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Health IT Now Says ONC Rule 'Gross Overstep,' Eyes Legislative, Legal Options

Health IT Now is weighing legislative and legal options to stop what its alleges is a “gross overstep” in authority by the Office of the National Coordinator for Health Information Technology to regulate health IT.

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CMS is temporarily suspending acceptance of new proposals that allow Medicare Advantage plans to automatically enroll new Medicare beneficiaries, a move praised by the Center for Medicare Advocacy, which is pushing for more consumer protections as CMS reviews its so-called seamless enrollment policies.

FDA and CMS will indefinitely extend their parallel review program for medical devices, the agencies announced Friday (Oct. 21).

FDA will release a series of documents on its proposed real-world evidence system over the next several months, and Rachel Sherman, deputy commissioner for medical products and tobacco, signaled the agency is bracing for potential pushback from some stakeholders.

Children's health care advocates are starting to put pressure on Congress to start the CHIP funding reauthorization debate and Ron Pollack, president of Families USA, said it will be a test to indicate the level of bipartisanship on health care issues for the next Congress.

The next round of the generic drug user fee program will tie industry fees to approved abbreviated new drug applications as opposed to requiring industry to pay fees when an application is submitted regardless of whether it is approved, FDA said Friday (Oct. 21).

The head of the generic drug industry lobby trumpeted new data showing generics comprise 89 percent of prescription drugs dispensed but only 27 percent of drug spending to drive home his message that generics are a drug-pricing solution, not the problem.

Key health insurance groups praise CMS for proposing a tweak to the medical loss ratio policy that the agency estimates could reduce the total amount of rebates insurers owe consumers by $11.6 million over four years.

CMS will consider input from stakeholders after the end of the formal comment period on Kentucky's Medicaid waiver proposal, and says that with the large number of comments received it will take time to weigh the feedback and discuss the comments with the state.