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Merck and Moderna recently reported that their personalized mRNA cancer vaccine, along with an immunotherapy treatment, was able to reduce the risk of recurrence or death by 42% in patients with melanoma, in today's bite-sized hospital and health industry news from the District of Columbia, Massachusetts, New Jersey, and New York.
- District of Columbia: The Department of Justice's (DOJ) National Fraud Enforcement Division and HHS' Office of Inspector General (HHS-OIG) have issued a new policy allowing healthcare organizations to self-disclose potential criminal conduct to the Fraud Division alone. This change provides organizations with one place to report healthcare-related fraud and receive credit from both federal agencies. HHS also updated its protocol to show that it covers conduct that may violate civil or administrative law while criminal conduct should be referred to DOJ. Overall, both agencies also recommend that organizations seeking credit under both programs report to DOJ's Fraud Division first. "Companies that discover fraud within their own operations should not have to navigate a maze of agencies before reporting it," said Assistant Attorney General Colin McDonald from DOJ's fraud division. "Today, together with our partners at HHS-OIG, we are eliminating unnecessary bureaucratic barriers that have caused confusion about whether companies must make multiple disclosures of potentially criminal conduct. There is now one clear point of contact: DOJ's Fraud Division." (Bosek, Becker's Hospital Review, 10/16; DOJ press release, 10/15)
- Massachusetts/New Jersey: Merck and Moderna recently reported that their personalized mRNA cancer vaccine, along with an immunotherapy treatment, reduced the risk of recurrence or death by 42% in patients with melanoma. In a Phase 3 clinical trial, patients with surgically resected stage 2B to 4 melanoma received the vaccine (intismeran autogene) and the immunotherapy Keytruda. The vaccine was personalized to include up to 34 neoantigens, or proteins specific to each patient's tumor. Overall, the vaccine and immunotherapy combination reduced the risk of recurrence or death by 42%. The combination also reduced the risk of distant metastasis or death by 38% compared to Keytruda alone. Although outcomes in the vaccine group were similar to the Keytruda-only group for the first six months, a sensitivity analysis found that those in the vaccine group had a 58% lower risk of recurrence or death and a 50% lower risk of distant metastasis or death compared to the Keytruda alone after six months. "You've effectively immunized the body to recognize the cancer and kill it," said Marjorie Green, head of oncology clinical development at Merck. According to Green, the company plans to apply for regulatory approval for the vaccine as soon as possible. Recently, interest in cancer vaccines has been growing, with several drugmakers testing their own versions for pancreatic, kidney, and brain cancer. NIH has also announced a public-private partnership to accelerate the development of personalized cancer vaccines. (Gregerson, Becker's Clinical Leadership, 10/22; Agrawal, New York Times, 10/23)
- New York: Oscar Health, which is one of the largest providers of individual health insurance coverage under the Affordable Care Act (ACA), is planning to expand its offerings to one new state and 140 counties next year. The new state Oscar is expanding into is South Carolina, bringing its total coverage region to 21 states. Oscar's expansion plan comes as other health insurers have pulled out of the ACA market. Earlier this year, both Cigna and CVS Health announced that they planned to exit the individual health insurance market, providing an opening for Oscar. "The individual market is built for everyone from entrepreneurs launching businesses to people working part-time to employees and gig workers of companies large and small," said Oscar CEO Mark Bertolini. Aside from its expansion efforts, Oscar is also rolling out several new products and expanding its partnership with the Midwest grocery and pharmacy chain Hy-Vee to include more parts of Iowa, as well as Nebraska, Missouri, and Kansas. (Japsen, Forbes, 10/20)
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