October 1, 2001
The Honorable Tommy G. Thompson
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Secretary Thompson:
As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the National Committee on Vital and Health Statistics (NCVHS) monitors the implementation of the Final Rules that adopt the health data standards required by the Administrative Simplification provisions of HIPAA.
On August 21-23, 2001, the NCVHS Subcommittee on Privacy and Confidentiality held public hearings on the implementation of the final rule for the “Standards for Privacy of Individually Identifiable Health Information” that was published on December 28, 2000. More than 30 people, including health care providers, payers, researchers, members of professional organizations, other users of health care information, and members of the public testified on four key issues identified by the Department of Health and Human Services Office for Civil Rights (OCR) and the NCVHS: (1) the requirement for consent in order to use protected health information for treatment, payment, and health care operations; (2) the requirement that covered entities make reasonable efforts to limit the use and disclosure of protected health information to the minimum necessary; (3) the regulation on research; and (4) the marketing provisions. Oral testimony was provided by both invited witnesses and the public; additional written comments also were submitted.
This letter addresses the first two issues, the consent requirements and the minimum necessary provisions. NCVHS will address the research and marketing issues in a future letter. The OCR attended the hearings and received copies of all the written comments, including comments that addressed issues that were beyond the scope of the hearings. Therefore, the OCR will have the opportunity to address additional issues and concerns not covered in this letter.
The focus of the hearings was to explore practical issues in implementing the final rule, including unintended consequences of the rule, possible inconsistencies, and areas needing further clarification. Panelists were asked to provide specific suggestions for possible modifications of the rule. Testimony in each of the four areas represented a broad range of opinions. Many panelists expressed their appreciation for the clarification provided in the Department of Health and Human Services (HHS)/OCR guidance.
Several speakers expressed concern about the difficulty of coming into compliance when parts of the rule may be amended. A few witnesses suggested that the compliance date should be delayed until two years from the date of the final revised rule. There was also testimony that the compliance date should be postponed until all the HIPAA standards are published. These specific issues, however, were not part of the Subcommittee’s request for testimony, and therefore, contrary testimony was not solicited. Consequently, NCVHS will not address them in this letter.
NCVHS will continue to seek public comments on the implementation of the HIPAA administrative simplification provisions. In light of the widely voiced concern about the lead time needed for implementation, NCVHS respectfully recommends that modifications to the privacy rule be made as expeditiously as possible.
Testimony on the consent requirement represented a wide range of perspectives from those urging HHS to delete the mandatory consent requirement and make consent optional for all covered entities to those requesting more stringent provisions. Many panelists expressed concern about the administrative burden involved in obtaining consent and then storing, tracking, and updating it to reflect restrictions or revocations. Several panelists asserted that the rule already has sufficient privacy protections without the additional requirement of consent. There was testimony that the consent provision does not provide patients a truly informed and voluntary choice, and that the requirement will provide an unintended but significant barrier to the effective delivery of health care services.
Others testified that the consent requirement is essential and an integral part of patients’ privacy rights. There was testimony that the requirement is not stringent enough because it does not protect disclosure to third parties, and it permits providers to refuse treatment if patients do not consent. There was also testimony that the rule coerces individuals into sharing their personal health information and limits individuals’ autonomy and their ability to control access to intimate details about their personal lives. Some panelists expressed concern that individuals will stop seeking treatment for fear of breach of confidentiality by covered entities.
The Committee makes the following recommendations related to the implementation of the privacy rule:
1. Emergency Access
Providers expressed concern about an unintended and potentially harmful consequence of the rule. Under the rule, if a provider learns that a medication is the subject of a Food and Drug Administration recall or a life threatening drug interaction, the provider would be unable to access the records of those patients who had not yet consented or who had revoked consent in order to identify the patients and warn them of the situation. Concern was also expressed about emergency situations. For example, if an unconscious patient arrives in an emergency room and has not yet consented or has revoked consent, a provider would have to treat the patient without access to the medical record.
The Committee believes that there are circumstances such as those above where records should be accessed without prior consent. NCVHS recommends that the OCR explore the specific circumstances where records can be accessed without the prior consent of the individual, and modify the rule as necessary.
2. Continuing Use of Information Obtained Before HIPAA
Several witnesses requested that the rule be modified to permit the continued use of data collected before the April 14, 2003 compliance date, and require consent only for data collected after that date.
The Committee believes that the transition provisions in the rule (§164.532) are adequate. NCVHS does not support a proposal that consent be required only for data collected after the compliance date.
3. Initial Contacts and First Encounters
Much concern was expressed regarding the need to use and disclose information without written consent prior to the first contact between a patient and a provider in order to facilitate the timely delivery of patient care.
While the guidance clarified several areas of concern to pharmacists, testimony indicated that some problem areas remain. It was recommended that in addition to phoned-in prescriptions (already the subject of a proposed change), the prior consent requirement should not apply to prescriptions brought to a pharmacy by any method other than face-to-face contact, such as prescriptions brought to a pharmacy by a neighbor, friend, relative, etc. of the patient, or prescriptions transmitted to the pharmacy by facsimile or electronic means. It was also requested that the modification allow pharmacists to fill or refill prescriptions not received by face-to-face contact after the compliance date if no consent is on file. Pharmacists also expressed concern about their inability to disclose potential adverse drug reactions to other providers, and their ability to meet state compliance requirements.
Written testimony also recommended a modification of the consent provision for direct treatment providers to whom a patient is referred for the first time that would be consistent with the Medicaid rule allowing a representative to sign for a patient who is physically or mentally unable to sign a consent form.
We understand that the modifications to the rule will allow direct treatment providers receiving a first time referral to schedule appointments, surgery, or other procedures before obtaining the patient’s signed consent.
The NCVHS recommends that the above modifications be expanded to cover all first contacts when not face-to-face (e.g. phone advice, scheduling without referral, new patients).
Testifiers recommended that continued use of existing data be allowed until a patient makes a physical appearance and is able to sign a consent form.
The Committee supports the recommendation that the continued use of existing data be allowed until a patient makes a physical appearance and is able to sign a consent form. NCVHS recognizes and supports the HHS/OCR’s effort to provide additional clarification or modification regarding first encounters, and urges a continuation of these efforts.
4. Revocation of Consent
Testimony reflected several specific concerns about the revocation provisions. Particular concern was expressed about information from the individual patient record that has “migrated” into other systems, such as registries for various diseases and procedures. Data are often integrated into systems, and it is difficult to redact information after a revocation of consent. In addition, data are used in registries and other secondary databases for quality control and improvement purposes, and there was concern that revocations would dilute the usefulness of these registries and secondary databases for quality purposes.
A number of organized health care entities function as both providers and health plans. HIPAA provisions permit a patient to revoke consent for treatment. If the patient revokes consent from a provider, the health plan may want to disenroll the member. However, other HIPAA portability provisions, Medicare rules, and Federal Employee Health Benefits Plan rules generally preclude disenrollment of members from a health plan except for nonpayment or fraud. In addition, state laws may prevent disenrollment.
NCVHS recommends that HHS/OCR reconsider and clarify the circumstances surrounding revocation, in particular, the circumstances noted above.
5. Consent by Minors
Another area of concern involves minors’ right to revoke parental consent at majority. Some providers continue to rely on past consent; others seek consent from the young adult when the adult comes in for care.
NCVHS recommends clarification regarding at what point a covered entity must obtain consent from a person who has reached the age of majority.
6. Disclosure for Accreditation/ Health Care Quality Purposes
Several panelists expressed concern that the final rule may have the unintended result of preventing the sharing of health information that fundamentally advances health plans’ role in facilitating quality health care for consumers. Under the final rule, consent for health care operations covers the provider’s health care operations; it does not include the operations of the health plan. Frequently, the information provided on claims is not sufficient for quality assessment and related purposes; further, capitated providers may not provide plans with encounter information for payment on a routine basis.
National Committee for Quality Assurance (NCQA) and Joint Commission on Accreditation of Healthcare Organizations accreditation rules require that these bodies have access to a random sample of charts to determine whether quality standards are being adhered to. This type of review would not be representative if it could not include data for members who had not yet consented or who had revoked consent. Health plans participating in the Medicare + Choice program are required to report Quality Improvement System for Managed Care performance measures to the Centers for Medicare and Medicaid Services. Many state statutes require health plans to report performance measures such as Health Plan Employer Data and Information Set (HEDIS) for all health plan members.
Access to protected health information held by providers for all the above accreditation, quality assurance, and performance measure activities related to health plan operations would be severely constrained if additional authorizations would have to be secured each time from the patient. Concern was also expressed that health plans would be unable to report accurate, statistically valid data if members revoke consent and disallow use and disclosure of that part of their record.
NCVHS recommends that the rule be amended to allow providers to disclose to health plans, without individual written authorization, information needed for accreditation and health care quality purposes. NCVHS recommends that provider groups also should have access to the same data for quality improvement, provider monitoring and credentialing, and health care operations, even if consent has not been obtained or has been revoked.
7. Involuntary Commitment
There was testimony that the privacy rule does not except from the consent requirements involuntarily committed patients who refuse to sign a release permitting use and disclosure of information. Although there is a legal duty to treat such individuals, a consent requirement for access to their records would compromise the quality of the treatment.
NCVHS recommends that HHS/OCR clarify the situations involving the involuntary commitment of competent patients who refuse to consent to treatment, and specifically address the issue of whether these persons are covered under the exception for legally mandated treatment.
Testimony on the minimum necessary provisions reflected a wide range of views, from those who felt the rule provides sufficient privacy protections without the requirement to those who view the minimum necessary requirement as embodying the essence of the privacy rule. While many panelists welcomed the flexibility inherent in the minimum necessary provisions, there was also concern that the vagueness of the standard might restrict the necessary flow of information, impede care, and lead to an increase in defensive information practices (the withholding of information important to health care for fear of liability). The rule’s use of terms such as “reasonable efforts” and “substantial discretion” were cited as examples of vagueness.
Several speakers expressed concern about the increased cost and administrative burden associated with the minimum necessary requirement; others stated that the cost in addition to existing routine administrative costs will barely be discernable. One panelist questioned whether the standard provides any advantage or protection for patients; another panelist stated that the minimum necessary standard will bolster the patient’s control of his or her medical information and encourage patients to be more candid with their doctors.
NCVHS strongly reaffirms the importance of the minimum necessary principle. The Committee would like to facilitate the necessary flow of information and minimize defensive information practices. The concerns and recommendations below address specific issues related to the implementation of the minimum necessary requirement.
1. Determination of Minimum Necessary
Witnesses differed over whether determinations of minimum necessary should be made by the requesting party or the recipient of the request. Many panelists found the guidance helpful in addressing questions about the standard. However, unresolved questions remain. It was suggested that the guidance could enumerate some disclosures that are presumed appropriate.
Case by case determinations are only required for non-routine uses of information. The holder of information is currently able to rely on the determination of minimum necessary by a covered entity and other entities identified in the rule.
NCVHS recommends that HHS/OCR provide additional clarification on the issue of reasonable reliance. In addition, NCVHS recommends that HHS/OCR clarify that a covered entity’s policies and procedures may address the minimum necessary requirement for the routine use of information.
2. Defensive Practices
Several panelists expressed concern that unresolved questions about the standard, fear of potential liability, and civil and criminal penalties could restrict the necessary flow of information, impede care, and lead to defensive information practices.
NCVHS recommends that HHS/OCR provide education to address the increasing concerns about liability and defensive information practices that lessen the flow of information and impede care.
The ambiguity of the minimum necessary standard and the cost and administrative burden of developing policies and procedures and implementing the requirement were frequently cited.
NCVHS recommends that HHS/OCR issue advisory opinions, publish best practices, and make available model policies, procedures, and forms for various purposes.
We appreciate the opportunity to offer these comments and recommendations.
John Lumpkin, M.D., M.P.H.