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, PMP HIMSS Staff Liaison, Enterprise IS Steering Committee Director, Healthcare Information Systems Healthcare Information and Management Systems Society (HIMSS) 215-530-5330 jklinedinst@himss.org : 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 jklinedinst@himss.org 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: schlosberg@blankrome.com
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 Society www.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’s Health Information Technology Plan: April 26, 2004 http://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, 2006 http://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: Schlosberg@blankrome.com
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 Association http://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 Process http://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
HIMSS Ambulatory Information Systems Steering Committee http://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
HIMSS Enterprise Information Systems Steering Committee http://www.himss.org/ASP/committees_ehr.asp : HIMSS Enterprise Information Systems Steering Committee http://www.himss.org/ASP/committees_ehr.asp
HIMSS Personal Health Record Steering Committee http://www.himss.org/ASP/committees_phr.asp : HIMSS Personal Health Record Steering Committee http://www.himss.org/ASP/committees_phr.asp
HIT Dashboard http://www.hitdashboard.com/ : HIT Dashboard http://www.hitdashboard.com/
HIT Dashboard: 2005 Davies Award Winner Congratulations! 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 FORUMS December 12 – Salt Lake City December 14 – Chicago May 3 – Orlando May 10 – Boston For 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 FORUMS Featured 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!