Claudia Schlosberg, Partner

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Stark, Anti- Kickback and Donations of Health
Information Technology

• Presented by
• Claudia Schlosberg, Partner
• Blank Rome, LLP
• 600 New Hampshire Avenue, N.W.
• Washington, D.C. 20037
• 202-772-5985
• Email Schlosberg_at_blankrome.com

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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.
STARK
Establishes criminal penalties for
offering/provide/receiving inducements for the
referral of business reimbursable under
federal health care programs.
Anti-kickback
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DHS Federal reimbursed Lab Services PT,OT and
Speech Radiology and Imaging Radiation
Therapy Nutrition Therapy Home health
Services Outpatient prescriptions In and
Out-patient Hospital
STARK
Any service reimbursable by federal health
care programs (Medicare, Medicaid, VA etc).
Anti-kickback
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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.

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Electronic Prescribing Stark Exception Anti-kickback Safe Harbor
Authority 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 MA 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 Limit
Expiration None None
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Electronic Health Records Stark Exception Anti-kickback Safe Harbor
Authority CMS Authority under SSA OIGs 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 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 donors costs for donated technology and training. Donor may not provide financing. Recipients must pay 15 of the donors costs for donated technology and training. Donor may not provide financing.
Expiration December 31, 2013 December 31, 2013
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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.

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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.

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Questions?