The Biden administration imposed a regulatory freeze in January, which among other things affected the final rule for the Medicare Coverage of Innovative Technologies (MCIT) program. Despite the freeze, Cybil Roehrenbeck, a partner in the D.C. office of Hogan Lovells US LLP, told BioWorld that this program enjoys broad support in Washington, and thus should survive the new administration’s review of the program under Xavier Becerra, should he be appointed the Secretary of Health and Human Services.
Becerra’s nomination to the HHS post included some debate over his approach to drug pricing, but the candidate’s appearance in Senate hearings was accompanied by a letter from several Republican legislators concerned about Becerra’s support for a single-payer health care system. Roehrenbeck said, “I don’t see a lot of daylight between what Becerra will do if he’s confirmed” and the Biden administration’s overall goals. “I think Becerra was very clear in the confirmation hearings, and also in some of the media briefings he has done, that his intent is to carry forward the goals and policy agenda of the Biden administration,” she said.
“Becerra has been, in the past, a vocal proponent of universal health care,” Roehrenbeck said, but the candidate said in Senate hearings his mission would be to act on the objectives of the Biden administration. The Biden administration has indicated it is more focused on building upon the Affordable Care Act rather than expand to a single-payer health care system, she said.
MCIT was ‘well received’ in Washington
For med-tech companies, however, the more immediate concern is the MCIT program, something device makers have been pushing for several years, but Roehrenbeck said industry has little to worry about. “That was a long thought-about policy that is really geared toward coordination between CMS and FDA,” she said, adding, “I think it was well received when it came out.” Some device makers would like to see the lookback to previous breakthrough devices longer than two years, which might not happen under this new administration. Nonetheless, Roehrenbeck said the rule will help bring products to market that help to deal with health care issues associated with the COVID-19 pandemic, and that the program might also aid in addressing health access inequities going forward.
Another area where Becerra was previously active was as part of a multi-state attorney general effort regarding discounts for the Medicare 340B drug program. His position on this issue “clearly dovetails around long-time support for that program Democrats have had” for some time, Roehrenbeck said. “I don’t think we’re going to see Becerra going out and doing a lot that isn’t consistent with what the Biden administration has set for its agenda.”
The Trump administration put a considerable effort toward revising its approach to the Stark and Anti-Kickback Statutes (AKS) in a larger effort to foster more coordinated care, and Roehrenbeck said this is unlikely to be a sore spot for HHS under Becerra. “I don’t see them revisiting the regulations themselves any time in the near future,” she said, although observers may see more activity from the Office of Inspector General (OIG) on violations, particularly for violations of the False Claims Act. “Program integrity and protecting the Medicare trust fund are always great things for HHS to talk about,” she noted, adding that OIG has already demonstrated a willingness to engage stakeholders on the question of regulations pertaining to telehealth.
Whether stakeholders can expect more in the way of waivers for telehealth is difficult to anticipate, particularly given the raft of legislation currently in the works on Capitol Hill. There is also some support in Congress for a meaningful expansion of the statutorily determined benefit categories for telehealth regardless of the cost to the taxpayer, and Roehrenbeck said advocates might assert that there is always more that can be done even without the help of Congress. One example of the potential for additional flexibilities outside the strict realm of telehealth is the May 2020 CMS policy that expanded the definition of an alternate care site to include sites such as gymnasiums and “even the patient’s home.”
Roehrenbeck said the focus for the time being at HHS is on activities directed toward the pandemic and activities that are focused on greater health equity.