Hall Render

JANUARY 12, 2023

The original overpayment rule, which was signed into law in 2014 with the Affordable Care Act and expanded to Medicare Parts A and B in 2016, requires a provider who has received an overpayment to report and return it within 60 days of the date that overpayment was identified (in most cases). Your primary Hall Render contact.

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Healthcare Law Blog

APRIL 14, 2023

April 7, 2023: Judge Thomas Rice rules that the FDA is prohibited from “altering the status quo and rights as it relates to the availability of Mifepristone” in seventeen states and the District of Columbia. April 10, 2023: DOJ seeks clarification from court regarding the FDA’s obligations in light of the Texas ruling.

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Hall Render

OCTOBER 7, 2022

million in Medicare Part B payments should not have been made during 2016-2021, which was a decrease from $51.6 million in improper payments during 2013-2016. Hall Render blog posts and articles are intended for informational purposes only. OIG found that $39.3

Hospitals 40

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Health Law Advisor

MAY 9, 2022

Are you prepared for state privacy law compliance required in 2023? Despite a shifting privacy landscape and passage of the EU’s General Data Protection Regulation ( GDPR ) in 2016, the United States has lagged in adopting a comprehensive Federal privacy law. 12/31/2023. Compliance Deadlines: Get Your House in Order.

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MedTrainer

JUNE 5, 2023

After years in limbo, USP <800> compliance will be required, effective November 1, 2023. The 2016 edition of USP <800> provided comprehensive guidance on handling and administering drugs. It’s the first USP standard that’s enforceable by State Boards of Pharmacy, OSHA, and the FDA.

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Healthcare Law Blog

JUNE 15, 2023

April 7, 2023: Judge Thomas Rice rules that the FDA is prohibited from “altering the status quo and rights as it relates to the availability of Mifepristone” in seventeen states and the District of Columbia. April 10, 2023: DOJ seeks clarification from the court regarding the FDA’s obligations in light of the Texas ruling.

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Hall Render

NOVEMBER 17, 2023

Background Originally published in 2013 and amended in 2016, the two-midnight rule provides that inpatient services are generally payable under Medicare Part A if a physician expects a patient to require medically necessary inpatient hospital care that spans at least two midnights. 1395w-22(a) ).

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Healthcare Law Blog

FEBRUARY 22, 2023

2] Please refer to our previous blog post on the IRA. The thirty-day public comment period ends on March 11, 2023. Part B inflation rebates are measured on a quarterly basis, with the first quarter having begun on January 1, 2023. 7] What is the Effect on Coinsurance Rates under Part B? 9] What are Key Dates and Timelines?

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MedTrainer

SEPTEMBER 8, 2023

Advocate Health Care HIPAA Breach (2016) In August 2016, Advocate Health Care Network —one of the largest healthcare systems in Illinois—agreed to settle potential violations of Privacy and Security Rules for $5.55

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Compliance HIPAA Medicaid Medicaid 52

Healthcare Law Blog

JANUARY 20, 2023

To add uniformity to this practice, CMS codified this flexibility in the 2016 Medicaid and Children’s Health Insurance Plan (CHIP) managed care final rule by authorizing coverage for “In Lieu of Service or Settings” (ILOS). [i] Please refer to our prior blog for more information on CalAIM.

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Medicaid Medicaid Medicare Medicare 52

Healthcare Blog

MAY 11, 2023

This blog post will discuss the different aspects and advantages of contract management software and how using contract management software creates more efficient contract processes. 2016, March 9). Healthcare organizations must focus on caring for their patients, not on paperwork. References Ball, B. Aberdeen Strategy and Research.

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Compliance 40

Healthcare Law Blog

JANUARY 25, 2023

Introduction: Defining Interprofessional Consultation In a January 5, 2023, letter to state health officials, the Centers for Medicare & Medicaid Services (“CMS”) clarified a Medicaid and Children’s Health Insurance Program (“CHIP”) policy on the coverage and payment of interprofessional consultations (the “Guidance”). 10] Dahlke, S.,

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Bill of Health

SEPTEMBER 13, 2023

Media reports indicated the number of Israeli women utilizing SEF has grown by ten times in 6 years (2011-16) , reaching almost 1000 per year in 2016. Israeli women represent a relatively high rate of labor force participation, (68.26% in 2023) , while simultaneously having an exceptionally high number of children.

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Bioethics Doctors COVID-19 Public Health 144

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.

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Fraud Compliance Medicaid Medicaid 52

MedTrainer

NOVEMBER 20, 2023

Patient Information Laws Signed into law in 2023, the CS/SB 264 legislation mandates that healthcare providers using certified electronic health record (EHR) technology store all patient data, whether in physical form or on cloud-based platforms, within the continental United States, its territories, or Canada.

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Compliance Licensing Regulatory Compliance Medicaid 52

Healthcare IT Today

DECEMBER 18, 2022

An ONC blog post described how the tool works: Developers answer questions about the type of health data the app will collect, the intended use of the app, and the type of entity developing the app to determine whether the app is subject to HIPAA, the information blocking rule, or other federal laws. Look for us again in 2023.

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Hospitals Doctors FDA HIPAA 92

Provider Trust

MARCH 13, 2023

Between 2016 and 2021, over 7,600 fake diplomas were sold to nursing students who used the fraudulent degrees to qualify for the National Council Licensure Exam (NCLEX). So, let’s say they were revoked in 2019; then they would issue the certificate and the diploma as if the student had attended between 2016 and 2017.”

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Fraud US Department of Health and Human Services Licensing Compliance Officers 52

Healthcare Law Blog

MARCH 20, 2023

Please refer to our blog for more information on the proposed rule. 3] California Department of Insurance, Health Insurance Benefits ; Approaches in Implementing the MHPAEA: Best Practices from the States , Substance Abuse and Mental Health Services Administration (2016). [4] 21, 2023). [5] Incentivizing provider participation.

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Medicaid Medicaid Licensing ACA 52

Health Law Advisor

AUGUST 10, 2023

2] Implementing the 21st Century Cures Act from 2016, regulated CDS software includes that intended to “analyze” “medical information about a patient or other medical information” “for the purpose of supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition.”

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FDA Licensing Hospitals Medicaid 98

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

SQA

SEPTEMBER 2, 2022

The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. Compared to the 2016 revised version, the draft of the 2022 version includes 101 more articles to conform to the pharmaceutical policy reforms in the recent years and the Drug Administration Law revised in 2019. Supplement 11.2,

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Healthcare Law Blog

JANUARY 5, 2023

Comments on due February 13, 2023. Please refer to our blog posts of November 4, 2022 , October 31, 2022 , and May 16, 2022. We’ve summarized some of the key changes in the Proposed Rule. Star Ratings. Addition of a Health Equity Index Reward. MA and Part D Marketing.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Healthcare Law Blog

DECEMBER 15, 2022

Further, payers should consider submitting comments on the Proposed Rule, which are due on March 13, 2023. Identifying Previous and Concurrent Payors and Opt In. CMS proposes that impacted payers maintain a process to identify a new patient’s previous and/or concurrent payer(s) to facilitate data exchange using the Payer-to-Payer API.

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Medicaid Medicaid Medicare Medicare 52

SQA

OCTOBER 18, 2022

PIC/S Sub-Committees have been elected for a two-year term starting on 01 January 2022 and ending on 31 December 2023. As the year has already started, objectives which cannot be completed by the end of 2022 will be rescheduled in 2023. Import, Advertising and Supply Compliance Priorities 2022 to 2023, 12 July 2022.

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US Department of Health and Human Services FDA COVID-19 Compliance 40

AIHC

FEBRUARY 16, 2024

Lessons Learned about Consequences & Incentives Submitted by the AIHC Education Department Introduction The Office of Inspector General has released the new General Compliance Program Guidance or “GCPG” in late 2023. The article states “An example of this was Wells Fargo in 2016.

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Compliance US Department of Health and Human Services COVID-19 Hospitals 52

AIHC

FEBRUARY 16, 2024

Lessons Learned about Consequences & Incentives Submitted by the AIHC Education Department Introduction The Office of Inspector General has released the new General Compliance Program Guidance or “GCPG” in late 2023. The article states “An example of this was Wells Fargo in 2016.

Compliance 52

Compliance US Department of Health and Human Services COVID-19 Hospitals 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. 2016) (citations omitted). 2016) (citation and quotation marks omitted).

Governance 52

Governance Payment Systems Hospitals Licensing 52

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

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”). 2016) (citation omitted). 3d 480, 495 (Cal. 274 (2d Cir.

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Drug & Device Law

APRIL 6, 2023

For much of the sixteen and a half years of this Blog, we have been tracking the acceptance and rejection of the learned intermediary doctrine. Why is this such a staple of the Blog? And Karl is not even controlling in West Virginia anymore, because the state legislature overturned it in 2016. 17-452 WES, 2023 U.S.

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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.

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Fraud FDA Hospitals Doctors 52

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 ”). See AHM I , 2023 WL 2825871, at *4 n.9 FDA litigation that is now before the Supreme Court. See Alliance for Hippocratic Medicine v. FDA , 78 F.4th

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FDA Fraud Pharmaceutical Industry Doctors 59

Drug & Device Law

JUNE 5, 2023

2023 WL 2565853 (N.D. March 17, 2023), reconsideration denied , 2023 WL 3032063 (N.D. Kelley was actually decided a couple of months ago, but due to Reed Smith’s involvement in the case, we could not blog about it until the matter recently settled. 2023 WL 3032063, at *2 (N.D. 2023 WL 1808396, at *2 (D.

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FDA Regulatory Compliance Compliance Fraud 59

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. 2016 WL 7197441, at *2 (S.D.W. Ethicon, Inc. ,

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Drug & Device Law

JULY 7, 2023

Today’s guest post is from friend-of-the-Blog Richard Dean of Tucker Ellis. 2023 WL 41877494 (U.S. June 27, 2023), personal jurisdiction decision, he is back again. . 2023 WL 4187749, at *14 (U.S. June 27, 2023) (concurring in part). 1142 (2023). Norfolk Southern Railway Co. , 600 U.S. ,

Public Health 72

Public Health 72

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.

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

HealthLaw Prof Blog

JULY 28, 2023

Patrick Sharkey (Princeton University), Megan Kang (Princeton University), The Era of Progress on Gun Mortality: State Gun Regulations and Gun Deaths From 1991–2016 (2023): Background: The recent rise of gun violence may lead to the perception that the problem of.

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