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

JURIST

JULY 26, 2022

after the Department of Health and Human Services (DHHS) said that Pfizer’s plan to cover patients’ copays for its heart failure medications violated US law. The post US Appeals Court rules Pfizer plan to cover heart medication copays violates US law appeared first on JURIST - News.

Court Rules 104

Court Rules Laws Court Healthcare 104

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

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).

Statute 52

Statute Healthcare Court Constitutional Law 52

JURIST

MARCH 1, 2022

Law students and young lawyers in Ukraine are filing for JURIST on the latest developments in that country as it defends itself against Russian invasion. During the first five days of combat, Russian forces attacked dozens of civilian targets, which do not qualify as legitimate military targets under international law.

Statute 197

Statute Legal Legal Healthcare 197

SCOTUSBlog

JUNE 28, 2024

Share In a major ruling, the Supreme Court on Friday cut back sharply on the power of federal agencies to interpret the laws they administer and ruled that courts should rely on their own interpretion of ambiguous laws. By a vote of 6-3, the justices overruled their landmark 1984 decision in Chevron v.

Court 145

Court Statute Cause of Action Legal 145

JURIST

APRIL 28, 2022

This decision clarifies what damages are available to individuals who sue under federal anti-discrimination statutes. Cummings then filed a lawsuit against Premier for discrimination on the basis of her disability, alleging that the company violated federal anti-discrimination laws when refusing to provide her with an interpreter.

Compensatory Damages 195

Compensatory Damages Contract Contract Law Statute 195

FDA Law Blog

OCTOBER 3, 2022

In a statement , the company denied all allegations raised in the case, saying that it believed its intent and conduct to be at all times lawful and appropriate. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have aggressively pursued antikickback cases in the healthcare industry. See 42 U.S.C.

Healthcare 105

Healthcare Statute Manufacturing Government 105

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 In Gardner v. 3d 98 (Tenn.

Statute 52

Statute Court Laws Healthcare 52

Day on Torts

JANUARY 23, 2023

When a party failed to file a motion for substitution for more than a year after filing a notice of death, misinterpretation of the law did not constitute excusable neglect and dismissal was affirmed. In Joshlin v. Halford , No. W2020-01643-COA-R3-CV (Tenn. Instead, plaintiffs needed to follow the Rule 25.01 procedure.

Laws 59

Laws Statute Healthcare Court 59

FDA Law Blog

APRIL 25, 2023

The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. Please refer to the help text in this section for the content that is required according to this statute.” Special 510(k)s.

Laws 105

Laws Manufacturing Drafting Technology 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.

Statute 52

Statute Court Court Decisions Healthcare 52

SCOTUSBlog

JUNE 11, 2021

They ask the court to clarify prior case law on bar-association dues and declare that the Oregon policy is subject to the same “exacting” First Amendment scrutiny as laws involving subsidized speech by public-sector unions. Lastly, Healthcare Distribution Alliance v. Oregon State Bar.

Healthcare 107

Healthcare Attorney Manufacturing Statute 107

FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

Manufacturing 59

Manufacturing Contract Laws Statute 59

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. Until now, the platform included primary source law only to the extent it related to the practice areas WK covers.

Legal Research 98

Legal Research Legal Legal Statute 98

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. 3d 774 (7th Cir. Greber, 760 F.2d

Mens Rea 83

Mens Rea Statute Healthcare Manufacturing 83

Constitutional Law Reporter

DECEMBER 16, 2022

Supreme Court recently agreed to consider a case that is expected to define the scope of federal identity theft law. 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. Facts of the Case.

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

Brevig, Senior Regulatory Device and Biologics Expert — Earlier this year, we posted on the still unsettled state of the law regarding whether “FDCA violations may, in certain circumstances, be material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.” By JP Ellison & Holly N.

Manufacturing 72

Manufacturing Healthcare Contract Government 72

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

SCOTUSBlog

JULY 22, 2022

In three of the past four terms, the Supreme Court has rejected broad readings of white-collar criminal laws urged by the federal government. Issue : Whether a federal court deciding a state-law issue in a bankruptcy case must apply the forum state’s choice-of-law rules or federal choice-of-law rules to determine what substantive law governs.

Healthcare 80

Healthcare Government Immigration Criminal Law 80

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). Samantha Handler: Apple Patent Victories Upheld by Tribunal After Arthrex Remand (Source: Bloomberg Law).

Healthcare 53

Healthcare Finance Statute Court 53

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.

Virtual Assistant 105

Virtual Assistant Healthcare Entertainment Education 105

At the Lectern

JULY 13, 2023

A federal Medicare statute preempts those claims, the court concludes. The court’s unanimous opinion by Justice Joshua Groban concludes Congress intended to broadly preclude state law actions regarding Medicare Advantage plans. United Healthcare Services, Inc. UnitedHealthcare, Inc. , 2016) 2 Cal.App.5th

Statute 40

Statute Healthcare Court Rules Court 40

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.

Manufacturing 105

Manufacturing Statute Healthcare Litigation 105

Patently O

AUGUST 5, 2024

Kaijet highlights the narrowness of the pre-filing grace period (safe harbor) provision under the America Invents Act (AIA) and serves as a reminder that there are a number of patents that would have been valid under the pre-AIA patent system may no longer be valid under the current law. In Helsinn Healthcare S.A. Sanho Corp.

Statute 111

Statute Court Healthcare Laws 111

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. Code Ann. § 34-6-208, would not apply to this power of attorney because it was executed in Mississippi.

Attorney 59

Attorney Statute Healthcare 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.

Court 45

Court Statute Healthcare Drafting 45

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. Until now, the platform included primary source law only to the extent it related to the practice areas WK covers.

Legal Research 52

Legal Research Legal Legal Statute 52

FDA Law Blog

JANUARY 6, 2022

That changed on October 18, 2021 when the Federal District Court for the District of Hawaii handed down a decision that construed key terms in the statute. Note that EKRA’s reach is broader than the Anti-Kickback Statute, which applies only to “federal healthcare programs” — e.g., Medicare, Medicaid, Tricare, etc. 18 U.S.C. §

Court 52

Court Statute Contract Litigation 52

Blumberg

MAY 25, 2021

This update complies with amendments to the Power of Attorney Statute that takes effect June 13, 2021. The distinctive boilerplate and usage in countless transactions have become the trusted choice of attorneys and the financial, real estate, business, and healthcare communities.

Attorney 45

Attorney Real Estate Healthcare Statute 45

At the Lectern

JANUARY 7, 2022

where the Second District, Division Seven, Court of Appeal held that a preemption clause in federal Medicare statutes preempted an action for negligence, elder abuse, and wrongful death against a private Medicare Advantage health care plan insurer and the plan’s health care provider. United Healthcare Services, Inc.

Court 53

Court Statute Healthcare Attorney 53

FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

Healthcare 59

Healthcare Manufacturing Attorney Statute 59

Patently O

MARCH 4, 2024

It held that under pre-AIA Federal Circuit precedent, a patentee’s sale of a product made by a secret process placed the process “on sale” under the statute, thus invalidating later patent claims to the process. But, the problem is that the statute expressly asks whether the invention was “on sale.”

Manufacturing 40

Manufacturing Statute Healthcare Court 40

Patently O

AUGUST 9, 2022

Accord Healthcare, Inc., Two groups of law professors have each filed an amicus brief in support of the petition. The patentee in the case argues that inherency is too strict a standard and that it goes beyond what is required by the statute and prior precedent. by Dennis Crouch. 21-1070; petition from 38 F.4th 4th 1013 (U.S.

Healthcare 61

Healthcare Court Law School Statute 61

Customs & International Trade Law

APRIL 18, 2024

The law attempts to reward whistleblowers and disincentivize committing fraud and can be used to expose customs fraud. The law attempts to reward whistleblowers and disincentivize committing fraud and can be used to expose customs fraud. What is the False Claims Act? Register here.

Government 40

Government Healthcare Statute Laws 40

At the Lectern

OCTOBER 3, 2024

Ruling on a habeas corpus petition, the superior court struck firearms sentence enhancements based on the retroactive application of new legislation, but it declined to revisit the defendant’s convictions based on other new statutes, including Assembly Bill No. 333 , which narrowed criminal liability for gang-related activities.

Court 49

Court Statute Healthcare Felony 49