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Archive for the ‘HIPAA Health Information privacy’ Category

Faxing Patient Health Information to Wrong Number – Compliance Risk Area

Tuesday, March 13th, 2018

Physician Revises Faxing Procedures to Safeguard PHI After Faxing PHI to Employer  by Mistake

faxing phi wrong numberA medical office recently settled with OCR after it allegedly disclosed a patient’s HIV status when the office mistakenly faxed medical records to the patient’s place of employment instead of to the patient’s new health care provider.  The employee responsible for the disclosure received a written disciplinary warning, and both the employee and the physician apologized to the patient.  To resolve this matter, OCR also required the practice to revise the office’s fax cover page to underscore a confidential communication for the intended recipient. The office informed all its employees of the incident and counseled staff on proper faxing procedures.

Two things pop about about this instance.  First, this was clearly a privacy violation.  The patient’s protected health information, which incidentally revealed his or her HIV status, we sent to the employer.  Secondly, it was evident from the facts that this was a mistake.  We aren’t told exactly how this mistake was made.  Was the fax number written down in the wrong box on the patient’s records?  Did the employee who faxed the records put the incorrect number on the fax cover sheet?  We may never know.  But this does raise the importance of being precise at all stages of the patient encounter to assure that no inadvertent violations occur.  Care you should be taken when information about the patient is initially entered into the system.  Individuals at all levels who may be responsible for transmitting PHI must be deliberate about their actions.  How many people have called or faxed something to the wrong person before?  How many people have written down the wrong telephone or fax number before?  Everyone?

This OCR settlement just illustrates that sometimes these small errors can have big implications.  It does not appear to have been any significant fines or loss of employment in this situation.  But we cannot downplay the potential embarrassment or other negative consequences of mistakes like these.  It is one thing to text your friend Bob rather than your friend Bobbie, and weirdly from Bob’s perspective say how wonderful last night was and how you can’t wait to see him again.  Telling a patient’s employer about their health condition can have consequences that are much harder to laugh off.

Patient Access to Medical Records Created by Another Provider

Wednesday, March 7th, 2018

Private Practice Provides Access to All Records, Regardless of Source

A private practice denied an individual access to his records on the basis that a portion of the individual’s record was created by a physician not associated with the practice. While the amendment provisions of the Privacy Rule permit a covered entity to deny an individual’s request for an amendment when the covered entity did not create that the portion of the record subject to the request for amendment, no similar provision limits individuals’ rights to access their protected health information. Among other steps to resolve the specific issue in this case, OCR required the private practice to revise its access policy and procedures to affirm that, consistent with the Privacy Rule standards, patients have access to their record regardless of whether another entity created information contained within it.

Medical Alerts – HIPAA Implications of Flagging Patient Records

Tuesday, February 27th, 2018

Identification of AIDS Status Through Medical Alert System

Dentist Revises Process to Safeguard Medical Alert PHI

AIDS identification external alert HIPAAA recent OCR investigation of a dental practice’s flagging of patients records highlights a potential HIPAA violation.  The OCR investigation confirmed allegations that the dental practice flagged some of its medical records with a red sticker with the word “AIDS” on the outside cover.   Records were handled so that other patients and staff without need to know could read the sticker.  A patient complaint commenced an OCR investigation into whether the practice potentially identified the AIDS status of patients within the office.

When notified of the complaint filed with OCR, the dental practice immediately removed the red AIDS sticker from the complainant’s file. To resolve this matter, OCR also required the practice to revise its policies and operating procedures and to move medical alert stickers to the inside cover of the records. Further, the covered entity’s Privacy Officer and other representatives met with the patient and apologized, and followed the meeting with a written apology.

The lesson here is not to place special medical alerts on the outside of physical patient records.  This is a particularly bad practice in a dental office where the typical office setup can result in visual identification by other patients.  If a patient is being escorted by staff and is seen by other patients, the identification on the outside of the patient’s chart can easily be connected to the patient.  This creates a very sensitive potential violation of HIPAA and other laws protecting against disclosure of the AIDS status of individuals.

Providing Protected Health Information in Response to Subpoena

Thursday, February 22nd, 2018

OCR Citation for Improper Disclosure of PHI in Response to a Subpoena

unauthorized release phi subpoenaA health care provider or other covered entity under HIPAA is permitted to disclose protected health information if it receives a lawful order from a court or administrative tribunal.  this does not mean that a provider can simply release everything it has in a patient record when it receives a court order.  Some records, such as mental health or substance abuse records might have special protections or limitations that apply.  Additionally a provider should closely review the relevant order and only disclose the information that is specifically required by the order.

The ability to release information in response to a subpoena, as opposed to an order of a court, is subject to different rules.  Patient information can only be provided under subpoena if certain notification requirements of the Privacy Rule are met. The notification requirements require the provider who received the subpoena to obtain evidence that there were reasonable efforts to notify the person who is the subject of the information about the request.  This is intended to give the individual an opportunity to object to the disclosure, or obtain a protective order from the court.

The application of these rules are illustrated by a relatively recent OCR settlement involving a hospital that was accused of improperly disclosing PHI in response to a subpoena.  The hospital apparently failed to determine that reasonable efforts had been made to notify that individual whose PHI was being sought under the subpoena.  This had the effect of denying the individual the right to object or seek a protective order.

As part of the settlement with the Hospital, OCR required the hospital to revise its subpoena processing procedures. The new policies adopted by the offending hospital hold a lesson for all covered entities.  If a subpoena does not meet the requirements of the Privacy Rule, policy should require the covered entity to reach out to the party who issued the subpoena to explain the notification requirements.  Until those requirements are complied with, the information cannot be released.

Court Orders and Subpoenas – Release of Protected Health Information

Mental Health Center Settlement for Failure to Provide Patient Record Copies

Tuesday, February 20th, 2018

OCR Sanction for Failing to Provide Patient Access to Protected Health Information

OCR Settlements Illustrate Area of HIPAA Risk

Access to Medical RecordsIn this case that was settled with the Office of Civil rights, the provider was a mental health center that was accused of refusing to provide a patient with a copy of her medical record, including psychotherapy notes. OCR’s investigation revealed that the Center provided the complainant with an opportunity to review her medical record, including the psychotherapy notes, with her therapist.  However, the provider failed to provide the patient with a copy of her records. The Privacy Rule requires covered entities to provide individuals with access to their medical records; however, the Privacy Rule exempts psychotherapy notes from this requirement if they are separately maintained by the covered entity. Although the Center gave the complainant the opportunity to review her medical record, this did not negate the Center’s obligation to provide the complainant with a copy of her records. Among other corrective action taken, the Center provided the complainant with a copy of her medical record and revised its policies and procedures to ensure that it provides timely access to all individuals.

The regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which protect the privacy and security of individuals’ identifiable health information and establish an array of individual rights with respect to health information, have always recognized the importance of providing individuals with the ability to access and obtain a copy of their health information. With limited exceptions, the HIPAA Privacy Rule (the Privacy Rule) provides individuals with a legal, enforceable right to see and receive copies upon request of the information in their medical and other health records maintained by their health care providers and health plans.  Thus, individuals have a right to a broad array of health information about themselves maintained by or for covered entities, including: medical records; billing and payment records; insurance information; clinical laboratory test results; medical images, such as X-rays; wellness and disease management program files; and clinical case notes; among other information used to make decisions about individuals. In responding to a request for access, a covered entity is not, however, required to create new information, such as explanatory materials or analyses, that does not already exist in the designated record set.

An individual does not have a right to access PHI that is not part of a designated record set because the information is not used to make decisions about individuals. This may include certain quality assessment or improvement records, patient safety activity records, or business planning, development, and management records that are used for business decisions more generally rather than to make decisions about individuals.

In addition, two categories of information are expressly excluded from the right of access:

  1. Psychotherapy notes, which are the personal notes of a mental health care provider documenting or analyzing the contents of a counseling session, that are maintained separate from the rest of the patient’s medical record. See 45 CFR 164.524(a)(1)(i) and 164.501.
  2. Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding. See 45 CFR 164.524(a)(1)(ii).

Written Agreement Requirement for Disclosure of Part 2 Records

Wednesday, January 31st, 2018

Disclosure of Part 2 Records for Payment or Health Care Operations Requires Written Agreement

Regulations issued by SAMHSA in January of 2018, permit a lawful holder of Part 2 Records (relating to alcohol or substance abuse treatment) to disclose those records, with written consent of the patient, to its contractors, subcontractors, or legal representatives to carry out payment or healthcare operations on behalf of the lawful holder. The regulations list 17 examples of situations where a release may be considered appropriate. Disclosures to contractors, subcontractors, and legal representatives to carry out other purposes such as substance use disorder patient diagnosis, treatment, or referral for treatment are not permitted under the new rule.

In order to take advantage of the rule permitting disclosure for payment and/or health care operations, the lawful holder of the information is required to have in place a written contract or comparable legal instrument with the contractor or voluntary legal representative, which provides that the contractor, subcontractor, or voluntary legal representative is fully bound by the provisions of part 2 upon receipt of the patient identifying information.

In addition to having a proper contract in place, when making any such disclosures, the lawful holder must take the following further steps:

  • furnish such recipients with the notice required under § 2.32 of the regulations;
  • require such recipients to implement appropriate safeguards to prevent unauthorized uses and disclosures; and
  • require such recipients to report any unauthorized uses, disclosures, or breaches of patient identifying information to the lawful holder.

The lawful holder may only disclose information to the contractor or subcontractor or voluntary legal representative that is necessary for the contractor or subcontractor or voluntary legal representative to perform its duties under the contract or comparable legal instrument. Contracts may not permit a contractor or subcontractor or voluntary legal representative to re-disclose information to a third party unless that third party is a contract agent of the contractor or subcontractor, helping them provide services described in the contract, and only as long as the agent only further discloses the information back to the contractor or lawful holder from which the information originated.

17 Examples SAMHSA Payment and Health Care Operations

Wednesday, January 31st, 2018

Examples of Disclosures of Part 2 Records for Payment and Health Care Operations

In regulations released in January of 2018, SAMHSA included a list of 17 specific types of payment and health care operations in the regulatory text that would be the basis for further disclosures by a lawful holder of patient identifying information. SAMHSA did not include this list of 17 items in the regulations.  Rather, these items were contained in the preamble reflecting that additional reasons for release for payment and health care operations may be permissible.  Examples of permissible activities under § 2.33(b) that SAMHSA considers to be payment and health care operations activities include:

  • Billing, claims management, collections activities, obtaining payment under a contract for reinsurance, claims filing and related health care data processing;
  • Clinical professional support services (e.g., quality assessment and improvement initiatives; utilization review and management services);
  • Patient safety activities;
  • Activities pertaining to:
  • The training of student trainees and health care professionals;
  • The assessment of practitioner competencies;
  • The assessment of provider and/or health plan performance; and
  • Training of non-health care professionals;
  • Accreditation, certification, licensing, or credentialing activities;
  • Underwriting, enrollment, premium rating, and other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits, and ceding, securing, or placing a contract for reinsurance of risk relating to claims for health care;
  • Third-party liability coverage;
  • Activities related to addressing fraud, waste and abuse;
  • Conducting or arranging for medical review, legal services, and auditing functions;
  • Business planning and development, such as conducting cost management and planning-related analyses related to managing and
    operating, including formulary development and administration, development or improvement of methods of payment or coverage
  • Business management and general administrative activities, including management activities relating to implementation of and compliance with the requirements of this or other statutes or regulations;
  • Customer services, including the provision of data analyses for policy holders, plan sponsors, or other customers;
  • Resolution of internal grievances;
  • The sale, transfer, merger, consolidation, or dissolution of an organization;
  • Determinations of eligibility or coverage (e.g. coordination of benefit services or the determination of cost sharing amounts), and adjudication or subrogation of health benefit claims;
  • Risk adjusting amounts due based on enrollee health status and demographic characteristics;
  • Review of health care services with respect to medical necessity, coverage under a health plan, appropriateness of care, or justification of charges.

SAMHSA believes it is important to maintain patient choice in disclosing information to health care providers with whom patients have direct contact. For this reason, the final provision in § 2.33(b) does not cover care coordination or case management and disclosures to contractors, subcontractors, and legal representatives to carry out such purposes are not permitted under this section. In addition, SAMHSA added language to the regulatory text in § 2.33(b) to clarify that disclosures to contractors, subcontractors and legal representatives are not permitted for activities related to a patient’s diagnosis, treatment, or referral for treatment.

Disclosures for Specific Payment or Health Care Operations Purposes (§ 2.33)

Wednesday, January 31st, 2018

Part 2 Records –  Specific Payment or Health Care Operations Purposes (§ 2.33)

Special restrictions apply to health information that is restricted under SAMHSA rules.  These rules protect patient information involving substance and alcohol treatment in Federal programs.  SAMHSA requirements are much more restrictive than HIPAA rules and must be considered, not only by substance abuse program, but also by providers and others who may receive these records and are subject to strict re-disclosure prohibitions.

The 2018 Rules finalizes the scope and requirements for permitted disclosures to contractors, subcontractors, and legal representatives for the purpose of payment and health care operations. SAMHSA lists 17 specific types of activities for which minimal information necessary may be disclosed for specific payment and health care operations activities. The 17 specific activites are listed in the preamble, rather than the regulatory text, as examples of potentially permissible disclosures.
SAMHSA states that its intent is for other appropriate payment and health care operations activities to be permitted beyond the 17 listed activities. In addition, consistent with SAMHSA’s prior statement in the SNPRM preamble, SAMHSA has added language to the regulatory text in § 2.33(b) to clarify that disclosures to contractors, subcontractors, and legal representatives are not permitted for activities related to a patient’s diagnosis, treatment, or referral for treatment. The rules require lawful holders of restricted information who engage contractors or subcontractors to carry out payment and health care operations activities to include specific contract provisions addressing compliance with part 2. Additionally, language was added to the regulation to clarify that disclosures to contractors, subcontractors, and legal representatives are not permitted for substance use disorder patient diagnosis, treatment, or referral for treatment.

Notice of Restriction on Re-Disclosure SAMHSA Records

Wednesday, January 31st, 2018

Prohibition on Re-Disclosure – Changes in New SAMHSA Final Rules (§ 2.32)

Redisclosure Notice SAMHSA RecordsOne of the primary new operative provisions that was created in the 2017 Final Rules is an expanded prohibition against re-disclosure of records that are covered under SAMHSA. Even when a disclosure is permitted, the 2017 rules required the disclosure to be accompanied by a lengthy written statement, notifying the recipient of the special status of the information and the prohibition against re-disclosure. The notification was rediculously long:

This information has been disclosed to you from records protected by Federal confidentiality rules (42 CFR part 2). The Federal rules prohibit you from making any further disclosure of this information unless further disclosure is expressly permitted by the written consent of the person to whom it pertains or as otherwise permitted by 42 CFR part 2. A general authorization for the release of medical or other information is NOT sufficient for this purpose. The Federal rules restrict any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient.

The new 2018 Rules create an abbreviated notice that is 80 characters long to fit in standard free-text space within health care electronic systems. The abbreviated notice in this final rule reads ‘‘Federal law/42 CFR part 2 prohibits unauthorized disclosure of these records.’’

The 42 CFR part 2 regulations have always required that a notice of the prohibition on redisclosure accompany each disclosure made with the patient’s written consent. With the adoption of electronic health record systems, it became difficult to comply electronically with the longer notification form due to character limits in freetext fields within electronic health record systems. Many electronic record systems contain a free text space with a maximum character capacity of 80 characters. The new 2018 Rules reflect SANHSA’s belief that offering an abbreviated notice option will be beneficial to providers who use electronic health record systems to exchange data.

SAMHSA recognizes concerns that an abbreviated notice could be insufficient to convey understanding of part 2 requirements. SAMHSA encourages part 2 programs and other lawful holders of restricted records that chose to use the abbreviated notice to discuss the restriction and redisclosure requirements applicable to SAMHSA protected records with those to whom they disclose patient identifying information.

First Article in SAMHSA Series

Confidentiality of Substance Use Disorder Patient Records

Wednesday, January 31st, 2018

New SAMHSA Clarifying Regulations for Part 2 Program Records

SAMHSA Regulations Substance Abuse RecordsNew Final regulations were issued on January 2, 2018 by the Substance Abuse and Mental Health Services Administration (SAMHSA). The new Final regulations supplement SAMHSA’s major regulation change that was finalized in regulations that were released in January of 2017. The new, 2018 Final regulations add some clarification and more specificity to some of the requirements of the 2017 rule.

These rules, commonly known as the “SAMHSA Rules” or “Part 2” describe special confidentiality restrictions that apply to Substance Use Disorder Patient Records related to certain substance use disorder treatment programs that receive federal financial assistance. The confidentiality requirements that apply to treatment records covered by the SAMHSA Rules are more stringent than apply to general patient health records. The special restrictions on these records has been in existence for decades, with the last major re-write occuring in 1987.

SAMHSA began a process of reconstituting the SAMHSA Rules in February of 2016, when it published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (81 FR 6988). SAMHSA’s stated purpose for revising the rules was to reflect development of integrated health care models and the use of electronic exchange of patient information. At the same time, SAMHSA’s aim was to accomodate new technologies while maintaining confidentiality protections for patients of covered treatment programs who could encounter discrimination if their information is not properly protected.

The  Final Rules that we published on January 18, 2017, provided for greater flexibility in disclosing patient identifying information within the health care system while continuing to address the need to protect the confidentiality of substance use disorder patient records. At the same time that it published the 2017 Final Rule’s, SAMHSA issued a supplemental notice of proposed rulemaking (SNPRM) to solicit public comment on additional proposals in a variety of areas covered by the SAMHSA Rule. The new Final Rules that were issued on January 2, 2018, address many of the issues suggested in the SNPRM and integrate some of the 55 regulatory comments that SAMHSA received in response to the SNPRM.

SAMHSA received numerous comments asking it to consider alignment of the special restrictions applicable through the SAMHSA Rules with the Health Insurance Portability and Accountability Act (HIPAA) or the Health Information Technology for Economic and Clinical Health (HITECH) Act. It is challenging for providers to establish different requirements for special status records. By its very nature, the more restrictive requirements that are applicable to SAMHSA covered records requires providers to “triage” record requests to be certain that they are not covered by the special restrictions of the SAMHSA Rules. This is especially problematic when a provide that does not provide alcohol or substance abuse treatment receives SAMHSA protected records from another provider. SAMHSA Rules not subject receiving providers to a direct prohibition against redisclosure.

SAMHSA says that it has attempted to align the final rule with HIPAA, the HITECH Act, and their implementing regulations to the extent feasible. Yet, the more stringent SAMHSA restrictions will be difficult to completely harmonize with HIPAA and HITECH. Part 2 provides more stringent federal protections than other health privacy laws such as HIPAA and seeks to protect individuals with substance use disorders who could be subject to discrimination and legal consequences in the event that their information is improperly used or disclosed. A similar issue exists with respect to many state laws that provide more stringent privacy restrictions on records related to mental health related services. Decision trees applicable to disclosure of special treatment records can be quite complex; particularly when HIPAA premption concepts are applied as an overlay to the base analysis.

Follow our article series on the SAMHSA Regulations on this site.

Next Article in Series

Notice of Restriction on Re-Disclosure

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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