Healthcare Law Blog

FEBRUARY 1, 2022

In the attached article , we highlight some of the key legal considerations that the digital health industry can expect in the coming year from the perspective of: (1) telehealth related laws and regulations, (2) FDA, (3) privacy and cybersecurity, (4) fraud and abuse, and (5) antitrust issues.

Fraud 52

Fraud FDA Governance HIPAA 52

Hall Render

MAY 28, 2024

With a deep understanding of the complexities of this field, Jemalyn works with health systems, hospitals, large physician practice groups and other health care organizations to navigate a broad range of strategic and operational issues including fraud and abuse, FDA compliance and corporate governance.

Fraud 40

Fraud FDA Governance Compliance 40

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

MedTrainer

JANUARY 12, 2024

Healthcare compliance is the process of following the laws, regulations, and ethical standards that govern the healthcare industry. Department of Health and Human Services focuses on preventing fraud, abuse, and waste in federal healthcare programs. What is Healthcare Compliance?

Compliance 52

Compliance Fraud Medicaid Medicaid 52

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 30, 2022

Maintaining compliance and safeguarding against fraud and abuse in today’s changing healthcare landscape can be challenging. OIG, SAM DEA, GSA, FDA. Learn more about how Verisys can assist your HCOs in meeting all government and regulatory standards. 5,600+ Total Sources. 2,500+ State Sources. FBI, PHS, ORI, DOJ, TRICARE.

Medicare 52

Medicare Medicare Regulatory Compliance Medicaid 52

Health Blawg

JANUARY 30, 2018

But untold billions are lost to waste, fraud and abuse. Related Stories FDA and Digital Health Regulation Texting patient information – The latest from CMS Rasu Shrestha, UPMC and Healthcare Innovation – Harlow On Healthcare. But untold billions are lost to waste, fraud and abuse. It was the best of times.

Fraud 113

Fraud Telemedicine FDA Governance 113

Health Populi

SEPTEMBER 8, 2021

The Pew Trusts recently discussed prospects for the FDA to regulate AI in health care. In the Progressive Era (from 1890 to 1920), regulation was focusing on preventing consumer fraud and in the case of food, preventing manufacturers from substituting sand for sugar, for example.

FDA 71

FDA Governance Fraud World Health 71

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

Therefore, a telehealth platform operating in all 50 states will, for example, need to comport with the laws governing corporate formation, provider licensure, scope of practice, and telehealth encounters in all 50 states. 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

Compliancy Group

AUGUST 14, 2023

Regulatory compliance in the healthcare industry plays a crucial role in patient safety, maintaining quality standards, and preventing fraud and abuse. Healthcare organizations are subject to numerous regulations that govern their operations, ranging from privacy and security requirements to billing and coding guidelines.

Regulatory Compliance 52

Regulatory Compliance Compliance Compliance Officers Fraud 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

AIHC

JUNE 6, 2023

Due-diligence is necessary to ensure their system has been tested, is compliant to government and payer standards and is affordable moving forward as AI evolves and our system or contract service with the company advances. AI technology would empower these professionals. Beware of new companies offering such services.

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

AIHC

JUNE 6, 2023

Due-diligence is necessary to ensure their system has been tested, is compliant to government and payer standards and is affordable moving forward as AI evolves and our system or contract service with the company advances. AI technology would empower these professionals. Beware of new companies offering such services.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

Health Blawg

JANUARY 30, 2018

But untold billions are lost to waste, fraud and abuse. Related Stories FDA and Digital Health Regulation Texting patient information – The latest from CMS HealthBI’s Scott McFarland says Step Away From the Fax Machine — Harlow on Healthcare. But untold billions are lost to waste, fraud and abuse. Stay tuned.

Fraud 60

Fraud Telemedicine FDA Governance 60

Health Blawg

JANUARY 30, 2018

But untold billions are lost to waste, fraud and abuse. Related Stories FDA and Digital Health Regulation Texting patient information – The latest from CMS HealthBI’s Scott McFarland says Step Away From the Fax Machine — Harlow on Healthcare. But untold billions are lost to waste, fraud and abuse. Stay tuned.

Fraud 60

Fraud Telemedicine FDA Governance 60

Health Blawg

JANUARY 30, 2018

But untold billions are lost to waste, fraud and abuse. Related Stories FDA and Digital Health Regulation Texting patient information – The latest from CMS HealthBI’s Scott McFarland says Step Away From the Fax Machine — Harlow on Healthcare. But untold billions are lost to waste, fraud and abuse. Stay tuned.

Fraud 60

Fraud Telemedicine FDA Governance 60

Health Blawg

JANUARY 30, 2018

But untold billions are lost to waste, fraud and abuse. Related Stories FDA and Digital Health Regulation Texting patient information – The latest from CMS Rasu Shrestha, UPMC and Healthcare Innovation – Harlow On Healthcare. But untold billions are lost to waste, fraud and abuse. It was the best of times.

Fraud 60

Fraud Telemedicine FDA Governance 60

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 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. Troubled NC nursing home set to lose nearly all its government funding — and patients. Government watchdog: Health care giants improperly denied Medicare benefits. HHS awards $16.3M

COVID-19 40

COVID-19 Nurses 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.) The government could do that because they had a centralized patient data system and could reliably identify patients.

Public Health 116

Public Health COVID-19 FDA Governance 116

Hall Render

MARCH 11, 2022

FDA final guidance presses industry to be ‘recall ready’ Final vaccine mandate deadlines still in play, despite removal vote. Kansas panel backs bill to limit government officials’ authority over masking, religion. Kentucky clinic owner sentenced to 10-plus years for fraud. COVID-19 funding is tapped out, HHS says.

COVID-19 40

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

Hall Render

JUNE 21, 2024

To Settle Telehealth Fraud Accusations State Health Dept, Hospital Association Honor Yale New Haven Hospital D.C. NATIONAL 50% of U.S. to buy property. Supreme Court weighs future of ER abortions Flinn Foundation report identifies bioscience growth areas for Phoenix metro Medical center office building in Chandler sells for $7.3

US Department of Health and Human Services 40

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

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

Hall Render

OCTOBER 25, 2024

They aren’t crazy about the alternative, either FDA outlines new Drug Supply Chain Security Act exemptions Healthcare executive pay rises 4.6% NATIONAL 3 federal moves to address rural healthcare gap 340B purchases hit $66.3B

Nursing Homes 40

Nursing Homes Nurses Hospitals Doctors 40

Hall Render

SEPTEMBER 20, 2024

See details Mississippi State Medical Association names new president A Decade of Dedication: Enhancing Perinatal Outcomes in Mississippi Mississippi program aims to connect jailed people to mental health services MISSOURI 3 health systems see workforce gains in partnerships Ascension posts $1.8B

US Department of Health and Human Services 40

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

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. Practical Implications.

FDA 130

FDA Governance Fraud Licensing 130

Hall Render

MAY 10, 2024

Million CALIFORNIA California hospital dismisses CEO California physician pleads guilty to $2.5M million expansion ‘Very, very unusual.’ Health Policy Commission still missing key document in Steward sale to Optum Local obesity drug developer lands deal worth up to $600M with Novo Nordisk Mass.

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Hall Render

OCTOBER 6, 2023

government grant for maternal health care Alabama slides to 50th on nursing home and long-term care report card Ascension sells Alabama hospital Ascension 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

government grant for maternal health care Alabama slides to 50th on nursing home and long-term care report card Ascension sells Alabama hospital Ascension 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

MARCH 31, 2023

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 in Financing for Medical Office Building in Utica, New York Jacobi hospital saw 20% of its nurses quit in 2022.

US Department of Health and Human Services 40

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

Hall Render

JUNE 7, 2024

News ranks hospitals in health equity. These hospitals earn top honors. million bird flu shots to U.S.

US Department of Health and Human Services 40

US Department of Health and Human Services Nurses Hospitals Nursing Homes 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

JUNE 3, 2022

Colorado hospital first to implant FDA approved stent. Most Oregon hospitals owe federal government for early pandemic loans. 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 17, 2025

healthcare fraud scheme New Orleans launches tool to help doctors find reproductive care drug amid tight state restrictions MAINE Owner of Woonsocket hospital expands into Maine St.

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Hall Render

FEBRUARY 10, 2023

Blue Shield of California is counting on it. million to UMass Memorial Health Care for COVID-19 costs Four Mass. million to UMass Memorial Health Care for COVID-19 costs Four Mass.

US Department of Health and Human Services 40

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