Unbiased Analysis of Today's Healthcare Issues
In July 2018, FDA released the Biosimilars Action Plan (BAP), which outlined FDA’s approach for expanding access to biosimilars for the American public. The plan focused on 4 key areas: A recent FDA report reviews some of their accomplishments since then. Most of these efforts revolve around guidance documents, additional staff, education products and websites,…
A federal judge says ‘no’. Endpoints reports: A New Jersey federal judge on Monday tossed cases brought by Johnson & Johnson and Bristol Myers Squibb against the Inflation Reduction Act, another victory for the law while Medicare works through the first year of price negotiations with industry. In a summary judgment, Judge Zahid Quraishi ruled…
According to the 2019 NSDUH survey, 27.7 percent of 18-22 year olds who are not enrolled in college full-time and 33.0% of 18-22 year old full-time college students reported binge drinking in the past month. Should society impose stricter restrictions on drugs and alcohol for younger individuals? On the one hand, drugs and alcohol harm…
While CMS has a target of getting 100% of Medicare beneficiaries into value-based payment (VBP) programs–such as accountable care organizations–by the end of the decade, implementing VBP in practice will be challenging. An editorial by Navathe et al. (2024) in Health Affairs provides some key considerations. Providers forego certain revenue for uncertain ‘bonus’ payments. “One…
Progression-free survival (PFS) is a surrogate endpoint is defined as follows (by ChatGPT): In essence, PFS refers to the length of time during a clinical study or treatment regimen where a patient’s disease doesn’t worsen or progress. For instance, in cancer research, it measures the time from the start of treatment until the cancer shows…
Medical debt in the U.S. is a major problem. While over 90% of individuals have health insurance, many people are uninsured and even those with insurance may be liable to high deductibles and copayments. A Kaiser Family Foundation (KFF) analysis uses data from Survey of Income and Program Participation (SIPP) and finds that: …20 million…
LLM approach expert levels in ophthalmology. Price controls in health care (Argentina) Will bird flu (H5N1) animal pandemic spread to humans? Lex Fridman interview with Mark Cuban (with discussion of Cost Plus Drugs) Spotlight on Medicare’s Chronic Care Management program.
Medicare Advantage (MA) plans have a number of advantages and drawbacks over traditional Medicare (TM) (i.e., fee-for-service). One advantage of MA plans is that cost sharing is often lower. Another benefit is that enrollees may receive additional coverage benefits. One drawback is that enrollee provider choice may be restricted. Fewer provider options may be bad…
Some key trends to watch from some of my colleagues at FTI in their article The Evolution of Healthcare: Trends to Watch in 2024. Commercialization of Healthcare. Over the past decade, private equity’s presence in the healthcare sector has significantly accelerated, with annual deal values soaring from $41.5 billion in 2010 to $119.9 billion in…
Samsung Bioepis has a Biosimilar Market Report for Q2 2024. Some key highlights: As of April 2024, the FDA has approved a total of 48 biosimilars across 15 unique biological molecules. Of the 48 approvals, 38 biosimilars have launched in the US market. In Q2 2024, 3 new biosimilars were approved in the US (Simlandi…