Verisys

DECEMBER 12, 2023

Rule 402(2) states that when a multistate licensee changes primary states of residence to another NLC party states, they shall apply for a multistate license in the new residence state within 60 days. 01ER ): Effective as a permanent rule on 11/13/2023. This has simplified CE requirements for regular and initial pharmacist renewal.

Regulatory Compliance 52

Regulatory Compliance Compliance US Department of Health and Human Services Licensing 52

Healthcare Law Blog

JUNE 15, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. May 17, 2023 : The Fifth Circuit heard oral arguments from the FDA, Danco, and the Plaintiffs. Had the U.S.

FDA 52

FDA Governance Telemedicine Licensing 52

Healthcare Law Blog

DECEMBER 11, 2023

When an invention is made with federal assistance, the federal government may exercise its “march-in” rights to license the patented invention to another party, even when the patent owner disagrees. See Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, available here (“Draft Guidance”).

Governance 52

Governance FDA Licensing 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] How healthcare providers are licensed in the metaverse is also an open question. Medical Device Regulations. 1, 2021).

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FDA HIPAA Medicare Medicare 90

Verisys

NOVEMBER 30, 2022

License Verification & Monitoring. OIG, SAM DEA, GSA, FDA. State Licensing Boards and Agencies. Verisys partners with health plans, background check organizations, healthcare and pharmacies, and provider organizations to ensure they understand any risks within their population. Exclusions, Debarments, and Sanctions.

Regulatory Compliance 52

Regulatory Compliance Medicare Medicare Medicaid 52

SQA

SEPTEMBER 2, 2022

United States Food and Drug Administration (FDA) – Regulations and Guidances. FDA Proposes Benefit-Risk Considerations for Product Quality Assessments, 20 June 2022. The FDA is announcing the availability of a draft guidance for industry entitled Conducting Remote Regulatory Assessments, Question and Answers.

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FDA COVID-19 Nursing Homes Compliance 91

MedTrainer

APRIL 22, 2024

For example, a healthcare IT vendor should include items related to HIPAA, while a checklist for a food vendor should focus on FDA or USDA regulations. Intellectual Property and Licensing Protect intellectual property rights through patents, trademarks, and copyrights.

Compliance 52

Compliance HIPAA Licensing Fraud 52

SQA

MARCH 25, 2021

United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency, January 2021.

COVID-19 52

COVID-19 FDA Public Health Licensing 52

Verisys

NOVEMBER 14, 2023

Primary source verification must be done to confirm a provider’s education, professional license and certifications, medical training, work history, references, and more. Provider information should be continuously monitored for any changes to exclusion or license status. However, verifying a provider’s credentials is essential.

Licensing 52

Licensing Medicaid Medicaid Governance 52

Innovaare Compliance

JANUARY 15, 2024

This blog delves into the details of these changes and their implications for plan sponsors and beneficiaries. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D.

Medicare 52

Medicare Medicare Compliance FDA 52

SQA

MAY 17, 2022

The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements. United States Food and Drug Administration (FDA) – Regulations and Guidances. United States Food and Drug Administration (FDA) – Recalls.

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FDA Compliance Informed Consent Hospitals 75

Healthcare Law Blog

OCTOBER 25, 2023

Effective January 1, 2022, an individual in Oregon who acts as a pharmaceutical representative for more than 15 days during the calendar year must have, and renew annually, a license from the Department of Consumer and Business Services (“DCBS”).

Licensing 52

Licensing Compliance FDA 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.

FDA 52

FDA Compliance COVID-19 Public Health 52

Pharmacy Law Blog

MARCH 13, 2018

To learn about a similar case involving a Florida compounding pharmacy, click here to read one of my prior blogs. The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits.

Fraud 52

Fraud Governance Licensing FDA 52

SQA

OCTOBER 18, 2022

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. United States Food and Drug Administration (FDA) – Regulations and Guidances.

US Department of Health and Human Services 40

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

Healthcare Law Blog

AUGUST 25, 2022

Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. For more information on this final rule, see our blog. Annually thereafter, HHS will publish up to 20 additional negotiation-eligible Part D and Part B drugs. Negotiation-Eligible Drugs.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

SQA

JUNE 10, 2021

The CDSCO has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017. FDA plant inspection and pay $50 million in fines and forfeiture. Guidance on the Licensing of Biosimilar Products, 06 May 2021.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

Hall Render

AUGUST 10, 2023

New Medical Technologies Beginning in 2025, CMS will require add-on payment applicants to have completed an FDA marketing request and provide documentation of such filing and FDA acceptance of the application by May 1 (rather than the current July 1 deadline) of the year prior to the beginning of the FY in which CMS is considering the application.

Hospitals 40

Hospitals Medicare Medicare Medicaid 40

Healthcare Law Blog

MARCH 8, 2023

First, the Biologics License Application approval letter from the U.S. Food and Drug Administration (“FDA”) approved only a single manufacturing facility, which is located on the campus of the “Treatment Center.” Thus, the Drug can be administered only at the Treatment Center by a qualified surgeon.

FDA 52

FDA Doctors Medicaid Medicaid 52

SQA

DECEMBER 16, 2022

Since health authorities have not yet published guidelines for a comprehensive control strategy specific to microbiological topics for ATMPs, it is up to the individual ATMP sponsor or license holder to apply these compendial references properly. United States Food and Drug Administration (FDA) – Regulations and guidance.

FDA 40

FDA Compliance COVID-19 Licensing 40

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

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections.

FDA 40

FDA Compliance Licensing World Health 40

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

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

Healthcare Law Blog

AUGUST 9, 2023

8] The court in Members of the Medical Licensing Board of Indiana, et al. 20 will take effect, including: requirements for all surgical abortions to take place in hospitals; licensing requirements for abortion clinics; expanded practice authority for certified nurse midwives; and new provisions for the “safe surrender” of an infant. [22]

Licensing 52

Licensing Informed Consent Nurses FDA 52

AIHC

JUNE 6, 2023

Algorithms perform relatively well on knowledge-based tests despite the lack of domain-specific training; ChatGPT achieved ~ 66% and ~ 72% on Basic Life Support and Advanced Cardiovascular Life Support tests, respectively, and performed at or near the passing threshold on the United States Medical Licensing Exam.

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

AIHC

JUNE 6, 2023

Algorithms perform relatively well on knowledge-based tests despite the lack of domain-specific training; ChatGPT achieved ~ 66% and ~ 72% on Basic Life Support and Advanced Cardiovascular Life Support tests, respectively, and performed at or near the passing threshold on the United States Medical Licensing Exam.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

The Health Law Firm Blog

AUGUST 22, 2023

By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years.

Fraud 52

Fraud FDA Licensing Nurses 52

The Health Law Firm Blog

AUGUST 8, 2023

By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years.

Fraud 52

Fraud FDA Licensing Nurses 52

The Health Law Firm Blog

JULY 17, 2023

By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years.

Fraud 52

Fraud FDA Licensing Nurses 52

The Health Law Firm Blog

JUNE 26, 2023

By George F. Indest III, J.D., Board Certified by The Florida Bar in Health Law On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years.

Fraud 52

Fraud FDA Licensing Nurses 52

Healthcare Law Blog

NOVEMBER 13, 2023

Please refer to our January 5, 2023 , November 4, 2022 and May 16, 2022 blog posts for more information. None of these changes addressed how MA organizations and Part D sponsors compensate agents, brokers and other TPMOs.

Medicare 59

Medicare Medicare Medicaid Medicaid 59

Healthcare Law Blog

JANUARY 12, 2022

At this point, providers using the Clover Assist system (and their members) are tethered to Clover but that is likely to change as Clover looks into licensing its software to other plans and providers. One interesting area is biosimilars.

US Department of Health and Human Services 52

US Department of Health and Human Services Doctors Nurses Medicare 52

Hall Render

APRIL 14, 2023

NATIONAL 94% of Organizations Experienced a Cyberattack in 2022 AHA blog: Strengthening crisis management in rural health care Biden signs bill ending Covid-19 national emergency Cancer drug shortages are creating dire circumstances for some patients CMS Releases FY24 IPPS Proposed Rule, Seeks to Boost Rates by 2.8%

Nursing Homes 40

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

Drug & Device Law

MARCH 7, 2022

Thus, Bexis made a note to blog on it – but only after he finished his chapter update due at the end of February. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., It does not give him license to evade the less rigid ? Medtronic Inc. 2022 WL 610276 (C.D.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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FDA US Department of Health and Human Services COVID-19 Informed Consent 105

HealthLaw Prof Blog

AUGUST 2, 2023

2023): In April 2023, a federal court in Texas preliminarily invalidated the license for mifepristone, the abortion drug approved by the FDA more than two decades. Lars Noah (University of Florida), Listening to Mifepristone, 80 N.Y.U.

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FDA Licensing 52