Here they are, all 427 pages. Can we crowdsource the content as we read them today?
My view is that ACO flexibilities are needed mostly in fraud & abuse, not antitrust. Let’s see what the proposed rule says.
Update 1: NEJM just posted a commentary on the new rules by Don Berwick. First stop is to look at the proposed quality-performance standards in the handy chart.
Update 2: The 26 page waiver rules are also out. [updated link]
Update 3: I’ve read the waiver rule. On the plus side, it covers Stark II, AKS and CMP in a coordinated fashion. Specifically, compliance with Stark II satisfies AKS (pp 15-16) (this is an exception to usual CMS practice and a welcome rule). For CMP, they relax a historically difficult rule (at 16) that has bedeviled gainsharing for decades, adding the qualifier “medically necessary.”
One limitation – it only protects ACO shared savings payments and related arrangements. It’s not a blanket waiver for all activities within an ACO. Not a surprise. The balance of the rule solicits further comments, including some specific scenarios. On balance, a welcome rule. Kevin @2.17pm: The Fraud & Abuse Waiver is very pro-ACO, breaking new ground that has frustrated health care lawyers for more than a decade.
Update 4: Now the 20 page FTC/DoJ joint statement on antitrust joins the party. Federal ACOs are deemed to meet clinical integration rules (not a surprise). The statement breaks ACOs into 3 categories, depending on market share. Those with less than 30% market share get a free pass; those with more than 50% get mandatory federal review; those in the middle can request review. Healthcare antitrust lawyers full employment act.
Update 5 (Don Taylor): One of the big discussions in the hospice and palliative care community has been that such care should be included in ACOs. p.224 of the doc mentions hospice in relation to section 3004 of the ACA which provides for more publicly available data toward the goal of helping ACOs move toward ‘value based purchasing’. The doc on p. 226 says
We seek comments on our proposals, including whether the proposed list includes
elements that should not be required, or excludes elements that are important for achieving
transparency or meaningful public disclosure within the Shared Savings Program and whether
we should standardize the format or allow ACOs the flexibility to try different and innovative
approaches for providing this information to beneficiaries.
It seems that more info on hospice, and especially how to provide info to the public about the quality of life gains of hospice are needed. The next portion of the doc pp. 227-28 talks about quality metrics, but doesn’t seem to include hospice which probably should be added.
Update 6: Kaiser Health News with lots of resources on the ACO regs including a video.
Update 7 (Aaron Carroll): My biggest complaint about the way ACOs have been portrayed has been that it’s all carrot and no stick. So I’d be especially interested in whatever you can find in those to regards, especially the sticks!
Update 8: Health Affairs blog with general link and one from Mark Lutes. 2006 Elliott Fisher paper advancing the notion.
Update 9: (Don Taylor) Federal Trade Commission draft policy statement/guidelines for anit-trust enforcement in light of ACO regulations. Public comments accepted on this statement through May 31, 2011. This will be an important part of the overall policy context of ACOs, especially if it turns out that hospitals are heavily involved.To my non-legal eye, this looks to be the key part:
The antitrust laws treat naked price-fixing and market-allocation agreements
among competitors as per se illegal. Joint price agreements among competing health care
providers are evaluated under the rule of reason, however, if the providers are financially or clinically integrated and the agreement is reasonably necessary to accomplish the procompetitive benefits of the integration. A rule of reason analysis evaluates whether the collaboration is likely to have
substantial anticompetitive effects and, if so, whether the collaboration’s potential
procompetitive efficiencies are likely to outweigh those effects. The greater the likely
anticompetitive effects, the greater the likely efficiencies must be to pass muster under
the antitrust laws.
As I think through this, I wonder how the detailed standards (percent of patients in a market controlled) listed in the FTC document will be worked out in a place like Durham/Chapel Hill, N.C. where Duke and UNC Health Care have already bought a great number of the private medical practices in the area. If anti-trust not already raised, does that mean ACO wouldn’t raise questions? I am not sure.
Looking at eligible providers (p. 16) I see these (@Steve in the comments, look here) it seems there are lots of ways for the doc practices that have been swallowed up by Duke and UNC and other places to be put into ACOs….and may give more ways to avoid anti-trust issues.
Section 1899(b)(1) of the Act establishes the types of groups of providers of
services and suppliers, with established mechanisms for shared governance, that are
eligible to participate as ACOs under the program, subject to the succeeding provisions of
section 1899 of the Act, as determined appropriate by the Secretary. Specifically,
sections 1899(b)(1)(A) through (E) of the Act provide, respectively, that the following
CMS-1345-P 16
groups of providers of services and suppliers are eligible to participate:
• ACO professionals in group practice arrangements.
• Networks of individual practices of ACO professionals.
• Partnerships or joint venture arrangements between hospitals and ACO
professionals.
• Hospitals employing ACO professionals.
• Such other groups of providers of services and suppliers as the Secretary
determines appropriate.
And further, these requirements for ACOs
The ACO shall be willing to become accountable for the quality, cost, and
overall care of the Medicare fee-for-service (FFS) beneficiaries assigned to it.
• The ACO shall enter into an agreement with the Secretary to participate in the
program for not less than a 3-year period.
• The ACO shall have a formal legal structure that would allow the organization
to receive and distribute payments for shared savings to participating providers of
services and suppliers.
• The ACO shall include primary care ACO professionals that are sufficient for
the number of Medicare FFS beneficiaries assigned to the ACO. At a minimum, the
CMS-1345-P 17
ACO shall have at least 5,000 such beneficiaries assigned to it in order to be eligible to
participate in the Shared Savings Program.
Update 10 (Aaron Carroll): More on carrots and sticks here.
Update 11 (Aaron Carroll): One-sided ACOs and the differences from two-sided ACOs.
