ACCC Policy Update, Part 2

In this election year, U.S. healthcare policy is center stage. ACCC is monitoring proposed rules and policy changes to gauge their impact on cancer care access and delivery.

ACCC Responds to CMMI on Oncology Care First Model

ACCC provided comments to the Center for Medicare and Medicaid Innovation’s (CMMI's) request for information on its concept for the Oncology Care First (OCF) Model. While applauding CMMI for making the OCF Model voluntary and envisioning a multi-payer model, ACCC urged CMMI to:

• Make significant changes to the risk tracks for the purposes of performance-based payment episodes.
• Structure the prospective payment for care management and certain other services as a supplemental payment.
• Provide more detail about the methodology for the novel therapy adjustment and ensure that the final adjustment adequately accounts for the cost of innovative and often life-saving new therapies.
• Provide more details and future opportunities to comment on the OCF before finalizing the Model.

340B Under Scrutiny

In early January 2020, the Government Accountability Office (GAO) released a report calling on the Health Resources and Services Administration (HRSA)—an agency of the U.S. Department of Health and Human Services (HSS)—to improve processes for assuring that participating non-governmental hospitals meet 340B Drug Pricing Program eligibility requirements.

Under the 340B Program, certain hospitals and other qualified entities that care for a high volume of low-income and uninsured individuals can receive discounted prices on outpatient drugs from drug manufacturers. About two-thirds of hospitals participating in the 340B Program (approximately 1,700) are non-governmental hospitals (i.e., private, nonprofit hospitals). The GAO report recommends that HRSA:

• Implement a process to verify that all non-governmental hospitals have contracts in place, including throughout hospitals’ audit periods
• Amend its contract reviews to include an assessment of whether contracts meet statutory requirements
• Provide better guidance on contract reviews

HHS agreed with the GAO recommendations with the exception of the recommendation to set up a process to verify that all non-governmental hospitals have contracts in place. HHS says that HRSA does not have the resources to carry out the recommended verification process and it would over-burden the agency.

Later in January, the GAO issued a second 340B report calling on HRSA and CMS to take action to prevent drug manufacturers from paying duplicate discounts under Medicaid and the 340 Drug Pricing Program. In response, HHS and 340 participating hospitals assert that HRSA cannot legally follow the GAO’s request to examine states’ duplicate discount prevention policies and procedures, then act to enforce these if providers do not comply. CMS states that HRSA lacks the authority to determine the adequacy and appropriateness of state Medicaid policies and procedures to prevent duplicate discounts. 

Although CMS has appealed the District Court decision that the agency exceeded its statutory authority under the Hospital Outpatient Prospective Payment Systems (OPPS) to adjust 340B drug payment rates, CMS recently signaled its intention to go forward with a survey of 340B participating hospitals to set payment rates based on the cost of drugs acquired under the program. A notice published on February 7, 2020 in the Federal Register states:

The acquisition cost data hospitals submit in response to this survey will be used to help determine payment amounts for drugs acquired under the 340B program. We want to ensure that the Medicare program pays for specified covered outpatient drugs purchased under the 340B program at amounts that approximate what hospitals actually pay.

Comments to the notice are due March 9.

Medicaid Block Grants: Impact on Cancer Patients

On January 29, 2020, CMS released guidance that would permit states to receive block grants for adults not otherwise eligible for Medicaid (i.e., adults younger than age 65). Dubbed the “Healthy Adult Opportunity,” the agency is calling the plan a demonstration. In accepting the block grant—and thus capping the state’s federal funding for Medicaid beneficiaries—the state would have greater flexibility in determining benefits’ coverage and enjoy a less complex process for adding work requirements and other restrictions. Oncology stakeholders, along with patient advocacy groups, expressed concern that the transformation of Medicaid through block grants could reduce access to care and result in the rationing of services for the most vulnerable patient populations. As with Medicaid work requirements, CMS’ legal authority to push this plan forward is likely to be the subject of litigation.

Stay tuned for more policy updates from ACCC.

Access Part 1 of ACCC’s Policy Update here