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CMS Assures Issuers They May Terminate Plans If FFM Subsidies End

The agreements to participate in the federally-facilitated marketplace (FFM) that CMS sent to issuers last week include a new clause assuring issuers that they may pull out of the contracts, subject to state laws, should federal subsidies cease to flow.

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Congress could allow for binding arbitration to help plans negotiate lower prices for unique specialty drugs, Harvard professors wrote in a January 2008 Health Affairs article that is getting new attention in light of the $94,500 price of a 12-week course of the newly approved hepatitis C drug Harvoni.

Companies developing biologics want FDA to begin the process of determining biologic exclusivity earlier than it has planned in recent draft guidance and assert that the agency has gone beyond its statutory mandate in asking them to prove their product's exclusivity instead of automatically granting it.

The House Energy and Commerce Committee is looking at speeding medical product development process by streamlining FDA reviews, providing added exclusivity, centralizing Institutional Review Board reviews, targeting NIH grants and leveraging data, committee staff and a key lawmaker said this week as the panel moves toward a January issuance of a discussion draft bill for its 21st Century Cures initiative.

Stakeholders disagree on how much risk information should be required on informed consent sheets provided to patients enrolling in clinical trials on investigational products, with a public interest group urging FDA to require more information on risks related to animal models while some other stakeholders say the agency already wants too much information included.

UnitedHealth Group, which entered only a handful of health insurance exchanges in year one, is on track to participate in about about two dozen states in 2015, United executives said in an earnings call with investors.

FDA recently met with industry stakeholders to discuss technical assessments that should be considered for devices manufactured using 3-D printing, with an agency official saying that the materials used, the process involved and the type of device should all be taken into account.

FDA Friday (Oct. 17) approved labeling for a third abuse-deterrent, extended-release opioid consistent with guidance on abuse-deterrent opioids evaluation and labeling.

CMS is collecting feedback on a standardized prior authorization form for beneficiaries enrolled in hospice to help Part D (drug) plans and hospice providers communicate about beneficiaries' medications, hospice enrollment and discharge.