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March 9, 2020 — The revival of legislation to change the regulation of laboratory-developed tests (LDTs) has drawn a mixed response. The reintroduction of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act is intended to remove barriers that are believed to have impeded the U.S. government’s response to the coronavirus epidemic.

The issue of diagnostics regulation has emerged as a political lightning rod, with some faulting the Trump administration’s response to the outbreak and others blaming what they claim is a history of federal overregulation of clinical labs.

“The industry associations that produce commercial IVD kits and pathologists who are concerned about overcommercialization of lab tests are clashing with representatives of the laboratories themselves.  These opinions represent longstanding positions of the players.”

Clinical labs are regulated by the U.S. Centers for Medicare and Medicaid Services (CMS) under CLIA and are not typically subject to oversight by the Food and Drug Administration (FDA). However, the FDA does regulate individual diagnostic tests, with diagnostic manufacturers required to gain FDA approval to market their assays. Yet another regulatory category, laboratory-developed tests, are tests that labs can develop and use on their own.

The situation has created several hurdles in responding to the novel coronavirus. When the FDA declared the coronavirus a public health emergency, it triggered a requirement that labs in the field get the FDA’s blessing to use their LDTs for the virus. The FDA subsequently waived this rule on February 29, but the need for a permanent solution to the regulatory environment is apparent…

To read more, please visit LabPulse.com: https://www.labpulse.com/index.aspx?sec=sup&sub=lab&pag=dis&ItemID=800854

 

coronavirus

The House of Representatives and Senate today passed an $8.3 billion spending package to help providers and local governments handle the spread of the coronavirus and to boost the development of vaccines and tests of the virus.  While vaccine support and spending on healthcare is expected, the bill also  boosts telehealth solutions with financial support and positive regulatory changes. 

Telehealth, or as Kalorama defines it, remote patient monitoring, is a $42-billion dollar market

The coronavirus response bill released by Congress on March 5th expands the Medicare reimbursement for  providers using who treat patients via telehealth to treat seniors at home.  The emergency spending bill waives Medicare’s geographical restrictions on telehealth during a public health emergency, enabling providers to use telehealth in both urban and rural areas as well as in the patient’s home as part of an “emergency area.”  Previously this was limited to rural areas.  It also loosens definition on telehealth devices, essentially allowing any device connecting physician and patient with audio and video capabilities.  This is a significant boost for telehealth and is understandable given the spread of the disease and the need to both service patients and protect physicians, nurses and other staff.

Most importantly, the bill contains mandatory funding authorization for $500 million over 10 years to be used toward a remote health care program.

This is a boost for the patient monitoring and telehealth market.  Kalorama Covers Remote Patient Monitoring in This Report: https://kaloramainformation.com/boost-for-42-billion-dollar-remote-patient-monitoring-market-in-covid-19-bill/

The global patient monitoring and telehealth market is estimated to be worth about $42 billion in 2019, inclusive of devices, peripherals, software, packaged services, monitoring services and other applications.  The market has benefited from the demand to move to a more wireless and streamline operation both within major health facilities and in-home treatment markets.  The demand to integrate data processing capabilities and EMR transfer options has also fueled the market.  There is also an increasing trend to upgrade to ambulatory and hand-held devices.

No longer is telehealth for rural patients alone.  For qualified providers, an emergency waiver will allow telehealth to be reimbursed by Medicare.   And extra funding is provided.

The interest in telemedicine and telehealth has exploded over the last decade.  Involvement in this care segment has several benefits and hospitals, caregivers, device manufacturers, and patients are continuing to jump on board with acceptance using this technology.  There are more than 700 clinical trials using telehealth recently completed, currently underway.  The global patient monitoring and telehealth market has continued its expansion in both the institutional and home segments of the health market with the United States and many European countries at the forefront of implementation.

 The industry spoke in the past few days and Congress listened.  In a recent letter sent to Senate Majority Leader Mitch McConnell, R-Kentucky, House Speaker Nancy Pelosi, D-California, and other Congressional leaders, the ATA – along with HIMSS, the eHealth Initiative, Health Innovation Alliance and Personal Connected Health Alliance – has asked Congress to make money from the COVID-19 supplemental appropriation available for more telehealth services.

Unique Opportunities in Telehealth/Telemedicine

There are a number of market opportunities in telemedicine that may offer some benefits over traditional office-based care.

For example, AMD Telemedicine’s General Exam Camera and Telephonic Stethoscope were used in a pilot program to treat Illinois inmates with HIV and Hepatitis.   Other examples include using telehealth to address the growing need for mental health monitoring and intervention.  This is an area where interest has increased significantly, as barriers to treatment are three-fold: lack of treatment resources; lack of adequate medical coverage; embarrassment.

Mental Health Assessment through Telemedicine

Telemedicine in the area of mental health disorders and conditions is often referred to as telemental health or telepsychiatry.

One area of mental health therapy is PTSD a type of anxiety disorder brought on by very traumatic situations such as war.

The costs of PTSD are difficult to accurately pinpoint because it may manifest itself in different ways for different people. Some patients seek therapy in unhealthy methods such as through alcohol and drugs. Lost wages, mortality, therapy sessions, physical health problems (non-psychiatric care), and prescription drugs are all costs associated with treating PTSD.

Caregivers may use telepsychiatry when they move or if the patient moves. Telehealth has the potential to increase the time a patient can see one caregiver, which has been linked to improved care, and can be beneficial for the worker who can keep some of their income after a move, even if it is only on a part-time basis.

Currently, in traditional fee-for-service Medicare, use of the telehealth benefit is limited to rural Health Professional Shortage Areas (HPSA1), CMS defined telehealth originating sites, and synchronous telehealth services. The Next Generation ACO Telehealth Expansion Wavier eliminates the rural geographic component of originating site requirements, allows the originating site to include a beneficiary’s home, and for the use of asynchronous telehealth services in the

specialties of teledermatology and teleophthalmology.

The waiver will apply only to beneficiaries aligned to a Next Generation ACO and for services furnished by a Next Generation Participant or Preferred Provider approved to use the waiver.  An aligned beneficiary will be eligible for the Telehealth Expansion Waiver if the beneficiary is located at their home or one of the Centers for Medicare & Medicaid Services (CMS) defined telehealth originating sites.

Medicare currently covers a limited number of Part B services delivered by an approved provider to a Medicare beneficiary. The beneficiary must be located in an approved “originating site” and services must be delivered by face-to-face consult using live video conferencing technology.   Originating site under existing Medicare telehealth rules include.

– Physicians’ or practitioners’ offices

– Hospitals

– Clinics and federally qualified health centers

– Hospital-based renal dialysis centers (including satellites)2

– Skilled nursing facilities (SNFs)

– Community mental health centers

There are a huge number of companies offering some form of wireless and remote technologies, patient data processing applications and equipment, and EMR data transfer equipment.  Competitors supplying patient monitoring and telehealth systems to hospitals are large, established healthcare companies, often working in conjunction with information technology (IT) companies on an entire system.  The home healthcare and other sectors are much more fragmented and are dominated by privately held companies.  In addition, some companies supply innovative products, but only for a small segment of the market; and some companies supply products on a regional basis only.

Although there are many participants in the market, a handful of companies continue to make a significant impact on the patient monitoring and telehealth technologies market.  The top five contributors to the market include:

  • Medtronic
  • Abbott Laboratories
  • Philips Medical
  • Boston Scientific
  • GE Healthcare