CMS recommends postponing most elective procedures

March 19, 2020 By Nancy Crotti Leave a Comment

The Centers for Medicare and Medicaid Services (CMS) released guidance late yesterday asking healthcare providers to postpone adult elective surgeries and procedures, including dental procedures, until further notice.

The move is an attempt to preserve the supply of ventilators and personal protective equipment such as masks and gowns while protecting patients and staff from exposure to the coronavirus. Dental exams in particular, which put the patient and provider in close proximity, pose one of the highest risks of transmission of the virus, and also deplete the supply of personal protective equipment, the agency said.

“Decisions remain the responsibility of local healthcare delivery systems, including state and local health officials, and those surgeons who have direct responsibility to their patients,” the agency said. “However, in analyzing the risk and benefit of any planned procedure, not only must the clinical situation be evaluated, but resource conservation must also be considered.”

CMS divided the types of procedures and its recommendations for those procedures into tiers. (See chart below.) Tier 1 includes outpatient and low-acuity procedures the agency recommends postponing, while Tiers 2 and 3 are for progressively more acute conditions.

Certain medtech firms will be harder hit than others given the new recommendations. Needham & Co. analyst Mike Matson said in an email that among the companies his firm covers, sacral modulation company Axonics Modulation Technologies (NSDQ:AXNX) and Cantel Medical (NYSE:CMD), which makes disposable products for endoscopies, will be most exposed to cutbacks on procedures in tiers 1 and 2.

Companies specializing in devices for higher-acuity procedures, including cardiovascular device firms AtriCure (NSDQ:ATRC), CryoLife Inc. (NYSE:CRY) and Cardiovascular Systems (NSDQ:CSII) might feel the pinch from cutbacks in the higher-tiered procedures, Matson said. Larger companies with broader product lines are exposed to a range of procedures and it is difficult to quantify the mix, he added.

CMS said the recommendations might change as the outbreak unfolds. “At all times, the supply of personal protective equipment (PPE), hospital and intensive care unit beds, and ventilators should be considered, even in areas that are not currently dealing with COVID-19 infections,” the agency added.

CMS recommended that hospitals and healthcare providers consider the following factors when deciding whether elective surgery should proceed:

- Current and projected COVID-19 cases in the facility and region.
- The supply of personal protective equipment to the facilities in a particular healthcare system.
- Staff availability.
- Bed availability, especially intensive care unit (ICU) beds.
- Ventilator availability.
- Health and age of the patient, especially given the risks of concurrent COVID-19infection during recovery.
- Urgency of the procedure.

CMS recommended decisions about procedures be made in consultation with the hospital, surgeon, patient and other public health professionals. The agency made up this chart to guide decision-making:

Tiers	Action	Definition	Locations	Examples
Tier 1a	Postpone surgery/procedure	Low acuity surgery/healthy patient Outpatient surgery Not life-threatening illness	HOPD* ASC** Hospital with low/no COVID-19 census	Carpal tunnel release EGD Colonoscopy Cataracts
Tier 1b	Postpone surgery/procedure	Low acuity surgery/unhealthy patient	HOPD ASC Hospital with low/no COVID-19 census	Endoscopies
Tier 2a	Consider postponing surgery/procedure	Intermediate acuity surgery/healthy patient Not life-threatening but potential for future morbidity and mortality. Requires in-hospital stay	HOPD ASC Hospital with low/no COVID-19 census	Low risk cancer Non-urgent spine & ortho: including hip, knee replacement and elective spine surgery Stable ureteral colic Elective angioplasty
Tier 2b	Postpone surgery/procedure if possible	Intermediate acuity surgery/unhealthy patient	HOPD ASC Hospital with low/no COVID-19 census
Tier 3a	Do not postpone	High acuity surgery/healthy patient	Hospital	Most cancers Neurosurgery Highly symptomatic patients
Tier 3b	Do not postpone	High acuity surgery/unhealthy patient	Hospital	Transplants Trauma Cardiac with symptoms Limb threatening vascular surgery

*Hospital Outpatient Department

** Ambulatory Surgery Center

Plastikos implements bio-contamination testing and compliance under ISO 14698
Plastikos (Erie, Pa.) recently announced that it has implemented a formal bio-contamination testing and compliance system that’s in full compliance with ISO 14698-1 and ISO 14698-2 — a move the company described as paramount amid the COVID-19 pandemic. Plastikos and Plastikos Medical presently mold medical devices and parts within multiple ISO-7 certified cleanrooms. The new… […]
How 3D printing is enabling ventilator splitting
Amid the shortage of ventilators due to the COVID-19 pandemic, researchers are finding success using 3D printing to enable “ventilator splitting.” The search continues to go on for more machines, but there have already been government actions taken to increase amounts, while researchers have taken it into their own hands to create homemade-style ventilators. However,… […]
How R&D departments are coping with coronavirus
Hardly anyone’s R&D workplace has been spared all the repercussions of the COVID-19 crisis. People are working remotely, staggering their hours in laboratories to avoid too many coworkers, and relying heavily on conference calls and video meetings. Our WTWH Media sister site R&D World spoke to a few industry people to see how they’re coping… […]
Europe waives tariffs, import taxes on COVID-19 medtech
The European Commission has decided to waive tariffs and value-added taxes (VAT) on certain medical devices and personal protective equipment (PPE) coming from outside the EU during the coronavirus pandemic. The measure includes testing kits, ventilators and other medical equipment and will remain in force for six months, the commission said today. “In this emergency,… […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency when… […]
BARDA opens research portal to fight COVID-19
By James Keller, Emergo Group The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, is seeking information from stakeholders on available medical countermeasures in development. It is particularly interested in products and technologies that have progressed into… […]
Group seeks manufacturers’ input to reduce medical supply shortages
The National Center for Manufacturing Sciences (NCMS) today announced a new partnership with the U.S. Department of Defense (DOD) and the Federal Emergency Management Agency (FEMA) to reduce the critical shortage of medical equipment and supplies due to the coronavirus pandemic. The industry organization said it is seeking feedback from advanced manufacturing companies about capability,… […]
What is medical tubing used for?
Medical tubing is designed for a number of applications that allow clinicians to administer fluid and devices or allow for gas flow. Common applications of medical tubing include ventilators and IVs, but tubing also finds uses supporting access devices and as a delivery method for other devices. For example, tubing can be used to drive […]
Hack the Crisis: Clippard expects growth as it increases production for ventilator pneumatics
Mary Gannon, Fluid Power World Cincinnati-based Clippard said today it expects to hire more staff to meet the growing demand for its components and subassemblies for ventilators, diagnostic equipment and other critical care devices to help fight the coronavirus. The company manufactures valves, electronic pressure controls, custom assemblies, cylinders, air-preparation equipment and fittings for hose… […]
EPA inspector general wants more public input on ethylene oxide exposure
The U.S. Environmental Protection Agency’s inspector general this week recommended opening a channel of communication between government officials and people who live near 25 plants that use ethylene oxide (EtO), including eight used for sterilizing medical devices. But EPA administrator Andrew Wheeler objected, publicly indicating that his office was blindsided by the request. The forum… […]
Don’t curb your enthusiasm, but be realistic about MacGyver ventilators
In a coronavirus pandemic in which patients on the best commercial ventilators will die, are garage enthusiasts ready to stand behind their work? Scott Thielman, Product Creation Studio Almost a decade ago, Dr. Robert Clark, a pulmonologist then at Regional Hospital for Respiratory and Complex Care near Seattle, approached my company with a warning and an… […]