Devoted Health Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

WASHINGTON, April 15 -- Devoted Health, Waltham, Massachusetts, has issued a public comment on the Centers for Medicare and Medicaid Services' proposed rule entitled "Medicare and Medicaid Programs: Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly". The comment was written on April 6, 2020, and posted on April 10, 2020:

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Devoted Health appreciates the opportunity to submit comments on the above proposed rule published by the Centers for Medicare & Medicaid Services (CMS), February 18, 2020. As a Medicare Advantage plan, Devoted Health is committed to working with CMS to help formulate rules and policies that advance what we believe are Medicare beneficiaries top priorities in health benefits: quality, cost and choice. Please consider the following comments and proposals.

D-SNP contracting: II. E, (pg. 53)

Devoted Health supports CMS' intent for meaningful oversight of products that have significant duals concentration. However, we are concerned that in states that limit D-SNP approval to parent organizations that have existing Medicaid contracts, this will have the anticompetitive effect of locking out new plan entrants. We are also concerned that the proposed requirements are overly stringent, especially with respect to new plan benefit package launches. Finally, while we applaud CMS' focus on D-SNPs as a meaningfully better choice for many full duals, we are concerned that the language as proposed will limit appropriate plan benefit package choices for partial duals.

We propose the following three points:

- Expand the proposed exemption for all new plan benefit packages to the first three years to allow time for the plan to appropriately respond to any unexpected enrollment patterns.

- Exclude states that require that the parent organization of the D-SNP to have an existing state Medicaid contract.

- Limit the numerator to full duals as opposed to both partial duals and full duals.

Permitting a Second, "Preferred", Specialty Tier in Part D (Secs. 423.104, 423.560, and 423.578): V. F (pgs. 173-203)

Devoted Health strongly supports the proposal for CMS to permit a second "preferred" specialty tier in Part D. This will give plans greater flexibility to align incentives to promote the use of cost-effective medications that result in the lowest net cost for the Part D program, beneficiaries, and participating value-based providers. Allowing a preferred specialty tier can afford plan sponsors the opportunity to align cost shares across medical (Part C) and pharmacy (Part D) benefits, providing greater clarity and expanding affordable choices to beneficiaries making joint decisions with their providers about treatment. We believe that a secondary preferred specialty formulary tier is an additional tool that plans can use to manage drug costs and should be considered optional based on a plan sponsor's specific circumstances.

We support:

- CMS allow plans the flexibility to adminster formularies with a second preferred tier

- Provide plan sponsors the choice to have a second preferred specialty tier or not

We do not support:

- The requirement that plans allow tier exceptions between the preferred and non-preferred specialty tiers. This adds administrative burden to the plan and can diminish the benefits of manufacturer discounts for drugs on the preferred specialty tier.

It is also misleading to the beneficiary as members who use specialty medication are generally in the catastrophic coverage phase by their second or third fill, making the results of a tier exception null.

- Limiting the cost share of the preferred specialty tier to 25-33% co-insurance. Given that the highest cost share allowed for drugs covered under the medical benefit is 20%, CMS should allow plans the flexibility to have cost shares as low as 20%, if not lower, providing parity across medical and pharmacy benefits and truly giving beneficiaries an apples-to-apples cost comparison between clinically equivalent medications.

- Limiting the preferred specialty tier to only generic and biosimilar drugs. Plans should be able to place drugs for which they are able to secure the lowest net cost in the preferred specialty tier. Brand or reference biologic drugs can, and in many cases are, lowest cost to the plan, and ultimately to the beneficiary, who experiences savings in Part D cost share or plan premium (or both).

Section V.E.5. Adding, Updating, and Removing Measures (c)(1) (page 159) New Measure: Transitions of Care (including non substantive changes also presented)

We agree with the non substantive changes, especially to broaden forms of communication.

Section V.E.5. Adding, Updating, and Removing Measures (a) (page 155) Removal of Rheumatoid Arthritis Management (ART) measure.

Devoted Health agrees with the removal of this measure. From a clinical perspective, a single fill of a DMARD medication is not indicative of effective treatment or proper access to care for rheumatic disease. Measuring adherence to DMARD therapy is a stronger indicator of effective management, but the methodology of the measure does not account of the reality of the treatment course of rheumatoid arthritis; specifically, it does not account for patients in remission nor does it account for patients who have alternative means of paying for treatment (resulting in gaps in claims data). In addition, historical performance data suggest that there is a performance ceiling effect to the current measure's methodology.

In the continuum of care for rheumatoid arthritis, ensuring that patients have been assessed by a rheumatologist is key in ensuring early detection and proper diagnosis.

Retrospective data suggest that care by a specialist can lead to better disease outcomes and less long-term functional disability. Access and continuous care by a rheumatologist in patients with rheumatoid arthritis should be considered when assessing the quality of care patients with this disease receive.

Section V.E.5. Adding, Updating, and Removing Measures (b)(2) (page 157) Reclassification of the Statin Use in Persons with Diabetes (SUPD) measure as a Process Measure, rather than as an Intermediate Outcomes measure, which changes the measure weight back to 1x-weight beginning with the 2021 measurement year.

Devoted Health agrees with classifying the SUPD measure as a Process Measure. A single fill of a statin medication does not constitute a therapeutic outcome. Statins are only a single part of a comprehensive strategy in lowering adverse cardiovascular outcomes and simply looking at initiation as an outcome measure is inappropriate. The measure also does not account for (i.e. exclude) patients who would otherwise qualify for the measure but are statin intolerant.

Section V.E.8. Quality Bonus Payment Rules

Codify rule that any new contract under an existing parent organization that has had MA contract(s) with CMS in the previous 3 years receives an enrollment-weighted average of the Star Ratings earned by the parent organization's existing MA contracts.

Devoted Health disagrees with the proposal to provide new contracts with a weighted average star rating and would propose to continue to give new contracts a 3.5% QBP payment. The proposed rule discourages growth of new entrants and instead favors growth of legacy plans who have more star ratings leverage in the weighted average.

This is especially sensitive to first plans given the disruption COVID poses. Most disaster policy accommodations allow plans to fall back on previous year rates, which new plans do not have the opportunity to fall back on.

Past Performance (Secs. 422.502 and 423.503) pg. 365

Devoted Health agrees with CMS' sub regulatory proposal to replace the current past performance methodology and replace it with a more narrow approach to evaluate three factors, each of which, on its own, represents significant non-compliance with an MA or Part D contract, as bases for denying an MA or Part D application: (A) the imposition of civil money penalties or intermediate sanctions, (B) low Star Ratings scores, and (C) the failure to maintain a fiscally sound operation.

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0010-0002

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