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

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

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 Medicare Medicare 98

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

Health Law Advisor

JANUARY 13, 2022

The proposed decision, which is subject to public comments that are due to CMS by February 10, 2022, does not endorse nationwide Medicare coverage for these drugs. After the FDA approval, several large medical centers stated that they would not be administering Aduhelm due to concerns about its efficacy. [1]. What Happens Next?

Medicare 52

Medicare Medicare FDA Medicaid 52

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

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).

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FDA COVID-19 Medicare Medicare 205

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 144

Medicare Medicare Medicaid Medicaid 144

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 144

Medicare Medicare Medicaid Medicaid 144

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.

FDA 184

FDA World Health Medicaid Medicaid 184

Innovaare Compliance

OCTOBER 6, 2022

Annual Election Period (AEP) is about two weeks away when Medicare Advantage Prescription Drug Plans (MAPD) will be signing up new enrollees by the thousands. According to the Centers for Medicare & Medicaid Services (CMS), enrollment in MAPD keeps rising. In 2022, 48% of all eligible Medicare beneficiaries are enrolled in MAPD.

Medicare 52

Medicare Medicare Compliance Public Health 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 144

Patient Advocacy Medicare Medicare FDA 144

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 Overpayments Overpayment 52

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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FDA Medicaid Medicaid Medicare 79

Healthcare Law Today

NOVEMBER 9, 2022

Starting January 1, 2023, Medicare will cover telehealth-based treatment services delivered by federally-accredited opioid treatment programs (OTPs), commonly referred to as “methadone clinics.” Background and History of Medicare Telehealth Coverage of SUD Treatment. New Changes to Medicare OTP Telehealth Services.

Medicare 52

Medicare Medicare COVID-19 Telemedicine 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.,

FDA 59

FDA Governance Medicare Medicare 59

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.

Overpayments 149

Overpayments Overpayment Medicare Medicare 149

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.

FDA 100

FDA Medicare Medicare Hospitals 100

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 190

Pharmaceutical Industry Governance FDA Public Health 190

HIT Consultant

MAY 3, 2023

Minuteful Kidney™ is marketed commercially across the United States and the United Kingdom and is the first and only FDA-cleared, smartphone-powered, at-home kidney test that allows patients to take the test in the privacy of their homes and receive immediate clinical-grade results. and the U.K.,

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FDA Medicare Medicare Health Insurance 98

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.

Hospitals 98

Hospitals FDA Compliance COVID-19 98

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 205

FDA COVID-19 Medicaid Medicaid 205

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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Compliance Fraud Medicaid Medicaid 52

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.

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FDA Medicaid Medicaid Hospitals 95

CMS.gov

OCTOBER 2, 2018

Modernizing Medicare to Take Advantage of the Latest Technologies. Administrator, Centers for Medicare & Medicaid Services. Modernizing Medicare to Take Advantage of the Latest Technologies. However, while medical technology is developing at a rapid pace, Medicare’s payment systems haven’t always been as quick to change.

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Medicare Medicare Payment Systems FDA 44

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?

Telemedicine 182

Telemedicine COVID-19 Governance Medicare 182

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 80

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

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

JANUARY 14, 2024

The American Telehealth Association announced its policy priorities for 2024 ; they include making Medicare telehealth flexibilities permanent before the end of the year and removing the in-person requirement for the remote prescribing of controlled substances. Wellness app Vivoo launched an at-home digital UTI test.

Medicaid 107

Medicaid Medicaid FDA Medicare 107

HIT Consultant

OCTOBER 17, 2022

Since its FDA clearance in 2020, the EyeArt system has been used in over 200 locations in 18 countries, including 14 U.S. It is the first and only technology to be cleared by the FDA for autonomous detection of both referable and vision-threatening diabetic retinopathy without any eye care specialist involvement.

FDA 52

FDA Medicare Medicare Licensing 52

Medisys Compliance

APRIL 20, 2022

Medicare to Cover Over-the-Counter COVID-19 Tests. On 4 th April 2022, CMS announced that more than 59 million Americans with Medicare Part B, including those enrolled in a Medicare Advantage plan, now have access to Food and Drug Administration (FDA) approved, authorized, or cleared over-the-counter COVID-19 tests at no cost.

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COVID-19 COVID-19 Vaccine Medical Billing Medicare 52

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. Medicare opt out. Medicare and Medicaid Opt-Outs. FBI, PHS, ORI, DOJ, TRICARE. 94 District Courts. 52 AG Sources.

Regulatory Compliance 52

Regulatory Compliance Medicare Medicare Medicaid 52

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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FDA Hospitals Medicaid Medicaid 52

Healthcare Law Blog

JANUARY 9, 2024

On the healthcare services side, NVIDIA mentioned GI Genius, which has an FDA approved AI-assisted endoscopy device that provides real-time identification and decision support to the provider conducting the endoscopy. More on the Cleveland Clinic tomorrow. Oncology was often mentioned today.

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Medicare Medicare Hospitals Doctors 59

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 112

US Department of Health and Human Services Telemedicine Hospitals Compliance 112

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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US Department of Health and Human Services FDA Medicaid Medicaid 40