Aging Panel Probes Enforcement Exemptions For Foreign Drugmakers

Leaders of the Senate Special Committee on Aging have asked FDA Commissioner Marty Makary to provide more information on exemptions granted to foreign drug manufacturing facilities from FDA enforcement policies, saying exemptions may have allowed the continued import of drugs despite safety and human rights concerns.

Tags: 
drug-safety
enforcement
generics
drug-import
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 10/10/2025
FDA Volume: 
Vol. 31, No. 41
Author: 
Jessica Karins

Hospital Rural Reclassification Issues Reignite As CMS Opens OBBB Rural Fund

Conversations about classification loopholes for rural hospitals are reigniting as CMS launches the Rural Health Transformation Program (RHTP) created in the GOP megabill enacted in July.

Tags: 
340b
hospital
rural-health
reconciliation
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 10/02/2025
CMS Volume: 
Vol. 28, No. 40
Author: 
Sigi Ris

Energy & Commerce Republicans Announce Sweeping Health Hearing

Lawmakers will consider a plethora of health care bills aimed at increasing patient access to care and reducing red tape for providers, House Energy & Commerce Republicans announced Thursday (Oct. 12).

Tags: 
home-health
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 10/19/2023
CMS Volume: 
Vol. 26, No. 42
Author: 
Bridget Early

HHS Recommends Marijuana Scheduling Change Using FDA Data

HHS has recommended to the Drug Enforcement Agency (DEA) that marijuana be moved from a Schedule I to a Schedule III drug under the Controlled Substances Act (CSA), a move that would allow it to be made available via prescription and increase its availability in medical research, winning immediate praise from Democrats who favor decriminalization.

Tags: 
CBD
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 09/01/2023
FDA Volume: 
Vol. 29, No. 35
Author: 
Jessica Karins

Labs Pleased CMS Opening Process For Revising Medicare Pay Rates

Laboratories are pleased that CMS is opening the process of setting reimbursement for laboratory services, just as it is doing for physician services, which will give labs more say over pay rates.

Newsletter Volume: 
Vol. 17, No. 28
Newsletter Issue: 
Inside CMS - 07/10/2014
Author: 
John Wilkerson

Moran Report: Outpatient Chemo Costs Higher Than Clinics

Patients who receive chemotherapy in hospital outpatient departments cost Medicare more than those who receive the same care in cancer clinics, according to a Moran Company report for the US Oncology Network and Community Oncology Alliance. The oncologists are using the report to fight CMS' proposal to pay the same rates for cancer care in physician offices and outpatient departments. The Moran report finds that outpatient chemotherapy spending per beneficiary was 25 percent to 47 percent higher than physician clinic chemotherapy spending.

Author: 
John Wilkerson

CBO Adds $3.9B To Estimate Of IRA Orphan Drug Exemption Cost

Exempting all orphan drugs from selection for the Medicare drug price negotiation program would cost taxpayers $8.8 billion by 2034, according to the Congressional Budget Office’s updated score, an increase of $3.9 billion from its original estimate after CBO accounted for the impact of newly exempting certain expensive blockbuster drugs sold under Part B.

Site Name: 
InsideHealthPolicy.com
Author: 
Gabrielle Wanneh

Kenvue Hints At Lawsuit If FDA Adds Autism Claims To Tylenol Label

Tylenol manufacturer Kenvue hints it may take legal action if FDA goes through with a label update backed by President Donald Trump and HHS Secretary Robert F. Kennedy Jr. linking the popular over-the-counter pain reliever to autism.

Tags: 
drug-safety
misinformation
Site Name: 
InsideHealthPolicy.com
Author: 
Jessica Karins

Commerce Threat To Claim University Patents Sparks Innovation Worries

Bayh-Dole Act advocates warn that the Commerce Department’s effort to claim partial ownership of university-held patents could reduce filings and dramatically slow innovation of medical products like immunotherapies and mRNA vaccines, but one patent expert tells Inside Health Policy reducing the number of low-value patents could clear the way for more researchers and companies to develop new therapies without negotiating dozens of overlapping licenses.

Tags: 
science
NIH
innovation
drug-patent
Site Name: 
InsideHealthPolicy.com
Author: 
Maaisha Osman

Industry Strengthens Push For Medicare To Overhaul AI Reimbursement

Companies and industry coalitions are ramping up calls for policymakers at CMS and on Capitol Hill to improve what they say is inconsistent and low Medicare reimbursement of artificial intelligence tools.

Site Name: 
InsideHealthPolicy.com
Author: 
Christian Robles

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