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Demystifying the Part D Audit: General Overview of Part D

2

EireneRx shared medication platform, e-prescribing

Dedicated geriatric-trained pharmacists

Dispensing and adherence packaging

PACE Medication Risk Mitigation™ Tools

Unique understanding of

participants’ needs

Now, please welcome

Dr. Richard Schamp

from Capstone Performance Systems

Presented by Matt Zimmerman Risk Adjustment Consultant

Capstone Performance Systems

1. Elements required of your Part D Compliance Plan.

2. Most common areas for Part D Audit deficiencies.

3. Developing a robust Compliance Plan and Work Plan for your PACE Organization, and staying on-schedule.

Requirement defined by CMS for PACE organizations ◦ As specified in Sections 1894 and 1934 of the Medicare

Modernization Act (MMA), PACE organizations shall provide all medically necessary services including prescription drugs, without any limitation or condition as to amount, duration, or scope and without application of deductibles, copayments, coinsurance, or other cost sharing that would otherwise apply under Medicare or Medicaid.

Success with Part D requires the assistance of many departments within the PACE model.

1. Accurate bidding for Part D expenses annually.

2. Detailed processing of prescriptions to validate the accepted bid.

3. Development and implementation of a comprehensive compliance program and initiatives to confirm or corroborate a plans commitment to the Part D program.

4. Accurate Part D bid reconciliation procedures

Part D programs for PACE began operation in 2006 and were not consistently audited until 2009.

CMS audit expectations have grown exponentially over the years to well beyond the required audit elements.

My History –

Worked in large PACE plan for 13 years building the Part D program from the ground up.

Experienced with: ◦ Part D audits

◦ Risk adjustment

◦ Medicare/Medicaid processes

◦ Compliance initiatives.

This experience has taught me to be prepared for anything with Medicare and Part D overall.

All plans must have policies, procedures and standards of conduct that: ◦ Define the commitment to comply with Federal and State

standards.

◦ Discuss how to address compliance issues

◦ Identify how to communicate compliance issues

◦ Determine how compliance issues are investigated and resolved

Policies and procedures must be developed to address all unique work processes or elements of a plans Part D program and each policy must reflect the plan commitment to being detailed, accurate and specific.

In the development of a Part D compliance program the following should identified: ◦ Compliance reporting structure – how are compliance issues

reported?

◦ Training requirements

◦ Reporting mechanisms – What steps will be done to address reporting needs?

◦ How investigations are conducted

◦ How issues are resolved

In the development of a Part D compliance program the following should identified: ◦ How consistent Monitoring & Auditing of all key areas will be

accomplished with a focus on accuracy, completeness and timeliness.

◦ Complete understanding of how the program is operationalized in the affected departments.

◦ How to address changes in laws and new requirements or initiatives put forth by CMS.

Generally all efforts should be easy to read and understandable by any user.

Now that a framework has been developed to address Part D. How will a plan know their compliance efforts are effective? ◦ Most compliance efforts start with

Policy and Procedure to define the unique processes involved with Part D Compliance.

First, just writing a policy alone is not effective. The policy must be implemented and supported by a detailed procedure. ◦ In order to pass a CMS audit it’s not enough to just have a

policy, a plan must demonstrate to CMS that they are ‘living’ the policy.

◦ Ask yourself this question.. Are these policies effective and are all efforts documented?

The P&P must be clear and achieve the desired results. For example, if the policy is regarding

processing PDE records in a timely manner a plan must demonstrate to CMS via a log or tracking mechanism how often PDE records are submitted and be within the acceptable federal standard for that process.

All policy must be updated appropriately not just in an annual review, but reviewed as regulations change.

All policy and procedure must be embraced!

Again ‘live’ that policy!!

All policy must be supported from the top down to achieve total success. ◦ That means the quality or compliance department and

executive leadership must support this effort, fully!

It’s important to focus continually on building the foundations of an effective Part D compliance plan.

◦ Who is responsible for coordinating this effort? ◦ Compliance objectives can be attained with the oversight of

a Compliance Officer or a Compliance Committee.

◦ Either way - Compliance initiatives must be accountable to the organizations CEO/Board of Directors and have an obligation to report all compliance instances.

Accountable to CEO or senior management. I just mentioned this, but the compliance officer is almost always the front line in the discovery of compliance issues.

That is a big responsibility and they need backup!

A Compliance Officer must be vested in the day to day operations of the Part D program. Informed and accountable.

Periodically a Compliance Officer should report to the plans governing body.

What is expected of the Compliance officer or Committee? ◦ Development and/or review of all related P&P

◦ Attend Medicare operations meetings or be informed of Medicare processes and associated initiatives.

◦ Monitor systems for compliance performance

◦ Enforcement of disciplinary standards at plan.

What is expected of the Compliance officer or Committee? ◦ Implementation of all systems to detect and assess

all risk ◦ Development of an auditing work plan or system ◦ Review of audit and monitoring results ◦ Monitor effectiveness overall and make

recommendations for improvement ◦ Must have a strong commitment to the ethics and

integrity of the plans process

Compliance committee or compliance officer? Either!! ◦ Smaller PACE plans and plans that are owned by a larger

organization do not always have a fully dedicated compliance officer due to the nature of their respective business.

◦ It’s more likely a compliance committee will be the best way to go.

◦ The Committee should meet monthly or at a minimum quarterly.

Should have members of varied backgrounds and expertise

◦ Include Medical personnel (pharmacists, pharmacy technicians, registered nurses

◦ Medicare operations personnel (finance, accounting & quality).

This will not be effective

if executive management is not

engaged in the process,

so include upper management.

Regardless of how a compliance department is structured - Ultimately responsible for: ◦ Development of compliance tools that will be used to

measure effectiveness

◦ Reporting and comparing compliance results over time to identify trends and exceptions.

◦ Maintenance of dashboards and key performance indicators that show compliance program effectiveness.

◦ To be effective a compliance program must find any issues early before they become a larger out of control problem.

Ultimately responsible for:

Review of CMS notices of non-compliance or corrective action plans (Think PROACTIVE not reactive to avoid this altogether)

Provide effective resolution

Finally, (but it’s really never final)

Compliance programs must ensure

effective implementation

of all CMS requirements.

Narrowing our scope

on Part D…

What elements

are required

for an effective

Part D compliance program?

Starting with the most critical element, Policy and procedure must be developed to address all required CMS Part D audit elements.

Additional P&P to address all Part D areas outside of required audit items.

Effective Internal Auditing and Monitoring procedures to demonstrate compliance to Part D processes demonstrates success.

True Out of Pocket (TrOOP) ◦ Tracked upon enrollment through disenrollment

◦ Gross Covered Drug Cost accumulation

PDE submission linking Part A,B & D

◦ Ensuring all PDE records are Part D

◦ Inpatient and Skilled stay exclusions for Part D

◦ Eliminate unnecessary Rx fills when Part A/B is primary

Processing Systems

◦ Demonstrate how PDE records are submitted

◦ Show how PDE systems are scalable and effectively process data.

Internal Auditing and Monitoring ◦ Demonstrate to CMS a robust adherence to Part D regulations

and processes. ◦ Supporting documentation and worksheets to exhibit

compliance.

Fraud Waste & Abuse ◦ Ensure all PDE records are accurate, complete & timely. ◦ Committed to detecting and eliminating unnecessary

expenses

Employer Group/Union Coverage ◦ Demonstrate accurate enrollment procedures ◦ Commitment to coordinating benefits

Certification of monthly enrollment and payment data ◦ Demonstrate to CMS a robust adherence to Part D regulations

and processes.

Written Policy and Procedure

◦ Demonstrate to CMS that plan has a robust and complete Part D compliance plan. POLICY & PROCEDURE – Live it!

Use of SSN/HICN

◦ Ensure CMS that confidential information is not included in ID cards.

While a CMS Auditor may only look at the required Audit elements they may ask to review additional processes – Be prepared! ◦ PDE record review at the batch level – Rx Script to Delivery receipt.

◦ 60-day notice of Medicare eligibility (New to Medicare validation)

◦ Health Plan Management System (HPMS) Memo Review and delivery process.

◦ Plan to plan policy

◦ Out of network claims policy

◦ Low-Income Subsidy policy

◦ Monthly Enrollment and Disenrollment procedures

◦ Daily Transaction Reply Report Review policy

First Tier/Downstream related entities (FDR) ◦ Requires a consistent review strategy to verify contracted

vendors for accuracy

Excerpt for CMS on FDR: ◦ ‘The burden of documenting contractors’ compliance with

applicable standards ultimately rests with the PACE organization. It is especially important to identify specific responsibilities of a contractor. The PACE organization must develop its own procedures to ensure that the entity complies with the standards of competency and quality of care.’ (from PACE Chapter 9)

Hands down #1!!! Is NOT demonstrating to CMS auditors that there is an effective Internal Auditing and Monitoring program at your plan!

Not providing or documenting required TrOOP letters to

disenrolled plan participants! ◦ Including not requesting prior plan TrOOP balances ◦ Not submitting TrOOP letters in a timely fashion (CMS requires this

within 7 days)

Not demonstrating to CMS that related entities (FDR) are audited and monitored.

Part D audit deficiencies commonly relate to numerous plan processes that upon first inspection do not appear related to Part D. ◦ Not reviewing the CMS daily transaction reply report (DTRR)

◦ Not demonstrating the reconciliation of the Monthly Payment report

◦ Not reviewing RAPS data consistently and incorporating RAPS file reviews and coding audits into Part D processes

◦ Not utilizing plan Quality Initiatives and overall findings to improve Part D practices

Staying on-schedule

Be Accurate, Timely & Complete

Part D compliance is a full time process, not an afterthought! Be consistent, timely and accurate in your compliance efforts. ◦ Meet early and often to review and update your work plan,

whether its developed fully or in process this step is critical to success

◦ Develop Part D procedures before anything becomes an issue.

Keep up to date with CMS initiatives and requirements

Clearly define the scope of your Part D efforts ◦ Standardize a format for the work plan

◦ Cross train and have a backup.

◦ Compliance is a team effort!

◦Remember CMS is always

evolving and so should

your Part D work plan!

A work plan is essentially an outline or a set of goals or processes.

A work plan will determine how goals are accomplished.

Provide everyone involved with a better understanding.

Generally work plans are used to break down the larger compliance plan into bite sized goals.

Work plans should include an introduction and background, goals and objectives.

There are several work plan related acronyms to help narrow down the scope of the process.

SWOT – Strengths, Weaknesses, Opportunities, Threats Development of a work plan with SWOT in mind will provide a

well-rounded approach.

Don’t forget to link your work plan to the mission and priorities of the company and its customers and participants.

There are several work plan related acronyms to help narrow down the scope of the process.

SMART – Specific, Measurable, Achievable, Relevant and Time Bound

◦ Most importantly a work plan must identify the scope, who is accountable and have a strategy for success.

Use your contracted Pharmacy, PBM or

3rd party administrator to

assist in your Part D compliance efforts

and work plan tasks.

Sample reports that your Pharmacy, Care Kinesis, can generate to assist in your compliance review efforts include:

• Executive Summary

• Top 25 Prescriptions by Dispense

• Top 25 Prescriptions by Cost

• Controlled Substance listings

• Overutilization Monitoring System (OMS)

• Prescription Tracking – from Rx script to Delivery receipt

• PDE level reporting – tracking and review

• Medication Adherence reviews

• Generic Utilization

Care Kinesis and Capstone We are here to help! Providing reporting assistance and consulting services.

Part D general training .

Readiness reviews in advance of an audit.

We are available to help assess your internal processes and assist in the development of a robust Part D work plan.

Matt Zimmerman

Risk Adjustment Consultant

Capstone Performance Systems

720-937-8364

JOB AIDS AND CMS CHAPTERS: Medicare Chapters on Compliance: All chapters have compliance related items in them, but focusing on

the following will provide your compliance plan with a boost. Chapter 9 - Organization's Relationship with Health Care Providers Chapter 10 - Quality Assessment and Performance Improvement Chapter 13 - Payments to PACE Organizations Chapter 14 - Coordination of Benefits Chapter 15 - Organization Monitoring and Auditing Chapter 16 - Sanctions, Enforcement Actions and Termination All chapters are here: http://www.cms.gov/Regulations-and-

Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS019036.html?DLPage=2&DLSort=0&DLSortDir=ascending

JOB AIDS AND CMS CHAPTERS: Medicare Chapters on Compliance: Other Chapters from CMS regarding Part D Chapter 1 - Introduction and General Provisions Chapter 5 - Benefits and Beneficiary Protection Chapter 9 - Compliance Program Guidelines ALL chapters are here:

http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/RxUtilization.html

Self-Assessment questionnaire from CMS http://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-

and-Part-D-Compliance-and-Audits/Downloads/Compliance-Program-Effectiveness-Self-Assessment-Questionnaire.pdf