Life Science Compliance Update

June 21, 2017

CMS Releases Proposed 2018 MACRA Rule (Including QI CME as Improvement Activity)


On Tuesday, the Centers for Medicare & Medicaid Services (CMS) released the long-anticipated proposed rule updating the Quality Payment Program – the program implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) – for 2018. The rule continues the CMS trend of allowing more and more physicians to delay MACRA implementation, as many smaller and rural providers have said their lack of capital and resources make compliance difficult.

MACRA will eliminate the sustainable growth formula and replace it with a .5% annual rate increase through 2019, when physicians are encouraged to shift to either a Merit-Based Incentive Payment System (MIPS) or an Alternative Payment Model (APM). CMS also used provider feedback to shape the second year of the program. If the rule becomes finalized, it will advance CMS’ goal of regulatory relief, program simplification, and state and local flexibility in the creation of innovative approaches to healthcare delivery.

Below is a comparison of current and proposed polices.

Policy Topic

Current Transition Year (CY 2017)

Second Year (CY 2018)

MIPS Policy

Low-Volume Threshold

Exclude individual MIPS eligible clinicians or groups with ≤$30,000 in Part B allowed charges OR ≤100 Part B beneficiaries during a low-volume threshold determination period that occurs during the performance period or a prior period.

Increase the threshold to exclude individual MIPS eligible clinicians or groups with ≤$90,000 in Part B allowed charges or ≤200 Part B beneficiaries during a low-volume threshold determination period that occurs during the performance period or a prior period.

Starting with 2019 MIPS performance period: let clinicians opt-in to MIPS if they exceed 1 or 2 of the low-volume threshold components: Medicare revenue, or Number of Medicare patients.

Additionally, CMS is proposing that in 2019 the opt-in process would be allowable for 3 items, and is seeking comment on a 3rd potential component: Number of Part B items and services

Virtual Groups

Not available

Key Proposals:

· Adding Virtual Groups as participation option for year 2, which would be composed of solo practitioners and groups of 10 or fewer eligible clinicians who come together “virtually” with at least 1 other such solo practitioner or group to participate in MIPS for a performance period of a year.

· In order for solo practitioners to be eligible to join a Virtual Group, they would need to meet the definition of a MIPS eligible clinician and not be excluded from MIPS based on one of the 4 exclusions (new Medicare-enrolled eligible clinician; Qualifying APM Participant; Partial Qualifying APM Participant who chooses not to report on measures and activities under MIPS; and those who do not exceed the low-volume threshold). In order for groups of 10 or fewer eligible clinicians to be eligible to participate in MIPS as part of a Virtual Group, groups would need to exceed the low-volume threshold at the group level. A group that is part of a Virtual Group may include eligible clinicians who do not meet the definition of a MIPS eligible clinician or may be excluded from MIPS based on one of the four exclusions.

· Allow flexibility for solo practitioners and groups of 10 or fewer eligible clinicians to decide if they want to join or form a Virtual Group with other solo practitioners or groups of 10 or fewer eligible clinicians, regardless of location or specialties.

· If the group chooses to join or form a Virtual Group, all eligible clinicians under the TIN would be part of the Virtual Group.

· CMS proposes various components that would need to be included in a formal written agreement between each member of the Virtual Group.

Virtual Groups that choose this participation option would need to make an election prior to the 2018 performance period (as outlined in the MACRA legislation).

· If/when TIN/NPIs move to an APM, CMS proposes to exercise waiver authority so that CMS can use the APM score instead of the Virtual Group score.

· Generally, policies that apply to groups would apply to Virtual Groups, except the following group-related policies:

  o Definition of non-patient facing MIPS eligible clinician.

  o Small practice status.

  o Rural area and Health Professional Shortage Area designations.

Facility-Based Measurement

Not available

Implement an optional voluntary facility-based scoring mechanism based on the Hospital Value Based Purchasing Program.

Available only for facility-based clinicians who have at least 75% of their covered professional services supplied in the inpatient hospital setting or emergency department.

The facility-based measurement option converts a hospital Total Performance Score into a MIPS Quality performance category and Cost performance category score.


Weight to final score:

· 60% in 2019 payment year.

· 50% in 2020 payment year.

· 30% in 2021 payment year and beyond.

Data completeness:

· 50% for submission mechanisms except for Web Interface and CAHPS.

· Measures that do not meet the data completeness criteria receive 3 points.


· 3-point floor for measures scored against a benchmark.

· 3 points for measures that don’t have a benchmark or don’t meet case minimum requirements.

· 3 points for measures that do not meet data completeness.

· Bonus for additional high priority measures up to 10%.

· Bonus for end-to-end electronic reporting up to 10%.

Weight to final score:

· 60% in 2020 payment year.

· 30% in 2021 payment year and beyond.

Data completeness:

· No change, but CMS proposes to increase the data completeness threshold to 60% for the 2019 MIPS performance period.

· Measures that do not meet data completeness criteria will get 1 point instead of 3 points, except that small practices will continue to get 3 points.


· Keep 3-point floor for measures scored against a benchmark.

· Keep 3 points for measures that don’t have a benchmark or don’t meet case minimum requirement.

· Measures that do not meet data completeness requirements will get 1 point instead of 3 points, except that small practices will continue to get 3 points.

· No change to bonuses.

· Proposed changes to the CAHPS for MIPS survey collection and scoring


Weight to final score:

· 0% in 2019 payment year.

· 10% in 2020 payment year.

· 30% in 2021 payment year and beyond.


· Will include the Medicare Spending per Beneficiary (MSPB) and total per capita cost measures.

· 10 episode-based cost measures.

· Measures do not contribute to the score, feedback is provided for these measures.

Weight to final score:

· CMS proposes 0% in 2020 MIPS payment year, but are soliciting feedback on keeping the weight at 10%.

· 30% in 2021 MIPS payment year and beyond.


· Include only the Medicare Spending per Beneficiary (MSPB) and total per capita cost measures in calculating Cost performance category score for the 2018 MIPS performance period. However, these measures will not contribute to the 2018 final score if the Cost performance category is finalized to be weighted at 0%.

· CMS expects to replace previous episode-based cost measures are developed in collaboration with expert clinicians and other stakeholders.

Improvement Activities

Weight to final score:

· 15% and measured based on a selection of different medium and high-weighted activities.

Number of activities:

· No more than 2 activities (2 medium or 1 high-weighted activity) are needed to receive the full score for small practices, practices in rural areas, geographic HPSAs, and non-patient facing MIPS eligible clinicians.

· No more than 4 activities (4 medium or 2 high-weighted activities, or a combination) for all other MIPS eligible clinicians.

· Total of 40 points.

· 92 activities were included in the Inventory.

Definition of certified patient-entered medical home:

· Includes accreditation as a patient-centered medical home from 1 of 4 nationally-recognized accreditation organizations; a Medicaid Medical Home Model or Medical Home Model; NCQA patient-centered specialty recognition; and certification from other payer, state or regional programs as a patient-centered medical home if the certifying body has 500 or more certified member practices.

· Only 1 practice within a TIN has to be recognized as a patient-centered medical home or comparable specialty practice for the TIN to get full credit in the category.


· All APMs get at least 1/2 of the highest score, but CMS will give MIPS APMs an additional score to reach the highest score based on their model. All other APMs must choose other activities to get additional points for the highest score.

· Designated specific activities within the performance category that also qualify for Advancing Care Information bonus.

· For group reporting, only 1 MIPS eligible clinician in a TIN must perform the Improvement Activity for the TIN to get credit.

· Allow simple attestation of Improvement Activities

Weight to final score:

· No change.

Number of activities:

· No change in the number of activities that MIPS eligible clinicians have to report to reach a total of 40 points.

· CMS is proposing more activities to choose from and changes to existing activities for the Inventory.

· MIPS eligible clinicians in small practices and practices in a rural areas will keep reporting on no more than 2 medium or 1 high-weighted activity to reach the highest score.

Definition of certified patient-centered medical home:

· CMS proposes to expand the definition of certified patient-centered medical home to include the CPC+ APM model.

· CMS proposes to make it clear that the term “recognized” is the same as the term “certified” as a patient-centered medical home or comparable specialty practice.

· CMS proposes a threshold of 50% for 2018 for the number of practices within a TIN that need to be recognized as patient-centered medical homes for the TIN to get the full credit for the Improvement Activities performance category.


· No change to the scoring policy for APMs and MIPS APMs.

· Keep designated activities within the performance category that also qualify for an Advancing Care Information bonus.

· For group participation, only 1 MIPS eligible clinician in a TIN has to perform the Improvement Activity for the TIN to get credit. CMS is soliciting comments on alternatives for a future threshold.

· Keep allowing simple attestation of Improvement Activities

Additional summaries can be found here, including proposed changes to the APM policy and other options/policies in the final and proposed rules.

Changes to CME

The proposed rule also includes changes that allow CME as an improvement activity. The relevant language is:

Completion of an accredited performance improvement continuing medical education program that addresses performance or quality improvement according to the following criteria:

  • The activity must address a quality or safety gap that is supported by a needs assessment or problem analysis, or must support the completion of such a needs assessment as part of the activity;
  • The activity must have specific, measurable aim(s) for improvement;
  • The activity must include interventions intended to result in improvement;
  • The activity must include data collection and analysis of performance data to assess the impact of the interventions; and
  • The accredited program must define meaningful clinician participation in their activity, describe the mechanism for identifying clinicians who meet the requirements and provide participant completion information.

“The proposed rule will provide more flexibility and freedom for educators to engage with clinicians in a learner-centered quality improvement process," said Graham McMahon, MD, MMSc, President and CEO, Accreditation Council for Continuing Medical Education (ACCME®). "We are pleased that the CMS proposal reflects the value of accredited CME and look forward to working together to address the quality and safety needs of communities and the patients we all serve.”  

CMS is focused on making the Quality Payment Program easier.  “We’ve heard the concerns that too many quality programs, technology requirements, and measures get between the doctor and the patient,” said CMS Administrator Seema Verma. “That’s why we’re taking a hard look at reducing burdens. By proposing this rule, we aim to improve Medicare by helping doctors and clinicians concentrate on caring for their patients rather than filling out paperwork. CMS will continue to listen and take actionable steps towards alleviating burdens and improving health outcomes for all Americans that we serve.”

May 26, 2017

Current State of Telemedicine


As we previously reported, the CHRONIC Care Act of 2017 was introduced by Senate Finance Committee Chairman Orrin Hatch and Ranking Member Ron Wyden, along with Johnny Isakson and Mark Warner, the co-chairs of the Committee’s Chronic Care Working Group. The bill is largely unchanged from the previous version, which was introduced in December 2016. The bill will have an especially large impact on telehealth services in the United States by allowing MA plans the ability to include telehealth services; gives some ACOs the opportunity to provide telehealth services; gives those receiving dialysis treatments at home the ability to check-in with their physician at home; and expands the availability of telehealth to ensure individuals who may be having a stroke receive the correct diagnosis and treatment.

Expanding Telemedicine Adoption

As of late 2012, 42 percent of U.S. hospitals had adopted telemedicine, but adoption rates vary significantly by geography. Alaska was the highest with 75 percent, while Rhode Island had minimal adoption. Additionally, states often require physicians to be licensed to practice in the “originating” site, i.e., the patient must be in the same state in which the attending physician is licensed to practice. Some states require that providers maintain a license with the board where the patient is located, which can lead to extra costs and paperwork for the providers.

Recent Telemedicine Developments

MACRA contained a number of provisions that aim to expand telemedicine. One provision limits restrictions on telemedicine only to fee-for-service (FFS) as opposed to alternative payment models (APMs) created through the law. It also directed the GAO to study telemedicine. Telemedicine is also promoted in the new “improvement activities” category in MIPS.

Furthermore, the 21st Century Cures legislation included provisions related to telemedicine, including requirements of CMS and the Medicare Payment Advisory Commission (MedPAC) to provide detailed information to Congress regarding the potential uses of telemedicine in Medicare. The Cures Act focuses on Medicare’s “originating site” requirement as well as the role of CMMI regarding telehealth. The law also on the House Energy & Commerce Committee Telemedicine Workgroup to develop next steps on Medicare telehealth.

Reimbursement for telemedicine

Among public payers, Medicare offers the most limited coverage of telehealth. Medicare pays for a narrow set of services and only in rural areas. Fee-for-service (FFS) Medicare covers a defined set of outpatient services furnished to an eligible beneficiary via an approved real-time interactive audio and video telecommunications system. Beneficiaries are eligible for the services if they receive care from an “originating site” located in a county outside of a Metropolitan Statistical Area (MSA) or A rural Health Professional Shortage Area (HPSA) located in a rural census tract.

Medicare covers a number of telehealth services in lieu of in-person services – including

“consultations, office visits, psychiatry services, and some physician fee schedule services.” These services are reimbursed “at the same rate as the comparable in-person medical service” according to the codes and applicable payments set forth in the current Medicare Physician Fee Schedule (MPFS). Ultimately, roughly 80% of Medicare beneficiaries do not qualify for telemedicine services because they live in a metropolitan area. In general, telemedicine coverage and reimbursement restrictions have remained in place out of “concern that the service might increase Medicare expenses” due to an increase in beneficiaries’ use of services.

In the Medicare Advantage (MA) program, reimbursement for telemedicine depends on the private plan. In contrast to Medicare FFS, a number of MA plans as well as Medicare Accountable Care Organizations (ACOs) have turned to telemedicine as a means by which to facilitate greater care management and beneficiary engagement. This is predominantly due to the fact that “[MA] plans have the option to offer telemedicine without the tight restrictions in the traditional Medicare program because they are paid a fixed amount by the federal government to care for seniors. As a result, Medicare is not directly paying for the telemedicine services; instead, the services are paid for through plan revenue.”

In Medicaid, the American Telemedicine Association (ATA) reports that all 50 states provide some level of reimbursement for telemedicine services. While federal Medicaid statute does not explicitly recognize telemedicine as a distinct service, states have considerable flexibility in covering and reimbursing for these activities. State Medicaid reimbursement for telemedicine services must meet broad federal requirements “of efficiency, economy and quality of care,” though states are encouraged to use the flexibility of the program to establish payment methodologies that serve their residents’ needs. Due to the flexibility of the program, states do not need to submit a separate State Plan Amendment (SPA) for establishing the coverage of telemedicine services if it reimburses providers the same as a face-to-face service. However, states must obtain approval from CMS if reimbursement differs from the face-to-face service.

In the private insurance market, state-mandated telemedicine coverage of has become increasingly prevalent over the past decade. However, only 16 of the 24 states with telemedicine parity laws for private insurance “authorize state-wide coverage, without any provider or technology restrictions.” Telemedicine advocates are pushing for more states to pass legislation requiring that telemedicine services be covered to the same extent and in a similar manner as in-person services.

March 01, 2017

OIG Reviews QPP


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 website during the Obamacare roll out. “ 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] and apply them to the MACRA program,” said a candid CMS employee.

OIG says that CMS staff reported that they drew on experiences from to rethink the agency’s approach to launching complex initiatives such as the QPP. Like, 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 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 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 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.


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.


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