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Generics Win SCOTUS Suit: Secret Drug Sales Start Patent-Filing Clock

In a win for the generic drug industry, the Supreme Court unanimously ruled Tuesday (Jan. 22) that secret sales of inventions start the one-year clock to file patents.

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Accountable care organizations, hospitals, doctors and others are asking CMS to push back the Feb. 19 deadline for applications to participate in the revamped Medicare Shared Savings program, with 12 stakeholder groups asking CMS to move the deadline to March 29 and AMGA urging CMS to push it back further to April 19.

An analysis from the National Association of Accountable Care Organizations says CMS’ changes to the threshold for differentiating high-revenue and low-revenue ACOs is estimated to keep more physician-affiliated ACOs and those affiliated with Federally Qualified Health Centers from having to take on risk at a faster rate under the new Medicare Shared Savings program rules, but NAACOS says concerns remain that the system could keep ACOs from integrating specialty care.

The judge overseeing the federal lawsuit challenging Kentucky’s plan to implement Medicaid work requirements denied a request from the Department of Justice to put the case indefinitely on hold during the partial government shutdown.

FDA Commissioner Scott Gottlieb said the month-old partial government shutdown “represents one of the most significant operational challenges in FDA’s recent history,” and he warned that more staff will be furloughed as the agency’s drug center runs out of Prescription Drug User Fee Amendment (PDUFA) funding.

Multiple organizations applauded CMS’ regulatory proposal to provide additional telehealth benefits to Medicare Advantage enrollees in 2020, while some also called for CMS to take more aggressive steps and others urged caution.

Food safety advocates say that the month-long partial government shutdown could have long-term negative effects on the morale of FDA’s food inspection staff, as well as FDA’s ability to retain and hire personnel, who might be turned off by the prospect of being furloughed.

CMS proposed Friday (Jan. 18) to share with insurers savings from lower Part D catastrophic spending in return for plans agreeing to penalties when they exceed spending targets.

Arizona is the eighth state to receive permission from the Trump administration to add work requirements to its Medicaid program, and after months of behind-the-scenes negotiations between state officials and CMS lawyers, CMS allowed the state to exempt some Native Americans from the requirements.

CMS on Friday (Jan. 18) announced a nation-wide expansion and several new features of its Value-Based Insurance Design model, which provides flexibility to Medicare Advantage plans with the goal of encouraging beneficiaries to consume high-value clinical services.