AIHC

NOVEMBER 29, 2023

The Centers for Medicare & Medicaid Services (CMS) HCC model was initiated in 2004 and is becoming increasingly prevalent as the environment shifts to value-based payment models. It’s important for compliance and historical trend analysis.

Medicare 59

Medicare Medicare Medicaid Medicaid 59

AIHC

NOVEMBER 29, 2023

The Centers for Medicare & Medicaid Services (CMS) HCC model was initiated in 2004 and is becoming increasingly prevalent as the environment shifts to value-based payment models. It's important for compliance and historical trend analysis. Data Retention Rate: Measures how long data is stored and maintained for future analysis.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

AIHC

OCTOBER 19, 2021

Respect is earned, not automatically “given,” after achieving a credential such as “ Certified Healthcare Auditor ” which has been offered by the American Institute of Healthcare Compliance since 2004. Are you a credentialed member of the American Institute of Healthcare Compliance (AIHC)?

Compliance 52

Compliance Governance 52

MRO Compliance

OCTOBER 23, 2022

October is National Cybersecurity Awareness Month, launched in 2004 by the National Cybersecurity Division of the Department of Homeland Security and the nonprofit National Cyber Security Alliance. National Cybersecurity Awareness Month: 4 Ways to Protect your Privacy Today.

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The Health Law Firm

JULY 11, 2012

million to settle False Claims Act allegations that occurred between 2004 and 2009. Hospital Self-Reported After Compliance Program Revealed Billing Errors. The hospital self-reported after its own compliance program revealed billing problems for ambulance services.

US Department of Health and Human Services 40

US Department of Health and Human Services Hospitals Compliance Governance 40

Healthcare Law Blog

FEBRUARY 13, 2023

This topic always involves a legal angle, such as Stark Law or Anti-Kickback compliance, or state fraud and abuse law considerations. C-02-1786 JSW (EMC), 245, 248, 2004 U.S. 23, 2004). [4] For example, consider physician compensation. However, it almost always involves a business angle too. Are bonuses involved? 2014), the D.C.

Compliance 52

Compliance Fraud Governance 52

Total HIPAA

JULY 21, 2020

HIPAA compliance for employers is a complicated and nuanced topic. According to HIPAA 45 CFR § 164.504(f)(iii) 4 , a plan sponsor is a Covered Entity and is required to work through the appropriate steps towards HIPAA compliance. The post Why Employers Need to be HIPAA Compliant appeared first on Total HIPAA Compliance.

HIPAA 40

HIPAA Health Insurance Compliance 40

SQA

APRIL 30, 2021

726/2004, 09 March 2021. 726/2004 , which essentially means duplicate MAAs for products authorized via the centralized procedure. These missions will allow the Commission to identify, and, if necessary, correct any non-compliance or weaknesses. Under Article 82(1) of Regulation (EC) No.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

OCTOBER 18, 2023

While preparing the patient’s compliance pack, the pharmacy misinterpreted the product to contain 500 mg of Calcium Carbonate when each tablet actually contained 500 mg of elemental Calcium. CGMP compliance is the floor and FDA is looking for companies to exceed those standards. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40

Total HIPAA

MAY 6, 2020

The Project BioShield Act of 2004 gives HHS the authority to waive some HIPAA provisions during a nationwide public health emergency so that transmission of patient information and patient care can be more freely facilitated. The post HIPAA Waiver: How COVID-19 Impacts HIPAA Compliance appeared first on Total HIPAA Compliance.

COVID-19 40

COVID-19 HIPAA Compliance Public Health 40

Drug & Device Law

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. 2004 WL 7334819, at *18 (Mag. 2004), transfer denied (Mo. Restatement §402A, comments a, d-e. Graphic Process Co. ,

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

FEBRUARY 11, 2022

citing provisions allowing “other appropriate actions,” actions “to compel compliance,” “orders necessary to enforce,” and to “assess civil penalties”). 2004), General Public Utilities v. Neither act expressly conveyed such power to sue, but CvM implied causes of action under general enforcement provisions. 2d 701 (Pa. 2d 567 (Pa.

Governance 72

Governance Compliance 72

Drug & Device Law

MAY 4, 2023

Ohio is one of several states, with New Jersey being the most notable , with statutes precluding punitive damages in product liability cases based on FDA approval or compliance. An argument that is often a long-shot at the pleading stage also came through. Warner-Lambert & Co. , 3d 85, 98 (2d Cir. Wyeth-Ayerst Labs. ,

FDA 64

FDA Fraud Compliance 64

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

MAY 5, 2022

2004), that provisions allowing the rebuttal of a compliance presumption based on alleged fraud on the FDA are preempted unless the FDA itself finds fraud. 2022 WL 1261318, at *1 (quoting N.J. McNeil Consumer & Specialty Pharms., 3d 372 (5th Cir. 2012), and Garcia v. Wyeth-Ayerst Labs. , 3d 961 (6th Cir.

Compliance 52

Compliance FDA Fraud 52

Drug & Device Law

NOVEMBER 21, 2023

An inferior vena cava (“IVC”) filter was implanted in plaintiff in 2004. Plaintiff is a resident of Texas and had her 2004 surgery in Texas, so the court applied Texas law which has a 15-year statue of repose. In re Cook Medical, Inc. LEXIS 205990, at *1 (S.D. Plaintiff next argued she qualified for the “latent disease” exception.

Compliance 59

Compliance 59