Senate User Fee Bill Speeds FDA’s Therapeutic Equivalence Decisions

Senate health committee Chair Patty Murray (D-WA) and ranking Republican Richard Burr (R-NC) on Friday (May 27) introduced their user fee bill with some changes from the draft version, including a new measure that aims to shorten FDA’s decision-making around whether 505(b)(2) drugs may be automatically substituted at the pharmacy for the brand drugs they reference. The bill also would require FDA to quickly finish its over-the-counter hearing aid rule and provide Congress with more information about its inspection activities...
Article Type: 
Daily News
Tags: 
user-fee
LDT
drug-reimbursement
generics
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 06/03/2022
FDA Volume: 
Vol. 28, No. 22
Author: 
Beth Wang
Secondary Author(s): 
Kelly Lienhard
Topics: 
ISSUE: FDA WEEK
Mid Day E-mail
Congress
Medical Devices
Rx Drugs
User Fees

Consumer Advocates Worry About Phone Scams In Post-PHE Renewals

A group of consumer protection advocates are concerned the Federal Communications Commission could open the door to scam calls and telemarketers if it gives too much flexibility to CMS, states and contractors who want to be able to call or text Medicaid and Children’s Health Insurance Program beneficiaries about their renewals once the public health emergency ends without the fear of violating the Telephone Consumer Protection Act. The advocates urge FCC to make sure such a contact policy includes appropriate...
Article Type: 
Daily News
Tags: 
medicaid
CHIP
corona
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 06/02/2022
CMS Volume: 
Vol. 25, No. 22
HEA Issue: 
Health Exchange Alert Weekly Report - 06/01/2022
HEA Volume: 
Vol. 10, No. 22
Author: 
Dorothy Mills-Gregg
Topics: 
ISSUE: INSIDE CMS
Health-Exchange-Alert
Mid Day E-mail
Biden Health Agenda
Congress
Coronavirus
Medicaid

Senate Accelerated Approval Reforms Mirror House Bill With One Exception

The Senate FDA user fee bill that was introduced Friday (May 27) includes accelerated approval reforms that mirror the House user fee bill, with the exception of a new measure in the Senate bill to create an “intra-agency coordinating council” to ensure uniform usage of accelerated approvals. The draft legislation that Senate health committee Chair Patty Murray (D-WA) and ranking GOP member Richard Burr (NC) released May 17 did not include changes to FDA’s accelerated approval path, which prompted lobbying...
Article Type: 
Inside Drug Pricing Daily News
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 05/30/2022
IDP Volume: 
Vol. 5, No. 22
Author: 
John Wilkerson

Rosen, Romney Introduce Bill To Research Nonprofit Pharma Sector

Sens. Jacky Rosen (D-NV) and Mitt Romney (R-UT) introduced legislation Friday (May 27) that would direct the Government Accountability Office (GAO) to study the impact of nonprofit generic drug makers on the drug industry and the barriers to their prominence. The bill is meant to help nonprofit generic drug makers, but it’s a far cry from Rosen’s previous bill, which would make it easier for them to acquire nonprofit tax-exempt status, provide them grants and low-interest loans, and waive FDA...
Article Type: 
Inside Drug Pricing Daily News
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 05/30/2022
IDP Volume: 
Vol. 5, No. 22
Author: 
Gabrielle Wanneh

CMS Report

CMS Press Release

HHS Press Release




Tele-Mental Health Bill Could Lead To Permanent Telehealth Legislation

Telehealth stakeholders say the Senate Finance Committee’s discussion draft of tele-mental health policies, unveiled Thursday (May 26), could signal lawmakers are ready to consider broader legislation to cement COVID-19 pandemic telehealth flexibilities before the end of the 151-day extension of waivers in the omnibus funding package. The draft would eliminate the in-person requirement for behavioral health services under Medicare, support use of audio-only care when clinically appropriate and mandate studies on telehealth usage. A 151-day blanket extension of COVID-19 pandemic...
Article Type: 
Inside Telehealth Daily News
Site Name: 
InsideHealthPolicy.com
Author: 
Cara Smith
Topics: 
Not Top Story

Bipartisan Bill Extends Telehealth Use In Dialysis Clinics Post-COVID-19

A bipartisan, bicameral group of lawmakers on Thursday (May 26) introduced legislation that would continue COVID-19 pandemic flexibilities allowing patients with End Stage Renal Disease (ESRD) to connect with providers via telehealth while receiving treatment in a dialysis clinic. The waiver that enabled a dialysis clinic to be a telehealth originating site under Medicare is attached to the COVID-19 public health emergency. Stakeholders are asking HHS to extend the COVID-19 pandemic public health emergency (PHE) beyond July to keep certain...
Article Type: 
Inside Telehealth Daily News
Site Name: 
InsideHealthPolicy.com
Author: 
Cara Smith
Topics: 
Not Top Story

HHS Axes Trump-Era Rule That Threatened Scores Of Health Care Regs

HHS on Thursday (May 26) withdrew a Trump-era final rule that would have automatically scrapped health agency regulations if they weren’t assessed every 10 years. The rule was universally disliked by industry and consumer groups, and a lawsuit against the rule said it could have eliminated thousands of regulations for public health, food and health systems. HHS in October began the process of repealing the Trump administration’s rule , Securing Updated and Necessary Statutory Evaluations Timely (SUNSET), which was published...
Article Type: 
Daily News
Tags: 
trump
enforcement
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 06/03/2022
FDA Volume: 
Vol. 28, No. 22
CMS Issue: 
Inside CMS - 06/02/2022
CMS Volume: 
Vol. 25, No. 22
HEA Issue: 
Health Exchange Alert Weekly Report - 06/01/2022
HEA Volume: 
Vol. 10, No. 22
Author: 
Beth Wang
Topics: 
ISSUE: INSIDE CMS
ISSUE: FDA WEEK
Health-Exchange-Alert
Biden Health Agenda

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