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Letter from Health Leadership Council
February 1, 2001
The Honorable Tommy G. Thompson
Secretary, U.S. Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue SW
Washington, D.C. 20201
Dear Secretary Thompson:
The organizations listed below are committed to protecting the
confidentiality of individually identifiable information used to
provide health care services. We have long advocated
the establishment of Federal standards providing nationally uniform
confidentiality protections.
Unfortunately, while certain aspects of the final HHS privacy regulations
("Standards for Privacy of Individually Identifiable Health Information")
are improved over the proposed version, key provisions of the final
regulations are unworkable and could seriously disrupt patient care.
New unprecedented barriers are created for patients to access the
health care system, and for our ability to continue to provide health
care services efficiently and effectively.
There are several specific problems we have identified:
- The final regulation contains substantive changes from the
proposed regulation, including entirely new sections and requirements
that were neither in the proposed regulation nor foreseeable by
those commenting on the proposed regulations.
This fact alone argues for a new public comment period.
- We are especially concerned about the impact of the new provision
that requires that patients sign a specific patient consent
before providers may use or disclose identifiable information
for treatment, payment, and health care operations. This
provision was not part of the proposed regulation. In fact,
HHS went to great lengths in the proposed regulation to
explain why such a consent requirement was unworkable and therefore
rejected in that version of the rule. Maine repealed
a similar law just 12 days after it took effect due to severe
disruptions for family members trying to obtain prescriptions
for elderly parents and other family members.
- This new requirement will have serious consequences for many
patients requiring medications. Pharmacists will not
be able to fill or refill prescriptions for consumers, and prescriptions
called in by physicians will not be filled, unless a written consent
is on file at the pharmacy. The requirements will create
delays for patients, for parents with sickf children, and others
who will have to come to the pharmacy to sign consents before
the pharmacist can fill or refill a prescription.
Elderly and disabled individuals, who often cannot pick up their
prescriptions because of various infirmities, will be forced to
sign a written consent form before anyone can pick up their prescriptions
for them. With over three billion prescriptions filled
in the United States last year, disruptions in even a small percentage
of these transactions could adversely impact millions of patients.
- The final regulation needs clarification as to whether it
requires covered entities to limit information to the "minimum
necessary" when using patient information for treatment.
The rule excludes "disclosures to or requests by" a health care
provider for treatment from the "minimum necessary" rule, but
is less clear on whether the standard applies to "use" of information.
This is not a minor technical detail. Definitive clarification
is needed that use of patient information for treatment
is not subject to the minimum necessary rule. Limiting the
ability of teams of health professionals, and health profession
trainees, in a hospital setting to use a patient's complete medical
chart or freely discuss and communicate among themselves in the
course of treating patients could be disruptive and potentially
dangerous.
- The lack of adequate transition provisions in the regulation
create a potentially chilling scenario two years after the February
26, 2001 effective date. On that date, no health care
provider will be able to use or disclose identifiable patient
information for most health care activities without a signed consent
from patients. How providers will obtain consent forms from over
200 million Americans by the compliance date is a staggering
problem that could interfere with everything from refilling routine
prescriptions, sending out reminder notices about appointments,
conducting disease management programs, maintaining quality assurance
programs, doing claims adjudication, medication compliance, and
so on.
- While the regulation was improved over the proposed version
with respect to research, we continue to have concerns.
By modifying the Common Rule with respect to the enormous quantity
of health research that requires access to archived patient records,
the final regulation will impose significant new burdens and record-keeping
requirements on research institutions that will divert resources
from research. In addition, we are concerned about the new
requirement that Institutional Review Boards (IRBs) make determinations
as to whether the privacy risks to individuals are "reasonable
in relation to the anticipated benefits if any to the individuals,
and the importance of the knowledge to be obtained from that research."
This introduces into the IRB process a determination for which
there are no normative standards, and which will of necessity
be based on the belief structures and ideologies of individual
IRB members.
- The final regulation is contrary to HIPAA's goals of "administrative
simplification," and at odds with the law's requirement that the
privacy standards reduce the administrative costs of providing
health care.
By no means is this an exhaustive list of problems we have identified.
A more detailed, technical list is being compiled which we will
forward to you as soon as possible.
The organizations listed below are asking you to review the February
26, 2001 effective date of the regulation to give the Department
an adequate opportunity to look at the areas of concerns we have
raised. Mr. Secretary, we stand ready to work with you
to develop protections that are workable and effective for patients
and the health care delivery system.
Sincerely,
Academy of Managed Care Pharmacy
AdvaMed
American Association of Health Plans
American Benefits Council
American Clinical Laboratory Association
American Managed Behavioral Healthcare Association
American Medical Rehabilitation Providers Association
American Occupational Therapy Association
American Pharmaceutical Association
American Physical Therapy Association
American Society of Consultant Pharmacists
American Medical Group Association
American Physical Therapy Association
Private Practice Section
Association of American Medical Colleges
Biotechnology Industry Organization
Blue Cross and Blue Shield Association
Disease Management Association of America
Easter Seals
The ERISA Industry Committee
Federation of American Hospitals
Food Marketing Institute
Home Medical Equipment Association of America
Hospice Association of America
Health Insurance Association of America
Healthcare Leadership Council
Medical Group Management Association
National Association of Chain Drug Stores
National Association of Health Underwriters
National Association for the Support of
Long-Term Care
National Association for Home Care
National Association of Manufacturers
National Association of Rehabilitation Agencies
Pharmaceutical Research and Manufacturers of America
Premier Inc.
Society for Human Resource Management
The National Business Coalition on
e-Commerce & Privacy
U.S. Chamber of Commerce
VHA Inc.
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