As part of the third “Healthcare Disruptive Technologies & Innovations” (HCDT&I) day, Credit Suisse https://www.credit-suisse.com hosted a virtual meeting with a group of executives to discuss COVID-19. Will Brady, Chief of Staff to the Deputy Secretary at HHS and Senior Advisor to the Secretary on Policy Issues and Program matters shared HHS’ views on COVID-19 plus how the agency is dealing with other issues.
He is also responsible for the operations and management of the HHS Chief Technology Office, the Office of Administration & Finance, and the National Security Office, In addition, he leads and supports cross departmental initiatives related to innovation, grants, acquisitions, employee performance, cybersecurity, and other special projects.
HHS regulates over 20% of the U.S economy, the largest R&D facility in the world, pays for over 30% of healthcare in the U.S., responds to natural disasters, and spends billions in education grants. The department purchases over $25 billion in goods and services and grants for over $100 billion per year.
As for HHS’s response to the COVID-19 Pandemic, Mr. Brady notes that the U.S is entering a new phase where testing will be much more readily and easily accessible as a result of the transition from public health laboratories to private sector automated high throughput testing.
Individuals are being tested at the recommendation of their providers using evidence-based guidance and CDC guidelines which allow for clinical discretion. The capacity for testing is expected to increase to a level potentially sufficient to meet the demand. HHS is also working to make testing easily accessible to those that need it the most, namely healthcare workers, first responders, and people with preexisting health conditions.
The Biomedical Advanced Research and Development Authority (BARDA) within HHS has announced that Mesa Biotech, a San Diego-based molecular diagnostic company, is going to develop their coronavirus diagnostic test with the ability to provide results in about 30 minutes.
Effort is being made to support the company in order for the company to complete the developmental work needed to obtain Emergency Use Authorization (EUA) from FDA. EUA is FDA’s emergency authorization process in place to provide fast-track unapproved medical products for use during a public health emergencies.
HHS is also taking unprecedented steps to expand Americans’ access to telehealth during the outbreak. This includes expanding Medicare coverage for telehealth visits across the country so that telehealth can be be provided directly to the home.
The administration has also waived potential HIPAA penalties, allowing telehealth visits to occur through everyday technologies like FaceTime, skype, and other video and audio communication tools. HHS has also provided flexibility for healthcare providers to reduce or waive beneficiary cost sharing for telehealth visits paid for by the federal healthcare program.
When asked if restrictions to telehealth could be waived permanently, not just in a public emergency, Mr. Brady said, “The current environment is unique in so many ways, however, the effectiveness and role that telehealth plays in these unusual circumstances will influence how the telehealth industry will be regulated going forward.
One of the key drivers of innovations is providing information so that people working on innovations thoroughly understand the commercialization process enabling innovative products to reach the market.
HHS is taking steps to move innovation and commercialization forward. These steps include decreasing regulatory reimbursement and cycle times and burden, increasing New Technology Add-On Payments (NTAP) from 50% to 65% payments. HHS plans to improve clarity by removing the regulatory hurdle for substantial clinical improvements for breakthrough devices and also to provide clarity on NTAP eligibility.
Mr. Brady notes, FDA has a program called “Breakthrough Devices”. This program is a voluntary accelerated review process used for certain medical devices and device-led combination products if there is no equal alternation and if the therapy needed is proven to be more effective in diagnosing life-threatening or irreversibly debilitating diseases or conditions.
Also, HHS is looking to improve coverage of innovative technologies and reform parallel review so that devices are approved by both FDA and CMS simultaneously.
Another issue is the importance of transitioning to value-based care. One of the actions that HHS is taking to achieve this goal is to initiate Primary Care First and Direct Contracting both CMMI models which would enable providers to take on risk for patient outcomes in the total cost of care vs process metrics and more burdensome tracking and management systems.
Mr. Brady highlighted the key area of kidney care. So far there has been a lack of innovation and new treatment therapies in this space. The Kidney Care Models are focused on improving organ transplants and enabling dialysis at home. HHS reimburses for kidney care involving virtual visits and remote patient monitoring within CMS and the FFS program.
As for barriers hindering good healthcare, HHS is focused on removing these barriers. Some of these barriers involve reforming the Anti-Kickback Statute and Stark Law to allow for value-based arrangements, outcomes-based payments on personal and management services, bundled warranties on medical devices and services, and provide protection for the sharing/donation of cyber security products and EHRs.
HHS has been focused on empowering consumers through data. The recent rules by the HHS Office of the National Coordinator (ONC) and CMS have opened up electronic access to personal health records and claims data to enable patients to make good decisions on how to manage their care.
HHS has also focused on banning pharmacy “gag clauses” to make sure that patients are informed about alternative options for purchasing prescription drugs in the pharmacy. HHS is also focused reimbursing for virtual visits and remote patient monitoring,
In addition, HHS has another CMMI model called ET3 which focuses on emergency services and treating patients both at home or via emergency management services or to take the patient to where they think is best for their care. HHS is also looking to change the incentive structure to allow patients to be taken to the most appropriate place of care.
There is an effort underway to develop a road map for healthcare to address the amount of quality metrics needed to develop since right now there are 25,000 metrics which have proven to be unmanageable.
As for liberating data to drive value, there are two real mediums that will impact making data more available and allow providers to use the data more effectively to deliver care. ONC is working to liberate data and has proposed adopting standard Application Program Interfaces (API), and standardizing data sets so that information is easily understood and accessible.
CMS published a complimentary rule that gives patients access to claims encounter and plan data. This rule also requires admission, discharge, and transfer information on patients to be shared with the Primary Care Physician and designated providers to help accelerate the delivery of healthcare.
Two items on the horizon are to improve pricing transparency and develop a synthetic data hub, being directed by an Executive Order to begin combining synthetic data from claims, clinical demographics plus more, for researchers to use to model various innovations.
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