Bill of Health

JULY 1, 2022

Frequency, Characteristics, And Outcomes Of Negative Advisory Committee Votes For FDA-Approved Drugs. Fixing The FDA’s Orange Book. Coverage of New Drugs in Medicare Part D. A full posting of abstracts/summaries of these articles may be found on our? Health Aff (Millwood). 2022 May;41(5):713-721. Health Aff (Millwood).

COVID-19 208

COVID-19 FDA Medicare Medicare 208

Fierce Healthcare

JULY 17, 2023

Alzheimer's disease drug Leqembi recently secured full approval from the Food and Drug Administration (FDA), and more expansive coverage from Medicare followed. | If projections are met, the new Alzheimer's drug meant to slow cognitive decline will cost Medicare more than $2 billion.

Medicare 98

Medicare Medicare FDA 98

Mobi Health News

APRIL 11, 2025

The Health Tech Investment Act would establish a reimbursement pathway for FDA-cleared AI-enabled medical devices.

Medicare 102

Medicare Medicare FDA 102

Healthcare Dive

JUNE 1, 2023

The agency will reimburse Alzheimer’s treatments if they receive full FDA approval, but plans to still require data collection via a patient registry.

Medicare 130

Medicare Medicare FDA 130

HIT Consultant

JULY 2, 2024

What You Should Know: – Eli Lilly’s Kisunla™ (donanemab-azbt) has been approved by the FDA as a treatment for adults in the early stages of Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) and mild dementia, who have confirmed amyloid plaque buildup in the brain.

FDA 98

FDA Medicare Medicare 98

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. N Engl J Med. Am J Prev Cardiol.

Prescription Drug Pricing 130

Prescription Drug Pricing FDA Medicare Medicare 130

Healthcare Dive

JULY 6, 2023

The broader approval is expected to push insurers, namely Medicare, to increase coverage of so-called amyloid-targeting therapies.

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FDA Medicare Medicare 130

Bill of Health

NOVEMBER 17, 2022

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Medicare’s National Coverage Determination for Aducanumab – A One-Off or a Pragmatic Path Forward? Limitations on the Capability of the FDA to Advise. JAMA Intern Med. 2022 Oct 3:e224226. 2022 Oct 5;379:e071752.

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FDA World Health Medicaid Medicaid 189

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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FDA Medicare Medicare Medicaid 115

HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. Health plans could, for example, consider covering OTC hearing devices as part of the hearing benefits package provided to their Medicare Advantage plan members. For Medicare Advantage plans, a positive member experience is critical in achieving 5-star ratings.

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FDA Public Health Fraud Medicare 98

Bill of Health

DECEMBER 27, 2022

Frequency of Approval and Marketing of Biosimilars With a Skinny Label and Associated Medicare Savings. A Review of Pregnancy and Lactation Postmarketing Studies Required by the FDA. Getting the Price Right: Lessons for Medicare Price Negotiation from Peer Countries. Healthcare Policy. 2022 Nov;18(2):14-26. 2022 Nov 28.

Medicare 147

Medicare Medicare Medicaid Medicaid 147

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. Treasury Dept U.S. State Dept Which Level of FACIS Search Does Your Organization Need?

Fraud 52

Fraud Medicaid Medicaid Compliance 52

Bill of Health

MARCH 24, 2023

The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with a skinny label and their associated Medicare savings, to a discussion of the Philips Respironics recall and the need for reforms to U.S. Characteristics of Prior Authorization Policies for New Drugs in Medicare Part D.

Medicare 147

Medicare Medicare Medicaid Medicaid 147

Health Populi

JUNE 5, 2022

Its longer more formal name was The Drug Price Competition and Patent Term Restoration Act of 1984, and it created a pathway for generic drug applications to the FDA. In 2006 the Medicare Part D program was implemented, covering older Americans for prescription drugs for the first time.

Overpayment 154

Overpayment Overpayments Medicare Medicare 154

Healthcare IT Today

MARCH 28, 2025

The company has already received 12 FDA clearances, and one of its CT Brain algorithms has FDA Breakthrough Device Designation and Medicare reimbursement through the New Technology Add-on Payment (NTAP). The company will focus on building its U.S. operations and growing the Harrison.ai customer base. Harrison.rad.1,

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FDA Hospitals Medicare Medicare 64

Bill of Health

MARCH 25, 2022

Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. A full posting of abstracts/summaries of these articles may be found on our? Updating the Bayh-Dole Act: March-in Rights and Transparency. 2022 Feb 24. Epub ahead of print. PMID: 35201276. J Gen Intern Med. 2022 Feb 9.

FDA 208

FDA COVID-19 Medicaid Medicaid 208

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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FDA COVID-19 Governance Medicaid 115

Bill of Health

JUNE 26, 2023

Once approved by the FDA, CalRx insulin will be made available at $30 to all Californians who need it. On August 7, 2022, the US Senate passed the Inflation Reduction Act , which gives Medicare the power to negotiate prices of certain high-cost drugs. Insulin is the first product the initiative will manufacture.

Pharmaceutical Industry 195

Pharmaceutical Industry Governance FDA Public Health 195

Health Populi

JUNE 29, 2021

The FDA’s approval of the first therapy to treat Alzheimer’s Disease in over twenty years brought attention to a not-yet-convened debate of U.S. The FDA regulatory process and aftermath. consumers’ bipartisan support for drug price regulation through Medicare negotiation and private/commercial sector adoption.

Medicare 62

Medicare Medicare FDA Bioethics 62

HIT Consultant

DECEMBER 9, 2024

Cala kIQ: Non-Invasive Relief for Hand Tremors The Cala kIQ System, featuring FDA-cleared Transcutaneous Afferent Patterned Stimulation (TAPS) therapy, is the only clinically validated non-invasive wearable device for action hand tremor relief in adults with essential tremor (ET) and Parkinsons disease (PD).

Medicare 52

Medicare Medicare FDA 52

Bill of Health

OCTOBER 11, 2023

The selections feature topics ranging from a review of the regulatory consequences of the FDA’s accelerated approval of eteplirsen, to a comparison of the safety and effectiveness of generic and brand-name fluticasone-salmeterol for COPD, to an analysis of free speech challenges to Medicare drug price negotiation under the Inflation Reduction Act.

Patient Advocacy 147

Patient Advocacy Medicare Medicare FDA 147

Mobi Health News

JUNE 7, 2019

The FDA approval closes a gap with competitors Dexcom and Abbott, as well as setting the company up for entry into the Medicare market.

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FDA Medicare Medicare 84

HIT Consultant

FEBRUARY 28, 2022

– XRHealth’s platform is FDA and CE registered and provides an immersive experience for users, transporting them to a virtual world for comprehensive therapeutic care. Patient care is covered by Medicare and is available under most major insurance providers. At-Home Drug-Free Alternative to Traditional Healthcare.

Medicare 98

Medicare Medicare FDA Health Insurance 98

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.

US Department of Health and Human Services 88

US Department of Health and Human Services Nurses Medicare Medicare 88

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 (..)

FDA 80

FDA Medicaid Medicaid Medicare 80

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.

FDA 114

FDA Medicaid Medicaid Medicare 114

AIHC

JANUARY 28, 2022

For more information on filing compliance cost reports, attend the Medicare Cost Report Camp in March 2022 presented by KraftCPAs and sponsored by the American Institute of Healthcare Compliance. The final rule updates Medicare fee-for-service payment rates and policies for inpatient hospitals and long-term care hospitals for FY 2022.

Medicare 40

Medicare Medicare Hospitals Payment Systems 40

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.

HIPAA 162

HIPAA FDA Informed Consent Health Insurance 162

Healthcare IT Today

JANUARY 5, 2024

The app-based digital therapeutics are the only FDA-authorized app-based treatments for SUD and OUD, respectively. Additionally, the company acquired reSET-A, a digital therapeutic for alcohol use disorder that received FDA breakthrough device designation, supporting the company’s expansion into alcohol addiction treatment and prevention.

FDA 119

FDA Medicaid Medicaid Hospitals 119

Innovaare Compliance

MARCH 1, 2022

The monthly premium for Medicare Part B rose 14.5%, from $148.50 By law, the Medicare Part B monthly premium must equal 25% of the estimated total Part B costs for enrollees age 65 and over. [1] By law, the Medicare Part B monthly premium must equal 25% of the estimated total Part B costs for enrollees age 65 and over. [1]

Medicare 52

Medicare Medicare Overpayment Overpayments 52

Innovaare Compliance

JANUARY 15, 2024

The Prescription Drug Program, commonly known as Medicare Part D, is undergoing significant transformations in 2025 due to the Inflation Reduction Act (IRA) of 2022. Medicare Part D will have three (3) phases instead of four (4) – Deductible, Initial Coverage Phase and Catastrophic Phase. generics) in the catastrophic phase.

Medicare 52

Medicare Medicare Compliance FDA 52

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] The introduction of the metaverse will likely exacerbate these interoperability issues. Medical Device Regulations. 1, 2021).

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FDA HIPAA Medicare Medicare 90

Healthcare IT Today

AUGUST 28, 2023

Regarding medication, several new psychiatric treatments have been approved by the FDA, including Auvelity for major depressive disorder, the SAINT transcranial magnetic stimulation protocol for treatment-resistant depression, and Zurzuvae for postpartum depression. The FDA’s RTA policy, effective Oct.

US Department of Health and Human Services 124

US Department of Health and Human Services Telemedicine Hospitals Compliance 124

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.

FDA 52

FDA Medicare Medicare Medical Billing 52

Healthcare Law Today

JANUARY 11, 2023

Food and Drug Administration (FDA) prior to distribution. violated the False Claims Act by causing medical providers to submit false claims to Medicare. The lawsuit alleged that the device was not approved or authorized by the FDA and that the procedure was not covered by Medicare. and Martech Medical Products Inc.,

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FDA Governance Medicare Medicare 59

Healthcare IT Today

MAY 5, 2024

Products GE HealthCare announced FDA 510(k) clearance for Portrait VSM , its portable vital sign monitor. CLEW released its FDA-cleared intelligent clinical surveillance platform for the inpatient setting. Intuity Medical received Medicare Part B coverage for POGO , its automatic blood glucose monitoring system.

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FDA Medicare Medicare Hospitals 92

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.

Hospitals 98

Hospitals Patient Satisfaction Regulatory Compliance FDA 98