CMS has released a proposed rule that would update program policies for Medicare Advantage and Medicare Part D beginning in 2021, if finalized. CMS has also released the draft Call Letter for 2021; however, this year’s Call Letter is limited to standard benefit parameters, risk-sharing, and other technical details and does not feature any additional policy proposals, as it had in previous years. CMS has said that the policy guidance typically found in the Call Letter is contained in the proposed rule.

Comments on the draft Call Letter are due by Friday, March 6, 2020.

Comments on the proposed rule are due Monday, April 6, 2020.

Plan Sponsors Would be Able to Have Two Specialty Tiers, CMS Proposes to Lower Maximum Specialty Cost-Sharing for All Plans

• CMS is proposing to allow plans to have two specialty tiers, with differential cost sharing, if they choose.
• In order to prevent discrimination and address concerns over actuarial equivalence, CMS is proposing the following parameters:
  • Plan sponsors would have option of allowing tiering exceptions between the two specialty tiers, if a clinically equivalent product is on the lower cost-sharing tier (e.g. both drugs could not both be on the same specialty tier);
  • Plan sponsors would still be permitted to not allow tiering exceptions to a non-specialty tier, in keeping with current policy;
  • CMS is not proposing a maximum cost-sharing amount for the preferred specialty tier, as long as the cost sharing on the preferred specialty tier is less than the cost-sharing on the non-preferred specialty tier;
  • Plans would not be required to place generics or biosimilars on the preferred specialty tier.

CMS Considers Limiting Specialty Tier Cost-Sharing to 25% for All Plans

• Under current policy, plans with a deductible may have up to 25% cost-sharing on their specialty tier; plans with no deductible may have up to 33% cost-sharing on the specialty tier;
• CMS is soliciting comment on a policy to cap the cost-sharing for a specialty tier at 25%, regardless of whether the plan has a deductible or not;
• In an instance where a plan would have two specialty tiers, the 25% maximum cost-sharing would apply to the non-preferred tier and the cost-sharing for the preferred specialty tier must be lower than 25%.

Specialty Tier Threshold Increases to $780, Ingredient Cost Would be Used Under Proposal

• CMS is proposing to increase the specialty tier threshold to $780, a $110 increase from the current threshold of $670;
• CMS is also proposing to review the threshold annually, but only increase the threshold if the increase would be a change of more than 10%;
• CMS is also proposing to use only the drug’s ingredient cost when determining the price of the drug and eligibility for specialty tier status.

Drug Management Programs (DMPs) for Beneficiaries At-Risk for Abuse or Misuse of Frequently Abused Drugs Become Mandatory in 2022

• The Comprehensive Addiction and Recovery Act of 2016 requires Part D plan sponsors to establish DMPs for potential at-risk beneficiaries;
• CMS notes that the majority of Part D plan sponsors have already voluntarily implemented DMPs, CMS is proposing to make the programs mandatory as of January 1, 2022 (as required under the SUPPORT Act);
• Beneficiaries with a history of opioid-related overdoses must be included in DMPs, and CMS is required to notify plan sponsors of any such identifications

Plans Must Implement Real Time Benefit Tool (RTBT) by 2022

• Previously, CMs adopted a requirement that plans support a prescriber electronic RTBT (“prescriber RTBT”) that could integrate with at least one e-prescribing or electronic health record (EHR) system beginning January 1, 2021.
• CMS is now proposing plan sponsors implement a beneficiary RTBT by January 1, 2022.
  • The tool must allow enrollees to view “accurate, timely, and clinically appropriate” patient-specific real-time formulary and benefit information.
  • The formulary status of clinically appropriate alternatives, including utilization management requirements, must also be available.
• The requirement could be fulfilled using existing secure patient portals.
• Plans would be allowed to offer rewards and incentives (RI) of nominal value to enrollees who log onto the RTBT or call the plan’s call center for this information.
  • The incentives may not be in the form of enrollee remuneration, such as waiving copays or deductibles, or cash or monetary donations.
• The information available through an RTBT would also have to be available through a customer service call center.
• Plans would be allowed to have their P&T committee evaluate whether certain medications should be excluded from the RTBT in certain situations.

CMS Proposes Technical Changes to Star Ratings

• CMS is proposing to increase the weight of the patient experience/complaints and access measures to a 4, up from a 2.
• Outliers will be removed prior to calculating cut points in an effort to increase the predictability and stability of the Star Ratings system.
• Collected data and performance measurements under these new rules would begin for the 2021 measurement period and the 2023 Star Ratings.
• CMS is also proposing to remove the Rheumatoid Arthritis Management (Part C) measure, update specification for two Health Outcomes Survey (HOS) outcome measures, modify the SUPD measure classification to a process measure, and add two new Part C measures.

Draft Call Letter Includes Proposed Benefit Parameters for 2021 Plan Year

Standard Benefit	2020	2021 (Draft)
Deductible Beneficiary is responsible for 100% of drug costs.	$435	$445
Initial Coverage Limit Beneficiary is responsible for 25% of drug costs and the plan sponsor is responsible for 75% of drug costs, until total drug costs reach $4,020.	$4,020	$4,130
Out-of-Pocket Threshold Beneficiary is in coverage gap until out-of-pocket spending (including the value of any manufacturer rebates) reaches $6,350. During this time, beneficiary is responsible for 25% of drug costs. Brand manufacturers are responsible for 70% of drug costs for branded products, via rebate. Plan sponsors are responsible for 5% of drug costs for branded products and 75% of drug costs for generic products.	$6,350	$6,550
Catastrophic Coverage Once a beneficiary reaches $6,350 in out-of-pocket costs (including the value of manufacturer rebates paid on the beneficiary’s behalf), beneficiaries face the greater of 5% of drug costs or the following cost-sharing for the remainder of the plan year: ·         Generic/Preferred Multi-Source Drug ·         Brand Drug	$3.60 $8.95	$3.70 $9.25
Maximum Copayments for Non-Institutionalized Dual Eligibles
Up to 100% of federal poverty level (FPL) ·         Generic/Preferred Multi-Source Drug ·         Brand Drug	$1.30 $3.90	$1.30 $4.00
Over 100% of FPL ·         Generic/Preferred Multi-Source Drug ·         Brand Drug	$3.60 $8.95	$3.70 $9.20
Partial Subsidy ·         Deductible ·         Coinsurance up to out-of-pocket threshold ·         Maximum copayments above OOP threshold ·         Generic/Preferred Multi-Source Drug/Biosimilar ·         Other	$89.00 15%   $3.60 $8.95	$92.00 15%   $3.70 $9.20