Rulemaking, Rules, & Regulatory Authority

Autumn signals seasonal changes, but one constant is the annual assessment of the policy implications of the proposed Medicare payment rules for the upcoming calendar year. In this 2019 rule-making cycle, access to care and the overall reimbursement and healthcare delivery landscape have the potential to undergo a drastic shift. In September ACCC submitted comments to both the 2019 Physician Fee Schedule and the Hospital Outpatient Prospective Payment System proposed rules. Of note, beyond the annual rule-making process, ACCC has also observed various actions from healthcare leadership within the current administration that also have implications for the future of healthcare delivery for oncology patients across the U.S.

CY 2019 PFS & OPPS Proposed Rules: Key Concerns
Site-neutral payment structure and healthcare delivery remained a huge focus for CMS in the CY 2019 OPPS proposed rule. For 2019, the agency proposes to lessen the gap in payment differentials between non-excepted and excepted hospital off-campus provider-based departments (PBDs). CMS is expected to finalize a proposal to reduce reimbursement to 40 percent of the OPPS rate for clinic visits, including hematology and oncology, as well as any excepted off-campus PBD that has engaged in service line expansion since November 2015.

ACCC's comments—which align with CMS’ own Advisory Panel on Hospital Outpatient Payment (HOP) Panel—urge that the agency not finalize these proposals.  While CMS continues to cite an “unnecessary increase” in the volume of outpatient clinic visits, the 2019 OPPS Proposed Rule provides no data or analysis to support this claim. ACCC believes that the agency’s proposals would drastically impact cancer delivery for patients across the country. Should CMS act to finalize these proposals, it is likely that providers will be forced to scale back services or close off-campus PBDs, requiring patients receiving treatment to seek care farther from their home. For the intent of these proposals to be realized, hospitals must be given the flexibility to adapt use of PBDs to better meet their patients’ needs.

Also included in the 2019 OPPS proposed rule was an additional Request for Information (RFI) on the possible revitalization of Medicare’s failed 2006-2008 Competitive Acquisition Program (CAP).

ACCC commented strongly that CMS should ensure that any model based on CAP authority is:

• voluntary for all participants,
• preserves patient access to treatment and provider flexibility, and
• promotes cost efficiency through more effective distribution and delivery of drugs and biologicals rather than utilization management tools.

The proposed 2019 Physician Fee Schedule rule also signals significant changes on the horizon for cancer care delivery. Most notably, CMS is proposing to consolidate reimbursement for level 2 through 5 Evaluation and Management (E/M) coded visits.

In comments to the agency, ACCC voiced strong concern over the impact of this policy proposal. ACCC stressed the need for continued work with other oncology patient and provider advocacy stakeholders before finalizing this proposed consolidation. Due to the complexity of cancer treatment, oncology providers often use level 4 and 5 visits. ACCC believes that condensing these E&M codes will devalue the work of these providers. Accordingly, ACCC opposes this reimbursement restructuring.

Healthcare Leadership Exercising Their Authority
Beyond the proposals put forth in the 2019 PFS and OPPS proposed rules, CMS and various members of the administration’s healthcare leadership team have used their regulatory authority to push forward major actions that stand to significantly impact cancer care. Most notably, in early August CMS issued a policy memo stating that on January 1, 2019, Medicare Advantage (MA) plans will be allowed to infuse step therapy as a utilization management tool for their beneficiaries accessing Medicare Part B drugs. ACCC has commented in opposition of this policy shift due to the access implications this regulation has for cancer patients across the country. However, since the agency used regulatory authority to make this policy change and no comment period is in sight—this change may potentially signal more movement to come. On August 29, a second agency policy memo announced changes to Medicare Part D plans and news of “indication-based pricing” in 2020.

As we await the final Medicare rules for 2019, keep in mind that healthcare leadership under this administration has untapped regulatory authority for potential mandatory demonstrations to test other value-based arrangements through the CMS Center for Medicare and Medicaid Innovation (CMMI).

ACCC continues to work with CMS, CMMI, and other patient and provider stakeholder organizations to proactively address and understand how best to navigate the future cancer delivery landscape in 2019 and beyond. Stay tuned.