AIHC

JUNE 6, 2023

AI Use in Healthcare Research & Quality As posted in the American Institute of Healthcare Compliance (AIHC) June monthly newsletter, the Agency for Healthcare Research & Quality (AHRQ) grantee is testing AI for use to improve breast cancer screening accuracy and efficiency.

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

AIHC

JUNE 6, 2023

AI Use in Healthcare Research & Quality As posted in the American Institute of Healthcare Compliance (AIHC) June monthly newsletter, the Agency for Healthcare Research & Quality (AHRQ) grantee is testing AI for use to improve breast cancer screening accuracy and efficiency.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

Healthcare Law Today

JANUARY 11, 2023

Food and Drug Administration (FDA) prior to distribution. As part of a deferred prosecution agreement, which must be approved by the court, Jet Medical admitted that it distributed misbranded devices and agreed to implement enhanced compliance measures. and Martech Medical Products Inc., and Martech Medical Products Inc.,

FDA 59

FDA Governance Medicare Medicare 59

Innovaare Compliance

OCTOBER 6, 2022

The purpose of these audits is to evaluate a plan sponsor’s efforts to prevent, detect, and correct fraud, waste, and abuse (FWA) in the Medicare Part C and Part D programs. If you have any questions, or you’d like to discuss these changes with one of our compliance experts, please call us at 1.408.850.2235. or Contact Us.

Medicare 52

Medicare Medicare Compliance Public Health 52

Hall Render

JANUARY 11, 2023

The Tool is a result of collaborative efforts between the FTC, HHS Office for Civil Rights (“OCR”), HHS Office of the National Coordinator for Health Information Technology (“ONC”) and the Food and Drug Administration (“FDA”). Regulatory Landscape.

Compliance 40

Compliance HIPAA FDA Due Diligence 40

Health Care Law Brief

JUNE 2, 2022

For the reasons discussed below, DTC telehealth platforms should re-visit their compliance plans and be prepared for increased state and federal regulatory scrutiny. For example, the Department of Justice has aggressively pursued health care fraud claims against individuals and entities involved in non-compliant telehealth models.

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Hall Render

OCTOBER 18, 2022

Defendant pharmaceutical manufacturers applied for and received approval from the FDA to manufacture Gamunex at a facility converted for that purpose. FDA regulations require current Good Manufacturing Practices [cGMP] to be met or the drug shall be deemed adulterated and prohibited from sale. United States ex rel. at *1 & fn.

FDA 40

FDA Governance Fraud Compliance 40

Hall Render

JANUARY 3, 2024

Liza Brooks is based in the firm’s Detroit office and focuses her practice on supply chain operations, health information technology and clinical research compliance. Katherine Schwartz focuses her legal practice on fraud and abuse analyses related to the federal Stark, Anti-Kickback and Civil Monetary Penalties laws.

Fraud 40

Fraud Hospitals Compliance FDA 40

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. OIG, SAM DEA, GSA, FDA. 5,600+ Total Sources. 2,500+ State Sources.

Regulatory Compliance 52

Regulatory Compliance Medicare Medicare Medicaid 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). The introduction of the metaverse will likely exacerbate these interoperability issues.

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FDA HIPAA Medicare Medicare 90

Healthcare Law Blog

MAY 11, 2023

As part of the Arrangement, a laboratory and its parent company (the “Companies”) would provide a prepaid card, such as a Visa or Mastercard gift card, of up to $75 to certain individuals to encourage those individuals to return the sample collection kit associated with an FDA-approved colorectal cancer screening test (the “Test”).

Medicare 52

Medicare Medicare Fraud Compliance 52

Verisys

DECEMBER 1, 2022

FDA Disbarment. The goal of healthcare professionals, organizations, and others is to give patients high-quality care while safeguarding them against fraud and abuse. Other databases included in a FACIS Level 3 search. SAM ( including SDN ). Treasury Dept. State Dept.

Medicaid 52

Medicaid Medicaid Fraud Governance 52

Verisys

NOVEMBER 14, 2023

Proven software and technology which continuously monitors these sources will ensure that your healthcare organization is in compliance at all times. Verisys’ owned and maintained Fraud Abuse Control Information System (FACIS) is a provider data supersource. Department of Justice (DOJ) U.S. Treasury Department U.S.

Licensing 52

Licensing Medicaid Medicaid Governance 52

Verisys

JANUARY 18, 2022

Proven software and technology which continuously monitors these sources will ensure that your healthcare organization is in compliance at all times. Verisys’ owned and maintained Fraud Abuse Control Information System (FACIS) is a provider data supersource. Food and Drug Administration (FDA). System for Award Management (SAM).

Licensing 52

Licensing Medicaid Medicaid Governance 52

Health Law Advisor

MARCH 7, 2023

Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications? DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications. 1301.28.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

Hall Render

SEPTEMBER 1, 2023

operating margin, $1B net gain halfway through its first year Illinois public health officials warn of “rising COVID-19 activity” St. Elizabeth Medical Center to receive nearly $400k in federal funds to combat substance abuse UofL lands nearly $12 million grant from National Institute of Health Winchester physician Michael Kuduk, M.D.,

COVID-19 40

COVID-19 Nurses Nursing Homes Hospitals 40

HIPAA Journal

JANUARY 23, 2024

The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct. Holmes, along with former company president Ramesh Balwani, were charged with criminal fraud for making false claims about the company’s technology and misleading investors.

Fraud 73

Fraud FDA Medicaid Medicaid 73

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

MARCH 31, 2023

in 2022, survey finds Senate votes to end COVID-19 national emergency Why are 600+ rural hospitals at risk of closing? County-owned buildings facing potential earthquake risk Gilead drops option to buy cancer therapeutics company Health and Life Organization Inc. buys industrial property in Rancho Cordova for $5.12

US Department of Health and Human Services 40

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

Hall Render

FEBRUARY 18, 2022

Meet new FDA chief Dr. Robert Califf: 5 things to know. Only 14% of Hospitals Met Price Transparency Rule Compliance. Florida physician convicted of $110M fraud. billing fraud. Montana health facilities report vaccine compliance, with some leaving jobs. 3 Texas medical labs charged in $300M fraud scheme.

COVID-19 40

COVID-19 Nursing Homes Nurses COVID-19 Vaccine 40

Hall Render

MAY 19, 2023

SOUTH CAROLINA Grand Strand hospitals hope to see positive impact from Certificate of Need repeal McMaster signs South Carolina’s certificate of need repeal Newly-passed bill allows MUSC to move forward with delayed Nexton Hospital build Prisma Health records $31.7M million to strengthen healthcare in WV Top Doctors Named Across W.Va.

Nurses 40

Nurses COVID-19 Hospitals Nursing Homes 40

Hall Render

DECEMBER 29, 2023

Here’s how to find quality care CEOs turn attention from recovery to growth ARKANSAS Statistics show many northern Arkansas locations considered maternity care deserts How broadband expansion is bolstering rural healthcare Arkansas leaders work to close gap between medical school graduates and in-state residencies Program in south Arkansas provides (..)

Nursing Homes 40

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

Hall Render

MARCH 8, 2024

What it’s saying — and not saying Idaho committee passes Medicaid extension for postpartum care Foundation opens fast-track grant cycle for rural health ILLINOIS 20 IL Hospitals Ranked Among The Best In The World: Report 4 hospitals with uncertain futures Attune Medical acquired by Massachusetts-based Haemonetics for $160 million Chicago building with (..)

Nursing Homes 40

Nursing Homes Nurses Hospitals COVID-19 40

Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. Where Hospital Price Transparency Compliance Is Lagging. FDA finalizes two guidances on including patient perspectives in medtech clinical trials. Federal officials arrest nursing home owner charged with more than $3M in Arkansas Medicaid fraud.

Nursing Homes 40

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

Hall Render

MARCH 24, 2023

Reeves’ desk. Here’s what they are.

Nursing Homes 40

Nursing Homes Nurses COVID-19 Hospitals 40

Hall Render

SEPTEMBER 29, 2023

million into USF Health’s new nursing simulation lab UF Health to open ER in former Lake County CVS Nurse Practitioner Convicted of $200M Health Care Fraud Scheme Florida joins 3 other states in adopting new, paid maternity leave for state workers GEORGIA Albany nonprofit addresses medical debt with D.C. officials, helps South Ga.

US Department of Health and Human Services 40

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

Hall Render

MARCH 22, 2024

Banner Health to expand clinical AI to 33 hospitals, 6 states Banner reports $282.8M family sues hospital over life-altering injuries Calif. 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

C&M Health Law

JANUARY 25, 2023

hospitalizations and emergency department visits) and to audit Medicare claims to assess potential fraud. The Act also contains provisions eliminating the opt-out for non-federal governmental health plans for mental health parity requirements and ensuring compliance with mental health and substance use parity requirements.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Hall Render

FEBRUARY 16, 2024

medical office sale in Bridgewater Low pay in primary care is leading to a care crisis in New Jersey N.J. hospitals are offering higher pay, flexible hours, and even child care to retain workers, survey finds St.

US Department of Health and Human Services 40

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

Drug & Device Law

MAY 24, 2022

In both New Jersey and Florida, there is a strong presumption against punitive damages in drug and device cases where there’s been regulatory compliance. In response to the summary judgment motions, plaintiff abandoned 11 of those claims including various strict liability, fraud/misrepresentation, and warranty claims. See Fla Stat.

FDA 52

FDA Regulatory Compliance Compliance Fraud 52

Drug & Device Law

NOVEMBER 1, 2022

Since the learned intermediary rule applies to misrepresentation and fraud claims – and plaintiffs did not claim any personal reliance – those claims also failed on causation grounds. Punitive damages also failed as a matter of law under Arizona’s compliance defense. It is undisputed here that the filter received FDA approval.

FDA 59

FDA Fraud Licensing Governance 59

Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Monsanto Co. ,

FDA 105

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

Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. has no power to enforce compliance”), aff’d , 405 F. Such power rests solely with the FDA.”

Doctors 52

Doctors Fraud Licensing Compliance 52

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 this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue.

FDA 52

FDA Compliance Fraud Hospitals 52

Drug & Device Law

JANUARY 23, 2023

As the court explained, there is a “narrow” exception for so-called “parallel” claims – claims that are based on violation of an FDA requirement, not on state requirements that are “different from, or in addition to,” the federal ones. In other words, “where a. if the plaintiff can link the alleged violation to her alleged injury.

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FDA Fraud Doctors Governance 111

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. Ortho-McNeil-Janssen Pharms.,

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FDA Fraud Compliance 64