Healthcare Compliance Blog

FEBRUARY 8, 2022

From 2015 through 2019, the pharmaceutical company that manufactures Nuedexta paid the Alabama psychiatrist more than $400,000 to make speeches about Nuedexta. Routine audits should be conducted, and the results of the audits should be reported at the compliance and ethics committee meetings and in reports to the governing body.

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Hall Render

JULY 25, 2023

At first glance, different outcomes based on the same type of APP support program suggest contradictory views from the government. The settlement arose out of a case initially filed in 2015 by a whistleblower who worked at the hospital involved in the settlement.

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MedTrainer

MARCH 28, 2024

In this blog, we’ll outline the many roles that impact healthcare compliance , the pros and cons of each role’s management responsibilities, and what each is accountable for in concert with the others. Establishes a governance structure, reviews compliance reports, and ensures the organization operates ethically and within legal boundaries.

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Bill of Health

JULY 18, 2023

floods and heat waves) have the potential to trigger migration decisions or prompt governments to plan for the relocation and resettlement of affected populations as some environments become uninhabitable. Yet, climate-induced slow onset pressures (e.g., sea level rise and desertification) and rapid onset events (e.g.,

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Healthcare Law Blog

APRIL 19, 2023

The issue is a significant one for both the government and relators on one side, and potential defendants on the other, as False Claims Act (FCA) liability imposes treble damages and penalties exceeding $20,000 per claim as well as relators’ attorneys’ fees and costs. The Court’s questioning did not signal the likely decision.

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MedTrainer

NOVEMBER 27, 2023

Georgia Healthcare Compliance Resources Let’s start with the important state government agencies you’ll need to work with: The Georgia Department of Public Health (DPH) plays a crucial role in safeguarding the health and well-being of Georgians. Keep reading for resources, tips, and regulations unique to healthcare compliance in Georgia.

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Compliance Licensing Medicaid Medicaid 52

Verisys

NOVEMBER 14, 2023

A healthcare facility’s accountability and overall reputation are dependent upon rigorous credentialing processes compliant with governing regulatory bodies, such as the National Committee for Quality Assurance. It is critical for hospitals and health systems to know that everyone on the staff is compliant and in good standing at all times.

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Licensing Medicaid Medicaid Governance 52

Hall Render

JANUARY 21, 2022

In 2015, the plaintiff’s application for reappointment and for medical staffing privileges was rejected by the Hospital. Plaintiff alleged that his application for reappointment and for medical staff privileges was rejected in retaliation for his “whistleblowing” to the federal government. JCC vote) took place.

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Hall Render

APRIL 6, 2022

Turning to the present case, in Safeway , the relator alleged that the defendant engaged in the submission of false claims to the government when it “reported its ‘retail’ price for certain drugs as its ‘usual and customary’ price.” Hall Render blog posts and articles are intended for informational purposes only.

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Hall Render

MAY 31, 2022

The City of Gainesville, Florida hired a Senior Housing Strategist, the first of its kind for a local government entity. Additionally, a total of 45M sf of new hospital construction is in progress, the largest number of projects since Revista began tracking this data in 2015 and a 57% increase from Q2 2020.

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Healthcare Law Blog

AUGUST 31, 2023

1] Some state governments have determined that a provider’s ability to deliver culturally competent care is an essential component to promoting effective and efficient healthcare delivery. [2] Cultural Competency Training Legislation in Other Jurisdictions S.B. For example, in Washington, D.C., 4] In Nevada, N.R.S. §

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Healthcare Law Blog

FEBRUARY 9, 2024

Key Takeaways While this is the first FCA settlement based on a hospital allegedly providing private physicians with free services in the form of hospital-employed clinicians, it may not be the last. ChristianaCare voluntarily entered into the CIA as part of its settlement of another prior unrelated FCA matter.

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Hospitals Compliance Officers Compliance Overpayments 52

Healthcare Law Blog

APRIL 6, 2022

The expansion of postpartum coverage is an important opportunity for states and the federal government to improve maternal and postpartum health outcomes as well as address racial healthcare disparities. Approximately 33% of maternal deaths occur more than seven days after delivery and 12% occur more than six weeks after birth. [2]

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Medicaid Medicaid ACA Public Health 52

Provider Trust

JULY 26, 2022

She was hired at the family practice in Norcross, Georgia after serving a prison sentence for 2015 state and federal fraud and narcotics convictions related to her illegal practice as a physician’s assistant in Mississippi. In addition to these allegations of fraud, waste, and abuse, Pickering had a history of fraud.

Licensing 52

Licensing Fraud Compliance Nurses 52

SQA

AUGUST 2, 2021

ISO5356-1:2015, Anesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. ISO 17510:2015, Medical devices – Sleep apnea breathing therapy – Masks and application accessories. government agencies and the private sector to collaborate in providing Americans with timely access to pharmaceuticals.

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

Exeed Regulatory Compliance

MARCH 5, 2020

It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article. Acknowledgments – this blog article was written in collaboration with Kelly Kammeraad , Principal Consultant at Baaj Quality System Consulting.

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

Health Law RX

JULY 18, 2023

As context, between 2015 and 2022, the DOJ reported FCA settlements with health IT vendors in an amount exceeding $500 million. The OIG also notes that it may evaluate allegations and prioritize investigations based, in part, on the volume of claims relating to the same (or similar) conduct by the same actor.

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Healthcare Law Blog

NOVEMBER 21, 2022

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting cost-sharing subsidies for life-saving oncology drugs. 2, 2015). [10] United States, et al. Case No 3:22-cv-714 (E.D.

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Medicare Medicare Governance Medicaid 52

SQA

JUNE 10, 2021

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021.

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FDA COVID-19 COVID-19 Vaccine Compliance 52

SQA

FEBRUARY 15, 2023

There were seven (7) observations with respect to the following: Quality Control Department: The establishment and/or the maintenance of a data governance plan was inadequate. The inspection resulted in a non-compliant rating. The electronic system was not validated for its intended use.

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

SQA

OCTOBER 18, 2023

In a 2015 survey, the overall prevalence of mineral supplement or vitamin use among Canadian men and women was 38% and 53%, respectively. In Canada, mineral supplements are regulated as natural health products (NHPs) under the Natural Health Products Regulations. These products are widely used by Canadians.

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FDA Compliance Licensing World Health 40

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 135 (Winter 2015) (citation and quotation marks omitted). 1145, 1165 n.135

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Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert.

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

Drug & Device Law

APRIL 28, 2022

This past weekend, there was an NCAA Division I clash of athletic teams ranked #5 and #7, respectively, that included two children of two different authors of this Blog. State and local government entities from very different parts of the country might want leeway in regulating things like the volume or time of demonstrations.

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Drug & Device Law

JANUARY 9, 2023

Since Levine is probably the worst prescription medical product liability decision to occur during the now 15-year lifespan of this Blog, when a citation like that appears, the result is not likely to be any good. 15, 2022), that we blogged about not too long ago , with the monstrosity that follows here. Levine , 555 U.S.

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FDA Governance Nurses 59

Drug & Device Law

JANUARY 30, 2023

For those of you accessing the Blog on mobile devices, this post may be hard to read. Plaintiffs Legal Committee , 531 U.S. 341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Davidowitz , 312 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

FEBRUARY 20, 2023

Yet another vaccine case addressed at length the reasons why viable design alternatives for products governed by the FDCA must be limited to those that the FDA has allowed onto the market. 0295, 2015 WL 5022618, at *12 (N.J. As we’ve said many times before, the Blog does not do the other side’s research for them.

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FDA Licensing Hospitals Governance 59

Drug & Device Law

APRIL 10, 2023

That’s why this defense oriented blog has inveighed against claims solely for “ medical monitoring ” ever since it was founded. Plaquemines Parish Government , 982 So.2d Ohio 2015). 2015); Krottner v. Prosser & P. Keeton, Prosser & Keeton on the Law of Torts , at 165 (5th ed. 1515, 1523 (D. Kentucky : Wood v.

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Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § 2015) (Gorsuch, J.). Plaintiffs’ Legal Committee , 531 U.S. 2022 WL 464149, at *1. 2022 WL 464149, at *4.

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Drug & Device Law

JUNE 23, 2023

We’ve blogged before about the plaintiffs’ self-defeating “injury” definition in the Taxotere mass tort litigation. T]he applicable body of law that governs these motions is identical. Sanofi U.S. Services , 2023 N.J. Lexis 927, at *2-3 (N.J. June 8, 2023). The court disagreed.

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Governance 59

Drug & Device Law

NOVEMBER 15, 2023

If you’ve read this blog for any length of time, you know that while SJS is a very rare disease, it is not so rare in the area of OTC litigation. Therefore, Alabama substantive law governed the case. Quoting the same 2015 statutory amendment that the Blog discussed (Ala. It filed a motion to dismiss the case under Fed.

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Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. 2015) (“motives are irrelevant to the Court’s Rule 407 analysis”) (both Chlopek -bound courts). continue to be subject to Rule 407-based exclusion. See , e.g. , Yates v.

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FDA Governance 52

HealthLaw Prof Blog

APRIL 14, 2024

Yi Lu (Peking University), Challenges in China-ASEAN Food Safety Cooperation Governance Through Soft Law, 3 Peking U. 2015): It has been 5 years since the ASEAN-China Free Trade Zone was established. Transnat’l L. This economic cooperation has injected much.

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