Questions and Requests for Stakeholder Feedback

Integrated Patient EHR Support

Push Patient-Generated Health Data into Integrated EHR

We live in a mobile and global world. Our health data need to reflect our mobile, instant, connected world. It is our right as patients to access and own the results of our medical care instantaneously for our own longitudinal record, and shared with whomever we please. We as patients should own our health information and digital results of our care free of charge. We already paid for them by paying for the medical service through our insurance premiums, copays, deductibles, and taxes.

We should be allowing for the design of the future rather than addressing the dysfunction of today. In doing so, this will empower the consumer to control their own health information so they can make better choices about their health.

This EHR should be readily available by the patient and secured by the patient’s choice of password combined with third party verification, biometric or facial recognition, or the state-of-the-art technology as used in other sectors.

Providers and their software vendors need to allow for open technology development, leveraging existing state-of-the-art security and patient safety measures like thumbprint, voice, or facial recognition and device verification. The electronic medical record should be transactional, mobile, and secure like mobile banking is in the financial industry. A patient-centered longitudinal record gives the patients the choice of when, how, with whom, and to what extent their own medical records can be shared.

The patient receipt of their own health care record should be automatic. We need to eliminate the requirement for the patient to ask for copies of their information and copies of their films. A copy or photo of an image or film should be automatically provided to the patient. The patient should not have to go to a separate location in the hospital, fill out a separate form, and then wait up to 30 days to receive their information. Those 3 things collectively inhibit timely and quality care. We can achieve timely and the best of quality care if we provide the patient with immediate access to his or her own patient-owned integrated EHR.

We need our electronic health record to follow us so we are free to receive care wherever we choose. Through cooperation and non-discrimination, we can have one, single, mobile, longitudinal record.

Multiple, separate portals from each provider, difficult to access, each acting as an island unto itself, is a broken way for a physician to provide optimal health care. It is onerous, expensive, and redundant. It is broken. It does not work.

Patients need ownership rights to their own health information and data, and ability to have an aggregated, integrated, longitudinal, patient-owned electronic health record. That EHR should be readily available to them through their mobile devices. Hospitals/providers should have open API’s, and images, films, EKG’s, CT’s, MRI’s, radiology, open notes regarding discharge and care should be readily accessible in a shared, open architecture for other institutions on behalf of the patient. The EHR should also have available linkage to the patient’s pharmacy for populating a history of prescription fills.

We can greatly improve the quality of health care and provide timely, life saving measures to patients in emergent care with informed physicians and patients, family and caregivers alike. We can substantially reduce costs of health care by eliminating redundancies in providing care across institutions. This common sense approach can, in fact, be readily done with today’s technology, as evidenced in almost every industry other than health care.

Digital copies of new tests and electronic files should be available immediately in the patient’s own designated banked account. As lab results, physician notes, and tests become electronically available to the physician and provider/facility, a copy should instantaneously be populated into the patient’s own, integrated and aggregated, patient-owned, “banked” EHR.

The patient’s integrated EHR should be transactionally populated, much like the financial community, where each digital transaction is shown in the patient’s “banked account.” It should be integrated and aggregated through the patient’s applications of choice, much like Mint or Quicken aggregate financial transactions. Wherever the patient receives care, the patient receives that information into the patient’s “banked account.” Categories such as labs can be dated and aggregated, and trends and results can then easily be charted by the patient and the patient’s care providers.

For example, as a test result or x-ray is read and becomes digitally available to the institution, the patient should be able to have the results and findings reported electronically to their own application and site of choice. Eventually, in addition to lab reports and radiology reads, relevant photos and images should be included in the patient-owned and integrated EHR.

Near term, providers and patients alike (especially emergency departments) need readily available, shared access to existing images produced for patients. Imaging sharing should be open such that any institution could pull up an image no matter where it is, and that access should be provided across institutions for the patient.

We should eliminate the need for the patient to fill out a form to get access to their information. It should be instantaneously populated, versus up to 30 days. Thirty days is not an acceptable time frame. Those 30 days greatly diminish the quality of care.

Patients should be able to secure what they want to keep private, and readily share what they choose to share with other providers, physicians, family members, caregivers. Patients should be able to determine the level of privacy and to whom they want to share their own integrated EHR. Patients should be able to choose to “time out” that sharing, similar to a feature of the Find My Friends and Life360 apps.

Innovation needs to allow for compatibility of our health records with all technology vendors, and for the ability to analyze, aggregate, and readily share health data.

The standard needs to be that the electronic record is provided instantaneously, mobile, portable, compatible with all applications in the repository of our choice, and allowing for state-of-the-art and future technologies.

We need a transparent patient-centered record with full visibility into all our health records – labs, radiology, prescription fills, and care plans – to ensure the best, timely, informed, and efficient care.

Likewise, we need transparency into the quality, performance, and cost of care. With access to these metrics, we can shop for physicians and medical services at a competitive marketplace, not be restricted to certain providers, and hold both patients and providers accountable for performance.

The patient needs to know per drug administered the cost to the patient, itemized by the care facility. For instance the cost of Zantac administered from an ER versus the acceptable range of costs versus over the counter. The billing system of the hospital needs to be aligned with the patient’s instantaneous care as it’s populated, so that the patient has full transparency into the costs being charged for services rendered. Additionally, when a procedure like an MRI can be done electively, the cost of that MRI other than under emergent care where available, should be provided, and the price range of cost for the patient choice. Any out-of-network cost should be revealed to the patient upfront.

Cost data should be aligned with the EHR and be visible to the patient and physician. Physicians and patients alike are blind as to the ultimate cost of procedures. They are blind to what is “in network” and “out of network.” The “out of network charges are additional charges that occur unknowingly to patients and can be gamed by providers. To ultimately give the patient freedom of knowledge and choice, we need to strive for a near-term goal of attaching the cost to the insurer and the cost to the patient as it is aligned with the care provided for the patient, real time to the doctor and to the patient when available.

With data driven choice, we can utilize sites similar to Yelp, Amazon, and OpenTable to shop, assess quality, and book our care globally. When aggregated health data is readily available for comparative quality, cost, research, and analysis, the cost of care lowers and the quality improves.

The Hippocratic oath is to “do no harm.” Today’s EHR software companies and providers are causing harm to the patient by using protectionism and misusing HIPAA, blocking the patient from this readily available, integrated, longitudinal record of his/her health. Let’s get it done. The technology is all here. It is being used cost effectively in almost every other industry. It would drastically change the economics of health care for the better and greatly improve the quality of care to patients, as well as the quality of the jobs of our health professionals. Let’s do the right thing and make a systemic commitment to enable the complete, integrated EHR and empower the patient and give the patient freedom of choice.

Patient Exchanging Secure Messages with Care Providers

Patients and providers should be able to have two-way communication through email, Facetime or Skype, texting, photos, videos, and phone calls. New communication technology conduits should be readily adopted for such two-way communication, rather than requiring a regulation or legislation to allow people to communicate.

The patient should be able to choose to communicate through a text or email with his or her provider and FaceTime where appropriate. Like in the legal world, providers may have a disclaimer regarding confidentiality and security.

The patient’s own choice of privacy and security should supersede any institutional requirements. The patient should be able to opt in for deeper levels of security but should automatically be able to choose to share their fully integrated electronic file where they deem fit. The integrated file should be automatically available for emergency care.

The current software allows for physician notes to be viewable to the patients themselves. Patients should have readily available access to these physician notes. In addition, patients’ ability to edit and provide comments to the physician notes would be an important link to their longitudinal care. Better yet, patient edited and co-produced notes with their providers may be optimal. Most importantly, the collective needs to allow for patient participation and communication two-way with the patient’s integrated EHR.

View, Download, and Transmit Data from EHR

Much like the financial community, patients should be able to download their medical data. If any provider or the patient himself wants to view the integrated lab tests and look at a five or ten year horizon, he/she should be able to readily download the data and compare and contrast changes. They should stored in machine-readable form to allow for data analytics by care providers, caregivers, patients, and for research (where the patient has chosen to opt in).

HHS should seek to remove blockage and process burdens on patients under HIPAA that may limit patient access to their health information based upon patient choice of levels of privacy. See our comments above regarding instantaneous population to the digital record and eliminating signing a form for access and waiting 30 days.

Patients should be able to view their complete patient record, including pricing, tests, films, lab results, and health care provider notes. The EHR should provide affiliated charges and pricing. Price and cost transparency, outside of emergency situations, should be provided upfront to the patient prior to rendering services. As patients access the EHR, they should access the range of pricing from the institution compared to other comparable price ranges for a similar procedure elsewhere.

Health care providers should be able to view their patient’s aggregated/comprehensive patient electronic health record. Health care providers should have a two-way ability to communicate via email, phone, and text with each other regarding patient care.

We support the OpenNotes movement for physician notes to be provided attached to the patient EHR and two-way communication to be allowed for patient engagement.

Remote Patient Authorization and Submission of EHR Data for Research

Patients should own their health information and be able to easily create a longitudinal health record that they can use or share with health care providers, caregivers, researchers and others.

Patient information should not automatically be used for research or brokered even if it is “anonymized.” Patients should have the choice to opt in to any broad or specific medical research, and the institution should not be able to broker the patient’s data without the patient having full transparency and the choice to opt in to having their information brokered and shared. Patients should be remunerated for the per-patient access to such information if the researcher and the institution are being compensated for delivery of such information.

The patient should be fully informed of wherever the institution sends the patient data, even if they claim it is anonymized. The patient should also be informed of the transactional brokerage of their health data and the extent to which it is forwarded to pharmaceutical companies and their subsidiaries or contracted firms, anonymized or not.

If the institution is being paid for those data, the patient should have full transparency into payments the provider or researcher received for his or her medical record. Remunerations should be considered for the use of such data.

We support the following submission to ONC:

• We live in a mobile and global world. Our health data need to reflect our mobile, instant, connected world. It is our right to access and own the results of our medical care instantaneously for our own longitudinal record, and shared with whomever we please.

• We as patients should own our health information and digital results of our care free of charge. We already paid for them by paying for the medical service through our insurance premiums, copays, deductibles, and taxes.

• We need our electronic health record to follow us so we are free to receive care wherever we choose. Through cooperation and non-discrimination, we can have one, single, mobile, longitudinal record, not multiple, separate portals from each provider, difficult to access.

• Innovation needs to allow for compatibility of our health records with all technology vendors, and for the ability to analyze, aggregate, and readily share health data.

• The standard needs to be that the electronic record is provided instantaneously, mobile, portable, compatible with all applications in the repository of our choice, and allowing for state-of-the-art and future technologies.

• We need a transparent patient-centered record with full visibility into all our health records – labs, radiology, prescription fills, and care plans – to ensure the best, timely, informed, and efficient care.

• Likewise, we need transparency into the quality, performance, and cost of care. With access to these metrics, we can shop for physicians and medical services at a competitive marketplace, not be restricted to certain providers, and hold both patients and providers accountable for performance.

• With data driven choice, we can utilize sites similar to Yelp, Amazon, and OpenTable to shop, assess quality, and book our care globally. When aggregated health data is readily available for comparative quality, cost, research, and analysis, the cost of care lowers and the quality improves.

• Providers and their software vendors need to allow for open technology development, leveraging existing state-of-the-art security and patient safety measures like thumbprint, voice, or facial recognition and device verification. The electronic medical record should be transactional, mobile, and secure like mobile banking is in the financial industry. A patient-centered longitudinal record gives the patients the choice of when, how, with whom, and to what extent their own medical records can be shared.

Push Patient-Generated…

Push Patient-Generated Health Data into Integrated EHR

We live in a mobile and global world. Our health data need to reflect our mobile, instant, connected world. It is our right as patients to access and own the results of our medical care instantaneously for our own longitudinal record, and shared with whomever we please. We as patients should own our health information and digital results of our care free of charge. We already paid for them by paying for the medical service through our insurance premiums, copays, deductibles, and taxes.

We should be allowing for the design of the future rather than addressing the dysfunction of today. In doing so, this will empower the consumer to control their own health information so they can make better choices about their health.

This EHR should be readily available by the patient and secured by the patient’s choice of password combined with third party verification, biometric or facial recognition, or the state-of-the-art technology as used in other sectors.

Providers and their software vendors need to allow for open technology development, leveraging existing state-of-the-art security and patient safety measures like thumbprint, voice, or facial recognition and device verification. The electronic medical record should be transactional, mobile, and secure like mobile banking is in the financial industry. A patient-centered longitudinal record gives the patients the choice of when, how, with whom, and to what extent their own medical records can be shared.

The patient receipt of their own health care record should be automatic. We need to eliminate the requirement for the patient to ask for copies of their information and copies of their films. A copy or photo of an image or film should be automatically provided to the patient. The patient should not have to go to a separate location in the hospital, fill out a separate form, and then wait up to 30 days to receive their information. Those 3 things collectively inhibit timely and quality care. We can achieve timely and the best of quality care if we provide the patient with immediate access to his or her own patient-owned integrated EHR.

We need our electronic health record to follow us so we are free to receive care wherever we choose. Through cooperation and non-discrimination, we can have one, single, mobile, longitudinal record.

Multiple, separate portals from each provider, difficult to access, each acting as an island unto itself, is a broken way for a physician to provide optimal health care. It is onerous, expensive, and redundant. It is broken. It does not work.

Patients need ownership rights to their own health information and data, and ability to have an aggregated, integrated, longitudinal, patient-owned electronic health record. That EHR should be readily available to them through their mobile devices. Hospitals/providers should have open API’s, and images, films, EKG’s, CT’s, MRI’s, radiology, open notes regarding discharge and care should be readily accessible in a shared, open architecture for other institutions on behalf of the patient. The EHR should also have available linkage to the patient’s pharmacy for populating a history of prescription fills.

We can greatly improve the quality of health care and provide timely, life saving measures to patients in emergent care with informed physicians and patients, family and caregivers alike. We can substantially reduce costs of health care by eliminating redundancies in providing care across institutions. This common sense approach can, in fact, be readily done with today’s technology, as evidenced in almost every industry other than health care.

Digital copies of new tests and electronic files should be available immediately in the patient’s own designated banked account. As lab results, physician notes, and tests become electronically available to the physician and provider/facility, a copy should instantaneously be populated into the patient’s own, integrated and aggregated, patient-owned, “banked” EHR.

The patient’s integrated EHR should be transactionally populated, much like the financial community, where each digital transaction is shown in the patient’s “banked account.” It should be integrated and aggregated through the patient’s applications of choice, much like Mint or Quicken aggregate financial transactions. Wherever the patient receives care, the patient receives that information into the patient’s “banked account.” Categories such as labs can be dated and aggregated, and trends and results can then easily be charted by the patient and the patient’s care providers.

For example, as a test result or x-ray is read and becomes digitally available to the institution, the patient should be able to have the results and findings reported electronically to their own application and site of choice. Eventually, in addition to lab reports and radiology reads, relevant photos and images should be included in the patient-owned and integrated EHR.

Near term, providers and patients alike (especially emergency departments) need readily available, shared access to existing images produced for patients. Imaging sharing should be open such that any institution could pull up an image no matter where it is, and that access should be provided across institutions for the patient.

We should eliminate the need for the patient to fill out a form to get access to their information. It should be instantaneously populated, versus up to 30 days. Thirty days is not an acceptable time frame. Those 30 days greatly diminish the quality of care.

Patients should be able to secure what they want to keep private, and readily share what they choose to share with other providers, physicians, family members, caregivers. Patients should be able to determine the level of privacy and to whom they want to share their own integrated EHR. Patients should be able to choose to “time out” that sharing, similar to a feature of the Find My Friends and Life360 apps.

Innovation needs to allow for compatibility of our health records with all technology vendors, and for the ability to analyze, aggregate, and readily share health data.

The standard needs to be that the electronic record is provided instantaneously, mobile, portable, compatible with all applications in the repository of our choice, and allowing for state-of-the-art and future technologies.

We need a transparent patient-centered record with full visibility into all our health records – labs, radiology, prescription fills, and care plans – to ensure the best, timely, informed, and efficient care.

Likewise, we need transparency into the quality, performance, and cost of care. With access to these metrics, we can shop for physicians and medical services at a competitive marketplace, not be restricted to certain providers, and hold both patients and providers accountable for performance.

The patient needs to know per drug administered the cost to the patient, itemized by the care facility. For instance the cost of Zantac administered from an ER versus the acceptable range of costs versus over the counter. The billing system of the hospital needs to be aligned with the patient’s instantaneous care as it’s populated, so that the patient has full transparency into the costs being charged for services rendered. Additionally, when a procedure like an MRI can be done electively, the cost of that MRI other than under emergent care where available, should be provided, and the price range of cost for the patient choice. Any out-of-network cost should be revealed to the patient upfront.

Cost data should be aligned with the EHR and be visible to the patient and physician. Physicians and patients alike are blind as to the ultimate cost of procedures. They are blind to what is “in network” and “out of network.” The “out of network charges are additional charges that occur unknowingly to patients and can be gamed by providers. To ultimately give the patient freedom of knowledge and choice, we need to strive for a near-term goal of attaching the cost to the insurer and the cost to the patient as it is aligned with the care provided for the patient, real time to the doctor and to the patient when available.

With data driven choice, we can utilize sites similar to Yelp, Amazon, and OpenTable to shop, assess quality, and book our care globally. When aggregated health data is readily available for comparative quality, cost, research, and analysis, the cost of care lowers and the quality improves.

The Hippocratic oath is to “do no harm.” Today’s EHR software companies and providers are causing harm to the patient by using protectionism and misusing HIPAA, blocking the patient from this readily available, integrated, longitudinal record of his/her health. Let’s get it done. The technology is all here. It is being used cost effectively in almost every other industry. It would drastically change the economics of health care for the better and greatly improve the quality of care to patients, as well as the quality of the jobs of our health professionals. Let’s do the right thing and make a systemic commitment to enable the complete, integrated EHR and empower the patient and give the patient freedom of choice.

Patient Exchanging Secure Messages with Care Providers

Patients and providers should be able to have two-way communication through email, Facetime or Skype, texting, photos, videos, and phone calls. New communication technology conduits should be readily adopted for such two-way communication, rather than requiring a regulation or legislation to allow people to communicate.

The patient should be able to choose to communicate through a text or email with his or her provider and FaceTime where appropriate. Like in the legal world, providers may have a disclaimer regarding confidentiality and security.

The patient’s own choice of privacy and security should supersede any institutional requirements. The patient should be able to opt in for deeper levels of security but should automatically be able to choose to share their fully integrated electronic file where they deem fit. The integrated file should be automatically available for emergency care.

The current software allows for physician notes to be viewable to the patients themselves. Patients should have readily available access to these physician notes. In addition, patients’ ability to edit and provide comments to the physician notes would be an important link to their longitudinal care. Better yet, patient edited and co-produced notes with their providers may be optimal. Most importantly, the collective needs to allow for patient participation and communication two-way with the patient’s integrated EHR.

View, Download, and Transmit Data from EHR

Much like the financial community, patients should be able to download their medical data. If any provider or the patient himself wants to view the integrated lab tests and look at a five or ten year horizon, he/she should be able to readily download the data and compare and contrast changes. They should stored in machine-readable form to allow for data analytics by care providers, caregivers, patients, and for research (where the patient has chosen to opt in).

HHS should seek to remove blockage and process burdens on patients under HIPAA that may limit patient access to their health information based upon patient choice of levels of privacy. See our comments above regarding instantaneous population to the digital record and eliminating signing a form for access and waiting 30 days.

Patients should be able to view their complete patient record, including pricing, tests, films, lab results, and health care provider notes. The EHR should provide affiliated charges and pricing. Price and cost transparency, outside of emergency situations, should be provided upfront to the patient prior to rendering services. As patients access the EHR, they should access the range of pricing from the institution compared to other comparable price ranges for a similar procedure elsewhere.

Health care providers should be able to view their patient’s aggregated/comprehensive patient electronic health record. Health care providers should have a two-way ability to communicate via email, phone, and text with each other regarding patient care.

We support the OpenNotes movement for physician notes to be provided attached to the patient EHR and two-way communication to be allowed for patient engagement.

Remote Patient Authorization and Submission of EHR Data for Research

Patients should own their health information and be able to easily create a longitudinal health record that they can use or share with health care providers, caregivers, researchers and others.

Patient information should not automatically be used for research or brokered even if it is “anonymized.” Patients should have the choice to opt in to any broad or specific medical research, and the institution should not be able to broker the patient’s data without the patient having full transparency and the choice to opt in to having their information brokered and shared. Patients should be remunerated for the per-patient access to such information if the researcher and the institution are being compensated for delivery of such information.

The patient should be fully informed of wherever the institution sends the patient data, even if they claim it is anonymized. The patient should also be informed of the transactional brokerage of their health data and the extent to which it is forwarded to pharmaceutical companies and their subsidiaries or contracted firms, anonymized or not.

If the institution is being paid for those data, the patient should have full transparency into payments the provider or researcher received for his or her medical record. Remunerations should be made to the patient for the use of such data.

Advocacy For Patient-Integrated EHR and Open Technology Platform

• We live in a mobile and global world. Our health data need to reflect our mobile, instant, connected world. It is our right to access and own the results of our medical care instantaneously for our own longitudinal record, and shared with whomever we please.

• We as patients should own our health information and digital results of our care free of charge. We already paid for them by paying for the medical service through our insurance premiums, copays, deductibles, and taxes.

• We need our electronic health record to follow us so we are free to receive care wherever we choose. Through cooperation and non-discrimination, we can have one, single, mobile, longitudinal record, not multiple, separate portals from each provider, difficult to access.

• Innovation needs to allow for compatibility of our health records with all technology vendors, and for the ability to analyze, aggregate, and readily share health data.

• The standard needs to be that the electronic record is provided instantaneously, mobile, portable, compatible with all applications in the repository of our choice, and allowing for state-of-the-art and future technologies.

• We need a transparent patient-centered record with full visibility into all our health records – labs, radiology, prescription fills, and care plans – to ensure the best, timely, informed, and efficient care.

• Likewise, we need transparency into the quality, performance, and cost of care. With access to these metrics, we can shop for physicians and medical services at a competitive marketplace, not be restricted to certain providers, and hold both patients and providers accountable for performance.

• With data driven choice, we can utilize sites similar to Yelp, Amazon, and OpenTable to shop, assess quality, and book our care globally. When aggregated health data is readily available for comparative quality, cost, research, and analysis, the cost of care lowers and the quality improves.

• Providers and their software vendors need to allow for open technology development, leveraging existing state-of-the-art security and patient safety measures like thumbprint, voice, or facial recognition and device verification. The electronic medical record should be transactional, mobile, and secure like mobile banking is in the financial industry. A patient-centered longitudinal record gives the patients the choice of when, how, with whom, and to what extent their own medical records can be shared.

2018 ISA Reference Edition Input

Attached please find our input to the 2018 ISA Reference Edition.

2018 ISA Reference Edition Input - Cerner Comments - Final.pdf

We are delighted to see the…

We are delighted to see the addition of Social, Psychological, and Behavioral Data content in the 2017 ISA and concur with all of the recommendations for use of LOINC for representing these observations.

AMA's comments to ONC on proposed 2018 ISA

On behalf of American Medical Association (AMA) I appreciate the ability to comment on ONC's questions and requests for stakeholder feedback regarding the Interoperability Standards Advisory (ISA).

 

Section V: Administrative Standards and Implementation Specifications

17-8. Please review the contents of the new Section V: Administrative Standards and Implementation Specifications and provide comments about the accuracy of any of the listed standards/specifications and attributes.

The Administrative Standards Section requires introductory material that indicates the general applicability of the law, the regulatory authority, and the parties required to meet compliance.  The HIPAA laws were created with completely different goals and have requirements that differ greatly from EHR regulations, making the insertion of transactional information potentially confusing and/or misleading without appropriate overview. CMS has considerable information on their website that provides introduction to this content.  Important pieces to cover are:

• Covered Entities
• Business Associates
• General Rules applicable to all administrative standards
  • All covered entity requirements (pursuant to 45 CFR 162.923)
  • Health plan requirements (pursuant to 45 CFR 162.925)
• Enforcement (Both the potential for the secretary under the law and the active enforcement using the ASETT Resource maintained by HHS)

Additionally, the subsections for each transaction would be greatly enhanced with some general information as to the purpose of each transaction.  Currently, the page simply lists technical content and information about when and how it was developed.  In order to truly provide appropriate overview, a short overview and potential link to relevant information would be appropriate.  CMS has an overview site with information that can be leveraged at https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/Transactions/TransactionsOverview.html.

• Use of the term standard throughout is not consistent with the governmental definition.  In the context of HIPAA, ASC X12 5010 is not a standard; it is a version of the entire set of standards (implementation guides for the transactions are the standards).  However, 5010 is the “standard” as it applies to ANSI, but is defined differently in the regulation. It is likely best for this resource to be consistent with the statutory definition as mandated in the HIPAA regulations.

837P Professional Claims

• We believe that the statement that EHR content duplicates information in administrative claims information is a bit of an overstatement/mischaracterization. There may be some overlap in basic patient demographic information, but claims data is used for payment and is revenue-cycle-oriented – not clinical – in nature.
• The language about testing seems a bit misleading.  If testing is conducted during implementation, then it is not really a test.  Testing by nature would occur before “implementation” as a standard.  As it is, there is no testing that occurs in advance of standards being named in regulation. We would also note that links to ASETT under “Test Tool Availability” appear to be broken throughout the ISA.

Eligibility for a Health Plan (Benefits and Coverage) – Request and Response (270/271)
 

• In order to avoid confusion about the function of the transaction, we recommend listing the formal title of the transaction, which is Health Care Eligibility Benefit Inquiry and Response.  The current heading could be misinterpreted to be a transaction used by patients or providers prior to becoming subscribers/network members of a health plan.

Health Care Attachments to Support Claims, Referrals and Authorizations: 

The X12N 278 - Health Care Services Request for Review and Response (006020X315) transaction is listed as not being federally required. While this is true, the 5010 version of the Health Care Services Request for Review and Response is in fact mandated under federal law and regulation.  Despite this mandate, a large majority of industry participants are not using the transaction, which may be due to the lack of an attachment transaction.

Additionally, this section requires a significant amount of introductory material to help people accessing the site understand the various standards listed in the chart.

Global question for Section V: What is the source for the adoption level of the various standards and operating rules? We assume that the CAQH Index is being used for the adoption level of the standards; if this is correct, it would be appropriate to reference that source. However, the CAQH Index does not evaluate operating rule adoption, so we are curious how this is being determine.

17-10. For Interoperability Need: Health Care Claims or Equivalent Encounter Information for Institutional Claims, feedback is requested on the update process for X12 standards, and how a more streamlined process can be implemented with greater industry engagement. Other improvement ideas are also encouraged to enhance the benefit of the transaction.

The current X12 update process does not satisfactorily meet the needs of the industry to improve and update transactions in a manner that is expeditious, transparent, and adequately representative of all industry stakeholders.  The X12 process is not sufficiently agile to satisfactorily respond to the quickly evolving needs of the health care industry.  Specifically, the updated 5010 version of the initially mandated 4010 HIPAA transactions was named in regulation in 2008.  Since this date, there has yet to be a mandated update to the transaction sets. This has led many providers, payers, and other industry participants to develop work arounds or to stifle innovation that would help advance the industry.

In addition to the lack of timely updates, the X12 transaction development and approval process fails to facilitate adequate inclusion and representation of all industry participants.  The 7030 transaction set, which is presumably the next version for which X12 will seek a regulatory mandate, is currently undergoing public review.  This review process is hindered and compromised by X12’s reluctance to release the implementation guides under review in an easily accessible and digestible manner, primarily due to intellectual property concerns.  Regardless of the justification, the obstacles interfering with easy access to the draft guides have limited the “public” review to the same exact industry stakeholders willing to commit significant time, resources, and finances to participating in X12 technical transaction development. Essentially, the entities that created the draft guides for review are the exact same parties that are now reviewing and commenting on the materials during the “public” comment process.  Due to the significant resources needed to effectively participate in the X12 technical standard development process, physicians and their representatives often cannot justify the enormous cost and time needed to participate, thereby creating an atmosphere that fails to represent physician views and is primarily driven by health insurers, vendors, and clearinghouses (despite HIPAA’s initial goal of protecting physician time and resources from burdensome administrative activities).   

Once a new guide is recommended for publication and mandated under regulation, physicians and health insurers are required to make significant, costly system changes to incorporate the new transaction sets.  For example, CMS has indicated that the transition from version 4010 to version 5010 of the X12 transactions took 5 years and cost the agency approximately $700 million.  X12 has recently transitioned to a licensed system of collecting money from industry participants utilizing their guides.  As a result of this transition and the need to justify the annual licensure fees to physicians and health plans, X12 should consider developing a system that allows yearly changes to be made and included in the annual updates that are promised under their licensure agreements. 

17-13. For Interoperability Need: Electronic Funds Transfer for Payments to Health Care Providers – Professionals and Institutions, are there known barriers to the use of the EFT transaction based on contract concerns, excessive fees, enrollment constraints or other non-EDI issues?

The main issues limiting the usage of the standard EFT transaction were implementation of alternative payment methods, such as virtual credit cards, and the imposition of improper fees on the EFT standard.  The recent guidance on EFT and virtual credit cards included in the CMS FAQs (https://questions.cms.gov/faq.php?id=5005&rtopic=1851) offers significant clarification and enumeration of provider rights related to electronic payment and should support increased adoption of EFT. At this stage, adequate provider education about their specific rights and the rules placed on insurers and vendors by this guidance will be important.  Additionally, the development of an audit or other improved enforcement mechanisms to ensure that health plans are adhering to standards and operating rules will be essential.  

Another frequently reported barrier to providers’ adoption of standard EFT is the burdensome, tedious enrollment process. Providers must enroll in EFT separately with each health plan, and sometimes even with different products for the same health plan. This is extremely time consuming and administratively burdensome. Multi-payer ERA and EFT enrollment systems, such as CAQH’s EnrollHub, can help reduce provider burdens and facilitate increased adoption of EFT.

17-14. For Interoperability Need: Health Care Payment and Remittance Advice, feedback is requested on how the transaction or use by the submitter and/or receiver can be improved to enhance its use and increase the value of the transaction.

The recent guidance on EFT and ERA in the CMS FAQs (https://questions.cms.gov/faq.php?id=5005&rtopic=1851) offers significant clarification and enumeration of provider rights related to electronic payment and remittance advice and should support increased adoption of ERA. At this stage, adequate provider education about their specific rights and the rules placed on insurers and vendors by this guidance will be important.  Additionally, the development of an audit or other improved enforcement mechanisms to ensure that health plans are adhering to standards and operating rules will be essential.  

Providers often cite the burdensome, tedious enrollment process as a barrier to ERA adoption. Providers must enroll in ERA and EFT separately with each health plan, and sometimes even with different products for the same health plan. This is extremely time consuming and administratively burdensome. Multi-payer ERA and EFT enrollment systems, such as CAQH’s EnrollHub, can help reduce provider burdens and facilitate increased adoption of ERA.

In addition, lack of health plan compliance with the ERA standard discourages more widespread adoption of the transaction. For example, some health plans do not provide balanced ERAs, despite the fact that this represents noncompliance with the standard. Other compliance issues include not following the required ratio of one ERA to one EFT and inconsistent/noncompliant use of CARCs and RARCs (reason codes for payment reductions or denials).

Lack of full vendor automation of the ERA transaction also hinders adoption. To reap the full efficiency and return on investment of ERA, provider vendor systems should support auto-posting of remittance advice and automated reconciliation/reassociation with EFT payments. However, these functionalities are not included in many vendor systems today.

17-15. For Interoperability Need: Referral Certification and Authorization Request and Response for Dental,

Professional and Institutional Services, feedback is requested to better understand the workflows that will increase adoption of this transaction.

Industry adoption of the Health Care Services Review – Request for Review and Response is abysmally low – 18% according to the most recent CAQH Index – despite the fact that this is a HIPAA-mandated transaction. Given the fact that the authorization process is burdensome and costly for both providers and health plans, increased adoption of this transaction could offer significant administrative savings for the industry. One frequently cited barrier to adoption of the transaction is the lack of a mandated electronic clinical attachment standard. Without a standard mechanism to electronically exchange supporting clinical documentation between providers and health plans, the authorization process remains relegated to manual processes, such as telephone calls, faxes, and mail. While proprietary health plan portals may offer some advantages over these traditional methods, they require unique logins/passwords for each plan, as well as extensive re-entry of data from the EHR – both of which are burdensome to providers. Health plans’ investments in their existing portals represent another substantial barrier to widespread adoption of the X12 278 transaction.

Other challenges to increased adoption of the transaction relate to its current usage (or misusage, as it may be). Health plans often inappropriately use the “pended” status message in response to authorization requests, even when no authorization is required, the authorization must be submitted to a third-party utilization management vendor, or no additional information is needed for processing the request. In addition, health plans often return a message of “pended” and then request that the provider use another method of communication – phone, fax, portal – to complete the authorization. Not only does this practice divert the authorization workflow from electronic data interchange, but it discourages any use of the X12 278 transaction by providers.

Finally, providers face significant challenges in determining what services and procedures require authorization. As long as there remains a lack of transparency around the services requiring authorization and the documentation providers need to submit to health plans to receive a determination, adoption of the transaction will remain low, as providers will chose to call the insurer to obtain this information.

17-16. For Interoperability Need: Operating Rules to Support Eligibility and Claim Status Transactions (Phase II), feedback is requested on: a) the process for creating the operating rules; b) current adoption of the batch vs. real time rules for both providers and health plans; c) need for other operating rules that will improve adoption of the transactions.

The operating rules represent an important supplement to the named standard transactions.  As a result of their status as a supplement to the X12 transactions, it is best to include information concerning their applicability and the rights/responsibilities created therein with their corresponding HIPAA standard in the appropriate tab of the ISA.  As new transactions are mandated under regulation, corresponding operating rules will be extremely important to ensure that they meet the business needs of industry participants. 

There is real value to the real-time requirements for the eligibility and claim status transactions, as getting this information quickly is of critical importance to providers. Requiring responses to eligibility and claim status requests in real time, as required by the operating rule, is extremely beneficial to providers.

Up until recently, CAQH CORE has undertaken operating rule development strictly according to regulatory direction. It would be beneficial to the entire industry if CAQH CORE would periodically assess the need for additional operating rules and undertake rule development without a government requirement. This would allow a more agile response to emerging industry needs. To its credit, CAQH CORE recently has done just that by establishing a Prior Authorization Subgroup to develop additional operating rules for the authorization transaction.

17-17. For Interoperability Need: Operating Rules for Electronic Funds Transfer (EFT) and Electronic Remittance Advice (ERA) for Payments and Reconciliation (Phase III), feedback is requested on other operating rules that will increase adoption and/or use of the standards for EFT and ERA.

The recent guidance on EFT and virtual credit cards included in the CMS FAQs (https://questions.cms.gov/faq.php?id=5005&rtopic=1851) offers significant clarification and enumeration of provider rights related to electronic payment and should support increased adoption of EFT. At this stage, adequate provider education about their specific rights and the rules placed on insurers and vendors by this guidance will be important.  To establish additional provider protections for electronic payment, CAQH CORE could consider incorporating some of the concepts in the FAQs – e.g., providers’ right to refuse payment via virtual credit cards, providers’ right to request and receive standard EFT with no health plan or vendor fees – into future operating rules. It would also be beneficial to address security of providers’ EFT enrollment information in a future operating rule, as we have learned of cases where providers’ bank routing information is changed without their knowledge or consent. An operating rule addressing EFT enrollment data security could help deter this type of criminal activity. Additionally, the development of an audit or other improved enforcement mechanisms to ensure that health plans are adhering to standards and operating rules will be essential.  

It should also be noted that CAQH CORE has created Phase IV operating rules for the authorization, claim, employee premium payment, and health plan enrollment/disenrollment transactions. These rules are voluntary and not mandated for the industry, but they should be listed in the ISA. CAQH CORE does offer certification for entities that are voluntarily complying with the Phase IV operating rules.

 

Pharmacy HIT Collaborative Comments to ONC on Proposed ISA

On behalf of the membership of the Pharmacy Health Information Technology Collaborative (Collaborative), we are pleased to submit comments for the advanced 2018 Interoperability Standards Advisory comment period.

The Collaborative has been involved with the federal agencies, including the Office of the National Coordinator (ONC), developing the national health information technology (HIT) framework since 2010. The Collaborative is supportive of the proposed standards for clinical health IT interoperability purposes.

Pharmacists provide patient-centered care and services, maintain various secure patient care records, and as part of the integrated health care team, they are directly involved with other health care providers and patients in various practice settings. Pharmacists are users of health IT and are especially supportive of interoperability standards incorporating HL7, SNOMED CT, LOINC, RxNorm, and NCPDP SCRIPT, and NCPDP Real Time Formulary and Benefits (currently under development). The Collaborative supports use of these particular standards which are important to pharmacists for allergy reactions, immunization historical and administered, immunization registry reporting, medications, medication allergies, patient problems, smoking status, reporting to public health agencies, clinical decision support services/knowledge artifacts, drug formulary checking, and electronic prescribing (including new versions).

The Collaborative recommends that consolidated CDA (C-CDA) Release 1.1 and 2.0 be included for the summary care record. For pharmacists providing patient care services, there have been joint NCPDP and HL7 standards development[1] and implementation guides work using C-CDA Release 1.1 and current work using C-CDA release 2.1 for Pharmacist eCare Plan[2].

[1] http://ncpdp.org/NCPDP/media/pdf/Pharmacist-eCare-Plan.pdf, accessed November 8, 2017.

[2] https://www.healthit.gov/techlab/ipg/node/4/submission/1376, accessed November 8, 2017.

The attached document are our comments regarding changes made to the final 2017 Interoperability Standards Advisory and the advance request for feedback regarding the 2018 Interoperability Standards Advisory that is in the development process. On behalf of the Pharmacy HIT Collaborative, thank you again for the opportunity to comment on the advanced 2018 Interoperability Standards Advisory.

 

PHIT Letter Advance 2018 ISA Comments 11-20-17v1.pdf

ANI comments to ONC Proposed 2018 ISA

Thank you for the opportunity to provide comments.  Please find the attached letter from the Alliance for Nursing Informatics (ANI).

ANI Letter to ONC ISA response Nov 20 2017 final.pdf

ISA 2018 Comments from Academy of Nutrition and Dietetics

Please find attached our comments concerning the 2018 ISA.  We appreciate both the opportunity to comment and consideration of our requests.

Lindsey Hoggle, MS, RDN, PMP

Letter ONC Standards Advisory Nov 2018 FINAL.pdf

NCPDP - Comment

General

17-1. In what ways has the ISA been useful for you/your organization as a resource? ONC seeks to better understand how the ISA is being used, by whom, and the type of support it may be providing for implementers and policy-makers.

Response: In general NCPDP does not use this document.

 

17-2. Over the course of 2017, various new functionality has been added to the ISA to make it a more interactive and useful resource (e.g., print-friendly pages, change notifications, advanced search functionality, etc). Are there additional features or functionalities that would enhance the overall experience?

Response: Consolidating some of the information as it pertains to NCPDP as indicated above.

 

17-3. An Appendix II has been added that includes educational and informational resources as recommended by the Health IT Standards Committee/2017 ISA Task Force. Are there other topics and/or existing resources which would be helpful to include in this area to increase stakeholder understanding of health IT interoperability issues?

Response: N/A

Section I: Vocabulary/Code Set/Terminology Standards

17-4. Are there additional Interoperability Needs (with corresponding standards) that represent specific sociodemographic, psychological, behavioral or environmental domains that should be included in the ISA?

Response: N/A

Section II: Content / Structure Standard and Implementation Specifications

17-5. A new interoperability need, Reporting Birth Defects to Public Health Agencies was added to Section II-R: Public Health Reporting. Please review and provide comment about the accuracy of the attributes.

Response: N/A

Section III: Standards and Implementation Specifications for Services

17-6. A new subsection, III-J: Consumer Access/Exchange of Health Information has been added, with four interoperability needs. Please review and provide comment about the accuracy of the attributes. ONC also seeks suggestions for additional consumer access related interoperability needs for inclusion, as well as other known standards or Open APIs that should be listed for existing consumer access interoperability needs.

Response: N/A

Section IV: Models and Profiles

17-7. Is the existing ISA format used for listing standards and implementation specifications applicable for listing Models and Profiles? Are there additional or different attributes that should be collected for them? Are there additional models and/or profiles that should be listed?

Response: N/A

Section V: Administrative Standards and Implementation Specifications

17-8. Please review the contents of the new Section V: Administrative Standards and Implementation Specifications and provide comments about the accuracy of any of the listed standards/specifications and attributes.

Response: Refer to comments provided in Section V: Administrative Standards and Implementation Specifications

 

17-9. Are there additional administrative-related interoperability needs that should be listed in this section?

Response: No

 

17-10. For Interoperability Need: Health Care Claims or Equivalent Encounter Information for Institutional Claims, feedback is requested on the update process for X12 standards, and how a more streamlined process can be implemented with greater industry engagement. Other improvement ideas are also encouraged to enhance the benefit of the transaction.

Response: NCPDP and ASC X12 recently participated in the National Committee on Vital and Health Statistics’ (NCVHS) Workshop on the Predictability Roadmap for Updating and Adopting Standards and Operating Rules. NCVHS has not yet issued their initial summary report from the workshop but we encourage ONC to look to the outcomes from the NCVHS effort for ways to streamline the overall process.

 

17-11. For Interoperability Need: Health Care Claims or Equivalent Encounter Information for Dental Claims, feedback is requested from the dental community on enhancements to the transaction to increase uptake on electronic transactions.

Response: N/A

 

17-12. For Interoperability Need: Enrollment and Disenrollment in a Health Plan, feedback is requested on the use of the adopted enrollment transaction, its value to the industry, and any enhancements that could be made to increase utilization.

Response: N/A

 

17-13. For Interoperability Need: Electronic Funds Transfer for Payments to Health Care Providers – Professionals and Institutions, are there known barriers to the use of the EFT transaction based on contract concerns, excessive fees, enrollment constraints or other non-EDI issues?

Response: NCPDP has a Work Group that supports pharmacy industry needs involving EFT transactions. At this time, NCPDP has not received any feedback on barriers to using EFT transactions.

 

17-14. For Interoperability Need: Health Care Payment and Remittance Advice, feedback is requested on how the transaction or use by the submitter and/or receiver can be improved to enhance its use and increase the value of the transaction.

Response: Pharmacy industry utilizes this transaction regularly. NCPDP has a designated Work Group to address any concerns and/or needs from its members. NCPDP, in conjunction with ASC X12 has a procedure that documents how this transaction supports the NCPDP real-time transactions.

 

17-15. For Interoperability Need: Referral Certification and Authorization Request and Response for Dental, Professional and Institutional Services, feedback is requested to better understand the workflows that will increase adoption of this transaction.

Response: N/A

 

17-16. For Interoperability Need: Operating Rules to Support Eligibility and Claim Status Transactions (Phase II), feedback is requested on: a) the process for creating the operating rules; b) current adoption of the batch vs. real time rules for both providers and health plans; c) need for other operating rules that will improve adoption of the transactions.

Response: Refer to response above (V-E: Operating Rules to Support Administrative Transactions)

 

17-17. For Interoperability Need: Operating Rules for Electronic Funds Transfer (EFT) and Electronic Remittance Advice (ERA) for Payments and Reconciliation (Phase III), feedback is requested on other operating rules that will increase adoption and/or use of the standards for EFT and ERA.

Response: NCPDP has not received comments from its members that would affect adoption and/or use of either EFT and/or ERA.