The ACCC 47th Annual Meeting & Cancer Center Business Summit (AMCCBS) took place virtually, March 1-5. Through a combination of five-star panels and interactive drop-in sessions, attendees learned about key themes and trends in oncology today: telemedicine/telehealth, virtual care models and remote monitoring, including home therapy for chemo; cancer service line efficiency and revenue optimization; leveraging data; managing alternative payment models; employer-driven models and addressing disparities in cancer care; long-and short-term impacts of Covid-19 on oncology; clinical research; and current trends and the changing landscape in oncology transactions.
Foley Partner Adria Warren, in partnership with Tynan Kugler (Principal at PYA, P.C.), discussed the new flexibilities introduced in the major overhaul of the Stark Law and Anti-Kickback Statute in 2021, and presented key highlights of the regulatory framework under the final rules. These new rules for the first time permit collaboration to advance the adoption of value-based care, introducing important Stark Law exceptions (and comparable Anti-Kickback safe harbors) for so-called “value-based arrangements.” There are three new exceptions (safe harbors) involving remuneration paid under a value-based arrangement with full financial risk, meaningful (substantial) downside risk, and value-based (or care coordination) arrangements. Each model has a variety of technical requirements, which have been discussed in a prior Health Care Law Today blog. Importantly, the requirements do not always line up across the two statutory frameworks. At a very high level, the more risk that is assumed by the participants to a value-based arrangement, the more flexibility the exceptions/safe harbors allow. The 2021 Stark Law and Anti-Kickback Statute revisions also updated the regulatory framework for donations of electronic health records, finalized a new exception/safe harbor for cybersecurity, and provided many important clarifications and explanations, including updates to the concepts of “fair market value” (FMV) and “commercial reasonableness” (CR) as applied to health care transactions. Ms. Kugler noted that the new rules have debunked many myths surrounding FMV and CR.
Among the many tidbits speakers highlighted was CMS’ clarified position that benchmark data is not necessarily determinative of fair market value: “It appears…that stakeholders may have been under the impression that it is CMS policy that reliance on salary surveys will result, in all cases, in a determination of fair market value…the FMV of a transaction…may not always align with published valuation data compilations, such as salary surveys.” She also pointed out that, in CMS’ view, arrangements could still potentially be commercially reasonable even if they are not profitable. In the new Stark rules, CMS cites examples of non-profitable arrangements including those that meet community care, fulfill licensure/regulatory obligations, and others. Profitability is still relevant, but, according to CMS’ final rule, “we are not convinced that the profitability of an arrangement is completely irrelevant or always unrelated to the determination of CR.”
It is important to remember that FMV and CR remain “facts and circumstances” specific, and FMV could fall above or below survey data based on qualitative and quantitative considerations. Continued regulatory evolution to promote care coordination and value-based reimbursement is not only expected, but ensured.
The speakers offered a number of practical tips including a need to actively monitor how compensation arrangements are implemented in light of changes to the “period of disallowance” (POD) provisions and reconciliation rules.
After a successful virtual conference, the ACCC 48th Annual Meeting & Cancer Center Business Summit is planning to be held in person in Washington, D.C. in March 2022!