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21st Century Cures Act: Considerations for working with survivors of intimate partner violenceLey Cures del Siglo XXI: Consideraciones para trabajar con sobrevivientes de la violencia de pareja

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The National Health Resource Center on Domestic Violence and the National Health Collaborative on Violence and Abuse present:

21st Century Cures Act: Considerations for working with survivors of intimate partner violence

Ley Cures del Siglo XXI: Consideraciones para trabajar con sobrevivientes de la violencia de pareja

June 23rd 10-11:30am PT23 de junio de 2021 10:00 AM hora del Pacífico

Zoom Webinar Tech Info

• Each participant received a unique link to join the webinar via the email used during registration.• All participants are muted and are not on video.• You may use the chat box for comments, and the Q&A function to submit questions for our

presenters. Please view the Q&A tab before submitting, your question may have already been answered.

• This webinar features closed captioning.• Select the [CC] button in the lower bar to view captions• To view complete captions select the “˄” carrot next to the [CC] button• Slides and a link to the webinar recording will be emailed to all participants, and posted to the

FUTURES website

National Health Resource Center on Domestic Violence

•Personalized technical assistance via email, phone, web, mail and face-to-face at conferences.•Free, downloadable health care information focusing on various specialties, populations and key issues. These include fact sheets, model programs and strategies, bibliographies and policies.•Educational and clinical tools for providers and patients.•A webinar series with expert presenters and cutting edge topics.•A biennial National Conference on Health and Domestic Violence - a meeting at which health, and medical and domestic violence experts and leaders explore the latest health research and programmatic responses to domestic violence

Today’s Speakers

Presenters/Presentadoras:

• Lena O'Rourke, O'Rourke Health Policy Strategies• Deven McGraw, Chief Regulatory Officer, Citizen Corporation• Dr. Kimberly S.G. Chang, Asian Health Services

Facilitator/Facilitador:• Lisa James, Director of Health Futures Without Violence

What is your role?

• DV/SV advocate – shelter, hotline, court-based• DV/SV advocate – based in a health setting• Health care provider• Social worker• Administrator• Other?

Survivors, Privacy, and Health Data

• Survivors will have questions about how their health data is collected and shared

• Important to address potential scenarios regarding survivors of domestic violence

• Adhering to privacy principles is critical

Scenarios of Concern for Survivors

Common examples:• Unauthorized providers could check the survivor’s record to see if abuse

was disclosed.• In small towns, where the hospital or the pharmacy is a primary

employer, it may be possible to access to a survivors record.• An abusive or controlling person might see documentation of IPV• A survivor may want assurances that the information will be controlled.

Questions About Health Data

Survivors will have questions about how their health data is being used:

• What is written in my Electronic Health Record (EHR) about my experiences of violence?

• What control do I have over my health information and what are my rights as a patient and as a survivor?

• Who has access to my electronic medical record and health data? • What will happen if my partner finds out that I have been talking to my provider

about the violence?• How will I be treated differently if other people on my care team know that I am

surviving violence?

Privacy and Confidentiality Considerations

o Robust, informed patient consent about sharing of healthcare data

o Patient control over how health data is shared and with whom

o Transparency over who has access to health data and wheno Sensitive information de-identified whenever possibleo Awareness of information shared on plan/billing documents

How does the Cures Act change the game?

The Cures Act does not override other health information privacy laws (Health Insurance Portability and Accountability Act - HIPAA):

• If access is not permitted, the new rules would not allow it• These risks are present with any use of electronic information• Access is not made any wider than what HIPAA permits

Health providers must help patients be aware of the limits of confidentiality and adhere to privacy principles

Patient Access and Notice

Patients must be informed about:

• What is being documented• How it is being documented• Why it is being documented• Circumstances under which the information could be shared• Who may be able access to this information

De-Identified Information

• Health information should be de-identified

• When personally identifiable information may be shared or exchanged, patients should give written authorization to share the data

• Patients should be able to or restrict the use or disclosure of personally identifiable information beyond certain core functions

Patient Communication

• Communications should be sent per patient preference (e.g., phone, email)

• No mention of domestic violence verbally or in writing should be made when communicating with providers

• Develop and adhere to best practices for coding to ensure no disclosure of domestic violence

Privacy Consent Follow Data

• All privacy and signed consents should follow the data

• If a survivors health information is shared, the consents should automatically follow it

Health providers’ discretion to withhold information

• Health providers should have broad discretion to limit information exchange when disclosure could harm patient

• They should implement a system safeguard that protects sensitive information

• This is consistent with the new “exemptions” to the Cures Act rules

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Protecting Patients and Compliance with Federal Information Blocking Rules-Yes, You Can Do Both

Deven McGraw, Esq.Co-Founder & Chief Regulatory OfficerCiitizenFormer Deputy Director, HHS Office for Civil Rightsdeven@ciitizen.com

• This material is designed to provide you with educational information about the new information blocking rules.

• The presenter is not providing or offering legal advice but, rather, practical and useful information that could help individuals in the audience better understand the new laws and, where applicable, work within their institutions and organizations to try to achieve compliance with the rules.

• Every reasonable effort has been taken to ensure that the educational information provided is accurate and useful.

Disclaimer

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• Signed into law on 12-13-2016• Today’s Focus: Prohibitions on

“information blocking” (part of the Cures Act) and HHS (the Office of the National Coordinator for Health IT or ONC) regulations and guidance to implement those prohibitions.

Cures Act

Images source: https://www.healthit.gov/curesrule/

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Applies to health care providers,

certified health information

technology vendors (EHR vendors)

and health information networks

or exchanges (a.k.a. “actors”).

(§4004)

Who Does This Apply To?

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• Only identifiable, electronic Health Information• All records that a patient has a right

to under HIPAA (a.k.a. the “designated record set”).• Until 5/1/22, applies only to certain

categories of information (otherwise known as the U.S. Core Data Set for Interoperability (USCDI).

What does it apply to?

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US Core Data For Interoperability

Vital Signs• Diastolic Blood Pressure• Systolic Blood Pressure• Body Height• Body Weight• Heart Rate• Respiratory Rate• Body Temperature• Pulse Oximetry• Inhaled Oxygen Concentration• BMI Percentile (2-20 Years) *NEW• Weight-for-length Percentile

(Birth - 36 Months) *NEW• Occipital-frontal Head Circumference

Percentile (Birth - 36 Months) *NEW

Care Team Members

Clinical Notes *NEW• Consultation Note • Discharge Summary Note• History & Physical• Imaging Narrative• Laboratory Report Narrative• Pathology Report Narrative• Procedure Note• Progress Note

Goals

Health Concerns

Immunizations

Medications

Problems

Provenance *NEW• Author Time Stamp• Author Organization

Smoking StatusAllergies and Intolerances *NEW• Substance (Medication) • Substance (Drug Class) *NEW• Reaction *NEW

Assessment and Plan of Treatment

ProceduresLaboratory• Tests• Values/Results

Unique Device Identifier(s) for a Patient’s Implantable Device(s)

Patient Demographics• First Name• Last Name• Previous Name• Middle Name (incl. middle initial)• Suffix• Birth Sex• Date of Birth• Race• Ethnicity• Preferred Language• Current Address *NEW• Previous Address *NEW• Phone Number *NEW • Phone Number Type *NEW• Email Address *NEW

For more info:HealthIT.gov/USCDI

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• Final info blocking rule was published on May 1, 2020 • Note: Vol. 85, No. 85 Federal Register

• Rule officially went into effect April 5, 2021. • CMS to set penalties for providers.

Timeline and penalties

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What does “information blocking” mean?

• It does NOT mean patient information must be disclosed to all requesters, for any purpose. • It creates a “presumption” that electronic health information should

be disclosed – but providers can still decline to disclose for good reasons.• Documentation of policies and of reasons for not disclosing will be

key.

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• HHS (ONC) created eight categories of exceptions – if you meet them, you are NOT information blocking (safe harbors). • We’re going to focus on two of them.

• What if you don’t meet an exception?• No guaranteed protection against penalties – but also

doesn’t mean you are “guilty” of information blocking.• Each situation is evaluated on a case-by-case basis

(why documentation is so important!)

Exceptions to Information Blocking

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1. Preventing Harm: Reasonably necessary practices to prevent harm to a patient or another person.

2. Privacy: Refusing to fulfill a request to protect a person’s privacy.

A. Exceptions for NOT Fulfilling Requests

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Must meet the requirements of at least one of these:• The law requires patient consent and the patient has not

consented• Requester is responsible for obtaining the patient’s consent

• Can deny an individual or personal representative’s request based on a reason for denying an individual’s right of access request under HIPAA.• If respecting an individual’s request not to share

information.

Privacy Exception

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• Applicable when individuals (or personal representatives) are seeking EHI• Can deny to patient when there is risk of harm to

life or physical safety to the patient or other person (subject to patient’s appeal rights under HIPAA).• Can deny to a personal representative (PR) when

disclosure to that PR risks substantial harm to the patient or another person.• Where information sought references another

person, can deny to individual or PR when there is risk of substantial harm to that referenced person.

• In each situation, you have to believe the denial will substantially reduce the risk.

Preventing Harm Exception –aligns with HIPAA patient right of access

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More on Preventing Harm

• Practice can be implemented based on organizational policy or in an individual case.• Organizational policy must be in writing, based on relevant expertise, and

applied in a consistent and nondiscriminatory manner.• If determining in an individual case (vs. application of a policy):

• Must be based on facts and circumstances known or reasonably believed at the time• Be based on relevant expertise. (Note: others can rely on treating provider’s

assessment.)

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Do I have to automatically update a patient’s portal with her medical information (for ex., test results?)• Bottom line: No, unless the patient asks for EHI to be placed in the portal.

“There is no requirement under the information blocking regulations to proactively make available any EHI to patients or others who have not requested the EHI. We note, however, that a delay in the release or availability of EHI in response to a request for legally permissible access, exchange, or use of EHI may be an interference under the information blocking regulations. If the delay were to constitute an interference under the information blocking regulations, an actor’s practice or actions may still satisfy the conditions of an exception under the information blocking regulations.” https://www.healthit.gov/curesrule/faq/do-information-blocking-regulations-45-cfr-part-171-require-actors-proactively-make-electronic

But be careful:• Cannot establish an institutional policy that automatically withholds all lab test results for a

particular period of time in order to allow the clinician time to inform the patient. https://www.healthit.gov/curesrule/faq/when-would-delay-fulfilling-request-for-access-exchange-or-use-ehi-be-considered-interference

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Cures Clinical Conundrums and Practical Applications: Asian Health Services (Oakland, CA)

New Factors for Providers to Consider

The intended reader(s) of the health record have increased1) other healthcare professionals/health information exchanges2) the patient

Do we have to/should we change the way we document or chart our notes?

What new factors should we consider when documenting our notes?• Transparent discussion on ground rules of documentation• Patient perspective• Agreement or disagreement with notes• Possible harm to patient• Should note be shared?

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Let's look at clinical situations

when the intended reader is other health care providers

Table of Choices for Provider and Patient Information Sharing to Other Providers

Patient

Share to other

providers

Do not share to other

providers

Provider

Share to other providers In agreement Conflict

Do not share to other providers Conflict In agreement

Let's look at clinical situations

when the intended reader is the patient or

the patient's representative

Table of Choices for Provider and Patient Information Sharing To Patient Portals/Patient Facing Documents

Patient

Share to Portal/Patient

Facing Documents

Do not share to

Portal/Patient Facing

Documents

Provider

Share to Portal/Patient

Facing DocumentsIn agreement Conflict

Do not share to Portal/Patient

Facing DocumentsConflict In agreement

Final Thoughts from the Frontline...

• Need institutional/organizational policies to address when conflicts arise between patient and provider• The default in conflicts over sharing seems to be to defer to NOT sharing:• to defer to patient autonomy and not share• to defer to provider concern for harm and not share

• Discuss ground rules on chart documentation with patients before addressing sensitive topics• Need provider t/ta on how to both discuss and document sensitive topics within the EHR• Recommend policies/protocols to protect notes on IPV and exploitation• And one question: Does the provider need to notify the patient when they decide not to

share information?

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Discussion

Futures Without Violence Health Initiatives

National Health Resource Center on Domestic Violenceipvhealth.org – toolkit for health settings and DV programs

ipvhealthpartners.org – step by step approach to addressing IPV in community health centers

Health Partners on IPV and Exploitationwww.futureswithoutviolence.org/health/nationalhealthnetwork

health@futureswithouviolence.orgfutureswithoutviolence.org/health/

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Appendix

• Information Blocking: An act or omission that “except as required by law or specified by the Secretary [in rulemaking], is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information [EHI].” (§4004)• Applies to any request for EHI, from any person, for any purpose.

What is Information Blocking?

Intent Matters• If conducted by a certified health information technology vendor or a health

information network or exchange, the entity ”knows or should know” that the practice is likely to interfere….”

• If conducted by a health care provider, the providers ”knows” the practice is unreasonable and likely to interfere…..

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• Practices that restrict access, exchange or use of EHI authorized under applicable state/federal law for treatment and other permitted purposes.• Implementing health IT in nonstandard ways that are likely to

substantially increase the complexity/burden of accessing, exchanging or using EHI.• Implementing IT in ways likely to restrict access/exchange/use of EHI

with respect to exporting complete information sets or facilitating transitions between health IT systems.• Implementing IT in ways likely to lead to fraud, waste, abuse or impede

innovations/advancement in EHI access/exchange or use.

Examples of Information Blocking (from the final rule)

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Info blocking “will almost always be implicated” when a practice interferes with access/exchange/use of EHI for these purposes:

• Providing patients with access to their EHI and the ability to exchange and use it without special effort (also charging individuals a fee to electronically access their EHI)• Ensuring health care professionals, caregivers, and other authorized persons

have EHI for treatment and care coordination• Ensuring payers get information they need to ”assess clinical value” and

promote transparency of cost and quality of care• Ensuring providers can get information for quality improvement and

population health management activities• Supporting access/exchange/use for patient safety and public health

purposes.

Priority Areas From Final Rule

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