Why Federally Mandated Electronic Prescribing for Controlled Substances will Benefit Public Health

Why Federally Mandated Electronic Prescribing for Controlled Substances will Benefit Public Health

Although 2022 has brought on a greater sense of normalcy, the past few years have distracted us from one of the most overlooked epidemics plaguing healthcare: prescription drug abuse.
Before Covid-19 diverted attention away from this problem, President Trump signed on to the SUPPORT for Patients and Communities Act of 2018, instating sweeping legislation for initiatives to address the opioid epidemic. The bill, among other initiatives, requires electronic prescriptions for controlled substances (EPCS) for any covered part D drug. Although the official start of the mandate was delayed two years to January 1, 2023, the importance of this federal intervention cannot be…

Continue Reading
Retrieving Billions in Overpayments by CMS

Retrieving Billions in Overpayments by CMS

Amid swirling accusations that Medicare Advantage Organizations (MAOs) are overbilling the U.S. government and calls for better oversight, the Centers for Medicare & Medicaid Services announced in early February that it would investigate overbilling by those plans. They expect to recoup 4.7 billion dollars through this program.
This article focuses on the relatively young technologies that enable CMS to uncover overbillings, whether they be errors or fraud. The article is based on an interview with Kel Pults, chief clinical officer and vice president of MediQuant. A future article will explain how Medicare Advantage plans are trying to improving data collection and reporting,…

Continue Reading
Digital as the Differentiator for Biopharma and Medtech

Digital as the Differentiator for Biopharma and Medtech

With the Inflation Reduction Act now on the books, the U.S. Centers for Medicare & Medicaid Services (CMS) will begin negotiating drug prices with the pharmaceutical industry. That, combined with other headwinds such as increased competition from me-too drugs, and ever-present pricing pressure from payers, means that pharma players now more than ever need a new and powerful tool to differentiate their products. We believe the next decade of transformation is digital.
Learning from the auto industry Almost every industry has had to confront a fundamental existential question: What is our product? Consider the automotive industry, which once was largely about hardware…

Continue Reading
HHS Aims To Reduce Prescription Drug Costs Through 3 New Models

HHS Aims To Reduce Prescription Drug Costs Through 3 New Models

The U.S. Department of Health & Human Services (HHS) unveiled three new models Tuesday that will be tested by the CMS Innovation Center and aim to lower prescription drug costs. The models include access to $2 generic drugs.
The news is in response to President Joe Biden’s executive order issued in October, which directed HHS to find ways to lower prescription drug costs and improve access to drug therapies for those enrolled in Medicare and Medicaid health plans. The models are meant to build on the Inflation Reduction Act of 2022, which includes allowing Medicare to negotiate lower prescription drug prices for…

Continue Reading
Where Are All the Patients?

Where Are All the Patients?

It’s no secret that patient enrollment is one of clinical research’s biggest hurdles. According to an analysis of trials listed, 55% of terminated trials were ended because of low patient enrollment. The analysis also reported that Phase III and Phase IV trials have an enrollment efficiency of less than 40%. Yet another analysis found more than 80% of studies do not enroll on time, often leading to a study extension or additional research sites.
The problem isn’t just enrollment, it’s also the enrollment of diverse patients. Racial and ethnic minorities, specifically Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native…

Continue Reading
Federal agencies offer updates on TEFCA, interoperability milestones

Federal agencies offer updates on TEFCA, interoperability milestones

On February 13, the government leaders thanked the Office of the National Coordinator for Health IT and six Qualified Health Information Networks (QHIN) for working to create a nationwide interoperability network under the 21st Century Cures Act. The ‘Network of Networks’ 
At the U.S. Department of Health and Human services, Secretary Xavier Becerra presented certificates of recognition to the CommonWell Health Alliance, eHealth Exchange, Epic TEFCA Interoperability Services, Health Gorilla, Kno2 and KONZA for moving into the pre-production testing process of the Trusted Exchange Framework and the Common Agreement.
With the framework, ONC and the Sequoia Project, TEFCA’s recognized coordinating entity, seek to establish…

Continue Reading
95% of Certified Health IT Developers Met ONC Cures Act Deadline

95% of Certified Health IT Developers Met ONC Cures Act Deadline

– More than 95 percent of certified health IT developers met the Cures Act Final Rule compliance deadline to provide customers with new technology, according to an ONC HealthITBuzz blog post. The Cures Act Final Rule mandated many changes to the Certification Program, including four updates set to have long-lasting interoperability impacts on patients, clinicians, and developers. ONC Certified Health IT developers must: Advance interoperability for patients and providers through the use of FHIR-based application programming interfaces (APIs);Enable patients, providers, and other stakeholders to have access to consistent data elements represented in at least version one of the United States Core…

Continue Reading
CDS Coalition requests FDA rescind final decision support guidance

CDS Coalition requests FDA rescind final decision support guidance

The CDS Coalition is asking the U.S. Food and Drug Administration to pull back on its clinical decision support guidance in order to ensure that the agency better balances its regulatory oversight with the healthcare sector’s need for innovation, while comporting with the statutory language of the 21st Century Cures Act. ‘Flagrant’ disregard for Congressional law and intent
The coalition’s stakeholders – clinical decision support software developers, patient advocacy organizations, clinical societies, healthcare providers and healthcare payers – say the FDA’s guidance exceeds Congress’s statutory definitions of what is considered CDS and threatens to undermine lawmakers’ goals.
“The Office of the National Coordinator for…

Continue Reading
Bipartisan House bill proposes permanent telehealth benefits

Bipartisan House bill proposes permanent telehealth benefits

The Telehealth Benefit Expansion for Workers Act would amend the Public Health Service Act, the Employee Retirement Income and Security Act of 1974 and the Internal Revenue Code of 1986 to allow employers to treat benefits for telehealth services like excepted benefits.WHY IT MATTERS
The bill aims to keep stand-alone telehealth benefits separate, not as a replacement of medical plans, offering them under a group health plan or group health insurance coverage as excepted benefits.
An excepted benefit allows employers to finance additional medical care, like vision or dental coverage, according to theCenters for Medicare & Medicaid Services FAQsfor insurance agents and brokers, requiring Congress…

Continue Reading