This week in managed care, the top stories included the announcement that Kentucky is the first state approved to require patients work to receive Medicaid benefits; FDA Commissioner Scott Gottlieb, MD, reveals a new program to improve clinical trial transparency; research finds the worst cases of attention-deficit/hyperactivity disorder could lower life expectancy.
States can now make people work for Medicaid, the FDA moves to boost clinical trial transparency, and an expert finds the worst cases of ADHD could lower life expectancy.
Welcome to This Week in Managed Care, I’m Laura Joszt.
Medicaid Work Requirements
States can now require able-bodied adults to work for Medicaid benefits, following guidance that CMS sent in a letter to state Medicaid officials.
CMS said states can submit plans to require working age adults to get a job, perform community service, attend school, act as a caregiver, or seek treatment for drug addiction.
States can allow exemptions during times of high unemployment or in areas with limited transportation.
Kentucky, the first state to see its plan approved, will charge premiums for Medicaid on a sliding scale.
Said CMS Administrator Seema Verma: “Medicaid needs to be more flexible so that states can best address the needs of this population. Our fundamental goal is to make a positive and lasting difference in the health and wellness of our beneficiaries.”
It is expected that the elderly, disabled, and pregnant women will be exempt, but critics of the plan say the guidance is not clear cut, and they note the federal government will offer no new funds to administer work rules.
Congressman Frank Pallone of New Jersey, a Democrats who played a key role in passage of the Affordable Care Act, said allowing work rules violates the Medicaid statute. “By allowing states to impose harmful work requirements, the Trump administration is endangering the life support systems millions of vulnerable Americans rely on every day.”
Kentucky’s Republican governor, Matt Bevin, said if the courts do not allow him to put his new work rules in place, he will cancel Medicaid expansion in his state, which has provided coverage to more than 500,000 people. Bevin’s plan allows Medicaid recipients to lose coverage for up to six months if they fail to meet work requirements.
Clinical Trial Transparency
The FDA is taking steps to boost transparency in clinical trials, through a new pilot program it hopes will increase innovation in drug development.
The program will work with sponsors of nine recently approved new drug applications to post information from clinical study reports, which contain methods and results. FDA will work to share the information that offered the most insight into its decisions on safety and efficacy.
Said FDA Commissioner Scott Gottlieb, MD, “These summaries provide important context on the basis for our approval decisions. But they are packaged in a format that can sometimes make it difficult for external audiences to extract all of the detailed clinical evidence that supported the FDA’s approval decision.”
Gottlieb shared the plan at a symposium at Johns Hopkins, where he said the FDA is also working to add ClinicalTrials.gov numbers to FDA communications about specific drugs.
First Treatment for BRCA-Mutated Breast Cancerr
This week, FDA approved a new use for AstraZeneca’s olaparib, sold as Lynparza. The drug was approved to treat patients with BRCA-mutated HER2-negative metastatic breast cancer. Along with the new indication, FDA approved a companion diagnostic, the BRACAnalysis CDx by Myriad Genetics.
Said AstraZeneca’s Dave Fredrickson: “This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved outside of ovarian cancer.”
ADHD and Life Expectancy
A presentation at a meeting last weekend suggested that patients with the worst cases of attention-deficit/hyperactivity disorder (ADHD) could have sharply lower life expectancy.
Russell Barkley, PhD, used a large database created by a center for actuarial studies for a pilot analysis, which he said shows that those with the worst cases of ADHD could see a 25-year reduction in life expectancy.
Barkley was speaking at the American Professional Society of ADHD and Related Disorders (APSARD), and noted that other research supports his hypothesis. Adults with ADHD are more likely to have risk factors that include:
For more on Dr Barkley’s presentation and other exclusive meeting coverage, visit the APSARD page.
Health IT Issue
Finally, AJMC® this week published its annual issue on health information technology (IT), which asks whether IT has become a mandatory part of health and healthcare.
The issue, featuring an essay by special guest editor Jacob Reider, MD, covers topics from electronic health records to the use of personal technology. Highlights include:
For all of us at the Managed Markets News Network, I’m Laura Joszt. Thanks for joining us.