AIHC

NOVEMBER 29, 2023

As more and more potential and real fraud, waste, and abuse was uncovered in the FFS arena, it was also discovered that patient outcomes were less than stellar. Data Governance Metrics: These include metrics related to data cataloging, metadata management, and data stewardship practices.

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Healthcare IT Today

JUNE 29, 2023

Medicare Payment Resources CMS implemented an Ambulatory Payment Classification-based payment methodology in 2008. Audits, fines, repayment demands, and government program suspensions are enforcement actions. Compliance Requirements for ASC Billing ASCs can face serious penalties for not complying with regulatory changes.

Compliance 52

Compliance Medicare Medicare Medical Billing 52

Hall Render

NOVEMBER 25, 2024

Previously, OIG released voluntary compliance program guidance (“CPG”) for nursing facilities in 2000 and supplemented the CPG in 2008. The CPG was designed to encourage nursing facilities to develop and implement internal monitoring controls to assure adherence to applicable statutes, regulations and compliance program requirements.

Nurses 40

Nurses Compliance Compliance Officers Medicare 40

Health Law Advisor

MARCH 7, 2023

Background on the Ryan Haight Act The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. 18 U.S.C. § Will DEA suggest through its guidance any guardrails for the industry to consider?

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Health Law Advisor

FEBRUARY 10, 2023

Lowest Total Recoveries Since 2008 Record-Shattering Number of New Cases Filed Health Care and Life Sciences Cases Continue to Dominate On February 7, 2023, the U.S. The total recoveries in fraud cases brought with respect to the health care and life sciences industries fell to the lowest level since 2009. Last year, $1.2

Fraud 52

Fraud COVID-19 Governance Medicaid 52

Health Law Advisor

MARCH 1, 2023

States and the federal government have been taking sides on the ability of pharmacies to dispense mail-order medications used for abortion. Once signed into law, the effect of H.B. an online questionnaire; []an email message; or []a patient-generated medical history. 152 , amending Utah Code § 26-60-103.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

Drug & Device Law

SEPTEMBER 18, 2023

312 (2008). So, if a plaintiff contends that a defendant abused the ASR program, that is a Buckman -preempted fraud on the FDA claim. Conversely, violation claims involving the ASR program are paradigmatic examples of agency fraud/private FDCA enforcement that are impliedly preempted by Buckman. 2d 381 (Pa. Medtronic, Inc. ,

FDA 59

FDA Fraud Governance Compliance 59

Drug & Device Law

JULY 18, 2023

312 (2008). But calling it design defect based on a failure to disclose doesn’t change the fact that this is really a fraud-on-the-FDA claim which is impliedly preempted by Buckman. at *46-47. “[I]t is for the federal government to prosecute suites for noncompliance with the MDA—not private plaintiffs.” Medtronic, Inc. ,

FDA 52

FDA Fraud Governance 52

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 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. Kent , 552 U.S. Albrecht , 139 S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

OCTOBER 10, 2022

3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. , 2022) (presuming that commission based compensation violates the AKS, while affirming dismissal for failure to plead fraud with the requisite particularity); United States v.

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 52