FDA Law

AUGUST 4, 2022

That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability. Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. Pfizer appealed to the Second Circuit.

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law

NOVEMBER 6, 2022

Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. At the center of Pfizer’s argument is whether an AKS violation requires corrupt intent. Background.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law

OCTOBER 24, 2023

Firm-generated communications must meet the general recommendations in the Draft Guidance and “should be truthful, non-misleading, factual and unbiased and provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the presented information.”

Clinic 64

Clinic Clinical Practice Provider Utilities 64

GeriPal

JULY 19, 2024

Summary Transcript Summary The US Preventive Services Task Force (USPSTF) concluded back in 2000 that there is insufficient evidence to recommend for or against routine screening for dementia in older adults. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

Screening 120

Screening Primary Care Patient-Centered IT 120

FDA Law

FEBRUARY 2, 2023

While these changes to the IND and the biosimilarity provisions represent real changes to the words governing FDA’s authority under the FD&C Act, we think it is worth asking just how measurable and immediate an impact they will have on day-to-day decision-making of the FDA and its review staff.

Clinic 64

Clinic IT Utilities Government 64

FDA Law

JULY 17, 2022

Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law

JUNE 27, 2024

The government’s expert testified that any red flag associated with a controlled substance prescription must be resolved and that resolution documented before dispensing. By Larry K. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). make a record of its resolution, assuming it is resolvable.”

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36 Million to Settle Claims of Controlled Substance Act Violations (June 8, 2022). 4, 2022).

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law

NOVEMBER 15, 2022

Any application from a State or Federal Government entity. One-time first submission fee waiver for a small business with gross receipts of sales $30 million or less. Exempt from any fee unless the device is to be distributed commercially. Exempt from any fee unless the device is to be distributed commercially. Not eligible. Not eligible.

Medical 59

Medical Provider IT Manufacturing 59

FDA Law

MARCH 20, 2022

FDA has model recall communication templates available here that firms can utilize. Walsh — All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field. Almost all recalls are conducted on a voluntary basis by the manufacturer.

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law

JUNE 16, 2023

Importantly, “price increase” is not defined in this statute. It appears not to mean a WAC increase, because the term WAC is specifically used in defining the price increase triggers, but not in reference to the manufacturer’s price increase. If a price increase is not an increase in WAC, its meaning is unclear. Is it an increase in AWP/SWP?

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.” GSK skinny label case , the U.S.

Government 72

Government Manufacturing IT Utilities 72

FDA Law

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). It has been a long, strange trip ever since.

Lab Testing 98

Lab Testing Government IT Manufacturing 98

GeriPal

JANUARY 20, 2023

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. He’s a geriatrician and Chair of Public Policy for the California Association of Long-Term Care Medicine. Welcome back to the GeriPal podcast, Mike. I hope I got that right. Mike: You got it right.

Finance 95

Finance Board-Certified IT Provider 95

PEMBlog

MAY 24, 2023

This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. Government. It is also episode 2 in a 5 episode series focused on agitation in children and adolescents.

Management 54

Management Patient-Centered Physicals Finance 54

FDA Law

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Sheldon, v.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law

SEPTEMBER 6, 2021

Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. The catch is, as we have learned from the GSK v. Until recently, there hasn’t been a need for such a safe harbor, as Courts have not found inducement to infringe in this context, but the GSK v.

IT 52

IT Provider ER Insurance 52

GeriPal

JULY 6, 2023

Summary Transcript Summary You may have heard of Area Agencies on Aging, but do you really know what they do or how they do it? What about State Departments of Aging or state master plans for aging? Do you know how these agencies fit in with programs like Meals-on-Wheels or other nutritional support programs? Susan: It is my anthem.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

JUNE 26, 2025

And the government can do something about that?!? Tsai-Chin’s article, published in Lancet Healthy Longevity, found a tantalizing hint that countries with stronger safety nets had lower incidence of wealth shocks, and less of a deleterious impact of the wealth shock on cognitive function. This is Eric Widera. Alex 00:12 This is Alex Smith.

Illness 60

Illness Hospital IT Patient-Centered 60

FDA Law

AUGUST 14, 2022

With one recent and minor exception (see our blogpost here ), all of the government discount and rebate programs heretofore have been founded on agreements between the government and manufacturers. Manufacturers receive no benefits in exchange for the inflation rebates.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

GeriPal

DECEMBER 21, 2023

Summary Transcript Summary We’ve talked a lot about comprehensive dementia care on the GeriPal podcast but while the evidence is clear that these programs work, the uptake has been limited largely because there hasn’t been a strong financial case for it. It requires a fight. It’s been going on for many decades now. Malaz: I love it.

Patient-Centered 126

Patient-Centered IT Families Family 126

FDA Law

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. Subtitle E is a slightly modified version of H.R. 3, the Elijah E. The AIM price is the volume-weighted average price of the drug in Australia, Canada, France, Germany, Japan, and the U.K.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

GeriPal

JULY 20, 2023

Before we do, I think, Joe, you have a song request for Alex. Joe: I do. I would like to hear Space Oddity and it’s because I can’t imagine being more lonely and isolated than being in a tin can orbiting around the earth by myself and just how comforting it is even to hear that scratchy little voice from ground control. Joe: Right.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

Doctors for America

APRIL 29, 2025

We hope that Commissioner Makary will utilize his experience to help ensure FDA puts patients over politics throughout his tenure. Both Secretary Kennedy and Commissioner Makary have proposed strategies to mitigate the “revolving door” between the government and the industries they regulate.

Medical Student 52

Medical Student Patients Medical Individual 52

FDA Law

SEPTEMBER 13, 2021

Medicare negotiation authority; encourage biosimilars and generic drug utilization). Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. Last Thursday, the U.S. The actual policy proposals read like a wish list.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98