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The Patient Protection and Affordable Care Act (aka the health reform law) added “patient engagement” and “patient-centeredness” to the United States Code’s lexicon.  Yesterday, the Centers for Medicare and Medicaid Services finalized the official definition of these terms for purposes of Accountable Care Organizations that may seek to participate in the Medicare Shared Savings Program.  There are about 700 pages of regulations released by CMS yesterday, and there are tax, antitrust, and fraud and abuse rules and regs accompanying the ACO regs that were also finalized yesterday, so you’ll forgive me for not providing a tidy summary and analysis.  Please feel free to peruse the CMS presser and links to the ACO resources (via my home blog, HealthBlawg).

So here are the unvarnished definitions (please note that “patient engagement” is defined as an element of “patient-centeredness”):

42 CFR §425.112 Required processes and patient-centeredness criteria.

(a) General. (1) An ACO must —
(i) Promote evidence-based medicine and beneficiary engagement, internally report on
quality and cost metrics, and coordinate care;
(ii) Adopt a focus on patient centeredness that is promoted by the governing body and
integrated into practice by leadership and management working with the organization’s health
care teams; and
(iii) Have defined processes to fulfill these requirements.
(2) An ACO must have a qualified healthcare professional responsible for the ACO’s
quality assurance and improvement program, which must include the defined processes included
in paragraphs (b)(1) through (4) of this section.
(3) For each process specified in paragraphs (b)(1) through (4) of this section, the ACO
must —
(i) Explain how it will require ACO participants and ACO providers/suppliers to comply
with and implement each process (and subelement thereof), including the remedial processes and
penalties (including the potential for expulsion) applicable to ACO participants and ACO
providers/suppliers for failure to comply with and implement the required process; and
(ii) Explain how it will employ its internal assessments of cost and quality of care to
improve continuously the ACO’s care practices.
(b) Required processes. The ACO must define, establish, implement, evaluate, and
periodically update processes to accomplish the following:
(1) Promote evidence-based medicine. These processes must cover diagnoses with
significant potential for the ACO to achieve quality improvements taking into account the
circumstances of individual beneficiaries.
(2) Promote patient engagement. These processes must address the following areas:
(i) Compliance with patient experience of care survey requirements in §425.500.
(ii) Compliance with beneficiary representative requirements in §425.106.
(iii) A process for evaluating the health needs of the ACO’s population, including
consideration of diversity in its patient populations, and a plan to address the needs of its
(A) In its plan to address the needs of its population, the ACO must describe how it
intends to partner with community stakeholders to improve the health of its population.
(B) An ACO that has a stakeholder organization serving on its governing body will be
deemed to have satisfied the requirement to partner with community stakeholders.
(iv) Communication of clinical knowledge/evidence-based medicine to beneficiaries in a
way that is understandable to them.
(v) Beneficiary engagement and shared decision-making that takes into account the
beneficiaries’ unique needs, preferences, values, and priorities;
(vi) Written standards in place for beneficiary access and communication, and a process
in place for beneficiaries to access their medical record.
(3) Develop an infrastructure for its ACO participants and ACO providers/suppliers to
internally report on quality and cost metrics that enables the ACO to monitor, provide feedback,
and evaluate its ACO participants and ACO provider(s)/supplier(s) performance and to use these
results to improve care over time.
(4) Coordinate care across and among primary care physicians, specialists, and acute and
post-acute providers and suppliers. The ACO must–
(i) Define its methods and processes established to coordinate care throughout an episode of
care and during its transitions, such as discharge from a hospital or transfer of care from a
primary care physician to a specialist (both inside and outside the ACO); and
(ii) As part of its application, the ACO must:
(A) Submit a description of its individualized care program, along with a sample individual
care plan, and explain how this program is used to promote improved outcomes for, at a
minimum, its high-risk and multiple chronic condition patients.
(B) Describe additional target populations that would benefit from individualized care plans.

Yes, the language is sort of impenetrable.  Humans at CMS are charged with determining what it really means.  I’d like to see if some of the other humans reading this have some thoughts about how the federales did with these definitions:  Are you satisfied that these definitions will ensure that accountable care organizations will be patient-centered, and will be patient engagement machines?  Are there any issues that CMS needs to be aware of as it reviews applications from organizations seeking recognition as ACOs?  Please join the conversation in the comments.

David Harlow is a health care lawyer and consultant at The Harlow Group LLC, and chairs the Society for Participatory Medicine’s public policy committee.  You should follow him on Twitter: @healthblawg.


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