The U.S. Department of Justice (DOJ) reported an indictment of three men alleged to have filed more than $100 million in genetic testing false claims directly or indirectly with the Medicare program. Two of the three defendants face as many as 65 years of incarceration if convicted, a clear sign that federal government agencies in the U.S. are more intent than ever on cracking down on fraud and abuse of federal health programs.
Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.
Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.
The actuary office at CMS reported that U.S. spending on health care grew by a modest rate of 2.7% in 2021, an outcome that would ordinarily prompt cheers by policy wonks who worry about the effect of ever-growing national health expenditures (NHEs) on the larger economy. The problem is that NHE had ballooned by more than 10% in 2020, a rate of growth that was driven in large part by the COVID-19 pandemic, but which statistically overshadowed the growth rate in 2021.
The U.S. CMS has posted a second draft rule that would streamline prior authorizations by Medicare Advantage insurers, a move sure to draw support from patients and clinicians alike. This would be achieved by requiring that payers adopt the Health Level 7 interoperability standard, a requirement that may take every bit of the three years to achieve before a final rule would go into effect under the terms of the proposed rule.
The U.S. Office of Inspector General examined the volume of tests for allergies and respiratory pathogens conducted during the COVID-19 pandemic, and found a few outlier testing labs that billed a conspicuous volume of such tests. While the agency recommended that the CMS examine these claims more closely, the results also suggest that enforcement action may be en route for the more than 160 labs identified as having filed a higher than typical volume of claims for these tests.
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product.
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product. The supporters of the legislation, a bipartisan group of members of the House Energy and Commerce (E&C) Committee, see the legislation as essential as a means of overcoming some of the ambiguities in a 2018 FDA guidance pertaining to communications between manufacturers and payers, and thus a replay of one of the more interesting methods of critiquing an FDA guidance.
In addition to the Medicare inflation rebate and the other pricing reforms of the Inflation Reduction Act, manufacturers of certain Part B drugs will be subject to a refund provision tucked away in the Infrastructure Investment and Jobs Act that was signed into U.S. law last year.
The U.S. CMS had the usual mix of good news and bad news in its hospital outpatient final rule for calendar year 2023, which served up a plate of bad news for Brainscope Inc. and Elucent Medical Inc., which will enjoy no new technology pass-through (NTPT) payments in the coming year for their applications. Conversely, Carlsmed Inc. and Microtransponder Inc. both came out of the annual NTPT scrum with wins, thus ensuring they’ll be able to more rapidly recapture their med tech investments.
