Life Science Compliance Update

March 01, 2017

OIG Reviews QPP

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As we have recently written, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) enacted clinician payment reforms designed to promote quality and value of care. These reforms, known as the Quality Payment Program (QPP), are a significant shift in how Medicare calculates compensation for clinicians and require the Centers for Medicare & Medicaid Services (CMS) to develop a complex system for measuring, reporting, and scoring the value and quality of care. CMS issued final regulations on October 14, 2016, and the first performance year will begin January 1, 2017, with the first payment adjustments taking effect on January 1, 2019. Clinicians may participate in one of two QPP tracks: the Merit-Based Incentive Payment System (MIPS) or Advanced Alternative Payment Models (Advanced APMs). Given the importance and complexity of these reforms and the tight timeline, the OIG conducted an early implementation review of CMS’s management of the QPP, raising some concerns about the Program.

Key Findings

As written in the OIG report, it found that CMS has made significant progress towards implementing the QPP. However, OIG identified two vulnerabilities that are critical for CMS to address in 2017, because of their potential impact on the program’s success: (1) providing sufficient guidance and technical assistance to ensure that clinicians are ready to participate in the QPP, and (2) developing IT systems to support data reporting, scoring, and payment adjustment.

Stakeholder Concerns

The OIG’s findings come, as the OIG notes, along with many stakeholder concerns about the program. Specifically, OIG notes that providers, professional associations, and members of Congress have expressed a variety of concerns about the QPP. CMS alone received over 4,000 comments on the proposed rule for the QPP published in May 2016.

OIG describes the major concerns of the QPP as follows:

  • Too burdensome for solo, small-practice, and rural providers. Stakeholders questioned whether small and/or rural providers will succeed under the QPP. Unlike large practices, small providers may not have the resources to hire an administrator or third-party vendor to handle reporting.
  • Too complex. Stakeholders raised concerns about the QPP’s complexity—in particular, the complicated formula for calculating MIPS Final Scores and determining payment adjustments. Stakeholders also noted that if clinicians in Advanced APMs do not know until late in the performance period whether they have reached the threshold to be Qualifying APM Participants, they may still need to prepare for MIPS reporting—reducing one of the incentives for participation in the Advanced APM track.
  • Applicability and validity of specific MIPS measures. Stakeholders offered feedback about the availability of MIPS measures relevant to different types of clinical practice and whether the measures will accurately reflect clinician performance.
  • Limited number of Advanced APM opportunities currently available. Stakeholders stated that more Advanced APM opportunities for clinicians, particularly specialists, are needed. Some recommended that CMS simplify and lower the financial-risk standards for Advanced APMs.

HealthCare.Gov Fiasco

The OIG report addresses the proverbial elephant in the room: the problems with the Healthcare.gov website during the Obamacare roll out. “HealthCare.gov was a really low moment for the agency, but it was a learning moment, which allowed us to learn the lessons of how to build new muscles [from the turnaround of] HealthCare.gov and apply them to the MACRA program,” said a candid CMS employee.

OIG says that CMS staff reported that they drew on experiences from HealthCare.gov to rethink the agency’s approach to launching complex initiatives such as the QPP. Like HealthCare.gov, the QPP requires coordination on policy, operational, and technological issues, as well as extensive collaboration across different components within CMS. In its report, OIG noted points at which CMS staff reported applying the lessons learned from HealthCare.gov to CMS’s management of the QPP.

Key Management Principles

From interviews with CMS leadership and staff and analysis of key documents, OIG identified CMS’ five key management priorities regarding the planning and early implementation of the QPP. These priorities include:

  • fostering clinician acceptance and readiness to participate;
  • adopting integrated internal business practices to accommodate a flexible, user-centric approach;
  • developing IT systems that support and streamline clinician participation;
  • developing flexible and transparent MIPS policies; and
  • facilitating participation in Advanced APMs.

Fostering Clinician Acceptance

The OIG found that CMS has taken a number of steps to foster clinician acceptance and readiness, including engaging clinicians and stakeholders, conducting user testing of the QPP Portal, establishing “Clinician Champions,” creating a transition year, and awarding contracts for education, support and technical assistance. Of the two vulnerabilities identified in the report, one is found within this management priority. The vulnerability relates to CMS ability to conduct outreach and provide technical assistance so that providers–especially solo, small-practice, and rural providers–have the information they need.

OIG writes: “If providers lack the knowledge, tools, or skills to participate, they will struggle to meet the QPP reporting requirements. Frustrated providers may even opt not to participate in the QPP despite the payment penalty, limiting the program’s ability to meet its goals.  To mitigate this risk, CMS must continue to monitor clinician readiness—especially as the first reporting deadline approaches—to identify and address any problems early on. CMS has begun its technical assistance and training efforts, but these activities must quickly be ramped up to full scale and continued throughout 2017 to support Medicare clinicians’ participation in the QPP.”

Adopting Integrated, Flexible Business Practices

As the OIG notes, implementing the QPP requires CMS to coordinate policy, technology, communications, and operations activities. Additionally, because the legacy programs on which the QPP is based are dispersed among various CMS components, staff with necessary expertise and experience are similarly dispersed. Staff working with many of the APMs, for example, report to the CMS Center for Medicare & Medicaid Innovation, while those involved in the Value-Based Payment Modifier program are located in the CMS Center for Medicare.

To address this logistical and organizational complexity, the report describes how CMS sought to learn from the problems of HealthCare.gov by adopting an integrated, flexible approach to both program management and IT development. To create this flexible management approach, CMS developed an overall QPP strategy, assigned executive leadership to each program component, established integrated project teams with shared office space, adopted agile IT development methods, adopted a new contracting approach, and awarded a systems integrator contract. According to the report, CMS is still planning on awarding additional contracts, expanding oversight of contractors, and hiring staff with expertise in agile development.

Developing IT Systems

Information technology is arguably CMS’ greatest challenge in the roll out. Front and center to CMS’ IT efforts is the QPP Portal. This portal will consist of three major components: a public-facing informational website, individualized accounts for clinicians, and backend systems necessary to receive and validate clinicians’ data, provide individualized performance feedback, calculate clinicians’ MIPS scores, and adjust Part B payments accordingly.   

QPP Portal

CMS launched the informational website in October 2016. However, CMS has yet to enable the individualized accounts or set up the backend systems. CMS staff have reported to OIG that individualized accounts will indeed be available in January 2017. These accounts will ultimately enable CMS to verify the user’s identity, inform clinicians of their eligibility for the Advanced APM track versus the MIPS track (so that clinicians know whether they must select and report MIPS measures), and provide individualized performance feedback.

OIG identified the development of the backend IT system as the second of the two vulnerabilities to the QPP’s roll out. OIG writes: “Building and testing the extensive IT systems necessary to support critical QPP operations will require significant and sustained effort over the forthcoming year. In the past, CMS has sometimes experienced delays and complications related to major IT initiatives, such as those required for the continued operation of Medicare Part D and HealthCare.gov. If the complex systems underlying the QPP are not operational on schedule, the program will struggle to meet its goal of improving value and quality.”

According to OIG, CMS plans to partially mitigate this risk by using the legacy systems for the existing reporting programs as a backup option for MIPS data submission.

Develop MIPS Policies

OIG noted that CMS was able to issue a final rule, including policies on MIPS, notwithstanding a challenging deadline and a massive number of public comments. OIG identified three future initiatives under this management priority, including issuing promised subregulatory guidance, finalizing policies for so-called “virtual groups,” and subsequent rulemaking in 2018 and beyond.

Facilitate Participation in Advanced APMs

OIG’s report identifies a number of steps that CMS has taken to address this management priority, including:

  • identifying which existing Medicare models meet criteria for Advanced APMs;
  • establishing policy for determining Qualifying APM Participants;
  • publishing the Final Rule, including Advanced APM policies for 2017; and
  • awarding contracts for technical assistance to prepare clinicians to participate in Advanced APMs.

The report lists a number of initiatives that remain, including determining which clinicians are Qualifying APM Participants, increasing Advanced APM opportunities, and increasing clinician participation in Advanced APMs over time.

Conclusion

This report is a mixed bag for CMS and stakeholders of the new QPP. On one hand, CMS is clearly trying to avoid the same kind of problems that impacted the ACA roll out. However, with such a massive undertaking, there are many vulnerabilities and it is not clear that CMS has the track record worth believing the agency’s promises to be ready. There will likely be technical challenges associated with the QPP and that may only further the calls to reform the program, especially with friendly staffers leading HHS and CMS in the Trump Administration.

December 12, 2016

Part Three: The Broader Impact of MACRA

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In part three of our MACRA series, we look at the broader implications of this rule on the healthcare world. We are especially interested in following what changes may occur with Republican control of both the White House and Congress.

Predictions: MACRA may be modified, but not scrapped

The election of President-elect Trump has many on the healthcare world wondering if there will be significant changes to MACRA. Much of the discussion has centered around the Affordable Care Act, but there is evidence that MACRA will not be repealed, although it could see some modifications. There is great speculation for the moment and we will keep you posted as developments continue.

As pointed out in Healthcare Finance, much of the conversation about MACRA changes centers around the Center for Medicare and Medicaid Innovation (CMMI). Although this was created as a part of the Affordable Care Act, it plays a significant role in the development of alternative payment models. Some analysts indicate that Congress may want to assert more control over CMMI and not provide it with as much authority to make payment changes. The biggest criticism of CMMI is that changes it make are not subjected to congressional approval. However, CMMI does give an administration tools to change payment and control spending without such approval, so there may be value in keeping CMMI.

The Healthcare Finance article suggests MACRA fits into a bipartisan reform landscape in general, since it repealed the sustainable growth rate and moved physicians towards performance-based payment, which has support on both sides of the aisle.

However, there are three major point the industry should focus on in the coming months. First is the scope of authority Congress wants to have over payment reform, something that could forecast whether CMMI survives. That is important for MACRA as the Center develops many of the programs that count as APMs within MACRA.

Second, the new Congress' view of ACOs in general will be telling. Third, it will crucial to see how much emphasis Congress places on performance-based penalties and bonuses. Will Congress look to achieve performance based payment by increasing the penalties and bonuses for quality performance?

On a related note, in a statement, the American Academy of Family Physicians said they do not believe MACRA as a whole is in any real danger of repeal.

Did CMS go too far in the final rule?

Despite bipartisan, bicameral support in Congress and backing from the much of the medical community, there were some questions raised by stakeholders after the release of the final rule. Earlier this year, Slavitt said the government needed to win back the "hearts and minds" of doctors soured on meaningful use and other reporting requirements. The new, slower ramp-up of MACRA reflects CMS’ effort to extend Medicare transformation beyond 2017, making economic reform a long-term program.

To some, this is a welcome pace, but it has been reported by other outlets that it, as Joe Antos of the American Enterprise Institute noted, “could be an opportunity; this could be a disaster … It’s hard to know.” Concerns were raised about MACRA turning into another failed program like the flawed Sustainable Growth Rate (SGR) that the law repeals, or similar to meaningful use and the PQRS/Value modifier programs.

Katherine Baicker, a professor of health economics in Harvard T.H. Chan School of Public Health's Department of Health Policy and Management, said that it was too soon to know if CMS' went too far in providing flexibility. "It could be a big step in the right direction, or it could be the next [Sustainable Growth Rate]," she said. The regulation also perpetuates Medicare's problems in quality programs by not providing timely feedback so doctors can pivot more quickly on problem areas, although CMS intends to try and shorten the feedback timeline. Right now, performance in 2017 is ultimately penalized or rewarded in 2019. It will be challenging without an astute eye to data metrics to understand best and worst practices  that result in rewards and penalties over a 2 year gap.

Will Congress intervene?

Upon release of the rule, Senate Finance Committee Chairman Orrin Hatch (R-Utah) issued the following statement, calling the final rule “an important step”:


“This Congress, Washington acted on what many thought was impossible and put meaningful and bipartisan Medicare reforms back on the books. Replacing the dysfunctional cycle of near annual patches for Medicare’s Sustainable Growth Rate (SGR) with an improved payment system rooted in smart policies that were debated and vetted by the Finance Committee has given beneficiaries peace of mind that they will have access to the care they need and deserve.

“Today’s rule marks another critical milestone in the implementation of this historic law. It demonstrates CMS’s continued commitment to working with American health care providers and reflects the shared goal of allowing doctors and medical centers to shift to the new payment system by participating in the reforms at their own pace, helping to lay the groundwork for a successful transition in 2017.

“While the rule must be carefully studied and examined in its entirety, this is an important step forward in the process. I hope CMS will continue to maintain a robust dialogue with Congress, Medicare beneficiaries, and the health care community as a whole to ensure the proper implementation of this critical program.”

This tepid, but supportive statement did not stop the GOP doctors caucus from dissenting, as reported by Medical Economics. The article notes:

The 18-member GOP Doctors Caucus is reviewing the final rule. “If the final rule is not satisfactory, the Doctors Caucus will look at a possible legislative fix. Our top priority is getting this right for patients and practitioners,” Rep. Phil Roe, MD, tells Medical Economics. A co-chair of the caucus, Roe represents Tennessee’s first district.

In response, CMS Acting Administrator Andy Slavitt told Medical Economics the agency worked closely with the Republican group and other physicians in crafting the final rule. “I’ll leave legislating to Congress because that’s what they do,” Slavitt says. “If I was a physician, I wouldn’t sit back and think, ‘Maybe there will be legislation to change things,’ however.”

Rep. John Fleming, MD, of Louisiana’s Fourth District, the caucus’s other co-chair, says MACRA and its reporting requirements are likely to frustrate doctors who would prefer to spend their time caring for patients rather than reporting on quality measures. If the final rule is too onerous for physicians to meet requirements, especially through the law’s Merit-based Incentive Payment System (MIPS) where most small practices will fall in 2017, Fleming is concerned many physicians may opt for direct-pay practice models and eliminate Medicare patients from their panels.

Both Roe and Fleming voted for MACRA because it replaced the never implemented and universally unpopular sustainable growth rate formula. But when CMS wrote the proposed rules to implement MACRA, those writing the rules made the law more complex, Fleming says. 

That complexity is likely to cause physicians to stop accepting Medicare patients, he told Medical Economics. “The bottom line is you have more and more doctors saying, ‘We can’t even figure out this rule,’” says Fleming, a primary care physician running for the U.S. Senate this year. “For my employees, it just seems like we have to do more and get paid less.”

MIPS may force physicians to spend less time with patients, he says, because they would need to devote so much effort to monitoring and reporting their performance in order to achieve MIPS’ quality goals. Even small physician groups of 10 or fewer would need to expend limited resources to monitor their performance on more than 20 measures, he added.

Are the MACRA regulations legal?

Lou Kartsonis is an ophthalmologist in San Diego, also writing in Medical Economics, goes one step further. Speaking for many physicians unhappy with the premises that underpin the MACRA law, he questions the legality of the effort. Specifically:

“In the transition from fee-for-service to pay-for-performance, one question that has not been asked is whether MACRA is legal. The Medicare law was passed in 1965 with the stipulation that government would not interfere with the practice of medicine.” The relevant clause, titled “Prohibition Against Any Federal Interference,” reads as follows:

Section 1801. Nothing in this title shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

“MACRA, with all of its distractions and fool’s errands, not only interferes with the way we practice, but threatens our compensation if we don’t get with the program,” he writes.

“This is a flagrant violation of the Medicare law. So why isn’t the medical establishment challenging the legality of this morass? If this were any other constituency—lawyers, cops, teachers, labor unions—a challenge would be filed in federal court and their lobbyists would be knocking doors down all over Capitol Hill.”

Industry response

Collecting an array of industry feedback, the consensus is a mostly positive response to the CMS final rule.

American Medical Association

The American Medical Association issued the following statement:

“The AMA acknowledges the commitment by Acting Administrator Andrew Slavitt and his senior team at CMS for listening to physician concerns and taking several concrete steps to help them adjust to this new Medicare payment framework,” said AMA President Andrew W. Gurman, MD. “By announcing the ‘Pick Your Pace’ approach to give physicians greater flexibility and increased options for participating in MACRA in 2017, HHS Secretary Burwell and Acting Administrator Slavitt took a significant step last month to address AMA concerns about the original proposal. The final rule includes additional steps to help small and rural practices by raising the low volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements.

“Our initial review indicates that CMS has been responsive to many of the concerns raised by the AMA, and in the days ahead, the AMA will conduct a comprehensive review of the final rule to ensure that it promotes flexibility and innovation in the delivery of care to help meet the unique needs of all patients. With the flawed Sustainable Growth Rate (SGR) formula – and its annual threat of steep payment cuts – permanently eliminated, the new law gives many physicians the opportunity to be rewarded for the improvements they make to their practices and for delivering high-quality, high-value care to Medicare patients.”

The American Academy of Family Physicians

“The final rule addresses many of the concerns family physicians have expressed about the complexity of the program, the pace of implementation, new administrative burdens and the usability of technology," AAFP President John Meigs, M.D., of Centreville, Ala., said in a statement.

"In particular, we are pleased that practices with low volumes of Medicare Part B patients are excluded in the first year and that family physicians will be able to move toward full participation without suffering penalties that will slow their progress," he added.

Burwell asserted that implementation of the Quality Payment Program would "strengthen our health care system for patients, clinicians and the American taxpayer."

CMS Acting Administrator Andy Slavitt pointed to the rule's built-in flexibility aimed at allowing physicians to work at their own pace.

"Today's policies are designed to get all eligible clinicians to participate in the program so they are set up for successful care delivery as the program matures," he said in the HHS news release.

American Hospital Association

Tom Nickels, executive vice president for Government Relations and Public Policy for the American Hospital Association, released the following statement:

“Today's final Medicare Access & CHIP Reauthorization Act of 2015 (MACRA) rule presents challenges and opportunities for hospitals and health systems, and the nearly 540,000 directly employed or contracted physicians with whom they partner to deliver quality care.

“While we are disappointed that CMS continues to narrowly define advanced alternative payment models (APMs), which means that less than 10 percent of clinicians will be rewarded for their care transformation efforts, we are encouraged that CMS is exploring a new option that would expand the available advanced APMs that qualify for incentives. We urge CMS to ensure that this option be available in 2017 and look forward to working with them so this new model achieves an appropriate balance between risk and reward.

“We are pleased that CMS has provided clinicians with increased flexibility to meet MACRA's aggressive timelines and reporting requirements. By allowing them to "pick their pace," clinicians in a variety of settings will be able to more easily transition to the new program. Furthermore, CMS's final measures for the advancing care information category of the Merit-based Incentive Payment System (MIPS) offer some welcome relief from the overly aggressive initial proposal.

“At the same time, the AHA remains concerned that the lack of sociodemographic adjustment to the measures used in the MIPS will unfairly disadvantage clinicians and hospitals caring for the poorest patients. Opportunities also remain to further align hospital and clinician performance measurement, and we will work with the agency to make that happen.

“We continue to review the details of the final rule and will provide guidance to hospitals and their clinician partners. As implementation moves forward, we remain committed to making sure patients benefit from the transformation of care envisioned by MACRA.”

As reported by HealthData Management, several other groups issued statements:

Medical Group Management Association

“MGMA is pleased with the significant burden reduction for physician practices in the first year of the MIPs program and new alternative payment model options outlined in the final rule. It’s disappointing that flexibility provided for quality reporting in 2017 largely disappears in 2018 and beyond. The Centers for Medicare and Medicaid Services missed an opportunity to close the two-year gap between the measurement and payment periods, which would facilitate improved patient care by providing actionable feedback to physicians and more timely incentives. The sheer magnitude of a 2,400-page regulation and its impact on physician practices can’t be ignored.”

American Medical Informatics Association

“CMS has crafted a set of policies that are strategic, flexible and reflective of feedback from the informatics community. AMIA recommended that CMS provide physicians with an on-ramp to participation in 2017 and they have responded with a strategy that will do just that. Beginning with a much-needed ‘transition year’ for participation and inclusive of an across-the-board reduction in scope, this final rule with comment period will ensure that success is within reach of every eligible clinician.”

Premier

“Members of the Premier alliance strongly support the potential of the Quality Payment Program under the Centers for Medicare & Medicaid Services (CMS) Medicare Access and CHIP Reauthorization Act (MACRA) to help fix the misaligned incentives in Medicare’s traditional fee-for-service program. Premier is an ardent supporter of a transition away from fee-for-service and toward a model where providers are accountable and rewarded for high-quality, cost-effective care. CMS wisely allowed a gradual transition to this pay for performance reality, striking a good balance overall.

“While we are pleased that CMS eased the policy defining the Advanced APM to allow additional programs to qualify and has signaled it will increase the number of available models, the nominal risk standard remains way too high. As we have learned from members in our Bundled Payment and Population Health Management Collaboratives, these models require significant investment in redesigning care through new technologies, data analytics, and additional staff. CMS has chosen to ignore these realities. We call on CMS to rethink this risk standard in future rules to incent greater participation. We also call on CMS to accelerate recognition of ‘virtual’ physician groups that would allow small practices to band together using technology to meet the minimum thresholds and comply with reporting requirements.

“CMS did the right thing by creating an accelerated timeline for determining whether clinicians meet the standards for the Advanced Alternative Payment Model (Advanced APM) before the end of the Merit-based Incentive Payment System (MIPS) performance period. This mitigates the uncertainty and added administrative work for ACOs and other organizations who otherwise would have reported through MIPS in the absence of certainty about whether they met the Advanced APM thresholds.”

CHIME

“While we are still reviewing the 2,400-page rule, the Centers for Medicare and Medicaid Services today seemed to take important steps in giving physicians much-needed flexibility for adopting health information technology as they transition to a new payment model. For instance, the final rule reduces the reporting burden on clinicians by giving them the option of a 90-day reporting period, or a full year. It also reduces the number of measures upon which clinicians must report.

“Unfortunately, CMS appears to have retained stringent language requiring hospitals and clinicians to attest that they are not engaging in information blocking. The agency does, however, clarify that providers ‘should not be held responsible for adherence to health IT certification standards or other technical details of health IT implementation that are beyond their expertise or control.’

“Meanwhile, the Office of the National Coordinator for Health IT today finalized a rule covering certification and oversight of certified health information technology. CHIME appreciates that steps that the agency is taking to increase transparency of health IT performance. Hospitals and clinicians must have confidence that the products they purchase work as intended and do not pose a significant risk to patient safety or public health.”

Conclusion

This MACRA final rule is the start of a long journey in Medicare fee-for service payment reform, brought about by rare bipartisan Congressional compromise legislation based on the common understanding that for Medicare to achieve long-term sustainability, volume-based incentives need to be replaced with rewards for quality and patient-centered care. To come in future years are more rigorous targets, including scoring for cost performance with CMS providing clinical feedback to clinicians on their reported performance. We especially note the importance of MACRA for manufacturers, as APMs and MIPS will increasingly influence care patterns in favor of treatments that improve downstream clinical, financial and patient-reported outcomes. Industry can help physicians understand the programs, their options and how their products fit into the value equation.

December 05, 2016

Part Two: MACRA More MIPS, and APMs

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In part two of our MACRA analysis, we continue our look at MIPS and evaluate the APM pathway of MACRA’s new quality payment program.

Small Practice Considerations

Exemption

Key finalized policies include a small practice-friendly low volume threshold. In 2017, the threshold has been set at “less than or equal to $30,000 in Medicare Part B allowed charges or less than or equal to 100 Medicare patients.” CMS says this new threshold represents 32.5 percent of Medicare clinicians but only 5 percent Medicare Part B spending.

CMS says that the new flexibilities from the final rule lessen the impact on small and solo practices. CMS says “we believe that small and solo practices will respond to MIPS by participating at a rate close to that of other practice sizes.” CMS estimates each practice size will achieve either an 80 percent or 90 percent participation rate, and that at least 80 percent of clinicians in small practices will receive a positive or neutral adjustment.

Virtual Groups

MACRA allows solo and small practices to join “virtual groups” to combine their MIPS reporting. Many commenters asked CMS to allow groups with more than 10 clinicians to participate as virtual groups, even though the statute limits virtual groups to groups of not more than 10 clinicians. CMS notes that it is not implementing virtual groups in the first year of the program, and that it believes it has addressed some of the concerns expressed by clinicians hesitant to participate in the Quality Payment Program. It left the question open and said it would work with stakeholders on how it would structure and implement virtual groups going forward.

In a letter signed by Robert Horne, Executive Director of Health IT Now addressed stakeholder concern over virtual groups. Dated October 17, 2016, the group wrote to CMS:

“There is growing recognition among lawmakers and the public that implementation of the MACRA statute will be challenging for both physicians and CMS. Establishment of virtual group reporting options appear no different. We recognize that part of the problem may lie with the CMS legacy IT system, which some suggest are incapable of performing many functions that are commonplace among IT systems today. While we believe it imperative that Congress work with the administration to identify ways that the CMS computer systems can be updated to increase Medicare’s efficiency and reduce costs, we do not believe such a barrier need impact the effectiveness of the virtual group concept. Rather, we believe that the solution can be found in closer collaboration with health IT industry leaders.

“Many members of Health IT Now (HITN), and the health IT community more generally, have platforms and expertise in technology solutions that could facilitate provider engagement in virtual groups, performance feedback in real-time, and other solutions that might better prepare providers to meaningfully engage in APMs. We want to collaborate more closely with CMS to put such ideas into practice.

“We encourage CMS to establish a virtual group reporting option, or at the very least begin laying the foundation for such an option, as soon as possible. There is ample public support for such a move, as demonstrated by comments on the proposed rule from various stakeholders. HITN has a number of ideas on how to accomplish this lofty goal, and stands ready to support your efforts.”

Problems for IT vendors

Beginning in 2018, physicians must use EHR technology that is certified for 2015 instead of 2014. That could be a problem, since more than 75% of the providers participating in the Medicare EHR Incentive Program as of July had 2014-certified edition technology, according to the Office of the National Coordinator for Health Information Technology, which establishes the certification criteria. This, as reported by Modern Healthcare, could be burdensome on smaller EHR vendors.

According to Corinne Proctor Boudreau, senior manager of marketing for physician experience at Meditech, a Westwood, Mass.-based developer of hospital and physician EHRs, under the meaningful-use program, “you have seen some of those smaller vendors not be able to make those requirements. But this is the direction the industry has been going in. It's a little bit the cost of doing business,” Boudreau said.

“This situation is unfortunate for providers who have invested in an EHR that does not acclimate to agile change at scale,” but it's not an issue for others, including athenahealth. According to a statement from Allison LaValley, executive director for quality performance and value-based care at athenahealth, “As a cloud-based network, we are very nimble and can adapt not just to MACRA but to anything the government throws forward.”

However, as noted by others in the industry, the rule did make concessions to the health IT community. EHR testing and certification launched in 2006 under the Office of National Coordinator for Health IT (ONC).  Since that time and accelerated by the Meaningful Use programs, there has been an ongoing narrowing of EHR vendors leaving healthcare providers to comtemplate a “rip and replace” IT strategy. Advancing Care Information (ACI) will not take an all-or-nothing approach to EHR requirements, especially since the final rule reduced the total number of required measures to five, ultimatley down from 18 under stage 2 meaningful use. The five ACI requirements include basic measures:

  • Security risk analysis,
  • e-Prescribing,
  • Providing patient access,
  • Sending a summary of care, and
  • Requesting and accepting a summary of care.

The rule also no longer requires reporting on measures for clinical decision support and computerized provider order entry.  The reduction was designed to ease the burden on providers and allow the EHR industry to address issues of usability and interoperability.

Arguably, CMS “reduced the number of measures … but the measures you do have to meet are predicated on interoperability,” which is often outside the control of the physician, said Mari Savickis, vice president of federal affairs at the College of Healthcare Information Management Executives, an association of chief information officers at hospitals and health systems. Yet Boudreau points out that interoperability-related measures such as sending and receiving a summary of care through EHRs “have been out there for a while for physicians that have been (participating in) meaningful use.” She supports the idea that the reduction in required measures under MACRA gives vendors some “breathing room” to develop certain tech capabilities. LaValley said vendors such as athenahealth have “skin in the game” regarding their clients' success under MACRA. More importantly, "the industry is rife with EHRs that are not architected to enable cross-continuum care coordination and connectedness, which is critical to long-term MACRA success.”

MIPS APMs

MIPS APM provides participants a pathway improve their MIPS scores through APMs that do not meet criteria to be Advanced APMs or do not meet the revenue or patient thresholds to be exempt from MIPS. Potentially included in these MIPS APMs, Medicare Shared Savings Program and Next Generation ACOs would report MIPS quality measures on behalf of their participants; and, the CPIA and ACI performance categories will be reweighted to 20 percent and 80 percent respectively. Non-ACO MIPS APM participants will have their quality score reweighted to zero for the 2017 performance period and the CPIA and ACI performance categories will be reweighted to 25 percent and 75 percent respectively.

Each year, CMS will compare the requirements of recognized APMs with the list of Improvement Activities and score those measures in the same manner they are otherwise scored for MIPS eligible clinicians. Prior to the start of each performance period, CMS will publish a list of the pre-assigned Improvement Activities score for each MIPS APM. In the event that the assigned score does not represent the maximum Improvement Activities score, APM Entities will have the opportunity to report additional Improvement Activities.

General thoughts on changes made by CMS in final MIPS rule

As pointed out in an article at Healthcare Informatics, John Goodson, M.D., staff internist at Massachusetts General Hospital and associate professor at Harvard Medical School, believes CMS’ decision to modify reporting measures and timelines in the final rule serves as a “strategic movie” to get more physicians invested in the program. Many physicians did not participate in PQRS, and Goodson noted that the reporting required in MACRA’s Quality Payment Program will necessitate good, solid data which CMS will never get unless they get doctors to buy into the reporting mechanisms. As such, the pathways laid out by the federal agency are attempts to at the least, get the community of providers engaged at a minor level, Goodson says.

Additionally, much of MACRA is already in law because of what has been spelled out by through bipartisan, bicameral Congressional efforts. Goodson does not think Congress will readdress the program right now and wants to see how it plays out. At some point physicians will have to make the choice between staying in Medicare or getting out. “There is a fear that this whole system will implode because doctors won’t want to play this game anymore. They think it’s too demanding and crazy.” However, Goodson believes that in the end, most providers want to partake in Medicare, and the key will be to be able to obtain the meaningful data that these programs under MACRA will inevitably require.

However, “getting out of Medicare” is a flawed strategy and here’s why.  MACRA has accelerated a growing industry trend towards APM contracting across the payer system at large.  For example, in Aug. 2016 UnitedHealth paid $148 million in performance-base bonuses to almost 1,900 primary care physicians.  37 Blue plans have over 350 value-based programs spanning 49 states, D.C., and Puerto Rico impacting more than 215,000 providers, including 237 ACO contracts with over 93,000 participating physicians.  As states privatize Medicaid through managed care contracting, value-based payment design is an increasing requirement.

Regarding smaller practices, Goodson believes they have more equity in their patient panel, leading to good will and trust, which is the way to save money in healthcare, he says. “Trust allows you to use time as a diagnostic tool and a therapeutic intervention. So if you’re close to your patients, live in the community, and have a relationship with them, you can be a high quality, low cost provider.” Goodson adds that the key thing for these small practices is to have complete control over their data. This means that they know exactly who their patients are, what their problems and medications are, and what all their diagnostic codes are, so every single thing that has been identified as a problem with the patient maps to an ICD code.

Given the growing role of data and measurement in a provider’s economic future, codified data capture within the encounter note, diagnostic results and pharmacologic therapies offer strength in positioning for future requirements.  Many of the larger EHR products map to a growing plethora of coded nomenclatures such as SNOMED, LOINC and NDC.

However, there is a risk the system could be “gamed,” by which a physician practices self-selection and reports only those measures in which they do well while not truly striving for improvements in care. This is particularly pronounced around attribution of patients to the physician and risk adjustment which have not been fully addressed by CMS. Goodson is quoted asking, “How will we as providers know who we are responsible for and held accountable for?” And for risk adjustment, he notes, “People worry so much about cherry picking, so if I deal with a complicated group of patients, will I be judged against someone who selects a much less demanding group of patients? If that happens, if people figure out how to cherry pick the system, things could start to melt down,” Goodson speculates.

Advanced Alternative Payment Models

Clinicians are exempt from MIPS and eligible for up to a five percent bonus payment through calendar year 2024 if they receive a sufficient portion of their payments or see a sufficient portion of their patients through an Advanced APM. These clinicians are referred to as APM Qualified Participants or “QPs.”

In step with MACRA legislative requirements, APMs seeking to qualify as an Advanced APM must meet what CMS describes as “ambitious but achievable goals,” including:

  • The use of certified EHR technology;
  • Payment for covered professional services based on quality measures comparable to those in MIPS’ quality performance category; and
  • Either (a) the bearing of downside financial risk in excess of a nominal amount or (b) being a nationally recognized accredited patient-centered medical home, expanded under section 1115A(c) of the Social Security Act.

Under the finalized nominal risk standard, APMs could qualify as Advanced APMs if the total annual amount that an APM Entity potentially owes CMS or foregoes is equal to at least:

  • For QP Performance Periods in 2017 and 2018, eight percent of the average estimated total Medicare Parts A and B revenues of participating APM Entities (the “revenue-based standard”); or,
  • For all QP Performance Periods, three percent (down from four percent as proposed) of the expected expenditures for which an APM Entity is responsible under the APM (the “benchmark-based standard”).

Physicians should be aware that they must have at least 25% of their Medicare Part B services or at least 20% of their Medicare Part B patients attributed to the APM to individually qualify for the 5% bonus payment. Nearly every primary care physician in an ACO model will easily push past these thresholds, but specialists and physicians in other models should be wary of this provision especially as it ramps up to 50% and 35% respectively in 2021 (reporting year 2019) and all the way to 75 and 50% in 2023 (reporting year 2021).

CMS understands that widespread clinician participation in Advanced APMs is unlikely, estimating a participation rate in the transition year of only 70,000 and 120,000 clinicians. CMS is clearly interested in encouraging clinician participation in APMs, as evidenced by the planned introduction of MIPS APMs and the ACO Track 1+ model.

Physician-Focused Payment Models

As for Physician-Focused Payment Models (PFPMs), the final rule expanded the definition of PFPM to include practitioners other than physicians. Payment models can target the quality and costs of services that other practitioners provide, order, or significantly influence, rather than just physician services. CMS proposed that in carrying out its review of PFPMs, the Physician-Focused Payment Model Technical Advisory Committee (PTAC, pronounced “P-tack”) shall assess whether the PFPM meets the following criteria:

  1. Incentives: Pay for Higher-Value Care
  • Value Over Volume: Provide incentives to practitioners to deliver high-quality healthcare.
  • Flexibility: Provide the flexibility needed for practitioners to deliver high-quality healthcare.
  • Payment Methodology: Pay APM Entities with a payment methodology designed to achieve the goals of the PFPM criteria. Addresses in detail through this methodology how Medicare and other payers, if applicable, pay APM Entities, how the payment methodology differs from current payment methodologies and why the Physician-Focused Payment Model cannot be tested under current payment methodologies.
  • Scope: Aim to either directly address an issue in payment policy that broadens and expands the CMS APM portfolio or include APM Entities whose opportunities to participate in APMs have been limited.
  • Ability to Be Evaluated: Have evaluable goals for quality of care, cost and any other goals of the PFPM.
  1. Care Delivery Improvements: Promote Better Care Coordination, Protect Patient Safety and Encourage Patient Engagement
  • Integration and Care Coordination: Encourage greater integration and care coordination among practitioners and across settings where multiple practitioners or settings are relevant to delivering care to the population treated under the PFPM.
  • Patient Choice: Encourage greater attention to the health of the population served while also supporting the unique needs and preferences of individual patients.
  • Patient Safety: Aim to maintain or improve standards of patient safety.
  1. Information Enhancements: Improving the Availability of Information to Guide Decision-Making
  • Health Information Technology: Encourage use of health information technology to inform care.

CMS is finalizing its proposed criteria for PFPMs with one modification: broadening the proposed scope criterion. The final scope criterion now requires that PFPMs aim to broaden or expand the CMS APM portfolio by addressing an issue in payment policy in a new way or including APM Entities whose opportunities to participate in APMs have been limited. What does all this mean? PTAC is an official 11-member federal advisory committee on APM payment innovation. While PTAC does not have the authority to approve a provider or community’s alternative payment model as qualifying for the advanced APM payment track, it does have the ability to make recommendations along those lines including whether the APM needs refinement, piloting, additional study and/or implementation. 

CMS initiative: “Reducing medical record review for clinicians participating in certain Advanced Alternative Payment Models”

Responding to concerns of excess paperwork burdens on physician practices, CMS recently launched an initiative that intends to allow physicians to spend more time on patient care and less time on paperwork. A recent study that was sponsored by the AMA found that for every hour physicians spend providing clinical care to patients, they spend two hours on administrative tasks. Another study found physician frustrations run so high that more than half of the doctors in a national survey have considered leaving the profession, with many saying they want to spend more time with patients and less with electronic health records.

As a first step, CMS announced a medical review reduction program to ease the reporting burden for physicians. This 18-month pilot program will relieve doctors who participate in specified advanced alternative payment models (APMs) from additional scrutiny under certain Medicare medical review programs, CMS said. Seeking aligned incentives, the agency identified APMs for the pilot with participating clinicians who shared financial risk with the Medicare program, specifically:

  • Next Generation ACOs,
  • Medicare Shared Savings Program ACOs – Tracks 2 and 3,
  • Pioneer ACOs, and
  • Oncology Care Model 2-side Track participants

The pilot program is part of a broader initiative seeking to boost engagement among clinicians and combat provider alienation driven by economic reform. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do--taking care of patients,” said CMS Acting Administrator Andrew Slavitt, in announcing the program. CMS said it will analyze results of the pilot program and consider expansion of the program to additional APMs, specialties and provider types. For more details about the pilot program, physicians can find a fact sheet on the initiative.

Do you need to know where your APM lands in the MACRA payment effort?  CMS published the following chart to outline current Advanced APMs and MIPS APMs, based on the criteria outlined in the final rule:

2017 APM List Based on Final Criteria

APM

MIPS APM under  the APM Scoring Standard

Medical Home  Model

Use of CEHRT Criterion

Quality Measures Criterion

Financial Risk Criterion

Advanced

APM

Accountable Health

Communities (AHC)

no

no

no

no

no

no

ACO Investment Model

(AIM)

no

no

no

no

no

no

Bundled Payment for

Care Improvement

Model  2 (BPCI)

no

no

no

no

YES

no

Bundled Payment for

Care Improvement

Model  3 (BPCI)

no

no

no

no

YES

no

Bundled Payment for

Care Improvement

Model  4 (BPCI)

no

no

no

no

YES

no

Comprehensive Care for

Joint Replacement

(non-CEHRT)

no

no

no

YES

YES

no

Comprehensive ESRD Care (CEC) Model  (LDO

arrangement)

YES

no

YES

YES

YES

YES

Comprehensive ESRD Care (CEC) Model  (non- LDO two-sided risk

arrangement)

YES

no

YES

YES

YES

YES

Comprehensive ESRD Care (CEC) Model  (non- LDO arrangement one-

sided risk arrangement)

YES

no

YES

YES

no

no

Comprehensive Primary

Care Plus (CPC +) Model

YES

YES

YES

YES

YES

YES

Financial Alignment

Initiative1

N/A

N/A

N/A

N/A

N/A

N/A

Frontier Community Health Integration Program (FCHIP)

no

no

no

no

no

no

1This table reflects the design of the Financial Alignment Initiative agreements between CMS and state and health plan participants.  CMS will assess agreements between states or health plans and health care providers under the All-Payer Combination Option.

APM

MIPS APM under  the APM Scoring Standard

Medical Home  Model

Use of CEHRT Criterion

Quality Measures Criterion

Financial Risk Criterion

Advanced

APM

Oncology  Care Model

(OCM) (two-sided risk arrangement)

YES

no

YES

YES

YES

YES

Prior Authorization: Repetitive Scheduled  Non-Emergent

Ambulance Transport

no

no

no

no

no

no

Prior Authorization: Non- Emergent Hyperbaric Oxygen Therapy Model

no

no

no

no

no

no

Initiative to Reduce Preventable Hospitalization Among Nursing Home Residents:

Phase 2

no

no

no

no

no

no

State Innovation

Models—Round 2 (SIM

2)2

N/A

N/A

N/A

N/A

N/A

N/A

Strong Start For Mothers

And Newborns

no

no

no

YES

no

no

Transforming Clinical

Practice Initiative (TCPI)

no

no

no

no

no

no

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