The Alexandria, Va.-based American Medical Group Association (AMGA), which represents the nation's largest-sized medical group organizations, has been at the forefront of healthcare provider associations expressing concerns over the proposed rule on accountable care organization (ACO) development released on March 31 by the federal Centers for Medicare and Medicaid Services (CMS). That rule fulfills a requirement coming out of the Accountable Care Act, the federal healthcare reform legislation passed in March 2010 by the U.S. Congress and signed into law by President Obama.
While the leaders of AMGA lauded the creation of a proposed rule by CMS, they have expressed dismay at some of the specifics revealed in the proposed rule itself. In that context, Donald W. Fisher, Ph.D., AMGA's president and CEO, on June 6 submitted formal comments to Donald Berwick, M.D., CMS' administrator, expressing the association's concerns over some of the specific elements embedded in the proposed rule.
Among the areas that Fisher's letter covered were concerns over overall strategic planning, population health management and patient data-sharing requirements, the complexity of the application process, issues around potential beneficiary involvement in ACO governance, patient assignment, the size, scope, and particulars of the quality data reporting requirements, the risk models involved and risk adjustment, withholds and a self-executing mechanism for repayment of losses, marketing guidelines, the minimum savings rate, Stark law issues and antitrust requirements, and the possible participation of federally qualified health centers and rural health clinics in the program.
Chet Speed, AMGA's vice president, public policy at AMGA, spoke with HCI Editor-in-Chief Mark Hagland regarding the association's formal comments to CMS, and its overall concerns. Below are excerpts from that interview.
Healthcare Informatics: What was AMGA hoping to accomplish in sending its formal comments to Dr. Berwick?
Chet Speed: What we hoped to accomplish was to convince CMS that they need to make some fairly dramatic changes from the proposed rule to the final rule, in order for this voluntary program to be successful; because when the proposed rule was drafted, there were so many elements that, when put together, made the vast majority of our members say they wouldn't participate, if the framework wasn't changed.
One big area was the framework for risk-sharing; another has to do with problems around data-sharing, which is very important to our members, because they practice population health management right now, and it's very difficult, if not impossible, to manage a population of chronically ill patients, if you don't have full access to their data.
CHALLENGE: PATIENT DATA SHARING OPT-OUT
HCI: Can you explain the opt-out issue in a bit of detail?
Speed: What the opt-out provision in the proposed rule allows is that, if a patient goes to a primary care physician in an ACO, they're allowed to opt out from having their data shared with specialists outside the ACO, so that if a patient opts out, but goes to specialists within the ACO, the ACO will not have access to that patient's claims data. And so the ACO is left in a vulnerable position. If you as a patient say that my ACO can't see the data from my visit with my cardiologist, that's a huge, huge concern, particularly for our members, because they've been doing population health management for a long time.
HCI: Have you received any communications from CMS about resolving that issue?
Speed: After we sent a letter on May 11, Dr. Berwick and Secretary Sibelius said the next day that they would try to make changes to make the rule work. They didn't specifically mention the data-sharing/opt-out issue. What's interesting is that this new Center for Medicare and Medicaid Innovation [CMI] is headed by Richard Gilfillan, M.D., formerly CEO [from 2005 to 2009] of the Geisinger Health Plan [the health plan affiliate of the Danville, Pa.-based Geisinger Health System]. But CMI announced three new programs, about 10 days ago, and one of them was this pioneer ACO program, which is mainly aimed, in my opinion, at potential ACOs that are used to being capitated and used to risk-sharing; so you're looking at California- and Pacific Northwest-based organizations. But one of the interesting elements was that those ACOs would get the claims information from the beneficiaries. So within the shared-savings program, patients could opt out, but within the pioneer program, they'd give them the data.
So perhaps they'll change this element. And one of the reasons for the opt-out is the privacy issues related to your health information; and the opt-out provision was probably related to the broader concern over the privacy of personal health information.
HCI: On the risk side, you and your member organizations basically felt that the risk terms are simply too stringent in the proposed rule?
Speed: Yes, a major concern of our members was the requirement that all ACOs in the proposed rule were required to share risk by the third year. And when you think about most healthcare providers, and that includes some of the most advanced group practices like Mayo Clinic and Cleveland Clinic, they're paid on a fee-for-service platform, and aren't used to or experienced in, risk-sharing; and to require that suddenly in the third year of the program was perhaps the most problematic element in the whole proposed rule. So we said, maintain the two tracks in the proposed rule-one would require risk-sharing from day one, which is appropriate for a subset of providers-and then the other track should have no downside risk at all.
HCI: Not ever?
Speed: Well, these are three-year agreements. So there's no doubt that over time, people would get to risk-sharing. If you think about it, the shared-savings program is sort of a bridge between fee-for-service and capitation, so that this program would take you over a period of five or six years to capitation. And even those providers taking only fee-for-service right now recognize that we need to eventually get to capitation; but CMS just got too quickly to that stage in the proposed rule.
HCI: What is your sense of the possibility that CMS will change or modify that?
Speed: This is also interesting: behind the scenes is the Office of Management and Budget [OMB]. And a lot of people are saying that OMB is the agency that pushed for the idea that there had to be some sort of downside risk for all ACOs. So we have to convince CMS that this is a non-starter; but we also have to convince OMB that this threatens the future of ACOs. We'll be sending a letter to OMB soon. Not many people are focusing on OMB; they really call the shots on how much savings they want any federal regulation to accrue.
HCI: You had said that the application process is too complex and burdensome. Might that be another element that could dissuade providers from participating in the program?
Speed: I thought our comments letter really laid out very nicely the problems involved in this. I used to practice law, and lawyers deal with paper. And the paperwork requirements to apply to be an ACO are just overwhelming. And essentially what we asked CMS to consider was, instead of requiring every documentation under the sun, let us attest to the fact that we have those. And I think that makes sense, because Cleveland Clinic, Mayo Clinic, Ochsner Clinic, these organizations have in-house counsel and outside counsel; and they are not going to let their clients attest to something that isn't true. So let that happen rather than going through the rigorous documentation production requirements in the proposed rule.
HCI: Is it your sense that the weight of comments from your organization and from other organizations will sway CMS?
Speed: Yes, it's not just us; Mayo Clinic, Cleveland Clinic, and Vanderbilt, all member organizations, have sent comments similar to ours. And the fact that there is such consensus from the group practice community-which is the target audience for ACOs-well, I hope they do listen to us. Because there is concern among our members that ACOs will not succeed. Because the question then is, what is the alternative? And the answer is these sorts of heavy-handed, across-the-board provider cuts.
HCI: What's the next step in all this?
Speed: I think there's a statutory requirement that they have to respond within three years. But I used to work at OIG within HHS [the Office of the Inspector General, Department of Health and Human Services]; and I know from experience that CMS reads every comment they receive. So as far as their getting a final rule out, it depends on, one, how long it takes them to read every comment, and I think there will be extensive comments; and, two, they have to determine what changes to make. So it seems like a fairly long path. But there's also a Jan. 1, 2012 deadline for ACOs to start. And realistically, providers need a final rule by September, just to do the financial and quality modeling, to see if it makes sense to them.
What CMS has said in public is that you could become an ACO at any time, so that if you want to apply to become an ACO after that, go for it. So I would expect that they would respond to the comments sometime in the fall. Because I think they're going to wrap it up as soon as possible. And the decisions that have to be made-that's a very, very big job. And with all due consideration…they'll do it as soon as they can.
Healthcare Informatics 2011 August;28(8):45-47