Congress Passes Sprawling Year-End Legislative Package that Impacts Cancer Research and Delivery

December 22, 2020

Congress recently passed an end-of-year legislative package that provides federal funding for Fiscal Year (FY) 2021 and includes numerous provisions that will directly impact patients with cancer and their entire cancer care team. The package includes:

CLINICAL TREATMENT Act – As part of the legislation, Congress passed the CLINICAL TREATMENT Act, one of the Association for Clinical Oncology’s (ASCO’s) top advocacy priorities. The bill requires Medicaid to cover routine care costs for patients with life-threatening conditions who are enrolled in clinical trials. ASCO thanks all of its members who wrote letters, made phone calls, and talked to policymakers about the importance of this legislation!

COVID-19 Relief – The bill allocates:

  • $3 billion for the Provider Relief Fund (PRF), which was established to provide financial relief to and support for healthcare providers affected by the COVID-19 pandemic
  • $22.4 billion in testing, contact tracing, surveillance, containment, and mitigation, with dedicated funding to expand access to high-risk and underserved populations
  • $19+ billion to manufacture, produce, and purchase COVID-19 vaccines, therapeutics, and ancillary supplies
  • $8.75 billion for vaccine distribution, administration, planning, preparation, promotion, monitoring, and tracking

The bill does not make permanent the flexibilities and reimbursement for telehealth granted during the Public Health Emergency (PHE), with small exceptions for mental health. ASCO will continue to advocate for those changes in 2021.

Funding for Cancer Research – The bill provides $42.934 billion for National Institutes of Health (NIH), a $1.25 billion increase over FY2020.

Specifically, the bill provides:

  • $6.56 billion for the National Cancer Institute (NCI), including $250 million to raise NCI’s paylines
  • $3.2 billion for the Food and Drug Administration (FDA), including full funding ($70 million) for the 21st Century Cures Act
  • Full funding ($30 million) for the STAR Act to expand research on childhood cancer and therapeutics to treat children with cancer

In 2021, ASCO will continue to advocate for more significant funding increases for cancer research, including emergency funding to the NIH to mitigate disruptions caused by COVID-19.

Evaluation and Management (E&M) Changes – The bill injects $3 billion into the 2021 Medicare Physician Fee Schedule (PFS) in 2021, resulting in payment increases across the board to help all Medicare providers during the ongoing COVID-19 pandemic. The bill  delays  the Centers for Medicare & Medicaid Services (CMS) from paying for the add-on code for inherently complex E&M visits under the PFS to 2024, the savings from which will be used to increase the conversion factor and therefore limit cuts to some specialties. ASCO is assessing the full impact of these changes on oncology and will provide additional details in early 2021.

Medicare Sequester Relief – The package included an additional three months of relief from the 2% sequestration cuts to Medicare payments. While the brief reprieve is welcome, ASCO will continue to advocate for a longer reprieve given the ongoing pandemic.  ASCO recently endorsed the Medicare Sequester COVID Moratorium Act (H.R. 8840), which would delay the Medicare sequester for the duration of the public health emergency (PHE). All ASCO members are encouraged to use the ACT Network to contact their representatives in Congress to urge their support for this important legislation.

Surprise Billing – The bill would also end surprise medical billing and ensure that patients are only responsible for in-network payment rates.

The agreement provides for a 30-day open negotiation period for providers and payers to settle out-of-network claims. If the parties are unable to reach an agreement, they may choose to use a binding arbitration process or an independent dispute resolution (IDR). The arbiters would consider median in-network rates, information related to the providers’ experience and the complexity of services. Parties will be allowed to batch and initiate dispute resolutions once every 90 days.

The bill also prohibits out-of-network providers from billing patients unless patients are notified 72 hours before receiving out-of-network services. Additionally, health care providers and facilities will need to verify three days in advance of service and not later than one day after scheduling of service, what type of coverage the patient is enrolled in and provide notification of a good faith estimate to the payer or patient whether or not the patient has coverage.

Temporary Freeze of Advanced Alternative Payment Models (APM) Payment Incentive Thresholds –

The package freezes the current payment and patient count thresholds for physicians and other eligible clinicians participating in APMs to receive a 5% incentive payment in payment years 2023 and 2024 (for performance years 2021 and 2022). It also freezes the Partial Qualifying APM participant payment threshold and the patient count threshold at current levels for performance years 2021 and 2022 (for payment years 2023 and 2024).

Delay of Radiation Oncology Model – The start of the CMS radiation oncology model demonstration will be delayed until January 1, 2022, six months beyond what CMS proposed in a final rule earlier in December. This delay is in line with requests by stakeholders, including ASCO.

Waiving Medicare Coinsurance for Certain Colorectal Cancer Screening Tests – The package gradually eliminates unexpected cost-sharing for Medicare beneficiaries with respect to colorectal cancer screening tests where a polyp is detected and removed.

Average Sales Price (ASP) Reporting – The year-end agreement requires all manufacturers of drugs covered under Medicare Part B to report ASP information to the Secretary of the Department of Health and Human Services beginning January 1, 2022. Specifically, it adds a new requirement for manufacturers that do not have a rebate agreement through the Medicaid Drug Rebate Program to report ASP information.

ASCO continues to review the bill and will provide additional details in early 2021.

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