Physicians and device manufacturers don’t always see things the same way, but there are large areas of overlap, such as the impact of prior authorization and the effects of certificates of need for radiology facilities. These two issues came up in a hearing of the House Small Business Committee, suggesting that legislation may be forthcoming that would tackle these and other issues that hamper both the practice of medicine and sales of medical devices.
Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial.
A committee of the U.S. House of Representatives met to review the Medicare coverage procedure for innovative drugs and devices, an event that seemed to gin up support for legislation that would help to streamline those processes. The problem for drug and device makers, however, may be that the Centers for Medicare & Medicaid Services
continues to labor under a flat appropriations picture that is eroding daily thanks to inflation.
The False Claims Act (FCA) has generated billions of dollars in fines each year in the U.S., and Atlanta-based Nextgen Healthcare Inc., is the latest to find itself on the wrong end of a whistleblower lawsuit based on the FCA. The U.S. Department of Justice reported that Nextgen will hand over $31 million to settle allegations that the vendor of electronic health records (EHR) not only misrepresented the capabilities of its software, but also paid kickbacks to physician providers to use its software, a pair of violations that have dinged the company’s finances and its reputation.
The U.S. CMS has released the draft Medicare physician fee schedule for calendar year 2024, inviting rebuttal from physician groups thanks to a proposed cut in rates of 1.25%. However, the draft’s proposed cut of roughly 2% for radiation oncology services has also provoked stakeholders who blasted the proposal as a detriment to cancer care, a particularly ironic move given the emphasis on the Biden administration’s Cancer Moonshot.
The U.S. CMS is proposing to expand coverage of angioplasty and stenting for the carotid arteries to include patients who currently cannot receive this treatment for carotid artery stenosis outside of a clinical trial, generally a cause for celebration among device makers. However, Silk Road Medical Inc. is one possible exception to the overall picture as utilization of its transcarotid artery revascularization (TCAR) system may suffer as a result.
The counterintuitive side of preventing a health crisis prompted by antimicrobial resistance showed itself at a July 11 U.S. Senate hearing, with witnesses saying that antibiotics exist to treat current infections but they often don’t have staying power in the market.
South Korea is making progress towards incorporating digital medical devices into its health care system and facilitating reimbursements, but these efforts may require giving up some entrenched practices. “Digital medical devices” covers a broad range of products, including software and technologies used in therapeutic interventions. They are usually supported by technologies like the Internet of Things (IoT), artificial intelligence (AI), cloud computing, machine learning, sensors and wearables, data analytics and others that can facilitate the shift from traditional health care into the digital world.
Electromedical Products International Inc. (EPI) Alpha-Stim AID technology is finally being made available by the NHS in the U.K. to treat patients with anxiety some two years after the National Institute for Health and Care Excellence (NICE) said there was not enough good-quality evidence to support the case for routine adoption.
The U.S. CMS posted a draft rule for home health payments for calendar year 2024, but the agency is not out of the woods yet with the established rule for CY 2023. The National Association for Homecare & Hospice (NAHC) announced July 6 that it has filed a lawsuit in the District Court for the District of Columbia seeking a reversal of rate cuts imposed by the agency for 2023, the results of which could spill over into the current round of rulemaking for home health payments.