Hall Render

JULY 25, 2023

Several months later, in May 2023, the Department of Justice (“DOJ”) reached a settlement of $29,744,065 with three health care entities to resolve allegations that they violated the False Claims Act by providing kickbacks to certain referring physicians by providing them with APPs at no cost or below fair market value.

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Compliance Hospitals Governance Doctors 40

Healthcare Law Blog

AUGUST 31, 2023

In 2023, Illinois legislators introduced two major bills that mandate cultural competency training: H.B. New Laws Mandating Cultural Competency Training for Illinois Healthcare Providers On August 8, 2023, Illinois Governor J.B. 2450 and S.B. Pritzker approved H.B. Cultural Competency Training Legislation in Other Jurisdictions S.B.

Licensing 52

Licensing Patient Satisfaction Nurses Nursing Homes 52

Hall Render

AUGUST 1, 2022

A CAH or hospital that converts to an REH can start participating in Medicare as an REH as early as January 1, 2023. million per year) for 2023. CMS is interpreting the Act to mean that the Bipartisan Budget Act of 2015 Section 603 payment limits will not apply to items and services furnished by an off-campus PBD of an REH.

Hospitals 40

Hospitals Payment Systems Medicare Medicare 40

SQA

OCTOBER 18, 2023

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products.

FDA 40

FDA Compliance Licensing World Health 40

Hall Render

JUNE 22, 2022

On Friday, June 17, 2022, the Centers for Medicare & Medicaid Services (“CMS”) posted a pre-publication copy of the Calendar Year (“CY”) 2023 Home Health Prospective Payment System Rate Update (“PPS Rule”). The following table shows the episodic rate calculation for 2023: CY 2022 National Standardized 30-Day Period Payment.

COVID-19 40

COVID-19 Payment Systems Medicare Medicare 40

Health Law RX

JULY 18, 2023

On June 27, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its long-anticipated final rule amending the OIG’s civil monetary penalty (CMP) regulations as they relate to information blocking (CMP Final Rule or Rule). The CMP Final Rule was published in the Federal Register on July 3, 2023.

Fraud 52

Fraud Compliance Medicaid Medicaid 52

Bill of Health

FEBRUARY 29, 2024

Around 65% of ancestral land was located within Nepal’s national parks and reserves by 2015, and many evicted Indigenous Peoples remain landless. NIDWAN disseminated an advocacy statement for disability-inclusive climate action from Indigenous women and girls with disabilities at COP27 and COP 28.

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Informed Consent Governance Compliance Public Health 201

SQA

JUNE 10, 2021

ANVISA has also released a set of 106 proposals for Regulatory Projects that will compose the 2021-2023 Regulatory Agenda. 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). The deadline for comments is 30 June 2021.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

SQA

SEPTEMBER 2, 2022

effective as of 01 July 2023. With the previous version of the Guide dating back to 2015, it was clear that a substantial overhaul of the text would be necessary to incorporate the technical progress and new policies that have been adopted in the intervening years. The European Pharmacopoeia (Ph. Supplement 11.2,

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FDA COVID-19 Nursing Homes Compliance 91

Healthcare Law Blog

JANUARY 4, 2023

As an alternative to limiting the plan offerings, HHS proposed to reinstate the meaningful difference requirement, which was first introduced by the Obama administration in 2015, but was reversed by the Trump administration in 2019. Comments on the Proposed Rule are due January 30, 2023.

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Health Insurance ACA Medicaid Medicaid 52

Drug & Device Law

DECEMBER 4, 2023

Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. 28, 2023) (“ CPAP I ”), addresses primarily medical monitoring. 2023 WL 7019667, at *3 (internal citations and quotation marks omitted). 2023 WL 7019667, at *11-13. Words fail us.

Fraud 52

Fraud FDA Hospitals Doctors 52

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

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

APRIL 13, 2023

4th , 2023 WL 2780348 (4th Cir. April 5, 2023), a pelvic mesh case where the defendant won a jury verdict on negligence after obtaining summary judgment on design defect because the plaintiff couldn’t meet the current West Virginia standard for proof of alternative design. 2023 WL 2780348, at *2 (suit filed in October, 2008).

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Drug & Device Law

FEBRUARY 20, 2023

0295, 2015 WL 5022618, at *12 (N.J. 14, 2015) (claimed alternative could not be considered for plaintiffs who “had their surgeries prior to the commercial availability of” the claimed alternative because it “was not approved by the Food and Drug Administration until June 2007 and was not commercially available until late” that year).

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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. 3d , 2023 WL 2577257 (N.H. 3d , 2023 WL 2577257 (N.H. March 21, 2023). 2023 WL 2577257, at *1. 2023 WL 2577257, at *2 (citations and quotation marks omitted) (emphasis original).

Malpractice 59

Malpractice Governance Hospitals 59

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

FDA 105

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

Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. 3d , 2023 WL 2825871 (N.D. April 7, 2023) (“ AHM I ”). 2023) (“ AHM II ”). et al. , “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical & Surgical Abortions, 1999–2015,” 8 H. FDA , 78 F.4th

FDA 59

FDA Fraud Pharmaceutical Industry Doctors 59

Drug & Device Law

OCTOBER 13, 2023

We blogged on similar cases here , here , and here. 18-cv-06972, 2023 WL 6390598, at *3 (N.D. 2015), and the Supreme Court’s opinion in Mutual Pharmaceutical Co. As we explained here , “hindsight” claims like these should not be allowed. Gilead Sciences, Inc. , Ortho-McNeil-Janssen Pharmaceuticals, Inc. , 3d 281 (6th Cir.

FDA 59

FDA Fraud 59

Drug & Device Law

JUNE 2, 2023

2023 WL 3632755 (U.S. May 25, 2023), has nothing whatever to do with drugs, or devices, or product liability, but we bring it to our readers’ attention because of what it has to say about federal appellate procedure. 2023 WL 3632755, at *4 (citations and quotation marks omitted). 318, 328 (2015)). Younger , S.

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FDA 59

Drug & Device Law

MARCH 4, 2024

3d , 2023 WL 8711617 (S.D.N.Y. 18, 2023), some late-arrival plaintiffs in that litigation sought a do-over, which is now being litigated. 2023) (denying do-over not an abuse of discretion; “allowing plaintiffs to designate a new expert would prejudice defendants”). 2023 WL 5322213, at *6 (6th Cir. 3d 480, 495 (Cal.

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Drug & Device Law

NOVEMBER 2, 2023

This post is solely from the non-Reed Smith side of the Blog. Wells Pharma of Houston, LLC , 2023 WL 6301651 (S.D. Wells Pharma of Houston, LLC , 2023 WL 6301651 (S.D. 2023), because it rejects the use of state law to impose requirements beyond those imposed by the FDA. 2023 WL 6301651, at *4. 2015) (Gorsuch, J.).

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FDA 59

Drug & Device Law

JUNE 23, 2023

We’ve blogged before about the plaintiffs’ self-defeating “injury” definition in the Taxotere mass tort litigation. Services , 2023 N.J. June 8, 2023). Adams , 2023 N.J. Sanofi U.S. Lexis 927, at *2-3 (N.J. Here, all four bellwether plaintiffs presented with essentially the same statute of limitations-related facts.

Governance 59

Governance 59

Drug & Device Law

NOVEMBER 15, 2023

2023 WL 7308325 (S.D. 6, 2023), furnishes fresh proof that the product liability element of product identification is alive and well in Alabama, thanks to the legislature’s restoration of sanity. Quoting the same 2015 statutory amendment that the Blog discussed (Ala. We discussed that solonic reversal here.) Pfizer, Inc.

Governance 59

Governance 59

Drug & Device Law

NOVEMBER 27, 2023

We’ve blogged a couple of times before about turncoat experts, so the recent decision in Hawkins v. 2023 WL 7292164 (D.D.C. 6, 2023), attracted our interest. 2023 WL 5624710 (D. 31, 2023); Cannon v. 2023 WL 7477903 (N.D. 16, 2023); McCoy v. 2023 WL 4551081 (S.D. 2023 WL 2974480 (W.D.

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Drug & Device Law

DECEMBER 11, 2023

London Women’s Care, PLLC , 2015 WL 3440492 (E.D. May 28, 2015)); here (discussing In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation , 2011 WL 2746086 (S.D. 2023 WL 2027835, at *3 (Mag. 26, 2023), adopted , 2023 WL 2021880 (W.D. 15, 2023); Torres v.

Malpractice 102

Malpractice Hospitals Doctors 102