Congress
Reconciliation. What a saga reconciliation has become. This week, the Energy and Commerce refused to include the Elijah Cummings Lower Drug Prices Now Act in their reconciliation package. Recall that bill includes mandatory rebates on drugs sales whose unit price increases exceed inflation – something Congress may live to regret if CPI and PPI keep rolling higher. This controversial provision would also extend to employer sponsored plan.
However, Ways & Means has cleared the controversial provision giving leadership about $700B in theoretical savings to offset the cost of extending traditional Medical coverage to vision, hearing and dental. Notwithstanding that little victory, the outcome on the floor is not assured.
Our Thought Bubble: With three Democrats breaking ranks on this issue that has been near and dear to their hearts for decades is not insignificant. It will have an impact on Senate Democrats’ view of how far to stick their neck out supporting the provision. We have been bearish on any legislative success on drug prices. The most important provision related to drug prices will likely be revisions to the Medicare Advantage benefit design which has bipartisan, bicameral support.
The White House
Medicare Rule-A-Rama.
Medicare Coverage of Innovative Technology. The administration has proposed to revoke this new pathway to reimbursement for FDA approved devices (which would include any in vitro test). The Trump administration had proposed and finalized it to bring certainty to Medicare reimbursement after a product is cleared as safe and effective by the FDA. CMS’s reason is that a product may not meet the agencies definition of reasonable and necessary and could cause harm to Medicare beneficiaries.
What the what?
Is the internal view of the FDA now so poor that they cannot be trusted with their primary charge to assure a product is safe and effective? Or has CMS determined that it merely want to reverse Trump policy decisions because they were Trump policy decisions? Who knows? Absent an egregious action, reversing fully finalized regulations without some extended public input makes the actions appear politically motivated which over the long term cannot be a good thing.
Other Rules.
None pending.
Boosters-gate. What a holy mess. First the White House front runs the CDC and the FDA on the appropriateness of booster shots; then two senior vaccine regulators retire; then same regulators along with several other international scientists publish a paper in The Lancet that concluded the evidence to date was insufficient to support a third booster shot universally distributed. Treading into the political, the authors further asserted vaccines should be distributed globally before a third one is made available.
Today the FDA Advisory Committee approved a COVID-19 booster for vulnerable populations and people over 65 but decided to forego universal approval for all eligible populations. The briefing documents can be found here. Assuming the FDA follows the advice of its AdComm, and there is no longer any guarantee that will happen, it calls into question MRNA's announcement that they would file for an EUA for boosters.
In any event, President Biden's plan to have boosters widely available by September 20th is not going to happen. Worse, it does not appear his mandate announcement has moved the needle except for people that decided it was best to finish the series. Five days after the vaccine mandate, there is a uptick in eligible people getting the second shot but not much reaction in administration of the first.
Provider Relief Funds. HHS announced the release of $25B in provider relief funds. About $17B will come out of the Phase 4 distribution to a wide range of providers demonstrating financial impact from COVID. The balance will be delivered to rural providers. It is
Other Stuff
Labor Shortages. The California Hospital Association sent a letter to the California Health and Human Services Secretary pleading for relief from staffing shortages. They ask for the reinstatement of cost sharing and housing for travel nurses. The Association claims that staffing agencies are now charging $300/hr. up from $200/hr. in January. The letter goes on to note the increased acuity brought on by delayed care and the impact vaccine mandates are having on labor availability.
Hospitalization Data. It is a little odd that a national news magazine would have a fully edited story the same day a preprint is released but that doesn’t make it any less interesting. Agenda pushing has become an Olympic sport the last year or so.
The Atlantic’s story on how we have measured hospitalization during COVID happens to make sense. The study authors don’t address incentives so we will. Reimbursement by the federal government for COVID cases includes a 20% add-on payment. Cost-sharing in the form of copays and deductibles are waived in most cases. Until recently, commercial insurers had followed suit.
If we know anything about the health care system, it’s nimbleness when it comes to getting paid is legendary. Read the study here.
SPAC and S-1 Corner
IPOs
Life Time Group Holdings. “Leading lifestyle brand offering premium health, fitness and wellness experiences to a community of nearly 1.4 million individual members, who together comprise more than 767,000 memberships, as of July 31, 2021.”
MiNK Therapeutics. “Clinical stage biopharmaceutical company pioneering the discovery, development and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. iNKT cells are a distinct T cell population that combine durable memory responses with the rapid cytolytic features of natural killer (NK) cells.”
SPACs.
While the SEC contemplates what regulation they may bring to bear on SPAC-land, you would think there would be decreasing interest in the vehicle. You would be right, of course. That did not stop three new filings this week, mostly with biotech targets.
You can access the updated SPAC spreadsheet here.
Emily Evans
Managing Director – Health Policy
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