CMS Agrees To Work With E&C On Digital Therapeutics, Remote Monitoring Bills

Lawmakers secured a verbal commitment from a CMS official to work with them on remote monitoring and prescription digital therapeutics legislation during a House Energy & Commerce Committee hearing Sept. 19. At the hearing, focused on improving Medicare beneficiaries’ access to medications and medical technologies, lawmakers discussed several bills, including two aimed at boosting Medicare coverage and payment for remote monitoring and digital therapeutics: the Expanding Access to Remote Monitoring and the Access to Prescription Digital Therapeutics Act. Rep. Bill...
Article Type: 
Inside Telehealth Daily News
Site Name: 
InsideHealthPolicy.com
Author: 
Emma Beavins
Topics: 
Not Top Story

Stakeholders Scramble To Extend Standalone Telehealth Before End Of Year

Over 40 telehealth stakeholders wrote a letter on Sept. 15 urging House and Senate leadership to endorse the Telehealth Benefit Expansion for Workers Act--that would extend pandemic waivers that allowed telehealth services to be treated similar to excepted benefit--before workers lose access to the standalone telehealth plans at the end of the year. On Tuesday (Sept. 19) telehealth lobby groups and their members descended on Capitol Hill to lobby for legislation that would formally classify telehealth as an excepted benefit,...
Article Type: 
Inside Telehealth Daily News
Site Name: 
InsideHealthPolicy.com
Author: 
Cara Smith
Topics: 
Not Top Story

Stakeholders Scramble To Extend Standalone Telehealth Before End Of Year

Over 40 telehealth stakeholders wrote a letter on Sept. 15 urging House and Senate leadership to endorse the Telehealth Benefit Expansion for Workers Act -- that would extend pandemic waivers that allowed telehealth services to be treated similar to excepted benefit -- before workers lose access to the standalone telehealth plans at the end of the year. On Tuesday (Sept. 19) telehealth lobby groups and their members descended on Capitol Hill to lobby for legislation that would formally classify telehealth...
Article Type: 
Daily News
Tags: 
telehealth
Site Name: 
InsideHealthPolicy.com
HEA Issue: 
Health Exchange Alert - 09/27/2023
HEA Volume: 
Vol. 11, No. 34
Author: 
Cara Smith
Topics: 
Health-Exchange-Alert
Congress

Stakes High For FDA As SCOTUS Weighs Hearing Mifepristone REMS Case

If the Supreme Court agrees to take up the high-profile case over FDA’s prescribing conditions for the abortion pill mifepristone, the ultimate ruling could have major implications for how courts consider FDA drug approvals and who can file suits over federal agency action, government attorneys and other legal experts say. The federal government and a mifepristone manufacturer recently asked the high court to overrule a circuit court ruling that second-guessed FDA by nixing its decision to let telehealth providers prescribe...
Article Type: 
Daily News
Tags: 
contraception
REMS
supreme-court
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 09/22/2023
FDA Volume: 
Vol. 29, No. 38
Author: 
Jessica Karins
Topics: 
ISSUE: FDA WEEK
Abortion
Rx Drugs
The Courts

New Draft Guidance Updates Info Needed For Biosimilar Labeling

FDA has issued new recommendations advising biosimilar sponsors how to adapt labeling from reference products, including updates to five-year old guidance when it comes to labeling for interchangeable products, pediatric use statements and immunogenicity data. The new draft guidance says the text of a biosimilar labels should track the reference label but doesn’t have to be identical and should reflect current information needed for the product’s safe and effective use. Any pediatric text should state whether clinical trials with pediatric...
Article Type: 
Daily News
Tags: 
biosimilar
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 09/22/2023
FDA Volume: 
Vol. 29, No. 38
Author: 
Jessica Karins
Topics: 
ISSUE: FDA WEEK
Rx Drugs

PhRMA: PBMs Now Profiting Off Fees More Than Rebates

The brand drug lobby says congressional efforts to make pharmacy benefit managers’ rebate practices more transparent are a good first step, but PBMs are now shifting to a new business model where opaque fees and specialty pharmacy markups comprise a greater share of their profits. The Pharmaceutical Research and Manufacturers of America released a new study Monday (Sept. 18) laying out the new PBM model, and today said Congress needs to beef up pending PBM reform bills in testimony before...
Article Type: 
Inside Drug Pricing Daily News
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 09/25/2023
IDP Volume: 
Vol. 6, No. 39
Author: 
Luke Zarzecki

PhRMA: PBMs Now Profiting Off Fees More Than Rebates

The brand drug lobby says congressional efforts to make pharmacy benefit managers’ rebate practices more transparent are a good first step, but PBMs are now shifting to a new business model where opaque fees and specialty pharmacy markups comprise a greater share of their profits. The Pharmaceutical Research and Manufacturers of America released a new study Monday (Sept. 18) laying out the new PBM model, and today said Congress needs to beef up pending PBM reform bills in testimony before...
Article Type: 
Daily News
Tags: 
PBM
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 09/21/2023
CMS Volume: 
Vol. 26, No. 38
HEA Issue: 
Health Exchange Alert - 09/27/2023
HEA Volume: 
Vol. 11, No. 34
Author: 
Luke Zarzecki
Topics: 
ISSUE: INSIDE CMS
Health-Exchange-Alert
Rx Drugs

CMS Finalizes Medicare Savings Program Enrollment Proposals

CMS on Monday (Sept. 18) released a final rule ensuring people who receive Supplemental Security Income are automatically enrolled in Medicare Savings Programs, the first in a set of two rules the agency is releasing to overhaul its enrollment processes. The rule finalizes a subset of proposals included in a sweeping August 2022 proposed rule to revamp Medicaid and Children’s Health Insurance Plan (CHIP) enrollment processes. The agency says it received over 7,000 comments and will be releasing a second...
Article Type: 
Daily News
Tags: 
enrollment
part-d
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 09/21/2023
CMS Volume: 
Vol. 26, No. 38
Author: 
Bridget Early
Topics: 
ISSUE: INSIDE CMS
Medicaid
Medicare

E&C To Discuss More PBM Reforms As Leadership Pushes Transparency Package

As House leadership seeks to quickly pass broad legislation that would bolster price transparency and oversight across the health care system, the Energy & Commerce Committee will meet Tuesday (Sept. 19) to discuss a slew of additional drug pricing policies and reforms for pharmacy benefit managers that weren’t tucked into the larger tri-committee package sent to the House floor. The House was slated to vote on the Lower Costs, More Transparency Act (H.R. 5378), which aims primarily to make the...
Article Type: 
Daily News
Tags: 
PBM
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 09/21/2023
CMS Volume: 
Vol. 26, No. 38
Author: 
Gabrielle Wanneh
Topics: 
ISSUE: INSIDE CMS
Congress
Medicare
Rx Drugs

Partisanship, Funding And Privacy Concerns Could Obstruct PrEP Access

A lack of funding, fears around data sequestration, and resistance to expanding sexual health measures are all reasons pointing to delays for increasing access to PrEP for uninsured and underinsured patients. While the U.S. Preventive Services Task Force (USPSTF) last month made headway for insured patients by giving it an “A” grade, questions remain about access for those without insurance. Since the Affordable Care Act (ACA) requires most health plans to cover preventative services with an “A” or “B” grade...
Article Type: 
Daily News
Tags: 
HIV
Site Name: 
InsideHealthPolicy.com
HEA Issue: 
Health Exchange Alert - 09/27/2023
HEA Volume: 
Vol. 11, No. 34
Author: 
Luke Zarzecki
Topics: 
Health-Exchange-Alert
Rx Drugs

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