FDA Law Blog

AUGUST 4, 2022

Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). The Second Circuit’s Interpretation of the Anti-Kickback Statute. Pfizer, Inc.

Statute 98

Statute Mens Rea Manufacturing Court 98

Paralegal Bootcamp

AUGUST 5, 2021

Know the Statute of Limitations Period. The statute of limitations is a time limit on a particular cause of action. If the law firm accepted the case before the statute of limitations period expired, it could result in a finding of legal malpractice. initial intake). Learn Medication Abbreviations.

Personal Injury 246

Personal Injury Paralegal Paralegals Law Firms 246

JURIST

NOVEMBER 7, 2023

” The case, originally filed in December 2022, alleged that Cencora “fueled” the opioid crisis by repeatedly ignoring reports of suspicious prescriptions for medications they distributed being filled at pharmacies as early as 2014, with the government seeking $1 billion in damages.

Statute 221

Statute Manufacturing Government Court 221

JURIST

MARCH 26, 2024

In a US Court of Appeals for the Ninth Circuit decision , the court found that third-party reimbursements could not be excluded under its statute. In contrast, a Tenth Circuit decision found that third-party expenditures could fall under contract support costs. The Supreme Court heard this issue because of the split among the circuit courts.

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Contract Healthcare Court Construction 118

Paralegal Bootcamp

MARCH 18, 2022

We’re up against statutes and tight deadlines, so when you get a file early on you should try to take advantage of it. Healthcare liens. Healthcare liens are the hardest to reduce, but that shouldn’t stop you from trying. Get involved early on. I include the settlement amount and attorney’s fees.

Paralegal 246

Paralegal Paralegals Personal Injury Real Estate 246

Constitutional Law Reporter

JULY 6, 2023

Supreme Court narrowed the scope of a federal aggravated identity theft statute. Facts of the Case Petitioner David Dubin was convicted of healthcare fraud under 18 U.S.C. The crux of the healthcare fraud was a misrepresentation about the qualifications of petitioner’s employee,” Justice Sonia Sotomayor wrote. 1028A(a)(1).

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Statute Healthcare Court Constitutional Law 52

Day on Torts

MAY 12, 2023

Where the trial court took judicial notice of items from the court case underlying a tort action for invasion of privacy, abuse of process, and intentional infliction of emotional distress, it did not convert the motion to dismiss to a motion for summary judgment and dismissal of the claims based on the statute of limitations was affirmed.

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Statute Court Tort Healthcare 59

JURIST

MARCH 1, 2022

According to the Ministry of Healthcare of Ukraine, at least 352 civilians, including 14 children were killed. Ukraine has not yet become a State Party to the Rome Statute of the ICC. However, Ukraine legally accepted the ICC’s jurisdiction over alleged crimes under the Rome Statute occurring on its territory.

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Statute Legal Legal Healthcare 197

Mondaq

MAY 9, 2022

Healthcare facilities and other entities receiving federal financial assistance can breathe a little easier after a U.S. Supreme Court decision issued last week barring the.

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Healthcare Statute Court Decisions Court 40

SCOTUSBlog

JUNE 28, 2024

The decision will likely have far-reaching effects across the country, from environmental regulation to healthcare costs. Under that doctrine, if Congress has not directly addressed the question at the center of a dispute, a court was required to uphold the agency’s interpretation of the statute as long as it was reasonable.

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Court Statute Cause of Action Legal 145

Paralegal Bootcamp

JUNE 3, 2021

Many larger healthcare organizations actually store their records at different locations based on record type. Most jurisdictions should have a statute that you can access to learn the limit of what a facility may be able to charge you to produce copies. 10 Determine if there are separate locations for various records types.

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Paralegal Paralegals Personal Injury Diligence 225

FDA Law Blog

OCTOBER 3, 2022

Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have aggressively pursued antikickback cases in the healthcare industry. The Alert described several factors that could potentially violate the antikickback statute.

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Healthcare Statute Manufacturing Government 105

FDA Law Blog

JUNE 15, 2022

The hospitals argued that the profits helped them offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities, something that Congress was well aware of and intended when it passed the Medicare Prescription Drug, Im­provement, and Modernization Act in 2003. Becerra, No.

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Statute Court Court Decisions Healthcare 52

Day on Torts

APRIL 15, 2021

Defendant argued that plaintiff’s claim could not stand because it was “premised solely on vicarious liability, but the underlying claims against the alleged agents were barred by the statute of limitations at the time suit was filed against [defendant].” Methodist Healthcare-Memphis Hospitals , 325 S.W.3d 3d 98 (Tenn. Code Ann. §

Statute 52

Statute Court Laws Healthcare 52

JURIST

JULY 26, 2022

The Inspector General said that the program would violate the federal Anti-Kickback Statute (AKS), a law meant to prevent fraud and abuse in connection with Medicare and Medicaid. However, the DHHS’s Inspector General prevented the program from being implemented.

Court Rules 104

Court Rules Laws Court Healthcare 104

JURIST

APRIL 28, 2022

This decision clarifies what damages are available to individuals who sue under federal anti-discrimination statutes. The US Supreme Court Thursday ruled Thursday that damages for emotional distress are not recoverable in a private lawsuit to enforce either the Rehabilitation Act of 1973 or the Affordable Care Act.

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Compensatory Damages Contract Contract Law Statute 195

FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background.

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Mens Rea Statute Healthcare Manufacturing 83

SCOTUSBlog

JUNE 11, 2021

Lastly, Healthcare Distribution Alliance v. These and other petitions of the week are below: Healthcare Distribution Alliance v. Issue : Whether the statute that compels attorneys to subsidize Oregon State Bar’s political and ideological speech is subject to “exacting” scrutiny. Oregon State Bar.

Healthcare 106

Healthcare Attorney Manufacturing Statute 106

LawSites

OCTOBER 29, 2021

However, there is one notable addition to the subscription site — a comprehensive collection of primary source content covering all federal and state statutes and regulations. There will be no changes to customers’ subscriptions. The new VitalLaw version adds a Laws & Regulations dashboard that users can search or browse.

Legal Research 98

Legal Research Legal Legal Statute 98

Day on Torts

JANUARY 23, 2023

6, 2023), plaintiff husband and wife filed a healthcare liability action based on alleged negligence related to the treatment of husband’s broken hip. Plaintiff argued that the substitution was not necessary because plaintiff wife was already a party to the matter and was also the “surviving plaintiff” under the wrongful death statutes.

Laws 59

Laws Statute Healthcare Court 59

Constitutional Law Reporter

DECEMBER 16, 2022

He was subsequently charged with healthcare fraud, as well as aggravated identity theft under 18 U.S.C. A jury found Dubin guilty of one charge of healthcare fraud and aggravated identity theft. The aggravated identity theft charge added a mandatory two-year prison sentence on top of the healthcare fraud charges.

Healthcare 52

Healthcare Court Felony Statute 52

At the Lectern

JULY 24, 2023

Interpreting federal statutes, regulations, and an administrative manual, the court adopts “[a] narrower definition of unallowable advertising,” one that makes a “distinction between advertising that educates potential beneficiaries about needed care and advertising designed to generate revenue.”

Healthcare 40

Healthcare Education Statute Government 40

FDA Law Blog

NOVEMBER 30, 2022

The Realtor argued that the government healthcare programs require that drugs not be “adulterated,” which means that Grifols’ manufacturing processes must comply with all applicable GMPs. Last month the United States Court of Appeals for the Second Circuit affirmed the district court’s decision to dismiss a False Claims Act (FCA) ( 21 U.S.C

Manufacturing 72

Manufacturing Healthcare Contract Government 72

The Paralegal Resource

NOVEMBER 13, 2013

refers to a recent federal statute (2010) that regulates the healthcare system of the United States. The Patient Protection and Affordable Care Act, generally called the Affordable Care Act, or simply ?ObamaCare?, Recent findings point towards immense political fraud.

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Healthcare Statute 40

Mondaq

OCTOBER 15, 2021

On July 21, 2021, the California Court of Appeal ruled that a plaintiff was permitted to pursue a PAGA claim for alleged violations of Labor Code Section 432.5.

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Statute Healthcare Court 40

LawTechnologyToday

JANUARY 25, 2021

Both serve to depict healthcare that is provided virtually and without physical contact with a healthcare provider. A patient explains his or her complaints virtually, often by video conferencing, and the healthcare provider will give a recommendation or diagnosis. Potential for fraud and abuse. Privacy and confidentiality.

Legal 65

Legal Legal Healthcare Technology 65

Patently O

SEPTEMBER 26, 2022

Import Ban (Source: Fierce Healthcare). Brandon Heard: Ontario Court of Appeal Affirms Dismissal of Apotex’s Statutes of Monopolies and Trademarks Act Claims Regarding Olanzapine (Source: JD Supra). Recent Headlines in the IP World: Heather Landi: Judge Rules Apple Watch Infringed AliveCor’s ECG Patent, Setting Up Potential U.S.

Healthcare 53

Healthcare Finance Statute Court 53

Day on Torts

APRIL 25, 2022

While the Agreement was ‘optional,’ it was bound up in the context of a healthcare decision[.] …The We conclude that…[the daughter’s] signing the Agreement on Decedent’s behalf was part and parcel of a healthcare decision. The POA did not provide or even contemplate healthcare decision-making power for [daughter]. …The

Attorney 59

Attorney Healthcare Court Rules Court 59

The Process Street

NOVEMBER 28, 2023

Applications of AI in healthcare Artificial intelligence in the healthcare industry has numerous applications that can improve patient care, diagnoses, and overall efficiency in the industry. Fraud detection AI can be used to detect and prevent fraudulent activities in government programs such as social security, tax, and healthcare.

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Virtual Assistant Healthcare Entertainment Education 105

SCOTUSBlog

JULY 22, 2022

This week, we highlight cert petitions that ask the court to consider, among other things, whether the government is correct that a federal identity-theft statute broadly applies to anyone who merely says or writes someone else’s name while committing a crime, or instead requires intentional misrepresentation of identity.

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Healthcare Government Immigration Criminal Law 79

FDA Law Blog

SEPTEMBER 19, 2023

The FTC expressed concern that patent listings that do not meet the statutory criteria undermine the competitive process, may disincentivize investment in developing generic and follow-on products, and reduce patient access to more affordable drugs thereby increasing costs to the healthcare system.

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Manufacturing Statute Healthcare Litigation 105

Day on Torts

MARCH 11, 2022

When the brother was admitted, plaintiff filled out admission paperwork, including an arbitration agreement, as plaintiff had a durable power of attorney for healthcare executed by the brother and naming plaintiff as the attorney-in-fact. internal citation omitted). Code Ann. §

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Attorney Statute Healthcare Court 59

FDA Law Blog

MARCH 24, 2024

They argue that the 340B statute had never intended to give contract pharmacies such an outsized role in the program, in part because their proliferation stretched HRSA’s enforcement capacity and resulted in widespread noncompliance. In 2021, HRSA threatened to impose penalties and the drug manufacturers sued to enjoin the agency. & Mfrs.

Manufacturing 59

Manufacturing Contract Laws Statute 59

At the Lectern

JULY 13, 2023

A federal Medicare statute preempts those claims, the court concludes. United Healthcare Services, Inc. UnitedHealthcare, Inc. , It doesn’t address whether preemption would preclude claims against the facility and the man’s treating physician. 2016) 2 Cal.App.5th There was no petition for review in Roberts.

Statute 40

Statute Healthcare Court Rules Court 40

Day on Torts

APRIL 21, 2021

Where an HCLA plaintiff sent pre-suit notice to twenty-one healthcare providers but failed to provide HIPAA authorizations for at least nineteen of those providers, dismissal was affirmed. Defendants] were therefore denied a benefit conferred by the statute, sufficient to demonstrate prejudice…. W2019-01448-COA-R3-CV (Tenn.

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Statute Litigation Litigating Court 59

At the Lectern

AUGUST 21, 2024

Silverscreen Healthcare. It held the “wrongful death claim sounds in professional negligence” and is thus governed by Code of Civil Procedure section 1295 , an arbitration statute in the Medical Injury Compensation Reform Act, as interpreted by the Supreme Court in Ruiz v. The court granted review in Holland v. Hernandez v.

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Court Statute Healthcare Drafting 45

Patently O

AUGUST 5, 2024

In Helsinn Healthcare S.A. ” The court emphasized the distinction between these terms and their different purposes in the statute. That case concerned whether the use of an invention (a modified corset spring) by one person was “a public use within the meaning of the statute.” Teva Pharmaceuticals USA, Inc. , 333 (1881).

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Statute Court Healthcare Laws 111