Presented by Claudia Schlosberg, Partner Blank Rome, LLP 600 New Hampshire Avenue, N.W. Washington, D.C Stark, Anti- Kickback and Donations of Health Information Technology

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.

STARK Anti-kickback Any service reimbursable by federal health care programs (Medicare, Medicaid, VA etc). 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

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 PrescribingStark ExceptionAnti-kickback Safe Harbor AuthorityMedicare 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. ValueNo Limit ExpirationNone

Electronic Health Records Stark ExceptionAnti-kickback Safe Harbor AuthorityCMS’ Authority under SSAOIG’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 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 ValuePhysician 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. ExpirationDecember 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.

Questions?