PQS Summary of Pharmacy/ Medication-Related Updates in the CY 2020 Final Call Letter

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Managing Performance Information in a Quality Driven World PQS Summary of Pharmacy/ Medication-Related Updates in the CY 2020 Final Call Letter REGULATORY UPDATE

PQS Summary of Pharmacy/ Medication-Related Updates in the CY 2020 Final Call Letter Key Dates & Links In February, PQS summarized the quality-related updates to the CY 2020 Draft Call Letter. To quickly understand how the proposed changes may have been finalized, confirmed, or changed, PQS has outlined in BLUE the confirmed details or comments as it relates to the proposed update or change. Final Call Letter Available HERE Deadline for submission of CY 2020 MTM Programs May 6, 2019 CY 2020 Bid submission deadline: June 3, 2019 Two-Minute Condensed/High-Level Summary of Medication-Related Updates in CY 2020 Final Call Letter 1. Many of the components and measures for 2020 will carryover from 2019. The largest changes contain: a. Changing the weighting for SUPD from a single weight to a triple weighted measure i. CMS changed their approach in the Final Call Letter and indicated this measure will remain a single weighting until further review and analysis is completed. b. Structure in place to evaluate impact from large, natural disasters in FEMA designated areas for the Part C and D summary and overall rating for MAPD contracts. Approach was confirmed. 2. New display measure anticipated to quickly transition to a Star Rating a. Transitions of Care measure will be an activity or service-based measure rather than a member-level measure. The denominator represents the number of discharges and will be scored against 4 different indicators which represent notifications of admission/discharge, documenting engagement post discharge and medication reconciliation post-discharge. b. Comments were received about the location/source of data for med-rec post discharge and NCQA is going to reevaluate how and where the documentation of med rec documentation can occur to receive numerator credit. 3. New measures lining up for the 2021 Display Page with the intent to become Star Rating Measures. The two polypharmacy measures are to be thought of as replacements for the HRM measure which will be retired from the display page. a. Concurrent Use of Opioids and Benzodiazepines b. Polypharmacy Use of Multiple Anticholinergic (ACH) Medications in Older Adults c. Polypharmacy Use of Multiple Central Nervous System (CNS)-Active Medications in Older Adults d. Overall, most commenters supported these measure additions to the display page. Some indicated the overlap between the two polypharmacy measures and the HRM measure and between the Poly-CNS and COB measures. CMS is going to perform additional analyses to assess the potential overlap and to ensure the measures are evaluating different concepts. e. Confirmed all three measures above will be added to the display page for 2021. 4. CMS is still evaluating potential changes to the methodology for calculating Star Ratings through a Technical Expert Panel. Additional details can be found here. 2

Enhancements to the 2020 Star Ratings and Future Measure Concepts (p. 120) New Measures for 2020 No new measures are being proposed for addition CONFIRMED. CMS is proposing 33 Part C Measures / 14 Part D Measures for CY 2020 CONFIRMED. Star Rating Measure Updates for 2020 (p.122) Medicare Adherence for Cholesterol (Statins) (Part D) [Steward: PQA] This adherence measure will also contain an exclusion for patients with End Stage Renal Disease (ESRD) for 2020 and joins the RASA and Diabetes adherence measures and the Statin Use in Persons With Diabetes (SUPD) measure to have an ESRD exclusion. For 2020, all PQA adherence measures plus SUPD will now have an ESRD exclusion. Medicare Adherence for: Diabetes Medications, Hypertension, Cholesterol (Statins) (all three) [Steward: PQA] Hospice Care Exclusion The current approach is to apply a PDC adjustment according to the time frame in which a member was enrolled in hospice. The new change is to simply exclude members who were enrolled in hospice at any time during the calendar year from the denominator completely. Some commenters also suggested additional exclusions or specification changes which were shared with PQA. Medication Therapy Management (MTM) Program Completion Rate for Comprehensive Medication Reviews (CMR) Measure (Part D) [Steward: PQA] As mentioned in previous summaries from past Call Letters, CMS is going to apply a new denominator rule focused on more accurately accounting for CMRs completed for enrolled beneficiaries with a limited time of total enrollment. More specifically, for beneficiaries who were enrolled in the MTM program for less than 60 days at any time during the calendar year, those members can be excluded from the denominator if a CMR wasn t received within the enrollment time period. However, if the member did end up receiving a CMR within the 59 day window, then the member can be counted for both the numerator and the denominator. Statin Use in Persons with Diabetes (SUPD) (Part D) [Steward: PQA] The 2019 Stars were the first year in which the SUPD measure became a Star Rating after coming off of the display measure bench. As such, any new measures newly added to the Star Ratings must contain a single weight. For the 2020 Stars, CMS is proposing to increase the weight of the SUPD measure to become a triple weighted measure (intermediate outcome measure). This has now changed, and CMS will continue with weight of 1. Many commenters opposed the classification of the measure since the Part C measure on Statin Therapy for Cardiovascular Disease is classified as a process measure. While CMS continues to review the measure, they will keep this measure as a single-weighted measure. o Commenters also detailed the need for the measure specifications to exclude statin-intolerant patients or that the measure should include non-statin therapies. v General Snapshot on Impact of Measure Weighting Of the proposed 14 measures for Part D for 2020, there are 5 measures endorsed by the Pharmacy Quality Alliance (PQA) where 3 out of the 5 measures will remain with a triple weight. The SUPD and MTM CMR Completion rate are both single weighted. As a result, the 5 measures will account for 40% of the contract s Part D Summary Star Rating. 3

Enhancements to the 2020 Star Ratings and Future Measure Concepts (cont.) Temporary Removal of Star Rating Measures for 2020 (p.125) Controlling High Blood Pressure (Part C) [Steward: NCQA] Measure will be removed from the 2020 Star Ratings and moved to the Display measures for 2020 and 2021, with the plan of reinstating as a Star Rating measure for 2022. Reasoning: o New hypertension treatment guidelines were released from the American College of Cardiology and the American Heart Association. As a result, the National Committee for Quality Assurance (NCQA) is updating the measure specifications to account for the new guidelines as well as some small structural updates to the calculation and qualifications as well. The updates include: Change blood pressure target to <140/90 mmhg Allow two outpatient encounters to identify the denominator and remove the medical record confirmation for hypertension One of the two outpatient encounters can be telehealth series Allow use of CPT category II codes for the numerator and allowing remote monitoring device readings for the numerator 2019 Star Rating Program and the Categorical Adjustment Index (p. 125) The Categorical Adjustment Index (CAI) was first implemented in 2017 as an interim analytical adjustment to account for disparities that exist in performance between contracts having beneficiaries with Low Income Subsidy and/or dual eligible (LIS/DE) and disability status. CMS has partnered with measure stewards to understand progress and potential impact of populations with LIS/DE and disabled beneficiaries, and additional work within the research community continues to take place to better understand and objectively define the impact of socioeconomic status (SES) on quality measurement. o PQA has completed draft considerations which will be finalized in 2019 once NQF has completed its review of needed measure endorsement maintenance. If finalized, CMS will consider how to implement the PQA recommendations for future Star Ratings. Specifically, PQA has drafted considerations for adjustment as it relates to the three adherence measures according to the characteristics of: age, gender, dual eligibility/lis status, and disability status and to stratify performance across the different characteristics to help understand how the patient population mix affects measure scores. CMS stated it will begin to test the draft specifications during the 2019 calendar year to understand the impact and potential implications for adopting in future years. o CMS has developed a set of candidate measures to re-evaluate for the Categorical Adjustment Index for the 2020 calendar year which contains the following potential measures: Adult BMI Assessment, Annual Flu Vaccine, Breast Cancer Screening, Colorectal Cancer Screening, Diabetes Care Blood Sugar Controlled, Diabetes Care Eye Exam, Diabetes Care Kidney Disease Monitoring, Improving Bladder Control, Medication Reconciliation Post-Discharge, MTM Program Completion Rate for CMR, Monitoring Physical Activity, Osteoporosis Management in Women who had a Fracture, Plan All-Cause Readmissions, Reducing the Risk of Falling, Rheumatoid Arthritis Management, Medication Adherence for Diabetes Medications, Medication Adherence for Hypertension, Medication Adherence for Cholesterol, Statin Therapy for Patients with Cardiovascular Disease, and Statin Use in Persons with Diabetes. Comments to the Draft Letter confirmed support and CMS clarified specific considerations for contracts in Puerto Rico. 4

Enhancements to the 2020 Star Ratings and Future Measure Concepts (cont.) 2019 Star Rating Program and the Categorical Adjustment Index (cont.) Extreme and Uncontrollable Circumstances Policy o CMS is proposing to potentially adjust the 2020 Star Ratings to consider extreme and uncontrollable circumstances that occurred during the measurement period o Impacted contracts would need to meet all the following criteria during the measurement period to be considered: Service area must be within an emergency area during an emergency period Service area must be within a county designated in a major disaster declaration under the Stafford Act A certain minimum percentage of the enrollees under the contract must reside in a FEMA designated Individual Assistance Area at the time of the extreme and uncontrollable circumstance o 25% of the enrollees must be in the area for consideration of a Star Adjustment o 60% of the enrollees must be in the area for consideration of exclusion from cut point and reward factor calculations o States/territories that had any counties with a FEMA declared disaster include: North Carolina, South Carolina, Florida, Georgia, Northern Mariana Islands, California and Alaska CONFIRMED. Comments to the Draft Letter confirmed support. Some commenters asked for additional consideration for contracts in locations with extreme and uncontrollable circumstances for multiple years. CMS stated they expect very few contracts to be impacted by multiple years and are concerned about too many years being pulled forward for the Star Ratings. 2020 Display Measures New Display Measures for 2020 (p. 144) Transitions of Care (Part C) [Steward: NCQA commissioned by CMS] o CMS has a strong desire to improve the quality of care transitions from an inpatient setting to home to help reduce hospital readmissions, costs, and adverse events. As a result, CMS has stated their intentions to transition this to a Star Rating in the near future. o The measure will exclude patients in hospice and will represent an age target of 18 years or older during the measurement year. o The measure will be an activity or service-based measure rather than a member-level measure. For example, the denominator will represent the number of discharges and will be scored against 4 different indicators. Indicators include: Notifications of admission/discharge Note: Documentation of primary care practitioner notification must occur on the day of or the following day of the admission. Documenting engagement post-discharge Note: Documentation of primary care practitioner notification must occur with 30 days of the discharge. 5 Medication reconciliation post-discharge Note: Documentation of medication reconciliation must occur with 30 days of discharge CONFIRMED. Most commenters supported the concept, and some had suggested ways to improve the measure.

2020 Display Measures (cont.) New Display Measures for 2020 (p. 144) Follow-up after Emergency Department Visit for Patients with Multiple Chronic Conditions [Steward: NCQA] o The measure will assess the percentage of emergency department visits for members 18 years and older who have high-risk multiple chronic conditions who had a follow-up service within 7 days of the ED visit between January 1st and December 24th of the measurement year. o This measure is not a member-level measure but is a visit-level measure where the denominator represents the number of ED visits, not members. o In order for the ED visit to count towards the new measure, members must have a diagnosis of two or more chronic conditions outlined below: v COPD and asthma Alzheimer s disease and related disorders Chronic kidney disease Depression Heart failure Acute myocardial infarction Atrial fibrillation Stroke and transient ischemic attack o Follow-up services below allow for numerator qualification: An outpatient visit (with or without telehealth), behavioral health visit, telephone visit, transitional care management services, case management visits, complex care management CONFIRMED. Most commenters supported the measure with most questions and comments to CMS relating to which services qualified as follow-up. To help clarify the services that would qualify as follow-up, CMS listed the following services that would meet the criteria: An outpatient visit (with or without telehealth modifier) A behavioral health visit A telephone visit Changes to Existing Display Measures for 2020 (p. 147) Transitional care management services Case management visits Complex Care Management Use of Opioids at High Dosage and from Multiple Providers (OHDMP) and Antipsychotic Use in Persons with Dementia (APD) (Part D) [Steward: PQA] o Measures will include updated methodology for calculating the total days supply which will also apply for The Use of Opioids at High Dosage (OHD) Use of Opioids from Multiple Providers (OMP) measures Concurrent Use of Opioids and Benzodiazepines (COB) Polypharmacy Use of Multiple Anticholinergic (ACH) Medications in Older Adults (Poly-ACH) Polypharmacy Use of Multiple Central Nervous System (CNS)- Active Medications in Older Adults (Poly-CNS) measures o Days supply calculation approach: Any days supply that extends beyond the end of the measurement period will be excluded In the case of multiple prescription claims with the same date of service, total days supply will only include the supply of the claim with the longest days supply In the case of multiple overlapping claims with different dates of service, there will be no adjustments for early fills or overlapping days supply (such as moving the prescription start date to the day after the previous fill has ended)* CONFIRMED. Most commenters supported the concept. Some commenters had suggested ways to improve the measure. *Noted above. 6

Looking at 2021 and Beyond Potential Changes to Existing Measures (p. 149) Plan All-Cause Readmissions (Part C) [Steward: NCQA] NCQA has made several changes to the measure which include: Adding observation stays as hospital discharges and readmissions in the denominator and numerator and removing individuals with high frequency hospitalizations (to prevent data from being skewed). Changing the population age from just those who are 65 years of age or older, to now include 18 and older. New recommendation to have a minimum denominator count of 150 in order for results to be included for assessment. Plan is for the measure to be a display measure for 2021 and 2022 and then shift to a Star Rating for 2023. Medication Reconciliation Post Discharge (Part C) [Steward: NCQA] NCQA is proposing to retire this standalone measure as it will be a component of the Transitions of Care measure mentioned earlier. Note: NCQA clearly indicated that the source data for completing the reconciliation post-discharge in the Transitions of Care measure must also be in the same location as the other indicators, which is the medical record of the primary care practitioner or ongoing care provider who is managing the patient s care. CONFIRMED, CMS will continue to use the standalone Med Rec post discharge measure. Concerns were raised regarding the requirement of the data source from the primary care or ongoing care provider s medical records in the transitions of care measure. As a result, NCQA will re-evaluate where the data should and can come from to meet numerator criteria. Use of Opioids from Multiple Providers and/or at High Dosage in Persons without Cancer (Part D) [Steward: PQA] PQA updated the measure specifications to align with the latest CDC Guideline where high dose opioids are 90 or greater morphine milligram equivalents (MME) over a period of 90 or more days. There are three measures looking at opioids at high doses, use from multiple providers, and then a combination of high dose and multiple providers Updated specifications will apply to the 2019 Patient Safety reports CMS plans to launch all three opioid measures for the 2021 display page CONFIRMED, majority of commenters approved the approach on the revision and inclusion for display. Some provided suggestions for additional exclusions and changes to the specifications which were shared with PQA. Additional detail was provided to indicate they will plan to add these measures to the 2023 Star Ratings. 7

Looking at 2021 and Beyond Potential Changes to Existing Measures Continued (p. 149) High Risk Medication Use in the Elderly (HRM) CMS has stated that the HRM measure will be retired as a display measure for 2021 and will also not report results in any patient safety reports CMS said they wanted to retire this measure so plan sponsors can spend more time focusing efforts on the two previously mentioned polypharmacy measures which will be added to the 2021 display page with the goal of having those two measures become Star Rating measures by 2023. CONFIRMED, commenters approved the measure to be retired. Additionally, CMS stated they will no longer report this measure in the Patient Safety results even for the 2019 measurement year. Adherence to Antipsychotic Medications for Individuals with Schizophrenia (Part C) [Steward: NCQA] This measure is currently only specified to assess care delivered to Medicaid enrollees aged 18-64. However, CMS began testing this measure in the fall of 2018 to evaluate the feasibility and potential to expand to include Medicare and older adults. CMS changed from previously stating it would be on the display page for 2021, and instead no longer provided a date until further testing is completed. Comments received were shared back to the measure steward, NCQA. 2021 Display Measures Additions with 2023 Star Rating Measure Targets Concurrent Use of Opioids and Benzodiazepines (COB) (Part D) [Steward: PQA] Polypharmacy Use of Multiple Anticholinergic (ACH) Medications in Older Adults (Poly-ACH) (Part D) [Steward: PQA] Polypharmacy Use of Multiple Central Nervous System (CNS)-Active Medications in Older Adults (Poly-CNS) (Part D) [Steward: PQA] Overall, most commenters supported these measure additions to the display page. Some indicated the overlap between the two polypharmacy measures and the HRM measure and between the Poly-CNS and COB measures. CMS is going to preform additional analyses to assess the potential overlap and to ensure the measures are evaluating different concepts. CONFIRMED. All three measures above will be added to the display page for 2021. 8

General Items Coverage Gap In a continued effort to reduce the coverage gap or donut hole associated with the Part D benefit, the co-insurance for 2020 is reduced. The cost sharing details for applicable and non-applicable medications are listed below: Applicable Medications (brand) Year Beneficiary Coinsurance (-10% from 2019) Plan Liability (-10% from 2019) Manufacturer Discount 2020 25% 5% 70% Non-Applicable Medications (generic) Year Beneficiary Coinsurance (-12% from 2019) Plan Liability (+12% from 2019) 2020 25% 75% Immunizations (p. 180) A 2018 study of Tdap and herpes zoster vaccine claims in Part D demonstrated that higher out-of-pocket cost-sharing was associated with higher rates of canceled vaccination claims, suggesting vaccination was abandoned. In this study, cost-sharing of $51 or greater was associated with a 2 to 2.7-times greater rate of canceled vaccination claims compared with $0 cost-sharing. In an effort to improve access to these and other Part D vaccines, CMS continues to encourage Part D sponsors to either offer a $0 vaccine tier, or to place vaccines on a formulary tier with low cost-sharing. v $ 2020 CY Estimated Proposed Out-of-pocket threshold: 9,719.38. Annual MTM Eligibility Cost Threshold CMS defines the general criteria for MTM eligibility where one of the criterion is the expected annual Part D drug costs for beneficiaries. The threshold for the 2020 program will be $4,255 (an increase of 5.21% from 2019). 9