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Medicare Expands Coverage of “Breakthrough” Medical Devices and Codifies “Reasonable and Necessary” Standard

On January 14, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published a final rule that significantly alters the Medicare reimbursement landscape for medical devices approved under the Food and Drug Administration’s (“FDA”) “Breakthrough Devices Program.” The rule, which represents the culmination of years of advocacy by the medical device industry and patient and provider interest groups, finalizes a September 1, 2020 proposed rule that aimed to address the substantial time lag between FDA authorization of medical devices and Medicare coverage of the same. Specifically, the rule establishes a Medicare Coverage of Innovative Technology (“MCIT”) pathway for Medicare coverage of Breakthrough Devices and related medical procedures during a four-year period that begins immediately upon FDA marketing authorization. The final rule also codifies the definition of the “reasonable and necessary” standard that is used to determine when other items and services (and MCIT devices after the four-year period) may be covered by the Medicare program. The new rule becomes effective March 15, 2021.

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House Members Send Letters to FBI, NIH Directors on Possible Racial Profiling of Chinese Scientists


Time to Read: 2 minutes Practices: Health Care

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Over the past few years, as the federal government has firmed its stance against intellectual property theft and foreign interference in scientific research, many in the U.S. research community have perceived a growing threat to scientific inquiry. Universities, academic medical centers, and other research institutions have warned that recent governmental efforts to combat Chinese espionage—a growing, persistent threat to American research—may fuel anti-Chinese bias and chill collaboration if pursued incautiously.

Though still secondary to foreign influence and theft concerns, the notion that government investigators have unfairly profiled Chinese scientists is receiving more attention in Congress.

On February 20, U.S. Representatives Jamie Raskin (D-MD) and Judy Chu (D-CA) expressed this concern in letters addressed to the directors of the Federal Bureau of Investigation and the National Institutes of Health. Raskin and Chu, both members of the House Committee on Oversight and Reform, noted that many innocent scientists have been “swept up in the FBI’s counterintelligence efforts,” and that related NIH efforts have been characterized as “racial profiling” indicative of “a new Red Scare.”

Their letter to FBI Director Christopher Wray highlighted several cases in which Chinese-American scientists were wrongfully accused of espionage. Noting that university officials are “reportedly unsure of what exactly the FBI is looking for,” Raskin and Chu requested “a description of investigations and prosecutions involving theft or attempted theft of intellectual property,” broken down by year, race, investigation type (e.g., economic espionage, counter-intelligence), and resolution. They further requested copies of all of the FBI’s communications with academic institutions regarding the monitoring of Chinese students and faculty, all of its communications with NIH regarding the investigation of ethnic Chinese individuals, pertinent documents from the College and University Security Effort, and China-related counterintelligence training materials.

Raskin and Chu’s letter to NIH Director Francis Collins makes a series of similarly broad requests. In addition to descriptions of cases currently being investigated by NIH, the letter asks for the details of the twenty-four cases that NIH is known to have referred to the Department of Health and Human Service’s Office of the Inspector General, NIH’s disclosure guidelines respecting foreign reporting requirements, and copies of any of NIH’s communications with the FBI pertaining to investigations of ethnic Chinese.

This changes little for recipients of federal research funds, as increased congressional oversight of enforcement activity isn’t expected to deter agencies like the FBI and NIH from pursuing foreign influence investigations. That said, closer scrutiny may end up clarifying, publicly, the policies and processes that govern their actions.

The letter to FBI Director Wray is available here, and the letter to NIH Director Collins, here.

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