Takeaway: Better to declare victory than open the door for defeat; What's Next Health Care conference; Monoclonal Antibody get bipartisan love

Politics. Seizing defeat from the jaws of victory is nothing new in politics. Richard Nixon’s decision to impose wage and price controls when inflation hit 4.5% in 1970 guaranteed it worked its way up to 12% later in the decade. Barack Obama’s decision “go big” and push through the ACA in 2010 left little time to consider consequences from policies like fixed MLRs, rich benefit design and narrow age bands.

Both price controls and health care legislation, polled well at the time. Nixon went on to win by a landslide in 1972 only to watch his popularity evaporate as stagflation took hold, his term ending ignominiously. Obama, on the other hand was well on his way to being a popular president in 2009 but extinguished most of his political capital with one bill and watched the normal mid-term challenge to his party turn into a clock cleaning.

President Biden may well rue his speech on Thursday when he announced vaccine mandates for employees at firms with more than 100 workers (or a negative test), and expansion of the recently imposed vaccination requirement for nursing homes to include hospitals, home health workers and “other health care facilities.”

 Vaccine mandates poll well. Rather than consider the cautionary tales offered by Nixon and Obama, declare victory for the unprecedent achievement of an effective vaccine AND administration of same to 73% of the eligible population, the Biden administration, after resisting Republicans’ bait for months, has now adopted vaccines as a wedge issue. Ignoring Oregon and Washington, whose outbreaks are nothing to be proud of, the vaccinated are deemed good; the unvaccinated bad.

The danger for the Biden administration lies in the inevitable outbreaks no matter what mandates are in place and where vaccination rates are high. Breakthrough infections, easily identified by the monumental scale of COVID testing, are clearly more common than the CDC’s reports suggest. There remain lingering questions of the risks associated with the vaccinations for young men which may become more apparent as time goes on.

Mandating something and making it happen are two different things. Enforcement is a slow and lumbering machine that will never move quick enough to change the headlines and the public's eroding confidence of the federal government's ability to manage outbreaks. The reluctant, seeking no affiliation with those deemed "good," may continue to stiffen their spines.

There is no doubt some consultant somewhere who thinks vaccinations as a wedge issue is a great idea, but at this point, anyway, there seems to be a lot that can go wrong for the White House. Irrelevance during the most pressing issue in a generation may become one of them.

Policy. Lost in the noise of mandates were two positive messages in Biden's speech. First, the administration is expanding the availability of REGN’s monoclonal antibody therapy. In retrospect, one of the major failings of the U.S. COVID response will be the diminished emphasis on therapies in 2020 and most of 2021. Both White Houses and many governors put all their eggs in the vaccination basket, ignoring the reality that not everyone, even if you could find them all, are going to get vaccinated.

Because several southern governors, led by Governors Ron DeSantis (FL) and Greg Abbott (TX), have been aggressively encouraging the deployment and uptake in monoclonal antibody treatments, some, mostly in the political health press, have characterized the treatment as “experimental.” While technically true, the treatment has an EUA from the FDA like several vaccines. Fortunately, the Biden administration is neutralizing that characterization and endorsing a treatment that may provide an alternative to the sick and unvaccinated.

The other development was the president’s announcement that they would be using the Defense Production Act to ramp up production of rapid at-home tests. The announcement does not distinguish between antigen tests like QDEL’s and point-of-care PCR tests. Given the shortage of the rapid antigen test at major retailers, we are going to presume the former.

Public health policy generally discourages use of at-home DTC tests for infectious disease. They are frequently not accurate, as is the case for the COVID tests being marketed. They also can be performed without notifying public health authorities of the result.

What rapid tests may do is act as an imperfect screening tool to keep people home if they have been exposed. If the Biden administration is successful to getting more people to test at home and employers accept a rapid negative test as evidence of compliance with the forthcoming guidance from the Department of Labor regarding vaccine mandates (and in lieu thereof, a negative test), case volumes as dutifully reported by the press and others will drop.

Perhaps not the best public health practice but we left that behind a long time ago.

Power. Years ago, before the money hose was turned on for venture capitalists and private equity funds, entrepreneurship in health care consisted of a. finding a product or service, regardless of its merits, for which you can get reimbursement or b. a roll-up of some woe begotten practice area under margin pressure.

After passage of the ACA, many of the law’s architects left Washington, raised a bunch of capital and proceeded to leverage the new law’s provisions into business models, most centered on the ill-defined value-based care, preferably with something about machine learning or AI in the two-pager.

All these approaches were ultimately dependent on one thing: that largess or, at least, the forbearance of a payer.

Conclusions from last week’s What’s Next Health Care conference put on by the always amusing Matthew Holt, publisher of The Health Care Blog and Jessica DaMassa, Host and Executive Producer of WTF Health (both, I hasten to add are a very efficient way to keep up with Silicon Valley trends) suggest that perhaps leveraging the typical American insurance model is futile.

Certainly, SHCR and SGFY were there to laud their contribution to “value-based care” but in nearly equal parts were companies like Parsley Health and HIMS, focused on the ACA bag holder: the young whose health insurance coverage is nearly meaningless. When these companies do depart from the DTC model, it is mostly to embrace employer-sponsored plans, that also got the short end of the ACA’s stick.

In other words, having determined there is little value to health or even, it appears, revenue streams, innovation is departing for another place where silly rules like Medicare’s prohibition on screening for most cancers and the mind-numbing requirements of prior authorization do not exist. If rumors are true and WMT’s longstanding designs on a health plan settle on HUM, the consumerization of health care may also arrive for the elder population.

As far as health care goes, health insurers, like Congress, continue their slow march toward irrelevance. That may be the best thing to ever happen to the industry and innovation.

Have a great rest of the weekend. 

Emily Evans
Managing Director – Health Policy


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