I've now spent two consecutive Memorial Day weekends at Hospital X with intractable vomiting. Last year I checked myself in. This year, I took the scenic route via three weeks of hard time at Hospital A followed by a transfer to Hospital X. When the nurse blindsided me with the transfer order to Hospital X after COB on a Friday night, I assumed it was a clerical error. The plan that'd been laid out by my primary hospitalist team was to transfer me to a hospital which specializes in CVS. When my (new) weekend hospitalist had run by for +/- 90 seconds Friday morning, he'd said I'd be transferred Monday as planned. 

But here I was, 8 hours later, hysterically crying over the prospect of being sent back to the hell which is  Hospital X. I finally got nursing to call the hospitalist so I could plead with him to change the order. I let him know that Hospital X's 'care' is better characterized as psychological and physical torture. I firmly believe I am better off facedown in a ditch, drowning in an inch of muddy water, than under the care of Hospital X. The hospitalist attempted to contain his exasperation while insisting that ditches are a far worse fate than Hospital X and I am lucky he had managed to secure a transfer to a new cyclic vomiting specialist there. I've now been admitted for 8 days at Hospital X and haven't seen anyone from the GI department, let alone a CVS specialist. I have, however, been told by hospital police that they would cuff me and take me to jail for taking photos of them ransacking my belongings following a syncopal episode. This egregious treatment doesn't surprise me - indeed, last month I wrote Hospital X a letter of complaint, copied below, which shared  how their lack humanity has broken my spirit. 

Dear Dr. X-

Thank you for your willingness to contact me, the patient in question, regarding my experience with Hospital X. Apologies for the lapse in time, your email disappeared to the bottom of my inbox whenI was readmitted to Hospital A with a central line infection. My choice to return to the facility which gave me the infection, instead of coming to Hospital X, is a good indication of the disdain with which I hold your hospital with. 

When Dr. Y visited me during a two-week stay in July, I thought Hospital X had hit rock bottom. During this stay my roommate’s bloody vomit sat clogged in the sink for three days before someone came to plunge it. Sanitary conditions pale in comparison to the forced separation from my friend and advocate who is a Medical Student with your facility. While I fully understand the need to keep relationships between students and patients professional to protect patient privacy/health and their education... Over the years my friend has come to know my health likely better than I do... and long ago I legally gave them permission to access my medical information [so any professional/educational distance is null].

However, that isn't the stay which brings me to tears when I answer people asking ‘What is the worst healthcare experience of your life?’ - that honor belongs to the 48 hours I spent housed in an on-call room last November.

November’s stay made me appreciate my cellphone in ways that you should not have to appreciate your phone while inpatient at a hospital. Here my phone wasn’t my connection to the outside world - it was how I connected the dots within. It enabled me to contact five of my physicians, all of whom are attending physicians at your institution, when my resident was unable to do so. When the resident insinuated I had not established care with hematology, I was able to call the hematology department and connect my hematologist to the resident in under 15 minutes. At the time of admission, I had given this resident a typed list of my specialists which included the same contact information I used successfully; as such I find it difficult to believe the resident attempted to verify I was an existing patient.

When the nurses couldn't hear the physical bells my roommate and I were given, I resorted to calling the nursing station on my cellphone (Ironically, courtesy of the speaker in the wall of our on-call room, we heard nurse requests from all the other patients on the floor). My roommate did not have a cellphone and I ended up relaying her requests by calling the nurses station each time my roommate rang her physical bell. As such, I didn't sleep the entire time we were in this closet.

However, these communications issues are simply annoyances in comparison to the emotional torture of a fellow human experiencing unrelenting pain.

My roommate, admitted for a Sickle Cell crisis, cried hysterically for over 12 hours while her pain remained unmanaged. During this time I called and emailed the patient advocate several times on my roommate’s behalf and ‘rang’ the nurse countless times.  Eventually my roommate’s attending came to see her. Unfortunately her physician was “Dr. Feelgood.” I had the misfortune of being this physician’s patient in July. I nicknamed him “Dr. Feelgood” for stopping my pain regimen (developed by a pain specialist) and insisting yoga (contraindicated with my joint condition) would magically fix all my problems. True to form, Dr. Feelgood insisted my roommate's issues related to positive thinking and refused to revert to a pain regimen that had apparently worked before. I’m not a physician and have no idea what pain medications this girl should have been on. But as a human I know that “Tears = Bad” and anyone that cries for twelve hours while begging someone, anyone, to call their physician of record isn't faking it. She didn’t stop crying until a doctor with some humanity sedated her following shift change. The complete disregard for her pain stripped her of her dignity and brought me to tears.

IMG_5401

27 hours in paradise... err... the ER Hallway. With a Pulmonary Embolism.

I’ve experienced many horrible things during my healthcare journey. I have experienced pain – I broke my femur in a remote location and spent hours in transit before receiving pain medication. I have experienced makeshift environments - last September I spent 27 hours in a hallway waiting for a bed to open while being treated for a pulmonary embolism. But this experience of complete powerlessness in the face of another’s pain is, bar none, the most profoundly heartbreaking experience of my life.

During this situation, I contacted the patient advocate several times via email/phone and complained in person post discharge. While I am appreciative of Dr. Y for bringing these issues to your attention and find your immediate response very encouraging, it saddens me that as a simple patient my voice wasn't heard.

Wishing you all the best,

 

Jess Jacobs

Here is their response:

4.16.15Response

Thanks to my forced transfer to this facility, I've found that nothing's improved. I was slated for discharge earlier today, only to be remanded over dangerously offkilter labs caught when the attending went to signoff on my discharge. These electrolyte imbalances did not become dangerous overnight and might have been treated when I passed out earlier this week. But no. Instead they looked for an illicit cause to my syncope, sending police in to toss my room during my post syncopal phase in which I shake. When the police came in I photographed their aggression. The officers immediately threatened to handcuff me and throw me in jail if I didn't delete the photos while they watched. Obviously I acquiesced instead of finding out whether you go to real jail or hospital jail when you get arrested by hospital rent-a-cops. 

Either way, the facility is now unwilling to return my central line supplies. This is a bit of a policy change from when I was admitted - the admitting charge nurse had given back my unlabeled pills with the understanding that I wouldn't take them while admitted. Now I'm being told that, while I have an active prescription from one of their own attendings and can show that I/my insurance paid for these items, the facility will not return the items because my infusion pharmacy didn't label each saline flush, heparin lock, and zofran vial with my name. Additionally, I must petition to have my medical record amended to strike their incorrect suspicion that I illicitly obtained/administered IV morphine to myself while admitted. 

But this was only the beginning of 'Big Brother.' Since I've now passed out twice, I have the pleasure of a Sitter. A Sitter is someone who sits in your room and watches you, presumably so you don't attempt to get out of bed on your own and fall. Previous Sitters have let me know they've found the task of watching me easy/boring/ridiculous since I know who/where I am and play by the posted 'Call! Don't Fall!' rules. This admission is no different. The two falls I've had I called nursing, told them I thought I was about to pass out, and,  fell to the floor despite nursing having their hands on me at the time. 

However, I can't blame the facility for trying to avoid another fall - as previously explained by a friendly CNA: "We'd rather have you die than fall. There's less paperwork." But with less paperwork comes unintended consequences for the patient - both physical and emotional. Physically I'm losing muscle mass and stability as my only exercise is the 8 or so feet between my bed and the toilet. Otherwise I'm stuck in an alarmed bed 24/7 which is so sensitive, it goes off if I roll over incorrectly. 

Emotionally, well, there's a loss of dignity that comes with someone watching you pee or, perhaps worse, visit with friends and family. Of course, this isn't an ever vigilant eye, that would require a living wage or technology implementation. Since we're on the 1980's technology/(presumably) minimum wage package, sometimes the Sitter is asleep.  Or visiting loudly with other employees passing in the hall at 4AM. Or singing a little song at 2AM. Or decides to snack on foods that makes you queasy. (Side Note: Mine's currently sitting 5 feet away eating bacon. She's also 8 months pregnant so I really hope I don't fall on her watch. This is a workers comp lawsuit just waiting to happen.)

When I told the charge nurse the Sitter singing/talking/eating at all hours was becoming the last straw, the Sitter took it personally. I tried to reassure her that she wasn't the only reason I hadn't slept in days. No, her disregard is just one of many items on the list - 3AM blood draws, 5AM vitals, 7AM physician visits - disrupting the painsomnia and nausea that have become all-encompassing since switching to oral meds. Why is Hospital X so committed to the oral med  'attempt/vomit/repeat' plan? Because the second I can hold something down, they can discharge. Not exactly the holistic care experience advertised on the website.

While I hate to say it, it seems my emotionally-charged-knee-jerk "I would be better off in a ditch than at Hospital X!" prophecy rings true. And, while my brain isn't quite working (indeed, much of this post was written prior to my semi-forced admission back to Hospital X), eventually it will return and I'll report Hospital X to the various licensing/quality bodies for the absurdity.

The sad thing is... I know my experience is not unique within the community of patients suffering from chronic disease. Everyday patients are harmed by the one-size fits all approach to medicine which makes no room for those with ill-defined syndromes and default to patient blaming. And these real problems can't be solved with hospital wide technology updates or private rooms. While there's a huge focus on prevention and population health (as there should be), we need to be careful we don't forget the 1% of unicorns who make up 20% of healthcare spending. And, while there's obviously no easy answer, there is an answer. We (yes, we as in me and you), as the people who've fallen in love with Mars Curiosity's delightful personality, can figure out how to deliver care that's individually appropriate on Earth. We can. I believe it.

IMG_1573.JPG

Gnome Garden - Courtesy of all my amazing friends.

Cover RockHealth

This week I've gotten several emails about my thoughts on the House's Energy and Commerce hearing on mobile app regulation by the FDA. While I could come up with my own thoughts on the hearing, I prefer to recap by sending you over to the incomparable Brian Dolan's lists: 5 take aways and 10 threads. Now you're caught up. So today, as promised in a rather polarizing VentureBeat article, Rock Health came out with a slide deck on digital health regulation by the FDA. (Side Note: when did we start calling it digital health? (Second Side Note: When do we get to call technology enabled healthcare just health?)). I loved all the details they gave on how to go through the 510(k) and PMA process - to date, haven't seen a group put out a free "how to navigate" the FDA presentation (so kudos Rock Health!).

FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health from Rock Health - produced by Malay Gandhi (@mgxtro) and Deborah Pascoe (@deborahpascoe).

A Few Comments:

Slide 1: In addition to the Mobile Medical Apps guidance I'd also suggest developers look at the Medical Device Data Systems and Design Considerations for Devices Intended for Home Use.

Slide 3: I’m not sure why the FDA's birthday is relevant - Personally, I would have gone with when the Food, Drug, and Cosmetic Act was signed into law - 1938. FDCA is what expanded the FDA’s regulation authority to include devices and cosmetics. I guess Rock Health doesn't share my love of flappers and the FDCA.

... following FDA regulations will actually make them a better company, with a higher quality process, and open the door to the entire healthcare market. - Geoff Clapp on Slide 23

Slide 4:

Rock Health Question: Why is the FDA looking at Digital Health?
Rock Health Answer: Widespread Availability & Public Interest

"Widespread Availability" and "Public Interest" are why the House Energy and Commerce Committee had a 3 day hearing on digital health. The FDA is a bit simpler - it looks at "digital" health because if something is a device, the FDA regulates it. That’s it.

Slide 5: Really not sure why they refer to the “current” definition of device. Device was codified way back in 1938's FDCA section 201(h) and isn't likely to change...

(h) The term “device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

So what’s this really mean? If you’ve got something that treats something with an ICD-9 code and isn’t a drug you’re a device. And if you are, you're subject to the medical excise tax. What won't be subject to the tax? Things that aren't medical devices (as the laughable Hotair puts it: "the federal government is munificently resisting the temptation to tax our smartphones" just like they're not taxing our fax machines. Or, for that matter, regulating our fax machines.).

device formula

Slide 6: Believe me, I really wanted to love this slide. Then I noticed that it wasn’t to scale and got sad.

MMA Vs Other Apps (not to scale)

MMA Vs Other Apps (not to scale)

Mobile Medical Apps vs Other Apps (Rock Health Numbers, to scale)

Mobile Medical Apps vs Other Apps (to scale)

Not such a big piece of the space, now is it? Since there isn't a numbered estimate for the gray area of apps which “might” be regulated, I couldn't scale that space.

RockHealth_mHealthGuidance_7_3.25.13
Slide 7: Again, so close to loving this slide. I just wish patient/consumer Safety had made the list. Yes, they said “consumer confidence” but when we’re talking about FDA oversight, we’re talking about medical devices and patient safety. FDA approval does increase physician confidence, but they’re not the end user/consumer in this continuum.

Slide 9: CMS doesn’t regulate devices. Pay for them, sure, but regulate? Not so much. I suppose we can go to futuristic imagination land where everything is mobile and talk about how a future iteration of Meaningful Use may require a provider to use a mobile application per CMS specifications. Barring that, CMS isn’t regulating mobile. Setting reimbursement guidelines, yes. Regulating? No. I’d definitely worry about the FTC before I even though about CMS – particularity in relation to apps which aren’t even considered devices. More on that regulatory continuum can be found in my HIMSS13 presentation. 
RockHealth_mHealthGuidance_9_3.25.13

 

RockHealth_mHealthGuidance_12_3.25.13
Slide 12:  Once I read this article, I understood what they were getting at with this example.  I think my brain still had a problem with it because their Class I example didn't have a mobile application associated with it. Glooko is a good example of the evolution of MMA stages - originally their system/cable was a Class I device - all the cable did was transmit data in its original form for recording. But they couldn't do analytics on it which means its usefulness was limited. Recently they received Class II clearance for their Glooko Logbooks Chart product. And maybe in a few years Glooko will come out with an app that helps control an artificial pancreas device and have to get Class III approval. 

Glooko Example

In closing, great job to the Rock Health team for interviewing so many thought leaders in this space - really enjoyed the emphasis on the FDA being composed of real people (believe me, they are!)!

Author Note: The views in this blog are strictly mine and should not be attributed to any organization mentioned. I do not work for the federal government and the contents of this site do not represent the views of any federal agency. It is important to note that my ORISE fellowship is with the FDA's Center for Drug Evaluation and Research and I do not have inside knowledge regarding the device approval process.

On March 5, 2013, Eric Wickland crossposted a recap of my session cross-posted to Healthcare IT News("Acronyms abound in mHealth Ecosystem"), HIMSS, ("HIMSS13 mHealth session explores federal policy issues") and mHIMSS ("Acronyms abound in mHealth Ecosystem").

HIMSS13
Copied below:

Thinking of diving into the mHealth ecosystem? You'll need a really good grasp of acronyms. And a healthy dose of patience.

Attendees of the 2013 HIMSS Conference and Exhibition were treated to a primer on the alphabet soup of organizations in "Federal mHealth Policy 101," a Monday-morning education session presented by Jessica A. Jacobs, MHSA, CPHIMS. Her hour-long session targeted the bigger federal players, including the HHS, CMS, FDA, FTC, FCC and the Office of Civil Rights.

It also brought to the forefront the realization that, with so many organizations wanting their share of the mHealth pie, the required rules, regulations and standards aren't showing up with any degree of haste.

To wit: The FDA's final document regarding regulation of mobile medical apps has been expected for several months, and still isn't here.

"I have seen a lot of predictions that say March," Jacobs shrugged. "But who knows?"

Also in the pipeline is a regulatory framework for mHealth that's being put together by the FDA, FCC and ONC. That one at least has a deadline, Jacobs pointed out, though that deadline is roughly one year distant.

Jacobs, who has worked with the ONC, FDA and HRSA and chaired the mHIMSS Mobile Devices and Regulatory Implications group, put together a primer on the various agencies involved in mHealth that touched on their responsibilities. She also noted that many of the agencies share those responsibilities and are working together to make sure the landscape is properly regulated.

During a Q&A session, she was asked about Happtique, the New York-based app store that recently unveiled a standards program for apps. Jacobs said Happtique's program, set to launch this spring, may very well be like the Certification Commission for Health Information Technology's EHR certification program. When asked if mHealth regulations might be too strict, and therefore serve to stifle innovation, she said the federal government is trying to take a broad-based approach so that it doesn't hinder creativity.

The key to the mHealth landscape going forward, she said, is collaboration.

"There are a lot of cabinet players in this mobile health space," she pointed out.

EMP_Wil

Social psychology shows that if you say thanks you're happier. Recently, Georgetown asked me to write a piece on my mentor-mentee relationship during grad school. You might know that I was an Innovation Fellow at the Office of the National Coordinator in 2010. While I was there, Special Assistant Wil Yu became my "Health IT and Innovation 101" guide. I definitely owe my health IT know-how to Wil and am certain that working with him changed the trajectory of my career (for the good!!!). Here's what I submitted to GU, it's a puff piece, but I think the gratitude comes through (their slightly modified post can be found here) (more…)

As you know - Meaningful Use Stage Two posted this week! Whoo hoo! There were a few changes from stage one and but from where I sit, it looks like things are aligned rather well. I did a summary of the NPRM (copy/pasted below (download it with pretty graphics here)), and also distributed by HIMSS. It's a pretty complete summary and highlights the differences between stage one and two. The only thing I didn't consider was the incentive/penalty structure. I'm not about to get into the business of telling people where the money's at!



HIMSS

HIMSS

Summary

The 2009 American Recovery and Reinvestment Act (ARRA) authorized incentive payments for the Meaningful Use of Electronic Health Records (EHR) through Medicare/Medicaid. This document is a high-level summarization highlighting the differences between the objectives in the Notice of Proposed Rule Making for Stage Two[i] and the Stage One Final Rule.[ii] CMS is “soliciting public feedback on several mechanisms for electronic CQM reporting, including aggregate-level electronic reporting group reporting options; and through existing quality reporting systems.”
Stage Two:

  • Eligible Providers (EPs): 17 core objectives, and 3 of 5 menu objectives
  • Eligible Hospitals and Critical Access Hospitals (EH/CAH): 16 core, 2 of 4 menu objectives

 This differs from Stage One:

  • EPs had 15 Core Objectives, 5 of 10 Menu Objectives, and 6 CQM.
  • EH/CAH had 14 Core Objectives, 5 of 10 Menu Objectives, and 15 CQM.

 

Timeline & Reporting

Reporting:

  • EPs: Calendar Year; EH/CAH: Federal Fiscal Year
  • 1st Year of MU (Stage One): Reporting Period is 90 days; Submission period is any time up to 2 months following the end of reporting period’s year
  • All other years of MU (All Stages): Reporting period, 1 year; Submission period, 2 months following the end of the reporting year

 Timeline:

The table below shows which Stage of Meaningful Use providers will need to achieve to receive incentive payments based upon their starting year.

First Payment Year

Payment Year[iii]

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2011

1

1

1

2

2

3

3

TBD

TBD

TBD

TBD

2012

1

1

2

2

3

3

TBD

TBD

TBD

TBD

2013

1

1

2

2

3

3

TBD

TBD

TBD

2014

1

1

2

2

3

3

TBD

TBD

2015

1

1

2

2

3

3

TBD

2016

1

1

2

2

3

3

2017

1

1

2

2

3

 

Guidelines and Definitions:

  • If a provider submits exclusion criteria for 1 of their menu sets, they are also attesting that they meet the exclusion criteria for all of the menu objectives that they did not select.
  • A Certified EHR must be used for at least 50% of a provider’s population over the entire reporting period. If the EP practices at multiple locations, this will include only patients seen at locations with certified EHRs.
  • Denominators will be one of four things:
    • Unique patients seen by the EP (stratified by age or previous office visit) or EH/CAH (stratified by age).
    • Number of Orders (medication, labs, radiology, imaging, and procedures).
    • Visits/Bed Days:
      • EP Office Visits: any billable visit that includes 1. Concurrent care/transfer of care visits; 2. Consultant visits or 3. Prolonged physician service without direct, face to face patient contact.
      • EH/CAH Inpatient bed days: admission day and each of the following full 24-hour periods during which the patient is in the inpatient dept of the hospital.
      • EPs will have latitude to include or not include telemedicine, minimal consulting services, and double counting (counting patient for both NP/PA and EP in same office).

Objectives

Changes to Stage One Criteria: 

  • This Stage Two rule alters some Stage One criteria – these changes will be optional in 2013 and required in 2014 (except otherwise noted):
    • CPOE: more than 30% of medication orders created by the EP/authorized providers at a EH/CAH are recorded using CPOE.
    • Vital Signs: addition of alternative age limitations (blood pressure will be only applicable for those over the age of three, while height/weight is for all ages) and exclusions (if all vitals, blood pressure, height/weight do not impact practice, provider does not have to record).
    • Exchange Key Clinical Data: Eliminated. Effective 2013.
    • Report CQM: Eliminated. Effective 2013.
    • Patient Electronic Communication: Same as Stage Two.
    • Public Health: Adds “except where prohibited” to language. Effective 2013.

 Differences between Stage One and Stage Two Criteria:

  • All Stage One Menu Set criteria are now in the core set, with the exception of two which will remain in the menu set: submitting syndromic surveillance data (EPs) and recording advanced directives (EH/CAH).
  • State Flexibility: States will continue to be able to specify transmission of data and public health measures so long as it does not require EHR functionality above and beyond that which is included in the ONC EHR certification criteria.
  • Other measures were Consolidated/Eliminated, including:

Consolidated/Eliminated Measures

Consolidated/Eliminated Measure

Logic

Drug/Drug and Drug Allergy Checks Combined into CDS.
Report CQM to CMS or States Completed with QMS reporting section of MU and not necessary as an objective.
Drug-Formulary Checks Combined into eRx
Maintain an up-to-date problem list of current and active diagnoses. Combined into Transition of Care.
Maintain active medication list.
Maintain active medication allergy list.
Provide patients with an electronic copy of their health information. Combined with objectives for online viewing and downloading
Provide patients with an electronic copy of their discharge instructions.
Capability to exchange key clinical information. Removed for Stage 2. Considering options for Stage 1.  Actual use case is more beneficial.


 



 

 

Stage Two

Objectives

Measure

Stage 1

Exclusions

Exclusions/Notes

Policy Priority: Improving quality, safety, efficiency, and reducing health disparities
Use computerized provider order entry (CPOE) for medication, laboratory and radiology orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local and professional guidelines to create the first record of the order.  Core, 60%Numerator: CPOE OrdersDenominator: All orders Core, 30% Providers with less than 100 orders. Must be used the first time the order is placed and before any action can be taken on the order.This measure has changed from “% of patients with one order in their EHRs”
EP Only: Generate, Compare to one drug formulary, and transmit permissible prescriptions electronically (eRx).  Core, 65%Numerator:  eRxDenominator: all Rx Core, 40% Less than 100 Rx’s writtenNo electronically connected pharmacy within 25 miles Does not include controlled substances for schedules II-V as many vendor offerings lack the required DEA specifications. Will revisit for MU III.In 2015 the MIPAA eRX program will be phased out for MU.MU Stage One “compare to a drug formulary” menu objective is rolled into this one.
Record the following demographics as structured data
  • Preferred language
  • Gender
  • Race
  • Ethnicity
  • Date of birth
  • Date and preliminary cause of death in the event of mortality (EH/CAH Only)
Core, 80%Numerator:  Patients with all demographic information recordedDenominator: All Patients Core, 50% If the patient refuses to give the information the provider can count that patient in the numerator.
Record and chart changes in vital signs as structured data:
  • Height
  • Weight
  • Blood pressure (age 3 and over)
  • Calculate and display BMI
  • Plot and display growth charts for patients 0-20 years, including BMI
Core, 80%Numerator: Patients with information recordedDenominator: All patients Core, 50% No patients over the age of 3 years old.The provider believes that height/weight or blood pressure have no relevance to their practice
Record smoking status for patients 13 years old or older Core, 80%Numerator: Patients with information recordedDenominator: All patients over 13 years Core, 50% No patients over 13 years old
Use clinical decision support to improve performance on high-priority health conditions Core, Implement 5 CDS rules related to 5 or more clinical quality measures at relevant point.Implement Drug/Drug and Drug/Allergy Interaction Checks. Core, 1 rule Previously Drug/Drug and Drug/Allergy checks was a Core standalone objective.
Incorporate clinical lab-test results into Certified EHR Technology as structured data (either positive/negative or numerical). Core, 55%Numerator: Lab Tests recorded as structured dataDenominator: All Lab Tests Menu, 50% EPs who do not order labs that are in a yes/no or numerical format.
Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach. Generate at least one report listing patients of the EP, eligible hospital or CAH with a specific condition. Menu, 1 list
EP Only: Use clinically relevant information to identify patients who should receive reminders for preventive/follow-up care. Core, 10%Numerator: Number of patients in the denominator who received a reminder during the EHR reporting periodDenominator: Unique patients who have an office visit with the EP in the 24 months prior to the EHR reporting period Menu, 10% No office visits in the 24 months before the reporting period Different from stage one – requires the use of EHR to identify appropriate reminders instead of just sending reminders based on patient preference.
EH/CAH Only: Automatically track medications from order to administration using assistive technologies in conjunction with an electronic medication administration record (eMAR). Core, 10%eMAR is implemented and in use for the entire EHR reporting period in at least one ward/unit of the eligible hospital or CAH. N/A, New Measure A ward or unit is defined having unique staff, patient population, geographic location or function from other IP/ER Departments.
Policy Priority: Engage patients and families in their health care
EP Only: Provide patients the ability to view and download their health information within four business days of the information [labs, imaging, etc] being available to the EP. Core, 50%Numerator: Patients who can access their informationDenominator: Number of Unique Patients Core, 50% within 4 days Providers who provide 50% of their care in areas where 50% of their patients do not have at least 4 Mbps broadband availability
Core, 10%Numerator: Patients who access/download/transmit their informationDenominator: Number of Patient Visits N/A
EH/CAH Only: Provide patients the ability to view online and download information about a hospital admission within 36 hours of discharge Core, 50%Numerator: Patients who can access their informationDenominator: Number of Unique Patients New 50% of patients do not have at least 4 Mbps broadband availability
Core, 10%Numerator: Patients who access/download/transmit their informationDenominator: Number of Patient Visits N/A
EP Only: Provide clinical summaries for patients within 24 hours for each office visit. Core, 50% Numerator: Office Visits with Clinical SummariesDenominator: Office Visits Core, 50% within 3 days No office visits in reporting period
Use Certified EHR Technology to identify patient-specific education resources and provide those resources to the patient. Core, 10% Numerator: Patients provided resourcesDenominator: Number of Unique Patients Menu, 10% No office visits in reporting period
EP Only: Use secure electronic messaging to communicate with patients on relevant health information. Core, 10% Numerator: Patients receiving messageDenominator: Number of Unique Patients New
Policy Priority: Improve care coordination
Medication Reconciliation is performed upon receiving a patient from another setting of care.Most accurate list of all medications that the patient is taking:
  • Name
  • Dosage
  • Frequency
  • Route

 

Core, 65% Numerator: Patients for which MR was performedDenominator: Patients received from another setting of care Menu, 50% It’s unlikely to be an automated process so the electronic exchange of information is not required.“another setting of care” is from outside the organization.
Any provider who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care should provide summary care record for each transition of care or referral. Core, 65% Numerator: TOC with Summary of Care Documents GeneratedDenominator:TOC/Referrals Menu, 50% Not the recipient of any TOC during the reporting period. Includes Eliminated Objectives:
  • Active Problem/Diagnosis List (Core, 50%)
  • Active Medication List (Core, 80%)
  • Active Medication Allergy List (Core, 80%)
Core, 10% Numerator: TOC with SOC generated electronicallyDenominator: TOC/Referrals N/A
Policy Priority: Improve population and public health
Capability to submit electronic data to immunization registries or immunization information systems. Successful ongoing submission. Menu, Test Ability If there are no appropriate agencies/registries to receive the information.If the registry/agency doesn’t accept electronic submissions format/standard specified by ONC’s certification rules.  If an HIE has been delegated to receive information on the agency/registry’s behalf this exclusion is not acceptable.Where prohibited, and in accordance with applicable law and practice. Stage 3 will likely be bidirectional.
EH/CAH Only: Capability to submit electronic reportable laboratory results to public health agencies, except where prohibited, and in accordance with applicable law and practice.
EP Menu; EH/CAH Core:  Capability to submit electronic syndromic surveillance data to public health agencies, except where prohibited, and in accordance with applicable law and practice. Core, Test Ability
Policy Priority: Ensure adequate privacy and security protections for personal health information
Protect electronic health information created or maintained by the Certified EHR Technology through the implementation of appropriate technical capabilities. Core.Conduct a security risk analysis in accordance with the requirements under 45 CFR 164.308


Menu Set Objectives

 

Eligible Providers (EPs): 17 core objectives, and 3 of 5 menu objectives

Eligible Hospitals and Critical Access Hospitals (EH/CAH):  16 core, 2 of 4 menu objectives.

Objectives

Measure

Stage 1

Exclusions

Exclusions/Notes

Policy Priority: Improving quality, safety, efficiency, and reducing health disparities
EH/CAH Only: Record advance directives as structured data for patients 65 years old or older who are admitted to the hospitals inpatient department. Menu, 50%Numerator: Patients with information recordedDenominator: All patients over 65 years Menu, 50% No patients over 65 years
Incorporate imaging results and information into/accessible through Certified EHR Technology.  Menu, 40% Numerator: Incorporated Imaging ResultsDenominator: Imaging Tests/Scans New No tests or scans Does not have to be structured data.Stage three is likely to include the exchange of the data.
Record patient family health history as structured data EHR reporting period for one or more first-degree relatives or an indication that family health history has been reviewed. Menu, 20%Numerator: Patients with Information RecordedDenominator: All Unique Patients New No Office Visits.

Objectives

Measure

Stage 1

Exclusions

Exclusions/Notes

EH/CAH Only: Generate, check against one formulary, and transmit permissible discharge prescriptions electronically (eRx). Menu, 10%Numerator: Rx GeneratedDenominator: Discharge Rx Written New Measure limited to new and changed Rx. Invited comment on whether refilled Rx should be included.
Policy Priority: Improve Population and Public Health
EP Only: Capability to identify and report specific cases to a specialized registry (other than a cancer registry). Successful ongoing submission. New Except where prohibited,  as appropriate to the provider’s practice, and in accordance with applicable law and practice
EP Only: Capability to identify and report cancer cases to a State cancer registry.
EP Menu; EH/CAH Core:  Capability to submit electronic syndromic surveillance data to public health agencies. Menu

Clinical Quality Measures

  • Many measures were put out in the NPRM, only a subset will be finalized.

EP CQM Measures: 125 Potential Measures

Two Options:

  • Option 1a: Select and submit 12 measures from the list of measures; one measure from each domain is required. If a provider’s EHR doesn’t include information for 12 measure, they must submit all of the measures that they can.
  • Option 1b: Report 11 “core” CQM, plus 1 “menu” CQM.
  • Option 2: Submit and satisfactorily report CQM under the Physician Quality Reporting System’s EHR Reporting Option (42 CFR 414.90).

Measures Include:

  • Conditions/Disease Management:
    • Asthma
    • Cardiology: Coronary Artery Disease, Ischemic Vascular Disease, Myocardial Infarction, Heart Failure, COPD, Atrial Fibrillation
    • Dementia
    • Eyes: Cataracts, Glaucoma
    • Hepatitis C
    • HIV/AIDS
    • Joints/Bones: Rheumatoid Arthritis, Osteoarthritis, Osteoporosis, Lower Back Pain, Knee/Hip Replacement
    • Kidney Disease
    • Oncology: General Oncology, Breast, Cervical, Colorectal, Colon, Prostate, Melanoma Diabetes
    • Otitis Externa
    • Psychiatric: Major Depressive Disorder, ADHD, Bipolar Disorder
    • Urinary Incontinence
    • Wound Care
    • Drug Management:
      • Antibiotic Use: Pharyngitis, Bronchitis, Upper Respiratory Infection, Perioperative Care
      • Asthma
      • ADHD
      • Cardiology: Heart Failure, Atrial Fibrulation, Coronary Artery Disease (CAD), Ischemic Vascular Disease (IVD), Myocardial Infarction (MI), Chronic Obstructive Pulmonary Disease (COPD),
      • Depression
      • Diabetes
      • Hypertension
      • HIV/AIDS
      • Kidney Disease
      • Oncology: Chemotherapy/Radiation/Pain, Colon, Breast, Prostate, Prostate
      • Osteoarthritis (OTC Assessments)
      • Perioperative VTE Prophylaxis and Antibiotic Timing
      • Preventative Care:
        • Alcohol/Drug Dependence
        • Antibiotic Use: Pharyngitis, Bronchitis, Upper Respiratory Infection, Perioperative Care
        • Blood Pressure
        • Chlamydia Screening
        • Cholesterol
        • Dental Decay
        • Immunizations: Flu, childhood, pneumonia, HCV, HBV
        • Falls Risk
        • Maternal/Prenatal Care
        • Tobacco Screening
        • Weight Screening
        • Medical Practice:
          • Adverse Event Reporting
          • Complex Chronic Condition Assessment
          • Diagnostic Imaging Reports
          • Medication Reconciliation
          • Specialist Referral Loop Closure
          • Use of High Risk Medications in Elderly


EH/CAH Measures: 49 possible measures

  Two options for attesting:

  • Select and submit 24 measures from a list of 49 measures (all 15 from Stage One are included); one measure from each domain is required.
  • Submit 24 CQM in a manner similar to the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot (Medicare Hospitals Only).
  • Drug Management:
    • Antibiotics: Pneumonia, Perioperative
    • Asthma
    • Cardiology: AMI, HF,
    • Ischemic Stroke
    • Pneumonia (antibiotics)
    • VTE Prophylaxis
    • Disease/Condition Care:
      • Asthma
      • Cardiology: Heart Failure, AMI,
      • Immunizations: Pneumococcal, Flu
      • Ischemic Stroke
      • Labor/Delivery: hearing, elective births, surfactant, complications
      • Surgical: VTE Prevention, Antibiotics, Catheter, Hair Removal
      • Medical Practice:
        • Home Management Plan of Care
        • Emergency Department Throughput
        • PICU Pain Assessments
        • NICU temperatures

[1] Author’s Note:  This summary was based upon publicly available knowledge and does not represent the view of the FDA, HHS, or ORISE. The author was not involved in writing this NPRM; any errors or omissions are solely the author’s. This summary was supported in part by an appointment to the Research Participation Program at the Center for Drug Evaluation and Research administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration. The author can be reached at jess.a.jacobs@gmail.com.


[i] References to Stage Two of Meaningful Use were taken from the Notice of Proposed Rule Making Released Feburary 23, 2012. http://www.ofr.gov/OFRUpload/OFRData/2012-04443_PI.pdf

[ii]References to Stage One of Meaningful Use were taken from the Final Rule Released July 28, 2010 http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf

[iii] Taken from the NPRM, Page 28: http://www.ofr.gov/OFRUpload/OFRData/2012-04443_PI.pdf#page=28