CMS publishes final rule on access to health technologies for older people

The Centers for Medicare and Medicaid Services issued a final rule Tuesday aimed to support innovative technology so that Medicare beneficiaries have access to newer and advanced devices, called Medicare Coverage of Innovative Technology (MCIT).

The hope is that this will help ease Medicare’s coverage path for innovative products, resulting in faster access to new devices for the elderly. The action is part of CMS’s Freeing Innovation and Patients Against Paperwork initiative.

Under current rules, approval of a device by the FDA is followed by an often lengthy and expensive process for Medicare coverage. The mismatch between the two causes innovators to spend time and resources first on FDA approval, and then on the Medicare coverage process. This, CMS said, places an undue burden on innovators and could delay access to potentially life-saving technologies during the process of determining existing Medicare coverage.

The MCIT rule is designed to eliminate this delay for the elderly and innovators, by creating a new path to accelerated Medicare coverage for innovative products that the FDA considers a “breakthrough,” which the FDA approves on a fast-track basis. This could include devices exploiting new technologies, such as implants or genetic tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions such as cancer and heart disease.

WHAT IS THE IMPACT ?

Under the MCIT rule, Medicare can provide national coverage concurrently with FDA approval, for up to four years. Once the coverage period ends, CMS will reassess the device based on clinical and actual evidence of improved health outcomes among Medicare beneficiaries to determine more permanent coverage.

This four-year timeline may prompt the manufacturers of these devices to develop additional evidence regarding the applicability of their products to the Medicare population, so that they can continue Medicare coverage beyond the first four years.

Since the MCIT rule will provide national Medicare coverage for four years, it will align with the Local Coverage Determination (LCD) process, in the hope that it will promote equal access for people. the elderly, regardless of their place of residence.

Currently, as part of the local coverage process, 16 Medicare Administrative Contractors (MACs) make Medicare coverage decisions at the local level – 12 for Medicare parts A and B and four for durable medical equipment. MACs may cover items or services on a case-by-case basis or via an LCD screen, which only applies to the jurisdiction of that MAC. In the absence of a national Medicare coverage decision for an innovative technology, the technology could be covered in one region of the country but not in another.

To secure an LCD screen, innovators are required to request separate decisions from each of the MACs. MCIT makes this step unnecessary for innovators. Under MCIT, breakthrough devices enjoy nationwide coverage for four years from the date of FDA approval, meaning innovators no longer have to search for LCDs at every MAC. Innovators will have the flexibility to choose when they want coverage to begin, with the intention that this will give them the flexibility to align the coverage process with their manufacturing and distribution cycles.

After the final rule comes into effect, at the request of the manufacturer, Medicare may cover, through the MCIT, eligible breakthrough devices approved by the FDA, including breakthrough devices that have received marketing authorization. the FDA market within two calendar years of the final rule’s effective date, providing Medicare beneficiaries with better access to devices.

The rule will also clarify standard uses of the CMS in determining whether Medicare should cover items and services, such as appliances and surgeries. Under Medicare, with few exceptions, the program can only cover items or services “reasonable and necessary” for the diagnosis or treatment of illness or injury or to improve functioning. of a malformed body member. The final rule will codify CMS’s definition of reasonable and necessary in regulation to give innovators a clearer understanding of CMS standards.

Based on public feedback, the final rule included a more flexible start date for MCIT coverage. Manufacturers can choose the start date of coverage to better align with market availability. In addition, as requested by stakeholders, CMS will collect more information on the use of commercial insurers’ coverage policies and use them in specific circumstances.

THE BIGGEST TREND

The MCIT pathway is only available for revolutionary devices designated by the FDA (which include certain diagnostic tests) which have subsequently been released into the market. Device manufacturers must apply to the FDA for breakthrough status, and then the FDA reviews the application to determine if the device meets the breakthrough criteria. Not all devices receive the breakthrough designation.

Revolutionary devices must match a statutory Medicare benefit category to be covered. There are revolutionary devices that do not have a Medicare benefit category (for example, some portable health devices that are directly purchased by consumers), so not all revolutionary devices may be covered by Medicare due to this legal requirement. And if CMS has issued an NCD on a particular revolutionary device, that revolutionary device is not eligible for MCIT.

ON THE RECORD

“Government processes have slowed down beneficiaries’ access to innovative treatments,” said Seema Verma, CMS administrator. “Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable and immediate access to breakthrough innovative devices. In an ever-changing healthcare market, CMS remains committed to transforming the healthcare delivery system through initiatives like MCIT that focus on results, removing government barriers to advancing innovations, promoting competition and ensuring faster access to the most advanced therapies for Medicare beneficiaries while providing them with better value and better outcomes. “

Twitter: @JELagasse
Email the author: [email protected]



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Arogga raises investments for its Falcon Network pharmacy and healthcare app

Falcon Network focuses on mission-driven entrepreneurs and businesses in high growth markets, and members include high net worth individuals from across Asia committed to investing in the potential of their home markets. Since its inception in 2018, Falcon Network has invested more than $ 2.5 million in technology companies disrupting critical sectors of their national economies, such as, among others, education, healthcare, transportation, services finance and agriculture.

Sayd Farook, Partner at Falcon Network, said: “The COVID-19 pandemic has revealed critical challenges in the provision of health services globally. As a result, the health technology industry is growing at an exponential rate globally, and Arogga is well positioned to be a market leader in Bangladesh, a country expected to reach the top 25 economies by 2034. As a result, we are absolutely delighted to support the growth of Arogga with our investment and board representation – our fourth investment in Bangladesh and our second investment in health technology. The team demonstrates a strong mix of entrepreneurial and operational expertise that will allow us to create an ecosystem of mobile health services, from pharmaceutical deliveries to e-health service delivery.

Arogga, which means ‘to heal’ in Bengali, has created a digital pharmacy and healthcare application of the future using technology that allows patients to easily manage, order and track the delivery of medicines and health products. affordably. Key features include easy prescription download, cash back rewards, and free drug delivery.

After launching earlier in 2020, Arogga faced an overwhelming response to its app, fulfilling over 4,400 orders in just a few months. Now, after relaunching in December 2020, with more than 28,000 app installs already, Arogga is set to make waves in Bangladesh, with the local market growing to $ 5.11 billion by 2023.

The founding team of Arogga is comprised of Fahad Hossain, Rosina Mazumder, Shamim Hasan and Yawar Mehboob, who bring synergistic skills in business, strategy, operations and technology, and are happy to obtain this Falcon seed funding.

Former investment banker turned celebrity entrepreneur, Rosina Mazumder has successfully used social media to launch and grow a global Cake Masters business and now sits on the UK SME Facebook Council, as well as being an Appointed Ambassador for Facebook since 2017. 2020 has become the ‘year of reassessing and exploring impact investing ideas in emerging markets, which led to becoming co-founder of Arogga.

Rosina Mazumder, CEO and Co-Founder, said: “With Bangladesh highlighted as one of the next biggest energy savings, and with the people embracing the digital revolution with the use of smartphone technology , our goal is to make Arogga the number one pharmacy and healthcare platform in Bangladesh. Solve issues related to the availability of genuine, affordable medicines while being delivered to your doorstep. With the first phase focused on pharmacy, we are excited to develop future verticals to improve Arogga and become the ultimate healthcare platform for Bangladesh. “

Shamim Hasan, CTO and co-founder, said they plan to use the investment to build and improve the technology behind the app, as well as to build on the infrastructure around the delivery of drugs and health products.

The deal marks Falcon Network’s fourth investment in Bangladesh and will impact how millions of people better manage their healthcare.

For more information or for investor relations, please contact:
Rosina Mazumder – Arogga
[email protected]

Sayd Farook – Falcon Network
[email protected]

© Press release 2021


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