W. Va. Dept. of Health and Human Resources/Behavioral Health v. E.H.
W. Va. Dept. of Health and Human Resources/Behavioral Health v. E.H.
Opinion of the Court
The West Virginia Department of Health and Human Resources, the Bureau for Behavioral Health and Health Facilities (“DHHR”), seeks to reverse the August 27, 2014, order of the Circuit Court of Kana-wha County, through which the DHHR was directed to immediately restore access to patients and patient records to the patient advocates working at this state’s two psychiatric hospitals.
I. Factual and Procedural Background
The underlying litigation had its genesis in 1981 with a petition for a writ of mandamus filed by a group of institutionalized individuals to address the civil rights of patients with mental disabilities.
In accordance with its obligations under the 1990 order, the DHHR immediately contracted with Legal Aid of West Virginia (“Legal Aid”) to provide patient advocacy services. In this role, which it has occupied since its selection in 1990, Legal Aid assists with and investigates individual grievances,
Court monitoring of the Hartley case continued until 2002 when, by agreement of the parties, the case was removed from the active docket of the court.
Systemic violations of patient rights, including the use of “chemical restraints,” were demonstrated during a two-day evidentiary hearing held before the circuit court in April 2009. At the conclusion of. the hearing, the trial court ordered the parties to participate in mediation which resulted in an agreement between the parties covering multiple issues. Under that court-approved agreement, commonly referred to as the “2009 Agreed Order,” the Ombudsman is charged with the duty to oversee implementation of the specific terms of the agreement. Included in those terms is a provision requiring Sharpe and Bateman to fully comply with the state regulations that address issues of patient care and patient advocacy services. See 64 C.S.R. §§ 59-1 to -20. The 2009 Agreed Order requires that “[p]eriodic review shall be established for compliance with [specified] sections.”
On January 5, 2010, the parties agreed that the patient advocates would create an assessment tool for the hospital audits necessary to enable the DHHR to comply with the periodic review contemplated by the 2009 Agreed Order. On March 31, 2010, the DHHR agreed that quarterly audits should be conducted by providing the patient advocates with complete access to at least two patients from each unit independent of any actual grievances filed. On May 5, 2010, the parties agreed that the audit instrument was finalized and the patient advocates were instructed “to begin implementation.”
•For more than a decade, the DHHR provided the- patient advocates with full access to computerized patient records, to the patient wards, and other areas of the hospitals. Then, in June 2014, with no prior notice, the DHHR began requiring the patient advocates to obtain signed releases from each
In response to this abrupt change of policy regarding access to patient records, the patient advocates filed a motion for emergency relief with the circuit court and a hearing was held on August 1, 2014. After finding no violation of federal or state law, the circuit court directed the DHHR, by order of August 24, 2014, to immediately restore Legal Aid to the previous levels of access at Sharpe and Bateman. On August 29, 2014, the circuit court denied the DHHR’s motion for stay of the August 27, 2014, amended ruling.
II. Standard of Review
Given our conclusion that the August 27, 2014, amended ruling constitutes a final order notwithstanding the trial court’s contrary ruling,
III. Discussion
A. Constitutional Privacy Rights
In support of its position that the lower court’s order improperly requires unfettered disclosure of patient records to the patient advocates, the DHHR maintains that the
Legal -Aid contends that the DHHR improperly seeks to inject constitutional error into this matter with an issue never addressed by the circuit court.
At the outset, we. observe that the constitutional concerns raised by the DHHR are confined to the previous longstanding practice of permitting the advocates to review patient records for purposes of assessing overall hospital Conditions.
Inherent in the DHHR’s argument is a presumption that the systemic review of patients’ records necessarily results in the wrongful disclosure of medical information. Given that the first and only complaint concerning an alleged violation of HIPAA was filed in 2014 by the DHHR — almost twenty years after the federal act became law — it is clear that inappropriate disclosure of patient information has not been taking place as implied by the DHHR. Not only have there been no complaints filed until the DHHR instituted one,
In seeking to convince this Court that the provision of advocacy services over the past two decades has just recently become a matter of constitutional significance, the DHHR ignores the annual HIPAA training, the executed confidentiality agreements, and state law provisions all designed for the purpose of, and apparently successful at, imposing a high level of confidentiality upon the patient advocates with regard to their review of sensitive health information. As Legal Aid explained, the review undertaken by the patient advocates is conducted in confidence without public disclosure of any protected health information. Critically, there has never been any complaint filed by a Bateman or Sharpe patient, or the patient’s representative, associated with the wrongful dissemination of confidential health information
B. HIPAA
Pursuant to HIPAA’s Privacy Rule (“Privacy Rule”), “[a] covered entity or business' associate may hot use or disclose
1. “Business Associate”
Under HIPAA, a “business associate” relates to and is defined in reference to a “covered entity.” The , Privacy Rule’s construct of a “covered .entity” extends to: ■ (1) a health plan, (2) a health care clearinghouse, or (3) a health care provider who transmits any health information in electronic form in connection with a covered transaction. See 45 C.F.R. § 160.103 (2014). As the -circuit court correctly ruled in its August 27th order, both Bateman and Sharpe qualify as covered entities under HIPAA With scant analysis,
Legal Ad repeatedly refers to itself as a “business associate” of the DHHR. Because the DHHR is not a “covered entity” under HIPAA, the relationship between Legal Ad and the DHHR is not controlling. To come within HIPAA’s exclusionary language, Legal Ad must be a “business associate” of Sharpe and Bateman. In further explanation of what is necessary to qualify as a “business associate,” the regulations provide that it is a person who:
(i) On behalf of such covered entity ,.. but other than in the capacity of a member of the workforce of such covered entity or arrangement, creates, receives, maintains, or-transmits protected health information for a function or activity regulated by this subchapter, including claims processing or administration, data analysis, processing or administration, utilization review, quality assurance, patient safety activities listed at 42 CFR 320, - billing; benefit management, practice management, and repricing; or
(ii) Provides, other than in the capacity of a member of the workforce of such covered entity, legal, actuarial, accounting, consulting, data aggregation ..., management, administrative, accreditation, or’financial services to or for such covered entity....
45 C.F.R. § 160.103.
The DHHR argues, and we agree, that the patient advocacy services performed at Bateman and Sharpe are not performed on behalf of either of those facilities within the meaning of the Privacy Rule. See id. . In purveying the list of activities that constitute services typically performed by a “business associate” for a “covered entity,” patient advocacy is noticeably absent. Rather than serving the interests' of the hospitals in terms of providing managerial assistance with their operations, the patient advocates serve the personal interests of the patients who .reside at those facilities. From the beginning, the provision of. patient advocacy services .was created to protect the interests of individual patients. See W.Va.Code § 27-5-9; 64 C.S.R. § 59-20.1 (mandating patient advocates in every behavioral health facility who are independent of facility management). Despite the expanded role of the patient advocates with regard to systemic auditing, the primary objective in conducting these reviews is compliance with patient-oriented rights.
2. “Health Oversight Agency”
Cherry picking parts of the HIPAA definition of a “health oversight agency,”
From the list of agencies recognized to engage in health oversight activities, such as state • insurance commissions, state health professional licensure agencies, state Medicaid fraud control units, the Pension and Welfare Benefit Administration, the HHS Office for Civil Rights,
While state regulations authorize- patient advocates to investigate and ensure compliance with! civil rights guaranteed by West Virginia Code' § 27-5-9, that authority does not imbue 'Legal Aid with health oversight
3. “Health Care Operations”
An additional HIPAA provision that the trial court found applicable is the exemption which permits a “covered entity” to “use or disclose protected health care information for its own treatment, payment, or health care operations.” 45 C.F.R. § 164.506(c)(1) (2014) (emphasis added).. Because “health care operations”., are defined ,to include “Conducting quality assessment,” “auditing .functions, including .,. abuse detection and compliance programs,” and “[rjesolution of internal grievances,” the trial court ruled that the advocacy and auditing services provided by Legal Ad are part of .the hospitals’ .covered health care operations. See 45 C.F.R. § 164.501 (2014).
Once again, the trial court has deemed a HIPAA exemption to apply based on a flawed interpretation of the subject definition. Reading from the bottom up, the trial court simply concludes that because auditing and compliance functions are part of “health care operations,” then the services performed by Légal Ad must necessarily be covered by this exemption. What the trial court overlooks is the critical distinction, similar to the limitation imposed on a “business associate”’ that these services, by definition, are those that are performed at the direction of or on behalf of the facility as part of its own internal operating procedures. “[Hjealth care operations are the listed activities undertaken by the covered entity that maintains the, protected health information.” 65 Fed. Reg. 82462-01, 82490 (emphasis supplied). The auditing and compliance functions performed by an independent entity such as Legal Ad-an entity Charged by law to uncover violations of patient rights by the facilities rather than to assist a facility with the management of its operations — do not fall within the meaning of “health care operations” as that term is .defined by HIPAA See 45 C.F.R. § 164.501.
Further distinguishing between the activities that constitute “health care operations” and those that do not, the DHHR explains that a hospital can access patient records within the meaning of the subject exemption to resolve internal grievances. In contrast, the initiation of a grievance, by Legal Ad is an activity external to the facility and thus beyond the scope of the exemption.. In the same.vein, a facility may access patient records for its own internal audits, but external audits such as those performed by Legal Ad fall outside the scope of the facility’s operations and thus the applicability of the exemption. Accordingly, we -find that the trial court erred in reasoning that the “health care operations” exemption under HIPAA. is available to Legal Ad.
4. ■ “Required by Law”
In generalized fashion, the trial court relied upon the HIPAA exemption that permits disclosure without written consent where “such use or disclosure is required by law.” 45 C.F.R. § 164.512(a). For more specific support,' the trial court cited the provision of HIPAA that permits a covered entity to disclose protected health information to' a government authority when the covered entity reasonably believes • that the information pertains to a victim of abuse or neglect.
As the DHHR clarifies, the exemption laced to a legal directive both contemplates and requires “a mandate contained in law that compels a covered entity to make a use or disclosure of 'protected health information ... that is enforceable in a court of law.” 65 Fed. Reg. 82462-01, 82497. Application of this exemption is specifically constrained by the requirement that “the use or disclosure complies with and is limited to the relevant requirements of such law.” 45 C.F.R. § 164.512(a). The DHHR contends that this exemption does not apply because there is no state law that requires the hospitals to disclose patient records in the unfettered fashion decreed by the trial court. We agree. While state regulations authorize patient advocates to gain access to patient records in the process of investigating grievances without express consent, there is no state-enacted law or regulation that expansively directs facilities such as Bateman and Sharpe to disclose all patient records to Legal Aid without' consent. See 64 C.S.R. § 59-11.5.1.d. The abuse and neglect provision is similarly inapplicable as it concerns disclosure to a governmental authority rather than to a private entity such as Legal Aid.
In its reach to come within the parameters of the “required by law” exemption, the trial court suggests that HIPAA’s requirements may be avoided with the entry of a court order, Not only is this deduction erroneous but it ignores the additional requirement that a court-directed disclosure applies only to “expressly authorized” disclosures made “in the course of any judicial or administrative proceeding.” 45 C.F.R. § 164.512(e)(l)(i).' A ruling that seeks to broadly sanction disclosure not expressly linked to a specific judicial or administrative matter falls outside the framework of the HIPAA exemption which permits disclosure pursuant to judicial authorization. See id. Moreover, as HIPAA makes clear, the provision for directives issued in the course of specific judicial and administrative proceedings “do[es] not supersede other provisions of this section that otherwise permit or restrict use or disclosure of protected health information. 45 C.F.R. § 164.512(e)(2).. We have little difficulty concluding that the HIPAA exemption premised on a judicial ruling has no application to the prospective disclosures contemplated by the August 27th decree as such disclosures would be made outside the framework of an ongoing proceeding. Accordingly, we find that the. trial court erred in its reliance on the HIPAA exemptions pertaining to legal mandates or ■ rulings. See 45 C.F.R. §§ 164.512(a), 512(e)(l)(i).
C. State Law
Having determined that federal law does not provide the necessary authority for disclosure of patients’ records to Legal Aid without consent, we proceed to determine if our state law provides an independent basis to support the lower court’s ruling. As the DHHR acknowledges, HIPAA?s preemption clause provides that the' federal act “shall supersede any contrary provision of State law,” unless state law is more stringent or-if one of several other exceptions applies: 42 U.S.C. § 1320d-7 (2012); 45 C.F.R. §§'160.202,-203 (2014) (listing exceptions'to preemption). If no exception applies, “State laws are contrary to HIPAA if: (1) it would be impossible for the health care provider to comply simultaneously with HIPAA and the state directive; or (2) the state provision stands as an obstacle to the accomplishment of the full objectives of HIPAA.” Wade v. Vabnick-Wener, 922 F.Supp.2d 679, 686 (W.D.Tenn. 2010).
From the record of this case, it is clear that this state undertakes to examine our codified law on an annual basis to analyze whether our state laws are more stringent than HIPAA’s for preemption purposes.
Within our state regulations that were adopted to provide “skillful, safe and humane” care to incarcerated patients' with mental health issues, the confidentiality of patient records is addressed at length. W.Va.Code § 27-5-9. The regulations specify in detail what information is deemed confidential and when a patient’s records may be disclosed. See 64 C.S.R. § 59-11.1. While a patient may authorize the release of his or her records to any person or entity, those records may also be obtained by the “providers of health, social, or welfare services involved in caring for or rehabilitating the client." 64 C.S.R. § 59-11.5.1.d. Under this same provision, it is provided that “[n]o written consent is necessary for employees of the department, comprehensive behavioral health centers serving the client or advocates under contract with the department.” Id. (emphasis supplied).
In an obvious attempt to thwart legislative intent, the DHHR denies that it has a contract with Legal Aid. The DHHR maintains that the Grant Agreement pursuant to which it employs Legal Aid on an annual basis to provide advocacy services for the patients at Sharpe and Bateman does nothing but address the exchange of money. Our review of the record demonstrates quite the opposite. In the initial sixteen pages of the Grant Agreement, standard contractual matters such as scope, term, cancellation, remedies, and assignment are addressed. Through a separate but expressly incorporated, ten-page document, the services and activities required of Legal Aid are delineated. A review of the Grant Exhibit, along with the multiple attached exhibits, wholly disproves the DHHR’s position that the document fails to address the legal obligations of the parties. As a result, we hold that a written agreement between the DHHR and the provider of patient advocacy services that specifies the legal obligations of the parties, including the manner of payment and the duties associated with the provision of patient advocacy services, constitutes a contract within the meaning of 64 C.S.R. § 59-11.5.1.d. for purposes of permitting patient advocates to access records without the written. consent of individuals hospitalized with mental health issues in state facilities. This conclusion is specifically premised on the fact that the DHHR is required by the 1990 Order to employ external patient advocates for purposes of complying with the mandate contained in West Virginia Code § 27-5-9.-
Returning to the trial court’s ruling, we affirm the lower court’s ruling that the DHHR’s revocation of patient advocate access to patients, staff, and patient records absent express written consent violates state law. The long term practice of providing unlimited record access to the patient advocates, .agreed to by the parties and sanctioned by the court through the 2009 Agreed Order, has become part of the rule of this, case. See generally Keller v. Norfolk & W. Ry. Co., 113 W.Va. 286, 167 S.E. 448 (1932). Thus, for the DHHR to act in violation of that established practice was contrary to the rule of law which governs this case. Furthermore, the policy adopted by the DHHR is not required by HIPAA as this state’s laws set forth in 64 C.S.R. § 59-1 to -20 are more stringent than those set forth in HIPAA.
We further affirm the trial court’s ruling that the patient advocates shall have access to patient records without limitation except when patients expressly request limitations on the disclosure of their individual, identifiable health information. There is a clear need for non-grievance related review of pa
IV. Conclusion
Based on the foregoing, the August 27, 2014, order, of the Circuit Court of Kanawha County is affirmed with regard to its multiple directives concerning the restoration of access without limitation by patient advocates to patients at Sharpe and Bateman.
Affirmed.
. Mildred Mitchell Bateman ("Bateman”) and William R. Sharpe, Jr. ("Sharpe”).
. See Syl. Pt. 3, Barnett v. Wolfolk, 149 W.Va. 246, 140 S.E.2d 466 (1965) ("This Court may, on appeal, affirm the judgment of the lower court when it appears that such judgment is correct on any legal ground disclosed by the record, regardless of the ground, reason or theory assigned by the lower court as the basis for its judgment.”).
. See W.Va.Code § 27-5-9 (2013) (providing, inter alia, that "[¿jach patient of a mental health facility ... shall receive care and treatment that is suited to his or her needs and administered in a skillful, safe and humane manner with full respect for his or her dignity and personal integrity”).
. This plan, a 330-page document, was reached by agreement among the parties. See Matin II, 189 W.Va. at 104 n. 2, 428 S.E.2d at 525 n. 2.
. Pursuant to that order, the DHHR was directed to “contract with an entity outside State government for the provision of advocacy.”
. These rules were adopted under authority of West Virginia Code § 27 — 5—9(g).
. "There shall be persons designated as client (or patient or resident) advocates who are independent of the facility management in every behavioral health facility.” 64 C.S.R. § 59-20.1.
. Court monitoring was resumed in 2009 based on reports of both the conditions and treatment of patients at Sharpe and Bateman.
. Those sections are 64 C.S.R. §§ 59-12, -13, - 14, -15.1.7, -15.1.12,--15.2, -15.3, and -16.4.2.
. Thiá language appears in each of the annual grant documents in ■ the record of this case. Those documents set forth the duties of Legal Aid in relation to the patient advocacy services and provide the necessary funding for such services.
. The decision to alter access was made by the DHHR’s Privacy Officer, Lindsey McIntosh. Before making this change in tack, Ms. McIntosh acknowledged she did not investigate the role or needs- of the advocates; she did not visit Bate- , man or Sharpe; shp did not speak- to Legal Aid; and she did not review any of the orders pertaining to this case.
. According to the DHHR’s representation in its response to the Motion for Emergency Relief,- - each authorization was good for 180 days.
. Minor changes were made to the previous ruling. The only substantive amendments were to remove the reference to the patient advocates as having been created by both federal and state law (they were created solely under state law) and to recognize that grievances may be initiated independently by a patient advocate separate from a patient’s allegation of abuse or assertion of a civil rights violation.
. By order entered on August 29, 2014, the . circuit court refused to grant the DHHR’s request to have the August 27, 2014, order deemed a final order. The rationale for its ruling is clear; the trial court was trying to prevent the DHHR from belatedly seeking relief from its previously unappealed 1990 Order. Because the court’s ruling was not impelled by the need to address additional issues arising from reduced access (i.e. a .lack of finality) and because there are no further issues to be resolved concerning
. Cf. Syl. Pt. 5, Riffe v. Armstrong, 197 W.Va. 626, 477 S.E.2d 535 (1996).
. Legal Aid asserts that the DHHR did not raise the issue of constitutional error at the August 1, 2014, hearing. In response, the DHHR states that the evidentiary proceeding was not the forum in which to assert legal error. The record demonstrates that the DHHR advanced the issue of constitutional error in its response to Legal Aid's Motion for Emergency Relief. Citing Griswold v. Connecticut, 381 U.S. 479, 85 S.Ct. 1678, 14 L.Ed.2d 510 (1965), the DHHR asserted that unlimited access to patient records absent patient consent is a violation of the right to privacy judicially deemed to arise under the First Amendment.
. It is difficult for this Court to avoid the conclusion that, while seeking to prevent access to the patient advocates under the guise of privacy concerns, the DHHR's true objective is to make the discovery of systemic problems more difficult for the advocates to identify.
. Legal'Aid asserts that the new policy implemented by the DHHR- prevents Legal Aid from complying with the time constraints pertaining to the investigation of abusé and neglect complaints under state law.- See 64 C.S.R. § 59--20.2.9 (requiring submission of written report by patient advocate “[wjithin the next eight (8) regular working hours” of receipt-of abuse-or neglect grievance).
. These periodic reviews, required by the 2009 Agreed Order, have been performed by the patient advocates. Additionally,- as noted by the
. During the evidentiary hearing held in this matter on August 1, 2014, the DHHR’s privacy officer, Lindsey McIntosh, - was questioned as to how the patient advocates-were going to do the ■ systemic audits "without access to records or patients or have conversations with staff without individual releases specifying specific grievances." She answered tire query by stating, "I don't know how you're going to conduct audits if you have to do that.”
. Finding it to be baseless, the trial court ordered the DHHR to dismiss its complaint. A .review of the complaint demonstrates that even the DHHR was dubious about the violation given its statement in the complaint that the "level of harm’’ was unclear.
. In contrast, there have been patient-initiated complaints since the DHHR imposed the new, limited access provisions. According to Legal Aid, the patients were frustrated by their inability to gain immediate access to the advocates, who were no longer permitted to freely roam the facilities where patients could easily seek them out when needed.
. As Legal Aid observes, there is no greater risk posed by the patient advocates than by any of the Hospital employees who have access to patient records.
. Disclosure is "the release, transfer, provision of access to, or divulging in any manner of information outside the entity holding the information." 45 C.F.R. § 160.103(2014).
. The trial court ruled that Legal Aid is a “business associate” as set forth in its contract with the DHHR and also due to its receipt of protected health information for quality assurance, patient safety, and other health care operations. As discussed infra, the DHHR'S description of Legal Aid as a "business associate” is neither controlling nor accurate. The review of protected health information as part of the provision of advocacy services at Sharpe and Bateman does not impel the conclusion that Legal Aid is a "business associate.”
. The fact that the institutions may benefit from the provision of these auditing services does not
. The Grant Agreement makes' clear that "'Business Associate shall have the meaning given to such term in 45 CFR § 160.103.", ,
. The DHHR stated that boilerplate business associate addendums were regularly attached to all grant agreements, even when unnecessary, in an effort to comply with HIPAAV"stern mandate to have an agreement in place with any business associate.”
. A-"health oversight agency” is defined as
an agency or authority of the United States, a State, ...’'of a person or entity acting under a grant of authority from or contract with such public, agency, . -.. that is authorized by law to oversee the health care system ... or government programs in which health information is necessary to determine eligibility or compliance, or to enforce civil rights laws for which health information is relevant.
45 C.F.R. § 164.501 (2014).
.Sge Standards for Privacy of Inclividually Identifiable Health Information, 65 Fed. Reg. 82462-01,82492.,
. The trial court looked additionally to the subsection permitting disclosure in the instance of incapacity when awaiting consent would materially and adversely impact an immediate enforcement activity. See 45 C.F.R. § 164.512(c)(l)(iii)(B).
. This annual analysis is required by HIPAA.
. Analyses completed in 2013 and 2014 entitled West Virginia Health Care Privacy Laws and HIPPA Preemption Analysis for the DHHR conclude that our state regulations set forth in 64 C.S.R. § 59 are not preempted by HIPPA as our provisions are more stringent. The 2015 analysis reached the same conclusion.
. See supra note 33.
. See 65 Fed, Reg. 82462-01,82463.
. See supra note 35.
.Consistent with the trial court’s directives, that access is subject to the right of patients to place limitations on the disclosure of their health information.
. Actually, "HIPAA mandated the passage of comprehensive privacy legislation by Congress within three years, otherwise the Department of Health and Human Services was required to step in and create privacy regulations.” Guthrie, "Time Is Running Out," 12 Annals Health L. at 144.
Dissenting Opinion
dissenting;
In this proceeding, Legal Aid sought to force DHHR to continue to allow Legal Aid to have complete access to patient records, without patient consent, at the Bateman and Sharpe psychiatric facilities. Before this Court, DHHR argued that it was violating federal law, specifically HIPAA, when it previously authorized Legal Aid' to have complete access to patient "records without the consent of the patients. The circuit court and majority opinion disagreed with DHHR. The circuit court found that Legal Aid did not need patient consent to have unfettered access to patient records, because Legal Aid came under the following exceptions recognized by HIPAA: business associate, health oversight agency, health care operations, and legal requirement. The majority opinion correctly found that not one of the exceptions relied upon, by the trial court applied to Legal Aid. Rather than stopping there and reversing the circuit court’s order, the majority opinion affirmed the circuit court on a different ground. With absolutely no legal analysis, the majority opinion determined that Legal Aid could have unfettered access to patient information because of the “more stringent” State law exception found under HIPAA
As I will demonstrate below, if the majority opinion had performed but a scintilla of the legal analysis that is required to determine whether a State law is more stringent than HIPAA, it would have reversed the circuit court’s order. Consequently, for the reasons set out below, I dissent.
The Majority Decision Authorizes Legal Aid to Violate Federal Law
Because of the arrogant and complete disregard of federal law by the majority opinion, I must start my dissent with a review of some basic legal principles. To begin, it has been noted that “[t]he preemption doctrine has its origin in the Supremacy Clause of the United States Constitution!;.]” Hartley Marine Corp. v. Mierke, 196 W.Va. 669, 673, 474 S.E.2d 599, 603 (1996). See also Harrison v. Skyline Corp., 224 W.Va. 505, 510, 686 S.E.2d 735, 740 (2009) (“[T]he preemption doctrine has. its roots in the supremacy clause of the United States Constitution and is based on the premise that federal law can supplant inconsistent state law.”). The Supremacy Clause of the federal constitution provides that the laws of the United States “shall be the supreme law of the Land; ...
Congress enacted HIPAA in 1996, in part, to protect the privacy of individually identifiable health information. See Jennifer Guthrie, “Time Is Running Out-The Burdens and Challenges of HIPAA Compliance: A‘ Look at Preemption Analysis, the ‘Minimum Necessary’ Standard, and the Notice of Priváey Practices,” 12 Annals Health L. 143, 146 (2003) (“The main premise of HI-PAA is to protect individually identifiable health- information. This means that certain information will not be revealed without a patient’s express authorization, in an effort to'contain important information tó as few people a's possible.”). For purposes' of 'HI-PAA, 'protected héalth information “is any health information, oral or recorded, that is individually identifiable ánd transmitted or-maintained by a covered entity in any form or medium.” Holman v. Rasak, 486 Mich. 429, 435-36, 785 N.W.2d 98, 102 (2010). The Secretary of Health and Human Services was directed by Congress to promulgate regulations setting privacy standards for health information. See Northwestern Mem’l Hosp. v. Ashcroft, 362 F.3d 923, 924 (7th Cir. 2004) (“Section 264 of HIPAA, 42 U.S.C. § 1320d ..., -directs the Secretary of Health and Human Services to promulgate regulations to protect the privacy of medical records!.]”).
“[T]he intent of HIPAA is to ensure the integrity and confidentiality of patients’ [medical] information and to protect against unauthorized uses or disclosures of the infor-mationf.]” In re Antonia E., 16 Misc.3d 637, 838 N.Y.S.2d 872, 874-75 (2007) (internal quotations and citations omitted). Under HIPAA, the general rule is that a covered entity may not use or disclose protected health information without a written authorization from the' individual. See 45 CFR 164.508. However, as recognized by the majority opinion, HIPAA enumerates several specific situations in which a covered entity may use or disclose protected health information without the written authorization of the individual. See Pal v. New York Univ., No. 06Civ.5892(BSJ)(FM), 2007 WL 1522618, at *3 (S.D.N.Y. May 22, 2007) (“HIPAA permits the disclosure of ‘protected health informar tion’ without a patient’s consent in a variety of circumstances.”). The majority opinion found that only one of HIPAA’s exceptions to the general privacy of health information applied to the facts of this case.
The majority opinion reached the conclusion that our State law was more stringent than HIPAA without performing any legal analysis of this complex issue. The majority opinion, in a rather awkward way, merely pointed out that DHHR had annually “eon-clud[ed] that our state laws' set forth in 64 CSR § 59 are not preempted by HIPAA as our provisions are more stringent.” The majority opinion then went on to provide:'
From the record submitted; in this' case, the protections set forth in Title 64, Series 59 have been determined to be more stringent than those required by federal law. Accordingly, our state regulations set forth in Title 64, Series 59 are not preempted by HIPAA.
This was the sum total of how and why the majority opinion determined that our State law was more stringent than HIPAA. This total lack of analysis makes no sense.' It is illogical to rely on a general finding by DHHR that its regulations are more stringent than HIPAA, when DHHR already had realized its disclosure’s to Legal Aid violated HIPAA, and DHHR tried to correct the violation by asserting that no authority exists for Legal Aid to indiscriminately access patient information. More fundaméntally, the yard stick used by the majority opinion , to determine whether a State law is more stringent than HIPAA is absurd! ■ Under the majority opinion’s mind-boggling yardstick, all that any state must do to get around HIPAA is unilaterally proclaim that its laws are more stringent than HIPAA. Surely Congress did not mean for HIPAA and the Supremacy Clause to be defeated in such a self-serving manner. Indeed, as I will dem-onstete below, this absolutely was not what Congress intended.
“[A] standard is more stringent if it provides greater privacy protection for the individual who is the subject of the individually identifiable health information than the standard set forth in the rules and regulations.” Bayne v. Provost, 359 F.Supp.2d 234, 237-38 (N.D.N.Y. 2005) (internal quotations and citations omitted). See also Wade v. Vabnick-Wener, 922 F.Supp.2d 679, 686 (“To meet the ‘more stringent’ .requirement, a state law must ‘provide greater protection for the individual who is the subject of the individually identifiable health information’ than the standard set forth by HIPAA and its regulations.”). More importantly, it has been recognized that, under federal law, “‘[m]ore stringent,’ as defined in 45 C.F.R. § 160.202, means, that the state law meets any one of six criteria.” Law v. Zuckerman, 307 F.Supp.2d 705, 709 (D.Md. 2004). See also Webb v. Smart Document Sols., LLC, 499 F.3d 1078, 1087 (9th Cir. 2007) (“‘More stringent’ laws are defined.”). The six criteria under HIPAA that define “more stringent,” have been summarized by the Fourth Circuit as follows:
■ [1] the state law prohibits or restricts a use or a disclosure of information where. HI-PAA would. allow it; [2] the state law provides an individual with greater-rights of access .or amendment to his medical information than provided under HIPAA; [3] the state law provides an individual vvith a greater amount of information about a use, a disclosure,, rights and remedies; [4] [state law -provides requirements that narrow the scope or duration, increase the privacy protections afforded, or reduce the coercive effect of .the circumstances surrounding the express legal permission of an individual to disclose information]; [5] the state law provides for the retention or reporting of more detailed information or for a longer duration; or [6] the state law provides greater privacy protection for the individual who is the subject of the individually identifiable health information.
South Carolina Med. Ass’n v. Thompson, 327 F.3d 346, 355 (4th Cir. 2003). Accord In re Antonia E., 838 N.Y.S.2d 872, 876 (2007).
Simply put, in order for a court to determine that a State law is more stringent than HIPAA, it must find that the'State law satisfies one of the six definitions of “more stringent” contained under 45 C.F.R. § 160.202.
' My research revealed that other courts called upon to decide whether a State law was more stringent than HIPAA have complied with federal law and applied the six criteria under 45 C.F.R. § 160.202. For example, a case which examined all six criteria under 45 C.F.R. § 160.202 is State v. La Cava, No. CR060128258S, 2007 WL 1599888 (Conn.Super.Ct. May 17, 2007). In La Cava, the court was asked to decide whether a Connecticut statute, whieh authorized disclosure of patient information in a judicial proceeding and in certain other circumstances, was more stringent than HIPAA. The Connecticut statute allowed:
(1) any patient who has been treated in a private hospital, public hospital society or corporation receiving state aid to, upon the demand, examine and/or copy her hospital record, including the history, bedside notes, charts, pictures and plates kept in connection with her treatment and authorize her physician or attorney to do the same; (2) a hospital, society or corporation that is served with a subpoena issued by competent authority directing the production of a hospital record to deliver such record or a copy thereof to the clerk of such court where it will’ remain sealed except upon the order of a judge of the court concerned; (S) any and all parts of the hospital record or copy that is not otherwise inadmissible to be admitted in evidence without the necessity of having a witness from the hospital identity the ‘records as ones kept in the usual course of business by the- hospital:
La Cava, 2007 WL 1599888, at *3. The decision in La Cava summarily applied the six criteria under 45 C.F.R; § 160.202 and determined that the Connecticut statute was not more stringent than HIPAA:
In comparison to - [HIPAA’s require.ments for disclosures for judicial and ad.ministrative proceedings], [the state statute] does not: (1) prohibit or restrict a use or disclosure in circumstances under which such use or disclosure otherwise would be permitted under the federal rule; (2) permit greater rights of access or amendment to the individual who is the subject of the -individually identifiable health information; (3) provide -a greater amount of information to the individual who is the subject of ■the individually identifiable health information about a use, a disclosure, rights, and remedies; (4) provide requirements that narrow the scope or duration, increase the privacy protections afforded, or reduce the coercive effect of the circumstances surrounding the need for express legal permission from the individual who is the subject of the individually identifiable health information with respect. to the form, substance, or the need for express legal permission; (5) provide for the retention or reporting of more detailed information or for a longer duration with respect to recordkeeping or requirements relating to accounting of disclosures; and (6) provide greater privacy protection for the individual who is the subject of the individually identifiable health information with respect to any other matter. Accordingly, the state statute is not more stringent than the federal regulation.
Because [the state statute] is a contrary state law that is not, more stringent than the Privacy Rule, it is preempted in accordance with 45 C.F.R. § 160.203 (2007).
La Cava, 2007 WL. 1599888, at *3.
In U.S. ex rel. Stewart v. Louisiana Clinic, No. CivA. 99-1767, 2002 WL 31819130 (E.D.La. Dec. 12, 2002), the defendants attempted to prevent disclosure, of patient information in a judibial proceeding by invoking the protections of a Louisiana statute. The ■ disclosure was allowed under HIPAA, but was not, allowed under Louisiana law. The--opinion in Stewart framed the issue as follows: . .
Defendants argue that HIPAA does not preempt Louisiana law concerning disclosure of nonparty patient records without patient consent_
Defendants focus solely on the “more stringent’,’ -element of this -regulatory test and- on paragraph (4) of the .definition of*297 “more stringent.” “More stringent” means a State law that meets one or more of the following criteria: ,■
(4) With respect to the form, substance, or the need for express legal permission from an individual, who is the subject of the individually identifiable health information, for use or disclosure of individually identifiable health information, provides requirements that narrow the scope or duration, increase the privacy protections afforded (such as by expanding the criteria for), or reduce the coercive effect of the circumstances surrounding the express legal permission, as applicable.
Defendants argue that the Louisiana health care provider/patient privilege law is more stringent than the- federal regulations.- They contend that-the Louisiana statute increases the privacy protections afforded to individual patients by-requiring either patient consent for the disclosure or, in the absence of consent, that a “court shall, issue an order for the production and disclosure of a patient’s records ... only: after a contradictory hearing with the patient ... and after a finding by the court that the release of the l’equested information is proper.”
Stewart, 2002 WL 31819130, at *4-5. The court in Stewart found that, based upon the defendants’ reliance solely on- the fourth criterion of 45 C.F.R. § 160.202, Louisiana law was not more stringent than HIPAA:
Defendants’ argument fails because this provision of Louisiana law does not address “the form, substance, or the need for express legal permission from an- individual,” as required by 45 O.F.R. § 160.202 for the exception to apply. Rather, the Louisiana statute provides-a way of negating the need for such permission. In other words, although the individual patient, may attend the contradictory hearing, the Louisiana provision states that the court shall issue an order for disclosure (despite the patient’s'lack of consent), if the court finds that release of the information is proper. Because the Louisiana statute does not fit within the exception from preemption cited by defendants, it is preempted by the HI-PAA regulations. Therefore, Louisiana law does not apply in this pure federal question case.
Stewart, 2002 WL 31819130, at *5.
A case which illustrates a' State statute that was actually found to be more stringent than HIPAA is Wade v. Vabnick-Wener, 922 F.Supp.2d 679. In Wade, the court was called upon to decide whether Tennessee’s privacy law, oii ex parte communication with' a plaintiffs treating physician was more stringent than HIPPA The opinion relied upon • the sixth' criterion of 45 C.F.R. § 160.202.- That is, “a state law must ‘provide greater protection for the individual who is the subject of the individually identifiable health information’ than the standard set forth by HIPAA and its regulations.” Wade, 922 F.Supp.2d at 686. The opinion determined that, based .upon the sixth criterion, Tennessee’s law was more stringent than HIPAA: < . .
It is therefore clear that Tennessee law is more stringent than HIPAA’s privacy rules concerning ex parte communications with health care providers. Absent a plaintiffs express consent, Tennessee law prohibits informal communications with the plaintiffs treating physician to obtain health information. On the contrary, HI-PAA only bars such communications prior to the entry of a qualified protective order. After the requisite protective order is entered, whether by ‘ consent or over the plaintiffs objection, defendant is free to utilize informal discovery, including specifi.cally ex parte interviews, under HIPAA.
Accordingly, because the laws of Tennessee are more stringent than HIPAA concerning defense counsels ability to make use of informal discovery methods, HIPAA does not preempt Tennessee’s ban ori ex parte communications with a plaintiffs non-party treating physician.
Wade, 922 F.Supp.2d at 691-92. See Nat’l Abortion Fed’n v. Ashcroft, No. 04 C 55, 2004 WL 292079, at *4 (N.D.Ill. Feb. 6, 2004) (“Because -we find that Illinois law is more stringent than HIPAA’s disclosure requirements and that it would be impossible for Northwestern to comply with both Judge Casey’s HIPAA-pursuant Order and various provisions of Illinois law, Illinois’s nonparty
The above cases clearly demonstrate that a court cannot determine that a State statute is more stringent' than HIPAA by relying solely on a state agency’s statement that a particular state law is more stringent than HIPAA If that was true, as the majority opinion concludes, then there would have been no reason to define “more stringent” under 46 C.P.R. § 160.202. The term “more stringent” is defined for a purpose. That purpose, to me, is quite clear. The definition is designed to harrow the circumstances in which a state law may be categorized as more stringent than HIPAA. “[W]e are not free to rewrite HIPAA’s mandates; we are required to follow them.” Holman v. Rasak, 486 Mich. 429, 458, 785 N.W.2d 98, 114 (2010) (Hathaway, J., dissenting). The majority opinion in this case has made a mockery of the unambiguous and mandatory language contained in 45 C.P.R. § 160.202.
I can surmise only that the majority opinion ignored the law as dictated under 45 C.P.R. § 160.202 because it wanted to reach a result that simply could not be reached by following the law. A cursory review of what the relevant state law allowed in this case clearly shows that it was not more stringent than HIPAA.
What should be clearly understood is that, for purposes of the “more stringent” requirement of HIPAA, “any state law providing greater privacy protection for the individual who is the. subject of the individually identifiable health information is a more stringent state law.” Natalie P. Weiss, “To Release or Not to Release: An Analysis of the HIPAA Subpoena Exception,” 15 Mich. St. U.J. Med. & L. 253, 260 (2011) (emphasis added). This point needs, to be emphatically understood— the “more, stringent” requirement under HI-PAA. can never, be. satisfied by a State law that provides lesser privacy protection.. In this case, the majority opinion has indicated that the applicable state law is. found in 64 C.S.R. § 59-11,5.1.d, which provides:
No written consent is necessary for employees of the department, comprehensive behavioral centers serving the client or advocates under contract with the department.
In sum, this state regulation allows Legal Ad, as an “advocate,” to have complete access to patient information without the consent of the patient. On its face, it is clear that this law does not provide greater privacy protection. Instead, it exposes all patient information to a private legal entity in the absence- of patient consent for either representation by the agency or the disclosure of their medical records to the agency.
It” has correctly been observed that “[i]f state law can force disclosure without a court order, or the patient’s consent, it is not ‘more stringent’ than the HIPAA regulations.” Law v. Zuckerman, 307 F.Supp.2d 705, 711 (D.Md. 2004). Through a summary application of HIPAA’s she criteria, it -is clear that the state regulation at issue in this matter does not: (1) prohibit or restrict a use or a disclosure of information where HIPAA would allow it; (2) provide an individual with greater rights of access or amendment to his medical information than provided under HI-PAA; (3) provide an individual with a greater amount of information about a use, a disclosure, rights and remedies; (4) provide requirements that narrow the scope or duration, increase the privacy protections afforded, or reduce the coercive effect of the circumstances surrounding the express legal
Finally, I wish to point out that the majority opinion conceivably has opened the floodgates for civil litigation, because of the unlawful access it has given Legal Aid to patient hospital information. This Court recently held that “[c]ommon-law tort claims based upon the wrongful disclosure of medical or personal health information are not preempted by the Health Insurance Portability and Accountability Act of 1996.” Syl. pt. 3, R.K. v. St. Mary’s Med. Ctr., Inc., 229 W.Va. 712, 735 S.E.2d 715 (2012). If the majority opinion is not appealed to the United States Supreme Court, I have no doubt that civil law suits will follow in the wake of the misguided majority opinion.
For the reasons so stated, I dissent.
. It is important that I point out the significance of the year in whi.ch HIPAA was created, 1996,
. For ease in understanding, I will refer to HI-PAA and the Privacy Rule collectively as HIPAA.
. The regulations define State law as "a constitution, statute, regulation, rule, common law, or other State action having the force and effect of law.” 45 C.F.R. § 160.202, See Crenshaw v. MONY Life Ins. Co., 318 F.Supp.2d 1015, 1028 (S.D.Cal. 2004).
. I previously noted that the majority opinion correctly found that the exceptions for business associate, health, oversight agency, health care operations, and required by law did not apply.
Reference
- Full Case Name
- WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES, Bureau for Behavioral Health and Health Facilities, Petitioners v. E.H., Et Al., Respondents
- Cited By
- 2 cases
- Status
- Published