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.