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OFFICIAL MAGAZINE OF AMErICAN HEALtH LAwyErs AssOCIAtION
For the health and life sciences law community
ahlaJune 2010 Volume 14 Issue 6
AHLA top Honors (page 14)
Achieving Meaningful Use of EHr technology
(page 23)
spotlight on Leaders (page 40)
In this issue
23
14
COLUMNS
1 First ReflectionsIn her last column as President, Elizabeth Carder-Thompson looks back at some of the significant events of the past year, and interviews AHLA President-Elect Rick Shackelford about his upcoming term in office.
80 Last WordAHLA Executive Vice President and CEO Peter Leibold recognizes the contributions of AHLA leaders who are ending their terms of service on the Association’s Board of Directors.
2 AHLA Connections June 2010
34
Postmaster: send address changes to ahla Connections, amEriCan hEalth laWYErs assoCiation, 1620 Eye street, nW, 6th Floor, Washington, dC 20006-4010.
printed on recycled paper
Achieving Meaningful Use of EHR Technology: Overview of the Proposed Rules, Areas of Concern, and Practical Tips for HospitalsIn this month’s Feature article, Michael D. Beauvais, Ropes & Gray LLP, examines key aspects of the EHR incentive programs from a hospital’s perspective, including a discussion of several contentious provisions and their likely impact on hospitals seeking to maximize incentive payments. The article concludes with practical tips to help organizations prepare for and achieve meaningful use of EHR-certified technology.
ERM—It’s BAAACK! Fiduciary Duty and Enterprise Risk ManagementThis month’s Analysis article, by Michael W. Peregrine, McDermott Will & Emery, discusses the emergence of enterprise risk management as an increasingly recognized component of the board’s fiduciary oversight obligation and the advisability for nonprofit hospitals and health systems to incorporate some form of ERM function within the board’s overall oversight activities.
AHLA Spotlight on Leaders 2010The Spotlight on Leaders section, which appears each June, lets us recognize and thank the many volunteer leaders who make AHLA’s success possible.
DEPARTMENTS
8 Connections to Learning
30 Public Interest
62 Member News
66 Annual Meeting and In-House Counsel Program
72 Classified Advertising
FOCUS ON
65 Consultants and Expert Witnesses
40
AHLA Top HonorsAHLA’s Top Honors, now in its seventh year, gives the Association the opportunity to honor the organizations behind our members—those law firms, healthcare organizations, and consulting and accounting firms that consistently and enthusiastically encourage and sustain their members’ and employees’ affiliation with AHLA. We want to thank both the organizations as well as the many members who help make AHLA a strong and vibrant presence in the healthcare field and legal community.
healthlawyers.org 3
The AHLA Alternative Dispute Resolution Service is:
✓ Cost-Effective – Far less expensive than competitors; no heavy administrative fees.
✓ Efficient – resolution experts in health law.
✓ Timely – rules include timelines to resolve disputes quickly.
If you practice health law, use the AHLA ADR Service as your health law dispute resolution solution! www.healthlawyers.org/adr (202) 833-0762
For sample Contractual language
to request an arbitrator, mediator, or hearing officer list
to becomean arbitrator, mediator, or hearing officer
to receive a Complimentary toolkit for managing healthcare Conflict
AHLA Resolvers are often content experts in the disputed issues that arise in healthcare agreements including:
Fraud and abuse issues
physician Employment Contracts with physician practices and hospitals (including non-compete clauses)
hospital/physician transaction disputes
plan/provider reimbursement disputes
medical staff disputes
provider and plan disputes with Vendors (including technology contracts)
recruitment agreements
This content expertise will save your clients time and expense in the ADR process. If you are an AHLA member drafting a contract with a dispute resolution clause, you should include the AHLA ADR Service.
The Health Law Dispute Resolution Solution
For information about the July 1
Arbitration training, see page 8. To register
go to www.healthlawyers.org/adr
For the health and life sciences law community
ahla
Editor-in-ChiefAllison E. Beard(202) [email protected]
EDITORIAL
Bianca L. Bishop, Esq. managing Editor(202) [email protected]
Cynthia Conner, Esq.Vice president, professional resources(202) [email protected]
Kerry B. Hoggard, CAE, PAHMVice president, membership & public interest(202) [email protected]
Peter M. LeiboldExecutive Vice president/CEo(202) [email protected]
GRAPHICS AND ADVERTISING
Mary Boutsikarisart and design director (202) [email protected]
Alex Leffersproduction specialist(202) [email protected]
Katy Shearmanadvertising representativenetwork media partners(410) [email protected]
Viewpoint/Writers’ Guidelines AHLA Connections must retain full copyright or unlimitedlicense before publishing. Factual accuracy and opinion contained in articles published inAHLA Connections are the responsibility of the authors alone and should not be interpretedas representing the views or opinions of the association. ahla is a non-partisan educationalorganization that does not take positions on public policy issues and instead provides a forumfor an informed exchange of views. Guidelines are available at www.healthlawyers.org/connections or by calling (202) 833-0779. We welcome letters to the Editor, no longer than250 words in length. longer responses may be submitted to [email protected] andwill be considered for publication on a space available basis, after review by our Editorial staff.
The Mission of the american health lawyers association is to provide a collegial forum for interaction and information exchange to enable its members to serve their clients more effectively; to produce the highest quality non-partisan educational programs, products,and services concerning health law issues; and to serve as a public resource on selectedhealthcare legal issues.
Diversity Statement in principle and in practice, ahla values and seeks diverse andinclusive participation within the association regardless of gender, race, creed, age, sexualorientation, national origin, or disability. the association welcomes all members as it leadshealth law to excellence through education, information, and dialogue.
4 AHLA Connections June 2010
AHLA Connections (issn 1949-9035) © 2010 is published each month, 12 times a year by amEriCan hEalth laWYErs assoCiation. Editorial, subscription and circulation offices at 1620 Eye street, nW, 6th Floor, Washington, dC 20006-4010. tel. (202) 833-1100. all rights reserved. the price of an annual subscription for ahla members ($45) is included inseparably in their dues. an annual subscription for non-members is $105. periodicals postage paid at Washington, dC, and at additional mailing offices.
Copyright/Reprint Permission: For academic purposes, contact Copyright Clearance Center at (978) 750-8400 or www.copyright.com. Further reprint request should be directed to Cynthia Conner, ahla, 1620 Eye street, nW, 6th Floor, Washington, dC 20006-4010. (202) 833-0755.
Letter from the Editor
June is traditionally the time to recognize the Association’s leaders and volunteers for their efforts over the past year, and I would like to take a moment to also thank several members of AHLA’s staff who make this magazine possible each month.
Our talented Art and Design Director, Mary Boutsikaris and Production Specialist Alex Leffers work tirelessly to turn out a creative and innovative product every month, even while working on all of AHLA’s other materials.
Bianca Bishop, our Managing Editor, is responsible for the Feature and Analysis, working with the authors, and serving as our chief legal editor. The content that you find so valuable to your practice is made possible by her expertise. So much of each month’s magazine reflects what is going on the different depart-ments of the Association, and I would like to thank the staff contributors who provide me with the meat of the magazine each month: Brian Davis (Practice Groups); Laurie Garvey (Programs); Andrew Hartman (Public Interest); and Ana Mayer (Professional Resources/Publications).
A very special thank you goes to Cat Davis and M.J. McLaughlin, who serve as editorial assistants, helping with membership-related content, and also putting up with my last minute questions about “what should we put in this empty space in the magazine?” Thanks for picking up the slack each month.
Finally, a huge thank you to Kerry Hoggard, Vice President of Membership and Public Interest, who serves as writer, eagle-eyed proofreader, magazine historian, and visionary for AHLA Connections, all at the same time.
With the contributions of these talented staff and writers, the next year of AHLA Connections is sure to be a success!
Allison E. BeardEditor in Chief
8 AHLA Connections June 2010
LEGEND
Teleconference/Webinar
Program/Training
Faculty
Hotel Information
Practice Group Luncheon
Registration Fees
June 2010June 16, 2010social media: the opportunities and the Challenges in healthcare
July 2010July 1, 2010arbitration trainingseattle, Wa
July 8, 2010private use: What is it and What Can i do to avoid it?
July 21, 2010domestic and international restric-tions affecting Your international healthcare transaction
September 2010september 26-28, 2010Fraud and Compliance Forumbaltimore, md
October 2010october 11-12, 2010tax issues for healthcare organizationsritz-Carlton pentagon Cityarlington, Va
october 24-26, 2010Fundamentals of health law hyatt regencyChicago, il
Webinar held from 1:00-2:30 pm Eastern. sponsored by the health information and technology practice Group.
this webinar offers a practical approach to navigating the legal issues inherent in the use of technology tools like blogs, wikis, twitter, Facebook, and other social media-driven technology. the webinar will examine the impact that social media is having on healthcare organizations and the industry. designed for both newcomers and seasoned users of social media, participants will benefit from the real-world experiences and insights of speakers actively engaged in advising clients regarding social media initiatives.
registration Fees: member of sponsoring practice Group: $145; Government Employee, academician, and solo practitioner: $95; ahla member: $190; non-member: $290; ahla member listener: $50; non-member listener: $60.
Faculty: robert l. Coffield, Flaherty sensabaugh & bonasso pllC, Charleston, WV; daniel s. Goldman, legal Counsel, mayo Clinic, rochester, mn; linda s. ross, honigman miller schwartz and Cohn llp, detroit, mi.
this one-day training program provides a strong foundation for service as an arbitrator in healthcare disputes. it also will enhance your skills as an advocate in an arbitration by giving you a greater understanding of the demands upon the arbitrator. specific training goals include: the process of an arbitration from case intake to award Current applicable arbitration law the legal and ethical issues in arbitration the challenges that ahla arbitrators typically confront, including
due process protocols, economic and billing issues, establishing terms of reference, and navigating challenges to the arbitral award
in addition, completing the arbitration training will provide you the opportunity to enroll in the ahla’s alternative dispute resolution (adr) service.
registration Fees: ahla members and ahla dispute resolvers: $465 non-ahla members: $540. register now for the arbitration training and the annual meeting and receive $50 off Your arbitration training registration Fee!
hotel reservations: sheraton seattle hotel (206) 621-9000 or the Grand hyatt hotel (206) 774-1234.
JUNE
16
JULY
1
Social Media: The Opportunities and the Challenges in Healthcare
Arbitration Trainingsheraton seattle hotel, seattle, Wa
healthlawyers.org 9
Webinar held from 1:00-2:30 pm Eastern. sponsored by the tax and Finance practice Group.
the faculty will discuss the common fact patterns that can result in private use, including some that you might not expect, together with a review of the safe harbor guidelines of rev. proc. 97-13. the discussion will focus on the application of the rules to specific hypotheticals.
registration Fees: member of sponsoring practice Group: $145; Government Employee, academician, and solo practitioner: $95; ahla member: $190; non-member: $290; ahla member listener: $50; non-member listener: $60.
Faculty: brenda horn, ice miller, indianapolis, in; lauren K. mack, sonnenschein nath & rosenthal llp, Chicago, il.
Webinar held from 1:00-2:30 pm Eastern. sponsored by the business law and Governance practice Group.
While the healthcare industry has been one of the last to explore and look for opportunities to provide goods and services in a market that is increasingly global, slowly, but unquestionably, business across borders is underway. international healthcare transactions are occurring on both sides of our borders. the international healthcare affinity Group of the business law and Governance practice Group has arranged a distinguished panel of practitioners with experience in international law and the unique issues that are implicated by cross-border transactions. not only will this webinar give the attendee a good basic understanding of u.s. laws affecting international transactions, like the FCpa, but healthcare lawyers will also learn from first-hand experience how the laws and culture of other countries, in particular asian and latin american countries, affect these transactions.
registration Fees: member of sponsoring practice Group: $145; Government Employee, academician, and solo practitioner: $95; ahla member: $190; non-member: $290; ahla member listener: $50; non-member listener: $60.
Faculty: Fred Entin, polsinelli shughart pC, Chicago, il; amy sommers, squire sanders and dempsey, shanghai, China; Joel rush, Epstein becker & Green, Washington, dC; rocco deGrasse, KpmG, Chicago, il.
JULY
8
JULY
21
Private Use: What Is It and What Can I Do to Avoid It?
Domestic and International Restrictions Affecting Your International Healthcare Transaction
Call for Speakersif you would like to be considered as a speaker, visit www.health-lawyers.org/speakers or submit your proposal or topic sugges-tions to [email protected] When emailing your submission, include a resume or curriculum vitae that includes a list of your previous presentations; describe the audience for whom the session is intended and why the subject matter is of importance; list four to six bullet points that describe the specific issues you plan to cover; indicate if the session would be introductory, interme-diate/legal update, or advanced in nature; and indicate what type of practical take-away materials you anticipate providing.
Questions? Contact laurie at [email protected], or call (202) 833-0783.
We are accepting proposals for the following program:
Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions January 27-28, 2011 Washington, dC proposals due: august 13, 2010
Physicians and Physician Organizations Law Institute February 2011 proposals due: august 20, 2010
Hospitals and Health Systems Law Institute February 2011 proposals due: august 20, 2010
Long Term Care and the Law February 2011 proposals due: august 20, 2010
10 AHLA Connections June 2010
this program is designed specifically for compliance officers and health attorneys who must advise their clients and institutions on the latest developments in fraud and abuse and compliance issues. attendees will hear from leading private practitioners and representatives from the office of Counsel to the inspector General, the department of Justice, and the Centers for medicare and medicaid services. the program will include sessions on topics such as stark, research compliance, the False Claims act, hospital-physician relationships, internal compliance challenges, and much more.
the Fraud and abuse, self-referrals, and False Claims practice Group luncheon will be held on september 27. hCCa will host a luncheon on september 28. there is an additional fee, space is limited and pre-registration is required for both of these luncheons.
hotel reservations: renaissance harborplace hotel at (410) 547-1200. indicate you are attending the ahla/hCCa program in order to be eligible for the special group rate of $229 for single or double occupancy. the room rates expire on Wednesday, september 8, 2010, but rooms at the group rate may sell out prior to the cut-off, so make your reservations early.
Whether you are a generalist who needs to know tax issues or a certified tax expert, you will not want to miss ahla’s annual tax issues program. as always, the program will feature representatives from the irs and leading private practitioners who will address and analyze recent developments such as practical aspects of the Form 990, governance issues, compensation issues and the impact of healthcare reform on exemption standards.
the tax and Finance practice Group will hold a luncheon and presentation. more information on this luncheon will be available soon. please note, there is an additional fee; pre-registration is required; space is limited.
hotel reservations: ritz-Carlton pentagon City at (800) 241-3333. special group rate of $235 for single or double occupancy. room rates expire on monday, september 20, 2010; make your reservations early.
pershing Yoakley & associates pC has provided sponsorship in support of this program.
SEPT26-28
OCT11-12
Fraud and Compliance Forumrenaissance harborplace hotel, baltimore, mdCo-sponsored with health Care Compliance association
Tax Issues for Healthcare Organizationsritz-Carlton pentagon City, arlington, Va
Fundamentals of Health Law
hyatt regency Chicago hotel, Chicago, il
the Fundamentals of health law program is a
valuable training program for new associates and in-house counsel and also an excellent refresher for experienced health lawyers. the program offers an array of health law topics, including medicare parts a-d, tax Exemption and tax issues, anti-Kickback and stark, antitrust, provider liability, False Claims and overpayments, and labor and Employment issues.
hotel reservations: hyatt regency Chicago hotel at
(312) 565-1234. indicate you are attending the ahla program in order to be eligible for the special group rate of $225 for single or double occupancy. the room rates expire on tuesday, october 5, 2010, but rooms at the group rate may sell out prior to the cut-off, so make your reservations early.
OCT24-26
14 AHLA Connections June 2010
Top Honors
Special Honors – Top 10 – Awards Of Excellence1 King & spalding llp 229
2 hall render Killian heath & lyman pC 149
3 Waller lansden dortch & davis pllC 148
4 Epstein becker & Green pC 115
5 nelson mullins riley & scarborough llp 85
6 hogan lovells llp 80
7 Garfunkel Wild pC 78
8 mcGuireWoods llp 64
9 drinker biddle & reath llp 60
10 polsinelli shughart pC 56
This “Spotlight on Leaders” issue lets us recognize and thank the many leaders who make AHLA’s success possible. It is also the issue that gives us
the opportunity to honor the organizations ‘behind the members’—those law firms, healthcare organizations, government agencies, and consulting and accounting firms that consistently and enthusiastically encourage and sustain their members’ and employees’ affiliation with AHLA. We want to thank both the organizations as well as the many members who help make AHLA a strong and vibrant pres-ence in the healthcare field and legal community.
For the past several years Modern Healthcare has contacted AHLA about printing a list of the ‘legal heavy-weights’, and in May 2010, Modern Healthcare printed the top 25 firms, which represented the number of attorneys at
the firm who were members of AHLA as of May 26, 2010. AHLA Connections magazine is again publishing a more extensive list of firms and organizations. The AHLA Top Honors—now in its seventh year—represents an increase over last year’s listing and the membership numbers of last year’s honorees remain strong. The following lists represent the number of attorneys at the firm who were members of the Association as of June 3, 2010.
Allison E. BeardEditor in Chief, AHLA Connections [email protected]
American Health Lawyers AssociationCongratulates and recognizes law firms and healthcare organizations that have the most members belonging to AHLA
healthlawyers.org 15
Top Honors
mintz levin Cohn Ferris Glovsky & popeo 54hancock daniel Johnson & nagle 50mcdermott Will & Emery 49proskauer rose 49reed smith 49bricker & Eckler 44Crowell & moring 44baker donelson bearman Caldwell & berkowitz 42Fulbright & Jaworski 42K&l Gates 42obEr/KalEr 42Foley & lardner 36ropes & Gray 36davis Wright tremaine 35bradley arant boult & Cummings 32balch & bingham llp 30polsinelli shughart pC 30alston & bird llp 29bass berry & sims plC 28arent Fox llp 27Jones day 27smith moore leatherwood llp 26husch blackwell sanders llp 25
On the following pages, we also recognize firms having between 10 and 54 AHLA members. A state-by-state listing—with recognition given to the top two firms in each state (those firms having at least four or more AHLA members)—and a regional listing recognizing the top firm in each region is also included. We also
want to recognize healthcare organizations, and accounting and consulting firms having multiple AHLA members.
Honorsice miller llp 25duane morris llp 23baker & hostetler llp 22Krieg deVault llp 21akin Gump strauss hauer & Feld llp 19manatt phelps & phillips llp 19morgan lewis & bockius llp 19powers pyles sutter & Verville pC 19sonnenschein nath & rosenthal llp 19arnall Golden Gregory llp 18dorsey & Whitney llp 18Quarles & brady llp 18schottenstein zox & dunn Co lpa 18sidley austin llp 18Greenberg traurig llp 17hooper lundy & bookman inc. 17post & schell pC 17Wyatt tarrant & Combs llp 17nixon peabody llp 16hinshaw & Culbertson llp 15von briesen & roper sC 15Kutak rock llp 14latham & Watkins llp 14
brown mcCarroll llp 13Faegre & benson llp 13Katten muchin rosenman llp 13bennett bigelow & leedom ps 12buchanan ingersoll & rooney pC 12Fox rothschild llp 12holland & Knight llp 12honigman miller schwartz & Cohn llp 12hooper lundy & bookman inc. 12snell & Wilmer llp 12squire sanders & dempsey llp 12Vorys sater seymour & pease llp 12akerman senterfitt 11Fredrikson & byron pa 11Godfrey & Kahn sC 11hanson bridgett llp 11miller & martin pllC 11miller Canfield paddock & stone plC 11moore & Van allen pllC 11
stevens & lee pC 11sullivan stolier & resor aplC 11Warner norcross & Judd llp 11Williams mullen 11baker & daniels llp 10broad & Cassel 10iseman Cunningham riester & hyde llp 10Jackson Walker llp 10maynard Cooper & Gale pC 10mcKenna long & aldridge llp 10saul Ewing llp 10taft stettinius & hollister llp 10thompson Coburn llp 10Wise Carter Child & Caraway pa 10Womble Carlyle sandridge & rice pllC 10
Also Recognized
16 AHLA Connections June 2010
Top Honors
hCa inc. 22sutter health 21Catholic healthcare West 20tenet healthcare Corporation 20Catholic health initiatives 18CVs Caremark 16mayo Clinic 15medstar health inc. 15university hospitals health system inc. 14Kaiser Foundation health plan inc. 13trinity health 13adventist health system 11
blue Cross blue shield association 11novant health 11providence health & services 11advocate health Care 10american medical association 10blueCross blueshield of tennessee 10Carolinas healthcare systems 10Genentech inc. 10intermountain healthcare 10Kaiser permanente 10shands healthCare 10
Recognizing Healthcare Organizations and Companies
Clifton Gunderson 9priceWaterhouse Coopers 9bKd llp 8navigant 7KpmG 6pershing Yoakley and associates 5
dixon hughes 4horne 4deloitte & touche 3Grant thornton 3rsm mcGladrey 3sullivan Cotter & associates 3
Recognizing Consulting and Accounting Firms
dhhs office of the General Counsel 366dhhs office of the inspector General 71mFCu iowa department of inspections and appeals 27attorney General of massachusetts 25navy medicine 13dhhs departmental appeals board 11Federal trade Commission bureau of Competition 10
mFCu of utah office of the attorney General 10irs-tEGE Exempt organizations r&a 10hhs/office of medicare hearings and appeals 6mFCu of north Carolina office of the attorney General 5mFCu of new mexico office of the attorney General 5oklahoma state Group insurance board 3mFCu hawaii office of the attorney General 3
AHLA’s Government Bundle Program Participants
100% InvolvementThis Honor Roll represents the firms and organizations that have 100% of their health law practice group members who belong to AHLA. If you believe your firm or organization has 100% membership in AHLA and should be listed, email [email protected].
baker & hostetler llp, healthcare industry teambaudino law Group plC benesch Friedlander Coplan & aronoff llp blanChard|manninG llp blankenship health law llC law offices of William mack Copeland llC Coppersmith schermer & brockelman plC lewis W. Fishman pa Florida health law Center Garfunkel Wild pC alice G. Gosfield and associates pC hancock daniel Johnson & nagle pC
the health law Firm husch blackwell sanders llp Kelly law Firm pC murphy austin adams schoenfeld llp national association for home Care and hospice’s Center for health Care law nutile law & associates rappel health law Group pl rogaliner law offices pC law offices of lynne m. rasmussen pllC schwartz law llC tsoules sweeney martin & orr llC
healthlawyers.org 17
Top Honors
Honor Roll By State – Top Two Law Firms(Those having at least 4 AHLA members)
STATE COUNT FIRM
AL 20 Balch & Bingham LLP
AL 10 Maynard Cooper & Gale PC
AR 4 Kutak Rock LLP
AZ 11 Snell & Wilmer LLP
AZ 8 Quarles & Brady LLP
CA 27 Hooper Lundy & Bookman Inc.
CA 15 Davis Wright Tremaine LLP
CO 8 Faegre & Benson LLP
CO 5 Holland & Hart LLP
CT 9 Murtha Cullina LLP
CT 8 Wiggin & Dana LLP
DC 85 King & Spalding LLP
DC 52 Epstein Becker & Green PC
FL 11 Akerman Senterfitt
FL 9 Broad & Cassel
GA 112 King & Spalding LLP
GA 21 Alston & Bird LLP
IA 5 Baudino Law Group PLC
ID 4 Beard St. Clair Gaffney PA
IL 27 Drinker Biddle & Reath LLP
IL 26 McGuireWoods LLP
IN 85 Hall Render Killian Heath & Lyman PC
IN 25 Ice Miller LLP
KS 7 Foulston Siefkin LLP
KS 4 Spencer Fane Britt & Browne LLP
KY 14 Wyatt Tarrant & Combs LLP
KY 7 Stites & Harbison PLLC
LA 11 Sullivan Stolier & Resor APLC
LA 6 Baker Donelson Bearman Caldwell & Berkowitz
MA 28 Mintz Levin Cohn Ferris Glovsky & Popeo PC
MA 14 Ropes & Gray LLP
MD 30 OBER | KALER
MD 5 Adelman Sheff & Smith LLC
MD 5 Gallagher Evelius & Jones LLP
ME 6 Kozak & Gayer PA
ME 6 Preti Flaherty Beliveau & Pachios LLP
ME 4 Verrill Dana LLP
MI 22 Hall Render Killian Heath & Lyman PC
MI 12 Honigman Miller Schwartz & Cohn LLP
MN 13 Dorsey & Whitney LLP
MN 10 Fredrikson & Byron PA
STATE COUNT FIRM
MO 20 Husch Blackwell Sanders LLP
MO 17 Polsinelli Shughart PC
MS 11 Baker Donelson Bearman Caldwell & Berkowitz PC
MS 7 Balch & Bingham LLP
NC 17 Smith Moore Leatherwood LLP
NC 15 Nelson Mullins Riley & Scarborough LLP
NE 7 Baird Holm LLP
NE 4 Stinson Morrison Hecker LLP
NJ 10 Epstein Becker & Green PC
NJ 10 Garfunkel Wild PC
NJ 8 Drinker Biddle & Reath LLP
NV 4 Nutile Law & Associates
NY 66 Garfunkel Wild PC
NY 23 Proskauer Rose LLP
OH 43 Bricker & Eckler LLP
OH 18 Schottenstein Zox & Dunn LPA
OK 8 McAfee & Taft PC
OK 6 Crowe & Dunlevy PC
OK 6 Doerner Saunders Daniel & Anderson LLP
OR 5 Schwabe Williamson & Wyatt PC
OR 4 Cooney & Crew LLP
OR 4 Stoel Rives LLP
PA 15 Post & Schell PC
PA 10 K & L Gates LLP
RI 4 Nixon Peabody LLP
SC 41 Nelson Mullins Riley & Scarborough LLP
SC 9 McNair Law Firm PA
TN 110 Waller Lansden Dortch & Davis LLP
TN 29 Bass Berry & Sims PLC
TX 17 Fulbright & Jaworski LLP
TX 13 Brown McCarroll LLP
TX 13 King & Spalding LLP
UT 4 Parsons Behle & Latimer
VA 50 Hancock Daniel Johnson & Nagle PC
VA 14 McGuireWoods LLP
VT 4 Dinse Knapp & McAndrew PC
WA 17 Davis Wright Tremaine LLP
WA 11 Bennett Bigelow & Leedom PS
WI 24 Hall Render Killian Heath & Lyman PC
WI 14 von Briesen & Roper SC
WY 5 Dray Thomson & Dyekman PC
Institutional Review Boards: A Primer, Second EditionBy Teresa A. Williams, Esquire, Richard G. Korman, Esquire, Janet M. Lis, Esquire, and Melinda G. Murray, Esquire
this new edition outlines the regulatory requirements and legal challenges associated with human subject research, and presents a thorough explanation of the role played by institutional review boards in this area of healthcare. the authors have expanded the coverage to include using independent irbs, children in research, payments to research subjects, clinical trial billing, and tissue and data repositories for research. as did the first edition, the publication explains the difference between the various regulatory schemes that govern human subject research, and outlines the necessary steps to take to set up an institutional review board that can adequately perform its role in this important healthcare setting.
the authors address: the various federal regulations that govern
research the clinical trial process the make up and purpose of an institutional
review board informed consent and the effect of the hipaa
privacy regulations Case law discussing incidents of research
misconduct.
a number of problem areas that arise in this setting are delineated, accompanied by suggestions for how to avoid these pitfalls. sample checklists and other useful documents are included.
Institutional Review Boards: A Primer, Second Edition will continue to be a valuable resource to those who need to understand this critical area of healthcare and how to comply with the rules that govern human subject research.
to order, go to www.healthlawyers.org/bookstore
or call (800) 533-1637.
Teresa A. Williams, Esquire Richard G. Korman, Esquire
Janet M. Lis, Esquire Melinda G. Murray, Esquire
Kate Bowen, Esq.Amy L. Bradshaw, Esq.
Tara Cowell, Esq.Amy Dow, Esq.
Kimberly H. Gillespie, JD, MPAJennifer R. Henderson, Esq.
Marta J. Hoffman, Esq.Veronica A. Marsich, Esq.
Tamara J. O’BlackKay M. Perry, Esq.
Carol A. Poindexter, Esq.Stacey Ries, RN, Esq.
Martha C. Romney, MS, JD, MPHJennifer Sharp, Esq.
Sarah Shulman Swank, Esq.Alexandra E. Trinkoff, Esq.
Leah A. Voigt, Esq.Catherine M. With, JD, LLM
SECOND EDitiON
iNStitu
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Oa
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S: a PR
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SECO
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N
by Teresa A. Williams, Esquire, Richard G. Korman, Esquire, Janet M. Lis, Esquire, and Melinda G. Murray, EsquireKate Bowen, Esquire, Amy L. Bradshaw, Esquire, Tara Cowell, Esquire, Amy Dow, Esquire, Kimberly H. Gillespie, JD, MPA, Jennifer R. Henderson, Esquire, Marta J. Hoffman, Esquire, Veronica A. Marsich, Esquire, Tamara J. O’Black, Kay M. Perry, Esquire, Carol A. Poindexter, Esquire, Stacey Ries, RN, Esquire, Martha C. Romney, MS, JD, MPH, Jennifer Sharp, Esquire, Sarah Shulman Swank, Esquire, Alexandra E. Trinkoff, Esquire, Leah A. Voigt, Esquire, Catherine M. With, JD, LLM.
This new edition outlines the regulatory requirements and legal challenges associated with human subject research, and presents a thorough explanation of the role played by institutional review boards in this area of healthcare. The authors have expanded the coverage to include using independent IRBs, children in research, payments to research subjects, clinical trial billing, and tissue and data repositories for research. As did the first edition, the publication explains the difference between the various regulatory schemes that govern human subject research, and outlines the necessary steps to take to set up an institutional review board that can adequately perform its role in this important healthcare setting.
ThE AuThoRs AddREss: • The various federal regulations that govern research
• The clinical trial process
• The make up and purpose of an institutional review board
• Informed consent and the effect of the HIPAA privacy regulations
• Case law discussing incidents of research misconduct.
A number of problem areas that arise in this setting are delineated, accompanied by suggestions for how to avoid these pitfalls. Sample checklists and other useful documents are included.
Institutional Review Boards: A Primer, second Edition will continue to be a valuable resource to those who need to understand this critical area of healthcare and how to comply with the rules that govern human subject research.
1620 Eye Street NW, 6th FloorWashington, DC 20006-4010 Website: www.healthlawyers.org Phone: (202) 833-1100 Fax: (202) 833-1105E-mail: [email protected] site: www.healthlawyers.orgISBN: 978-1-4224-9113-3
PEEr rEvIEW GUIDEBOOKsECoNd EdITIoN
iNStitutiONal REviEw BOaRDS: a PRimER
iNStitutiONal REviEw BOaRDS: a PRimER
Now AvAILAbLe IN tHe AHLA bookstore
healthlawyers.org 23
IntroductionOn March 15, 2010, the public comment period on the proposed federal rules for the “meaningful use” of certified electronic health record (EHR) technology ended with the submission of more than 2,000 comments.
This article examines key aspects of the EHR incentive programs from a hospital’s perspective, including a discussion of several conten-tious provisions and their likely impact on hospitals seeking to maxi-mize incentive payments. The article concludes with practical tips to help your organization prepare for and achieve meaningful use of EHR-certified technology.
Brief History of the EHR Incentive Programs and Certification CriteriaThe American Recovery and Reinvestment Act of 2009, through the Health Information Technology for Economic and Clinical Health Act (HITECH Act), promotes the adoption and meaningful use of interop-erable health information technology (HIT) and “qualified EHRs” through a combination of incentive payments and penalties.1 The underlying principle is that such technology, if standardized and widely adopted, will increase administrative efficiency and improve care quality through, among other things, a reduction in medical errors and improved coordination of care.
Achieving Meaningful Use of EHR Technology: Overview of the Proposed Rules, Areas of Concern, and Practical Tips for HospitalsMichael D. Beauvais, Ropes & Gray LLP, Boston, MA
62 AHLA Connections June 2010
Member News
Deane K. Corliss, a partner at Bradley Arant Boult Cummings LLP in Birmingham, AL, has been named to Alabama Super Lawyers for 2010.
She was also listed among the Top 25 Women Lawyers in Alabama.
Alan S. Goldberg of McLean, VA, is now an accredited attorney for claimants for healthcare and other veterans bene-fits before the U.S.
Department of Veterans Affairs and is admitted to the U.S. Court of Appeals for Veterans Claims and the U.S. Court of Appeals for the Federal Circuit. He is also now admitted to the bar of the Commonwealth of Pennsylvania. Mr. Goldberg is a Past President and AHLA Fellow.
Eric B. Gordon has been named head of McDermott Will & Emery LLP’s Los Angeles, CA, office. He is currently partner-
in-charge of the firm’s California health practice, the national co-chair of the firm’s Academic Medical Center practice, and was recently named a Vice Chair of AHLA’s Teaching Hospitals and Academic Medical Centers Practice Group.
Bobby Guy, a partner at Frost Brown Todd LLC in Nashville, TN, has been appointed Co-Chair of the American Bankruptcy
Institute’s Health Care Committee.
F. Peter Lehr, of Tallman Hudders & Sorrentino, the Allen-town, PA, office of Norris McLaughlin & Marcus PA, has been
selected for inclusion in the Health Care section of the 2010 issue of Pennsylvania Super Lawyers – Rising Stars Edition.
Robert J. Light-foot II has joined Von Briesen & Roper SC in Milwaukee, WI, as a Shareholder.
Jill T. Ojserkis has joined Cooper Levenson in Atlantic City, NJ, as Chair of the firm’s Healthcare Law Practice Group.
Tina M. Allen and Martha Rabaut Boonstra have joined Hall Render Killian Heath & Lyman PC as associate attorneys in the Troy, MI, office.
Matthew R. Sorren-tino, a Member of Tallman Hudders & Sorrentino, the Allen-town, PA, office of Norris McLaughlin &
Marcus PA, has been selected for inclu-sion in the Pennsylvania Super Lawyers 2010 for his fifth year in the Health Care Practice Area.
Author Thanks
AHLA would like to thank Daniel Mullholland, Lauren M. Massucci, and Charles J. Chulack for authoring the fourth edition of the Peer Review Guidebook. This new edition is a good resource for understanding the peer review process and disciplinary proceedings involving physicians and contains information about the new Joint Commission standards on Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Practice Evaluation (OPPE), a discussion of the Patient Safety and Quality Improvement Act, as well as the latest from the National Practitioner Data Bank. To order, go to www.healthlawyers.org/bookstore.
healthlawyers.org 63
Member News
Linda M. Robison (Partner), Mark D. Folk (Partner), Suzanne Sterling (Of Counsel), and Liston E. Radney III (Associate) have joined Shutts & Bowen LLP and are based in the firm’s Fort Lauderdale, FL, office.
Don’t Miss Out—Six New Practice Group Newsletters Practice Groups (PGs) always try to provide their members with in-depth and recent articles in time for each year’s Annual Meeting. This year is no different. Members of the following PGs should have or will receive an email this month, notifying them of their PG newsletter’s publication.
Life Sciences Business Law and Governance Regulation, Accreditation, and Payment Healthcare Liability and Litigation Physician Organizations In-House Counsel
To access your newsletters, visit www.healthlawyers.org/practicegroups, and use the list of PGs on the left-hand toolbar.
Business Law &
GovernanceA Publication of the American Health Lawyers Association
Business Law and Governance Practice Group
Volume 3 • Issue 2 • May 2010
The Corporate Practice
Of Medicine Doctrine:
Is it Applicable to Your
Client?Michael F. Schaff, Esquire
Glenn P. Prives, Esquire
Wilentz Goldman & Spitzer PA
Woodbridge, NJ
Introduction
Many clients are not sure if the state in which they want to form their
medical practices has adopted the Corporate Practice of Medicine Doctrine
(CPOM Doctrine), and if it has, whether it is applicable to their particular
practices’ corporate structure. The rapid and complex changes in the
healthcare delivery system have led to a renewed focus by federal and
state governments and insurance companies on the corporate structure of
medical entities that could complicate the establishment of such entities and
even lead to potential violations by your client’s current corporate structure.
Under the auspices of protecting the public, the American Medical Asso-
ciation (AMA) promulgated the initial version of the CPOM Doctrine.1 In
simple terms, the CPOM Doctrine essentially bans unlicensed individuals
and entities from engaging in the practice of medicine by restricting them
from employing licensed physicians.2 In practice, many states with CPOM
laws permit professional service entities to practice
medicine, but only if owned by physicians
licensed in that state.3 Authority for state
CPOM laws ranges from statutes and rules
to case law and state attorney general (AG)
opinions.
Healthcare providers must be careful
to comply with local laws because
violating these laws could result in a
provider’s loss of license and repay-
ment of all revenue for billed services
to insurance companies and the
government. It is also important for
parties that enter into ventures with
physicians to understand the CPOM
Doctrine because it can affect the struc-
tures of these types of relationships (i.e.,
employment versus independent contractor).
Table of Contents
The Corporate Practice Of Medicine
Doctrine: Is it Applicable to Your
Client?
Michael Schaff, Esq.
Glenn Prives, Esq. ................................ 1
Editor’s Notes
William Horton, Esq ............................ 4
Best Practices in Negotiating
Healthcare Joint Venture Agreements
Karen Gledhill, Esq .............................. 8
Ambiguous Ambiguity and Contract
Drafting
Dale Van Demark, Esq ....................... 12
Chinese Health Reforms—Drug,
Device, and Hospital Developments
Gordon Schatz, Esq. ........................... 15
Business Law & Governance © 2010 is published by the American Health
Lawyers Association. All rights reserved. No part of this publication may be
reproduced in any form except by prior written permission from the publisher.
Printed in the United States of America.“This publication is designed to
provide accurate and authoritative information in regard to the subject matter
covered. It is provided with the understanding that the publisher is not
engaged in rendering legal or other professional services. If legal advice or
other expert assistance is required, the services of a competent professional
person should be sought.” —from a declaration of the American Bar Association
Physician Organizations
A Publication of the American Health Lawyers Association Physician Organizations Practice Group Volume 13 • Issue 2 • June 2010
“It Takes Two to Tango”1— Increased Government Enforcement Against Individual PhysiciansPooneh Ghiassi, Esquire Douglas M. Wolford, Esquire Bass Berry & Sims PLC Nashville, TN
The Trusted GatekeepersPhysicians play a central role in the ordering and delivery of healthcare services. As “gatekeepers to the healthcare system,”2 the government has historically placed an “enormous amount of trust in the physician’s judgment.”3 Based on this trust, individual physicians historically were not subject to the same level of governmental scrutiny as were hospitals and other healthcare facilities. In addition to appearing less sympathetic to a potential jury, hospitals and health-care facilities were also more appealing enforcement targets because of their more significant financial resources. As a consequence, some in the physician community often viewed compliance with federal healthcare laws and regulations as more of a
concern for the healthcare facility, and not the physician.
Although in past years hospitals and healthcare facilities have been the government’s primary target, several recent settlements involving individual physicians demonstrate that the govern-ment could be expanding its enforcement net to include the other side of those financial relationships—physicians accused of soliciting and/or accepting illegal remunera-tion in exchange for referrals. As a result, physicians and their counsel should take note of the risks of government enforcement actions in response to any involve-ment in transactions with healthcare facilities and providers that may violate
Table of Contents“It Takes Two to Tango”—Increased Government Enforcement Against Individual PhysiciansPooneh Ghiassi, Esq. Douglas Wolford, Esq. .......................1
Medicare’s Recent Elimination of Consultation Codes—Intended and Unintended ConsequencesNicole DiMaria, Esq. ........................5
Seven Key Issues When Representing a Physician Entering Into His or Her First Employment AgreementMichael Schaff, Esq. Glenn Prives, Esq. .............................8
When is the Physician-Patient Relationship Formed? The Oregon Court of Appeals Clarifies, But Questions RemainStephen Bush, Esq ...........................11
Physician Organizations © 2010 is published by the American Health Lawyers Association. All rights reserved. No part of this publication may be reproduced in any form except by prior written permission from the publisher. Printed in the United States of America.“This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is provided with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice or other expert assistance is required, the services of a competent professional person should be sought.” —from a declaration of the American Bar Association
In-House Counselor
A Publication of the American Health Lawyers Association In-House Counsel Practice Group
Volume 16 • Issue 1 • January 2010
Too Much Information—The Use and Abuse of RVU Statistics in Physician CompensationJoseph V. Truhe, Jr., EsquireWaller Lansden Dortch & Davis LLP Franklin, TN
IntroductionSo you solved the problem of acquired physicians “retiring on the job” by adopting a work Relative Value Unit (wRVU) productivity compensation model? Now you can go back to figuring out how to make emergency room on-call payments without attracting the Office of Inspector General’s atten-
tion, right? Not so fast. Illustrating yet again that statistics can be dangerous in the wrong hands, the Medical Group Manage-
ment Association (MGMA), which publishes a widely used physician compensation survey, recently cautioned against building productivity-based compensation
models from survey data without understanding how to use it properly. One such problem stems from using MGMA’s report on compensation per wRVU without appreciating the difference between statistics and statistical
reasoning.
Productivity-Based CompensationResponding to the somehow unanticipated discovery that physicians who are paid flat
salaries by hospitals and other facilities, employing them after years in private prac-tice, suddenly decide not to work so hard, many have turned to productivity-based compensation models. A physician whose
compensation is based in whole or in part on wRVU productivity retires on the job at
a price. The model is simple enough. A unit of compensation per wRVU is selected and multiplied by the number of wRVUs actually performed over time. Endless variations, ranging from pure productivity as just
described, to base salaries with productivity bonuses and penalties triggered at thresholds,
Table of Contents
Too Much Information—The Use and Abuse of RVU Statistics in Physician CompensationJoseph Truhe, Jr., Esq, .......................1
Editor’s ColumnCharles Whipple, Esq., MHSA .........3
Discussion List Threads Compiled by Carla Gazes, Esq., and Charles Whipple, Esq., MHSA ..........4
Chair’s ColumnTeresa Williams, Esq. ........................7
In-House Counselor © 2010 is published by the American Health Lawyers Association. All rights reserved. No part of this publication may be reproduced in any form except by prior written permission from the publisher. Printed in the United States of America.“This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is provided with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice or other expert assistance is required, the services of a competent professional person should be sought.”
—from a declaration of the American Bar Association
Life Sciences
A Publication of the American Health Lawyers Association
Life Sciences Practice Group
Volume 4 • Issue 2 • May 2010
HIPAA Privacy and Security for Device and Drug Manufacturers: A Post-HITECH Refresher Robert Keenan, III, Esq. ....................1Board and Executive Certification
of Compliance Effectiveness: Implementation Implications of a Compliance Program Aligned With CIA TrendsJulie Edgeworth, MHA Bernard Ford, MBA Saul Helman, MD Julia Singleton David Yarin, MBA .............................6Prescription Drug Importation:
A Casualty of Healthcare ReformDavid Kopans, Esq. .........................12The Beginning of the End of the
Generic Preemption DefenseStephanie Rippee, Esq. Ceejaye Peters, Esq. ........................16
Table of Contents
Life Sciences © 2010 is published by the American Health Lawyers
Association. All rights reserved. No part of this publication may be
reproduced in any form except by prior written permission from the
publisher. Printed in the United States of America.“This publication is
designed to provide accurate and authoritative information in regard to
the subject matter covered. It is provided with the understanding that the
publisher is not engaged in rendering legal or other professional services.
If legal advice or other expert assistance is required, the services of a
competent professional person should be sought.” —from a declaration of the American Bar Association
HIPAA Privacy and Security for Device and Drug Manufacturers: A Post-HITECH Refresher
Robert M. Keenan, III, Esquire*King & Spalding LLP Atlanta, GA
IntroductionWhen the federal stimulus legislation was signed into law in February 2009,1 it
included profound changes to the privacy and security provisions of the Health
Insurance Portability and Accountability Act of 1996 (HIPAA).2 Among other
things, the Health Information Technology for Economic and Clinical Health
Act (HITECH Act) dramatically increased civil penalties for HIPAA violations,
introduced sweeping breach notification requirements, and made key provisions
of the HIPAA privacy and security rules directly applicable to HIPAA “business
associates” (BAs) for the first time. Although drug and device companies rarely
are HIPAA-“covered entities” subject to the full range of HIPAA requirements,
many such companies do enter into a variety of BA relationships with covered-
entity customers, and to that extent now are subject to dramatically increased
BA responsibilities and risk. This article's purpose is to provide a brief refresher
course on HIPAA-covered entity and BA status issues for device and drug compa-
nies, and to highlight the changes brought about by HITECH for
drug and device companies that are BAs.HIPAA-Covered Entities—GenerallyMany health lawyers have observed the widely
held but erroneous belief by the uniniti-ated that HIPAA applies to personal health information, regardless of where it is found. In fact, HIPAA applies to a surprisingly narrow scope of regulated entities. The HIPAA-regulated entities known as covered entities consist of the following three categories: (1) health plans; (2) “health care clearinghouses,” which are entities that receive data in a non-standard form and translate it into standard form, or vice versa; and (3) healthcare providers that transmit health
information electronically in connection with
Liability & LitigationSuccessfully Challenging
California Department of
Public Health Citations
Michael J. LeVangie, Esquire
Eric S. Emanuels, Esquire
Prout • LeVangie LLP
Sacramento, CA
Since 2005, we have actively worked to create a model for the cost-effec-
tive challenge of citations issued to our skilled nursing facility (SNF)
clients by the California Department of Public Health (CDPH). The
model that the authors have developed continues to show significant success,
and they believe it alters the “playing field” with CDPH. The authors have not
included many of the details of the program for obvious reasons. However, if
after reviewing this article you have more specific questions, the authors are
happy to discuss them.
Overview
In California, state surveyors, known as Health Facility Evaluator Nurses
(HFEN), perform annual inspections and respond to anonymous complaints
regarding the quality of patient care services. State regulation obligates HFENs
to respond to complaints unannounced. The HFEN will review portions of
the patient medical record and interview staff and other percipient witnesses.
If the case involves a patient transferred to a general acute-care hospital, the
HFEN will likely also review acute-care hospital records and speak with the
physicians involved in the care.
Following this initial investigation,
CDPH then determines whether the
complaint is “substantiated” or
“unsubstantiated.” To do this,
the HFEN prepares a draft
report and submits it to his or
her supervisor and a medical
consultant. A decision is then
collectively made to find the
complainant substantiated or
unsubstantiated.
This article addresses the proce-
dure for challenging a CDPH
Citation based upon alleged viola-
tion of state or federal regulations and
HealthcareA Publication of the
American Health Lawyers Association
Healthcare Liability and Litigation Practice Group
Volume 12 • Issue 1 • June 2010
Successfully Challenging
California Department of Public
Health Citations
Michael LeVangie, Esq.
Eric Emanuels, Esq. ..........................1
Practice Pointer: Deposing the
Plaintiff’s Expert
Sean Byrne, Esq. ...............................6
“Excessive Traction” and
Obstetrical Palsies: Are These
Claims Losing Traction?
James Rosenblum, Esq.
James Biondo, Esq. ..........................10
U.S. Government’s Prosecution of
Alleged Stark Violations Under
False Claims Act Results in
Split Verdict
Kelly Jolley, Esq. .............................13
Table of Contents
Healthcare Liability & Litigation © 2010 is published by the American
Health Lawyers Association. All rights reserved. No part of this publication
may be reproduced in any form except by prior written permission from
the publisher. Printed in the United States of America.“This publication
is designed to provide accurate and authoritative information in regard to
the subject matter covered. It is provided with the understanding that the
publisher is not engaged in rendering legal or other professional services.
If legal advice or other expert assistance is required, the services of a
competent professional person should be sought.”
—from a declaration of the American Bar Association
RAP SheetA Publication of the American Health Lawyers Association Regulation, Accreditation, and Payment Practice Group Volume 13 • Issue 1 • June 2010
Understanding Medicare’s Physician Supervision RulesThomas E. Bartrum, EsquireHannah M. Metzger, EsquireBaker Donelson Bearman Caldwell & Berkowitz PC Nashville, TN
T here was a time when Medicare’s varied and complex physician super-vision rules were beyond the purview of most healthcare attorneys. Instead, healthcare attorneys would structure the transaction, analyze
the self-referral and kickback concerns, obtain any necessary authorizations
to deliver the service and, if healthcare attorneys were lucky, ultimately close
the transaction, leaving the day-to-day operational aspects of delivery of the
service to other more clinically inclined folks. Unfortunately, our days of innocence are long behind us. For more than a decade now, not only have
healthcare attorneys had to focus on the operational details of whether a particular service is structured in a manner to facilitate adequate physician
supervision to bill Medicare, but healthcare attorneys have had to do so in a
landscape of shifting physician supervision rules, interpretations, clarifica-tions, and restatements. The Centers for Medicare & Medicaid Services (CMS) generally takes the approach that the provision of a service without the requisite level of physi-
cian supervision amounts to the delivery of care that is not “reasonable and
necessary for the diagnosis and treatment of illness or injury or to improve the
functioning of a malformed body member.”1 In other words, such services are
excluded from Medicare coverage under Section 1862(a)(1)(A) of the Social
Security Act.2 Accordingly, in order to ensure payment for services furnished
to Medicare beneficiaries, it is essential that the underlying service complies
with the applicable physician supervision standard.However, the difficulty arises in determining the applicable physician super-
vision standard. In an ideal world, we would be able to examine the service
itself and conclusively determine the level of physician supervision required.
However, under the various Medicare Part B physician supervision rules, it is
also necessary to determine where the service is being furnished and, ulti-mately, the statutory basis for payment. For instance, although the provision
of an “incident to” service or supply in a physician’s office and a hospital outpatient department both require “direct supervision,” CMS defines direct
supervision in a slightly different way in each setting. Further, the particular
setting in which a service is furnished may require one level of supervision
but the applicable Medicare coverage criteria for the service may require a
different, often higher level of physician supervision. This article will attempt
The
Understanding Medicare’s Physician Supervision RulesThomas Bartrum, Esq. Hannah Metzger, Esq. .......................1Tips for RAC Appeal StrategiesLisa Thompson, JD, MPH .................8
DME Surety Bonds—Only the Beginning of New Pay-to-Play Requirements? Donald Romano, Esq. .....................14A Highly Idiosyncratic Review of the 2010 Medicare Physician Fee Schedule Final Rule
Sean Timmons, Esq. ........................17
Table of Contents
The RAP Sheet © 2010 is published by the American Health Lawyers Association. All rights reserved. No part of this publication may be reproduced in any form except by prior written permission from the publisher. Printed in the United States of America.“This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is provided with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice or other expert assistance is required, the services of a competent professional person should be sought.” —from a declaration of the American Bar Association
Celebrate Diversity at the ‘RED’ ReceptionJune 28, 2010, Seattle, WA
AHLA’s Advisory Council on Diversity will host its annual ‘RED’ reception on Monday, June 28, 2010 from 5:30-6:30 pm as part of AHLA’s Annual Meeting. This special event celebrates diversity in the health law bar and provides a venue for members of diverse backgrounds to network with their AHLA colleagues and leadership.
Enjoy a relaxing and informal meeting with colleagues and friends who not only share your interest in healthcare law and policy, but also your commitment to furthering the Association’s diversity efforts and initiatives.
Please indicate on your Annual Meeting registration form if you would like to attend or contact Andrew Hartman at [email protected].
We are pleased to have this event sponsored by the AHLA Diversity Council in cooperation with the Minority Corporate Counsel Association.
72 AHLA Connections June 2010
Additional Listings: May be found in our National Job Bank. Go to: www.healthlawyers.org/jobbank Deadlines: Space reservations, copy, and payment are due on the 5th of the month prior to publishing. Copy for basic classifieds and contact information should be emailed in basic text format to [email protected]. Payment information should also be included in the email. For a copy of our media kit or for more information about Display, Classified, and Online advertising, please contact: Katy Shearman, Phone: (410) 584-1982, Fax: (410) 584-1998, Advertising: [email protected]
CaliforniaOakland, CA: Healthcare Provider Contracting and Transactional Attorney – Kaiser Permanente. Kaiser Permanente is currently seeking a Healthcare Provider Contracting and Transactional Attorney with 5+ years experi-ence in provider contracting with hospitals and other institutional providers. Additional experi-ence with large law firms and healthcare transactional work is preferred. Please visit www.jobs.kp.org and submit your resume to job # 000865. Kaiser Permanente is proud to be an EOE. Salary is commensurate with experience.
San Diego, CA: See Boston, MA listing for Staff Attorney at Mintz Levin Cohn Ferris Glovsky and Popeo PC.
San Francisco Bay Area, CA: Assistant General Counsel – Sutter Health. Sutter Health seeks an Assistant General Counsel to assist the Senior Vice President & General Counsel with at least 10 years experience in advising medical and health-care clients with emphasis in a nonprofit setting. The AGC role will have subject matter expertise in Business, Tax & Governance issues. The successful candidate must have a comprehensive understanding of tax-exempt healthcare entity structures including corporate and joint venture formation and ongoing operations mergers, acquisitions, and governance of tax-exempt healthcare providers. Other preferred experience includes
regulatory requirements and other operations issues related to ambulatory surgery centers, pharmacy, laboratory and home health and hospice agencies, abuse (Stark, Anti-kickback and False Claims Act) and a working knowledge of issues involving Medicare and Medicaid. Candidates with deep reimburse-ment expertise may qualify for a separate AGC position opening within the company. Extensive knowledge of providing legal advice to healthcare clients is required. Experience of working with or for an integrated health-care delivery system is desired. Sutter Health offers outstanding compensation and benefits. Our client has engaged Solutus Legal Search on an exclusive basis. Interested candidates, please submit resumes to [email protected] for consider-ation using reference # 135-SLS. Resumes submitted directly to Sutter Health will be forwarded to Solutus for evaluation.
ColoradoDenver, CO: General Counsel – The Colorado Permanente Medical Group PC. The Colorado Permanente Medical Group PC seeks to hire an attorney to serve as General Counsel. Candidates must possess a minimum of 8 years experience advising healthcare institutions (preferably physicians and physician organizations) and 5 years handling employment-related issues. CPMG offers excellent benefits, competi-tive salary, and an opportunity to be a part of the Colorado
Region of Kaiser Permanente. In 2009, KPCO was named the top-ranked commercial health plan in Colorado and the No. 1 Medicare plan in the U.S. Submit resume to: [email protected] and for more information visit us at: http://physician careers.kp.org/co/ & www.kaiser permanentejobs.org.
Greeley, CO: Associate General Counsel – Banner Health. Banner Health has an oppor-tunity for an Associate General Counsel position in Greeley, CO. Greeley is a beautiful community of approximately 90,000 with a home town atmosphere. We are a non-profit healthcare organiza-tion and our professionals are nationally recognized for excel-lence in a myriad of programs. Banner Health is seeking a highly motivated attorney to provide legal advice and services to management and medical staff in the areas of medical staff governance, credentialing, peer review, general contracting, and general hospital and healthcare operations. Working knowledge of, and some experience in, labor and employment issues is preferable. Candidates must also have 5-15 years of experience. Salary ranges between $120,000 and $167,000. Banner Health has all the benefits that come with working with a large health-care system such as: tuition reimbursement, growth oppor-tunities, relocation assistance, on-site childcare and more. We also offer on-site, expense paid interviews. For more information, please visit www.BannerHealth.
com or contact Elizabeth McKinney-Tobias at [email protected].
GeorgiaNorcross, GA: Assistant General Counsel – UHS-Pruitt Corporation. This AGC will primarily be responsible for trans-actions, specifically including acquisitions and financing/refi-nancing; corporate documents, applications and record mainte-nance; and licenses, intellectual property and various contract issues. Healthcare regulatory experience is a plus. Admission to or eligible for admission to the GA bar is required. Admission to practice in NC and/or SC is also a plus. Candidates shall expected limited travel. Competitive salary and benefits! For more information, please visit www.uhs-pruitt.com or contact Lori Pearson at lpearson@ uhs-pruitt.com.
IowaDavenport, IA: Associate Counsel – Iowa-based healthcare system. This position will advise, recom-mend and provide legal counsel to the organization under the supervision and direction of the Vice President of Legal Affairs, and provide quality legal services to the hospital. They will also be responsible for transactional legal services which may include new and existing physician agree-ments, purchase of physician practices, real estate matters, vendor contracts, and other third party agreements, including joint ventures.
healthlawyers.org 73
Possible candidates are preferred to have five years of experience practicing healthcare law with exposure to non-profit organizations while working in a large law firm, corporate, or healthcare law dept or legal setting. Salary is negotiable and benefits include: PTO; Holidays; Health Care and Dental; Vision; Life Insurance; ADD; Dependent Life Insurance; Supplemental Life; LTD; Prescription Plan; Flexible Compensation; Retirement; Employee Assistance; Jury Pay; Worker’s Comp; Tuition Assistance; Employee Health Service; Bereavement Pay; Credit Union; Tax Deferred Annuity; Cafeteria Discount; and Day Care Services. For more information, please visit www.mrgpeople.com. Interested candidates should send their resume to Dan Portes at [email protected] or contact him via phone using (563) 323-3333 or fax (563) 323-0767.
IndianaIndianapolis, IN: IT Attorney – Hall Render Killian Heath and Lyman PC. As the second largest health law firm in the United States, Hall Render Killian Heath & Lyman repre-sents health systems, hospitals, pharmaceutical companies, nursing homes, behavioral health authorities, graduate medical education programs, regional health information organizations and physicians in a wide variety of healthcare and technology related issues. We are currently seeking an IT attorney(s), with anywhere between three and twelve years of experience, for placement at our Indianapolis, Milwaukee or Troy, MI offices.
Excellent writing and client skills required. Responsibilities will include negotiating, drafting and reviewing an extensive range
of business and technology transactions, including complex technology contracts (software licenses, IT services, network access and outsourcing agree-ments), distribution, promotion, research, purchase/supply, and clinical agreements. The indi-vidual will also counsel clients on a wide range of U.S. laws.
Responsibilities include: managing legal aspects of client relationships, and assistance with regulatory and other compli-ance programs, including risk management; corporate gover-nance and transactional projects; and other duties as assigned. Familiarity with HIPAA, privacy and security matters highly desirable. For more information, please visit www.hallrender.com. Send resume, letter of interest and writing sample to Courtney Olson, Hall Render Killian Heath & Lyman PC, 2000 One American Square, Box 82064, Indianapolis, IN 46282 or email [email protected]. Hall Render Killian Heath & Lyman is an EOE. No phone calls please.
MassachusettsBoston, MA: Staff Attorney – Mintz Levin Cohn Ferris Glovsky and Popeo PC, a large international law firm with more than 400 attorneys in eight offices, is seeking a staff attorney to join our Health Law section in either of our Boston, DC, New York or San Diego office. Mintz Levin represents the full spectrum of healthcare providers and suppliers, insurers, industry lenders and investors, and facility owners, managers and developers. Our clients include independent hospitals, hospital systems, ambulatory service providers, managed care organi-zations, long term care facilities, medical device manufacturers and suppliers, clinical labora-tories, physicians, physician
groups, biotechnology and pharmaceutical companies, and real estate developers.
This individual would be assigned to the team respon-sible for a large provider client’s transactional work (e.g., mergers, acquisitions and joint ventures). Candidates must have at least 5 years of the following experience in the health industry: mergers and acquisitions, joint ventures, financing, contracting, and general corporate matters. Knowledge of the Stark Law and the Anti-kickback Statute a plus and strong writing and interper-sonal skills required. For more information, please visit www.mintz.com. Interested candidates should submit a resume to [email protected].
MarylandBaltimore, MD: Senior Compliance Auditor – The Johns Hopkins Health System Corporation. This position is responsible for the development, implementation, and ongoing monitoring of the Corporate Compliance Program with a particular emphasis on Billing Compliance and Compliance Education for the Johns Hopkins Health System Corporation and its affiliates. Responsibilities will include a risk assessment of affiliate service lines, development of audit plans, review of medical and billing records and drafting of an audit report.
Requirements include: Bachelor of Science in Nursing, Accounting, Business Administration, Hospital adminis-tration, or other related discipline; minimum of 10 years of experi-ence in healthcare, billing compli-ance, hospital management or other relevant experience; professional level of knowledge of billing practices and proce-dures; and in depth knowledge in
the areas of Medicare, Medicaid, and commercial insurance billing regulations. We invite you to apply online at www.hopkins-medicine.org/careers and refer to requisition # 28347.
MissouriSpringfield, MO: Senior Healthcare Attorney – St. John’s Health System. This is a newly created position in the Central Region of Mercy. Mercy is the 8th largest Catholic Healthcare System in the United States. It operates in seven states with 26 acute care hospitals, 36,900 coworkers and 4650 medical staff members. The Central region encompasses Mercy communities in southwest Missouri, southeast Kansas, and Arkansas. This position will be based in Springfield, MO working under the direction of the Mercy Central Region General Counsel. The Senior Attorney will provide legal counsel and advice including, but not limited to, transactions, compliance, contract drafting and review, physician compensation, development of new processes and products and supervision of outside counsel.
Requirements include: a minimum of 3 years of healthcare legal experience with significant exposure to HIPAA, compliance and fraud and abuse statutes; either a MO or AR license and eligibility for dual state licensure; and some travel within central region. Apply online at www.stjohns.com or contact Alan Chapman, St. John’s Health System Employment Specialist, at Phone: (417) 820-3387; Fax: (417) 820-7799; Toll Free: (800) 835-5199; or email [email protected].
76 AHLA Connections June 2010
accredited institution. 15 years of strong litigation experi-ence; experience in healthcare, government investigations and False Claim Act liability required; preferably with large corporate setting a plus. Candidates must
be proficient in legal research, including Westlaw and other research tools; working knowl-edge of databases; knowledge-able of the federal False Claims Act; and knowledgeable in Financial Accounting Standards
(FAS 5) Analysis. For more information, please visit www.tenethealth.com or contact [email protected].
WashingtonWashington, DC: See Boston, MA listing for Staff Attorney at Mintz Levin Cohn Ferris Glovsky and Popeo PC.
Advertising Index
AHLA ADR Service 3Affiliated Monitors, Inc. 39Butler Snow 33Coding Compliance Solutions 13 Compliance 360 Inside Front CoverJAMS 5K & L Gates LLP 7MediTract, Inc. Inside Back Cover
Navigant Consulting 11Pershing Yoakley & Associates Back CoverQHR Consulting 37Thomson Reuters 64University of Washington 61Value Management Group-VMG Health 29VantagePoint, LLC 61
healthlawyers.org 77
Annual Meeting and In-House Counsel ProgramBoston Marriott Copley Place and Westin Copley PlaceJune 26–29, 2011
American Health Lawyers Association
Save the Date!
ANNUAL MEETING SALE!Get 10% Off!
Missed a recent webinar? Wish that you could listen to it at your own leisure, on your computer, iPod, or iPhone? Webinar recordings are now available in a MP3 format for instant download on the AHLA website. Here is your chance to obtain great additions for your resource library at 10% off! The sale will occur at the Annual Meeting Resource Center and online during the Annual Meeting, June 27-30, 2010.
Practice Group-sponsored webinars are held throughout the year on hot topics with analyses of healthcare law-related issues and cases.
Please note that all recordings are accompanied with materials, and all past webinars starting with July 2009 also include a bonus MP4 recording (video format).
Our diverse inventory includes the following best-sellers:
Acquisition of Physician Practices by Hospitals (October 8, 2009)
Supervising Medicare Services: What You Need to Know in a Changing Landscape (December 8, 2009)
Breach Notification: A Case Study in Three Acts (January 6, 2010)
The Meaningful Use NPRM: An Overview and Path to EHR Incentive Payments for Your Organization and Clients, Part I: Overview of the Meaningful Use and Certified EHR Rulemaking (February 17, 2010) and Part II: Drill Down on Key Issues (March 4, 2010)
Fraud and Abuse Fundamentals, Part I: Anti-Kickback (February 18, 2010) and Part II: Stark Physician Self-Referral Law (March 10, 2010)
New Jobs Bill for Lawyers: Healthcare Reform—An Initial Analysis and Discussion of the Healthcare Reform Legislation (March 30, 2010)
Best Practices in Structuring Call Coverage and Indigent Care Services After OIG Advisory Opinion 09-05 (March 31, 2010)
Note: We no longer offer audio recordings and materials on CD.
Teleconference and Webinar Recordings
To purchase a recording of one of our past teleconferences/webinars at a sale price, please review our offerings on our website at www.healthlawyers.org/Webinars/Past from June 27-30, 2010, or visit our AHLA representative at the Annual Meeting Resource Center.
For a complete listing and more information about future webinars, please visit our webinar calendar at www.healthlawyers.org/Webinars.
www.healthlawyers.org/bookstore (800) 533-1637
Ambulatory Surgery Centers: Legal and Regulatory Issues, Fourth Edition
Enterprise Risk Management Handbook for Healthcare Entities, First Edition
AHLA’s Guide to Healthcare Legal Forms, Agreements, and Policies, First Edition
AHLA’s Federal Healthcare Laws & Regulations 2009-2010 Ed.
ORDER TODAY!
80 AHLA Connections June 2010
Last Word
Each year, I take pen (or cursor) in hand to thank members of the Board who are rotating off for their many contributions to the life of the American Health Lawyers Associa-tion. This column makes me nostalgic because as members of the Board reach the end of their terms, it is a concrete reminder of the passage of time both professionally and personally.
At my first Annual Meeting as CEO eleven years ago, each of my children could be comfortably carried in my arms as we made our way through the revolving doors of the Chicago Sheraton. This month, my eldest son who looks me squarely in the eye will graduate from high school followed next year by his younger brother. They will work this summer, as they transition to men, having responsibilities other than joining their dad in Seattle. As Board members “graduate,” it is a gentle reminder that time moves on, careers mature, children grow up, and orga-nizations benefit enormously from the labor of their volunteers. Graduations close the door on a special time in life, but they also open up a window to new opportunities. It is the stuff of life, and it leaves me nostalgic.
This year, three members of our Board will reach the end of their terms.
Myra Selby of Ice Miller in Indianapolis, IN, has graced the Board with her calm, deliberative approach to problem solving. This composure is balanced with a keen sense of humor and wit. When Myra leans in with a smile on her face and exposes a weak-ness in your argument or provides a contrary perspective, you realize simul-taneously that her logic is impeccable and that she has gained the upper hand with such grace that you didn’t even know you were outwitted. Myra has contributed to the life of our Associa-tion by chairing its Diversity Council, serving on numerous Board Commit-tees, serving on its ADR Task Force and as an arbitrator.
Cindy Wisner of Trinity Health in Farmington Hills, MI, often starts a meeting with a game or exercise to build a sense of camaraderie among her committee or team. She is known for creative problem solving and an incred-ibly strong intellect. Several people have said to me over the years that she might be one of the smartest health lawyers they know. She is a person of faith with a commitment to excellence in everything she undertakes. Cindy has chaired the Board’s Membership and Practice Group Committees, developing numerous initia-tives to increase member benefits. While she chaired the Membership Committee, the Association moved past the 10,000 mark in membership, an important mile-post in the organization’s growth.
Joel Hamme of Powers Pyles Sutter & Verville of Washington, DC, a longtime friend and neighbor in Falls Church, VA, finishes his year as Past President in June. Joel approaches issues by learning everything he can about them and then applying his considerable intellect to determining the wisest course. He also leavens his data-driven approach with a discerning sense of humor and sharp wit. Joel has contributed too much to the organization to recount in this word-limited article, but I would stress two themes – increasing member benefit and careful, proactive stewardship of the organization’s resources. Joel led in tumultuous economic times, and he would not abandon his desire to increase benefits for the members and improve the Association’s economic standing – simultaneously. He accomplished both, and we are all the better for it.
In the last magazine before the Annual Meeting, I also like to pay tribute to our outgoing President. Elizabeth Carder-Thompson has served the Association with grace, skill and diplo-macy for her entire tenure on the Board. In her presidential year, she has guided the Association through the uncertain-ties of a recession and a downturn in
revenues, always cheerfully confident that AHLA would weather the storm, serve members, and achieve success. She led the Association in its coverage of health reform. Elizabeth conducted interviews for this magazine with some of our nation’s most important and thoughtful healthcare experts. Readers appreci-ated the efforts she made to keep them informed on the changing health reform landscape. As a former Membership Committee chair, Elizabeth also focused her engaging personality, creativity and intellect on expanding the Association into the life sciences arena. This effort has been important in the organization’s effort to grow its membership.
One of Elizabeth’s priorities for the year was to show appreciation for AHLA staff, and she has done so time and again. Last week, she brought home-baked brownies over to the staff after our office move, a thoughtful gesture appreciated by everyone as they orga-nized their new offices. For Elizabeth, the professional and personal mesh in a refreshing, warm-hearted approach to leadership. The Board and the staff have appreciated her charismatic and effective tenure as head of the Association. We will miss her in this role, but are very glad that she will remain on the Board as Past President in fiscal year 2011.
Our Association is better for the participation of these Board volunteers, as well as the participation of many of you in other leadership positions who have been left unheralded in this article.
All are deserving of praise and gratitude for their contribu-tions. Thank you from a grateful staff.
PETER M. LEIBOLDExecutive Vice President, CEO [email protected]
Graduations