Fierce Healthcare

JUNE 1, 2023

The Centers for Medicare and Medicaid Services outlined plans Thursday to broadly cover a new class of Alzheimer’s drugs once the medications get full approval from the Food and Drug Administration | CMS outlined plans Thursday to broadly cover a new class of Alzheimer’s drugs once the medications get full approval from the Food and Drug Administration. (..)

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Bill of Health

MARCH 25, 2022

Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018. A full posting of abstracts/summaries of these articles may be found on our? 2022 Feb 24. Epub ahead of print. PMID: 35201276.

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Bill of Health

NOVEMBER 17, 2022

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Limitations on the Capability of the FDA to Advise. Medicaid Spending on Antiretrovirals from 2007-2019. A full posting of abstracts/summaries of these articles may be found on our? JAMA Intern Med. 2022 Oct 3:e224226.

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Bill of Health

JANUARY 19, 2022

Raising Medicaid Rebates For Drugs With Accelerated Approval. A full posting of abstracts/summaries of these articles may be found on our? Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action. JAMA Netw Open. 2021 Dec 1;4(12):e2138793. Rome BN, Kesselheim AS.

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Healthcare IT Today

DECEMBER 22, 2024

DUOS updated its digital health platform for seniors to enable end-to-end applications for federal and state assistance programs such as SNAP and Medicaid. It’s initially being used in Stelo, Dexcom’s FDA-cleared over-the-counter glucose biosensor. Dexcom launched a proprietary generative AI platform build on Google Cloud.

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Fierce Healthcare

AUGUST 8, 2024

The Centers for Medicare and Medicaid Services released a final procedural notice on Wednesday to expedite Medicare coverage of novel medical devices and get the devices to Medicare benef | CMS released a final procedural notice on its TCET rule, which would expedite coverage for FDA Breakthrough medical devices.

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Verisys

APRIL 8, 2025

At a minimum, FACIS Level 1M satisfies the requirements of the OIG and CMS (Centers for Medicare & Medicaid Services) by screening providers for exclusions, debarments, disciplinary actions , and related issues. T his information provides organizations with detailed reports for making well-informed hiring decisions. Treasury Dept U.S.

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HIPAA Journal

DECEMBER 22, 2022

Funding for the Centers for Medicare and Medicaid Services will increase by $100 million, the National Institutes of Health will receive an additional $2.5 Funding for the Centers for Medicare and Medicaid Services will increase by $100 million, the National Institutes of Health will receive an additional $2.5 The bill proposes $120.7

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HIT Consultant

OCTOBER 28, 2024

Transforming Dental Care with Technology Grin’s platform combines the Grin App with the first-of-its-kind Grin Scope®, an FDA-listed medical device that provides comprehensive views of patients’ mouths. This investment in Grin reinforces their commitment and aligns with their mission to address the oral health crisis.

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Bill of Health

DECEMBER 27, 2022

A Review of Pregnancy and Lactation Postmarketing Studies Required by the FDA. Variations in Use of Diabetes Drugs With Cardiovascular Benefits Among Medicaid Patients. The Philips Respironics Recall of Ventilators and Positive Airway Pressure Machines-Breakdowns in Medical Device Surveillance. JAMA Internal Medicine. 2022 Nov 14.

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Bill of Health

OCTOBER 7, 2022

Food and Drug Administration (FDA) advisory committees, an analysis of the key patents covering drugs recently approved by the FDA, and an examination of high-risk cardiovascular devices approved by the FDA for use in children and adolescents. Improving the Use of FDA Advisory Committees. 2022 Aug;162(2):433-435.

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Bill of Health

MARCH 24, 2023

Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020. Market dynamics of authorized generics in Medicaid from 2014 to 2020. JAMA Health Forum. 2023 Feb 3;4(2):e225610. Pham C, Le K, Draves M, Seoane-Vazquez E. JAMA Intern Med. 2023 Feb 13:e226787. Epub ahead of print. Health Serv Res.

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Healthcare IT Today

JANUARY 14, 2024

Product and Company News from CES 2024 Elevance Health will make smartphones eligible to qualified Medicaid members at no cost through a partnership with Samsung and service providers AT&T, T-Mobile, and Verizon. Infant monitoring company Owlet launched two FDA-cleared devices : Dream Sock and BabySat.

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HIT Consultant

SEPTEMBER 26, 2024

What You Should Know: Cognoa , a leading child development and behavioral health company, today announced its inclusion as a covered benefit under Wyoming Medicaid that will cover the cost of the company’s flagship product, Canvas Dx – the first FDA authorized diagnostic for children at risk of developmental delays including autism.

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Healthcare IT Today

JANUARY 5, 2024

The proceeds from the financing will support PursueCare’s ongoing collaborative care initiatives with health systems across 11 states, as well as expansion into value-based care with Medicaid managed care and other health plans. Patients can also seek treatment without a referral by downloading the app from Google Play or the Apple Store.

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Fierce Healthcare

JUNE 23, 2023

The Centers for Medicare & Medicaid Services released new details Thursday about how it plans to collect patient data as a condition of coverage for a new class of Alzheimer’s drugs, once the m | CMS released new details Thursday about how it plans to collect patient data as a condition of coverage for a new class of Alzheimer’s drugs, once the (..)

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HIT Consultant

JULY 18, 2024

What You Should Know: – AliveCor , the global leader in AI-powered cardiology, today announced that the American Medical Association (AMA) has granted new Category III Current Procedural Terminology (CPT) codes that are applicable to the company’s Kardia™ 12L ECG System, which received FDA clearance in June 2024.

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Healthcare IT News - Telehealth

JANUARY 25, 2023

FDA is currently reviewing use of Selux's NGP Gram-Negative panel. Through Work & Mother's app, parents with insurance or Medicaid coverage can access same-day appointments with Nest's IBCLCs without copays, out-of-pocket costs or deductibles. Inspira Technologies said it received patent approval from the U.S.

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Prescription Drug Pricing Doctors FDA Health Insurance 177

HIT Consultant

MAY 2, 2024

– The Centers for Medicare and Medicaid Services (CMS) created two new coverage codes specifically for POGO Automatic, recognizing this new and significantly different technology compared to traditional blood glucose meters (BGMs). What You Should Know: – Intuity Medical, Inc., million seniors age 65 and up living with diabetes.

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Bill of Health

OCTOBER 27, 2023

The regulation and administration of health care in the United States suggests a list of familiar institutional names — the Department of Health and Human Services, the Food and Drug Administration, Centers for Medicare & Medicaid Services, and the National Institutes of Health, to list a few.

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Healthicity

OCTOBER 8, 2024

Stay ahead of compliance risks with these September 2024 OIG Work Plan updates including FDA safety signals, Medicaid MLRs, & hospital price transparency.

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HIT Consultant

NOVEMBER 11, 2021

The round, which included investments from F-Prime Capital , JAZZ Venture Partners , Sway Ventures and SVB Ventures , set up AppliedVR for rapid growth as it prepares for its decision from the FDA on its first de novo submission.

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HIPAA Journal

MAY 6, 2025

Food and Drug Administration (FDA) that sought to reclassify laboratory-developed tests (LDTs) as medical devices, thus regulating the LDTs under the Federal Food, Drug, and Cosmetic Act (FDCA). The rule was first proposed by the FDA on October 3, 2024, and a final rule was added to the Federal Register on May 6, 2024. laboratories.

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HIT Consultant

OCTOBER 15, 2024

Recent data from the Centers for Medicare & Medicaid Services (CMS) indicates that patients treated at home experience lower mortality rates and fewer complications compared to those receiving traditional inpatient care.

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HIT Consultant

JUNE 6, 2024

RelieVRx: A Breakthrough in Pain Management Across Diverse Demographics The study published in the Journal of Medical Extended Reality revealed that AppliedVR’s FDA-authorized RelieVRx device produced clinically effective results across various demographics, including age, gender, race/ethnicity, and socioeconomic status.

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Compliancy Group

APRIL 30, 2025

This includes Medicare, Medicaid, and others. It checks employees and vendors weekly against 55 exclusion lists, including the OIG LEIE, SAM, and FDA. Compliancy Groups Exclusion Monitoring Tool is an exclusion screening software that helps build that structure into your workflow.

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Bill of Health

APRIL 25, 2022

Anticipated efficiencies, real costs: Medicaid managed care organizations and the pharmacy benefit. A full posting of abstracts/summaries of these articles may be found on our website. Bendicksen L, Kesselheim AS. J Manag Care Spec Pharm. 2022 Mar;28(3):354-361. Dhruva SS, Darrow JJ, Kesselheim AS, Redberg RF.

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Healthcare IT News - Telehealth

MAY 6, 2020

It also equips providers with Eko’s FDA-cleared AI to assist in remote screening for AFib, heart murmurs, tachycardia and bradycardia. In addition, the company is awaiting FDA approval for an onboard ECG feature for spot detection of atrial fibrillation. iRhythm Technologies.

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Healthcare IT Today

DECEMBER 30, 2024

This shift, driven by the FDA’s Diversity Action Plans, will accelerate trial enrollment, improve representation, and ultimately enhance patient safety by ensuring more diverse data in research. This API-first approach will be driven by health plans needing to perform with Medicare Advantage and managed Medicaid.

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Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] Medical Device Regulations. 1, 2021). [2]

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Jane Sarashon

DECEMBER 30, 2024

The graphic shows the recently FDA-cleared blood pressure monitor from Withings, the BPM Pro 2. Earables and hearables : the FDAs clearance of direct-to-consumer (DTC) hearing aids turbocharged the market for over-the-counter devices, raising awareness and empowerment among people seeking greater hearing clarity.

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Healthcare IT News - Telehealth

DECEMBER 13, 2024

The AI could suggest that patients with psoriasis who are on topicals or creams may need systemic treatments, and could be advised about orals or biologics that are available and FDA-approved. "Then the patient has to take that message to their physician to have that conversation," Ahadome said.

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Healthcare IT Today

MARCH 2, 2025

Massachusetts Medicaid and CHIP program MassHealth chose PointClickCare to manage its Behavioral Health Treatment and Referral Platform. Company News Google received FDA clearance for its Loss of Pulse Detection feature starting with Pixel Watch 3; the feature will be available in the U.S. at the end of march.

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Healthcare IT Today

OCTOBER 23, 2022

GE Healthcare has received more FDA authorizations for AI-enabled medical devices , with 42, than any other company. The FDA has issued 510(k) clearances to more than 500 devices in all. Cloud service provider Gainwell Technologies implemented the Medicaid administration platform for the state of Kansas.

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HIPAA Journal

DECEMBER 8, 2022

The FDA should also make it clear that security updates are required, not optional. One way to support healthcare organizations financially would be to make sure that Medicare and Medicaid fixed payments accurately reflect the cost of care. Many hospitals rely on these payments, but they are often less than the cost of providing care.

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HIPAA FDA Governance Hospitals 131

Healthcare IT Today

JUNE 7, 2023

In the comments that we will submit to ONC on HTI-1, we’ll also be encouraging ONC and the Centers for Medicare and Medicaid Services (CMS) to work more closely together to address the misalignments that frequently occur between when ONC tells software developers to deploy new certified versions and when CMS requires providers to be using them.

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Healthcare IT Today

FEBRUARY 27, 2024

The product is patent protected, FDA cleared, and FSA, HSA, Medicare, and Medicaid eligible. Postal Service’s approved mail-back program. HealthBeacon also provides a digital risk management platform for prescribing restricted medication to oncology patients.

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