Post-COVID regulatory agenda takes shape.
The Biden administration filed its first “Unified Agenda” last week. The “Unified Agenda” is a somewhat creepy term for the administration’s regulatory priorities. The agenda has two main components: Spring 2021 priorities and Long-Term Actions. The Unified Agenda is not necessarily a list of things that are going to get done; some will be delayed, some will get shot down by industry concerns; but it gives you a strong sense of what the administration wishes to accomplish. From here we listen to what they say and who lobbies what.
Unified Agenda. The length of some of the Agency lists, particularly at the FDA and the SEC is noteworthy, suggesting regulation is back. The question is after four years of freewheeling it, will the business community acquiesce?
Request for Information: Transplant System Modernization (CMS-3409)
The Biden administration is continuing a policy that a few of the health reform intelligentsia raised. Treatment of End Stage renal Disease is expensive and possibly avoidable if the organ availability system is working properly, among other things.
The Biden administration has made it no secret that they seek to strengthen and enhance the ACA. A key success story has been Medicaid expansion (although we can argue another day as to whether that means better health). States have used various approaches to manage their eligible populations, not all of them customer-friendly, some even designed to discourage enrollment. It appears, CMS plans to propose standards for the states which is certain to be meet with some resistance.
Assuring Access to Medicaid Services (CMS-2442)
The wording of the agenda item is vague, but it pairs up nicely with the above. We are presuming some network requirements, increased availability of home and community-based services and reporting on beneficiary utilization by demographic. The administration has been heavily focused on HCBS in the infrastructure bill and this may be a work-around if the legislation makes it across the finish line without it.
The Biden administration is reviving an Obama-era effort to establish workplace standards to protect against infectious diseases. There is renewed interest in the effort in the wake of COVID-19.
As promised the Biden administration is seeking to press companies into more disclosure on climate risks and “opportunities.” For health care, this is going to be tricky as most ESG r-related disclosure pressures have focused on use of fossil fuels. We should expect that the supply chain will be a focus, adding more pressure to repatriate some of its more sensitive parts.
Human Capital Management Disclosure.
Together with climate disclosures, this agenda item is designed to extend the ESG-focus. We would expect greater scrutiny of pay scales and demographics. Here health care may not fare so well. The demographic profile of the industry has a disproportionate number of minorities at the lower end of the pay scale, especially in large institutional brick and mortar settings.
Cybersecurity Risk Governance.
Also a tenet of most ESG frameworks and very significant to health care which was pushed into the digital age suddenly and without construction of important safeguards. Health records are very valuable as they can be used to submit claims through the deaf and dump Medicare FFS system.
Special Purpose Acquisition Companies.
No surprise here as the issue has developed some urgency which is likely to intensify as some SPACs fail to get even close to their forecasts.
We are on a lag, but this effort is certainly related to open accusations and quiet whispers that some of the claims about ESG investing are hard to square with reality.
Long Term Actions. The administration has also identified some long-term actions, many of which are Obama-era initiatives that were deep-sixed by President Trump.
The Obama administration tried to rein in pharmaceutical advertising and threw in the towel in 2012. Biden’s hope, with good reason, to make progress.
Short-Term Limited Duration Insurance; Update (CMS-9904).
Biden and SecHHS Becerra are getting a lot of pressure to do away with short term insurance plans and there are certain to acquiesce.
What is missing? I see nothing to suggest further development of the CBD regulations at the FDA which were returned for further study when Biden became president.
Call with questions.
Emily Evans
Managing Director – Health Policy
Twitter
LinkedIn
