.520]

Please also read the original HIPAA Administrative Simplification statute:

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

PUBLIC LAW 104-191
AUG. 21, 1996
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996
Public Law 104-191
104th Congress

Please also see Public Law 110-233Genetic Information Non-discrimination Act of 2008 for our discussion relating to genetics/genomics:

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ233.110

and

http://thomas.loc.gov/cgi-bin/bdquery/z?d110:HR00493:@@@D&summ2=m&

October 30, 2010 | Permalink

August 24, 2010

GMU Health Law Fall 2010 Syllabus

The Syllabus for our course is now posted at:

Health Law Syllabus Fall 2010

August 24, 2010 | Permalink

August 20, 2010

GMU Health Law Fall 2010 Introduction for Law Students

Welcome to our Health Law course. Here is some important information regarding our course.

1. Health Law 233; 3 credits; Hazel Hall, Room 224, Tuesday and Thursday 4:30 pm - 5:45 pm. Information regarding the course including the syllabus will be posted at:

http://www.healthlawyerblog.com

2. Attendance: in accordance with GMUSL policy. Students are expected to be in each class and to be prepared to discuss the assigned readings for each class. Other than in an emergency, you should advise Prof. Goldberg in advance if you are not able to attend any class. All students must sign the sign-in sheet at the beginning of each class.

3. Coursebook: Furrow et al.: Health Law, Cases, Materials and Problems, 6th Edition, Copyright: 2008 and Health Care Reform: Supplementary Materials (2010) for the Coursebook, Publisher: West Law School; and Pocket Edition of the Constitution of the United States; and compilation of the Affordable Care Act (ACA or PPACA) prepared by the Office of the Legislative Counsel for the use of the U.S. House of Representatives available at: http://docs.house.gov/energycommerce/ppacacon.pd f and additional materials will be provided via email and online at http://www.healthlawyerblog.com from time to time. The syllabus will be provided soon, after the first class meeting and after all of the student CV submissions are received.

4. 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.

5. There will be no class on October 12 ("Tuesday" is "Monday") and there will be no class on the November 25 Thanksgiving holiday.

6. For the 2nd class, 8/24/10, please locate and study the portions of either the Virginia Code, or locate the statutes in another jurisdiction in which you expect to practice law or otherwise use your law school education, that address licensure and regulation of physicians and nurses. In particular, focus on what constitutes the practice of medicine and the practice of nursing and how each differs from the other of them. In addition, study cases found in the Coursebook at pp. 117, 120, 132, 141, and 150, and study the Supplement pages 28-30. For the 3rd class, 8/26/10, study the cases found in the Coursebook at pp. 195, 203, 212, 219, 222, and study the Supplement pages 38-39, 41-46, and 48-49.

7. Study Massachusetts Board of Medicine materials regarding Massachusetts patient tissue "diagnosed" by physician licensed in New Hampshire but not licensed in Massachusetts.

August 20, 2010 | Permalink

July 13, 2010

George Mason University School of Law, Health Law, Fall 2010, Tu & Th 4:30-5:45 PM

Welcome to Health Law, Fall 2010. The assigned readings for our course will be in the following required texts:

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. (2008), Publisher: West Law School, ISBN-13: 9780314184740, and

Furrow, Greaney, Johnson, Jost and Schwartz' Health Care Reform: Supplementary Materials (2010), Publisher: West Law School, ISBN-13: 9780314266873, and

Pocket Edition of the Constitution of the United States.

In addition, students should download the following legislative material:

COMPILATION OF PATIENT PROTECTION AND AFFORDABLE CARE ACT PREPARED BY THE Office of the Legislative Counsel FOR THE USE OF THE U.S. HOUSE OF REPRESENTATIVES

http://docs.house.gov/energycommerce/ppacacon.pdf

The syllabus for our class is being prepared, and will be available here and also on the law school web site soon.

Your first assignment is to provide me, via email, with a copy of your current CV including academic and work experience, please. Thank you.

July 13, 2010 | Permalink

April 30, 2010

Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 - Summer 2010 -Engineering Building 1110

If you are registered for Legal Iss Relevnt Hlthcare Adm. GMU SUMMER 2010, welcome to our course.

Please visit my blog

http://www.healthlawyerblog.com

if you are interested in reading about my past classes in health law. You will note in particular that the Summer 2009 syllabus material is on my blog, and indicates the same coursebooks for this Summer 2010 term, as noted below. Our current syllabus will be available after our first classroom meeting and will differ from prior syllabi, inter alia, because of changes in the law. There also will be other reading materials, mostly on the internet/web, that will be assigned later.

In the meantime, your first assignment is to provide me, via email, at your early convenience, with your current CV/academic/professional biography, please, that includes your goals in attending GMU now and your particular experiences and interests professionally in health care and health law. Please be sure to place your name in the Subject area of your email to me.

Regarding timing for our course, we will discuss how the term will be planned and timed when we meet during our first class. Until I receive all of the CV materials and meet you in person during our first class, I am unable to determine how best to plan our course so that both substantively and time-wise our course is most responsive to your needs and schedules. It will be my pleasure to welcome you to Legal Iss Relevnt Hlthcare Adm.

Please also know that your attendance during and participation in our classroom discussions is mandatory and your final grade will be based upon the grading of your term paper, the quality of your classroom participation, your attendance, and your verbal presentation of your term paper to the entire class during the latter part of your course. There is no final examination for this course.

The required books for the course, which should be available via the GMU bookstore 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

April 30, 2010 | Permalink

March 03, 2010

Syllabus: Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 - Spring 2010

REVISED MARCH 5, 2010:

The following are assigned readings from the Health Law course book. In addition, there will be a special class (date not yet determined) for the study of "health reform" please. Students should also study the material on the CD-ROM provided from CMS.

March 3, 2010 - Pages 29-75, clinical standards of practice, medical errors, regulatory responses, never events, disclosures, pay for performance

March 10, 2010 - NO CLASS

March 17, 2010 - Pages 115-128, 130-150, licensing and quality control, discipline, alternative/complementary medicine, unlicensed providers; pages 159-169, 181-188, regulation of health care institutions, configurations, regulatory systems, survey/inspection; pages 849-873, staff privileges

March 24, 2010 - Pages 191-194, 195-203, 219-222, private accreditation, professional-patient relationship, contract between physician and patient, exculpatory clauses; pages 230-246, 286-288, informed consent, the institution's obligation

March 31, 2010 - Pages 327-354, 412-421, standard of care, proving negligence, contributory fault of patient; pages 437-503, liability of health care institutions, medical staff and hospital governance, independent contractors, duty to treat, corporate negligence, negligent credentialing, peer review immunity and corporate negligence

April 6, 2010 - Term papers due

April 7, 2010 - Pages 767-848, Medicare and Medicaid

April 14, 2010 - Papers

April 21, 2010 - Papers

April 28, 2010 - Papers, final class

March 03, 2010 | Permalink

December 26, 2009

Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 - Spring 2010 - Books

To my students for Legal Iss Relevnt Hlthcare Adm - GMU HHS 750 - Spring 2010: welcome!

Please know that the required books for our course are:

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 the curriculum/assignments and updates/changes, on

http://www.healthlawyerblog.com

Welcome to health law!

December 26, 2009 | Permalink

October 23, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

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

Medicare program Notice of Privacy Practices for the Original Medicare Plan

http://www.inova.org/upload/docs/Patients%20&%20Visitors/privacy-policy.pdf

INOVA NOTICE OF PRIVACY PRACTICES

http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.pdf

Background - OCR publication regarding NOTICE OF PRIVACY PRACTICES FOR PROTECTED HEALTH INFORMATION [45 CFR 164.520]

Please also read the HIPAA Administrative Simplification statute:

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

PUBLIC LAW 104-191

AUG. 21, 1996

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996

Public Law 104-191

104th Congress

Note please that the HIPAA Administration Simplification statute is affected by several subsequently enacted statutes, including most recently the The American Recovery and Reinvestment Act of 2009, Public Law 111-005 enacted February 17, 2009

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

which includes the so-called HITECH Act found at pages 112 et seq.

TITLE XIII—HEALTH INFORMATION

TECHNOLOGY

SEC. 13001. SHORT TITLE; TABLE OF CONTENTS OF TITLE.

(a) SHORT TITLE.—This title (and title IV of division B) may be cited as the ‘‘Health Information Technology for Economic and Clinical Health Act’’ or the ‘‘HITECH Act’’.

October 23, 2009 | Permalink

October 20, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please study the attached AHLA material which AHLA generously has made available to us. We will discuss this material during our class on October 22, 2009.

http://www.healthlawyers.org/Resources/PI/Policy/Documents/Stark White Paper.pdf

http://sn.im/sm3qq-drp

Please also see below for a hot link to a copy of the so-called Stark Law, which we also will study during our class on October 22, 2009.

http://sn.im/sm41e-aod

OR

http://www.ssa.gov/OP_Home/ssact/title18/1877.htm

and to the so-called health care civil monetary penalties false claims and antikickback statutes

http://www.ssa.gov/OP_Home/ssact/title11/1128A.htm

http://www.ssa.gov/OP_Home/ssact/title11/1128B.htm

And recall also that in a prior email, you were asked to study a recent OIG advisory opinion:

http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2009/AdvOpn09-17.pdf

in anticipation of our discussion this week of seeking advisory opinions from the Office of Inspector General of the US Department of Health & Human Services.

October 20, 2009 | Permalink

October 17, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Further regarding Blick vs. Connecticut pending litigation, please study the Complaint available via the hot link referenced below:

Blick v. Connecticut

October 17, 2009 in Weblogs | Permalink | Comments (0)

October 15, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please see the article hot linked below regarding the latest developments in health reform:

http://www.washingtonpost.com/wp-dyn/content/article/2009/10/13/AR2009101300998_pf.html

Please also see:

http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2009/AdvOpn09-17.pdf

in anticipation of our discussion next week of seeking advisory opinions from the Office of Inspector General of the US Department of Health & Human Services.

Please also see:

http://www.compassionandchoices.org//documents/CTPressKit.pdf

and

http://www.courant.com/health/hc-web-suicide-1008oct08,0,6575409.story

and

http://compassionandchoices.org/act/legal_work/Blick

in anticipation of our studying dying and death in the next several weeks in class.

October 15, 2009 | Permalink

October 03, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please see the latest development regarding health reform legislative initiatives:

http://voices.washingtonpost.com/capitol-briefing/2009/10/senate_finance_committee_relea.html

http://www.washingtonpost.com/wp-srv/nation/documents/Americas_Healthy_Future_Act_amended_100209.pdf

Consider, as you peruse the above hot-lined materials, how, among others, members of Congress who are not physicians or hospital administrators, and physicians, and patients, will, or can, understand and apply changes in health care that would be implemented by detailed rules eventually to be published with policies to follow, pursuant to the current version of the bill referenced above. Do you perceive any areas most likely to be subject to fraud and abuse, error, confusion, and undue complexity?

October 03, 2009 | Permalink

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please study the hot-linked work plan referenced below, which provides an informative outline and (a usually very reliable) prediction regarding how our favorite government's enforcement resources will be focused. Interesting how the OIG tells providers and others where enforcement likely will be initiated, unlike some agencies which operate without such advance publicity. Is this good or bad from a policy perspective? Are the programs subject to the OIG's investigative process likely to be flawed if so much oversight and potential prosecution is necessary in order to seek to prevent wrongdoing?

http://oig.hhs.gov/publications/docs/workplan/2010/Work_Plan_FY_2010.pdf

The file is 115 sheets or so long, so be patient with the downloading, please. We'll study this material when we discuss fraud and abuse and related topics, please.

October 03, 2009 | Permalink

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please study the hot linked rule referenced below for our Medicare program discussions; thank you. Consider, please, whether a typical relatively inexperience-in-practice physician in a small group or a solo medical practice will or should be able to read, understand, and apply what you are going to read. Consider also whether there should be anything included in health reform legislation addressing concerns that providers, and their patients, and each and all of us as well, might have regarding what you will read and how the procedures therein described enhance or derogate from good health care delivery.

Recoupment Rule Change

quote

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 405

[CMS-6025-F]

RIN 0938-AN42

Medicare Program; Limitation on Recoupment of Provider and

Supplier Overpayments

AGENCY: Centers for Medicare & Medicaid Services (CMS),

HHS.

ACTION: Final rule.

SUMMARY: This final rule implements a provision of the

Medicare Prescription Drug, Improvement, and Modernization

Act of 2003 (MMA) which prohibits recouping Medicare

overpayments from a provider or supplier that seeks a

reconsideration from a Qualified Independent Contractor

(QIC). This provision changes how interest is to be paid to

a provider or supplier whose overpayment is reversed at

subsequent administrative or judicial levels of appeal.

This final rule defines the overpayments to which the

limitation applies, how the limitation works in concert with

the appeals process, and the change in our obligation to pay

interest to a provider or supplier whose appeal is

successful at levels above the QIC.

October 03, 2009 | Permalink

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please study the recent CMS transmittal 303, hot linked below, a corrective transmittal, in the context of our readings regarding reasonable and necessary, medical necessity, competence, malpractice, disallowances, and all the rest; thank you.

http://www.cms.hhs.gov/transmittals/downloads/R303PI.pdf

quoted snip

LCDs specify under what circumstances a service is generally considered to be reasonable and necessary. In rare and unusual circumstances during complex medical review MACs, FIs and carriers have the authority to apply an exception to the clinical criteria described in an LCD.

quote

Background:Local coverage determinations are determinations made by a fiscal intermediary, carrier, or MAC respecting whether or not a particular item or service is covered on an intermediary-, carrier-, or MAC- wide basis. LCDs specify under what circumstances a service is generally considered to be reasonable and necessary. In rare and unusual circumstances during complex medical review MACs, FIs and carriers have the authority to apply an exception to the clinical criteria described in an LCD.

In rare and unusual circumstances, contractors have the authority to apply an exception to the clinical criteria described in an LCD for individual claims

CERT RAC

6586.2

Contractors shall base their exceptions requests on a thorough review of the patient’s medical record and the relevant evidence in the medical literature.

CERT RAC

6586.3

Contractors other than RACs shall use this process for the purposes of approving or denying an individual claim. RACs shall only use the exception process to not deny an individual claim.

CERT RAC

6586.4

Contractors shall document in a log the individual claims that are approved or denied based on an LCD exception.

October 03, 2009 | Permalink

September 30, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Medicare program additional assignment:

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

As discussed in our class yesterday, the foregoing hot link will take you to the CMS booklet regarding the Medicare program, which you should study in anticipation of our classes next week, please. The booklet is a large file and so be patient during downloading. Let me know if you have difficulty obtaining the linked material.

The foregoing hot link is found at

http://www.medicare.gov/Library/PDFNavigation/PDFInterim.asp?Language=English&Type=Pub&PubID=10050

Please also study the basic Medicare program statutory framework, found at

http://www.law.cornell.edu/uscode/usc_sup_01_42_10_7_20_XVIII.html

and

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

Note in particular the following

quote

§ 1395. Prohibition against any Federal interference

Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

and

§ 1395a. Free choice by patient guaranteed

(a) Basic freedom of choice

Any individual entitled to insurance benefits under this subchapter may obtain health services from any institution, agency, or person qualified to participate under this subchapter if such institution, agency, or person undertakes to provide him such services.

September 30, 2009 | Permalink

September 28, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please see below for a timely health reform update, in anticipation of our October 6 class in particular. See also, for differing perspectives from opposite sides of the political spectrum:

http://healthreform.kff.org/

http://www.commonwealthfund.org

http://www.hoover.org/research/healthcare

http://healthcare.cato.org/

http://majorityleader.house.gov/members/health_care.cfm

http://www.whitehouse.gov/realitycheck/

http://republican.senate.gov/public/?CFID=16246856&CFTOKEN=41654504

September 28, 2009 | Permalink

September 27, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please study the following article in connection with our consideration of Medicare reimbursement policies, the practice of medicine, and reasonable and necessary care and treatment.

CMS's Landmark Decision on CT Colonography

http://content.nejm.org/cgi/reprint/NEJMp0904408v1.pdf

The New England Journal of Medicine

Perspective

Published at www.nejm.org May 27, 2009 (10.1056/NEJMp0904408)

CMS's Landmark Decision on CT Colonography — Examining the Relevant Data

Sanket S. Dhruva, M.D., Steve E. Phurrough, M.D., M.P.A., Marcel E. Salive, M.D., M.P.H., and Rita F. Redberg, M.D., M.Sc.

September 27, 2009 | Permalink

September 22, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please study the following statutory material, which may be found as a part of the hot linked statute referenced below, in anticipation of our discussion of health care investigative and enforcement actions.

Public Law 111-21 Fraud Enforcement and Recovery Act of 2009 or FERA

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ021.111

a) Clarification of the False Claims Act.--Section 3729 of title 31, United States Code, is amended--

(1) by striking subsection (a) and inserting the following:

(a) Liability for Certain Acts.-- (1) In general.--Subject to paragraph (2), any person

who--

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

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

(D) has possession, custody, or control of property or money used, or to be used, by the Government and knowingly delivers, or causes to be delivered, less than all of that money or property;

(E) is authorized to make or deliver a document certifying receipt of property used, or to be used, by the Government and, intending to defraud the Government, makes or delivers the receipt without completely knowing that the information on the receipt is true

(F) knowingly buys, or receives as a pledge of an obligation or debt, public property from an officer or employee of the Government, or a member of the Armed Forces, who lawfully may not sell or pledge property; or

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

is liable to the United States Government for a civil penalty of not less than $5,000 and not more than $10,000, as adjusted by the Federal Civil Penalties Inflation Adjustment Act of 1990 (28 U.S.C. 2461 note; Public Law 104-410), plus 3 times the amount of damages which the Government sustains because of the act of that person.

(2) Reduced damages.--If the court finds that-- (A) the person committing the violation of this subsection furnished officials of the United States

responsible for investigating false claims violations with all information known to such person about the violation within 30 days after the date on which the defendant first obtained the information;

(B) such person fully cooperated with any Government investigation of such violation; and

(C) at the time such person furnished the United States with the information about the violation, no criminal prosecution, civil action, or administrative action had commenced under this title with respect to such violation, and the person did not have actual knowledge of the existence of an investigation into such violation, the court may assess not less than 2 times the amount of damages which the Government sustains because of the act of that person.

(3) Costs of civil actions.--A person violating this subsection shall also be liable to the United States Government for the costs of a civil action brought to recover any such penalty or damages.;

(2) by striking subsections (b) and (c) and inserting the following:

(b) Definitions.--For purposes of this section-- (1) the terms 'knowing' and 'knowingly'--

(A) mean that a person, with respect to information--

(i) has actual knowledge of the information;

(ii) acts in deliberate ignorance of the truth or falsity of the information; or

(iii) acts in reckless disregard of the truth or falsity of the information; and

(B) require no proof of specific intent to defraud;

(2) the term `claim'-- (A) means any request or demand, whether under a

contract or otherwise, for money or property and whether or not the United States has title to the money or property, that--

(i) is presented to an officer, employee, or agent of the United States; or

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

(I) provides or has provided any portion of the money or property requested or demanded; or

(II) will reimburse such contractor, grantee, or other recipient for any portion of the money or property which is requested or demanded; and

(B) does not include requests or demands for money or property that the Government has paid to an individual as compensation for Federal employment or as an income subsidy with no restrictions on that individual's use of the money or property;

(3) the term 'obligation' means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, from a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment; and

(4) the term 'material' means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.

September 22, 2009 | Permalink

September 20, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Here is some exciting news regarding our October 6, 2009 class and health reform. We have just learned that the following distinguished speakers will join us for this class and will participate in a special open door forum and panel discussion regarding health reform and the Medicare program and related topics referenced below. Their names follow and each, in addition to the responsibilities indicated, is a graduate of a distinguished law school and everyone who is a member of our class will be expected to participate in our discussions, please, and appropriately to be prepared to address and to understand the perspectives each of our panel members has regarding the topics to be discussed:

1. GUEST, a former state Governor and State Insurance Commissioner, who has been nominated to be the new Administrator of the Centers for Medicare and Medicaid Services;

2. GUEST, who serves as the Chief Executive Officer of the Health Insurance Political Action Committee which supports and actively is advising the US health insurance industry regarding health reform;

3. GUEST, who is a patient advocate for the elderly, the infirm, and people with disabilities, and as a licensed social worker has dedicated her life to providing charitable care for those in need;

4. GUEST, who recently completed a combined forty years of service as a United States Senator and before that, served as a member of the House of Representatives, and more particularly served on several Congressional committees responsible for health care oversight and reimbursement;

5. GUEST, MD, JD, LLM, PhD, MPH, CPA, DDS, D.Pharm, RN, who is President of the American Physicians, Nurses, Registered Pharmacists, and Dental Association;

6. Her Honor, retired GUEST, who, before serving for forty years as a member of the United States Supreme Court, was a plaintiffs' attorney involved in asserting, on a contingency fee basis, medical malpractice claims against health care providers and institutions; and

7. His Excellency, King GUEST, the reigning and benevolent monarch of the Principality of HisKingdomAlone, wherein the King is in the process of designing and soon will implement a new health care delivery and payment system for his subjects that he believes is best for the entire population and that is not bound by existing law or any political constraints, because his kingdom has no elected legislature and no elected executive branch; there are none: he's the King, after all, and it's good to be the King!

Our panel will, of course, prepare for this event by studying materials relative to health reform proposals and the current Medicare program, as will all other members of our class, and we will discuss all of this in the weeks before and in order to prepare for our October 6 class. We are grateful to the foregoing panel members, and to each and every member of our class, for preparing to and for being willing to participate in this exciting and unique event, during which we'll discuss, inter alia:

A. Universal health care coverage;

B. Death and life panels;

C. Health care rationing;

D. Comparative effectiveness;

E. Malpractice reform; and

F. Access to the Medicare program before age 65.

Please be sure to plan to attend this class: you won't want to miss it!

September 20, 2009 | Permalink

September 09, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

Please know that our class originally scheduled for September 15 will not occur. Information regarding a substitute date will be provided soon.

Please read the health reform (page 5) article in The Docket issue of September 1, 2009 and the follow-up article mentioned. Please also watch, listen to, and read, the POTUS speech on health reform scheduled for 8 PM EDT on September 9, 2009. Thereafter additional reading materials will be assigned for our discussions relating to health reform.

September 09, 2009 | Permalink

August 22, 2009

Welcome to Health Law Fall 2009

Aug 22, 2009

To: My Health Law Students

Good morning. Welcome to Health Law Fall 2009.

Kindly favor me with a copy of your CV/resume/professional biography before our next class. Please include information regarding particular areas of health care and health law that are of interest to you in your academic work and professionally. Please also visit http://www.healthlawyerblog.com occasionally because updates to our syllabus and other information regarding our class will be posted there as well as beging sent to you via email. If you have additional email addresses that you would like me to include in my email transmittals to you, please advise.

It is my pleasure to present health law to you this term. Surely the many new developments in health care and health reform currently underway will provide much for us to ponder and learn, and will complement our studying the many interesting and complex legal issues that have arisen in the past.

I look forward to meeting you again on Tuesday. Please be sure to bring to class your copy of the Constitution as well as the coursebook.

August 22, 2009 | Permalink

June 20, 2009

George Mason University School of Law, Health Law, Fall 2009, Tu & Th 4:30-5:45 PM, Rm. 224

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

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. Additional assignments are set forth in the Syllabus, subject to change, please.

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

June 20, 2009 | Permalink

June 06, 2009

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/upload/docs/Patients%20&%20Visitors/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

June 06, 2009 | Permalink

June 04, 2009

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

June 04, 2009 | Permalink

May 28, 2009

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

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

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

______________________________________________________________________

May 28, 2009 | Permalink

May 17, 2009

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

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

May 17, 2009 | Permalink

April 20, 2009

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!

April 20, 2009 | Permalink

March 05, 2009

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 ....

_____________

March 05, 2009 | Permalink

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