STAT

DECEMBER 29, 2022

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

Insurance 98

Insurance Documentation FDA 98

pharmaphorum

SEPTEMBER 30, 2021

There is a lot of discussion about the power of drawing out insights from information hidden within electronic health records and insurance claims, but little regulatory guidance on how that should be undertaken. The FDA stresses it is a preliminary document and is encouraging comments, which can be filed up to 60 days after publication.

FDA 81

FDA Documentation Insurance 81

The Checkup by Singlecare

FEBRUARY 7, 2023

The rising cost of living in the United States is making it harder to pay for prescription medicines, even among individuals with health insurance. PAPs are programs that help people with no health insurance and those who are underinsured pay for their medications. Here’s how they work. How do patient assistance programs work?

Insurance 98

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98

The Checkup by Singlecare

MARCH 7, 2024

Ozempic (semaglutide) is an injectable medication approved by the Food and Drug Administration (FDA) to treat Type 2 diabetes. Because it often leads to weight loss, it’s become an in-demand drug for patients with type 2 diabetes and patients looking to lose weight , even though it’s not currently FDA approved for weight loss.

Insurance Coverage 52

Insurance Coverage Insurance FDA Dosage 52

The Checkup by Singlecare

MAY 1, 2024

The FDA has approved these devices for mild to moderate hearing loss. Financial assistance for hearing aids There are several ways to make hearing aids more affordable, including insurance coverage, nonprofit organizations, and discount programs. Workers’ compensation insurance may cover work-related hearing loss.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Insurance Coverage Communication 52

The Checkup by Singlecare

SEPTEMBER 7, 2023

Some drugs in this class are FDA-approved to aid in weight loss and management. Unfortunately, insurance companies generally won’t cover Mounjaro for unapproved indications like weight loss. These drugs can get expensive, costing several hundreds of dollars a week for treatment if not covered by insurance.

Insurance 52

Insurance Insurance Coverage FDA Dosage 52

The Checkup by Singlecare

NOVEMBER 30, 2023

These include the following: Adults 19-64 years of age who are not eligible for Medicare Children 1-18 years of age Infants (younger than 1) Youth in foster care and former foster care youth Children not eligible for Medicaid may be able to get coverage through Child Health Plus , an expanded health insurance program.

Nursing Homes 52

Nursing Homes Insurance Insurance Coverage Documentation 52

The FDA Law Blog

AUGUST 7, 2023

Participation is encouraged from: Companies Academia Clinical facilities Medical device incubators and accelerators Health insurers Health technology assessment groups Others, including previous participants in the ELP or the FDA’s other site visit programs. Complete a Site Visit Agenda ( Sample Site Visit Agenda ).

Documentation 40

Documentation Insurance FDA 40

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.

FDA 98

FDA Insurance Chemotherapy Documentation 98

pharmaphorum

AUGUST 31, 2021

The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. Within this framework, the FDA seeks to answer outstanding questions on how it will ultimately assess RWD, as well as address any prospective issues, such as cohort bias and data quality.

FDA 70

FDA Insurance Coverage Documentation Insurance 70

The Checkup by Singlecare

APRIL 5, 2024

Many patients look to health insurance or Medicare for help with Mounjaro’s out-of-pocket price. And when it’s prescribed for diabetes, not weight loss, insurance often delivers. Like many prescription drugs, without insurance coverage, Mounjaro isn’t cheap. However, it depends on the provider and plan. Does BCBS cover Mounjaro?

Insurance 90

Insurance Insurance Coverage Documentation FDA 90

European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

Compounding 84

Compounding Documentation Insurance Immunization 84

The Checkup by Singlecare

APRIL 5, 2024

When the Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) in 2022 to treat Type 2 diabetes, some people hailed the GIP and GLP-1 medication as the next great antidiabetic drug. Without health insurance coverage, Mounjaro’s average cash price ranges from $1,400–$1,500 for a pack of four 5 mg/0.5 And it’s not just hype.

Insurance 59

Insurance Compounding Pharmacies Compounding Insurance Coverage 59

The FDA Law Blog

DECEMBER 4, 2023

Pharmacists and pharmacy management should pay heed to these prescribing red flags, resolve them when they appear and document their resolution. The order also enjoins the pharmacist-owner from serving as a PIC at any other pharmacy for seven years. Consent Agreement and Final Judgment ¶ 17.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

The Checkup by Singlecare

MAY 5, 2024

Prior authorization is a common part of the process of receiving coverage for a prescription drug through your insurance provider. All insurance companies have their own set of criteria that determine which drugs they cover and at what cost to the patient. Cigna insurance plans are no different.

Insurance 98

Insurance Health Insurance Companies Documentation FDA 98

ISPE

OCTOBER 27, 2022

Given the public health emergency, health authorities offered greater flexibilities in the use of digital health platforms and technologies such as: Enhanced HIPAA (Health Insurance Portability and Accountability Act of 1996) flexibilities in the use of telemedicine services 3.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

The Checkup by Singlecare

JANUARY 25, 2023

According to the Food and Drug Administration (FDA) , one popular misconception surrounding SPF relates to the time of solar exposure. Sun protection factor (SPF) measures the solar energy needed for sunburn-protected skin compared to unprotected skin. 84% reportedly do not believe this.

Documentation 52

Documentation Insurance FDA 52

pharmaphorum

JANUARY 9, 2023

Higher income countries will also pursue plans to localise in 2023: Germany wants statutory health insurers to consider local production for drugs in tenders to prefer reliable European manufacturers, and the EU medicines strategy in March 2023 will ensure a future-proof and resilient system, reducing the EU’s dependency on third party countries.

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 94