HIPAA Regulations: Preemption of State Law - General Rule and Exceptions - § 160.203
As Contained in the HHS HIPAA Rules
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HHS Regulations as Amended August 2002 |
A standard, requirement, or implementation specification adopted under this subchapter that is contrary to a provision of State law preempts the provision of State law. This general rule applies, except if one or more of the following conditions is met:
(a) A determination is made by the Secretary under §160.204 that the provision of State law:
(1) Is necessary:
(i) To prevent fraud and abuse related to the provision of or payment for health care;
(ii) To ensure appropriate State regulation of insurance and health plans to the extent expressly authorized by statute or regulation;
(iii) For State reporting on health care delivery or costs; or
(iv) For purposes of serving a compelling need related to public health, safety, or welfare, and, if a standard, requirement, or implementation specification under part 164 of this subchapter is at issue, if the Secretary determines that the intrusion into privacy is warranted when balanced against the need to be served; or
(2) Has as its principal purpose the regulation of the manufacture, registration, distribution, dispensing, or other control of any controlled substances (as defined in 21 U.S.C. 802), or that is deemed a controlled substance by State law.
(b) The provision of State law relates to the privacy of individually identifiable health information and is more stringent than a standard, requirement, or implementation specification adopted under subpart E of part 164 of this subchapter.
(c) The provision of State law, including State procedures established under such law, as applicable, provides for the reporting of disease or injury, child abuse, birth, or death, or for the conduct of public health surveillance, investigation, or intervention.
(d) The provision of State law requires a health plan to report, or to provide access to, information for the purpose of management audits, financial audits, program monitoring and evaluation, or the licensure or certification of facilities or individuals.
| HHS Response to Comments Received Preemption of State Law - General Rule and Exception |
Most of the comments received on proposed Subpart B lumped together the proposed process for exception determinations under section 1178(a)(2)(A) with the proposed process for issuing advisory opinions under section 1178(a)(2)(B), either because the substance of the comment applied to both processes or because the commenters did not draw a distinction between the two processes. We address these general comments in this section.
Comment: Numerous commenters, particularly providers and provider groups, recommended that exception determinations and advisory opinions not be limited to states and advocated allowing all covered entities (including individuals, providers and insurers), or private sector organizations, to request determinations and opinions with respect to preemption of state laws. Several commenters argued that limiting requests to states would deny third party stakeholders, such as life and disability income insurers, any means of resolving complex questions as to what rule they are subject to. One commenter noted that because it is an insurer who will be liable if it incorrectly analyzes the interplay between laws and reaches an incorrect conclusion, there would be little incentive for the states to request clarification. It would also cause large administrative burdens which, it was stated, would be costly and confusing. It was also suggested that the request for the exception be made to the applicable state's attorney general or chief legal officer, as well as the Secretary. Various changes to the language were suggested, such as adding that “a covered entity, or any other entity impacted by this rule” be allowed to submit the written request.
Response: We agree, and have changed Sec. 164.204(a) below accordingly.
The decision to eliminate advisory opinions makes this issue moot with respect to those opinions.
Comment: Several commenters noted that it was unclear under the proposed rule which state officials would be authorized to request a determination.
Response: We agree that the proposed rule was unclear in this respect. The final rule clarifies who may make the request for a state, with respect to exception determinations. See, Sec. 160.204(a). The language adopted should ensure that the Secretary receives an authoritative statement from the state. At the same time, this language provides states with flexibility, in that the governor or other chief elected official may choose to designate other state officials to make such requests.
Comment: Many commenters recommended that a process be established whereby HHS performs an initial state-by-state critical analysis to provide guidance on which state laws will not be preempted; most suggested that such an analysis (alternatively referred to as a database or clearinghouse) should be completed before providers would be required to come into compliance. Many of these comments argued that the Secretary should bear the cost for the analyses of state law, disagreeing with the premise stated in the preamble to the proposed rules that it is more efficient for the private market to complete the state-by-state review. Several comments also requested that HHS continue to maintain and monitor the exception determination process, and update the database over time in order to provide guidance and certainty on the interaction of the federal rules with newly enacted or amended state laws that are produced after the final rule. Some comments recommended that each state be required to certify agreement with the HHS analyses.
In contrast, one hospital association noted concerns that the Secretary would conduct a nationwide analysis of state laws. The comment stated that implementation would be difficult since much of the law is a product of common law, and such state-specific research should only be attempted by experienced health care attorneys in each jurisdiction.
Response: These comments seem to be principally concerned with potential conflicts between state privacy laws and the privacy standards, because, as is more fully explained below, preemption of contrary state laws not relating to privacy is automatic unless the Secretary affirmatively acts under section 1178(a)(2)(A) to grant an exception. We recognize that the provisions of sections 1178(b) (state public health laws), and 1178(c) (state regulation of health plans) similarly preserve state laws in those areas, but very little of the public comment appeared to be concerned with these latter statutory provisions. Accordingly, we respond below to what we see as the commenters' main concern.
The Department will not do the kind of global analysis requested by many of these comments. What these comments are in effect seeking is a global advisory opinion as to when the federal privacy standards will control and when they will not. We understand the desire for certainty underlying these comments. Nonetheless, the reasons set out above as the basis for our decision not to establish a formal advisory opinion process apply equally to these requests. We also do not agree that the task of evaluating the requirements below in light of existing state law is unduly burdensome or unreasonable. Rather, it is common for new federal requirements to necessitate an examination by the regulated entities of the interaction between existing state law and the federal requirements incident to coming into compliance.
We agree, however, that the case is different where the Secretary has affirmatively acted, either through granting an exception under section 1178(a)(2)(A) or by making a specific determination about the effect of a particular state privacy law in, for example, the course of determining an entity's compliance with the privacy standards. As is discussed below, the Department intends to make notice of exception determinations that it makes routinely available.
We do not agree with the comments suggesting that compliance by covered entities be delayed pending completion of an analysis by the Secretary and that states be required to certify agreement with the Secretary's analysis, as we are not institutionalizing the advisory opinion/analysis process upon which these comments are predicated. Furthermore, with respect to the suggestion regarding delaying the compliance date, Congress provided in section 1175(b) of the Act for a delay in when compliance is required to accommodate the needs of covered entities to address implementation issues such as those raised by these comments. With respect to the suggestion regarding requiring states to certify their agreement with the Secretary's analysis, we have no authority to do this.
Comment: Several commenters criticized the proposed provision for annual publication of determinations and advisory opinions in the Federal Register as inadequate. They suggested that more frequent notices should be made and the regulation be changed accordingly, to provide for publication either quarterly or within a few days of a determination. A few commenters suggested that any determinations made, or opinions issued, by the Secretary be published on the Department's website within 10 days or a few days of the determination or opinion.
Response: We agree that the proposed provision for annual publication was inadequate and have accordingly deleted it. Subpart B contains no express requirement for publication, as the Department is free to publish its determinations absent such a requirement. It is our intention to publish notice of exception determinations on a periodic basis in the Federal Register. We will also consider other avenues of making such decisions publicly available as we move into the implementation process.
Comment: A few commenters argued that the process for obtaining an exception determination or an advisory opinion from the Secretary will result in a period of time in which there is confusion as to whether state or federal law applies. The proposed regulations say that the federal provisions will remain effective until the Secretary makes a determination concerning the preemption issue. This means that, for example, a state law that was enacted and enforced for many years will be preempted by federal law for the period of time during which it takes the Secretary to make a determination. Then if the Secretary determines that the state law is not preempted, the state law will again become effective. Such situations will result in confusion and unintended violations of the law. One of the commenters suggested that requests for exceptions be required only when a challenge is brought against a particular state law, and that a presumption of validity should lie with state laws. Another commenter, however, urged that “instead of the presumption of preemption, the state laws in question would be presumed to be subject to the exception unless or until the Secretary makes a determination to the contrary.”
Response: It is true that the effect of section 1178(a)(2)(A) is that the federal standards will preempt contrary state law and that such preemption will not be removed unless and until the Secretary acts to grant an exception under that section (assuming, of course, that another provision of section 1178 does not apply). We do not agree, however, that confusion should result, where the issue is whether a given state law has been preempted under section 1178(a)(2)(A). Because preemption is automatic with respect to state laws that do not come within the other provisions of section 1178 (i.e., sections 1178(a)(2)(B), 1178(b), and 1178(c)), such state laws are preempted until the Secretary affirmatively acts to preserve them from preemption by granting an exception under section 1178(a)(2)(A).
We cannot accept the suggestion that a presumption of validity attach to state laws, and that states not be required to request exceptions except in very narrow circumstances. The statutory scheme is the opposite: The statute effects preemption in the section 1178(a)(2)(A) context unless the Secretary affirmatively acts to except the contrary state law in question.
With respect to preemption under sections 1178(b) and 1178(c) (the carve-outs for state public health laws and state regulation of health plans), we do not agree that preemption is likely to be a major cause of uncertainty. We have deferred to Congressional intent by crafting the permissible releases for public health, abuse, and oversight broadly. See, Secs. 164.512(b)--(d) below. Since there must first be a conflict between a state law and a federal requirement in order for an issue of preemption to even arise, we think that, as a practical matter, few preemption questions should arise with respect to sections 1178(b) and 1178(c).
With respect to preemption of state privacy laws under section 1178(a)(2)(B), however, we agree that the situation may be more difficult to ascertain, because the Secretary does not determine the preemption status of a state law under that section, unlike the situation with respect to section 1178(a)(2)(A). We have tried to define the term “more stringent” to identify and particularize the factors to be considered by courts to those relevant to privacy interests. The more specific (than the statute) definition of this term at Sec. 160.202 below should provide some guidance in making the determination as to which law prevails. Ambiguity in the state of the law might also be a factor to be taken into account in determining whether a penalty should be applied.
Comment: Several comments recommended that exception determinations or advisory opinions encompass a state act or code in its entirety (in lieu of a provision-specific evaluation) if it is considered more stringent as a whole than the regulation. It was argued that since the provisions of a given law are typically interconnected and related, adopting or overriding them on a provision-by-provision basis would result in distortions and/or unintended consequences or loopholes. For example, when a state law includes authorization provisions, some of which are consistent with the federal requirements and some which are not, the cleanest approach is to view the state law as inconsistent with the federal requirements and thus preempted in its entirety. Similarly, another comment suggested that state confidentiality laws written to address the specific needs of individuals served within a discreet system of care be considered as a whole in assessing whether they are as stringent or more stringent than the federal requirements. Another comment requested explicit clarification that state laws with a broader scope than the regulation will be viewed as more stringent and be allowed to stand.
Response: We have not adopted the approach suggested by these comments. As discussed above with respect to the definition of the term “more stringent,” it is our view that the statute precludes the approach suggested. We also suggest that this approach ignores the fact that each separate provision of law usually represents a nuanced policy choice to, for example, permit this use or prohibit that disclosure; the aggregated approach proposed would fail to recognize and weigh such policy choices.
Comment: One comment recommended that the final rule: permit requests for exception determinations and advisory opinions as of the date of publication of the final rule, require the Secretary to notify the requestor within a specified short period of time of all additional information needed, and prohibit enforcement action until the Secretary issues a response.
Response: With respect to the first recommendation, we clarify that requests for exception determinations may be made at any time; since the process for issuing advisory opinions has not been adopted, this recommendation is moot as it pertains to advisory opinions. With respect to the second recommendation, we will undertake to process exception requests as expeditiously as possible, but, for the reasons discussed below in connection with the comments relating to setting deadlines for those determinations, we cannot commit at this time to a “specified short period of time” within which the Secretary may request additional information. We see no reason to agree to the third recommendation. Because contrary state laws for which an exception is available only under section 1178(a)(2)(A) will be preempted by operation of law unless and until the Secretary acts to grant an exception, there will be an ascertainable compliance standard for compliance purposes, and enforcement action would be appropriate where such compliance did not occur.
Section 160.203(a)--Criteria for Exception Determinations
Comment: Numerous comments criticized the proposed criteria for their substance or lack thereof. A number of commenters argued that the effectiveness language that was added to the third statutory criterion made the exception so massive that it would swallow the rule. These comments generally expressed concern that laws that were less protective of privacy would be granted exceptions under this language. Other commenters criticized the criteria generally as creating a large loophole that would let state laws that do not protect privacy trump the federal privacy standards.
Response: We agree with these comments. The scope of the statutory criteria is ambiguous, but they could be read so broadly as to largely swallow the federal protections. We do not think that this was Congress's intent. Accordingly, we have added language to most of the statutory criteria clarifying their scope. With respect to the criteria at 1178(a)(2)(A)(i), this clarifying language generally ties the criteria more specifically to the concern with protecting and making more efficient the health care delivery and payment system that underlies the Administrative Simplification provisions of HIPAA, but, with respect to the catch-all provision at section 1178(a)(2)(A)(i)(IV), also requires that privacy interests be balanced with such concerns, to the extent relevant. We require that exceptions for rules to ensure appropriate state regulation of insurance and health plans be stated in a statute or regulation, so that such exceptions will be clearly tied to statements of priorities made by publicly accountable bodies (e.g., through the public comment process for regulations, and by elected officials through statutes). With respect to the criterion at section 1178(a)(2)(A)(ii), we have further delineated what “addresses controlled substances” means. The language provided, which builds on concepts at 21 U.S.C. 821 and the Medicare regulations at 42 CFR 1001.2, delineates the area within which the government traditionally regulates controlled substances, both civilly and criminally; it is our view that HIPAA was not intended to displace such regulation.
Comment: Several commenters urged that the request for determination by the Secretary under proposed Sec. 160.204(a) be limited to cases where an exception is absolutely necessary, and that in making such a determination, the Secretary should be required to make a determination that the benefits of granting an exception outweigh the potential harm and risk of disclosure in violation of the regulation.
Response: We have not further defined the statutory term “necessary”, as requested. We believe that the determination of what is “necessary” will be fact-specific and context dependent, and should not be further circumscribed absent such specifics. The state will need to make its case that the state law in question is sufficiently “necessary” to accomplish the particular statutory ground for exception that it should trump the contrary federal standard, requirement, or implementation specification.
Comment: One commenter noted that a state should be required to explain whether it has taken any action to correct any less stringent state law for which an exception has been requested. This commenter recommended that a section be added to proposed Sec. 160.204(a) stating that “a state must specify what, if any, action has been taken to amend the state law to comply with the federal regulations.” Another comment, received in the Transactions rulemaking, took the position that exception determinations should be granted only if the state standards in question exceeded the national standards.
Response: The first and last comments appear to confuse the “more Stringent” criterion that applies under section 1178(a)(2)(B) of the Act with the criteria that apply to exceptions under section 1178(a)(2)(A). We are also not adopting the language suggested by the first comment, because we do not agree that states should necessarily have to try to amend their state laws as a precondition to requesting exceptions under section 1178(a)(2)(A). Rather, the question should be whether the state has made a convincing case that the state law in question is sufficiently necessary for one of the statutory purposes that it should trump the contrary federal policy.
Comment: One commenter stated that exceptions for state laws that are contrary to the federal standards should not be preempted where the state and federal standards are found to be equal.
Response: This suggestion has not been adopted, as it is not consistent with the statute. With respect to the administrative simplification standards in general, it is clear that the intent of Congress was to preempt contrary state laws except in the limited areas specified as exceptions or carve-outs. See, section 1178. This statutory approach is consistent with the underlying goal of simplifying health care transactions through the adoption of uniform national standards. Even with respect to state laws relating to the privacy of medical information, the statute shields such state laws from preemption by the federal standards only if they are “more” stringent than the related federal standard or implementation specification.
Comment: One commenter noted that determinations would apply only to transactions that are wholly intrastate. Thus, any element of a health care transaction that would implicate more than one state's law would automatically preclude the Secretary's evaluation as to whether the laws were more or less stringent than the federal requirement. Other commenters expressed confusion about this proposed requirement, noting that providers and plans operate now in a multi-state environment.
Response: We agree with the commenters and have dropped the proposed requirement. As noted by the commenters, health care entities now typically operate in a multi-state environment, so already make the choice of law judgments that are necessary in multi-state transactions. It is the result of that calculus that will have to be weighed against the federal standards, requirements, and implementation specifications in the preemption analysis.
Comment: One comment received in the Transactions rulemaking suggested that the Department should allow exceptions to the standard transactions to accommodate abbreviated transactions between state agencies, such as claims between a public health department and the state Medicaid agency. Another comment requested an exception for Home and Community Based Waiver Services from the transactions standards.
Response: The concerns raised by these comments would seem to be more properly addressed through the process established for maintaining and modifying the transactions standards. If the concerns underlying these comments cannot be addressed in this manner, however, there is nothing in the rules below to preclude states from requesting exceptions in such cases. They will then have to make the case that one or more grounds for exception applies.