[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of March 18, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR1001.952]
[Page 1124-1144]
TITLE 42--PUBLIC HEALTH
CHAPTER V--OFFICE OF INSPECTOR
GENERAL--HEALTH CARE,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 1001--PROGRAM INTEGRITY--MEDICARE AND STATE HEALTH CARE PROGRAMS--Table of Contents
Subpart C--Permissive Exclusions
Sec. 1001.952 Exceptions.
The following payment practices shall not be treated as a criminal
offense under section 1128B of the Act and shall not serve as the basis
for an exclusion:
Sec. 1001.952 Exceptions.
The following payment practices shall not be treated as a criminal
offense under section 1128B of the Act and shall not serve as the basis
for an exclusion:
* * * * *
(x) Electronic prescribing items and services. As used in section
1128B of the Act, ``remuneration'' does not include nonmonetary
remuneration (consisting of items and services in the form of hardware,
software, or information technology and training services) necessary
and used solely to receive and transmit electronic prescription
information, if all of the following conditions are met:
(1) The items and services are provided by a--
(i) Hospital to a physician who is a member of its medical staff;
(ii) Group practice to a prescribing health care professional who
is a member of the group practice; and
(iii) A PDP sponsor or MA organization to pharmacists and
pharmacies participating in the network of such sponsor or organization
and to prescribing health care professionals.
(2) The items and services are provided as part of, or are used to
access, an electronic prescription drug program that meets the
applicable standards under Medicare Part D at the time the items and
services are provided.
(3) The donor (or any person on the donor's behalf) does not take
any action to limit or restrict the use or compatibility of the items
or services with other electronic prescribing or electronic health
records systems.
(4) For items or services that are of the type that can be used for
any patient without regard to payor status, the donor does not
restrict, or take any action to limit, the recipient's right or ability
to use the items or services for any patient.
(5) Neither the recipient nor the recipient's practice (or any
affiliated individual or entity) makes the receipt of items or
services, or the amount or nature of the items or services, a condition
of doing business with the donor.
(6) Neither the eligibility of a recipient for the items or
services, nor the amount or nature of the items or services, is
determined in a manner that takes into account the volume or value of
referrals or other business generated between the parties.
(7) The arrangement is set forth in a written agreement that--
(i) Is signed by the parties;
(ii) Specifies the items and services being provided and the
donor's cost of the items and services; and
(iii) Covers all of the electronic prescribing items and services
to be provided by the donor (or affiliated parties). This requirement
will be met if all separate agreements between the donor (and
affiliated parties) and the recipient incorporate each other by
reference or if they cross-reference a master list of agreements that
is maintained and updated centrally and is available for review by the
Secretary upon request. The master list should be maintained in a
manner that preserves the historical record of agreements.
(8) The donor does not have actual knowledge of, and does not act
in reckless disregard or deliberate ignorance of, the fact that the
recipient possesses or has obtained items or services equivalent to
those provided by the donor.
Note to paragraph (x): For purposes of paragraph (x) of this
section, group practice shall have the meaning set forth at 42 CFR
411.352; member of the group practice shall mean all persons covered
by the definition of ``member of the group or member of a group
practice'' at 42 CFR 411.351, as well as other prescribing health
care professionals who are owners or employees of the group
practice; prescribing health care professional shall mean a
physician or other health care professional licensed to prescribe
drugs in the State in which the drugs are dispensed; PDP sponsor or
MA organization shall have the meanings set forth at 42 CFR 423.4
and 422.2, respectively; prescription information shall mean
information about prescriptions for drugs or for any other item or
service normally accomplished through a written prescription; and
electronic health record shall mean a repository of consumer health
status information in computer processable form used for clinical
diagnosis and treatment for a broad array of clinical conditions.
(y) Electronic health records items and services. As used in
section 1128B of the Act, ``remuneration'' does not include nonmonetary
remuneration (consisting of items and services in the form of software
or information technology and training services) necessary and used
predominantly to create, maintain, transmit, or receive electronic
health records, if all of the following conditions are met:
(1) The items and services are provided to an individual or entity
engaged in the delivery of health care by--
(i) An individual or entity that provides services covered by a
Federal health care program and submits claims or requests for payment,
either directly or through reassignment, to the Federal health care
program; or
(ii) A health plan.
(2) The software is interoperable at the time it is provided to the
recipient. For purposes of this subparagraph, software is deemed to be
interoperable if a certifying body recognized by the Secretary has
certified the software within no more than 12 months prior to the date
it is provided to the recipient.
(3) The donor (or any person on the donor's behalf) does not take
any action to limit or restrict the use, compatibility, or
interoperability of the items or services with other electronic
prescribing or electronic health records systems.
(4) Neither the recipient nor the recipient's practice (or any
affiliated individual or entity) makes the receipt of items or
services, or the amount or nature of the items or services, a condition
of doing business with the donor.
(5) Neither the eligibility of a recipient for the items or
services, nor the amount or nature of the items or services, is
determined in a manner that directly takes into account the volume or
value of referrals or other business generated between the parties. For
the purposes of this paragraph (y)(5), the determination is deemed not
to directly take into account the volume or value of referrals or other
business generated between the parties if any one of the following
conditions is met:
(i) The determination is based on the total number of prescriptions
written by the recipient (but not the volume or value of prescriptions
dispensed or paid by the donor or billed to a Federal health care
program);
(ii) The determination is based on the size of the recipient's
medical practice (for example, total patients, total patient
encounters, or total relative value units);
(iii) The determination is based on the total number of hours that
the recipient practices medicine;
(iv) The determination is based on the recipient's overall use of
automated technology in his or her medical practice (without specific
reference to the use of technology in connection with referrals made to
the donor);
[[Page 45137]]
(v) The determination is based on whether the recipient is a member
of the donor's medical staff, if the donor has a formal medical staff;
(vi) The determination is based on the level of uncompensated care
provided by the recipient; or
(vii) The determination is made in any reasonable and verifiable
manner that does not directly take into account the volume or value of
referrals or other business generated between the parties.
(6) The arrangement is set forth in a written agreement that --
(i) Is signed by the parties;
(ii) Specifies the items and services being provided, the donor's
cost of those items and services, and the amount of the recipient's
contribution; and
(iii) Covers all of the electronic health records items and
services to be provided by the donor (or any affiliate). This
requirement will be met if all separate agreements between the donor
(and affiliated parties) and the recipient incorporate each other by
reference or if they cross-reference a master list of agreements that
is maintained and updated centrally and is available for review by the
Secretary upon request. The master list should be maintained in a
manner that preserves the historical record of agreements.
(7) The donor does not have actual knowledge of, and does not act
in reckless disregard or deliberate ignorance of, the fact that the
recipient possesses or has obtained items or services equivalent to
those provided by the donor.
(8) For items or services that are of the type that can be used for
any patient without regard to payor status, the donor does not
restrict, or take any action to limit, the recipient's right or ability
to use the items or services for any patient.
(9) The items and services do not include staffing of the
recipient's office and are not used primarily to conduct personal
business or business unrelated to the recipient's clinical practice or
clinical operations.
(10) The electronic health records software contains electronic
prescribing capability, either through an electronic prescribing
component or the ability to interface with the recipient's existing
electronic prescribing system, that meets the applicable standards
under Medicare Part D at the time the items and services are provided.
(11) Before receipt of the items and services, the recipient pays
15 percent of the donor's cost for the items and services. The donor
(or any affiliated individual or entity) does not finance the
recipient's payment or loan funds to be used by the recipient to pay
for the items and services.
(12) The donor does not shift the costs of the items or services to
any Federal health care program.
(13) The transfer of the items and services occurs, and all
conditions in this paragraph (y) have been satisfied, on or before
December 31, 2013.
Note to paragraph (y): For purposes of paragraph (y) of this
section, health plan shall have the meaning set forth at Sec.
1001.952(l)(2); interoperable shall mean 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; and electronic health record shall
mean a repository of consumer health status information in computer
processable form used for clinical diagnosis and treatment for a
broad array of clinical conditions.
Dated: June 15, 2006.