The government shutdown isn't stopping Food and Drug Administration advisory committee meetings scheduled this month, according to drug and device manufacturers.
Some analysts warned that the shutdown could limit the FDA's panel discussions, postpone meetings and ultimately delay product launches and spook investors.
Read more »
PhRMA has sued to block implementation of a rule that lets providers in the 340B drug discount program buy orphan drugs at reduced prices if the drugs are used to treat non-orphan conditions.
Read more »
HHS is searching for the best idea for a system that captures essential data from durable medical equipment, such as loss of power, GPS location and privacy-protected user information during emergencies.
Thousands of people in the U.S. rely on electrically powered durable medical equipment to meet their medical needs at home and often have to find help in shelters or emergency rooms during extended power outages, according to HHS.
The department's office of the Assistant Secretary for Preparedness and Response, or ASPR, kicked off the Ideation Challenge, a contest to find ideas for determining the location and the status of durable medical equipment—such as oxygen concentrators and portable ventilators—to help users in emergencies. The system should also gather the power level and battery life of the equipment and the time and date. HHS envisions a network that's accessible to all those who use durable medical equipment in their homes and sends data securely to other secure information systems.
Read more »
A trade group representing the orthotics and prosthetics industry is accusing the CMS of failing to enforce anti-fraud and abuse laws against unlicensed providers at a time when legitimate providers are coming under fire from increasingly aggressive Medicare recovery auditors.
The American Orthotic and Prosthetic Association—which represents more than 2,000 businesses that manufacture, distribute and supply patients with orthopedic braces and artificial limbs—released the results of a study this week that says the number of Medicare patients receiving the medical equipment from noncertified personnel has not changed significantly even though the rules were tightened in 2000 and 2005.
Read more »
A rule that would require medical devices to be marked with unique identifiers is still stuck in the regulatory process, and the delay is drawing complaints from lawmakers and health systems.
Four House lawmakers sent a letter to the Office of Management and Budget, which has yet to release the final rule for the unique device identification system, urging OMB to provide a status update. It has been six years since Congress mandated the development of a device identification system.
Read more »
A small group of healthcare providers took to the op-ed pages of the New York Times to press their case that the business practices of group purchasing organizations are causing drug shortages.
The group, which is called Physicians Against Drug Shortages, is made up of about seven physicians, a pharmacist and a long-time critic of the GPO industry who say their aim is to restore the supply of generic drugs that have had shortages.
Read more »
Have you heard this joke before?
How do you know when a total joint implant sales rep is at the hospital? When the orthopedic surgeons' cars aren't the nicest ones in the parking lot.
Read more »
Healthcare industry groups are pressing regulators to issue the delayed final rule requiring manufacturers to mark medical devices with unique identifiers to improve patient safety and help healthcare providers during product recalls.
Read more »
