WASHINGTON — A stream of new federal and state healthcare laws and regulations took effect in January and more changes are coming. Meanwhile, the partial government shutdown continues.
Feds, States Implement Raft of Health New Rules in 2019
The new year in the U.S. brings with it ball drops, resolutions, gym memberships… and a raft of new federal and state rules on everything, including healthcare. Among the key changes are Congress’s repeal of the Affordable Care Act’s individual mandate, the Trump administration’s rollback of an ACA provision mandating no co-pay contraception, and requirements for hospitals to post their prices online.
In December 2017, Congress passed a massive tax bill that included a provision scrapping the Affordable Care Act’s (ACA’s) individual mandate penalty requiring all eligible Americans to buy health insurance or pay a fine.
The change took effect January 1, 2019, but even before its enactment most Americans had already made their enrollment decisions. The window for open enrollment on the ACA’s exchanges ended December 15 with some exceptions.
In the past, policy experts have cautioned that the ACA needs both “carrots” and “sticks” in order to remain in balance — with subsidies serving as the carrots — and many warned that stripping the law of the mandate while maintaining the guarantee that individuals can access insurance would lead to millions of people dropping out of the exchanges. Some feared that healthy young people would stop buying insurance and only sick, older adults would enroll, causing premiums to rise and leading to a “death spiral” on the exchange.
For 2019, those predictions haven’t held true. Enrollment dropped only slightly below 2018 figures with 8.5 million Americans enrolling as of mid-December — about 300,000 less than the previous year, Vox reported.
Most Federal Health Agencies OK Despite Shutdown
The partial shutdown of the federal government doesn’t appear to have had an immediate effect on most healthcare-related agencies, but observers expressed concern over what the shutdown might mean for the long term.
The Department of Health and Human Services (HHS), obviously the largest healthcare-related agency, has been largely unaffected by the shutdown, which began at 12:01 a.m. December 22, since most of the department is already funded through fiscal year 2019. However, the FDA is affected because its appropriations fall under a different authorization bill than the rest of HHS, so the agency had to furlough 7,053 staff members; the remaining 10,344 staff members were retained, either because they were performing functions critical to public health and safety, such as protecting ongoing experiments, or because their programs — such as tobacco regulation or new drug development — are funded by user fees.
The Alliance for a Stronger FDA — a group of patient organizations, trade associations, and pharmaceutical and biomedical companies that support adequate funding for the agency — expressed some concerns about the shutdown. “The FDA regulates products that make up 20% of consumer spending,” the organization said in a statement. “The agency’s responsibilities cannot be fully met when 7,000 employees are furloughed. Further, when the FDA is not fulfilling its critical public health responsibilities, there is no backstop to the agency’s work.”
Top CMS Official Departs
Mary Mayhew, director of CMS’s Center for Medicaid and CHIP Services, resigned on Friday to take a new position with Florida Governor-elect Ron DeSantis (R).
“I appreciate her efforts at CMS and I look forward to continuing to work with her as she uses her many talents to help the state of Florida create a healthcare system that serves the needs of its citizens,” said CMS Administrator Seema Verma in a press release.
Mayhew said, “I will forever be grateful to Administrator Seema Verma for allowing me the opportunity to serve this Administration and to help advance her vision of supporting states with increased control over their Medicaid programs to better meet the healthcare needs of their citizens… It is this vision for state flexibility that excites me about returning to the state level to help Governor-elect DeSantis partner with Administrator Verma to serve the citizens of Florida.”
No-Baseline-Needed Concussion Test OK’d
An eye-tracking test for concussion that requires no baseline assessment is cleared for U.S. marketing, said neurodiagnostics company Oculogica.
To be sold as EyeBOX, the 4-minute, non-invasive test is approved for use in patients ages 5 to 67. Oculogica said it’s the first such test to win FDA marketing authorization. Patients watch a short video with their heads placed in a chin-and-forehead rest similar to those commonly used in optometry clinics. Eye movements are analyzed with a proprietary algorithm.
Initial distribution will be limited to “select, qualified sites,” the firm said.
Approval (via the FDA’s “de novo” authorization pathway for novel, low- to moderate-risk devices) was based primarily on a 282-patient clinical study involving children and adults presenting to emergency departments and concussion clinics with head injuries. Patients were evaluated within 2 weeks of injury. Full results have not yet been published.
One journal paper involving another Oculogica study indicated that, in children with suspected concussion, the test achieved 72% sensitivity with 84% specificity when patients were evaluated an average of 22 weeks after injury.
On Friday, the FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee meets to discuss cardiovascular safety data for the gout drug febuxostat (Uloric).