Thread by @motorcycle_guy

Everyone else is napping at this time, so I’m finally getting around to my first read through of #TheSANERRule. I haven’t quite started yet, but am hoping that what I find can make that label stick. federalregister.gov/documents/2022…

federalregister.gov/d/2022-08268/p… says: “would also revise the hospital and critical access hospital (CAH) conditions of participation (CoPs) for infection prevention and control and antibiotic stewardship programs”, this is why I might call it #TheSANERRule, and where I will focus.

#TheSANERRule has 638 pages in print form govinfo.gov/content/pkg/FR…, and covers a number of additional topics. I’m expecting that somewhere around 200-250 pages matter to me.

related and only partially relevant to my focus on the #TheSANERRule are Changes to the Medicare Promoting Interoperability Program: federalregister.gov/d/2022-08268/p…

But this “m. Condition of Participation (CoP) Requirements for Hospitals and CAHs To Report Data Elements To Address Any Future Pandemics and Epidemics as Determined by the Secretary” is why I’m calling it #TheSANERRule federalregister.gov/d/2022-08268/p…

Words I love to read: “we propose to require hospitals and CAHs to report specific data elements to the CDC's National Health Safety Network (NHSN), or other CDC-supported surveillance systems, as determined by the Secretary”. I strongly support having NHSN doing this work.

I’d hate to see NHSN expertise lost in this effort. If it were to go elsewhere, perhaps a restructuring based on core NHSN expertise would work IMHO. It was already a loss when it transitioned away from NHSN in the first COVID-19 summer
#THeSANERRule

“this section would apply to local, state, & national PHEs as declared by the Secretary. Additionally, we are proposing that the hospital (or CAH) provide the information specified on a daily basis, unless the Secretary specifies a lesser frequency [based on] … ongoing risks.”

Unlike other rules I read, #TheSANERRule requires my digging into the costs section. images.federalregister.gov/EP10MY22.002/o… — after all, these are the very costs that SANER is trying to avoid.

Skipping way ahead in #TheSANERRule to 11. ICRs for Condition of Participation (CoP) Requirements for Hospitals & CAHs To Report Data Elements To Address Any Future Pandemics & Epidemics as Determined by the Secretary

federalregister.gov/d/2022-08268/p…

hate TOC links can’t open to new tab

Important details finally: “we do not expect that these categories of data elements would require hospitals and CAHs to report any information beyond that which they have already been reporting” … but continue to report until 2024 or the secretary says done #TheSANERRule

“For purposes of burden estimates, we do not differentiate among hospitals and CAHs as they all would complete the same data collection.” Is so wrong headed. Most hospitals have an IT dept to provide support. Some CAH’s have a guy that comes in once a week. manual burden >>>>$$

Youngest is listening to @GameGrumps while I review #TheSANERRule. The number of times that game commentary seems applicable to this rule is hilarious.

“.. likely overestimates the costs associated with reporting because it assumes that all hospitals and CAHs will report manually. Efforts are underway to automate hospital & CAH reporting that have the potential to significantly decrease reporting burden and improve reliability”

A reference to what they are actually talking about in that last tweet might be nice. CMS failed to provide one, but obviously, The SANER Project and new work in Helios in HL7 we are engaged in are two of these efforts. #TheSANERRule

federalregister.gov/d/2022-08268/p…

#theSANERRule “In addition, we are proposing to establish reporting requirements for future PHEs related to epidemics and pandemics… Acute Respiratory Illness”

federalregister.gov/d/2022-08268/p…

I am reminded of a story told at PHIN by a keynote speaker some 10-15 yrs ago…

… in which she said basically, we spend all this money on systems XXXX flu, and it was useless for YYYY flu (XXXX,YYYY =some form of bird flu and swine flu in I don’t recall what order).

Please don’t forget that not all pandemics are respiratory

#TheSANERRule

#TheSANERRule Page 28643 and last link already has me drafting first comment on “require hospitals & CAHs to report specific data elements to the CDC's National Health Safety Network (NHSN), or other CDC-supported surveillance systems, as determined by the Secretary”

It reads: “We strongly support building reporting efforts upon the core expertise of NHSN who nas been handling hospital, CAH and LTC infectious disease reporting for decades.”

#TheSANERRule

It’s not stealing if I give permission. Feel free to copy that text into your own comments on #TheSANERRule

Family has reawoken, back to vacation… I’ll be back to this later

Resuming my read through of #TheSANERRule over this holiday/vacation weekend:

“The proposed requirements of this section would apply to local, state, and national PHEs as declared by the Secretary.”

I note this covers national, state and local …

What about territorial and tribal Public Health Entities? Are they required to report for #TheSANERRule? There may be jurisdictional issues here, as this is mandated as a condition of participation, and so may not be applicable in these regions.

#TheSANERRule

“categories of data elements that this report would include are …:

* Suspected & confirmed infections of the relevant infectious disease pathogen among patients and staff;
* total deaths attributed to the relevant infectious disease pathogen among patients & staff;

…

* personal protective equipment & other relevant supplies in the facility;

#TheSANERRule

* capacity and supplies in the facility relevant to the immediate & long term treatment of the relevant infectious disease pathogen, such as ventilator & dialysis/continuous renal replacement therapy capacity and supplies;

[this can be parameterized by disease]

* total hospital bed and intensive care unit bed census, capacity, & capability;
* staffing shortages;
* vaccine administration status of patients and staff for conditions monitored under this section and where a specific vaccine is applicable;

#TheSANERRule

* relevant therapeutic inventories and/or usage;
* isolation capacity, including airborne isolation capacity;
* & key co-morbidities and/or exposure risk factors of patients being treated for the pathogen or disease of interest …

#TheSANERRule

All if this “captured with interoperable data standards & elements.”

Disease = ValueSet
Treatment Devices = ValueSet
Vaccine = ValueSet
Theraputics (meds or biologics) = ValueSet
Co-morbidities = ValueSet

Page 28643
federalregister.gov/d/2022-08268/p…

#TheSANERRule

federalregister.gov/d/2022-08268/p…

“We are also proposing to require that, unless the Secretary specifies an alternative format by which a hospital (or a CAH) must report each applicable infection (confirmed and suspected) and the applicable vaccination data in …

#TheSANERRule

… a format that provides person-level information, to include medical record identifier, race, ethnicity, age, sex, residential county and zip code, and relevant comorbidities for affected patients,
…

unless the Secretary specifies an alternative format by which the hospital (or CAH) would be required report these data elements.

#TheSANERRule

We are also proposing in this provision to limit any person-level, directly or potentially individually identifiable, information for affected patients and staff to items outlined in this section or otherwise specified by the Secretary. …

#TheSANERRule

We note that the provided information obtained in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it will be held in strict confidence, will be used only for the purposes stated,
…
#TheSANERRule

and will not otherwise be disclosed or released without the consent of the individual, or the institution in accordance with Section 304, 306, and 308(d) of the Public Health Service Act (42 U.S.C. 242b, 242k, and 242m(d)).

#TheSANERRule

…. a hospital (or a CAH) would provide the information specified on a daily basis, unless the Secretary specifies a lesser frequency, to the Centers for Disease Control and Prevention's … NHSN or other CDC-supported surveillance systems as determined by the Secretary.”

FYI:

The @HL7 FHIR Situationanal Awareness for Novel Epidemic Response (SANER) IG has the capacity to support this reporting and we have demonstrated this at several connectathons over the past two years (Since May 2020).

That guide takes advantage of the same standards promoted by @ONC_HealthIT for use of #FHIR APIs for patient data access , but also includes provisions to support data access for other information not routinely stored in an EHR such as devices and inventory.

#TheSANERRule

federalregister.gov/d/2022-08268/p…
“For purposes of this burden collection, we acknowledge the unknown and the ongoing burdens that may exist even if CMS is not collecting information outside of a declared PHE.
…
#TheSANERRule

…

We recognize that considerations such as building and maintaining the infrastructure to support readiness are necessary to ensure compliance with this requirement.”

…
#TheSANERRule

…

Therefore, we are soliciting comment on the burden associated with these proposed requirements given the intended flexibility provided in reducing or limiting the scope and frequency of reporting based on the state of the PHE and ongoing circumstances.
…

… asking for comment on the potential burden associated with the proposed reporting requirements as they might relate to any differences in the public health response to one specific pathogen or infectious disease versus another that would be directly related to the declared PHE

We are also interested in public comments addressing burden estimates (and the potential differences in those estimates) for variations in the required reporting response for a local PHE versus a regional PHE versus a national PHE

…

Burden Table at federalregister.gov/d/2022-08268/p…

The proposed regulation itself that I’ve been talking about in #TheSANERRule
Starts here: federalregister.gov/d/2022-08268/p…

There are seperate conditions of participation for hospitals and CAH as There are seperate programs these COP apply to, but they read largely the same.
#TheSANERRule

Thus ends my first read through, some thoughs on #TheSANERRule follow:

1. The IPPS rule is an annual thing
2. Conditions of participation are part of IPPS
3. Thus a rule like this will never get separated
4. But I really wish it would for better focus on just this topic

I’m generally both OK and somewhat disappointed in the content, but it matches expectations at this stage.

1. No direct mention of SANER, that can be both good and bad
2. Good in that “the secretary can declare”, bad is it seems to indicate a lack of awareness.

#TheSANERRule

This is an opportunity to inform CMS about SANER

Even more so, @CDCgov, @ASPRgov and @ONC_HealthIT. All of whom I am to understand are working together with unprecedented coordination on this topic.

#TheSANERRule

There are at least two Federal Requests for proposals that I expect might even be delayed by feedback on this rule, including grants to states and modernization

The feds are Thinking Hard on pandemic response

#TheSANERRule

#TheSANERRule provides you with an opportunity to provide input to that thinking. Much of what you might say may have NO DIRECT impact on this regulation. In fact there are regulations about that.

I pretty much acknowledge this rule can likely NOT mandate use of SANER, …

It cannot b/c it isn’t mentioned as a possibility, only briefly is it even vaguely referenced. But other provisions cite “the secretary can declare” and that is where your input about SANER in #TheSANERRule will help inform “The Secretary”.

I’m done on this first read through of #TheSANERRule, and returning to my vacation.

Screen saver on

. @threadreaderapp rollup please