CMS Audit Universes as a Tool for Ongoing Compliance Monitoring

CMS Audit Universes as a Tool for Ongoing Compliance Monitoring

One of the most arduous and time-consuming activity for MAPD and PDP plans is the creation of the required universes for submission to the CMS. Health plans often struggle with the critical step of universe creation followed by ensuring that the universes are clean or error-free.
If you have been through a CMS program audit in 2015 or 2016, you would be familiar with the rigors of timeliness review of your Part C Organization Determinations, Appeal, and Grievances (ODAG) and Part D Coverage Determinations, Appeals, and Grievances (CDAG) universes to validate the accuracy of universes and to measure timeliness in each of the audit areas.
CMS Update
Now, all MADP and PDP plans will face reviews, regardless of whether they are selected for a CMS audit this year. CMS in November 2016 announced that it will implement an industry-wide timeliness monitoring activity related to Part C organization determinations and appeals and Part D coverage determinations and appeals. This has two reasons, one, to evaluate the integrity and completeness of the Independent Review Entity (IRE) data, and second, to improve the overall monitoring of compliance.
Beginning January 2017, CMS started collecting 7 ODAG universes and 10 CDAG universes from each contract to assess timeliness in processing both Part C and D requests, as well as compliance with forwarding cases to the IRE. The CMS describes an acceptable universe in terms of field type, length, and description, as well as how to determine the dates for date fields.
Plans have a maximum of three attempts to submit accurate and timely universes during a CMS audit, failing which they could be referred for Invalid Data Submission (IDS) condition for every audit element that cannot be tested or grouped by the type of case. This could adversely impact STAR ratings and audit score. Failure to successfully submit universes may result in compliance actions by CMS.
Universes as a powerful compliance tool
To mitigate risks arising from generating inaccurate or untimely audit universes, we empower plans to create clean, accurate and timely audit universes that are CMS-ready and can also be used as a tool for ongoing compliance monitoring. The universes can be a powerful tool for plans to evaluate their operational performance. Ongoing review of universes can also help plans identify issues proactively and address them in advance.

Questions to ponder? Are you generating clean universes for CMS submission? What is the error rate? What is the cost in terms of man-hours needed to rectify errors? Are you using your universes as an ongoing monitoring tool? Are you facing penalties and delays? To know about our solution for generating clean audit universes, please visit Universe Scrubber.

CMS launches largest-ever multi-payer initiative to improve primary care

The Centers for Medicare & Medicaid Services (CMS) announced its largest-ever multi-payer initiative to transform and improve how primary care is delivered and paid for in America. The effort, the Comprehensive Primary Care Plus (CPC+) model, will be implemented in up to 20 regions and can accommodate up to 5,000 practices, which would encompass more than 20,000 doctors and clinicians and the 25 million people they serve. The initiative is designed to provide doctors the freedom to care for their patients the way they think will deliver the best outcomes and to pay them for achieving results and improving care. Read more >>


Americans with Disabilities Act (ADA) Changes

I attended a call recently with CMS and the ADA, CMS is looking to adhere to the Americans with Disabilities Act (ADA), when it comes to assessing monetary penalties to health plans that are not providing information in an alternative format due to a member’s disability. The following background should help.

The Americans with Disabilities Act (ADA) was signed into law on July 26, 1990, by President George H.W. Bush. The ADA is one of America’s most comprehensive pieces of civil rights legislation that prohibits discrimination and guarantees that people with disabilities have the same opportunities as everyone else to participate in the mainstream of American life — to enjoy employment opportunities, to purchase goods and services, and to participate in State and local government programs and services.

Civil Monetary penalties inflation adjustment under Title III

On March 28, 2014, the Department of Justice issued a Final Rule that adjusts for inflation the civil monetary penalties assessed or enforced by the Civil Rights Division, including civil penalties available under title III of the Americans with Disabilities Act of 1990 (ADA). For the ADA, this adjustment increases the maximum civil penalty for a first violation under title III from $55,000 to $75,000; for a subsequent violation, the new maximum is $150,000. The new maximums apply only to violations occurring on or after April 28, 2014.

This Final Rule is a non-discretionary agency action made pursuant to Section 4 of the Federal Civil Penalties Adjustment Act of 1990, as amended (Adjustment Act), which mandates the Attorney General to adjust for inflation the civil penalties assessed or enforced by the Department of Justice. The amounts of the adjustment were determined according to a specific mathematical formula set forth in Section 5 of the Adjustment Act.

Therefore, when a plan has Identified that a member is requesting their materials in an alternate format due to disability (such as Braille, large print, audio tapes) and the material is not provided in that alternative method then the ADA has the right to Assess the above-mentioned penalty per member affected.

This came to light in an Audit at one of our clients. During their ODAG audit, it was identified that a member has requested the need for larger fonts due to sight disability and the materials were not sent out in large font or Braille. As a result, the plan has been notified that as of May 1st they would be charged the penalty, and have been asked for a corrective action to address the issue.

Have a question? Please contact Brenda Wade or Gabe Viola

Optimize your Appeals and Grievances Process

When it comes to appeals and grievances, most healthcare organizations struggle to improve compliance, productivity, visibility, and ratings while lowering penalties.

Steps to optimize your Appeals and Grievances process:

  1. Make reaching out to complain a child’s play: Complaints are nothing but valuable data about what you could do better to improve your processes, products, customer experience and ultimately bottom lines. Easy of filing a complaint has a direct and positive impact on member and provider satisfaction. So focus on making the process easy and inexpensive.
  2. Establish your cost-per-complaint: It is critical that you establish your cost-per-complaint before you settle for a solution that tracks every appeal or grievance and then provides analytics and actionable insights based real-time data.
  3. Reduce your cost-per-complaint: You can reduce your cost-per-complaint by automating the process end-to-end and across channels. Rely on an easy to use technology that requires minimal training and on-boarding of staff to be able to deliver positive outcomes.
  4. Build a robust complaining culture: Develop a transparent, automated solution that closes a complaint within hours and sends automated alerts and status reports to the complainant. Recognize good complaining trends and set benchmarks that reflect in improved operational efficiencies. Develop, deploy and modify automated appeals and grievances processes for rapid time to value and continuous improvement.

Have a question? Please contact Brenda Wade or Gabe Viola

Reasonable Outreach: Are you missing what CMS expects?

The Centers for Medicare & Medicaid Services (CMS) on April 20th of 2016 released several job aids in order to assist plan sponsors with improving their operations and ensuring compliance with CMS requirements.

These job aides are based on common performance issues found in their Coverage Determination Audits of both CDAG and ODAG and continue to be the two areas that are the key source of most audit findings

I want to focus on the one CMS issued for Reasonable Outreach.

The process they outlined is typical, First the staff is expected to Determine if an expedited or standard decision is needed, figure out the level of service requested (expedited or Standard), review the case and if additional information is needed, they are then to follow the Plans protocols to reach out and obtain the information.

Now here is where many plans start to miss what CMS is expecting. First of all, CMS is expecting a minimum of Three attempts to obtain the missing or needed information. Document how outreach was conducted (e.g., phone, fax) and what information is missing or needed. Be specific about what is needed to approve coverage, you will also need to document the date and time of all outreach attempts and whether outreach was successful.

This sounds simple enough, however, you would be surprised how often plans do not properly document what was requested and how many times they reached out for the information.

A few best practices also mentioned in the Job Aide is to:

• Use different methods of outreach from your initial attempt when possible.
• When feasible, make outreach attempts only during business hours. If you can’t then follow the after-hours instructions.
• Leave at least a few hours between attempts for the provider to respond.
• Be specific. Notify provider what information must be received
• Clearly document all outreach attempts; note method, date and time.
• Make sure you thoroughly document all your attempts, including date, time and method

Have a question? Please contact Brenda Wade or Gabe Viola

2015/2016 CMS Program Audit Protocols and Process Updates

CMS conducts program audits to evaluate the performance of the Medicare Advantage/Prescription drug plans (MAPDs) and prescription drug plans (PDPs) that provide health care coverage to Medicare eligible beneficiaries.

In February of 2015 CMS published the audit protocols that will be utilized for performance audits in the current calendar year. CMS introduced significant revisions compared to how the audits have been conducted in previous years. The changes, increased expectations for the timely and accurate submission of plan universes, and amplified consequences for failing to meet the new universe demands.

Key changes in the CMS Audit Protocols include:

  • A restructured format and composition of the audit universes;
  • Establishment of a required record layout for each universe;
  • Institution of a “3-strikes” policy for the submission of accurate and timely universes;
  • Redesign of the Compliance Program Effectiveness (CPE) protocol; and
  • Submission of Pre-Audit Issue Summary and associated Beneficiary Impact Analysis (BIA).

These key changes in audit protocols posed numerous challenges throughout the 2015 performance audits of MAPD and PDP plans, as well as the pharmacy benefit management (PBM) companies used by the plans. Based on the audits CMS conducted in early 2015, CMS updated and revised the protocols on October 20, 2015 and is planning on having the revised protocols remain in effect for 2016.

CMS added two additional weeks from the date of receipt of the audit start notice to the date the audit began. This allowed sponsors one additional week to compile universes and one additional week for CMS to analyze and validate universes prior to selecting samples.

The majority of the revisions in the October protocols focuses on modifying or clarifying the changes introduced in February. The following four areas are mostly impacted.

1. Record layout modifications

In February, CMS introduced all new record layouts for plans to follow when constructing the requested universes. The record layouts contained detailed information (i.e., field name, type, length, and description) however insufficient detail for populating, data elements often left plans puzzled about how to create universes based on the new record layouts. The October release provides greater clarity along with additional instructions for producing the required universes.

The format of the record layouts remains the same except for the addition of a “Column ID” field. CMS added changes to streamline and clarify the content, including: rearranging variables, adding or renaming variables, removing superfluous fields and revising field descriptions to include more detail, examples of what was being requested and/or additional entry options.

CMS expanded the record layouts to allow sponsors to more easily recreate and conduct the universe timeliness tests for CDAG and ODAG. CMS has incorporated a data dictionary into the record layouts defining what was expected for each field.

The most affected layouts are those of Part C organization determinations, appeals, and grievances (ODAG) and Part D coverage determinations, appeals, and grievances (CDAG)

Modifications to the Compliance Program Effectiveness (CPE) record layouts are a bit more complex now due to the several new fields that have added more complexity than the previous versions due to the fact that the information required is normally stored in multiple fields requiring plans to consolidate the answer into one new field.

2. Invalid Data Submission classification.

The New protocols introduced a “3-strikes” policy for the submission of timely and accurate universes. Plans are given a maximum of 3 attempts to provide the correct universes. If a plan does not submit the correct universe by the third attempt the result is an “Immediate Corrective Action Required” (ICAR) finding—worth 2 audit points—for every condition that could not be tested. With so many universes required this can pose a significant risk to any plan.

The revised protocols maintain the 3-strike policy, but introduce a new “Invalid Data Submission” (IDS) condition, which is worth 1 audit point. Now, instead of an ICAR after 3 failed attempts, an IDS will be cited relative to each element that cannot be tested, grouped by the type of case. An IDS will also be cited if an accurate universe cannot be produced in fewer than 3 attempts due to missing or unavailable data.

3. Beneficiary Impact Analysis

Plans are now required to submit a Pre-Audit Issue Summary of previously disclosed and self-identified issues of noncompliance to CMS within 5 business days of receiving the audit start notice using the templates provided in the protocols by CMS.

The revised protocols change the name from “Beneficiary Impact Analysis” to “Impact Analysis” (IA), and include revised templates. They are no longer required to be submitted with the Pre-Audit Issue Summary, but are required to be submitted as requested by the CMS Audit team for every issue discovered during the audit that has potential beneficiary impact. Though this can be considered a relief a plan will have limited time to produce this IA report, therefore, plans will have to prepare for these type of queries in advance.

4. Compliance Program Effectiveness

CMS redesigned the protocol used to test the 7 elements of an effective compliance department. Instead of conducting a content review of over 30 documents, CMS used 5 tracer samples to follow the flow of an issue as it moved through the elements of its compliance program. At first Plans did not receive much guidance on how to create these tracer samples and often scrambled in the time leading up to an audit to produce a comprehensive tracer sample. A new template was introduced in June 2015 and explained in more detail during the Spring Conference.

For 2016, CMS will review 6 tracer samples, a tracer template is now provided with the revised protocols, In addition to the changes to the tracer process, the compliance interview process modification includes a reduction in employee interviews and adds an interview with an individual responsible for managing the oversight of the plans “first-tier, downstream and related entities.” Because of the complexities in creating a comprehensive tracer sample, plans should practice building these samples on a routine basis.

Overhauling of the CPE audit protocol resulted in a decrease in the volume of documentation requested in advance of each audit


Although the revised protocols do not reduce the burden of work for Medicare Part C and D plans, they can be viewed overall as a positive step in helping plans prepare for an audit. The revised protocols demonstrate that CMS’s is series about a shift toward greater transparency, and their willingness to work with our industry to improve the overall audit process and experience.

CMS is in a new cycle of auditing. CMS is planning to evaluate the sustainability of compliance as they audit sponsors that also underwent audit in the last cycle.

With CMS’s continued scrutiny of data accuracy, plans should invest in the time and resources needed to:

  • Improve Quality assurance.
  • Conduct Mock audits—both internal and external—to evaluate their audit readiness,

Review the quality of their universe pulls as often as is feasible (Quarterly).

2015 CMS Audit Protocol: Your Takeaway

In early February, the CMS released its new audit protocols and process updates for 2015 for Medicare Advantage organizations and Part D sponsors. The new audit memorandum has given way to a lot of speculation and confusion among the medicare advantage community.

As per the new mandate, 2015 begins a new audit cycle, wherein sponsors audited in the previous audit cycle (2010-2014) will be re-audited in the new cycle. In the 2014 audit, CMS has audited parent organizations that provide services to 96% of Medicare Advantage and Prescription Drug enrollees. A number of smaller sponsors were not audited in the 2014 audits.

CMS has established that it “will continue to utilize a risk-based approach to select sponsors for audit (both high and low risk), while also taking into account other key factors like, the sponsor has never previously been audited; the sponsor is new to the program; or the sponsor represents a large percentage of MA or Part D enrollment” for the 2015 Program Audit Cycle.

In this blog we attempt to bring more clarity on the areas that have been discontinued, modified and added and what the policy changes mean in terms of impact and compliance.

Discontinued elements

  1. Formulary and Benefit Administration Element (FA)
    What’s new: The review of the Pharmacy and Therapeutics (P&T) Committee has been removed. CMS indicated that it will continue to evaluate alternate methods to review the use of the P&T Committee and the implementation of the committee’s recommendations.

Modified elements

  1. Organization Determinations, Appeals, and Grievances (ODAG) & Coverage Determinations, Appeals, and Grievances (CDAG).

    What’s new: Modifications have been made to the ‘universe timeliness test and universe submissions’. In the past CMS required only consolidated data. However, CMS found it difficult to test timeliness using consolidated data. Hence, for 2015 CMS has requested additional universes to test data. This makes it crucial for entities to verify that all universe requirements are documented and reviewed regularly.

    This change has resulted in significant increase in the number of universes submitted and the number of samples requested.

  2. Compliance Program Effectiveness (CPE)

    What’s new: Under the new protocol for this element the seven elements of a compliance program will be tested through ‘five tracer samples’ that will be traced as they move through the organization’s compliance department.

Newly added elements

CMS will initiate two pilot elements starting mid 2015 for which test scores will be given in the 2016 cycle.

  • Medication Therapy Management (MTM): A Pilot Program
    Sponsors are required to have an established MTM program to ensure optimum therapeutic outcomes for targeted beneficiaries through improved medication use. The objective of this program includes:

    1. Assess the sponsor’s performance against the CMS-approved MTM program.
    2. Educate sponsors and correct area(s) of deficiency
    3. Identify possible performance measures.
  • Provider Network Adequacy: A Pilot Program
    Sponsors are required to maintain an adequate provider network including specialty and subspecialty providers. The objective of this program includes:

    1. Evaluate adequacy of sponsor provider network.
    2. Examine the plan network and validate open access.

Audit process changes

  • Timeframes

    A selected sponsor will receive a letter of engagement six weeks prior to the start date. Upon receipt, the plan sponsor will have three weeks to submit universes to CMS. CMS increased this time to allow plan sponsors additional time to review and correct errors if any prior to submission.
  • Penalty

    For the 2015 cycle, CMS has added a high cost to incorrect universe submission. If there are errors in the third submission the plan will be give an ICAR for all elements tested on that universe. With this move CMS expects plan sponsors to submit correct universes in a timely manner.
  • Beneficiary impact analysis

    Within five days of receiving the audit engagement letter, the plan sponsor is liable to submit a beneficiary impact analysis to identify and highlight any previously disclosed and self-identified non-compliance issue/s. The sponsor must have rectified the issue before receipt of the engagement letter. CMS will consider an issue corrected if there is evidence of appropriate and adequate remediation, both in the sponsor’s systems and for the sponsor’s enrollees. CMS allows a maximum of three attempts to provide the Pre-Audit Issue Summary and the associated beneficiary impact analysis. If multiple attempts are made, CMS will consider the last document submitted.

To view the full CMS memorandum, click here.

How Inovaare’s A&G software can help

Inovaare’s out-of-the-box yet simple compliance Appeals and Grievances solutions automate member appeal process, enforce compliance and generate various management, operational, compliance and quality related dashboard and reports. The Grievances software enables organization to manage various types of member grievances and provides end-to-end process from case intake to case closure. With built-in regulatory rules and appropriate case categorization, the grievances system helps organization to achieve regulatory compliance and quality mandates.

The TracX software from Inovaare offers a centralized repository for all the evidence required for review and submission during the audit. Using TracX entities can, not only meet the CMS threshold of 95% compliance, but also identify the missing elements comprising 5%, and be prepared before the CMS audit submission. TracX, has been known to bring to light and rectify critical process errors that could result in significant penalties and possibly sanctions. TracX is a perfect compliance solution in view of the narrow lead time between the Program Audit notice and the audit submission, making the compliance process less cumbersome, on-time and error-free.

With multiple audit updates and mandate changes, Inovaare’s CQMS software can help you automate quality and compliance operations, reduce risk, lower operational cost and increase compliance visibility.

Be ready, be compliant with Inovaare compliance software!

To know more about our compliance products, click here.

What are the potential risks?

  • CMS Imposed 43 CMP totaling $8 Million on some 30+ plans.
  • Possible suspension of enrollment and marketing.

Be ready before it is too late

Are you in control of your compliance processes?

May 19, 2015

Compliance maintenance and oversight for health plans can be a resource and time-consuming restraint. Challenges with manual processes, inefficient workflows and frequent compliance audits prove to be disruptive and expensive. Regulatory demands for health plans can result in higher costs, increased resources, and unplanned expenses.

Common compliance concerns include:

1. Conflicting directives for health plans with multiple regulators
2. Un-finalized regulations causing uncertainty on ongoing lawsuits
3. Regulatory timeframes shortening the window of time for review of compliance processes and protocols
4. Significant changes and implementation needs to comply with healthcare reform, or the routine changes
5. Frequent regulatory revisions and sub laws making it difficult to maintain compliance

Health plans are increasingly seeking solutions to streamline their compliance and quality processes and deliver better patient care. Software automation has gained a lot of attention and increased adoption to facilitate compliance. Proactive and technically-advanced health plans have automated their core business and operational processes. This has included handling sensitive patient information, validation of insurance coverage, appointment management, medical billing and records management.

Compliance automation not only reduces errors but also ensures protection of critical patient data which allows for better care management. Automation software allows for the user to generate powerful and insightful reports that aid in decision making, business planning and overall compliance adherence.

Inovaare’s Healthcare Cloud Platform provides a unique and comprehensive, yet simple framework. This platform allows health plans to transform their complex business processes and disparate data sources into a centralized and streamlined information management system.

Inovaare’s solutions allow health plans to determine whether they adhere to the rules and procedures necessary to ensure operational or regulatory compliance across all their functions.

Through our CQMS TracX health plans can centralize, streamline and automate process management. Complex and cross-functional process become easier to manage. This can include customer issue management such as appeals, grievances and complaints, Regulatory and compliance events and reporting, incident investigations, correspondence and other activities.

With the CQMS Audit module, health plans can easily perform audits and assessments efficiently and timely without disrupting the day to day operations. These may also include on-going monitoring and oversight of their business associates and delegated entities. This easy-to-use system helps schedule assessments, track progress, and manage corrective action plans in a centralized platform.

Health plans will continuously be in need of adjusting to ongoing regulation changes and requirements. Understanding the new and changing laws can prove to be cumbersome and may require additional compliance oversight. In order to be at the forefront of competition, health plans must adopt technology solutions to automate their core processes to help shift resources and focus on the more demanding and productive areas. Compliance and quality automation software is the solution to achieve balance between the compliance and quality needs.