CMS Program Audit Universes and Protocol Changes Tabled Until 2022

The Centers for Medicare and Medicaid Services (CMS) recently released the 2021 Program Audit Memo, which announced that it will start sending engagement letters in March of 2021, and will continue to do so through July of 2021. CMS also announced that it will continue to use the 2020 protocols for program audits in 2021. CMS initially intended to use the updated protocols in 2021, but is still waiting for approval from the Office of Management and Budget (OMB).

CMS has stated: “Delaying implementation of the updated protocols proposed under CMS-10717 will give stakeholders sufficient lead-time to apply and test the updated protocols prior to CMS using them to conduct audits.”

Health plans should use the time to ensure that they and their Pharmacy Benefit Manager (PBM) have reviewed the updated protocols anticipated for 2022 to ensure compliance with data extraction and population. Of note is one of the new universes, “Universe Table 7: Comprehensive Addiction and Recovery Act (CARA) At Risk Determination (AR) Record Layout”. Plans should verify whether they are aligned with their PBM to define the responsible party and confirm that the layout has been reviewed and is ready for use in 2022.

CMS’s 2019 Part C and Part D Program Audit and Enforcement Report did not include the common conditions cited during program audits, as it has done in years past. This exclusion is unfortunate in that it is typically a helpful learning tool for plans to modify oversight activities and incorporate noted best practices into their operations. That being said, with the goal of ensuring member access to entitled benefits and focusing on noncompliance related to access to care, GHG would expect CMS’s areas of focus to include COVID-19 flexibilities and proper administration of opioids edits in Formulary Administration.

In the 2020 Part C Organization Determinations, Appeals, and Grievances (ODAG) protocol, CMS eliminated the Call Log universe (Table 14). In the Compliance Program Effectiveness (CPE) protocol, CMS suspended the CPE self-assessment questionnaire and made several changes to the CPE universes.

As we head into the 2021 CMS Program Audit season, take the appropriate steps to ensure that your health plan has updated its universe data pulls accordingly.


Where Do We Go from Here?

With all the stressors on health plans in the current environment and the ever-changing landscape of the COVID-19 pandemic, the news from CMS to continue use of the 2020 audit protocols may come as a bit of a relief. However, plans must not be complacent about audit preparation and should remain diligent about their PBM oversight activities. Plans are still encouraged to perform mock audits to evaluate their operations and practice the experience.

Gorman Health Group (GHG) assists plans in implementing process improvements in relation to new CMS requirements. Our team of subject matter experts also conduct readiness assessments and mock program audits to validate adherence and identify potential areas of risk or concern. Contact us today to start the conversation.

 


Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance

On December 30, 2019, the Centers for Medicare & Medicaid Services (CMS) announced updates to the Parts C & D Enrollee Grievance, Organization/Coverage Determination and Appeals Guidance, which became effective as of January 1, 2020.  Noteworthy changes are summarized below:

  • In Section 10.5.3, the guidance was expanded to include more detail about verbal notifications. This section details when and under what circumstances the verbal notification is considered delivered, what defines a successful verbal notification (e.g., speaking with the person that submitted the request or leaving a voicemail message), and the appropriate steps to take if written notice is required along with verbal notification. CMS also deleted subsection 10.5.4: Good Faith Effort to Provide Verbal Notification, which was a new section introduced in the February 2019 version of the Guidance. There is a notable revision to guidance for a favorable decision that a plan “may” deliver written confirmation of its decision after initially providing verbal notification of the decision. This is a change from the 2019 guidance indicating the plan “must” deliver written notification. (See updated Section 40.8.)
  • Throughout the Parts C & D Guidance, CMS revised existing requirements to now include Part B Drugs.
  • Section 40 (Coverage Determinations, Organization Determinations [Initial Determinations] and At-Risk Determinations) has several significant updates:
    • There is a more detailed description of the process for requesting a Part C pre-service organization determination or Prior Authorization (PA). CMS provides clarification that Medicare Advantage (MA) plans should be prepared to address medical necessity as required in these scenarios. (See Section 40.1.)
    • There is a new Part D provision that applies to circumstances where a plan is asked to waive a PA or other Utilization Management requirement. Updated language provides for tolling of the timeframe by up to 14 calendar days after the receipt of a request to receive the supporting statement. (See Sections 40.4 and 40.5.3.)
    • Also noted are new Part D notification timeframes surrounding Exception Requests. In previous guidance, plans were instructed not to keep requests for supporting statements open indefinitely. This language is deleted in the updated guidance, and in its place, CMS outlines specific new timeframes for enrollee and prescribing physician (as appropriate) notification of plan decisions for both expedited and standard requests, and includes notification timeframes for circumstances when the supporting statement is not received with the 14 calendar day timeframe.
    • CMS has included Part B Drugs in the decision timeframes (favorable, partially favorable, or adverse) as well as processing timeframes (72 hours for standard requests for Part B Drugs and 24 hours for expedited). CMS also clarified that requests for Part B Drugs and payment timeframes cannot be extended.
  • Section 50 Reconsiderations and Redeterminations (Level 1 Appeals) contains a number of updated clarifications to existing requirements. Most noteworthy changes are the provisions for adjudication timeframes for Part B Drugs. 
  • CMS clarifies Health Care Pre-Payment Plans (HCPPs) are not regulated by Section 100 (Provider Notices in Hospital, SNF, HHA and CORF Settings [Part C Only]) and clarifies that HCPP enrollees must follow Original Medicare immediate review processes.
  • The Medicare Managed Care Appeals Process Overview for Part C (Appendix 1) is amended to include timeframes for Part B Drugs in both the standard and expedited processes. Also, for both Parts C and D Process Overviews, the “Amount in Controversy” (AIC) is increased to $170 at the Administrative Law Judge (ALJ) Hearing stage. The AIC is also increased at the Federal District Court stage to $1,670.

Plans should carefully review the
updates and incorporate the numerous changes to existing plan policy.

Image result for did you know

GHG assists plans in implementing process improvements in relation to new CMS requirements. We also conduct assessments and mock audits to validate adherence. Contact us today for additional information.


Latest Audit Enforcement Actions Issued by CMS

Like clockwork, the Centers for Medicare & Medicaid Services published the enforcement action notices issued to sponsors related to 2017 program audits. Additional detail regarding conditions, audit scores, and enforcement is expected to be included in the 2017 Program Audit Enforcement Report, which the agency hopes to release before their conferences taking place May 9-10. In the meantime, we break down the published data, which includes not only program audit actions but others as well:

  • Eighteen sponsors were issued almost $2.6 million in Civil Money Penalties (CMP) between September 2017 and February 2018 based on their 2017 program audit findings.
    • 72% of sponsors cited for Coverage Determinations, Appeals, and Grievances violations
    • 61% of sponsors cited for Formulary and Benefit Administration violations
    • 39% of sponsors cited for Organization Determinations, Appeals, and Grievances violations
    • 22% of sponsors cited for Part C Beneficiary Protections/cost sharing violations
  • A Program of All-inclusive Care for the Elderly (PACE) sponsor was issued a CMP in November of 2017, and two PACE sponsors had enrollment suspended in the fourth quarter of 2017.
    • PACE plans: You are small but have a mighty sense of responsibility. If you have not done so already, review the posted enforcement notices, distribute within your organization, and create an action plan if you identify any similar findings.
  • One Prescription Drug Plan sponsor had enrollment suspended due to medical loss ratio.
  • Two sponsors were issued CMPs in 2017 based on outlier status of auto-forwards to the Independent Review Entity.

CMS noted in their draft call letter the agency is considering adding a CMP icon in Medicare Plan Finder (MPF) starting in 2019. If the agency proceeds that way, sponsors undergoing audits this year and incurring CMPs will be impacted by this new indicator. We support efforts such as this which promote beneficiary transparency. As I outlined in our analysis, sponsors should take note. Low Performing Icon information has not been limited to the MPF. Marketing organizations and other industry publications have taken that information and run with it, which may give an advantage to competitors of affected plans. In a recent Bloomberg Law article, I further discuss enforcement actions and the implications of this Low Performing Icon.

Remember that enforcement actions can be levied not just for program audit performance but also for a host of other violations. While I have provided some recent statistics, an analysis of actions taken year over year show patterns in some regards, and no rhyme or reason in other regards. Don’t spend too much time slicing and dicing these figures for your management; let us do that here in these articles. Focus on plan performance and continuous improvement. The goal should be to ensure your organization does not end up with enforcement actions in the first place.

 

 

Resources:

Gorman Health Group’s summary and analysis of the 2019 Advance Notice and Draft Call Letter for Medicare Advantage and Part D is now available. Download now

Registration is open for the Gorman Health Group 2018 Forum, April 25-26, 2018, at the Red Rock Resort ideally located near the Red Rock Canyon in Las Vegas. Download our agenda here.

Want to stay up to date on policy and regulation changes? The Insider is GHG’s exclusive intelligence briefing, providing in-depth analysis and expert summaries of the most critical legislative and political activities impacting and shaping your organization. Read our full press release >>

Stay connected to industry news and gain perspective on how to navigate the latest issues through GHG’s weekly newsletter. Subscribe


Noteworthy Evolution for Star Ratings in 2017 MA Draft Call Letter

Last week's release by the Centers for Medicare & Medicaid Services (CMS) of the 2017 Medicare Advantage (MA) Advance Notice of Methodological Changes and Call Letter ended the mystery surrounding potential policy and payment changes on the horizon.  As our Founder and Executive Chairman, John Gorman, recently noted: "There's a lot to like — and much to fear." Although CMS is proposing higher-than-expected rates for 2017 and has introduced both payment and Star Ratings relief for plans serving dual-eligible beneficiaries, this positive news was counterbalanced somewhat by a number of factors, including proposals to increase compliance scrutiny in challenging areas such as network adequacy, provider directory accuracy, and medication therapy management programs.

As anticipated from a Star Ratings perspective, there were few surprises but quite a bit of noteworthy evolution for MA this year.  CMS' proposals include:

  • Accounting for the Star Ratings Impact of Dual-Eligible and Disabled Beneficiaries:

After a lengthy research process and significant pressure from the industry, CMS proposes moving forward with an interim analytical solution to account for the Star Ratings impact of dual-eligible and disabled beneficiaries. Despite the fact only a handful of plans would likely gain or lose a full half-star in their rounded overall Star Rating, this is a huge methodological win for plans serving dual-eligible members and will be important to monitor closely.  When combined with CMS' simultaneous proposal to adjust revenues based on beneficiaries' status as either full duals, partial duals, or non-duals, as well as for their status as both aged and/or disabled beneficiaries, my colleague, Dan Weinrieb, advises, "This will mean timely reconciliation and maintenance of clean enrollment data has never been more important for MA plans." This proposal, in combination with the proposed strategy to account for the lack of low-income subsidy (LIS) support to meet Puerto Rican beneficiary needs, reflects a noteworthy shift in CMS' willingness to adjust the Star Ratings program to account for scientifically-supported evidence of nuances within MA.

  • In-Home Risk Assessments

CMS' decision to leave in-home risk assessments untouched is great news for the many MA plans who are leveraging these important visits not only for risk adjustment, but also to connect members with needed care (as measured by Healthcare Effectiveness Data and Information Set (HEDIS®) and Prescription Drug Event (PDE) Star Ratings measures), to coordinate care across the spectrum of providers (as measured by Consumer Assessment of Healthcare Providers and Systems  (CAHPS®) Star Ratings measures), and to help support member's social and lifestyle challenges (as measured by Health Outcomes Survey (HOS) Star Ratings measures). We interpret this to mean CMS now better understands the incredible value in-home care can bring to a patient's holistic healthcare experience. However, despite this welcome news, plans should certainly ensure their program adheres to the best-practice expectations previously set forth by CMS, and supported by encounter data, in order to drive payment.

  • Termination of Contracts Below 3 Stars for 3 Years

CMS not only reaffirmed its previously-announced plans to terminate contracts earning 3 consecutive Part C or Part D Summary Ratings of less than 3 stars, but also set forth an annual calendar by which this practice will become standard. With CMS guidance indicating these termination decisions are non-negotiable, plans will likely expedite efforts to improve Star Ratings performance such that impactful work begins as soon as it looks possible their first Summary Rating below 3 stars may be on the horizon.

  • Connecting Compliance and Star Ratings

From a compliance perspective, CMS proposes to continue strengthening its connections between compliance, data integrity, and Star Ratings. CMS reminds organizations of its policy to reduce a contract's measure rating to 1 star if it's determined biased or erroneous data was submitted. Our experience this year indicates CMS is leveraging this authority much more frequently than it has in past years, which means plans will want to pay particular attention to Medicare Plan Finder and PDE data requirements, Organization Determinations, Appeals, and Grievances (ODAG) and Coverage Determinations, Appeals, and Grievances (CDAG) processes, internal controls to prevent errors in operational areas directly impacting the data reported or processed for specific measures, and Part C and D reporting requirements data validation for specific measures. CMS points out, and we're hearing evidence to support, it continues to identify new vulnerabilities where inaccurate or biased data could exist, which could result in the reduction of a star measure to 1 star. As my colleague, Regan Pennypacker, details in her recent article, CMS' proposed changes will require plans to "implement creativity and do more with less while enhancing the beneficiary experience." Certainly this will be no easy task as we survive 2016 and plan for 2017 under a new administration.

  • Measure Updates

CMS is not proposing to add any new measures to the 2017 Star Ratings, although several measure specification changes are proposed for use in the 2017 ratings. As previously proposed, CMS indicated both the Improving Bladder Control (Part C) and High Risk Medication (Part D) measures will be moved to the Display page for 2017.

CMS proposes the addition of two new measures to the 2018 ratings (based on 2016 services/operations): Medication Reconciliation Post-Discharge and Hospitalization for Potentially Preventable Conditions. Addition of previously-proposed statin therapy and asthma measures were pushed out at least another year, possibly as a show of support for the recently-released and newly-aligned quality measures, giving plans a bit of breathing room to work with providers in this new area.

As we look ahead with CMS' foreshadowing of future program updates, continued attention is being paid to Care Coordination measures (with the National Committee for Quality Assurance's (NCQA's) assistance) and Depression measures (with NCQA and Minnesota Community Measurement's support), and the Advance Notice highlights a number of potential measure specification changes, which may take effect for the 2018 ratings.

Whether your organization is working to improve performance on your entire Star Ratings program, or just a few Star Ratings measures, or needs assistance understanding how the proposals contained in the Advance Notice may impact your plan, we can help. For additional questions and inquiries about how Gorman Health Group (GHG) can support your organization's Star Ratings programs, please contact me directly at msmith@ghgadvisors.com.

 

Resources

On Tuesday, March 1, from 2:30-3:30 pm ET, join John Gorman, GHG's Executive Chairman, and colleagues Olga Walther, Senior Legislative & Policy Advisor, and Leslie Mullins, GHG's Senior Consultant, as they provide a hard-hitting analysis of critical areas addressed in the document. Learn what the proposed "methodology changes" could mean for your organization and your partners and the steps you can take to soften the impact. Register now >>

Register your team for the 2016 GHG Forum! For more details around the event and agenda, download the full conference brochure or visit our websiteRegister now >>

Stay connected to industry news and gain perspective on how to navigate the latest issues through GHG's weekly newsletter. Subscribe >>