Takeaway: Plus Replay of anti-trust discussion with Paul Glenchur

Top of the Funnel: Macro + Earnings

Paul Glenchur, Hedgeye’s legal analyst, and I came up with quite a few important catalyst on the anti-trust front on Wednesday. You can listen/watch here.

(Note, in my post-COVID addled state, I misspoke Biogen when I meant Amgen. I apologize for the error)

CONGRESS.

Shutdown Showdown. Broadly, the possibility of a government shutdown is front of mind. However, the Senate is making progress on another must-pass bill, the Pandemic and All-Hazards Preparedness Act reauthorization.

The bill has been split into two separate actions. One funds the Administration for Strategic Preparedness and Response. The other would fund activities at the CDC. Funding the CDC is controversial on the House side which slipped flat funding into its appropriation a few weeks ago. Their move is not likely to fly on the Senate side but using zero as the starting point is not a positive for the agency.

Schumer’s List. In preparation for the final leg of the 2023 year – and before 2024 campaigns ramp – Senate Majority Leader, Chuck Schumer sent a letter to colleagues outlining his priorities.

As is typical for the Majority Leader, the list is probably much too long. The most precious resource in Washington is Senate floor time. For our purposes, however, Sen. Schumer indicates that drug prices remain an issue, especially the cost of insulin.

Wishful Thinking. The House Budget Committee launched a task force last month that is charged with looking at innovative ways to cut health care costs. One area of interest has been the approach the CBO uses to score preventive measures, which is mostly as a debit.

Proponents of Medicare coverage of the new GLP-1 drugs see the task force’s work as an opening. Unfortunately, the state of the research on the value of preventive services is not particularly good so the CBO will have a tough time assessing the cost-benefit.

Color us skeptical for now.

Transparency. The House committees of jurisdiction agreed to a package of health bills that include improvements in the hospital price transparency. It also would require a site neutral payment policy for the administration of drugs, phased in over four years.

The proposal is currently lashed to a set of Medicare extenders and a delay in DSH cuts which will make is more palatable to the Senate.

AI Regulation. Making Majority Leader Schumer’s “honey-do” list is preliminary steps for regulation of Artificial Intelligence. Sen. Bill Cassidy wants to take more of a “wait and see” approach and let agencies identify issues, assess if existing regulatory authorities apply and ask Congress to fill in any gaps.

Sen. Cassidy released a white paper this week on regulation of Artificial Intelligence by the health agencies in which he advocates for letting them lead.

THE WHITE HOUSE.

CMMI and Total Cost of Care CMS’s innovation center, CMMI announced the latest iteration of its total-cost-of-care models. The idea is to advance a global payment structure to providers. Maryland has been the most notable users of this approach.

The AHEAD model will emphasize primary care over acute.

The uptake on this approach has not been great as hospitals have generally resisted anything that shifts payments away from them. So, don’t expect much but credit for trying.

OTHER STUFF.

FDA & The Practice of Medicine. The Fifth Circuit Court of Appeals issued a ruling last week that said, in effect, the FDA cannot engage in the practice of medicine by tweet or otherwise.

At issue was the FDA’s opposition to prescribing Ivermectin to treat COVID symptoms. Three physicians brought a lawsuit claiming the FDA was interfering with the practice of medicine, something they are statutorily prohibited from doing.

Humana v. US. Humana has sued the federal government over its proposed RADV audits. The company claims the government violated the Administrative Procedures Act by not providing a reasoned explanation for excluding a Fee-for-Service adjuster. Another complaint is the retroactive nature of extrapolation audits.

There is no mention of the use of extrapolation itself. The practice is not without controversy in that is has raised due process questions

 Have a great weekend.

Emily Evans
Managing Director – Health Policy



Twitter
LinkedIn