Life Science Compliance Update

May 27, 2016

CMS Administrator Goes to Twitter to Explain the Proposed Rule for the Medicare Access and CHIP Reauthorization (MACRA)

In an very unusual move for a government regulator, the CMS acting administrator Andy Slavitt took to Twitter to explain his agency's strategy around the new Medicare payment law, also known as MACRA. This comes as CMS released the long-awaited proposed MACRA rule which is open for comment until June 27. The proposed rule creates a "Quality Payment Program" to replace old reporting programs. There two tracks, the first called the Merit-based Incentive Payment System (MIPS) consolidates components of the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program. A second track involves alternative payment models (APM). Because of the high bar set to qualify for the APM track, CMS projects that only 30,000 to 90,000 clinicians will be in the APM track. An estimated 687,000 to 746,000 physicians will be in MIPS.

Here are the highlights from Slavitt's tweet-storm:

 

1- Today I will summarize how much listening we've been doing around #MACRA & lay out the opportunities to hear the basics & get engaged.

3:04 PM - 21 May 2016

 

2. Our goal is to close the gap between Washington DC and front line realities of patient care. In May, we have over 35 events on #MACRA.

3:06 PM - 21 May 2016

   

3. We've hosted ten #MACRA webinars this month with over 30,000 attendees.

3:06 PM - 21 May 2016

 

4. To join one of our five upcoming #MACRA webinars, visit:https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Quality-Payment-Program-Events.html …

3:07 PM - 21 May 2016

 

5. We're hosting #MACRA listening sessions. We've visited specialties, PC, & rural. You can invite #CMS to eventshttps://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Speaking-Engagement-Criteria.html …

3:10 PM - 21 May 2016

 

6. With each event, we take common Qs & answer them through fact sheets. Our latest is on #MACRA & small practices:https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Small-Practices-Fact-Sheet.pdf …

3:11 PM - 21 May 2016

7. We post new content each week. Join the #CMS #MACRAlistserv to keep up-to-date: https://public-dc2.govdelivery.com/accounts/USCMS/subscriber/new?topic_id=USCMS_12196 …3:11 PM - 21 May 2016

   

8. Or you can visit our #MACRA website to learn the latest: http://go.cms.gov/QualityPaymentProgram …

3:12 PM - 21 May 2016

 

He continued the next day:

 

Today, I will lay out some of the top interest & feedback areas we have heard for the Quality Payment Program under#MACRA.

11:32 AM - 22 May 2016

 

1. One area of input is the need to use #MACRA to increase focus on practice of medicine/pt care, not reporting/measurement & paperwork.

5:30 PM - 22 May 2016

 

2. A 2nd area is how small practices will fare relative to larger sized practices under #MACRA. We put this out:https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Small-Practices-Fact-Sheet.pdf …

5:33 PM - 22 May 2016

 

3. A 3rd area is the availability of payment models like med homes, ACOs, including how they overlap & how to ease the path in to qualify.

5:34 PM - 22 May 2016

 

4. We have received other questions around flexibility, burden, timing, specialty care & payment adjustments.

5:37 PM - 22 May 2016

 

5. Will create fact sheets 4 key questions as we answer them as we've been doing.

5:39 PM - 22 May 2016

 

6. My takeaways: first, very encouraged by all the engagement, particularly the critics.

5:42 PM - 22 May 2016

 

7. My takeaways: Second, people want a philosophical change- a program that doesn't get in the way of practicing medicine, but supports it.

5:44 PM - 22 May 2016

 

8. My takeaways: third, walking thru basics has been critical. Payment adjusts., measurement, paperwork r all better than today's Medicare.

5:49 PM - 22 May 2016

 

9. My takeaways: fourth, more time, more to learn, more#MACRA meetings coming up. 35 in May alone. Grateful for all the engagement.

5:54 PM - 22 May 2016

 

Comment

Stakeholders have been struggling with the rule's complexity and length, so it is not surprising that CMS wants to explore all possible avenues for communication. It is unlikely these tweets will do much to change the confusion and challenges facing physicians, but it is laudable that the government is thinking outside of the box and looking to connect over social media. But the biggest takeaway seems to be that CMS recognizes the complexity of the rule and this could be insight into the possible comments that should be sent to the agency. 60 days to analyze one of the most important Medicare regulations in a quarter century is simply not sufficient. CMS is bound by difficult congressional deadlines, but it may be smart for all of Washington, D.C. to rethink the MACRA implementation process. It is too important for physicians and patients alike to rush through massive changes that almost no physician truly understands.

May 25, 2016

Understanding the CMS Proposed Rule for the Medicare Access and CHIP Reauthorization (MACRA) and Alternative Payment Model (APM’s)

After reviewing the Merit-based Payment System (MIPS) in detail, we now focus our attention on the alternative payment model (APM) track of the new Quality Payment Program. This stems from the Centers for Medicare and Medicaid Services' (CMS) recently proposed rule to implement the Medicare Access and CHIP Reauthorization Act (MACRA).

Advanced APMs

Beginning in 2019, eligible clinicians who participate in Advanced APMs may become qualifying participants (QPs) each year by meeting certain thresholds; upon becoming QPs, they are excluded from the MIPS program for any years in which they qualify as QPs. For 2019 and 2020, eligible clinicians may become QPs only by participating in Advanced APMs; Medicare is the payer for all Advanced APMs. For 2021 and beyond, eligible clinicians may continue to become QPs by participating solely in Advanced APMs, but they also can achieve QP status by participating in a combination of Advanced APMs and APMs with other payers (Other Payer Advanced APMs). For 2019 through 2024, while the Medicare annual physician fee schedule (PFS) conversion factor update is zero (0.0%) for QPs and for MIPS clinicians, each QP receives a lump sum incentive payment (5 percent of the QP's prior year Part B covered professional services payments). Starting in 2026, the PFS annual update will be set higher for QPs (0.75%) than for eligible clinicians who are not QPs. A tremendous article that breaks down the specific requirements of Advanced APMs can be found here.

In the proposal, CMS revised or clarified key terms include the following: "Eligible" APM is replaced by "Advanced" APM; APMs for which CMS is not the payer are termed "Other Payer APMs"; "APM entity" is defined as any entity participating in an APM; "Eligible alternative payment model entity" is replaced by "Advanced APM entity"; "Advanced APM entity" is one participating in an APM determined to be an Advanced APM by CMS; and "Medical homes" are APM entities that are associated with their respective APMs; such APMs are termed "medical home models". CMS seeks comments on the proposed terms including their definitions and their naming.

CMS proposes two mandatory elements for a Medical Home Model. First, participants include primary care practices or multispecialty practices containing primary care practitioners and offering primary care services. Second, each patient is assigned to the panel of a primary clinician. Additionally, a Medical Home Model must have at least four additional elements chosen from the following seven:

  • Planned coordination of chronic and preventive care
  • Patient access and continuity of care
  • Risk-stratified care management
  • Coordination of care across the medical neighborhood
  • Patient and caregiver engagement
  • Shared decision-making
  • Payment arrangements in addition to, or substituting for, FFS payments (e.g., population-based).

CMS proposes that these mandatory and discretionary elements are consistent with medical home standards and accreditation across the health care market. CMS seeks comments on these elements and which ones should be required rather than optional. CMS further proposes that a Medical Home Model must demonstrate a primary care focus through model design elements related to eligible clinicians.

CMS continues by discussing Advanced APMs in great detail. First, an Advanced APM must meet the MACRA criteria to be an APM. An APM is any of the following:

  • a CMMI model (other than an innovation award)
  • a MSSP
  • a demonstration under section 1866C, the Medicare Health Quality Demonstration Program (e.g., Acute Care Episode Demonstration)
  • a demonstration required by federal law (e.g., Physician Hospital Collaboration MMA 2003).

In the proposed rule, CMS further specifies that a demonstration required by law will be an APM only if the demonstration is compulsory under the statute, has a "thesis" to be evaluated, and requires the participating entities to be governed by a CMS agreement or statute or regulation. CMS seeks comments on this additional specification proposal.

To be an Advanced APM, an APM through its payment entity must also meet all three MACRA criteria:

  • Require participants to use certified electronic health record technology (CEHRT)
  • Provide for payment for covered professional services based on quality measures comparable to those in MIPS
  • Require that the participating APM entities bear more than nominal financial risk for monetary losses under the APM or that the APM be a medical home expanded under CMS Innovation Center authority.

An APM Entity holds primary responsibility for healthcare cost and quality provided to beneficiaries as governed by its direct agreement with CMS. All entities participating in Advanced APMs are Advanced APM Entities.

CMS Examples of Advanced APM Tracks within an APM

CMS plans to identify those APMs that have been determined to be Advanced APMs, posting the list on its website. This list will expand over time. No later than January 1, 2017 the Advanced APM list applicable to the first QP Performance Period (2017) will be released. Subsequently, CMS will update the list on a rolling basis, including its Advanced APM determination as part of the first public notice of each new APM. The list will be updated at least annually. CMS seeks comment on the proposed process for release of Advanced APM determinations, especially suggestions for promoting clarity for users concerning which Advanced APMs are operating within a particular QP Performance Period.

Continuing, Advanced APMs must provide payment for covered services based upon quality measures comparable to those described for use in the MIPS performance category. CMS proposes the following principles for selecting Advanced APM measures to enhance comparability to MIPS measures:

  • Measures chosen should have an evidence-based focus
  • Measures chosen should harmonize high priority measures with those of MIPS (e.g., clinical outcomes)
  • Measures chosen should be those most appropriate to an APM's population, as determined by the APM participants
  • Some, but not all, quality measures for which an APM is assessed must be MIPS-comparable
  • Some, but not all, quality-based payments made to Advanced APM entities must be contingent upon MIPS-comparable measures
  • Payments not tied to quality measures are not required to be MIPS comparable.

Consistent with these principles, CMS proposes that the Advanced APM quality measure set upon which payment will be based must include at least one of the following measure types:

  • Any of the measures on the proposed annual list of MIPS quality measures
  • Quality measures endorsed by a consensus-based entity (e.g., National Quality Forum)
  • Quality measures developed under 1848(s) of the Act
  • Quality measures submitted in response to the MIPS Call for Quality Measures
  • Any other quality measures determined by CMS to have an evidence-based focus.

Each measure chosen for inclusion in the payment-linked set must be evidence-based, reliable, and valid. CMS invites comment about whether all MIPS comparable measures should be required to be reliable, valid, and have an evidence-based focus.

Qualifying APM Participant (QP) and Partial QP Determination

MACRA defines a MIPS-eligible professional for 2019-2021 as a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, or a group containing such professionals. In 2021 and beyond, the Secretary of HHS may expand and revise this list. In the proposed rule, MIPS-eligible professional is replaced by MIPS-eligible clinician or simply eligible clinician. An eligible clinician may become a Qualified Professional (QP) or a Partial QP by participating in an Advanced APM in which the eligible clinicians as a group meet specific payment or patient thresholds.

The QP and Partial QP determination payment thresholds change over time. QP for 2019 and 2020: at least 25 percent of the eligible clinician group's Medicare Part B fee-for-service (FFS) covered professional services payments. QP for 2021 and 2022: at least 50 percent of Medicare Part B FFS covered professional services payments or at least 50 percent of All-Payer payments (with at least 25 percent of Medicare payments). QP for 2023 and beyond: at least 75 percent of Medicare payments or 75 percent of All-Payer payments (with at least 25 percent of Medicare payments)

The Secretary of HHS may choose to base the QP/Partial QP determination upon patient count thresholds rather than payment thresholds. Therefore, CMS will also make QP and Partial QP determinations each year using patient counts. Preliminary analysis by CMS shows that the proposed QP/Partial QP payment and patient count thresholds yield results that are very similar.

Like the payment thresholds, the patient count thresholds change over time. QP for 2019 and 2020: at least 20 percent of the eligible clinician group's attributable beneficiaries. QP for 2021 and 2022: at least 35 percent of the eligible clinician's group's attributable beneficiaries or at least 35 percent of All-Payer attributable beneficiaries (with at least 20 percent of Medicare attributable beneficiaries). QP for 2023 and beyond: at least 50 percent of the eligible clinician's group's attributable beneficiaries or 50 percent of All-Payer attributable beneficiaries (with at least 20 percent of Medicare payments)

Finally, an eligible clinician determined to be a QP receives the following benefits:

  • For 2019 through 2024, while the Medicare annual physician fee schedule (PFS) conversion factor update is zero (0.0%) for QPs and for MIPS clinicians, each QP receives a lump sum incentive payment (5 percent of the QP's prior year Part B covered professional services payments)
  • Starting in 2026, the annual PFS annual update will be set higher for QPs (0.75%) than for eligible clinicians who are not QPs
  • A QP is excluded from MIPS payment adjustments.

The benefit of Partial QP status for an eligible clinician is the option to choose whether or not to report MIPS data and thereby be subject to a MIPS-related payment adjustment. CMS seeks comment on the proposed patient count thresholds and on using sequential calculations for QP determination.

CMS proposes that identification of eligible clinicians for each Advanced APM Entity be a single point in time assessment. CMS proposes December 31st of each QP performance period as the best single opportunity to comprehensively assess active participation by eligible clinicians in their Advanced APMs. CMS invites comment on this approach. CMS further proposes a single exception to collective group-level QP determinations. This exception would accommodate the eligible clinician who participates in multiple Advanced APMs. CMS also proposes to require that each Advanced APM Entity make an election annually on behalf of all of its identified eligible clinicians on whether to report to MIPS should the clinician group be determined to be Partial QPs for a given year. CMS wishes to notify Advanced APM Entities and their member clinicians about their QP/Partial QP status determinations as soon as determinations have been made and validated.

CMS QP Determination Tree, Payment Years 2019-2020

 

CMS QP Determination Tree, Payment Years 2021-2022

CMS QP Determination Tree, Payment Years 2023 and Later

Risk in Advanced APMs

To become an Advanced APM, MACRA mandates that an APM must meet what CMS terms the "financial risk criterion." Meeting this criterion means that a) the APM is an expanded medical home model or b) the APM Entity "bears more than nominal financial risk if actual aggregate expenditures exceeds expected aggregate expenditures." The financial risk criterion is addressed by structuring the design elements of the APM financial risk arrangement to meet the proposed requirements. Meeting the criterion is not dependent upon actual savings achievement or other APM success metrics. No additional financial risk performance criteria would be applied by CMS for the purpose of meeting the criterion.

Although CMS prefers to prioritize consistency of standards across the APM structural spectrum, two separate standards are proposed in this rule, a Generally Applicable Advanced APM Standard and a Medical Home Model Standard. CMS therefore proposes distinct Medical Home Model standards for financial risk and nominal loss that apply only to Medical Home Models whose medical home APM entities have 50 or fewer eligible clinician participants in the organization through which the medical home entity is owned and operated. Comment is specifically invited about an alternative limiting the Medical Home Model standard to APMs within which 10 percent or fewer of eligible clinicians are part of parent organizations with more than 50 clinicians.

The Generally Applicable Advanced APM standard applies if actual expenditures for which an APM entity is responsible under the APM structure exceed expected expenditures. For an Advanced APM, in such situations CMS can:

  • Withhold payment for services to the APM Entity and/or the entity's eligible clinicians
  • Reduce payment rates to the APM Entity and/or the entity's eligible clinicians
  • Require the APM Entity to owe payment(s) directly to CMS

Reductions in bonus payments not be allowed. One-sided risk arrangements would not meet the above standard. Expenditures of time and money incurred to become and remain an Advanced APM would not be counted towards APM entity losses; such losses are not tied directly to performance and are difficult to objectively and consistently quantify. CMS expresses belief that the Advanced APM financial risk criterion should be designed to be met only by APMs truly committed to transforming care by challenging all participants. CMS welcomes comment on alternative specifications for a financial risk criterion that would be objective and meaningful.

The Medical Home Model standard applies if actual expenditures for which the APM entity is responsible under the APM structure exceed expected expenditures or if APM Entity performance on specified measures does not meet or exceed expected performance on such measures. For a Medical Home Model to be an Advanced APM, in either of these situations CMS can:

  • Withhold payment for services to the APM Entity and/or the entity's eligible clinicians
  • Reduce payment rates to the APM Entity and/or the entity's eligible clinicians
  • Require the APM Entity to owe payment(s) directly to CMS
  • Lose the right to all or part of an otherwise guaranteed payment or payments.

This standard differs from the Generally Applicable Advanced APM Standard primarily through the last provision above, which allows for reductions of "bonus-type" payments. CMS seeks comment on the proposed standards for both Advanced APM Medical Home Models and all other APMs and on types of financial risk arrangements not clearly captured by the risk standard proposal.

Once an APM risk arrangement is found to meet the applicable proposed standard, CMS next considers whether the amount of the risk exceeds a nominal amount, in which case the Advanced APM financial risk criterion is met. The "nominal amount standard" links to a specified quantitative risk value at which potential losses under the risk arrangement are deemed more than nominal. As for the financial risk standard, CMS again proposes a bifurcated structure. For most APMs, a generally applicable nominal amount standard will apply while a separate standard will apply to Medical Home Models.

Under the generally applicable nominal amount standard, total risk percentages represent the Medicare expenditure amount above which an APM Entity owes losses and below which an APM Entity earned savings. Total risk percentages are based upon the target price (episode payment models) or the APM Entity benchmark (other models). The contributions of Part A and Part B to Medicare expenditures vary across APMs. Further, the ratio between entity revenue and expenditures captured in an APM benchmark varies across different types of APM entities. CMS attempts to define a generally applicable nominal amount standard that can be applied to all types of APM entities. Medical Home Models have a separate nominal amount standard, under which total risk percentages are based on Part A and Part B revenue.

To set the generally applicable Advanced APM nominal amount standard, CMS looked for amounts that would be meaningful but not excessive to APM entities. CMS derived reference points for the nominal amount standard from MIPS adjustments under MACRA and existing APM risk arrangements (e.g., MSSP, Pioneer ACO, and the Bundled Payments for Care Improvement (BPCI) Initiative). CMS believes the potential losses and marginal risk rates of its reference programs to be optimal, having undergone extensive, careful review during the development process for each APM. CMS identified three dimensions of risk to incorporate into the proposed generally applicable nominal amount standard:

  • Marginal risk: the percentage of the amount by which actual expenditures exceed expected expenditures for which an APM Entity is liable under its APM
  • Minimum loss rate (MLR): a percentage by which actual expenditures may exceed expected expenditures without triggering financial risk
  • Total potential risk: the maximum potential payment for which an APM Entity could be liable under the APM structure.

Based upon the dimensions of risk, an APM can meet the generally applicable Advanced APM nominal amount standard when all of the following conditions are met:

  • The specific level of marginal risk must be at least 30 percent of losses in excess of expected expenditures
  • The minimum loss rate must be no greater than 4 percent of expected expenditures
  • Total potential risk must be at least 4 percent of expected expenditures.

Expected expenditures are defined to be the level of expenditures reflected in the target price for episode payment models and in the APM benchmark for other models. Marginal risk is calculated as a percentage by which actual expenditures exceeded expected expenditures. Including a marginal risk standard helps maintain a more than nominal level of average or likely risk under an Advanced APM.

Setting a maximum allowable minimal loss rate accommodates APMs that include zero risk for small losses but otherwise satisfies the marginal risk standard. When actual expenditures exceed expected expenditures by an amount exceeding the MLR, then all excess expenditures (including those within the MLR) become subject to the marginal risk requirements. For the occasional circumstance in which an APM can satisfy the marginal risk requirement despite a high MLR, CMS will review the risk arrangement and possibly grant an MLR exception though such exceptions will be rare. The MLR is set by the APM as part of the APM entity agreement with CMS.

To assess the total potential risk dimension of the nominal amount standard, CMS would identify the maximum potential payment an APM could be required to make as a percentage of expected APM expenditures. When this percentage is four or more, the total risk standard is met.

CMS Example of Risk Arrangement that would meet the Nominal Amount Standard (75% marginal risk rate, 2% minimum loss rate, 10% total risk, and non-episode payment model)

CMS Amounts of Risk Sufficient to Meet the Nominal Amount Standard

CMS seeks comment on appropriate levels for allowable MLR and on parameters to consider that might warrant an exception in a risk arrangement from the MLR portion of the nominal amount standard. CMS also seeks comments on the generally applicable Advanced APM nominal amount standard in general and with regard to the specific provisions, especially the MLR component.

CMS proposes that full capitation risk arrangements would automatically meet the Advanced APM financial risk criterion relative to both risk-bearing and nominal risk amount. Continuing, no CMS Medical Home APMs have been expanded as yet under section 1115A(c) of the Act. CMS has reviewed its sponsored APM portfolio and identified those anticipated to become Advanced APMs for the first QP performance period that begins in January 2017. The following six APMs of the twenty-four reviewed by CMS met all of the criteria to be Advanced APMs.

  • Comprehensive End Stage Renal Disease Care (Large Dialysis Organization arrangement)
  • Comprehensive Primary Care Plus (CPC+)
  • MSSP Track 2
  • MSSP Track 3
  • Next Generation ACO Model
  • Oncology Care Model (OCM) two-sided risk arrangement.

Many APMs did not meet all of the proposed Advanced Payment APM criteria including the Comprehensive Care for Joint Replacement (CJR) model, the Bundled Payment for Care Improvement Models, and Track 1 participants in the MSSP. As you can see from the following charts CMS has created a very high bar to climb.

CMS APM List Based on Proposed Criteria

Physician-Focused Payment Models

Section 101(e)(1) of MACRA adds a new section 1868(c) to the Act which establishes the Physician-Focused Payment Model Technical Advisory Committee (PTAC) and sets forth requirements for criteria and a process for stakeholders to propose physician-focused payment models (PFPMs) for review by the PTAC. After review, the PTAC provides comments and recommendations to CMS on the PFPM for a detailed response from, and possible testing of the PFPM by, the agency. You can see meeting minutes from the PTAC here.

CMS proposes to define a PFPM as an alternative payment model that meets all of the following requirements:

  • It has Medicare as a payor.
  • It includes APM entities (i.e., physician group practices or individual physicians).
  • It targets the quality and costs of physician services.

Stakeholders may propose an APM or an Advanced APM to the PTAC; CMS recommends that a PFPM proposal include information about whether it might qualify as an Advanced APM.

CMS proposes criteria that it believes are sufficiently broad to encompass all physician specialties and provide flexibility in designing PFPMs. It proposes to organize the criteria in three categories: (i) payment incentives for higher-value care, (ii) care delivery improvements, and (iii) information enhancements. For each criterion, CMS encourages stakeholders to provide detailed and specific information on how the PFPM meets the goals of the criterion. The PFPM criteria for payment incentives include (i) value over volume, (ii) flexibility, (iii) quality and cost, (iv) payment methodology, (v) scope, and (vi) ability to be evaluated.

A PFPM should incentivize practitioners to deliver high-quality care; a PFPM should indicate the specific payment incentives (or adjustments) and explain how they will incentivize quality. A model should demonstrate that it has the flexibility needed for practitioners to deliver high-quality health care (e.g., is it operationally feasible to adapt to clinical differences in different patient subgroups or to adapt to changing technology, such as new drug therapies). The PTAC would assess the extent to which a PFPM is expected to meet the goals of improving health care quality at no additional cost, maintaining health care quality while decreasing cost, or both. Stakeholders should include information on specific quality measures, including prior measure validation and whether the measures are patient-reported outcomes or beneficiary experience of care measures.

A PFPM would also be assessed based on its payment methodology and how the methodology would achieve the goals of the PFPM criteria. Stakeholders must explain how their model is different from current payment methodologies, and why the model cannot be tested under current payment methodologies. CMS also proposes that a PFPM must either (i) directly address an issue in payment policy that broadens and expands the APM portfolio or (ii) include APM Entities whose opportunities to participate in APMs have been limited. A model should either address a new issue or include a new specialty; a PFPM that includes multiple specialties would meet this criterion if at least one of the specialties is not currently addressed by another APM.

Finally, a PFPM must have evaluable goals for quality of care, cost, and any other goals of the proposed model. CMS seeks detailed information explaining how the impact of a proposed model would be evaluated, which could include a description of potential approaches for evaluation, such as study design, comparison groups, key outcome measures, level of precision of the evaluation, and the extent to which the impact of each element can be evaluated.

The Comptroller General of the United States appointed the 11 members of the PTAC on October 9, 2015. CMS does not propose to evaluate PFPM proposals before their submission to the PTAC, and CMS states that it cannot commit to test all models that the PTAC recommends, in part due to available resources and competing priorities. CMS also clarifies that there is no need for a second application to CMS to test a PTAC-recommended model.

CMS declines to set deadlines for PTAC recommendations and comments on a proposed PFPM; it also declines to set deadlines for the CMS response as well as the testing of the model. CMS notes that it normally takes the agency 18 months to develop an APM, and additional time is needed for a number of actions, including for the entities to complete applications, for CMS to review applications and prepare participation agreements, for entities to review the agreements and to begin planning to implement the model. CMS also believes that the PTAC should determine the process for submitting proposals to the PTAC; for this reason, CMS does not propose to define what "on-going basis" means for purposes of the statutory mandate that proposals may be submitted to the PTAC on an on-going basis

May 24, 2016

Understanding the CMS Proposed Rule for the Medicare Access and CHIP Reauthorization (MACRA) and the Merit-Based Incentive Payment System (MIPS)

As we have reported, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule to implement the Medicare Access and CHIP Reauthorization Act (MACRA). This is a significant rule with fundamental changes for Medicare. In our continuing coverage, we will provide a more detailed analysis of the regulation. Today, we look at the rule's content related to the Merit-based Incentive Payment System (MIPS).

As a refresher, the rule creates a two-track Quality Payment Program. The first is called the Merit-based Incentive Payment System (MIPS) consolidates components of the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program. A second track involves alternative payment models (APM). Because of the high bar set to qualify for the APM track, CMS projects that only 30,000 to 90,000 clinicians will be in the APM track. An estimated 687,000 to 746,000 physicians will be in MIPS. The program will begin grading physicians in 2017 for changes in their payments starting 2019. You can learn more at one of the many CMS webinars listed here.

MACRA Background

Last year, Congress and President Obama approved a bipartisan bill for United States healthcare reform, the bill known as the "doc fix" bill, or "MACRA," which stands for Medicare Access and CHIP Reauthorization Act of 2015. MACRA repealed the Medicare Part B Sustainable Growth Rate (SGR) reimbursement formula and replaces it with a new pay-for-performance program – the Merit-Based Incentive Payment System (MIPS). MACRA fundamentally alters how the Medicare program pays for services, as well as how providers interact with Medicare.

MACRA provides for updates to the fee schedule of .5% from July 2015 through 2019, at which point services on the physician fee schedule will remain at the 2019 level and be adjusted based on a provider's participation in MIPS or a qualifying APM. After 2026, providers participating in a qualified APM will receive a .75% update and all others will receive a .25% update.

Instead of applying the typical "one size fits all approach," MACRA allows eligible professionals and eligible organizations to identify quality measures and then tailor the quality measures that best fit their individual practice and specialty. Eligible professionals are assessed only on the categories that apply to them, and the categories may be reweighted to compensate, as needed. Each year, the Secretary will establish a performance threshold based on the performance of all participating eligible professionals, who will be informed of how they performed in the prior period and what performance threshold they must meet to be eligible for incentive payments and to avoid penalties. Additionally, eligible professionals who scores fall into a high performance category will receive an additional bonus payment, and providers who make notable gains in performance will be rewarded.

Advancing Care Information Performance Category

The meaningful use of certified EHR technology, now known as advancing care information, is one of the four performance categories under the MIPS reported by eligible clinicians. CMS will continue to review and evaluate this performance category and seeks comments on future potential changes, including methods to increase the stringency of the advancing care information performance measures; how eligible clinicians could be potentially measured more directly on how the use of health IT contributes to the overall health of their patients; measures that would be needed within the advancing care information performance category and the other performance categories to develop a more patient-focused health IT program; and functionalities needed within certified EHR technology to develop a more patient-focused health IT program. Read more from CMS' perspective here.

CMS proposes to align the performance period for the advancing care information performance category to the proposed MIPS performance period of one full calendar year. Under this proposal, for the first year of MIPS, MIPS eligible clinicians would need to submit data based on a performance period starting January 1, 2017 and ending December 31, 2017. CMS states this proposal would reduce reporting burden and streamline requirements so that all performance categories have a common timeline for data submission.

CMS proposes to allow the submission of advancing care information performance category data through qualified registry, EHR, QCDR, attestation and CMS Web Interface submission methods. Regardless of data submission method, all MIPS eligible clinicians must follow the reporting requirements for the objectives and measures to meet the requirements of the advancing care information performance category.

CMS also proposes a group reporting mechanism for individual MIPS eligible clinicians to have their performance assessed as a group for all performance categories. Therefore, the data submission criteria for the advancing care information performance category would be the same when submitted at the individual and group level, but the data submitted would be aggregated for all MIPS eligible clinicians within the group practice.

CMS Proposed Data Submission Mechanisms for MIPS Eligible Clinicians Reporting Individually as a TIN/NPI

CMS Proposed Data Submission Mechanisms for Groups

CMS proposes that performance in the advancing care information performance category will comprise 25 percent of a MIPS eligible clinician's CPS for payment year 2019 and each year thereafter. CMS is proposing that that the score would be comprised of a score for participation and reporting, referred to as the "base score", and a score for performance at varying levels above the base score requirements, referred to as the "performance score". CMS is also proposing two variations of a scoring methodology for the base score, a primary (table 6 in rule) and an alternative proposal (table 7). For either proposal, the base score would account for 50 percent, out of a total of 100 percent, of the advancing care information performance category score.

CMS proposes that a MIPS eligible clinician would earn additional points above the base score for performance on eight associated measures under the Patient Electronic Access, Coordination of Care through Patient Engagement, and Health Information Exchange objectives. The eight associated measures would each be assigned a total of 10 possible points. An eligible clinician has the potential to earn a performance score of up to 80 percent. The combination of the performance score with the base score would provide a total score that is more than the total possible 100 percent for the advancing care information performance category. CMS states this allows flexibility for eligible clinicians to focus on measures that are most relevant to their practice to achieve the maximum performance score.

CMS proposes to sum the base score, performance score and the potential Public Health and Clinical Data Registry Reporting bonus point to obtain the overall score for this performance category. If the sum of the MIPS eligible clinician's total score is greater than 100 percent, CMS would apply an advancing care information performance category score of 100 percent. The total percentage score (out of 100) would then be applied to the 25 points allocated for the advancing care information performance category. Extreme and uncontrollable circumstances, such as natural disasters in which an EHR or practice buildings are destroyed, can prevent a MIPS eligible clinician to be able to access certified EHR technology.

CMS Base Score Primary Proposal Advancing Care Information Objective and Measure Reporting

CMS total Estimate Burden for Advancing Care Information Performance Category Data Submissions

Clinical Practice Improvement Activity (CPIA) Category

This is a new area so it may be advisable to spend extra time learning about the category. There will be a June 22, 2016 CMS webinar (details here). The agency proposes baseline requirements for the CPIA category and plans to revise the requirements in future years to have more stringent requirements with a focus on continuous improvement over time. CMS discusses two themes emerged in the comments it received in response to the MIPS and APMs RFI. First, that all subcategories should be weighted equally and that MIPS eligible clinicians or groups should be able to select from any subcategory most applicable to them. Second, commenters supported inclusion of a diverse set of activities. CMS states they took these recommendations into consideration for the proposal.

CMS proposes that the CPIA performance will account for 15 percent of the overall score. A MIPS eligible clinician or group that is certified as a patient-centered medical home or comparable specialty practice for a specific performance period must be given the highest potential score for the CPIA performance category for the performance period. CMS proposes a patient-centered medical home (PCMH) will be recognized if it is a nationally recognized accredited PCMH, a Medicaid Medical Home Model, or a Medical Home Model. See full list of proposed CPIA activities and their scoring weights.

MACRA also provides 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 notes that consistent with the statute, a MIPS eligible clinician or group is not required to perform activities in each CPIA subcategory or participate in an APM to achieve the highest potential score for the CPIA performance category. In addition, if a MIPS eligible clinician or group fails to report on an applicable CPIA that is required to be reported, they will receive the lowest potential score applicable to that CPIA.

CMS proposes that for the first year only, all MIPS eligible clinicians and groups, or third party entities such as health IT vendors, QCDRs and qualified registries that submit for an eligible clinician or group, must designate a yes/no response for activities on the CPIA Inventory. The MIPS eligible clinicians or groups will certify all CPIAs that have been performed, and the third party entity submits on their behalf.

MACRA mandates a differentially weighted scoring model by requiring 100 percent of the potential score in the CPIA performance category for PCMH participants, and a minimum 50 percent score for APM participants. For additional activities, CMS proposes a differentially weighted model for the CPIA category with two categories: medium and high. CMS states this allows flexible scoring for the measures, which is important since they consider these measures as being undefined activities; CPIA activities are not nationally recognized and there is no entity equivalent to the NQF for CPIA measures.

CMS requests comments on this proposal, including criteria or factors it should take into consideration to determine whether to weight an activity as medium or high. CMS reminds commenters that a good guide in determining if a commenter believes a CPIA should be medium or high is considering how that activity compares with a PCMH, which achieves the highest possible CPIA score.

CMS proposes that the highest potential score of 100 percent is equivalent to a CPIA performance score of 60 points and assigns 10 points for a medium-level activity and 20 points for a high-level activity. To achieve the highest potential score of 100 percent, CMS requires submission of three high-weighted CPIAs (20 points each) or six medium-weighted CPIAs (10 points each), or a combination of CPIAs to achieve a total of 60 points. MIPS eligible clinicians or groups that select less than the designated number of CPIAs to achieve 60 points will receive partial credit based on the weighting of the CPIA selected.

CMS discusses the following exception for MIPS eligible clinicians and groups, including eligible clinicians or groups that are small groups (less than 15 clinicians), located in rural areas or geographic HPSAs, or non-patient-facing MIPS eligible clinicians, are required to submit two CPIAs (either medium or high) to obtain a score of 100 percent. To obtain a score of 50 percent, only one CPIA (either medium or high) is required. Or, eligible clinicians or groups that are participating in an APM will receive 50 percent of the total CPIA score (30 points). To achieve 100 percent of the total CPIA score, eligible clinicians or groups will need to select additional CPIAs for an additional 30 points to reach the 60 point score, the CPIA highest score.

CMS proposes that MIPS eligible clinicians or groups must perform CPIAs for at least 90 days during the performance period for CPIA credit. CMS states that additional clarifications for how some activities meet the 90-day rule or if additional time is required are included in the description of the activity in the CPIA inventory (Table H of the Appendix).

The CPIA performance category must include the following subcategories: Expanded practice access; Population management; Care coordination; Beneficiary engagement; Patient safety and practice assessment; and Participation in an APM. The statute also provides the Secretary the discretion to specify additional subcategories and in the MIPS and APMs RFI, CMS requested recommendations on the following potential new subcategories: Promoting health equity and continuity; Social and community involvement; Achieving health equity; Emergency preparedness and response; and Integration of primary care and behavioral health. For the first year of MIPS, in addition to the CPIA subcategories required in the statute, CMS proposes adding Achieving health equity; Integrated behavioral and mental health; and Emergency preparedness and response. CMS seeks comments, including potential CPIA activities, on two additional subcategories for future consideration: Promoting health equity and continuity; and Social and community involvement.

CMS also discusses the process they used to ensure that the initial CPIA Inventory is inclusive of activities that correspond with the statutory intent. CMS proposes to consider the addition of a new subcategory or activity to the CPIA Inventory when the following criteria are met:

  • The subcategory represents an area that could highlight improved beneficiary health outcomes, patient engagement, and safety based on evidence.
  • The new subcategory has a designated number of activities that meet the criteria for a CPIA activity and cannot be classified under the existing subcategories.
  • The newly identified subcategory would contribute to improvement in patient care or improvement in performance on quality measures and resource use performance categories.

CMS plans to develop a call for measures and activities for future years where stakeholders may recommend activities for inclusion in the CPIA Inventory. CMS also plans to develop a process and establish criteria to remove or add new activities to CPIA.

Consistent with scoring for the quality and resource use categories, CMS proposes to calculate the CPIA category score as the sum of points earned on CPIAs divided by the maximum possible 60 points. The score would be capped at 100 percent. Table 24 in the proposed rule provides an example of CPIA category score for an eligible clinician.

Quality Performance Category

The Quality performance category (compared to PQRS) will account for 30 percent of the composite performance score (CPS). However, for the first and second years of MIPS, the percentage of the CPS applicable for the quality performance category will be increased so that the total percentage points of the increase equals the total number of percentage points by which the percentage applied for the resource use performance category is less than 30 percent. For the first year, not more than 10 percent of the CPS will be based on the resource use category and for the second year, not more than 15 percent of the CPS will be based on the resource use category. Starting on page 773 of the rule, CMS lists proposed quality measures for MIPS reporting in 2017.

We have broken out proposed quality measures:

List of Proposed Reportable Quality Measures

List of Proposed Cross Cutting Measures

List of Measures with Significant Changes for MIPS

List of New Measures

CMS proposes for payment years 2019 and 2020, the quality performance category will account for 50 percent and 45 percent, respectively, of the CPS. For the third and future years, 30 percent of the MIPS CPS will be based on performance on the quality performance category. CMS states that under their proposed scoring policy, a MIPS eligible clinician or group that reports on all required measures could potentially obtain the highest score possible within the performance category, presuming it performed well on all the measures reported. A MIPS eligible clinician or group that does not meet the reporting threshold would receive a zero score for the unreported items in the category which would prevent it from obtaining the highest possible score.

CMS seeks comments on its proposal to allow reporting of specialty-specific measure sets to meet the submission criteria for the quality performance category, including those measure sets with fewer than six measures, including one cross-cutting measure and one outcome measure, or if an outcome measure is not available another high priority measure. Specifically, CMS seeks comments on whether it is appropriate to allow reporting of a measure set at the subspecialty level to meet the submission criteria, since reporting at the subspecialty level could require reporting on fewer measures. Additionally, should CMS only consider reporting up to six measures at the higher overall specialty level to satisfy the submission criteria?

MACRA requires the Secretary to use rulemaking to establish an annual list of quality measures from which MIPS eligible clinicians may choose for purposes of their assessment for a performance period. The annual list of quality measures must be published in the Federal Register no later than November 1 of the year prior to the first day of a performance period and updates to the annual list must also be published in the Federal Register no later than November 1of the year prior to the first day of each subsequent performance period. In the first year of MIPS, CMS proposes to maintain a majority of previously implemented PQRS measures for inclusion in the annual list of quality measures.

Additionally, the Secretary must solicit a "Call for Quality Measures" each year and must request that eligible clinician organizations and other relevant stakeholders identify and submit quality measures to be considered in the annual list of quality measures, as well as updates to the measures. CMS will accept quality measures at any time but only measures submitted before June 1 of each year will be considered for inclusion in the annual list of quality measures for the performance period beginning 2 years after the measure is submitted. For example, a measure submitted prior to June 1, 2016 would be considered for inclusion in the 2018 performance period.

To score this category, one to ten points would be assigned to each measure, based on a clinician's performance compared to benchmarks. For each measure, a case minimum would have to be met for a clinician to receive a score. Zero points are awarded if the clinician fails to submit data on a required measure. If data submission is completed, the clinician would either receive a score or the measure would not be counted because the case minimum is not met or for another reason the measure cannot be scored. The total domain score would be the sum of all the points assigned for the scored measures plus bonus points (up to a cap) divided by the sum of total possible points. In general, clinicians would be required to submit six measures and would also be scored on up to three population-based measures calculated from administrative claims data. The total possible points for the quality performance category would be 90 points.

Unlike PQRS, which requires eligible professionals to meet all the criteria or be subject to a penalty, under the MIPS CMS proposes to move away from the "all or nothing" scoring approach. Clinicians would be given some amount of points for all measures that are successfully reported. If the case minimum is not met for a measure, that measure would not be included in the score. But CMS wants to discourage clinicians who are able to submit measures that can be scored from continuing to submit the same measures year after year that cannot be scored because they do not meet the case minimum. Comments are sought on safeguards to minimize gaming attempts.

To calculate the quality performance category score, a methodology is proposed. The sum of the weighted points assigned to measures required by the quality performance category criteria would be added to any bonus points earned. That total would be divided by the weighted sum of total possible points to equal the quality performance category score. CMS notes that if an eligible clinician reports more than the minimum number of measures, it would include in the category total only the scores for the measures with the highest assigned points. This would allow eligible clinicians to gain experience reporting measures before they are included in the score.

Resource Use Performance Category

MACRA requires the development of care episode and patient condition groups, and classification codes. In addition, care episode and patient condition groups are to account for a target of an estimated one-half of expenditures under Parts A and B, with the target increasing over time as appropriate. To facilitate the attribution of patients and episodes to one or more clinicians, MACRA requires the development of patient relationship categories and codes that define and distinguish the relationship and responsibility of a clinician with a patient.

On or after January 1, 2018, claims for services furnished by a physician or applicable practitioner will include applicable codes established for care episode groups, patient condition groups, and patient relationship codes. Claims will also include the NPI of the ordering physician or applicable practitioner. This information will be used to attribute patients to one or more physicians or applicable practitioners and determine resource use. For measuring resource use, the Secretary will use per patient total allowed charges for all services under Parts A and B, and if the Secretary determines appropriate Part D.

The resource use performance category will account for not more that 10 percent of the CPS for the first MIPS payment year (2019) and not more than 15 percent for the second MIPS payment year (2020). CMS proposes for payment years 2019 and 2020, the resource use performance category will account for 10 percent and 15 percent, respectively, of the CPS. For the third and future years, 30 percent of the CPS will be based on the resource use performance category.

CMS proposes 41 clinical conditions and treatment episode-based measures for the 2017 MIPS performance period: 34 are Method A measures and 7 are Method B measures. The broad clinical topics for the episode-based measures include breast cancer, and diseases related to cardiovascular, cerebrovascular, gastrointestinal, genitourinary, infectious, neurologic, musculoskeletal, respiratory and vascular conditions. The Method B measures also include an ophthalmology measure related to lens and cataract procedures. Although CMS is proposing 41 measures, because these measures have never been used for payment purposes, CMS states they may choose to only include a subset of these measures in the final rule.

CMS Resource Use Performance Category Example

Regarding attribution, CMS proposes that acute condition episodes would be attributed to all MIPS eligible clinicians that bill at least 30 percent of inpatient evaluation and management visits during the initial treatment or "trigger event" that opens the episode. CMS states these visits are directly related to the management of the acute condition and that eligible clinicians who bill at least 30 percent of the IP E&M visits are likely to have been responsible for the oversight of the care during the episode. Using this methodology, CMS notes it is possible that more than one MIPS eligible clinician will be attributed to a single episode. CMS proposes that procedural episodes would be attributed to all MIPS eligible clinicians that bill a Part B claim with a trigger code during the trigger event of the episode.

CMS proposes that any Part B claim or line item during the trigger event with the episode's triggering procedure code is used for attribution. If more than one eligible clinician bills a triggering claim, the episode is attributed to each of the eligible clinicians. If co-surgeons bill the triggering claim, the episode is attributed to each MIPS eligible clinician. If only an assistant surgeon bills the triggering claim, the episode is attributed to the assistant surgeon or the group. If an episode does not have a concurrent Part B claim with a trigger code for the episode, then the episode is not attributed to any eligible clinician. Additionally, CMS proposes to use the minimum of 20 cases for all episode-based measures and not to include any measures that do not have average moderate reliability at 20 episodes.

To score measures in the resource use performance category would be similar to scoring of measures in the quality performance category: benchmarks would be calculated as deciles and from 1 to 10 achievement points awarded depending on where the clinician's performance falls within the benchmarks. The measure scores would be averaged and then divided by the total number of potential points to determine the clinician's performance category score.

MIPS APMs

CMS proposes to establish a scoring standard for MIPS eligible clinicians participating in certain types of APMs that will reduce participant reporting burden by eliminating the need for such APM eligible clinicians to submit data for both MIPS and their respective APMs. CMS proposes to use the APM scoring standard for MIPs eligible clinicians in APM Entity groups participating in certain APMs that meet the criteria.

CMS proposes that the APM scoring standard would not apply to MIPS eligible clinicians participating in APMs that are not MIPS APMs. CMS notes that since the criteria for the identification of MIPS APMs are independent of the criteria for Advanced APM determinations, a MIPS APM may or may not also be an Advanced APM. Based on the proposed policy, the APM scoring standard would not apply to MIPS eligible clinicians involved in APMs that include facilities as participants (such as the Comprehensive Care for Joint Replacement Model) and to APMs that do not base payment on cost/utilization and quality measures (such as the Accountable Health Communities Model).

The proposed APM scoring standards would still require MIPS eligible clinicians to report certain data under MIPS regardless of whether they ultimately become Qualifying APM Participants (QPs) or Partial Qualifying APM Participants (Partial QPs) through their participation in Advanced APMs. Although QPs and Partial QPs who elect not to participate in MIPS would be excluded from MIPS payment adjustments, CMS believes for operational and administrative reasons, it is necessary to treat these eligible clinicians as MIPS eligible clinicians unless and until the QP or Partial QP determination is made.

CMS proposes that the performance period for MIPS eligible clinicians participating in MIPS APMs would generally match the applicable calendar year performance period proposed for MIPS. For a new MIPS APM for which the first APM performance period begins after the start of the corresponding MIPS performance period, CMS proposes the participating MIPS eligible clinicians would submit data to the MIPS in the first MIPS performance period for the APM either as individual MIPS eligible clinicians or as a group, and report to CMS using the APM scoring standard for subsequent MIPS performance periods.

CMS states that the proposed APM scoring standard is similar to the proposed group assessment under MIPS except for the following:

  • Depending on the terms and conditions of the MIPS APM, an APM Entity could be comprised of a sole MIPS eligible clinician (for example, a physician practice with only one eligible clinician could be considered an APM Entity);
  • The APM Entity could include more than one unique TIN, as long as the MIPS eligible clinicians are identified as participants in the APM by their unique APM participant identifiers; and
  • The composition of the APM Entity group could include APM participant identifiers with TIN/NPI combinations such that some MIPS eligible clinicians in a TIN are APM participants and other MIPS eligible clinicians in the same TIN are not APM participants.

CMS proposes that depending on the type of MIPS APM, the weights associated with performance categories may be different than the generally applicable weights for MIPS eligible clinicians. CMS proposes that under the APM scoring standard, the weight for the resource use performance category will be zero. CMS also proposes that for certain APMs, the weight for the quality performance category will be zero for the 2019 payment year. Neither the APM Entity nor the eligible clinicians would need to report quality performance data. CMS would redistribute the weights for the quality and resource use performance categories to the CPIA and advancing care information performance categories to maintain a CPS of 100 percent.

CMS plans to establish and maintain an APM participant database that will include all of the MIPS eligible clinicians who are part of the APM Entity. CMS proposes that each APM Entity would be identified in the MIPS program by a unique APM Entity identifier, and that the unique APM participant identifier for a MIPS eligible clinician would be a combination of four identifiers, including (1) APM identifier (established by CMS); (2) APM Entity identifier (established by CMS); (3) the eligible clinician's billing TIN; and (4) NPI.

CMS APM Entity Submission Method for Each MIPS Performance Category

Physician Compare

CMS reviews the requirements regarding public reporting on the Physician Compare website under MACRA and the Affordable Care Act, and in accordance with these requirements proposes for each MIPS eligible clinician, composite scores and performance by category; and aggregate information on the range of MIPS composite scores and range of performance by category. These data would be added on the profile pages or in the downloadable database, as technically feasible. CMS proposes that statistical testing, consumer testing, and consultation with the Physician Compare Technical Expert Panel would determine how and where the data are reported. CMS seeks comments on the advisability and feasibility of including data voluntarily reported by EPs and groups not subject to the MIPS adjustment.

All CPIA category data would be available for public reporting on Physician Compare. CMS proposes to identify a subset of data that meet public reporting standards. An indicator that a clinician has successfully met CPIA category requirements may be posted. Because CPIA is a new category CMS intends to employ consumer testing as well as statistical testing in identifying data for public reporting. With respect to the advancing care information category, CMS proposes to expand the information provided on Physician Compare regarding clinicians' performance on measures of meaningful use. It says this type of information resonates with consumers.

MIPS Exclusions and Payments

CMS proposes that a new Medicare-enrolled eligible clinician is defined as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims as a Medicare-enrolled eligible clinician either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. CMS also proposes that in no case would a MIPS adjustment factor apply to items and services provided by new Medicare-enrolled eligible clinicians. Additionally, partially-qualifying APM participants will have the option to elect whether or not to report under MIPS, which determines whether or not they will be subject to MIPS adjustments.

In terms of thresholds, CMS proposes to define MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the performance period, has Medicare billing charges less than or equal to $10,000 and provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. CMS states that this threshold excludes MIPS eligible clinicians who do not have a substantial quantity of interactions with Medicare beneficiaries or furnish high cost services. CMS also notes it considered using items and services instead of the number of Part B-enrolled individuals but there were only small differences between the two methods.

To define an eligible clinician, CMS proposes to include physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetist, and a group that includes such professionals. CMS anticipates that eligible clinicians who are not MIPS eligible professionals during the first two years of the program, such as physical and occupational therapists and others that have been reporting quality measures under the PQRS, will want to have the ability to continue to report and gain experience under MIPS.

CMS further proposes to define a non-patient-facing MIPS eligible clinician for MIPS as an individual MIPS eligible clinician or group that bills 25 or fewer patient-facing encounters during a performance period. CMS considers a patient-facing encounter to include general office visits, outpatient visits, surgical procedure codes, and telehealth services; it intends to publish the proposed list of face-to-face encounter codes on a CMS website (similar to the list of face-to-face encounter codes for PQRS). CMS selected this threshold based on analysis of non-patient-facing HCPCS codes billed by MIPS eligible clinicians, which indicated that the majority of clinicians enrolled in specialties such as anesthesiology, nuclear medicine and pathology, were identified as non-patient facing.

The MIPS adjustment factor would be applied to Part B payments as a percentage adjustment for a payment year. Part B amounts otherwise payable would be multiplied by 1 plus the MIPS adjustment percentage. Furthermore, the statute provides that the MIPS adjustment factor be calculated so that eligible clinicians with a CPS at or above the performance threshold receive a zero or positive adjustment factor. The adjustment of 0 percent is assigned for a CPS at the performance threshold and a maximum adjustment factor of the "applicable percent" (4 percent for 2019) is assigned for a CPS of 100 percent; a linear sliding scale determines the adjustment for CPS that falls between these amounts. For eligible clinicians with a CPS below the performance threshold, the MIPS adjustment factor is negative, with the maximum negative adjustment of the applicable percent assigned to a CPS equal to or greater than zero but not greater than one-fourth of the performance threshold. A linear sliding scale between the CPS of zero maximum negative adjustment and the threshold adjustment of zero determines the negative adjustment for a CPS between these amounts. It was unclear if CMS would pursue such a linear structure, or have the majority of MIPS participants in a neutral position, only adjusting the extremes at the positive and negative ends of the spectrum.

CMS Illustrative Example of MIPS Adjustment Factors Based on Composite Performance Scores (CPS)

  

CMS Weights by Performance Category

 

*The weight for advancing care information could decrease (not below 15 percent) if the Secretary estimates that the proportion of physicians who are meaningful EHR users is 75 percent or greater. The remaining weight would then be reallocated to one or more of the other performance categories.

 

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