Provider Trust

AUGUST 16, 2023

While medical providers comprise a large percentage of healthcare vendors, other facility staff members also fall under this category. ProviderTrust data has also shown that 20% of vendor information changes annually. Gather vendor information: Obtain as much information as possible from vendors to conduct exclusion checks accurately.

Fraud 52

Fraud Compliance Licensing Compliance Officers 52

Health Law RX

FEBRUARY 2, 2022

The Florida Legislature previously approved a requirement that hospitals and ambulatory surgical centers (ASCs) conduct patient safety surveys and tasked the Agency for Health Care Administration (AHCA) with implementing a rule specifying the submission process for these surveys. Patient Safety Surveys. Survey Questions.

Hospitals 52

Hospitals Licensing Medicaid Medicaid 52

Provider Trust

JANUARY 26, 2022

According to the OIG site on Fraud Risk: OIG applies published criteria to assess future risk and places each party to an FCA settlement into one of five categories on a risk spectrum. OIG uses its exclusion authority differently for parties in each category (as described in the criteria…). So what are the risk categories?

Fraud 52

Fraud US Department of Health and Human Services Medicaid Medicaid 52

Healthcare Law Blog

MARCH 20, 2023

For example, an overwhelming sixty percent (60%) of recently-surveyed licensed psychologists reported having no openings for new patients, with many having a volume of patient requests that outweighs their ability to even maintain a waitlist. [1] Please refer to our blog for more information on the proposed rule.

Medicaid 52

Medicaid Medicaid Licensing ACA 52

SQA

FEBRUARY 22, 2021

Noteworthy changes consist of the down-classification of 15 device types (including optical endoscopes and medical microscopes) and revisions to the entries for 13 product categories (including additional classification adjustments). 26 of 2020 (link in Chinese), relating to the submission of Unique Device Identifier (UDI) information.

COVID-19 52

COVID-19 Compliance Licensing Governance 52

Hall Render

JANUARY 31, 2022

Information Needed within Four Hours of Entrance. laundry room, kitchen, unit, ward, wing) and if the staff is PRN/floater/agency, indicate their assigned work area on the first day of the survey. The sample size will not change if staff in a category do not exist. Six unvaccinated staff, if available.

COVID-19 Vaccine 40

COVID-19 Vaccine Nurses COVID-19 Nursing Homes 40

Provider Trust

MAY 18, 2022

If the answer is yes, then the best mechanism for limiting CMP liability is to screen all persons that perform under that contract or that are in that job category. In addition, the suit involved alleged submission of false claims for reimbursement to the Massachusetts Medicaid Agency. The defendants settled and paid $19.95

Compliance 52

Compliance Due Diligence Medicaid Medicaid 52

Healthcare Law Blog

JANUARY 26, 2023

251 (1997), included conscience provisions for Medicaid and Medicare programs, prohibiting Medicaid managed care-managed organizations and Medicare Advantage plans from prohibiting or restricting a physician from informing a patient about their health and full range of treatment options. The proposed regulation 45 C.F.R.

ACA 105

ACA Medicaid Medicaid Compliance 105

Healthcare Law Blog

MAY 16, 2022

CMS also advises the Final Rule will equip MAOs with the “person-level information” that will help them better connect people to covered services, social service organizations, and public programs that can help resolve housing instability, food insecurity, or transportation challenges.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

SQA

FEBRUARY 15, 2023

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

US Department of Health and Human Services 40

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

SQA

MAY 24, 2023

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. The reporting period begins on the day after the awareness date of a serious incident. Although the original awareness date in Section 1.2c

FDA 40

FDA Licensing Governance Compliance 40

SQA

DECEMBER 16, 2022

This guidance will help applicants interpret how to implement Essential Principles of Medical Device Safety and Performance using information that was issued in March 2020. European Medicines Agency (EMA). to express their interest in participating or to gather more information. CMDE Announcement No. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

Health Law Advisor

AUGUST 10, 2023

In the last couple of years, each Fall, FDA has been updating a list of machine learning applications in health care that the agency has cleared or otherwise approved. [1] Implementing a Constitutional limit, FDA does not regulate a licensed practitioner who makes devices for use in his or her own practice. For example, if Dr.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

OCTOBER 18, 2022

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. ’s recall and will inform the public if any new health risks are identified.

US Department of Health and Human Services 40

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

Healthcare Law Blog

NOVEMBER 13, 2023

In addition, the notification would include the scope of the benefit, cost-sharing, instructions on how to access the benefit, any network application information for each available benefit, and a customer service number to call if additional help is needed.

Medicare 59

Medicare Medicare Medicaid Medicaid 59

Hall Render

MARCH 25, 2022

Nebraska HIE to Offer Individuals Health Information Across Providers. Women of Influence 2022: From an idea to an agency, this is how Cathy Schueler built Bosque Mental Health Associates. Nurses are frustrated by months-long delays to get licensed in some states. State investigating patient assault at Montana State Hospital.

COVID-19 40

COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40

HIPAA Journal

JANUARY 2, 2023

Texas Department of Aging and Disability Services – $1,600,000 penalty for risk analysis failures, access control failures, and information system monitoring failures. Impermissible Disclosures of Protected Health Information. Removing protected health information from a healthcare facility places that information at risk of exposure.

HIPAA 106

HIPAA Compliance Hospitals Medicare 106

Kaiser Health News

JUNE 6, 2022

It’s a category in which the government says it will defer trying to deport someone so they can deal with a severe illness. Citizenship and Immigration Services, however, until just recently, and the approval came only after inquiries to the agency from members of Congress and a reporter. He heard nothing back from U.S.

Health Insurance 72

Health Insurance Doctors Governance Licensing 72

SQA

FEBRUARY 26, 2024

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. is a medical device or an accessory to a medical device.

FDA 52

FDA Compliance COVID-19 Public Health 52

Hall Render

FEBRUARY 16, 2024

CALIFORNIA 8 ASCs opening in Florida, California and New York A bankrupt California hospital left a health care desert. million operating loss Judge Keeps FCA Case Against Kaiser Permanente Alive Kaiser Permanente reports $4.1B medical office sale in Bridgewater Low pay in primary care is leading to a care crisis in New Jersey N.J.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

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. 19, comment d. 19, comment f. See UCC §§2-103(1)(m), 2-105(1). 673, 676 (Cal.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

NOVEMBER 9, 2023

However, the FDA’s new Draft Guidance introduces another phrase, “scientific information on unapproved use(s)” (“SIUU”), that at least has a decent acronym, so we will use that. Unfortunately, the FDA has been stuck in the rut of criminalizing speech for so long that hasn’t wanted to change unless courts forced it to.

FDA 64

FDA Health Insurance Nurses Medicare 64