The Clinical Problem Solvers

DECEMBER 16, 2020

Our esteemed publications should ensure that investigations that utilize racial variables follow these guidelines before being published. September 8, 2020. Examining the Potential Impact of Race Multiplier Utilization in Estimated Glomerular Filtration Rate Calculation on African-American Care Outcomes. Published July 2, 2020.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

DECEMBER 16, 2024

The final guidance appears not to make any meaningful changes that are actually likely to support or incentivize its increased utilization, which is disappointing, although not unsurprising. The guidance also addresses FDAs obligation to provide considerations on third party compensation, information sharing, and conflicts of interest.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law Blog

NOVEMBER 7, 2024

One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days.

Provider 69

Provider IT Consulting Utilities 69

FDA Law Blog

NOVEMBER 6, 2022

The Court found that there is at best little utility in interpreting the AKS by reference to the BIS. As Pfizer has argued throughout this legal battle, its proposed copay assistance program “poses no risk of corrupting independent decision making” or of inducing improper utilization of tafamidis. Pfizer’s Petition to SCOTUS.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

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. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law Blog

JULY 4, 2023

The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process. Rather than modify the existing FDR guidance and issue separate guidance on consolidated proceedings, FDA has issued a single draft guidance covering both topics.

Utilities 52

Utilities Provider Individual IT 52

FDA Law Blog

JUNE 3, 2021

As we initially reported here , Texas enacted a law in June 2019 requiring manufacturers to submit two types of reports beginning in January 2020. A summary of these new state law developments is included below. The North Dakota law includes three reporting requirements for drug manufacturers.

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

PEMBlog

SEPTEMBER 13, 2023

The lack of utility of laboratory testing in children with an unprovoked generalized seizure, or a simple febrile seizure is supported by several observational studies. A careful history and physical examination are ways that we as providers can “see what’s going on inside the head.” 2000; 55(5):616-623.

Patients 52

Patients Screening Illness Physicals 52

PEMBlog

MAY 15, 2023

Our role as providers is to identify the patients who have a life-threatening etiology to their syncope. 2020, pemcincinnati.com/blog/redflags-syncope/. Syncope is described as a brief loss of consciousness and postural tone caused by transient global cerebral hypoperfusion. It is followed by a complete recovery. 2017): 189-198.

Utilities 97

Utilities Screening Physicals Medical 97

The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population. They can use their training and privilege to advocate for meaningful policy reform.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

FDA Law Blog

JUNE 7, 2021

It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. be “reasonably likely to predict” ultimate clinical benefit). Yesterday’s approval of Aduhelm helped answer that.

Clinic 98

Clinic IT Private Practice Utilities 98

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. With their regular providers? However, its main predictors are age, comorbidity, and healthcare utilization. In their communities?

Patient-Centered 122

Patient-Centered IT Illness Patients 122

GeriPal

OCTOBER 26, 2023

And so I did all of my research training in health services research, health policy, and then was very grateful to be recruited by Dr. Christine Ritchie when she transitioned here to MGH in September of 2020. We provide critical education. We provide critical conversations with colleagues and families to coordinate transition planning.”

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

JANUARY 20, 2023

You were on a National Academy of Sciences committee started in 2020? To me, I think the Greenhouse folks have proven that you can provide quality care in a home-like environment cost effectively if it’s done right. Eric: All right, let’s jump into this topic. Improving nursing home quality. Jasmine: Yes. Is that right?

Finance 95

Finance Board-Certified IT Provider 95

FDA Law Blog

JULY 9, 2024

For rare diseases, although patient numbers may be too small to detect meaningful differences in safety or effectiveness, the Draft Guidance states that consistent representative enrollment may still provide opportunities for hypothesis generation and further study. providing language assistance); Reducing participant burden (e.g.,

Clinic 59

Clinic Provider Individual IT 59

FDA Law Blog

NOVEMBER 16, 2021

First, section 90006 imposes a moratorium on HHS’s implementation of an HHS OIG final rule, published on November 30, 2020, which amends the Federal health care program antikickback statute safe harbors as they apply to drug rebates paid to Medicare Part D plans and Medicaid Managed Care plans (or their PBMs).

Manufacturing 40

Manufacturing Utilities Management Provider 40

GeriPal

OCTOBER 19, 2023

As you mentioned, it was published in JAGS in 2020, and we really started from the time of inception of POLST, so in the early 1990s, up until about February 2020 was the date that we cut off. I think that policy in the emergency department is showing that no matter what that provider is looking to see if a patient has a preference.

Patient-Centered 126

Patient-Centered IT Patients Illness 126

PEMBlog

APRIL 26, 2023

From 2019 to 2020, the rate of firearm related deaths among children increased by 30%. Studies demonstrate that utilizing one of these storage methods can reduce the suicide and unintentional gun deaths in children by up to 54%. [ Kristen ] Great question. Each year, 3200 children die from firearm-related injuries.

Families 52

Families Family Mental Health Healthcare 52

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. We weren’t randomizing providers or patients. Remember, this was March 2020, around that time when we got all this training and we were having now these conversations really often.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

GeriPal

FEBRUARY 13, 2025

Like, would you include the doctors that I work with, healthcare providers where I live in Marin? And resource utilization was very low in all the groups. But again, hindsight’s 2020 probably wasn’t the best measure to look the other one we tested in an exploratory way was feeling heard and understood.

Consulting 63

Consulting Community Patient-Centered Families 63

FDA Law Blog

AUGUST 21, 2023

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 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

BMJ

MAY 10, 2022

METHOD The cross-sectional study was conducted on family physicians and family health staff working in primary care family health centers in Üsküdar district of Istanbul with a population of 520,771 between 25-29 December 2020 [4]. Primary care visits increase utilization of evidence-based preventative health measures. BMC Fam Pract.

Vaccination 40

Vaccination Healthcare Professional Healthcare Primary Care 40

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. They deal with that.

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 Families Family 125

FDA Law Blog

SEPTEMBER 14, 2021

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. The AIM price is the volume-weighted average price of the drug in Australia, Canada, France, Germany, Japan, and the U.K. PART 2: INFLATION REBATES UNDER MEDICARE PARTS B AND D.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law Blog

NOVEMBER 8, 2023

The rule also aimed to provide “consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options.” Yet the milestone should not pass without recognition, and it provides a great opportunity for objective evaluation.

Utilities 64

Utilities IT Engineering Appointment 64