Tuesday, June 18, 2013

Weekly State Round-Up: QHP Plans Brace For 'Deficiency Letters,' Connectivity Testing Kicks Off

Carriers seeking to participate as qualified health plans (QHPs) in federally-facilitated exchanges are awaiting word from CMS as to whether they will need to resubmit applications due to data deficiencies discovered by the agency.

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Health Reform

Safety, Generic Concerns Factors In Proposed AMA Biosimilar Resolution

A perceived lack of safety information about biosimilars and past problems with substitution of generic drugs led neurologists and rheumatologists to ask the American Medical Association to study the safety of the follow-on biologics, according to a physician who helped spearhead the proposal that will be taken up by the medical group at a meeting next week.

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Wyden Hopes To Attach Medicare Data Transparency Bill To SGR Fix

Sen. Ron Wyden (D-OR) hopes to attach a Medicare claims transparency bill he crafted with Sen. Chuck Grassley (R-IA) to legislation replacing the Sustainable Growth Rate physician payment formula.

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Budget Cuts Threaten To Halt NIH Drug Repurposing Program

Continued federal budget cuts could quash a program at the National Institutes of Health National Center for Advancing Translational Sciences (NCATS) to repurpose pharmaceutical compounds, the center's top official said.

Fourth Circuit Appeals Court Strikes Labor Board's Notice Posting Rule

A second federal appeals court has struck down the National Labor Relations Board's (NLRB) contentious rule to require employers, which broadly affects hospitals and other health care providers, to post an official board notice informing employees of their rights under the National Labor Relations Act -- a rule fiercely opposed by Republicans who depicted it as a power grab by the labor mediation body.

Internal FDA Memo: New Steering Committee To Guide Next Phase Of GDUFA

FDA is moving into the next phase of the generic user fee program after hiring new employees, collecting the bulk of user fees and working to reduce the backlog of generic drug applications during the first year of the new user fee program, according to an internal agency memo.

CA, AZ, MI, ME Take Up Medicaid Expansion As Arkansas Preps Draft 1115 Expansion Waiver

Arkansas plans to make a draft of the state's 1115 alternative Medicaid expansion premium assistance waiver available for comment at the end of June, an official from the Arkansas Department of Human Services told Inside Health Policy, as states that remain undecided on expansion potentially could view Arkansas' plan as a model.

Senate Appropriators Address FDA's Sequestered Fees Through Report Language

A key Senate appropriator is working to protect FDA user fees from sequestration and has included language in a report accompanying the agency funding bill that highlights the issue.

SCOTUS 'Pay-For-Delay' Ruling Continues Uncertainty Over Settlements

The Supreme Court's ruling that courts should examine the antitrust effects of reverse payment settlements on a case-by-case basis may not end long-standing disagreements over the legality of the deals, attorneys said.

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Focus On Duals

CBO Lists Duals Reform Options, Says Mandatory Managed Care Would Hike Savings

The Congressional Budget Office gave lawmakers a list of ways to change the health care programs for beneficiaries who are eligible for both Medicare and Medicaid, including letting either the states or federal government take over dual eligibles, and said requiring dual-eligible beneficiaries to participate in Medicare’s managed care program could improve the services provided while decreasing costs.