Hall Render

JULY 25, 2023

At first glance, different outcomes based on the same type of APP support program suggest contradictory views from the government. The settlement arose out of a case initially filed in 2015 by a whistleblower who worked at the hospital involved in the settlement. The post Mixed Signals?

Compliance 40

Compliance Hospitals Governance Doctors 40

Healthcare Compliance Blog

FEBRUARY 8, 2022

From 2015 through 2019, the pharmaceutical company that manufactures Nuedexta paid the Alabama psychiatrist more than $400,000 to make speeches about Nuedexta. Routine audits should be conducted, and the results of the audits should be reported at the compliance and ethics committee meetings and in reports to the governing body.

Nursing Homes 52

Nursing Homes Nurses Compliance Medicare 52

AIHC

NOVEMBER 6, 2023

HITECH puts a “bite” into specific elements of the HIPAA rule, such as higher penalty amounts for non-compliance. Combining the requirements of both Acts and implementing best practices will help mitigate risk suffering non-compliance consequences for violating the rules. Why HITECH? What about Artificial Intelligence?

HIPAA 59

HIPAA Compliance Governance Health Insurance 59

AIHC

NOVEMBER 6, 2023

HITECH puts a “bite” into specific elements of the HIPAA rule, such as higher penalty amounts for non-compliance. Combining the requirements of both Acts and implementing best practices will help mitigate risk suffering non-compliance consequences for violating the rules. Why HITECH? What about Artificial Intelligence?

HIPAA 52

HIPAA Compliance Governance Health Insurance 52

C&M Health Law

NOVEMBER 9, 2020

The Interim Final Rule provides these Actors with “additional flexibilities” to implement the provisions of the ONC Rule including updated compliance dates. See CMS and ONC Enforcement Deadlines Chart for more information about compliance dates for the ONC Rule. Information Blocking. Information Blocking. Conditions of Certification.

Compliance 40

Compliance COVID-19 Public Health Governance 40

Healthcare Law Blog

FEBRUARY 9, 2024

million to resolve a lawsuit filed by the system’s former Chief Compliance Officer, Ronald Sherman. Global billing or collaborative care arrangements are not per se violations of the Anti-Kickback Statute, however, there is greater fraud and abuse risk in these types of arrangements unless there is active, ongoing monitoring for compliance.

Hospitals 52

Hospitals Compliance Officers Compliance Overpayments 52

Hall Render

JUNE 1, 2022

For more than 15 years, Ritu has been an active member of AHLA and has held leadership roles consistently since 2015. Ritu also serves as the Chair of the Hospitals and Health Systems Practice Group and has been a member of the Editorial Board for the Health Care Compliance Professionals Manual since 2019.

Compliance 40

Compliance Fraud Governance Hospitals 40

Health Law Advisor

FEBRUARY 3, 2022

According to DOJ’s statistics, the government paid out $238 million to relators in FY 2021, the lowest number since FY 2008. As it relates to the health care and life sciences industries, the $452 million collected in FY 2021 is the largest recovery since FY 2015 and the second largest recovery in reported history. KEY TAKEAWAYS.

Fraud 52

Fraud COVID-19 Governance Medicare 52

Healthcare Law Blog

APRIL 19, 2023

The issue is a significant one for both the government and relators on one side, and potential defendants on the other, as False Claims Act (FCA) liability imposes treble damages and penalties exceeding $20,000 per claim as well as relators’ attorneys’ fees and costs. The Court’s questioning did not signal the likely decision.

Governance 52

Governance Fraud Compliance 52

Health Law RX

AUGUST 10, 2021

On July 21, 2021, the DOJ announced that the government settled FCA claims against the Alliance Family of Companies, LLC (“Alliance”), a national electroencephalography (“EEG”) diagnostic testing company, and Ancor Holdings LP (“Ancor”), the private equity firm that invested in Alliance. Moreover, the U.S.

Due Diligence 40

Due Diligence Compliance Governance Fraud 40

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. It is critical for hospitals and health systems to know that everyone on the staff is compliant and in good standing at all times.

Licensing 52

Licensing Medicaid Medicaid Governance 52

Provider Trust

JULY 26, 2022

She was hired at the family practice in Norcross, Georgia after serving a prison sentence for 2015 state and federal fraud and narcotics convictions related to her illegal practice as a physician’s assistant in Mississippi. Chief Compliance Officer, ProviderTrust. The Importance of Conducting License Verification and Monitoring.

Licensing 52

Licensing Fraud Compliance Nurses 52

Florida Health Care Law Firm

DECEMBER 7, 2021

Under the scheme, from June 2015 through April 2018, deceived tens of thousands of patients and more than 100 doctors in order to defraud health care benefit programs out of approximately $174 million and submit nearly a billion in fraudulent claims for payment. CLOSING THOUGHTS.

Fraud 40

Fraud Telemedicine Governance Compliance 40

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. ISO 9001:2015 (quality management). Utilization Review Accreditation Commission (URAC) accredited.

Licensing 52

Licensing Medicaid Medicaid Governance 52

SQA

JUNE 10, 2021

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

HIT Consultant

JANUARY 16, 2024

This represents significant interest by the federal government on AI. We have now entered the era of “Ethical AI” – a period of healthcare technology where our use of AI must be matched by our commitment to patient care and comport with the new standards being established by the government. New standards, for one.

US Department of Health and Human Services 124

US Department of Health and Human Services Compliance Governance 124

Compliancy Group

JANUARY 25, 2022

This is the second-largest number of records reported breached on the government site since 2015. The 2015 total included the largest single healthcare data breach on record – health insurer Anthem’s 77.8 Let’s Simplify Compliance Learn how to protect your business from breaches in our upcoming webinar!

HIPAA 98

HIPAA Ransomware Governance Fraud 98

Bill of Health

FEBRUARY 29, 2024

However, severe climate hazards coupled with institutional and structural barriers and limited government responses are challenging their ability to adapt. Around 65% of ancestral land was located within Nepal’s national parks and reserves by 2015, and many evicted Indigenous Peoples remain landless.

Informed Consent 201

Informed Consent Governance Compliance Public Health 201

HIPAA Journal

OCTOBER 5, 2022

HSCC is a private sector-led critical infrastructure advisory council of large, medium, and small health industry stakeholders, that works with government partners to identify and mitigate threats and vulnerabilities that have the potential to affect the ability of the sector to deliver healthcare services. Now that H.R.

HIPAA 113

HIPAA COVID-19 Compliance Health Insurance 113

Healthcare IT Today

OCTOBER 19, 2022

Beyond the fact that DotCom Therapy has been successfully delivering services since 2015, a review of two dozen studies in 2019 found that phone and video therapies were equally effective at treating conditions like anxiety, depression, and post-traumatic stress disorder as in-person therapy.

Medicaid 107

Medicaid Medicaid Telemedicine COVID-19 107

Healthcare IT News - Telehealth

DECEMBER 16, 2020

In March, as states were issuing stay-at-home orders, the FDA published pandemic-specific guidance for trial sponsors, institutional review boards and investigators on how to ensure the safety of their trial participants and reduce risks to trial integrity, while sustaining compliance with good clinical practice.”

COVID-19 216

COVID-19 Hospitals Doctors Health Insurance 216

HIT Consultant

NOVEMBER 29, 2022

Beyond the fact that DotCom Therapy has been successfully delivering services since 2015, a review of two dozen studies in 2019 found that phone and video therapies were equally effective at treating conditions like anxiety, depression, and post-traumatic stress disorder as in-person therapy.

Medicaid 98

Medicaid Medicaid Telemedicine Governance 98

HIPAA Journal

JUNE 28, 2022

The Government Accountability Office (GAO) has recommended that the Department of Health and Human Services (HHS) establish a feedback mechanism to improve the effectiveness of its data breach reporting process. OCR is the main enforcer of compliance with the Health Insurance Portability and Accountability Act (HIPAA).

HIPAA 87

HIPAA Compliance Health Insurance Governance 87

Exeed Regulatory Compliance

MARCH 5, 2020

-FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

SQA

FEBRUARY 15, 2023

There were seven (7) observations with respect to the following: Quality Control Department: The establishment and/or the maintenance of a data governance plan was inadequate. The inspection resulted in a non-compliant rating. The electronic system was not validated for its intended use.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Health Law RX

JULY 18, 2023

Those subject to the CMP Final Rule should consider prioritizing their compliance efforts because the OIG will begin enforcing the Rule on September 1, 2023. As context, between 2015 and 2022, the DOJ reported FCA settlements with health IT vendors in an amount exceeding $500 million. What would such collaboration look like?

Fraud 52

Fraud Compliance Medicaid Medicaid 52

Hall Render

APRIL 6, 2022

Turning to the present case, in Safeway , the relator alleged that the defendant engaged in the submission of false claims to the government when it “reported its ‘retail’ price for certain drugs as its ‘usual and customary’ price.”

Medicare 72

Medicare Medicare Medicaid Medicaid 72

Redox

DECEMBER 4, 2020

Immunization information systems (IIS) have received special focus as part of government health initiatives (Meaningful Use 1 and 2), so every state has one or more: More accurate information about the number of distinct IIS in the US: [link] — Lisa Bari (she/her/hers) (@lisabari) November 17, 2020. The government thought the same.

Public Health 52

Public Health Governance Doctors Medicare 52

Total HIPAA

AUGUST 23, 2021

A Password Manager Can Help Pave the Way to HIPAA Compliance. The HIPAA law mandates that password management be part of your HIPAA compliance plan. Dashlane’s strong security uses AES-256 encryption , which is the same standard used by the federal government to protect classified information. Password Managers and HIPAA.

HIPAA 52

HIPAA Compliance Licensing Governance 52

SQA

OCTOBER 18, 2023

In a 2015 survey, the overall prevalence of mineral supplement or vitamin use among Canadian men and women was 38% and 53%, respectively. While preparing the patient’s compliance pack, the pharmacy misinterpreted the product to contain 500 mg of Calcium Carbonate when each tablet actually contained 500 mg of elemental Calcium.

FDA 40

FDA Compliance Licensing World Health 40

SQA

AUGUST 2, 2021

ISO5356-1:2015, Anesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. ISO 17510:2015, Medical devices – Sleep apnea breathing therapy – Masks and application accessories. government agencies and the private sector to collaborate in providing Americans with timely access to pharmaceuticals.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

HIPAA Journal

MARCH 17, 2023

Considering the Health Insurance Portability and Accountability Act (HIPAA) is now in its third decade, the Privacy Rule took effect 20 years ago, and compliance with the HIPAA Security Rule has been mandatory for 18 years, there have been relatively few financial penalties over the years, with just 130 imposed by OCR to resolve HIPAA violations.

HIPAA 86

HIPAA Compliance Health Insurance Governance 86

Drug & Device Law

JULY 31, 2023

135 (Winter 2015) (citation and quotation marks omitted). 2015), held that digital files for 3D printing were not material things as required to invoke the Tariff Act of 1930. Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. 1145, 1165 n.135

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

SEPTEMBER 21, 2023

337(a) bars enforcement of a private contract that requires compliance with the FDCA. 2015 WL 2115342, at *9 (S.D. The question before the Thogus court was whether 21 U.S.C. § As a reminder, § 337(a) states that all actions to enforce the FDCA “shall be by and in the name of the United States.” 2016); Anderson v. Medtronic, Inc.

FDA 59

FDA Governance Compliance 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. The case was governed by North Carolina substantive law, and NC rejects strict liability altogether. Polansky v. UnitedHealthcare, Inc. ,

FDA 105

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

Drug & Device Law

JANUARY 30, 2023

Davidowitz , 312 U.S. Moran , 536 U.S. Dow Agrosciences LLC , 544 U.S. United States , 567 U.S. 387 (2012), immigration case, again rejected obstacle preemption as giving force to “judicially divined legislative purposes” Nothing in the text of federal immigration statutes “indicates that Congress intended enforcement. . . Maretta , 569 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

AUGUST 8, 2022

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. 2015 WL 6393869 (S.D. has no power to enforce compliance”), aff’d , 405 F.

Doctors 52

Doctors Fraud Licensing Compliance 52