BluePeak provides fresh insight into the CMS Proposed Rule for 2024

On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published proposed rule (CMS_FRDOC_0001-3474) in the Federal Register. If finalized, this proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, medication therapy management, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, identification of overpayments, formulary changes, and other programmatic areas. This proposed rule would also codify regulations implementing section 118 of Division CC of the Consolidated Appropriations Act, 2021, section 11404 of the Inflation Reduction Act, and includes a large number of provisions that would codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs. This proposed rule would also amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for an identified overpayment.

BluePeak provided a summary to the proposed rule and outlined the key provisions. BluePeak held webinars on January 26, 2023 covering highlights and impacts for Medicare Advantage Plan and February 2, 2023 covering highlights and impacts for PACE Organizations. Gain further insights on the MA implications, spotlight on PACE past performance and one potential impact of the proposed rule, and consultant corner thought article by BluePeak’s Part C lead in the below features.

Comments on the proposed rule are due to CMS on or before February 13, 2022.

Civil Money Penalty Methodology

In 2022, CMS revised its policies to update the minimum CMP penalty amounts once every three years. The intent of the minimum penalty increase policy was to establish the CMP calculation methodology document in regulation to ensure consistency and transparency with CMP penalty amounts.  Although the regulations set standards for CMP penalties, CMS believes that other parts of the regulations unnecessarily complicate CMS’s approach to calculating CMPs.  As a result, CMS’s ability to protect beneficiaries is limited when CMS determines that a Plan’s non-compliance warrants a CMP amount that is higher than what would normally be applied under the CMP methodology.  Additionally, even though CMS always had the authority to impose CMPs up to the maximum, part of the minimum penalty increase policy may have inadvertently given the false impression that CMS was limiting its ability to impose CMPs up to the maximum permitted by regulation.

To correct, CMS proposes to remove regulations related to the cost-of-living multiplier and regulations that describe how CMS calculates and applies the minimum penalty amount. CMS also proposed to add new provisions to explain that CMS will set standard minimum penalty amounts and aggravating factor amounts for per determination and per enrollee penalties on an annual basis.   CMS also restated that they have discretion to issue penalties up to the maximum amount they determine that a Plan’s non-compliance merits a penalty that is higher than would be applied under the minimum penalty amounts set by CMS.

CMS indicated that if these changes are finalized, they would continue to follow the existing CMP methodology and would only impose the maximum CMP amount when a situation warrants a higher penalty.

Call Center Changes

In its continued efforts to help ensure adequate and appropriate access are available for non-English speaking and limited English proficient beneficiaries, CMS has proposed to codify the minimum qualification requirements for interpreters available at MA and Part D call centers that were recommended in its December 16, 2021 memo entitled “2022 Part C and Part D Call Center Monitoring—Timeliness and Accuracy & Accessibility Studies”,  CMS has proposed to require Plans to use interpreters that adhere to generally accepted interpreter ethics principles, including confidentiality, demonstrate proficiency in speaking and understanding at least spoken English and the spoken language in need of interpretation, and interpret effectively, accurately, and impartially, both receptively and expressively, to and from the language and English, using any necessary specialized vocabulary, terminology, and phraseology.

CMS’ newly proposed interpreter qualifications are also in line with the August 2, 2022 Notice of Proposed Rulemaking published by HHS regarding Section 1557 of the Affordable Care Act, which would codify a definition of qualified interpreter similar to what CMS has proposed.

Collections:  Failure To Collect and Incorrect Collections of Part D Premiums and Cost Sharing Amounts

CMS proposes to bring Part D Plans into alignment with MA Plans by requiring that Part D Plans make a reasonable effort to collect monthly beneficiary premiums and to ensure collection of cost share when drugs are dispensed, including billing for and recovering premium or cost sharing amounts after the fact.   CMS also proposes to add that any adjustments to the premium or costs sharing amounts be made within the timeframe for coordination of benefits, which is 3 years from the date on which the monthly premium was due or on which the prescription for a covered Part D drug was filled.  CMS also proposes that a Part D sponsor could decline to attempt to recover amounts if they are below the de minimum amount set for purposes of low-income subsidies, which is $2 for 2023.

Because there was previously no historical limit or threshold for these refunds and recoveries, establishing both a 3-year lookback period and de minimis amount would remove significant administrative burden, particularly in circumstances where the amount to be refunded or recovered is minimal.  Essentially, a Part D Plan wouldn’t need to make a premium or claims adjustment if more than 3 years has passed from the date of service, which aligns with the requirement for Part D Plans to coordinate benefits for 3 years.

Medication Therapy Management

Medicare Advantage Plan Part D Sponsors are required to incorporate a Medication Therapy Management (MTM) Program into their annual plan benefits.  The longstanding goal of MTM has been to target and enroll beneficiaries with complex diseases states and high medication usage to optimize therapeutic outcomes by reducing adverse effects and improving medication adherence. Recent trends have demonstrated plans are experiencing limited beneficiary enrollment due to use of the most restrictive MTM program identification criteria to qualify beneficiaries in their MTM programs. Many beneficiaries with complex drug regimens have not been included in MTM programs due to the use of narrow inclusion criteria as well as the increasing annual cost thresholds.

CMS is proposing several changes to the minimum identification requirements for inclusion in MTM programs in their proposed rule. Currently, plans are required to select a minimum of five chronic diseases from a subset of nine disease states for inclusion in their identification criteria. CMS is proposing all nine core chronic diseases states plus HIV/AIDS must be included in MTM targeting criteria. In terms of individual medications, a minimum threshold between two and eight medications is also currently required for identification. The proposed rule reduces the maximum number of medications from eight to five and requires inclusion of all maintenance medications for identification. Lastly, the annual cost threshold for 2023 is $4,935. CMS is proposing a decrease to $1,004 in 2024.  CMS believes these changes will better align MTM eligibility criteria with statutory goals to reduce medication errors and optimize therapeutic outcomes.

Additionally, CMS is proposing the Comprehensive Medication Review (CMR) must include an interactive consultation that is conducted in real-time, regardless of whether it is done in person or via telehealth. These changes may result in increased enrollment into MTM programs and require increased resources to comply with the proposed rule.  Therefore, plans should be proactive and consider taking the following actions:

• Review the proposed updates for MTM
• Draft and submit comments about the proposed MTM changes
• Have discussions with the plan’s MTM vendor (if delegated) to ensure that they would be able to support to the proposed changes
• Use modeling to determine how the proposed changes will impact the number of members that qualify for MTM and whether additional resources will be needed

Updating Translation Standards for Required Materials and Content

Through its oversight activities, CMS learned that many enrollees need to request materials in other languages or alternate formats each time they need a document and also learned that some Plans were not providing individualized care plans (ICPs) to SNP members in their preferred language or format.  Under the proposal, MA organizations and Part D sponsors would be required to provide materials, including ICPs, on a standing basis to enrollees in any non-English language that is the primary language of at least 5% of the individuals in a Plan benefit package service area or is accessible using auxiliary aids and services, as long as the enrollee remains enrolled in the Plan or advises otherwise.

These requirements are in addition to requirements related to providing meaningful access to individuals with limited English proficiency and effective communication for individuals with disabilities. Where one set of regulations imposes a higher or different standard, but it is not impossible for the Plan to comply with both, the Plan must comply with both.

CMS is also proposing to require that fully integrated dual eligible special needs plans (FIDE SNPs), highly integrated dual eligible special needs plans (HIDE SNPs), and applicable integrated plans (AIPs) translate required materials into any languages required by the Medicare translation standard plus any additional languages specified through their Medicaid capitated contracts.

It is suggested that Plans review their processes to ensure that once an enrollee requests materials in another language or an alternate format, your systems have the capability to retain that request and it is applied for all requests going forward.  Additionally, this information should be shared with all FDRs that interact or send information to enrollees to ensure they are also able to effectively implement.

Updating Translation Standards for Required Materials and Content

CMS has proposed several updates and some new marketing requirements to help ensure beneficiaries receive clear and consistent messaging from Plans that are not confusing or misleading.   Some of the highlights include CMS’ proposal to expand requirements for third party marketing organizations (TPMOs) by requiring them to submit marketing materials they develop directly to CMS for approval after the TPMO has obtained approval from each Plan it will be used for.  Additionally, CMS also proposed that TPMOs be required to go over each CMS required question or topic with beneficiaries during the enrollment process to ensure the TPMO truly understands the beneficiaries’ needs and helps to place them in the correct Plan.  CMS is also looking to reduce misleading marketing by requiring that marketing be tailored to each service area to avoid beneficiaries receiving marketing and benefit information that is not available to them in their service area.

In additional to new requirements for TPMOs, CMS has also proposed that Plans have Oversight and Monitoring Plans for their TPMOs to ensure they are conducting activities and interfacing with beneficiaries in a correct manner and have a process for reporting non-compliance to CMS.

Star Rating Changes

CMS proposed many changes to its Quality Rating System, also known as the Star Ratings, for the 2024 measurement year, which would equate to the 2026 Star Ratings.

Health Equity Index (HEI):  CMS proposes adding a health equity index (“HEI”) reward for the 2027 Star Ratings to further incentivize MAOs and Part D sponsors to focus on improving care for enrollees with social risk factors (“SRFs”), such as dual eligibility, low-income subsidies and disability.  A health equity index summarizes contract performance among those with specified SRFs across multiple measures into a single score. The HEI would reward contracts for obtaining high measure-level scores for the subset of enrollees with specified SRFs. It is CMS’s intent in implementing an HEI to improve health equity by incentivizing Plans to reduce disparities in care. Plans can play a key role in advancing health equity by driving value in care delivery, developing metrics to accountability and equitable delivery of preventive and medical benefits, offering supplemental benefits to address gaps in care.

CMS also proposes several additions, deletions and revisions to the Star Ratings themselves, but some of the more significant changes involve CMS moving the following three Part D Measures from the Display Pages to the Star Ratings:

• COB: Concurrent Use of Opioids and Benzodiazepines
• Poly-ACH – Polypharmacy use of multiple Anticholinergic Medications
• Poly-CNS – Polypharmacy use of multiple Central Nervous System Active Medications

CMS also proposes to reduce the weight of patient experience/complaints and access measures by half (from four to two) to further align with other CMS quality programs and the current CMS Quality Strategy that promotes quality outcomes. In addition, CMS proposes to remove guardrails (bi-directional caps that restrict upward and downward movement of a measure’s cut points compared to the prior year) when determining measure-specific-thresholds for non-Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures, modify the Improvement Measure hold harmless policy; include an additional rule for the removal of Star Ratings measures; and remove the 60 percent rule that is part of the adjustment for extreme and uncontrollable circumstances. The proposed changes would further drive quality improvement and health equity in MA and Part D.