Dose | Health Policy Week in Review + Vaccine Mandates, LDT Regulations & CLOV

Chart of the Week

Congress

Part D Redesign. The Congressional Budget Office has scored some provisions of the Build Back Better Act (a.k.a. Reconciliation) including the redesign of Medicare Part D benefit. The CBO estimates the provision will increase the budget deficit by about $1B in five years but reduce it by $1B over 10 years.

It is a shame changes to the benefit – long overdue especially in the era of specialty medicines and Pharmacy Benefit Managers – has been lashed to the mast of a very controversial and increasingly unpopular piece of legislation. I still give it a better than fighting chance of making it into law, but it would be nice to have another vehicle.

Reconciliation. We are in “wake us up when it is over” mode but we remain obligated to tell you the House of Representative passed the Build Back Better Act with a lot of the health care bells and whistles. We wait on Senate action to get more serious about our prognostications excluding Medicare Advantage redesign noted above.

The White House.

Vaccine Mandates. With the 6^th Circuit issuing a stay, OSHA decided to stop enforcing the vaccine mandate for employers with over 100 workers. Additionally, all the cases, filed in various states will be consolidate at the court in New Orleans.

The requirement is nearly unenforceable anyway, so OSHA’s decision isn’t that meaningful. Worse for the White House, outbreaks in highly vaccinated states are suggesting the durability of the vaccine is limited. That being the case, the notion that an unvaccinated person poses a direct risk to the workplace may be challenged.

LDT Regulations. HHS has restored the FDA’s power to regulate Laboratory Developed Tests after revocation by the Trump administration in a fit of pique. The FDA, early in the pandemic, had sent confusing and often contradictory messages on LDTs for COVID, creating unnecessary delays in test development. Statements on the policy decision are focused on the implications for COVID-19 tests, suggesting the FDA will continue to exercise enforcement discretion for other tests but it isn't entirely clear.

Medicare Rule-A-Rama.

Pending.

Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Policy Issues and Level II of the Healthcare Common Procedure Coding System (HCPCS) (CMS-1738)

Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2022 Rates (CMS-1752) Final Rule.

Other Rules.

HHS Notice of Benefit and Payment Parameters for 2023 (CMS-9911) The latest exchange rule should be as aggressive as the administration thinks it can get away with.

Other Stuff

CLOV.  The little insurance company in New Jersey issued 60M shares (including underwriter’s option) and raised about $284M in additional capital. Most people have learned to ignore CLOV but it’s filings indicate the challenges before unsophisticated health insurers, in the face of rising acuity, increased labor costs and competition from more capitalized companies.

Events

Recent Events. 

Labor, Inflation, De-Factor Deregulation: 3Q Earnings Policy Recap. Replay and slides here. (Unplugged subs - look for replay and timestamps in you inbox next week.)

Upcoming Events. None

Searchable Calendar of events and notes here. 

SPAC and S-1 Corner

IPOs.  Nothing noteworthy.

SPACs. Believe it or not, we have two new SPACs focused on health care. I know, I know, CLOV and a handful of others has ruined it but remember, health care has a lot of capital needs in the face of requisite innovation. So still worth tracking. SPAC spreadsheet here.

Have a great weekend.

Emily Evans
Managing Director – Health Policy



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