Published on October 31, 2007
Stark Anti-kickback Legislation:An Overview of Suggested Tools for Compliance: Stark Anti-kickback Legislation: An Overview of Suggested Tools for Compliance A General Resource Prepared by the Enterprise IS Steering Committee for Use by HIMSS Members October 12, 2006 Presented by:JoAnn W. Klinedinst, CPHIMS, FHIMSS, PMPHIMSS Staff Liaison, Enterprise IS Steering CommitteeDirector, Healthcare Information SystemsHealthcare Information and Management Systems Society (HIMSS)215-530-5330[email protected]: Presented by: JoAnn W. Klinedinst, CPHIMS, FHIMSS, PMP HIMSS Staff Liaison, Enterprise IS Steering Committee Director, Healthcare Information Systems Healthcare Information and Management Systems Society (HIMSS) 215-530-5330 [email protected] With Special Thanks and Recognition to: Claudia Schlosberg | Blank Rome LLP Blank Rome Government Relations LLC The Watergate Building, 600 New Hampshire Avenue NW | Washington, DC 20037 Phone: 202.772.5985 | Fax: 202.572.8403 | Email: [email protected] Agenda: Agenda Welcome and Introductions Intent of the Regulations Defining the Terms Stark, Anti-Kickback and Donations: A Presentation by Claudia Schlossberg, Blank Rome, LLP EHR Implementation Life Cycle Tools to Use to Facilitate Collaboration SWOT Analysis Business Plan Project Plan Narrative Identifying Funding Sources Additional Resources Opportunities for Additional Discussion HIMSS Healthcare Information and Management Systems Societywww.himss.org: HIMSS Healthcare Information and Management Systems Society www.himss.org 501c(4) Not for Profit Educational Association 17,000 Individual Members 275 Corporate Members 43 Individual Chapters President George W. Bush’sHealth Information Technology Plan: April 26, 2004http://www.whitehouse.gov/infocus/technology/economic_policy200404/chap3.html: President George W. Bush’s Health Information Technology Plan: April 26, 2004 http://www.whitehouse.gov/infocus/technology/economic_policy200404/chap3.html Federal Register: August 8, 2006http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-6666.pdf : Federal Register: August 8, 2006 http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-6666.pdf Intent of the Regulations: Intent of the Regulations On August 1, 2006 Health and Human Services (HHS) Secretary Mike Leavitt announced final regulations establishing rules intended to support physician adoption of electronic prescribing and electronic health records. The final regulations became law on October 10, 2006. Intent of the Regulations: Intent of the Regulations “We believe the final rule strikes the appropriate balance between protecting the adoption of health information technology and protecting against fraud and abuse.” Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45113 Defining the Terms: Defining the Terms Stark Regulations Anti-Kickback Statue Safe Harbors Safe Harbor Protections Electronic Health Record Interoperability Remuneration Stark Regulations: Stark Regulations On March 26, 2004, the Centers for Medicare and Medicaid Services ("CMS") released new regulations interpreting the 1995 federal physician self-referral prohibition commonly known as the "Stark Law." The Stark Law governs the financial relationships between physicians and entities to which they refer certain designated health services ("DHS"). http://www.bccb.com/publications/Detail.aspx?id=1fa1b138-2384-495d-a7b1-4f00e7bbf6a1 Anti-Kickback Statute: Anti-Kickback Statute “The Anti-Kickback statue states that criminal penalties will be issued for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration intended to induce or reward referral of business reimbursable under any of the Federal health care programs, i.e., Medicare, Medicaid, or other Federal Health Care programs.” Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45110 Remuneration: Remuneration “Remuneration is defined as pay or salary, typically monetary payment for services rendered, as in an employment.” http://en.wikipedia.org/wiki/Remuneration Safe Harbor: Safe Harbor “A safe harbor is a provision which would specify various payment and business practices that would not be treated as criminal offenses under the anti-kickback statute, even though they may potentially be capable of inducing referrals of business under the Federal health care programs.” Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45110 Safe Harbor Protections: Safe Harbor Protections “The safe harbor would protect certain arrangements involving hospitals, group practices, and prescription drug plan (PDP) sponsors and Medicare Advantage (MA) organizations that provide to specific recipients certain non-monetary remuneration in the form of hardware, software, or information technology and training services necessary and used solely to receive and transmit electronic prescription information.” Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45110 Electronic Health Record: Electronic Health Record “An electronic health record will be defined as a repository of consumer health status information in computer processable form used for clinical diagnosis and treatment for a broad array of clinical conditions.” Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45122 Interoperability: Interoperability “At the time of donation, the software is able to communicate and exchange data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks, in various settings, and exchange data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.”.” Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45126 Slide17: Presented by Claudia Schlosberg, Partner Blank Rome, LLP 600 New Hampshire Avenue, N.W. Washington, D.C. 20037 202-772-5985 Email: [email protected] Stark, Anti- Kickback and Donations of Health Information Technology Slide18: STARK Anti-kickback Prohibits Physicians from making referrals for designated health services payable by Medicare to an entity in which he/she (or a family member) has a financial relationship. Establishes criminal penalties for offering/provide/receiving inducements for the referral of business reimbursable under federal health care programs. Slide19: STARK Anti-kickback Any service reimbursable by federal health care programs (Medicare, Medicaid, VA etc). DHS that are Federally reimbursed: Lab Services PT,OT and Speech Radiology and Imaging Radiation Therapy Nutrition Therapy Home health Services Outpatient prescriptions In and Out-patient Hospital How do donations of HIT relate?: How do donations of HIT relate? Stark - Establishes the financial relationship between the physician and the referral source unless the donation meets an “exception.” Anti-kickback - May constitute an inducement unless donation meets a “safe harbor.” Technical Requirements: Technical Requirements Arrangements must be in writing. Recipients cannot be chosen based on volume or value of business generated. E-prescribing IT must be compatible with e-prescribing program that meets applicable standards under Medicare Part D. EHR donations must be “interoperable.” Software may be “deemed” interoperable if certified by certifying body recognized by the Secretary. Moving Forward: Moving Forward No one has all the answers. Each arrangement must be evaluated individually There are other Stark exceptions and anti-kickback safe harbors that may be useful. Consider using the OIG Advisory Opinion Process. CMS may also provide additional guidance. Covered Technology: Covered Technology “The core functionality of the technology must be the creation, maintenance, transmission, or receipt of individual patients’ electronic health records.” Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45124 Types of Covered Technology Protected by Safe Harbors: Types of Covered Technology Protected by Safe Harbors Transfers of electronic health records software; Information Technology (including broadband or wireless internet connectivity and maintenance services); Training services (including HelpDesk and other similar support); And others deemed “necessary and used predominantly to create, maintain, transmit, or receive electronic health records.” Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45116; 45121 Examples of Covered Technology Protected by Safe Harbors: Examples of Covered Technology Protected by Safe Harbors Software, Information Technology and Training Services necessary and used predominantly for electronic health records purposes to include the following: Interface and translation software Rights, licenses, and intellectual property related to electronic health records software Connectivity services, including broadband and wireless service Clinical support and information services related to patient care Maintenance Services Secure Messaging, e.g., permitting physicians to communicate with patients through electronic messaging Patient portal software Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45125 EHR Implementation Life Cycle:Suggested Guidelines: EHR Implementation Life Cycle: Suggested Guidelines Tools Organizations Can Use to Help Facilitate a Decision to Enter a Collaborative Relationship: Tools Organizations Can Use to Help Facilitate a Decision to Enter a Collaborative Relationship SWOT Analysis Business Plan Project Plan Narrative Tools that Facilitate Collaboration Equate to a Roadmap:Getting from Here to There: Tools that Facilitate Collaboration Equate to a Roadmap: Getting from Here to There The Suggested Tools Facilitate Effective Documentation Practices: The Suggested Tools Facilitate Effective Documentation Practices “Moreover, we are requiring that the cost sharing contribution be made and documented before the items and services can quality for safe harbor protection. The documentation must be specific as to the items and services donated, the actual cost to the donor, and the amount of the recipient’s cost sharing obligation. The documentation must cover all of the electronic health records items and services to be provided by the donor (or affiliated parties) to the recipient.” Federal Register/Vol. 71, No. 152/Tuesday, August 8, 2006/Rules and Regulations, 45134 Assessing Existing Business Practices:The SWOT Analysis: Assessing Existing Business Practices: The SWOT Analysis Assessing Existing Business Practices:The SWOT Analysis: Assessing Existing Business Practices: The SWOT Analysis A tool that is used to identify the strengths, weaknesses, opportunities, and threats; Related to accomplishing a specific task or project; Requires a facilitator, knowledgeable participants, and a positive attitude among all working together; Identifies the good and not so good of accomplishing a specific task. Components of a SWOT Analysis: Components of a SWOT Analysis A SWOT Analysis Example: A SWOT Analysis Example An Additional Tool to Help Facilitate a Decision for a Collaborative Agreement: A Business Plan: An Additional Tool to Help Facilitate a Decision for a Collaborative Agreement: A Business Plan An Additional Tool to Help Facilitate a Decision for a Collaborative Agreement: A Business Plan: An Additional Tool to Help Facilitate a Decision for a Collaborative Agreement: A Business Plan A business plan will provide the structure needed to create a roadmap for getting from a current state to a future state by doing the following: Describing the Current Situation Identifying Future Plans Defining Opportunities Identifying Financial, Operational, and Organizational Strategies Needed to Achieve the Objective Suggested Components of a Business Plan: Suggested Components of a Business Plan Aspects to Consider When Entering into a Collaborative Agreement: Types of Business Models: Aspects to Consider When Entering into a Collaborative Agreement: Types of Business Models Vendor Selection Phase: Vendor Selection Phase Prepare a RFI/RFP Identify a Short List of Vendors Host Demos Conduct Site Visits Check References Shorten the List Even Further Check References Independent of Vendor Negotiate Contract Execute Contract An Additional Tool to Help Facilitate a Decision for a Collaborative Agreement: A Project Plan Narrative: An Additional Tool to Help Facilitate a Decision for a Collaborative Agreement: A Project Plan Narrative An Additional Tool to Help Facilitate a Decision for a Collaborative Agreement: A Project Plan Narrative: An Additional Tool to Help Facilitate a Decision for a Collaborative Agreement: A Project Plan Narrative A project plan narrative serves as the document that will explain not only what is to be accomplished but how it will be accomplished. Just as the business plan serves as the roadmap for getting from here to there, the project plan narrative serves as the navigational tools to do so. Suggested Components of a Project Plan Narrative: Suggested Components of a Project Plan Narrative A High Level EHR Implementation Life Cycle:Be Aware of the Many Phases Once a Contract is Signed: A High Level EHR Implementation Life Cycle: Be Aware of the Many Phases Once a Contract is Signed Hardware Phase: Review, Acquire, and Install Software Phase Software Features and Functions Review and Analysis Workflow Analysis and Re-Design Integration Analysis and Design Implementation Phase Testing Phase Acceptance Testing Pre-Production Testing Policy and Procedure Review and Update Mock Live Training Phase: Super User, Clinician, Non-Clinician Pre-Production Final Analysis Phase Move to Production Post-Production Support and Follow-up Aspects to Consider When Entering into a Collaborative Agreement: Aspects to Consider When Entering into a Collaborative Agreement Post-Production Support and Follow-up Resolving Outstanding Issues Modifying Workflow to Accommodate “Features” Installing Additional Features Planning for the Next Upgrade Installing Additional Interfaces User Management: Adds, Changes, Deletes Identifying Potential Sources of Funding: Identifying Potential Sources of Funding Potential Sources of Funding: Federal Agencies: Potential Sources of Funding: Federal Agencies Health Resources and Services Administration http://www.hrsa.gov National Institutes of Health http://www.grants.nih.gov Centers for Disease Control http://www.cdc,gov Department of Health and Human Services http://www.hhs.gov Potential Sources of Funding: Foundations: Potential Sources of Funding: Foundations The Commonwealth Fund http://www.cmwf.org The Verizon Foundation http://www.foundation.verizon.com W. K. Kellogg Foundation http://www.wwfk.org National Associations that Focus on Grant Writing and Making: National Associations that Focus on Grant Writing and Making The American Association of Grant Professionals http://www.grantprofessionals.org The Foundation Center http://www.foundationcenter.org Additional Resources: Additional Resources American Health Lawyers Associationhttp://www.healthlawyers.org/Content/NavigationMenu/Health_Law_Resources/Health_Law_Web_Sites/Healthcare_and_Health_Law_Sites.htm: American Health Lawyers Association http://www.healthlawyers.org/Content/NavigationMenu/Health_Law_Resources/Health_Law_Web_Sites/Healthcare_and_Health_Law_Sites.htm Office of Inspector General: Advisory Opinion Processhttp://oig.hhs.gov/fraud/advisoryopinions/aofaq.html#8: Office of Inspector General: Advisory Opinion Process http://oig.hhs.gov/fraud/advisoryopinions/aofaq.html#8 Certification Commission for HIT: http://www.cchit.org : Certification Commission for HIT: http://www.cchit.org HIMSSAmbulatory Information Systems Steering Committeehttp://www.himss.org/ASP/committees_ambulatory.asp : HIMSS Ambulatory Information Systems Steering Committee http://www.himss.org/ASP/committees_ambulatory.asp Slide55: HIMSS Resources http://www.himss.org/content/files/GettingStartedEMR_Flyer1.pdf Slide56: HIMSS Resources http://www.himss.org/content/files/SelectingEMR_Flyer2.pdf HIMSSEnterprise Information Systems Steering Committeehttp://www.himss.org/ASP/committees_ehr.asp : HIMSS Enterprise Information Systems Steering Committee http://www.himss.org/ASP/committees_ehr.asp HIMSSPersonal Health Record Steering Committeehttp://www.himss.org/ASP/committees_phr.asp : HIMSS Personal Health Record Steering Committee http://www.himss.org/ASP/committees_phr.asp HIT Dashboardhttp://www.hitdashboard.com/ : HIT Dashboard http://www.hitdashboard.com/ HIT Dashboard: 2005 Davies Award WinnerCongratulations!Citizens Memorial Healthcare: HIT Dashboard: 2005 Davies Award Winner Congratulations! Citizens Memorial Healthcare Mark Your Calendar’s for the Latest in Health Information Exchange Forums!CONNECTING COMMUNITIES REGIONAL FORUMSDecember 12 – Salt Lake CityDecember 14 – ChicagoMay 3 – OrlandoMay 10 – BostonFor more information www.himss.org/hieforums : Mark Your Calendar’s for the Latest in Health Information Exchange Forums! CONNECTING COMMUNITIES REGIONAL FORUMS December 12 – Salt Lake City December 14 – Chicago May 3 – Orlando May 10 – Boston For more information www.himss.org/hieforums What you will take away from attending the CONNECTING COMMUNITIES REGIONAL FORUMS: What you will take away from attending the CONNECTING COMMUNITIES REGIONAL FORUMS By hearing from today’s leaders on the “front lines,” you will gain valuable and practical information on Planning your HIE strategy. Learn which approaches work best to attain ongoing organizational sustainability. Demonstrating value. Engage active stakeholder participation in RHIOs and HIEs by showcasing the benefits of these activities. Exploration of different RHIO models. Investigate a wide range of RHIOs models, as portrayed by those who have first-hand experience. Finding successful resolutions and solutions. Apply remedies and achieve results to address common HIE issues as your business and technology evolves. CONNECTING COMMUNITIES REGIONAL FORUMSFeatured Speakers: CONNECTING COMMUNITIES REGIONAL FORUMS Featured Speakers Bill Braithwaite, Chief Medical Officer, eHealth Initiative and Foundation, Washington, DC Holt Anderson, Executive Director, North Carolina Healthcare Information and Communications Alliance, Park, NC John Halamka, Chief Information Officer at CareGroup Healthcare System, Boston, MA John Blair, President and CEO at Taconic IPA, Inc, Fishkill, NY Marc Overhage, Research Scientist, Regenstrief Institute, Indianapolis, IN Bob Steffel, Executive Director, Greater Cincinnati HealthBridge, Inc, Cincinnati, OH Carladenise Edwards, President and CEO, The BAE Company, LC, Miami Shores, FL For more information, see www.himss.org/hieforums Opportunities for Further Discussion: Opportunities for Further Discussion Thank you!