New Program Standards Established During 3-Year Agreement Period

• ACOs would be subject to future changes in regulation with the exception of the following program areas:  eligibility requirement concerning the structure and governance of ACOs; calculation of sharing rate; and beneficiary assignment (e.g., ACOs would be subject to changes in regulation related to the quality performance standard.  The language of the ACO agreement would be explicit to ensure that ACOs understand the dynamic nature of this part of the program and what specific programmatic changes would be incorporated into the agreement)—(Note : at a minimum they should NOT be subject to changes in the middle of a performance year).
• In those instances where regulatory modifications effectuate changes in the processes associated with an ACO pertaining to design, delivery, and quality of care that the ACO will be required to submit to us for review and approval, as a supplement to their original application, an explanation of how they will address key changes in processes resulting from these modifications.  If an ACO fails to effectuate the changes needed to adhere to the regulatory modifications, the ACO would be placed on a corrective action plan, and if after being given an opportunity to act upon the corrective action plan, the ACO still fails to come into compliance, it would be terminated from the program.
•  ACO participants will continue to be subject to all requirements applicable to FFS Medicare, such as routine CMS business operations updates and changes in FFS coverage decision, as they may be amended from time to time (i.e., nothing in the SSP shall be construed to affect the payment, coverage, program integrity, and other requirements that apply to providers and suppliers under FFS Medicare).

Managing Significant Changes to the ACO

During the Agreement Period, the ACO may experience other changes within the course of the 3-year agreement period which would subject the ACO to review by CMS and other agencies (e.g., deviations from approved application; material changes in the ACOs provider composition; government-required ACO reorganization or exclusion of ACO participants or ACO providers/suppliers):

•  The ACO may not add ACO participants during the course of the 3-year agreement.
• In order to maintain flexibility, however, we propose that the ACO may remove ACO participant(TINs) or add/subtract ACO providers/suppliers (NPIs). 
•  (CMS requests comments on the proposal that ACOs may not add ACO participants and how this proposal might impact small or rural ACOs).
  
• (Note:  This doesn’t make sense if the beneficiary’s are reassigned at the end of each performance year). 
•  The ACO will be required to notify CMS in order to have its new structure approved whenever significant changes, such as those referenced previously, occur to its structure.  There are five possible outcomes of the review:
  •  The ACO may continue to operate under the new structure with savings calculations for the performance year based upon the updated list of ACO participants and ACO providers/suppliers;
  • The remaining ACO structure qualifies as an ACO but is so different from the initially approved ACO structure that the ACO must start over as a new ACO with a new 3-year agreement, including an antitrust review if warranted;
  •  The remaining ACO structure qualifies as an ACO but is materially different from the initially approved ACO structure because of the inclusion of additional ACO providers/suppliers that the ACO must obtain approval from a reviewing Antitrust Agency before it can continue in the program.
  • The remaining ACO structure no longer meets the eligibility criteria for the program, and the ACO would no longer be able to participate in the program (e.g., if the ACO’s assigned population falls below 5,0000 during an agreement year).
  • CMS and the ACO may mutually decide to terminate the agreement.
•  (Note:  it seems there should be some flexibility built into the agreements to allow for certain levels and types of change that can be made without going through the process all over again)
• When an ACO reorganizes its structure by excluding ACO participants or by adding or excluding ACO providers/suppliers, deviates from its approved application, changes information contained in its approved application, or experiences other changes which may make it unable to complete its 3-year agreement, it must notify CMS within 30 days of the event for reevaluation of its eligibility to continue to participate in the SSP.
• (CMS requests comment on the above proposal).
  
• (Note:  The inequities are somewhat obvious here, CMS can change the regulations and the ACO is expected to comply, but if the ACO makes changes, it must seek review and possibly be terminated from the program.  At a minimum CMS needs to build in some flexibility for change and limit review to material changes.  CMS would need to make clear what are considered material changes that would require review).

 Future Participation of Previously Terminated Program Participants:

•  The ACO would be required to disclose to CMS whether the ACO, its ACO participants, or its ACO providers/suppliers have participated in the program under the same or a different name, and specify whether it was terminated or withdrew voluntarily from the program.  If the ACO, it’s ACO participants or ACO providers/suppliers were previously terminated from the program, the applicant must identify the cause of termination and what safeguards are now in place to enable the prospective ACO to participate in the program for the full period of the 3-year agreement period.
• The ACO would not be able to begin another 3-year period until the original agreement period has lapsed.  (Note:  is this really necessary? They should be able to begin again on the next Jan 1 if they meet all the criteria by the next application date).
•   An ACO may not reapply to participate in the SSP if it previously experienced a net loss during its first 3-year agreement period.  (Note: again this seems harsh, there should be some threshold for determining which one are inherently flawed vs which ones might have experienced particularly bad year—an extreme example would be natural or other disasters that result in a significant level of injury, trauma, and death in a geographic region….).
• (CMS is seeking comment on these proposals and whether requirements for denying participation to ACOs that previously under-perform would create disincentives for the formation of ACOs particularly among smaller entities.)