C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Healthcare Law Today

FEBRUARY 1, 2022

It also requires that the Secretary report to Congress on the state of the SNS, and to issue guidance and hold annual meetings with public health officials and stakeholders on how states, territories, and Tribes can access the SNS. Modernizes public health data through biosurveillance and infectious disease data collection.

COVID-19 98

COVID-19 FDA Public Health Health Services Administration 98

Exeed Regulatory Compliance

OCTOBER 26, 2020

A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. COVID-19 continues to cause damage to both the public health and the economy at large. FDA is requiring additional post-market studies. CONTACT US.

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COVID-19 FDA Hospitals Public Health 52

SQA

SEPTEMBER 2, 2022

Call for Companies to Register their Industry Single Point of Contact (i-SPOC) on Supply and Availability, 28 June 2022. All pharmaceutical companies with a centrally-or nationally-authorized medicinal product in the EU are required to register a single point of contact. ISPE Good Practice Guide: Critical Utilities GMP Compliance.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

Exeed Regulatory Compliance

JULY 20, 2020

The Accuracy of Covid-19 Antibody Tests As we write this blog, the FDA has authorized 30 different antibody tests for Emergency Use. The second risk is related to the FDA Emergency Use Authorization process itself. Under normal circumstances, FDA would require a lot more data on clinical validation before approving these tests.

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COVID-19 FDA Public Health 52

Health Law Pulse

MARCH 30, 2022

Users are first prompted to select whether they have tested positive for COVID-19 or whether they had close contact with someone who had COVID-19. This recommendation came after the FDA gave authorization for this fourth round for older and immunocompromised individuals. Only Pfizer and Moderna are approved for a second booster.

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COVID-19 FDA Public Health 52

Exeed Regulatory Compliance

MARCH 5, 2020

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

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US Department of Health and Human Services FDA Public Health COVID-19 52

Healthcare IT News - Telehealth

FEBRUARY 5, 2024

One of the great use cases for telemedicine has proven to be mental health. It does not require physical contact between caregiver and patient (though seeing a patient's affect in person can be better than via video). Rarely does mental health require in-person tests. Taking vitals is not necessary.

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COVID-19 Public Health Licensing FDA 133

AIHC

AUGUST 2, 2022

The monkeypox virus is spreading mostly through close, intimate contact with someone who has monkeypox. Monitoring Exposures First, educate yourself, coworkers with direct patient contact, and your patients regarding how to prevent becoming infected with this virus. These cases occurred on multiple continents.

US Department of Health and Human Services 98

US Department of Health and Human Services FDA Licensing Compliance 98

Exeed Regulatory Compliance

JULY 31, 2020

It is a public health emergency of massive scale that has affected nearly all aspects of our life. In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease.

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FDA COVID-19 US Department of Health and Human Services Public Health 52

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

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FDA Compliance COVID-19 Public Health 52

SQA

AUGUST 2, 2021

Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the United States Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in United States pharmaceutical supply chains. b) and 320.31(d)(3)).

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Medisys Compliance

APRIL 20, 2022

As Public Health Emergency (PHE) has extended beyond 16 th April 2022 by 90 days, various waivers are continued, making no change in billing guidelines in pandemic. In fact, concerned authority extended the current COVID-19 pandemic telehealth waivers for five months beyond the end of the public health emergency.

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COVID-19 COVID-19 Vaccine Medical Billing Medicare 52

SQA

DECEMBER 10, 2021

Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The agencies conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA. European Medicines Agency (EMA). The EMA and the U.S.

FDA 52

FDA Compliance Public Health Hospitals 52

Exeed Regulatory Compliance

APRIL 6, 2020

Recently, the FDA has authorized the emergency use of the Battelle CCDS Critical Care Decontamination System , which uses vapor phase hydrogen peroxide to decontaminate N95 or N95-equivalent respirators for reuse by healthcare personnel. This is one of the criteria used by the FDA for granting the Emergency Use Authorization.

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COVID-19 FDA Public Health 52

Hall Render

MARCH 16, 2022

The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. An overview of the FY 2022 funding bill and a summary of its health care-related provisions can be found below. .

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COVID-19 Medicare Medicare FDA 40

AIHC

FEBRUARY 2, 2022

Encounter for screening for COVID-19, asymptomatic Z20.822 Contact with and (suspected) exposure to COVID-19/ SARS-CoV-2 Z86.16 Encounter for screening for COVID-19, asymptomatic Z20.822 Contact with and (suspected) exposure to COVID-19 Z86.16 Encounter for screening for other viral diseases (asymptomatic) Z11.52

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Medicare Medicare 52

Innovaare Compliance

OCTOBER 6, 2022

Adult vaccine recommended by ACIP is a covered Part D drug when licensed by the US Food and Drug Administration (FDA) under the Public Health Service Act for use by adult populations and administered in accordance with recommendations of ACIP. or Contact Us. appeared first on Inovaare.

Medicare 52

Medicare Medicare Compliance Public Health 52

SQA

OCTOBER 18, 2022

The UK sees the plans as an opportunity to introduce new regulations after Brexit in order to strengthen the public health sector. Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

DECEMBER 16, 2022

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. Applicants and MAHs can contact EMA via rawdatapilot@ema.europa.eu United States Food and Drug Administration (FDA) – Regulations and guidance.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. PCPC’s current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

FDA 40

FDA Licensing Governance Compliance 40

Health Law RX

JULY 25, 2022

The EEOC notes that employers will meet the “business necessity” standard when such testing is consistent with current guidance from Centers for Disease Control and Prevention (“CDC”), Food and Drug Administration (“FDA”), and/or state/local public health authorities. Returning to Work After COVID-19.

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COVID-19 ADA FDA Health Insurance 52

Bill of Health

NOVEMBER 15, 2023

health care system, but that are especially present for behavioral health needs like substance use, and are exacerbated by other challenges related to stigma, lack of employment, and fragmented or nonexistent care coordination. This reality reflects structural, policy, and legal misalignments common to the entire U.S.

Governance 167

Governance Public Health Telemedicine Medicaid 167

Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview.

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COVID-19 FDA Compliance Public Health 52

Health Law Advisor

MARCH 7, 2023

Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications? DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications. 1301.28.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Health Law Advisor

MARCH 1, 2023

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. Contact an EBG attorney for more information on how to stay compliant. [1] Utah Code § 58-83-306. 1] [link]. [2]

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. FDA finalizes two guidances on including patient perspectives in medtech clinical trials. State health officer discusses Alabama’s COVID-19 peak. California health system to outsource RCM jobs to Optum. Here’s what’s on tap.

Nursing Homes 40

Nursing Homes COVID-19 US Department of Health and Human Services Nurses 40

Hall Render

MARCH 11, 2022

FDA final guidance presses industry to be ‘recall ready’ Final vaccine mandate deadlines still in play, despite removal vote. How Nonprofit Hospitals, Health Systems Compensate Executives. Encompass Health’s home health unit attracts acquisition interest-sources. COVID-19 funding is tapped out, HHS says.

COVID-19 40

COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40

Hall Render

MAY 20, 2022

AHA asks HHS to continue the public health emergency until conditions stabilize. Considerations for Social Determinants of Health Screening Design. COVID-19 public health emergency set to be extended. Covid-19 remains a public health emergency in US, administration says.

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COVID-19 Nursing Homes Nurses Hospitals 40

Hall Render

JULY 14, 2023

billion behavioral health contract to Centene Idaho Drops Panel Investigating Pregnancy-Related Deaths as US Maternal Mortality Surges Kootenai Health CEO to retire after nonprofit conversion Kootenai Health on track for nonprofit conversion Ammon Bundy a no-show for beginning of St. to 18 central Mass. Not everyone is happy.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Hall Render

FEBRUARY 18, 2022

Lawmakers call on Biden to end public health emergency. Meet new FDA chief Dr. Robert Califf: 5 things to know. 5 recent hospital, health system COO moves. of Public Health website. 8 recent hospital, health system executive resignations. Report: Tennessee ranks 40th in nation for youth mental health.

COVID-19 40

COVID-19 Nursing Homes Nurses COVID-19 Vaccine 40

Hall Render

JANUARY 7, 2022

FDA expands use of Pfizer vaccine, green-lights boosters for children 12-15. Fitch Ratings: Kronos ransomware attack harms healthcare public finance sector. Health systems eye outpatient sector as hospital M&A continues to slump. Alabama Department of Public Health at ‘highest level’ of concern over COVID cases surge.

COVID-19 40

COVID-19 Nursing Homes US Department of Health and Human Services Nurses 40

Healthcare IT News - Telehealth

MAY 6, 2020

In the middle of the COVID-19 pandemic, connected health and RPM are more important than ever, because they enable physicians to monitor patients without having to come into contact with them, thus preventing the spread of the novel coronavirus. The system can be used to conduct telehealth visits between two or more clinics.

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COVID-19 FDA Hospitals Elder Care 183

SQA

JANUARY 25, 2021

The companies concerned at this stage have been contacted and duly informed. The Metformin HCl Extended-Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued in September 2020. Nostrum Laboratories, Inc.

COVID-19 40

COVID-19 Compliance FDA Hospitals 40

Hall Render

JUNE 3, 2022

Alameda Health System data breach potentially affects 90,000 patients. Colorado hospital first to implant FDA approved stent. Nearly half of Colorado’s rural counties are without a mental health provider. Anthem partners with Northern Light Health facilities as Tier 1 providers. is different.

COVID-19 40

COVID-19 Nursing Homes US Department of Health and Human Services Nurses 40

Healthcare Law Blog

OCTOBER 25, 2023

As with Oregon’s requirements, licensees in Chicago must also complete an educational course for both the initial license as well as any subsequent renewals, which are subject to audit by the Chicago Department of Public Health. Violations of the educational requirements can be subject to fines $1,000 to $3000 per day of violation. [ix]

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Licensing Compliance FDA Public Health 52