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Highlights of CMS-Proposed Changes in Draft 2019 Call Letter

By March 6, 2018CMS, CPE, Part C, Part D

The Centers for Medicare and Medicaid Services (CMS) proposes changes to Star Ratings, validation audits, annual Compliance Program Effectiveness (CPE) audits, Part D opioid overutilization policy, and more in the draft 2019 Call Letter that was released February 1, 2018. BluePeak provides a high-level summary of the proposed changes and clarifications below.

Parts C and D

Star Measures

CMS proposes two new measures for 2019 Star Ratings: Statin Use in Persons with Diabetes (Part D) and Statin Therapy for Patients with Cardiovascular Disease (Part C). CMS also proposes the retirement of the Beneficiary Access and Performance Problems (BAPP) (Parts C and D) measure and the temporary removal of the Reducing the Risk of Falling (Part C) measure. For 2020 and beyond, CMS proposes 12 potential new measures.

Data integrity issues discovered during Parts C and D Reporting data validation and Timeliness Monitoring Project (TMP) review can reduce a plan’s contract’s measure score to 1 Star for measures that rely on these data. CMS proposes to define a contract as being non-compliant if it receives a “no” or a 1, 2 or 3 on the 5-point Likert scale in the specific data element’s data validation and employ a scaled Star Rating reduction, based on the degree of missing Independent Review Entity (IRE) data from the TMP review, to the appeal measures.

Independent Validation Audits

CMS also proposes changes to the independent validation audit process. Currently, plan sponsors are required to hire an independent auditor if there are more than five non-Compliance Program Effectiveness (CPE) program audit conditions in their final audit report. CMS is considering changing this threshold. CMS proposes to create a validation work plan template that plans undergoing independent validation audits in 2019 would be required to submit. Additionally, plans would have 180 days (currently 150 days) from the date that CMS accepts their program audit Corrective Action Plans (CAPs) to undergo a validation audit and submit the report to CMS for review.

Annual CPE Audit Requirement

Plans that have undergone a CMS program audit must still conduct their annual CPE audit. CMS proposes allowing plans that have undergone a program audit to treat the program audit as meeting the annual CPE audit requirement for one year from the date of the CMS program audit.

Provider Directory Deficiencies

Appeals timeliness and IRE auto-forward data hasn’t been the only data in which CMS has been focused on accuracy. In the past couple of years, CMS has focused on the accuracy of provider directories. In 2016, over 45 percent of provider directory locations listed in these online directories were inaccurate, and in 2017, the inaccuracy rate increased to over 52 percent. Plans with provider directory deficiencies have received Notices of Non-Compliance (NONCs) or warning letters. While not a change in policy, but may be a possible forewarning, CMS clarifies that it has the discretion to enforce Civil Money Penalties (CMPs) for provider directory errors. CMPs imposed for provider directory errors would initially be calculated on a per determination basis. BluePeak is experienced in provider directory reviews and has found the same type of discrepancies as CMS.

CMP Plan Finder Icon

If a plan is unfortunate enough to receive a CMP for provider accuracy or other deficiencies, their misfortune may be on display on Plan Finder. CMS proposes to display a CMP icon on Plan Finder for the 2019 Annual Enrollment Period (AEP), for plans that receive a CMP in 2018, or a CMP for a 2017 CMS program audit.

Part C

Encounter Data

CMS will continue to hold encounter data listening forums in 2018. CMS presented its plan to monitor the completeness and accuracy of encounter data submissions, which included operational, completeness and accuracy performance, in the 2018 Call Letter. Stakeholder feedback suggested CMS adopt an incremental approach, while continuing to seek stakeholder feedback. CMS will review comments and finalize the performance and monitoring metrics and thresholds in an HPMS memo to be distributed in early 2018.

Part D


CMS will post a final CY 2019 Formulary Reference File (FRF) in March and proposes to move the summer update window, during which plans can remove drugs from their formularies prior the start of the plan year, from July to August. CMS will make the supplemental Additional Demonstration Drug (ADD) file available in the Health Plan Management System (HPMS) prior to the submission deadline. The supplemental Non-Extended Day Supply (NDS) file has been eliminated for CY 2019. CMS proposes to offer an over-the-counter (OTC) reference file for CY 2019.

Part B vs D Drugs

Proposed new guidance on immunosuppressant and inhalation drugs and whether they’re covered under Part B or Part D will provide much-needed clarification for plans. CMS proposes new guidance on how Part D sponsors should determine whether an immunosuppressant drug is a Part B drug and when to revise its findings if the information from CMS changes. Factors to consider when determining B vs D include whether the member had claims history, whether the plan received information from CMS and the member’s Medicare Advantage Prescription Drug System (MARx) indicator.

Medicare Part B covers certain inhalation drugs as supplies under the DME benefit; however, the DME benefit is not available to beneficiaries residing in long-term care facilities. Inhalation drugs administered in a long-term care setting where the stay is not covered under Medicare Part A can be covered under Part D. The challenge for plans has been how to determine if the drug was administered in a long-term care facility. CMS clarifies that Part D sponsors should rely on a patient residence code of “3” or “9” on a pharmacy claim for determining when such inhalation drugs may be covered under Part D. CMS will only pay claims for these products when the pharmacy claim includes these specified patient residence codes.

Opioid Overutilization

As the opioid crisis continues to worsen, CMS proposes several changes to the opioid overutilization edits that will help to identify and prevent overutilization. Some of the more significant proposed changes include implementing a hard edit when the daily Morphine Milligram Equivalent (MME) reaches or exceeds 90 mg, implementing a soft point-of-sale (POS) edit for duplicative therapy of long-acting opioid therapy, and implementation of a concurrent opioid and benzodiazepine soft POS safety edit. Monitoring and oversight is crucial in this area. BluePeak offers a claim review service to ensure plans are compliant in this area. CMS will align changes in opioid overutilization policy in Overutilization Management System (OMS) reporting and retrospective and concurrent Drug Utilization Review (DUR).

Final Call Letter

CMS plans to release the final 2019 Medicare Advantage and Part D Advance Notice and Draft Call Letter by April 2.