Bill of Health

MARCH 25, 2022

Biomarker qualification at the European Medicines Agency: a review of biomarker qualification procedures from 2008 to 2020. Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. A full posting of abstracts/summaries of these articles may be found on our? 2022 Feb 9.

FDA 205

FDA COVID-19 Medicaid Medicaid 205

Innovaare Compliance

MARCH 1, 2022

The monthly premium for Medicare Part B rose 14.5%, from $148.50 By law, the Medicare Part B monthly premium must equal 25% of the estimated total Part B costs for enrollees age 65 and over. [1] By law, the Medicare Part B monthly premium must equal 25% of the estimated total Part B costs for enrollees age 65 and over. [1]

Medicare 52

Medicare Medicare Overpayments Overpayment 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. § Are the proposed record-keeping obligations reasonable and/or sufficient? 1301.28.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Healthcare IT News - Telehealth

MARCH 18, 2022

Companies like Pear Therapeutics, Limbix, Applied VR and Click Therapeutics are treating people with clinically validated and FDA-approved (or pending) digital interventions. Fortunately, government, investors and startups are working together to close some of these care gaps.

Medicaid 199

Medicaid Medicaid COVID-19 Telemedicine 199

Drug & Device Law

OCTOBER 10, 2022

The manufacturer sought to cover Medicare patients’ Part D cost-sharing obligations for the drug – which were estimated at approximately $13,000 per year – but the OIG said “no thanks,” and the Second Circuit has affirmed that outcome. That being said, Medicare does not cover the entire cost of the drug. 1320a-7b (“AKS”).

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 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. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

MARCH 31, 2022

The Orthopedic Bone Screw would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product. Thus, we were pleased that the Medicare recipient in Dobson v. 1396r-8(k)(6).

Medicare 52

Medicare Medicare FDA Governance 52