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What We're Reading: Medical Device Approval; Medical Laboratories Sue Government; ACA Sign-Up Deadline

AJMC Staff
FDA is considering a faster approval process for medical devices; the American Clinical Laboratory Association is suing the federal government over a new reimbursement system; there are 2 Obamacare special enrollment periods that a greater-than-usual number of people could be eligible for.

Speeding Medical Devices to Market

A potential new FDA approval process for medical devices could get these products to the market faster. According to The Wall Street Journal, FDA Commissioner Scott Gottlieb, MD, indicated that he would want a faster process with evidence to assess performance at a later date. However, doctors are concerned that such a process could put more patients at risk initially. Medical devices already have a less strict approval process than drugs, but Gottlieb believes the new process will not majorly increase risks to patients.


Medical Laboratory Association Sues Government

The American Clinical Laboratory Association (ACLA) is suing the federal government over a new reimbursement system. The lawsuit claims that the new process would reduce Medicare reimbursement for labs by about $670 million in 2018 alone, reported Reuters. Under a 2014 law, laboratories are required to report private payer rates to Medicare in order for CMS to set reimbursement rates. In the lawsuit, the ACLA contends that CMS cherry-picked data from laboratories that received the lowest private payer rates, rather than using data from all reporting laboratories. As a result, CMS is making deep reimbursement cuts for lab tests.


Open Enrollment Doesn’t End Friday for All

While the deadline for picking Affordable Care Act (ACA) coverage is Friday, December 15, some people will still be eligible to pick plans after that date—they just might not know it. Kaiser Health News reported that there are 2 special enrollment periods (SEPs) that could affect a large number of people eligible for ACA coverage. One SEP is for people whose 2017 plan is being discontinued in 2018, and the second is for people affected by the hurricanes that hit Texas, parts of the southeastern United States, and Puerto Rico.

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