HIMSS 2007 Annual Meeting Health Information Exchange Pre-Conference Symposium February 25, 2007

Transcription

1 HIMSS 2007 Annual Meeting Health Information Exchange Pre-Conference Symposium February 25, 2007 Stark, Anti - Kickback & Donations of Health Information Technology Presented by Claudia Schlosberg, Partner Blank Rome, LLP 600 New Hampshire Avenue, N.W. Washington, D.C Schlosberg@BlankRome.com

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4 STARK Prohibits physicians from from making referrals for for designated health services payable by by Medicare to to an an entity entity in in which which he/she (or (or a family member) has has a financial relationship. Anti-kickback Establishes criminal penalties for for offering/providing/receiving inducements for for the the referral of of business reimbursable under under federal health care care programs.

5 STARK DHS DHS Federal reimbursed: Lab Lab Services PT,OT PT,OT and and Speech Radiology and and Imaging Radiation Therapy Nutrition Therapy Home Home health health Services Outpatient prescriptions In In and and Out-patient Hospital Anti-kickback Any Any service reimbursable by by federal health care care programs (Medicare, Medicaid, VA VA etc). etc).

6 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.

7 Electronic Prescribing Authority Covered Technology Protected Donors and Recipients Value Expiration Stark Exception Medicare Modernization Act (Congress) Items and services necessary and used solely to transmit and receive electronic prescription information including hardware, software, internet connectivity and training support. DONORS - Hospitals to members of their medical staff, group practices to physician members, PDP sponsors and MA organizations to prescribing physicians. RECIPIENTS - physicians No Limit None Anti-kickback Safe Harbor Medicare Modernization Act (Congress) Items and services necessary and used solely to transmit and receive electronic prescription information including hardware, software, internet connectivity and training support. 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. No Limit None

8 Necessary and Used Solely Protected Upgrades of equipment or software that significantly enhance functionality. Not Protected Donations of items and services that duplicate what a physician already has. Billing, scheduling, administrative and other general office software or bundled software.

9 Compliance with E-prescribing Standards Items and services must be part of, or used to access, an e-prescription drug program that meets applicable standards under Medicare Part D CMS E-prescribing Standards First set Finalized on Nov. 7, 2005 Final standards due April 1, 2008

10 Electronic Health Records Authority Stark Exception CMS Authority under SSA Anti-kickback Safe Harbor OIG s Authority under SSA Covered Technology Protected Donors and Recipients Value Interoperable 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. DONORS - Entities that furnish any DHS to any physician. Does not include pharmaceutical manufacturers, RHIOs, research based biopharma industry or HIT vendors. RECIPIENTS physicians. Physician recipient must pay 15% of donor s costs for donated technology and training. Donor may not provide financing. Interoperable 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. 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 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

11 Interoperable EHR donations must be interoperable at time of donation. Able to communicate and exchange data accurately, effectively, securely and consistently with different information technology systems, software applications and networks in various settings, and Able to exchange data such that the clinical or operational purpose and meaning are preserved and unaltered. Software may be deemed interoperable if certified by certifying body recognized by the Secretary within 12 months of date of receipt by recipient.

12 Necessary Protected Upgrades Not Protected Duplicative technology Hardware On site staff support

13 Used Predominately Protected Technology where core functionality is creation, maintenance, transmission or receipt of individual patient s electronic health records May include other functionality related to treatment of individual patients including scheduling functions, billing and clinical support Interface and translation software Licenses and intellectual property Connectivity services (broadband and wireless) Clinical support services Patient portal software Secure messaging Training and support Not Protected Technology used primarily for personal business or business unrelated to clinical practice

14 E-Prescribing Capability Donated EHR systems must include: An electronic prescribing component, or Ability to interface with recipient s existing e- prescribing system System must meet final standards adopted by Secretary.

15 15% Donation (Cost Share) Recipient must pay 15% of donor cost before taking receipt of items and services Cost allocation must be reasonable and verifiable and will be closely scrutinized. Upgrades and modifications trigger new cost sharing obligations. Donors cannot provide financing or loans. Contemporaneous and accurate documentation is advisable.

16 Written Arrangement Applies to both Stark Exception and Anti- Kickback Safe Harbor Writing must: Be signed by parties Specify all items and services Donors costs for those items and services, and Amount of recipient s contributions.

17 Prohibitions DONOR Cannot chose recipients based on volume or value of business generated. Cannot limit/restrict the use, compatibility or interoperability of the donated EHR or e-prescribing technology. Cannot limit physicians ability to use items or services for any patient without regard to payor status. RECIPIENT Cannot make receipt of donation a condition of doing business.

18 Moving Forward No one has all the answers. Each arrangement must be evaluated individually. There are other Stark exceptions and antikickback safe harbors that may be useful. Consider using the OIG advisory opinion process. CMS may also provide additional guidance. Other considerations.

19 QUESTIONS?