Life Science Compliance Update

February 13, 2018

OIG Releases Review of QPP


The Office of the Inspector General (OIG) released a review of the Quality Payment Program (QPP), concluding CMS has made progress towards implementing the QPP, but challenges remain. CMS appears on track to deploy the IT systems needed for data submission but the OIG has identified two vulnerabilities that are critical for CMS to address in 2018 because of their potential impact on the program's success.

OIG Study

According to the OIG, it interviewed CMS staff and reviewed internal CMS documents as well as publicly available information. The OIG conducted qualitative analysis to identify key milestones (both those achieved and those yet to come), priorities, and challenges related to QPP implementation.

In 2016, OIG conducted an early implementation review of CMS’s management of the QPP. It found that CMS had made significant progress towards implementing the QPP, including fostering clinician acceptance, adopting integrated business practices, building IT systems, and developing key program policies.

However, the review also identified two potential vulnerabilities that were critical for CMS to address in 2017 because of their potential impact on the program’s success: (1) Completing information technology systems to support critical QPP functions. In the past, CMS has experienced delays and complications related to major information technology (IT) initiatives. If CMS does not complete the complex IT systems underlying the QPP on schedule, implementation of quality-based payment adjustments may be delayed. (2) Ensuring clinician readiness to participate in the QPP. If clinicians lack sufficient information and assistance, they may struggle to meet QPP reporting requirements or choose not to participate at all.

The OIG’s objectives in this follow-up review were to assess CMS’s progress in mitigating these potential vulnerabilities and to identify emerging challenges. If CMS fails to sufficiently address these issues, the QPP may be unable to achieve its goal of promoting high-value care and patient outcomes while minimizing burden on clinicians.

Large IT System Necessary to Support QPP

As described by the OIG, building the IT systems to support the QPP is a significant undertaking for CMS, requiring both public-facing products (e.g., an interface for data submission) and back-end systems (e.g., a module to calculate MIPS final scores). These complex systems must be completed on schedule so that key elements of the program, such as data submission, can occur according to the timeframe specified in statute and regulation. The IT systems for the QPP encompass the following six products:

  • The platform is the infrastructure that underlies and supports all of the other QPP products. It ensures that various development efforts are coordinated and employ common methods.
  • The website is the central site where all clinicians, their partners, and developers interested in interacting with the QPP come to perform tasks. Ultimately, it will include both public webpages with general information and other pages where individual users can access secure, authenticated accounts providing QPP performance information.
  • The eligibility product uses CMS data sources to determine clinicians’ eligibility for the QPP (i.e., whether they are required to participate to avoid a negative payment adjustment), including whether they are qualified to participate under the MIPS track or the Advanced APM track.
  • The data submission product enables clinicians, as well as other staff or vendors authorized to provide data on their behalf (e.g., office administrators, registries), to submit MIPS data to CMS. CMS will support a variety of submission mechanisms.
  • The scoring product will enable CMS to calculate each clinician’s final MIPS score based on the data submitted. These scores will also be used to determine the payment adjustment that each MIPS clinician will receive in 2019.
  • The feedback product will produce individualized reports providing clinicians with information about their performance, including their respective final MIPS scores and payment adjustments.

In its assessment, the OIG states, “IT development appears on track to deploy all products necessary for data submission to begin on January 1, 2018.” This is good news for CMS, as the first vulnerability described by the OIG is related to the agency’s IT systems. Specifically: “If clinicians do not receive sufficient information and assistance, they may struggle to succeed under the QPP or choose not to participate. This is of particular concern for small practices and clinicians in rural or medically underserved areas, who may lack the resources to fully engage in the QPP without customized technical assistance to meet practice-specific needs,” says the OIG.

Clinician Readiness for QPP

As described by the OIG, CMS officials have consistently stated that clinicians’ acceptance of and readiness to participate is crucial to the program’s success. For 2017—the program’s first performance period—CMS set a goal of 90 percent participation in QPP. To reach this goal, CMS has used multiple channels to educate clinicians, provide technical assistance, and collect feedback. For example, CMS held numerous webinars and other events; issued subregulatory guidance; and established a Service Center to respond to questions and resolve problems. CMS also awarded a variety of contracts to provide technical assistance specific to clinicians’ practice types and needs.

Through these efforts, CMS has raised awareness of the QPP, and a majority of eligible clinicians have reported to CMS that they intend to participate. CMS staff said that because the QPP was an entirely new initiative, it was necessary for early outreach efforts to focus on general education and awareness. However, CMS staff report that as QPP implementation continues, a greater focus on specialized, practice-specific technical assistance will be needed to help clinicians fully participate in the new program.

This results in the second vulnerability outlined by the OIG. If clinicians do not receive sufficient technical assistance, they may struggle to succeed under the QPP or choose not to participate. According to clinician feedback collected by CMS demonstrates widespread basic awareness of the QPP, but also indicates uncertainty regarding details of participation such as who must report and how to submit data.

Further, to date, CMS contractors have focused largely on general education initiatives, with fewer resources devoted to more customized, practice-specific technical assistance. CMS needs to continue to assess progress and increase the proportion of contractors’ efforts devoted to specialized technical assistance to support high levels of clinician participation. Small practices and clinicians in rural or medically underserved areas, who may have fewer administrative resources and less experience with prior CMS quality programs, should be prioritized for assistance, according to the OIG.

January 18, 2018

Study Highlights Physician QPP Preparedness


Fewer than one in four physicians feel they are prepared to meet requirements under the CMS’ Quality Payment Program (QPP), a new American Medical Association and KPMG survey shows. Out of 1,000 physicians involved in practicing decision-making related to the QPP, only 8% said they were “deeply knowledgeable” about MACRA and QPP. In contrast, almost 92% said they were “somewhat knowledgeable” or not knowledgeable. All of this spells danger for the new program as CMS struggles to inform physicians about the new requirements even as a performance year has almost already been completed.

Study Results

According to the study, 7 in 10 respondents had in fact begun preparing to meet the requirements of the QPP for 2017. Nearly 9 in 10 feel somewhat prepared or well prepared to meet the low-bar requirements set forth by CMS in the first year. Of those participating in the MIPS track of QPP, only 65% felt prepared to meet the requirements, indicating that alternative payment model members have a higher likelihood of feeling prepared. Additionally, of those participating in MIPS, 90% felt the requirements are slightly or very burdensome, with over half responding they were at the higher level of burden.

Respondents to the survey indicated the reporting time required to comply is the most significant challenge and suggest it will be one in future years. Respondents also struggled to understand requirements like MIPS scoring and the cost of reporting.

Previous programs like PQRS and the VBPM contributed to the level of readiness for QPP. The legacy programs set up physicians to be more successful than those with no experience with them. Only 25% of physicians with prior reporting experience felt well prepared for the QPP, however.

An interesting finding in the study is that even among those who feel prepared, they do not fully understand the total impact of the QPP. While they may be prepared to check boxes and complete forms, they lack “long-term strategic financial vision to success in 2018 and beyond.” Only 8% of respondents feel they are very prepared for long-term success with 26% feel not prepared at all.

Findings Support Number of Assumptions About QPP

According to the study, its results confirm assumptions that are widely held regarding physician knowledge and preparedness for QPP requirements:

  • Some challenges are universal regardless of practice size, specialty, or previous value-based payment experience, particularly the time required and the complexity of reporting.
  • Physicians, especially in small practices, need more help to prepare.
  • Physicians want more alternative payment models available to them.
  • Physicians with value-based payment reporting experience are more confident about their preparedness regarding performance under MIPS.
  • Physicians remain deeply concerned about the long-term financial ramifications of the QPP.

December 28, 2017

In Depth Review of CMS MACRA QPP Regulations


As we continue our coverage of the MACRA Quality Payment Program (QPP) rule, the following article provides a more in-depth look at the regulations promulgated by CMS. We drafted an initial summary when the rule was released in early November.

Biggest surprise: cost category of MIPS

In its proposed rule in July 2017, CMS proposed completely removing the cost domain from MIPS for 2018, despite the underlying statute requiring that cost account for 30% of the overall MIPS score by 2019. However, in the final rule, CMS shocked many when it reversed its position and finalized a cost domain weight of 10 percent for the 2018 performance year.

As described in Health Affairs, by incorporating cost measures for 2018, CMS has created several new “facts on the ground” for health care providers:

  • The cost domain will be the major differentiating factor among clinicians in MIPS over time, and CMS’s inclusion of cost in the 2018 performance period signals that the administration supports using cost as a measure of value and to determine MIPS payment adjustments.
  • Clinicians have little power to influence the total cost of care for their patients when acting alone. Only teams including support staff like care coordinators, dietitians, pharmacists, social workers, and others working together across care settings—with appropriate financial incentives—will reduce costs and improve quality. The cost domain confuses clinicians and provides a wildcard for most practices with less than 200 doctors who have no experience managing cost metrics (see visualization below).
  • Despite significant confusion and hope that a new administration would delay or undercut payment reform and MACRA, it is moving ahead quickly, and payments to physicians will be adjusted based on MIPS performance.

Virtual groups

Any individual MIPS eligible clinician or a group of 10 or fewer clinicians can form a Virtual Group with at least one other such individual eligible clinician or group. Each participating individual clinician must meet the low volume threshold definition of MIPS Eligible clinician. That is, have greater than $90,000 in Medicare Part B allowed charges and care for more than 200 Medicare Part B patients. Each participating group also has to meet the low volume threshold requirements at the group level. A group may have clinicians that do not meet the low volume threshold requirements at individual level. However, there must be at least one MIPS eligible clinician in the group.

A Virtual Group election process requires a formal written agreements among individual clinicians and groups electing to form a Virtual Group and will select a representative. This person would make the election on behalf of the members of a Virtual Group regarding the formation of a Virtual Group for the applicable performance period, by the election deadline. Virtual Groups have until December 31, 2017 to make the election for 2018 performance year.

Some other important aspects to Virtual Groups:

  • A Virtual Group is created for at least one performance period. Participants are NOT allowed to change the selection during the performance period.
  • An individual or a group may only participate in one Virtual Group during a performance period. This is determined at the TIN level.
  • There is no limit to number of participants in a Virtual Group
  • Virtual Group is recognized as an official collective entity for reporting purposes but is not a distinct legal entity for billing purposes. As a result, Virtual Group will not need to establish a new TIN nor reassign their billing rights to a new or a different TIN.

Furthermore, most of the reporting requirements applicable to groups would also generally be applicable to Virtual Groups, unless otherwise specified. Virtual groups will aggregate data for each NPI under each TIN within the virtual group by adding together the numerators and denominators to report the measure ratio for a measure at the Virtual Group level. Most of the quality measures reporting requirements such as requiring 6 measures including one outcome measure or high priority would apply to Virtual Group. All Cause Hospital Readmission Measure would be included if the Virtual Group has more than 15 clinicians and meets the case volume of 200 cases.

Data completeness requirements for Virtual Groups would apply cumulatively across all TINs in a Virtual Group. If the Virtual Group has one TIN that falls below the 60 percent data completeness threshold for measure, they may still report on that measure as long as the Virtual Group cumulatively exceeds such threshold. Virtual Groups submitting quality measures data using the CMS Web Interface or a CMS approved survey vendor to report the CAHPS for MIPS survey must meet the data submission requirements on the sample of the Medicare Part B patients CMS provides.

ACI data for Virtual Groups will be aggregated by combining data from Certified EHR Technology from all participants. If the groups (not including solo practitioners) that are part of a Virtual Group have CEHRT that is capable of supporting group level reporting, the Virtual Group would submit the aggregated data across the TINs produced by the CEHRT. If a group (TIN) that is part of a Virtual Group does not have CEHRT that is capable of supporting group level reporting, such group would aggregate the data by adding together the numerators and denominators for each MIPS eligible clinician within the group for whom the group has data captured in CEHRT. If an individual MIPS eligible clinician meets the criteria to exclude a measure, their data can be excluded from the calculation of that particular measure only.

The Virtual Group MIPS Score will be calculated by combining the scores of all the performance categories using the score calculation rules applicable for MIPS groups. Each eligible clinician in a Virtual Group will receive this Virtual Group score that will be reflective of the combined performance of the Virtual Group.

Also, the Virtual Group MIPS Score would be applied to all TIN/NPIs billing under a TIN included in the Virtual Group during the performance period. The payment adjustments would be applied at the TIN/NPI level based on the Virtual Group Score. The clinicians who are a part of a Virtual Group, but are also Qualified Participants (QP status) in an Advanced APM, will have their performance counted as a part of the Virtual Group, but will not receive payment adjustment based on the Virtual Group MIPS score. These clinicians’ payment adjustment will be covered under the Advanced APM entity. 

Part B drugs

In the final rule, CMS determined that Eligible Clinician’s MIPS score would impact not only their professional services reimbursement but also billed Medicare Part B drugs. These are often very expensive drugs and include those used in the treatment of such diseases as cancer and renal failure. Injected and infused drugs are included as well as those related to transplantation, osteoporosis, and numerous other conditions. The Proposed Rule indicated these Part B drug costs in most circumstances would be included in the MIPS reimbursement and eligibility calculations.

According to the CMS:

“MACRA legislation now requires that MIPS payment adjustments be made to payments for both items and services under Medicare Part B, including Part B drugs. For each MIPS payment year, the MIPS payment adjustment factor, and, if applicable, the additional MIPS payment adjustment factor for exceptional performance are applied to Medicare Part B payments for items and services furnished by MIPS eligible clinicians during the year. These adjustments apply to all of the Medicare Part B items and services furnished by, and billed under, the combined Taxpayer Identification Number (TIN)/National Provider Identifier (NPI) of a MIPS eligible clinician and not only to services paid under the Medicare PFS.”

Complex patients

There has been a lot of discussion since the Quality Payment Program was unveiled regarding how complex patients could drag down quality metric reporting as physicians struggle for adherence and/or care improvement. In 2018, CMS will award five bonus points in the MIPS program for treatment of such patients. This is seen as a move to appease critics who urged CMS not to water down standards and maintain their uniformity, while acknowledging adherence struggles for some patient

QPP’s unintended consequences

Politico recently reported that physicians are avoiding some of the nation's sickest patients out of concern that deaths or other poor outcomes following treatment could cause Medicare or insurers to cut their payments or shame them with poor marks on their health care quality measures.

"It breaks my heart because it's undermining engagement of physicians with their patients," said David Barbe, president of the American Medical Association said to Politico, who added he often hears a colleague say he or she is avoiding a complex patient because it will "kill my scores."

In fact, a recent study found that physicians who served higher-risk patients under the Value-Based Payment Modifier (the precursor to QPP) ultimately had lower quality scores, giving them more penalities and fewer bonuses.

"If people see that pattern happening, they will have a lot of incentive to stop caring for sick patients," said Karen Joynt, the study's author and physician at the Washington University School of Medicine.

Reactions to final rule

Becker’s Hospital Review rounded up quotes from across the health care industry. Two in particular that stood out:

Tim Gronniger, former CMS deputy chief of staff and senior vice president of strategy and development at Caravan Health, a consultant, presented a mixed reaction. "The final rule for 2018 makes clear that for the vast majority of clinicians MACRA is here to stay, so it's time to start planning for how to succeed rather than hoping CMS makes it all go away," Mr. Gronniger said. "While we would have preferred CMS not increase the low-volume threshold, clinicians who see any significant number of Medicare patients are still in the program, and clinicians who are excluded will see their compensation frozen for the coming five years."

Tom Nickels, executive vice president of government relations and public policy at the American Hospital Association, felt the final rule "continues a flexible approach to the MACRA's physician quality payment program urged by hospitals, health systems, and the more than 500,000 employed and contracted physicians with whom they partner to deliver care."

"While we believe it could be adopted in 2018, we understand CMS' decision to eventually adopt a facility-based clinician measurement option that will allow many hospitals and clinicians to spend less time collecting data, and more time collaborating to improve care," Mr. Nickels said. "While we applaud CMS for providing much-needed relief from unrealistic and unfunded mandates for EHR capabilities for clinicians, we are disappointed the agency has yet to provide similar relief for hospitals. We also urge CMS to provide additional avenues for clinicians to earn incentives for partnering with hospitals to provide better quality, more efficient care through advanced alternative payment models.”


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