| August
15, 2002 © |
Paul J. Breaux completed
Pharmacy School in 1965. After practicing pharmacy
for several years, he entered L.S.U. Law School,
graduating in 1972, and he has practiced law since
then. His practice is located in Lafayette, Louisiana. |
The "Health Insurance Portability & Accountability
Act of 1996" (August 21), Public Law 104-191, which
was referred to often during its debate in the United States
Congress as the "Kennedy-Kassebaum Act," eventually
came to be referred to as simply "HIPAA." By the
time the Act was approved by Congress, several matters other
than just portability of insurance coverage had been added – one
of those topics being what Congress called "Administrative
Simplification."
Congress declares at Section 261 of HIPAA that a goal of
the Act's Administration Simplification sub-title is " ...
to improve … the efficiency and effectiveness of … the
health care system … by encouraging the development
of a health information system … " that addresses
both the transmission and the maintenance of health information.
We all eventually learned that what this language means
is that Congress wants: (1) to improve the efficiency of
delivery of health care by standardizing the interchange
(transmission and receipt) of electronic data, and (2) to
ensure the (i) confidentiality and (ii) integrity of "individually
identifiable health information" by setting, and enforcing,
privacy and security standards.
Administrative Simplification affects all health care professionals – hospitals,
physicians, pharmacists, to name just a few. And it affects
practices of all sizes – health care practices with
only one practitioner and those with 100 and more. It will
also require certain contracts, called Business Associate
Agreements, between a practitioners and many of their suppliers
and vendors.
There are four major elements of Administrative Simplification,
each of which having generated a variety of "rules" or "standards." Many
of the rules and standards are still in only the "proposed" (draft)
stage of publication. The rules, when final, will have different
compliance deadlines. The four major elements of Administrative
Simplification are:
- Electronic Health Transactions and Code Sets Standards — this
will require the electronic transfer of information between
trading partners in a standard/uniform format; and, electronic
Coding/Code Sets used to describe diseases and other
health problems, as well as their causes and the actions
taken,
will be uniform. All parties to any transaction will
have to use and accept the same coding.
- Unique Identifiers — while the current system allows
different parties to have different identification numbers
when dealing with each other, these numbers will become unique
and universal – meaning that each provider, employer,
etc., will have one and only one number used to identify
them across the health care system for and in all transactions
(claims filing, health plan eligibility, claims payment,
coordination of benefits and others).
- Security and Electronic Signature Standards — this
will mandate safeguards for physical storage and maintenance,
for transmission, and for access to individual health
information, but will not mandate any specific technologies,
all with
the aim of ensuring the integrity and confidentiality
of a person's health information.
- Privacy Standards — this will define what are appropriate
and inappropriate uses and disclosures of individually
identifiable health information and how patient rights
are to be protected
and enforced.
For most entities, the compliance date for each standard
or rule will be 24 months from the effective date of a final
rule. Most often, the effective date is 60 days after a final
rule's publication date. The final Transactions and Code
Sets Rule was published on August 17, 2000, making the compliance
date for that rule October 16, 2002. The only other standard
in final form, the Privacy Rule, had a publication date of
December 28, 2000, but due to a glitch in the last weeks
of the Clinton administration didn't become effective until
April 14, 2001. The required compliance date for the Privacy
Rule thus became April 14, 2003. None of the other standards
(Security, Unique Identifiers, etc.) have yet been published
as final, so not any of those can be said to yet have an
official compliance date.
HIPAA mandates severe civil and criminal penalties for
noncompliance, including: civil fines up to $25,000 for multiple
violations of the same standard in a calendar year; and criminal
fines up to $250,000 or imprisonment up to 10 years, or both,
for knowing misuse of individually identifiable health information.
There will be much more detail to learn as the regulations
that are to be prepared unfold more. For now: "HIPAA
Medical Privacy?" The "HIPAA" stuff, as it
relates to health care, is Congress' "Administrative
Simplification" ideas, and the "medical privacy" stuff
is only one of the four parts/elements of Administrative
Simplification. What's more, the edicts (both statutory and
regulatory) are MANDATORY — meaning that, unlike the
D.H.H.S.'s Office of Inspector General anti fraud and abuse "suggestions" (OIG
has ordained them "Guidances"), those who are part
of the health care system and affected by the HIPAA provisions
MUST comply, and do so by the compliance dates that will
be give, or suffer the rather harsh penalties.
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