WASHINGTON — The Trump Administration released a final rule giving small businesses (potentially including private-practice physicians) a way to buy cheaper insurance, which critics call “junk” plans; and the FDA approved the first long-term implantable continuous glucose monitor (CGM).
Labor Dept. Issues Final Rule on Association Health Plans
The Trump Administration rolled out a final rule on association health plans (AHPs) Tuesday — a rule supporters say will allow more small businesses to access affordable health insurance, while critics charge that it will leave purchasers vulnerable to higher premiums and coverage denials.
“As the cost of insurance for small businesses has increased, the percentage of small businesses offering coverage has dropped substantially,” Labor Secretary Alex Acosta said on a teleconference with reporters. “Today the Trump administration hopes to level the field by expanding access…. [This] will offer millions of American more affordable coverage options.”
The idea behind AHPs is to allow small businesses to band together as associations — organized either by geographic region or business type — to purchase health insurance for their employees. Although a few such plans currently exist, they are subject to Affordable Care Act regulations as well as restrictions on recruiting from across state lines.
FDA OK’s 90-Day Implantable Continuous Glucose Monitor
The FDA approved the first long-term implantable continuous glucose monitor (CGM), the maker Senseonics announced.
The Eversense CGM System features an implantable glucose sensor that can remain in place for up to 3 months, beating out the usual wear time of 3-10 days for many of the other CGMs currently available.
The small cylindrical device, measuring 3.5 Ă— 18.3 mm, is made of a fluorescence-based glucose sensor implanted subcutaneously under local anesthesia in the patient’s upper arm. The glucose data is then transmitted via Bluetooth to the user’s mobile application and stored in a HIPAA-compliant cloud. Indicated for use in adults age 18 and older with diabetes — type 1 or type 2 diabetes — the CGM is intended to be used in addition to traditional fingerstick blood glucose monitoring.
‘We Have Failed’ at Giving Diet Advice, Says Former FDA Chief
“I’m not sure I know what to eat.”
Was this a child at a buffet, or maybe someone on a sodium-restricted diet wondering which foods contain salt? No, these were the words of former FDA commissioner David Kessler, MD, trying to figure out what his own regular diet should be.
“Something has led all of us to get bigger and bigger,” Kessler said Wednesday at an event sponsored by The Washington Post and the BlueCross BlueShield Association. “It’s coming from what we eat and we don’t fully understand it … I think we have failed in giving nutritional advice to people. If diet and exercise were the answer, we’d all do it and there wouldn’t be a problem.”
The country needs to “go back to the basics” when it comes to nutrition research, he continued. “I think it’s time to set up a National Institute for Nutritional Sciences and try to get answers to very basic questions — Is a calorie a calorie? Can I eat unprocessed meat? What’s going on in my brain? I think we have failed the American public when it comes to giving them basic information.”
Physicians Unhappy with Child Immigrant Detention Policy
Despite President Trump’s executive order to stop immigrant children from being separated from their parents at the border, the physician community has kept up its attacks on the former policy and questioned whether the new version adequately addresses the concerns.
For starters, Trump’s order didn’t indicate how, if, or when the approximately 2,300 children who have already been removed from their parents under the earlier policy will be reunited with them.
“The fact that the president is now saying we are not going to separate parents and children … that’s a good first step. But there’s a lot of ‘now what’s,'” said Colleen Kraft, MD, MBA, president of the American Academy of Pediatrics.
“Once they’re reunited, we cannot put these kids in a situation where they’re re-traumatized,” she stressed, panning the idea of families being held together in detention centers.
FDA Shakes Up Guidance on Antidepressant Trial Design
The FDA released new draft guidance for development and testing new pharmacologic agents indicated to treat major depressive disorder.
For example, the new guidance offers specifics on testing the emerging classes of rapid-action antidepressants such as ketamine and its analogues. The guidance also notes that because placebo effects in depression are so strong, traditional non-inferiority trials comparing two active drugs are impossible, and thus all trials of new agents must include a placebo group.
Studies assessing drugs indicated for maintenance treatment should last at least 6 months, the FDA stated, and should also include long-term safety considerations. Of note, the agency also highlighted interest in exploring if treatment response with maintenance treatment can be sustained at a lower dose than what’s needed for short-term efficacy, and whether or not tolerability can improve with a lower maintenance dose.
On Monday, the National Comprehensive Cancer Network hosts a policy summit to discuss new innovations in cancer care.
On Tuesday, the Senate Finance Committee will discuss drug price affordability.
Also on Tuesday, the Heritage Foundation hosts a discussion about why free-market principles matter in healthcare.
And the FDA hosts a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to assess another oxycodone product formulated to deter abuse.
On Wednesday, the Senate Committee on Homeland Security and Governmental Affairs will address the issue of Medicaid fraud and overpayment.
And the Senate Health, Education, Labor and Pensions Committee will explore ways to reduce healthcare costs.
Also the Senate Committee on Veterans’ Affairs will discuss the nomination of Robert Wilkie for Secretary of Veterans Affairs.
And the National Academies of Science, Engineering and Medicine will examine disparities in access to genomic medicine.
On Friday, the Alliance for Health Policy hosts a briefing on healthcare costs in America.