February 2019 Volume 23 Issue 2
For the health and life sciences law community
Feature Title (page xx)
Secondary Title (page xx)
Secondary Title (page xx) Telepharmacy: The Next Future in Telemedicine? —page 18 The Future of the General Acute Care Hospital—page 10 Compliance Corner—page 32
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AHLA Navigates Change with Continuing Commitment to Excellence
As the AHLA Board of Directors met in January for in-house, academia, compliance officers, etc.). I expect that its mid-year meeting, I was again thankful for the depth a final decision on the Board size will be made before the of commitment to AHLA shown by its numerous volunteers Annual Meeting in Boston and that any reduction will be and AHLA staff. Our focus is always on how best to serve the phased in over time. educational and other needs of our members while also serving Other proposals for governance changes focus on Board as a resource on select public interest issues. I am happy to committees. For example, while many AHLA activities fall report that due to the continuing work of so many of you, under the general heading of education, the educational AHLA continues to be the “go to” resource for excellent resources have often been overseen by committees that reflect educational health law content and a provider of important the way in which the particular resource is delivered to public interest resources. members. As a case in point, if the information is provided at One key initiative over the last two years has been to look an in-person meeting, it is currently overseen by the Programs at the governance of AHLA itself in light of association best Committee; a written publication is handled by the Profes- practices and the specific needs of our members. Last year this sional Resources Committee. One proposal is to change project resulted in the adoption of shorter term limits for new our committee structure to have an overarching Education members of Practice Groups, Program Planning Committees, Committee so that AHLA can oversee all educational resources and other volunteer groups in order to offer more opportunities regardless of how they are delivered to members. We expect that for volunteers to participate in these groups. Building on the this will make it easier to coordinate and maintain the excellent work of the Diversity+Inclusion Council, tools and training quality of AHLA resources upon which our members rely. were also provided to the leaders of AHLA’s volunteer groups In addition, the Public Interest Committee is looking at the so they could better achieve AHLA’s diversity and inclusion scope of its activities and how best AHLA may serve its public goals. These efforts have already shown significant results interest commitment. An evaluation of our dues structure and thanks to everyone’s efforts. branding is also underway by the Membership and Practice Our focus on corporate governance includes a review of Group Committees. the Board of Directors itself and its committee structure. A As many of you know from your work with clients and other special committee comprised of both Board and non-Board organizations, good corporate governance can be key to the long- members has been working for many months to determine term success of an organization. While evaluating these possible possible changes, with several submitted for continuing input changes, AHLA Board members and staff are committed to at the mid-year Board meeting. The Board has received advice continuing to provide excellent member benefits in a collegial from governance consultants and reviewed materials from environment as we all have come to expect from AHLA. the American Society of Association Executives. Yes, there is I look forward to providing further updates as this process even an association for association executives, which makes continues. sense given the complex and changing environment in which associations operate. Specific proposals include a possible reduction in the size of the Board, which the current By-Laws provide may be comprised of up to 28 directors. Best practices for nonprofit associations suggest that an optimal Board size may be smaller. However, key considerations for AHLA include the desire for input from a diverse group of directors in keeping with our Diversity Statement, which confirms that we value and seek to advance and promote diverse and inclusive participation “regardless of gender, race, ethnicity, religion, age, sexual orientation, gender identity and expression, national origin, or disability.” In addition, AHLA seeks to have its leadership Marilyn Lamar reflect a diversity of practice areas, geographic locations, and President, FY19 practice settings (e.g., large firm, small firm, solo practice, [email protected]
healthlawyers.org 1 Contents HEALTH CARE ARBITRATION 10 The Future of the General TRAINING Acute Care Hospital March 20-21, 2019 William T. Marshall considers how Baltimore, MD various factors may shift the control of the continuum of care from payers to consumers, and the potential implications and opportunities for general acute care hospitals.
18 Telepharmacy: The Next Future in Telemedicine? Darshan Kulkarni, Anjali B. Dooley, and Health Care Arbitration Training| March 20-21, 2019 | Baltimore, MD| Erin Grant discuss what telepharmacy Page 6 is and how it works, including its advantages, potential barriers to widespread use, and the laws shaping telepharmacy practice.
32 Compliance Corner: Building an Effective Compliance Program with Limited Resources Board of Directors
PRESIDENT *Marilyn Lamar, Liss & Lamar PC, Oak Brook, IL
PRESIDENT ELECT *Robert R. Niccolini, Ogletree Deakins, Washington, DC
PRESIDENT-ELECT DESIGNATE *S. Craig Holden, Baker Donelson PC, Baltimore, MD
IMMEDIATE PAST PRESIDENT *Eric Zimmerman, McDermott Will & Emery LLP, Washington, DC Departments *Timothy B. Adelman, Hall Render Killian Heath & Lyman PC, Annapolis, MD Mark A. Bonanno, Oregon Medical Association, Portland, OR *Dawn R. Crumel, Vanderbilt University Medical Center, Nashville, TN Gregory E. Demske, DHHS Office of the Inspector General, Washington, DC 1 First Reflections Kirk L. Dobbins, Kaiser Foundation Hospitals/Health Plan, Portland, OR Todd M. Ebersole, OptumRx Inc, Irvine, CA 6 Connections to Learning James F. Flynn, Bricker & Eckler LLP, Columbus, OH Anne W. Hance, BlueCross BlueShield of Tennessee, Chattanooga, TN Maryam Khotani, Pharmacyclics, an AbbVie company, Sunnyvale, CA 7 Focus On Mark S. Kopson, Plunkett Cooney PC, Bloomfield Hills, MI Joanne R. Lax, Southfield, MI 8 Member Service Amy S. Leopard, Bradley, Nashville, TN Kim Harvey Looney, Waller Lansden Dortch & Davis LLP, Nashville, TN 16 Member News Patricia A. Markus, Nelson Mullins Riley & Scarborough LLP, Raleigh, NC R Harold McCard Jr., Quorum Health Corporation, Brentwood, TN Linda Sauser Moroney, Manatt Phelps & Phillips LLP, Chicago, IL 26 Women’s Network *Cynthia Y. Reisz, Bass Berry & Sims PLC, Nashville, TN Asha B. Scielzo, American University Washington College of Law, Washington, DC 28 Communities *Thomas N. Shorter, Godfrey & Kahn SC, Madison, WI *Toby G. Singer, Chevy Chase, MD Christine L. White, Northwell Health, New Hyde Park, NY 30 Young Professionals *Executive Committee
YOUNG PROFESSIONAL DELEGATE TO THE BOARD 35 Career Center Jennifer Wooten Ierardi, Northwestern Memorial Health Care, Chicago, IL
EXECUTIVE STAFF David S. Cade, Executive Vice President/CEO Wayne Miller, Deputy Executive Vice President/Chief Operating Officer Cynthia Conner, Vice President of Publishing Kerry B. Hoggard, CAE, Vice President of Membership and Public Interest Anne Hoover, Vice President of Programs
2 AHLA Connections February 2019 Jon Burroughs, MD, MBA, FACHE, FAAPL
A national healthcare administration consulting practice and expert witness with an emphasis in: • Physician engagement and alignment strategies • Medical Staff redesign President and CEO, The Burroughs Healthcare Consulting Network, Inc. • Physician performance management strategies Winner of the 2016 James A. Hamilton Award • Negligent credentialing/privileging/peer review for Outstanding Healthcare Management Book of the Year “Redesign the Medical • Fair/Judicial Hearings Staff-A Collaborative Approach” • Medical Staff Bylaws, Policies/Procedures, Rules Mobile: 603-733-8156 and Regulations [email protected] • Population Health and Clinical Integration www.burroughshealthcare.com
“We appreciate Dr. Burroughs’ hard work and flexibility. He did a terrific job for the defense.” — Peter Eidenberg, Esq. / Keating, Jones & Hughes, PC / Portland, Oregon
“Dr. Burroughs did an excellent job for the medical staff in a difficult and complex fair hearing and contributed significantly to a positive outcome for the medical staff and healthcare system.” — Patrick Moore, Esq. / Patrick K. Moore Law Corporation / Irvine, CA
“I retained Dr. Jon Burroughs recently on a difficult and complex case. Jon thoroughly addressed the issues, provided fantastic insight and literature, and gave a spotless deposition! Highly recommended!” — James Ball, Esq. / The Ball Law Group / Chicago, Illinois
“In addition to providing a thorough review and extraordinarily detailed report, Dr. Burroughs takes the time to break down difficult concepts in all aspects of hospital administration. Dr. Burroughs gives attorneys the tools necessary to present very strong system failure cases. He exceeds all expectations to include giving a rock solid deposition. I highly recommend Dr. Burroughs.” — Carol Hay, Esq. / Las Vegas, Nevada
healthlawyers.org 3 AHLA Speaking of Health Law
Executive Vice President/CEO: David Cade Publisher: Cynthia Conner Editor in Chief: Ana Greene Creative Director: Mary Boutsikaris Graphic Designer: Jen Smith Senior Managing Editor: Bianca L. Bishop Senior Legal Editor: Lisa Salerno Associate Editor: Matt Ausloos AHLA CONNECTIONS 1620 Eye Street NW, 6th Floor, Washington, DC 20006-4010 202.833.1100 [email protected] www.healthlawyers.org/connections ADVERTISING INQUIRIES Samantha Leland, MCI Group 410.584.1996 Conversations with [email protected] www.ahla-mediaplanner.com/
PRINTED ON RECYCLED PAPER AHLA Leadership COPYRIGHT/REPRINT PERMISSION: Further reprint request should be directed to: AHLA Editorial, 1620 Eye Street, NW, 6th Floor, Washington, DC 20006-4010 This Podcast Episode: Marilyn Lamar, AHLA President [email protected]. VIEWPOINT/WRITERS’ GUIDELINES AHLA Connections must retain full copyright or an unlimited license before publishing. Factual accuracy and opinion contained in articles published in AHLA Connections are the respon- sibility of the authors alone and should not be interpreted as representing the views or opinions of the Association. AHLA is a non-partisan educational organization that does not take positions on public Join us for our new series! policy issues and instead provides a forum for an informed exchange of views. Guidelines available at www.healthlawyers.org/connections or contact Craig Hunter of Coker Group interviews AHLA President, [email protected]. Marilyn Lamar, and finds out her goals for the MISSION The Mission of the American Health Lawyers upcoming year and what excites her in health law. 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 educa- You don’t want to miss it! tional programs, products, and services concerning health law issues; and to serve as a public resource on selected health care legal issues. SPONSORED BY: AHLA DIVERSITY+INCLUSION STATEMENT In principle and in practice, the American Health Lawyers Association values and seeks to advance and promote diverse and inclusive participation within the Association regardless of gender, race, ethnicity, religion, age, sexual orientation, gender identity and expression, national origin, or disability. Guided by these values, the Association strongly AHLA Connections (ISSN1949-9035) is published monthly (12 times a year) by the American Health encourages and embraces participation of diverse Lawyers Association (AHLA), 1620 Eye Street, NW, 6th Floor, Washington, DC 20006-4010. The price individuals as it leads health law to excellence of an annual subscription for AHLA members ($45) is included inseparably in their dues. Annual through education, information, and dialogue. subscription for non-members is $105. Title registered U.S. Pat. And TM office ©2019 by AHLA, All rights reserved. Printed in the United States. Periodicals postage paid at Washington, DC, and additional mailing offices.
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4 AHLA Connections February 2019
Connections to Learning
February 7 26 Payers, Plans and Lawyers New to Health Managed Care Group Care—Gaining the Edge: 4-6 Educational Call/Open A Panel Discussion for Physicians and Hospitals Member Call, featuring the Young Professionals Law Institute Health Plan Affinity Group and Law Students Grand Hyatt San Antonio San Antonio, TX Platinum Sponsor: HORNE LLP 12 27-March 1 ACE Affinity Group Long Term Care and Gold Sponsors: PYA and Educational Call the Law SullivanCotter Sheraton Grand Phoenix Silver Sponsor: HealthCare Phoenix, AZ Appraisers, Inc. 13 Plante Moran, Principle Valuation, • Feb 4—Antitrust and Physicians and PYA have provided sponsorship Organizations Practice Group Beyond Advance in support of this program. Luncheons Directives: What Attorneys Need to Know About • Feb 27—Networking and Diversity • Feb 4—Networking and Diversity Advance Care Planning +Inclusion Reception, hosted by +Inclusion Reception, hosted by AHLA’s Diversity+Inclusion Council, AHLA’s Diversity+Inclusion Council, Don’t Forget about the States! The sponsored by Plante Moran PLLC, sponsored by HORNE LLP Powers of State Attorneys General to Impose Conditions in Order to Principle Valuation LLC, and PYA • Feb 5—Labor and Employment Approve Transactions–Antitrust • Feb 28—Post-Acute and Long and Medical Staff, Credentialing, Educational Call Term Services Practice Group and Peer Review Practice Group Luncheon Luncheons • Feb 5—Networking Breakfast and 19 Table Topic Discussions, hosted March by AHLA’s Women’s Leadership Highlights of the 2019 Council, sponsored by Pinnacle Medicare Physician Fee Healthcare Consulting Schedule 20-21 • Feb 6—Health Information and Tech- Health Care Arbitration nology Practice Group Luncheon, Training sponsored by HORNE Cyber 20 Baltimore Marriott Waterfront Hotel How to Make the AHLA Baltimore, MD Dispute Resolution 6 Service Work for You Regulation, Accreditation, and Payment Practice Group Educational Call
Educational Call Leadership Opportunity For more information on all In-Person Program, Training Member Event AHLA events and to register, go to www.healthlawyers.org/events or Webinar Networking, Reception call (202) 833-1100, prompt #2. Free Volunteer Opportunity
6 AHLA Connections February 2019 Connections to Learning
20-22 June 16-18 Institute on Medicare and Fundamentals of Medicaid Payment Issues Health Law Baltimore Marriott Waterfront Hotel 23 Chicago Marriott Magnificent Mile Baltimore, MD In-House Counsel Program Chicago, IL PYA has provided sponsorship in Boston Marriott Copley Place support of this program. Boston, MA • March 20—Regulation, Accredita- Focus On tion, and Payment Practice Group Technology Solutions Luncheon 24-26 • March 20—Networking and Diver- Annual Meeting sity+Inclusion Reception, hosted Boston Marriott Copley Place by AHLA’s Diversity+Inclusion Boston, MA LW Consulting Inc Council, sponsored by PYA 5925 Stevenson Avenue Harrisburg, PA 17112 (800) 320-5401 April September www.lw-consult.com/ 11 25-27 Fraud and Compliance AHLA Day Ntracts Inc Forum 212 West 10th Street, Suite D395 Renaissance Harborplace Hotel Indianapolis, IN 46202 Baltimore, MD (317) 912-1513 May www.ntracts.com 1-3 October Health Care Transactions JW Marriott Nashville Hotel 21-22 Nashville, TN Tax Issues for Health Care PYA Platinum sponsor: PYA Organizations One Cherokee Mills 2220 Sutherland Avenue Gold Sponsor: HORNE LLP, Veralon The Ritz Carlton Hotel Pentagon City Knoxville, TN 37919 Silver Sponsor: HealthCare Arlington, VA www.pyapc.com Appraisers, Inc. LinkedIn: https://www.linkedin.com/ company/pyapc/ • May 1—Networking and Diversity Twitter: @PYAHealthcare +Inclusion Reception, hosted by November AHLA’s Diversity+Inclusion Council, sponsored by PYA 14-15 Visit the AHLA Business • May 2—Networking Breakfast and Institute for Health Plan Table Topic Discussions, hosted Directory online at Counsel by AHLA’s Women’s Leadership www.healthlawyers.org/ Council Chicago Marriott Downtown resources to find more Magnificent Mile • May 2—Business Law and Gover- Chicago, IL service providers and nance Practice Group Luncheon, sponsored by SullivanCotter other categories.
healthlawyers.org 7 Member Service
Volunteer Recognition: November 2018
AHLA has a wonderful tradition of members sharing their expertise and insight with each other. Members generously donate their time and energy through speaking, writing, and other service to the organization. Volunteers are the heart of the Association—thank you for all you do!
PROGRAMS AND DISTANCE LEARNING Jeff Joseph Wurzburg, Norton Rose Fulbright Educational Calls Christopher Yook, King & Spalding LLP Accreditation, Certification, and Barbara Jane Youngberg, Loyola University In-Person Programs Enrollment AG Educational Call Chicago College of Law Beazley Institute for Emily W. G. Towey, Hancock Daniel & Fundamentals of Health Law Health Law and Policy Johnson PC Christopher B. Anderson, Jones Day Institute for Health Plan Counsel Thomas D. Anthony, Frost Brown Todd LLC Antitrust PG Educational Call Brian C. Betner, Hall Render Killian Heath Michael Apolskis, Health Care Service Michael Moiseyev, Federal Trade Commission & Lyman PC Corporation Maria Raptis, Skadden Arps Slate Meagher Annapoorani Bhat, PYA Miranda L. Berge, Hogan Lovells US LLP & Flom LLP Anthony H. Choe, Polsinelli PC Thomas Bixby, Thomas D. Bixby Law Brian Savage, Teva Pharmaceuticals Office LLC Ritu Kaur Cooper, Hall Render Killian Enterprise Risk Management TF Kimberly Brandt, Centers for Medicare Heath & Lyman PC Educational Call & Medicaid Services Caroline Lindsay Farrell, DHHS Office of Michaela D. Poizner, Baker Donelson Lisa M. Campbell, Groom Law Group the General Counsel Bearman Caldwell & Berkowitz PC Theresa Claffey Carnegie, Mintz Levin Cohn Randall R. Fearnow, Quarles & Brady LLP Fay A. Rozovsky, The Rozovsky Group Inc Melesa A. Freerks, Foley & Lardner LLP Ferris Glovsky & Popeo PC Fraud & Abuse Fridays Marc D. Goldstone, Prime Healthcare A. Courtney Cox, Blue Shield of California Kimberly Brandt, Centers for Medicare Services Inc Edward Crooke, U.S. Department of Justice & Medicaid Services Jeanna Palmer Gunville, Polsinelli PC Gary Scott Davis, McDermott Will & Vicki L. Robinson, DHHS Office of the Carla J. Hartley, Dillingham & Murphy LLP Emery LLP Inspector General Carol A. Hendry, Providence Health & Ankur J. Goel, McDermott Will & Emery LLP Lisa Ohrin Wilson, Centers for Medicare Services Beth Connor Guest, Cigna & Medicaid Services Donn H. Herring, Spencer Fane LLP Steven D. Hamilton, McGuireWoods LLP William W. Horton, Jones Walker LLP Anne W. Hance, BlueCross BlueShield of Health Information and Technology PG Jennifer C. Hutchens, Robinson Bradshaw Tennessee Educational Call & Hinson PA Lisa A. Hathaway, Aetna Inc James Cannatti, Brouse McDowell LPA Albert D. Hutzler, HealthCare Appraisers Inc Kirstin Ives, Falkenberg Ives LLP Amanda L. Enyeart, McDermott Will & Travis F. Jackson, King & Spalding LLP William H. Jordan, Alston & Bird LLP Emery LLP William Chris Jenkins, Blue Cross of Idaho Dina A. Kasper, Cigna Malpractice Trends in Pediatric Hospitals Health Services Inc David E. Kopans, Jones Day Mary Anne Hilliard, Children’s National David E. Kopans, Jones Day Amy L. Mackin, Hall Render Killian Heath & Health System Kim Harvey Looney, Waller Lansden Dortch Lyman PC Julie Watson Lampley, Butler Snow LLP & Davis LLP Kate McDonald, McDermott Will & Emery LLP Greg Larcher, Aon Risk Solutions Steven M. Mitchell, U.S. Department of David McFarlane, Crowell & Moring LLP Health and Human Services, Office of Erin McKenna, Aetna Inc Regulation, Accreditation, and Payment PG Civil Rights Emily A. Moseley, Strategic Health Law Educational Call Michael E. Paulhus, King & Spalding LLP Kirk J. Nahra, Wiley Rein LLP Alan H. Einhorn, Foley & Lardner LLP Brooks Newman, Humana Inc Robert A. Pelaia, University of South Florida Update on State and Local Tax Issues: How Mark Newsom, Humana Inc Iliana L. Peters, Polsinelli PC South Dakota v. Wayfair Impacts Healthcare Barbara Otto, Smart Policy Works James Max Reiboldt, Coker Group Organizations Patrick D. Pilch, BDO USA Terra Reynolds, Latham & Watkins LLP Al Mercier, Crowe LLP Kathryn A. Roe, Health Law Consultancy Todd Presnell, Bradley Arant Boult Michael F. Schaff, Wilentz Goldman & Cummings LLP Spitzer PA Archana Rajendra, CareSource Thomas Spellman, Fresenius Medical Care Michelle M. Rothenberg-Williams, Anthem North America Blue Cross and Blue Shield Judith A. Waltz, Foley & Lardner LLP Courtney Schoenfeld, AMITA Health Linda A. Wawzenski, U.S. Attorney’s Office, Jean Wright Veilleux, Mission Health Northern District of Illinois Teresa A. Williams, Integris Health
8 AHLA Connections February 2019 Member Service
Webinars Podcasts MedStaff News Rachel Fleischer, The Joint Commission Modernizing the Stark Law: Anti-Kickback Speaking of Health Law—Conversations with Lindsay Maleson, Nixon Peabody LLP Statute and Beneficiary Inducement CMPs for AHLA Leadership Eric J. Neiman, Lewis Brisbois Bisgaard & Value-Based Care Craig Hunter, Coker Group Smith LLP Shira Nicole Hollander, American Hospital Marilyn Lamar, Liss & Lamar PC Sharon C. Peters, Lewis Brisbois Association Speaking of Health Law—The Lighter Side of Bisgaard & Smith LLP Nesrin Garan Tift, Bass Berry & Sims PLC Health Law Blake H. Reeves, Polsinelli PC Navigating Indemnification Obligations in a Norman G. Tabler Kathryn E. Spates, The Joint Commission Health Care Transaction: Managing Health Maureen M. Vogel, Polsinelli PC Care Liability Practice Group Alerts Carly Eisenberg Hoinacki, Epstein Becker & MATCHED MENTORS AND MENTEES Green PC New Guidance on HSR Reporting Require- ments for Not-for-Profit Affiliations Andrea M. Praeger, J&H Marsh & McLennan Mentors Jodi Rosensaft, Marsh Inc Steve Vieux, Shook Hardy & Bacon Igor Gorlach, King & Spalding LLP Survey and Certification Issues for Co-Located Practice Group Bulletins Jamie Katz, Beth Israel Deaconess Medical Clinics—Provider-Based and Freestanding Center Colin P. McCarthy, McGuireWoods LLP Breaches of Fiduciary Duty, the BJR and Tatiana Melnik, Melnik Legal David R. Wright, Centers for Medicare and Exculpatory Clauses: D&O Liability in the Ethan Rii, Vedder Price Medicaid Services Context of a Bankrupt Hospital Dowin Coffy, Land of Lincoln Legal Cori Turner, Husch Blackwell LLP Assistance Foundation Inc PUBLICATIONS, RESOURCES, AND Mentees PERIODICALS Delaware Court Finds a Material Adverse Effect, Allowing Termination of Merger Colleen Anderson, University of Iowa College of Law AHLA Connections Agreement Annette M. Bevans, Hofstra University Danielle Holley, O’Connell & Aronowitz PC The 2019 Part D Final Rule Maurice A. Deane School of Law Syed Madani, Michael Best & Friedrich LLP T. Mitchell James, ViiV Healthcare Bhavesh Modi, Texas Attorney General Delivering Virtual Pediatric Care Across State Shannon L. Wiley, Bass Berry & Sims PLC Office—Civil Medicaid Fraud Division Lines: Regulatory Barriers and Opportunities Abby Nash, Abby S. Nash PC Navigating Indemnification Obligations in a Katie Boyer, Nemours Children’s Health Emely Sanchez, University of Miami School Health Care Transaction System of Law Carly E. Hoinacki, Epstein Becker & Maya Uppaluru, Crowell & Moring LLP Green PC New NPDB Guidebook Expands Entity Anjana D. Patel, Epstein Becker & Green PC Reporting Obligations Relating to Clinical Policy and Procedure Best Practices Privilege Actions and Makes Other Changes Opt-In to the Melissa Borrelli, Mazars USA LLP Alexis L. Angell, Polsinelli PC Robin Locke Nagele, Post & Schell PC Q&A: AHLA Mentoring Program Offers a Volunteer Pool “Leg Up” for Young Professionals Recent CMS Expansion of Reimbursement Carol Carden, PYA Opportunities for Providers of Telehealth and Complete Your Kathryn A. Culver, PYA Services Heather Alleva, Buchanan Ingersoll & Speak Up: Insights from an AHLA In-Person Volunteer Profile Rooney PC Program Speaker AHLA has revised the volunteer Annapoorani Bhat, PYA Settlement Reached Between Atrium Health and DOJ on Anticompetitive Steering process. To opt-in to the Volunteer Pool and complete your Volunteer AHLA Weekly Restrictions Shaina Vinayek, Crowell & Moring LLP Profile, visitwww.healthlawyers. Grappling with Site Neutral Medicare org/volunteer. This will help us Payments: Hospitals Unhappy with New CMS Practice Group Newsletters know what kind of volunteer Policies in 2019 OPPS Final Rule opportunities you are interested Baylie M. Fry, BakerHostetler LLP Labor & Employment in. Going forward, you will receive Jennifer P. Whitton Leipow, Timothy J. Buckley, Seyfarth Shaw LLP email alerts when we think you’ll BakerHostetler LLP Anthony S. Califano, Seyfarth Shaw LLP be a good fit for a new volunteer Hannah M. Caplan, Brownstein Hyatt Farber opportunity. Welcomed Whiplash: National Labor Schreck LLP Relations Board Set to Change Joint Kristin G. McGurn, Seyfarth Shaw LLP Employment Standard (Again) Martine T. Wells, Brownstein Hyatt Farber Jaklyn Wrigley, Fisher & Phillips LLP Schreck LLP Jaklyn Wrigley, Fisher & Phillips LLP healthlawyers.org 9 The Future of the General Acute Care Hospital
William T. Marshall
ince the enactment of the Affordable Care Act in 2010 money from the ultimate payer to the seller. However, unlike (ACA), there has been an effort by commercial health other industries, in the current health care delivery system, the care insurers (CHIs) to control what is often referred ultimate consumer (the patient) is not truly aware, nor has had to as the continuum of care in the health care industry. the incentive to know, the amount that those in the continuum SAll general acute care hospitals (General ACHs) in the United of care are being paid and why. This lack of consumer aware- States are feeling the pressure of declining margins as Medicare ness has essentially granted the CHIs the patients’ de facto and Medicaid limit reimbursement and as CHIs pursue more proxy in the continuum of care, which means CHIs have vertical integration. If this vertical integration of payers and substantial influence in the decision making that occurs in providers persists, General ACHs may continue to experience health care. falling inpatient volumes and reimbursement levels. It is possible that the future direction of health care can Health industry spending is approaching 18% of the Gross shift if the consumer—i.e. the patient—becomes a more National Product.1 Meanwhile, the population is aging, and informed and engaged decision maker. This scenario may play chronic conditions are increasing around the world. Health out as patients shoulder an increasing portion of their health care costs for the next decade are expected to rise at more than care costs through higher premiums and deductibles. With the twice the rate of the Consumer Price Index, the rate that Social help of new technology, and the increased push for the interop- Security cost-of-living adjustments are pegged, and 64% of erability of medical records and price transparency, CHIs may pre-retirees, including those who are affluent, are “terrified” by no longer have the patients’ de facto proxy along the continuum the health care costs of their retirement plans.2 of care. Each participant in the health care delivery chain is trying This article discusses the current influence third-party to maximize its percent of the profit dollars that flow through payers, and CHIs in particular, have on the continuum of care the health care delivery system. This delivery system, like any while acting as the de facto proxy of the patient. The article other industry, begins with the consumer (the patient) and ends then considers how various factors may shift the control of the with the seller (the service provider). Like other industries, such continuum of care from payers to consumers, and the potential as retail goods, there are many other parties in the delivery implications and opportunities for the future of General ACHs. system responsible for various functions in transferring the
10 AHLA Connections February 2019 It is possible that the future health care service providers. These network agreements often include Physician Hospital Organizations (PHOs), Inde- pendent Practice Associations (IPAs), Clinically Integrated direction of health care can Networks (CINs), and Financially Integrated Networks (FINs). By growing these networks, CHIs have the ability to carve out shift if the consumer—i.e. “high-cost” hospitals or certain services from contracts, which will mean lower volume and revenues for General ACHs.3 Even the patient—becomes a health care investors are steering away from large General ACH systems and instead focusing investments on urgent care, home more informed and engaged health, micro-hospitals, and other specialty inpatient facilities.4 To increase their bargaining power in the continuum of care, General ACHs have been employing physicians in large decision maker. numbers. Hospitals employed 42% of physicians in July 2016, up from 25% of physicians in July 2012.5 The goal of these hospital systems is to become an integrated delivery system CHIs’ Influence on the Continuum of Care that can be centrally managed with a fixed budget. But the CHIs do not carry the hefty overhead of full-service General centrifugal forces that could disrupt those plans are gathering ACHs and are able to vertically integrate and provide preven- speed. Outside capital is being poured into stand-alone imaging tive, outpatient, and post-acute care to their insured customers and procedure centers, storefront and workplace clinics, and at lower cost. As part of efforts to vertically integrate, CHIs concierge-style primary care practices. These outside forces often enter into network agreements with certain hospitals, have business models that depend on the eventual disaggre- primary care physicians, specialty care physicians, and other gation of the continuum of care. The General ACH systems cannot afford to ignore those threats.
healthlawyers.org 11 Those General ACHs that do not adapt to the current evolving continuum of care could get squeezed out.
Could a Knowledgeable Consumer Change the Future of the Continuum of Care? CHIs are currently dominating the continuum of health care. Could a more knowledgeable consumer impact where the health care industry goes next? The current administration certainly seems to think so. Citing her own personal experience with a disjointed health care delivery system, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma unveiled a new federal initiative—”MyHealthEData”—aimed at advancing a patient-centered health care system.7 While short on details, the idea behind the initiative is that health data follows the patient and allows information to be shared seamlessly with health care providers at the push of a button. The Trump administra- tion believes the initiative will help empower patients, ulti- mately driving down health care costs and improving health outcomes.8 Despite the significant initial financial losses in the indi- New technology-savvy players also are entering the market vidual market after the ACA took effect, CHIs’ profitability in to meet growing consumer demands for control of their health the individual market has rebounded of late. CHIs remaining in information. For example, Apple and 13 prominent health care the individual and small group markets seem to have accounted centers, including John Hopkins and the University of Pennsyl- for the ACA’s insurance market reforms and the older, more vania, recently disclosed an agreement that would allow Apple costly risk pools by charging higher premiums largely subsi- to download onto its various devices the electronic health data dized through federal premium tax credits. Large CHIs, many of those systems with the patients’ permission.9 of whom left the individual market, also are profiting from On January 24, 2018, Apple introduced a significant the Medicaid expansion, which is primarily provided through update to its Health App, debuting a feature for customers private managed care and paid for by the federal government. to see their medical records on their iPhones. The updated Since the ACA’s implementation on January 1, 2014, health Health Records component within the Health App makes insurance stocks outperformed the S&P 500 by 106%.6 it easy for consumers to see their available medical records These factors may enhance CHIs’ ability to grow further across participating providers on demand instead of piecing and direct more patients to lower-cost entities, effectively their information together manually from multiple provider marginalizing General ACHs. Those General ACHs that do platforms. According to the company, “Apple worked with the not adapt to the current evolving continuum of care could get health care community to take a consumer-friendly approach, squeezed out. creating Health Records based on Fast Healthcare Interopera-
12 AHLA Connections February 2019 bility Resources (FHIR), a standard for transferring electronic medical records.”10 Now nearly 40 health systems have part- nered with Apple to contribute medical records to the tech company’s updated Health Records section for iPhone. The new records section, which is still in beta mode, allows customers to view their medical records with the Health App. Twelve health systems, including heavy hitters like Geisinger, Johns Hopkins Medicine and MedStar Health, were name-dropped as partners in their original January 2018 release. Apple has made E-HEALTH DATA the feature available to anyone who updates their phone’s IOS software to the latest version.
Today’s patients must be viewed in the same way Implications and Opportunities for General ACHs other industries learned a Current trends—i.e., increased consumer cost-sharing, greater consumer engagement, and calls for transparency—have implications for General ACHs but also present opportunities decade ago to see their core to shape their future. General ACHs have fallen behind other business sectors customers: as empowered like retail or financial services when it comes to engaging consumers in the decision-making process. As consumers are shielded less and less by their insurers from the growing cost consumers who want a of health care, incentives for patients to participate actively in the continuum of care will drive greater demand-side value. cohesive experience in the General ACHs can use this opportunity to position themselves to show value to their communities by improving their opera- tional processes, offering greater transparency, and striving to health care marketplace more fully engage their patient base.11 Today’s patients must be viewed in the same way other from touchpoint to their last industries learned a decade ago to see their core customers: as empowered consumers who want a cohesive experience in the health care marketplace from touchpoint to their last encounter. encounter. General ACHs that fail to adapt to this changing market- place could be replaced with micro-hospitals, specialty hospitals, outpatient facilities, walk-in clinics, independent laboratories, and other specialty low-cost providers of hospital care.
healthlawyers.org 13 William T. Marshall 1 Medicare Payment Advisory Comm’n, Report to Congress: Medicare Payment , BSBA, CPA (inactive), Policy, p. xiv (Mar. 2018). MBA, JD has extensive experience in complex 2 IIana Polyak, Clients are living longer-How will your practice adapt?, J. Of issues inherent in health care laws that affect Accountancy (Mar. 2018). hospitals, physicians, and other health care 3 Moody’s Investor Services, In-Depth: Not-for-profit and public healthcare-US providers. After working for HCA in their Hospitals face new threat from health Insurers’ disruptive growth strategies, https://www.moodys.com/researchdocumentcontentpage.aspx_docid=PBM corporate headquarters in Nashville, TN and at (subscription required); Press Release, https://www.moodys.com/research/ their owned 342-bed general acute care hospital, which was in Moodys-Health-insurers-disruptive-growth-strategies-threaten-NFP-hospi- Little Rock, Arkansas, he has provided representation in private tal-volume-PR_379801. practice in Little Rock, Arkansas to health care providers for 4 McGuire Woods Healthcare and Life Sciences Private Equity & Finance Conference, Feb. 2018, Track C: Focused Hospitals Investments: Psych more than 37 years related to a wide range of strategic, regula- Hospitals, Micro Hospitals, Surgical Hospitals, Specialty Hospitals and Other tory, tax, and transactional matters. Bill has a BSBA, MBA and Hospital Investments, Jeffery M. Peterson, Partner, McGuire Woods, LLP. JD, all with honors, from the University of Arkansas. Bill is also 5 Physician Advocacy Inst., Updated Physician Practice Acquisition Study: a CPA (Inactive). He is listed in The Best Lawyers in America National and Regional Changes in Physician Employment 2012-2016, Mar. 2018, http://www.physiciansadvocacyinstitute.org/Portals/0/assets/ for health care and has an AV rating from Martindale-Hubbell. docs/2016-PAI-Physician-Employment-Study-Final.pdf. 6 See Rachel Fehr, Cynthia Cox and Larry Levitt, Individual Insurance Market Performance in Mid-2018, Oct, 5, 2018, Henry J. Kaiser Family Found., https://www.kff.org/health-reform/issue-brief/individual-insurance-mar- ket-performance-in-mid-2018/. Thanks go out to the leaders of Hospitals and 7 CMS Administrator Seema Verma, Speech: Remarks at the Health Informa- Health Systems Practice Group (HHS PG) for tion and Management System Society Trade Show, IMSS18 Conference, contributing this feature article: Emily Black Grey, Mar. 6, 2018, https://www.cms.gov/Newsroom/MediaReleaseDatabase/ Press-releases/2018-Press-releases-items/2018-03-06-2.html. Breazeale Sachse & Wilson LLP, Baton Rouge, LA (Chair); 8 Id. See also CMS Press Release, Trump Administration Announces MyHeal- Gregory D. Anderson, HORNE LLP, Hattiesburg, MS thEData Initiative to Put Patients at the Center of the US Healthcare System, (Vice Chair—Publications); Ritu Kaur Cooper, Hall https://www.cms.gov/newsroom/press-releases/trump-administration-an- nounces-myhealthedata-initiative-put-patients-center-us-healthcare-system. Render Killian Heath & Lyman PC, Washington, DC 9 David Blumenthal and Aneesh Chopra, Apple’s Pact with 13 Health Systems (Vice Chair—Strategic Planning and Special Projects); Might Actually Disrupt the Industry, Harv. Bus. Rev., Mar. 23, 2018, https:// Nicole F. DiMaria, Chiesa Shahinian & Giantomasi PC, hbr.org/2018/03/apples-pact-with-13-health-care-systems-might-actually- Kimberly S. disrupt-the-industry.html (noting the deal “could herald truly disrupt change in West Orange, NJ (Vice Chair—Membership); the U.S. health care system. The reason: It could liberate health care data for Ruark, BakerHostetler, Atlanta, GA (Vice Chair—Research game changing new uses, including empowering patients as never before.”). & Website); Julia K. Tamulis, Bass Berry & Sims PLC, 10 Apple, Announcement, Apple announces effortless solution bringing health Washington, DC (Vice Chair—Educational Programs); records to iPhone, Health Records Brings Together Hospitals, Clinics and the Existing Health App to Give A Fuller Snapshot of Health, Jan. 24, 2018, Neerja Razdan, University of Maryland Medical System, https://www.apple.com/newsroom/2018/01/apple-announces-effort- Baltimore, MD (Social Media Coordinator). less-solution-bringing-health-records-to-iPhone/. On March 29, 2018, Apple made IOS 11.3 available to download. 11 Lisa Winfield, PhD, Increasing Consumer Engagement and Drive Value, Healthcare Financial Management Association (HFMA), Mar. 2018, https:// www.hfma.org/Content.aspx?id=59781 (login required)..
14 AHLA Connections February 2019 Lawyer-Friendly Technical Expertise
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Firm News In Memory: James F. Doherty Sr.
In early December 2018, AHLA lost one of our founding members, James F. Doherty Sr. Jim was the Founding President of the National Health Lawyers Association and retained this position from 1976 to 1979. Whiteford Taylor & Preston is pleased to announce that Sigrid C. Haines and The following is taken from Jim’s interview for Roseanne M. Matricciani are listed the Past President’s Board Book recalling how among the 2018 Super Lawyers and he helped created the National Health Lawyers Rising Stars in Maryland. Both lawyers Association: specialize in health care. I was appointed General Counsel of the Group Health Association of America (GHAA) in“ 1971. There was little generally available knowledge regarding the legal envi- ronment in which plans operated. The Federal HMO Act was first introduced in 1971 and the initiative was gaining interest as a result, and President Nixon signed the Federal HMO Act into law in 1973, further stimulating the growth of the fledgling managed care industry. Through informal discussions, a relatively small group of attorneys initially became interested in creating a forum for the exchange of information on the King & Spalding LLP is pleased to legal aspects of these newly emerging health care delivery models. We hired announce that Daron Tooch, Glenn David J. Greenburg as a consultant. David had been associated with the Amer- Solomon, and Amanda Hayes- ican Society of Hospital Attorneys and had a wealth of experience in organiza- Kibreab have joined the firm’s Health tional operation and development of organized health care systems. David was a Care team in its Los Angeles, CA office. key staff member (and, for a time, the only staff member) and was instrumental Mr. Tooch specializes in managed care in the early formation and growth of what was to become the National Health litigation and represents hospitals, Lawyers Association (NHLA). medical groups, physicians, pharmacies, I decided to address the uncertainty and ignorance of the legal framework of laboratories, surgery centers, and home organized health care systems by holding a conference of attorneys who repre- health companies. Mr. Solomon special- sented these clients. A one-day conference was held at the Chicago Hilton Hotel izes in managed care and has represented near the O’Hare Airport. Over 300 attendees were drawn from federal and state many prominent hospitals and health governments and large and small law firms from across the country. Based on systems, medical groups, independent the response to the first educational conference, it became obvious that the time physician associations, management had come for a national organization. Jamie Clements (General Counsel for the services organizations, and other health Scott & White Clinic located in Temple, TX), David, and I met at the Fairmount care providers and entities. Ms. Hotel in Dallas and laid the groundwork for the formation of NHLA. Hayes-Kibreab has experience as a health care commercial litigator representing Other memories of Jim: ” prominent hospitals and health systems AHLA was a labor of love for Jim and his family. When a Washington Post in a variety of commercial litigation reporter once asked him why a busy executive with seven children would take actions. on“ outside projects like this, he said, ‘it beats the hell out of playing golf.’ —James F. Doherty Jr. ” Jim Doherty’s personality and accomplishments can best be summed up in my opinion in one sentence: Jim Doherty brought together Richard Nixon “and Ted Kennedy to support the original Federal HMO Act and thus served as the founding father of the modern managed care industry. He brought people together because he cared. —Alan Bloom
To read more about Jim’s legacy” to AHLA, please visit our Past President’s page at https://www.healthlawyers.org/About/Leadership/PastPresidents/ Pages/default.aspx. We also ran a profile on him in the October 2017 issue of AHLA Connections, viewable at www.healthlawyers.org/Connections.
16 AHLA Connections February 2019 NEW! Vaccine, Vaccination, and Immunology Law By Brian Dean Abramson with John R. Thomas and Peter O. Safir
This treatise provides thorough coverage of all issues encountered in the prac- tice of the law related to vaccines and vaccination, from product development and intellectual property protections, to regulation, public mandates, and vaccine injury claims. Vaccine, Vaccination, and Immunology Law will be invaluable not only to lawyers and business professionals in the health care industry, but also to regulators, public health officials, and scientific researchers. Vaccine, Vaccination, and Immunology Law covers the wide range of laws and issues that impact the field, including: • FDA oversight, enforcement, and regulation of the research and development process • Public mandates, including mandatory child vaccinations, opposition, and the legal conse- quences of failure to vaccinate, as well as medical, religious, and philosophical exemptions • State-by-state coverage of each jurisdiction’s common requirements and unique legal characteristics related to childhood and adult vaccinations, state exemptions, administration of vaccines, and isolation and quarantine matters • Patent law elements important to securing and enforcing protection for vaccines, as well as other intellectual property protections such as trademark, trade secret, unfair competi- tion, and copyright law • Compensation for vaccine injuries under the National Vaccine Injury Compensation Program (NVICP), injuries listed in the Vaccine Injury Table, jurisdictional prerequisites, filings, and substantive and postjudgment proceedings • Injury claims outside the NVICP such as products liability, failure to warn, medical malpractice, punitive damages and more • Reporting via the Vaccine Adverse Event Reporting System (VAERS), with specifics on who may or must report and what are reportable events • Specific vaccines, mandated, unmandated, or in development, as well as other ingredients in vaccines • Access to, and promotion of, vaccines, and funding and cost issues
AHLA members save 10% and Get FREE 30-Day Review. Order online at www.bna.com/bnabooks/ahla. healthlawyers.org 17 Telepharmacy: The Next Future in Telemedicine? Dr. Darshan Kulkarni, Synchrogenix; Anjali B. Dooley, Forefront Telecare Inc; and Erin Grant, Forefront Telecare Inc
18 AHLA Connections February 2019 here are 45.7% fewer pharmacists per capita in rural Advantages of Telepharmacy vs. urban settings.1 This localized clinical pharmacist Telepharmacy has a number of potential advantages, including shortage is the frustrating reality faced by many rural increasing accessibility to pharmacists, as well as improving hospitals, despite a surplus of qualified clinical phar- patient access to care.18 Telepharmacy can facilitate immediate or Tmacists in more urban and suburban areas.2 While mail-order near-immediate turnaround on medication orders in the event pharmacies and rural health clinics have helped to fill this that a hospital pharmacist or other appropriate staff are not avail- gap, they are limited in their ability to provide live interaction able.19 Telepharmacy also increases the availability of expertise, with a pharmacist.3 These rural patients consequently have no as organizations can recruit knowledgeable pharmacists (either pharmacist available to answer medically related questions, through traditional employment or contract work) and use them determine clinically relevant drug interactions, and prevent to cover a number of facilities at once, in lieu of a single in-house potential medication errors.4 pharmacist.20 Telepharmacy also helps health care organizations Rural pharmacies5 and pharmacy deserts6 face significantly reach individuals who would not otherwise have access to medi- more challenges in retaining and maintaining pharmacy cations, such as those living in pharmacy deserts.21 services; for example, health care organizations might not have There are also a number of barriers to telepharmacy practice, pharmacists to review medication orders or may not be able to though these are primarily caused by a myopic view of the practice provide 24/7 pharmacy services, leading to medication errors, of pharmacy as well as a lack of legislative and political support, lack of care coordination between clinical providers, and lack both of which will likely diminish as telepharmacy use grows. of overall access to pharmacy services.7
What Telepharmacy Is, Its History, and How It Works Telepharmacy is part of Telepharmacy is part of the general push towards various electronic health care services, including telemedicine. Tele- the general push towards medicine is defined by the World Health Organization as “the delivery of healthcare services, where distance is a critical various electronic health factor, by all healthcare professionals using information and communication technologies for the exchange of valid infor- care services, including mation for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing educa- tion of healthcare providers, all in the interests of advancing telemedicine. the health of individuals and their communities.”8 Telepharmacy, like telemedicine, enables the delivery of pharmacy services at a distance,9 including medication review, Barriers to Telepharmacy 10 patient counseling, and prescription verification. In telephar- One major barrier to the widespread use of telepharmacy is macy, a licensed pharmacist may supervise a pharmacy techni- that existing pharmacy laws and regulations were developed 11 cian at a remote site through video conferencing technology. for onsite pharmacy practice, focusing on issues such as where The technician may prepare the drug for dispensing while the pharmacists must physically provide services, the minimum 12 pharmacist communicates with the technician. Though the amount of time pharmacists must provide services onsite, types 13 legal definition of telepharmacy varies by location, telephar- of technologies pharmacists must use, and roles of pharmacy macy practice typically involves a pharmacist in a remote loca- extenders.22 These laws are often irrelevant to telepharmacy, tion reviewing prescriptions and aiding pharmacist technicians yet its practice must contort to fit these existing paradigms.23 14 and patients in correct medication use and administration. Several states have taken the initiative to address the limitations Telepharmacy has a long history, beginning in the United in their regulations and to allow for the practice of pharmacy States as early as the 17th Century. However, telemedicine from remote locations, including North and South Dakota, technology as it is known today truly began in the 1960s due Texas, Montana, and Idaho.24 15 to medical needs that arose during the Space Race. In 2001, In addition to archaic laws and regulations, telepharmacy the North Dakota State Board of Pharmacy initiated the Pilot also can be complex and difficult to implement.25 Telepharmacy Telepharmacy Rules to evaluate how to use telepharmacy to requires not only an investment into the traditional pharmacy 16 combat an increase in rural pharmacy closings in the state. infrastructure, but also into a substantial, secure, and validated This technology was then adopted by health systems during the IT infrastructure.26 Using and supporting this infrastructure 17 1970s to begin providing care to rural communities and has also requires substantial resources and extensive training. continued to grow in its potential and influence today. Telepharmacies also must deal with inertia from their potential customer base and pharmacy providers. Individ- uals—particularly the elderly—may be reluctant to forego the traditional face-to-face interaction with a pharmacist.27
healthlawyers.org 19 Telepharmacies also must In addition to these issues, telepharmacy may present an even greater potential for fraud or abuse than telemedicine generally, as pharmacy remains one of the heaviest utilized deal with inertia from their avenues in committing Medicare fraud.39 Common allegations of fraud and abuse often involve auto-refills for which the potential customer base and pharmacy bills Medicare without the patient’s knowledge; the provision of gifts to patients to incentivize pharmacy use; or pharmacy providers. switching the type of drug a patient is prescribed (i.e., from a tablet to a capsule) to maximize reimbursement.40 The opportu- nities to commit these types of fraud may grow as telepharmacy Laws Shaping Telepharmacy Practice conceivably increases overall pharmacy utilization. As with telemedicine, there are a number of legal and regula- tory constructs specifically affecting telepharmacy practice. The Retail Pharmacy Laws most significant are discussed below. Additionally, laws governing retail pharmacy either may permit or prohibit the practice of telepharmacy in a particular state. The Ryan Haight Act For telepharmacy to be permitted within a state, providers must Passed in 2008, the Ryan Haight Online Pharmacy Consumer be authorized to offer outpatient pharmacy and drug delivery Protection Act is intended to target “rogue” internet phar- services.41 However, even if states authorize telepharmacy prac- macies and prevent the prescribing of controlled substances tice, many still impose geographic limitations or restrictions on online.28 The Act prevents prescriptions of controlled the types of facilities, staffing, or interstate service offerings.42 substances to a patient without an in-person medical eval- These constraints vary between states and require fact-specific uation, exempting telemedicine practitioners only in cases investigations. of emergency.29 Though federal law prohibits prescriptions for controlled substances without an in-person exam, some Interstate Practitioner Licensing states have created exceptions.30 These differences between Physicians practicing in telepharmacy have the capability to see federal and state standards, as well as potential Supremacy patients located in other states. However, most states currently Clause issues, will likely require resolution in the near future.31 define this activity as the practice of pharmacy in their own 43 Congress has proposed permitting states to prescribe controlled state. As such, practitioners are required to hold a license in 44 substances via telemedicine; however, as of this writing, these the state in which the patient is located. The purpose of these proposals have not been enacted.32 laws has been to ensure practitioner competency; however, these requirements also may inhibit the spread of telepharmacy Prescription Drug Monitoring Programs and, consequently, patient access to care.45 Steps have been Prescription drug monitoring program (PDMP) law is another taken to make interstate licensure easier, with initiatives such area affecting pharmacy practice. A PDMP is “a statewide elec- as the National Association of Boards of Pharmacy’s Electronic tronic database which collects designated data on substances Licensure Transfer Program®,46 offering expedited licensure for dispensed in the state,” and is typically administered and physicians wishing to practice in more than one state. housed by a statewide regulatory, administrative, or law enforcement agency.33 Forty-nine states currently have PDMPs The Pharmacist-Patient Relationship in place, many of which mandate that providers, prescribers, Though less frequently discussed than the traditional physi- or both enter prescription drug information into the system cian-patient relationship, telepharmacy also raises questions regularly.34 However, some barriers remain to PDMP use. In about what duties pharmacists assume towards their patients addition to technical and interoperational challenges,35 PDMPs and the extent of these duties. In traditional medical practice, a do not take into account socioeconomic or psychosocial risk physician-patient relationship is established when the physician 47 factors that might predispose patients to drug abuse, impeding first undertakes to treat the patient. This normally occurs with proactive and preventive identification of at-risk patients.36 a physical examination, an in-office consultation, a diagnosis, or some other effort or interaction in which the physician seeks Fraud and Abuse in Telepharmacy to treat the patient.48 The process for how a physician-patient As with telemedicine generally, telepharmacy expands avenues relationship begins for in-person care is relatively uniform across for fraud and abuse violations by broadening the potential the United States.49 However, the requirements to establish a financial and clinical relationships that may trigger fraud accu- physician-patient relationship via telemedicine, as compared to sations, including billing and collection issues and access to a traditional physician-patient relationship, tend to be defined new or additional health care providers or treatment locations statutorily and also tend to vary significantly.50 This amor- not available with traditional medical practice.37 The interstate phous nature of the physician-patient relationship is especially operation of telepharmacies also expands exposure to each compounded in states that do not define the beginning the state’s fraud and abuse laws, requiring a new level of organiza- physician-patient relationship at all. In these situations, consid- tional compliance monitoring and complexity.38 ering the informality51 and the limited scope52 of many telehealth encounters, particularly among startup telemedicine companies, the line defining where liability arises is muddled.53 20 AHLA Connections February 2019 The nature of the pharmacist-patient relationship and any Evidence shows telepharmacy consequent duties has even less clarity, though more attention is being given to this area due to developments in managed care.54 Historically, a pharmacist’s duty consisted of providing may create efficiencies within a patient with drugs accurately in accordance with a physician’s directions;55 however, this duty is expanding, though the limits health care organizations, of this expansion are not yet known.56 While courts are often divided on the extent of a pharmacist’s duty some areas where particularly for rural or liability may be expanding include whether a pharmacist has a duty to warn patients about adverse drug effects, whether the pharmacist has a duty to monitor a patient’s drug history, smaller hospital systems. and whether the pharmacist must control the patient’s refills,57 though the latter two are changing due to state-level PDMP Is Telepharmacy the Future of Pharmacy? laws and efforts to curb opioid use. Pharmacists also may be As telemedicine grows in prevalence, will telepharmacy also required to identify barriers to obtaining medications and to become the future of pharmacy services? The answer to that inform patients on how to overcome these barriers.58 Overall, question likely depends on whether telepharmacy (1) is finan- there is a greater recognition of pharmacists’ role in “furthering cially lucrative, or at least financially stable; (2) provides oppor- the well-being of their patients,” particularly as managed care tunities for better quality of patient care; (3) improves pharmacist and population health grow.59 satisfaction with services or creates efficiencies in care; and (4) Data Privacy and Security empowers patients to better understand their own care. Telepharmacy practice also has potentially expanded liability Financial Viability around data privacy and security law. Current federal statutes Though telepharmacy is still new to the world of health care and regulations governing data privacy in the United States finance,69 financial analyses indicate that telepharmacy opera- include the Federal Trade Commission Act, the Financial tions tend to be profitable when a sufficient volume of patients Services Modernization Act, the Electronic Communica- is reached.70 Telepharmacy also offers returns on investment to tions Privacy Act and, perhaps most importantly, the Health organizations through potential cost-savings due to preventing, Insurance Portability and Accountability Act (HIPAA) and its identifying, and resolving medication-related problems before they Breach Notification Rule.60 Further, each state has its own data arise.71 One study demonstrated a reduction in per-drug expenses protection requirements.61 In the pharmacy world, confidenti- of $12.87, resulting in a cost avoidance of $984,321 for a commu- ality and privacy have become greater concerns as pharmacists 72 now possess more access to patient information, which is also nity teaching hospital and $611,595 for a community hospital. 62 more readily retrievable. Pharmacists’ duties in protecting Higher Quality Patient Care patient privacy and confidentiality, particularly under HIPAA, Telepharmacy also may provide higher-quality patient care are similar to other organizations managing patient health by improving patient safety, reducing the number of medi- information, and include conducting risk analyses, safe- cation-related reporting errors, and increasing medication guarding protected health information, and ensuring that this turnaround time for pharmacies that do not staff full-time information is not improperly disclosed.63 pharmacists.73 Telepharmacy may not only reduce inappro- Payment Parity priate or over prescribing, but also may facilitate better care 74 Another area of law shaping telepharmacy practice is coverage coordination, especially among larger patient populations. and payment parity. In many states, coverage of and payment One study noted that, following telepharmacy implementation: for telepharmacy services may differ from in-person services.64 The differences between coverage and payment parity is subtle; The number of times that nurses obtained and adminis- however, “[c]overage parity laws involve efforts by legislatures tered medications without pharmacist review declined by to require insurers to cover telemedicine services to the same 35.3% after implementation of the telepharmacy service. extent they cover in-person services. Meanwhile, payment There was a significant reduction in the percentage of parity laws require insurance companies to pay telemedicine high-risk medications obtained without a pharmacist re- providers the same amount as they would in-person health- view. Three potential adverse drug events were discovered care providers for the same service.”65 Federal law has made before implementing remote order review versus none in attempts to introduce parity into telemedicine reimbursement the postimplementation period. The number of pharma- generally, such as through the CHRONIC Care Act, which cist interventions increased from 15 to 98 per week after increases coverage for telemedicine under Medicare Advantage implementing remote order review by pharmacists. Esti- plans.66 However, coverage and payment parity varies signifi- mated cost savings resulting from preventing, identifying, cantly between states,67 and will continue to shape the expan- and resolving medication-related problems were $261,109 sion of telepharmacy.68 per hospital in total cost saved or avoided. Nurses’ survey scores reflected increased comfort with the medication-use system, patient safety, and job satisfaction.75 healthlawyers.org 21 Patient Satisfaction Conclusion Patients also may derive additional satisfaction from telephar- Telepharmacy is likely the next wave of telemedicine, espe- macy services. The simplicity of having a single point of access cially considering the opioid crisis, as evidence shows that areas to address pharmaceutical needs,76 or the possibility of a more lacking pharmacy access tend to suffer from higher rates of convenient point of access to obtain refills,77 have been shown opioid abuse,84 and telepharmacy may provide onsite pharma- to raise patient satisfaction with pharmacy services. However, cists the time that they need to engage in more patient-centered more study on the effects of telepharmacy on patient satisfac- care activities such as counseling patients on their medications.85 tion are still needed, as results are mixed.78 Telepharmacy, though not a new concept, has been growing in tandem with technological capacity and capabilities and will continue to push innovative, social, and legal-regulatory Telepharmacy, though not boundaries. Its growth will likely be reinforced by the fact that telepharmacy makes good business sense: not only from a a new concept, has been financial perspective (presenting both profits and cost savings to providers), but also for the potential to improve the quality of growing in tandem with care and increase patient and pharmacist satisfaction. Dr. Darshan Kulkarni, Pharm.D, MS, JD is technological capacity and Vice President of Regulatory Strategy and Policy at Synchrogenix, a Division of capabilities and will continue Certara—a global consulting organization where he is called on to advise on various FDA to push innovative, social, and regulatory matters including on transparency, submissions and patient centricity. He is also Principal Attorney at the Kulkarni Law Firm and has been Visiting legal-regulatory boundaries. Professor at the University of the Sciences where he won the Best Adjunct Professor award. Darshan has worked in most pharmacy settings including long term care facilities, retail, Efficiencies in Patient Care large academic centers, and small community hospitals, and is Evidence shows telepharmacy may create efficiencies within called on to advise on inpatient and outpatient pharmacy health care organizations, particularly for rural or smaller settings including on issues relating to clinical trial pharmacy hospital systems. For smaller, rural facilities or health systems audits for compliance with FDA regulations, addressing privacy that cannot afford full-time pharmacists at each site, tele- concerns, medical marijuana issues, and compounding issues. pharmacy allows for a single pharmacist to log into each facility’s medication management system, monitor and talk Anjali B. Dooley, JD, MBA is the Chief Legal with pharmacy technicians as they prepare medications, and & Compliance Officer & Corporate Secretary of verify and approve medication orders.79 These efficiencies, and Forefront Telecare Inc, a behavioral health consequent improvements in patient care, also may correspond telemedicine company, and is admitted to the with increased pharmacist satisfaction. One study noted that bars in the states of Missouri, Illinois, and telepharmacy decreases the concerns about patient safety that Kansas. She is an entrepreneur, and business tend to erode pharmacist job satisfaction, potentially leading leader with extensive experience in health care, emerging to increases in workplace happiness.80 Additionally, telephar- technology, and business law. In her private law practice, her macy makes it possible for health care organizations to operate focus was on the representation of start-up businesses in a pharmacy full-time without requiring pharmacists to work financing and business development matters and on health care unpopular night shifts, creating more potential to increase regulatory compliance. Previously, she has served as both a workplace satisfaction.81 Special Prosecutor and Public Defender. Anjali is a leader within the American Bar Association Health Law Section, Patient Empowerment serving as Vice-Chair of the Section’s eHealth, Privacy, and Telepharmacy also may empower patients to manage their own Security Interest Group. Her longstanding interest in rural 82 health care. Remote patient monitoring, when used in conjunc- health has led her to serve on various policy committees for the tion with telepharmacy, can better enable patients to manage National Association of Rural Health Clinics. She also served as and monitor their medication use in a way that more effectively an Adjunct Professor and Coleman Fellow at Saint Louis 83 controls their symptoms and maintains their health. University, MBA Program in Entrepreneurship, which is ranked 12th nationally.
22 AHLA Connections February 2019 Erin Grant is Associate Counsel for Forefront 17 Id. 18 Amy K. Erickson & Diana Yap, On the Line: Telepharmacy Technol- TeleCare Inc, a nationwide organization ogy Expands Hospital Pharmacists’ Reach, 22 Pharmacy Today 4, 4 focused on delivering behavioral telehealth (2016). services to rural populations, where she devotes 19 Id. her time to health care legal issues such as Stark 20 Id. and AntiKickback, HIPAA, MACRA, and 21 See generally Qato supra note 6. See also Brian Collins et al., Utili- other compliance matters. She also serves as an Administrative zation of Prescription Medications and Ancillary Pharmacy Services Fellow at Memorial Health System in Illinois. Among Rural Elders in West Texas: Distance Barriers and Impli- cations for Telepharmacy, J. Health & Human Servs., at 75, 90-91 (Summer 2007). Though there is no official definition for a pharmacy Endnotes desert, several authors have created helpful descriptions. See, e.g., 1 PipelineRx, Solving the Clincal Pharmacist Shortage in Rural id. at 1960, which defined an urban pharmacy desert (noting that, America, https://www.pipelinerx.com/blog/pharmacist-shortage/. in the study, “[a] community was designated as a pharmacy desert 2 Id. if it was considered both low access and low income.” This defini- 3 Justin Sherman, Telepharmacy? A Promising Alternative for Rural tion, taken from the U.S. Department of Agriculture definition of a Communities, Pharm. Time (Jan. 1, 2007), https://www.pharmacy- “food desert,” considered a community low-access “if more than times.com/publications/issue/2007/2007-02/2007-02-6296. See 33 percent of its population lived more than a mile from a pharma- also Charles D. Peterson et al., Telepharmacy, in Telemedicine Tech- cy or if more than 33 percent of the population of a ‘low vehicle nical Assistance Document: A Guide to Getting Started in Telemedicine access’ community lived more than a half mile from a pharmacy. 206, 206-07 (Howard C. Anderson et al. eds., 2004). Communities were designated as having low vehicle access if more 4 Peterson et al., supra note 3, at 206. than a hundred households did not own a vehicle.”); Zach Schlade- 5 Rural Pharmacy and Prescription Drugs, Rural Health Information tzky, Trend: What is a Pharmacy Desert?, TelePharm (Apr. 8, 2017), Hub, https://www.ruralhealthinfo.org/topics/pharmacy-and-pre- http://blog.telepharm.com/what-is-a-pharmacy-desert (defining a scription-drugs (last updated May 28, 2015). rural pharmacy desert as “any area within a 10-mile radius without 6 See generally Dima M. Qato et al., ‘Pharmacy Deserts’ are Prev- ready access to a pharmacy). alent in Chicago’s Predominantly Minority Communities, Raising 22 Poudel & Nissen, supra note 8, at 79. Medication Access Concerns, 11 Health Affairs 1958-65 (2014). 23 Id. 7 See Philip J. Schneider, Evaluating the Impact of Telepharmacy, 24 Tzanetakos, G., Ullrich, F. & Mueller, K. Telepharmacy Rules and 70 Am. J. Health Sys. Pharm. 2130, 2130 (2013). Statutes: A 50-State Survey, 5 Am. J. Med. Res. 2, 8 (2018). 8 Arjun Poudel & Lisa M. Nissen, Telepharmacy: A Pharmacist’s 25 Id. See also generally Douglas S. Wakefield et al.,Implementation Perspective on the Clinical Benefits and Challenges, 5 Integr. of a Telepharmacy Service to Provide Round-the-Clock Medication Pharm. Res. Pract. 75, 76 (2016). Order Review by Pharmacists, 67 Am. J. Health Sys. Pharm. 2052 9 Id. (2010) (noting the critical steps health care organizations have 10 Id. at 76-77. taken to successfully implement telepharmacy systems). 11 Telepharmacy, N.D. State U., https://www.ndsu.edu/telepharmacy/ 26 Poudel & Nissen, supra note 8, at 80. (last updated June 18, 2018). 27 Id.; Luann Dart, Digital Doses: Telepharmacies Save People in 12 Id. Small Towns and Rural Areas from Having to Drive Hundreds of 13 See Kevin E. McCarthy, Connecticut General Assembly, Telephar- Miles to Fill a Prescription, Rural Electric 30 (Jan. 2005), https:// macy, OLR Research Report, 2013-R-0423 (Nov. 25, 2013). The www.ndsu.edu/fileadmin/telepharmacy/RuralElectricMagazineTele- definition of telepharmacy varies by legal jurisdiction. For example, pharmacyFeature.pdf. North Dakota, one of the first jurisdictions to formally implement 28 See generally Ryan Haight Online Pharmacy Consumer Protection telepharmacy programs statewide, defines telepharmacy as “a Act of 2008, H.R. 6353, 110th Cong., 2d Sess. (2008). See also central pharmacy with one or more remote sites in which all sites Nathaniel M. Lacktman, Prescribing Controlled Substances Without are connected via computer link, videolink, and audiolink.” N.D. an in-Person Exam: The Practice of Telemedicine Under the Ryan Admin. Code § 61-02-08-02(3). Cf. California law, which defines Haight Act, Healthcare L. Today (Apr. 17, 2017), https://www. telepharmacy as “a system that is used by a supervising pharmacy healthcarelawtoday.com/2017/04/17/prescribing-controlled-sub- for the purpose of monitoring the dispensing of prescription drugs stances-without-an-in-person-exam-the-practice-of-telemedicine- by a remote dispensing site pharmacy and provides for related drug under-the-ryan-haight-act/. regimen review and patient counseling by an electronic method, 29 Cong. Res. Serv., Summary: H.R. 6353 (110th): Ryan Haight Online including, but not limited to, the use of audio, visual, still image Pharmacy Consumer Protection Act of 2008, GovTrack (Oct. 15, capture, and store and forward technology,” Cal. Bus. & Prof. Code 2008), https://www.govtrack.us/congress/bills/110/hr6353/sum- § 4044.7, and Texas law, which defines a telepharmacy system as mary. “a system that monitors the dispensing of prescription drugs and 30 See, e.g., Ind. Admin. Code § 25-1-9.5-8 (“A prescriber may issue a provides for related drug use review and patient counseling services prescription to a patient who is receiving services through the use by an electronic method, including the use of the following types of of telemedicine if the patient has not been examined previously by technology: (1) audio and video; (2) still image capture; and (3) store the prescriber in person if the following conditions are met . . . . [A] and forward.” Tex. Occupations Code § 562.110(a). n opioid may be prescribed if the opioid is a partial agonist that 14 Poudel & Nissen, supra note 8, at 77. is used to treat or manage opioid dependence . . . .”); Haw. Rev. 15 Vera Gruessner, The History of Remote Monitoring, Telemedicine Stat. § 329-38 (“No controlled substance in schedule II may be Technology, MHealthIntelligence (Nov. 9, 2015), https://mhealth- dispensed without a written prescription of a practitioner, except . . intelligence.com/news/the-history-of-remote-monitoring-telemedi- . . When dispensed directly by a practitioner, other than a pharma- cine-technology. cist, to the ultimate user . . . .”); and Haw. Rev. Stat. § 453-1.3 (only 16 History and Progress of HRSA/OAT Telepharmacy Funding, North requiring an in-person examination prior to prescribing opioids and Dakota State University, https://www.ndsu.edu/telepharmacy/histo- medical cannabis). ry/ (last visited June 20, 2018).
healthlawyers.org 23 31 Nathaniel M. Lacktman & Thomas B. Ferrante, Congress Propos- undertaking an operation or other case, is under the duty, in the es Change to Ryan Haight Act to Allow Telemedicine Prescribing absence of an agreement limiting the service, of continuing his of Controlled Substances, Healthcare L. Today (Mar. 5, 2018), attention, after the first operation or first treatment, so long as the https://www.healthcarelawtoday.com/2018/03/05/congress-pro- case requires attention.”); Mead v. Legacy Health Sys., 283 P.3d poses-change-to-ryan-haight-act-to-allow-telemedicine-prescrib- 904, 914 (Or. 2012) (“[I]t is sufficient if [the physician] either knew ing-of-controlled-substances/. or reasonably should have known that he was diagnosing [the 32 See Improving Access to Remote Behavioral Health Treatment patient’s] condition or providing treatment to [the patient]. In that Act of 2018, Discussion Draft, 115th Cong., 2d Sess. (2018) (“To event, a physician-patient relationship arose and defendant owed a amend the Controlled Substances Act to clarify the eligibility of duty of reasonable care to [the patient].”). [community mental health or addiction treatment centers] to register 48 See Mead v. Legacy Health Sys., supra note 47. to dispense controlled substances, and to include such centers 49 See Robert D. Truog, Patients and Doctors—The Evolution of a within references to hospitals and clinics in the definition of the term Relationship, 366 New Eng. J. Med. 581, 581-83 (2012). Note, how- ‘practice of telemedicine’, and for other purposes.”); Special Regis- ever, that though the process for establishing a physician-patient tration for Telemedicine Clarification Act of 2018, Discussion Draft, relationship is relatively similar across the United States, the point at 115th Cong., 2d Sess. (2018) (“To impose a deadline for the prom- which it is established consistently remains a pattern of debate be- ulgation of interim final regulations...specifying the circumstances tween medical malpractice attorneys, as this point depends heavily in which a special registration may be issued to a practitioner to on the facts of the situation. See id. engage in the practice of telemedicine [without the need for a prior, 50 See, e.g., Del. Code § 1769D (“Physicians who utilize telemedicine in-person appointment]....”); Lacktman & Ferrante, supra note 31 shall, if such action would otherwise be required in the provision (noting that the bill “would allow certain community mental health of the same service not delivered via telemedicine, ensure that a centers and addiction treatment centers to obtain DEA registration proper physician-patient relationship is established either in-person as a clinic, thereby allowing telemedicine providers to prescribe or through telehealth which includes but is not limited to: (1) fully controlled substances to patients present at those sites without the verifying and authenticating the location and, to the extent possible, need for an in-person examination”). identifying the requesting patient; (2) Disclosing and validating 33 State Prescription Drug Monitoring Programs, Drug Enforcement the provider’s identity and applicable credential or credentials; (3) Admin., https://www.deadiversion.usdoj.gov/faq/rx_monitor.htm#1 Obtaining appropriate consents from requesting patients after (last updated June 2016). disclosures regarding the delivery models and treatment methods 34 See generally Substance Abuse and Mental Health Admin., Using or limitations, including informed consents regarding the use of tele- Prescription Drug Monitoring Program Data to Support Prevention medicine technologies…; (4) Establishing a diagnosis through the Planning, https://www.samhsa.gov/capt/sites/default/files/resourc- use of acceptable medical practices, such as patient history, mental es/pdmp-overview.pdf (last visited June 27, 2018). status examination, physical examination (unless not warranted by 35 Haffajee, R.L., et al. Mandatory Use of Prescription Drug Monitoring the patient’s mental condition) and appropriate diagnostic and lab- Programs, 313 JAMA 9 (2014). oratory testing to establish diagnoses, as well as identify underlying 36 Weiner, J., Bao, Y. & Meisel, Z. Prescription Drug Monitoring Pro- conditions or contra-indications, or both, to treatment recom- grams: evolution and Evidence, Penn LDI (June 8, 2018), https:// mended or provided; (5) Discussing with the patient the diagnosis ldi.upenn.edu/brief/prescription-drug-monitoring-programs-evolu- and the evidence for it, the risks and benefits of various treatment tion-and-evidence. options; (6) Ensuring the availability of the distant site provider 37 Jown W. Kaveney & Megan R. George, Potential for Fraud and or coverage of the patient for appropriate follow-up care; and (7) Abuse in the Administration of Telehealth Services, ABA Health eS- Providing a written visit summary to the patient.”); R.I. Bd. of Med. ource (Apr. 2018) https://www.americanbar.org/groups/health_law/ Licensure and Discipline, Guidelines for the Appropriate Use of Tele- publications/aba_health_esource/2017-2018/april2018/fraud.html. medicine and the Internet in Med. Practice ((“The [Board of Medical 38 Jeanne M. Born & Matthew B. Roberts, State of Telehealth in South Licensure and Discipline] defines the beginning of the physician-pa- Carolina: Fraud and Abuse Issues in Telehealth, Nexsen Pruet, Pre- tient relationship as being clearly established when the physician sentation to Palmetto Care Connections 11 [PowerPoint presenta- agrees to undertake diagnosis and treatment of the patient and tion] (Apr. 27, 2016). the patient agrees, whether or not there has been an in-person 39 Pirestani, J., How Medicare Fraud Schemes are Perpetrated by encounter between the physician (or other health care practitioner) and the patient.”); Vt. Bd. of Med. Pract., Policy on the Appropriate Pharmacies, American J. Pharm. Benefits (June 8, 2017), https:// www.ajpb.com/news/how-medicare-fraud-schemes-are-perpetrat- Use of Telemedicine Technologies in the Practice of Med., Section Two ed-by-pharmacies. (2015) (“[I]n most cases formation of the relationship starts when an individual with a health-related matter seeks assistance from 40 Id. a physician who may provide assistance. The relationship is fully 41 Keith J. Mueller, Telepharmacy Rules and Statutes: A 50-State established when, through words or actions, the physician agrees Survey, Rural Health Res. Gateway (Apr. 27, 2017), https://www. to undertake diagnosis and treatment of the patient, and the patient ruralhealthresearch.org/alerts/168. agrees to be treated, whether or not there has been an encounter 42 Id. in person between the physician (or other appropriately supervised 43 Nat’l Telecomm. & Info. Admin., Telemedicine Report to Congress: health care practitioner) and patient.”); W.V. Code § 30-14-12d(c) Legal Issues--Licensure and Telemedicine (Jan. 31, 1997), https:// (2) (“If an existing physician-patient relationship is not present prior www.ntia.doc.gov/legacy/reports/telemed/legal.htm; Nat’l Ass’n to the utilization to telemedicine technologies, or if services are of Boards of Pharm., Licensure Transfer, https://nabp.pharmacy/ rendered solely through telemedicine technologies, a physician-pa- programs/licensure-transfer/ (last visited Oct. 18, 2018). tient relationship may only be established: (A) Through the use of 44 Id. telemedicine technologies which incorporate interactive audio using 45 Id. store and forward technology, real-time videoconferencing or similar 46 Nat’l Ass’n of Boards of Pharm., e-LTP Frequently Asked Ques- secure video services during the initial physician-patient encounter; tions, https://nabp.pharmacy/programs/licensure-transfer/faqs/ or (B) For the practice of pathology and radiology, a physician-pa- (last visited Oct. 18, 2018). tient relationship may be established through store and forward 47 See, e.g., Ricks v. Budge, 64 P.2d 208, 314 (Utah 1937) (“We telemedicine or other similar technologies.”). believe the law is well settled that a physician or surgeon, upon
24 AHLA Connections February 2019 51 See, e.g., Online Doctor Consultation Services, VSee, https://vsee. https://aphameeting.pharmacist.com/sites/default/files/slides/ com/online-doctor-consultation/ (last visited June 24, 2018) (show- Hot%20Topics%20Telehealth%20Pharmacy_handout.pdf. ing a list of telemedicine companies providing on-demand doctor 69 Shamima Khan et al., Is There a Successful Business Case for Tele- visits via telemedicine with little to no cost or commitment required pharmacy?, 14 Telemed. & E-Health 235, 235 (2008). by the patient). 70 Id. at 242. However, it must be noted that, as telepharmacy grows, 52 See, e.g., Birth Control, Nurx, https://app.nurx.com/oc (last visited the market may (even soon) reach its saturation point, limiting June 24, 2018) (providing birth control to patients with no doctor potential profitability.Id. More market studies are required to assess encounter required). this possibility. Id. 53 Mark Abramson, Medical Malpractice Liability in the Information 71 Schneider, supra note 7, at 2132. Age—The Evolution of the Physician-Patient Relationship on 72 Id. at 2133. the New Healthcare Frontier, Abramson, Brown, & Dugan (Aug. 73 Kenna Hawes, How Your Pharmacist Can Be in Six Places at Once, 28, 2008), https://www.arbd.com/medical-malpractice-liabili- Advisory Board (Nov. 3, 2015), https://www.advisory.com/research/ ty-in-the-information-age-the-evolution-of-the-physician-patient-re- oncology-roundtable/oncology-rounds/2015/11/telepharmacy. lationship-on-the-new-healthcare-frontier/ (“The nationwide trend 74 Mark Monane et al., Improving Prescribing Patterns for the Elderly is that electronic, telephonic and remote medical consultations, as Through an Online Drug Utilization Review Intervention, 280 JAMA well as any other consultations such as radiology, pathology or oth- 1249, 121-52 (1998). er specialized services, will create a physician-patient relationship 75 Schneider, supra note 7, at 2133. and give rise to a duty owed by a physician if the consultation or 76 See generally D. Friesner & D.M. Scott, Exploring the Formation of service provided involves the medical management and treatment Patient Satisfaction in Rural Community Telepharmacies, 49 J. Am. of a patient, because it is the medical treatment provided (or not Pharm. Assoc. 509 (2009). provided) that dictates the patient’s outcome.”) (emphasis added). 77 See generally Timothy R. Hudd et al., The Impact of an Urban Tele- 54 Jack H. Simmons, Tort Law: Pharmacist Malpractice Liability, pharmacy on Patient Medication Adherence in a Federally Qualified Berman Simmons, https://www.bermansimmons.com/law-articles/ Health Center, 27 J. Pharm. Tech. 117 (2011). tort-law-pharmacist-malpractice-liability (last visited Oct. 18, 2018). 78 See, e.g., Aimee Skrei & Michelle M. Rundquist, Pharmacy Services See also David B. Brushwood, Massachusetts Case Recognizes in Telepharmacy: How It’s Working, Where It’s Working, and What’s Pharmacists’ Duty in Prior Authorization, 24 Pharm. Today 42, 42 Required to Practice in This New Setting, 1 J. Student Solutions to (Aug. 2018). Pharm. Challenges 1, 3 (2017). 55 Id. 79 Hawes, supra note 73. 56 Id. 80 Schneider, supra note 7, at 2134. 57 Fred G. Weissman, Jim Pinder, & Mark R. Berns, Negligence (Part 81 Bill Siwicki, Telepharmacy at Rural Hospitals Provides Big Savings, II): Duty and Breach of Duty, printed in Pharm. Pract. & Tort L. Quality Improvements, Healthcare IT News (Jan. 3, 2018), https:// (2016), https://accesspharmacy.mhmedical.com/content.aspx?- www.healthcareitnews.com/news/telepharmacy-rural-hospi- bookid=1824§ionid=126858214. tals-provides-big-savings-quality-improvements. 58 David B. Brushwood, Massachusetts Case Recognizes Pharma- 82 Remote patient monitoring is defined as the use of digital tech- cists’ Duties in Prior Authorization, 24 Pharm. Today 42, 42 (Aug. nology that collects and submits health data from the patient to a 2018). remote provider. 59 See generally id. 83 Melissa E. Badowski et al., Examining the Implications of Analytical 60 Ieuan Jolly, Data Protection in the United States: Overview, West- and Remote Monitoring in Pharmacy Practice, Clinical Pharm. (June law (July 1, 2017), https://content.next.westlaw.com/Document/ 5, 2017), https://www.pharmaceutical-journal.com/research/exam- I02064fbd1cb611e38578f7ccc38dcbee/View/FullText.html?contex- ining-the-implications-of-analytical-and-remote-monitoring-in-phar- tData=(sc.Default)&transitionType=Default&firstPage=true&bhcp=1. macy-practice/20202516.article?firstPass=false. 61 Id. 84 Levin, A., Overcoming Opioid Abuse in Rural U.S. Requires Varied 62 David B. Brushwood, Case Underscores Value of Confidentiality Approach, Psych. News (Mar. 24, 2016), available at https://psych- in Pharmacist-Patient Relationship, 24 Pharm. Today 54, 54 (Mar. news.psychiatryonline.org/doi/full/10.1176/appi.pn.2016.4a20. 2018). 85 Ciolko, C., Telepharmacy Helps Fight the Opioid Epidemic, Pipelin- 63 HIPAA Compliance for Pharmacies, HIPAA J. (Apr. 6, 2018), avail- eRX (Sept. 23, 2016), available at https://www.pipelinerx.com/blog/ able at https://www.hipaajournal.com/hipaa-compliance-for-phar- telepharmacy-fights-opioid-epidemic/. macies/. 64 Matthew Loughran, Telemedicine Reimbursement Laws Challenge Insurers and Providers Alike, Bloomberg L. (Oct. 17, 2017), https:// www.bna.com/telemedicine-reimbursement-laws-n73014471059/. 65 Id. 66 See Pub. L. No. 115-123, Title III, Subtitle C. See also Loughran, supra note 64. 67 See Telemedicine Reimbursement Policy in the 50 States, VSee, https://vsee.com/telemedicine-reimbursement-by-state/ (last up- dated Oct. 1, 2014). 68 See APhA, Expanding Opportunities Through Patient Care, pre- sentation at the APhA Annual Meeting and Exposition (Mar. 2016),
healthlawyers.org 25 Women’s Network
Marketing You: You Are Your Brand Kathryn Culver, PYA
Attendees of the 2018 AHLA Fundamentals of Audit your online presence and be purposeful in Health Law program had the opportunity to attend what you share. a panel hosted by the Women’s Leadership Counsel Every tweet, every status, every picture shared contributes to titled, “Branding and Self-Marketing.” This panel your personal brand. Your digital footprint is created every included early-to-late career lawyers (i.e., Lindsay Holmes, second of every day with each interaction you make. There is Michael Paulhus, Jennifer Ieradi, and David Cade), who nothing wrong with interweaving professional and personal discussed the importance of building your personal brand, experiences on social media, but be tactical with what you what building your personal brand means, and key strategies share, knowing that each person viewing your social media is for success. The panel offered useful takeaways and specific creating an image of your personal brand. Once you under- actions to help attendees build their brand: stand how you wish people to perceive your brand, you can start to be more strategic. Your brand is not the same as your title. Your brand extends well beyond your position within a profes- Associate with other strong brands. sional organization. In fact, your personal brand is shared Your personal brand is strengthened or weakened by your with your peers and family (most of whom have no connec- connection to other brands—and this includes other people tion with your professional status) as well as your colleagues and organizations. Find and leverage strong brands that can and organization. Therefore, ensure that, when building your elevate your own brand. Just as your brand extends to others, personal brand, you consider ways to stretch its impact across their brand extends to you. Your association with a strong multiple facets of your life. You should feel empowered to create brand is an effective way to self-market. a brand that embodies more than your career, as it will be cast over everything you do, inside and outside of your professional Most importantly, understand that a personal brand will always organization. be omnipresent and evolving. If your career is going to be successful, then investing in personal branding is crucial. Not only will it help build trust, it can help pave the way for future Be true to you. opportunities. People are attracted to uniqueness. Being different gives you an advantage, an edge. There are billions of people in this world Kathryn Culver performs fair market value who are competing for the same job, the same client, and the analyses for physician practice groups, same promotion. The key to marketing yourself is to discover hospitals, and health systems in the areas of what makes you unique, learn to embrace that uniqueness, and business valuation and fair market value capitalize on what it affords you as a result. compensation. Her work in the health care valuation realm includes a variety of business Bridge capital inside and outside of your valuations, physician services, management contracts, and organization. accountable care organizations. Licensed in the states of California and Tennessee, Kathryn is a Certified Public Professionals tend to over focus on “building capital” and Accountant and has extensive knowledge of financial reporting under focus on “bridging capital.” In other words, professionals and analysis. She is accredited in Business Valuation from the often have too many connections who are similar to them (i.e., American Institute of Certified Public Accountants and is an same organization, same credential, same industry) and not Accredited Senior Appraiser of the American Society of nearly enough who are dissimilar. When only a select demo- Appraisers. graphic is aware of your talents and abilities, you put your personal brand at risk and have fewer people to sponsor your personal brand. Therefore, it is important to consciously culti- vate a broad network of individuals.
26 AHLA Connections February 2019 Healthcare Consulting | Tax | Audit | Valuation | Strategy & Integration | Real Estate Some Things Get Better with Age Healthcare today requires vision
Something a worn pair of cowboy boots, PYA, and AHLA have in common—history! With vision and wisdom beyond our more than 35 years, PYA has always sought the right partners to help serve the needs of the healthcare organizations you represent. It allows us a point-of-view that aligns with the unique and changing needs of LARGEST your clients. With an unwavering commitment to AUDITOR outstanding client service, we remain your trusted of AHA’s Top U.S. Multi-Hospital Systems -Ames Research Group source for healthcare consulting solutions. If you want to know where the industry is headed, start by asking those who know where it has been.
ATLANTA | KANSAS CITY | KNOXVILLE | NASHVILLE | TAMPA 800.270.9629 | www.pyapc.com Communities
Hot Topics on AHLA Communities
Here’s what people are talking about on the AHLA Communities. To view responses, add input, or post a question of your own, go to http://communities.healthlawyers.org.
Physician Organizations Health Information Can an open-staff hospital (one that freely admits qual- Are any of you aware of any official commentary from ified doctors to its medical staff) instruct its employed OCR addressing a covered entity’s obligation to report hospitalists and certain ICU doctors to refer only to breaches caused by others? For example: employed specialists, and not to others on the medical ❯❯ Hospital discovers that physician in independent staff, regardless of who is on call? A patient with trouble practice mistakenly disclosed PHI of a patient, whose breathing is admitted to an open staff hospital by a Hospi- PHI included hospital records. Breach occurred at talist who is employed by that Hospital. Even though a physician’s independent office and had nothing to do particular private practice pulmonologist is on staff, and with hospital. on call, the Hospitalist is instructed by his Employer ❯❯ Patient’s family member takes video in hospital, and (the Hospital) to refer the patient to a different Pulmon- video captures images of other patients. ologist who is also employed by the Hospital. On being ❯❯ U.S. Post Office reports that it lost packages containing questioned about it, the Hospital confirms that they have PHI that were shipped by hospital. instructed their employed Hospitalists to do exactly this. ❯❯ Significantly, the breach notification rule is not Any comments are welcome. expressly limited to reporting breaches caused by the covered entity; instead, it simply states, “A covered entity shall, following discovery of a breach, notify ...” However, it seems patently unreasonable to interpret Medical Staff, Credentialing, and Peer Review the rule to require reports of all breaches of which the We have a number of clients (primarily specialists) who covered entity becomes aware regardless of the covered practice in concentrated metropolitan areas with large entity’s connection to the breach. So where does one hospitals and large hospital systems who complain that draw the line? they have not been notified, let alone consulted, when I note “breach” is defined as “the acquisition, access, use their patients are admitted to the hospital. The typical or disclosure of [PHI] in a manner not permitted under scenario is the patient gets admitted to the hospitalist subpart E”, i.e., the privacy rule. The privacy rule does not service through the ED, and then the hospitalists consult apply to non-covered entities or non-business associates; the system’s specialists rather than the specialist who accordingly, one might argue that disclosures by such has been treating the patient as an outpatient, notwith- persons are not prohibited by the privacy rule and, hence, do not constitute a reportable “breach.” As always, I look standing that the outpatient physician does have privileges at the hospital. Has anyone had any good experience in forward to your collective wisdom. resolving this issue? Community Library
Did you know that each community has its own library? Fraud and Abuse You can share different types of documents from Can a physician practice invite an employee of a DHS entity templates to photographs. You can upload files directly to to which it makes referrals to a holiday party? The non-mon- the library. You can also attach files to your message when you post in a community. The attached files will automat- etary compensation exception only applies to gifts provided ically be stored in the library (you will receive a follow up by DHS entities to referring physicians. Here, the physician email confirming that your files are saved in the library practice would be providing remuneration to an employee of and reminding you that you can move the file to any the DHS entity. sub-folder within the library). To access a library, go to a community’s homepage and click on the “library” tab.
28 AHLA Connections February 2019 New Webinar from AHLA Dispute Resolution Service
How to Make the AHLA Dispute Resolution Service Work for You Date/Time: February 20, 2019 2:00-2:45 PM (EST)
Learn how AHLA’s Dispute Resolution Service can help your health care clients resolve disputes more effectively and save money. The speakers are the director of the service and two top litigators who use the service and participate in AHLA.
As the health care industry grows in complexity, having informed decision-makers becomes ever more important. Thus, in recent years, AHLA has invested in providing easy access to a nationwide roster of arbitrators and mediators with health law and health care expertise. The webinar explains how to take advantage of this service and leverage technology to keep costs down.
Faculty: Rebekah Plowman, Arnall Golden Gregory Atlanta, GA Edwin E. Brooks, McGuire Woods LLP Chicago, IL
Free Webinar! Sign up today at www.healthlawyers.org/webinars
healthlawyers.org 29 Young Professionals
Flipping the Script: 3 Tips for Young Professionals to Overcome Imposter Syndrome Elizabeth A. Leahy, Massachusetts Association of Health Plans
On November 1st, I attended AHLA’s Institute for Tip #2: Document your successes, and then Health Plan Counsel. As a brand-new member of AHLA remind yourself of them. and an attorney with Massachusetts’ health plan trade asso- This works hand-in-hand with Tip #1. In their study, Clance ciation, I was feeling apprehensive. Should I even be attending and Imes found that those suffering from imposter syndrome this program since I’m not in-house at a health plan? Will there tend to attribute their successes to temporary causes, such as be any other young professionals in attendance? What if I’m not luck or effort, and tend to explain failure with lack of ability. up-to-speed on all the issues? To combat this phenomenon, try keeping a running list of It turns out these questions are the result of a broader your accomplishments. It might feel strange at first, but it’s phenomenon experienced by many people at some point in incredibly helpful to review when you need to give yourself their careers, called Imposter Syndrome. Psychologists Pauline that pep talk. R. Clance and Suzanne A. Imes coined the term in 1978, describing it as the “internal experience of intellectual phoni- Tip #3: Embrace a growth mindset. ness in people who believe that they are not intelligent, capable, Seasoned “imposters” worry that they will be figured out, or creative despite evidence of high achievement.”1 Over five that others will discover they are not smart or successful. years, Clance and Imes studied over 150 highly successful These feelings are entrenched in a performance mindset, women: women who earned PhDs in various specialties, where mistakes made or feelings of inadequacy are thought who were respected professionals in their fields, or who were of as evidence of underlying inadequacies. The trick is to students recognized for their academic excellence. Despite their reject this mindset and instead adopt a growth mindset. documented successes, praise, and professional recognition Psychologist Carol Dweck defines a growth mindset as one from colleagues and respected authorities, the women in the where individuals take on challenges and learn from them, study considered themselves to be imposters. focusing on hard work and effort rather than focusing Since then, experiences of imposter syndrome have been solely on the result.3 Adopting a growth mindset allows us well-documented. As a matter of fact, even the former First “imposters” to see mistakes as part of the learning process Lady has some experience with it. At a recent stop on her book instead of more evidence of underlying failures. tour for her memoir, Becoming, Michelle Obama confessed she still has a little bit of imposter syndrome, noting, “it doesn’t It turned out that my fears surrounding the Institute for Health go away, that feeling that you shouldn’t take me that seriously. Plan Counsel were unwarranted. There were many young What do I know? I share that with you because we all have professionals in attendance, the program was excellent and doubts in our abilities.”2 informative, and the issues were germane to much of the work If all of us high-achieving, hard-working professionals that I do. But that internal critic kept trying to make her voice experience imposter syndrome every now and then, how can heard—that is, until I flipped the script on her and embraced we defeat it? the experience as a learning opportunity.
Tip #1: Give yourself the pep talk you would give Elizabeth A. Leahy, PAHM is the Director of to someone seeking your advice. Advocacy and Stakeholder Engagement for the Of all the advice I’ve seen to overcome imposter syndrome, Massachusetts Association of Health Plans. She this is the one that resonates the most. Think of your role in specializes in fostering collaboration with your office and the countless times that you’ve been called on stakeholders across the health care industry to give advice to others. Would you talk to your colleagues and oversees legislative and regulatory the way the voice in your head is speaking to you? Would advocacy efforts relative to dual-eligible you discredit their successes and question their abilities? Of managed care programs, public health, and administrative course not! Silence that inner critic by giving yourself the simplification. pep talk you would give to someone else. Imagine one of your direct reports, a colleague, or a trusted friend came to 1 Clance, P. R., & Imes, S. A. (1978). The imposter phenomenon in high achieving women: Dynamics and therapeutic intervention. Psychotherapy: you and shared the same apprehensions you are currently Theory, Research & Practice, 15(3), 241-247. http://dx.doi.org/10.1037/ experiencing. What advice would you give them to silence h0086006. their inner critic? How would you convince them their fears 2 Welch, Ashley. (2018, December 5). What is imposter syndrome? Michelle Obama says she has it, and “it doesn’t go away”. CBS News. Retrieved are unwarranted? Now tell yourself those same things. from: https://www.cbsnews.com/news/what-is-impostor-syndrome-michelle- obama-says-she-has-it/. 3 Dweck, C. S. (2006). Mindset: The New Psychology of Success. New York, NY, US: Random House.
30 AHLA Connections February 2019 February Webinars
Beyond Advance Directives: What Attorneys Lawyers New to Health Care—Gaining Need to Know About Advance Care Planning the Edge: A Panel Discussion for Young February 13, 2019 at 2:00 PM (EST) Professionals and Law Students
❯❯ What advance care plans (POLST/MOLST, advance directives, February 26, 2019 at 2:00 PM (EST) DNRs) are and how they fit into CMS COPs The Young Professionals Council is hosting a free call for Young ❯❯ Identifying a surrogate decision maker for an incapacitated Professionals and Law Students. Panelists will share experiences patient or resident and advice on succeeding in health care law. Topics will include: ❯❯ Ethical issues: handling conflicts and facility religious or ethical ❯❯ How to break into the health care field objections to resident requests ❯❯ Whether to focus on specialty versus general practice ❯❯ How to gain expertise and attract clients, and ❯❯ Tips on networking and mentoring Highlights of the 2019 Medicare Physician Panelists will include David Cade, CEO of AHLA, Karen Fee Schedule Palmersheim, Senior Counsel with Cigna, and Jeff Wurzburg, February 19, 2019 at 2:00 PM (EST) counsel with Norton Rose Fulbright US LLP. Patrick Garcia (YPC member) of Hall Render Killian Heath & Lyman PC will moderate the This webinar will be comprised of a panel of four experts covering panel with questions from YPC members. the following hot topics: ❯❯ Streamlining evaluation and management of Medicare payment and reduction of clinical burden ❯❯Practice flexibility provisions for radiology assistants and Medicare payment changes for the delivery of outpatient therapy services as well as reporting changes in therapy services To register for any of these webinars, please go to ❯❯Changes to Medicare payment for technology-based services, telehealth services, and expansion of payment for telehealth www.healthlawyers.org/webinars. ❯❯Appropriate Use Criteria for advanced diagnostic imaging
healthlawyers.org 31 Compliance Corner By Compliance Professionals, For Compliance Professionals.
Building an Effective Compliance Program with Limited Resources By Marti Arvin, Vice President of Audit Strategy at CynergisTek
What is an effective compliance program? To across multiple operational departments. For example, in paraphrase Supreme Court Justice Potter Stewart’s a large, better-resourced program, the Privacy Officer may statement on what is obscene, “I can’t define it, but be responsible for all privacy policies but in a smaller orga- I know it when I see it.” That statement is also true of an nization with fewer resources, some or all of these may be effective compliance program. What needs to be addressed the responsibility of a department like Health Information is how to “see” an effective program. If there are limited Management Services (HIMS). If HIMS is responsible for the resources, which is so often the case, this will mean lever- drafting and maintenance of these policies, compliance may aging the right resources across multiple business units. Often just need to review them. This also may be true for policies on when evaluating a compliance program for effectiveness, the billing and coding, conflicts of interest, and other compliance tendency is to look at the Compliance Office and the oversight areas. An effective program will have compliance policies of the Compliance Officer. Particularly in an organization with that are reviewed and updated as appropriate on a regular limited resources for compliance activities, that “look” will basis. Thinking of ways to share the burden rather than have it need to go beyond the Compliance Office to create and main- centralized in one department with limited resources can help tain an effective program. ensure policies are kept up to date.
When it comes to measuring effectiveness, an organization Compliance Program Oversight must be able to demonstrate the core characteristics under the What is an effective oversight structure? It should demonstrate Seven Elements of an Effective Compliance Program defined senior leadership’s involvement. All too often, the responsibility by Chapter 8 of the Federal Sentencing Guidelines. When for compliance oversight begins and ends with the Compliance resources are limited, more of these elements may be addressed Officer. If the Compliance Officer is under resourced this just outside the Compliance Office. adds to the demands. Regardless of resourcing, to demonstrate effectiveness, there should be evidence of the discussion of Policies, Standards, and Procedures items across the seven elements with leadership. Ideally, the The first question to ask is do policies exist? If the organization meeting agendas and minutes will be structured to follow the has limited resources, policy ownership may be distributed seven elements and reflect the discussion of the committee on
32 AHLA Connections February 2019 Compliance Corner By Compliance Professionals, For Compliance Professionals. key compliance issues and decisions. It should be clear that the naire would then be shared with the Compliance Officer so governing body was aware of the organization’s risks and made issues and red flags can be trended at the organization and/ decisions on how to prioritize them. Looking at the organiza- or business unit level. If robust monitoring done by business tion’s processes around this can help guide legal counsel on owners can be demonstrated, then a reduced level of auditing whether the compliance program is effective. by the Compliance staff can still lead to an effective compliance program. Training and Education Review what training and education is being done around Background Checks compliance topics, including not only what Compliance is Background checks may seem to be the easiest area to demon- doing, but what is happening across operational units. This is strate effectiveness, but that is not always the case. Someone particularly important when the Compliance Office has limited must be responsible for checking the OIG List of Excluded training and education resources. The Compliance Officer Individuals and Entities or the General Services Adminis- can produce material for the operational business owners to tration’s System of Award Management (SAM) databases. use in routine staff meetings, huddles, and other regularly These checks must be done not only at the point of hire, but scheduled meetings. This should include an attendance sheet, also on a routine basis, such as monthly or quarterly. If there so the training can be tracked. It is highly likely that Human is a match, there must be documentation that the match was Resources (HR) is already tracking other types of training. evaluated, and appropriate action was taken (i.e. assessing the Compliance can leverage HR to record the training when the individual’s involvement in services billed to governmental business owner submits the sign-in sheet, helping the organi- payers). However, not all of this responsibility needs to be on zation demonstrate effectiveness in this element but not make the shoulders of the Compliance Officer. Other business units training and education the sole responsibility of Compliance. like HR for staff and the Medical Staff Office for providers can report their findings to Compliance, which can do a sample Auditing and Monitoring to help ensure the controls are appropriate. Documentation of Demonstrating an effective auditing and monitoring program these activities and appropriate corrective action when a match starts with a process for the risk assessment, which should is found will demonstrate effectiveness. show the engagement of senior leadership and business owners. The assessment should be tied to the relevant portions of the Reporting and Investigations Department of Health and Human Services Office of Inspector Does the organization have an anonymous reporting line? If so, General’s (OIG’s) annual workplan, what is happening in the is there evidence employees are aware of it and use it? A lack of industry and the enforcement landscape, new service lines, significant reports on the anonymous reporting line does not etc. The risk assessment also should evaluate what controls the mean a program is ineffective. If there is a method for tracking organization has in place. For example, if the OIG is looking at issues brought directly to the Compliance Office and those a particular service, that does not necessarily mean the orga- numbers are high, it could mean employees do not feel the need nization must conduct auditing and monitoring around that to report anonymously. Additionally, it could mean that they service if a process for compliance already has been developed feel comfortable reporting directly because they do not fear and tested. retaliation for raising legitimate concerns.
A key factor in demonstrating effectiveness in auditing and Look at what the Compliance Office is investigating. Are issues monitoring is assessing the high-risk areas for the organization. brought to Compliance being investigated? If the Compliance When the Compliance Office is underfunded, doing the neces- Office does not have the resources to investigate, this is likely sary level of auditing may be challenging. Again, this is where an area where leveraging other departments may be diffi- other departments must be leveraged. Compliance may seek to cult. While other business units, such as General Counsel or partner with Internal Audit to cover more high-risk areas. Internal Audit, support investigations, effectiveness will suffer if compliance concerns are not investigated because of the lack It is critical to capture all monitoring activity occurring in the of resources. Investigations must be independent and objective organization. Oftentimes, monitoring occurs within multiple so this an area where using the involved business unit is not a business units, making it important to understand and docu- good option. ment these practices to take credit for any monitoring already being done. The Compliance Office must have the resources to investigate properly to be effective. If investigations are taking months There also may be opportunities to engage business units in without valid reasons, that is a sign of a problem. This may additional monitoring. The Compliance Officer may develop a be the one area where the Compliance Officer must convince questionnaire that business units must complete on a routine senior leadership that additional resources are necessary. basis to assure they are doing certain activities. The question-
healthlawyers.org 33 Compliance Corner By Compliance Professionals, For Compliance Professionals.
Corrective Action Marti Arvin is Vice President of Audit Strategy When an issue was identified, is there evidence that an appro- at CynergisTek. She has more than three priate corrective action was implemented such as prompt decades of operational and executive leadership refunds and any necessary disciplinary actions? Corrective experience in the fields of compliance, research, action needs to be documented and there must be evidence and regulatory oversight in academic medical that disciplinary action is consistent for similar infractions. If a and traditional hospital care settings. Ms. physician is given a slap on the hand but her nurse counterpart Arvin leads strategic business development around compliance is fired that sends a message that some staff are not held to the services and utilizes her industry recognized expertise in same standard. This is one more area where Compliance could health research to inform the development of privacy and partner with HR to share the burden to track discipline and security services to meet that communities underserved needs. with Internal Audit to follow-up on corrective action plans. She is a nationally recognized speaker and contributor to the thought leadership around health care compliance and research An effective compliance program is not the sole responsibility and contributes to CynergisTek’s industry outreach and of the Compliance Officer—it is a team effort. This is even more educational programs. She has extensive experience in building critical when Compliance has limited resources. and managing compliance and research programs and served as the Chief Compliance Officer for Regional Care Hospital Partners and the UCLA Health System and David Geffen School of Medicine.
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34 AHLA Connections February 2019 https://careercenter.healthlawyers.org Career Center
California associate with four to five years of health cover letter. Epstein Becker & Green PC is Orange, CA: Staff Counsel—Contracts, law/health care industry knowledge and an equal opportunity employer. Children’s Hospital of Orange County. At transactional experience to join our Health CHOC Children’s Hospital, we strive to be Law Practice in the Washington, DC Maryland the leading destination of children’s health office. Candidates must possess a strong Baltimore, MD: Associate Staff Counsel, by providing exceptional and innovative academic background and strong writing, The University of Maryland Medical care. This position will work under the contract drafting, and interpersonal skills System. The University of Maryland supervision of the Associate General and a commitment to client service. Medical System is a 14-hospital system Counsel by providing legal counsel and Experience researching, analyzing, and with academic, community, and specialty services to the executive teams of CHOC advising on Medicaid and Medicare A, B, medical services reaching every part Children’s Hospital, including interpreta- C, and/or D requirements as well as state of Maryland and beyond. UMMS is a tion of, advice regarding, and represen- and federal fraud and abuse laws (e.g., national and regional referral center for tation on a wide variety of matters related the Anti-Kickback Statute, the Stark Law, trauma, cancer care, NeuroCare, cardiac to hospital and health system operations. the False Claims Act, similar state laws) is care, women’s and children’s health, and Experience: Two to five years of expe- preferred. Experience representing clients physical rehabilitation. UMMS is the fourth rience. Preferences for prior large law in a variety of transactions (including largest private employer in the Baltimore firm or in-house experience; health care mergers, stock and asset acquisitions metropolitan area and one of the top experience related to contract drafting and sales, and joint ventures) and drafting 20 employers in the state of Maryland. and transactional matters; experience contracts is strongly preferred. Experi- UMMS is seeking a full time Staff Counsel analyzing arrangements under the Stark ence with pharmacy matters, including for our corporate location. The following Law, Anti-Kickback Statute and other specialty pharmacies, pharmacy benefit is required: Juris Doctor degree from fraud and abuse laws, EMTALA, HIPPA, managers, and wholesalers is also an accredited law school, three years of antitrust laws, and any other regula- preferred but not required. This position progressively responsible experience as a tory requirements applicable to health is for the Washington, DC office only. To practicing health care attorney, member- care arrangements; and experience apply for this position, please visit the ship in good standing of the bar in at advising physician groups on acquisition, AHLA Career Center at www.healthlaw- least one state, preferably Maryland, and transactional, and regulatory issues. yers.org. On the top navigation bar, click current knowledge of health care-related Skills: Strong communication, analytical, on “Find a Resource,” then select “Career statutes and regulations as well as current problem-solving, strategic thinking, and Center.” legal issues affecting the health care organizational skills. To apply for this posi- industry. Apply online at http://jobs.umms. tion, please visit the AHLA Career Center Illinois org/ShowJob/Id/1396035/Staff-Coun- at www.healthlawyers.org. Chicago, IL: Life Sciences/FDA Regulatory sel-General-Healthcare-UMMS/. The Associate, Epstein Becker & Green PC. University of Maryland Medical System is Colorado The Chicago office of Epstein Becker & an equal opportunity employer. Denver, CO: Health Care Regulatory Green PC seeks an attorney to work at Associate, Greenberg Traurig. The Denver the level of a fourth to sixth year associate Michigan office of Greenberg Traurig, a global law to join its Health Care and Life Sciences Wyoming, MI: Associate General Counsel, firm, currently has an opening for a Health Practice. Candidates should possess Metro Health—University of Michigan Care Regulatory Associate with three strong academic credentials and have Health. The Associate General Counsel to seven years of significant experience excellent oral and written communica- will be employed on site full time with representing hospitals, physician groups, tion skills. An ideal candidate will have Metro Health Corporation in Grand ancillary service providers, and other experience representing clients in the Rapids, Michigan. The Associate General investors in the health care industry life sciences industry in regulatory and Counsel will collaborate with existing with state and federal fraud and abuse transactional matters and should have Associate General Counsel at Metro and compliance matters, licensure and expertise in FDA regulatory matters, fraud Health Corporation and the University of reimbursement matters, and operational and abuse, advertising and promotion, Michigan and be responsible for providing matters. Experience in transactional corporate compliance matters, and legal advice and legal services in support matters in the health care industry such as clinical research. Experience negotiating of Metro Health Corporation and its affil- mergers and acquisitions, joint ventures, commercial agreements is preferred but iated entities. Such services will include contractual agreements, and license and not required. Juris Doctorate degree addressing health care legal questions lease agreements is a plus. To learn more required. All interested applicants should as well as identifying and advising local visit www.gtlaw.com/careers. send their cover letter, resume, and management on legal issues arising in the writing sample to Amy Simmons, Director establishment of joint ventures, partner- of Legal Recruitment & Professional District of Columbia ships and/or alliances, contracts, and Development, at [email protected]. ensuring compliance with all govern- Washington, DC: Health Law Associate, Please reference Health Associate in your Mintz Levin. We are looking for an mental requirements. Requirements: Juris
ADDITIONAL LISTINGS: May be found in our National Job Bank. Go to: https://careercenter.healthlawyers.org/. DEADLINES: Space reservations, copy, and payment are due on the 5th of the month prior to publishing. Copy for 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 information on pricing, visit www.ahla-mediaplanner.com or contact Samantha Leland, MCI Group, (410) 584-1938, [email protected].
healthlawyers.org 35 Career Center
Doctorate degree. A minimum of seven ical services agreements, academic affiliation broad range of general health care legal years of experience practicing law in a agreements, professional services agree- and state and federal regulatory matters, health care environment or health law ments, and other transactional matters. The including Stark and anti-kickback issues; practice group of a law firm. Must have position will be based in New Brunswick with review, draft, and negotiate commercial knowledge of the operations of the health approximately one day a week in Newark. To and health care contracts, including care industry and the health care delivery apply for this position, please visit the AHLA physician, information technology, clinical system. Must have knowledge of local, Career Center at www.healthlawyers.org. research, leases, and other health care state, and federal legislation as it relates On the top navigation bar, click on “Find a business agreements; and provide legal to selected areas of law. Apply online at Resource,” then select “Career Center.” support and guidance with respect to www.metrohealth.net/jobs. strategic transactions. The ideal candi- West Orange, NJ: Corporate Health date must have a JD degree, and experi- Missouri Care Attorney, RWJBarnabas Health. ence reviewing, drafting, and negotiating Kansas City, MO: Associate General RWJBarnabas Health is the most commercial and physician contracts is Counsel, Blue Cross Blue Shield of comprehensive health care delivery preferred. In addition, the ideal candidate Kansas City. Provides legal opinions system in New Jersey, treating over three must have a minimum of five years of to the appropriate members of the million patients a year. The system has experience in an intensive health care law company’s management and executive 13 hospitals, 1,200 employed physicians, environment at either a top law firm and/ team. Develops solutions to complex 9,000 private attending physicians, and, or in the legal department of a large orga- legal questions for teams implementing as New Jersey’s second largest private nization. To apply, contact Deidra Carey corporate initiatives. Selects and assists employer, 32,000 employees. We have an at [email protected]. outside counsel on matters relating to immediate opportunity for an experi- highly specialized areas of law. Drafts and enced corporate or health care attorney New York negotiates vendor, customer, and other to become a member of our growing White Plains, NY: Health Care Attorney, contracts. Advises the General Counsel team of legal professionals. This position Bleakley Platt & Schmidt LLP. We seek and other key executives on corporate is a high-profile growth opportunity with an experienced health care attorney for governance matters. Improves processes immediate responsibility. The successful our White Plains, New York office. The and implements best practices. Antici- applicant will counsel on a broad range attorney will join our highly successful pates legal risks and proactively works to of general health care legal and state and health law practice and will serve as mitigate those risks. Keeps the General federal regulatory matters, including Stark outside counsel to a premier physician Counsel apprised of developing regula- and anti-kickback issues; review, draft, group serving patients throughout the tions and litigation that may impact the and negotiate commercial and health Hudson Valley. This is a partnership track company. Interfaces and negotiates with care contracts, including information opportunity. Compensation is compet- regulatory authorities. Minimum Qual- technology, clinical research, construc- itive. Candidates must have excellent ifications: JD and at least four years of tion, leases, physician, and other health academic credentials and at least two legal experience. Preferred Qualification: care business agreements; and provide years of experience within a law firm or Experience in one or more of the following legal support and guidance with respect in-house setting practicing health law. areas: HIPAA, employment, employee to strategic transactions. Must have Successful candidates will have substan- benefits, litigation, health insurance, excellent academic credentials and JD tial expertise representing clients in and health care, including representing degree from a nationally recognized law matters involving fraud and abuse laws, providers in health care regulatory compli- school and a minimum of seven years of HIPAA, cyber security laws, IT contracts, ance and contracting. Experience with a experience in an intensive health care law and New York health care regulatory laws. health insurance carrier. To apply, contact environment at either a top law firm and/ Substantial experience in contract and Mindy Miller at [email protected]. or in the legal department of a large orga- corporate transactional law is strongly nization. To apply, contact Deidra Carey preferred. Spanish language skills are at [email protected]. New Jersey desirable. To apply, contact Mary Ann Zeolla at [email protected]. New Brunswick, NJ: Senior Assistant General West Orange, NJ: Health Care Generalist/ Counsel, Rutgers. Rutgers, The State Transactional Attorney, RWJBarnabas Advertising Index University of New Jersey, seeks a Senior Health. RWJBarnabas Health is New AHLA Podcast ���������������������������������������� 4 Assistant General Counsel—Health Care for Jersey’s largest private employer—with AHLA Day ���������������������Inside Front Cover The Rutgers General Counsel Office. This more than 33,000 employees, 9,000 AHLA Dispute Resolution Service ��������� 29 position reports to the Senior Vice President physicians, and 1,000 residents and AHLA Distance Learning ����������������������� 31 and General Counsel as well as the Asso- interns—and routinely captures national AHLA Focus On �������������������������������������� 7 ciate Vice President and Deputy General awards for outstanding quality and safety. AHLA Mentoring ����������������������������������� 34 Counsel. The Senior Assistant General We have an immediate opportunity for AHLA Programs ���������������������� Back Cover Counsel—Health Care is primarily assigned an experienced corporate or health care AHLA Publishing ������17, Inside Back Cover to advise Rutgers University’s health attorney to become a member of our The Burroughs Healthcare sciences schools, institutes, and centers. growing team of legal professionals. This Consulting Network Inc ��������������������������� 3 The position provides legal representation for position is a high-profile growth oppor- LW Consulting ����������������������������������������15 Rutgers University in various areas, including tunity with immediate responsibility. The Ntracts Inc. ��������������������������������������������� 5 negotiating and advising on contracts, clin- successful applicant will: counsel on a PYA ������������������������������������������������������� 27
36 AHLA Connections February 2019 RSVP TODAY
APRIL 11, 2019 The Stark Law Comprehensive Analysis + Practical Guide » » ENGAGE SHARE ENCOURAGE Sixth Edition
Charles B. Oppenheim, Ben A. Durie, Amy M. Joseph, Authors
The Stark Law is complex, with new twists and turns that must be contemplated by attorneys advising physicians, hospitals, and others involved with the AHLADAY business of medicine. This completely updated and significantly expanded edition of Atlanta | Denver | Nashville | Washington, DC The Stark Law is not just a summary of the law. It is an in-depth critical analysis with a wealth AHLA Day is an opportunity to engage with your colleagues by promoting your involvement in the Association, of pointers and practical advice—and a look at what future direction Stark might take. share why you belong and what you gain from your affiliation, andencourage your colleagues to join you. Table of Contents Join us on April 11th in Atlanta, Denver, Nashville, or Washington, DC for a networking reception with fellow Ch. 1 Introduction and Background AHLA members and those interested in joining our community. Additionally, a variety of other networking Ch. 2 Key Themes in the Stark Law and Regulations events will be held across the country—if there isn’t one in your city, let’s plan one! Ch. 3 Key Definitions and Interpretations Don’t forget to bring a colleague! Pass along the AHLADAY19 coupon code Ch. 4 Remaining Problem Areas to your colleagues and they will save $50 when they join now through April 11th! Ch. 5 Analysis of Group Practices Visit www.healthlawyers.org/AHLADay for more details! Ch. 6 Permissible Joint Ventures and ACOs Ch. 7 Addressing Potential Violations Ch. 8 Proposed Solutions to “Intractable” Stark Problems Thank you to our AHLA Day 2019 sponsors for their generous support. Ch. 9 Preventing Violations/Practical Tips Platinum Sponsor: Firm Sponsors: Ch. 10 The Future of the Stark Law Appendix A Chronological Guide to Stark Rulemaking Appendix B Stark Rules Indexed by Topic Appendix C Prohibitions on Self-Referral by State Now available for order!
Showcase your firm’s leadership and invest in AHLA Day 2019 today. www.store.lexisnexis.com/ahla Contact Valerie Eshleman at [email protected] for more information on sponsorship or hosting an event in your area. INSTITUTE
For the most comprehensive program available ON MEDICARE on legal issues related to reimbursement, attend AHLA’s Institute on Medicare and AND MEDICAID Medicaid Payment Issues. The program is a practical, informative program that brings together knowledgeable public and private PAYMENT ISSUES sector speakers with CMS and other agency LEARN. NETWORK. ENGAGE. representatives. Topic areas covered include Part A, Part B, Medicaid, fraud Premier Education in Health Law and abuse, compliance, transactional, procedural, and ancillary issues in March 20-22, 2019 | Baltimore, MD reimbursement.
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