WASHINGTON -- Under a new final rule from the Department of Veterans Affairs, nurse anesthetists won't be allowed to practice independently, and they are predictably steamed. Also, Republican and Democratic members of Congress agreed that MACRA will remain on the books and must be implemented responsibly, and even some liberals said that turning Medicaid into a block grant program could have its good points.
Nurse Anesthetists Planning to Oppose VA Rule
The Department of Veterans Affairs (VA) decision not to allow nurse anesthetists to practice independently in VA facilities will not be the last word on the subject -- if the nurse anesthetists have anything to do with it.
"We definitely have a strategy -- we are not unprepared, just like in our anesthesia lives we're not unprepared," Cheryl Nimmo, DNP, president of the American Association of Nurse Anesthetists, told MedPage Today in a phone interview.
On Tuesday, the VA published a final rule regarding the role of advance practice nurses working in VA facilities. "Certified Registered Nurse Anesthetists (CRNA) will not be included in VA's full practice authority under this final rule, but comment is requested on whether there are access issues or other unconsidered circumstances that might warrant their inclusion in a future rulemaking," the agency said.
Chantix, Zyban Lose Boxed Warning on Psych Effects
The stop-smoking drugs varenicline (Chantix) and bupropion (Zyban) no longer need to carry a boxed warning about serious neuropsychiatric event risk, such as suicidality, the FDA announced Friday.
"We have determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected," the agency said.
However, the drugs' labels will still carry information about the risk in the their warnings sections.
MACRA Implementation Key Issue for Next Congress
Members of the next Congress -- from both sides of the aisle -- will be watching to see whether the Medicare Access and CHIP Reauthorization Act (MACRA) is being properly implemented over the next few years, congressional staff members said here Thursday.
"Making sure MACRA is a success [is important]; we all held hands and jumped on that one," a Republican congressional aide said at the event, which was sponsored by the Alliance for Health Reform and the Jayne Koskinas Ted Giovanis Foundation for Health and Policy. "We all own it, and it needs to be a success, because this was our effort to take ideas from both sides and say 'This is how we want to slowly start reforming the Medicare program.'"
Staff members at the briefing agreed to be quoted only if they were not identified by name.
"Knee Cartilage Repair Product Wins FDA Nod
The FDA approved a novel product to repair damaged knee cartilage, called MACI, in which a patient's own cartilage tissue is engineered to grow on artificial scaffolds and then implanted.
It's the first such product to win FDA approval, the agency said.
MACI consists of autologous cartilage tissue that is expanded ex vivo and attached to a bioresorbable collagen membrane taken from pigs. It is implanted over damaged or surgically removed areas of knee cartilage.
The approval was based primarily on a 2-year, parallel-group trial in which 144 patients received MACI implants or microfracture procedures, which was followed by a three-year extension study. "Overall efficacy data support a long-term clinical benefit from the use of the MACI implant in patients with cartilage defects," according to the FDA.
Medicaid Block Grants: Not Such a Bad Idea?
Turning Medicaid into a block grant program, with states given more flexibility to set their own rules, could improve "social determinants" of health, said health policy scholars and financial experts at a briefing here.
Critics of block granting Medicaid -- allocating lump-sum payments to states to spend as they see fit, within broad guidelines -- have argued that some states might mismanage the funds. Even those straddling the fence emphasize that the fear of block granting being used as a "blunt" budgetary tool is real.
However, both liberal and conservative panelists at the Monday briefing, hosted by the Alliance for Health Reform and sponsored by the faith-based group Ascension, pointed to benefits that could come from a block grant structure.
Several of the GOP Obamacare replacement plans have proposed Medicaid block grants, including one developed by Rep. Tom Price (R-Ga.), tapped to be Secretary of Health and Human Services. Block granting Medicaid was also included in President-elect Trump's healthcare agenda.
FDA Affirms Bladder Cancer Warning for Pioglitazone
The FDA said today that an increased risk of bladder cancer associated with the diabetes drug pioglitazone (Actos and other brands) cannot be ruled out, thus current warnings about the risk will stay on the drug's label.
The conclusion came despite a 10-year study commissioned by Actos manufacturer Takeda showing no increased bladder cancer risk, as well as an independent study conducted in Europe with similar findings.
Earlier this year, a British analysis found a hazard ratio of 1.63 for bladder cancer among patients taking pioglitazone compared with other anti-diabetic agents, although the absolute risk remained very small.
In reviewing these and other studies, the FDA said, "Some studies found an increased risk of bladder cancer with pioglitazone use and others did not ... Overall, we conclude that pioglitazone may be associated with an increased risk in urinary bladder cancer, and we have updated the drug labels to include information about these additional studies."