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Home » Topics » Regulatory » Medicare

Medicare
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Hospital at home tech2

OIG sees holes in Medicare oversight of remote patient monitoring

Sep. 27, 2024
By Mark McCarty
In some ways, remote patient monitoring (RPM) came of age during the COVID-19 pandemic, but payers still worry about the potential for fraud and abuse. A recent report from the U.S. Office of Inspector General supported concerns about fraud and abuse with RPM, a problem CMS will have to address to constrain unnecessary and potentially illicit spending.
Read More
Lab chip skin wound healing with electricity

Industry wary of CMS’s view of skin substitutes in doc fee draft

Sep. 20, 2024
By Mark McCarty
The draft Medicare physician fee schedule for calendar year 2025 provoked a strong backlash from physician societies due to a net cut in physician pay. Device makers have their own concerns, including the latest in a series of controversies over coverage of skin substitutes.
Read More
Gears with regulatory words

MDMA urges CMS to craft separate outpatient payments for RDN devices

Sep. 19, 2024
By Mark McCarty
The U.S. CMS believes it has a quandary on its hands with regard to transitional pass-through payment for renal denervation devices, but the Medical Device Manufacturers Association urged the agency to provide separate payment mechanisms for these devices as seen in the inpatient final rule.
Read More
US flag, gavel, book

DOJ tracking device industry’s coverage and coding recommendations

Sep. 13, 2024
By Mark McCarty
The U.S. Department of Justice reported that THD America Inc., and its Italian corporate parent company agreed to pay $700,000 over inducing physicians to use incorrect payment codes in Medicare and Medicaid claims.
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Medicare puzzle

Medicare contractors withdraw policy for allograft rejection testing

Aug. 26, 2024
By Mark McCarty
The U.S. CMS said its Medicare administrative contractors withdrew a draft local coverage determination that would have restricted the use of surveillance testing for allograft rejection.
Read More
Gears with regulatory words

Lack of UDIs on claims forms still a source of drag on FDA surveillance

Aug. 20, 2024
By Mark McCarty
The U.S. Government Accountability Office’s report on FDA oversight of medical devices acknowledges that the agency has made strides in its efforts to develop surveillance systems to track adverse events, but there are shortcomings.
Read More
Medicare puzzle

Medicare inpatient final rule adds DRG for ablation, LAA closure

Aug. 15, 2024
By Mark McCarty
Device makers and physicians alike were less than enthused about several features of the draft Medicare inpatient rule for fiscal year 2025, but thanks in part to support from the device industry, the final rule provides a new code that encompasses both left atrial appendage closure and ablation, a change that may reduce spending without dinging sales of these devices.
Read More

US HHS wins another round; associational standing questioned

Aug. 12, 2024
By Mari Serebrov
In turning the U.S. Department of Health and Human Services’ (HHS) one initial defeat into a victory, a federal district court handed HHS a 7-0 record in getting constitutional challenges to Medicare price negotiations dismissed.
Read More
Medicare puzzle

US Medicare’s TCET final fuzzy on definition of ‘similar device’

Aug. 8, 2024
By Mark McCarty
The U.S. CMS announced the release of the Transitional Coverage for Emerging Technologies policy, which is less than clear on the definition of a key term.
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Medicare puzzle

Industry supportive of new DRG code for combination of procedures

July 30, 2024
By Mark McCarty
The U.S. CMS proposed a series of changes to the Medicare series of codes for diagnostic-related groups, and device makers had pointed remarks about some of those proposals.
Read More
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