The U.S. Government Accountability Office (GAO) recently published a report on the pandemic-driven expansion of telehealth for Medicare beneficiaries, and pointed to some privacy and security risks of which patients may be unaware. However, GAO also noted that the CMS does not yet have a good handle on the rate of telehealth fraud and has not yet collected reliable data on telehealth outcomes, two gaps that will have to be filled if Congress is to comfortably vote to make permanent some of these pandemic-driven telehealth policies.
The U.S. response to the emergence of the COVID-19 pandemic may by now be the stuff of public health policy lore, with both the FDA and the CDC contributing to the chaos in the first months of the pandemic. The Office of Inspector General has issued an analysis of the situation, and while OIG revisited some of the known miscues, the report also made the case that a national strategy for pandemic response will be needed if federal government efforts in the future are to be less a hazard to the lives of American citizens than those seen in the first half of 2020.
Payers are known to have a significant burden in crafting coverage and reimbursement policies for in vitro diagnostics, but Gillian Hooker, chief scientific officer at Concert Genetics Inc., of Nashville, Tenn., told an audience at the Next Generation DX Summit that the dilemma may be more expensive than commonly appreciated. Hooker said administrative costs may add as much as $125 per administered test, an artifact of a fragmented value chain that seems to enjoy few, if any prospects of improvement in the near term.
Davita Inc., lost a U.S. Supreme Court ruling regarding limits to the private payer coverage for outpatient dialysis services despite, a development that took a double-digit bite out of Davita’s shares. However, shares of competitor Fresenius also took a hit, suggesting that the market sees the decision as a major setback for both companies.
The U.S. CMS has suspended the rulemaking for payment for radiation oncology for Medicare patients, but the suspension hasn’t assuaged the fears of industry and health care professionals. Anne Hubbard, health policy director for the American Society for Radiation Oncology told BioWorld that despite the suspension, CMS’s interest in the much-criticized proposal for site-neutral payment is unlikely to ebb anytime soon.
Clinical laboratories and hospitals have routine commercial interactions, and most of those are entirely legal, but this is not always the case. The Office of Inspector General (OIG) at the U.S. Department of Health and Human Services recently decreed that an arrangement in which the hospital pays the lab for blood specimen collection handling services, or a “draw fee,” would not be permissible under the Anti-Kickback Statute (AKS), reinforcing an existing understanding that such activities present a significant legal hazard for operators of clinical labs.
Making his first in-person appearance April 27 before the House Energy and Commerce Subcommittee on Health, U.S. Health and Human Services Secretary Xavier Becerra was prepared to answer questions about President Joe Biden’s fiscal 2023 budget that would increase HHS’ discretionary budget to $127 billion, nearly a 27% increase over the 2021 enacted level.
The release by the U.S. CMS of the final national coverage determination (NCD) for Biogen Inc.’s Alzheimer disease (AD) drug, Aduhelm (aducanumab), lit speculation on the meaning for others in the space. CMS is “still being conservative,” said Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “We’re in a new era. It’s unprecedented that Medicare doesn’t pay for a drug that received approval from the FDA,” even though it was not a full but an accelerated clearance.
The spike in U.S.-based telehealth visits during the COVID-19 pandemic was greeted with cheers among advocates of the technology, but the Government Accountability Office (GAO) has advised the Centers for Medicare & Medicaid Services (CMS) to take a closer look at the benefits of telehealth for Medicaid beneficiaries.
The U.S. Center for Medicare & Medicaid Services (CMS) opened a 30-day comment window on its proposed national coverage determination (NCD) to limit Medicare access to monoclonal antibodies targeting amyloid beta in Alzheimer’s disease (AD) only in clinical trials. Biogen Inc., clearly the target, along with its AD treatment Aduhelm (aducanumab), was among the first to respond.
