Regulatory Digest

Policy Update – Week of September 9, 2024

Introduction

This week: Government brinkmanship, Presidential debate post-mortem, and (Taylor) Swift(boats) Trump

Weekly Spotlight

Well, Congress is back and we have just 17 days until the government runs out of money. This seems as good a time as any to remind you all of my thoughts on government shutdowns and share another “Brief History of of U.S. Government Shutdowns and Why Other Countries Do Not Have Them.”

Hopefully you’ve had your fill of post Harris/Trump debate memes. For fear of pouring salt in some open wounds, I’ll leave that here. Anyone up for trading friendship bracelets?

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

US will still pay at least twice as much after negotiating drug prices

The U.S. government’s first-ever negotiated prices for prescription drugs are still on average more than double, and in some cases five times, what drugmakers have agreed to in four other high-income countries, a Reuters review has found.

#Drug, #Patient

Why Medicare Advantage plans are losing more providers

More providers are opting out of contracts with Medicare Advantage plans as national insurers reconfigure their networks, leaving patients in limbo.

#Payer, #Patient

Food and Drug Administration (FDA)

Diversity Action Plans for Clinical Trials: Evaluating FDA’s Draft Guidance

FDA has issued a draft guidance for sponsors — mainly the pharmaceutical industry — entitled “Diversity Action Plans [DAPs] to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” After a formal commenting period set to end September 26, 2024, the guidance will become official, pending revisions. A critical analysis reveals opportunities and challenges prior to finalization

#Drug, #Device, #Patient, #Provider

Health and Human Services (HHS)

Feds strengthen mental health parity rules for insurers

Health insurance companies will have to upgrade their mental health benefits to match the coverage they offer for other care under a final rule three federal departments issued Monday.

#Payer, #Patient

Hill Happenings

Congressional fighting could derail healthcare agenda —again

Many lawmakers assumed there would be a short-term continuing resolution, and a full-year spending bill passed after the election. But in the multiple stopgaps that Congress passed for this year’s spending, attempts to add popular, bipartisan health measures failed.

#All

Schumer Outlines September Plan

Schumer tells Senate what to expect this September – warns the only way to an appropriations deal is through bipartisanship.

#All

Ahead of Senate Hearing, Senator Markey Releases New Report: “The Steward Health Care Report: How Corporate Greed Hurt Patients, Health Workers, and Communities

Sen. Markey, chair of the Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security, unveiled “The Steward Health Care Report: How Corporate Greed Hurt Patients, Health Workers, and Communities.” The report spotlights patient and worker experiences, hospital quality data, and information on hospital closures in Massachusetts and around the country, to document the devastating impacts of Steward Health Care’s (“Steward’s”) mismanagement. The report was published s in advance of the September 12 HELP Committee hearing on Steward’s bankruptcy for which Steward CEO Dr. Ralph de la Torre was subpoenaed to testify at failed to show.

#Hospital

5 takeaways from Congress’ hearing on overhauling organ transplant system

It’s been a year since the private nonprofit United Network for Organ Sharing lost its longtime job as the sole manager of the Organ Procurement and Transplantation Network, or OPTN — a role UNOS had held since 1986.

#Patient

Notable Notes

Economists Support Price Transparency Expansions

Hospitals are already obligated to disclose some price information. A federal rule that went into effect in 2021 requires hospitals to post the cash prices and rates negotiated with health insurers for a broad list of procedures in a computer-readable format so the information can be analyzed. The rule also mandates hospitals post estimates for at least 300 services so consumers can compare prices.But critics say there are too many loopholes in the existing federal rule.