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Our Comments on the Proposed MACRA Regulations: MIPS and AAPMs

Published Date

These are unedited comments on proposed Federal regulation. They aren’t short and they aren’t ACO 101. 

Dear Administrator Slavitt,

Aledade partners with 159 primary care physician practices, FQHCs and RHCs in value-based health care. Organized into eight accountable care organizations across 14 states these primary care physicians are accountable for over 130,000 Medicare beneficiaries. More than half of our primary care providers are in practices with fewer than ten clinicians. As an organization that is dedicated solely to helping independent physicians lead the transition from volume to value, we have a particular set of experiences and perspectives that are highly relevant to the key policy issues faced by CMS in implementing the MACRA legislation.

  • Independent and small practices are not only capable of taking accountability for the total cost of care, but –unburdened by concerns of “demand destruction”-they may be uniquely positioned to do so[1]. A focus on outcomes moves practices beyond mere compliance with quality measure reporting, health IT use, or medical home processes. Creating a viable pathway for them to participate in Advanced Alternative Payment Models (AAPMs) must be prioritized.
  • Independent and small practices are feeling intense pressure from multiple fronts, which is contributing to the continued consolidation of local provider markets. A lack of healthy competition in local markets results in higher societal costs with no apparent improvement in patient care. Creating a viable pathway for these practices to stand on “equal footing” with larger and more integrated groups is a key policy priority.


As described in more detail in our comment letter, a few critical changes to the proposed MACRA regulation could dramatically improve the attainment of these policy objectives.

  1. Defining “more than nominal financial risk” such that smaller practices are motivated but do not face an existential threat. We propose basing financial risk on the participating APM Entity’s Part A and B Medicare revenue, and a pathway for making it available in time for 2019 payments.
  2. Allowing independent practices to come together in “virtual groups” now for all aspects of MIPS reporting, and rewarding their clinical practice and health IT advances as they work towards participation in APMs (like gain share only ACOs) and on to AAPMs.
  3. Providing administrative flexibility for these small businesses by comparing their performance under MIPS to that of their peers by practice size.


Thank you very much for your consideration as we move together through this exciting time in health care. Please feel free to follow up with me or Travis Broome (travis@aledade.com) if you or your staff have questions or would like to explore these positions further

Summary 

Advanced Alternative Payment Models
Financial Risk
Before defining financial risk, the purpose of financial risk must be established. As most alternative payment models (APMs) are voluntary, CMS should not expect that any organization will continue to participate over multiple years of losses. Medicare will benefit from APMs primarily from sharing in positive value created by health care providers. The non-financial effect of risk is to be a motivating factor making positive value creation more likely and of greater magnitude. CMS should evaluate the definition of financial risk through the lens of whether it motivates APM participants more than having no financial risk.

More than Nominal Financial Risk
Congress highlighted the use of risk-based models for motivation with the phrase “more than nominal financial risk.” The risk needs to motivate, it needs to be enough to matter, it needs to be more than very small in amount, but more than nominal clearly does not translate into financial ruin. The lack of participation in downside risk in APMs to date is a clear signal about how serious entities consider downside risk and the effect it would have on organizations that take on downside risk. However, just as the lack of participation is a signal of its effectiveness it should also be a signal to CMS of the need to strike the right balance in using MACRA to create a better model of two-sided risk.

The proposal to base the determination of “more than nominal” on the benchmark of the APM will not succeed in moving more providers to financial risk and clearly does not meet the Congressional intent of the “more than nominal” provision. Using the benchmark creates vastly different amounts of risk depending on the organization and depending on the APM model. How risky something is to an organization is dependent on the level of risk relative to their financial situation. This variation creates a situation where CMS will not be able to gauge the amount of financial risk any APM entity is actually taking on. What could be disastrously risky for one organization could be less than nominal for another organization. Rather than trying to collect information about each organization in order to be able to minutely evaluate the level of risk, CMS should utilize a key factor it already knows about each organization: how much revenue the organization and/or its members received from Medicare. CMS proposed this approach for Medical Home Models and it makes sense for all APM entities. We propose

15 percent of the APM Entity’s participants aggregate Medicare Parts A and B revenue
Not only is this far more significant than the threshold under the Medical Home Model Standard, it also represents considerably more revenue than is at risk under MIPS even in the later years of MIPS. Yet at the same time it a level of risk that every organization of any size can contemplate undertaking without risking their entire business to a single, abnormal year.

 

MIPS
We support CMS’s proposal to use APM quality reporting for the quality aspect of MIPS for the Medicare Shared Savings Program (MSSP). The same logic behind this proposal also supports ACO level reporting in clinical practice improvement activities (CPIA) and advancing care information (ACI) as well. This not only simplifies administration for both the ACO and CMS it represents a better measure in all three areas than the mere summation of practice level performance. As other APMs increase the robustness of their quality reporting requirements we encourage CMS to consider APM level reporting beyond the MSSP.

Quality
In addition to our support for ACO-level reporting, we encourage CMS to measure like sized practices to like sized practices. There are two components to measuring quality. The quality of the care itself and the collection and reporting of the data. The administrative burden of collecting and reporting creates a situation where much larger practices with much greater administrative abilities score higher and therefore potentially earn bonuses disproportionate to their quality. This hurts the small businesses that are small practices and encourages consolidation.

Clinical Practice Improvement Activities
We propose the CMS should go beyond the minimum required by the statute and grant full credit to eligible clinicians who are participating in an APM. Participation in an APM moves eligible clinicians beyond just process measures of CPIA and focuses them on the outcomes of those processes.

Advancing Care Information
In addition to our support for ACO-level reporting, we encourage CMS to consider the effects of APM participation on ACI beyond the use of certified EHR technology. Specifically, we propose a 20-point bonus structure for integrating clinical and claims data into a population health tool and for timely notification of transitions of care. Using a bonus point structure allows CMS to reward advanced use of health information technology without penalizing eligible clinicians within or without an APM for not yet having access to these cutting edge integrations.

Resource Use
After much consideration, we support the exclusion of resource use from MIPS for APMs. However, we carefully considered and urge CMS to carefully consider the argument that the different comparison made for costs in MIPS versus the APM means the concept of “double dipping” is not as clear cut as it may appear.

AAPM: Use of Certified EHR Technology
We support the proposed definition of Certified EHR Technology and the requirement for a percent of eligible clinicians to be using CEHRT in order to be an AAPM. We do have some concerns about the discussion CMS included in the proposed rule that seem to indicate that CMS is contemplating creating significant additional requirements to define use. Congress specifically referenced meaningful use for MIPS and just use for AAPM. We believe that distinction is good policy that accounts for the differences between the goals of MIPS and AAPMs.

We believe that CMS should not attempt to create different version of meaningful use (now referred to as Advancing Care Information) through the AAPM requirements. CMS should, as they proposed in this regulation, define use simply as use of Certified EHR Technology in the AAPM. Different AAPMs will have different health information technology needs. They will all have a need to keep medical records and to make those records available to patients, care givers and other health care providers which is why we support the requirement that the EHR Technology be certified, but specific uses, measurement of those uses and the effects on the financials of the AAPM should be allowed to vary significantly from AAPM to AAPM.

In addition, many eligible clinicians working in facility settings would potentially be in an AAPM. CMS should make it clear that CEHRT certified to either inpatient or ambulatory standards qualifies for use in an AAPM.

AAPM: Quality
We support the principles proposed by CMS while leaving the measure selection itself up to the AAPM. Principle 5 of other quality measures as determined by CMS is a needed provision to allow flexibility in measure inclusion in AAPM, but we urge CMS to always have the goal of any measure included by principle 5 to qualify under one of the other principles as soon as possible. We recommend that CMS express its intent to have no measure qualify for more than 2 years based solely on principle 5.

We also encourage CMS to continually look at measures that monitor for any perverse incentives that may occur as CMS experiments with AAPMs. For example, stinting or the forgoing of care to save costs in the short term is a risk not usually prevalent in fee for service, but could be a risk in certain AAPMs. In developing all APMs, CMS should always ensure that they contain a quality component that meets the proposed criteria and that the measures in the APM reflect monitoring for the desired outcomes of the model. While Congress outlined this as a requirement for Advanced APMs, we see no reason why all APMs developed by CMS should not be designed to meet this criterion.

AAPM: Defining Financial Risk
There are two primary sources of risk for an APM entity. The first is the investment that the APM entity and/or its participants are making in work that will only generate financial returns if the APM entity is successful in their APM. The second is the risk that due to failure in the APM the APM entity and/or its participants will owe money or otherwise receive less money for the same services than they would have had they not participated in the APM. The second risk would always be layered on top of the first risk. While to the accountant these risks might be the same, we believe they influence behavior differently. The experience of MSSP and our own experiences demonstrate that APM entities are more likely to undertake the investment risk while extremely unlikely to undertake the levels of contract risk that currently exist in MSSP.

This is primarily because that while the investment made be at complete financial risk, there are always perceived ancillary benefits such as increased quality and being the right thing to do for patients. Contract risk is not seen as having any ancillary benefit so is viewed in pure financial terms i.e. the APM entity gets x more revenue if they take on y risk. This would indicate that taking on contract risk will create additional motivation due to the lack of ancillary benefits and the lack of sunk cost effects. All three of CMS proposed definitions are likely to be additionally motivating over just investment risk.

The fourth definition of financial risk used for Medical Home Models by CMS (today the Comprehensive Primary Care Plus) is not obviously additionally motivating over investment risk. We are concerned that the only revenue that is at risk is revenue not available outside of the APM. We encourage CMS to continue to evaluate the inclusion of the fourth definition to ensure that it truly serves as an additional motivating factor beyond investment risk.

AAPM: What is More than Nominal?
Working with primary care physicians across the county, we have found that they view losses as mostly beyond their control and savings as within their control. Because of this they focus on the work case scenario when considering risk. Almost in anticipation of this very situation, Congress set financial risk as more than nominal or more than very small in amount. This aligns completely with the physician perspective of worrying about the worst case scenario and will my practice, the source of my livelihood and the livelihoods of my staff, survive if it happens? However, CMS’s proposal does not align with this perspective or what we believe Congressional intent is. This is due to the extreme variability in the amount of financial risk the AAPM nominal amount standard would impose on any given APM entity. Financial risk is best measured as a percentage of revenue so that it is the right amount of risk for each organization.

For these reasons we strongly recommend that CMS add a revenue measure to the AAPM more than nominal amount standard.

While the proposed rule and the MACRA statute use graduated thresholds over time, we recommend that CMS simplify and set a percentage for all years for the Medicare revenue that is greater than the Medical Home Model in any year and greater than the potential financial risk under MIPS which is 9 percent of Medicare Part B revenue. Similarly, the AAPM bonus payment is 5 percent of Medicare Part B revenue. By including Part A and by setting the percentage at 15 percent we believe it is incontrovertible that our proposal represents more risk than any other path under MACRA and more than satisfies the Congressional standard of more than nominal risk.

We strongly recommend that CMS include 15 percent of the APM Entity’s participants aggregate Medicare Parts A and B revenue in the AAPM normal more than nominal amount standard.

We view that as the single most important policy change in MACRA implementation and absolutely crucial to encouraging eligible clinicians to embrace AAPMs.

Below is a table that shows how the addition of the revenue measure would play out if a total cost of care AAPM choose to adopt it as its stop loss in the model. Denominator is the label for CMS’ current proposal as exists in Track 2 Year 2 of MSSP.

Total Cost of Care$100,000,000

 

 

As you can see organizations with aggregate revenue greater than the total cost of are still advantaged under this model, but the disadvantage of facing catastrophic losses due to one abnormal year is removed for smaller organizations. We cannot believe that Congress intended for 100% of revenue to be at risk to meet a more than nominal standard. We understand the appeal of the symmetry on the shared losses and shared savings, but that symmetry is not necessary to achieve the motivational benefits of two-sided risk and is not an accurate measure of whether the financial risk being undertaken by APM entity is more than nominal. Maintaining the sole definition of using the benchmark of the AAPM as the denominator in determining financial risk creates an incentive for providers to consolidate to reduce their relative financial risk as clearly shown in the table above. This would decrease competition which is itself a powerful force to increase the value in health care.

AAPM: QP Performance Period
In addition to changing the way risk is measured, we recommend that CMS change the timeline over which it is measured. We believe that the QP performance period can be slightly altered to create additional time for eligible clinicians to join an AAPM and receive the bonus in 2019. The tight implementation timeline outlined in the proposed rule puts everyone at a disadvantage this year in having to decide on model participation before a final regulation comes out. Perhaps more importantly it creates a three-year lag on any new Advanced APM introduction. A new model announced in 2019 with an immediate application period for a start date of Jan 1, 2020 wouldn’t affect payments until 2022.

By moving the date from December 31st of the QP performance period to January 1st the day following the conclusion of the QP performance period, CMS and eligible clinicians gain an entire year. We note that CMS will already know which eligible clinicians have been approved for a start date of January 1st well in advance of January 1st. In most APMs the claims data that is the basis of the benchmark calculations is from the year or years prior so using data from the QP performance period to calculate payment threshold or patient counts is aligned with the importance of that period to success in the APM.

Many of our proposals create downstream effects requiring changes to APMs and changes in other regulations. We included at the end of our comment letter detailed comments on the implementation aspect.

MIPS: Composite Performance Score
We agree that MIPS should score Medicare Shared Savings Program (MSSP) ACO eligible clinicians’ CPIA and ACI performance categories at the ACO level to ensure consistency between performance measures across MSSP and MIPS. We also fully support CMS’s proposal to use the MSSP APMs’ quality reporting through the CMS Web Interface and for the MIPS quality reporting category. MIPS eligible clinicians participating in APMs have already agreed to be accountable for each other and encourage this shared risk and performance to be reflected in MIPS.

However, the logical extension of ACO level scoring in the three categories is to support ACO level reporting across all three categories. We would like to see consistent APM Entity level reporting across all of the performance categories in MIPS. We believe this would ensure the reliability of performance measures between MIPS and MSSP. For example, an ACO may focus patient engagement through the primary care practices funneling information from specialists to patients through the Certified EHR Technology of the primary care physician, measured at the individual clinician level this may create artificially high scores for the primary care practice and artificially low scores for the specialty practice. This is just one of many examples were actions that provide better care in the APM decrease the comparability of individual eligible clinician scores to those scores of individual eligible clinicians not in an APM.

Additionally, APM entity level reporting in CPIA and ACI would reduce administrative burden. CMS currently proposes that “any Shared Savings Program ACO participant billing TIN that does not submit data for the MIPS CPIA and/or advancing care information performance categories would contribute a score of zero for each performance category for which it does not report; and that score would be incorporated into the resulting weighted average score for the Shared Savings Program ACO. All MIPS eligible clinicians in the ACO (the APM Entity group) would receive the same score that is calculated at the ACO level (the APM Entity).” By allowing for APM entity level reporting CMS eliminates the compliance actions APM Entities will undoubtedly take up to ensure this happen. CMS also reduces its own burden by reducing the number of submissions dramatically and by not having to weight the scores themselves. We understand the strains on CMS’s own administrative budget that these programs create and believe this is an obvious area where good policy and lower costs line up.

Overall, we propose that if all MIPS eligible clinicians are held accountable for each other’s CPIA and ACI reporting measures due to being in an APM Entity, then the APM Entity should be able to report the CPIA and ACI reporting measures. This will allow for a more accurate CPS score to be captured for all MIPS eligible clinicians in the APM Entity group; and simplifies administration for both the APM Entity and CMS.

Not all MIPS eligible clinicians are ready to participate in an APM. Congress created another option for these eligible clinicians, virtual groups. We do not deny that CMS faces significant operational challenges in creating virtual groups; however, we do not understand why these operational hurdles prevent CMS from creating the regulations that will govern these virtual groups. CMS should go to extraordinary effort to implement the virtual group concept as soon as possible.

The Congressional mandate is reason enough; however, there are more fundamental policy reasons to creating the regulations for virtual groups now and implementing them as soon as possible. By servings as an alternative to consolidation, virtual groups can stem the revenue shift from small to large practices projected in the impact statement which in turn stems consolidation and preserves competition.

By at least creating the regulations for virtual groups and thereby defining what a virtual group is it allows eligible clinicians to include it as an option for their future even if it cannot be implemented next year. But a nebulous definition of what a virtual group is means that is not a serious option for eligible clinicians to consider. If CMs is not able to create a definition fo virtual group for this final regulation, they should consider how the impact of the unavailability of virtual groups adversely affects small practices in the first year and seek to mitigate that impact through the CPS score.

MIPS: Quality
Reporting on quality measured requires two significant components, (1) the action of providing and maintaining quality care, and (2) the collection, management and reporting of patient and operational data. The actions of providing and maintaining quality care are integrated into the practice’s daily operations and do not typically require significant additional resources. However, the actions of collecting, managing and reporting patient and operational data do require additional tasks that are time consuming and costly.

For example, many large practices have allocated funds to hire additional staff or outsource these tasks to vendors. This has given larger practices an advantage over smaller practices because smaller practices do not have the funds or administrative personnel to sufficiently perform these tasks. Moreover, small practices have to sacrifice time and attention that would have been dedicated to their beneficiaries’ care to reporting on their quality performance. Overall, it is more difficult for smaller practices to capture their true level of quality in their reporting measures compared to larger practices.

This administrative burden on smaller practices creates a situation where larger practices can receive quality performance scores reflective of their administrative prowess not their quality of care and earn inaccurate bonuses. Considering the disadvantages outlined above we encourage CMS to compare quality scores from like sized practices to like sized practices. The practice breakdown used in the value-based modifier is well understood and could be incorporated here. This is an area where simplicity should be paramount; therefore, we recommend comparing practice size at the TIN level regardless of reporting mechanism.

We applaud and support CMS’s extensive efforts to include specialists in the quality component of MIPS.

MIPS: Clinic Practice Improvement Activities
We believe that MIPS eligible clinicians or groups that CMS identifies as participating in APMs for MIPS should receive the full 60 credits for the CPIA performance category. The activities that lead to success in an APM directly overlap with the activities CMS outlines as clinical practice improvement activities. The incremental value of reporting on just 2 or 3 additional activities is simply not enough to justify the administrative burden to both CMS and the eligible clinicians in the APM. Section 1848(q)(5)(C)(ii) of the Act states that “MIPS eligible clinicians or groups who are participating in an APM for a performance period must earn at least one half of the highest potential score for the CPIA performance category for the performance period.” CMS clearly has the latitude to do more than “at least.” APMs incentivize eligible clinicians to not only focus on activities within the subcategories of the CPIA measure such as expanded practice access, care coordination, population management and beneficiary engagement but also puts great emphasis on the outcomes of these processes. Putting the value of APM participation at just two clinical practice improvement activities undervalues the work required to participate in an APM.

We also support the concession for small, rural or health Professional Shortage Areas (HPSA) Practices to submit a minimum of one activity to achieve partial credit or two activities to achieve full credit. If CMS were to not adopt our proposal of full CPIA credit for APM participation, we certainly would hope that CMS would grant full CPIA credit to eligible clinicians who fit in this category and participate in an APM as the point value CMS proposes to count as full credit equals the point value CMS proposed to give for APM participation.

MIPS: Advancing Care Information
We support the goal of the Advancing Care Information (ACI) performance category to increase clinician and patient engagement, improve the use of health IT to achieve better patient outcomes, and continue the use of Certified EHR Technology. Eligible clinicians participating in APMs lead many of the efforts to use Certified EHR Technology in innovative ways. In addition to the group reporting discussed earlier, we recommend that CMS encourage such innovative uses by making bonus points available to eligible clinicians participating in APMs. Specifically, we recommend that a 20-point bonus be available for integrating clinical and claims data into a population health tool and for timely notification of transitions of care.

For consistency, we adopted the CMS proposal of half of the points for use and half of the points for performance.

These points should be bonus points instead of replacing existing ACI points to recognize that not all APMs are capable of these advanced integrations. By integrating the bonus points, CMS would recognize those eligible clinicians participating in APMs that are able to go beyond the proposals laid out by CMS in their proposal for ACI while not penalizing eligible clinicians who are not yet capable of these cutting edge integrations.

Additionally, as an advocate for small independent practices we would like to urge CMS to extend a modified version of the special consideration for the CPIA performance category to the ACI performance category. As we previously stated we fully support the goals and incentives of the ACI performance measure but we also understand the resource constraints and reporting burden small, rural and HPSA practices experience. Implementing, managing and efficiently utilizing health IT are costly and time consuming tasks that are still relatively new to small, rural and HPSA practices. We appreciate the flexibility provided for MIPS eligible clinicians to focus on measures which are most relevant to their practice. Therefore, we recommend that CMS lower the required amount of 100 points to 75 points for small, rural and HPSA practices to receive full credit in this performance category. For example, small, rural and HPSA practices could receive 50 points in the base category and 25 points in the performance category to receive a total of 75 points and the full credit for the ACI performance category.

Attestation Statements as Part of ACI
We are concerned with the requirement for eligible clinicians to attest to CMS that he or she cooperated in good faith with the surveillance and ONC direct review of his or her CEHRT under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, including by permitting timely access to such technology and demonstrating its capabilities as implemented and used by MIPS eligible clinician in the field. The wording of the attestation assumes such cooperation already occurred at the time of attestation when in all likelihood it will not have occurred at the time of authorization. We recommend that the attestation be changed to he or she will cooperate or has cooperated in good faith. At the time of attestation CMS should make available links to descriptions of the surveillance program as it is likely that the majority of eligible clinicians will be unaware of the program until they reach this attestation statement.

The attestation statements regarding the support for health information exchange and the prevention of information blocking while well intended could be very difficult for eligible clinicians to implement. We attempted to envision an audit of these attestation statements and immediately encountered several concerns. Most notably the second and third statements include language that implies active monitoring.

the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it implemented technologies, standards, policies, practices, and agreements reasonably calculated to ensure, to the greatest extent practicable and permitted by law, that the certified EHR technology was, at all relevant times: connected in accordance with applicable law; compliant with all standards applicable to the exchange of information, including the standards, implementation specifications, and certification criteria adopted at 45 CFR part 170; implemented in a manner that allowed for timely access by patients to their electronic health information; (including the ability to view, download, and transmit this information) and implemented in a manner that allowed for the timely, secure, and trusted bi-directional exchange of structured electronic health information with other health care providers (as defined by 42 U.S.C. 300jj(3)), including unaffiliated providers, and with disparate certified EHR technology and vendors.

the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it responded in good faith and in a timely manner to requests to retrieve or exchange electronic health information, including from patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and other persons, regardless of the requestor’s affiliation or technology vendor.

In the second statement there are many statements that would require clarification such as at what point is implementation complete, is compliance with standards a requirement to use those standards exclusively? Would an auditor expect to see an active monitoring system to detect connection down times and the timeliness of electronic responses or would written policy be sufficient? Rather than engage in the difficult task of determining what level of action these two statements require, we recommend that CMS remove the second attestation statement. This attestation is covered in the attesting to the availability of individual certified EHR technology capabilities as part of the ACI score. We then recommend combining the first and third statement to center around the did not knowingly and willfully take action to limit or restrict standard. Our recommended consolidated attestation statement is:

The EP, eligible hospital and CAH attests that it has established a workflow to respond in good faith and in a timely manner to requests to retrieve or exchange electronic health information, including from patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and other persons, regardless of the requestor’s affiliation or technology vendor and neither in the development of the workflow nor in any subsequent action did the EP, eligible hospital and CAH knowing and willfully take action to limit or restrict the compatibility or interoperability of certified EHR technology.

MIPS: Auditing
If the audit includes chart review ten business days is far too short of a timeline to provide documentation to CMS. We are aware of no such audit process that requires source documents to be generated in such an unreasonable timeframe. We strongly recommend that CMS lengthen this time requirement to at least 30 days.

In addition in the year 2017, CMS should not expect that all primary sources for reporting quality, CPIA and especially ACI are available as documents that can be transferred. CMS should request access to systems when they are the primary source. This can be done through remote access or facilitated through scheduled screen sharing sessions with the remote auditor and the MIPS eligible clinician or their representative. This will save countless hours both for the MIPS eligible clinicians and for CMS. It would also be a far more rigorous audit than simply relying on printed reports. When designing an information technology, it is simply not possible to predict what the auditor might someday require to substantiate that a document was generated by a primary source. For example, in auditing meaningful use auditors requested that the EHR logo or other trademarked identifier be on the meaningful use data reports. Many if not most EHR developers did not anticipate this requirement. By relying on an antiquated audit methodology the relies on the ability to produce transferrable documents, CMS will undoubtedly create new, unanticipated requirements that while created with good intentions will detract from the work of ensuring the actual primary system works well. It is time for CMS to move past documentation based auditing.

Implementing MACRA for APMs
MACRA sets the rules by which APMs are judged. As most APMs already exist, if MACRA is to impact the transition from volume to value quickly CMS will have to engage in rapid cycle updates if eligible clinicians are to adapt to the changes in MACRA. The two implementation factors with the most urgency are:

CMS should alter existing APMs so they all have at least one track that qualifies as an Advanced APM by requiring the use of CEHRT, meeting quality requirements and contain only the minimal risk requirement to qualify as an AAPM
Eligible clinicians currently locked into APM contracts should be able to change APMs or move between tracks in their APMs before the APM contract expires for both 2017 and 2018 APM participation
We provide methods to accomplish both of these goals in the Medicare Shared Savings Program as that is the APM in which we currently participate; however, it is equally important that these goals be accomplished for all APMs if MACRA is to succeed.

A MACRA-era Two-Risked Risk Track for MSSP
The MSSP is one of CMS’s most mature and most popular APMs. Yet uptake in two-sided risk has been low. We believe MACRA outlines an opportunity to create a more desirable two-sided risk track in MSSP. Earlier, in this letter we proposed a risk measurement based on Medicare Part A & Part B revenue received by the ACO participants to meet the normal nominal risk standard for AAPM. This risk can be easily integrated as a stop loss scenario into Track 2 and Track 3 with the addition of one line of regulation text for Track 2 and Track 3 MSSP ACOs each. Changes are in bold

For Track 2: 42 CFR 425.606 (g)

(3) 10 percent in the third and any subsequent performance year, or

(4) 15 percent of the Medicare Parts A and Part B revenue of the ACO participants in any performance year.

For Track 3: 42 CFR 425.610

(g) Loss recoupment limit. The amount of shared losses for which an eligible ACO is liable may not exceed 15 percent of its updated benchmark as determined under § 425.602 or 15 percent of the Medicare Parts A and Part B revenue of the ACO participants in any performance year.

These straight forward changes could be proposed in the upcoming Physician Fee Schedule proposed rule which has been used to make changes to the Medicare Shared Savings Program in the past. Alternatively, another proposed regulation could be issued this year for this express purpose.

While this addresses the financial risk aspect of the move to two-sided risk in MSSP and its relationship with MACRA, we would be remiss not to include here other model changes that could encourage health care providers to move to two sided risk.

CMS should change how it view risk adjustment. Rather than the current view of fear that it will lead to paying for coding, CMS should focus on the true purpose of risk adjustment which is make different populations comparable to one another. We have advocated, along with many others, for the last two years that to measure real ACO value risk scoring must accurately reflect the measured population. The artificial cap imposed by CMS on risk scoring turns ACOs into mini-insurance companies. This in turn scares ACOs away from two-sided risk because they are no longer responsible for just population health, but also statistical anomalies. Nothing keeps ACOs out of two-sided risk more than the cap on risk scores. It is also the only area where CMS is not leading the accountable care movement, but falling behind commercial health plans.

The third important step CMS can take to measuring ACO value is to include regional inflation update factors instead of national inflation update factors in all contract years. CMS should seek to reward ACOs for the work they do in creating difference in difference ACO value not because they happen to be in a low cost or high cost area on any given year. CMS’s own analysis for their recent regulations on the MSSP shows that very few ACOs can individually impact their area’s cost curve. Every ACO can impact whether the person got better care in the ACO than they did out of it. A regional inflation update ensures that the work of the ACO impacts the ACO’s financial future instead of regional cost arbitrage. ACOs have begun to calculate headwinds and tailwinds (i.e. is the benchmark lower or higher than the most recent year’s costs) to determine their likelihood of success. This is what CMS intended to reward areas with falling costs with more ACO participation. However, this intent has gone awry. First, rarely does any individual ACO have significant impact on their regional costs so the reward or disincentive is not due to the past work of the ACO participants. Second, ACOs have not been able to determine these headwinds or tailwinds prior to receiving ACO data from CMS so the phenomenon cannot drive increases or decreases in ACO participation. Given that the hoped for effects of this policy have not materialized it is time to revert to the more accurate measurement of regional inflation in benchmarking and annual update factors in the first contract and end the unnatural arbitrage opportunities national inflation updates are causing across the MSSP.

Combining these three improvements to the MSSP will result in a significant increase in two-side risk participation which will in turn increase the value generated for beneficiaries and Medicare by health care providers.

Creating Time: Supporting Informed Decisions by Eligible Clinicians
There are two ways that CMS can create more time for eligible clinicians to make informed decisions about how best to participate in MIPS or AAPM. First, CMS can support eligible clinicians’ ability to make informed decisions by allowing all eligible clinicians to re-evaluate their APM participation in light of the finalized MACRA implementation regulations. Many APMs, including MSSP, have multi-year contracts. Eligible clinicians by definition could not have included adequate information about MACRA in their decision making process. Eligible clinicians currently locked into APM contracts should be able to change APMs or move between tracks in their APMs before the APM contract expires for both 2017 and 2018 APM participation. Not allowing this flexibility will inevitably slow the transition to AAPMs with no obvious gain from not allowing the transition. We strongly recommend that CMS include their intention to allow all eligible clinicians to make a choice on whether to participate in an AAPM in 2017 or 2018 after the eligible clinicians have the opportunity to review the finalized regulations governing MACRA.

The second as we addressed earlier in our comment letter is to make the AAPM qualifying participant determination on the day after the QP performance year instead of the last day of the QP performance year. The operational requirements for shortening the timeframe for AAPM measurement include: a) calculation of payment or patient count thresholds to determine eligibility b) calculation of total Medicare Part B revenue and c) incentive award payment by Jan 1, 2019.

The current proposal is to use qualifying AAPM participation as of Dec 31, 2017, combined with a 2018 analysis of 2017 total revenue and AAPM revenue to determine Jan 1 2019 payment.

However, AAPM participation begins far in advance of the performance period. ACOs must establish governance and recruit practices prior to the July 31 2017 application deadline. Individual NPIs and TINs are verified by CMS throughout the fall, and a final determination of ACO participation and preliminary beneficiary attribution is conducted well before Dec 31st 2017. This accurate list of eligible clinicians who will be participating in eligible AAPMs in 2018 can and should be used as the basis for calculation of payment or patient count thresholds to determine eligibility for AAPMs. Calculation of total Medicare Part B revenue can be done in Q1 2018 based on 2017 (benchmark year) revenue in order to establish incentive award payment by Jan 1, 2019.

In essence, we are proposing that the timeframe for AAPM participation be moved by one day from Dec 31, 2017 to Jan 1, 2018. By including one additional day for the determination date for AAPM the timeframe for model innovation can be shortened by a year.

In reality, practices interested in participating in AAPMs will be simultaneously applying for AAPMs and performing quality improvement activities under MIPS regardless of whether our proposal is adopted or not. Due to the application deadlines, no clinician can be 100% certain of their MIPS performance or exclusion during 2017. Alignment between MIPS activities and ACO performance should ensure that there is minimal duplication of effort. While the benefits of these changes are particularly acute for 2019 given the regulatory timeframe, it would have lasting benefits every time a new Advanced Alternative Payment Model is introduced.

**Alternative**

The statute specifically allows for the provision of less than a year. The first six months of 2018 (or the last six months of 2017 combined with the first six months of 2018) could be used for 2018 participants in at least annual commitments. This potentially creates a more accurate measurement of whether a participant met the threshold. However, it creates a new timeframe and would not allow CMS any opportunity to inform the participant during the MIPS submission window of whether they qualify. In this alternative all 2018 participants should submit for MIPS. It does still allow for plenty of time for CMS to make accurate FFS payments on Jan 1, 2019.

 

[1]

Dear Administrator Slavitt,

Aledade partners with 159 primary care physician practices, FQHCs and RHCs in value-based health care. Organized into eight accountable care organizations across 14 states these primary care physicians are accountable for over 130,000 Medicare beneficiaries. More than half of our primary care providers are in practices with fewer than ten clinicians. As an organization that is dedicated solely to helping independent physicians lead the transition from volume to value, we have a particular set of experiences and perspectives that are highly relevant to the key policy issues faced by CMS in implementing the MACRA legislation.

  • Independent and small practices are not only capable of taking accountability for the total cost of care, but –unburdened by concerns of “demand destruction”-they may be uniquely positioned to do so[1]. A focus on outcomes moves practices beyond mere compliance with quality measure reporting, health IT use, or medical home processes. Creating a viable pathway for them to participate in Advanced Alternative Payment Models (AAPMs) must be prioritized.
  • Independent and small practices are feeling intense pressure from multiple fronts, which is contributing to the continued consolidation of local provider markets. A lack of healthy competition in local markets results in higher societal costs with no apparent improvement in patient care. Creating a viable pathway for these practices to stand on “equal footing” with larger and more integrated groups is a key policy priority.

As described in more detail in our comment letter, a few critical changes to the proposed MACRA regulation could dramatically improve the attainment of these policy objectives.

  1. Defining “more than nominal financial risk” such that smaller practices are motivated but do not face an existential threat. We propose basing financial risk on the participating APM Entity’s Part A and B Medicare revenue, and a pathway for making it available in time for 2019 payments.
  2. Allowing independent practices to come together in “virtual groups” now for all aspects of MIPS reporting, and rewarding their clinical practice and health IT advances as they work towards participation in APMs (like gain share only ACOs) and on to AAPMs.
  3. Providing administrative flexibility for these small businesses by comparing their performance under MIPS to that of their peers by practice size.

Thank you very much for your consideration as we move together through this exciting time in health care. Please feel free to follow up with me or Travis Broome (travis@aledade.com) if you or your staff have questions or would like to explore these positions further

Summary

Advanced Alternative Payment Models

Financial Risk

Before defining financial risk, the purpose of financial risk must be established. As most alternative payment models (APMs) are voluntary, CMS should not expect that any organization will continue to participate over multiple years of losses. Medicare will benefit from APMs primarily from sharing in positive value created by health care providers. The non-financial effect of risk is to be a motivating factor making positive value creation more likely and of greater magnitude. CMS should evaluate the definition of financial risk through the lens of whether it motivates APM participants more than having no financial risk.

More than Nominal Financial Risk

Congress highlighted the use of risk-based models for motivation with the phrase “more than nominal financial risk.” The risk needs to motivate, it needs to be enough to matter, it needs to be more than very small in amount, but more than nominal clearly does not translate into financial ruin. The lack of participation in downside risk in APMs to date is a clear signal about how serious entities consider downside risk and the effect it would have on organizations that take on downside risk. However, just as the lack of participation is a signal of its effectiveness it should also be a signal to CMS of the need to strike the right balance in using MACRA to create a better model of two-sided risk.

The proposal to base the determination of “more than nominal” on the benchmark of the APM will not succeed in moving more providers to financial risk and clearly does not meet the Congressional intent of the “more than nominal” provision. Using the benchmark creates vastly different amounts of risk depending on the organization and depending on the APM model. How risky something is to an organization is dependent on the level of risk relative to their financial situation. This variation creates a situation where CMS will not be able to gauge the amount of financial risk any APM entity is actually taking on. What could be disastrously risky for one organization could be less than nominal for another organization. Rather than trying to collect information about each organization in order to be able to minutely evaluate the level of risk, CMS should utilize a key factor it already knows about each organization: how much revenue the organization and/or its members received from Medicare. CMS proposed this approach for Medical Home Models and it makes sense for all APM entities. We propose

  • 15 percent of the APM Entity’s participants aggregate Medicare Parts A and B revenue

Not only is this far more significant than the threshold under the Medical Home Model Standard, it also represents considerably more revenue than is at risk under MIPS even in the later years of MIPS. Yet at the same time it a level of risk that every organization of any size can contemplate undertaking without risking their entire business to a single, abnormal year.

 

MIPS

We support CMS’s proposal to use APM quality reporting for the quality aspect of MIPS for the Medicare Shared Savings Program (MSSP). The same logic behind this proposal also supports ACO level reporting in clinical practice improvement activities (CPIA) and advancing care information (ACI) as well. This not only simplifies administration for both the ACO and CMS it represents a better measure in all three areas than the mere summation of practice level performance. As other APMs increase the robustness of their quality reporting requirements we encourage CMS to consider APM level reporting beyond the MSSP.

Quality

In addition to our support for ACO-level reporting, we encourage CMS to measure like sized practices to like sized practices. There are two components to measuring quality. The quality of the care itself and the collection and reporting of the data. The administrative burden of collecting and reporting creates a situation where much larger practices with much greater administrative abilities score higher and therefore potentially earn bonuses disproportionate to their quality. This hurts the small businesses that are small practices and encourages consolidation.

Clinical Practice Improvement Activities

We propose the CMS should go beyond the minimum required by the statute and grant full credit to eligible clinicians who are participating in an APM. Participation in an APM moves eligible clinicians beyond just process measures of CPIA and focuses them on the outcomes of those processes.

Advancing Care Information

In addition to our support for ACO-level reporting, we encourage CMS to consider the effects of APM participation on ACI beyond the use of certified EHR technology. Specifically, we propose a 20-point bonus structure for integrating clinical and claims data into a population health tool and for timely notification of transitions of care. Using a bonus point structure allows CMS to reward advanced use of health information technology without penalizing eligible clinicians within or without an APM for not yet having access to these cutting edge integrations.

Resource Use

After much consideration, we support the exclusion of resource use from MIPS for APMs. However, we carefully considered and urge CMS to carefully consider the argument that the different comparison made for costs in MIPS versus the APM means the concept of “double dipping” is not as clear cut as it may appear.

AAPM: Use of Certified EHR Technology

We support the proposed definition of Certified EHR Technology and the requirement for a percent of eligible clinicians to be using CEHRT in order to be an AAPM. We do have some concerns about the discussion CMS included in the proposed rule that seem to indicate that CMS is contemplating creating significant additional requirements to define use. Congress specifically referenced meaningful use for MIPS and just use for AAPM. We believe that distinction is good policy that accounts for the differences between the goals of MIPS and AAPMs.

We believe that CMS should not attempt to create different version of meaningful use (now referred to as Advancing Care Information) through the AAPM requirements. CMS should, as they proposed in this regulation, define use simply as use of Certified EHR Technology in the AAPM. Different AAPMs will have different health information technology needs. They will all have a need to keep medical records and to make those records available to patients, care givers and other health care providers which is why we support the requirement that the EHR Technology be certified, but specific uses, measurement of those uses and the effects on the financials of the AAPM should be allowed to vary significantly from AAPM to AAPM.

In addition, many eligible clinicians working in facility settings would potentially be in an AAPM. CMS should make it clear that CEHRT certified to either inpatient or ambulatory standards qualifies for use in an AAPM.

AAPM: Quality

We support the principles proposed by CMS while leaving the measure selection itself up to the AAPM. Principle 5 of other quality measures as determined by CMS is a needed provision to allow flexibility in measure inclusion in AAPM, but we urge CMS to always have the goal of any measure included by principle 5 to qualify under one of the other principles as soon as possible. We recommend that CMS express its intent to have no measure qualify for more than 2 years based solely on principle 5.

We also encourage CMS to continually look at measures that monitor for any perverse incentives that may occur as CMS experiments with AAPMs. For example, stinting or the forgoing of care to save costs in the short term is a risk not usually prevalent in fee for service, but could be a risk in certain AAPMs. In developing all APMs, CMS should always ensure that they contain a quality component that meets the proposed criteria and that the measures in the APM reflect monitoring for the desired outcomes of the model. While Congress outlined this as a requirement for Advanced APMs, we see no reason why all APMs developed by CMS should not be designed to meet this criterion.

AAPM: Defining Financial Risk

There are two primary sources of risk for an APM entity. The first is the investment that the APM entity and/or its participants are making in work that will only generate financial returns if the APM entity is successful in their APM. The second is the risk that due to failure in the APM the APM entity and/or its participants will owe money or otherwise receive less money for the same services than they would have had they not participated in the APM. The second risk would always be layered on top of the first risk. While to the accountant these risks might be the same, we believe they influence behavior differently. The experience of MSSP and our own experiences demonstrate that APM entities are more likely to undertake the investment risk while extremely unlikely to undertake the levels of contract risk that currently exist in MSSP.

This is primarily because that while the investment made be at complete financial risk, there are always perceived ancillary benefits such as increased quality and being the right thing to do for patients. Contract risk is not seen as having any ancillary benefit so is viewed in pure financial terms i.e. the APM entity gets x more revenue if they take on y risk. This would indicate that taking on contract risk will create additional motivation due to the lack of ancillary benefits and the lack of sunk cost effects. All three of CMS proposed definitions are likely to be additionally motivating over just investment risk.

The fourth definition of financial risk used for Medical Home Models by CMS (today the Comprehensive Primary Care Plus) is not obviously additionally motivating over investment risk. We are concerned that the only revenue that is at risk is revenue not available outside of the APM. We encourage CMS to continue to evaluate the inclusion of the fourth definition to ensure that it truly serves as an additional motivating factor beyond investment risk.

AAPM: What is More than Nominal?

Working with primary care physicians across the county, we have found that they view losses as mostly beyond their control and savings as within their control. Because of this they focus on the work case scenario when considering risk. Almost in anticipation of this very situation, Congress set financial risk as more than nominal or more than very small in amount. This aligns completely with the physician perspective of worrying about the worst case scenario and will my practice, the source of my livelihood and the livelihoods of my staff, survive if it happens? However, CMS’s proposal does not align with this perspective or what we believe Congressional intent is. This is due to the extreme variability in the amount of financial risk the AAPM nominal amount standard would impose on any given APM entity. Financial risk is best measured as a percentage of revenue so that it is the right amount of risk for each organization.

For these reasons we strongly recommend that CMS add a revenue measure to the AAPM more than nominal amount standard.

While the proposed rule and the MACRA statute use graduated thresholds over time, we recommend that CMS simplify and set a percentage for all years for the Medicare revenue that is greater than the Medical Home Model in any year and greater than the potential financial risk under MIPS which is 9 percent of Medicare Part B revenue. Similarly, the AAPM bonus payment is 5 percent of Medicare Part B revenue. By including Part A and by setting the percentage at 15 percent we believe it is incontrovertible that our proposal represents more risk than any other path under MACRA and more than satisfies the Congressional standard of more than nominal risk.

We strongly recommend that CMS include 15 percent of the APM Entity’s participants aggregate Medicare Parts A and B revenue in the AAPM normal more than nominal amount standard.

We view that as the single most important policy change in MACRA implementation and absolutely crucial to encouraging eligible clinicians to embrace AAPMs.

Below is a table that shows how the addition of the revenue measure would play out if a total cost of care AAPM choose to adopt it as its stop loss in the model. Denominator is the label for CMS’ current proposal as exists in Track 2 Year 2 of MSSP.

Total Cost of Care$100,000,000

 

APM chart

 

As you can see organizations with aggregate revenue greater than the total cost of are still advantaged under this model, but the disadvantage of facing catastrophic losses due to one abnormal year is removed for smaller organizations. We cannot believe that Congress intended for 100% of revenue to be at risk to meet a more than nominal standard. We understand the appeal of the symmetry on the shared losses and shared savings, but that symmetry is not necessary to achieve the motivational benefits of two-sided risk and is not an accurate measure of whether the financial risk being undertaken by APM entity is more than nominal. Maintaining the sole definition of using the benchmark of the AAPM as the denominator in determining financial risk creates an incentive for providers to consolidate to reduce their relative financial risk as clearly shown in the table above. This would decrease competition which is itself a powerful force to increase the value in health care.

AAPM: QP Performance Period

In addition to changing the way risk is measured, we recommend that CMS change the timeline over which it is measured. We believe that the QP performance period can be slightly altered to create additional time for eligible clinicians to join an AAPM and receive the bonus in 2019. The tight implementation timeline outlined in the proposed rule puts everyone at a disadvantage this year in having to decide on model participation before a final regulation comes out. Perhaps more importantly it creates a three-year lag on any new Advanced APM introduction. A new model announced in 2019 with an immediate application period for a start date of Jan 1, 2020 wouldn’t affect payments until 2022.

By moving the date from December 31st of the QP performance period to January 1st the day following the conclusion of the QP performance period, CMS and eligible clinicians gain an entire year. We note that CMS will already know which eligible clinicians have been approved for a start date of January 1st well in advance of January 1st. In most APMs the claims data that is the basis of the benchmark calculations is from the year or years prior so using data from the QP performance period to calculate payment threshold or patient counts is aligned with the importance of that period to success in the APM.

Many of our proposals create downstream effects requiring changes to APMs and changes in other regulations. We included at the end of our comment letter detailed comments on the implementation aspect.

MIPS: Composite Performance Score

We agree that MIPS should score Medicare Shared Savings Program (MSSP) ACO eligible clinicians’ CPIA and ACI performance categories at the ACO level to ensure consistency between performance measures across MSSP and MIPS. We also fully support CMS’s proposal to use the MSSP APMs’ quality reporting through the CMS Web Interface and for the MIPS quality reporting category. MIPS eligible clinicians participating in APMs have already agreed to be accountable for each other and encourage this shared risk and performance to be reflected in MIPS.

However, the logical extension of ACO level scoring in the three categories is to support ACO level reporting across all three categories. We would like to see consistent APM Entity level reporting across all of the performance categories in MIPS. We believe this would ensure the reliability of performance measures between MIPS and MSSP. For example, an ACO may focus patient engagement through the primary care practices funneling information from specialists to patients through the Certified EHR Technology of the primary care physician, measured at the individual clinician level this may create artificially high scores for the primary care practice and artificially low scores for the specialty practice. This is just one of many examples were actions that provide better care in the APM decrease the comparability of individual eligible clinician scores to those scores of individual eligible clinicians not in an APM.

Additionally, APM entity level reporting in CPIA and ACI would reduce administrative burden. CMS currently proposes that “any Shared Savings Program ACO participant billing TIN that does not submit data for the MIPS CPIA and/or advancing care information performance categories would contribute a score of zero for each performance category for which it does not report; and that score would be incorporated into the resulting weighted average score for the Shared Savings Program ACO. All MIPS eligible clinicians in the ACO (the APM Entity group) would receive the same score that is calculated at the ACO level (the APM Entity).” By allowing for APM entity level reporting CMS eliminates the compliance actions APM Entities will undoubtedly take up to ensure this happen. CMS also reduces its own burden by reducing the number of submissions dramatically and by not having to weight the scores themselves. We understand the strains on CMS’s own administrative budget that these programs create and believe this is an obvious area where good policy and lower costs line up.

Overall, we propose that if all MIPS eligible clinicians are held accountable for each other’s CPIA and ACI reporting measures due to being in an APM Entity, then the APM Entity should be able to report the CPIA and ACI reporting measures. This will allow for a more accurate CPS score to be captured for all MIPS eligible clinicians in the APM Entity group; and simplifies administration for both the APM Entity and CMS.

Not all MIPS eligible clinicians are ready to participate in an APM. Congress created another option for these eligible clinicians, virtual groups. We do not deny that CMS faces significant operational challenges in creating virtual groups; however, we do not understand why these operational hurdles prevent CMS from creating the regulations that will govern these virtual groups. CMS should go to extraordinary effort to implement the virtual group concept as soon as possible.

The Congressional mandate is reason enough; however, there are more fundamental policy reasons to creating the regulations for virtual groups now and implementing them as soon as possible. By servings as an alternative to consolidation, virtual groups can stem the revenue shift from small to large practices projected in the impact statement which in turn stems consolidation and preserves competition.

By at least creating the regulations for virtual groups and thereby defining what a virtual group is it allows eligible clinicians to include it as an option for their future even if it cannot be implemented next year. But a nebulous definition of what a virtual group is means that is not a serious option for eligible clinicians to consider. If CMs is not able to create a definition fo virtual group for this final regulation, they should consider how the impact of the unavailability of virtual groups adversely affects small practices in the first year and seek to mitigate that impact through the CPS score.

MIPS: Quality

Reporting on quality measured requires two significant components, (1) the action of providing and maintaining quality care, and (2) the collection, management and reporting of patient and operational data. The actions of providing and maintaining quality care are integrated into the practice’s daily operations and do not typically require significant additional resources. However, the actions of collecting, managing and reporting patient and operational data do require additional tasks that are time consuming and costly.

For example, many large practices have allocated funds to hire additional staff or outsource these tasks to vendors. This has given larger practices an advantage over smaller practices because smaller practices do not have the funds or administrative personnel to sufficiently perform these tasks. Moreover, small practices have to sacrifice time and attention that would have been dedicated to their beneficiaries’ care to reporting on their quality performance. Overall, it is more difficult for smaller practices to capture their true level of quality in their reporting measures compared to larger practices.

This administrative burden on smaller practices creates a situation where larger practices can receive quality performance scores reflective of their administrative prowess not their quality of care and earn inaccurate bonuses. Considering the disadvantages outlined above we encourage CMS to compare quality scores from like sized practices to like sized practices. The practice breakdown used in the value-based modifier is well understood and could be incorporated here. This is an area where simplicity should be paramount; therefore, we recommend comparing practice size at the TIN level regardless of reporting mechanism.

We applaud and support CMS’s extensive efforts to include specialists in the quality component of MIPS.

MIPS: Clinic Practice Improvement Activities

We believe that MIPS eligible clinicians or groups that CMS identifies as participating in APMs for MIPS should receive the full 60 credits for the CPIA performance category. The activities that lead to success in an APM directly overlap with the activities CMS outlines as clinical practice improvement activities. The incremental value of reporting on just 2 or 3 additional activities is simply not enough to justify the administrative burden to both CMS and the eligible clinicians in the APM. Section 1848(q)(5)(C)(ii) of the Act states that “MIPS eligible clinicians or groups who are participating in an APM for a performance period must earn at least one half of the highest potential score for the CPIA performance category for the performance period.” CMS clearly has the latitude to do more than “at least.” APMs incentivize eligible clinicians to not only focus on activities within the subcategories of the CPIA measure such as expanded practice access, care coordination, population management and beneficiary engagement but also puts great emphasis on the outcomes of these processes. Putting the value of APM participation at just two clinical practice improvement activities undervalues the work required to participate in an APM.

We also support the concession for small, rural or health Professional Shortage Areas (HPSA) Practices to submit a minimum of one activity to achieve partial credit or two activities to achieve full credit. If CMS were to not adopt our proposal of full CPIA credit for APM participation, we certainly would hope that CMS would grant full CPIA credit to eligible clinicians who fit in this category and participate in an APM as the point value CMS proposes to count as full credit equals the point value CMS proposed to give for APM participation.

MIPS: Advancing Care Information

We support the goal of the Advancing Care Information (ACI) performance category to increase clinician and patient engagement, improve the use of health IT to achieve better patient outcomes, and continue the use of Certified EHR Technology. Eligible clinicians participating in APMs lead many of the efforts to use Certified EHR Technology in innovative ways. In addition to the group reporting discussed earlier, we recommend that CMS encourage such innovative uses by making bonus points available to eligible clinicians participating in APMs. Specifically, we recommend that a 20-point bonus be available for integrating clinical and claims data into a population health tool and for timely notification of transitions of care.

For consistency, we adopted the CMS proposal of half of the points for use and half of the points for performance.

 

MIPS chart

These points should be bonus points instead of replacing existing ACI points to recognize that not all APMs are capable of these advanced integrations. By integrating the bonus points, CMS would recognize those eligible clinicians participating in APMs that are able to go beyond the proposals laid out by CMS in their proposal for ACI while not penalizing eligible clinicians who are not yet capable of these cutting edge integrations.

Additionally, as an advocate for small independent practices we would like to urge CMS to extend a modified version of the special consideration for the CPIA performance category to the ACI performance category. As we previously stated we fully support the goals and incentives of the ACI performance measure but we also understand the resource constraints and reporting burden small, rural and HPSA practices experience. Implementing, managing and efficiently utilizing health IT are costly and time consuming tasks that are still relatively new to small, rural and HPSA practices. We appreciate the flexibility provided for MIPS eligible clinicians to focus on measures which are most relevant to their practice. Therefore, we recommend that CMS lower the required amount of 100 points to 75 points for small, rural and HPSA practices to receive full credit in this performance category. For example, small, rural and HPSA practices could receive 50 points in the base category and 25 points in the performance category to receive a total of 75 points and the full credit for the ACI performance category.

Attestation Statements as Part of ACI

We are concerned with the requirement for eligible clinicians to attest to CMS that he or she cooperated in good faith with the surveillance and ONC direct review of his or her CEHRT under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, including by permitting timely access to such technology and demonstrating its capabilities as implemented and used by MIPS eligible clinician in the field. The wording of the attestation assumes such cooperation already occurred at the time of attestation when in all likelihood it will not have occurred at the time of authorization. We recommend that the attestation be changed to he or she will cooperate or has cooperated in good faith. At the time of attestation CMS should make available links to descriptions of the surveillance program as it is likely that the majority of eligible clinicians will be unaware of the program until they reach this attestation statement.

The attestation statements regarding the support for health information exchange and the prevention of information blocking while well intended could be very difficult for eligible clinicians to implement. We attempted to envision an audit of these attestation statements and immediately encountered several concerns. Most notably the second and third statements include language that implies active monitoring.

the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it implemented technologies, standards, policies, practices, and agreements reasonably calculated to ensure, to the greatest extent practicable and permitted by law, that the certified EHR technology was, at all relevant times: connected in accordance with applicable law; compliant with all standards applicable to the exchange of information, including the standards, implementation specifications, and certification criteria adopted at 45 CFR part 170; implemented in a manner that allowed for timely access by patients to their electronic health information; (including the ability to view, download, and transmit this information) and implemented in a manner that allowed for the timely, secure, and trusted bi-directional exchange of structured electronic health information with other health care providers (as defined by 42 U.S.C. 300jj(3)), including unaffiliated providers, and with disparate certified EHR technology and vendors.

the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it responded in good faith and in a timely manner to requests to retrieve or exchange electronic health information, including from patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and other persons, regardless of the requestor’s affiliation or technology vendor.

In the second statement there are many statements that would require clarification such as at what point is implementation complete, is compliance with standards a requirement to use those standards exclusively? Would an auditor expect to see an active monitoring system to detect connection down times and the timeliness of electronic responses or would written policy be sufficient? Rather than engage in the difficult task of determining what level of action these two statements require, we recommend that CMS remove the second attestation statement. This attestation is covered in the attesting to the availability of individual certified EHR technology capabilities as part of the ACI score. We then recommend combining the first and third statement to center around the did not knowingly and willfully take action to limit or restrict standard. Our recommended consolidated attestation statement is:

The EP, eligible hospital and CAH attests that it has established a workflow to respond in good faith and in a timely manner to requests to retrieve or exchange electronic health information, including from patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and other persons, regardless of the requestor’s affiliation or technology vendor and neither in the development of the workflow nor in any subsequent action did the EP, eligible hospital and CAH knowing and willfully take action to limit or restrict the compatibility or interoperability of certified EHR technology.

MIPS: Auditing

If the audit includes chart review ten business days is far too short of a timeline to provide documentation to CMS. We are aware of no such audit process that requires source documents to be generated in such an unreasonable timeframe. We strongly recommend that CMS lengthen this time requirement to at least 30 days.

In addition in the year 2017, CMS should not expect that all primary sources for reporting quality, CPIA and especially ACI are available as documents that can be transferred. CMS should request access to systems when they are the primary source. This can be done through remote access or facilitated through scheduled screen sharing sessions with the remote auditor and the MIPS eligible clinician or their representative. This will save countless hours both for the MIPS eligible clinicians and for CMS. It would also be a far more rigorous audit than simply relying on printed reports. When designing an information technology, it is simply not possible to predict what the auditor might someday require to substantiate that a document was generated by a primary source. For example, in auditing meaningful use auditors requested that the EHR logo or other trademarked identifier be on the meaningful use data reports. Many if not most EHR developers did not anticipate this requirement. By relying on an antiquated audit methodology the relies on the ability to produce transferrable documents, CMS will undoubtedly create new, unanticipated requirements that while created with good intentions will detract from the work of ensuring the actual primary system works well. It is time for CMS to move past documentation based auditing.

Implementing MACRA for APMs

MACRA sets the rules by which APMs are judged. As most APMs already exist, if MACRA is to impact the transition from volume to value quickly CMS will have to engage in rapid cycle updates if eligible clinicians are to adapt to the changes in MACRA. The two implementation factors with the most urgency are:

  • CMS should alter existing APMs so they all have at least one track that qualifies as an Advanced APM by requiring the use of CEHRT, meeting quality requirements and contain only the minimal risk requirement to qualify as an AAPM
  • Eligible clinicians currently locked into APM contracts should be able to change APMs or move between tracks in their APMs before the APM contract expires for both 2017 and 2018 APM participation

We provide methods to accomplish both of these goals in the Medicare Shared Savings Program as that is the APM in which we currently participate; however, it is equally important that these goals be accomplished for all APMs if MACRA is to succeed.

A MACRA-era Two-Risked Risk Track for MSSP

The MSSP is one of CMS’s most mature and most popular APMs. Yet uptake in two-sided risk has been low. We believe MACRA outlines an opportunity to create a more desirable two-sided risk track in MSSP. Earlier, in this letter we proposed a risk measurement based on Medicare Part A & Part B revenue received by the ACO participants to meet the normal nominal risk standard for AAPM. This risk can be easily integrated as a stop loss scenario into Track 2 and Track 3 with the addition of one line of regulation text for Track 2 and Track 3 MSSP ACOs each. Changes are in bold

For Track 2: 42 CFR 425.606 (g)

(3) 10 percent in the third and any subsequent performance year, or

(4) 15 percent of the Medicare Parts A and Part B revenue of the ACO participants in any performance year.

For Track 3: 42 CFR 425.610

(g) Loss recoupment limit. The amount of shared losses for which an eligible ACO is liable may not exceed 15 percent of its updated benchmark as determined under § 425.602 or 15 percent of the Medicare Parts A and Part B revenue of the ACO participants in any performance year.

These straight forward changes could be proposed in the upcoming Physician Fee Schedule proposed rule which has been used to make changes to the Medicare Shared Savings Program in the past. Alternatively, another proposed regulation could be issued this year for this express purpose.

While this addresses the financial risk aspect of the move to two-sided risk in MSSP and its relationship with MACRA, we would be remiss not to include here other model changes that could encourage health care providers to move to two sided risk.

CMS should change how it view risk adjustment. Rather than the current view of fear that it will lead to paying for coding, CMS should focus on the true purpose of risk adjustment which is make different populations comparable to one another. We have advocated, along with many others, for the last two years that to measure real ACO value risk scoring must accurately reflect the measured population. The artificial cap imposed by CMS on risk scoring turns ACOs into mini-insurance companies. This in turn scares ACOs away from two-sided risk because they are no longer responsible for just population health, but also statistical anomalies. Nothing keeps ACOs out of two-sided risk more than the cap on risk scores. It is also the only area where CMS is not leading the accountable care movement, but falling behind commercial health plans.

The third important step CMS can take to measuring ACO value is to include regional inflation update factors instead of national inflation update factors in all contract years. CMS should seek to reward ACOs for the work they do in creating difference in difference ACO value not because they happen to be in a low cost or high cost area on any given year. CMS’s own analysis for their recent regulations on the MSSP shows that very few ACOs can individually impact their area’s cost curve. Every ACO can impact whether the person got better care in the ACO than they did out of it. A regional inflation update ensures that the work of the ACO impacts the ACO’s financial future instead of regional cost arbitrage. ACOs have begun to calculate headwinds and tailwinds (i.e. is the benchmark lower or higher than the most recent year’s costs) to determine their likelihood of success. This is what CMS intended to reward areas with falling costs with more ACO participation. However, this intent has gone awry. First, rarely does any individual ACO have significant impact on their regional costs so the reward or disincentive is not due to the past work of the ACO participants. Second, ACOs have not been able to determine these headwinds or tailwinds prior to receiving ACO data from CMS so the phenomenon cannot drive increases or decreases in ACO participation. Given that the hoped for effects of this policy have not materialized it is time to revert to the more accurate measurement of regional inflation in benchmarking and annual update factors in the first contract and end the unnatural arbitrage opportunities national inflation updates are causing across the MSSP.

Combining these three improvements to the MSSP will result in a significant increase in two-side risk participation which will in turn increase the value generated for beneficiaries and Medicare by health care providers.

Creating Time: Supporting Informed Decisions by Eligible Clinicians

There are two ways that CMS can create more time for eligible clinicians to make informed decisions about how best to participate in MIPS or AAPM. First, CMS can support eligible clinicians’ ability to make informed decisions by allowing all eligible clinicians to re-evaluate their APM participation in light of the finalized MACRA implementation regulations. Many APMs, including MSSP, have multi-year contracts. Eligible clinicians by definition could not have included adequate information about MACRA in their decision making process. Eligible clinicians currently locked into APM contracts should be able to change APMs or move between tracks in their APMs before the APM contract expires for both 2017 and 2018 APM participation. Not allowing this flexibility will inevitably slow the transition to AAPMs with no obvious gain from not allowing the transition. We strongly recommend that CMS include their intention to allow all eligible clinicians to make a choice on whether to participate in an AAPM in 2017 or 2018 after the eligible clinicians have the opportunity to review the finalized regulations governing MACRA.

The second as we addressed earlier in our comment letter is to make the AAPM qualifying participant determination on the day after the QP performance year instead of the last day of the QP performance year. The operational requirements for shortening the timeframe for AAPM measurement include: a) calculation of payment or patient count thresholds to determine eligibility b) calculation of total Medicare Part B revenue and c) incentive award payment by Jan 1, 2019.

The current proposal is to use qualifying AAPM participation as of Dec 31, 2017, combined with a 2018 analysis of 2017 total revenue and AAPM revenue to determine Jan 1 2019 payment.

However, AAPM participation begins far in advance of the performance period. ACOs must establish governance and recruit practices prior to the July 31 2017 application deadline. Individual NPIs and TINs are verified by CMS throughout the fall, and a final determination of ACO participation and preliminary beneficiary attribution is conducted well before Dec 31st 2017. This accurate list of eligible clinicians who will be participating in eligible AAPMs in 2018 can and should be used as the basis for calculation of payment or patient count thresholds to determine eligibility for AAPMs. Calculation of total Medicare Part B revenue can be done in Q1 2018 based on 2017 (benchmark year) revenue in order to establish incentive award payment by Jan 1, 2019.

In essence, we are proposing that the timeframe for AAPM participation be moved by one day from Dec 31, 2017 to Jan 1, 2018. By including one additional day for the determination date for AAPM the timeframe for model innovation can be shortened by a year.

In reality, practices interested in participating in AAPMs will be simultaneously applying for AAPMs and performing quality improvement activities under MIPS regardless of whether our proposal is adopted or not. Due to the application deadlines, no clinician can be 100% certain of their MIPS performance or exclusion during 2017. Alignment between MIPS activities and ACO performance should ensure that there is minimal duplication of effort. While the benefits of these changes are particularly acute for 2019 given the regulatory timeframe, it would have lasting benefits every time a new Advanced Alternative Payment Model is introduced.

**Alternative**

The statute specifically allows for the provision of less than a year. The first six months of 2018 (or the last six months of 2017 combined with the first six months of 2018) could be used for 2018 participants in at least annual commitments. This potentially creates a more accurate measurement of whether a participant met the threshold. However, it creates a new timeframe and would not allow CMS any opportunity to inform the participant during the MIPS submission window of whether they qualify. In this alternative all 2018 participants should submit for MIPS. It does still allow for plenty of time for CMS to make accurate FFS payments on Jan 1, 2019.

[1] http://www.nejm.org/doi/full/10.1056/NEJMsa1600142

[1]

 http://www.nejm.org/doi/full/10.1056/NEJMsa1600142