Healthcare It News

DECEMBER 16, 2022

FDA and evolving regulations for digital therapeutics, software as a medical device. Up to 18 million people could lose Medicaid coverage after COVID-19 PHE. Automation, and how it can help clinician burnout and back-office processes. Cybersecurity and the patient safety risks of ransomware.

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COVID-19 Public Health Ransomware FDA 284

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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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

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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Prescription Drug Pricing FDA Medicare Medicare 130

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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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

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 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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HIT Consultant

OCTOBER 21, 2022

US hospital systems validate the safety, clinical utility, and robustness of newly FDA-approved devices, 510(k) cleared, before adopting them into clinical practice. Your FDA 510(k) cleared device must be designed for and evaluated by a number of stakeholders. Rolland Carlson, CEO of Immunexpress. About Rolland Carlson, PhD | LinkedIn.

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Hospitals FDA Compliance COVID-19 98

MedTrainer

JANUARY 12, 2024

Here are some of the key organizations involved in regulating healthcare compliance: Centers for Medicare & Medicaid Services (CMS): CMS is a federal agency within the U.S. Department of Health and Human Services responsible for administering and regulating healthcare programs such as Medicare and Medicaid.

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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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HIPAA FDA Informed Consent Health Insurance 157

HIT Consultant

AUGUST 24, 2022

It is the only provider of cloud-based insulin management software across the continuum of care, and Glytec’s FDA-cleared titration software and proprietary algorithms power the only solution capable of delivering personalized diabetes treatment recommendations from hospital to home.

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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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The Health Law Firm

DECEMBER 7, 2020

In a September 15, 2020 memorandum, the current Secretary of the US Department of Health and Human Services (HHS), Alex Azar, barred the 0Food and Drug Administration (FDA) and other federal health agencies under his authority from independently enacting any new federal regulations.

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Verisys

NOVEMBER 30, 2022

organizations that receive any funds from Medicare, Medicaid, TRICARE, or other federal programs cannot afford to employ individuals or entities excluded from even one program. OIG, SAM DEA, GSA, FDA. 38 Medicaid Sanctions. Medicare and Medicaid Opt-Outs. 5,600+ Total Sources. 2,500+ State Sources. Medicare opt out.

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Bill of Health

SEPTEMBER 12, 2023

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent. It was a long time coming.

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HIT Consultant

APRIL 4, 2023

In Q1 2023, an acronym soup of federal agencies (FDA, CMS, DEA, FTC) announced preliminary steps and timelines for refining policies across digital health. State agencies are beginning to unwind expanded Medicaid coverage in conjunction with the expiration of a 2020 federal provision requiring continuous enrollment.

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Health Law Advisor

JANUARY 13, 2022

In 2021, the FDA approved the first anti-amyloid monoclonal antibody drug, Aduhelm, which is intended to trigger a response by the patient’s own immune system that destroys the accumulation of amyloid plaques. The FDA’s determination does not mandate Medicare coverage for Aduhelm. What Happens Next?

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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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Verisys

DECEMBER 1, 2022

FDA Disbarment. A FACIS Level 3 search also includes all state-level Federal Healthcare Entitlement Program (FHEP) sources such as: State Medicaid Exclusions, State Contractor Disqualification/Debarment Lists, HEAT Task Force News, State Attorney General News, Federal District – Attorney General News, and Medicare/Medicaid Opt-Out Lists.

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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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Healthcare IT Today

AUGUST 20, 2023

MedArrive and Heartbeat Health are collaborating to provide on-demand cardiovascular services to Medicaid beneficiaries. received De Novo FDA approval for its hypertrophic cardiomyopathy detection algorithm. Florida’s Agency for Health Care Administration chose HHS Technology Group to streamline Medicaid provider management.

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Health Insurance Medicaid Medicaid FDA 92

Healthcare IT News - Telehealth

MAY 30, 2023

Some of those expansive measures, like expanded Medicare reimbursement for telehealth, will remain, at least temporarily, and others, like continuous Medicaid enrollment, will be phased out entirely in the next few months. What does the end of the PHE mean for the future of telemedicine?

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Telemedicine COVID-19 Governance Medicare 180

CMS.gov

SEPTEMBER 13, 2021

The Centers for Medicare & Medicaid Services (CMS) is committed to ensuring people on Medicare have quicker access to innovative medical technologies for life-threatening or irreversibly debilitating diseases – like cancer and heart disease. The rule would have granted expedited Medicare coverage for up to four years for any U.S.

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Healthcare IT News - Telehealth

MARCH 18, 2022

Norden is particularly passionate about funding companies focused on the Medicaid population – a traditionally tricky and often ignored area. Companies like Pear Therapeutics, Limbix, Applied VR and Click Therapeutics are treating people with clinically validated and FDA-approved (or pending) digital interventions.

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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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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 123

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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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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Hall Render

AUGUST 10, 2023

On August 1, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its Final Hospital Inpatient Prospective Payment System (“IPPS”) and Long-Term Care Hospital (“LTCH”) PPS rule for fiscal year (“FY”) 2024 (“Final Rule”). The Final Rule increases the rate for IPPS payments by 3.3% in FY 2024 but applies a 0.2%

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Medval Compliance Blog

OCTOBER 21, 2021

Prilosec, the first proton pump inhibitor approved by the FDA in 1989, has been widely utilized for more than three decades to treat a variety of gastrointestinal conditions such as heartburn, acid reflux and gastric ulcers. History of Prilosec (Omeprazole). Dramatic Price Decrease. per capsule to $0.14 per capsule.

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Healthcare IT Today

FEBRUARY 25, 2024

X-trodes receives FDA 510(k) clearance for Smart Skin , its wireless wearable for monitoring brain, heart, eye, and muscle activity. Mental health service provider Brightside Health expanded Medicare and Medicaid coverage with payers in more than a dozen states.

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Telemedicine Compliance FDA Hospitals 89

Healthcare IT Today

APRIL 14, 2024

CloudWave renewed its partnership with the FDA to share threat intelligence data for medical device security. Massachusetts-based health plan Health New England selected Wellth ‘s digital behavioral health product for its Medicaid ACO members. Apixio is partnering with Vim to capture and analyze patient data at the point of care.

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Healthcare IT Today

NOVEMBER 12, 2023

RapidAI received FDA clearance for Rapid SDH , which helps to detect bleeding in the brain. Community care provider Wider Circle tapped ApolloMed to support Enhanced Care Management for Medicaid members in California. Healthcare consumer data vendor Freshpaint launched its Healthcare Privacy Platform.

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Healthcare IT Today

APRIL 18, 2023

The first is a standard special enrollment period for those who lose Medicaid or CHIP coverage , and the second is guidance for states to apply for Medicaid Section 1115 Demonstration to provide coverage to those being released from incarceration , with a key role for care coordination technology that leverages FHIR.

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HIT Consultant

AUGUST 23, 2022

The Center for Medicare and Medicaid Services (CMS) is leading the charge in value-based-care, with recent updates, including the CY 2023 Medicare Advantage Rate Notice to its CY 2023 Physician Fee Schedule (PFS) Proposed Rule. Cryoport: CYRX is an industry leader for its cryogenic logistics solutions and services.

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Verisys

NOVEMBER 14, 2023

Department of Justice (DOJ) U.S. Treasury Department U.S. Many healthcare organizations find themselves in a merger and suddenly serve more providers than their staff can handle.

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