I agree with my colleagues that CMS appears to be looking to the industry to guide them on waiver development, as well as other details of the Medicare Shared Savings Program.
CMS intends to grant waivers that would apply uniformly to all ACOs, ACO participants and ACO providers/suppliers participating in the Medicare Shared Savings Program. Because the waivers are intended to be applicable to all ACOs (not just the requesting entity) it is likely that such waivers will be narrowly tailored so as to not undermine existing law. It also appears that CMS intends to publish these waivers contemporaneously with, or very close to, the publication of the Medicare Shared Savings Program final rules (possibly even before the final rules’ publication). Therefore, it is critical that interested parties submit their comments as soon as possible.
Specifically, CMS is looking for comments regarding waivers covering the following topics:

  • Arrangements related to establishing the ACO (formation, governance, building technological or administrative capacity).
  • Arrangements between or among ACO participants and/or ACO providers/suppliers related to ongoing operations of the ACO and achieving ACO goals.
  • Arrangements between the ACO, ACO participants, and/or ACO providers/suppliers and outside individuals or entities.
  • Distributions of shared savings or similar payments received from private payers.
  • Other financial arrangements.
  • Duration of waivers (during the term of the ACO agreement or for some longer/shorter period?).
  • Additional safeguards.
  • Scope of waivers (e.g. what should “necessary and directly related to the ACO’s participation” mean?).
  • Whether different waivers are appropriate for ACOs participating in the two-sided risk model.
  • Continued use of the electronic health records arrangements exception and safe harbor after the 2013 sunset.
  • Beneficiary inducements.
  • Timing of waivers.

As Peter pointed out previously, much of the “beef” of the ACO regulations has yet to be developed. Because CMS intends to issue waivers that are applicable to all ACOs along with the final rules (or even shortly before the final rules) I think it will be difficult for the comments and CMS waivers to address all of the issues that might arise as the Shared Savings Program evolves. Unless CMS is open to implementing waivers subsequent to the publication of the final rules, this could limit the flexibility and creativity contemplated under the ACO program. Unfortunately, the commentary is silent regarding further waiver development.