50 Things to Know About the Proposed ACO Regulations
Medicare Shared Savings Program proposed rule — which established Medicare accountable care organizations — released by the U.S. Department of Health and Human Services on March 31. The article begins with a summary of key 45 provisions included in the proposed regulations and then provides five general observations regarding the ACO program, as established by the regulations.
45 key provisions in the proposed ACO regulations
1. ACO Participants cannot participate in other Medicare shared savings programs. A Medicare provider cannot participate in the Shared Saving Program as an ACO participant if it also participates in the independence at home medical practice pilot program or other Medicare programs that include shared savings.
2. An ACO may include the following types of groups of providers:
• ACO professionals (i.e., physicians and hospitals meeting the statutory definition in a group practice arrangement);
• Networks of individuals practices of ACO professionals;
• Partnership or joint venture arrangements between hospitals and ACO professionals;
• Hospital employing ACO professionals; and
• Other Medicare providers and suppliers as determined by the HHS Secretary.
3. The regulations provide for a once-a-year start date of Jan. 1. Under the proposed rule, ACOs would apply for the three-year program and, if accepted, would be part of a cohort of ACOs joining the Shared Savings Program every Jan. 1.
4. ACO agreements will be for three years with one-year performance measurement periods.
5. Medicare fee-for-service beneficiaries will be retroactively assigned to ACOs based on primary care utilization during a performance year. "We are proposing to assign beneficiaries for purposes of the Shared Savings Program to an ACO if they receive a plurality of their primary care services from primary care physicians within that ACO."
6. Beneficiaries will not be assigned to more than one ACO.
7. Beneficiaries will not receive advance notice of their ACO assignment. However, providers participating in ACOs will be required to post signs in their facilities indicating their participation in the program and to make available standardized written information to Medicare fee-for-service beneficiaries whom they serve. Additionally, all Medicare patients treated by participating providers must receive a standardized written notice of the provider's participation in the program and a data use opt-out form.
8. CMS expects 5 million Medicare beneficiaries to receive care from providers participating in a shared savings program.
9. An ACO must have at least 5,000 beneficiaries. If an ACO accepted into the program falls short of the 5,000 requirement, it will be placed on a corrective action plan.
10. The board of an ACO must include some Medicare beneficiaries. "Another of the proposed patient-centered criteria discussed previously is the requirement that ACOs provide for patient involvement in their governing processes. We are proposing that, in order to satisfy this criterion, ACOs will be required to demonstrate a partnership with Medicare FFS beneficiaries by having representation by a Medicare beneficiary serviced by the ACO, in the ACO governing body."
11. The ACO board must include representation from all ACO participants. CMS requires this in order ensure all ACO participants are provided "an appropriate proportionate control over the ACO's decision-making process."
12. No more than 25 percent of board seats can be held by non-ACO participants such as entrepreneurial companies. "In order to be eligible for participation in the Shared Savings Program, the ACO participants must have at least 75 percent control of the ACO's governing body."
13. The proposed regulations do not require an ACO to become a separate legal entity with a separate Tax Identification Number. However, CMS recognized not requiring this could make it more difficult for CMS to audit ACO performance. Thus, it is seeking comment on whether all ACOs should be required to be formed as separate legal entities.
14. The ACO can enter into a one-sided or two-sided shared savings agreement. Under the first "one-sided" risk model, an ACO that creates a savings of at least 2 percent would get 50 percent of the money above that threshold, but it would have no penalty if it spent more in the first and second year. Under the "two-sided" model, an ACO could receive 60 percent of the money above the threshold but also would be penalized if it led to higher costs. By the third year of the program, all ACOs would become responsible for losses.
15. Cost targets, from which savings will be calculated, will be based on retrospective review of aggregate beneficiary-level data for the assigned population. Spending targets will be compared to actual spending and any savings above the ACO's minimum savings rate (generally 2 percent), will be shared between CMS and the ACO.
16. CMS will set spending benchmarks based on three years of data. These will be set with a higher weighting on the most recent year and the lowest weighting on the year three years ago (i.e., a 60, 30, and 10 rating). There are several adjustments to the benchmarking.
17. Generally there is no savings shared or costs to be borne unless savings are at least 2 percent above or below the benchmark. The higher the number of beneficiaries, the lower the minimum savings rate. For smaller populations (e.g., 5,000 beneficiaries), the minimum savings rate can be higher (i.e., up to 3.9 percent). However, there are exceptions to the rule for rural ACOs.
18. The ACO entity is responsible for distributing savings to participating entities. Medicare will pay the savings to the ACO, which will distribute it to participants in the ACO.
19. ACOs will be subject to a withhold of shared savings to offset possible future losses. "The ACO will be subject to a 25 percent withhold of shared savings in order to offset any future losses under the two-sided model." If an ACO completes its three-year agreement, it can recoup the 25-percent withhold. If an ACO terminates its agreement before the three-year requirement, CMS will retain any portion of shared savings withheld.
20. To be eligible to receive shared savings, the ACO must also meet certain quality standards. There are five standard measures for quality or areas. These include patient care giver experience, care coordination, patient safety, preventive health and at risk population/frail elderly health. CMS will designate scoring and measurement concepts. "Each of the [five] domains is equally weighted in determining an ACO's overall quality performance score, regardless of whether the ACO is in Track 1 or Track 2."
21. An ACO must develop a process to promote evidence-based medicine, patient engagement and coordination of care.
22. ACOs must have a patient survey tool in place.
23. ACOs must have a process for evaluating the health needs of the population it serves.
24. ACOs must have systems to identify high-risk beneficiaries and develop individual care plans for target populations.
25. An ACO must report and maintain a database of all ACO participants and their National Provider Identifiers.
26. ACOs must have a compliance plan and conflicts of interest policies and means to screen ACO participants.
27. ACOs must get approval for any changes in ACO participants (i.e., providers) during the three-year contract period.
28. Where an ACO's structure or participants changes during a term, CMS has five different ways it may respond. In some cases, the ACO will be allowed to move forward in the program. In others, it would be required to start over with a new three-year agreement. In some cases, the ACO would no longer be eligible for the Shared Savings Program. (See page 137 of the proposed regulations for the full list of CMS responses.)
29. Primary care providers may only participate in one ACO. However, a hospital can participate in more than one ACO, as can non-primary care medical and surgical providers.
30. Physicians eligible for primary care provider status include internal medicine, general practice, family practice and geriatric medicine specialists.
31. At least 50 percent of an ACO's primary care physicians must be meaningful EHR users as defined by the HITECH Act and subsequent Medicare regulations.
32. Each ACO will have significant public reporting requirements in a standardized format. Name; location; contact; participating providers; identification of participants in joint-ventures between ACO professionals and hospitals; identification of representatives on the governing body; associated committees and leadership; quality performance standard scores; shared savings information, total proportion of savings distributed to participants; and total used to support quality performance will be reported publicly.
33. ACOs must have a data-use agreement with CMS. However, Medicare beneficiaries assigned to ACOs can opt-out of data sharing. The ACO must supply beneficiaries with a form that allows them to opt-out.
34. CMS will share aggregate population data regarding the ACO's population several times per year. Data from CMS will include financial performance; quality performance scores; aggregate metrics on the assigned beneficiary population; utilization data at the start of the agreement period based on historical beneficiaries; and identification of historically assigned beneficiaries used to calculate the benchmark.
35. CMS may monitor to ensure they are not avoiding at-risk beneficiaries or distributing unapproved marketing materials in addition to a whole range of other issues. In regards to marketing materials, CMS must approve any marketing materials or other communications promoting the ACO.
36. ACOs must agree to be open wholly to audits. "We further propose that, if such data are generated by ACO participants or another individual or entity, or a contractor, or subcontractor of the ACO or the ACO participants, such ACO participant, individual, entity, contractor, or subcontractor must similarly certify the accuracy, completeness, and truthfulness of the data and provide the government with access to such data for audit, evaluation, and inspection."
37. The regulations set forth 16 grounds for termination of an ACO's shared savings agreement with CMS. Examples of these grounds include failure to report quality standards or failure to meet quality thresholds and avoidance of at-risk beneficiaries. (A full list of the 16 grounds can be found on pg. 409 of the proposed regulations.)
38. There are several concepts which are not subject to appeal by an ACO if it is terminated from the program by CMS. (A list of these can be found on pg. 412 of the proposed regulations). ACOs may appeal an initial determination if it is not prohibited for administrative or judicial review.
39. CMS can change the program during a contract term, but can't change the rules regarding the eligibility requirements of an ACO, calculation of the shared savings rate and beneficiary assignment.
40. CMS and the OIG have proposed waivers with regard to Civil Monetary Penalty, Antikickback and Stark laws solely as to relationships wholly related to an ACO. For Stark and Antikickback, the waiver applies only to distributions of shared savings (not any other financial relationships). To view the CMS and OIG guidance, click here.
41. Preliminary guidance from IRS available. The IRS has issued preliminary guidance to provide tax-exempt entities information on participating in ACOs. To view the IRS guidance, click here.
42. Preliminary guidance from antitrust agencies available. The FTC and DOJ have also issued a proposed statement of antitrust enforcement policy as to ACOs. According to the guidance, ACO participants will not be challenged if they have a combined share of less than 30 percent of the common service in each area. If outside the safe zone it can still proceed if less than 50 percent. If more than 50 percent it must receive an approval to participate. If less than 50 percent, it doesn't need a review, but can request one. To view the antitrust guidance click here.
43. The core concepts of the ACO program are to achieve better care for individuals, better health for populations and lower growth for Medicare expenditures.
44. Comments on the proposed rule will be accepted for 60 days after the proposed rule is published in the Federal Register (expected April 7, 2011, so until June 6, 2011).
45. The ACO program is scheduled to go into effect on Jan. 1, 2012.
General observations on the ACO program
46. Will require massive bureaucracy. Given the scope of the regulations and the number of actions and approvals to qualify and participate and be accountable as an ACO, the ACO regulations likely will require the establishment of a massive bureaucracy. In some ways, it's a different form with much more integration than providers that manage a Medicare advantage plan system but with arguably even more complexity.
47. Regulations are idealistic. The regulations in many ways speak of what is viewed by CMS as ideal concepts in healthcare, concepts used as platitudes such as "patient-centered care," "patient engagement" and many other terms. It will be fascinating to see how the actual practical hard-nosed implementation meshes with such ideals.
Further, the regulations speak of the kind of leadership expected in ACOs as though government can choose leaders or dictate what they look like in what we know is an imperfect world and where the reality of capitalism and a free market. In reality, who leads such organizations is never going to be as clean and clear as the regulations seem to believe and the leaders won't fit a certain stereotype.
48. Regulations limit business involvement. The program set forth the kind of negative attitude that one might expect from CMS towards business and further tends to reflect CMS' demonization of business and insurance. For example, while some might think business involvement is needed to drive this, the regulations specifically require that business interests cannot make up more than 25 percent of the board in ACOs.
49. Regulations require beneficiary representation in ACO governance. The program requires a means for equal and shared governance in ACOs and requires beneficiaries to have a say in the ACO governance. Specifically, the proposed regulations require the ACO governing body to include including "a Medicare beneficiary serviced by the ACO."
50. Regulations favor PCPs. The ACO regulations — much like intended reform in the 90s — view the primary care physician as the leader of patients' healthcare and really relegates many other parties to being cost centers. Language regarding PCP roles is somewhat glowing, further suggesting this perspective.
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