ACO Proposed Rule Review: Part 6

IIC—Establishing the 3-year Agreement with Secretary

•     Options for Start Date of the Performance Year–applications would be considered on an annual, calendar year, basis:

o     (1)ACO applications must be submitted by a deadline established by CMS;

o     (2) CMS will review the applications and approve applications from eligible organizations prior to the end of the calendar year;

o     (3) The requisiste3-year agreement period will begin on the January 1 following approval of an application; and

o     (4) The ACO’s performance periods under the agreement will begin on January 1 of each respective year during the agreement period.

o     (CMS solicits comments on any alternatives to a January 1 start date for the first year of the Shared Savings Program (SSP) such as whether CMS should allow a July 1 start date and increase the term to 3.5 years).

•     Timing and Process for Evaluation Shared Savings

o     (For purposes of this section, which attempts to determine when the amount of savings should be calculated, “claims run out period” is the time between when a Medicare-covered service has been furnished to a beneficiary and when the final payment is actually issued for the respective service.  A 3 month run out period would result in a completion percentage of approximately 98.5 % for physician services and 98% for Part A services; a 6 month run out of claims data results in a completion percentage 99.5 for physician services and 99 percent for Part A services).

o     A 6-month claims run-out would be used to calculate the benchmark and per capita expenditures for the performance period.

o     (CMS is seeking comment on the need to provide timely feedback to an ACO vs the need for more accurate and complete claims data to ensure that savings are calculated as accurately as possible. CMS is also seeking comments on whether there are additional considerations that might make a 3-month claims run-out more appropriate).

•     Data Sharing—(Note:  There are not specific requirements proposed in this section although data sharing will be addressed in another sections.  That said, the following bullets provide some of CMS’ thinking on data sharing).

o     CMS believes that providing ACOs with an opportunity to request CMS claims data on their potentially assigned beneficiary population would allow the ACO to understand the totality of care provided to beneficiaries assigned to them by identifying the services and supplies that fee-for-service beneficiaries received during the performance year both within and outside of the ACO. 

o     CMS could provide data to ACOs in different forms with a focus on different levels of information, e.g., aggregated population level data or beneficiary identifiable data, so that ACOs would be able to see how ACO participants and ACO providers/suppliers measure up to benchmarks and targets, how they perform in relation to peers internally, and identify which categories of beneficiaries would benefit most from care coordination and other patient-centered approaches.  

•     Sharing Aggregate Data

o     CMS would provide aggregate data reports, which would include, when available, aggregated metrics on the assigned beneficiary population, and beneficiary utilization data at the start of the agreement period based on historical data used to calculate the benchmark.

o     CMS would include these data in conjunction with the yearly financial and quality performance reports.

o     CMS would provide quarterly aggregate data reports to ACOs based upon the most recent 12 months of data from potentially assigned beneficiaries.

o     (Note carefully: Potentially assigned beneficiaries are those who are likely to be assigned to the ACO based on a plurality of primary care services. This seems to be the case for the year before the agreement period and for each performance year during the 3 year term.  So, ACO beneficiaries are not actually assigned for the purpose of determining shared savings until the end of a performance year based on a plurality of the primary care services received during the previous year; therefore, assigned beneficiaries can change from year to year based on where the beneficiary seeks a plurality of their primary care services.   According to CMS, based on experience with the PGP demonstration, a high percentage of historically assigned patients continue to receive care from the ACO participants and ACO providers/suppliers.  If anyone understands this differently, please feel free to share that with the list serve).

o     (CMS would like comments on the above as well as the kinds of aggregate data and frequency of data reports that would be most helpful to the ACO’s efforts in coordinating care, improving health, and producing efficiencies).

     Identification of Historically Assigned Beneficiaries

o     At the beginning of the agreement period (first performance year), upon request of the ACO, CMS would provide the ACO with a list of beneficiaries who received the plurality of primary care services from primary care physicians (FP, IM, GP, Geriatrics) who are ACO participants.  The information would include the: (1) name, (2) date of birth, (3) sex, and (4) Health Insurance Claim Number (HIC) of the historically assigned beneficiary population.

o     (CMS seeks comment on this proposal and on whether and how this information would be beneficial to the goals of improved care coordination and improving care delivery for the ACO’s assigned beneficiary population).

•     Sharing Beneficiary-Identifiable Claims Data

o     The ACO would be given the opportunity to request certain beneficiary identifiable claims data on a monthly basis, in compliance with applicable laws, in the form of a standardized data set about the beneficiaries currently being served by the ACO participants and ACO providers/suppliers.

o     Beneficiaries covered by such data sets would be limited to those who have received a service from the PCP participating in the ACO during the performance year, and who have not opted out of having CMS share their claims data with the ACO. (However, for information from federally assisted substance abuse facilities, written consent of the beneficiary would be needed to share this information).

o     The content of this data would be limited to the minimum data necessary for the ACO to effectively coordinate care of its patient populations.

o     If an ACO chooses to request beneficiary identifiable claims data as part of the application process, the ACO would be required to explain how it intends to use these data to evaluate the performance of ACO participants and ACO providers/suppliers, conduct quality assessment and improvement activities, and conduct population-based activities to improve the health of its assigned beneficiary population.  If an ACO does not choose to request these data at the time of its application, it will be required to submit a formal request for data during the agreement period that includes a description of how it intends to use the requested data for the purposes noted previously.

o     (CMS solicits comments on the above proposals).

o     Also, when an ACO is accepted to participate in the SSP, the ACO would be required to enter into a Data Use Agreement (DUA) prior to receipt of any beneficiary identifiable claims data.  Under the DUA, the ACO would be prohibited from sharing the Medicare claims data provided by CMS through the SSP with anyone outside the ACO (this will require that the information be segregated in whatever medium it is retained by the ACO).

o     The DUA must include a provision that the ACO agree not to use or disclose the claims data obtained under the DUA in a manner in which a HIPAA covered entity could not without violating the HIPAA privacy rule.

o     Compliance with the DUA would be a condition of the ACO’s participation in the SSP—non-compliance with this requirement would result in the ACO no longer being eligible to receive data, and could lead to termination from the SSP or additional sanctions and penalties under law.

o     The ACO would be required to certify compliance with the DUA in the same manner in which prospective ACOs did in the original application process.

o     Legal Authority to Disclose Beneficiary-Identifiable Claims Data to ACOs

Sharing Data Related to Medicare Parts A and B

•     ACOs would be required to attest in either their initial application or in their subsequent formal request for data if they failed to request data in the application stage, that; (1) they are a covered entity or a business associate of covered entity ACO participants and ACO suppliers/providers under the SSP; (2) their business associate agreement with these ACO participants and ACO providers/suppliers for one of the health care operations purposes laid out previously; (3) their request reflects the minimum data necessary to do that health care operations work; and (4) that their use of these requested date would be limited to the SSP activities related to one or more of the health care operations purposes laid out previously or (1) they are a HIPAA covered entity; (2) they are requesting the claims data about their own patients for one of the health care operations purposes laid out previously; (3) their request reflects the minimum data necessary to do that health care operations work; and (4) that their use of these requested data would be limited to the SSP activities related to one or more of the health care operations purposes laid out previously. 

Sharing Data Related to Medicare Part D

•     ACOs would be provided with the minimum Part D data necessary to permit the ACO to undertake evaluation of the performance of ACO participants and ACO providers/suppliers, conduct quality assessment and improvement activities with and on behalf of the ACO participants and ACO providers/suppliers, and conduct population-based activities relating to improved health for Medicare beneficiaries who have a primary care visit with a PCP used to assign patients to the ACO during a performance year.

•     The minimum data elements necessary to perform these functions would include data elements such as:  beneficiary ID, prescriber ID, drug service date, drug product service ID, and indication if the drug is on the formulary.

Beneficiary Opportunity to Opt-out of Claims Data Sharing

•     ACOs would be required to, as part of its broader activities to notify patients at the point of care that their provider or supplier is participating in an ACO, to inform beneficiaries of its ability to request claims data about them if they do not object.  The only exceptions to this advanced notice would be the initial four data points (name, DOB, sex, HICN) that would be provided to ACOs for individuals in the 3-year data set used to determine the ACO’s benchmark).

•     Meaningful choice would (1) allow the individual advance notice and time to make a decision; (2) be accompanied by adequate information about the benefits and risks of making their data available for the proposed uses; (3) not compel consent; and (4) not use the choice to permit their information to be shared for discriminatory purposes. 

•     Beneficiaries would be provided the ability to opt-out of sharing their protected health information with the ACO.  When the beneficiary has a visit with the PCP, the PCP would inform the beneficiary at the visit that he or she is an ACO participant or ACO provider/supplier and that the ACO would like to be able to request claims information from CMS in order to better coordinate the beneficiary’s care.  If the beneficiary objects, the beneficiary would be given a form stating that they have been informed of their physician’s participation in the ACO and explaining how to opt-out of having their personal data shared. The form could include a phone number and/or email address for beneficiaries to call and request that their data not be shared.  (It is not clear if this must occur every visit).

•     CMS would develop a communications plan that would offer insight into both the SSP in general and the beneficiaries’ right to opt-out of the data sharing portion of the ACO SSP. 

•     (Note:  a decision by a beneficiary to opt-out only applies to the data sharing and not assignment to the ACO).


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