Healthcare Compliance Blog

MARCH 16, 2022

In a March 11, 2022, release by the Northern District of Georgia’s Office of the Department of Justice, it was reported that an investigation determined a Georgia nursing home knowingly submitted claims for unreasonable, unnecessary, and unskilled services for Medicare patients. This amount was based on the nursing home’s ability to pay.

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Provider Trust

JULY 26, 2022

On June 7, 2022, Theresa Pickering of Norcross, Georgia was indicted by a federal grand jury on federal charges of health care fraud, aggravated identity theft, and distribution of controlled substances. According to the U.S. You should also be aware of peculiar birth dates and/or a history of frequent relocation.

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SQA

DECEMBER 16, 2022

SQA Regulatory Surveillance Summary for September and October 2022. ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. ANVISA published answers to questions received during an online seminar on clinical research of medicinal cannabis held in May 2022. 30 of 2022.

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FDA Compliance COVID-19 Licensing 40

Healthcare Law Blog

NOVEMBER 10, 2023

2022), the Federal Circuit decided the issue of whether commercial activities relating to a medical device prior to the critical date invoked the on sale bar of pre-AIA 35 U.S.C. § 208, 216 (2014). In Ex parte Loose, Appeal 2022-001026 (PTAB June 6, 2022), the PTAB did both in the context of medical device technology.

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Regulatory Compliance Compliance 52

SQA

SEPTEMBER 2, 2022

SQA Regulatory Surveillance Summary 2022 – June. Brazil’s ANVISA Repeals Medical Device Regulations Related to The Coronavirus Pandemic, 20 May 2022. ANVISA Extends Brazilian Good Manufacturing Practice Requirements to More Medical Device Manufacturers, 27 May 2022 . By Laurel Hacche & Debra Cortner SQA Associates.

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FDA COVID-19 Nursing Homes Compliance 91

Health Law Advisor

FEBRUARY 1, 2023

But I want to point out here that I am actively opposing FDA’s publication of the Final Guidance on Clinical Decision-Support Software (or “CDS Guidance”) [2] published on September 28, 2022. Indeed, the MDDS guidance was rather groundbreaking in 2014 because FDA was proposing a significant deregulation of certain hardware and software.

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FDA Compliance 52

Healthcare IT Today

JANUARY 2, 2023

As we kick off a new year, I thought it would be fun to take a quick look back at some of the top resources, articles, videos, and podcasts we shared in 2022. Most Visited Healthcare IT Today Articles Published in 2022. Final 2022 Health IT Predictions – Looks like people loved the potpurri of predictions too.

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Electronic Medical Records HIPAA Hospitals 98

Healthcare Law Blog

MAY 16, 2022

On April 29, 2022 , the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”).

Medicare 52

Medicare Medicare Medicaid Medicaid 52

HIT Consultant

AUGUST 2, 2022

Vaccination-related employee departures at 55 hospitals, health systems. Becker’s Hospital Review. American Hospital Association. Trendwatch: Hospital and Health System Workforce Strategic Planning. January 2020. US Bureau of Labor Statistics. Medical Records and Health Information Specialists. Occupational Outlook Handbook. Visited Feb.

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Hospitals Compliance COVID-19 HIPAA 97

Healthcare Law Blog

MARCH 25, 2022

20-50963, 2022 WL 807554, at *1 (5th Cir. To effectuate the program, HHS created a three-step risk-adjustment methodology: First, for each individual enrolled in an insurer’s plan, an actuarial risk score is computed using demographic and diagnostic data to determine the predicted cost of insuring that enrollee ( see 2014 Final Rule, 78 Fed.

ACA 52

ACA US Department of Health and Human Services Health Insurance Medicaid 52

SQA

AUGUST 8, 2023

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023. mt and 0.5

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FDA Compliance COVID-19 World Health 40

Healthcare Law Blog

JANUARY 10, 2022

On January 6, 2022 , the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Proposed Rule”). Comments are due by March 7, 2022.

Medicare 98

Medicare Medicare COVID-19 Medicaid 98

SQA

MAY 24, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices , which will come into force on 01 March 2023.

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FDA Licensing Governance Compliance 40

Healthcare Law Blog

JANUARY 11, 2023

There is no statutory requirement currently for two-way coding to be used (a 2014 CMS proposed regulation was never put into effect), but it is considered to be best practice. for 2022 as the Medicare FFS Comprehensive Error Rate Testing result.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Health Law Advisor

SEPTEMBER 1, 2023

The following chart outlines the top 10 Part D drugs that will be subject to the first round of CMS’s negotiations, including the total Part D expenditures for each product and the average 2022 out-of-pocket costs for non-low-income subsidy (non-LIS) enrollees. 31, 2023 $2,791,105,000 48,000 $2,005 Entresto Novartis Heart failure Nov.

Medicare 69

Medicare Medicare Licensing Medicaid 69

Health Law Advisor

AUGUST 10, 2023

In this blog post, we take on the question of when machine learning software developed by those involved in delivering health care is FDA regulated. The September 2022 Guidance seems to be referencing a practice that qualifies under the doctrine of practice of medicine, i.e., a regulated practice. 2022), available at [link]. [3]

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FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

Ltd, a Contract Research Organization (CRO) in Kharadi, India, was subject to a Good Clinical Practice (GCP) inspection in November 2020 and November 2022 by the Spanish Agency for Medicines and Medical Devices (AEMPS). 6/2022 , Medical Product Alert No.7/2022 7/2022 , Medical Product Alert No.1/2023

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FDA Compliance COVID-19 Public Health 52

Drug & Device Law

DECEMBER 4, 2023

2014), involved pipe, and specifically exempted prescription products from the “proposition” CPAP II claims it established. 2014), involved prescription drugs, not medical devices and negligence, not strict liability. CPAP II asserts that two cases that did not involve prescription medical devices at all changed Pennsylvania law.

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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. 171, 212 (Fall 2022). 2014 WL 46696, at *5 (C.D. Aqua Connect, Inc.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). 21, 2022). 5, 2022). Boehringer Ingelheim Pharmaceutical, Inc. Cartee , No.

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FDA 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. 2022 WL 2274876, at *10-11 (D. June 23, 2022). 2022 WL 909406, at *3 (E.D.N.C. March 28, 2022). 2014 WL 3868022, at *5 n.5 5, 2014); Rosmer v. Prosser & P. 544, 552 (D.

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Malpractice Governance Hospitals 59

Drug & Device Law

MARCH 7, 2022

Thus, Bexis made a note to blog on it – but only after he finished his chapter update due at the end of February. 2022 WL 610276 (C.D. 31, 2022), fell into our laps. Gloucester County , 2014 WL 1599499, at *3 (D.N.J. April 21, 2014). 2014 WL 12787639, at *10 (C.D. 2014 WL 12717702, at *13 (D.

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Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

NOVEMBER 22, 2022

was orally argued on November 8, 2022. We spotted Brown even before the Supreme Court decided it, and have been following personal jurisdiction issues on the Blog ever since. 117 (2014), established that the Brown “at home” standard meant what it said and signified the end of expansive general jurisdiction. Brown , 564 U.S.

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Governance 72

Drug & Device Law

FEBRUARY 10, 2023

The number of favorable fraudulent joinder opinions on the Drug and Device Law Blog is few and far between, despite the laudable efforts of the intrepid bloggers, which speaks to the difficulty defendants have in prevailing on this argument. In fact, the last such case dates back to November 2022.

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Doctors 52

Drug & Device Law

FEBRUARY 20, 2023

3d , 2022 WL 6225596 (S.D. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. 2022 WL 6225661, at *5 (S.D. 4:20-CV-02256, 2022 WL 6225573, at *3 (S.D. 4:20-CV-02256, 2022 WL 6225573, at *3 (S.D. Johnson & Johnson , 2022 WL 2115075 (D. Ethicon, Inc. ,

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FDA Licensing Hospitals Governance 59

Drug & Device Law

OCTOBER 20, 2022

Regular readers of the blog know and appreciate our focus (fixation?) Weeks opinion adopting innovator liability in 2014. 2022 WL 4588887, at *1 (Ala. 30, 2022) (to be published in So. on the learned intermediary rule. Not because it is fun to say and makes us feel smart. The current assault comes in Blackburn v.

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Doctors 59

Drug & Device Law

MARCH 17, 2022

2022 WL 274498 (11th Cir. 31, 2022), id not a drug and device case and not precedential (note: the Fed. 2022 WL 274498, at *2 (citation omitted). 277 (2014), that involved a plaintiff asserting a purely federal cause of action, that being a Bivens constitutional tort. Here’s another example. LG Chem, Ltd. Fiore , 571 U.S.

Governance 59

Governance 59

Drug & Device Law

JANUARY 13, 2022

4th —-, 2022 WL 99508, at *7 (1st Cir. Second, as readers of this blog are aware, after a string of unfortunate decisions allowing failure-to-report claims to proceed—specifically, Stengel v. 4th 413 (2014) —the tide has turned. 2014) (failure to file mandatory child abuse reports). USA, Inc. , — F.4th Medtronic, Inc. ,

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FDA Hospitals 45

Drug & Device Law

MARCH 4, 2024

2014), the MDL court let plaintiffs try again. 10, 2020), aff’d , 2022 WL 11112695 (4th Cir. 19, 2022), a party − the defendant, this time − “chose to designate [the excluded expert] as its sole standard-of-care expert and vigorously persisted in” supporting that expert only. 2014 WL 12577131, at *3-4 (C.D. 2d 449 (E.D.

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Drug & Device Law

JUNE 9, 2022

2022 WL 1261318 (3d Cir. As an astute reader of the blog, Blank Rome’s Terry Henry, noted that Greisberg applied the presumption to a 510(k) device, i.e. , a device that had received premarket clearance rather than premarket approval. 2022 WL 1261318, at *2. 2014 WL 1876957, *10 (D.N.J. Boston Scientific Corp. Globus Med.,

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Compliance FDA Fraud 59

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As both the blog and many of us defense practitioners can attest, the statute before repeal, Mich. . 2022 WL 5265300 (D.N.J. 13327 (Oct.

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FDA Compliance Fraud Hospitals 52

Drug & Device Law

FEBRUARY 24, 2022

3d —-, 2022 WL 464149 (N.D. 2022), rejected that sophistry. 2022 WL 464149, at *1. 2022 WL 464149, at *4. But, as the Supreme Court has held and readers of this blog know, state-law requirements that parallel federal requirements can be impliedly preempted even if they are not expressly preempted. 3d 1026, 1034 n.22

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FDA Governance Fraud 72

Drug & Device Law

JUNE 28, 2022

2022 WL 2276808 (U.S. June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. Patrick , 2014 WL 1454696 (D. April 15, 2014) (“ Zogenix I ”), and Zogenix, Inc. Patrick , 2014 WL 3339610 (D. The ban was preempted. “If

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