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.
Summer is the time when device makers press their cases for add-on and pass-through payments from the Medicare program, and this year’s draft hospital outpatient prospective payment system for calendar year 2024 is no exception. Both Cook Medical and Philips North America are pushing CMS for new technology pass-through (NTPT) payments for their offerings, but these two larger firms have a lot of company in the NTPT sweepstakes.
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.
In releasing a revised guidance June 30 detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services addressed some of the issues raised in recent constitutional challenges to the guidance and the underlying negotiation provision in the Inflation Reduction Act.
Beneficiaries in the U.S. Medicare program have access to several technologies and procedures for treatment of glaucoma, but Medicare administrative contractors (MACs) seem to be looking sideways at some of these offerings. Both Wisconsin Physician Services and Palmetto GBA have floated draft local coverage proposals that deem procedures such as goniotomy and the combination of canaloplasty and trabeculectomy to be investigational, suggesting that claims for these and other services and devices will not be paid by these MACs.
Most enforcement activities in the U.S. related to physician participation in fraud deal with activities that run to six figures at most, but the U.S. Department of Justice (DOJ) reported recently that it has snared a much bigger fish.
As the clock ticks toward the “full,” or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug when the approval comes.
U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure made her first appearance April 26 before the House Energy and Commerce’s Subcommittee on Health, ostensibly to discuss legislative solutions to increase transparency and competition in health care. But member after member, regardless of political party, demanded answers about why CMS continues to severely restrict access to Eisai Co. Ltd.’s Alzheimer’s drug, Leqembi (lecanemab), especially since another government agency is covering it for all veterans that meet the labeling requirements.
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