Last week, CMS released the Calendar Year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule. Here, we've summarized the most important implications for cancer programs, along with takeaways from the 2023 Medicare Physician Fee Schedule (MPFS) proposed rule.
2023 OPPS/ASC proposed rule
1. The 340B payment rate will likely increase to ASP +6%
Though CMS formally proposed to continue the payment rate of ASP -22.5% for 340B-acquired drugs for CY 2023, the agency noted it intends to change the rate to ASP +6% in CY 2023 final rule. This announcement comes after the Supreme Court's recent decision in American Hospital Association v. Becerra to invalidate the 340B payment reduction to ASP-22.5% CMS implemented back in 2018.
In the ruling, the Supreme Court said the payment reduction was illegal because CMS did not survey hospitals to determine their average drug acquisition costs. This is a win for hospitals participating in the 340B program that will likely see additional revenue from cancer (and other) drug reimbursement.
2. Lymph node biopsy or excision will be added to the ASC Covered Procedures List (CPL)
Through its analysis of the procedure and consultation with stakeholders and clinical advisors, CMS determined that biopsy or excision of the lymph node(s) can be safely performed in the ASC setting. While the addition to the CPL means that lymph node biopsy or excision can be conducted in the ASC setting, it doesn't mean it has to be.
It'll be interesting to see to what extent this procedure shifts to the ASC setting in coming years. CMS noted that adding procedures like lymph node biopsy to the CPL can free up hospital capacity and promote site neutrality.
3. CMS will pay for new cancer-related devices, drugs, and technologies
CMS is considering granting device pass-through status for several cancer devices, including the NavSlim and NavPencil devices for real-time 3D navigation for the excision of pre-defined soft tissue specimens and the SmartClip Soft Tissue Marker for anatomical surgical guidance, along with some diagnostic devices.
This means CMS would potentially reimburse for these new devices temporarily while evaluating cost data to include them in CMS' normal reimbursement pathways in the future. CMS is inviting public comment on whether these devices meet the device pass-through criteria.
Similarly, CMS will continue transitional pass-through payments for 18 new cancer drugs, biologicals, and radiopharmaceuticals that received pass-through status within the last year. It'll also continue these payments for several cancer treatments that were granted pass-through status in previous years.
Finally, CMS is considering a formal policy to pay for software as a service (SaaS), including clinical decision support software, clinical risk modeling, and computer aided detection (CAD). Of note for oncology leaders, CMS assigned a New Technology APC to an AI solution for lung cancer prediction. CMS is still seeking comments about the specific payment approach it could take and how to prevent bias. Reimbursement for these technologies could lead to greater cancer program adoption of clinical software solutions.
4. The new Breast Cancer Screening Recall Rates OQR measure (OP-39) reporting period starts in CY 2023
The three-year reporting period for the Hospital Outpatient Quality Reporting (OQR) Program's new Breast Cancer Screening Recall Rates OQR measure (OP-39), which was finalized last year, starts in CY 2023. This is a claims-based measure, so providers don't have to report any specific data for this measure. It's calculated at the facility level as the percentage of screening mammography and digital breast tomosynthesis (DBT) studies that are followed by a diagnostic mammography, diagnostic DBT, breast ultrasound, or breast MRI study performed in an outpatient or office setting on the same day or within 45 days. There is no financial penalty for facilities performing outside the target recall rate range of 5-12%.
2023 MPFS proposed rule
1. CMS will launch a new, oncology-specific MIPS Value Pathway (MVP) called Advancing Cancer Care
The voluntary Advancing Cancer Care MVP focuses on providing fundamental treatment and management of cancer care and is aimed at oncology and hematology clinicians. It includes 11 cancer-related quality measures and two Qualified Clinical Data Registry measures that focus on patient experience, end-of-life care, and appropriate diagnosis and treatment. It also includes 13 improvement activities and a Total Per Capita Cost measure.
There is some overlap in the improvement activities of the Advancing Cancer Care MVP and the requirements of CMS' new Enhancing Oncology Model (EOM), such as guideline-concordant treatment, 24/7 access to clinicians, and advanced care planning. It's also likely that there will be overlap between the quality measures for the two programs, since we know the EOM quality measures will focus on patient experience, management of end-of-life care, and other similar areas.
For cancer programs, the Advancing Cancer Care MVP is an opportunity to participate in MVP reporting, where CMS says it's headed in the long-term, rather than reporting through traditional MIPS. It also provides quality reporting and care transformation experience that could help clinicians prepare for participation in alternative payment models, like the EOM, without having to take on financial risk.
Cancer programs will need to decide whether it makes most sense for their organization to participate in the Advancing Cancer Care MVP, the EOM, or traditional MIPS reporting. They should compare the respective requirements, financial implications, and other potential participation benefits (e.g., access to data) of each program before deciding which one to move forward with.
2. CMS will expand Medicare coverage for colorectal cancer screening
In accordance with a recommendation by the U.S. Preventive Services Task Force (USPSTF), CMS will lower the minimum age at which it will cover certain colorectal cancer screening tests from 50 to 45 starting in CY 2023. Covered screening tests include barium enema tests and blood-based tests not recommended by USPSTF.
CMS will also consider colonoscopies conducted after positive non-invasive stool-based screening tests to be screening tests rather than diagnostic tests or treatment, meaning beneficiaries wouldn't have any cost-sharing responsibilities. These policies will help more beneficiaries access screening, allow for earlier cancer detection and treatment, and reduce cancer mortality.
For more information on the proposed payment updates, read Advisory Board's Daily Briefing article on the 2023 MPFS proposed rule.