The FDA Law Blog

OCTOBER 3, 2022

This settlement is the largest ever FCA settlement secured without the intervention of the United States. HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. See 42 U.S.C. 1320a-7b(b).

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Documentation 105

IDStewardship

JUNE 5, 2023

In this article the artificial intelligence program ChatGPT is interviewed about antimicrobial stewardship. In the ongoing battle against this complex challenge, antimicrobial stewardship programs have become crucial in promoting responsible antimicrobial use and combating the proliferation of resistant organisms. Gauthier, Pharm.D.,

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The Checkup by Singlecare

NOVEMBER 30, 2023

New York state has one of the largest populations covered by Medicaid programs, with nearly 9 million people receiving benefits as of 2023. The healthcare program, designed for lower-income and certain disabled New Yorkers, covers people of all ages, but eligibility requirements vary.

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Nursing Homes Insurance Insurance Coverage Documentation 52

The Checkup by Singlecare

OCTOBER 10, 2023

While Texas Medicaid has not expanded its program to cover low-income younger adults, as other states have, it does have options for children, pregnant women, the elderly, and those with disabilities. Read on to see what program requirements Texans must meet to access Medicaid, what it covers, and how to apply.

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ISPE

MAY 16, 2023

Yet despite many of the external challenges the core technology behind blockchains has remained secure, available, and immutable – just as they were designed to do. Supply chain management: Blockchain technology can create a secure and transparent supply chain by enabling the tracking and tracing of drugs. Information Systems GAMP®

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The Checkup by Singlecare

AUGUST 30, 2023

The Medi-Cal program in California serves a significant portion of the state’s population, with enrollment exceeding one-third of its residents. This comprehensive guide is expertly designed to enhance your understanding of the intricacies of Medicaid in California to empower you to make well-informed decisions. What is Medi-Cal?

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The Checkup by Singlecare

NOVEMBER 11, 2022

Fortunately, there are some programs available to help those with lower incomes. Medicare Savings programs can help offset the cost-share and premiums associated with Original Medicare. Qualifying beneficiaries can use this program to lower their Medicare cost-share to a manageable amount. What is the Medicare Savings Program ?

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The Checkup by Singlecare

AUGUST 30, 2023

This vital program aims to assist individuals with low incomes who may struggle to afford health insurance independently. Understanding the complexities of Florida Medicaid and its related program, Florida KidCare, can be daunting. At the beginning of 2023, the state of Florida had more than 3.9

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PQA

SEPTEMBER 28, 2022

Social determinants of health (SDOH) are a priority for PQA because, in addition to traditional care, issues like medication cost, literacy, transportation and food security impact a person’s ability to access medications and use them safely and effectively. Twelve of the guide’s 20 initiatives address food security.

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pharmaphorum

DECEMBER 18, 2022

Dispensing pharmacies, while incentive-aligned on starting and keeping patients on therapy, may not have the tools, time, or incentives to secure the lowest out-of-pocket pricing for the patient. On top of that, traditional solutions provide delayed program data. Use technology to align incentives: technology frees up information.

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Specialty Pharmacies 98

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Loose Ends IDEs.

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pharmaphorum

MAY 19, 2022

Get your critical questions answered to supercharge your clinical programs , direct your drug pipelines and ensure you take lessons learned to successfully modulate integrins to improve treatment regimens in chronic, familiar, and rare diseases. . Access the official agenda for more information.

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pharmaphorum

FEBRUARY 23, 2022

As investment in gene therapies continues to grow rapidly, more effectively engaging patients throughout development has become a priority for any company serious about building safer and more meaningful gene therapy programs. Access the official agenda for more information.

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IDStewardship

JUNE 6, 2023

Patient Education and Adherence : AI chatbots or virtual assistants can be developed to provide patients with on-demand information about their medications, dosages, potential side effects, and adherence strategies. This empowers patients to make informed decisions and fosters better medication adherence.

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The Checkup by Singlecare

MARCH 7, 2024

This guide provides a brief overview of what medical debt entails and essential information that consumers need to manage it effectively. Additionally, some states have not taken advantage of Medicaid expansion , reducing the percentage of people who qualify for the program. Here are several ways to find medical debt relief programs.

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Digital Pharmacist

SEPTEMBER 20, 2023

Transparency in premium calculations empowers beneficiaries to make informed decisions during the Annual Enrollment Period. Expansion of the Medicare Part D Low Income Subsidy (Extra Help) program to those between 135% and 150% of the federal poverty line, increasing accessibility.

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The Checkup by Singlecare

FEBRUARY 28, 2024

The Illinois Medicaid program is an essential health insurance plan for Illinois residents and a leader in the nation for its expansive service coverage, especially its coverage for families. You’ll find all the information you need to access Illinois Medicaid for yourself and your loved ones. It now covers more than 3.9

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Digital Pharmacist

SEPTEMBER 13, 2023

Number of Medications: Some programs may require individuals to be taking a certain number of medications, typically a minimum of three to five prescription medications, to be eligible for MTM services. Chronic conditions can include diabetes, hypertension, asthma, heart disease, and more.

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European Pharmaceutical Review

FEBRUARY 28, 2023

Unfortunately, there are many programs and instruments that use different proprietary formats. Recently, a postgraduate I spoke to said one of the programs they use produces data that cannot be used with any of their other programs; this was a major pain point. Another challenge is data security and trust.

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Documentation 96

ISPE

MARCH 1, 2023

Robust cleaning and disinfection programs are needed to meet the required cleanroom microbial grades, to prevent cross contamination and subsequent microbial contamination of products. For more information or to unsubscribe, review our Privacy Policy or contact us at ask@ispe.org. Leave this field blank

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Communication 98

PQA

FEBRUARY 9, 2023

PQA started the year by publishing the second edition of the PQA Social Determinants of Health (SDOH) Resource Guide and will continue education offerings through quality forum webinars, highlighting PQA members during the 2023 PQA Annual Meeting and the much-anticipated relaunch of the PQA Medication Use Quality certificate program.

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ISPE

NOVEMBER 23, 2022

The Symposium program comprised a wide range of presentations and panel discussions on GMP-related topics, which included participation from Heads of Medicines Agencies, Heads of GMP Inspectorates, official PIC/S representatives and ISPE. ™ program and the contents of the upcoming ISPE’s Baseline Guide Pharma 4.0™.

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Documentation FDA Communication 98

PQA

SEPTEMBER 23, 2022

PQA offers a variety of student and professional programs, including experiential rotations, internships and fellowships. PQA is now accepting applications for our student and professional programs for 2023-2024. million in grants for programs that leverage food as medicine. Learn more about each program that PQA offers.

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pharmaphorum

NOVEMBER 1, 2022

Along their journey, specialty pharma patients interact with a series of siloed institutions: clinics, specialty pharmacies, copay program vendors, patient assistance programs, nurses, etc. Not unlike the financial industry, these institutions still exchange patient information via fax machines.

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The FDA Law Blog

SEPTEMBER 6, 2023

Many of our clients have been confounded by their inability to secure a change in the classification of the facility, or to convince FDA to meet with representatives of the owner of the facility to explain what else they need to do. And the Guidance may be used as leverage to secure action from FDA on a meeting request.

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PQA

MARCH 28, 2024

Our members include community and specialty pharmacy organizations, pharmacists and other healthcare providers, pharmacies, health plans, pharmacy benefit managers, life sciences, technology vendors, government agencies, health information technology partners, researchers, accrediting organizations and academia.

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Specialty Pharmacies Communication Insurance Pharmaceutical Companies 40

PQA

MARCH 27, 2024

Our members include community and specialty pharmacy organizations, pharmacists and other healthcare providers, pharmacies, health plans, pharmacy benefit managers, life sciences, technology vendors, government agencies, health information technology partners, researchers, accrediting organizations and academia.

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Specialty Pharmacies Communication Insurance Pharmaceutical Companies 40

Digital Pharmacist

MARCH 23, 2023

For more information on DIR fees and strategies and tools to help increase your profit margins and drive additional revenue to offset fees, be sure to check out our eBook. Medication Therapy Management (MTM) : A part D sponsor must offer Medication Therapy Management that meets MTM program requirements. Download today!

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Mail-Order Pharmacies HIPAA Communication Insurance 52

Omnicell

JANUARY 10, 2023

One of the growing complaints that I have heard from 340B providers over the past decade is that the benefit of the program is being transferred from safety net hospitals, health centers and clinics to private payers. For more information on the programs history and a digestable synopsis of the 340B program explained , visit our blog!

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The Happy PharmD

JANUARY 13, 2023

With the revolution of Meaningful Use legislation, creating an electronic medication record was mandated by the USA government, thus experts were required to initiate the program. An IP is an intersection between pharmacy and health information technology (HIT). Informatics Pharmacist Job Requirements.

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Communication Medical Records Patient Care 52

DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. pharmaceutical industry is wrapped up in a web of regulations, and one of the most significant in recent years is the Drug Supply Chain Security Act (DSCSA).

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Independent Pharmacies Packaging Documentation FDA 52

The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

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European Pharmaceutical Review

MARCH 9, 2023

Discussing the opt-out model, Leslie Bell, SCTR Regulatory Knowledge and Support Program Manager highlighted: “So now when you log into that questionnaire, it shows that you have defaulted to receive notifications about research opportunities, and you can unselect that to opt out.”

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Communication 97

The FDA Law Blog

AUGUST 23, 2023

More recently, use of wearable sensors and applications running on mobile devices (Apps) by study participants has introduced new questions on how to incorporate DHTs into the study, and what information is needed to verify and validate that they are fit for purpose in the study.

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ISPE

MAY 9, 2023

Recently, the NC Biotech led a diverse coalition of companies, universities, community colleges, government agencies, and organizations that was awarded a $25 million grant from the US Economic Development Agency, for a program they call “Accelerate NC - Life Sciences Manufacturing.” Leave this field blank Management Workforce of the Future

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Communication 52

Impact Pharmaceutical Services

SEPTEMBER 28, 2023

Insufficient manufacturing information can be mitigated by providing detailed manufacturing processes, critical steps, quality control protocols, and batch consistency data. A team of consultants with regulatory, clinical, nonclinical, and CMC expertise was assembled to provide strategic input and guidance on the US development program.

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indispensable health

JANUARY 18, 2024

The Value of Being a Good Customer: The benefits of fostering positive customer relationships within healthcare extend far beyond simply securing a reliable supplier. Proactive communication, keeping business partners informed of changes or concerns, builds trust, and minimizes friction.

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