ACCC 47th Annual Meeting & Cancer Center Business Summit (AMCCBS): Positive Disruption in the COVID-19 ERA – Part 2

07 April 2021 Health Care Law Today Blog
Authors: Adria Warren Alexis Finkelberg Bortniker

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.

You can also review our additional AMCCBS focused blogs on “Moving Forward Under the Biden Administration” and “The Next Wave in Oncology Transactions” by clicking the available links.

Change is the Only Constant: The 2021 “Level Set” in the Sprint to Value-Based Care

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!

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services