Enforcement against false claims filed with federal health care programs continues to snare a number of testing clinics as demonstrated by the recent news that a clinical lab has come to terms with federal prosecutors over urine drug testing. MD Spine Solutions LLC, of Reno, Nevada, has agreed to pay up to $16 million to settle allegations that it performed unnecessary urine drug tests, a case brought to the attention of the courts not by a former employee, but by Omni Healthcare Inc., which has been active in the False Claims Act space, thus highlighting the hazards of third-party litigation to clinical lab operators.

The U.S. Centers for Medicare & Medicaid Services’ (CMS) withdrawal of a proposal to provide automatic coverage of FDA-designated breakthrough devices has drawn criticism from device makers, but the industrial reaction runs the gamut.

The Ernst & Young Pulse of the Industry 2021 report outlined several ways med-tech companies can benefit from fundamental changes in business wrought by the pandemic to build a stronger foundation for the future. While the need for more agile supply chains and the drive to measure social and environmental impact as well as financial metrics have affected all economic sectors, COVID-19 transformed the med-tech industry in specific ways that could have long-lasting impact.

The U.S. Office of Inspector General (OIG) said a review of claims for implant of neurostimulation devices indicates that many of these claims lack the data to ensure that the devices were appropriately implanted.

The demise of the Medicare Coverage of Innovative Technologies (MCIT) rule may not be the end of the breakthrough devices coverage story, but Lee Fleisher of the U.S. Centers for Medicare & Medicaid Services (CMS) said the MCIT rule was riddled with deficiencies. Fleisher said CMS is of the view that expedited coverage of breakthrough medical devices would be better handled under existing statutory authorities, suggesting the agency sees no need for the MCIT-driven provisions of the Cures 2.0 legislation.

Physicians occasionally go over the line where Medicare services are concerned, but the U.S. Department of Justice announced Sept. 15 that a cardiologist in Orlando, Fla., went farther than the ordinary illicit billing.

The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the rule for the Medicare Coverage of Innovative Technologies (MCIT) program, an action that predates the agency’s self-imposed deadline of December 2021 by three months. The agency cited some previously discussed issues with the rule, but the move was blasted by industry as thwarting the support of the majority of stakeholders.

Medicare coverage does not necessarily mean appropriate reimbursement levels, a point pressed by Inspire Medical Systems Inc. at the Aug. 23 Medicare outpatient advisory panel hearing. The panel agreed that the company’s hypoglossal nerve stimulation (HNS) device for sleep apnea was subject to an inappropriate device offset figure, which could lead to a Medicare rate increase of more than $7,000 and a significant boost of sales of the company’s flagship Inspire HNS device.

The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed to drop its national non-coverage policy for pulmonary embolectomy, a procedure for which multiple devices have been cleared or approved by the FDA. Several stakeholders, including more than one med-tech trade association, had requested such a change, and CMS indicated that much more evidence will be needed before it can forge a national coverage policy that would eliminate the impending geographically differentiated patient access.

The U.S. Centers for Medicare & Medicaid Services (CMS) had previously waded into a sea of opposition from device makers and medical societies alike in its proposal to eliminate the inpatient-only (IPO) list. The new administration at CMS has proposed to reverse that move and sustain the IPO, which should alleviate concerns that outpatient procedures will ding the reputations of these devices.