IMDA eNews 030723

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Albuterol shortage may be long-term

An ongoing shortage of albuterol – commonly used to treat people with breathing difficulties such as asthma, bronchitis and emphysema – is expected to get worse following the shutdown of Akorn Operating Company, the only company to make certain albuterol products used for continuous nebulizer treatment, reports CNN. Liquid albuterol has been in short supply since last summer and has been on the FDA’s shortages list since October. With the Akorn shutdown, products from the one remaining major domestic source of liquid albuterol — Nephron Pharmaceuticals — have been on back order, according to Paula Gurz, senior director of pharmacy contracting with Premier.

Advamed: Faster coverage needed for breakthroughs

AdvaMed – an association for medical manufacturers – has asked the 118th Congress to find a way for faster Medicare coverage for breakthrough medical innovations. The association called for Congress to pass legislation similar to the Ensuring Patient Access to Critical Breakthrough Products Act, introduced last Congress by U.S. Rep. Suzan DelBene (D-Wash.) and the late Rep. Jackie Walorski (R-Ind.). A March 2022 study by the Stanford Byers Center for Biodesign found it takes an average of five years for medical technologies to achieve nationwide coding, coverage, and payment. 

What’s holding up Medicare coverage for medical innovation?

Speaking of breakthrough devices, the Stanford Byers Center for Biodesign identified six factors that hold up Medicare coverage for devices cleared for marketing by the FDA:

·       Coding: Assignment of specific billing codes (AMA CPT process) to replace provisional codes takes time and requires evidence on clinical use.

·       Coverage: FDA-approved products can be billed on an individual claim basis, but “local” coverage decisions may be unclear, and (infrequently but importantly) the need for a National Coverage Determination may result in delays.

·       Payment: New technology add-on payment (NTAP) may be needed for costly devices used in inpatient settings or other bundled payment programs.

·       Evidence: Breakthrough devices are cleared for marketing with limited evidence on long term outcomes and durability and other evidence of real-world success.

·       Confidence: Beneficiaries and clinicians need evidence and experience to make confident decisions about using a new device.

·       Appropriateness and value: Medicare services are increasingly delivered through Medicare Advantage plans and accountable providers and specialists in Traditional Medicare. There is increasing concern about treatments that are high cost, relative to available evidence of their benefits. 

Self-charging face mask

A research team at City University of Hong Kong reports it has engineered a face mask that can continuously replenish its electrostatic charge as the user wears and breathes through the mask, increasing the filtering performance for up to four hours, reports Medical Device and Diagnostic Industry. The mask sandwiches an electrospun polyvinylidene fluoride (PVDF) nanofiber filter medium between two triboelectric nylon fabric layers. With this, the self-charging air filter continuously generates electrostatic charges excited by breathing. The researchers say the mask maintained a high efficiency of 95.8% after 60 hours of testing. That testing included 30 hours of wearing.

Renal denervation for treatment of high blood pressure

Patients whose high blood pressure persists despite medication and lifestyle changes can be treated with renal denervation, a minimally invasive procedure that uses a radiofrequency or ultrasound device on a catheter to ablate nerves in the renal artery, according to a consensus statement in the European Heart Journal, reports MedTech Dive. Early on, clinical trial failures loomed over the treatment, but results of more recent randomized controlled trials point to safety and efficacy. Based on these findings, an expert panel recommended the treatment as an option for patients whose high blood pressure hasn’t responded to lifestyle changes and taking a combination of three blood pressure medications. It is also a viable option for patients who can’t tolerate long-term therapy using antihypertensive medication.