GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective. Joe, your thoughts?

Screening 119

Screening Primary Care Patient-Centered IT 119

FDA Law Blog

FEBRUARY 2, 2023

Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. FDORA replaces the language in (bb) regarding animal studies with “an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc).”

Clinic 64

Clinic IT Utilities Government 64

FDA Law Blog

JUNE 27, 2024

Public Interest Factors The Controlled Substances Act provides that DEA may suspend or revoke a registration upon finding that the registrant has committed acts that would render the registration inconsistent with the public interest. The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

NOVEMBER 15, 2022

In this blog post, we provide a primer on user fees and the Small Business Program. These fees supplement the annual funding Congress provides for FDA. While the fees provide funding for a review, meeting the timeline 100% is not guaranteed and the performance goals do account for this potential. Exemptions or Waivers.

Medical 59

Medical Provider IT Manufacturing 59

FDA Law Blog

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. The Guidance provides practical guidelines for both firms and direct accounts. The Guidance emphasizes that firms need to be “recall ready.”

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law Blog

JULY 13, 2022

If the biosimilar has not been licensed and marketed within the approved delay period (either 1 or 2 years depending on likelihood of licensure), the manufacturer of the biological product must pay a rebate to the government for the lost savings due to the delay. Each product is limited to two years of delay.

IT 52

IT Manufacturing Utilities Complication 52

FDA Law Blog

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

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. Part of it’s what Mike was saying, it’s accountability as a country, as a nation and as the government. This is a problem that’s existed for decades. What are they accountable for?

Finance 95

Finance Board-Certified IT Provider 95

FDA Law Blog

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. The preamble provides an example of reporting an incorrect baseline AMP, which reduces the unit rebate amount. Sheldon, v.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law Blog

NOVEMBER 16, 2021

Medicare Part B reimburses providers for quantities of drugs packaged in single-use containers that are left over after administration and discarded. In addition, section 90004 of the Act requires manufactures of drugs sold in single-dose containers to pay refunds to Medicare for discarded Part B drugs.

Manufacturing 40

Manufacturing Utilities Management Provider 40

FDA Law Blog

SEPTEMBER 6, 2021

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. Especially now with the utility of the use code minimized. But what is a “true carve-out?”

IT 52

IT Provider ER Insurance 52

GeriPal

JULY 6, 2023

It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. The long-term care is being actually provided in the community at a much higher rate than what the formal system provides. But, what you need is a community-based game there.

Community 89

Community Nurse Practitioner Provider IT 89

FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. Manufacturers receive no benefits in exchange for the inflation rebates.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Eric: Okay.

Patient-Centered 125

Patient-Centered IT Family Families 125

FDA Law Blog

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

FDA Law Blog

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. Subtitle E is a slightly modified version of H.R.

Manufacturing 52

Manufacturing Insurance Government Patients 52

GeriPal

JULY 20, 2023

What was life for you as a provider pre-pandemic? We were the highest utilizers of telemedicine in the whole UCSF health system at that time which we’re very proud of. And so we’re able to provide access to those patients that may be home-bound or home limited or have a lot of struggles to get in.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

Doctors for America

APRIL 29, 2025

However, this assessment comes with alarm – essential services our patients rely on and that we as clinicians need to provide high-quality, evidence-based care have been obliterated by seemingly haphazard decision-making. Commitment to Transparency: Under President Trump, HHS and FDA have rapidly become less transparent.

Medical Student 52

Medical Student Patients Medical Individual 52

FDA Law Blog

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. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98