CRS: Lawmakers Face Challenges In Harmonizing AI Health Care Rules

A Congressional Research Service report advises the new 119th Congress on the need to harmonize emerging regulatory requirements on frameworks for the safe and effective use artificial intelligence in health care, to ensure the technology delivers on the benefits promised by its developers. “The potential need for harmonization amongst party efforts and who should lead such harmonization initiatives (e.g., public versus private groups, or perhaps public-private partnerships) are among the emerging considerations,” says the Dec. 30 report in laying out...
Article Type: 
Daily News
Tags: 
AI
telehealth
Site Name: 
InsideHealthPolicy.com
Author: 
Rick Weber
Topics: 
ISSUE: INSIDE CMS
ISSUE: FDA WEEK
AI
Congress

IDR Administrative Fee Stays At $115 For 2025

The non-refundable administrative fee that providers and plans must pay for using the federal independent dispute resolution (IDR) process created by the No Surprises Act will continue to be $115 per party in 2025, CMS told stakeholders in late December, the same rate the agency settled on last year after a district court nixed an attempt to raise it to $350 for 2023 -- but lower than the $150 rate that the agency proposed in a separate rule on IDR...
Article Type: 
Daily News
Tags: 
balance-billing
Site Name: 
InsideHealthPolicy.com
Author: 
Amy Lotven
Topics: 
ISSUE: INSIDE CMS
Health-Exchange-Alert
Health Reform Debate

USTR Urges Trading Partners To Curb Illicit Online Pharmacy Activity

U.S. government agencies have limited regulatory and enforcement abilities to curtail the activities of illicit online pharmacies, the Office of the U.S. Trade Representative said Wednesday in its latest annual report on counterfeiting and piracy, calling on trading partners to do more to prevent the manufacture and export of counterfeit drugs. USTR each year issues a Review of Notorious Markets for Counterfeiting and Piracy identifying physical and e-commerce markets known for selling counterfeit of pirated goods “to increase public awareness...
Article Type: 
Daily News
Tags: 
drug-patent
Site Name: 
InsideHealthPolicy.com
Author: 
Brett Fortnam
Topics: 
ISSUE: FDA WEEK
Rx Drugs

RFK Jr.’s Role In Samoa Measles Outbreak Blasted By Hawaii Gov, Dems; Cassidy, HHS Nominee Discuss Vaccines

Hawaii Governor Josh Green (D) and four Democratic House members with public health expertise condemned Robert F. Kennedy Jr.'s nomination to lead HHS during a Wednesday (Jan. 8) press conference on Capitol Hill, as RFK Jr. concurrently met with another round of senators, including health committee Chair Bill Cassidy (R-LA), ahead of his highly-contested confirmation hearing. Cassidy shared in a post on X that they had a “very frank conversation” about his nomination for HHS secretary. “We spoke about vaccines...
Article Type: 
Daily News
Tags: 
misinformation
NIH
science
trump
vaccine
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 01/10/2025
FDA Volume: 
Vol. 31, No. 2
Author: 
Jalen Brown
Topics: 
ISSUE: INSIDE CMS
ISSUE: FDA WEEK
HEALTH AUTO EMAIL
Congress
Transition 2025

Telehealth Community Watches State AI Regs, Shield Laws, Private Equity Requirements In 2025 Sessions

As dozens of state legislatures begin their 2025 legislative sessions this month, telehealth stakeholders are monitoring legislation regulating artificial intelligence tools, strengthening shield laws and imposing new requirements on private equity investments in health care at the state level. As states step in to fill Congress’ legislative void in regulating health technology, conflicts over federal preemption of state laws are likely to influence federal action. Key bills stakeholders are watching include broad AI regulations in Connecticut and Texas, new health...
Article Type: 
Inside Telehealth Daily News
Site Name: 
InsideHealthPolicy.com
Author: 
Christian Robles

CDC Chief Warns Budget Cuts Could Jeopardize Public Health Progress

With Republican leaders poised to take the reins of Washington health agencies, Biden administration Centers for Disease Control and Prevention (CDC) Director Mandy Cohen is urging lawmakers to preserve and strengthen the agency’s resources instead of cutting funding. In a new op-ed, Cohen warns that proposed budget cuts and calls to overhaul CDC could jeopardize progress made in protecting public health and leave the country vulnerable to future crises. Cohen’s concerns come as House Republicans consider deep reductions in CDC...
Article Type: 
Daily News
Tags: 
vaccine
trump
gottlieb
NIH
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 01/10/2025
FDA Volume: 
Vol. 31, No. 2
Author: 
Maaisha Osman
Topics: 
ISSUE: FDA WEEK
HEALTH AUTO EMAIL
Congress
Coronavirus
Transition 2025

Trump’s Denmark Tariff Threat Sparks Concerns For Danish Drug Giant Novo Nordisk

President-elect Donald Trump’s threat to "tariff Denmark at a very high level” unless the nation cedes Greenland to the United States could create new challenges for Novo Nordisk, the Danish drugmaker behind the blockbuster weight-loss and diabetes drugs Ozempic and Wegovy. A tariff on Danish products would likely drive Novo Nordisk to raise drug prices in the United States, a key market for the company, according to an expert. Novo Nordisk told Inside Health Policy that it is closely...
Article Type: 
Daily News
Tags: 
obesity
trump
AI
rebate
Site Name: 
InsideHealthPolicy.com
Author: 
Maaisha Osman
Topics: 
HEALTH AUTO EMAIL
AI
Rx Drugs
Transition 2025

Lilly Granted Permission To Intervene In GLP-1 Compounding Case

Eli Lilly will be allowed to intervene in a case over whether FDA was right to remove tirzepatide, the active ingredient its GLP-1 drugs, from the drug shortage list, allowing it to advance a broader argument that FDA is violating the law by allowing compounding of drugs that have not been added to the 503A bulks list under an interim policy. The Outsourcing Facilities Association, the plaintiff in the case, initially opposed Lilly’s motion to intervene in the case but...
Article Type: 
Daily News
Tags: 
compounding
GLP-1
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 01/10/2025
FDA Volume: 
Vol. 31, No. 2
Author: 
Jessica Karins
Topics: 
ISSUE: FDA WEEK
HEALTH AUTO EMAIL
Rx Drugs
The Courts

Under New Policy, FDA Will Cut Off ‘Interim’ Compounding Of Some New Drugs

FDA will limit the drug substances that can be compounded by 503A and 503B outsourcing facilities after being proposed for, but not yet approved for, its lists of bulk drug substances, the agency says in new guidance on the issue. 503A compounding pharmacies will be able to continue compounding most substances, including those that are the active ingredient in an FDA-approved drug, have a U.S. Pharmacopeia monograph, or are placed in FDA’s “Category 1” list of proposed bulk drugs that...
Article Type: 
Daily News
Tags: 
compounding
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 01/10/2025
FDA Volume: 
Vol. 31, No. 2
Author: 
Jessica Karins
Topics: 
ISSUE: FDA WEEK
HEALTH AUTO EMAIL
Rx Drugs

Admin Announces 24M ACA Sign-Ups So Far; Urges Congress To Keep Enhanced Credits

Nearly 24 million people have already signed up for Affordable Care Act coverage, already topping last year’s record 21 million sign-ups -- and there’s still another week or more for consumers to select a plan, White House officials said in a call with reporters Tuesday (Jan. 7). Officials also stressed how integral the enhanced ACA tax credits are to maintaining a stable marketplace and affordable plans, and urged Congress to renew them. Congress faces a choice this year, White House...
Article Type: 
Daily News
Tags: 
enrollment
ACA
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 01/09/2025
CMS Volume: 
Vol. 28, No. 2
Author: 
Amy Lotven
Topics: 
ISSUE: INSIDE CMS
Health-Exchange-Alert
HEALTH AUTO EMAIL
Health Reform Debate

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