Life Science Compliance Update

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.

April 18, 2016

Quality Measure Core Set Implementation Plan

For the past three years, the Centers for Medicare and Medicaid Services (CMS) has worked to align quality measures across different public programs in an attempt to support consistent high quality care for patients and to reduce complexity and burden for clinicians in how they report on quality improvements. CMS has already aligned quality measures across acute care hospital programs, such as the Inpatient Quality Reporting Program, Hospital Value Based Purchasing, and the Hospital-Acquired Condition Reduction program. Hospitals report their quality measures once, which are then used for multiple programs.

CMS recently announced the release of seven sets of core clinical quality measures intended for use in multi-payer settings. These measures were selected to support multi-payer alignment on core measures primarily for physician quality measurement program, as measure requirements are often not aligned among payers, which often results in confusion and complexity for reporting providers.

The guiding principles used to develop the core measure sets are that they be meaningful to patients, consumers, and physicians, while reducing variability in measure selection, collection burden, and cost. The goal is to establish broadly agreed upon core measure sets that can be harmonized across commercial and government payers.

The seven core measure sets focus on the following areas: Accountable Care Organizations (ACOs), Patient Centered Medical Homes (PCMH), and Primary Care; Cardiology; Gastroenterology; HIV and Hepatitis C; Medical Oncology; Obstetrics and Gynecology; and Orthopedics.

The seven measures were selected as a part of a collaboration between CMS, America's Health Insurance Plans (AHIP), private payers, and other stakeholders, known as Core Quality Measures Collaborative, to establish "broadly agreed upon core measure sets that could be harmonized across both commercial and government payers." Current measures acted as a model for the new measure sets, and CMS plans to use the rulemaking process to introduce additional measures from the new sets into public reporting programs.

According to CMS Acting Administrator Andy Slavitt, "In the U.S. Health care system, where we are moving to measure and pay for quality, patients and care providers deserve a uniform approach to measure quality. This agreement … will reduce unnecessary burden for physicians and accelerate the country's movement to better quality."


Implementation will occur in several stages. When it comes to private payers, the measure sets will be phased in over time as contracts between providers and payers are renewed and renegotiated. The implementation of certain measures will depend on the provider's ability to collect and report data through their Electronic Health Record (EHR). While some plans and providers may be able to collect certain clinical data, a robust infrastructure to collect data on all the measures in the core set does not currently exist, and further infrastructure may be required for certain measures.

The Health Care Payment Learning and Action Network (HCPLAN), a public-private collaboration established by CMS, will integrate these quality measure into their efforts to align payment model components with public and private sector partners. In addition, CMS is working with federal partners (i.e., the Office of Personnel Management, Department of Defense, and Department of Veterans Affairs) and state Medicaid programs to further align quality measures.

Given ongoing local and regional efforts at quality improvement, provider performance on some of the measures in the core sets may be topped out in particular areas of the country or within a particular provider's patient population. Private payer-provider collaboration will help to determine the appropriate subset of core measures that should be implemented.

The Core Quality Measures Collaborative will use the upcoming year as a transitional period, as it begins to adopt and harmonize the measures. The Collaborative will continually monitor the use of these measures to modify them as needed, based on lessons learned. In addition to monitoring progress, the Collaborative will invite broader participation and add additional measures and measure sets.

Debra L. Ness, president of the National Partnership for Women & Families, believes that "alignment across payers is key to making sure measurement doesn't waste resources or create unnecessary burden. Ultimately, it plays a foundational role in achieving better health and better health care at lower costs."

December 05, 2014

National Quality Forum Begins Annual Review of Quality Measures, Comments Open December 23 on the 202 Proposed Measures


On Monday, the Measure Applications Partnership (MAP) began its annual review of performance measures that the Centers for Medicare and Medicaid Services (CMS) is considering for use in 20 federal health programs. The 202 measures considered by the group have been made public (view the  PDF), and will be available for review and comment beginning December 23, 2014.

Established by the National Quality Forum (NQF) in 2011, MAP is a forum of approximately 150 healthcare leaders and experts, representing nearly 90 private-sector organizations. MAP comprises consumers, purchasers, labor, health plans, clinicians and providers, communities and states, suppliers, and liaisons from seven federal agencies.

“MAP brings the public and private sectors to consensus on how quality can be measured effectively and efficiently in federal health programs,” said NQF President and CEO Dr. Christine Cassel. “A key goal for MAP is to streamline the measures used by the federal government so that patients receive the quality care they deserve and providers can focus on how best to improve the care they deliver.”

What do some of these 202 new measures look like?

The measures included for review cut across a wide variety of treatments. Measures included on the list cover preventative care and a number of conditions, including diabetes, asthma, surgery, and cancer.

One measure, x4208, looks at opioid addiction. It seeks to quantify the percentage of patients with a diagnosis of current opioid addition who were counseled regarding psychosocial and pharmacologic treatment options for opioid addition within the 12 month reporting period.

Another, measure x3798, quantifies how often patients with diagnosis of a muscular dystrophy had a scoliosis evaluation ordered. Measure E0056 measures how many patients with diabetes received a foot exam during the measurement year. Another measure seeks to curb "unnecessary colonoscopies" in patients over age 86, when the risks apparently are reduced (X3769).

Some measures are extremely detailed. For example, x3773, entitled "Optimal Asthma Care," covers a wide range of required testing, tracking, and patient education protocols.

The list of applicable Federal programs (available on pg. 6-7 of the PDF) includes:

  • Ambulatory Surgical Center Quality Reporting Program;
  • End‐Stage Renal Disease (ESRD) Quality Incentive Program;
  • Home Health Quality Reporting Program;
  • Hospice Quality Reporting Program;
  • Hospital‐Acquired Condition Reduction Program;
  • Hospital Inpatient Quality Reporting Program;
  • Hospital Outpatient Quality Reporting Program;
  • Hospital Readmission Reduction Program;
  • Hospital Value‐Based Purchasing Program;
  • Inpatient Psychiatric Facility Quality Reporting Program;
  • Inpatient Rehabilitation Facility Quality Reporting Program;
  • Long‐Term Care Hospital Quality Reporting Program;
  • Medicare and Medicaid Electronic Health Record (EHR) Incentive Program for Eligible Professionals;
  • Medicare and Medicaid EHR Incentive Programs for Eligible Hospitals or Critical Access Hospitals;
  • Medicare Shared Savings;
  • Medicare Physician Quality Reporting System;
  • Physician Compare;
  • Physician Feedback/Quality and Resource Utilization Reports;
  • Physician Value‐Based Payment Modifier Program;
  • Prospective Payment System‐Exempt Cancer Hospital Quality Reporting Program; and
  • Skilled Nursing Facility Value‐Based Purchasing Program.

Starting on p. 330, the pdf breaks down the CMS program that corresponds to each measure title.  

Download CMS List of Quality Measures


CMS notes that they are issuing this list of measures to comply with Section 1890A(a)(2) of the Social Security Act, which requires the Department of Health and Human Services to make publicly available a list of certain categories of quality and efficiency measures that it is considering for adoption through rulemaking for the Medicare program. “Because this List contains measures that were suggested to us by the public, this List contains more measures than will ultimately be adopted by CMS for optional or mandatory reporting programs under Medicare,” states the report. “When organizations, such as physician specialty societies, request that CMS consider measures, CMS makes every effort to include those measures and make them available to the public so that [MAP], the multi‐stakeholder groups convened as required under 1890A of the Act, can provide their input on all potential measures.” 

The measures considered by the group are made public at the beginning of the forum and will be available for review and comment beginning December 23, 2014.


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