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

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

C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

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.

FDA 90

FDA HIPAA Medicare Medicare 90

Verisys

DECEMBER 1, 2022

A check of government exclusion lists is essential because many healthcare groups receive financing from federal sources. FDA Disbarment. The goal of healthcare professionals, organizations, and others is to give patients high-quality care while safeguarding them against fraud and abuse. SAM ( including SDN ). Treasury Dept.

Medicaid 52

Medicaid Medicaid Fraud Governance 52

Verisys

NOVEMBER 14, 2023

A healthcare facility’s accountability and overall reputation are dependent upon rigorous credentialing processes compliant with governing regulatory bodies, such as the National Committee for Quality Assurance. Verisys’ owned and maintained Fraud Abuse Control Information System (FACIS) is a provider data supersource.

Licensing 52

Licensing Medicaid Medicaid Governance 52

Verisys

JANUARY 18, 2022

A healthcare facility’s accountability and overall reputation are dependent upon rigorous credentialing processes compliant with governing regulatory bodies, such as the National Committee for Quality Assurance. Verisys’ owned and maintained Fraud Abuse Control Information System (FACIS) is a provider data supersource.

Licensing 52

Licensing Medicaid Medicaid Governance 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. Once signed into law, the effect of H.B. 152 , amending Utah Code § 26-60-103.

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

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 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

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 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

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

Hall Render

MAY 19, 2023

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 West Virginia Gov.

Nurses 40

Nurses COVID-19 Hospitals Nursing Homes 40

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) (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. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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. Furthermore, trade associations often serve to assist the government in areas that it does not regulate.

Doctors 52

Doctors Fraud Licensing Compliance 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.

FDA 111

FDA Fraud Doctors Governance 111

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

FDA 59

FDA Fraud Governance Compliance 59

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

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. Plaintiff was missing any “indicia of fraud, wrongdoing, domination, misuse, or subversion of corporate formalities. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements.

FDA 52

FDA Fraud Doctors Governance 52