2015 Health IT Certification Criteria Capture Patient Sexual Orientation and Gender Identity

The 2015 Health IT certification criteria include the capture of sexual orientation and gender identity in the demographics certification criteria. 

As part of an important patient matching initiative by the Office the National Coordinator for Health IT (ONC), patient sex is one of five key attributes that are now part of the certification criteria.  NAHAM News readers will know that NAHAM is developing Recommended Best Practices on the Collection of Key Patient Attributes.  (Learn more in NAHAM News: “Key Patient Matching Attributes Included in 2015 Health IT Certification Criteria”.)

During the development of the 2015 criteria, patient sex was proposed to be captured with the following values: male (M), female (F), and unknown (UNK).  Of significance in the final rule for health IT certification was the decision to use the coding for “sex” to present birth sex. 

The ONC did not adopt recommendations made by commenters from the general public to capture a patient’s sexual orientation or gender identity as part of this criterion. Instead, the ONC proposed the capture of sexual orientation and gender identity (SO/GI) data as part of the proposed ‘‘social, psychological, and behavioral data’’ certification criterion.  Follow the ONC’s narrative on this issue found in the final rule –

Sexual Orientation and Gender Identity (SO/GI)

We [the ONC] did not propose to include a requirement to capture a patient’s sexual orientation or gender identity as part of this criterion. Rather, we proposed the capture of SO/GI data as part of the proposed ‘‘social, psychological, and behavioral data’’ certification criterion.

Comments. We [the ONC] received a significant number of comments from providers, consumers/individuals, and health care coalitions strongly recommending that we consider including sexual orientation and gender identify as a component of the Base EHR definition (e.g., in the demographics certification criterion) or Common Clinical Data Set definition. These commenters suggested that there are mature vocabulary standards for representing SO/GI and there is strong clinical value in having this data to inform decisions about health care and treatment. Commenters indicated that by including SO/GI in the Base EHR or Common Clinical Data Set definitions, providers would be required to possess this functionality for participation in the EHR Incentive Programs, which could have a large impact for evaluating the quality of care provided to lesbian, gay, bisexual, and transgender (LGBT) communities.

Response. We [the ONC] thank commenters for their feedback. Given this feedback, the clinical relevance of capturing SO/GI, and the readiness of the values and vocabulary codes for representing this information in a structured way, we require that Health IT Modules enable a user to record, change, and access SO/GI to be certified to the 2015 Edition ‘‘demographics’’ certification criterion. By doing so, SO/GI is now included in the 2015 Edition Base EHR definition. The 2015 Edition Base EHR definition is part of the CEHRT definition under the EHR Incentive Programs. Therefore, providers participating in the EHR Incentive Programs will need to have certified health IT with the capability to capture SO/GI to meet the CEHRT definition in 2018 and subsequent years. We note that like all information in the ‘‘demographics’’ criterion, certification does not require that a provider collect this information, only that certified Health IT Modules enable a user to do so. We believe including SO/GI in the ‘‘demographics’’ criterion represents a crucial first step forward to improving care for LGBT communities. We have not included it in the Common Clinical Data Set at this time.

Comments. One commenter recommended we consider including structured and coded questions for soliciting SO/GI information as part of certification.

Response. While we [the ONC] thank the commenter for providing this recommendation, we do not believe that the suggested questions have yet been scientifically validated for use in health care settings and, thus, have not adopted them. We do, however, believe that these questions are being used today in health care settings as ‘‘best practices,’’ and would suggest that health care providers and institutions decide whether to include these questions in the collection of SO/GI information. These ‘‘best practice’’ questions and the answers we have adopted are:

·        Do you think of yourself as:

o   Straight or heterosexual;

o   Lesbian, gay, or homosexual;

o   Bisexual;

o   Something else, please describe.

o   Don’t know.

·        What is your current gender identity? (Check all that apply.)

o   Male;

o   Female;

o   Transgender male/Trans man/Female-to-male;

o   Transgender female/Trans woman/Male-to-female;

o   Genderqueer, neither exclusively male nor female;

o   Additional gender category/(or other), please specify.

o   Decline to answer.

Does your Access Department have protocols in place to capture birth sex only, or gender as noted on an official government-issued identification, or do you record only what the patient reports?  Does your information technology have fields or do you attempt to capture sexual orientation or gender identity if different from what is reported on a government-issued identification?  Is Patient Access ready to capture these attributes?

Waiting on CMS to Finalize MOON

Access Departments may expect to provide Medicare patients with the new Medicare Outpatient Observation Notice (MOON). As of mid-day today, August 2, CMS has not finalized the MOON.  A draft MOON, different from an earlier draft notice form, along with instructions and background information, may be found on the CMS webpage here.  NAHAM will provide additional information as we are able to obtain it from CMS.

The Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act) of 2015 requires hospitals and Critical Access Hospitals (CAH) to provide written and oral notification to individuals receiving observation services as outpatients for more than 24 hours. The NOTICE Act required the Secretary of Health and Human Services (HHS) to develop a notice form that explains why the patient is receiving observation services, the implications of receiving outpatient observation services, such as cost sharing, and post-hospitalization eligibility for Medicare coverage of skilled nursing facility (SNF) services. The NOTICE Act also created an effective date of August 6, 2016.  In an April 27, 2016 proposed rule, CMS provided an opportunity for public comments on its proposed hospital and CAH notification procedures for outpatients receiving observational services.

Hospitals and CAHs will be required to furnish a new CMS-developed standardized notice, the Medicare Outpatient Observation Notice (MOON), to a Medicare beneficiary or enrollee who has been receiving observation services as an outpatient for more than 24 hours. The notice must be provided no later than 36 hours after observation services are initiated. 

In its guidance, CMS notes that although hospitals must provide a hard copy of the MOON to CMS beneficiaries and enrollees, hospitals may retain a copy of the signed MOON electronically.  In cases where the beneficiary has a representative who is not physically present, hospitals are permitted to give the MOON by telephone as long as a hard copy is delivered to the representative.

CMS indicates that “When delivering the MOON, hospitals and CAHs are required to explain the notice and its content, document that an oral explanation was provided and answer all beneficiary questions to the best of their ability.” Because oral explanation of the MOON must be provided, as a practical matter that explanation will be provided in conjunction with the delivery of the hard copy notice.  CMS indicates that a Spanish language version of the MOON will be made available.  Where an individual receiving the notice is unable to read its written contents and/or comprehend the required oral explanation, CMS expects hospitals and CAHs to “employ their usual procedures to ensure notice comprehension”.  CMS will provide guidance for oral notification in its forthcoming Medical manual provisions.

A signature must be obtained from the individual, or an individual qualified to act on their behalf, to acknowledge receipt and understanding of the notice (or in cases of refusal of signature by such individual, signature by the staff member of the hospital or CAH providing the notice).

It is very likely Access Departments will be asked to provide a copy of the MOON notice at the point of entry, much as most Access Departments do with the IMM (Important Message from Medicare). This may be the most practical way to meet the requirement that the notice be given no later than 36 hours after observational services are initiated.  The requirement that a verbal explanation be given as well, Access Departments should anticipate having to provide the oral explanation of the MOON as well.  If the patient has any specific questions about the notice, the form of the notice or his or her observational status, Access Departments can refer the patient to Case Management.

Because the MOON is a CMS standardized notice, it was required to go through the Paperwork Reduction Act process, thus affording the public an opportunity to comment on the proposed MOON. This has caused a delay in finalizing the content and format of the notice by the August 6 statutory effective date. 

Waiting on CMS to Finalize MOON

Access Departments may expect to provide Medicare patients with the new Medicare Outpatient Observation Notice (MOON). As of mid-day today, August 2, CMS has not finalized the MOON.  A draft MOON, different from an earlier draft notice form, along with instructions and background information, may be found on the CMS webpage here.  NAHAM will provide additional information as we are able to obtain it from CMS.

The Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act) of 2015 requires hospitals and Critical Access Hospitals (CAH) to provide written and oral notification to individuals receiving observation services as outpatients for more than 24 hours. The NOTICE Act required the Secretary of Health and Human Services (HHS) to develop a notice form that explains why the patient is receiving observation services, the implications of receiving outpatient observation services, such as cost sharing, and post-hospitalization eligibility for Medicare coverage of skilled nursing facility (SNF) services. The NOTICE Act also created an effective date of August 6, 2016.  In an April 27, 2016 proposed rule, CMS provided an opportunity for public comments on its proposed hospital and CAH notification procedures for outpatients receiving observational services.

Hospitals and CAHs will be required to furnish a new CMS-developed standardized notice, the Medicare Outpatient Observation Notice (MOON), to a Medicare beneficiary or enrollee who has been receiving observation services as an outpatient for more than 24 hours. The notice must be provided no later than 36 hours after observation services are initiated. 

In its guidance, CMS notes that although hospitals must provide a hard copy of the MOON to CMS beneficiaries and enrollees, hospitals may retain a copy of the signed MOON electronically.  In cases where the beneficiary has a representative who is not physically present, hospitals are permitted to give the MOON by telephone as long as a hard copy is delivered to the representative.

CMS indicates that “When delivering the MOON, hospitals and CAHs are required to explain the notice and its content, document that an oral explanation was provided and answer all beneficiary questions to the best of their ability.” Because oral explanation of the MOON must be provided, as a practical matter that explanation will be provided in conjunction with the delivery of the hard copy notice.  CMS indicates that a Spanish language version of the MOON will be made available.  Where an individual receiving the notice is unable to read its written contents and/or comprehend the required oral explanation, CMS expects hospitals and CAHs to “employ their usual procedures to ensure notice comprehension”.  CMS will provide guidance for oral notification in its forthcoming Medical manual provisions.

A signature must be obtained from the individual, or an individual qualified to act on their behalf, to acknowledge receipt and understanding of the notice (or in cases of refusal of signature by such individual, signature by the staff member of the hospital or CAH providing the notice).

It is very likely Access Departments will be asked to provide a copy of the MOON notice at the point of entry, much as most Access Departments do with the IMM (Important Message from Medicare). This may be the most practical way to meet the requirement that the notice be given no later than 36 hours after observational services are initiated.  The requirement that a verbal explanation be given as well, Access Departments should anticipate having to provide the oral explanation of the MOON as well.  If the patient has any specific questions about the notice, the form of the notice or his or her observational status, Access Departments can refer the patient to Case Management.

Because the MOON is a CMS standardized notice, it was required to go through the Paperwork Reduction Act process, thus affording the public an opportunity to comment on the proposed MOON. This has caused a delay in finalizing the content and format of the notice by the August 6 statutory effective date.