Verisys

NOVEMBER 30, 2022

Maintaining compliance and safeguarding against fraud and abuse in today’s changing healthcare landscape can be challenging. Excluded from one means excluded from all, and the fines for non-compliance will likely be in the hundreds of thousands. License Verification & Monitoring. OIG, SAM DEA, GSA, FDA.

Regulatory Compliance 52

Regulatory Compliance Medicare Medicare Medicaid 52

Verisys

NOVEMBER 14, 2023

Primary source verification must be done to confirm a provider’s education, professional license and certifications, medical training, work history, references, and more. Provider information should be continuously monitored for any changes to exclusion or license status. Department of Justice (DOJ) U.S. Treasury Department U.S.

Licensing 52

Licensing Medicaid Medicaid Governance 52

Healthcare Law Blog

MAY 31, 2022

However, traditional healthcare players, subject to the Health Insurance Portability and Accountability Act (“HIPAA”), may also find themselves innovating in this space (and grappling with how to stand up a HIPAA compliance program in the metaverse). How healthcare providers are licensed in the metaverse is also an open question.

FDA 90

FDA HIPAA Medicare Medicare 90

SQA

JUNE 10, 2021

Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. The Government of Canada’s number one priority is to protect the health of Canadians. FDA plant inspection and pay $50 million in fines and forfeiture.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies.

FDA 52

FDA Compliance COVID-19 Public Health 52

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. products in color and typeface and uses the BTNX Inc. device identifier “COV-19C25.”

US Department of Health and Human Services 40

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

Health Care Law Brief

OCTOBER 27, 2021

This means that although ketamine is approved by the FDA for some medical uses, it is not specifically approved to treat depression. Such laws and regulations are largely governed at the state level, and there may be (i) considerable variations among state laws and (ii) frequent updates to such laws. 1] [link]. [2] 2] [link]. [3]

Licensing 40

Licensing Telemedicine COVID-19 FDA 40

Verisys

JANUARY 18, 2022

Primary source verification must be done to confirm a provider’s education, professional license and certifications, medical training, work history, references, and more. Provider information should be continuously monitored for any changes to exclusion or license status. Food and Drug Administration (FDA).

Licensing 52

Licensing Medicaid Medicaid Governance 52

AIHC

AUGUST 2, 2022

Written by: AIHC Blogger This educational article is based on clinical information as of the publication date and primarily based on government and coding guidelines to assist coders, billers, clinical documentation improvement professionals and auditors address appropriate documentation for filing claims in the United States.

US Department of Health and Human Services 98

US Department of Health and Human Services FDA Licensing Compliance 98

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The written procedure for recall was inadequate and this procedure had not been implemented.

FDA 40

FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

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

Health Law Advisor

MARCH 1, 2023

On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). States and the federal government have been taking sides on the ability of pharmacies to dispense mail-order medications used for abortion. 1] [link]. [2]

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

Healthcare IT Today

JANUARY 19, 2024

With the majority of AI tools lacking the necessary FDA clearance for use in healthcare settings, health systems will need to properly evaluate their AI investments to prioritize legitimized solutions that will ensure patient safety and legal compliance.”

Hospitals 94

Hospitals Governance FDA Licensing 94

Hall Render

MARCH 22, 2024

Nevada Medicaid must cover abortion services, judge rules Clark County health rankings improve, but physicians per capita still well below U.S. Nevada Medicaid must cover abortion services, judge rules Clark County health rankings improve, but physicians per capita still well below U.S.

Nursing Homes 40

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

Hall Render

SEPTEMBER 29, 2023

NATIONAL Amazon moves into healthcare generative AI with $4B investment Biden administration to ban medical debt from credit scores CMS encourages physicians to apply for new Making Care Primary model CMS settles $9.2M in Stark law self disclosures: 3 things to know CMS’ staffing proposal will cost nursing homes $6.8B Margaret’s CEO blames $7.3

US Department of Health and Human Services 40

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

Hall Render

MARCH 31, 2023

in 2022, survey finds Senate votes to end COVID-19 national emergency Why are 600+ rural hospitals at risk of closing? What happens if it disappears?

US Department of Health and Human Services 40

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

Hall Render

MARCH 8, 2024

government contract to accelerate AI platform Rothman Orthopaedics’ 5-year recap: 36 big moves Summit inspires Pittsburgh to take lead in health care safety again through technology Temple Health hospital CEO steps down Temple Health overhauling leadership team at Chestnut Hill Hospital Penn Highlands Healthcare Q4 losses add to woes for Pa.’s

Nursing Homes 40

Nursing Homes Nurses Hospitals COVID-19 40

Hall Render

MARCH 3, 2023

Clair Health partners with Duquesne University College of Osteopathic Medicine UPMC sees lower operating income in 2022 as economic headwinds persist UPMC settles lawsuit with federal government for $8.5

Nursing Homes 40

Nursing Homes COVID-19 Nurses Hospitals 40

Hall Render

MAY 19, 2023

ProMedica taps Ascension St. operating loss in Q2 As RI legislators near session’s end, compromise on expensive proposals looks inevitable ‘It is wrong’: Charlesgate workers ask state to keep nursing home open. Utah Among Three Lowest States for Mammograms, USU UWLP Reports VERMONT Vermont State University receiving $6.3M

Nurses 40

Nurses COVID-19 Hospitals Nursing Homes 40

Drug & Device Law

NOVEMBER 1, 2022

Punitive damages also failed as a matter of law under Arizona’s compliance defense. It is undisputed here that the filter received FDA approval. but Mixson II saved the best for last – rejecting plaintiff’s attempt to bar the expert “from referencing the FDA 510(k) process – or the FDA generally.” quoting Ariz.

FDA 59

FDA Fraud Licensing Governance 59

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

FDA 105

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

Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

MAY 22, 2023

The statute of repose also does not apply if the product is subject to a government-mandated, safety-related recall, so long as the plaintiff’s lawsuit is related to the reason for the recall. Fifth , the Montana law creates a qualified safe harbor for regulatory approval and compliance.

FDA 59

FDA Compliance Governance Licensing 59

Drug & Device Law

JUNE 15, 2022

It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on this Blog. Subsection (a) shall not be construed to affect the authority of a State, Tribal, or local government—. “(1) b) Exceptions.—Subsection b) Exceptions.—Subsection

FDA 52

FDA Governance Licensing Compliance 52

Drug & Device Law

JULY 26, 2023

2018), holding (as discussed here ) that New Jersey multi-county mass-tort litigation will henceforth be governed exclusively by New Jersey law, no matter where the plaintiff resided. 22, 2015) (admitting §510(k) compliance in pelvic mesh case under North Carolina law). 3d 503, 523 (N.J. at 523-24. See Winebarger v. Lohr , 518 U.S.

Compliance 52

Compliance FDA Licensing Governance 52