Medical Device Regulation: An Overview from the FDA

I don't usually cover medical device related topics in this blog, but the recent MDDS final rule (pdf) from the FDA has potential impacts on Health IT solutions using separate  interface engines.  As interface enginers are commonly used with Health IT, and they  could under this rule be considered a Medical Device Data System, I thought this webinar might be of interest to my readers.


  -- Keith


The FDA is presenting on the Medical Device Regulation on an upcoming HIMSS Webinar (April 13^th). You will need to register for this event (free to HIMSS members).  Thanks!

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Medical Device Regulation: An Overview from the Food and Drug Administration

Date: 4/13/2011
4:00-5:00PM EDT

Cost: $0.00 for HIMSS members $79.00 for non-HIMSS members

Registration Information

Description:

Abstract: 

The Food and Drug Administrations (FDA)'s Center for Devices and Radiological Health (CDRH) has the responsibility for assuring safety and effectiveness of medical devices in the United States.  The CDRH oversees medical devices by classifying them based on risk along with a number of oversight tools to promote health and reduce risk of harm to patients.  On February 15, 2011, the FDA published its final rule to reclassify Medical Device Data Systems (MDDS).  A Medical Device Data System is a new category of medical device that acts as a conduit for communication of electronic data obtained from other medical devices.  Learn more about the new rule and its implications for your organization from two key representatives of the Center for Devices and Radiological Health.

Learning Objectives: 

• Explore the role of the Center for Devices and Radiological Health plays in the regulation of medical devices
• Gain an understanding of risk-based oversight
• Discuss the Final "Medical Device Data Systems" rule

Speakers:

• Anthony D. Watson, BS, MS, MBA, Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration 
• Bakul Patel, MSEE, MBA, Policy Advisor, Officer of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration

Continuing Education:

This webinar has been approved for up to 1.0 continuing education (CE) hours for use in fulfilling the continuing education requirements of the Certified Professional in Healthcare Information & Management Systems (CPHIMS)

REGISTER AT: http://www.himss.org/asp/ContentRedirector.asp?ContentId=76857&cetID=200

Using XPointer in CDA URI references

I've written previously of use cases where the HL7 CDA specification supports Natural Language Processing capabilities.  One of the challenges in natural language processing is that you can have conflicting parses of the same sentence structure, resulting in overlapping spans of text which have alternative representations.  There are also cases where non-contiguous spans of text provide evidence for information (especially in sentences using lists and conjunctions).  I ran into this problem previously in the XML world, but fortunately for me, I worked in the office next store to one of the guys writing a W3C standard that would help.  It is a problem that is quite adequately solved these days using the XPointer standard.  XPointer is essentially an extension of the W3C  XPath languages.  It allows a URI Fragment identifier -- you know, that part of the URI after the hash sign (#) to be written as an XPath expression and has some additional XPath extensions.

To link an observation element in the CDA document to the text which generated it using NLP (another use case for linking entries to content), you would create an XPointer expression which pointed to the text that provided the evidence for it.  An example appears below.

Patient denies alcohol or tobacco use.

In this example, only the first and last parts of the sentence provide evidence for the specific observation "Patient denies tobacco use".  The middle words are NOT part of the textual evidence supporting that observation.  A second observation on the denial alcohol use would different parts of the text:

Patient denies alcohol or tobacco use.

There is no way to mark up the spans of text simultaneously  to support both observations using spans enabled by the CDA content tag and simple URI fragment identifiers.  One possible markup that could work using XPointer is:
<br /> <content ID='id1'>Patient denies</content><content ID='id2'>alcohol</content> or <content ID='id3'>tobacco</content> <content ID='id4'>use</content>.<br />

The XPointer expressions become #xpointer(#id1|#id3|#id4) and #xpointer(#id1|#id2|#id4).  A challenge that a developer recently reported to me with this example is that when the XPointer expression was included in the XML and his XML parser complained that it violated the rules for the anyURI data type.  Specifically it reported:

error: cvc-datatype-valid.1.2.1: '#xpointer(XPointer expression)' is not a valid value for 'anyURI'.
error: cvc-attribute.3: The value '#xpointer(XPointer expression)' of attribute 'value' on element 'reference' is not valid with respect to its type, 'url'.

So, what is wrong here?

The problem is fairly straight-forward and has to do with W3C Schema constraints on anyURI.  Most specifically, the production for anyURI requires certain special characters appearing in parts of a URI to be escaped according to RFC-2369.  The specific rules for escaping characters can be found in the W3C XLink specification in the section on link-locators.  Appropriately escaping the special characters in the XPath expression will remove the error.

In the examples above, the special characters are the hash-marks (#) inside the XPointer expression and the pipe-characters or vertical-bars (|).  The parenthesis are actually OK.   So # must be replaced with %23 and | must be replaced with %7c in order to make the fragment identifier legal as far as the production rules for anyURI.  The new (and now fragment identifiers instead of XPointer expressions) are:   #xpointer(%23id1%7c%23id3%7c%23id4) and #xpointer(%23id%7c%7c%23id2%7c%23id4).  These may ugly but should work.

Most programming languages provide a language specific function to escape text appearing in a URL (e.g., URLEncoder.encode(String) in Java or HttpUtility.UrlEncode in .NET) .  I recommend using those functions to escape anything after the #xpointer string in the URL fragment as they should return a correctly escaped string. If you let it escape the initial # as %23, you will have a different problem because that character is what identifies the following text as being part of the URL fragment identifier.

Cervicular Radiculopathy: An unscientific experiment in HCSM and EBM

If you want to know what it is (and it isn't a funny looking anything), this is actually a pretty useful query.  As an Health IT expert and social intermediary I thought I'd use my recent diagnosis as an opportunity to see what patients who suffer from more severe diseases encounter when they look into disease information using the web and social media.

First of all, I applaud Google's efforts on putting NIH material at the top of the list of returns on my query.  That was most helpful and decided to use that content as a baseline against which I could compare other reading material.  Also, Google's spelling correction of my original spelling (Cervical Radiculapthathy) was great. Any search tool that doesn't include spelling corrections on complex medical terminology is NOT consumer friendly.  My first attempt to type in this term I didn't initially know how to spell produced an excellent result in Google because it spell corrected my mistakes.  But that was not true in any of three other medically focused search engines that I tried.  The Google results were much better organized than the medical search engines.

I tried Bing with the same query and got nearly similar results with TWO important distinctions.  One:  Bing didn't include the NIH material.  Two:  Bing totally failed my ad-hoc spelling correction test.  Come on Microsoft, I know you have spelling correction software ... use it.

As soon as I put the words "Blog" after my search criteria, my experience changed.  The quality of the material went down greatly.  Several blogs included copious Google Ads.  I hate sites that abuse Google AdWords with a passion.  That was enough to drive me away from any site containing healthcare data.  The site creator seems more worried about funding the site than the patient/user experience.  The other things that I saw were sites that were "single-treatment" focused.  These tended to be mono-focused on how "their product" produced results.  I shied away from these as I would a snake-oil salesman but I can see how this stuff is very scary to physicians.

A couple of blogs turned up with the HONcode logo.  That means they've made some effort to be visibly authoritative and conform to a particular code of behavior.  I did not find any other similar effort expressed in more than one site (nor would I have been able to recognize it).  I find myself giving those sites higher marks and it became something I actively looked for.  I used the HONcode search engine and found a rather wide variety of opinions on diagnosis and treatment of my particular condition.  I was frankly surprised somewhat by the variety there, especially given the general consistency I found within other sites I found with pretty authoritative content.

Most notable in many sites was a complete lack of citations to evidence-based-medicine.  The only site that got good marks for that was the NIH site.

A couple of things that I found to be indicative of good content in this brief survey of the web:

1. References to Evidence-based-medicine, especially NLM curated citations (e.g., PubMed).
2. Content attested by a well known clinical organization.
3. Content with a clearly identified last review date.
4. Professionally produced graphics and/or video (especially animation).  Content like that isn't cheap, and anyone who puts some effort into producing it is at least investing in the content, unlike the sites which used tons of adwords and short bits of text clearly lifted from online references.
5. Good indexing.  Often a medical term will have several significant variations (herniated disc was an alternate search term I used).  People who invest in making content accessible are paying attention.
6. Clear signs that the site conformance to a code of ethics (e.g., a link to ethics page, or logo like HONcode).
7. Good search technology.

And bad content:

1. Single treatment focused -- this drug, that therapy, et cetera, especially if the site is clearly benefiting someone who has a drug or therapy they sell.
2. AdWords... Especially at the top of the useful content ... nuf said.
3. Clearly copied content.

I looked separately for patient created content (the other side of the social media conversation).   A good quick test query for that was "I have diagnosis".  That sent me to a number of different message boards that I didn't recognize. Thinking about it a little, it seems obvious that these are pretty much wide open web-sites/message boards that I really would rather avoid.  I want to have others have established at least some level of "membership" before I gave them a way to access  content I created about me and my disease (this post doesn't count -- if it was a more serious or embarrassing concern, I'd be much more circumspect).   So, how would I find a more personally but still social site.  

I went to one pretty well-known patient healthcare social site only to discover that it fails to work with my favorite web browser (Chrome) -NOR- with IE behind the corporate firewall.  So I had to switch back to the home computer to access using my least favorite browser (I will note that it also worked on my iPad just fine).  Using my own equipment is more appropriate, but also raises some interesting policy issues for corporate America. For patients living with chronic health conditions, using employer equipment to access HCSM websites that help them manage their health may be quite worthwhile.

The Chrome failure made me wonder about the tech-savvyness of ePatients.  I expect most (but not all) patients using HCSM would be more tech savvy that the prototypical e-mail-using facebook-posting grandmother (that would be my mother here).  Hmm, I just equated ePatients with users of HCSM.  Is that a fair equation?  Probably not.  There are surely differences here, which requires more in-depth exploration.  Just because all the ePatients I know are also users of social media does not make them the same group.  And my mother, while not a techy-genious practically invented the PHR [she just uses Microsoft Word and a lot of paper to carry it around].

My search from that one social site turned up little for my specific condition without joining.  It did turn up enough aggregate anonymous data to let me know that I was already much better off than others who had turned to it (simply by reading the treatments used).  I didn't fit the typical patient profile (not surprising, considering this was an experiment encouraged by a real life event rather than real life use).  I had similar issues with bad search indexes and lack of spelling correction there.  They didn't cover Cervicular Radiculopathy in their search index, so I fell back to "herniated disc", which did work.  I also tried "herneated disc" and "herniated disk" which failed to turn up anything.  The average patient wouldn't have been as persistent as I was, but then again, the average patient probably wouldn't be at that page to begin with.   

As a patient, did I find my very brief foray into HCSM valuable?  Yes, I did.  Several of the blogs referenced therapy options that neither my PCP nor my PT mentioned.  I'll be asking about one of those options later this week, since I have some indications based on my PT assessment that it may be helpful.   I also discovered some information that about some early symptoms of Carpal Tunnel that my doctor reported to me, but which don't line up with what I've read myself.  I'll be asking him about them on my follow up visit next week.  I'll report my results with my providers after I follow up.  Would I use a patient driven HCSM site?  I think it would depend on my condition and needs.  Certainly I already find a great deal of support in social media for other activities both professional and personal.  I would certainly look for and be happy to find an online community to support my health needs were they much greater than at present.  Even now my social network provides a good deal of support.

This was a fairly safe diagnosis to be testing these waters with.  There are certainly some easy lessons to be learned in this particular space.  I wonder about the convergence between #HCSM and #HealthIT and #CDS and #EBM.  Some folks are onto an idea that would readily bring these together, but that idea is just starting to emerge.

My own prognosis is good, and while my current pain makes it difficult to work, treatment seems to be helping.  Interestingly enough... typing doesn't aggravate the problem, but writing code or XML does.  It has to do with how I need to use my body for the latter task.  Writing this blog keeps my hands fairly well in the same place and mostly involves small hand and wrist motions.  Coding or writing XML involves mouse + keyboard activity which uses shoulder, arm and neck (to track the mouse across the screen).  That is much more difficult for long periods of time.

Already I've redesigned my workplace a bit, getting a larger monitor and raising it up on a swing arm to counteract bad posture brought on by my aging eyes (and I also made my long overdue appointment for an eye exam).  I've readjusted my chair to ensure a more upright posture while sitting and that also helps.

Today I even got close to writing some XML... tomorrow I'll work on it more and maybe even test out coding again...

ONC S and I Framework Newsletter

Another missive in my inbox regarding the ONC Standards and Interoperability Framework:

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Health Story: Webinar Invitation (HL7 ballot participation)

If you've been following the CDA Consolidation project, and intend to vote on the outcomes, this is a useful webinar to attend.

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Dear Members and Friends of the Health Story Project

You are invited to participate in an education session to encourage participation in the current HL7 ballot cycle for the HL7/IHE Health Story Consolidation Project implementation guide.  Please register using the link below, and forward as you wish to colleagues who may have an interest.

Webinar: HL7/IHE Health Story Consolidation Project: How to Participate in the HL7 Ballot

When: Wednesday, April 13, 4-5 PM eastern

Register for Webinar: https://www2.gotomeeting.com/register/810108362

The HL7 International data standards organization will soon open a ballot for an important package of standards for health information exchange.  The Health Story Project is hosting a webinar is to show those unfamiliar with the process how to participate in the ballot.

The HL7/IHE Health Story Consolidation Project has harmonized exchange standards for eight common types of clinical documents along with the HL7 Continuity of Care Document (CCD) standard and the HITSP C32 requirements for Meaningful Use into one single implementation package.  ONC's Office of Standards and Interoperability (S&I) is hosting the effort within its S&I Framework and is facilitating the project.  Within HL7, the project is sponsored by the Structured Documents Work Group.  

Development of the original eight implementation guides for History & Physical, Discharge Summary, Operative Note, Consult Note, Progress Note, Procedure Note, Unstructured Documents and Diagnostic Imaging Reports was supported by the Health Story Project through an associate charter agreement with HL7. The project has harmonized these with complementary IHE Profiles and will result in a series of corresponding change proposals to IHE and updates to templates required for Meaningful Use.

The HL7 Ballot is open to all. This webinar will review all administrative, documentary and technical steps needed to cast your ballot and to participate in the ballot reconciliation process.

On behalf of the Health Story Project

Integrating Narrative Notes and the EHR

www.healthstory.com

A sumary of a summary: What is an ACO and how does HealthIT matter?

This is in response to a request from a colleague that I simplify my summary of the proposed ACO rule from Friday. This summary is based on that post, and vastly simplifies the 427-page rule. Read the post from Friday, or better yet, the rule and various commentary on it for full details (see the Friday post for links).

What is an ACO?
An ACO is an organization that contracts with CMS to take responsibility for care of patients, agreeing to terms that include providing high quality, patient-centered, evidenced-based care.  In so doing, the ACO hopes to reduce costs of care incurred by those patients. When those patients are Medicare eligible, and the ACO provides most of the primary care for that patient, the ACO can receive incentive payments from Medicare. If it fails to reduce costs, it would share (eventually) in the increased expense by paying Medicare back. In order to receive incentive payments, an ACO must report quality measures, exceed certain thresholds in quality and patient experience, and generate a savings over baseline costs as established by Medicare. If it "wins" (meets all quality and cost goals set by CMS), it can get a significant chunk (more than half) of that savings back.

An ACO can be formed by doctors, nurse practitioners, clinical nurse specialists and physician assistants, and hospitals that employ them. It can also include Federally qualified Health Centers and Rural Health Centers. CMS has some additional incentives for an ACO if they do. It can also include Skilled Nursing Facilities, Nursing Homes, Long Term Care Hospitals and Critical Access Hospitals.

An ACO must be a legal entity, and might be an existing legal entity if appropriately structured and governed. Governance requirements include a certain percentage of physician control, existence of physician directed quality programs, and patient involvement.

As a patient, if your primary care provider becomes part of an ACO, your rights don't change. You still have the option to get care anywhere you want, just as you have today. However, a couple of things will be different. CMS and your provider will tell you about the ACO. You will be given the option to opt-out of sharing certain data that CMS has on you with the ACO. The ACO will communicate with you clearly about your care options, and will make it easy to get access to your records, and transfer them to other care providers.

If you aren't a Medicare patient, how could this rule effect you? Well, CMS seems to be encouraging other payers to take advantage of the rule. I presume payers other than CMS could make agreements with the ACO for their own members as well.

How does all of this effect Health IT?
There are several requirements in the rules regarding support for Meaningful Use (e.g., 50% of providers would have to be meaningful users), the quality reporting requirements are rather detailed and require health IT support, and the need to exchange summary data on patients, and to utilize individually and aggregated data from CMS on patient populations will all require Health information technology to support these capabilities. There are a lot of other opportunities for Health IT to make ACOs better able to support their mission.

A Patient and HealthIT Centric summary of the ACO Rule

Yesterday, HHS published the long awaited regulation on Accountable Care Organizations (pdf).  If you want the bookmarked version, get it here. At the same time, the Office of the Inspector General released a notice on waiver designs (pdf) regarding Anti-trust, physician self-referral and certain other penalties with regard to the formation of ACOs.  Also, the FTC and DOJ released a separate notice on a proposed Antitrust Enforcement Policy (pdf) regarding ACOs.  HHS also released a FAQ sheet (pdf)  for providers, and the New England Journal of Medicine published a perspective article written by Don Berwick on the NPRM.  There's plenty of chat about the ACO NRPM on twitter, as well as blog commentary by the usual suspects.  Today, there's apparently even a leaked memo (pdf) providing some key answers to questions critical of the rule.

The complexity of the ACO rule leads to an interesting structure in the explanatory material preceding the actual proposed regulation.  There's a lot of discussion of various options that were considered, as well as the identification of the option proposed in the NPRM.  In this, you can treat these options as a sort of multiple-choice question in your responses.  If you don't like what was proposed, look at the other options discussed to see what might be better, or combine features of two or more options.

My particular specialty is in the exchange of clinical data.  I don't usually deal with administrative data, payments, claims or Medicare.  So, I'm looking at these rules from two different viewpoints:  As a consumer of healthcare, how do these rules affect me and my family, and as an IT expert, what Health IT changes will be needed to support these new organizations with regard to clinical data.

Let's start off with a quick review of the rule from a consumer perspective:

1. First off, I want to address the "Morality of budgeted care" issue brought up on the HHS ACO call yesterday by a physician as the first issue.  Under the proposed rule, an ACO has to meet stringent guidelines to receive additional incentives, including quality, coordination, used of evidence based medicine, and support for at-risk populations.  See the second response on page 2 of the leaked memo for some more details on that topic.  And to that provider I have to say: "Remember your own oath", as the NRPM does (page 14).
2. This is a program that affects Medicare beneficiaries (page 15 and §425.2(a) on page 372).
   If you aren't a beneficiary under Medicare, this rule does not directly affect you (yet -- you will be beneficary someday), but it may do so indirectly as ACOs are formed and payers discover how to take advantage of them also (see page 277).
3. ACO may be formed by your group or individual physician practice, or a hospital in your neighborhood (page 40) including some critical access hospitals (page 48 and §425.2(b) on page 372). According to the rule, doctors and healthcare practioners (which includes physician assistants, nurse practitioners, and clinical nurse specialists), and hospitals employing them can form ACOs. (see §425.5(b) on page 377)
4. Other suppliers of healthcare may participate in the ACO (but may not form one on their own), including Federally qualified health centers (FQHCs), rural health centers (RHCs), skilled nursing facilities (SNFs), nursing homes, long-term care hospitals (LTCHs) and all critical access hospitals (CAHs) (page 48).  And in fact, ACOs are encouraged to include FQHCs and RHCs by an increased incentive (page 273).  
5. Existing legal entities performing similar functions for patients may be qualified if they have appropriate governance structures, so if you are getting care from a similar entity today, it could become your ACO.  (page 49 and §425.5(d)(8) on page 383)
6. Your health plan, even though not a Medicare-enrolled entity could partner with an ACO and help administer it, but ACO participants would need to have 75% control of the ACO. (Page 57)
7. An ACO will contract with the Federal government to be an ACO for a minimum 3 year period initially, so if your HCP becomes a member of an ACO, you can be assured a commitment to the program. (page 62 and §425.5(d)(1 and 3) starting on page 378)
8. The Clinical management of the ACO will be overseen by "a senior-level medical director who is also a board certified physician", so you can be assured that a physician, and not claims administrator will be setting ACO policy. (page 63 and §425.5(d)(9)(iii) on page 385)
9. Included also are physician directed quality assurance and process improvement program requirements, and implementation of evidence based guidelines by all members of the ACO (page 63 and §425.5(d)(9)(v-vi) on page 385) 
10. There are several provisions suggested that are being used to prevent behaviors by the ACO to avoid high-risk beneficiaries -- with significant and escalating penalties for non-compliance. (page 64, 115, 312, 316-318 and §425.12(b) on page 405)
11. ACOs will agree to certify their accountability to CMS for the quality, cost and overall care of Medicare beneficiaries. These organizations will be making a commitment to CMS regarding how they treat you. (page 67).
12. CMS will pay cost savings benefits to the ACO directly, rather than the participants, and the ACO will share those savings with its participants (the healthcare providers). [Sorry, patients don't get any payments back]. (Page 69)
13. The ACO will have a large enough population of patients (minimum of 5000) to provide appropriate care for you, and will have enough primary care physicians to support you and/or your family members (page 71 and §425.5(d)(13) on page 389). 
14. The ACO will actively promote engagement of you and your family in your care (page 79 and §425.5(d)(15)(i)(B) on page 390).
15. Even though your primary healthcare provider may be a member of an ACO, they are not allowed to restrict the care you get.  You may go outside the ACO for care, and your benefits will not be affected by doing so (page 81).
16. Care will be patient-centric (last paragraph of page 81 - page 86 and all of §425.5(d)(15) starting on page 390)
17. There will be a mechanism for patient involvement in ACO governance!  (page 84 second bullet, and page 90-92, §425.5(d)(8)(ii)(b) on page 383 and  §425.5(d)(15)(ii)(B)(2) on page 391)
18. There will be processes to communicate with you that are understandable (page 85 first bullet and  §425.5(d)(15)(ii)(B)(6) on page 392 )
19. ... and to get your medical records (page 85 second bullet and §425.5(d)(15)(ii)(B)(8) on page 392)
20. You get to "grade" your providers by completing a survey about your experience (page 87).  The suggested grading tool is the CAHPS Clinician and Group Survey. (see §425.5(d)(15)(ii)(B)(1) on page 391)
21. As a member of an at-risk group or minority, be sure that ACOs must develop plans to address needs of diverse populations (page 92), population disparities (page 93) and individualized care.  (See §425.5(d)(15)(ii)(B)(3) on page 391)
22. Because of concerns about misleading or confusing consumers, CMS proposes that all marketing materials be approved by CMS prior to use (page 96 and 97 and §425.5(d)(4) on page 381).  This is one provision that seems a bit overboard to me.  I'd rather see strong guidelines provided, with strong penalties for misuse rather than this level of oversight.  Note that this provision does not apply to normal clinical (e.g., reminders or referrals) or administrative communications (e.g. billing and claims issues).
23. The ACO will have a compliance officer responsible for ensuring compliance of the ACO to requirements under the rule (page 99 and §425.5(d)(10) on page 388).
24. Your "ACO" will be determined based on what physician provides (they use the word "plurality") of your primary care during the prior year. (page 102, 139, 153-161).  If you decide to change primary care physicians during the year, the ACO primary care physician providing you with the most care will receive the benefit.  Don't like your ACO provider?  Change them, there is no penalty for you as a patient. (See §425.6 on page 392)
25. Primary care (see #24 above) includes outpatient evaluation and management (History and Physicals, Consultations) provided by a physician in internal medicine, general practice, family practice, or geriatric medicine.  Do you see your specialist as an outpatient more than your PCP as many patients with chronic conditions?  They would NOT be your primary care provider under the rule (page 147-153).  If this is a concern to you, comment.  Other options were considered that would include specialists. 
26. ACOs will be able to request your claims data (including procedure code, diagnosis code, beneficiary ID; date of birth; gender; and, if applicable, date of death; claim ID; the from and thru dates of service; the provider or supplier ID, and the claim payment type; prescriber ID, drug service date, drug product service ID, and indication if the drug is on the formulary) to have a better idea what care you have recieved (page 108).  You may opt-out of such sharing (page 128).  You must opt-in to share any data regarding alcohol and substance abuse treatment. (page 125).  See §425.19 starting on page 418
27. You will be communicated to by CMS and ACO affiliated providers you receive care from regarding your ACO options (page 162-165 and §425.5(d)(5) on page 381).
28. ACOs will be measured on 65 quality measures (page 166 - 195)
29. At least 50% of the providers in your ACO will use an EHR (page 200 and and §425.11(b) on page 40).
30. The amount of quality improvement required by your providers will ramp up year over year (page 211 and §425.8 on page 401).  I'm not sure about all of the scoring details (see all of §425.7 starting on page 394), but in reading through them I'm reminded Garrison Keillor's home town, Lake Wobegone, where all children are above average...
31. You will be able to find out: "information regarding: (1) providers and suppliers participating in the ACO; (2) parties sharing in the governance of the ACO; (3) quality performance standard scores; and (4) general information on how an ACO shares savings with its members." (page 226, §425.5(d)(1) on page 378 and §425.23 on page 426) 
32. The rule notes that: The standards for Accountable Care Organizations proposed in this rule are among the first quality standards for doctors and health care organizations established under the Affordable Care Act (page 228).
33. There is a stick with the ACO carrot of shared savings, which is shared losses.  In year 3 for all ACOs and in year 1 and 2 for those that opt-in, expenditures over the benchmark set by CMS would be shared with the ACO. (page 233).  I'm in favor of the carrot and stick approach, because it provides additional incentives to succeed.  I'll pass on commenting about where the benchmark is set because I'm not an actuary.
34. Your geography and whether or not you are served by a hospital that serves a disproportionate share of low-income payments may affect the performance of the ACO that you are in.  While geographic and income-level adjustments are made to Medicare, these are not accounted for in the rule given limitations under the law. (Page 253, and 259-261).
35. However, ACO participation in other Incentive programs will not impact the ACO, as these are meant to be complimentary, not competing (page 256-257).
36. I'll cover one and only one statement in the Impact Analysis:  This program does not affect the beneficiary's freedom of choice regarding providers or care. (page 360).

And a review of Health IT related provisions:

1. Deemed critical is "Health information technology that facilitates the aggregation and analysis of data, allows patient-level feedback, and provides alerts and reminders at the point of care." (page 59)
2. In addressing Anti-trust issues, the rule notes that clinical integration is required and: "To demonstrate clinical integration, participants must show a degree of interaction and interdependence among providers in their provision of medical services that enables them to jointly achieve cost efficiencies and quality improvements." (page 60).  Some of the clinical integration can be addressed through Health IT.
3.  "The ACO would have an infrastructure, such as information technology, that enables the ACO to collect and evaluate data and provide feedback to the ACO providers/suppliers across the entire organization, including providing information to influence care at the point of care via, for example, shared clinical decision support, feedback from patient experience of care surveys or other internal or external quality and utilization assessments." (page 64 and §425.5(d)(9)(vii) on page 386).
4. "Measures for promoting patient engagement may include, but are not limited to, the use of decision support tools and shared decision making methods with which the patient can assess the merits of various treatment options in the context of his or her values and convictions." (page 79) Health IT may help here in assessing cost, quality and potential outcomes.
5. "developing a population health data management capability, or implementing practice and physician level data capabilities with point-of-service (POS) reminder systems to drive improvement in quality and cost outcomes." (page 79-80 §425.5(d)(15)(ii)(B)(4) on page 391)
6. "define processes to… coordinate care, such as through the use of telehealth, remote patient monitoring, and other such enabling technologies. ... Compliance with this requirement may include ... A capability to use predictive modeling to anticipate likely care needs." (page 80 §425.5(d)(15)(ii)(B)(5) on page 391 )
7. "... The establishment and use of health information technology, including electronic health records and an electronic health information exchange to enable the provision of a beneficiary's summary of care record during transitions of care both within and outside of the ACO." (page 81 and §425.5(d)(15) on page 390)
8. In addition, the ACO should have a process in place (or clear path to develop such a process) to electronically exchange summary of care information when patients transition to another provider or setting of care, both within and outside the ACO, consistent with meaningful use requirements under the EHR Incentive program.(page 85 and §425.5(d)(15)(ii)(B) on page 391 )
9. "...an ACO typically should have, or is moving toward having, complete information for the services it provides to or coordinates on behalf of its FFS beneficiary population, it may not have complete information on a FFS beneficiary who, for example, has chosen to receive services, medications or supplies from providers of services and suppliers outside its organization. We believe that providing ACOs with an opportunity to request CMS claims data, as described later in this proposed rule, on their potentially assigned beneficiary population would allow them to understand the totality of care provided to beneficiaries assigned to them by identifying the services and supplies that fee-for-service beneficiaries receive during the performance year both within and outside of the ACO."  (page 110 and §425.19 starting on page 418) More Health IT to request process the claims data.
10. "...where feasible, we should provide information to help ACOs improve the quality of care, improve the health of their beneficiary population, and create efficiencies within their systems. One possible approach is to provide aggregated data on beneficiary use of health care services." (page 111)
11. There will be plenty of quality reporting needing Health IT (65 measures in all): "In this portion of the proposed regulation, we propose: (1) measures to assess the quality of care furnished by an ACO; (2) requirements for data submission by ACOs; (3) quality performance standards; (4) the incorporation of reporting requirements under section 1848 of the Act for the Physician Quality Reporting System; and (5) requirements for public reporting by ACOs." (page 166-195 and §425.9-10 on page 401).
12. At least 50% of eligible providers in an ACO will use an EHR (page 200), but not necessarily hospitals (page 222 and §425.11(b) on page 404).  Furthermore, CMS may terminate the ACO agreement if the number of meaningful users falls below 50%! (same page).
13. "...eligible professionals would be required to submit data through the ACO on the quality measures proposed in Table 1 using the GPRO tool and methodology described in section II.E.3. of this proposed rule to qualify for the Physician Quality Reporting System incentive under the Shared Savings Program" (page 216 and §425.11(a) on page 404) PQRI = more Health IT requirements.
14. Note that in the above, CMS plans "to align the incorporated Physician Quality Reporting System requirements with the general Shared Savings Program reporting requirements, such that no extra reporting is actually required in order for eligible professionals or the ACO to earn the Physician Quality Reporting System incentive under the Shared Savings Program. Thus, for ACOs that meet the quality performance standard under the Shared Savings Program for the first performance period, the Physician Quality Reporting System eligible professionals within such ACOs will be considered eligible for the Physician Quality Reporting System incentive under the Shared Savings Program for that year." This is a potential two-for-one deal for ACO participating providers.  It is double or nothing for providers that fail to meet the quality and shared savings requirements, but if they only fail to meet the shared savings requirements, they can still get the PQRS benefit (page 218).

OK, that's enough for the day.  I have to say that I am impressed by this rule.  I find it to be pretty understandable (except for the actuarial stuff), but it's still a lot to deal with.  I would say that overall I have a positive response, but there is definate room for improvement.

As always, the opinions expressed in this blog are my own, and not that of my employer or any of the organizations that I represent as a volunteer.  As these are my opinions, they also do not constitute legal advice either, since I am not a legal professional either.