The federal government has issued regulations designed to make electronic
health care records and electronic prescribing more attractive to
The regulations are spelled out in two rules issued separately in August by
the Centers for Medicare and Medicaid Services (CMS) and the Office of the
Inspector General (OIG). They were required by the Medicare Prescription Drug,
Improvement, and Modernization act of 2003.
The new rules, which will become effective on October 7, create new
exceptions and "safe harbors" to existing federal fraud and abuse
laws governing the provision of electronic health information technology and
services by health plans and other entities to physicians and hospitals for
handling electronic health records and electronic prescribing
In some respects the CMS and IOG rules mirror each other, but they are
dealing with separate sections of the Social Security Act. The CMS rule deals
with prohibitions on physician self-referral, while the OIG rule addresses
prohibitions on kickbacks.
Specifically, the CMS rule creates two exceptions to the federal
prohibition on physician self-referral that will protect doctors from
violating that law when they accept compensation in the form of computer
products and services. One exception allows physicians to accept items and
services used solely to facilitate electronic prescribing; the other exception
allows them to accept information technology, software, and training services
used predominantly to handle electronic health records.
The scope of donors and recipients included in the final rule is
considerably broader than originally proposed by CMS last year.
The OIG rule is similar, establishing two "safe harbors" from
the federal anti-kickback statute to protect arrangements in which certain
health care organizations provide specified recipients with remuneration in
the form of technology and services used for electronic prescribing and
electronic health records systems.
A buzzword in the field of health information technology is"
interoperability," the ability of information systemsto"
talk" to each other to allow seamless transfer of information
across the health care landscape—a concept that presupposes wide-spread
adoption of computerization. Yet one of the barriers to widespread adoption is
the reluctance of physician groups to invest in technology that may not be
compatible, and hence will have to be replaced at some point.
Consequently, some health plans and other entities may offer physicians
hardware and software for e-prescribing as well as reimbursement for
first-year subscription fees; such transactions could be interpreted as
violating federal laws, hence the importance of the new rules providing
exceptions and safe harbors.
"These important regulations will help promote the adoption of
essential health information technology while protecting the federal health
care programs and beneficiaries from fraud and abuse," said Health and
Human Services Inspector General Daniel Levinson in a statement.
In comments submitted to CMS last year, APA Medical Director James H.
Scully Jr., M.D., said APA generally supports the movement toward
e-prescribing and electronic health records. But he expressed a range of
concerns including the potential for federal sanction of physicians who
receive in-kind donations of computer technology and services related to
Until adequate exceptions and safe harbors are provided under existing
federal laws, "any physician dealing with Medicare patients who accepts
value inkind such as software, hardware, Web access, training, educational
materials, discounts, rebates, or other assistance related to e-prescribing
infrastructures may be subject to federal sanctions," he wrote.
"Managed care entities, software, computer hardware, and Web services
companies will make various offers to physicians to make their products
competitive and otherwise induce them to adopt e-prescribing practices,"
Scully wrote. "E-prescribing requirements should not force psychiatrists
to either pay the entire cost of an e-prescribing system or accept assistance
from external entities but risk potential federal action."