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

WASHINGTON, July 1 -- Kristin Julason Damato, vice president for global public policy and government affairs at Cigna, has issued a public comment on the Centers for Medicare and Medicaid Services proposed rule entitled "Medicaid Program: Establishing Minimum Standards in Medicaid State Drug Utilization Review and Supporting Value-Based Purchasing for Drugs Covered in Medicaid, etc.; Delays of Effective and Inclusion Dates". The comment was written on June 25, 2021, and posted on June 28, 2021:

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Cigna welcomes the opportunity to respond to the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS or the agency) of the Department of Health and Human Services relating to delaying certain effective dates for establishing minimum standards in the Medicaid State Drug Utilization Review and supporting value-based purchasing (VBP) for drugs covered in Medicaid. Cigna appreciates CMS's efforts to encourage VBP arrangements with manufacturers of prescription drugs.

Cigna Corporation is a global health service organization dedicated to helping people improve their health, well-being, and peace of mind. Our subsidiaries are major providers of medical, pharmacy, dental, and related products and services, with over 175 million customer relationships in the more than 30 countries and jurisdictions in which we operate.

Within the United States, Cigna provides medical coverage to approximately 14 million Americans in the commercial group health plan market, predominantly in the self-insured segment. We also provide coverage in the individual Affordable Care Act insurance segment in several states, both on- and off-Exchange, to about 235,000 people. Additionally, we serve more than 4.5 million people through our Medicare Advantage, Medicare Prescription Drug Program and Medicare Supplemental products. In all of the segments we serve, Cigna is focused on creating products and services that support a quality, affordable, equitable, and sustainable health care system for all Americans.

With that context as background, Cigna offers the following comments on the proposed rule.

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Comments on Proposed Delays in Effective and Inclusion Dates of Certain Regulation Provisions As noted in our July 20, 2020 comment letter in response to the 2020 proposed rule on this subject,/1 Cigna supports the broader adoption of VBP arrangements to tie the payment of medications to clinical outcomes. VBP arrangements are a critical tool used by payers and pharmaceutical manufacturers to continue to shift our health care system to one that enables the investment of resources to maximize clinical value to patients, payers, states, and the federal government.

Further, Cigna supports revising existing definitions under the Medicaid Drug Rebate Program to clarify how manufacturers should account for discounts, rebates, and other price concessions resulting from VBP arrangements when determining average manufacturer price and best price for a covered outpatient drug.

Cigna appreciates CMS's recognition of the complexity of implementing the new VBP policy and its proposal to delay the amendatory instruction 10.a. of the December 31, 2020 final rule/2 for six months. While the final rule takes positive steps to increase the adoption of VBP arrangements, Cigna urges CMS to leverage the additional time to review the final rule for potential enhancements that would further align with CMS's goal of supporting state flexibility and promoting further VBP innovation. For example, CMS should continue to focus on providing adequate resources and assistance to states in developing the necessary systems and technology needed to facilitate the timely collection and reporting of patient clinical outcomes. To the greatest extent possible, CMS should encourage and incentivize consistency in these systems across states. Additionally, CMS should provide clarity on whether and to what extent new VBP arrangements run afoul of the federal anti-kickback statute (AKS), and should work to remove barriers imposed by the AKS that limit or prevent the adoption of VBP arrangements.

Finally, the proposed rule notes that CMS expects to issue additional guidance before the new effective date on the VBP program, including specifications related to beneficiary protections. Cigna requests that any such guidance be issued expeditiously to allow all stakeholders sufficient time to align implementation to the guidance.

Thank you for your consideration of these comments. Cigna would welcome the opportunity to discuss these issues with you in more detail at your convenience.

Respectfully,

Kristin Julason Damato

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Footnotes:

1/ Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (85 FR 37286)

2/ Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (85 FR 87000)

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The proposed rule can be viewed at: https://www.regulations.gov/document/CMS-2020-0072-30224

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