Health Care Law Brief

APRIL 11, 2022

For example, in October, 2008 , the OIG allowed a non-profit organization that provides outpatient treatment services for patients with psychoactive substance abuse dependence to offer incentives in the form of $5–$10 gift cards to motivate those patients to adhere to their treatment plans, which include urine drug screening and counseling sessions.

Fraud 52

Fraud Medicare Medicare Compliance 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

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

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

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

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