RISE summarizes the latest regulatory headlines that impact the health care industry.

CMS rescinds MCIT/R&N final rule for failure to protect Medicare patients

The Centers for Medicare & Medicaid Services (CMS) announced Friday it will repeal the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule because of concerns that the provisions in the final rule may not have been sufficient to protect Medicare patients. By rescinding the rule, CMS said it can take action that will better address those safety concerns in the future. 

The final rule was published on January 14 and was supposed to take effect on Dec. 15.

“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” said CMS Administrator Chiquita Brooks-LaSure in the news release. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”

The MCIT/R&N final rule would have granted expedited Medicare coverage for up to four years for certain Food and Drug Administration (FDA)-designated “breakthrough” devices once it receives or clears market authorization. However, the kinds of clinical studies needed for FDA market authorization might not consider the differences in clinical profiles, complexities of medical conditions, or associated treatments of the diverse population of Medicare patients.

CMS said it intends to explore coverage process improvements that will enhance access to innovative and beneficial medical devices in a way that will better suit the health care needs of people with Medicare. This will also help to establish a process in which the Medicare program covers new technologies based on scientifically sound clinical evidence, with appropriate health and safety protections in place for the Medicare population. 

“CMS is committed to coverage that provides an appropriate balance of support for innovation with necessary protections for Medicare patients,” said Dr. Lee Fleisher, CMS chief medical officer and director for the Center for Clinical Standards and Quality (CCSQ). “Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions.”

While CMS is officially rescinding the MCIT/R&N final rule today, there remain existing and proven pathways that allow for coverage of a specific medical device or service. Devices may still be covered through claim-by-claim determinations, under one or more local coverage determinations, or a national coverage determination. CMS plans to work with the FDA, Agency for Healthcare Research and Quality, medical device manufacturers, and other stakeholders to develop a process to cover innovative devices that benefit Medicare patients and intends to hold at least two stakeholder public meetings in CY 2022 to inform future policy-making in this space.

Justice Department sues Uber for overcharging people with disabilities

The Justice Department this week filed a lawsuit against Uber Technologies Inc. (Uber) for charging “wait time” fees to passengers who, because of disability, need more time to enter a car. The lawsuit, filed in the U.S. District Court for the Northern District of California, alleges that Uber violated Title III of the Americans with Disabilities Act (ADA), which prohibits discrimination by private transportation companies like Uber.

According to the Justice Department, in April 2016, Uber began charging passengers wait time fees in several cities, eventually expanding the policy nationwide. Wait time fees start two minutes after the Uber car arrives at the pickup location and are charged until the car begins its trip.

The department’s complaint alleges that Uber violates the ADA by failing to reasonably modify its wait time fee policy for passengers who, because of disability, need more than two minutes to get in an Uber car. Passengers with disabilities may need additional time to enter a car for various reasons. A passenger may, for example, use a wheelchair or walker that needs to be broken down and stored in the car. Or a passenger who is blind may need additional time to safely walk from the pickup location to the car itself. The department’s lawsuit alleges that, even when Uber is aware that a passenger’s need for additional time is clearly disability-based, Uber starts charging a wait time fee at the two-minute mark.

The lawsuit seeks relief from the court, including ordering Uber to stop discriminating against individuals with disabilities. Additionally, the department asks the court to order Uber to modify its wait time fee policy to comply with the ADA; train its staff and drivers on the ADA; pay money damages to people subjected to the illegal wait time fees; and pay a civil penalty to vindicate the public’s interest in eliminating disability discrimination.

“People with disabilities deserve equal access to all areas of community life, including the private transportation services provided by companies like Uber,” Assistant Attorney General Kristen Clarke for the Justice Department’s Civil Rights Division said in the announcement. “This lawsuit seeks to bring Uber into compliance with the mandate of the Americans with Disabilities Act while sending a powerful message that Uber cannot penalize passengers with disabilities simply because they need more time to get into a car. Uber and other companies that provide transportation services must ensure equal access for all people, including those with disabilities.”

KFF: Average family premiums rose 4% this year to top $22K

Annual family premiums for employer-sponsored health insurance rose 4 percent to average $22,221 this year, according to the 2021 benchmark Kaiser Family Foundation (KFF) Employer Health Benefits Survey released this week. The survey found that on average, workers this year are contributing $5,969 toward the cost of family coverage, with employers paying the rest. This year’s survey also assesses how the pandemic affected workplace health benefits, including mental health services and telemedicine.

KFF conducted the annual employer survey between January and July of 2021. Researchers surveyed 1,686 randomly selected, non-federal public and private firms with three or more employees that responded to the full survey. An additional 2,413 firms responded to a single question about offering coverage.

The annual change in premiums roughly matches the year-to-year rise in workers’ wages (5 percent) and inflation (1.9 percent), though what workers and employers pay toward premiums over time has risen more quickly. Since 2011, average family premiums have increased 47 percent, more than wages (31 percent) or inflation (19 percent).

About 155 million Americans rely on employer-sponsored coverage, and the 23rd annual survey of nearly 1,700 small and large employers provides a detailed picture of the trends affecting it. In addition to the full report and summary of findings, the journal Health Affairs is publishing an article with select findings online and in its December issue.

Among large employers with at least 200 workers, half report that health care utilization among their plan enrollees has been about what they expected for the most recent quarter. More say utilization has been below expectations (32 percent) than above it (18 percent), consistent with other data showing a slowdown in total health spending during the COVID-19 pandemic.

“In a year when the pandemic continued to cause health and economic disruption, there were only modest changes in the cost of employer-provided health benefits,” said Gary Claxton, a KFF senior vice president and director of the Health Care Marketplace Project, in the survey announcement. “Some employers adapted their plans to address mental health and other challenges facing their workers due to COVID-19.”

Among firms with at least 50 workers that offer health benefits, almost four in 10 (39 percent) report making changes to their mental health and substance abuse benefits since the beginning of the pandemic.

This includes 31 percent who increased the ways enrollees can access mental health services, such as through telemedicine, and 16 percent who offered new mental health resources, such as an employee assistance program. Small shares say they expanded their in-network mental health and substance abuse providers (6 percent), waived or reduced cost-sharing for related services (4 percent) or increased coverage for out-of-network services (3 percent).

Overall 12 percent of employers with at least 50 workers that offer health benefits reported an increase in their enrollees’ use of mental health services. Among the largest employers (with 1,000 or more workers), more than a third (38 percent) reported such an increase.