Presented byClaudia Schlosberg, Partner

Blank Rome, LLP600 New Hampshire Avenue, N.W.

Washington, D.C. 20037202-772-5985

Email: Schlosberg@blankrome.com

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).

DHSFederal 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 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

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 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.

Questions?