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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FDA Law Blog

JUNE 15, 2022

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. The statute sets this “average price” as ASP plus 6%.

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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. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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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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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.”

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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.

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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. AI and machine learning: a simple explanation What is artificial intelligence?

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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. There are also informed consent requirements that vary by state.

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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.

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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. §

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Customs & International Trade Law

APRIL 18, 2024

The FCA, 31 U.S.C. §§ 3729 – 3733 , is a federal statute enacted in 1863 in response to defense contractor fraud during the Civil War. The FCA provides that any person who knowingly submits, or causes to submit, false claims to the government is liable for three times the government’s damages plus a penalty.

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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. §

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Healthcare Manufacturing Attorney Statute 59

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. §

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FDA Law Blog

JUNE 16, 2023

Importantly, “price increase” is not defined in this statute. It appears not to mean a WAC increase, because the term WAC is specifically used in defining the price increase triggers, but not in reference to the manufacturer’s price increase. The Board may then initiate a cost review of any such identified drug product.

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At the Lectern

JULY 27, 2023

San Jose Healthcare System (the Supreme Court granted two separate petitions for review by the plaintiff ( here and here )) found no UCL or CLRA violations. the Fourth District, Division Two, published opinion held a county’s child services department conducted an appropriate initial inquiry required by state statute.

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JURIST

FEBRUARY 19, 2025

According to the UN, the RSF has been conducting deliberate attacks on civilians and civilian objects since early 2023 when it began conflicting with the Sudanese government forces. These victims have also been exposed to acute hunger and lack of healthcare services. million people.

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JURIST

APRIL 23, 2025

Lebanon researcher at HRW, Ramzi Kaiss, said, “More and more evidence is emerging that Israeli forces repeatedly failed to protect civilians or adequately distinguish civilians from military targets during its strikes across Lebanon in 2023 and 2024” Kaiss claims the Lebanese government should ensure justice for the victims.

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SCOTUSBlog

NOVEMBER 15, 2023

It presents the question whether, in prosecuting a woman accused of smuggling drugs into the United States, the government can introduce expert testimony that most couriers know they are carrying drugs and that drug-trafficking organizations do not typically entrust large quantities of drugs to unwitting transporters. United States.

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Healthcare Contract Court Government 110

FDA Law Blog

MARCH 30, 2022

healthcare system. This proposal would substantially increase the likelihood that generic versions of patent-protected drugs will come into the market in a timely fashion, and that multiple versions of generic products will be approved quickly (leading to significant cost savings).

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Manufacturing Healthcare Government Statute 40

JURIST

NOVEMBER 7, 2023

The government will now only be able to prosecute the company for failure to report suspicious prescriptions after October 2018, when the Controlled Substances Act (CSA) was amended. US District Court Judge Jerry Pappert limited the liability of opioid distributor Cencora (previously known as Amerisourcebergen) on Monday in the case US v.

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SCOTUSBlog

APRIL 2, 2025

Representing the federal government, Kyle Hawkins told the justices that their cases emphasized that rights-creating statutes are atypical. But the any qualified provider provision, he stressed, is a run-of-the-mill spending clause statute, and holding otherwise would invite line-drawing problems.

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JURIST

JULY 7, 2024

This decision mandated that any government action impairing this right must pass “strict scrutiny,” which is the highest standard of judicial review. This means the state must show that the law serves a compelling government interest and is narrowly tailored to achieve that interest.

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JURIST

SEPTEMBER 11, 2021

The DOJ also said that the law regulates areas that are preempted by federal government authority because of the impact this ban will have on interstate commerce. Attorney General Merrick Garland noted that “the statute includes an unprecedented scheme to, in the Chief Justice’s words, ‘insulate the State from responsibility.'”

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JURIST

JUNE 30, 2024

The court reasoned that since SB 14 does not violate a constitutionally protected interest, it can be found unconstitutional only if it is not rationally related to a legitimate government interest.

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Court Felony Healthcare Statute 104

InHouseOps

OCTOBER 1, 2021

Michael Vernick, government contracts partner with Akin Gump, discusses various aspects of the False Claims Act, including the potential for increased enforcement activity under the Biden administration, especially actions related to the CARES Act, and how companies and institutions can mitigate whistleblower and compliance related risks.

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SCOTUSBlog

JUNE 3, 2022

They ask that the justices require the government to file its opposition brief within 30 days without extension so that the justices could hear the argument at its first sitting in October 2022. government has not disputed is Turkey for jurisdictional purposes. Also on Jan. In contrast, according to Halkbank’s petition, the U.S.

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Healthcare Government Court Statute 100

Constitutional Law Reporter

JANUARY 31, 2022

Overall, the justices appeared more receptive to the healthcare worker vaccine mandate. 1231 is entitled by statute, after six months of detention, to a bond hearing at which the government must prove to an immigration judge that the alien is a flight risk or a danger to the community; and (2) whether, under 8 U.S.C.

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Immigration Statute Tort Healthcare 52

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. § internal citation omitted).

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Constitutional Law Reporter

FEBRUARY 1, 2022

Two District Courts enjoined enforcement of the rule, and the Government now asked the Supreme Court to stay those injunctions. According to the majority, the Secretary of Health and Human Services was within his authority in imposing the vaccine mandate on healthcare workers.

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SCOTUSBlog

JUNE 20, 2024

In its opposition, the government argues that there is no such disagreement, that it recently issued clarifying regulations obviating the need for Supreme Court review, and that in any event the D.C. Courts of Appeals for the 4th Circuit and the 9th Circuit have reached the same conclusion. But the U.S. relisted after the Jan.

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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.

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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.

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FDA Law Blog

FEBRUARY 9, 2022

While the Final Order does not necessarily introduce any new red flags, it does appear that DEA is attempting to refine these requirements and impose bright line standards related to “red flags” and the need for documentation, which are not currently defined in the statute or regulations. at 62,341; see Jones Total Healthcare Pharmacy, L.L.C.

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SCOTUSBlog

JUNE 13, 2024

Coverage of federal fraud statutes Porat v. The government adds that plenary review and argument are not necessary “[i]n light of the obviousness of the error.” The court held that the jury should decide whether “government funds were involved in the payments.” This week’s relists are a real grab bag of issues.

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SquirePattonBoggs

JANUARY 13, 2022

The Court agreed with the Government that the CMS mandate “falls within the authorities that Congress has conferred upon” the agency. According to Justice Thomas, the Government had not established that any statute empowers it to impose a vaccine mandate.

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SCOTUSBlog

JANUARY 13, 2022

The government expected the mandate to cover 84 million workers. But in the end, the court posited, other government actors – who are politically accountable – must “weigh such tradeoffs,” rather than the justices. For Gorsuch, the “answer is clear”: the states and Congress.

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SCOTUSBlog

JUNE 6, 2024

(relisted after the Jan. 26, May 9, May 16, May 23 and May 30 conferences) L.W. rescheduled before the Mar. 26 and May 9 conferences; relisted after the May 16, May 23 and May 30 conferences) Jane Doe 1 v. Kentucky ex rel.

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