Stark Anti-kickback Legislation: An Overview of Suggested...
64
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
Transcript of Stark Anti-kickback Legislation: An Overview of Suggested...
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 MembersOctober 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
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• 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
• 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
Federal Register: August 8, 2006 http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.a
ccess.gpo.gov/2006/pdf/06-6666.pdf
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
“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• Stark Regulations• Anti-Kickback Statue• Safe Harbors• Safe Harbor Protections• Electronic Health Record• Interoperability• Remuneration
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
“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.”F d l R i t /V l 71 N 152/T d A t 8 2006/R l d R l ti 45110
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
“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“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.”
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“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
Presented byClaudia Schlosberg, Partner
Blank Rome, LLP600 New Hampshire Avenue, N.W.
Washington, D.C. 20037202-772-5985
Email: [email protected]
Stark, Anti- Kickback
and
Donations of
Health Information Technology
STARK
Anti-kickback
Prohibits Physicians from making referrals
for designated health servicespayable by Medicare to an entity
in which he/she (or a family member)
has a financialrelationship.
Establishes criminal penalties for
offering/provide/receivinginducements for the referral of
business reimbursableunder federalhealth careprograms.
STARK
Anti-kickback
Any service reimbursable
by federalhealth care programs(Medicare, Medicaid,
VA etc).
DHS that areFederally reimbursed:
Lab ServicesPT,OT and Speech
Radiology and ImagingRadiation TherapyNutrition Therapy
Home health ServicesOutpatient prescriptions
In and Out-patient Hospital
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.”
Electronic Prescribing Stark Exception Anti-kickback Safe HarborAuthority Medicare Modernization Act
(Congress)Medicare Modernization Act (Congress)
Covered Technology
Items and services necessary and used solely to transmit and receive electronic prescription information including hardware software, internet connectivity and training support.
Items and services necessary and used solely to transmit and receive electronic prescription information including hardware software, internet connectivity and training support
Protected Donors and Recipients
Donors - Hospitals to members of their medical staff; group practices to physician members, group practices to physician members, PDP sponsors and Medicare Advantage organizations to prescribing physicians.
Recipients – Physicians
Donors – Broadly any individual or entity that provides services covered by a federal health care program including health plans. Pharmaceutical, device and DME manufacturers or vendors who indirectly furnish items and services are NOT included. Recipients – Any individual or entity engaged in delivery of health care covered by a federal program.
Value No Limit No LimitExpiration None None
Electronic Health Records
Stark Exception Anti-kickback Safe Harbor
Authority CMS’ Authority under SSA OIG’s Authority under SSA
Covered Technology
Software necessary and used predominately to create, maintain, transmit or receive EHRs. May include admin functions, training, internet connectivity and help desk support. Must include E- Prescribing capability.
Software necessary and used predominately to create, maintain, transmit or receive EHRs. May include admin functions, training, internet connectivity and help desk support. Must include E- Prescribing capability
Protected Donors and Recipients
Donors - Entities that furnish any DHS (designated health services) to any physician. Does not include pharmaceutical manufacturers, RHIOs, research – based biopharma industry or HIT vendors.
Recipients – Physicians.
Donors -Individuals/entities that provide covered services and submit claims or request for payment to Federal health care programs and health plans.Recipients – Individuals and entities engaged in health care delivery
Value Physician recipient must pay 15% of donor’s costs for donated technology and training. Donor may not provide financing.
Recipients must pay 15% of the donor’s costs for donated technology and training. Donor may not provide financing.
Expiration December 31, 2013 December 31, 2013
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• 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“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
• 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
• 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
Conduct a SWOT Analysis
Select a Vendor Prepare a Project Plan Narrative
Prepare a Business PlanImplement the EHR Solution
Post-Production Support and Follow-up
Tools Organizations Can Use to Help Facilitate a Decision to Enter a Collaborative Relationship
SWOT Analysis Business Plan Project PlanNarrative
Tools that Facilitate Collaboration Equate to a Roadmap: Getting from Here to There
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
• 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
Introduction Participants state the purpose of the SWOT and the intended outcomes.
Vision Participants identify the objective, project, task, or end state that the organization is planning to achieve, the reasons for it, and the expected outcome.
Strengths Participants identify the attributes of the organization that are helpful to achieving the goal.
Weaknesses Participants will identify those attributes that represent a minor weakness or barrier, either internal or external, to achieving the objective.
Opportunities Participants will identify tasks, initiatives, or other items that will help to accomplish the objective.
Threats Participants will identify those tasks, initiatives, or other items that represent major barriers, either internal or external, to achieving the objective.
A SWOT Analysis Example
Hospital-Perspective Physician Practice-Perspective
Introduction Establish a collaborative relationship to help facilitate the adoption of EHR technology.
Establish a collaborative relationship to help facilitate the adoption of EHR technology.
Vision By developing a collaborative relationship with physician practices, the Hospital seeks to facilitate care in the community by sharing its healthcare information technology expertise with physician practices in order to accelerate EHR adoption.
By utilizing the healthcare information technology expertise of the Hospital, the physician practice seeks to improve healthcare quality, patient safety, and efficiency while automating outcomes reporting for the betterment of general population health.
Strengths The Hospital has an established methodology that includes hardware, software, implementation, training, and support staff for both the clinical and non-clinical aspects.
The practice leadership recognizes the significance that an EHR will provide in the communication, facilitation, and care of its patients.
Weaknesses The Hospital HelpDesk service levels are a source of contention among some existing customers.
Healthcare information technology knowledge and experience is limited within the practice.
Opportunities The Hospital seeks to develop a relationship with a physician practice focused on internal medicine.
The EHR will enable the practice to create a complete, electronic record of the patient’s encounter.
Threats The Hospital has a backlog of six months of EHR implementations based on the existing staffing levels.
A significant amount of hardware currently used in the practice is approaching end of life and will need to be upgraded.
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
Executive Overview This section includes a summary statement of the organization’s goals, objectives, mission, vision, and values as related to accomplishing an initiative.
Organizational Overview Components in this section include a mission statement, a values statement, an overview of key programs, a description of the organization’s business model, goals and objectives of the initiative (including specific aims), and values related to accomplishing a particular initiatives.
An Understanding of the Current Healthcare Environment
Use this section to identify key players, potential barriers to acceptance, profile potential business partners, a product description for the types of technologies to be used, and an analysis of the longer-term perspective of the technological components of the architecture to be used.
Financial Review Use this section to emphasize all aspects needed to achieve the objectives by preparing a master budget, being certain to include all project costs, i.e., implementation, planning, installation, and post-implementation support; identifying sources of funds; preparing an ROI; and preparing a sustainability plan.
Action Plan This section defines the goals of achieving the objective from a short-term, intermediate term, or long-term perspective; it documents next steps; and identifies an approach to the project structure.
Appendices Use the Appendices section to include any references to the business plan.
Attachments Use the Attachments section to include exhibits of documents that will further explain the objectives to be accomplished.
Aspects to Consider When Entering into a Collaborative Agreement: Types of Business Models
Vendor-Supported ASP A “company” that provides some type of specialty automation service or access, under a service agreement for a customer, with the business model of being able to provide expertise and reliability at a desired lower cost than the customer could provide for itself within a local data center.
Hospital-Supported ASP A “hospital” that provides some type of specialty automation service or access, under a service agreement for a customer, with the business model of being able to provide expertise and reliability at a desired lower cost than the customer could provide for itself within a local data center.
Hospital-Supported Non- ASP
An independent approach through a collaborative agreement between a Hospital and a Physician Practice where all aspects of hardware, software, installation, training, and support are provided based on fees.
Standalone An independent approach where no collaboration or partnership occurs with the Hospital: the physician practice assumes all responsibilities for identifying, acquiring, installing, and supporting all aspects of hardware, software, installation, training, and support are provided based on fees.
.
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
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 NarrativeProject Charter This section contains information that explains the project in a concise, specific manner.
Components include are the project justification; project sponsor; project manager; executive sponsor; summary level budget information; product description; a high level overview of the organization’s strategic plan; historical information; participating organizations; objectives; business model approach; assumptions; and barriers to acceptance.
Preliminary Project Scope Statement
Components of this section includes identifying the various sub-projects required to accomplish the objective, as identified by the following functional sub-projects: hardware, software, implementation, training, production, and post-production support; or, in the form of various types of leadership needed to accomplish an objective: executive, clinical, technical, privacy and security, and sustainability. A high-level project deliverables structure is also included in this section related to the sub-projections: overview of the current environment; the future environments; action items; constraints; assumptions; or areas of concerns.
Statement of Work This section includes details over and above those identified in the preliminary project scope statement, i.e., a scope of work; location of the work; the period of work performance; a deliverables schedule; acceptance criteria; and any special requirements.
Project Quality Management Components of this section includes ways to ensure that quality is built into the process by identifying items such as quality planning that include assuring quality and controlling the quality of tasks to be accomplished.
Project Communications Management
Components of this area determine what information is to be communicated, but how, to whom, when, and assurances that that information is received as intended.
Project Risk Management Components of this section allow the project manager to concentrate on all aspects of risk: planning for risk; identifying risk; responding to risk; and monitoring and controlling risk. Answers to the question “what if?” something does or does not happen are addressed in this section.
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
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
Potential Sources of Funding: Federal Agencies
• Health Resources and Services Administrationhttp://www.hrsa.gov
• National Institutes of Healthhttp://www.grants.nih.gov
• Centers for Disease Controlhttp://www.cdc,gov
• Department of Health and Human Serviceshttp://www.hhs.gov
Potential Sources of Funding: Foundations
• The Commonwealth Fundhttp://www.cmwf.org
• The Verizon Foundationhttp://www.foundation.verizon.com
• W. K. Kellogg Foundationhttp://www.wwfk.org
National Associations that Focus on Grant Writing and Making
• The American Association of Grant Professionalshttp://www.grantprofessionals.orgThe Foundation Centerhttp://www.foundationcenter.org
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
Office of Inspector General: Advisory Opinion Process
http://oig.hhs.gov/fraud/advisoryopinions/aofaq.html#8
HIMSS Ambulatory Information Systems Steering
Committee http://www.himss.org/ASP/committees_ambulatory.asp
HIMSS Resourceshttp://www.himss.org/content/files/GettingStartedEMR_Flyer1.pdf
HIMSS Resourceshttp://www.himss.org/content/files/SelectingEMR_Flyer2.pdf
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
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
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
•• Bill BraithwaiteBill Braithwaite, Chief Medical Officer, eHealth Initiative and Foundation, Washington, DC
•• Holt Anderson,Holt Anderson, Executive Director, North Carolina Healthcare Information and Communications Alliance, Park, NC
•• John HalamkaJohn Halamka,, Chief Information Officer at CareGroup Healthcare System, Boston, MA
•• John BlairJohn Blair, President and CEO at Taconic IPA, Inc, Fishkill, NY•• Marc OverhageMarc Overhage, Research Scientist, Regenstrief Institute, Indianapolis, IN•• Bob SteffelBob Steffel, Executive Director, Greater Cincinnati HealthBridge, Inc,
Cincinnati, OH•• Carladenise EdwardsCarladenise Edwards, President and CEO, The BAE Company, LC,
Miami Shores, FL
For more information, see www.himss.org/hieforums
Opportunities for Further Discussion
Thank you!
