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

MedTrainer

APRIL 22, 2024

While adherence to these guidelines is voluntary, organizations implementing effective compliance programs are better equipped to identify and address potential compliance risks, mitigate fraud and abuse, and uphold the integrity of healthcare programs and services.

Compliance 52

Compliance HIPAA Licensing Fraud 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”). The Tool does not present a comprehensive list of laws and regulations that may apply to mobile health apps.

Compliance 40

Compliance HIPAA FDA Due Diligence 40

Healthcare Law Blog

MARCH 17, 2022

Like these other AOs, OIG found that while the Proposed Arrangement could generate fraud and abuse risks under both the Federal anti-kickback statute (i.e., Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented.

US Department of Health and Human Services 52

US Department of Health and Human Services Informed Consent Medicare Medicare 52

Health Care Law Brief

JUNE 2, 2022

Variety of Risks Present in Telehealth Arrangements. The severity and type of risk present in a telehealth business will vary—by jurisdiction, by provider type, by service offering, and by payor mix. If so, how will patient fees be structured to comport with these restrictions? Provider Licenses.

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Bill of Health

SEPTEMBER 29, 2022

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. Background Context.

FDA 130

FDA Governance Fraud Licensing 130

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1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via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. Utah Code § 58-83-305.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 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.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Healthcare Law Blog

MARCH 8, 2023

Food and Drug Administration (“FDA”) approved only a single manufacturing facility, which is located on the campus of the “Treatment Center.” Requestor does not have and would need FDA approval to transport the Drug to other treatment facilities aside from the Treatment Center.

FDA 52

FDA Doctors Medicaid Medicaid 52

Hall Render

MAY 13, 2022

FDA limits J&J COVID-19 vaccine due to rare blood clot risk. Prism pays $650K to settle Medi-Cal fraud claims filed in San Diego. ‘So much is new’: ScionHealth launch presents wealth of opportunities, CFO says. 340B hospitals amplify loss projections as more drugmakers unveil restrictions. HHS awards $16.3M

COVID-19 40

COVID-19 Nurses Nursing Homes Hospitals 40

Hall Render

DECEMBER 1, 2023

fraud scheme Nursing home must face vaccine-related wrongful firing claim, but not $2M retaliation accusations Transgender woman sues employer, Harvard Pilgrim for discrimination MICHIGAN 48-unit senior housing development could go up next to Vicksburg Halls in Marysville Can ads help a Michigan nursing home fix a staffing crisis?

Nursing Homes 40

Nursing Homes Nurses Ransomware 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

MARCH 25, 2022

FDA to revive facility visits. Moderna wants the FDA to authorize its COVID-19 vaccine for kids under 6. 2 sentenced for $48M medical reimbursement account fraud scheme. lawmaker presents plan to improve women’s healthcare. Massachusetts Doctor Faces Health Care Fraud Charges. fraud scheme against payers, patients.

COVID-19 40

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

Hall Render

FEBRUARY 18, 2022

Meet new FDA chief Dr. Robert Califf: 5 things to know. Florida physician convicted of $110M fraud. Lack of ICU doctors presents challenges for healthcare in Idaho. billing fraud. 3 Texas medical labs charged in $300M fraud scheme. Hospitals urge HHS to fix, not end, direct contracting model.

COVID-19 40

COVID-19 Nursing Homes Nurses COVID-19 Vaccine 40

Hall Render

JUNE 9, 2023

High-level nursing officer from Houston hospital joins Baptist Memorial Hospital for Women Siloam Health names Katie Richards permanent CEO Upperline Health closes $58.35

Nurses 40

Nurses COVID-19 Nursing Homes Hospitals 40

Hall Render

OCTOBER 6, 2023

federal contract to help school mental health workers WYOMING Wyoming Hospital Association presents inaugural Healthcare Leadership Awards Sheridan hospital board celebrates success of Wyoming Regional Emergency Medical Service St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

US Department of Health and Human Services 40

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

Hall Render

OCTOBER 6, 2023

federal contract to help school mental health workers WYOMING Wyoming Hospital Association presents inaugural Healthcare Leadership Awards Sheridan hospital board celebrates success of Wyoming Regional Emergency Medical Service St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

US Department of Health and Human Services 40

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

Hall Render

FEBRUARY 2, 2024

continues crackdown on nursing homes, 2 more cited for poor care and ‘massive fraud’ Wow! Inman College of Nursing FDA clears Collierville startup CircumFix’s medical device for surgery, marketing FTC opposes Novant Health’s $320M hospital deal with Community Health Systems HCA CFO to retire HCA nets $5.2B

Nursing Homes 40

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

Hall Render

DECEMBER 8, 2023

CT presents draft settlement in YNHH-Prospect hospitals sale Mandell-Braunstein family gifts $2.5M ’s Vanda Pharmaceuticals scores FDA review of key drug after multiyear battle D.C.’s CT presents draft settlement in YNHH-Prospect hospitals sale Mandell-Braunstein family gifts $2.5M NATIONAL 8.5M NATIONAL 8.5M

US Department of Health and Human Services 40

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

Healthcare IT Today

FEBRUARY 28, 2023

(President Biden, in his State of the Union speech, warned “we remain vigilant” while calling for an end to the emergency, but quickly switched the subject from the urgency of public health to prosecuting fraud.) Pinho called for real-time decision making as well.

Public Health 101

Public Health COVID-19 FDA Governance 101

Hall Render

JULY 29, 2022

Testing the Limits: How a Covid-19 testing company accused of sloppiness, fraud and profiteering kept expanding. COVID-19 cases rising in Oklahoma, new variant present. Portland device maker garners FDA breakthrough designation. fraud crackdown. Community Hospital of Anaconda seeks public input about health care needs.

COVID-19 40

COVID-19 Nursing Homes Nurses Hospitals 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

JULY 14, 2023

Vernon receives award to improve stroke care Health system to expand Illinois hospital after $23.5M renovation Reid Health details restructuring effort to reduce costs Cameron Hospital, Trine break ground on $10M nursing education center IOWA 26 Nursing Homes Close in the Past Year Across Iowa Groundbreaking set for new UnityPoint – St.

US Department of Health and Human Services 40

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

Hall Render

JANUARY 12, 2024

Lima FLORIDA Allstate accuses Florida clinic of billing fraud, unnecessary spine surgeries Baptist Health, Compass Surgical Partners to launch ASC network Broward Health taps former Cleveland Clinic Florida CEO Cape Coral medical office building sells for $2.2M to settle improper billing allegations COVID-19 variant JN.1

Nursing Homes 40

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

Hall Render

NOVEMBER 3, 2023

Joe’s among busiest hospital ERs in nation, poll reveals New ASC, medical building proposed in New Jersey New Jersey hospital innovation director appointed to FDA committee New Jersey hospital rebuffs criticism from US senator Nurses testify that 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

DECEMBER 4, 2023

We must apply the law of the forum as we infer it presently to be, not as it might come to be. CPAP I states that seven states’ statutes (Connecticut, Indiana, Kansas, New Jersey, Ohio, Tennessee, and Washington) all permit recovery notwithstanding a plaintiff’s lack of present detectable injury. 2023 WL 7019667, at *11-13. 341 (2001).

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

Fraud 52

Fraud FDA Doctors 52

Drug & Device Law

NOVEMBER 10, 2023

Indeed, the FDA stated, in connection with the same drug recalls that the Valsartan plaintiffs use to define their classes, 2023 WL 1818922, at *20-21: [These] medicines. . . FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. 18, 2019) (emphasis added). 2023 WL 1818922, at *36.

FDA 59

FDA Governance Fraud 59

Drug & Device Law

MAY 24, 2022

In response to the summary judgment motions, plaintiff abandoned 11 of those claims including various strict liability, fraud/misrepresentation, and warranty claims. The only evidence plaintiff offered to support her claim was a notice by the FDA that came out three years after plaintiff’s surgeries – making it immaterial.

FDA 52

FDA Regulatory Compliance Compliance Fraud 52

Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). A little background is in order. ATTR-CM only affects about 150,000 Americans, who are mostly elderly. Pfizer , 42 F.4th This is ultimately what transpired. Nicholson v.

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 52

Drug & Device Law

NOVEMBER 1, 2022

Starting with the to-be-published Mixson I , this IVC filter case presented rather complex choice of law issues because the plaintiff implantee was in the military when the surgery in question occurred, and the army sent him to Texas for treatment, even though he was a Florida resident. 2022 WL 4364153, at *2. quoting Ariz. 12-689(A)(1)).

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. Plaintiffs present no evidence that would suggest that if the [association’s expert committee] determines that an ingredient is unsafe for use, manufacturers must cease using that ingredient. Such power rests solely with the FDA.”

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

NOVEMBER 28, 2022

While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). The “reason” was “to allow for public access to data that undermines claims that plaintiffs’ experts and counsel continue to present to courts and factfinders.” 11-17 (Jan. citation and quotation marks omitted). quoting 45 C.F.R.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

JANUARY 19, 2023

Significantly, the court found that Allergan had no duty to disclose that purported “fact” because the evidence presented on summary judgment demonstrated that it was not true. The court found that Allergan had no duty to disclose that its textured breast implants had a higher incidence rate than other manufacturers’ implants.

FDA 52

FDA Fraud 52

Drug & Device Law

MARCH 4, 2022

their testimony does not present a genuine issue of medical fact.” 702; to the contrary, “expert testimony need not guarantee that a plaintiff prevail in order to be admissible.” In his negligence claim, the plaintiff asserted that, in violation of FDA regulations, the defendants did not seek FDA approval when the modified the modular hip.

FDA 59

FDA Fraud Governance 59