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Does My Practice Have
to Comply With the HIPAA Privacy Rules?
For the vast majority of health care providers, including
doctors and doctors’ offices, the answer to this question
is "yes." Only the rare doctor or provider who never
uses a computer to transmit health care claims or benefit
information through billing programs, emails or computerized
faxes, can hope to avoid the Privacy Rule.
When Are Health Care Providers
Required to Be in Compliance With the Privacy Rules?
The compliance deadline for the HIPAA Privacy Rules is April
14, 2003. By that date, health care providers should have
privacy policies and procedures drafted and in place in their
organizations. In addition, certain administrative changes
will need to be made in most doctor offices. Physical and
security measures may have to be implemented as to office
and physical plant conditions, computer systems, medical record
storage, fax machines and other physical arrangements. Finally,
the Privacy Rules also require that all employees be trained
regarding the HIPAA Privacy Rules by the compliance deadline
of April 14, 2003. This training program is designed to assist
doctor offices in preparing for the HIPAA compliance deadline
as well as to assist in ongoing compliance efforts after the
deadline arrives.
About the Program
This training program will focus exclusively on the privacy
rules issued by the Department of Health and Human Services
("HHS") pursuant to the HIPAA statute. Completion
of these materials will satisfy HIPAA’s requirement
for the training of all practice personnel. Although each
doctor's office is unique, compliance with the HIPAA Privacy
Rules raises a common set of issues for all health care providers.
For example, the Privacy Rules require that every covered
health care provider appoint a privacy officer. The Rules
also require the designation of a "contact person"
who can respond to patient complaints as well as answer questions
regarding the doctor’s privacy practices. These requirements
apply regardless of the size or nature of the organization.
Thus, a doctor practice with multiple doctors and many employees
must appoint a privacy officer and designate a contact person;
likewise, a small office with just two or three employees
must do the same. The suggested use of these materials is
as follows. First, finish reading the next several pages of
the "Overview/Introduction" material. Second, take
the Pre-Test and review the results. Third, proceed to the
section, "Training For All Practice Personnel."
Finally, in the Job-Specific Training section, choose the
module applicable to you and complete those materials. This
is outlined on the "How To Use This Program" page,
found at the beginning of this program. If you are the Privacy
Officer, you should also complete the Gap Analysis Checklist
and all of the Job-Specific Training. There is another CD-ROM
that you will utilize, that contains forms and practice policies.
This training program is designed to assist you in understanding
the complex Privacy Rules and to help you learn how to implement
these rules in a simple, practical and effective manner. Complicated
policies and procedures are of little value if they simply
remain in a book sitting on the shelf in your Practice. Doctors
and staff must be trained to understand the Rules and know
how to apply them in the day-to-day situations that arise
in every medical practice. The careful completion of this
training program will make this possible. Now is the time
to draft your privacy practice forms, prepare and implement
privacy policies, and train your staff.
A Brief History of HIPAA
The Health Insurance Portability and Accountability Act of
1996, now universally known as HIPAA, represents Congress’
efforts to make health insurance for individuals portable
anywhere across this country, to make patient information
private and secure, and to reduce health care fraud and abuse.
To accomplish these goals, HIPAA first prohibited health insurers
from limiting coverage for an individual because of pre-existing
health conditions, so long as the individual could demonstrate
prior continuous health care coverage. These people were now
free to move about the country to seek new jobs, relocate
with their family or just follow their wanderlust without
concern that any existing health condition would keep them
from finding health care insurance when they reached their
new home. To make health care claims and benefit issues easier
to administer as people changed their jobs, geography and
even their names, HIPAA also included a section entitled "Administrative
Simplification." One provision of the Administrative
Simplification Section required establishment of national
standards for most of the common health care claims and benefit
transactions that were transmitted electronically. The Department
of Health and Human Services ("HHS") was mandated
to adopt standardized electronic data sets for these basic
claims and benefit transactions, and health care plans and
insurers were required to accept electronic transactions using
the standard electronic data sets. HHS published its rule
and established standards for Electronic Transaction and Code
Sets (the Electronic Transaction Rule) effective August 17,
2000. This rule originally required compliance by October
16, 2002. Another provision of the Administrative Simplification
Section of HIPAA also required HHS to develop national identifier
numbers for all health care providers, employers, health plans
and individual patients. However, creating all this standardized
electronic health care information also meant that across
the country, patients and providers, identified by their national
identification numbers, could have their entire medical care
histories instantly available to any one given access to any
computer where the information was stored. In response to
concerns about the potential loss of anonymity and privacy
that could result from having everyone’s medical information
instantly available in digitized form, Congress also included
another provision in the Administrative Simplification Section
mandating the development of privacy standards for all health
care information that can, in any way, be related to specific
individuals. HHS was required under HIPAA to develop these
privacy standards.
The Privacy Rule Compliance
Requirements
Pursuant to HIPAA’s mandate, HHS issued its Privacy
Rule on December 28, 2000. This Privacy Rule, as promulgated
by HHS, imposes comprehensive limitations on the use and release
of individually identifiable health information ("IIHI").
It applies to virtually every health care provider, plan or
clearinghouse that transmits any of this information in electronic
form in connection with any of the claims and benefit transactions
described in the Privacy Rule. The IIHI covered by the Privacy
Rule is called "protected health information" ("PHI")
and those health care providers, plans and clearinghouses
that are subject to the Privacy Rule requirements are termed
"covered entities." HIPAA, and related HHS rules,
also required providers to use federally standardized data
sets for most claims and benefit transactions transmitted
electronically and required health care plans and insurers
to accept all such electronically submitted transactions.
Moreover, most insurers, including Medicare, had or intended
to eliminate paper transactions. Thus with few exceptions,
all health care providers would have to comply with the requirements
of the Privacy Rule with regard to their patients’ information.
The Privacy Rule requires all providers who are covered entities
under the Privacy Rule to be in compliance with its requirements
by April 14, 2003.
In general, to comply, providers will need to:
- 1. Develop notices informing patients of
their privacy rights and provider practices regarding PHI;
- 2. Prepare authorization forms for release
of PHI;
- 3. Draft and implement policies to protect
patient medical records and provide patient access to these
records, and procedures to deal with requested amendments
to those records; and
- 4. Certify that their office and clinical
staff have been trained in Privacy Rule standards and their
office privacy practices.
Providers will therefore need to have a detailed statement
explaining their privacy practices to distribute to their
patients. The receipt of this notice of privacy practices
is to be acknowledged in writing by every patient. Written
and signed authorizations are needed for patients for any
non-routine use of PHI by covered entities (i.e. uses other
than for treatment, payment or internal operations). Another
form of authorization may be needed when patients want to
request their own records or have their records sent at their
request to their attorney or other persons. Business associate
agreements must be developed and executed to ensure that businesses
providing services to the health care provider, such as billing
companies, accountants, or practice management companies,
will keep private any protected health information to which
they may have access. Formal policies and procedures also
need to be drafted to address patient requests for their own
records and patient requests to amend or correct their records.
HIPAA initially intended that covered entities, as a first
step, would begin using the standardized electronic claims
and benefit communications before they would have to begin
to comply with the Privacy Rule. The Electronic Transaction
Rule was published and effective August 17, 2000, and required
that all covered entities comply with the Electronic Transaction
Rule by October 16, 2002, which was approximately 6 months
prior to the compliance date for the Privacy Rule.
The Simplification Act–Limited Relief for Providers
However, as the time drew close for compliance with the Electronic
Transaction Rule, it became apparent that neither the providers
and other covered entities nor the companies developing the
data sets and related computer programs could have the systems
in place in time for full compliance. To deal with this and
other problems, Congress took action and passed the Administrative
Simplification Compliance Act (the "Simplification Act"),
which was signed by the President on December 27, 2001. The
Simplification Act permits a covered entity to obtain a one-year
extension for compliance with the electronic data set standards,
but only if it has submitted a Plan of Compliance to HHS by
October 15, 2002. HHS has made submitting a Plan of Compliance
under the Electronic Transaction Rule as easy as possible.
All a provider needed to do was to go to the HHS website,
complete a simple Compliance Plan form, and click submit.
Covered entities that submitted this Compliance Plan on or
before October 15, 2002, are given until October 16, 2003,
to begin using the federally standardized electronic transaction
data sets when transmitting claims and benefit information.
The Simplification Act also requires submission of all Medicare
claims electronically and ends processing of all paper claims
by October 16, 2003. However, the Simplification Act provides
an exception to the "no paper" rule for those doctors
and other health care practitioners with fewer than 10 full
time equivalent employees. These providers, unless the law
is again changed, may now be able to avoid complying with
the Electronic Transaction Rule and the Privacy Rule if they
only submit paper claims and benefit information to Medicare
and to all other health care carriers and covered entities.
This situation is perhaps not easy or realistic, but possible.
Who must be trained about HIPAA?
The Privacy Rules specifically state that all of the covered
entity’s affected personnel must be trained. In a doctor’s
office, that would mean training everyone. In the author’s
view, all medical staff should have general HIPAA training
(“HIPAA 101”); further training should be directed
to the specific job (i.e. billing staff, receptionist, back
office, etc…) The training prepared in the HIPAA Compliance
Program is designed to accomplish both the general and job
specific training.
If a medical office already
has a HIPAA policy and procedures manual, why is a training
program needed?
A policy is no more than a statement of a rule. A
complex set of rules, as is required with HIPAA, cannot be
understood in a vacuum- explanations, examples, illustrations,
scenarios, are necessary to enable medical personnel to understand
and properly apply the complex set of rules. Interestingly,
the HIPAA regulations themselves are accompanied by approximately
400 pages of governmental “preamble” which is
the government’s attempt to explain the rules. The government
itself did not feel the privacy rules were understandable
without extensive explanations.
However, these extension and exception provisions in the
Simplification Act should not confuse health care providers,
plans and clearinghouses. There has been no extension for
complying with the Privacy Rule. If a health care provider
transmits any health information in electronic form using
either the mandated data sets or non-standard electronic formats,
such as emails or other billing programs, that provider becomes
a covered entity under the Privacy Rule and must be in full
compliance with the Privacy Rule on April 14, 2003.
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