Vol. 76, No. 6, June
2003
Balancing Federal and Wisconsin Medical Privacy
Laws
The federal HIPAA Privacy Rule, effective on
April 14, 2003, preempts all conflicting state law, except for state
laws that are more stringent. Most conflicts between the federal and
state laws arise in connection with the use and disclosure of
confidential medical information. Read about a practical approach for
determining how the federal and Wisconsin laws interact.
by Timothy A. Hartin
he new federal privacy regulations for health
information (the "Privacy Rule" or "Rule") issued by the Department of
Health and Human Services under the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) went into effect on April 14,
2003.1 Part I of this article, which
appeared in the April 2002 Wisconsin Lawyer, gave an overview
of the Privacy Rule. Part II discusses the interaction of the Privacy
Rule and Wisconsin medical privacy laws by: 1) identifying some of the
restrictions and obligations that the Privacy Rule imposes on Wisconsin
health care providers that may affect customary uses or releases of
information; and 2) indicating situations in which compliance with the
Privacy Rule alone does not result in compliance with more stringent
Wisconsin provisions. Specifically, Part II focuses on the interaction
of the Privacy Rule with the Wisconsin patient confidentiality
statute2 and then briefly addresses the
Wisconsin mental health treatment statute3
and the Wisconsin HIV test statute.4
Analyzing Privacy Rule Interaction with Wisconsin
Law
The Privacy Rule preempts all conflicting state law, except for state
laws that are more "stringent" because they provide greater privacy
protections or greater rights for individuals.5 Effectively, this means that Wisconsin's existing
privacy laws remain generally unchanged, as there are very few, if any,
instances where Wisconsin law both conflicts with the Privacy Rule
and is less stringent than the Privacy Rule. The administrative
requirements imposed by the Privacy Rule generally have no counterpart
under Wisconsin law and consequently will apply as set forth in the
Privacy Rule without interacting with Wisconsin law. Patient rights
guaranteed by the Privacy Rule raise few issues under the Wisconsin
patient confidentiality or HIV test statutes, although the interaction
of the Privacy Rule and the mental health treatment statute does result
in some "hybrid" patient rights, as discussed below. Most of the issues
created by the interaction of the Privacy Rule and Wisconsin law arise
in connection with the use and disclosure of confidential medical
information.
Both Wisconsin law and the Privacy Rule impose restrictions on the
disclosure of confidential medical information and have similar
conceptual structures for restricting the disclosure of this
information. Each contains blanket prohibitions on the disclosure of
medical information while allowing the individual who is the subject of
the information (referred to below as the "patient") to authorize
disclosure. Wisconsin law and the Privacy Rule also create a series of
exceptions that allow disclosure without the patient's
authorization.6
Given the parallel structure of Wisconsin law and the Privacy Rule, a
practical approach to the question of how the Privacy Rule interacts
with Wisconsin privacy law treats the Privacy Rule as the baseline for
privacy obligations and then identifies any Wisconsin legal requirements
that are more stringent. Thus, when confronted with the issue of whether
a patient's written authorization is required for a given disclosure of
information, the first question is whether the Privacy Rule allows the
disclosure without the patient's authorization. If the Privacy Rule
requires an authorization, then one should be obtained, and there will
be no compliance issues under Wisconsin law, which also allows the
release of health information with the patient's authorization. If the
Privacy Rule allows the disclosure without the patient's authorization,
the next question is whether Wisconsin law also allows the disclosure
without authorization. If Wisconsin law requires the patient's
authorization before health information can be disclosed, then the
authorization must be obtained even though the Privacy Rule does not
require it. The only time a disclosure can be made without a patient's
authorization is when both the Privacy Rule and Wisconsin law
permit.
Definitional Problems
As with any statutory or regulatory issue, the first concern is
understanding and reconciling the relevant definitions. While the
Privacy Rule and the Wisconsin patient confidentiality statute have very
similar overall structures, potentially significant issues are raised by
the Wisconsin statute's use of some significant undefined terms.
"Covered entity" versus "custodian of records." The
Privacy Rule applies to "covered entities," defined as health plans,
clearinghouses that translate electronic information from one format
into another, and health care providers who electronically transmit
health care information in specified transactions.7 The Wisconsin patient confidentiality statute does
not limit its application to any particular class of persons or entities
and appears to apply to anyone who possesses patient health care
records. The Wisconsin statutory provisions allowing for enforcement
refer to "custodians" of records and to "any person" who violates the
statute.8 Thus, it appears that any covered
entity that possesses patient health care records is subject to the
Wisconsin patient confidentiality statute. However, the converse is not
true. Many custodians of patient health care records subject to the
Wisconsin patient confidentiality statute are not covered entities under
the Privacy Rule and consequently will not be subject to the Privacy
Rule.
"Protected health information" versus "patient health care
records." The Privacy Rule regulates "protected health
information," which is broadly defined as information, including
demographic information, that is created or received by a covered entity
and relates to the physical and/or mental health or condition of the
patient, the patient's health care or payment for that health
care.9 This protected health information is
somewhat broader than the "patient health care record" protected by the
Wisconsin patient confidentiality statute. The Wisconsin statute refers
to "records related to the health of a patient prepared by or under the
supervision of a health care provider ...,"10 and is generally understood to exclude
demographic or identifying information that is not combined with medical
information. Consequently, the Privacy Rule regulates a broader class of
information than does the Wisconsin patient confidentiality statute.
Some uses and disclosures of patient information previously outside the
Wisconsin statute are regulated by the Privacy Rule and thus cannot be
disclosed as before in Wisconsin.
"Use" and "disclosure" versus "release." The Privacy
Rule refers to the "use" and "disclosure" of protected health
information. "Use" refers to sharing and employment of and access to
information within a covered entity, while "disclosure" refers to the
release or transfer of information outside the covered entity.11 The Wisconsin patient confidentiality statute
uses the term "release," which is not defined. Clearly, "release"
encompasses the disclosure of information as defined by the Privacy
Rule. However, "release" may also encompass the use of this information
within the entity holding the information. Certain of the exceptions
that allow the release of information without patient consent refer to
internal activities by staff of a health care provider or other records
custodian.12 Thus, a prudent starting point
for analysis of this issue is to assume that "release" in the Wisconsin
statute includes both use and disclosure as defined in the Privacy
Rule.
Treatment, Payment, and Health Care Operations
Both the Privacy Rule and the Wisconsin patient confidentiality
statute allow disclosure of patient information by health care providers
without patient authorization for treatment and for payment
purposes.13 Neither the Privacy Rule nor
the Wisconsin statute imposes significant restrictions on the exchange
of information for the purpose of treating the patient. Similarly, both
the Privacy Rule and the Wisconsin statute allow providers to use or
disclose information to obtain payment for themselves. The Privacy Rule
further allows a provider to disclose protected health information to
another covered entity or health care provider so the other entity or
provider may obtain payment. Comparatively, the Wisconsin patient
confidentiality statute only permits the release of records "to the
extent the records are needed for billing, collection, or payment of
claims"14 and does not address the question
of whether a provider may release patient information so that another
person or organization may seek payment. As a result, it is unclear
whether patient health care records may be released for this purpose
without patient authorization in Wisconsin.
The Privacy Rule allows health care providers to use and disclose
protected health information without patient authorization for "health
care operations," including a variety of activities that are related to
the provision of treatment or obtaining or processing payment, including
quality assessment and improvement activities, credentialing or
evaluating health care practitioners, training, underwriting, medical
review, legal services and auditing, business planning and development,
and business management and general administrative activities.15 Of the activities defined as health care
operations by the Privacy Rule, the Wisconsin patient confidentiality
statute only explicitly allows the release of patient health care
records without patient authorization for medical records management and
certain audits, program monitoring, accreditation and health care
services review activities by health care facility staff committees or
accreditation or review organizations.16
Thus, in Wisconsin the release of confidential health information for a
wide range of health care operations purposes apparently requires
written authorization.
It seems likely that health care providers and others have assumed
that the treatment and payment activities for which disclosure is
allowed by the Wisconsin statute included the activities defined as
health care operations by the Privacy Rule, as evidenced by many records
custodians using and disclosing patient health care records for these
purposes without patient authorization. However, this assumption is
called into question by the explicit definition of these terms in the
Privacy Rule, clearly distinguishing between treatment and payment on
the one hand and health care operations on the other. Under the Privacy
Rule, these categories are treated as mutually exclusive - an activity
that is a "health care operation" is not a treatment or payment activity
as those terms are defined in the Privacy Rule. Applying the Privacy
Rule approach to these critical categories means that disclosing patient
health care records for most health care operations without patient
authorization (as allowed by the Privacy Rule) violates Wisconsin
law.
Informal Agreement
If a patient's "informal agreement" has been obtained, the Privacy
Rule allows the use and disclosure of protected health information
without written authorization for facility directories and to family
members or others involved in a patient's care or payment for that
care.17 An informal agreement consists of
notice and opportunity to object, and may be obtained orally. The
Wisconsin patient confidentiality statute does not recognize oral
authorization or agreement for the release of patient health care
records.
Facility directories. A variety of health care
facilities, including hospitals and nursing homes, traditionally create
facility directories listing their current patients or residents and
make them available to the public. This information has been released
without patient authorization because the patient health care records
protected by Wisconsin law have not been read to include the demographic
or identifying information contained in a directory (the name of the
patient, his or her location in the facility, and arguably a general
description of his or her condition). In Wisconsin, if this information
is not part of the protected patient health care record, it may be
released without written authorization. However, under the Privacy Rule
this release of information is allowed only with the patient's informal
agreement. Because directory information cannot be disclosed pursuant to
informal agreement except to clergy and persons who ask for the patient
by name, the Privacy Rule requires written authorization from the
patient for publicly posted facility directories, such as those commonly
used in nursing homes.
Family and friends. Although relatively
straightforward from a legal perspective, the release of information to
family, friends, and others involved in the patient's care or payment
for care presents difficult practical issues. Except for releases to
personal representatives such as the parents of a minor, court-appointed
guardians, or active health care agents, the Wisconsin patient
confidentiality statute contains no provision allowing the release of
patient health care records to family members or others without the
patient's written authorization. Thus, the common practice of discussing
a patient's condition, treatment, and outlook with the patient's spouse,
children, or other family members or friends without the patient's
written authorization is a violation of the Wisconsin patient
confidentiality statute. Health care providers and others may mistakenly
believe that they are fully complying with the law when they are in
compliance with the Privacy Rule, but obtaining the patient's informal
agreement under the Privacy Rule for these conversations does not cure
the violation, as Wisconsin law does not recognize informal agreement.
Regardless of whether the Wisconsin requirement for written
authorization in these circumstances is in conflict with the Privacy
Rule, Wisconsin law is more stringent and will continue in effect.
Unfortunately, strict application of Wisconsin law results in
termination of discussions about medical care with spouses, family
members, and others that are universally regarded as productive and even
necessary in managing a patient's care. The written consent of patients
to disclosures of their health information to family members or others
may not be difficult to obtain in treatment settings, such as hospitals
or nursing homes, that have formal intake procedures conducive to
obtaining this kind of documentation. For other providers in other
treatment settings, this provision of Wisconsin law presents a very real
dilemma, placing compliance with the law in opposition to other values
and activities on which the provider may place a high value.
Exceptions for Public Benefit Activities
The Privacy Rule and the Wisconsin patient confidentiality statute
both contain long lists of public benefit exceptions - activities for
which the patient's written authorization (or, in the case of the
Privacy Rule, informal agreement) is not required.18 While there are too many public benefit
exceptions (more than 20 in the Wisconsin patient confidentiality
statute alone) to discuss individually in this article, an understanding
of basic principles behind the interaction of the exceptions provided
under Wisconsin law and the Privacy Rule may help providers and
practitioners understand how to approach these situations as they
arise.
Two principles underlie the exceptions listed in the Privacy Rule.
First, many of the Privacy Rule exceptions are intended to preserve to
some degree those provisions of state or federal law allowing or
requiring the disclosure of confidential information without the
patient's permission. Second, the Privacy Rule exceptions do not
displace any other state or federal law limiting the disclosure of
protected health information. If there is other law, including state
law, that prohibits or limits the disclosure of confidential
information, then disclosure is not allowed regardless of any exception
under the Privacy Rule. Thus, disclosure of protected health information
without the permission of the patient to whom the information relates is
generally allowed only when there are "overlapping" exceptions in both
the Privacy Rule and Wisconsin law.
Preservation of existing law. Most of the Privacy
Rule exceptions refer to disclosures that are otherwise required or
authorized by law and thereby are intended to preserve existing law
allowing disclosure without patient authorization. For example, the
Privacy Rule preserves existing Wisconsin law by creating exceptions
allowing disclosure to "public health authorities or other appropriate
government authorities authorized by law to receive reports of child
abuse or neglect"19 and disclosure "to a
health oversight agency for oversight activities authorized by
law."20 These Privacy Rule exceptions
preserve, respectively, those provisions of the Wisconsin patient
confidentiality statute allowing reporting of suspected child abuse, and
allowing reporting to, or access by, various government agencies charged
with oversight or licensing of health care providers.21
"Overlapping" exceptions. A covered entity must
confirm that disclosure without a patient's authorization is allowed by
both the Privacy Rule and Wisconsin law, because the exceptions created
by the Privacy Rule and the Wisconsin patient confidentiality statute
are not identical. For example, the Privacy Rule allows for disclosure
of protected health information in response to a subpoena, discovery
request, or other lawful processes that are not accompanied by a court
order. On the other hand, Wisconsin allows disclosure in this situation
only in response to a court order (which can encompass a subpoena signed
by a judge). Hence, while the Privacy Rule allows disclosure in response
to a subpoena or discovery request signed by an attorney that is
unaccompanied by the patient's authorization, Wisconsin law prohibits
the release of patient health care records in response to such a
document.
On the other hand, some Wisconsin exceptions are broader than their
counterparts in the Privacy Rule. For example, the Wisconsin patient
confidentiality statute allows the release of patient information in
response to a written request of a government agency to perform a
legally authorized function (although this provision allows certain
private pay patients to deny access).22 As
a result, before a covered entity makes a disclosure in response to a
written request by a government agency, it must also find an exception
under the Privacy Rule allowing the disclosure - even though the written
request is sufficient under Wisconsin law. Consequently, a Wisconsin
provider could disclose patient information in response to a written
request from a health oversight agency such as the Department of Health
and Family Services (DHFS) Bureau of Quality Assurance in connection
with a compliance survey or complaint investigation, because such a
disclosure is allowed by both the Privacy Rule and the Wisconsin patient
confidentiality statute. However, a Wisconsin provider may not disclose
patient information in response to a written request from the Department
of Workforce Development to conduct a study on workforce injuries, as
there is no Privacy Rule exception that allows such a disclosure without
patient authorization.
The overlap between the exceptions in the Privacy Rule and the
Wisconsin patient confidentiality statute is significant. This is in
large part because both sets of exceptions were drafted for the purpose
of allowing access to information for the same basic set of public
benefit activities. Of all the exceptions in the Privacy Rule, only a
few have no counterpart in the Wisconsin patient confidentiality
statute, including the Privacy Rule exceptions for medical surveillance
of the workplace, for reporting domestic violence, reporting crime on
the premises of the covered entity, and reporting crimes in emergencies.
Although some exceptions from the Wisconsin patient confidentiality
statute are limited by the Privacy Rule because the overlap between the
Wisconsin exception and the Privacy Rule exception is not complete, it
seems that all the Wisconsin patient confidentiality exceptions are at
least partially preserved under the Privacy Rule.
Marketing
Demographic or contact information, such as mailing lists, is not
generally considered part of the patient health care record under the
Wisconsin patient confidentiality statute. Therefore, the release of
this information for marketing purposes has not been significantly
restricted in Wisconsin. The Privacy Rule requires patient authorization
before patient mailing lists can be used for marketing, as defined by
the Privacy Rule. The Privacy Rule contains a complex series of
definitions and exceptions relating to the use or disclosure of
protected health information for marketing activities. "Marketing" is
broadly defined as any "communication about a product or service that
encourages recipients of the communication to purchase or use the
product or service."23 Given the breadth of
this definition, which includes a great many communications essential to
the modern practice of medicine, several exceptions are carved out to
allow normal patient treatment and other activities. These exceptions
include communications that describe health-related products or services
provided by the covered entity making the communication, communications
that are part of the treatment of the patient, and communications for
case management, care coordination, or to recommend alternative
treatments, providers, or care settings.
Many health care providers in Wisconsin send newsletters or similar
communications. A newsletter that is purely informational and does not
encourage the purchase or use of a product or service is not a marketing
communication as defined by the Privacy Rule. A newsletter that
describes only health-related products or services provided by the
covered entity sending the newsletter, or that directs or recommends
alternative treatments, therapies, providers, or settings of care, is
also not a marketing communication. However, a newsletter that contains
any other marketing content, such as an advertisement for a health club
not owned by the covered entity, or a description of the services of
another health care provider that could be interpreted to encourage the
purchase or use of the other provider's services, is a marketing
communication and may not be sent to a patient without his or her
written authorization.
Wisconsin Mental Health Statute
The Privacy Rule has relatively little effect on the current
practices of Wisconsin mental health providers regarding the use and
disclosure of mental health treatment records. This is because the
Wisconsin mental health statute's privacy protections are generally more
stringent than those of the Privacy Rule.
|
Timothy A. Hartin, Harvard
1987, is a partner in the Madison office of Michael Best & Friedrich
LLP. He focuses his practice on health care law and government relations
and recently has been developing HIPAA compliance tools for use in
Wisconsin and nationwide.
This article is a follow-up to Hartin's April 2002 Wisconsin Lawyer
article, "New Federal Privacy Rules for Health Care Providers," which
discusses the new privacy rules, who they affect, and how.
|
|
Mental health providers and legal practitioners should be wary of
assuming that compliance with the Privacy Rule also constitutes
compliance with the Wisconsin mental health statute. The Privacy Rule
allows relatively broad use and disclosure of protected health
information for treatment, payment, and health care operations without
patient authorization, but the Wisconsin mental health statute does not.
Wisconsin allows release of mental health treatment records without
patient authorization for treatment purposes only within the mental
health treatment facility where the patient is being treated and in
emergencies.24 Wisconsin allows release of
mental health treatment records without patient authorization for
billing or collection purposes only to the DHFS or a county
department.25 Finally, Wisconsin allows the
release of mental health treatment records for only a handful of the
health care operations recognized by the Privacy Rule, including
management and financial audits, program monitoring and evaluation, and
training.26
The Wisconsin mental health statute's exceptions to the requirement
for patient authorization are generally preserved by the Privacy Rule,
as the Wisconsin exceptions tend to be narrower than the corresponding
exceptions under the Privacy Rule. Relatively few of the Wisconsin
mental health exceptions are limited by their Privacy Rule counterparts,
because the Privacy Rule generally allows disclosure without patient
authorization in a wider range of situations than does the Wisconsin
mental health statute. The danger for mental health practitioners may
arise from a mistaken belief that compliance with the Privacy Rule also
means compliance with Wisconsin law.
Patient rights. The Wisconsin mental health statute
grants mental health patients broad rights of access to their mental
health treatment records as well as the right to amend their treatment
records. With respect to patient rights, providers are obligated to
recognize the broader grant of rights, so that a mental health patient's
right to access and amend his or her records is a hybrid of the rights
granted by the Privacy Rule and the Wisconsin mental health statute.
Even when the Wisconsin mental health statute would allow providers
to deny patients access to their treatment records, this access must be
provided unless the Privacy Rule also allows denial of access. The
Wisconsin mental health statute allows the director of a treatment
facility to restrict a patient's access to treatment records during the
patient's treatment, except that access to records of medications and
somatic treatments may not be denied.27 The
discretion of the treatment facility director to deny access is
significantly restricted by the Privacy Rule, which only allows the
denial of access in limited and defined situations. Conversely, the
Wisconsin mental health statute gives a patient who has been discharged
the right to access "any or all of his or her treatment records" as well
as "a complete record of all medications and somatic treatments" and a
copy of his or her discharge summary.28
This post-discharge right of access is somewhat broader than the access
rights guaranteed by the Privacy Rule. Before denying a mental health
patient access to his or her treatment records, providers must make sure
that both the Privacy Rule and the Wisconsin mental health statute allow
such a denial.
Both the Privacy Rule and the Wisconsin mental health statute allow
patients to amend their records. However, the right to amend granted by
the Wisconsin mental health statute is narrower than the corresponding
right under the Privacy Rule, because the Wisconsin statute only grants
the right to challenge and request amendment of factual
information.29 Further, the Wisconsin
mental health statute requires that the amendment be responded to by the
provider within 30 days, which is a shorter deadline than the 60 days
allowed by the Privacy Rule, and the Wisconsin statute does not
recognize some of the grounds for refusal to amend that are granted by
the Privacy Rule (for example, the records were not created by the
provider, the records are not part of the patient's "designated record
set," or the records are not subject to the patient's right of access).
The compliance obligations imposed by the Privacy Rule and Wisconsin law
result in a "hybrid" right of amendment combining the shorter deadline
and fewer exceptions allowed by Wisconsin law for amendments of factual
information with the Privacy Rule provisions that allow amendment of any
other mental health treatment records.
Wisconsin HIV Test Statute
Like the Wisconsin mental health statute, the Wisconsin HIV test
statute is generally more stringent than the Privacy Rule. While the
Wisconsin HIV test statute allows for disclosure of HIV test results
without patient authorization to health care providers who provide care
to the patient, it does not allow the disclosure of HIV test results
without authorization in order to obtain payment for services or for
health care operations. The only exceptions are for preparation or
storage of records, program monitoring and evaluation, and health care
services reviews by specified organizations.
The exceptions to the requirement for written authorization by the
HIV test subject under Wisconsin law tend to be narrower than their
counterparts under the Privacy Rule, meaning that the Wisconsin
exceptions will be preserved largely unaffected by the Privacy Rule.
Most significantly, the Wisconsin HIV test statute allows disclosure of
HIV test results without authorization to certain persons who may have
been significantly exposed to the test subject.30 The Privacy Rule, which contains an exception
allowing disclosure to "a person who may have been exposed to a
communicable disease ... if the covered entity or public health
authority is authorized by law to notify such person,"31 preserves these notification provisions.
Conclusion
As of April 14, 2003 (the compliance date for the Privacy Rule for
health care providers), privacy compliance in Wisconsin became a great
deal more complex. Not only must health care providers come into
compliance with the lengthy and complicated Privacy Rule, they must
avoid two "traps for the unwary." First, they must avoid assuming that
uses and disclosures of information customarily allowed in Wisconsin
without patient authorization are permitted under the Privacy Rule, as
the Privacy Rule imposes new restrictions on what may be done without
patient authorization. Second, and perhaps more dangerous in the wake of
innumerable Privacy Rule seminars and "generic" Privacy Rule compliance
toolkits that do not take Wisconsin law into account, they must not
assume that compliance with the Privacy Rule also amounts to compliance
with Wisconsin privacy law. Wisconsin privacy law contains a number of
provisions that are more stringent than the Privacy Rule and will
continue to affect how health information is used and disclosed.
Endnotes
145 C.F.R. parts 160-164.
2Wis. Stat. § 146.82.
3Wis. Stat. § 51.30. See
also Wis. Admin. Code chapter HFS 92 for accompanying
regulations.
4Wis. Stat. § 252.15.
545 C.F.R. § 160.203.
6Wis. Stat. § 146.82(1); 45
C.F.R. § 160.502.
745 C.F.R. § 160.103.
8Wis. Stat. § 146.84.
945 C.F.R. § 164.501.
10Wis. Stat. §
146.81(4).
1145 C.F.R. § 164.501.
12Wis. Stat. §
146.82(2)(a)2.
1345 C.F.R. §
164.502(a)(1)(ii); Wis. Stat. § 146.82(2)(a)2.-3.
14Wis. Stat. §
146.82(2)(a)3.
1545 C.F.R. §
164.502(a)(1)(ii).
16Wis. Stat. §
146.82(2)(a)1.
1745 C.F.R. § 164.510.
1845 C.F.R. § 164.512; Wis.
Stat. § 146.822(a).
1945 C.F.R. §
164.512(b)(1)(ii).
2045 C.F.R. §
164.512(d).
21Wis. Stat. §§
146.82(2)(a)5., 11.
22Wis. Stat. §
146.82(2)(a)5.
2345 C.F.R. § 164.501.
24Wis. Stat. §
51.30(4)(b)6., 8.
25Wis. Stat. §
51.30(4)(b)2.
26Wis. Stat. §
51.30(4)(b)1., 6.
27Wis. Stat. §
51.30(4)(d)1.
28Wis. Stat. § 51.34(d)(2),
(3).
29Wis. Stat. §
51.30(4)(f).
30Wis. Stat. §
252.15(2)(a)7m.
3145 C.F.R. §
164.512(b)(1)(iv).
Wisconsin Lawyer