Hall Render

JANUARY 4, 2023

Mayo Alao (Denver/Indianapolis offices) practices in the area of health care law with a focus on hospital and health system matters, regulatory and compliance issues, corporate transactions and hospital/physician alignment. James Junger (Milwaukee office) focuses his practice on pharmacy and health care compliance issues.

Fraud 40

Fraud Compliance Hospitals 40

Health Law RX

JANUARY 31, 2023

In such cases, a defendant is typically accused of falsely attesting to compliance with conditions of payment or other requirements under government programs. The concept of intent – known legally as “scienter” – has proven to be difficult in FCA cases involving allegations of “legal falsity.” of America v. Burr , 551 U.S.

Governance 52

Governance Fraud Compliance 52

HIPAA Journal

MARCH 10, 2022

In 2007, the Reporters Committee for the Freedom of the Press published a Guide to Medical Privacy Law. Therefore, we have highlighted a few of the most common exceptions and recommend Covered Entities seek professional compliance advice to identify others that may be relevant to their specific circumstances.

HIPAA 75

HIPAA Compliance Public Health Hospitals 75

Health Law Advisor

AUGUST 14, 2023

1] With the end of the PHE having occurred over three months ago, that temporary waiver of sanctions ended and can no longer be relied upon for legal compliance with the Stark Law. [2] 5, 2007) (emphasis added). [5] 4] and (B) each such physician (not their staff) personally perform all DMEPOS Supplier requirements. [5] 2, 2023). [2]

COVID-19 52

COVID-19 Medicare Medicare Public Health 52

HIT Consultant

AUGUST 18, 2021

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA. Ronan Brown is SVP and Head of IQVIA Integrated Global Compliance, where he connects IQVIA’s global partners with high-tech solutions to manage their compliance challenges. The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools.

COVID-19 52

COVID-19 COVID-19 Vaccine Pharmaceutical Industry FDA 52

Hall Render

JUNE 7, 2023

47 (2007), the U.S. Thus, it’s important to seek legal counsel to resolve concerns about statutory or regulatory non-compliance. 47, 70 (2007). [10] 7] This decision corrects several circuit courts’ application in the FCA context of an objective scienter standard borrowed from the Fair Credit Reporting Act (“FRCA”) context. [8]

Fraud 40

Fraud Medicaid Medicaid Governance 40

Medisys Compliance

JULY 29, 2022

As per CMS-Ruling 1536-R, effective for services on and after January 22, 2007, Medicare will allow beneficiaries to pay additional charges (which are non-covered by Medicare as these additional charges are not part of a Medicare benefit category) for insertion of an astigmatism correcting intraocular lens (AC-IOL).

Medicare 52

Medicare Medicare Medical Billing Medical Billing Outsourcing 52

Health Law RX

JUNE 2, 2023

Given the now enhanced role that evidence of subjective knowledge will play in defending FCA claims, clients should take this opportunity to evaluate the role that counsel plays in compliance decisions. 1] United States ex rel. SuperValu Inc. , 21-111, 2023 WL 3742577 (U.S. June 1, 2023). [2] 2] 31 U.S.C.A. 3] Safeco Ins. of America v.

Fraud 52

Fraud Governance Medicaid Medicaid 52

Healthcare Law Blog

APRIL 19, 2023

We will report the Court’s decision and offer guidance companies can use to strengthen their compliance and risk-management programs as appropriate. And, based on that decision, the D.C. Circuit, in a decision joined by then D.C.

Governance 52

Governance Fraud Compliance 52

Healthcare Law Blog

FEBRUARY 13, 2023

This topic always involves a legal angle, such as Stark Law or Anti-Kickback compliance, or state fraud and abuse law considerations. For many healthcare attorneys, these types of dual-purpose communications are more common than communications involving only purely “legal” advice. For example, consider physician compensation. 2014), the D.C.

Compliance 52

Compliance Fraud Governance 52

HIT Consultant

MAY 31, 2023

A study on hospital market concentration found between 2007 and 2017, one single hospital system was serving 19% of the market — 11.2 While the FTC works against anticompetitive behavior and enforces antitrust law compliance, there is still a great deal of work to be done. million Americans.

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals FDA Telemedicine 96

SQA

AUGUST 8, 2023

TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. Compliance with MoCRA requires independent judgement based upon facts of a particular situation, and this Toolkit is not intended to replace regulatory counsel to ensure compliance. TR 43 applies solely to empty glass containers.

FDA 40

FDA Compliance COVID-19 World Health 40

Innovaare Compliance

FEBRUARY 9, 2021

Launched in 2007, star ratings enable the CMS as well as consumers to compare health plans on metrics other than cost. A&G automation with single-click compliance. Acknowledgement, extension letter and determination letters are automatically generated, using pre-populated formats to ensure continuous compliance.

Medicare 40

Medicare Medicare Medicaid Medicaid 40

Hall Render

APRIL 6, 2022

In establishing these requirements, it is critical that providers work with counsel who can ensure compliance and provide validation and support to justify the reasonableness of the provider’s interpretation. SuperValu Inc., held that the scienter requirement articulated by the Supreme Court of the United States in Safeco Ins. of America v.

Medicare 72

Medicare Medicare Medicaid Medicaid 72

Health Law Advisor

FEBRUARY 1, 2022

Data on race come from the results section of the repository, which was launched in September 2008 to implement Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). It took a while to kick in, but the last four years have seen reasonably high compliance rates.

FDA 52

FDA Compliance 52

Bill of Health

MAY 5, 2022

In Mexico, the National Reproductive Rights Alliance (ANDAR) facilitated the decriminalization of abortion in Mexico City’s Legislature in 2007. Coahuila is expected to follow this path in compliance with the Supreme Court’s recent abortion ruling.

Public Health 69

Public Health Doctors Governance Compliance 69

Drug & Device Law

JULY 31, 2023

2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). 2007), held that “defective computer software may give rise to strict products liability in tort.” Buhimschi , 2007 WL 2902896, at *16 (E.D. 28, 2007), aff’d , 396 F. Henry , 2007 WL 2743097, at *2 (W.D.

Governance 52

Governance Payment Systems Hospitals Licensing 52

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. has no power to enforce compliance”), aff’d , 405 F. May 14, 2010) (“Defendant [standards institute’s] standards are voluntary, consensus standards, and Defendant. . . 471 (11th Cir.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

JANUARY 25, 2024

142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. Philip Morris Cos. ,

Medicare 52

Medicare Medicare FDA Regulatory Compliance 52