Health Law Blog - Healthcare Legal Issues

Providing Protected Health Information in Response to Subpoena

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

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).

Applying Section 1557 Discrimination Rules to Employer Sponsored Health Plans

February 11th, 2018

Section 1557 Covered Entities and Employer Sponsored Health Plans

Health Plan 1557 ComplianceSection 1557 of the Affordable Care Act (ACA) prohibits “covered entities” discrimination in health programs that receive federal financial assistance from the Department of Human and Health Services.  Regulations were issued in 2016 that define the details of compliance with Section 1557 which prohibits discrimination based on race, color, national origin, age, disability and sex.  (including discrimination based on pregnancy, gender identity and sex stereotyping).  The stated purpose for the rules is to expand access and eliminate barriers to the ability to obtain health care coverage.

The definition of “covered entities” to which Section 1557 apply is extremely broad.  Through the broad definition, the requirements of Section 1557 apply to any health program or activity that received federal financial assistance through the Department of Health and Human Service.  This definition includes most health care providers, such as hospitals, nursing homes, and physician, who receive Medicare or Medicaid reimbursement, insurance marketplace and exchanges and participating health plans.

The Section 1557 rules extend to some (but not all) employers that are group health plan sponsors.  Determining whether Section 1557 applies to a specific employer can be quite complicated and is based on several factors such as the sponsor’s primary business function, the nature and extent of federal financial assistance, whether the employer plan is self-funded or insured, and variety of other factors.

Failing to comply with Section 1557, where necessary, can expose an employer to significant risk.  Significant compliance exposure, coupled with complicated rules defining application of Section 1557, make this an extremely important area for employers. Employers should carefully assess whether they are subject to the requirements of Section 1557 and take steps to assure compliance where necessary.

Written Agreement Requirement for Disclosure of Part 2 Records

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

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
    policies;
  • 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)

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

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

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

CMS Position On Texting Physician Orders

January 29th, 2018

Texting of Physician Orders : CMS Statement Clarifies Position on Texting

Physician Order Texting RegulationsThe CMS Center for Clinical Standards and Quality/Survey & Certification Group recently released a Memorandum clarifying its position regarding texting of health care information. In S&C 18-10-ALL, dated December 28, 2017, CMS clarifies the following issues:

  • Texting of PHI Within Health Care Team.  CMS says that this is permissible on a secure platform.  Providers should develop policies covering texting among the care team.  Providers may want to consider special conditions, or even limiting or prohibiting this practice.  CMS, HIPAA and other standards need to be considered when developing provider specific policy.  State laws may differ and certain types of information may be subject to special restrictions.
  • Texting of Patient Orders.  Even though texting communication between care team members is permissible, CMS clarifies that texting patient orders is always prohibited; even on a secure platform.
  • Preferred Use of CPOE.  CMS clarifies that Computerized Provider Order Entry (CPOE) is the preferred method for a provider to enter a patient order.  Providers should review their policies regarding acceptable order platforms.  Special attention should be paid to texting practices.  Verbal orders are also an area of significant compliance and liability concerns.  Over-use of verbal orders and non-compliance with authentication requirements is very common and is a significant risk area.

You can reference the CMS Texting Guidance Letter on this issue directly.

I have been posting a series of articles on compliance issues relating to physician orders that you can also reference for additional guidance.  And as always, if you have additional questions, please do not hesitate to contact me thhrough the contact form on this blog or directly through contact information on my law firm web site.

 

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

 

Authentication of Verbal Orders by Other Responsible Practitioner

January 24th, 2018

Authentication of Verbal Orders

Authenticating Verbal OrdersIn a past blog article, I discussed the need for physicians to promptly authenticate verbal orders. The failure of a physician to timely sign a verbal order can have reimbursement implications. In some cases, in some states, another responsible provider can sign a verbal order that is originally given by another practitioner. This option is not always available and depends a lot on whether state law permits the practice. Some states require the practitioner who gave the verbal order to authenticate the order. With the use of electronic medical records, practitioners cannot expect leniency on these types of requirements.

In states that permit one practitioner to authenticate for another, the authenticating proxy practitioner should understand that he or she is accepting responsibility for the authenticated verbal order. State scope of practice rules apply to cross authentication of orders. In otherwords, the practitioner authenticating the order must have practice authority to have provided the original verbal order. Facilities can develop policies that a more restrictive then what the law permits. Policy can eliminate or restrict cross authentication practices. There is inherent risk in permitting cross authentication because the authenticating provider did not give the original verbal order. Additionally, as covered in previous blog articles, verbal orders are over-used in many facilities and carry inherent risks. Facilities can enact policies to curtail the use of verbal orders. At minimum, facility policy should echo the CMS comments regarding the appropriate scope of use of verbal orders. Practices can be audited to determine whether a practitioner is overusing verbal orders.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

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

Search
Disclaimer
The Health Care Law Blog is made available by Ruder Ware for educational purposes and to provide a general understanding of some of the legal issues relating to the health care industry. This site does not provide specific legal advice and you should not use the information contained on this site to address your specific situation without consulting with legal counsel that is well versed in health care law and regulation. By using the Health Care Law Blog site you understand that there is no attorney client relationship between you and Ruder Ware or any individual attorney. Postings on this site do not represent the views of our clients. This site links to other information resources on the Internet; these sites are not endorsed or supported by Ruder Ware, and Ruder Ware does not vouch for the accuracy or reliability of any information provided therein. For further information regarding the articles on this blog, contact Ruder Ware through our primary website.