Takeaway: FDA (re) decides decision support software really is a device, confusion ensues; PCE looks normal; CR w/ User Fee Leg Passes; CLOV, UNH,ANTM

(Correction: Last week I referred to a CPI-linked payment update for ASCs which was incorrect. My apologies, Friday afternoon brain cramp.)

Dose | Health Care PCE Acting Like it Should; Decision Support Software Becomes a Device; CR Passes - 2022.09.30 Dose

Top of the Funnel | Marco Data, Policy Position Monitor

PCE. Personal Consumption Expenditures on health care rose 4.46% YoY in August,  0.56% MoM, making it look a lot like a typical August. If the pattern holds the next few months will represent the usual end of year acceleration.

After the new year, there are certain risks. Insurance contracts have been renegotiated and premiums, no doubt, will increase. As they do, high deductible plans will look more attractive.

The good news for health care is Medicare Advantage premiums will decline as will Part B premiums. Medicaid disenrollment remains TBD.

No Changes to the Policy Position Monitor.

CONGRESS

The End of a (Mini) Era. This week Congress approved a Continuing Resolution to keep the federal government running until mid-December. Assuming Republicans take the House, the days of big government spending are over for the foreseeable future.

If you couple the return of deficit politics with regulatory restrictions imposed by the recent SCOTUS decision, West Virginia v. EPA, the Biden administration’s agenda gets squeezed immeasurably.

Members and the White House, of course, already know that. The accelerated manner in which the majority has sought approval of sweeping legislation since 2010, tells you that.

Just as well. The world has become more dangerous and there will be bigger fish to fry than health insurance policy.

FDA User Fee. The Continuing Resolution includes a “clean” user fee section, as predicted. The relevant chairman, Sen. Richard Burr and Sen. Patty Murray had reached agreement on a few policy riders, but Majority Leader Mitch McConnell threw cold water on that idea.

The policy riders may now be set up for a debate in December. Recall, one of those is the VALID Act which would regulate Laboratory Developed Tests. 

THE WHITE HOUSE.

Decision Support Software. ((CLOV (-), CANO (-), PRVA (-), CMAX (-) ANTM (-)) The FDA released expanded guidance on Clinical Decision Support software to include any system that provides specific advice on the treatment of a patient as a “device.”

This change will come as a surprise for lots of people that read the 21st Century Cures Act. That bill endeavored to leave the FDA out of regulating certain types of software. In question now are all the decision/clinical support programs that have been lauded by everyone from CLOV to ANTM to CANO.

Another open question is whether Congress responds. When the White House reversed the pathway for reimbursement of breakthrough devices, there was a Congressional response but not yet a legislative one.

Good Food. The White House introduced a new initiative on diet and nutrition this week. It is an important message and perhaps it is sincere. Or it could be a Richard Nixon redux. Recall that the the now disgraced president - back when disgrace was not a thing - made food and nutrition a policy as inflation began to rage. So, probably no coincidence. 

Either way, to say America is less healthy after the pandemic is an understatement. The focus of this new effort is salt and sugar reduction in the food supply. Another area of concern is updating what foods can call themselves “healthy,” the definition of which has not changed since 1993.

Other Stuff.

Masks. The CDC updated its mask guidance for health care facilities to drop universal masking requirements when community transmission is not high. The requirement is much less controversial among health care workers but a welcome change nonetheless.

The USPSTF Empire Expands. Last week the United States Preventive Services Taskforce voted to recommend screening all adults for depression and all adults under 65 for anxiety. The Taskforce gave the service a ‘B’ grade that makes it eligible for preventive services coverage under the Affordable Care Act.

Recent Events

The Failure of (Federal) Science with Dr. Tracy Beth Hoeg.

mRNA Technology: More Downside Than Upside, a Discussion with Dr. Aditi Bhargava.

PFE: Bad for America Part II

Searchable calendar of weekly events and notes can be found here.

Have a great weekend.

Emily Evans
Managing Director – Health Policy



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