Supplemental briefs filed in AHA challenge of CMS rebilling policy   10/31/2013
The AHA and its five hospital system co-plaintiffs Monday filed a supplemental brief in their lawsuit challenging the Centers for Medicare & Medicaid Services’ continuing refusal to pay for certain claims denied by Recovery Audit Contractors, arguing that the government’s contention that the case is not “ripe” fails to survive the issuance of a final rebilling policy as part of the final inpatient prospective payment system rule for fiscal year 2014. "The argument's premise - that rulemaking is still pending - has evaporated [and t]he Secretary's speculation that rulemaking might result in a 'revision' of CMS' relevant positions also has turned out to be wrong [because] the Final Rule adopts the policies in the proposed rule," the AHA and hospitals said. They also argue that the Health and Human Services secretary may not "arbitrarily label" the lawsuit as seeking to reopen old claims just to make the claims unreviewable by the court. Filed in federal district court in Washington, D.C., the brief responds to the court's request for additional information regarding the effect of the final rule on the government's motion to dismiss the rebilling litigation. In a simultaneously filed brief, the government concedes the plaintiffs’ ripeness argument but attempts to advance a new argument, that the final rule makes the case moot because it supersedes the interim policy being litigated.
FDA issues proposed rule, plan for early notice of drug shortages   10/31/2013
The Food and Drug Administration today released a proposed rule requiring all makers of certain medically important prescription drugs to notify FDA of permanent discontinuances or temporary interruptions in manufacturing that are likely to disrupt their supply, as required by the Food and Drug Administration Safety and Innovation Act of 2012. The rule also would extend the early notification requirement to medically important biologic products. In addition, FDA today sent Congress a strategic plan for strengthening the agency’s ability to respond to imminent or existing drug shortages and for developing longer-term approaches to address the underlying causes of production disruption, also required by the FDASIA. “The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. The agency will accept comments on the provisions of the proposed rule for 60 days after publication in the Nov. 4 Federal Register, and comments on the information collection requirements for 30 days after publication.
Committees seek comment on physician payment proposal   10/31/2013
Leaders of the House Ways and Means and Senate Finance committees today released a discussion draft of a bipartisan proposal to replace the Medicare Sustainable Growth Rate formula for annual payment updates under the Physician Fee Schedule with a value-based payment program starting in 2017. The proposal, which does not specify a funding source, would freeze current payment levels under the PFS through 2023. After 2023, physicians and professionals who participate in an advanced Alternative Payment Model that involves two-sided financial risk and quality measurement would receive an annual update of 2%, while all other physicians and professionals would receive an annual update of 1%. Payment penalties under the Physician Quality Reporting System, Electronic Health Record Incentive Program and Value-Based Modifier would sunset in 2016. Instead, the penalties that would have been assessed under those programs would fund a Value Based Purchasing program under which physicians and other professionals would receive an incentive payment based on their performance on quality measures, resource use, clinical practice improvement activities and EHR meaningful use. Physicians and other professionals paid under the PFS who receive a significant portion of their revenue from an advanced APM would be exempt from the incentive program and instead receive a bonus payment starting in 2016. The proposal also would establish payment for complex chronic care management for physicians and other professionals practicing in a patient centered medical home or comparable specialty practice, among other provisions. The committees will accept comments on the proposal through Nov. 12 at sgrcomments@finance.senate.gov and sgrwhitepaper@mail.house.gov.
HHS guidance that 'QHPs' are not federal health care programs available online   10/31/2013
The Department of Health and Human Services yesterday issued guidance concluding that it does not consider qualified health plans and other programs related to federal health exchanges, state health exchanges and certain other programs to be federal health care programs. Because the federal anti-kickback statute only applies to federal health care programs, it will not apply to qualified health plans and, as a result, will not be a barrier for hospitals or health systems that wish to subsidize premiums for health plans purchased on the exchanges for individuals in need of assistance. AHA members should watch for a follow-up advisory next week and can view the recent AHA Legal Advisory for background on potential barriers.