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

Hall Render

MAY 20, 2022

FDA Bill Includes Medical Device Security Requirements For Manufacturers. Brigham and Women’s gets FDA warning for drug manufacturing. Michigan suspends contact tracing contract as COVID cases surge. Medicare fraud. to settle billing fraud claims. COVID-19 public health emergency set to be extended.

COVID-19 40

COVID-19 Nursing Homes Nurses Hospitals 40

Hall Render

FEBRUARY 18, 2022

Meet new FDA chief Dr. Robert Califf: 5 things to know. Florida physician convicted of $110M fraud. billing fraud. 3 Texas medical labs charged in $300M fraud scheme. Wisconsin COVID-19 app popular, but close contact use unclear. Hospitals urge HHS to fix, not end, direct contracting model. 7 ASC moves in Florida.

COVID-19 40

COVID-19 Nursing Homes Nurses COVID-19 Vaccine 40

Hall Render

JUNE 9, 2023

New, 96-bed psychiatric hospital to meet ‘growing’ behavioral health need New $14.6M to lure Amedisys away from Option Care merger Optum makes surprise $3.2B

Nurses 40

Nurses COVID-19 Nursing Homes Hospitals 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.) For data reporting, Diameter Health improved lab data to adhere to standard and interoperable formats.

Public Health 102

Public Health COVID-19 FDA Governance 102

Hall Render

JUNE 3, 2022

Colorado hospital first to implant FDA approved stent. Monkeypox vaccine offered to close contacts of patient at Massachusetts General Hospital. Justice Department says sweeping lab test fraud in Texas involved dozens of doctors and front companies. Bakersfield Rehabilitation Hospital Opens in Bakersfield, California.

COVID-19 40

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

Hall Render

JANUARY 7, 2022

FDA expands use of Pfizer vaccine, green-lights boosters for children 12-15. Empower Healthcare to pay $1 million penalty in Medicaid fraud settlement. fraud case in Arkansas. Number of COVID Patients in CT Hospitals Grows, Healthcare Workers Contacting Virus. fraud case in Arkansas. Former N.J. Former N.J.

COVID-19 40

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

Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. 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. Iowa surgical group pays $612K to resolve fraud allegations. MISSISSIPPI.

Nursing Homes 40

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

C&M Health Law

JANUARY 25, 2023

For more information, or to better understand how the Act impacts your organization, please contact the professionals listed below, or your regular Crowell & Moring contact. hospitalizations and emergency department visits) and to audit Medicare claims to assess potential fraud.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Hall Render

MARCH 11, 2022

FDA final guidance presses industry to be ‘recall ready’ Final vaccine mandate deadlines still in play, despite removal vote. Kentucky clinic owner sentenced to 10-plus years for fraud. 12 physicians sentenced to prison for $250M billing fraud. New Jersey physician convicted in multimillion-dollar fraud scheme.

COVID-19 40

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

Drug & Device Law

MARCH 2, 2022

That is a different condition, the product is different, the science is different, and the FDA regulatory story is different. There might have been other cases in which a patient did have direct contacts and some sort of special relationship of trust with a manufacturer, but nobody said that happened in the Dupere case.

Fraud 80

Fraud FDA 80

Drug & Device Law

MARCH 19, 2024

Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Therefore, plaintiff’s claims could not possible “arise out of or relate to” that defendant’s contacts with Rhode Island. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements.

FDA 52

FDA Fraud Doctors Governance 52

Drug & Device Law

FEBRUARY 14, 2024

In 2017, the plaintiff sued his eye doctor professionals and the manufacturer of contact lenses, claiming that the lenses caused him to suffer serious injuries, including vision loss. Nor did the plaintiff identify particular Ohio state-law duties that parallel any FDA requirement. Pleas Feb. Made necessary more indignant blogposts?)

FDA 52

FDA Fraud Doctors 52