Today's News and Commentary

About pharma

FDA Plans Meeting on Real-World Evidence, Patient-Focused Drug Development: “The FDA has scheduled a Nov. 7 public meeting to discuss how to improve its drug development programs in the Office of New Drugs (OND) with the use of real-world evidence and an increase patient focus.”

U.S. FDA approves TB Alliance's treatment for drug-resistant tuberculosis: The FDA approved the non-profit TB Alliance’s triple drug regimen to treat multi-drug resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB). The therapy is over 6 months versus the standard 2 year course- a significant improvement to aid compliance.

Top 10 all-star drugs in 2024: Humira's captain, but who else makes the roster?: The headline is a teaser for which drugs will reach the top of the sales charts in 5 years. As you read the list, contrast which are biologics and which are traditional “small molecules.”

Boehringer, MD Anderson build out 'virtual R&D center' for cancer research: This partnership is the most recent example of industry-medical center cooperation, in this case to develop oncology drugs.

Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018: “Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.”

About healthcare IT

VA releases tool for better integrating agency’s dozens of apps: “The VA’s new Launchpad app includes the ability to view and share electronic health records, book medical appointments, refill prescriptions, as well as communicate with the agency’s healthcare providers.”

About health insurance

Harvard Pilgrim Health Care, Tufts Health Plan to merge: This merger will give significant local market power to the new organization, which will “serve 2.4 million members in Massachusetts, Maine, Rhode Island, Connecticut and New Hampshire and would offer both employer-sponsored and government plans.”

Appeals court revives changes to Medicaid DSH payment rules: DSH [Disproportionate Share Hospital] payments are federal government subsidies to those facilities providing high volumes of care to Medicaid and uninsured patients. In 2017, CMS formalized a previous opinion that DSH payments should subtract third-party payments, such as those from private insurers and Medicare. That CMS decision prompted a group of children's hospitals to “ file a lawsuit claiming CMS overstepped its authority.” A federal judge ruled in favor of the hospitals, finding that the rule is inconsistent with the plain language of the Medicaid Act. CMS appealed the ruling, and the U.S. District Court of Appeals for the D.C. Circuit overturned the lower court's ruling. Will this decision be appealed by the plaintiffs and reach the Supreme Court? Many hospitals’ finances will depend on this critical decision.

As States Strive To Stabilize Insurance Marketplaces, Insurers Return: The Kaiser Family Foundation writes that since more states have implemented programs to stabilize their insurance markets (like premium subsidies and reinsurance programs), more private insurers will enter or return to them.

Will Increasing Primary Care Spending Alone Save Money?: Authors of this study point out that evidence for an affirmative answer to the title question is lacking. What they fail to point out are three important factors about primary care. First, many practitioners are not trained or inclined to deliver broad-based services. For example, many internists refer their diabetic patients to podiatrists to cut toenails when they could deliver the same service as part of routine office visits. Second, even if primary care physicians did deliver such services, they are also not trained or inclined to manage entire episodes of care. Finally, higher payments are needed to attract physicians to primary care specialties. Compare primary care physician income to other specialties and it is no wonder there is such shortage.

About healthcare quality and patient safety

Rating the Raters: An Evaluation of Publicly Reported Hospital Quality Rating Systems: Six experts in quality methodology graded four hospital quality rating reports. This is a landmark evaluation of the reported evaluating the reporters. Their findings? “There were no hospital quality rating systems meriting an A or A-. The highest grade received was a B by U.S. News. The CMS Star Ratings received a C. The lowest grades were for Leapfrog (C-) and Healthgrades (D+) (Table 3). We qualitatively agreed that the U.S. News rating system had the least chance of misclassifying hospital performance. There was considerable agreement in overall grade assignments among the six individuals who performed the ratings.” Read the study for details.